WO2023161746A1 - Continuous monitoring system of clinical conditions and intelligent self-regulation of continuous infusion of drugs - Google Patents

Continuous monitoring system of clinical conditions and intelligent self-regulation of continuous infusion of drugs Download PDF

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Publication number
WO2023161746A1
WO2023161746A1 PCT/IB2023/051077 IB2023051077W WO2023161746A1 WO 2023161746 A1 WO2023161746 A1 WO 2023161746A1 IB 2023051077 W IB2023051077 W IB 2023051077W WO 2023161746 A1 WO2023161746 A1 WO 2023161746A1
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WO
WIPO (PCT)
Prior art keywords
section
ultrasonic
patients
monitoring
injection
Prior art date
Application number
PCT/IB2023/051077
Other languages
French (fr)
Inventor
Mohammad Abdollahi
Shekoufeh NIKFAR
Masoud ARABAMERY
Mohammadhossein SHARIFNIA
Original Assignee
Mohammad Abdollahi
Nikfar Shekoufeh
Arabamery Masoud
Sharifnia Mohammadhossein
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Application filed by Mohammad Abdollahi, Nikfar Shekoufeh, Arabamery Masoud, Sharifnia Mohammadhossein filed Critical Mohammad Abdollahi
Priority to PCT/IB2023/051077 priority Critical patent/WO2023161746A1/en
Publication of WO2023161746A1 publication Critical patent/WO2023161746A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0883—Detecting organic movements or changes, e.g. tumours, cysts, swellings for diagnosis of the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/026—Measuring blood flow
    • A61B5/0261—Measuring blood flow using optical means, e.g. infrared light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/06—Measuring blood flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/06—Measuring blood flow
    • A61B8/065—Measuring blood flow to determine blood output from the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42—Details of probe positioning or probe attachment to the patient
    • A61B8/4209—Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames
    • A61B8/4236—Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames characterised by adhesive patches
    • 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
    • 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
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • 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
    • 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
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42—Details of probe positioning or probe attachment to the patient
    • 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
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records

Definitions

  • the connection between the central processor (CPU) and, indeed, the "software section designed for monitoring the clinical conditions of the patients" claimed with the electronic module of the “ultrasonic detector” section has caused the continuous sending of information to the profile relating to patients in the hospital information system (HIS). Furthermore, it allows the direct supervision of the treating team on the process of making decisions and interventions adopted by the "Intelligent infusion pump device with self-regulation capability in dosing and speed of drug injection”.
  • HIS hospital information system
  • a method of blood flow monitoring for a patient comprising the steps of: a) receiving a first signal indicative of the real time cardiac output for the patient; b) processing the continuous wave Doppler signal to provide an estimate of blood flow velocity as a function of time; c) receiving a pressure measurement indicative of the blood flow resistance through the patient; and d) calculating an Inotropy measure indicative of the potential and kinetic energy of the cardiac output of the patient.
  • Systems and methods for assessment of tissue properties, noninvasively, by acquiring data relating to at least one aspect of intrinsic and/or induced tissue displacement, or associated biological responses, are provided.
  • Data relating to tissue displacement and associated biological changes may be acquired by detecting acoustic properties of tissue using ultrasound interrogation pulses, preferably in a scatter or Doppler detection mode. Based on this data, tissue properties are assessed, characterized and monitored.
  • Specific applications for systems and methods of the present invention include non-invasive assessment and monitoring of intracranial pressure (ICP), arterial blood pressure (ABP), CNS autoregulation status, vasospasm, stroke, local edema, infection and vasculitus, as well as diagnosis and monitoring of diseases and conditions that are characterized by physical changes in tissue properties.
  • Methods and systems for localizing physiological condition(s) and/or biological response(s), such as pain, by targeting and selectively probing tissues using the application of focused ultrasound are also provided.
  • the present invention provides an apparatus and methods for continuous intravascular measurement of whole blood concentration, blood pressure, and pulse pressure.
  • the intravascular catheter incorporates a sensor to measure whole blood sound velocity, attenuation, backscatter amplitude, and blood flow velocity and also incorporates existing technologies for multiple physiologic measurements of whole blood. Pulse wave velocity and wave intensity are derived mathematically for purposes of estimating degree of local vascular tone.
  • a fluid management system including a pass-through fluid volume measurement system to provide continuous measurement of fluid returned from a surgical site during transit to a waste collection system.
  • the pass-through fluid volume measurement system eliminates the need to physically replace full fluid collection containers during the medical procedure with new, empty fluid collection containers.
  • a system and method for non-invasive and continuous measurement of cardiac chamber volume and derivative parameters including stroke volume, cardiac output and ejection fraction comprising an ultrawideband radar system having a transmitting and receiving antenna for applying ultrawideband radio signals to a target area of a subject's anatomy wherein the receiving antenna collects and transmits signal returns from the target area which are then delivered to a data processing unit, such as an integrated processor or PDA, having software and hardware used to process the signal returns to produce a value for cardiac stroke volume and changes in cardiac stroke volume supporting multiple diagnostic requirements for emergency response and medical personnel whether located in the battlefield, at a disaster site or at a hospital or other treatment facility.
  • a data processing unit such as an integrated processor or PDA
  • the claimed invention is in connection with designing a device based on infusion pumps of drugs.
  • the continuous infusion pumps are efficient equipment to inject and infuse drugs, especially drugs with a short half-life or vital for establishing proper hemodynamic conditions, including vasopressors, inotropes, protective agents for fatal cardiac dysrhythmias (arrhythmia drugs), and vascular protective agents such as anticoagulant drugs (anticoagulants, antiplatelets or antithrombotics, and thrombolytics).
  • anticoagulant drugs anticoagulants, antiplatelets or antithrombotics, and thrombolytics
  • Modern equipment and existing infusion pumps enjoy the capability of injecting a uniform dose in a specific time period; moreover, the possibility of changing the speed of the infused dose in the same pumps.
  • unstable hemodynamic conditions and micro-circulation and macro-circulation disorders are accompanied by many difficulties in predicting the patients' conditions followed by the medical diagnosis and performing the therapeutic interventions of the patients.
  • the claimed cardiac function monitoring system which is referred to as an ultrasonic detector in the following, is a system based on the Doppler method using ultrasonic beams, which have the possibility of continuous monitoring of cardiac function and cardiac hemodynamic factors.
  • the measurable cardiac hemodynamic factors in this claimed system will continuously measure and monitor cardiac output (CO), cardiac index (CI), and systemic vascular resistance (SVR) using the claimed mechanism.
  • the claimed performance monitoring system will be operated without using hands and wires based on continuous ultrasonic beam radiation through transmit element and the continuous reception of the reflected beam through receive element, followed by analyzing the variations in wavelength and frequency between the emitted and reflected ultrasonic beam on the basis of the Doppler method for measuring and monitoring the claimed hemodynamic factors. How to communicate and transmit the analyzed data from the cardiac function monitoring system to the infusion pump is made possible via Bluetooth, and transferring information to the Bluetooth Circuit Board embedded in the infusion pump is carried out from the claimed cardiac function monitoring system.
  • an electronic board is composed of three sections: 1- Bluetooth Circuit Board, 2- analysis circuit, and 3- command circuit.
  • 1- Bluetooth Circuit Board a communication system between the designed and installed computer or mobile software associated with the heart function monitoring system and subsequently, a north-circuit command system on the same software to enable monitoring and, if necessary, apply the required changes by the medical staff, the medical team, or the attending physicians.
  • wireless and Bluetooth-based information transfer is performed both to the receiving circuit deployed in the infusion pump and to the information receiving system in the mobile phone or computer by the continuous monitoring of the claimed hemodynamic factors using the hands-free cardiac monitoring system.
  • the infusion pump conducts an intelligent self-regulation process to adjust or increase the prescribed dose of medications.
  • the physician's logic is investigated by the analysis board deployed on the infusion pump and optimized its basic analytical algorithms until making changes in the process of therapeutic interventions in subsequent patients, optimization, and effectiveness and cost-effectiveness of therapeutic interventions for patients be optimized.
  • the ultrasonic detector (1) through two elements of transmitter and receiver by irradiating high-frequency ultrasonic rays into the body and analyzing the return waves sends the results from the waves via Bluetooth (or Wi-Fi) (2) to the central processing unit (CPU) (3) and the profile designed for the patient in the Hospital Information System (HIS) software and then to the embedded analysis circuit and after that to the processor deployed on the infusion pump device (5).
  • the central processor also sends the analyzed waves to the processor installed on the infusion pump via Bluetooth (or Wi-Fi) (4) in the same manner by analyzing the data received from the ultrasonic detector.
  • the infusion pumps find the possibility of changing the dose and speed of drug injection.
  • the claimed ultrasonic detector device is composed of two parts, including the body (6) and the positioning of ultrasonic and infrared sensors (7).
  • the body part allows fixing on the neck of the patients and placing the claimed sensors on the jugular artery with a proper angle (45 to 55 degrees to the sagittal axis).
  • the claimed infrared sensors (8 and 10) provide the likelihood of detecting the exact location of the jugular artery for nurses and treatment staff of the patients and specify the right angle and placement of the ultrasonic elements of the claimed transmitter (9) and receiver (11) for medical personnel so that the monitoring process of the target hemodynamic parameters in patients be optimized.
  • a protruding part (13) is embedded in the sensor module body (12), which makes the possibility of fixing the device both using adhesive and stitching to the areas adjacent to the skin.
