WO2013138537A1

WO2013138537A1 - Medical flow rate monitor and method of use

Info

Publication number: WO2013138537A1
Application number: PCT/US2013/031107
Authority: WO
Inventors: Nathaniel R. DISKINT; Vincent P. SPINELLA-MAMO; Andrew S. DEJONG; Francisco Tejada; Caitlin E. KEATING
Original assignee: Diskint Nathaniel R; Spinella-Mamo Vincent P; Dejong Andrew S; Francisco Tejada; Keating Caitlin E
Priority date: 2012-03-14
Filing date: 2013-03-14
Publication date: 2013-09-19
Also published as: WO2013138537A9

Abstract

A device and method to determine the flow rate of a liquid passing through a deformable tubing. As liquid is passed through a segment of deformable tubing, an externally mounted sensor is capable of determining the flow rate of the liquid. This is accomplished by calculating a cross-correlation of outputs from laser diodes, LED's, or acoustic sensors, or by using a pressure sensor and calculating the flow rate in terms of the pressure and physical parameters of the tubing and the liquid. An end user may program the device to perform certain actions in response to a measured instantaneous flow rate, or calculated total flow rate. These actions include audio and visual alerts transmitted over wireless, as well as performing other actuations such as switching a valve or deforming the tubing.

Description

MEDICAL FLOW RATE MONITOR AND METHOD OF USE

CROSS-REFERENCE TO RELATED APPLICATIONS This PCT Application claims the benefit of co-pending United States

Provisional Patent Application Serial No. 61/610,468, filed on 14 March 2012, and co-pending United States Provisional Patent Application Serial No. 61/668,776, filed on 06 July 2012.

BACKGROUND OF THE INVENTION Technical Field

The invention relates to a method for determining an instantaneous flow rate of a liquid passing through a deformable section of tubing. More particularly, the present disclosure relates to a device that is able to alert a user and perform certain actions in response to the instantaneous flow rate or a calculated total volume of liquid.

Background Art

The present invention provides a method to detect the flow rate of a fluid passing through deformable tubing and alert a user with audio and visual signals, or perform a programmed action, in response to a detected flow rate or calculated total volume of liquid. Furthermore, it is possible to determine the total volume of fluid that has passed through a given section of tubing by performing a time integration on the instantaneous flow rate. Flow metering is crucial in a variety of fields from medical to industrial to environmental. In medicine, the precise delivery of pharmaceuticals, nutrients and other fluids plays a critical role in patient health and safety. Both incorrectly high and low flow rates can lead to symptoms like hypothermia, myocardial infarction and death.

"The FDA's Adverse Event Reporting System from 1993 to 1998 found that... almost 10% of deaths [related to medications] occurred because nurses gave medications by the wrong route. Sometimes nurses incorrectly gave drugs IV that were intended to be administered orally or EVl. Other nurses used the wrong amount of diluent or active ingredient or administered drugs at the wrong rate.

Experts call for greater vigilance when administering "high-alert" drugs, especially medications that would be dangerous if diluted incorrectly or given too quickly - concentrated potassium chloride, IV calcium, IV magnesium, 50% dextrose, IV narcotics, and concentrated sodium chloride.

Another drug requiring great care is Diazepam (Valium), an anti-anxiety agent very sensitive to infusion rate. In pediatric patients it is import the infusion rate not exceed 1.5 mg/minute or 0.25mg/kg/dose. In adults, when given IV, diazepam should be injected at rates not exceeding 5mg/minute to prevent apnea, venous thrombosis, phlebitis and hypertension.

Medical diagnostic procedures also demand accurate fluid metering. Uroflowmetry, for example, is a test that measures the volume, speed and duration of urine released from the body. Uroflowmetry is used to evaluate the functioning of the urinary tract and can help diagnose bladder outlet obstruction and prostate enlargement. Urine flow rate can also be used in the calculation of clearance - the rate a substance is removed from the blood - and glomerular filtration rate -the flow rate of filtered fluid through the kidneys.

Sanitation is a paramount concern across a variety of fields, particularly medicine. To meet health and safety requirements medical devices must be sterilized and decontaminated after each use. Thus there is a rapidly growing demand for medical devices that are disposable. Disposable equipment, however, comes with significant sacrifice price points must be kept low because the expense of single-use equipment cannot be distributed over multiple patients. Therefore, the quality of materials often suffers to achieve a practical price point. Multi-use equipment is often made of higher quality materials and has better performance than single-use equipment because the cost of the equipment can be offset over time.

There are three classifications of medical equipment for sterilization purposes: low risk, intermediate risk, and high risk. Because stethoscopes, furniture and other low risk equipment only come in contact with intact, healthy skin or with the inanimate environment (e.g. walls and lab benches), cleaning with detergent and drying is usually adequate. Intermediate risk equipment like thermometers and endotracheal tubes do not penetrate the skin or enter sterile areas of the body, but do come in close contact with mucous membranes or non-intact skin. For such equipment, cleaning with detergent followed by high-level disinfection (HLD) is usually adequate. High-risk equipment like surgical instruments and implants penetrate sterile tissues and require cleaning followed by sterilization3. Medical sanitation practices not only address the transmission of pathogens but also the cross- contamination of pharmaceutical agents. There is an expense and time cost associated with each level of sterilization. Consequently, there is a demand to develop equipment with lower risk ratings.

Technologies frequently confront three design pressures: (1) cost, (2) performance and (3) convenience of which, usually only two may be had simultaneously. The disclosed apparatus for flow metering and control represents the junction of all three.

