RAPID ASSIST DEVICE FOR IV FLUID INFUSION

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62/391 ,084, filed April 19, 2016, which is herein incorporated by reference in its entirety.

INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

FIELD

[0003] This invention relates generally to a pump that can monitor and maintain constant pressure, and, more specifically, to such a pressure bag infuser used for intravenous administration of fluids.

BACKGROUND

[0004] In an emergency situation, a critically ill or injured patient may require rapid administration of fluids or blood products. Clinical conditions for which rapid infusion of intravenous crystalloids and colloids are recommended include cardiac arrest, hypovolemic shock, some endocrine disturbances, distributive shock states, and systemic inflammatory response syndrome. In such cases, IV (intravenous) bags are pressurized to increase the flow rate for the IV fluids therein. Currently, this is done by positioning a pressure bag infuser around the IV bag and inflating the pressure bag to a desired pressure with a hand-held, manual pump. The pressure on the IV bag causes the fluids inside the IV bag to flow into the patient more rapidly than could be achieved with the IV bag and gravity alone.

[0005] In emergencies away from the hospital, such as on the battlefield, a blood pressure cuff/pressure infuser is often used to wrap around an IV bag and then inflate to pressurize the bag, causing the fluids inside to outflow more rapidly.

[0006] One of the drawbacks to these systems is the requirement of constant monitoring by medical personnel. As fluid flows out of an IV bag, the IV bag decreases in size, thus decreasing the force exerted on the outside of the bag by the pressure infuser, whose position and pressure is fixed, resulting in a decreased infusion rate. Frequently the pressure infuser must be re-pumped manually to maintain constant, rapid IV flow. In a fast-paced, acute care setting or battlefield, critical time is wasted as personnel stop to reassess infusion rates and repeatedly increase pressure in the infuser. Yet, such vigilance is crucial, as failure to assess and maintain the infusion will result in inadequate rapid volume delivery to the patient.

[0007] There is a need to automatically maintain pressure on an IV bag to ensure the patient receives the prescribed amount of fluid at the desired rapid rate and to relieve medical personnel of the burden of constant checking. [0008] There are many devices currently on the market that achieve rapid infusion via various methods as well as many more intellectual property submissions for rapid infusers. Most devices focus on the mechanics of pressure infusion via pliable pressure bags or hard cases. As well, many focus on the mechanism of delivery (mechanical or microprocessor driven). What these devices lack is intuitive user interface, robust device functionality, and transportability and usability of the device

SUMMARY OF THE DISCLOSURE

[0009] In one aspect, a system for performing rapid infusion of fluids is provided. The system comprises a pressure vessel comprising a vertical centerline, an opening for receiving an IV bag, a closure for sealing the IV bag within the pressure vessel, a pole aperture at the top of the pressure vessel, an expandable bladder, and a tubing slot to allow passage of IV tubing coupled to the IV bag through a bottom portion of the pressure vessel; and a pumping device comprising a controller in fluid

communication with the expandable bladder and configured to be attached to the pressure vessel, wherein the pumping device and the pole aperture are positioned away from the centerline.

[00010] In some embodiments, the pressure vessel and pumping device are connected using a connection incompatible with luer fittings. The pressure vessel and pumping deice can be connected using a hook. In some embodiments, the pumping device comprises a tubing opening to allow passage of IV tubing therethrough. The pumping device can further comprise a bubble detector. In some embodiments, the pumping device comprises a bubble detector positioned proximate to a tubing opening to allow passage of IV tubing therethrough. The pumping device can comprise an indicator light. In some embodiments, the pumping device comprises a display screen. The closure can comprise at least one of snap fits and an adhesive strip. In some embodiments, the pumping device is connected to the pressure vessel using a pneumatic connector. The system can comprise a sensor to detect connection of the pressure vessel to the pumping device. In some embodiments, the system comprises a sensor configured to authenticate a pressure vessel. In some embodiments, the system comprises a pressure sensor. The pumping device can comprise a clamp configured to prevent or allow flow within the IV tubing. In some embodiments, the pumping device is configured to bring the system up to about 300 mm Hg pressure within about 10 seconds. The pumping device can be configured to restart the motor and pump at an inline pressure of 275 mm Hg. In some embodiments, the pumping device comprises a pump and a motor. The pump and motor can be configured to deliver air pressure up to 300 mm Hg. The motor can be a DC motor. The DC motor can be brushed, brushless, or iron core. The pump can be a diaphragm pump. In some

embodiments, the pumping device is configured to run until a desired pressure is sensed and

communicated to the controller. The desired pressure can be about 300 mm Hg. In some embodiments, the pumping device is configured to restart at a threshold pressure as IV fluid flows out of the IV bag. The threshold pressure can be about 270 mm Hg. The pumping device can be configured to alert the user to a failure to sense a pump restart or an unexpected delay in sensing a pump restart. In some embodiments, the pumping device is configured to alert the user to pump restarts occurring faster than a desired timing. The pumping device can comprise an electronic tag communicator configured to encode computer readable data to an electronic tag of a separate component. In some embodiments, the pumping device is configured to encode, in computer readable code, at least one of operating settings, mode of operation, total infusion time, and a serial number or name of the pumping device to the tag. The system can comprise a communications device configured to communicate with affiliated components. In some embodiments, the affiliated components comprises at least one of a pressure vessel, a beeper, a bubble sensor, a clamp, and a charging dock. The pumping device can comprise a power supply. In some embodiments, the power supply comprises a rechargeable battery pack. The battery pack can be removable. In some embodiments, the power supply is recharged using at least one of a charging dock and a charging cable. The charging dock can comprise a communications module. In some embodiments, the pumping device is attached to a front of the pressure vessel. The back surface of the pumping device can be concavely curved to conform to a convexly curved surface of the pressure vessel when an IV bag is inserted. In some embodiments, a back surface of the pumping device is curved to conform to an outer surface of the pressure vessel during use. A weight of the pumping device can be less than about 1 pound.

[00011] In another aspect, a pressure vessel for use in rapid infusion is provided. The pressure vessel comprises an enclosure comprising a front side and a back side, and an opening between the front and back side configured to receive an IV bag, the opening comprising a closure for sealing the IV bag within the pressure vessel; a pole aperture positioned at a top side of the enclosure; a tubing opening positioned at a bottom portion of the pressure vessel for allowing passage of IV tubing therethrough; an air bladder for exerting pressure on an inserted IV bag; and a pneumatic connector for directly connecting the pressure vessel to a pumping device.

[00012] In some embodiments, the pressure vessel comprises two layers of material. The two layers of material can be fused together to created one or more air bladders. In some embodiments, the front side and back side are sealed together along a first side and a top side of the pressure vessel. The front side and back side can be open along at least a portion of a second side and a portion of the bottom side extending from the portion of the second side. In some embodiments, the pressure vessel is configured to allow insertion of an IV bag with an IV line already attached. The pressure vessel can comprise a closure along the bottom side for sealing the bottom side after insertion of the IV bag with the IV line already attached. The pressure vessel can be side-loading or end-loading. In some embodiments, an inner layer is more flexible and elastic than an outer layer of the pressure vessel. The outer layer can be made less flexible and elastic by having a thicker layer than the inner layer and/or by having a fiber reinforced weave. The pressure vessel can comprise PVC or TPU. In some embodiments, the pressure vessel comprises a height of about 1 1 inches. The pressure vessel can comprise a width of about 4.5 inches. In some embodiments, dimensions of the pressure vessel are selected to minimize extra loose space around an inserted IV bag. An inner surface of the pressure vessel can comprise texture features. In some embodiments, the pressure vessel comprises an air bladder configured to be positioned on one side of an inserted IV bag. The air bladder can be configured to be positioned on both sides of an inserted IV bag. In some embodiments, the pressure vessel is configured to hold up to about 375 mm Hg. The closure can comprise at least one of snap buttons or an adhesive. In some embodiments, the closure comprises a flap that folds over and is connected to the front or back surface of the pressure vessel. The pneumatic connector can be incompatible with luer fittings. In some embodiments, the pneumatic connector comprises a direct press connector. The pneumatic connector can comprise a tapered, circular female opening sealed against the pressure vessel, an outer edge of the opening comprises a shoulder. In some embodiments, the pneumatic connector is configured to mate with a circular male connector of the pumping device, the connector comprising an outer spring configured to catch on the shoulder. The pressure vessel can comprise a near field communication (NFC) tag configured to communicate with a corresponding electronic reader on the pumping device. In some embodiments, the pressure vessel comprises a physical connector for connecting to a pumping device. The physical connector can comprise a slot configured to engage a hook on the pumping device. In some embodiments, the physical connector comprises a sleeve configured to engage a feature on the pumping device. The pressure vessel can comprise sensor components affixed to the pressure vessel. In some embodiments, the pressure vessel comprises a heating device. The pressure vessel can comprise capacitive sensors configured to allow tracking of fluid level of the IV bag.

[00013] In another aspect, an embodiment of a pressure vessel for use in rapid infusion is provided. The pressure vessel comprises an enclosure comprising a front side and a back side, and an opening between the front and back side configured to receive an IV bag, the opening comprising a closure for sealing the IV bag within the pressure vessel; a tubing opening positioned at a bottom portion of the pressure vessel for allowing passage of IV tubing therethrough; an air bladder for exerting pressure on an inserted IV bag; and a pneumatic connector on the front side or the back side of the enclosure, for directly connecting the pressure vessel to a pumping device.

[00014] In yet another aspect, an embodiment of a pumping device for use in rapid infusion is provided. The pumping device comprises a motor and air pump configured to drive pressurized air to a fluidly connected pressure vessel configured to receive an IV bag; a pneumatic connector configured to connect the air pump to the pressure vessel; and a controller configured to calculate a volume of air delivered to the pressure vessel.

[00015] In another aspect, another embodiment of a pumping device for use in rapid infusion is provided. The pumping device comprises a motor and air pump configured to drive pressurized air to a fluidly connected pressure vessel configured to receive an IV bag; a pneumatic connector configured to connect the air pump to the pressure vessel; and a controller configured to calculate moles of air delivered to the pressure vessel.