  • cables (14) and connectors (15) are deployed on the claimed device as a supplement, allowing transmitting information to the CPU or the analysis circuit of the infusion pump in addition to the Bluetooth (or Wi-Fi) wireless mode.
  • the claimed ultrasonic detector contains an electronic module (21) in the side part of the body, which is connected by bases (24) to the body (30) of the ultrasonic detector, and cables (18) and connectors (19) are attached to the set of infrared and ultrasonic sensors corresponding to the cables (19) and connectors for fault detection (20).
  • the battery location, the positive pole metal base (25), the negative pole metal base (27), and the charger holding magnet (26) are placed in the side part near the electronic module.
  • the capacitive effect touch sensor section (22) is mounted next to the connection flat of the capacitive sensor to the module (23) for the possibility of turning on or off the device, allowing the medical staff to hibernate the device, if necessary.
  • the information gained from the set of claimed sensors is transferred through the connection flat of the display board (28) to the display circuit (29), which is held by the bases (31) embedded in the body.
  • the rechargeable backup battery (34) of the device is positioned in the vicinity and in the lower part of the electronic module and on a flexible transition area (32) and is connected to the electronic module via the connection cable (33) and supplies the energy needed by the module as its power source.
  • the body of the claimed ultrasonic detector device also makes up of a protective glass part (38) for the LCD display screen (39), a sealing resin for the glass screen on the display (37), and a sealing resin of the surface section of the device body to provide the possibility of protecting the boards, modules, and other electronic components embedded inside the body against possible destructive environmental, moisture, or thermal changes.
  • the built-in electronic module (21) contains numerous electronic elements.
  • the central section of the module comprises a processor (microcontroller) responsible for the analysis of the data gained from the ultrasonic transmitter and receiver based on the Doppler Effect (or Doppler shift), which is linked and connected to several electronic elements.
  • this processor is connected to the set of infrared sensors (8 and 10), the module of ultrasonic transmitter-receiver sensors (44), and the Bluetooth (or Wi-Fi) module (43).
  • the claimed processor is connected to the amplifier transistor for fault detection of the ultrasonic sensor module (45), the voltage stabilization demodulator of the claimed module (46), the output voltage regulation capacitor (47), the input voltage stabilization capacitor (48), the variable resistance of the transistor excitation regulation (49), the transistor of the output signals of the infrared sensors (50), and the fault detection connector of the detector device (20) for optimizing the data received from the module of ultrasonic transmitter-receiver sensors.
  • the processor deals with the interpretation and analysis of the data achieved from the ultrasonic module and converts it into equivalent, corresponding, and numerical values of the target hemodynamic parameters (the most critical of these parameters are cardiac output (CO), cardiac index (CI), and systemic vascular resistance (SVR)), which have the capability of processing by the available processors in the later devices.
  • CO cardiac output
  • CI cardiac index
  • SVR systemic vascular resistance
  • the data gained from the ultrasonic detector processor is transferred to the CPU and processor and analysis circuit deployed on the injection device containing a set of infusion pumps via the Bluetooth (or Wi-Fi) module.
  • Infusion pumps encompass a mechanism set of injection pump tanks (53), electronic modules of injection pumps (52), a chamber for placing the mechanism set of injection pump tanks (54), and the surface lid of the chamber (51).
  • the claimed injection device comprises a magnetic section (55) and a module holding section (57) on the surface of the chamber beside the non-magnetic body (56), which makes easy the installation of the device in different circumstances.
  • a slot corresponding to the connector (58) of the claimed detector device is installed near the module holder so that the possibility of wired transmission of information from the detector or the central processor to the electronic module of the injection pumps, besides the claimed wireless mode, be provided.
  • the lower part of the chamber embraces the flexible legs (60), the rubber part of the leg (61), and the tank containing the air enclosed around the leg (62), which is attached to the body of the chamber by connecting pins (63).
  • the electronic module of the injection pumps (52) is composed of a set of connector ports (64). These claimed connector ports are attached to the motor system and sensors (65) associated with the mechanism of the injection pumps tanks via cables. It should be noted that the ports related to the power connector and fault detection of injection pumps are embedded in the lower part of the claimed electronic module for monitoring the performance and secondary applied changes by the pumps.
  • the electronic module of injection pumps is also constituted of numerous electronic elements.
  • the central part includes the processor (microcontroller) (75) of injection pumps; on the one hand, it is connected to the stepper motor driver module (78), Bluetooth (or Wi-Fi) module (77), display (68), internal settings of injection pumps and keyboard (79) for manual data entry.
  • the claimed processor is connected to a set of linear variable resistors (76), injection pump feeding and fault detection connectors, voltage regulation resistor (73), input voltage stabilization capacitor of regulator or demodulator (70), and output voltage stabilization capacitor of the regulator (71), besides the LED (72) displaying the operation of the injection pumps corresponding to the increase in the sensitivity of the stepper motor driver module to changes in the circuit current for enhancing the precision of the injection pumps under the circuit designed on the basis of the figure.
  • the handle of the chamber lid (80) On the chamber lid of the infusion pump, there are sections and parts including the handle of the chamber lid (80), the metal bases holding injection pumps (81), and the flexible layers (83), which are embedded in the form of components and protrusions from the metal body (82) of the chamber lid that the drug storage tanks (84) are located and embedded among the claimed parts.
  • Drug storage tanks (84) are deployed in an electromechanical system made up of the injection chassis (85), driving electric motor (86), piston assembly (89), piston functional position sensor section (87), drug tank cylinder section (88), and gearbox gears, which allows injecting microliter doses and speeds of the medicine dissolved in water for the medical staff by employing these infusion pumps.
  • the claimed electromechanical system is constituted of a holding surface (91) for the chassis of tanks with a metal body (92), the built-in conductor holes in the front section of the motor (93), the passage and entrance of the motor shaft (94), and correspondingly, the passage of the spiral shaft of the piston (95), which is positioned near the motor shaft.
  • the cylinder section that is a place for drug transfer from the drug storage tank to the peripheral or central injection line (CV line) consists of the inlet opening (99), the outlet section of the drug storage tank, the valve return spring (100), the fixed section (102) and the actuator (101) of the cylinder inlet valve in the inlet section.
  • the output section of the claimed cylinders is composed of the outlet valve return spring (103), the outlet valve actuator (104), the fixed port of the output valve (105), and a place to connect the tube embedded for the drug release (106).
  • drug storage tanks (84) consist of convex surfaces in the upper part (108), the place of loading and filling of the tank from the injection form of the prepared drug (109), the tank blocking valve (110) after loading the prepared injection form of the medicine in the upper part.
  • the tank outlet (111) and the flexible medium of the tank and cylinder (112) are embedded in the lower part of the claimed tanks such that the process of drug transfer could be conducted based on the decisions and adjustment of dosing and the rate of injections made by the central processor (CPU) and the electronic module of the injection pumps.
  • the claimed stepper motor also known as a step motor or stepping motor, is composed of a motor length spacer (113), a shaft retaining bushing (114), a magnet (115) on the upper part, protrusions on the upper and front part of the stepper motor (116), and the output shaft of the driving force (117), electric coils (118), the lower protrusion (119), and the connector related to the electrical connection (120).
  • the output shaft position sensors (121) and the mediator of the connection between the spacer and the body (122) of the claimed step motors are also deployed in the vicinity of the connectors associated with the electrical connection, where the claimed parts are covered and protected by the end cap (125) of the step motor.
  • the driving force gained from the output shaft of the stepper motor is enabled by the operation of a set of gears including the headgear (126) and the output gear (128), and the operation of the said gears is made possible by the intermediate gears (127), and the driving force output is received through the central spiral hole (129) embedded on the output gear which is the place of entry and passage of the piston assembly (89).
  • the claimed piston assembly is made up of a flexible piston (134), a retaining washer (133), a spiral axis (131) corresponding to the spiral shape of the hole embedded in the central hole of the claimed output gear, and a rotational limiting metal blade (130).
  • the piston assembly position sensor (87) which has been designed and incorporated with the goal of examining the operational condition of the piston, consists of the piston spiral passage (141), gearbox passing holes (140), maximum reporting micro-switch (139), carbon blade section (138), electrical connection connector (137), and minimum reporting micro-switch (136), which is positioned inside the metal body (134) and is covered and protected by the metal cap of the gearbox (135).
  • ICUs intensive care units
  • the optimized management of patients' hemodynamic disorders and the occurrence of organ-organ interaction failure conditions after receiving a specific therapeutic intervention (which in most cases will be a heavy regimen from the viewpoint of drugs and with the extensiveness of diversity in the used items).
  • patients admitted to different departments of the hospital, especially patients hospitalized in ICUs do not have stable hemodynamic conditions.
  • the typical monitoring systems and parameters such as blood pressure, respiratory rate, heart rate, and saturated blood oxygen of patients (SpO2), cannot be regarded as suitable efficiency for continuous monitoring of patients.
  • the continuous monitoring system of clinical conditions and intelligent self-regulation of continuous infusion of drugs based on the hemodynamic conditions of patients is a smart initiative.
  • This system provides the possibility of self-regulation and optimization of the dose and speed of administration of sensitive injectable drugs, including inotropes, anticoagulants, antiarrhythmics, anti-seizures, and antibiotics, which are employed to control pathophysiological conditions such as cardiac, cerebral, infectious, and shock events in hospitalized patients, on the basis of sensitive hemodynamic parameters such as cardiac output (CO), cardiac index (CI), and systemic vascular resistance (SVR), which will lead to an improvement in therapeutic interventions, an enhancement in the cost-effectiveness of interventions, and an increase in the more assurance of the medical team to more systematic and optimal monitoring of patients' hemodynamic conditions, and correspondingly, a promotion in the favorable outcomes of the interventions done on the patients.
