Abstract:
A fluid level monitoring device and a method of use are disclosed for alerting a user that the fluid in a container, such as an intravenous (i.v.) injection or irrigation bag or collection of waste from a human body (catheter) have reached a pre-determined volume.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of Patent Cooperation Treaty application number PCT/US2015/014928, filed 6 Feb. 2015, which in turn claims the benefit of U.S. application No. 61/937,963, filed 10 Feb. 2014 and which are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    Disposable containers are used in many industries to hold and dispense fluids of various natures. When the fluid has been used and the container is empty, or when it is filled with waste, it is usually thrown away. Some examples of this type of packaging are flexible plastic i.v., catheter and irrigation bags commonly used in hospitals. 
         [0003]    Sterile i.v. bags are normally used to dispense plasma, whole blood, replacement electrolyte, etc. The bags are usually imprinted or screen-labelled with the required documentation to identify the contents. When using containers of the i.v. bag type, the normal procedure is to dispense a metered amount over a given period of time by unmonitored, gravity-fed, drip feeding. The containers themselves come in different sizes, and i.v. fluids are administered to patients requiring widely varying flow rates. For example, 250 milliliter (ml.) to 3 liter plastic i.v. bags or bottles may be used to dispense a solution of 0.9% saline, Ringers lactate, 5% glucose, plasma, or blood to an adult over a 10-40 minute or longer time period, at rates of 1-25 ml. per minute (or more depending on the need). 
         [0004]    It is a common practice to pre-set the gravity-driven flow rates via a visual drop-counting metering mechanism located above the i.v. catheter. However, pre-set flow rates can vary over a substantial range, due to changing resistance to outflow resulting from several variables. Some of the variables that can affect the flow rate include: the changing height of the insertion site relative to the fluid level as the patient moves about; a partial or complete closing (kinking) of the tubing; the thrombosis (clotting) promoting propensities of the solution being dispensed; the angle of the needle influencing the occlusion of its beveled opening; the settling of the various components of the fluid in the container, such as blood cells; and other reasons. In a chaotic environment such as an operating or emergency room, it is not always possible for someone to constantly monitor the amount of fluid in an i.v. bag. 
         [0005]    It is detrimental to a patient to have the flow of an i.v. fluid come to a complete stop. Complications which can occur after the flow has stopped include the clogging of the needle due to blood clotting, usually requiring reinsertion of a new needle, or blood passing out of the patient into the tubing. It is important to note that, in addition to pain, the risk of infection and hematoma increases every time a needle has to be inserted and reinserted into a vein. In a high stress environment such as a hospital operating room or trauma center, staffs are often engaged in a variety of vital tasks at one time and the fluid levels of i.v. bags are often not changed, resulting in harm to the patient. 
         [0006]    This contributes to the rise in healthcare costs, as patients require more care; while physicians and medical facilities are forced to payout large sums of money in medical malpractice lawsuits. 
         [0007]    Similarly, many endoscopic surgeries, require that the bodily cavity be irrigated with a saline or similar solution. These irrigation solutions are delivered through a container, similar to an i.v. bag. Failure to monitor the bag may result in injury to the patient; for example, failure to maintain irrigation pressure, during a bladder surgery may result in a collapse of the compartment, causing the surgeon to lose track of the area he was working on or even cause inadvertent injury to the urethral orifices or puncturing the bladder cavity. 
         [0008]    Operating room nurses and technicians currently have the responsibility for monitoring i.v. fluid levels and making sure they do not run out. However, in a busy operating room environment there are many distractions and demands for attention increasing the likelihood of an i.v. fluid inadvertently running out. A need, therefore, exists to find a practical, low-cost solution to the problem of how to determine, without constant direct human observation, when the fluid in one of these containers reaches a level requiring action by the nurse, doctor, attendant, or patient, and to get their attention at the required time. The present invention fills this need. 
       SUMMARY OF THE INVENTION 
       [0009]    A primary object of the present invention is to provide the medical profession with an efficient, inexpensive way to continuously monitor the fluid levels in bags used for dispensing an i.v. or irrigation fluid or for collecting body fluids and alert the user when the fluid levels reach a pre-set weight. 
         [0010]    The present invention provides a weight sensing fluid level monitoring system for determining when the amount of fluid in a container, for example, a disposable plastic bag used for intravenous infusion or the collection of biological fluids or other waste from a human body has reached a point where the container must be replaced or emptied. The device in its various embodiments can provide both visual and audible alarms at the patient&#39;s bedside or wirelessly transmit the alarm to a remote location, such as a nurse&#39;s station, by way of the internet or intranet. 