[00016] In some embodiments, the pneumatic connector comprises a switch configured to sense connection of a pressure vessel. The pneumatic connector can be incompatible with luer fittings. In some embodiments, the controller is configured to detect a high pressure caused by failure to connect to an incompatible fitting. The controller can be configured to turn off the device upon detection of the high pressure. In some embodiments, the pneumatic connector comprises a male connector comprising an outer spring configured to catch on a shoulder of a female opening of the pressure vessel. The pneumatic connector can comprise a threaded connector. In some embodiments, the pneumatic connector comprises a clip-on locking hub. The pneumatic connector can comprise an electronic connection to sensors embedded within the pressure vessel. In some embodiments, the pneumatic connector comprises contact points configured to allow communication between the pumping device and the pressure vessel. The device can comprise a pressure sensor configured to sense pressure between the air pump and the pressure vessel. The device can comprise a temperature sensor. In some embodiments, the controller is configured to calculate a volume of air delivered based on a number of moles delivered, the pressure, and the temperature. The controller can be configured to determine a number of moles delivered based on a pressure and flow rate relationship of the pump and motor. In some embodiments, the controller is configured to determine a number of moles delivered based on a number of revolutions of the motor. The device can be configured to indicate a volume of IV fluid delivered from the IV bag. In some embodiments, the device comprises an optical sensor comprising a light source and a detector positioned near IV tubing, the light source positioned off axis from the tubing and the detector positioned to receive light from the light source and refracting through fluid in the tubing. The optical sensor can be configured to detect presence of tubing and of bubbles in the tubing. The optical sensor can comprise an additional detector positioned directly across the tubing from the light source. In some embodiments, the optical sensor comprises a reflective sensor configured to indicate the presence of tubing. The optical sensor can comprise a series of detectors positioned along a length of tubing. In some embodiments, the controller is configured to determine a volume of a bubble based on information from the optical sensor. The controller can determine the volume based on a time duration between leading and trailing edges of the bubble and a flow rate of IV fluid. In some embodiments, the device is configured to alert an operator and/or automatically shut down flow upon detection of a bubble larger than a threshold volume. The device can comprise a slot for receiving IV tubing. In some embodiments, the device comprises a door configured to allow access to the slot. The device can comprise a sensor configured to sense closure of the door. In some embodiments, the device comprises a clamp configured to prevent flow through the IV tubing. The controller can be configured to control operation of the clamp based on feedback from one or more device sensors. The device can comprise a sensor in communication with the controller and configured to authenticate components. In some embodiments, the device comprises a sensor in communication with the controller and configured to identify components. The sensor can comprise a near field sensor. In some embodiments, the sensor is configured to sense a unique resistance of a component. The sensor and controller can be configured to read at least one of the following:

authenticating information, estimated fluid to be infused, settings for infusion from a tag on a component. In some embodiments, the sensor and controller are configured to write information to tags on affiliated components. The information can comprise at least one of infusion settings and estimated fluid to be infused. In some embodiments, the pumping device is configured to bring the system up to about 300 mm Hg pressure within about 10 seconds. The pumping device can be configured to restart at an inline pressure of 275 mm Hg. In some embodiments, the pumping device comprises a pump and a motor. The pump and motor can be configured to deliver air pressure up to 300 mm Hg. The motor can comprise a DC motor. In some embodiments, wherein the DC motor is brushed, brushless, or iron core. The pump can be a diaphragm pump. In some embodiments, the pumping device is configured to run until a desired pressure is sensed. The desired pressure can be about 300 mm Hg. In some embodiments, the pumping device is configured to restart at a threshold pressure as IV fluid flows out of the IV bag. The threshold pressure can be about 270 mm Hg. In some embodiments, the device is configured to alert the user to a failure to sense a pump restart or an unexpected delay in sensing a pump restart. The pumping device can be configured to alert the user if IV flow is greater or equal to about 5cc/s. In some embodiments, the device is configured to alert a user to any combination of the following: pressure out of nominal range, pressure out of acceptable range, flow rate out of acceptable range, bubble detected, IV bag empty, bolus delivered, undesired clamp state, open door, lack of connection between device and pressure vessel, and unauthenticated component. The device can be configured to provide a visual or audible alert regarding operating state of the device. In some embodiments, the device is configured to send alerts regarding operating information to an operator of the device. The device can comprise a pressure relief valve. The device can comprise a display. In some embodiments, the display is configured to display any combination of status of wireless signal, status of battery, operating mode status, current infusion status, current run settings, guidance to initiate setup, guidance of user-action necessary to verify or clear alarm, and a dynamic legend. The display can be configured to show quickstart settings upon completion of device setup. In some embodiments, the quickstart settings comprise administering 1 L at a maximum accepted flow rate. The user can modify the quickstart settings. In some embodiments, the user can modify the settings based on at least one of IV Bag Start Volume, Bolus Volume, and Pressure Level. The device can comprise user controls. In some embodiments, the controls comprise at least one of a display and buttons. The device can be configured to receive user-defined settings. In some embodiments, wherein the device is configured to pause infusion during setting editing. The device can comprise a power supply. In some embodiments, the power supply is removable and rechargeable. The device can comprise a recharging stand. In some embodiments, the recharging stand comprises a communication portal. The device can comprise a visual feedback region. In some embodiments, the visual feedback region comprises colored lights to indicate system status. The visual feedback region can use at least one of flash patterns and color to indicate a level of urgency. In some embodiments, the visual feedback region comprises progressive lighting configured indicate a progression of infusion. The device can comprise a cylindrical shape. In some embodiments, the device comprises at least one of a metal and a plastic composite. In some embodiments, the device comprises an elastomer bumper on at least some ends or edges of the device. The device can comprise a balanced weight along a length of the device. In some embodiments, the device is configured to decompress the pressure vessel. The device can comprise a multifunction switch in communication with the controller. In some embodiments, differently patterned pushes are used convey different input to the switch. The device can comprise an air manifold in direction communication with an input and outlet of the pumping device, with the pneumatic connector, and with external atmosphere, the air manifold comprising tandem bi-stable valves. In some embodiments, the device comprises a wireless transmitter configured to populating electronic health records via standardized device integration standards The device can comprise a wireless transmitter configured to allow collection of device operation data. [00017] In another aspect, embodiments of a pumping device is provided. The device comprises a motor and air pump comprising an outlet and configured to drive pressurized air to a fluidly connected pressure vessel configured to receive an IV bag; and a controller in communication with the pump and outlet and configured to calculate a number of moles delivered by the pump.

[00018] In another aspect, embodiments of a method of rapid infusion are provided. The method comprises inserting an IV bag into a pressure vessel; sealing the pressure vessel around the IV bag;

fluidly connecting the pressure vessel to a pumping device comprising a pump, motor, and controller; inflating the pressure vessel using the pumping device; causing infusion of IV fluid from the IV bag; and calculating a volume of IV fluid infused based on an amount of air delivered to the pressure vessel, using the controller.

[00019] In some embodiments, calculating the volume of IV fluid infused is also based on a sensed pressure and temperature. The method can comprise sensing a pressure of the pressure vessel. In some embodiments, a frequency of the sensing is about 2-10 times per second. A frequency of the sensing can be about 25-75 times per minute. The method can comprise sensing a pressure of the external atmosphere. In some embodiments, the method comprises the controller comparing the external atmosphere pressure and the pressure vessel pressure to compensate for environmental pressure changes. The method can comprise sensing a temperature of the pressure vessel. In some embodiments, the method comprises physically connecting the pressure vessel and pumping device, separate from the fluid connection. The method can comprise fluidly connecting the pressure vessel and pumping comprises directly connecting the pump of the pumping device to an air bladder of the pressure vessel. In some embodiments, inserting the IV bag into the pressure vessel occurs after IV lines are already connected. The method can comprise detecting bubbles in IV tubing of the IV bag in a bubble detector region of the pumping device. In some embodiments, the method comprises detecting presence of tubing in the bubble detector region using a same sensor as that used to detect bubbles. The method can comprise using a bubble detector as described herein. In some embodiments, the method comprises authenticating the pressure vessel using a reader on the pumping device. The method can comprise placing IV tubing through a slot in the pumping device. In some embodiments, the method comprises clamping the IV tubing based on a signal from the controller. The signal can be based on sensed information or user input. In some embodiments, the method comprises the pumping device reading identifying information from the pressure vessel. The method can comprise the pumping device electronically writing identifying information to the pressure vessel. In some embodiments, inflating the pressure vessel comprises initially pressurizing the pressure vessel to a target pressure. The target pressure can be about 300 mm Hg. In some embodiments, the method comprises restarting the pumping device as the pressure falls and reaches a threshold pressure. The threshold pressure can be about 275 mm Hg. In some embodiments, the method comprises counting the revolutions of the motor. The method can comprise continually monitoring a flow rate out of the pump. The method can comprise continually monitoring a flow rate out of the IV bag. The method can comprise continually monitoring a pressure of the pressure vessel. In some embodiments, the method comprises sensing connection of the pumping device to the pressure vessel. The method can comprise displaying to a user any combination of status of wireless signal, status of battery, operating mode status, current infusion status, current run settings, guidance to initiate setup, guidance of user-action necessary, and a dynamic legend. In some embodiments, the method comprises preventing infusion until the pressure vessel is pressurized to a target pressure. The method can comprise alerting a user to any combination of the following: pressure out of nominal range, pressure out of acceptable range, flow rate out of acceptable range, bubble detected, IV bag empty, bolus delivered, undesired clamp state, open door, lack of connection between device and pressure vessel, and unauthenticated component. In some embodiments, causing infusion of IV fluid comprises accepting quickstart setting provided by the pumping device. In some embodiments, causing infusion of IV fluid comprises choosing settings based on at least one of IV Bag Start Volume, Bolus Volume, and Pressure Level.

[00020] In another aspect, embodiments of a method of rapid infusion are provided. The method comprises connecting a pumping device to a pressure vessel; flowing a fluid from a bag within the pressure vessel by operating the pumping device to inflate the pressure vessel according to computer readable instructions in a controller of the pumping device; and using computer readable instructions in the controller of the pumping device for estimating a volume of fluid flowing from the bag within the pressure vessel based on an amount of air pumped into the pressure vessel using the pumping device.

[00021] In some embodiments, the step of using computer readable instructions for estimating a volume of fluid flowing from the bag comprises a calculation based on a sensed pressure or a sensed temperature of the pressure vessel. The sensed pressure or the sensed temperature of the pressure vessel can be related to the air within the pressure vessel or to the ambient conditions surrounding the pressure vessel. In some embodiments, the amount of air pumped into the pressure vessel is related to a number of mols of air within the pressure vessel. The connecting step can comprise a step of connecting the pumping device housing to the pressure vessel and a step of connecting an outlet of the pumping device and an inlet of the pressure vessel. In some embodiments, the step of connecting an outlet of the pumping device and an inlet of the pressure vessel places the pumping device in communication with an air bladder of the pressure vessel. Before the flowing step, there can be a step of inserting a fluid filled bag into the pressure vessel. In some embodiments, the fluid filled bag is an IV bag and the inserting a fluid filled bag step occurs after an IV line is connected to the IV bag. The method can comprise using computer readable instructions in the controller of the pumping device for detecting bubbles in the IV line. In some embodiments, the computer readable instructions include an input from a bubble detector in communication with the controller of the pumping device. The method can comprise detecting the presence of a bubble in a tube carrying the fluid flowing from the bag within the pressure vessel using a sensor in communication with the controller of the pumping device. In some embodiments, the method comprises detecting the presence within a bubble detector region of the pumping device of a tube carrying the fluid flowing from the bag within the pressure vessel using a sensor in communication with the controller of the pumping device. The method can comprise providing, using a single sensor in communication with the controller of the pumping device, an electronic indication of the presence of a bubble in a tube carrying the fluid flowing from the bag within the pressure vessel and an electronic indication of the presence within a bubble detector region of the pumping device of a tube carrying the fluid flowing from the bag within the pressure vessel. In some embodiments, the sensor is a bubble detector as described herein. The method can comprise preventing operation of the pumping device until the controller of the pumping device performs a step of authenticating the pressure vessel. In some embodiments, the step of authenticating is completed using a near field communication link between the controller of the pumping device and a sensor on the pressure vessel. The near field communication link can comprise at least one of Bluetooth, WIFI, NFC, and RFID. In some embodiments, the flowing step comprises flowing 500 ml of an isotonic crystalloid fluid.