The disclosed apparatus meets the highest sanitation standards by never coming in direct contact with the measured substance. Thus in the medical field it may be classified as low-risk equipment, requiring only cleaning with detergent and drying. The technology is also accessible due to its potential for low cost production. And depending on its application, the apparatus may be small in size and have low power supply demands.

Increasing the availability of medical flow metering and control devices will significantly reduce the risks of medical infusions and increase the quality of patient care. The disclosed apparatus may have a variety of applications outside the medical industry. Fluid metering and control is commonly used in both industrial and consumer settings, like in fuel lines and coolant propulsion, and in the production and distribution of foods and beverages.

Pressure independent flow rate regulation is desirable for many medical and research procedures. Without a costly "bench top" syringe infusion pump, it is nearly impossible to achieve highly regulated flow. However this type of pump is not always an option for under funded research or special experimental procedures, for which human administration must often be utilized. Human administration is also sometimes the only option for out-of hospital medical personnel. Effective field equipment must fulfill five criteria:

1. Accurate & precise: Medical equipment must meet quality and performance standards. Operating protocol for medical providers is useless if their equipment can't perform as needed.

2. Portable: There's no room for dead weight in out-of-hospital medicine, whether it's in a field kit or in an ambulance.

3. Durable: Like EMS providers, equipment must be able to handle the toughest conditions.

4. Reliable: In the field conditions are constantly changing. That's why EMS provider's equipment of choice must be well tested.

5. Cost-effective: out-of-hospital EMS systems often have limited budgets, and why not let a budget, big or small, go farther?

There are currently several methods of administering fluids at a regulated rate, including centrifugal and positive displacement pumps. "Centrifugal pumps transfer energy to a fluid via a spinning impeller, converting the impeller energy to fluid pressure which moves the fluid. These types of pumps are very pressure and fluid dependant and are typically not utilized for metering due to their inability to maintain very accurate flows under changing inlet and discharge conditions. Their advantage lies in providing high flow rates at low pressures." Centrifugal pumps also need priming, meaning they must be pre-filled with the fluid in order to function. This wastes already limited supplies of medicines, as well as time, which is always too little.

"Positive displacement pumps operate by trapping a fixed volume of fluid and moving this fluid via gears, pistons, diaphragms, vanes or other devices. These pumps typically operate at lower speeds, are less sensitive to changes in discharge and suction conditions, and allow flow regulation by adjusting speed and displacement. "

Neither positive displacement nor centrifugal pumps fulfill all five of the criteria for effective field equipment design. Infusion pumps remove the researcher and the medical provider from the act of administration while a pressure-independent flow regulator for syringes incorporates them into the procedure of fluid administration and facilitates open-ended delivery. Many medicine therapies require the administrator monitor the patient's vital stats and condition and the therapy is terminated either when the maximum dose is reached or the patient's condition improves (increase or decrease or heart rate, breathing rate and volume, level of consciousness, etc).

In the same way technology is making the world smaller, it is also narrowing the gap between hospital and field-based medical care. The syringe is the international standard for medical fluid delivery and draw. However, the human component in the syringe-administrator "team" has proven fallible time and again at the expense of their patients. The state-of-the-art provided two solutions: use the stopwatch method (use a watch and try to evacuate a syringe at an even rate over a certain length of time) or get an infusion pump. Infusion pumps are costly, unwieldy, and delicate instruments generally ill-suited to the rigors of field work. They also demand a high amount of effort on part of the user - programming, filling, hooking up, cleaning, etc.

What is desired is a small, lightweight, and portable mechanism for delivering a flow rate regulated intravenous injection. Furthermore, the device must also maintain a sterile environment and enable quick replacements. DISCLOSURE OF THE INVENTION

The basic inventive concept provides a device for controlling the flow speed of a fluid.

In accordance with one embodiment of the present invention, the invention consists of an apparatus for monitoring flow of a fluid through a flexible or compressible tube, the monitoring apparatus comprising: a monitoring sensor positioned about an exterior of the flexible tube, wherein the sensor determines a flow rate of the fluid through the tube using one of: a change in diameter of the flexible tube; a change in pressure of the flexible tube; and a photovoltaic material monitoring motion through a clear version of the flexible tube; a digital analysis device in signal communication with the monitoring sensor, the digital analysis device comprising software to determine the flow rate of the fluid through the flexible tube; a user input/output interface in signal communication with the digital analysis device, the user input/output interface providing a communication interface with at least one of a monitoring system and an individual.

In a second aspect, the digital analysis device is provided in signal communication with at least one fluid flow-controlling valve enabling a change in flow rate of the fluid through the flexible tube.

In another aspect, the device can be fluidly coupled with other fluid components by an attachment mechanism at one and a secondary attachment mechanism at another end. In yet another aspect, the fluid can be introduced into the device by applying negative pressure at an attachment mechanism. In yet another aspect, the negative pressure causes the fluid to be pulled from a fluid container though a needle and further through a one-way valve.

In yet another aspect, a positive pressure is applied at the attachment mechanism, wherein the positive pressure forces the fluid to move through a second one-way valve in a direction from the attachment mechanism to the second attachment mechanism.

In yet another aspect, the negative and positive pressures are created by a syringe.

In yet another aspect, the fluid passes a detector. In yet another aspect, the sensor is a pressure detector.

In yet another aspect, the sensor is a fluid velocity detector.

In yet another aspect, a user enters a desired flow speed at an interface.

In yet another aspect, the user input/output interface is one of a dial, a keypad, a touch- screen, and a set of switches. In yet another aspect, the digital analysis device (or similar digital processor) receives a signal from the interface and the detector and performs a comparison evaluation.