         [0011]    The device is pre-programmed to alert the user when the weight of fluid in a container, such as an i.v., irrigation or catheter bag, reaches a certain pre-programmed level. The device is suspended between an i.v. stand or hook and a container, by way of top and bottom hooks projecting from the device. Internally, the hooks are attached to one or multiple strain gauges, which detect deformations in the hook members, caused by the weight of the container. It then transmits that information to a microprocessor by way of an analogue to digital converter. As the fluid in the container reaches its pre-programmed weight, the microprocessor triggers visual and audible alarms to notify the user that the container bag must be replaced. 
         [0012]    In one embodiment, when the user sets the device with the container fluid amount and alarm threshold level. When the fluid level in the container decreases to a pre-determined level, the visual and audible alarms activate to notify the user that the level is becoming critically low. In another embodiment, when the fluid level in a bag collecting body fluids rises to a pre-determined level, the visual and audible alarms activate to notify the user that the level is becoming critically high. 
         [0013]    In a further embodiment, the device contains a wireless transmitter for connection to the internet. When the fluid reaches its pre-programmed level, an alarm will be triggered at a remote location, (e.g., a nurse&#39;s station). 
         [0014]    In yet another embodiment of the device, the device is pre-programmed with, its location in the medical facility, the fluid that it is monitoring, the amount of fluid in the container, and the alarm threshold. When the threshold fluid level is reached, the device, through the wireless transmitter notifies a medical facility&#39;s automated inventory system that the container must be changed. The automated inventory system, in turn, alerts the supply room to bring a new container to the device&#39;s pre-programmed location and sends an acknowledgement back to the device so it may let the operating room staff know that more material is on the way 
         [0015]    Thus, the present invention in its different embodiments provides an easy-to-use, inexpensive, portable fluid level monitoring device which can be installed in every hospital room, ambulance, or mobile medical facility. The immediate advantages of using such a fluid level monitor would include reducing the incidence of injury to patients caused by failure to timely change the i.v. or catheter bag and increasing productivity for the medical professionals by not having to continuously monitor fluid levels. Furthermore, the energy source necessary to power this device is self-contained, in the form of readily available batter(ies), making the device completely portable. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]    These and other objects, features, and aspects of the invention will be better understood and more fully described upon reading the following detailed description in conjunction with the appended drawings wherein: 
           [0017]      FIG. 1  is a block diagram of a system for determining the fluid level in container in accordance with the present invention; 
           [0018]      FIG. 2  is a left perspective view of the preferred embodiment of a fluid level sensor; 
           [0019]      FIG. 3  is a right perspective view of the preferred embodiment of a fluid level sensor; 
           [0020]      FIG. 4  is a front view of the preferred embodiment of a fluid level sensor; 
           [0021]      FIG. 5  is a rear perspective view of the preferred embodiment of a fluid level sensor with the battery cover removed; 
           [0022]      FIG. 6  is a front view, of the preferred embodiment of the sensing assembly of the fluid level sensor; 
           [0023]      FIG. 7  is a right, top perspective view of the preferred embodiment of the sensing assembly of the fluid level sensor; 
           [0024]      FIG. 8  is a front perspective view of the preferred embodiment of the sensing assembly of the fluid level sensor under stress; 
           [0025]      FIG. 9  is a front perspective view, of the preferred embodiment of a fluid level sensor with the front casing, view screen, and microprocessor board removed; 
           [0026]      FIG. 10  is a front perspective view of the preferred embodiment of a fluid level sensor with the front of the housing, view screen and microprocessor removed. 
       
    
    
     DETAILED DESCRIPTION 
       [0027]    Referring now to  FIG. 1 , depicting the operation of the preferred embodiment of a weight measuring fluid level monitoring device (hereinafter the “device) constructed in accordance with the present invention is shown. The device is suspended between a hook or i.v. stand  2  and a container  3 , such as an i.v., irrigation or catheter bag, or bottle by a sensing assembly  4 , with top and bottom hook members  19 , 20  comprised of a double bending hook member and four strain gauges  5 . The four strain gauges  5  measure the distortions in the sensing assembly caused by the weight of the container and transmit that information to a microprocessor board  8  by way of a 24-bit sigma-delta analog-to-digital converter board  6  which is tightly integrated with the sensing elements and an integrated switch board  9 . The microprocessor then signals a speaker to emit an audible alarm  9  and a view screen  10  to emit a visual alarm in the form of a flashing LED backlight. The device is activated through an on/off switch  11 . 
         [0028]    In the preferred embodiment, the tare is automatically set at the time the unit is first turned on. The user sets the initial alarm threshold using a momentary center-off programming switch  12 . The threshold level is set based on the initial volume of fluid in the container; given that the fluid, such as saline, used in many medical uses has a density of approximately 1 gram per milliliter, weight and volume may be used interchangeably. The threshold value may be set for any value down to the milliliter. Alternative embodiments of the invention may tradeoff precision and accuracy of the measurement and alarm, or utilize a programming element in the form of a touch enabled view screen; USB-connected peripheral device, such as a tablet or smartphone; or from a remote location by way of an internet enabled, wireless transmitter  13   
         [0029]    While the preferred embodiment of this device utilizes a four strain gauge configuration, alternative embodiments may utilize one or two strain gauge configuration, with tradeoffs in cost, dynamic range, sensitivity, accuracy and/or precision. 