[00022] In yet another aspect, embodiments of an optical bubble sensor are provided. The sensor comprises a tubing region configured to receive tubing for flowing a fluid; a light source configured to be positioned on a first side of the tubing region and off-axis to the tubing when tubing is present in the tubing region; a first detector configured to be positioned on a second side of the tubing region in a location to receive light from the light source refracting through fluid in the tubing; and a second detector configured to be positioned on the second side of the tubing region and directly across the tubing region from the light source. In some embodiments, the optical sensor is configured to detect presence of tubing and of bubbles in the tubing. The sensor can comprise a reflective sensor configured to indicate the presence of tubing. In some embodiments, the sensor comprises a series of detectors positioned along a length of tubing. The sensor can comprise a controller configured to determine a volume of a bubble based on information from the optical sensor. In some embodiments, the controller is configured to determine the volume based on a time duration between leading and trailing edges of the bubble and a flow rate of fluid in the tubing. The controller can be configured to alert an operator and/or automatically shut down flow upon detection of a bubble larger than a threshold volume. In some embodiments, the sensor comprises a series of light sources positioned on a first side of the tubing region and a series of detectors positioned on a second side of the tubing region. The tubing region can comprise a slot for receiving tubing.

BRIEF DESCRIPTION OF THE DRAWINGS

[00023] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[00024] FIGS. 1 A-1 B show various views of an embodiment of a pumping device and a pressure vessel.

[00025] FIGS. 2A-2B depict embodiments of a connection between a pumping device and a pressure vessel.

[00026] FIG. 3 illustrates a side view of an embodiment of a pressure vessel and a pumping device.

[00027] FIGS. 4A-4C illustrate embodiments of pressure vessels.

[00028] FIGS. 5A-5F show various views of embodiments of pressure vessels.

[00029] FIGS. 6A-6C depict embodiments of air bladders of a pressure vessel. [00030] FIGS. 7A-7E illustrate embodiments of pressure vessels.

[00031] FIG. 8 shows another embodiment of a pressure vessel.

[00032] FIGS. 9A-9D depict various views of an embodiment of a pumping device.

[00033] FIGS. 10A- 10E illustrate embodiments of an optical sensor.

[00034] FIGS. 10F- 10G illustrate the principle of pulse width modulation of a light source.

[00035] FIGS. 1 1 A-l IB show embodiments of a bottom portion of a pumping device.

[00036] FIGS. 12A-12C depict embodiments of mechanical schematics of a pumping device.

[00037] FIG. 13 illustrates an embodiment of a communication link of a pumping device.

[00038] FIG. 14 shows an embodiment of a pump and motor combination.

[00039] FIG. 15 illustrates an embodiment of a relationship between pressure and pump flow rate.

[00040] FIG. 16 depicts an embodiment of an example flow control algorithm.

[00041] FIG. 17A shows an embodiment of a simulation of pressure over time.

[00042] FIG. 17B illustrates an embodiment mass of air pumped into the system and IV flow out over time.

[00043] FIG. 18 depicts an embodiment of a display screen.

[00044] FIGS. 19A-E show embodiments of mode status that can be displayed on the display screen.

[00045] FIGS. 20A-E illustrate embodiment of infusion status that can be displayed on the display screen.

[00046] FIGS. 21 A-D depict embodiments of legend/guidance information that can be displayed on the display screen.

[00047] FIGS. 22A-22B show embodiments of infusion status/error information that can be displayed on the display screen.

[00048] FIGS. 23A-23C illustrates embodiments of hierarchical lists that can be shown on the display screen.

[00049] FIGS. 24 depict embodiments of icons that can be shown on the display screen.

[00050] FIG. 25 shows an embodiment of startup sequence logic and sensor feedback, and user interaction.

[000511 FIGS. 26A-D illustrate embodiments of screens that can be displayed during user editing of system settings.

[00052] FIG. 27 depicts an embodiment of a dynamic infusion display that can be shown on the display screen.

[00053] FIG. 28 shows an embodiment of a workflow showing the system continually monitoring flow rate.

[00054] FIG. 29 illustrates an embodiment of a pumping device and pressure vessel.

[00055] FIG. 30 depicts an embodiment of a pumping device.

[00056] FIG. 31 shows an embodiment of a pumping device connected to a pressure bag.

[00057] FIGS. 32A-B depict an embodiment of a pumping device.

[00058] FIGS. 33A-33H illustrate embodiments of connectors for connecting a pumping device to a pressure vessel. [00059] FIGS. 34A-E show embodiments of connectors for connecting a pumping device to a pressure vessel.

[00060] FIG. 35 depicts an embodiment of a display screen.

[00061] FIG. 36 illustrates an embodiment of a pressure vessel.

[00062] FIG. 37 shows an embodiment of a pressure vessel.

[00063] FIG. 38 depicts an embodiment of a pressure vessel.

[00064] FIGS. 39A-B illustrate embodiments of attaching a pumping device to a pressure vessel.

[00065] FIG. 40 shows an embodiment of a schematic of components of a pumping device system.

[00066] FIG. 41 depicts an embodiment of a pumping device and pressure vessel.

[00067] FIGS. 42A-F illustrate embodiments of routing IV tubing to the pumping device.

[00068] FIGS. 43A-C show embodiments of clamps that can be used with a pumping device and pressure vessel.

[00069] FIGS. 44A-C depict embodiments of an air manifold.

[00070] FIG. 45 illustrates an embodiment of a simulation of pressure over time.

DETAILED DESCRIPTION

[00071] Embodiments of a rapid infusion device or rapid assist device (RAD) are provided herein. The RAD can comprise a delivery system used to increase the flow rate of IV infusions for rapid delivery of a particular volume into a patient. The RAD is generally made up of two main components, a pumping device and a pressure vessel. The pressure vessel is configured to be coupled to (e.g., surround) an IV bag and apply pressure to the IV bag. The pumping device is generally configured to pressurize and monitor the pressure of the pressure vessel.

[00072] The device comprises an air pump and motor, a microprocessor, a power supply, multiple sensors including but not limited to pressure, temperature, accelerometer (positioning) optical or ultrasound sensors for flow rate or bubble detection, and audio/visual feedback and alarms, which include one or more light sources as well as a possible digital display to further communicate device status.

[00073] With an IV fluid bag enclosed within the pressure vessel and the device connected via the integrated connector, the system is able to automatically inflate the pressure vessel to a preprogrammed nominal pressure in order to exert force on the outside of the bag, thereby accelerating the flow of IV fluid to the patient. The device continually monitors the infusion through use of various sensors and control algorithms and automatically adjusts device output from the pump to maintain this target pressure throughout the infusion of the IV bag. Additional functions may be selected by the user at the time of infusion.

[00074] The device is intended for use in the hospital environment, specifically emergency department, ICU, surgery and anesthesia. It may also be used outside the hospital in a pre-hospital environment, ambulance or helicopter (or other air) transport. The RAD may also be configured for military field use. Different versions of the device can be configured with the specific needs for each setting. [00075] FIGS. 1 A-1 B illustrates an embodiment of a pumping device 100 and a pressure vessel 102. FIG.

1 A shows a top perspective view of the pumping device 100 and pressure vessel 102. FIG. I B shows a front view of the pumping device 100 and pressure vessel 102. The pressure vessel 102 is configured to receive an IV bag (not shown). The pressure vessel 102 is shown mounted to a front portion of the IV bag.

[00076] The pressure vessel comprises a loop or hole 104 to hang the system on an IV pole. The IV pole hanger 104 can comprise an aperture used to hang the pressure vessel to an IV stand. The pole hanger 104 can be formed integrally with the pressure vessel. In some embodiments, the pole hanger 104 is formed separately from and attached to the pressure vessel. The construction of the pole hanger is designed such that the pole hanger 104 can support the weight of the pressure vessel, an IV bag and IV tubing, and the pumping device. In some embodiments, the pole hanger 104 is reinforced with extra material.

[00077] The pole hanger 104 is positioned along the top of the pressure vessel 102. In some

embodiments, as shown in FIG. 1 , the pole hanger is offset from the center of the pressure vessel. The pumping device 100 can be positioned so that it generally lines up with the pole hanger along a vertical axis. This alignment can prevent the weight of the pumping device 100 from tilting the pressure vessel and IV bag. Having the pumping device offset from the center can allow a clearer view of the contents of the IV bag and any instructions on the pressure vessel. This positioning of the pumping device can also allow easier access to the IV port. Other configurations are also possible. The pole hanger 104 may be positioned in the center of the pressure vessel or on the opposite side of center as shown in FIG. 1. The pumping device 100 positioned can be modified along with the pole hanger 104 position.

[00078] In some embodiments, the pressure vessel is a single use product. Subsequent use of the vessel may be prevented using various features described herein. The pressure vessel can allow for intuitive and rapid set up as the need for rapid infusion can occur suddenly in a clinical environment. The pressure vessel is generally configured to encase an IV bag while allowing the IV bag ports to be exposed. In some embodiments, the pressure vessel allows for encasing of the IV bag while the IV line is already attached.

[00079] The pressure vessel is open (e.g., not sealed, welded) on at least a portion of one side 108 of the pressure vessel. The pressure vessel 102 can receive an IV bag through the open side 108. In some embodiments, the pressure vessel 102 is open along an entire edge of the pressure vessel. In some embodiments, the pressure vessel is open along a portion of the edge of the pressure vessel (e.g., about 60%, 70%, 80%, 90%, 95%, etc.). The pressure vessel can be open on three sides. Additional configurations are contemplated and described herein.

[00080] The pressure vessel 102 comprises a mechanism 106 to seal the open side of the pressure vessel upon insertion of the IV bag. In some embodiments, the pressure vessel comprises snap buttons (e.g., like those used on a hospital bracelet). Other configurations are also possible. For example, a strip of adhesive can be used. In some embodiments, the mechanism for sealing the bag is not reusable. In such embodiments, once the pressure vessel is sealed, it cannot be opened and reused. [00081] The pressure vessel 102 also has an opening (not shown) at its bottom to allow passage of the IV ports. This opening can be wide enough to allow passage of the IV ports. The IV ports can typically comprise one IV tubing port and one medication port. The width of the IV ports on major manufacturers' IV bags can range from about 1 1/4" (about 3 cm) to 2 1/8" (about 5 cm). Thus in some embodiments, the width of the opening is about 5-6 cm.

[00082] The pressure vessel 102 is fluidly connected with the pumping device 100. Referring now to FIG. 2 A, the pressure vessel 102 is directly connected to pumping device at connection point 202. FIG. 2 illustrates how the pump 204 within the pumping device 100 connects directly from its outlet to bladder 206 of the pressure vessel. IV bag 208 is shown positioned within the pressure vessel 102. The bladder comprises two compartments 206, 210, one positioned on either side of the IV bag. FIG. 2B illustrates a pressure vessel 102 connected to the pumping device 100, as in FIG. 2A, but in FIG. 2B, the bladder 206 is only positioned on one side of the IV bag 208.