In yet another aspect, the processor is a field-programmable gate array (FPGA), a microcontroller, circuit, or computer having a computer readable medium that stores a program, which, when executed, performs the comparison evaluation.

In yet another aspect, if the signal or flow rate established by the machine operator is greater than the signal from the detector, the processor will output a first signal to a controller.

In yet another aspect, if the signal from the detector is greater than the signal or flow rate established by the machine operator, the processor will output a second signal to a controller. In yet another aspect, the controller will alert the user if a first signal is generated.

In yet another aspect, the controller will alert the user if a second signal is generated. In yet another aspect, the controller is located between the detector and the second attachment mechanism.

In yet another aspect, the first signal causes the controller to decrease the speed of the fluid.

In yet another aspect, the second signal causes the controller to increase the speed of the fluid.

In yet another aspect, the controller changes the speed of the fluid by changing the cross sectional area through which the fluid passes.

In yet another aspect, the controller changes the shape of the cross-section area by flowing the fluid through a deformable tube and engaging the tube on one side by a moveable component and the remaining sides by non-deformable material.

In yet another aspect, the moveable component is controlled by a stepper motor, which moves the moveable component into or out of the tube.

A further aspect is that the device may be single-use.

In yet another aspect of the invention, the device may be able to be sterilized for multiple uses.

In a method embodiment, the present invention provides a method for maintaining fluid speed comprising: drawing fluid into a flow control device by applying a negative pressure; applying a positive pressure to force the fluid through a tube in the flow control device; setting a desired fluid flow rate on an input device; using a detector to determine a measured fluid flow rate; comparing the measured fluid flow rate to the desired fluid flow rate; and sending a signal to a controller, which deforms the tube to alter the fluid flow rate. Yet in another method embodiment, the present invention provides a method for maintaining fluid flow rate comprising: applying a positive pressure to force the fluid through a tube in the flow control device; setting a desired fluid speed on an input device; using a detector to determine a measured fluid speed; comparing the measured fluid speed to the desired flow speed; and sending a signal to a controller, which deforms the tube to alter the fluid speed.

The basic inventive concept provides a device for measuring an instantaneous flow rate of a liquid passing through a deformable tubing comprising: a flow sensor, a microprocessor in signal communication with the flow sensor, an input/output controller in signal communication with the

microprocessor, a moveable stage in mechanical communication with the deformable tubing; and a stage actuator engaging with the moveable stage wherein a position of the moveable stage modifies the circumferential shape of the deformable tubing.

In another aspect, the sensor is a light emitting element, including at least one laser emitting diode, a light emitting diode, an incandescent light, and the like. In yet another aspect, the sensor includes at least one acoustic sensor.

In yet another aspect, the sensor includes at least one pressure sensor.

In yet another aspect, the flow sensor is supported by the moveable stage, enabling the system to change a position of the flow sensor respective to the deformable tubing, wherein the moveable stage position is changed by extending or retracting the stage actuator.

In yet another aspect, the stage actuator is one of a linear actuator, piezoactuator, or stepper motor.

In yet another aspect, the stage is moved towards the deformable tubing, positioning the flow sensor proximate the tubing until a change in the output of the flow sensor is detected.

In yet another aspect of the invention, the instantaneous flow rate is calculated by performing a cross-correlation of the outputs of the flow sensor.

In another aspect of the invention, the instantaneous flow rate is calculated by the microprocessor using the output of the pressure sensor in conjunction with a cross-sectional area of the tubing and a density of the liquid.

In another aspect of the invention, a total volume of liquid is calculated by the microprocessor based on the instantaneous flow rate. It is understood that the system can monitor an initial time and completion time of the flow rate to determine the total volume of fluid that passed thereby.

In yet another aspect, an output of the microprocessor is conveyed to an end user by way of the input/output controller.

In yet another aspect, the input/output controller allows the device to communicate with the user by transmitting data to a wireless device, including a smartphone a portable computer connected over a wireless protocol, a tablet, a personal data assistant, a pager, a radio, and the like.

In another aspect of the invention, the input/output device is a touch screen. In yet another aspect of the invention, the user is able to program the microprocessor via the input/output controller to alert the user by a combination of audio and visual signals when the instantaneous flow rate is above a user defined value. In yet another aspect of the invention, the user is able to program the microprocessor via the input/output controller to alert the user by a combination of audio and visual signals when the instantaneous flow rate is below a user defined value.

In yet another aspect of the invention, the user is able to program the microprocessor via the input/output controller to alert one or more desired individual's by a combination of audio and visual signals when the total volume is above a user defined value.

In yet another aspect of the present invention, an inner diameter of the tubing is calculated by: recording an initial position of the stage; driving the stage into the deformable tubing until the stage cannot move any further; recording a final position of the stage; and subtracting the final position of the stage from the initial position of the stage.

In yet another aspect, the user is able to program the microprocessor via the input/output controller to actuate an actuator when the instantaneous flow rate is above a user defined value, wherein the actuator reduces the instantaneous flow rate.

In yet another aspect, the user is able to program the microprocessor via the input/output controller to actuate an actuator when the instantaneous flow rate is below a user defined value, wherein the actuator increases the instantaneous flow rate. In yet another aspect, the user is able to program the microprocessor via the input/output controller to actuate an actuator when the total volume is above a user defined value, wherein the actuator terminates the instantaneous flow rate.

In yet another aspect, the actuator is an electrically controlled switching valve. In yet another aspect, a position of the electrically controlled switching valve controls whether the fluid exits the device into a primary channel or a secondary channel.

In yet another aspect, the actuator deforms the deformable tubing when actuated. In yet another aspect, the actuator controls a pinch valve.

In yet another aspect, the actuator controls an iris, wherein the iris surrounds the deformable tubing.