  • sensitive injectable drugs including inotropes, anticoagulants, antiarrhythmics, anti-seizures, and antibiotics, which are employed to control pathophysiological conditions such as
  • the upper picture shows the internal section and the exit location of the elements of the claimed sensor set; Also, the lower image shows the external raised cross-section of the alleged sensor set.
  • the display shows how to place and install the drug storage tanks and the electronic module of the infusion pump, in the compartment of the infusion pumps and next to the upper cover of the claimed compartment.
  • FIG. 1 shows two upper side directions and a table of the installation of the complex consisting of drug storage tanks and the mechanism part of the injection pump tanks in the infusion pump chamber.
  • stepper motor shows the components of the upper and lower surface sections of the stepper motors, the upper part showing the parts of the electrical connection connector of the stepper motor, the state sensors of the stepper motor shaft, and the intermediary connecting the spacer and the stepper motor body, as well as the lower part, indicating the location The passage and input of the output shaft of the stepper motor.
  • step motor shows several images of a part of the side section of the step motor, which includes the part of the electric coil (bobbins) and the bush holding the step motor shaft.
  • FIG. 1 shows a cross-section of the "piston assembly position sensor", laterally, in order to determine the position of the various embedded parts.
  • Connector to connect detector to sensors 18. Cable connecting the detector to the sensors 19. Diagnostic cable of detector 20. Diagnostic connector of the detector 21. Electronic module of the detector 22. Capacitive touch sensor on and off the device 23. Flat to connect the capacitive sensor to the module 24. The bases for connecting the module to the body of the detector 25. Positive metal base for battery charging 26. Charger holder magnet 27. The base of the negative connection of the battery charge 28. Display board connection panel 29. Display circuit 30. The detector body 31. Display holder base 32. Flexible battery spacer 33. Module power connection cable 34. Backup rechargeable battery
  • the detector body 31.
  • Display holder base 32.
  • Flexible battery spacer 33.
  • Module power connection cable 34.
  • Backup rechargeable battery 35.
  • Sealing resin for the detector door 37.
  • Display glass sealing resin 38.
  • Screen protector glass 39.
  • FIG. 1 shows two upper side directions and a table of the installation of the complex consisting of drug storage tanks and the mechanism part of the injection pump tanks in the infusion pump chamber.
  • Injection machine door handle 81 Metal bases holding injection tanks 82. Metal body of the door 83. Flexible layer
  • Drug storage tank 85 Chassis of injection tanks 86. Electric drive motor 87. Cover and sensor of the position of the piston assembly 88. Medicine tank cylinder set 89. Piston set
  • Drug storage tank 85 Chassis of injection tanks 86. Electric drive motor 87. Cover and sensor of the position of the piston assembly 88. Medicine tank cylinder set 89. Piston set 90. Gears of the gearbox
  • Chassis tank holding surface 92. Chassis metal body 93. Conductor holes in front of the engine 94. Engine shaft entry point 95. The passage of the piston spiral shaft 96. Conductor holes placed on the protrusion of the body 97. Cylinder inlet to chassis
  • Step motor electrical connection connector 120.
  • Stepper motor shaft status sensors 122.
  • Intermediary connecting the spacer and the body of the stepper motor 123.
  • Shaft cut 124.
  • Step motor metal body 125. End cover of step motor
  • Stepper motor 116. Conductor protrusions in front of the stepper motor 117. Step motor power output shaft 118. Step motor electric coils 119. Stepper motor rear conductor emergence 120. Step motor electrical connection connector 121. Stepper motor shaft status sensors 122. Intermediary connecting the spacer and the body of the stepper motor 123. Shaft cut 124. Step motor metal body
  • step motor shows several images of a part of the side section of the step motor, which includes the part of the electric coil (bobbins) and the bush holding the step motor shaft.
  • Step motor end cover 126 Motor head gear 127. Intermediary gears 128. Output gear 129. Spiral hole
  • the claimed invention is a system composed of three different devices.
  • the first one is a “continuous monitoring device for hemodynamic conditions of patients based on high-frequency ultrasonic waves and infrared waves”
  • the second one is “an intelligent infusion pump with the capability of self-regulation in the dose and speed of drug injection”
  • the third one is a “software section designed for monitoring the clinical conditions of patients in the hospital”.
  • the continuous monitoring device of hemodynamic conditions of patients based on ultrasonic and infrared waves is placed on the jugular artery.
  • the recent device which has the capability of continuous measurement and monitoring of patients' hemodynamic conditions based on high-frequency ultrasonic wave transmitter-receiver elements (higher than 2 MHz that the optimum efficiency is observed in the range of 4 to 7 MHz) as the primary factor and the infrared sensor as an auxiliary sensor for the right location and positioning of the device on the jugular artery will cause the continuous measurement and sending of the information gained from the claimed hemodynamic parameters via Wi-Fi or Bluetooth to the analysis circuit board embedded on the claimed intelligent infusion pump.
  • Wi-Fi or Bluetooth Wireless Fidelity
  • the claimed analysis board changes the speed of injection and administration of medicine in the vessel tailored to the claimed and specified algorithms. The changes made are evaluated and re-verified proportional to the data received from the first device after performing variations in the conditions of the intervention.
  • the data sent from the first device is simultaneously sent to the monitoring software available in the HIS (Hospital Information System) in the patient profile section via Wi-Fi or Bluetooth, which checks the feasibility of observing the data and subsequently, the process of changes applied by the second device, and will provide the possibility of monitoring and, if necessary, intervention in the decision-making process of the second device to the attending physicians, medical team, and medical staff.
  • HIS Hespital Information System
  • the claimed invention is applicable in the area of various departments of hospitalization of patients in hospitals, clinics, medical clinics, and especially in ICU, CCU, and surgery departments.

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  • Bioinformatics & Cheminformatics (AREA)
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Abstract

This is an invention composed of a coordinated monitoring system, predicting clinical conditions, and making decisions for changing the conditions of drug therapy interventions to improve the clinical conditions and the prognosis of patients' recovery, changes in the systemic resistance of the blood vessels. A collection of communication and operation of three different general systems, which are described as follows: - "Continuous monitoring of patients' hemodynamic conditions based on high-frequency ultrasonic waves and infrared waves" - "Intelligent infusion pump device with self-regulation capability in dosing and speed of drug injection" - "Software section designed for monitoring clinical conditions". The connection between the central processor (CPU) and, indeed, the "software section designed for monitoring the clinical conditions of the patients" claimed with the electronic module of the "ultrasonic detector" section has caused the continuous sending of information to the profile relating to patients in the hospital information system (HIS). Furthermore,

Description

Continuous Monitoring System of Clinical Conditions and Intelligent Self-Regulation of Continuous Infusion of Drugs
This is an invention composed of a coordinated monitoring system, predicting clinical conditions, and making decisions for changing the conditions of drug therapy interventions to improve the clinical conditions and the prognosis of patients' recovery. changes in the systemic resistance of the blood vessels. A collection of communication and operation of three different general systems, which are described as follows: - "Continuous monitoring of patients' hemodynamic conditions based on high-frequency ultrasonic waves and infrared waves" - "Intelligent infusion pump device with self-regulation capability in dosing and speed of drug injection" - "Software section designed for monitoring clinical conditions".
the connection between the central processor (CPU) and, indeed, the "software section designed for monitoring the clinical conditions of the patients" claimed with the electronic module of the "ultrasonic detector" section has caused the continuous sending of information to the profile relating to patients in the hospital information system (HIS). Furthermore, it allows the direct supervision of the treating team on the process of making decisions and interventions adopted by the "Intelligent infusion pump device with self-regulation capability in dosing and speed of drug injection".
A61B5/05, A61B5/02, A61B5/412, A61M5/31533, G16H20/17, A61M2005/14208, A61M2005/1726, A61B5/14532, A61B5/72
COMBINED BLOOD FLOW AND PRESSURE MONITORING SYSTEM AND METHOD
United States Patent Application 20150351703
A method of blood flow monitoring for a patient, the method comprising the steps of: a) receiving a first signal indicative of the real time cardiac output for the patient; b) processing the continuous wave Doppler signal to provide an estimate of blood flow velocity as a function of time; c) receiving a pressure measurement indicative of the blood flow resistance through the patient; and d) calculating an Inotropy measure indicative of the potential and kinetic energy of the cardiac output of the patient.
Systems and methods for making noninvasive physiological assessments
United States Patent 6875176
Systems and methods for assessment of tissue properties, noninvasively, by acquiring data relating to at least one aspect of intrinsic and/or induced tissue displacement, or associated biological responses, are provided. Data relating to tissue displacement and associated biological changes may be acquired by detecting acoustic properties of tissue using ultrasound interrogation pulses, preferably in a scatter or Doppler detection mode. Based on this data, tissue properties are assessed, characterized and monitored. Specific applications for systems and methods of the present invention include non-invasive assessment and monitoring of intracranial pressure (ICP), arterial blood pressure (ABP), CNS autoregulation status, vasospasm, stroke, local edema, infection and vasculitus, as well as diagnosis and monitoring of diseases and conditions that are characterized by physical changes in tissue properties. Methods and systems for localizing physiological condition(s) and/or biological response(s), such as pain, by targeting and selectively probing tissues using the application of focused ultrasound are also provided.
