WO2022190137A1 - Dispositif de surveillance de perfusion automatisé et système associé - Google Patents

Dispositif de surveillance de perfusion automatisé et système associé Download PDF

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Publication number
WO2022190137A1
WO2022190137A1 PCT/IN2022/050231 IN2022050231W WO2022190137A1 WO 2022190137 A1 WO2022190137 A1 WO 2022190137A1 IN 2022050231 W IN2022050231 W IN 2022050231W WO 2022190137 A1 WO2022190137 A1 WO 2022190137A1
Authority
WO
WIPO (PCT)
Prior art keywords
drip
monitoring device
infusion
fluid
temperature
Prior art date
Application number
PCT/IN2022/050231
Other languages
English (en)
Inventor
Beigh MIRZA MOHAMMAD IDREES UL HAQ
Original Assignee
Bala Industries And Entertainment Pvt Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bala Industries And Entertainment Pvt Ltd filed Critical Bala Industries And Entertainment Pvt Ltd
Publication of WO2022190137A1 publication Critical patent/WO2022190137A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1414—Hanging-up devices
    • A61M5/1417—Holders or handles for hanging up infusion containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/1684—Monitoring, detecting, signalling or eliminating infusion flow anomalies by detecting the amount of infusate remaining, e.g. signalling end of infusion
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01F—MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F23/00—Indicating or measuring liquid level or level of fluent solid material, e.g. indicating in terms of volume or indicating by means of an alarm
    • G01F23/20—Indicating or measuring liquid level or level of fluent solid material, e.g. indicating in terms of volume or indicating by means of an alarm by measurement of weight, e.g. to determine the level of stored liquefied gas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/18—General characteristics of the apparatus with alarm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature

Definitions

  • the present invention relates to an automated drip monitoring device and a system thereof. More particularly, the present invention relates a drip monitoring device with an alarm which monitors and sends a push notification for variations in temperature and humidity parameters of the surrounding in which drip is placed, with the help of a smart mobile phone application or web-based application thereby reducing the load on the health care management.
  • the said automatic drip monitoring device and system of the present invention help in monitoring the infusion of nutrient fluid in blood vessels remotely.
  • device is to be construed as a set of technical components (also referred to as “members”) that are communicatively and/or operable associated with each other, and function together as part of a mechanism to achieve a desired technical result
  • Intravenous Infusion Therapy is employed during the unsuitability of oral administration. It is used for various purposes like electrolyte imbalance, in the management of dehydration, fever, anaemia delivering chemotherapeutic agents, transfusion of blood, etc. to deliver fluid to the patient’s body at a given rate per hour.
  • EID Electronic Infusion Device
  • the intravenous infusion system consists of a drip bottle, drip chamber, back check valve, access port, IV tube, and roller clamp.
  • the drip bottle contains the fluid; an Intravenous tube is connected to the drip bottle from which fluid nutrients are pumped through or by gravity flows into the patient’s bloodstream.
  • Intravenous Infusion Therapy is associated with drawbacks like interrupted delivery of fluid nutrients due to sudden jamming of drip, infiltration of IV fluid into patient’s tissues due to improper insertion of the needle of the IV tube into patient’s blood vessel at the mid of infusion/ from the start of the infusion, backflow of the fluid into capillary tube due to low level of fluid in drip bottle, denaturation of the fluid nutrients, etc.
  • US patent US6690280B2 discloses an apparatus and a process for infusion monitoring.
  • the invention involves an electronic weight sensing mechanism, control circuit, alarm system, display unit, and central station connected to more than one monitoring apparatus.
  • the process for monitoring infusion into the patient involves hanging a fluid bag from the monitoring apparatus; the weight of the fluid bag is measured periodically using an electronic weight sensing mechanism and microprocessor. At the point when the bag is empty or the amount of fluid is less, the alarm is activated and the rate of fluid loss from the fluid bag is calculated and displayed.
  • This document fails to demonstrate the capability of the system to sense and alarm about the jammed state due to backflow and the environmental conditions before fluid resuscitation. This document also fails to demonstrate fluid resuscitation necessity which is of vital importance in our system.
  • US patent US9752913B2 discloses a method for determining the empty state of an IV bottle by IV infusion monitoring device. It is a network monitoring system that gives information regarding liquid level (remaining liquid weight), the liquid flow' rate (infusion rate), remaining time for completion of the infusion process as well as the empty state, sets alarm on the emptying of IV bottles.
  • This document fails to disclose the loaded state and the jammed state of the drip. Also, the said system uses an electric wire to a sensor connected to the system, the chances of fluid contamination increase due to the effect of electrolysis through a metal needle inside the fluid. Further to this, it fails to demonstrate the effect of environmental temperature on the drip management system and the fluid resuscitation necessity.
  • EP2094333BT discloses apparatus for detecting medical device acceleration conditions.
  • the invention includes an ambulatory medical device for the detection of acceleration, temperature, and humidity conditions. It comprises the infusion device, a drive mechanism, a processor, an indicator, an acceleration sensor, a memory device, a transmitter/receiver, an acceleration sensor.
  • a major objective of the present invention is to provide an automated drip monitoring device and system that analyses the change of volume pattern, temperature, and humidity in case of drip jamming, drip emptying, and to keep a check on whether the drip is continued.
  • Another objective of the instant invention is to provide a system for detecting temperature and humidity conditions and alter its operation of infusion rate in feedback.
  • Yet another objective of the invention is to simplify the complicated clinical procedure to determine the fluid resuscitation necessity.
  • Yet another objective of the invention is to provide a system for the automatic drip monitoring system for sending notification by wired or wireless communication to the connected devices in case the state of drip system status changes if drip gets jammed, if drip finishes, or if it is emptied or any change in temperature or humidity conditions and processes the information for sending the push notifications to the concerned personnel.
  • an automatic drip monitoring device and system comprising of load analyzer module, temperature sensor, humidity sensor, microcontroller, communication module, display unit, online server, and a Smart mobile phone application or web-based application for health care management.
  • Automatic drip monitoring device and system checks the fluid resuscitation necessity by getting inputs from the user and running an algorithm. It also monitors the loading and unloading of infusion bags with fluid nutrients by load analyzer module along with an online server. The said load analyzer analyses the volume pattern in a given drip system and computes the state of the drip system.
  • GUIs Graphical User Interfaces
  • Apple TM Macintosh TM operating systems Aqua TM
  • IBM TM OS/2 TM IBM TM OS/2 TM
  • Microsoft TM Windows TM e.g., Aero, Metro, etc.
  • Unix X -Windows TM web interface libraries
  • web interface libraries e.g., ActiveX, Java, JavaScript, AJAX, HTML, Adobe Flash, etc.
  • a temperature sensor to determine the temperature is also coupled with the apparatus adapted to provide a temperature output signal as a function of temperature in the housing.
  • a temperature sensor records variations in calefaction and its implications on the infusion of fluid nutrients on the blood circulation system.
  • the processor is adapted to control the infusion device by causing the indicator to provide an alarm or a warning to the person about the temperature output signal.
  • a humidity sensor is coupled with infusion apparatus that senses variation in humidity as compared to a predetermined humidity threshold to suffice the temperature sensor and provides alarm or notification to the person about the change. Variation in humidity indicates the entry of water into the housing also.
  • Non-Animal trials were conducted to determine the effects of outside environment (temperature and humidity) on an infusion bag(s) of 500 ml, which is often used in an Intra Venous (IV) bag.
  • Trials were conducted at different scales of Temperatures ranging between -13°C to 52°C as depicted in tables 2, 3, and 4 wherein the graphical representation is shown in corresponding figures 4, 5 and 6.
  • the automatic drip monitoring device and system which is a user-friendly handling of drip which measures parameters via a smart mobile phone application or a web -based application for health care management.
  • a scale is devised to determine the fluid resuscitation necessity and hence will augment the clinical aspect. If the score is > 6, then the patient may need fluid resuscitation, and if ⁇ 6 then further laboratory assessments or consultations are needed.
  • the said device, the Intra Venous bag(s) were initially warmed up till 39°C with the help of fluid warmer (Soft Sack iv fluid warmer, FDA Approved 510K #K060851,) whose thermal rate of rising is 1 ⁇ 2° Fahrenheit per minute.
  • IV Intravenous
  • X Set flow rate
  • the said device, the fluids were collected and the temperatures of collected fluid were recorded at 6-minute intervals as most rapid changes were recorded.
  • the recorded temperatures as depicted in table 2 showed a significant change in temperature between the Intravenous (IV) bag and the administration/ catheter site.
  • the temperature change recorded was more significant with colder temperatures.