In yet another aspect, the actuator comprises one of a linear actuator, stepper motor, or piezoelectric actuator. In yet another aspect, the microprocessor, input/output controller, and a power source are housed within an electronic housing.

In yet another aspect, a portion of the input/output controller is externally mounted to the electronic housing.

In yet another aspect, the flow sensor and auxiliary sensors are mounted to a stage.

In yet another aspect, the auxiliary sensor is any of a color sensor, infrared receiver, or a temperature sensor.

In yet another aspect, the stage is moveably connected to the electronic housing. In yet another aspect, the stage is moved towards and away from the electronic housing by a stage actuator, which is controlled by the microprocessor. In yet another aspect, the electronic housing is affixed to, or integrally formed with, a base plate.

In yet another aspect, the base member is connected to a top plate by a series of fasteners, wherein the deformable tubing is positioned passing between the top plate and the base plate.

In yet another aspect, a top segment and sections of a base segment are designed to conform to the outer diameter of the deformable tube and are pivotally connected to one another.

In yet another aspect, the top segment and the base segment may be locked by a locking mechanism to prevent further pivoting.

In yet another aspect, the electronic housing is formed integrally with the base member.

These and other advantages of the invention will be further understood and appreciated by those skilled in the art by reference to the following written specification, claims and appended drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described, by way of example, with reference to the accompanying drawings, where like numerals denote like elements and in which:

FIG. 1 presents an exemplary fluid flow rate monitoring and management system diagram illustrating interactivity between various components of a fluid flow rate measurement, monitoring and management system;

FIG. 2 presents an exemplary flow chart defining steps in using the flow rate monitoring and management apparatus;

FIG. 3 presents an exemplary flow chart defining a series of volume flow rate considerations made by a central processor to determine and manage a fluid flow rate;

FIG. 4 presents a second exemplary embodiment of a fluid flow rate monitoring and management system;

FIG. 5 presents a third exemplary fluid flow rate monitoring and management system diagram system; FIG. 6 presents a side view of the fluid flow rate monitoring and management system diagram system originally introduced in FIG. 5;

FIG. 7 presents a top view of the fluid flow rate monitoring and management system diagram system originally introduced in FIG. 5;

FIG. 8 presents an isometric view of an alternate monitoring sensor assembly configuration of the fluid flow rate monitoring and management system diagram system originally introduced in FIG. 5;

FIG. 9 illustrates an end view of the alternate assembly originally introduced in FIG. 5;

FIG. 10 presents a fourth exemplary embodiment of a fluid flow rate monitoring and management system;

FIG. 11 presents an isometric view of another exemplary embodiment of the flow monitoring system; FIG. 12 presents an exemplary webpage enabling remote interface with any of the exemplary flow monitoring systems;

FIG. 13 presents an exemplary data entry pop up window of the webpage enabling data entry by a system operator; and FIG. 14 presents a second exemplary data entry pop up window of the webpage enabling editing of the digital data in the device by the system operator.

Like reference numerals refer to like parts throughout the various views of the drawings.

MODES FOR CARRYING OUT THE INVENTION

The following detailed description is merely exemplary in nature and is not intended to limit the described embodiments or the application and uses of the described embodiments. As used herein, the word "exemplary" or "illustrative" means "serving as an example, instance, or illustration." Any implementation described herein as "exemplary" or "illustrative" is not necessarily to be construed as preferred or advantageous over other implementations. All of the implementations described below are exemplary implementations provided to enable persons skilled in the art to make or use the embodiments of the disclosure and are not intended to limit the scope of the disclosure, which is defined by the claims. For purposes of description herein, the terms "upper", "lower", "left", "rear", "right", "front", "vertical", "horizontal", and derivatives thereof shall relate to the invention as oriented in FIG. 1. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the inventive concepts defined in the appended claims. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting, unless the claims expressly state otherwise.

Medical devices tend to be either multi-use and are sterilized after each use, single-use and disposable, or a combination of the two. Multi-use devices tend to be of a high quality, impossible to achieve with cost-effective single-use devices. Combination type devices must maintain a sterile environment without being chemically, temperature, or otherwise sterilized between uses. One method to achieve this is to have a cost-effective impermeable, and interchangeable material between the sterile and non-sterile environments. The method and device described below can be used as an intermediate component between a syringe and a needle, which can be either single- or multi-use to maintain a sterile environment. An overview of the flow orifice regulator 100 is shown in FIG. 1. As further illustrated in FIG. 1, the flow orifice regulator 100 is used in conjunction with standard medical or other fluid transfer or dispensing equipment. The flow orifice regulator 100 includes a tubular section 102, wherein the tubular section 102 is connected on one side to a syringe or other dispensing mechanism by a first attachment mechanism 103 and is attached to a needle or other fluid dispensing element on the opposing side by a second attachment mechanism 104. Although a syringe is referenced in FIG. 1 for exemplary purposes, it is conceivable that any other suitable element may be employed for a user to administer positive and negative pressure using the connection provided at the first attachment mechanism 103. For exemplary purposes, the first attachment mechanism 103 and the second attachment mechanism 104 can be luer locks, however any other mechanism may be employed, including barbed or pressure fit connectors, and the like. A vial 112 contains a pharmaceutical agent or other fluid 113 that is to be administered. A needle 110 is inserted into the vial 112 to draw the contained fluid 113 into the flow orifice regulator 100. A first one-way valve 106 ensures that when negative pressure is applied by a syringe, the fluid can only flow into the flow orifice regulator 100. When positive pressure is applied on the syringe, a second one-way valve 108 ensures that the fluid flows towards the distal end, as connected by second attachment mechanism 104, while the first one-way valve 106 ensures that the fluid is not returned to the vial 112.