Multipara meter whole blood monitor and method
United States Patent 7559894
The present invention provides an apparatus and methods for continuous intravascular measurement of whole blood concentration, blood pressure, and pulse pressure. The intravascular catheter incorporates a sensor to measure whole blood sound velocity, attenuation, backscatter amplitude, and blood flow velocity and also incorporates existing technologies for multiple physiologic measurements of whole blood. Pulse wave velocity and wave intensity are derived mathematically for purposes of estimating degree of local vascular tone.
FLUID MANAGEMENT SYSTEM WITH PASS-THROUGH FLUID VOLUME MEASUREMENT
United States Patent Application 20180000998
A fluid management system including a pass-through fluid volume measurement system to provide continuous measurement of fluid returned from a surgical site during transit to a waste collection system. The pass-through fluid volume measurement system eliminates the need to physically replace full fluid collection containers during the medical procedure with new, empty fluid collection containers.
SYSTEM AND METHOD FOR NON-INVASIVE INSTANTANEOUS AND CONTINUOUS MEASUREMENT OF CARDIAC CHAMBER VOLUME
United States Patent Application 20170055872
A system and method for non-invasive and continuous measurement of cardiac chamber volume and derivative parameters including stroke volume, cardiac output and ejection fraction comprising an ultrawideband radar system having a transmitting and receiving antenna for applying ultrawideband radio signals to a target area of a subject's anatomy wherein the receiving antenna collects and transmits signal returns from the target area which are then delivered to a data processing unit, such as an integrated processor or PDA, having software and hardware used to process the signal returns to produce a value for cardiac stroke volume and changes in cardiac stroke volume supporting multiple diagnostic requirements for emergency response and medical personnel whether located in the battlefield, at a disaster site or at a hospital or other treatment facility.
Proper management of the hemodynamic conditions of hospitalized patients is one of the existing difficulties facing the hospital's medical staff. The conditions of hospitalized patients, particularly those with substantial loss of consciousness, because of hemodynamic instabilities caused by this loss of consciousness and subsequently, the resulting micro-circulation and macro-circulation disorders in patients encounter a lot of difficulties in monitoring therapeutic interventions and drug therapy conducted on the patients. Moreover, conditions such as cerebrovascular accident (CVA), types of myocardial infarction (MI), arteriosclerosis, and thrombosis in conjunction with comorbidities such as a history of hypertension, diabetes, renal and liver failure can exacerbate these difficulties, irregularities, and uncertainty in prognosis in the process of management and drug treatment interventions of patients. Thus, the claimed device monitors the process of therapeutic interventions and drug therapy of patients by employing reliable non-invasive diagnosis factors and consequently, analysis and conclusions on the basis of the explained algorithms. Furthermore, it will effectively optimize the appropriate dosage regulation of the drug regimen applied for patients.
Proper management of the hemodynamic conditions of hospitalized patients is one of the existing difficulties facing the hospital's medical staff. The conditions of hospitalized patients, particularly those with substantial loss of consciousness, because of hemodynamic instabilities caused by this loss of consciousness and subsequently, the resulting micro-circulation and macro-circulation disorders in patients encounter a lot of difficulties in monitoring therapeutic interventions and drug therapy conducted on the patients. Moreover, conditions such as cerebrovascular accident (CVA), types of myocardial infarction (MI), arteriosclerosis, and thrombosis in conjunction with comorbidities such as a history of hypertension, diabetes, renal and liver failure can aggravate these difficulties, irregularities, and uncertainty in prognosis in the process of management and drug treatment interventions of patients. Thus, the claimed device monitors the process of therapeutic interventions and drug therapy of patients by employing reliable non-invasive diagnosis factors and consequently, analysis and conclusions on the basis of the explained algorithms. Furthermore, it will effectively optimize the appropriate dosage regulation of the drug regimen applied for patients.
Solution of problem
The claimed invention is in connection with designing a device based on infusion pumps of drugs. Actually, the continuous infusion pumps are efficient equipment to inject and infuse drugs, especially drugs with a short half-life or vital for establishing proper hemodynamic conditions, including vasopressors, inotropes, protective agents for fatal cardiac dysrhythmias (arrhythmia drugs), and vascular protective agents such as anticoagulant drugs (anticoagulants, antiplatelets or antithrombotics, and thrombolytics). Modern equipment and existing infusion pumps enjoy the capability of injecting a uniform dose in a specific time period; moreover, the possibility of changing the speed of the infused dose in the same pumps. As noted, unstable hemodynamic conditions and micro-circulation and macro-circulation disorders are accompanied by many difficulties in predicting the patients' conditions followed by the medical diagnosis and performing the therapeutic interventions of the patients.
Among the conditions in which the claimed items are of substantial importance is the intubation weaning of patients hospitalized in different departments of the hospital, in particular ICU and CCU. In this respect, numerous examples can be mentioned, in which there have been remarkable resistances to the interventions made in relation to the claimed debate even though having seemingly stable clinical conditions and the relative desirability of the patient's heart rate, blood pressure, and breathing rate. This represents the inauthenticity of the listed parameters and consequently, the presence of double dependent parameters implying organ-organ interaction and claimed micro-circulation and macro-circulation disorders to predict the patient's clinical response to variations of the therapeutic approaches and interventions.
The claimed cardiac function monitoring system, which is referred to as an ultrasonic detector in the following, is a system based on the Doppler method using ultrasonic beams, which have the possibility of continuous monitoring of cardiac function and cardiac hemodynamic factors. The measurable cardiac hemodynamic factors in this claimed system will continuously measure and monitor cardiac output (CO), cardiac index (CI), and systemic vascular resistance (SVR) using the claimed mechanism. The claimed performance monitoring system will be operated without using hands and wires based on continuous ultrasonic beam radiation through transmit element and the continuous reception of the reflected beam through receive element, followed by analyzing the variations in wavelength and frequency between the emitted and reflected ultrasonic beam on the basis of the Doppler method for measuring and monitoring the claimed hemodynamic factors. How to communicate and transmit the analyzed data from the cardiac function monitoring system to the infusion pump is made possible via Bluetooth, and transferring information to the Bluetooth Circuit Board embedded in the infusion pump is carried out from the claimed cardiac function monitoring system.
In the infusion pump mentioned, an electronic board is composed of three sections: 1- Bluetooth Circuit Board, 2- analysis circuit, and 3- command circuit. Notably, while allowing connection between the infusion pump and the claimed cardiac function monitoring system via Bluetooth, there should be a similar communication system between the designed and installed computer or mobile software associated with the heart function monitoring system and subsequently, a north-circuit command system on the same software to enable monitoring and, if necessary, apply the required changes by the medical staff, the medical team, or the attending physicians.
Therefore, wireless and Bluetooth-based information transfer is performed both to the receiving circuit deployed in the infusion pump and to the information receiving system in the mobile phone or computer by the continuous monitoring of the claimed hemodynamic factors using the hands-free cardiac monitoring system. Employing the analysis algorithms tested by the medical staff, the infusion pump conducts an intelligent self-regulation process to adjust or increase the prescribed dose of medications. Moreover, in the event of lacking sufficient desirability of changes and automatic and intelligent self-regulations made by the infusion pump analysis system or if necessary, the intervention of the medical staff in the changes performed, the possibility of applying secondary changes by the attending physician and other treatment teams who are allowed to intervene in the treatment will be provided. It is worth noting that the physician's logic is investigated by the analysis board deployed on the infusion pump and optimized its basic analytical algorithms until making changes in the process of therapeutic interventions in subsequent patients, optimization, and effectiveness and cost-effectiveness of therapeutic interventions for patients be optimized.
Subsequently, the functional details of the various components and devices constituting the claimed invention are addressed.
As noted, the ultrasonic detector (1) through two elements of transmitter and receiver by irradiating high-frequency ultrasonic rays into the body and analyzing the return waves sends the results from the waves via Bluetooth (or Wi-Fi) (2) to the central processing unit (CPU) (3) and the profile designed for the patient in the Hospital Information System (HIS) software and then to the embedded analysis circuit and after that to the processor deployed on the infusion pump device (5). It is worth mentioning that the central processor also sends the analyzed waves to the processor installed on the infusion pump via Bluetooth (or Wi-Fi) (4) in the same manner by analyzing the data received from the ultrasonic detector. Followed by the received analytical data, the infusion pumps find the possibility of changing the dose and speed of drug injection. The claimed ultrasonic detector device is composed of two parts, including the body (6) and the positioning of ultrasonic and infrared sensors (7). With its unique design, the body part allows fixing on the neck of the patients and placing the claimed sensors on the jugular artery with a proper angle (45 to 55 degrees to the sagittal axis).
It is worth noting that the claimed infrared sensors (8 and 10) provide the likelihood of detecting the exact location of the jugular artery for nurses and treatment staff of the patients and specify the right angle and placement of the ultrasonic elements of the claimed transmitter (9) and receiver (11) for medical personnel so that the monitoring process of the target hemodynamic parameters in patients be optimized. To properly fix the ultrasonic detector device on the neck area, a protruding part (13) is embedded in the sensor module body (12), which makes the possibility of fixing the device both using adhesive and stitching to the areas adjacent to the skin. Besides, cables (14) and connectors (15) are deployed on the claimed device as a supplement, allowing transmitting information to the CPU or the analysis circuit of the infusion pump in addition to the Bluetooth (or Wi-Fi) wireless mode. In the case that the components and circuit of the claimed ultrasonic detector are elaborately explored, it contains an electronic module (21) in the side part of the body, which is connected by bases (24) to the body (30) of the ultrasonic detector, and cables (18) and connectors (19) are attached to the set of infrared and ultrasonic sensors corresponding to the cables (19) and connectors for fault detection (20).
