WO2022190137A1

WO2022190137A1 - An automated drip monitoring device and a system thereof.

Info

Publication number: WO2022190137A1
Application number: PCT/IN2022/050231
Authority: WO
Inventors: Beigh MIRZA MOHAMMAD IDREES UL HAQ
Original assignee: Bala Industries And Entertainment Pvt Ltd
Priority date: 2021-03-12
Filing date: 2022-03-12
Publication date: 2022-09-15

Abstract

The present invention relates to an automated drip monitoring device and a system thereof. Particularly, the said system comprises of a load analyzer module, humidity sensor, temperature sensor, micro-controller, an online server, display unit and a smart phone application or web-based application for health care management. More particularly, the present invention relates a drip monitoring device with an alarm which monitors and sends 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 helps monitoring of infusion of nutrient fluid in blood vessels remotely.

Description

FIELD OF THE INVENTION

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.

BACKGROUND OF THE INVENTION AND DESCRIPTION OF THE PRIOR ART Throughout this specification, the use of the words “comprise” and “include”, and variations such as “comprises”, “comprising”, “includes”, and “including” may imply the inclusion of an element or elements not specifically recited. Further, the disclosed embodiments may be embodied in various other forms as well.

Throughout this specification, the use of the word “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. This sets the path for running fluid from the IV tube to the blood vessels either by gravity or by an intravenous infusion pump, called as Electronic Infusion Device (EID). 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. The drip chamber observes the flow of liquid and calculates the drops per minute. A back -check valve avoids up travelling of fluid back into the bag. A roller clamp regulates the speed or stops or starts the infusion of fluid. 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. If this malfunctioning remains unattended or unnoticed by attendant or health care worker for a longer time it may result in severe complications like embolism, tissue hypoxia, reduced cardiac output, and in extreme cases death. So, the medical establishment must monitor every IV on a regular interval basis and there is a need in medical establishments across the world, to ease the clinical procedure in determining fluid resuscitation necessity. Hence it is needed to have an apparatus having unity with Clinical procedure, outside temperature/humidity, and drip system to monitor/conduct IV-infusion procedures after checking the resuscitation necessity and raise a warning in case of an anomaly so as to minimize the morbidity as well as mortality. In recent years, several methods have been developed for automated monitoring and flow' regulation of intravenous infusion.

Reference may be made to US patent US6690280B2 which 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.

Reference may be made to US patent US9752913B2 which 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.

Reference may be made to EP2094333BT which 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.

Reference may be made to US Patent, US8692678B2, which discloses, an automated intravenous (IV) monitoring device comprising of a sensor for sensing drips passing through an IV drip chamber, a processing unit for calculating the total infused volume over a predetermined period, and a display for displaying the total infused volume. However, it is noteworthy to mention here that the cited document demonstrates the flow rate by calculating the no. of drops, whereas the system used in the instant invention doesn’t contain any sensor as a counter system. The cited document also fails to demonstrate the capability of the system to sense and alarm about the environmental conditions before and during fluid resuscitation and also doesn’t demonstrate fluid resuscitation necessity which is of vital importance in our system.

Although there are various literatures that has reported the usage of an automated Intravenous (IV) monitoring device to calculate and display the flow rate of the drips, the solutions disclosed in the hitherto reported prior art suffer from drawbacks such as failure to disclose the need for drip system i.e. whether the subject is in need of fluid resuscitation, importance of surrounding temperature and humidity in fluid resuscitation and a user friendly push notification based alert system.

Thus, in view of the drawbacks reported in the above prior-arts, there exists a dire need to develop a simple, safe, cost-effective, and auto-regulated intravenous infusion system with an alarm that allows the monitoring of drips in real-time coupled with monitoring of humidity and temperature of the surrounding where the drip is being placed with the help of a smart mobile phone application or web-based application for health care management. OBJECTIVES OF THE INVENTION

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.

SUMMARY OF THE INVENTION

Accordingly, the present invention discloses 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. The online server is integrated with client app or software so that user can monitor infusion from any part of the world; Graphical User Interfaces (GUIs) may be employed, including, without limitation, Apple TM Macintosh TM operating systems’ Aqua TM, IBM TM OS/2 TM, Microsoft TM Windows TM (e.g., Aero, Metro, etc.), Unix X -Windows TM, web interface libraries (e.g., ActiveX, Java, JavaScript, AJAX, HTML, Adobe Flash, etc.), or the like. After checking the fluid resuscitation necessity, it computes the state of the drip system as empty, loaded, or jammed, and pushes a notification to registered devices via an online server. In an embodiment of the present invention, 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. In one embodiment, if the change in the surrounding temperature output signal than predetermined temperature threshold is noted, 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.