         [0030]    A one or two strain gage system may be created either by simply mounting only one or two strain gages on the existing double bending beam configuration. Alternately, a simpler single beam mechanical configuration may be employed, with that mechanism becoming more susceptible to off-axis forces. 
         [0031]    In another embodiment, the device contains a wireless transmitter for connection to the internet, allowing for notification of a remote location, such as a nurse&#39;s station or connecting to a medical facility&#39;s store room. 
         [0032]      FIG. 2  illustrates a left perspective view of the device  1 . The housing consists of front and rear assemblies  14 ,  15 . The alarm threshold is set by a momentary center-off programming switch  12 . Guard fences, located front and rear of the momentary center-off switch  16 ,  17 , provide protection from damage, such as a from a drop. A stainless steel captive thumbscrew  18  is used to secure the rear battery compartment cover to the device. Top and bottom hook members  19 ,  20  of the sensing assembly can be seen protruding from the top and bottom of the device between the front and rear assemblies, the hook members are asymmetric and opposing one another; from this view, the top hook member is partially obscured. 
         [0033]      FIG. 3  illustrates a right perspective view of the device  1 . The housing consists of front and rear assemblies  14 ,  15 . The device is activated by an on/off switch  11 . Guard fences  16 ,  21 , located front and rear of the programming switch provide protection from damage, such as from a drop. A stainless steel captive thumbscrew  18  is used to secure the rear battery compartment cover to the device. Top and bottom hook members  19 ,  20  of the sensing assembly can be seen protruding from the top and bottom of the device between the front and rear assemblies, the hook members are asymmetric and opposing one another; from this view, the top hook member is partially obscured. 
         [0034]      FIG. 4  illustrates a frontal view of the device. From this view the asymmetric and opposing placement of the top and bottom hook members  19 ,  20  is apparent. In the preferred embodiment, the view screen  10  supports a 2-line alphanumeric display, with up to 16 characters per line, red, green, or blue LED status dependent backlighting which blinks, and then flashes as fluid level goes below pre-programmed threshold level. The top line displays approximate fluid remaining; the bottom line displays alarm threshold or other messages as appropriate. Alternative embodiments, may support another display type, such as a touch screen enabled liquid crystal display. 
         [0035]      FIG. 5  illustrates a rear perspective view of the preferred embodiment of the device with the battery compartment cover  22  removed, exposing the battery compartment  23 ; the stainless steel captive thumbscrew  18  is used to secure the battery compartment cover to the device and stays with the battery case cover when it is removed from the body of the device. In the preferred embodiment, commercially available AA batteries are used as a power source; though other embodiments may utilize other battery types, such as AAA, 9 V or a lithium ion battery. 
         [0036]      FIG. 6  illustrates a front view of the sensing assembly. The sensing assembly  4  is composed of a double bending hook member constructed of a single piece of aluminum, though other metals or materials may be used. The double bending hook member is further comprised of a rectangular member and two hook members. The rectangular member is composed of top and bottom horizontal legs  24 ,  25 ; right and left vertical legs,  26 ,  27 . The vertical legs are thick, relative to the horizontal legs and form the top and bottom hook members  19 ,  20  which couple the load to the horizontal legs  24 ,  25 . The top and bottom hook members  19 ,  20  protrude outward from their respective vertical legs, through the housing and are situated so that they are asymmetric and opposing to one another. The top hook member  19  is suspended from a hook or i.v. stand  2  and the load, the fluid container, is attached to the bottom hook member  20 . One vertical leg  26  contains holes  28  for attachment directly to the housing. The configuration of the sensing assembly  4  in a dual bending beam configuration with the two bending beams, the top and bottom horizontal legs  24 ,  25 , widely separated; naturally resists torsional and off-axis forces from affecting a reading. 
         [0037]      FIG. 7  illustrates a right, top perspective view of the sensing assembly. The centers of the two horizontal legs,  24  and  25  are hollowed out and tapered with the thinnest section at the center so the mechanical strain is more uniformly distributed across the area of the beam, this allows them to become the bending beams for the load cell; this also serves to improve the efficiency of the strain gauges. The four strain gauges  5  of the preferred embodiment, each the width of the rectangular member are placed along the horizontal legs, one at each corner of the rectangular member. Each horizontal member contains two strain gauges  5 , one to measure compression, while the other strain gauge measures tension. Alternative embodiments of the invention may utilize a two strain gauge configuration, wherein both strain gauge are placed along either the top or bottom horizontal leg; or a one strain gauge configuration where a single strain gauge is placed along ether the top or bottom horizontal leg. 