[00083] The connection between the pumping device 100 and the pressure vessel 102 can be an air tight connection. In some embodiments, the connection between the two components is unique and prevents inadvertent connection to any other device likely in the environment for use (e.g., luer fittings used for IV lines). The connection can allow a fast and secure fit that allows a user to complete the connection without having to juggle the pumping device, IV bag, and/or pressure vessel. In some embodiments, the connection is a simple direct press connector. On the pressure vessel side, it is a circular female opening that is slightly tapered in and sealed against the sheet by a wide flange. At the outer edge of the opening, there is a 2 ^nd flange or shoulder that acts as a catch for the male side of the connector. On the device side, there is a circular male connector with matching taper to the female. The male connector has an outer spring that will expand open over the edge of shoulder on the female side and spring closed once it passes the edge. The pumping device side of the connection can also comprise a switch (e.g., mechanical micro switch) that is activated when the pumping device is properly connected to the pressure vessel. The switch can communicate proper connection to a controller. This automatic control can eliminate a program input step from a user, simplifying a rapid infusion process.

[00084] FIG. 3 shows a side view of the pressure vessel 102 connected to the pumping device 100. As shown in FIG. 3, the system can have a physical connection between the pumping device 100 and pressure vessel 102, in addition to the fluid connection described above. As shown in FIG. 3, the physical connection can comprise a hook 302 that is inserted into a slot or loop 304 provided on the pressure vessel. The hook 302 can extend about 2 cm or less away from the pumping device. This close fit of the hook to the bag can help prevent the hook 302 catching and/or breaking on anything. The width of the hook can be about 1-2 cm.. In some embodiments, the width of the slot can be about 1 -2 cm. The width can be large enough to catch the hook without extra effort to join the two components. Other physical connections are also possible. For example, snap fits, Velcro, clips, or a loop/bar on the pumping device and catch on the pressure vessel can be used. The physical connection can help to ensure that the pumping device 100 maintains a close fit with the pressure vessel 102. As shown in FIG. 3, in some embodiments, the back surface 306 of the pumping device 100 comprises a concavely curved surface to conform to the convexly curved surface of the pressure vessel 102.

[00085] The pressure vessel can comprise double layers of transparent material creating an air chamber or chambers that allows a balloon-effect when inflated with air. Transparency can allow a user to easily see the contents and read the label of an inserted IV bag.

[00086] FIGS. 4A-C show examples of pressure vessels illustrating the construction of the multiple layers of material. Pressure vessel 440 of FIG. 4A comprises two layers of material. The pressure vessel 440 is shown unfolded, during construction. The side facing up in the figure is the outside of the pressure vessel. Front section 444 comprising fluid port 450 is to be folded over onto back section 448. Dashed lines 442 represent seal or weld lines. As there is no break in the seal line 442, the air pocket of the front side 444 of the vessel cannot communicate with any air pocket in the back side 448, created an air bladder on only one side of an inserted IV bag. The pressure vessel 440 comprises a flap 446 that can be folded over and adhered or connected to the front portion 444. Pressure vessel 460 of FIG. 4B comprises an inner layer 464 and outer layer 462 of material like pressure vessel 440. In this embodiment, there is a break in the weld lines 466 between the front slide 468 and the back side 470, so the air pockets can communicate, forming a bladder on either side of an inserted IV bag. FIG. 4C shows an embodiment of how a fluid connector can be attached to pressure vessel 484 by securing (e.g., welding) a flange 482 in between the inner and outer layers. The pressure vessel 484 can comprise some texturing 486 (e.g., ripples) that show where the flange is attached to an interior of the pressure vessel 484.

[00087] FIGS. 5A-5F illustrates an embodiment of a pressure vessel 400. FIG. 5 A shows a front view of the pressure vessel 500. The pressure vessel comprises a fluid connector 502 and physical connector 504 (e.g., loop). Pole aperture 506 is positioned at a top portion of the pressure vessel. Closures 508 are positioned on a side of the pressure vessel. Closure 510 is positioned on a bottom edge 12 of the pressure vessel. Opening 514 allows passage of IV ports and connected IV tubing therethrough. The pressure vessel can be open along region 516 allowing insertion of an IV bag that has IV lines already connected. After insertion of the IV bag, closure 510 can be used to seal the bottom edge 512. The pressure vessel can be open along region 516. The pressure vessel comprises a shape generally configured to conform to available IV bags and to minimize excess material and surface area around an inserted IV bag. As shown in FIG. 5A, in some embodiments, the pressure vessel comprises a generally rectangular shape with rounded corners. Other configurations are also possible (e.g., ovular).

[00088] FIGS. 5B and 5C show sectional perspective views of the pressure vessel. The pressure vessel comprises a bladder configured to be inflated and pressurized by the pumping device. The pressure vessel of FIG. 5B comprises one air bladder 520 on the front side of the pressure vessel and a second air bladder 518 on the back side of the pressure vessel. The pressure vessel of FIG. 5C is similar to FIG. 5B, but shows a bladder 520 only positioned on the front side of the pressure vessel. As noted above the pressure vessel has connectors configured to interact with connectors on the pumping device. The connectors can be offset from a center of the pressure vessel, as described above. The pressure vessel comprises a fluid (e.g., pneumatic) connector connecting the bladder to the pumping device. The pressure vessel can comprise physical connector to hold the pressure vessel to the pumping device. In some embodiments, more than one fluid or physical connector may be used.

[00089] FIG. 5D illustrates a back view of the pressure vessel 530. The pressure vessel 530 comprises pole hanger 506, IV port opening 514 and closures 508. The shaded region 535 indicates where the front and back sides of the pressure vessel are fused (e.g. welded) together. In the pressure vessel 530, there is no bottom closure, and the bottom edge is sealed along region 532. An IV bag can be inserted through the opening on side 534, and the ports can be maneuvered to be at or near tubing opening 514. The IV line can then be connected after positioning of the IV bag. FIG. 5E shows a perspective view of the pressure vessel 530 of FIG. 5D.

[00090] FIG. 5F shows a side view of the pressure vessel 540. Pressure vessel 540 comprises fluid connector 502 and physical connector 504.

[00091] The pressure vessel can be made in multiple sizes to accommodate a range of intravenous bag sizes, including, but not limited to, 250 ml, 500ml, and 1000ml intravenous bags and standard blood administration bags. The pressure vessel can comprise a height and width to accommodate a number of standard IV bags. The pressure vessel can have a height of about 12" (e.g., about 9-13", 10", 1 1", 12", 13", 14", etc.) The pressure vessel can have a width of about 5.5" (e.g., about 5-7", 5", 6", 7", etc.) These dimensions can refer to the overall size of the pressure vessel. As noted above, the pressure vessel comprises a front and back side fused (e.g., welded) together to create an internal space for receiving an IV bag. The internal space can have a height of about 1 1" (e.g., about 8-12 in, 9", 10", 1 1 ", 12", etc.). The internal space can have a width of about 4.5" (e.g., about 4", 5", 6" 4-6", etc.). These dimensions can be greater than those of the IV bags in Table 1 below, to accommodate the thickness of the IV bag. A slot on the bottom of the pressure vessel can allow 2 centered ports or an off center port to dangle. The pressure vessel can be designed to accommodate IV bags from the various major manufacturers. It does this by sizing its vertical and dimensions to adapt to the largest dimension from the various IV bags.

Table 1

[00092] It is ideal to minimize extra loose space or volume to the expanding pressure vessel. Any loose space will lead to a longer initial inflation of the vessel to the target 300 mm Hg and cause a slight delay to the work flow. [00093] In some embodiments, individual pressure vessels could be customized for each IV bag manufacturer. In this way, the pressure vessel could more tightly conform to the IV bag leading to a faster initial inflation.

[00094] The outside layer of the pressure vessel can be relatively flexible and non-stretchy. This configuration can help insure the PV will not blow up like an expanding balloon on the outside, and instead forces the expansion to the IV bag on the inside. The non-stretch of the outside layer could be achieved by a thicker layer of sheet compared to inside layers. In some embodiments, the non-stretch can be a result of fiber reinforced weave laminated to the sheet, for example, a weave, a spiral wrap, a braid, a knit, a non-woven construction. Nylon monofilament is commonly used with PVC or TPU sheets.

[00095] The inside layers will hold the pressure but can stretch and continue to apply pressure evenly as the volume if the IV bag decreases. A thinner layer of material (e.g., as compared to the outer layers) may allow even stretch. In some embodiments, folds, pleats or a pucker of the inner layer unfolds or expands against the IV bag as its volume decreases.

[00096] In some embodiments, the materials used to form the pressure vessel lend themselves to high speed assembly. RF welding is a common means to high volume assembly. Polar polymer chains are needed for this process and likely materials are PVC, TPU and EVA. Impulse welding applies heat and can be used with non-polar polymers, PE, PP.

[00097] The material of the pressure vessel can be puncture/tear resistant material. In some embodiments, the material forming the pressure vessel is clear or highly translucent to allow the user to see fluid remaining in the IV bag, read the large print on the IV bags and allow scanning of bar codes on the IV bag.

]00098] Avoiding stiction can be advantageous when considering material and design configuration for the pressure vessel. Stiction is the static friction that needs to be overcome to enable relative motion of stationary objects in contact. Stiction between the IV bag and the pressure vessel can hinder free inflation of the bladder of the pressure vessel. Stiction can be a particular issue for polymer layers with a high gloss finish. IV bags are typically produced from a smooth high gloss material. Avoiding stiction can help ensure there is even pressure across the pressure surfaces to the IV bag. Should there be stiction to the IV bag, the pressure may not apply evenly across the surfaces and lead to trapped IV fluid inside the IV bag as it can cause uneven pressure distribution as the IV fluid drains. In addition to stretching to expand pressure bladder we may also use a pleated layer in the pressure vessel that unfolds against IV bags as the IV fluid drains out to the patient. One way to avoid stiction is material selection, fluorinated (e.g., Teflon, PVDF, etc.) or polyolefin (e.g., PE, PP) polymers may avoid gripping to typical IV bag materials (e.g., PVC or TPU layers). One can also avoid stiction by reducing the surface contact area between the two layers. This can be accomplished by adding texture (raised spots or rough surface) to one or both of the contact surfaces.

[00099] The pressure vessel can be disposable once the fluid of the IV bag is dispensed, and therefore preferably has minimal cost of production. The layers of the pressure vessel can be connected using RF and impulse sonic welding. Thus, possible different materials can preferably be selected and tested as compatible for the weld type. As an example, a vessel made from thermoplastic polyurethane (TPU) could use a relatively rigid polymer sheet on the outside layers (forcing expansion inward) and a softer more elastic grade on the inside that allow expansion. With both layers made from TPU the bond will be compatible. Stiffer PVC formulations without plasticizers may be on the outside and softer PVC with plasticizers can be employed on the inside layers. Using PE and EVA combinations, while generally not elastic as grades of TPU or PVC, may lend themselves to the folded or pleated inner layers and be more likely to slide against the tackier surface of the IV bag.