The battery location, the positive pole metal base (25), the negative pole metal base (27), and the charger holding magnet (26) are placed in the side part near the electronic module. In the upper part near the device's battery, the capacitive effect touch sensor section (22) is mounted next to the connection flat of the capacitive sensor to the module (23) for the possibility of turning on or off the device, allowing the medical staff to hibernate the device, if necessary. After analysis in the electronic module, the information gained from the set of claimed sensors is transferred through the connection flat of the display board (28) to the display circuit (29), which is held by the bases (31) embedded in the body. The rechargeable backup battery (34) of the device is positioned in the vicinity and in the lower part of the electronic module and on a flexible transition area (32) and is connected to the electronic module via the connection cable (33) and supplies the energy needed by the module as its power source. The body of the claimed ultrasonic detector device also makes up of a protective glass part (38) for the LCD display screen (39), a sealing resin for the glass screen on the display (37), and a sealing resin of the surface section of the device body to provide the possibility of protecting the boards, modules, and other electronic components embedded inside the body against possible destructive environmental, moisture, or thermal changes.
The built-in electronic module (21) contains numerous electronic elements. The central section of the module comprises a processor (microcontroller) responsible for the analysis of the data gained from the ultrasonic transmitter and receiver based on the Doppler Effect (or Doppler shift), which is linked and connected to several electronic elements. On the one hand, this processor is connected to the set of infrared sensors (8 and 10), the module of ultrasonic transmitter-receiver sensors (44), and the Bluetooth (or Wi-Fi) module (43). On the other hand, the claimed processor is connected to the amplifier transistor for fault detection of the ultrasonic sensor module (45), the voltage stabilization demodulator of the claimed module (46), the output voltage regulation capacitor (47), the input voltage stabilization capacitor (48), the variable resistance of the transistor excitation regulation (49), the transistor of the output signals of the infrared sensors (50), and the fault detection connector of the detector device (20) for optimizing the data received from the module of ultrasonic transmitter-receiver sensors. Ultimately, the processor deals with the interpretation and analysis of the data achieved from the ultrasonic module and converts it into equivalent, corresponding, and numerical values of the target hemodynamic parameters (the most critical of these parameters are cardiac output (CO), cardiac index (CI), and systemic vascular resistance (SVR)), which have the capability of processing by the available processors in the later devices.
As pointed out, the data gained from the ultrasonic detector processor is transferred to the CPU and processor and analysis circuit deployed on the injection device containing a set of infusion pumps via the Bluetooth (or Wi-Fi) module. Infusion pumps encompass a mechanism set of injection pump tanks (53), electronic modules of injection pumps (52), a chamber for placing the mechanism set of injection pump tanks (54), and the surface lid of the chamber (51). Moreover, the claimed injection device comprises a magnetic section (55) and a module holding section (57) on the surface of the chamber beside the non-magnetic body (56), which makes easy the installation of the device in different circumstances. It is worth mentioning that a slot corresponding to the connector (58) of the claimed detector device is installed near the module holder so that the possibility of wired transmission of information from the detector or the central processor to the electronic module of the injection pumps, besides the claimed wireless mode, be provided.
Furthermore, protruding sections with cavities are incorporated near the electronic module and the injection pumps to allow the process of changing the rate and injection dose of the infusion pumps. The lower part of the chamber embraces the flexible legs (60), the rubber part of the leg (61), and the tank containing the air enclosed around the leg (62), which is attached to the body of the chamber by connecting pins (63). The electronic module of the injection pumps (52) is composed of a set of connector ports (64). These claimed connector ports are attached to the motor system and sensors (65) associated with the mechanism of the injection pumps tanks via cables. It should be noted that the ports related to the power connector and fault detection of injection pumps are embedded in the lower part of the claimed electronic module for monitoring the performance and secondary applied changes by the pumps.
Notably, the electronic module of injection pumps is also constituted of numerous electronic elements. The central part includes the processor (microcontroller) (75) of injection pumps; on the one hand, it is connected to the stepper motor driver module (78), Bluetooth (or Wi-Fi) module (77), display (68), internal settings of injection pumps and keyboard (79) for manual data entry. On the other hand, the claimed processor is connected to a set of linear variable resistors (76), injection pump feeding and fault detection connectors, voltage regulation resistor (73), input voltage stabilization capacitor of regulator or demodulator (70), and output voltage stabilization capacitor of the regulator (71), besides the LED (72) displaying the operation of the injection pumps corresponding to the increase in the sensitivity of the stepper motor driver module to changes in the circuit current for enhancing the precision of the injection pumps under the circuit designed on the basis of the figure. On the chamber lid of the infusion pump, there are sections and parts including the handle of the chamber lid (80), the metal bases holding injection pumps (81), and the flexible layers (83), which are embedded in the form of components and protrusions from the metal body (82) of the chamber lid that the drug storage tanks (84) are located and embedded among the claimed parts.
Drug storage tanks (84) are deployed in an electromechanical system made up of the injection chassis (85), driving electric motor (86), piston assembly (89), piston functional position sensor section (87), drug tank cylinder section (88), and gearbox gears, which allows injecting microliter doses and speeds of the medicine dissolved in water for the medical staff by employing these infusion pumps. The claimed electromechanical system is constituted of a holding surface (91) for the chassis of tanks with a metal body (92), the built-in conductor holes in the front section of the motor (93), the passage and entrance of the motor shaft (94), and correspondingly, the passage of the spiral shaft of the piston (95), which is positioned near the motor shaft. It is worth noting that holes are intended in the lower part (96) of the claimed electromechanical system, which is located in the protruding section and fixed. As well as, it should be noted that the placement of the cylinder inlet to the chassis (97) and the piston inlet opening to the cylinder (98) is placed in the rear part.
The cylinder section that is a place for drug transfer from the drug storage tank to the peripheral or central injection line (CV line) consists of the inlet opening (99), the outlet section of the drug storage tank, the valve return spring (100), the fixed section (102) and the actuator (101) of the cylinder inlet valve in the inlet section. The output section of the claimed cylinders is composed of the outlet valve return spring (103), the outlet valve actuator (104), the fixed port of the output valve (105), and a place to connect the tube embedded for the drug release (106). Subsequently, one can argue that drug storage tanks (84) consist of convex surfaces in the upper part (108), the place of loading and filling of the tank from the injection form of the prepared drug (109), the tank blocking valve (110) after loading the prepared injection form of the medicine in the upper part. Besides, the tank outlet (111) and the flexible medium of the tank and cylinder (112) are embedded in the lower part of the claimed tanks such that the process of drug transfer could be conducted based on the decisions and adjustment of dosing and the rate of injections made by the central processor (CPU) and the electronic module of the injection pumps.
The claimed stepper motor, also known as a step motor or stepping motor, is composed of a motor length spacer (113), a shaft retaining bushing (114), a magnet (115) on the upper part, protrusions on the upper and front part of the stepper motor (116), and the output shaft of the driving force (117), electric coils (118), the lower protrusion (119), and the connector related to the electrical connection (120). To examine the motor's performance and driving power, the output shaft position sensors (121) and the mediator of the connection between the spacer and the body (122) of the claimed step motors are also deployed in the vicinity of the connectors associated with the electrical connection, where the claimed parts are covered and protected by the end cap (125) of the step motor. The driving force gained from the output shaft of the stepper motor is enabled by the operation of a set of gears including the headgear (126) and the output gear (128), and the operation of the said gears is made possible by the intermediate gears (127), and the driving force output is received through the central spiral hole (129) embedded on the output gear which is the place of entry and passage of the piston assembly (89).
The claimed piston assembly is made up of a flexible piston (134), a retaining washer (133), a spiral axis (131) corresponding to the spiral shape of the hole embedded in the central hole of the claimed output gear, and a rotational limiting metal blade (130). Eventually, the piston assembly position sensor (87), which has been designed and incorporated with the goal of examining the operational condition of the piston, consists of the piston spiral passage (141), gearbox passing holes (140), maximum reporting micro-switch (139), carbon blade section (138), electrical connection connector (137), and minimum reporting micro-switch (136), which is positioned inside the metal body (134) and is covered and protected by the metal cap of the gearbox (135). The harmonious operation of the said parts has made it possible to inject small doses up to microliters for intravenous injection of drugs in patients admitted in different wards of the hospital. Followed by the performance and analytical effect of the electronic module of the injection pumps and its impact on the changes in current applied to the driver module of the stepper motors, the self-regulation of variations in the speed and dosing of drug injection will be carried out influenced by the hemodynamic parameter changes measured by the ultrasonic detector, simultaneously with the coordinated changes in the function of the stepper motor, the cylinder section, and the designed and embedded piston assembly.