In an embodiment of the present invention, 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.

In an embodiment of the present invention, 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.

Yet another embodiment of the present invention, 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. Following the algorithmic score, 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.

In an embodiment of the present invention, 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 ½° Fahrenheit per minute. The fluid was made to traverse through Intravenous (IV) tubing at the X drops /kg / min rate (X= Set flow rate) in the outside environment temperature to check the decrease of the fluid temperature from bag(s) to catheter site(s). In an embodiment of the present invention, 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. Also in the induction of moderate hypothermia for cerebral protection during anaesthesia for cerebral aneurysm clipping, the outside temperature is of utmost clinical importance.

In yet another embodiment of the present invention, 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.

In an embodiment of the present invention, 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.

In an embodiment of the present invention, 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.

In an embodiment of the present invention, 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.

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.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

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.

DETAILED DESCRIPTION OF THE INVENTION

The present invention discloses an automatic drip monitoring device and system, its components, and its process of flow. 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. 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.

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.

Following the algorithmic score, 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. Alternatives (including equivalents, extensions, variations, deviations, etc., of those described herein) will be apparent to persons skilled in the relevant art(s) based on the teachings contained herein. Such alternatives fall within the scope and spirit of the disclosed embodiments. Also, the words "comprising," "having," "containing," and "including," and other similar forms are intended to be equivalent in meaning and be open-ended in that an item or items following any one of these words is not meant to be an exhaustive listing of such item or items, or meant to be limited to only the listed item or items. It must also be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context dictates otherwise.

EXAMPLES

The following examples are given by way of illustration only and therefore should not be construed to limit the scope of the present invention in any manner.

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.

Example 1

Following algorithmic score scale is devised to determine the fluid resuscitation necessity and hence will augment the clinical aspect. 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.

Table 1: Alarm system-based on volume:

Initial Conditions considered:

1. Total volume of IV Fluid = 500ml

2. Drop factor = 15 gtts/ml or drops/ml 3. Infusion time = 84mins [Infusion time = Total volume (ml)/flow rate(ml/hr)]

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

The result of Table 2 is reflected in figure 04.

Table 3: Temperature of IV Fluid bag without warming

The result of Table 3 is reflected in figure 05.

Table 4: Temperature of IV Fluid bag after cooling at 5°C

The result of Table 4 is reflected in figure 06.

ADVANTAGES OF THE INVENTION > Minimizes the risks of morbidity and mortality involved in intravenous treatment.

> Sends 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.

> Reduces the workload of nurses or hospital staff; > Health care staffs can be automatically informed of the intravenous drip state, blood return can be automatically avoided.

> Guarantees the safe and reliable of infusion process to corresponding mobile terminal automatic alarm suggestion when accomplishing the infusion or taking place emergency.

Claims

We Claim:

1. An automatic drip monitoring device and a system comprising: a. a smart load analyzer module (202); b. a communication module; c. online server; d. client app/software; e. housing (207); f. humidity sensor (203); g. temperature sensor (204); h. microcontroller (201) such that it may be connected to components including, i. memory drives, j. removable disc drives which employing connection protocols such as Serial Advanced Technology Attachment (SATA), k. Integrated Drive Electronics (IDE); IEEE-1394; l. Universal Serial Bus (USB); m. fiber channel; n. Small Computer Systems Interface (SSI) ; o. a Display Unit (208), and firmware; p. a clamp (205) embedded in housing for joining smart drip with a drip stand; and q. a Hook (206) accompanying the stand holds the drip bottle.

2. The automatic drip monitoring device and a system as claimed in claim 1(e), wherein the housing encases a microcontroller, a load analyzer module, communication module, temperature sensor, humidity sensor, power source, and a display unit.

3. The present automatic drip monitoring device and system as claimed in claim 1 provides remotely monitoring of infusion drip by sending push notifications to the client/user about the state of the infusion drip from algorithms.

4. The present automatic drip monitoring device and system as claimed in claim 1 wherein the clinical assessment in resuscitation necessity is supplemented to diminish the percentage of chance of morbidity or mortality.

5. The present automatic drip monitoring device and system as claimed in claim 1 wherein the healthcare staff may be automatically informed of the intravenous drip state thereby avoiding the blood return.