[000100] In some embodiments, the bladder completely surrounds the interior of the pressure vessel, the region where the IV bag is inserted. In such an embodiment, pressure can be applied to the IV bag from multiple directions, assisting in constant pressure maintenance. FIGS. 6A-6C show various embodiment of air bladders of the pressure vessel. The air bladder of the pressure vessel can be a single chamber 632 positioned on one side of the intravenous fluid bag 630 to exert force evenly across the intravenous fluid bag (FIG. 6A). In another embodiment of the pressure vessel, two air chambers 632 are present (FIG. 6B), in communication with each other and oriented opposite of each other to exert force on the intravenous fluid bag 630 from opposing direction. In yet another embodiment, a series of smaller air chambers 632 in communication with each other form an annular orientation around the intravenous fluid bag 630 to exert force evenly around that bag (FIG. 6C).

[000101] The pressure vessel can be configured to hold up to about 375 mm Hg. Other configurations are also possible (e.g., about 325, 350, 400 mm Hg.)

[000102] FIG. 7A shows an embodiment of IV bag insertion into the pressure vessel 102. The pressure vessel 102 is sealed along a side 710 of the pressure vessel and top edge 712 of the pressure vessel. The pressure vessel 102 is sealed along the bottom edge 714, other than a portion 718 in the center configured to allow passage of the IV tubing 716 therethrough. The pressure vessel can be open on the second side 702 and along a portion 718 of the bottom side. An IV bag 708 can be inserted into the pressure vessel from the second side 702. After insertion of the IV bag, the pressure vessel 102 can be sealed using connectors 706 (e.g., snap connectors), as described above. The snap connectors may be configured to only be used once, making the pressure vessel disposable. More (e.g., 4, 5) or fewer (e.g., 1 , 2) connectors may be used.

[000103] FIGS. 7B-C show another embodiment of a pressure vessel 720. The pressure vessel comprises a front section 722 and two flaps 724 on either side of the front section 722 creating a wrap around sleeve. The front section 722 and two flaps 724 comprise adhesive 726 to adhere to an inserted IV bag. Any or all of the sections can comprise an air bladder. FIG. 7C shows a back view of the unfolded pressure vessel 720. The adhesive connection can ensure a tight wrap around the IV bag, enabling the pressure vessel to inflate to an optimal pressure quickly.

[000104] FIG. 7D illustrates another embodiment of a pressure vessel 740. The pressure vessel 740 resembles an envelope configuration. The front and back of the pressure vessel 740 are fused along its entire upper edge 742 and side edge 744. The bottom edge 748 can be fused to a midpoint and is then open to allow side loading of the IV bag and previously connected IV tubing. Side edge 756 is open and comprises flap 752 comprising adhesive 750. The flap 752 is configured to be folded over and adhered to the front portion of the pressure vessel 720. A flap configuration can be helpful in resisting shearing above 350 torr.

[000105] FIG. 7E depicts another embodiment of a pressure vessel 760 similar to that shown in FIG. 7A. Pressure vessel 760 comprises similar connectors 766, but has a fold over flap design, as shown in FIG. 7D, in which flap 764 comprises connectors 762 and is configured to fold over, aligning connectors 766 with connectors 762. Having one layer of film extending beyond the front edge and folding back over can spread the stress over the entire folded edge instead of concentrating it at the connectors.

[000106] In some embodiments, the IV bag is inserted into the pressure vessel while the IV line is already connected to the IV bag. In such embodiments, a pressure vessel 772 as shown in FIG. 8 can be used. The pressure vessel 772 is open along its bottom edge at region 774 so the IV bag can be easily slid inside with the IV line attached. A connector 776 is positioned along the bottom region 774 to close the pressure vessel after insertion of the IV bag 768.

[000107] FIGS. 9A-9D illustrate various views of an embodiment of a pumping device 900. FIG. 9A shows a perspective view of the device 900. FIG. 9B shows a front view of the device 900. The front of the device has a generally rectangular shape. The front of the device comprises a display screen 902, input controls 904, and a start/stop control 906. The device comprises raised features 908 configured to enable a user to pull down and open trapdoor 910. A side opening 912 allows for passage of IV tubing therethrough.

[000108] FIG. 9C illustrates a side view of pumping device 900. The device 900 comprises a fluid connector 914, such as those described above (e.g., connection point 202 of FIGS. 2A and 2B), for fluidly connecting to a pressure vessel. The device 900 also comprises a physical connector 916 (e.g., hook) for attaching to a pressure vessel. A back surface 918 of the device 900 can be concavely rounded to allow conformance to a convexly shaped pressure vessel. FIG. 9D shows a back view of the device 900, including fluid connector 914 and physical connector 916, as well as trapdoor 910, described in more detail below.

[000109] The pumping device can weigh less than about 1 lb. With the weight of the pressure vessel and a full 1 L IV bag, the system weight can be about 3 lbs.

Bubble Sensor

[000110] In some embodiments, the pumping device comprises a new type of bubble sensor that allows the absolute detection of air and liquid in a tube, and provides identification that a tube is inserted in the sensor. The detector can perform auto-calibration by dynamically adjusting the sensor sensitivity and light source brightness automatically, based on a proposed layout, without a user inputting any parameters. The sensor works using both the absorbance and the refractance of light in response to the liquid.

[000111] FIG. 10A shows an embodiment of a traditional bubble detector comprising a light source 1002 shining through IV tubing 1004 comprising fluid 1006 and onto detector 1008. Such a sensor can require calibration every time a tube is changed as the optical characteristics of the system can change upon changing of the tubing. The system can analyze the light impinging upon detector 1008 and determine the presence of bubbles, depending on the absorbance and refractance of the liquid. Changes in the light intensity hitting the optical detector may indicate the leading or trailing edge of an air bubble in the IV line. The presence of a band of microbubbles in the IV line may lead to scatter of the light and decreased optical signal at the detector.

1000112] FIG. 10B illustrates an embodiment of a bubble detector. A light source 1002 (e.g., narrow band LED) shines through a tube 1014 comprising fluid 1016 off-axis (a height off-axis at approximately the inner radius of the tube for maximum refraction) and onto an optical sensor 1018 on the other side of the tube, as shown in FIG. 10B. The detector 1018 is arranged so that the light passing through the tube and refracting through the liquid will hit the detector. If liquid is not in the tube, the light will not refract, and little to no light will impinge upon the detector. Regardless of the opacity of the tubing, light will only hit the detector if a liquid with a refractive index greater than air is in the tubing. The optimal location of the sensor will depend upon the refractive index of the liquid, and the diameter of the tubing (e.g., based on expected path of the refracted light).

[000113] For tubes or liquids that are extremely optically transparent or more optically opaque, it is optimal to modulate the intensity of the light source. A scenario with light hitting the detector 1018 means that liquid is present absolutely. A scenario with no light hitting the detector 1018 can mean a variety of things: 1 ) No tubing present; 2) Opaque tubing or liquid; or 3) Air in tubing. Thus, this embodiment allows a single detector to detect the presence or absence of liquid.

[000114] Adding an additional detector 1020 directly across from the light source provides a means for auto-calibrating the system by detecting tubing and measuring the relative opacity of the liquid and tubing. Maximum light impinges this detector with no tubing obstructing the light source. Less light hitting the detector provides a means of detecting tubing in the sensor, and the relative amount of light hitting the detector is a measure of the opacity of the tubing and liquid. Detecting tubing in the sensor can allow the system to verify that the IV tubing is properly in place. As noted above, a scenario with no light hitting the detector 1018 can mean a variety of things: 1 ) No tubing present; 2) Opaque tubing or liquid; or 3) Air in tubing. Adding the additional detector 1020 removes any ambiguity caused by a lack of tubing or air in the tubing. Additionally, a measurement of tubing opacity can allow dynamic adjustments for auto-calibration of the bubble sensor system. If the opacity is high enough, the light output from the source can be increased and/or the detector's sensitivity can be increased to restore the dynamic range of the sensor and ensure the detection of air in the line. Likewise, if the tubing and fluid are highly transparent, the light source can be decreased and/or the detector's sensitivity can be decreased so as not to saturate the detector.

[000115] In this way, the detector 1020 can serve as a servo or feedback loop, adjusting the system parameters in real time. In some embodiments, the detector 1020 can be used to keep the detector value within a certain range at all times, rather than just adjusting when limits are exceeded. [000116] Most bubbles present in thin tubing displace the liquid across the entire inner diameter of the tubing. When the sensor detects that no liquid is present, it is an indication that the line is dry or that there is a large bubble in the tubing. Bubble detection applications typically require fluid flow, and the length of time the sensor detects a bubble can be correlated to the size of the bubble. Another bubble situation can occur, where many small bubbles are dispersed in the liquid. This is referred to as microbubbles. This situation can also be detected, and would be characterized as a drop in signal at the liquid detector as well as a drop in signal at the tubing detector. A better way to detect microbubbles 1030 is to arrange a series of detectors 1028 down the length of the tubing 1024, as shown in FIG. IOC. These detectors 1028 will pick up the complicated refraction, reflection and diffraction, optical scatter, from the small bubbles.

[000117] In applications that monitor a variety of liquids, multiple light sources 1032, and multiple detectors 1034 can be employed to optimally monitor these liquids without requiring manual calibration before or during use, as shown in FIG. 10D. Liquids can be optically transparent or opaque at a narrow range of wavelengths. For instance, oxygenated blood has an absorption minimum in the green light region around 530nm, and has relatively low absorption in the infrared region. If multiple, narrow-band light sources 1032 are used, these liquids can be used without adjustment. By controlling these sources, this also provides a means of liquid identification. If identification is not a requirement, a single, broadband source can be used.

[000118] In applications where tubing and liquid don't change over a wide range of opacities, additional means of tubing detection can be employed, such as a contact switch, or a reflective sensor.

[000119] A reflective sensor 1040 can be added to the detector arrangements described herein, either by utilizing the existing light source, or adding a second source for the reflective sensor. The reflective sensor 1040 can be on the light emitter side, and placed so that the reflection of the light off the tubing is detected.

[000120] With a light source offset from the axis of the tube, light will be reflected off the tubing at an angle that allows it to be detected, as shown in FIG. 10E. By incorporating a second sensor like this for tubing detection, the other two sensors can be used exclusively for bubble detection and dynamic range control of the tubing and fluid. The sensor 1040 can also provide a means of identifying 100% opaque and 100% transparent tubing sets as very transparent tubing sets could present a problem to the detector 1020 if so much light is detected that it assumes that no tube is inserted.

[000121] For the best dynamic range, the sensors should be shielded from ambient lighting, so as not to influence the sensors. Positioning the optical sensor within the device housing (e.g., accessible by trapdoor, described below) can aid in shielding from stray light. This shielding can be particularly important when the device is used outside in bright daylight or indoors under various light sources, (e.g., incandescent, UV, LED) that can throw various wavelengths of light.