Advantage effects of invention
Among the major problems prevailing in the discussion of therapeutic interventions, critical care interventions, and emergency medicine for patients admitted in different sections of the hospital, particularly patients hospitalized in the intensive care units (ICUs) is the optimized management of patients' hemodynamic disorders and the occurrence of organ-organ interaction failure conditions after receiving a specific therapeutic intervention (which in most cases will be a heavy regimen from the viewpoint of drugs and with the extensiveness of diversity in the used items). Because of multiple organ involvements and organ-organ interaction failure conditions, patients admitted to different departments of the hospital, especially patients hospitalized in ICUs do not have stable hemodynamic conditions. In this case, the typical monitoring systems and parameters, such as blood pressure, respiratory rate, heart rate, and saturated blood oxygen of patients (SpO2), cannot be regarded as suitable efficiency for continuous monitoring of patients. Indeed, multiple cases can be noted in which the patient apparently exhibits good clinical conditions and the usual monitoring parameters claimed indicate a stable condition for the patient, while discontinuing anticoagulant drugs and antiarrhythmic drugs cause worsening of clinical and hemodynamic conditions of patients and subsequently, exacerbation of arrhythmic attacks, clot return, respiratory failure, and heart failure by changing the conditions of interventions and diminishing the severity of the patient's treatment regimen or taking into account improving clinical conditions for extubation winning, which can ultimately result in increased mortality rate in patients.
The continuous monitoring system of clinical conditions and intelligent self-regulation of continuous infusion of drugs based on the hemodynamic conditions of patients" is a smart initiative. This system provides the possibility of self-regulation and optimization of the dose and speed of administration of sensitive injectable drugs, including inotropes, anticoagulants, antiarrhythmics, anti-seizures, and antibiotics, which are employed to control pathophysiological conditions such as cardiac, cerebral, infectious, and shock events in hospitalized patients, on the basis of sensitive hemodynamic parameters such as cardiac output (CO), cardiac index (CI), and systemic vascular resistance (SVR), which will lead to an improvement in therapeutic interventions, an enhancement in the cost-effectiveness of interventions, and an increase in the more assurance of the medical team to more systematic and optimal monitoring of patients' hemodynamic conditions, and correspondingly, a promotion in the favorable outcomes of the interventions done on the patients.
: It shows the communication path between the ultrasonic detector device, the central processor and the infusion pump processor through the Bluetooth (or Wi-Fi) module.
: It indicates the ultrasonic detector and the set of ultrasonic and infrared sensors connected to it.
: It displays different sections in 2D form, from the set of ultrasonic and infrared sensors, connected to the ultrasonic detector. The mentioned sizes for the dimensions of the claimed sensor set are in millimeters.
: The upper picture shows the internal section and the exit location of the elements of the claimed sensor set; Also, the lower image shows the external raised cross-section of the alleged sensor set.
: It displays various sections in 3D form, from a set of ultrasonic and infrared sensors, connected to the ultrasonic detector.
: It shows the upper (section C-C), lower and side (section A-A and section B-B) sets of ultrasonic and infrared sensors, connected to the ultrasonic detector.
: It shows one of the two side sections (section A-A) of the set of ultrasonic and infrared sensors, connected to the ultrasonic detector. Also, the indicated angle is degree type.
: It shows the internal section of the ultrasonic detector and its electronic components.
: It shows different directions of the ultrasonic detector in 2D form.
: It shows different directions of the ultrasonic detector in 3D.
: It indicates the external components, parts and parts installed on the body of the ultrasonic detector, including the base connection to the detector, the sealing resin of the device door, the sealing resin of the display glass and the display protective glass.
: It shows the bottom section and different side sections of the ultrasonic detector device, in 2D.
: It shows one of the side sections (section C-C) and the constituent parts related to the ultrasonic detector.
: It shows the upper section and various additional side sections of the ultrasonic detector in 2D.
: It shows the PCB circuit and electronic elements related to the module of the ultrasonic detector and the set of ultrasonic and infrared sensors connected to it.
: It shows different directions of infusion pumps along with the representation of constituent parts such as drug storage tanks, pins of the lower part and upper cover and handle, in 2D form. The indicated sizes for the dimensions of the claimed infusion pumps are in millimeters.
: It shows different directions of infusion pumps in 3D.
: It shows the upper, lower and different side sections of infusion pumps in 2D.
: The display shows how to place and install the drug storage tanks and the electronic module of the infusion pump, in the compartment of the infusion pumps and next to the upper cover of the claimed compartment.
: It shows more details and different directions of the placement and installation of the collection consisting of drug storage tanks and the mechanism part of the injection pump tanks in the infusion pump chamber.
: shows two upper side directions and a table of the installation of the complex consisting of drug storage tanks and the mechanism part of the injection pump tanks in the infusion pump chamber.
: shows the surface sections of infusion pumps from different directions and angles.
: shows the surface sections of the infusion pumps, focusing on the lower part of the claimed pumps, from different directions and angles.
: shows the upper, lower and different side angles of the infusion pump chamber in 2D.
: shows different directions and angles, along with the dimensions of the injection pump electronic module. The mentioned sizes for the dimensions of the claimed module are in millimeters and the defined scale is real and in a ratio of 1 to 1.
: shows the PCB circuit and electronic elements related to the injection pump electronic module.
: shows different directions and angles of the injection pump housing cover, along with its constituent parts, in 2D.
: shows different directions and angles of the injection pump housing cover, along with its constituent parts, in 3D.
: shows different directions and angles of the collection consisting of drug storage tanks and the mechanism part of injection pump tanks, in 2D form. In this picture, the details of the parts that make up the mechanism of the injection pump tanks, which include the chassis of the injection pumps, the driving electric motor part, the cap and the status sensor of the piston assembly, the piston assembly and the cylinder-tank assembly.
: shows different directions and angles of the collection consisting of drug storage tanks and the mechanism part of the injection pump tanks in 3D.
: shows the upper, lower sections and different side angles of the "injection pump tank mechanism" in 2D.
: shows different directions and angles related to the assembly and installation of different parts related to the "injection pump tank mechanism".
: shows more details of the constituent parts of the "injection pump tank mechanism" and how to assemble and install the claimed parts from different directions and angles.
: shows the electromechanical system, as one of the constituent parts of the "injection pump tank mechanism", from different directions and angles in 2D.
: shows the electromechanical system from different directions and angles in 3D.
: shows the upper, lower and different side angles of the electromechanical system in 2D.
: shows different directions and angles of the drug cylinder-tank set and its dimensions in 2D. The mentioned sizes for the dimensions of the drug cylinder-reservoir set are in millimeters and the defined scale is real and in a ratio of 1:1.
: shows different directions and angles of the drug cylinder-reservoir complex in 3D. Also, in this picture, the components of the cylinder-tank connection are shown.
: shows the upper, lower and different lateral angles of the cylinder-tank assembly.
: shows different directions and angles of drug storage tanks in 2D form.
: shows different directions and angles of surface and internal sections of drug storage tanks, as well as the dimensions of different sections, in 3D.
: shows one of the side sections of the medicine storage tank and its different components.
: shows different directions and angles and dimensions of different sections of the stepper motor system in 2D.
: shows different directions and angles of the stepper motor system in 3D.
: shows the upper, lower and different side angles, along with the components of the stepper motor system.
: shows the components of the upper and lower surface sections of the stepper motors, the upper part showing the parts of the electrical connection connector of the stepper motor, the state sensors of the stepper motor shaft, and the intermediary connecting the spacer and the stepper motor body, as well as the lower part, indicating the location The passage and input of the output shaft of the stepper motor.
: shows the side surface sections of stepper motors in 3D.
: shows several images of a part of the side section of the step motor, which includes the part of the electric coil (bobbins) and the bush holding the step motor shaft.
: shows different directions and angles of the "wheeling system" that connects the piston assembly with the output shaft of the stepper motor, in 3D form and with the dimensions of its different sections.
: shows the different directions and angles of the parts that make up the "piston assembly", in 2D form, along with the dimensions of its different sections.
: shows the different directions and angles of the parts that make up the "piston assembly" in 3D.
: shows the different directions and angles of the "piston set position sensor", in 2D form, along with the dimensions of its different sections.
: shows different directions and angles of the "piston assembly position sensor" in 3D.
: shows a cross-section of the "piston assembly position sensor", laterally, in order to determine the position of the various embedded parts.
: 1. Ultrasonic detector 2. Bluetooth waves detector and processor 3. Central processor 4. Bluetooth waves between the processor and the injection device 5. Injection device
: 6. Detector device
: It displays different sections in 2D form, from the set of ultrasonic and infrared sensors, connected to the ultrasonic detector. The mentioned sizes for the dimensions of the claimed sensor set are in millimeters.
: 7. Detector sensors 8. Infrared sensors towards the heart 9. Ultrasonic transmitter sensor 10. Infrared sensors towards the artery 11. Ultrasonic receiver sensor 12. Sensor module body 13. Placement of glue or strap to the body 14. Sensors data transmission cable
: It displays various sections in 3D form, from a set of ultrasonic and infrared sensors, connected to the ultrasonic detector.
: It shows the upper (section C-C), lower and side (section A-A and section B-B) sets of ultrasonic and infrared sensors, connected to the ultrasonic detector.
: 8. Infrared sensors towards the heart 9. Ultrasonic transmitter sensor 10. Infrared sensors towards the artery
: 17. Connector to connect detector to sensors 18. Cable connecting the detector to the sensors 19. Diagnostic cable of detector 20. Diagnostic connector of the detector 21. Electronic module of the detector 22. Capacitive touch sensor on and off the device 23. Flat to connect the capacitive sensor to the module 24. The bases for connecting the module to the body of the detector 25. Positive metal base for battery charging 26. Charger holder magnet 27. The base of the negative connection of the battery charge 28. Display board connection panel 29. Display circuit 30. The detector body 31. Display holder base 32. Flexible battery spacer 33. Module power connection cable 34. Backup rechargeable battery
: It shows different directions of the ultrasonic detector in 2D form.