  • Such significant temperature change due to surrounding temperature and humidity) via infusion through drip may lead to e.g. Perioperative hypothermia, which usually is stressful as it elevates blood pressure, heart rate, and plasma catecholamine concentration that may increase the risk of cardiac complications, bleeding, wound infection, and post-anaesthesia care unit stay.
  • Perioperative hypothermia which usually is stressful as it elevates blood pressure, heart rate, and plasma catecholamine concentration that may increase the risk of cardiac complications, bleeding, wound infection, and post-anaesthesia care unit stay.
  • the outside temperature is of utmost clinical importance.
  • the smart mobile phone application or web-based application for health care management takes the input from an attendant or medical establishment and augments to determine the necessity of the fluid resuscitation in the fonn of push notification of the drip system on a smart mobile phone application or web- based application for health care management.
  • the said device the automatic drip monitoring system records threshold values of the change in temperature, change in humidity, and change in load analyzer and computes them with the real-time values of temperature, humidity, and load analyzer to inform the decision of drip monitoring system in the form of a Push notification of the drip system is ON [ loaded] , OFF [unloaded] or Jammed on a smart mobile phone application or web-based application for health care management.
  • the said device provides an automated drip monitoring device and a system that analyses the change of volume pattern, temperature, and humidity in case of drip jamming, drip emptying, and whether the drip is continued.
  • the said device comprising a smart load analyzer module (202), communication module, online server, client app/software, housing (207), humidity sensor (203), temperature sensor (204), microcontroller (201); that may connect to components including, without limitation, memory drives, removable disc drives, etc., employing connection protocols such as Serial Advanced Technology Attachment (SATA), Integrated Drive Electronics (IDE), IEEE-1394, Universal Serial Bus (USB), fiber channel, Small Computer Systems Interface (SSI), etc.
  • SATA Serial Advanced Technology Attachment
  • IDE Integrated Drive Electronics
  • USB Universal Serial Bus
  • SSI Small Computer Systems Interface
  • a further advantageous feature of the present invention is that it demonstrates important and vital feature about resuscitation necessity.
  • the smart drip system of the instant invention is unique in the features that it augments the health care worker, attendant or client in determining the fluid resuscitation necessity with the help of system software integration.
  • the present system is unique also in the sense that it demonstrates how environmental conditions like temperature impacts fluid resuscitation and provide necessary alarms to the health care worker/ attendant etc.
  • the present system uses a sensor to determine the fluid volume changes in the bag and alert the user/ health care worker, the attendant, etc. by alerting with the simple three status messages (Loaded, Empty, Jammed) of the drip system.
  • Figure 1 illustrates a device for the surveilling of a level of intravenous fluid, in real-time, during an intravenous medical procedure.
  • Figure 2 illustrates a device wherein the interaction of user with the system and the system interaction within.
  • the user inputs data to check fluid resuscitation necessity via client app software which reaches the microcontroller through an online server.
  • the firmware inside the microcontroller uses the data and pushes the score-based output to the client/app software in the form of push notifications.
  • the system alerts the user before resuscitation about the surrounding temperature and humidity conditions. All the communications between the client/ app software and the system are being enabled by a communication module integrated with the microcontroller.
  • the microcontroller senses the volume of the IV drip system with the help of a smart load analyzer and pushes the notifications to the client/ app software with the help of a communication module via an online server.
  • Figure 3 illustrates a device for pushing notification about the current drip status to the health care worker/ user/ attendant.
  • the smart load analyser analyses the drip volume and communicates the microcontroller about the drip status which is simplified into three parts, unloaded [off], loaded [on] and jammed as shown in table 1.
  • Figure 4 illustrates a device for the temperature of intravenous Fluid at catheter site during resuscitation after warming it to more than room temperature as shown in Table 2.
  • Figure 5 illustrates a device for the temperature of intravenous fluid at catheter site during resuscitation at surrounding room temperature as shown in Table 3.
  • Figure 6 illustrates a device for the temperature of intravenous fluid at catheter site after cooling it to below than room temperature as shown in Table 4.
  • Automatic drip monitoring device and system (101) comprises of smart load analyzer module (202), communication module, online server, client app/software, housing (207), humidity sensor (203), temperature sensor (204), microcontroller (201); that may connect to components including, without limitation, memory drives, removable disc drives, etc., employing connection protocols such as Serial Advanced Technology Attachment (SATA), Integrated Drive Electronics (IDE), IEEE- 1394, Universal Serial Bus (USB), fiber channel, Small Computer Systems Interface (SSI), etc.
  • SATA Serial Advanced Technology Attachment
  • IDE Integrated Drive Electronics
  • USB Universal Serial Bus
  • SSI Small Computer Systems Interface
  • the memory driv es may further include a drum, magnetic disc drive, magneto -optical drive, optical drive, Redundant Array of Independent Discs (RAID), solid-state memory systems, solid-state drives, etc., Display Unit (208), and firmware. It consists of a clamp (205) embedded in housing for joining smart drip with a drip stand. Hook (206) accompanying the stand holds the drip bottle. Housing encases a microcontroller, a load analyzer module, communication module, temperature sensor, humidity sensor, power source, and a display unit.
  • RAID Redundant Array of Independent Discs
  • the present automatic drip monitoring device and system provides advantages like remotely monitoring of infusion drip, sending notifications to the client about the state of the infusion drip from algorithms, and user-friendly handling of drip parameters via a smart mobile phone application or a web-based application for health care management.
  • a scale is devised to determine the fluid resuscitation necessity and hence will augment the clinical aspect. If the score is > 6, then the patient may need fluid resuscitation, and if ⁇ 6 then further laboratory assessments or consultations are needed. Further clinical assessment is to be supplemented to diminish the percentage of chance of morbidity or mortality.
  • the illustrated steps are set out to explain the exemplary embodiments shown, and it should be anticipated that ongoing technological development will change the manner in which particular functions are performed. These examples are presented herein for purposes of illustration, and not limitation. Further, the boundaries of the functional building blocks have been arbitrarily defined herein for the convenience of the description. Alternative boundaries can be defined so long as the specified functions and relationships thereof are appropriately performed.
  • the present automatic drip monitoring device and system provides advantages like remotely monitoring of infusion drip, push notification sending to client about state of infusion drip from algorithms and user-friendly handling of drip parameters via a smart mobile phone application or a web based application for Health care management.
  • the score of -2, 0, +1, +2, +3 indicates the importance of the parameter(s) while resuscitation only and may vary in different parameter weight age scenario. For the following, if the score is >6, then patient may need fluid resuscitation and if ⁇ 6 then further laboratory assessments or consultations are needed. Further clinical assessment is to be supplemented to diminish the percentage of chances of morbidity or mortality.
  • IV Flow rate 6ml/min and 7ml/min (calculated using the web Omni calculator - fhttps://www.omnicalculator.com/health/iv -flow-ratel Table 2: Temperature of IV Fluid bag after warming to 39°C