[000122] A simple electronic technique can be used to remove ambient lighting effects on the sensor. This involves pulse-width modulating the light source by periodically turning it on and off, as shown in FIG. 10F. The values of the sensors with the light source turned off provides a baseline measurement that is subtracted from the measurements of the sensors with the light sources on, as shown in FIG. 10G. As long as the sensors are not saturated by the lighting, this method works well. FIG. 10F illustrates this operating principle.

[000123] The optical bubble sensor can identify the leading and trailing edge of the bubbles and the time between those two events. That information alone is not enough to identify the size (e.g., volume) of the bubble. The device (e.g., controller or processor), however, also knows or infers an IV flow rate based on the amount of air being pumped into the pressure vessel, as described in more detail below. Knowing the moles of air in the system allows inference of the flow rate (ml/sec) of IV fluid out of the IV bag. Knowing the flow rate (ml/sec) and the time (sec) between the leading and trailing edges of the bubble passing the optical sensor, the system can identify a volume of the bubble. The pumping device can then stop air into the system and activate the clamp to stop IV flow for bubbles over a particular volume. It could also shut off flow before the trailing edge is seen for a bubble larger than a target threshold.

Trap door & clamp for IV Tubing

[000124] As described above, the pumping device can comprise an optical bubble sensor. In some embodiments, this sensor is housed at a bottom portion of the pumping device. As shown in FIGS. 1 1 A- 1 I B, the pumping device can comprise a trap door 1 1 10 that opens and allows the IV tubing 1 1 14 from the IV bag (positioned within the pressure vessel 1 1 16) to be draped around and inserted into a slot 1 1 12 for the optical sensor. Once the tubing 1 1 14 is in place, the door 1 1 10 is closed. Closing this door can activate several activities for the system. This section with the IV line enclosed can also comprise a clamp that will be activated by the pumping device when a "clinically significant" bubble is detected by the sensor. The clamp can comprise any mechanism that serves to pinch the tubing line (e.g., shown in FIGS. 43A-C).

[000125] The trap door may include a spring or protrusion that would push the IV to seat properly into notch (not shown) of the optical sensor. This would overcome any installment error from the user improperly placing the tubing. A micro switch on the door can communicate to the microprocessor the door is closed and tubing is installed and eliminate the need for a user input step. Conversely, the switch can alert the system to the door being open.

[000126] The clamp may be configured to clamp the IV tubing upon receiving a signal from the device controller. The clamp may also be configured to unclamp the IV tubing upon receiving a signal from the device controller. In some embodiments, the clamp is a bi-stable metal spring that in one position (stable state) leaves the tubing undamped and IV flow flowing. The pumping device can move the clamp to the other state that applies pressure, crimping the IV tubing and stopping flow. The act of mechanically opening the trap door, clearing the bubble from the line and reclosing the door could reset the clamp to an open and IV fluid flowing position. Other signals from the system can cause the controller of the device to close the clamp (e.g., desired volume delivered, pressure out of acceptable range, flow rate out of acceptable range, etc.). The clamp can also be closed by the user, for example, to pause infusion to rotate infusion to a different IV site. [000127] FIG. 12 depicts a mechanical schematic of the various components of the pumping device. The device comprises a control board 1202 connected to a power supply 1204 (e.g., rechargeable battery). The system can comprise a temperature sensor 1206. 1208. The device comprises a motor 1210 (e.g., DC motor). The motor 1210 can comprise a tachometer 1212. The motor works with pump 1214. The pump 1214 leads to the fluid connection 1218 between pumping device and the pressure vessel. The switch 1222 can indicate whether or not the pressure vessel and pumping device are connected. A pressure relief valve 1216 is positioned between the pump and connector. A pressure sensor 1220 is positioned inline from the pump to the pressure vessel. Another pressure sensor 1208 provides the pressure reference to the atmosphere. With changing atmospheric pressure or elevation changes (helicopter rescue) the system can maintain a gauge pressure of 300mm Hg to the IV bag. A near field reader 1224 can be positioned on the pumping device. A near field antenna/chip 1226 can be positioned on the pressure vessel and configured to be read by the near field reader 1224. The pumping device can have communications capability 1228 (e.g., Wifi, Bluetooth). The pumping device can comprise a display screen 1230. Input switches are represented at 1232. The bubble sensor and clamp is shown at FIG. 12B. The sensor comprises a light source 1234 (e.g., LED) and an optical sensor (1236) or multiple light sources and sensors. Clamp 1240 can be connected to actuator 1238. Clamp backstop 1242 is shown on the opposite side of tubing 1244. FIG. 12C shows a tube-on view of the bubble sensor and shows the trapdoor. The door is shown at 1252. Spring 1254 can be used to push the tubing 1250 into a slot. The door can comprise switch 1256 to indicate whether the door is open or closed. The dashed line indicates an electrical connection to the pumping device control board. Although not shown in FIG. 12A, the device can comprise lights (e.g., LEDs) comprising a visual feedback region (e.g., warning lights, progress lights). The lights can comprise colored lights with, for example, green showing smooth operation, yellow showing a warning, and red showing an error condition The device may also comprise a speaker to generate audible alerts or alarms. As shown in FIGS. 12A-12C, the pumping device control board contains all the devices and connections necessary to operate the pumping device. It contains the pressure sensor and microcontroller that provide the basis for the control and operation of the device. Connected to the control board are peripherals such as the display, buttons, motor and pump, clamp, bubble sensor, and indicator lights.

Near Field sensor

[000128] Referring to FIG. 13, the pumping device can comprise a Near Field Communication (NFC) device that allows it to communicate with attachments 1306 to the device. This allows authentication of the attachments. Attachments such as a pressure vessel (e.g., l OOOmL IV pressure vessel) can contain an NFC tag 1308, preprogrammed with the bag size and authentication information. The tag can be positioned on a portion of the pressure vessel positioned near the pumping device after connection of the pressure vessel to the pumping device. In some embodiments, the tag 1308 is positioned between the layers of material of the pressure vessel. This positioning can prevent tampering with or removal of the clip. [000129] The pumping device, upon reading the information stored in the TAG, can process the authentication information to ensure that it is a genuine bag, and has not been reused. Then, it can configure the parameters in the pumping device to display relevant configuration information to the user.

Displaying this information to the user can prevent operator error should the user be responsible for inputting parameters such as bag size, which affects operation of the pumping device and can cause serious runtime errors.

[000130] As described above, the pumping device can be configured to closely conform to or be closely situated with the pressure vessel using a combination of fluid and physical connections. This close, reliable positioning can enable near field communication between the pumping device and the pressure vessel (e.g., for the purposes described herein).

[000131] Besides reading information from the NFC tag embedded in the attachment, the pumping device can also write data to the tag. Writing to the tag of a pressure bag could include disabling the tag after a successful infusion to prevent bag reuse. Writing to the tag could also be used to store status information, such as estimated IV fluid remaining. For instance, if the pumping device infused 500mL from a 1 L IV bag, that information can be stored in the tag. If the pumping device is removed for some reason, and the same or a different pumping device is connected to finish the infusion, the pumping device, upon reading the tag, would initialize with the correct settings for finishing the infusion. Another possible use case would be to store information on the tag related to logging the infusion. This could include the mode of operation, such as multiple small boluses or single full volume infusion, the total infusion time, and the serial number and/or name of the pumping device performing the infusion. Upon removal from the pumping device, the bag could be scanned by an NFC scanner connected to a computer, and the information can be recorded to the electronic health record.

[000132] Another possible use case for the NFC tag on the pressure bags could include the destruction of the tag after an infusion. This will prevent reuse of the bag, since the NFC tag cannot be read by the pumping device for subsequent infusions. The tag can be destroyed by mounting the tag in a location on the pressure bag that expands under pressure. If the expansion is severe enough, the foil antenna of the tag will be distorted or broken.

[000133] NFC may also be used for future device attachments, providing a means of authentication as well as information regarding the use of the attachment. Configuration settings in the pumping device can also be updated using NFC, which could include default settings, operating settings, patient specific parameters, updates to the device firmware, and connection settings for wireless connectivity including, but not limited to, Bluetooth and WiFi connections.

Motor and Pump

[000134] The pumping device comprises an air pump and motor. The motor and pump can be capable of delivering air pressure up to 300 mm Hg pressure. The motor and pump can have an air flow rate capacity to bring the pumping device and connected pressure vessel up to pressure (e.g., about 300 mm Hg) within roughly 10 seconds. The pump can be configured to cycle on and off around the pressure target (e.g., about 300 mm Hg). As the IV fluid exits the IV bag, the pressure will decrease. Once it reaches a certain pressure, the motor and pump can be configured to restart and bring the system back up to pressure. In some embodiments, the motor and pump combination are configured to restart at an inline pressure (e.g., about 275 mm Hg).

[000135] In some embodiments, the motor voltage rating is compatible with the battery power from the Li-ion battery(s). A single cell battery is typically a 4V source. In some embodiments, the pump and motor must be small and light to fit into the pumping device enclosure and robust within the enclosure to withstand potential drops. In some embodiments, the pump and motor combinations are capable of a minimum of 10 cycles per day for 5 years of use. (A cycle is a complete lOOOcc IV bag infusion.) This equates to roughly 500hr run life with frequent starts and stops.

[000136] In some embodiments, a DC motor is used. DC motors may be brushed, brushless, iron core or any other variety that are small, compact and will provide sufficient power from available DC voltage. An advantage of brushless motors is the control and feedback of motor revolutions and with that strokes of the pumps. Knowing the motor revolutions, the pumps strokes and mass flow of air into the system and pressure vessel can be closely approximated. With a brushless pump correlations of mass flow can be made by knowing the pump run time and having a well characterized pressure and mass flow curve for the system.

[000137] The pump can be a diaphragm style design. The pump may be single, double or even triple diaphragms driven off an eccentric arm from the motor shaft. Example candidate pump and motor combinations include a RMJ 5DC 18C or a KNF S020L, as shown in FIG. 14.

Algorithms

[000138] Control over the pump can be governed by pressure data in line to the connector. As noted earlier, the pump will initially rise to a target pressure. As the pressure lowers as IV fluid exits the bag, the pressure will reach a threshold pressure that causes the pump to restart. For example, the pump may initially run until a 300 mm Hg target is reached. Once at 300 mm Hg, the control algorithm can cause the pump to shut off. Once at the target pressure, the IV fluid will start to flow more quickly (rapid infusion) and volume of the IV bag will decrease. As the IV volume decreases the pressure vessel can compensate by expansion of the air bladder against the IV bag. This expansion will cause the inline pressure to drop. When the inline pressure reaches a threshold, for example 270 mm Hg, the control algorithm will turn the motor and air pump back on pushing the pressure back to 300mm Hg. This sequence will continue until the IV fluid has drained from the IV bag.