: It shows different directions of the ultrasonic detector in 3D.
: 35. Connecting the base to the detector 36. Sealing resin for the detector door 37. Display glass sealing resin 38. Screen protector glass
: It shows the bottom section and different side sections of the ultrasonic detector device, in 2D.
: 30. The detector body 31. Display holder base 32. Flexible battery spacer 33. Module power connection cable 34. Backup rechargeable battery 35. Connecting the base to the detector 36. Sealing resin for the detector door 37. Display glass sealing resin 38. Screen protector glass 39. LCD display 40. Pins fixing the display location 41. Back door of the detector
: It shows the upper section and various additional side sections of the ultrasonic detector in 2D.
: 42. Detector processor 43. Bluetooth module detector 44. Ultrasonic sensors module 45. Transistor amplifier for troubleshooting and testing ultrasonic sensors 46. Module voltage stabilization regulator 47. Output voltage adjustment capacitor 48. Input voltage stabilization capacitor 49. Transistor excitation adjustment resistance 50. Output signal transistor of infrared sensors
: It shows different directions of infusion pumps along with the representation of constituent parts such as drug storage tanks, pins of the lower part and upper cover and handle, in 2D form. The indicated sizes for the dimensions of the claimed infusion pumps are in millimeters.
: It shows different directions of infusion pumps in 3D.
: It shows the upper, lower and different side sections of infusion pumps in 2D.
: 51. Injection machine door 52. Electronic module of injection device 53. The mechanism of the tanks of the injection device 54. Injection device tank mechanism compartment
: It shows more details and different directions of the placement and installation of the collection consisting of drug storage tanks and the mechanism part of the injection pump tanks in the infusion pump chamber.
: shows two upper side directions and a table of the installation of the complex consisting of drug storage tanks and the mechanism part of the injection pump tanks in the infusion pump chamber.
: 55. The magnetic part of the housing 56. Non-magnetic housing body 57. Module holder 58. Connector access slot 59. Conductor protrusions of the tank mechanism of the injection device 60. Flexible foundations 61. Basic rubber part 62. Base air chamber 63. Pins connecting the base to the body
: shows the surface sections of the infusion pumps, focusing on the lower part of the claimed pumps, from different directions and angles.
: shows the upper, lower and different side angles of the infusion pump chamber in 2D.
: 64. Port of connectors 65. Connectors for connecting to the engine/sensors of the mechanism of the tanks of the injection device 66. Body cut 67. Feeding connector and injection device troubleshooting
: 68. Display of the internal settings of the injection device 69. Supply voltage converter 70. Regulator output voltage stabilization capacitor 71. Regulator input voltage stabilization capacitor 72. LED display device is working 73. Voltage regulation resistor 74. Sound detector of warnings 75. Injection device processor 76. Linear variable resistors 77. Bluetooth module 78. Step motor driver module 79. Injection device programming keyboard
: 80. Injection machine door handle 81. Metal bases holding injection tanks 82. Metal body of the door 83. Flexible layer
: shows different directions and angles of the injection pump housing cover, along with its constituent parts, in 3D.
: 84. Drug storage tank 85. Chassis of injection tanks 86. Electric drive motor 87. Cover and sensor of the position of the piston assembly 88. Medicine tank cylinder set 89. Piston set
: shows different directions and angles of the collection consisting of drug storage tanks and the mechanism part of the injection pump tanks in 3D.
: shows the upper, lower sections and different side angles of the "injection pump tank mechanism" in 2D.
: shows different directions and angles related to the assembly and installation of different parts related to the "injection pump tank mechanism".
: 84. Drug storage tank 85. Chassis of injection tanks 86. Electric drive motor 87. Cover and sensor of the position of the piston assembly 88. Medicine tank cylinder set 89. Piston set 90. Gears of the gearbox
: 91. Chassis tank holding surface 92. Chassis metal body 93. Conductor holes in front of the engine 94. Engine shaft entry point 95. The passage of the piston spiral shaft 96. Conductor holes placed on the protrusion of the body 97. Cylinder inlet to chassis
: shows the electromechanical system from different directions and angles in 3D.
: shows the upper, lower and different side angles of the electromechanical system in 2D.
: shows different directions and angles of the drug cylinder-tank set and its dimensions in 2D. The mentioned sizes for the dimensions of the drug cylinder-reservoir set are in millimeters and the defined scale is real and in a ratio of 1:1.
: 98. Piston to cylinder inlet opening 99. The inlet of the drug tank to the cylinder 100. Valve return spring 101. Inlet valve actuator 102. Fixed orifice of inlet valve 103. Output valve return spring 104. Outlet valve actuator 105. Fixed outlet valve port 106. The connection point of the drug outlet hose
: shows the upper, lower and different lateral angles of the cylinder-tank assembly.
: shows different directions and angles of drug storage tanks in 2D form.
: shows different directions and angles of surface and internal sections of drug storage tanks, as well as the dimensions of different sections, in 3D.
: 107. Medicine storage tank body 108. The upper convex surface of the tank 109. The entrance of medicine to the tank 110. Blocking the drug entrance door 111. Tank outlet 112. The flexible medium of the drug injection tank and cylinder
: shows different directions and angles and dimensions of different sections of the stepper motor system in 2D.
: shows different directions and angles of the stepper motor system in 3D.
: 112. The flexible medium of the drug injection tank and cylinder 113. Increaser of engine length spacer 114. Stepper motor shaft holder bush 115. Magnet step motor 116. Conductor protrusions in front of the stepper motor 117. Step motor power output shaft 118. Step motor electric coils 119. Stepper motor rear conductor emergence
: 120. Step motor electrical connection connector 121. Stepper motor shaft status sensors 122. Intermediary connecting the spacer and the body of the stepper motor 123. Shaft cut 124. Step motor metal body 125. End cover of step motor
: 116. Conductor protrusions in front of the stepper motor 117. Step motor power output shaft 118. Step motor electric coils 119. Stepper motor rear conductor emergence 120. Step motor electrical connection connector 121. Stepper motor shaft status sensors 122. Intermediary connecting the spacer and the body of the stepper motor 123. Shaft cut 124. Step motor metal body
: shows several images of a part of the side section of the step motor, which includes the part of the electric coil (bobbins) and the bush holding the step motor shaft.
: 125. Step motor end cover 126. Motor head gear 127. Intermediary gears 128. Output gear 129. Spiral hole
: 130. Metal blade to prevent rotation 131. Spiral axis 132. Piston retaining washer 133. Flexible piston
: shows the different directions and angles of the parts that make up the "piston assembly" in 3D.
: shows the different directions and angles of the "piston set position sensor", in 2D form, along with the dimensions of its different sections.
: shows different directions and angles of the "piston assembly position sensor" in 3D.
: 134. Metal body of piston position sensor 135. Metal gearbox cover 136. Micro switch reporting min 137. Electrical connection connector 138. Carbon blade 139. Micro switch reporting max 140. Gearbox conductor holes 141. The passage of the piston spiral
Examples
As pointed out, the claimed invention is a system composed of three different devices. The first one is a "continuous monitoring device for hemodynamic conditions of patients based on high-frequency ultrasonic waves and infrared waves", the second one is "an intelligent infusion pump with the capability of self-regulation in the dose and speed of drug injection", and the third one is a "software section designed for monitoring the clinical conditions of patients in the hospital". "The continuous monitoring device of hemodynamic conditions of patients based on ultrasonic and infrared waves" is placed on the jugular artery. The recent device, which has the capability of continuous measurement and monitoring of patients' hemodynamic conditions based on high-frequency ultrasonic wave transmitter-receiver elements (higher than 2 MHz that the optimum efficiency is observed in the range of 4 to 7 MHz) as the primary factor and the infrared sensor as an auxiliary sensor for the right location and positioning of the device on the jugular artery will cause the continuous measurement and sending of the information gained from the claimed hemodynamic parameters via Wi-Fi or Bluetooth to the analysis circuit board embedded on the claimed intelligent infusion pump. By sending the acquired data in adjustable intervals, it makes possible the continuous analysis of the prognosis, and clinical and hemodynamic conditions of the patient based on the claimed hemodynamic parameters and analytical algorithms dependent on these claimed variables. Taking into account the continuous monitoring and analysis of clinical and hemodynamic conditions of patients, the possibility of examining the efficiency and effectiveness of the treatment regimen and, accordingly, the speed and dosing of administration of the claimed drugs from the infusion pump, followed by analyzing the subsequent data received for the medical staff and the device's analysis circuit board, is provided. In the meantime, the claimed analysis board changes the speed of injection and administration of medicine in the vessel tailored to the claimed and specified algorithms. The changes made are evaluated and re-verified proportional to the data received from the first device after performing variations in the conditions of the intervention. Notably, the data sent from the first device is simultaneously sent to the monitoring software available in the HIS (Hospital Information System) in the patient profile section via Wi-Fi or Bluetooth, which checks the feasibility of observing the data and subsequently, the process of changes applied by the second device, and will provide the possibility of monitoring and, if necessary, intervention in the decision-making process of the second device to the attending physicians, medical team, and medical staff.
The claimed invention is applicable in the area of various departments of hospitalization of patients in hospitals, clinics, medical clinics, and especially in ICU, CCU, and surgery departments.