In an alternate embodiment, referred to as a flow orifice regulator 400, shown in FIG. 4, the syringe (syringe 110 of FIG. 1), or otherwise, may be pre-filled with the fluid. Like features of the flow orifice regulator 400 and the flow orifice regulator 100 are numbered the same except preceded by the numeral '4' .

The syringe is then directly connected to tubing 402 by a first attachment mechanism 403 so that when a force is applied to the syringe, the fluid flows directly to the subsequent components.

Once the fluid flows past a second one-way valve (similar to second one-way valve 108 of FIG. 1), a flow detector 414 measures a speed of the fluid. This can be accomplished directly via a fluid velocity sensor, or inferred by a pressure sensor in conjunction with knowledge of the physical parameters such as fluid density and use of tubing 402 fabricated of a flexible material. The measured data from flow detector 414 is delivered to a processor 416, which performs certain functions or calculations in conjunction with a user interface 418. The processor 416 may be a field-programmable gate array (FPGA), microcontroller, or other suitable electronic component capable of performing Boolean operations, including a computer having a computer readable medium having a program stored on it, which when run performs the functions shown in FIG. 3 and described further below. It is noted that the user interface 118 can be any of computer, a website, a smartphone application, a tablet application, and the like, an example of which is depicted in FIGS. 12-14. The processor 416 and the user interface 418 are provided in signal communication using a wired or wireless signal communication interface. A user is able to set the desired rate via the user interface 418. For exemplary purposes, the user interface 418 may be a dial or set of switches, however other embodiments may incorporate entry on a keypad or touch screen with corresponding visual feedback in the form of a display or other Graphical User Interface (GUI). In addition, the user may set maximum and minimum rates to set bounds for the fluid delivery to be within.

Data obtained from the user interface 418, in conjunction with the flow detector 414, are used as parameters in the processor 416 to ensure that the speed of the fluid flowing through the flow orifice regulator 400 is what is desired by the user. If the speed is either too fast or too slow, the processor 416 sends a signal to a flow controller 420, which is able to control the speed of the drug delivery by deforming the tubing through which it flows. One possible embodiment is a stepper motor, which is connected to a knife edge, which engages with one side of the tubing. If the other sides of the tubing are held in a rigid, or non-deformable, configuration, the cross-sectional area of the tubing will be reduced. Though a knife-edge has been shown for exemplary purposes, it can be contemplated that a pinch-valve, or otherwise, could also be used.

Decreasing the size of the orifice of the tubing 402 creates a non-zero area perpendicular to the flow of the fluid. This area creates a reactionary force, which is transmitted to the source of an applied force. In the case of a syringe, the force is a user depressing an end. The sum of the applied force and the reactionary force ultimately decrease the total force applied on the fluid, thereby decreasing the flow rate of fluid through the device. Similarly, by enlarging the cross-sectional area, the flow rate of the fluid respectively increases.

The fluid then flows past the flow controller 420 and through the second attachment mechanism 404. The second attachment mechanism 404 engages with a standard sized medical needle for intravenous or subcutaneous delivery.

Returning to FIG. 1, the first attachment mechanism 103, the first one-way valve 106 and the second one-way valve 108 can be connected by a Y-junction or other similar tubing configuration. The second-one way valve 108 and the second attachment mechanism 104 are connected by a section of deformable tube 102. The flow detector 114 and the flow controller 120 can be attached over the tubing, connecting the flow detector 114 and the flow controller 120. Alternatively, the flow detector 114 and 120 can protrude into the tubing connecting the second one-way valve 108 and the second attachment mechanism 104.

An exemplary process flow diagram is presented in FIG. 2. A method for controlled flow speed delivery 200 includes the steps described herein. In a filling step 210, the user draws on the syringe. After a desired amount of fluid is drawn, and in an injecting step 212, the user depresses the syringe to dispense the drawn fluid accordingly. In the alternate embodiment of FIG. 4, the user would begin at step 212. In a monitoring step 214, the fluid flow rate is measured by a flow detector 114. In a flow rate comparison step 216, signals from the processor 116 and the user interface 118 determine if the actual fluid flow rate is greater than, less than, or equal to the flow rate entered by the user in user interface 118. In a control step 218, a signal is sent from the processor 116 to the flow controller 120 to adjust the speed of the fluid. Finally, in a delivery step 220, the fluid flows out of the flow orifice regulator 100. The function performed by processor 116 is further illustrated in FIG. 3. A comparison evaluation 300 is described by the following series of steps. In an initial step 310, fluid flow is commenced. In this step, the flow controller 120 is set to a neutral position. In other embodiments, the flow controller 120 may be set to a predefined setting based on calibrated data stored in processor 116. In a monitoring step 312, the flow detector 114 measures the fluid flow and delivers the information to a processor 116. In a first comparison step 314, the processor 116 assesses whether there is any fluid flow. This may occur in three states: (1) the user has not yet begun to administer the fluid, (2) the user has finished administering the fluid, or (3) the user has paused administration. In any of the aforementioned states, there is no reason to alter the fluid flow, so the system is placed in a hold or wait state until a non-zero flow is detected. In the monitoring step 312, if the flow is non-zero, the processor 116 will proceed to a second comparison step 316. In second comparison step 316, the processor compares the flow rate from flow detector 114 with the user input of the user interface 118. If the measured flow rate from the flow detector 114 is greater than the user defined input flow rate, the processor 116 will proceed to an decrease orifice step 318, in which the cross- sectional area will be decreased to slow the fluid velocity, otherwise the processor 116 will proceed to a third comparison step 322. After decreasing the orifice size, the processor 116 will proceed to the third comparison step 322. If the detected fluid flow from the flow detector 114 is less than the user input at user interface 118, the user interface 118 will send a signal to the flow controller 120 to increase the flow rate by increasing the cross-sectional area of the tubular member 102 carrying the fluid in a increase orifice step 320, otherwise the flow orifice regulator 100 will return to the monitoring step 312. Once the processor 116 performs the increase orifice step 320, the processor 116 will return to the monitoring step 312. In addition, if either of the decrease orifice step 318 or increase orifice step 320 is activated, audio or graphical alerts may be sent to the user to indicate that the fluid flow is above or below the desired level.