[000139] As the pressure is maintained by the air pump between the high pressure and low pressure targets, the control algorithm can track IV fluid dispensed from the IV bag, inferring the value using the Ideal Gas Law. Pump flow rate performance with pressure can be carefully characterized. In other words, the relationship between pressure in the line and pump flow rate can be known, as shown in FIG. 15. Additionally, pump performance with available voltage can be known. By knowing the mass flow rate from the pump (e.g., using the sensed pressure or the voltage) with run time can provide the mass of air into the PV and inline system. Volume stretch of the pressure vessel with pressure can also be characterized so the amount of air in the pressure vessel is known. Knowing the moles of air entering the system, the pressure, and the temperature, allows the calculation of the volume of fluid out of the IV bag using the ideal gas law, PV=nRT.

[000140] If flow out of the IV bag should be stopped, the system would know by timing the frequency or duration between pump restarts. Failure to sense the restart pressure or an unexpected long delay to restart could send a warning or error message.

[000141] Free flow of an open IV line to a bucket with no resistance could model an over flow situation. Should pump restarts happen this quickly this too could cause an error message. Pump restarts happening too quickly can indicate that IV flow is too fast (e.g. indicating improper IV connection, IV flow too fast). In some embodiments, 5cc/sec (lOOOcc in 3min 20 sec) is greater than an acceptable rate of IV fluid flow. At that point, the vein may not be able handle the flow and infiltration of the line outside the vein is likely.

[000142] An example 1 ^st generation algorithm being used for motor and pump selection is shown at FIG. 16.

[000143] This graph show the pressure and flow characteristics of the pump. A fast flow at low pressure will provide a fast initital inflation to the uninflated pressure vessel. The downward slope of the line shows decreased airflow as the pressure increases and linearity of the downslope helps predictability of airflow as pressure is changing. Using that pressure and flow information the air pumped into the PV can be used to create a model of the system response.

[000144] As described above, by entering the parameters for the pressure vessel (bag), motor performance, assumptions of IV flow, estimates of the pump run time, motor energy consumption, initial time to pressurize and total IV dispensing time, IV fluid dispensed can be estimated. With a functioning system, the assumptions built into this model can be replaced with actual performance data and the accuracy of the modeled system can be refined.

[000145] This model can be reflected in the pumping device display screen during use by showing total CCs of IV fluid dispensed and expected time to completion among other parameters.

[000146] An example flow control algorithm using the ideal gas law is shown at FIG. 16. The system is initially set up, as shown at 1602. The pneumatic connector switch (at fluid connection between pressure vessel and pumping device) indicates that the pressure vessel or disposable is connected. The near field sensor can indicated a proper pressure vessel is being used, and can also identify the pressure vessel (e.g., 1000 or 500cc disposable). The IV tubing can be placed into the pumping device so that the optical reader senses tubing. The IV tubing clamp can be in the closed position.

[000147] The system then performs the initial pressurization, as shown at 1604. The pump inflates to a target pressure vessel (e.g., to 300mm Hg), causing the pump to shut off. The run time and pressure/flow information is converted into the number of moles of air pumped into system. The inflated volume of pressure vessel determined V=nRT/P.

[000148] IV flow is opened, as shown at 1606. IV flow out is equal to the volume expansion of pressure vessel and causes pressure drop. The moles of air in the system is unchanged since the pump is shut off. The pressure drops to a threshold pressure (e.g., 270mm Hg), causing the pump to turn on and re inflate to the target pressure (e.g., 300mm Hg). The run time and pressure/flow information are converted into additional moles of air pumped into system. The system can cycle, letting more IV fluid out until the desired amount of fluid is delivered.

[000149] Because the moles of air in relates to IV flow out, the system can track: 1 ) Amount IV fluid dispensed so far; 2) % progress of full bolus; 3) IV flow rate; 4) IV fluid remaining for full bolus; 5) Estimated time to finish. From this information, the system can send alerts to a user (e.g., end of bag alert, end of bolus fraction alert, etc.).

[000150] FIG. 17A shows a simulation of pressure over time. The pump inflates to a target pressure (e.g., 300mm Hg) and shuts off, losing pressure as IV flows and air bladder expands. The saw tooth on the graph represents cycles of restart of the pump bringing pressure back to target pressure. The slope of the saw tooth reflects the expanding volume of air bladder and the resulting slower inflate/deflate cycles as the IV fluid is pushed to the patient and inflated bladder expands in the pressure vessel.

[000151 ] FIG. 17B shows the mass of air pumped into the system and IV flow out of the system over time. The system tracks the moles of air pumped into the system and can closely approximate the IV flow out of the system.

[000152] In some embodiments, the pumping device comprises a motor with a tachometer or encoder. This combination can enable precise tracking of revolutions of the motor shaft. This information can be equated back to molar output from the pump.

[000153] In some embodiments, the pumping device allows flow of the IV fluid to the patient as the system does its initial inflation to target pressure. This will allow an unknown amount of IV fluid out of the system before the air pump reaches its initial full inflation and sets initial bladder volume. This can reduce accuracy, but since initial inflation is expected to take no longer than 10 seconds, the IV volume unaccounted for is likely less than 3% of the overall volume and not clinically significant.

Sensors, Relief valve

[000154] As shown in FIG. 12A the pumping device comprises a pressure sensor. The pressure sensor can comprise a 2 stage system that tracks ambient and atmospheric pressure and air pressure inside the pneumatic line from the pumping device to the pressure vessel. Other pressure sensors are also possible.

[000155] The pumping device can also comprise a temperature sensor. The temperature sensor can be positioned on the control board or anywhere within the case of the pump. The temperature sensor can provide input to a controller to allow calculations involving the Ideal Gas Law. Since the pumping device is intended for use in various environments, both indoors and out in the field, the temperature can have an impact. The temperature sensor can comprise Thermocouples, resistive temperature detectors (RTDs), thermistors, etc.

[000156] In some embodiments, the infusion system comprises a pressure relief valve (e.g., pressure relief valve 1216 of FIG. 12A). In some embodiments, the pressure relief valve is a mechanical pressure relief valve. Its purpose is to fail safe by releasing air pressure from an over pressurized line. Over pressurization may come from a software failure or faulty pressure sensor. Mechanical relief valves or check valves are typically spring loaded to seal an exhaust outlet. A ball is pushed in place by the spring and blocks the flow of air. As pressure works against the seal, the spring will yield to increased pressure. As air pressure increases, the pressure can overcome the force of the spring to keep the ball in place and air leaks around the ball and vents. In some embodiments, the pressure relief valve is configured to open above the operating pressure of the pumping device. For example, the valve can have a burst range around +/- 20% , so a properly spec'd valve opens above the 300mm Hg operating pressure of the pumping device (e.g., 300 mm Hg + 20% ~ 360mm Hg relief pressure).

Display, contact switches, User Interface

[000157] In some embodiments, the pumping device comprises a display. As shown in FIG. 18, the display 1802 can show multiple data points necessary for decision support in a simplistic and organized manner as to quickly identify any combination of: 1 ) Status of wireless signal and battery (maintenance data) 1804; 2) Operating mode status 1806 ; 3) Current infusion status including: (e.g., Volume infused counter, estimated time to completion, alarm code details) 1808; 4) Current run settings (e.g., automatic or user selected) 1810; 5) Guidance to initiate setup (e.g., verified by sensor feedback) (not shown); 6) Guidance of user-action necessary to verify alert/to clear alarm (not shown); 7) Dynamic legend/guidance (e.g., association of input keys to function) 1812.

[000158] The mode status can show the screens displayed in FIGS. 19A-E. The modes shown include Paused (FIG. 19A), Edit Setup (FIG. 19B), Edit pressure (FIG. 19C), Setup (FIG. 19D), and Infusing (FIG. 19E). Other screens are also possible.

[000159] The current infusion status screen can display the screen embodiments shown in FIG. 20A-F. A quickstart setting screen is shown in FIG. 20A. An air-in-line warning is shown in FIG. 20B. A fluid delivered screen is shown in FIG. 20C. FIG. 20D shows an alert screen indicating the trapdoor is open to the user. FIG. 20E shows a screen shown to user after the door open error is corrected. FIG. 20F shows a screen displaying real time volume and time to completion. Other screens and any combination of the information displayed are also possible.

[0001 0] FIGS. 21 A-D illustrate possible screen embodiments for the legend/guidance portion of the display, a portion of the display indicating buttons to push if the user wants to make a change. FIG. 21 A shows screen indicating the button for the user to push to pause an infusion. FIG. 2 IB shows a screen indicating the burton for the user to push to accept or edit infusion settings. FIG. 21 C shows a screen instructing a user how to navigate among a hierarchical list to select infusion settings. FIG. 2 ID is another screen explaining how to navigate among a hierarchical list to select infusion settings. Other screens and any combination of the information displayed are also possible.

[000161] FIGS. 22A and 22B show examples of screens in the infusion status/error section of the display. FIG. 22A shows an infusion setting screen showing the IV bag start volume, the bolus to be delivered volume, and the pressure. FIG. 22B shows an error screen indicating a bubble in the tubing and providing instructions to a user to clear the error. Other screens and any combination of the information displayed are also possible. [000162] In some embodiments, user defined infusion can use hierarchical selection lists on the display to define parameters, as shown in FIGS. 23A-C. FIG. 23A shows an Edit Setup screen, allowing a user to edit IV Bag Start Volume, Bolus Volume, or Pressure Level. The user can navigate to Pressure Level using the up and down arrows as indicated in the guidance portion of the screen. Once the user selects Pressure Level, the Edit Pressure screen shown in FIG. 23B is displayed. Again, the user can use the up and down arrows to navigate to the desired pressure. Once the pressure is selected, the display shows the selection as depicted in FIG. 23C. The user can press the check button to continue as indicated in the guidance portion.

[000163] In some embodiments, the display has a dimension of about 2.25 to 2.4 inches diagonal. The display can be a thin film transistor (TFT) display with backlight/sidelight for device readability indoors and outdoors. The display can be Black and white/grey scale format with variable font size to highlight important data. In some embodiments, color is utilized for additional value in the display of data. The data can be displayed in portrait orientation to accommodate the amount of data necessary for decision-support. Data can be presented in an alphanumeric and icon combination.

[000164] As described above, the use of universal-meaning icons will be utilized in combination with or in replacement of alpha-numeric data in order to universalize data transmission to end users, thereby either supporting and/or minimizing language-based data formatting. Examples of icons are shown in FIG. 24.

Sensors and performance-tracking algorithm

1000165] As described herein, the controller of the pumping device receives data from a number of sensors including, but not limited to, NFC/RFID, contact switch at connection between pumping device and pressure vessel, tubing sensor near bubble detector.

[000166] Workflow engine rules (WER) are defined as preprogrammed instruction sets that translate input from the operator and sensors into actionable routines based on context of function. The purpose of these rules is efficient performance of device as well as intuitive/guided interaction with operator including simplistic feedback both with color coded lighting and audible alerts as well as a data display with simplistic format for easy interpretation. The WER in combination with sensor monitoring, flow/run algorithm and a unique user interface with guidance mitigate much of the complexity of set up and maintenance found commonly with automated infusers.