         [0038]      FIG. 8  illustrates the sensing assembly while under a weight load bearing stress. While supporting weight, the interior surface of the bending beam where the strain gauges are mounted, half of a single horizontal member is in tension  29 , and the other half is in compression  30 , causing the horizontal member to bend in a sigmoidal shape due to the orientation of the hooks. By utilizing two strain gauges in each bending arm, a Wheatstone bridge is formed. 
         [0039]      FIG. 9  illustrates a front perspective view of the device with front housing assembly  14 , including the view screen  10  and microprocessor board  8 , and switch-interface board  7 , removed. In the preferred embodiment, strain from the weight of a container  3  suspended from the bottom hook  20  of the sensing assembly is measured by a series of four strain gauges  5  in a Wheatstone bridge configuration. 
         [0040]    One of the vertical legs  31  is attached directly to the housing; while the other vertical leg  32  and both horizontal legs  24 ,  25  are free floating inside the enclosure; this allows for free movement of the bending beams and the lower hook, while under load. The analogue to digital converter  6  sits at the center of the rectangular member. The analogue to digital converter is connected by soldered wires, not shown, to each strain gauge  5 . 
         [0041]    The rear housing  20  has a precision cavity  33  machined into it to accommodate the rectangular member of the sensing assembly and allow for the hook members to protrude from the top and bottom. Under the current embodiment, the aluminum bending beams are capable of supporting an object of up to 30 pounds weight or 57,200 psi of force, before the bending beams reach their elastic limit of 0.055″ of displacement. The clearance between the horizontal legs of the sensing assembly and the housing is less than 0.05″, therefore preventing deformation of the bending beams before the elastic limit is reached. This allows for sufficient deflection on the horizontal legs, less than would be required for permanent elastic deformation under high stress or fault conditions, such as being dropped, yet enough so that linear operation through the intended stress range is allowed. 
         [0042]    According to the preferred embodiment of the device, the sensing assembly is able to detect changes in the weight down to one-tenth of a milliliter or gram; however in practice, the device will be set down to the milliliter or gram level; with the lowest available threshold alarm setting at approximately 50 mL or g. 
         [0043]    When fluid levels drop to a pre-programmed level, the strain on the horizontal legs of the rectangular member will lessen, that loss of strain will be measured by the strain gauges which will then transmit that loss of strain through the analogue to digital converter and on to the microprocessor board; the microprocessor board will then activate both a visual alarm, and sound an audio alarm. Both alarms will continue until the fluid level monitoring device is shut-off, re-set by the user, or a new bag is hung. 
         [0044]    Also illustrated in  FIG. 9  are a retention bar  34 , the speaker  9 , a USB connector  35 , and a feed through  35  to the battery compartment. The placement of the retention bar allows for drop protection. The USB connector allows for pre-programming from a personal computer, or a mobile device such as a tablet or smartphone. 
         [0045]      FIG. 10  illustrates a front perspective view of the device with the front housing, including view screen  10 , and microprocessor board  8  removed. The rear side of the switch-interface board  7  connects to the analog to digital converter board, while the microprocessor board connects to the front housing assembly. The switch-interface board also provides a mounting plane for the switches, the speaker, the USB connector, and a feed through connector to the battery compartment. 
         [0046]    In an alternate embodiment of the device, the fluid level monitoring device has a wireless connection interface and is connected to a medical facility automatic ordering system through a wireless internet connection. Prior to use, the fluid level monitoring device is uniquely identified and pre-programmed with its location, the nature of the fluid it is monitoring, the initial volume or weight of the fluid container, and a threshold weight corresponding to a fluid volume which will trigger the alarms. When the pre-programmed alarm threshold is initially reached, the visual display flashes and the audible alarm sounds to notify the local user that the fluid level has reached its pre-programmed threshold. The device further transmits instructions to the medical facility&#39;s automatic ordering system that a new container is needed; in turn the automatic ordering system contacts the facility stock room and requests that a new container be brought to the fluid level monitoring device&#39;s location. 
         [0047]    In review, it can now be seen that the fluid level monitoring device of the present invention provides an inexpensive, easy-to-use, self-contained device having numerous applications. Each of the various embodiments described above provide particular advantages in various applications of fluid level monitoring. An acknowledgement is sent back to the device. If an acknowledgement is not received by the time the fluid reaches a lower predetermined level the device will alarm again, indicating personal intervention is needed 
         [0048]    While preferred embodiments of the invention have been illustrated, it will be obvious to those skilled in the art that various modifications and changes may be made thereto without departing from the spirit and scope of the invention as hereinafter defined in the appended claims.