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne un dispositif de surveillance de perfusion automatisé et un système associé. Plus spécifiquement, ledit système comprend un module analyseur de charge, un capteur d'humidité, un capteur de température, un microcontrôleur, un serveur en ligne, une unité d'affichage et une application de téléphone intelligent ou une application Web pour la gestion de soins de santé. Plus particulièrement, la présente invention concerne un dispositif de surveillance de perfusion avec une alarme qui surveille et envoie une notification push pour des variations de température et de paramètres d'humidité de l'environnement dans lequel une perfusion est placée, à l'aide d'une application de téléphone mobile intelligent ou d'une application Web, ce qui permet de réduire la charge sur la gestion de soins de santé. Ledit dispositif et le système de surveillance automatique de perfusion de la présente invention permettent de surveiller l'apport d'un fluide nutritif dans des vaisseaux sanguins à distance.
PCT/IN2022/050231 2021-03-12 2022-03-12 Dispositif de surveillance de perfusion automatisé et système associé WO2022190137A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202121010408 2021-03-12
IN202121010408 2021-03-12

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WO2022190137A1 true WO2022190137A1 (fr) 2022-09-15

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108057143A (zh) * 2017-12-11 2018-05-22 莱芜职业技术学院 自动静脉输液控制系统及其输液方法
CN108159531A (zh) * 2018-02-28 2018-06-15 刘少杰 非悬挂的输液控制系统及其输液方法
WO2021079375A1 (fr) * 2019-10-22 2021-04-29 Mehta Dr Vijay Mohanlal Unité multifonctionnelle de surveillance et de commande de perfusion et procédé associé

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108057143A (zh) * 2017-12-11 2018-05-22 莱芜职业技术学院 自动静脉输液控制系统及其输液方法
CN108159531A (zh) * 2018-02-28 2018-06-15 刘少杰 非悬挂的输液控制系统及其输液方法
WO2021079375A1 (fr) * 2019-10-22 2021-04-29 Mehta Dr Vijay Mohanlal Unité multifonctionnelle de surveillance et de commande de perfusion et procédé associé

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