A schematic representation of a flow rate monitoring device 500 is shown in FIG. 5. In the flow rate monitoring device 500, a deformable tubing 502 is placed in contact with a flow sensor 514. The flow sensor 514 can either measure the flow rate by using such sensors as a series of laser or light emitting diodes or acoustic sensors and performing a cross-correlation, or by using an externally mounted pressure sensor and calculating the flow rate based on known physical parameters, such as the density of the fluid and cross sectional area of the deformable tubing 502. If laser diodes or LED's are to be used, it is important that the deformable tubing 502 be at least optically translucent. An output of the flow sensor 504 is passed to the microprocessor 516. The microprocessor 516 is able to perform various mathematical functions, such as integration, on the output of the flow sensor 514 before finally outputting that information to an input/output controller 518. If the output desired is the instantaneous flow rate, the microprocessor 516 will calculate a computed flow rate value based on which sensor is used as the flow sensor 514, i.e. performing a cross- correlation or determining the flow rate from the sensed pressure, and then output the computed flow rate value to the input/output controller 518. If the total volume of liquid that has flowed past the sensor is desired, the microprocessor 516 can perform a time integration on the computed flow rate value to produce a computed volume value. The input/output controller 518 can transmit the output of the microprocessor 516 to an end user either via a screen on the flow rate monitoring device 500 or via a wireless transmission to a receiving device, such as a computer or mobile smart phone, using an appropriate wireless protocol. The input/output controller 518 is also able to relay information from an end user to the microprocessor 516 either wirelessly via a smart phone or a computer over connected using a wireless protocol, or using a touch screen or similar device located on the flow rate monitoring device 500. This enables the end user to set which mode the device is operating in, instantaneous flow or total volume, as well as to set any alerts or function to be performed when user entered thresholds are exceeded. These functions may be displayed on and performed by a website or smart phone application as depicted in FIGS. 12 through 14. For exemplary purposes, the user may enter a value of maximum or minimum flow rates so that if these levels are exceeded, the end user is notified via the input/output controller 518 with a combination of audio and visual alerts. The flow rate monitoring device 500 may optionally include a plurality of auxiliary sensors 550. Any auxiliary sensor 550 serves to provide additional information about the fluid to the microprocessor 516 and, ultimately, to an end user. For exemplary purposes, the auxiliary sensor 550 may be a temperature sensor or a color sensor. Per this example, if the liquid passing through the deformable tubing is urine, the temperature sensor provides critical information on the internal body temperature of the patient, where the color sensor can provide information on the functioning of the kidneys. The flow rate monitoring device 500 may also optionally include a memory storage device, which is able to record the output data from the microprocessor 516. The data stored on the storage device may be transmitted via the input/output controller 518 in the form of wireless transmissions or via a port located on the flow rate monitoring device 500 which may be connected to a computer. FIGS. 6 and 7 demonstrate how the flow rate monitoring device 500 is affixed to the deformable tubing 502. The microprocessor 516 and input/output controller 518 are located within an electronics housing 534. A portion of the input/output controller 518, for example, a touch screen, may be externally located on the flow rate monitoring device 500. The electronics housing 534 also contains a power source 540, which is able to provide power to all components. The electronics housing 534 is either connected to or integral with a base plate 532. The base plate 532 is connected to a stage 544 via a stage actuator 542. The stage 544 hold the flow sensor 514 and, if present, the plurality of auxiliary sensor 550. A plurality of fasteners 560 is thread through a front plate 530 and into receiving portions of the base plate 532. The fasteners 560 are thread through locations on the front plate 530 so as to allow the deformable tubing 502 to pass between them. The fasteners 560 are long enough such that when fully thread through the front plate 530 and received in the base plate 532, the space between the front plate 530 and the base plate 532 is slightly longer than the outer diameter of the deformable tubing 102, the width of the stage 544, and the maximum length of the stage actuator 542 combined. When the flow rate monitoring device 500 is activated, the microprocessor 516 will control the stage actuator 542 to move the stage 544 towards the deformable tubing 502 until a significant change in the output of the flow sensor 514 is detected. This indicates that the flow sensor 514 is now in contact with the deformable tubing 502 and measurements of the flow rate may begin. Furthermore, in order to determine the inner diameter of the tubing used, it is possible for the microprocessor 516 to record an initial position of the stage 544 and continue to move in the same direction until no further change in position is detected. Since the outer diameter of the tubing is known from the initial position of the flow sensor 514 with respect to the front plate 530, it is possible to calculate the inner diameter of the tubing. The inner diameter is simply the difference of the two recorded positions, as shown in the equations below:

(1) OD = L - Xi

(2) 2t = L - X₂

(3) ID = OD - 2t = (L - Xi) - (L - X₂) = X₂-Xi Where L is the distance between the front plate 530 and the power source 540, XI is a first recorded position of the stage 544 and X2 is a second recorded position of the stage 544, t is the thickness of the tubing, OD is the outer diameter, and ID is the inner diameter. Once calculated, the stage 544 will be moved back to the initial position. It is important to know the inner diameter of the tubing, as the cross sectional area is required to determine the flow rate from the pressure.