Claims (29)

  1. This is an invention composed of a coordinated monitoring system, predicting clinical conditions, and making decisions for changing the conditions of drug therapy interventions to improve the clinical conditions and the prognosis of patients' recovery.
  2. According to claim 1, predicting the patients' clinical conditions is based on the data gained in the monitoring and analysis path of the data obtained through decision-making algorithms and applying the required changes tailored to the predicted results by the claimed decision-making algorithms.
  3. According to claim 2, the data achieved from the claimed monitoring path actually are the hemodynamic parameters of each patient.
  4. According to claim 3, the claimed hemodynamic parameters for each admitted patient are exclusively used for that person and have a high sensitivity to represent the clinical conditions of the patients.
  5. According to claim 4, the most critical hemodynamic parameters claimed, which can be monitored by the latest monitoring system in this invention, are stroke volume, cardiac output, cardiac index, and systemic vascular resistance. It should be noted that the claimed monitoring system, in addition to measuring the recent parameters, will allow measuring the parameters of blood flow time, corrected flow time, and changes in the systemic resistance of the blood vessels.
  6. The claimed invention is a collection of communication and operation of three different general systems, which are described as follows:
    • "Continuous monitoring of patients' hemodynamic conditions based on high-frequency ultrasonic waves and infrared waves"
    • "Intelligent infusion pump device with self-regulation capability in dosing and speed of drug injection"
    • "Software section designed for monitoring clinical conditions"
  7. According to claim 3, the "continuous monitoring device of hemodynamic conditions of patients based on high-frequency ultrasonic waves and infrared waves" in the claimed invention comprises an "ultrasonic detector" section and a "set of infrared and ultrasonic sensors" section.
  8. According to claims 6 and 7, the "infrared and ultrasonic sensor set" section is composed of two infrared sensors and receiver-transmitter ultrasonic elements. In the claimed section, the claimed ultrasonic elements are placed at close distances and horizontally parallel to the transverse axis relative to each other. Correspondingly, two infrared sensors are embedded vertically parallel to the length of the body with greater distances compared to the claimed ultrasonic elements.
  9. According to claim 8, the two claimed infrared sensors are deployed in the claimed "infrared and ultrasonic sensor set" section for detecting the anatomical path of the jugular artery vessel and adjusting the correct positioning angle of the ultrasonic elements on the said jugular artery.
  10. According to claim 9, receiver-transmitter elements have the possibility of detecting, measuring, and monitoring the claimed hemodynamic parameters through the Doppler Effect by irradiating ultrasonic waves in the high-frequency ultrasonic range. Actually, the operation of these two elements generates the claimed monitoring system in claim 1 in the present invention.
  11. According to claim 10, the "ultrasonic detector" section, with its electronic module, will have the capability of detection, analysis, and conversion of the time difference and frequency changes of the reciprocating ultrasonic waves of transmitter-receiver elements into the numerical values of the claimed hemodynamic parameters.
  12. According to claim 8, the ultrasonic receiver-transmitter elements existing in the "infrared and ultrasonic sensor set" section continuously radiate ultrasonic waves into the patient's jugular artery and allows the continuous measurement and monitoring of the claimed hemodynamic parameters in patients.
  13. According to claim 12, the possibility of continuous monitoring of clinical conditions is provided followed by continuous measurement and monitoring of hemodynamic factors, and the feasibility of prognosis of the improvement or deterioration of the clinical condition of the patients is also provided for the attending physician and the medical staff with high sensitivity.
  14. According to claim 12, a rechargeable battery is incorporated in the lower part near the electronic module of the claimed "ultrasonic detector" section, and a magnet for the battery charger is installed in parallel with the claimed battery, allowing the wireless battery charging via a magnetic connection. Moreover, a touch sensor with a capacitive effect is located in the upper part near the claimed magnet, facilitating the process of turning on, hibernating, and turning off the claimed "ultrasonic detector" for the medical staff.
  15. According to claim 14, the section "Infrared and Ultrasonic Sensors" has the ability to be attached to the patient's skin via adhesive or stitching because of its body design pattern through its protruding part. Furthermore, the "ultrasonic detector" and the "infrared and ultrasonic sensor set" sections are attached to each other using embedded connectors.
  16. According to claim 15, a location for connecting the device to the support base is positioned in the rear part of the body of the "ultrasonic detector" section, which makes it possible to fix the "ultrasonic detector" near the patient's body. This embedded piece allows fixing the "ultrasonic detector" to the bed, wall, and even the patient's body in a fixed manner and enhances the device's sensitivity and precision because of reducing movements.
  17. According to claim 16, special sealing resins are employed to protect and prevent possible reduction of accuracy or sensitivity of the claimed "ultrasonic detector" in inappropriate temperature and humidity conditions for designing the body and display glass of this claimed part.
  18. According to claim 17, the claimed resins allow washing and disinfecting of the claimed "ultrasonic detector" section, in the case of being used by another patient.
  19. According to claim 18, the "ultrasonic detector" section provides the possibility of wireless data exchange and transfer to the CPU and the processor embedded in the electronic module of the injection pump due to the Bluetooth (or Wi-Fi) module available in its electronic module.
  20. According to claim 5, the "intelligent infusion pump device with self-regulation capability in dosing and speed of drug injection" is composed of two main parts: "mechanism of infusion pump tanks" and "electronic module of injection pump".
  21. According to claim 20, the "electronic module of injection pump" section is the wireless communication part of the claimed "intelligent infusion pump device with the self-regulation capability in dosing and speed of drug injection" with the CPU and the " intelligent infusion pump device with the self-regulation capability in dosing and speed of drug injection". Actually, it allows transferring of data associated with the prediction of clinical conditions gained by the monitoring system for analysis and decision-making to change the conditions of drug therapy interventions.
  22. According to claim 21, the claimed "electronic module of injection pump" section supplies and analyzing and decision-making factor for creating changes in dosing and speed of drug injection based on specified decision-making algorithms.
  23. According to claim 22, the existence of the claimed "Electronic Module of Infusion Pump" section causes the generation of "self-regulation" capability and subsequently, the creation of an intelligent feature to control the hemodynamic conditions of patients. This will establish an intelligent process in clinical intervention and control of patients' hemodynamic conditions, independent of the direct stewardship and decision-making of the patient's treating team.
  24. According to claim 23, after the process of analysis and decision-making claimed, the "Electronic Module of Infusion Pump" section conveys the process of changes in dosing and speed of drug injection from the infusion pump to the "mechanism of injection pump tanks" section, which itself makes up of drug storage tanks, cylinder-tank assembly, piston assembly, stepper motors, and electronic module of stepper motors. The electronic module of the stepper motors provides the decision adopted by creating variations in the driving force of the stepper motors and subsequently, changes in the speed of the drug flow in the cylinder-tank assembly and the piston assembly, which finally results in changing the speed of drug injection.
  25. According to claim 20, the potential of removing and reinserting the drug storage tanks exists in the "intelligent infusion pump device with self-regulation capability in dosing and speed of drug injection". This feature causes the minimization of the changes in status required to refill the infusion pump system with medications and makes the trend of management of the claimed clinical interventions easy for both the claimed system and the medical staff.
  26. According to claim 25, reporting micros-witches are embedded at the beginning and end of the piston position sensor. Following the operation and suction created by the electric motor embedded in the path of the cylinder-tank assembly, they can render high accuracy and sensitivity in the injection of drug volumes through the stepper motors positioned in the electromotor section of the "mechanism of injection pump tanks" by reporting the minimum and maximum position change of the piston assembly.
  27. According to claim 1, the connection between the central processor (CPU) and, indeed, the "software section designed for monitoring the clinical conditions of the patients" claimed with the electronic module of the "ultrasonic detector" section has caused the continuous sending of information to the profile relating to patients in the hospital information system (HIS). Furthermore, it allows the direct supervision of the treating team on the process of making decisions and interventions adopted by the "Intelligent infusion pump device with self-regulation capability in dosing and speed of drug injection".
  28. According to claim 27, this possibility in the "software section designed for monitoring the clinical conditions of patients" was made available to the patient's treatment team so that they can intervene and modify the decision-making process adopted by the "electronic module of the injection pump" section if deemed necessary.
  29. According to claim 28, the possibility in the designed decision-making algorithms claimed is provided in a way to optimize decision-making in future patients by identifying the existing weaknesses and problems through analyzing interventions of the medical team in the decision-making performed for each patient, taking into account allowance of intervention of the medical team in the decision-making of the claimed "electronic module of injection pump".
PCT/IB2023/051077 2023-02-07 2023-02-07 Continuous monitoring system of clinical conditions and intelligent self-regulation of continuous infusion of drugs WO2023161746A1 (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080294019A1 (en) * 2007-05-24 2008-11-27 Bao Tran Wireless stroke monitoring
WO2021127239A1 (en) * 2019-12-19 2021-06-24 IllumeSense Inc. System for integrating data for clinical decisions
US20210345954A1 (en) * 2020-05-06 2021-11-11 Janssen Pharmaceuticals, Inc. Monitoring and communicating information using drug administration devices

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080294019A1 (en) * 2007-05-24 2008-11-27 Bao Tran Wireless stroke monitoring
WO2021127239A1 (en) * 2019-12-19 2021-06-24 IllumeSense Inc. System for integrating data for clinical decisions
US20210345954A1 (en) * 2020-05-06 2021-11-11 Janssen Pharmaceuticals, Inc. Monitoring and communicating information using drug administration devices

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