FIGS. 8 and 9 depict an alternate method of securing the flow rate monitoring device 500 to a deformable tubing 502. Here, instead of a plurality of fastener 560, the power source 540 is placed into a base segment 570. The base segment 570 is pivotally connected to a cover segment 572 using a hinge 574. For exemplary purposes, the hinge 574 may be a living hinge. The base segment 570 and cover segment 572 are designed in such a way as to conform to an outer diameter of the deformable tubing 502. The cover segment 572 pivots about the hinge 574 and closes around the deformable tubing 502. The base segment 570 and cover segment 572 are then secured in place by a base locking mechanism 576 and a cover locking mechanism 578. The base locking mechanism 576 and cover locking mechanism 578 fit together so as to restrict any pivotal motion of the base segment 570 relative to the cover segment 572. As shown in FIG. 9, the microprocessor 516, input/output controller 518, and power source 540 are located within the base segment 570, with a component of the input/output controller 518 possibly being visible externally, for example a touch screen. A cavity 580 is formed in the base segment 570 in order to allow a stage 544 to be connected to the base segment 570 via a stage actuator 542. As before, the stage 544 contains a flow sensor 514 and, optionally, a plurality of auxiliary sensors 550 which are brought into contact with the deformable tubing 502 via a stage actuator 542. As before, the stage actuator 542 is controlled via the microprocessor 516.

FIG. 10 depicts an alternative embodiment of the present invention. Here a flow actuating device 600 is capably of determining a flow rate or total volume of liquid and perform an actuation in response to a user entered value. As in the flow rate monitoring device 500, a flow actuating device 600 is able to determine an instantaneous flow rate of a liquid passing through a deformable tubing 602. The instantaneous flow rate is calculated by a microprocessor 616 via the output of a flow sensor 614. The total volume of liquid may also be calculated by the microprocessor 616 based on the flow sensor 614. An input/output controller 618 allows an end user to interact with the microprocessor 616. The input/output controller 618 may be a touch screen, a combination of visualizations, alarms, and keypads or enable interaction of the microprocessor 616 with a computer or smart phone over a wireless protocol. The input/output controller 618 allows the user to set predefined conditions for actions by the microprocessor 616, such as alerting the user when a certain flow rate has been exceeded. The flow actuating device 600, however, also has an actuator 690. The actuator 690 may be used to alter the flow of the liquid passing through the deformable tubing 602. For exemplary purposes, the actuator 690 may be an electronically controlled valve and programmed via the input/output controller 618 to switch between a primary flow channel 692 and a secondary flow channel 694 of the deformable tubing 602. As an example only, this could be used in patients who are required to use a catheter and drainage bag. The end user may program the flow actuating device 600 to switch to a reserve drainage bag when a total volume has passed the sensor and alert the user with audio and visual signals via the input/output controller 618. As an alternate example, the actuator 690 may be a linear actuator or stepper motor used to control a pinch valve or an iris engaged with the deformable tubing and the user may program the flow actuating device 600 to change the inner diameter of the deformable tubing 602 in response to a measured flow rate of liquid passing through the deformable tubing 602.

Referring now to FIG. 11, a flow monitoring system 700 is provided to control the flow rate of a liquid through a segment of deformable tubing 702. In some intravenous delivery systems, a segment of deformable tubing 702 is connected to a drip chamber 704. The flow monitoring system 700 establishes the flow rate of said liquid by taking advantage of the drip chamber 704. A light emitting diode 710 is placed on one side of the drip chamber 704 and a photo detector 712 is placed directly opposite to receive the light generated by the drip chamber 704. The light emitting diode 710 and photo detector 712 are held in a fixed position relative to the drip chamber 704 by a flow device housing 706. The drip chamber 704 causes the liquid to form into a droplet at an upper end of the drip chamber 704. When that droplet becomes large enough, it falls to a lower end of the drip chamber 704. As the droplet passes between the photo detector 712 and light emitting diode 710, the change in light transmitted between the light emitting diode 710 and the photo detector 712 will trigger a counting event within a processing unit 714. The light emitting diode 710 and the photo detector 712 are assembled to the flow device housing 706 by a detector housing 708. For exemplary purposes, said counting event could be triggered by the output of the photo detector 712 amplified by an operational or instrumentational amplifier along with a reference voltage being input into a comparator such that a change in light causes a change in voltage from the comparator. The output of the comparator could then be fed into a standard counter integrated circuit (IC). The number of counts may be sent to a remote router using a wireless connection available through the processing unit 714. The processing unit 714 also contains circuitry to control the fluid flow rate by means of a flow control valve 718. A maximum flow rate is set by an end user and entered either via an input device connected to the processing unit 714 (i.e. a touch screen or keypad). Alternatively, the flow rate may be set remotely using wireless circuitry contained in processing unit 714, as depicted in FIGS. 12 through 14. If the number of droplets counted in a given period of time are greater than the maximum flow rate, the processing unit 714 send a signal to the flow control valve 718 to close the flow control valve 718 about the deformable tubing 702, thereby restricting the flow. All of the components and circuitry are held in place in a flow device housing 706. In addition to controlling the flow rate of the liquid passing through the deformable tubing 702, the flow monitoring system 700 may optionally be equipped with at least one inlet port 720. The inlet port 720 allows is designed to receive a disposable infusion device. For exemplary purposes, such a disposable infusion device could be the polymer based infusion pump offered by Medipacs, Inc. Referring now to FIGS. 12 through 14, a web-based program can be used to set the maximum flow rate, as well as other parameters of the flow monitoring system 700 using a wireless connection. In order to set these parameters, an end uses a web browser (whether on a computer connected to the internet or a smart phone with internet connectivity) to visit a website. The website is able to communicate with the flow monitoring system 700, as described below.

A remote valve control system 800 allows a user to interact with the device via a remote server. A device display panel 802 displays a snapshot of all of the devices, which are currently in use and owned by the end user. The device display panel 802 may be sorted, for example, by Last Name, First Name, or Room Number. When an end user clicks on any members in the list displayed in device display panel 802, the program populates the remainder of the website with data from that device. That information includes patient name display area 804, pharmaceutical display area 805, flow rate display area 808, total volume display area 810, patient room display area 806, device serial number display area 803, and battery display area 812. The flow rate display area 808, total volume display area 810, battery display area 812, and total flow time display area 814 are continually updated based on data which is transmitted from the device to the remote server. When an end user clicks on add device button 818, a pop-up window displays a add device page 820. The add device page 820 has a serial number entry area 822, a patient last name entry area 824, a patient first name entry area 826, a pharmaceutical entry area 828, and an room number entry area 830 to allow the user to enter information about a new device that is to be used. The end user may save this information by clicking on a save button 860 or cancel the operation by clicking a cancel button 866. When the user clicks the edit device button 816, a further window will pop-up to display an edit device page 840. The edit device page 840 will display the device serial number, or other indicating string, in a serial number display 842. The end user can set a patient last name entry 852, a patient first name entry 854, a pharmaceutical entry 856, and a room number entry 858. By clicking on a patient first name entry 854, the end user will save the entered data about the device to the server. Clicking on a reset button 862 will set the total volume flow and the instantaneous flow rate of the device stored on the remote server to zero. Clicking on the delete button 864 will remove the device from the list of devices in the remote valve control system 800.

Since many modifications, variations, and changes in detail can be made to the described preferred embodiments of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalence.

Claims

What is claimed is:

1. A fluid flow rate monitoring apparatus comprising: a monitoring sensor positioned about an exterior of the flexible tube, wherein the sensor determines a flow rate of the fluid passing through the flexible tube using one of: a change in diameter of the flexible tube, a change in pressure of the flexible tube, a drip flow rate monitor, and a photovoltaic material monitoring motion through a clear version of the flexible tube; a digital analysis device in signal communication with the monitoring sensor, the digital analysis device comprising software to determine the flow rate of the fluid through the flexible tube; a user input/output interface in signal communication with the digital analysis device, the user input/output interface providing a communication interface with at least one of a monitoring system and an individual.

2. The fluid flow rate monitoring apparatus as recited to claim 1, further comprising a flow rate control mechanism, wherein the flow rate control mechanism compresses the flexible tubing, reducing a cross sectional area to reduce flow rate of the fluid.

3. The fluid flow rate monitoring apparatus as recited to claim 1, wherein the fluid flow rate is determined by measuring a pressure exerted by a wall of the tubing.

4. The fluid flow rate monitoring apparatus as recited to claim 1, the digital analysis device further comprising flow rate analysis software to determine at least one of:

(a) whether the measured flow rate is zero, (b) whether the measured flow rate is greater than a maximum predetermined flow rate, and

(c) whether the measured flow rate is less than a minimum predetermined flow rate.

5. The fluid flow rate monitoring apparatus as recited to claim 1, further comprising a flow controller, wherein the flow controller is provided in communication with the tubing and is operationally controlled by the digital analysis device.

6. The fluid flow rate monitoring apparatus as recited to claim 1, wherein the monitoring sensor is assembled circumscribing a peripheral exterior surface of a segment of the flexible tube.

7. The fluid flow rate monitoring apparatus as recited to claim 1, wherein the monitoring sensor is carried by an actuator, wherein the actuator draws the monitoring sensor in contact with the flexible tube.

8. The fluid flow rate monitoring apparatus as recited to claim 1, further comprising an actuator, wherein the monitoring sensor is carried by the actuator and the actuator draws the monitoring sensor in contact with the flexible tube.

9. The fluid flow rate monitoring apparatus as recited to claim 1, the digital analysis device further comprising flow rate analysis software, wherein the flow rate analysis software enables an operator to establish at least one of a minimum fluid flow rate and a maximum fluid flow rate.

10. The fluid flow rate monitoring apparatus as recited to claim 9, the flow rate analysis software further comprising a direction for accomplishing at least one of:

(a) increasing the fluid flow rate when the measured flow rate is lower than the operator defined minimum flow rate, and (b) decreasing the fluid flow rate when the measured flow rate is greater than the operator defined maximum flow rate.

11. The fluid flow rate monitoring apparatus as recited to claim 9, further comprising a compressive mechanism, wherein the compressive mechanism changes a compression force applied to the flexible tubing to alter the fluid flow rate.

12. The fluid flow rate monitoring apparatus as recited to claim 1, further comprising a compressive mechanism, wherein the compressive mechanism changes a compression force applied to the flexible tubing to alter the fluid flow rate.

13. The fluid flow rate monitoring apparatus as recited to claim 1, further comprising a wireless communication interface, wherein the wireless communication interface provides wireless signal communication between the digital analysis device and the user input/output interface.

14. The fluid flow rate monitoring apparatus as recited to claim 1, wherein the user input/output interface is one of a computer, a website, a smartphone application, and a tablet application.

15. The fluid flow rate monitoring apparatus as recited to claim 1, further comprising additional sensors, including at least one of a second flow rate sensor, a temperature sensor, and a color sensor.