[000167] FIG. 25 illustrates an example of startup sequence logic and sensor feedback and user interaction. As shown at box 2502, the system checks the connection between the pressure vessel and the pumping device. If the system finds the two are not connected, it instructs the user to correct the error, as shown at box 2504 (e.g., using the display screen, lighting, audible alert, etc.). If the system finds the two are connected, it moves onto the next check. At box 2506, the system can check the input from the NFC or RFID sensor to authenticate an attachment such as the pressure vessel. The system can also check for any identifying or infusion status information. If the system does not authenticate the attachment, the system can instruct the user to correct the error, as shown at box 2508 (e.g. using the display screen, lighting, audible alert, etc.). If the system authenticates the attachment, it moves onto the next check. At box 2512, the system checks the tubing sensor. If the system finds the tubing is not properly in position, it can instruct the user to correct the error, as shown at box 2512 (e.g., using the display screen, lighting, audible alert, etc.). If the system verifies the tubing is in position, it can move onto the next check. At box 2514, the system checks the tubing door sensor. If the system finds the door is open, the system alerts the user to correct the error, as shown at box 2516. If the system verifies the door is closed, the system moves onto the next check. At box 2518, the system checks whether the clamp is in the proper position (open or closed). If the system finds the clamp is not in the proper position, it alerts the user to correct the error (e.g., using the display screen, lighting, audible alert, etc.). If the system finds the clamp is in position, the system can be ready to run and can display the quickstart setting screen to the user, as shown at box 2522.

[000168] The auto-quick-start mode presumes optimal conditions for maximum efficiency of the most common type of rapid infusion, being a full liter volume delivered at maximum accepted flow rate. This is accomplished by a preset device protocol that recognizes a new pressure vessel (via NFC/RFID communication between the pressure vessel and the pumping device), the size of the pressure vessel (500ml and 1000ml sizes) and maximal infusion from a maximum pressure of 300mmHg. FIG. 26A shows an example of a quickstart settings screen. The operator can accept the setting by hitting the select (check) button. The operator can edit the settings by hitting the indicated (e.g., left arrow) button, as shown in FIG. 26A.

[000169] If the operator wants to use settings other than the quickstart settings, the operator can adjust parameters of the device in real-time, however, thereby adjusting the machine function to meet the operational/logistical needs as well as the clinical condition of the patient. The three parameters that the operator can adjust are: 1. Volume of IV bag; 2. Volume to be delivered; and 3. Pressure at which to deliver IV fluid.

[000170] FIG. 26B shows a screen with the IV Bag Start Volume option selected. Situations occur that will impact the amount of IV bag fluid volume at the start of a bolus. In these scenarios, the volume is not 1 OOOmL as is automatically populated (and verified) at Quick-start. Partial bag volume can be remaining at time of insertion into the pressure vessel and use of device. Situations occur where a gravity (e.g., slow) infusion is changed to rapid infusion (bolus under pressure). In these cases, the operator now has the remainder of the bag to infuse with the pumping device. That volume of the remainder can by entered into the pumping device by the operator, so that the device knows the physical starting volume of the bag. In the case of a bolus of a remaining 800mL of fluid from a 1 OOOmL bag under pressure, the operator manually enters 800mL, a deviation from 1 OOOmL in Quick-start mode. The device also knows that the volume to be delivered cannot exceed the volume available, so that the Quick-start volume to be delivered of 1 OOOmL no longer applies in this situation and cues operator to adjust to correct volume to be delivered.

[000171] With the current pumping device, the operator is encouraged to use a corresponding pressure vessel for use with IV bags (e.g., 1 OOOmL Pressure Vessel should be used with 1 OOOmL IV fluid bag, 500mL Pressure Vessel used with 500mL IV fluid bag). However, the system is designed to adapt to varying logistical situations (e.g., the lOOOmL Pressure Vessel can be used with a 500ml IV fluid bag; the

500mL pressure vessel can be used with a unit of blood product, which is often a volume of 300mL- 375mL). In these situations, manual entry of Volume of IV bag can allow the device to adjust for extra start-up dead space in Pressure Vessel without cueing operator as to why the initial inflation time deviated from that of expected time in corresponding pressure vessel and IV bags. Also, the control algorithm will look to advise the user of time to finish and end infusion (e.g., clamp IV tubing) when the target volume has been dispensed.

[000172] FIG. 26C shows an example of a screen with the Bolus Volume option selected. Clinical conditions and patient history/co-morbidities contribute, in some cases, to the delivery of smaller IV bolus volumes. By using the pumping device, the operator is able to give a rapid infusion, but a fraction of the volume of the IV bag. This allows the operator to still use standard-size IV fluid bags (e.g., lOOOmL), avoiding the need for smaller-volume IV fluid bags (e.g., 250mL), thereby avoiding the need to change workflows. The pumping device can calculate volume delivered and then clamp the infusion when the target amount is reached regardless of volume left in IV bag. This also helps to avoid under- delivery of IV fluid volume (operator guess) or the "run-away-bag" phenomena (over-delivery of IV volume) in the current manual process of using a manual pressure bag.

[000173] These patients may include Congestive Heart Failure Disease patients and End Stage Renal Disease/Chronic Renal Failure/Acute Renal Failure patients that do not have the normal renal function (elimination through urination) to compensate for large volumes of IV fluids added to their circulating volume, but still would benefit from Rapid Infusion. In these cases, the best-practice approach of 250mL rapid infusion before reassessment can be achieved every time the pumping device is used. The clinician has the ability reassess the patient's response to each bolus before initiating another.

[000174] Additionally, in the case of military combat casualty care protocol, because of the dynamics of the battlefield, including mechanism of traumatic injury and logistics of rendering medical care in a dynamic environment with limited resources, the operator is able to effectively deliver smaller target boluses; after which the pumping device automatically stops, allowing the operator to assess the effect of the bolus(es).

[000175] FIG. 26D shows an example of a screen with the Pressure Level option selected. Clinical considerations for adjustment of pressure level from nominal 300mmHg include flow rate parameters for any equipment in line as well as IV site/patient factors that may guide operator to select lower pressure for integrity of system. In-line equipment flow rate restrictions can exist. Most IV tubing/peripheral catheters/central catheters are rated to accept a force of 300mmHg exerted on infusing fluid or fluid flow- rate of 5ml/sec. There are, however, IV equipment and implanted vascular devices that are rated for less pressure/flow rate before failure. The operator can reduce the pumping device pressure setting in order to attain target flow rate. Some fluid warming equipment, used in conjunction with rapid infusions have a maximum flow rate less than 3.5ml/sec to maintain a constant target temperature. Again, in this case, the operator can reduce the pumping device pressure level in order to attain the target flow rate. [000176] The operator can also adjust the roller clamp on a typical IV line to adjust flow rate.

While using at higher pressure setting of 300 mm Hg, applying the roller clamp to restrict flow, the controller will still sense pressure drops in the pneumatic line and refill back to the target but at a slower restart rate than if the flow were unrestricted. As shown in FIG. 27, the display will indicate a flow rate that will respond to externally forced restrictions (roller clamp, kinked IV line...) to flow and can be the user's cue to set a proper flow rate.

[000177] Patient condition flow rate considerations can also exist. In patients with known "delicate" peripheral IV access, the operator of the pumping device can reduce the infusion pressure level of the device in order to maintain IV access site/vein integrity while still delivering a rapid infusion until a larger venous access can be accomplished.

[000178] Feedback, valuable for relaying operating parameters and device function to operator, includes simplified hierarchical lists displayed by the device for the user to maneuver, select and verify at the time of infusion set-up/initiation. Additionally, the real-time flow rate calculation results, displayed to the operator in an intuitive, consistent format, confirms the performance of the device based on automatic or manually selected settings prior to the infusion start. The dynamic infusion display includes mode, function, selected parameters; as well as amount infused, estimated time to completion and calculated flow rate (in minutes or seconds) based on the operator need, as shown in FIG. 27. If an adjustment needs to be made in any parameter setting, the pump can be paused while adjustments are made and then restarted with the new operating parameters.

[000179] FIG. 28 shows an example workflow showing the system continually monitoring the flow rate. As shown at box 2802, the system monitors sensors during the run, continuously calculating the flow volume. If the flow rate stays in the nominal range, as shown at box 2806, the system can display the rate, display a visual indicator of acceptable rate (e.g., a green light), and continue the run. If the flow rate decreases, but stays within the acceptable range, as shown at box 2804, the system can display the change to the user, display a visual alert (e.g., yellow light), emit an audible alert, continue run, and/or display the option to confirm a rate range, as shown at box 2812. If the flow rate increases, but stays within the acceptable range, as shown at box 2808, the system can display the change to the user, display a visual alert (e.g., yellow light), emit an audible alert, continue run, and/or display the option to confirm a rate range, as shown at box 2812, as shown at box 2814. If the flow rate decreases outside of the acceptable range, as shown at box 2816, the system can display the change to the user, provide a visual alert (e.g., a red light), emit an audible alert, stop the run (e.g., by auto-clamping tubing), and/or display the option to clear the alarm, as shown at box 2820. If the flow rate increases outside of the acceptable range, as shown at box 2818, the system can display the change to the user, provide a visual alert (e.g., a red light), emit an audible alert, stop the run (e.g., by auto-clamping IV tubing), and/or display the option to clear the alarm, as shown at box 2822

[000180] With workflow engine rules, the microprocessor can, through continuous monitoring of device/sensors/auto or manually set function parameters and continual calculation of variations in pressure over time, perform the following functions. [000181] The pumping device can alert/guide user through the set up process to administer IV bolus.

[000182] The device can alert the user to any change of feedback from sensors (e.g., tubing out, door open or compromised connection with the Pressure Vessel), and display guidance for mitigating alert

[000183] The device can warn user of battery needs (charging) or of connection needs (wireless communication).

[000184] The device can automatically reactivate alarms/alerts after user silences.

[000185] The device can automatically populate quick start parameters for operator to verify.

[000186] The device can allow an operator to edit parameters prior to infusion and, when appropriate, edit parameters during infusion, including total starting volume, bolus volume and pressure level. As a safety measure, the device will pause (e.g., clamp) the infusion during editing. The infusion tracking algorithm will not allow operator defined changes that will conflict with infusion (e.g., decreasing bolus volume below what has already been delivered).

[000187] The device can alert user to increase or decrease in calculated flow rates, related to multiple environmental factors, while continuing infusion if within acceptable parameters

[000188] The device can pause infusion (e.g., clamp) for increase or decrease in calculated flow rate beyond acceptable parameters. The device can pause infusion (e.g., clamp) for significant air bubbles. This can include both single significant air bubbles and cumulative smaller air bubbles calculated along continuum of infusion. The device can pause infusion (e.g., clamp) by operator on- command, as well as aborting infusion run on-command.

[000189] The device can administer total volume or partial volume boluses from the same bag with user defined parameters. The device can adjust for altitude during infusion to compensate for dynamics of patient transportation (air and ground). The device can allow an operator to select use for blood product volume as well as crystalloid volume infusions. The device can allow an operator to select additional modes of operation, such as transducer mode (constant target pressure, minimum volume delivery mode used to keep arterial catheter access patent). The device can allow an operator to access limited infusion history at the device for patient care, usage reference. The device can allow access to device settings with proper authorization (e.g., IT personnel). The device can communicate usage reports via data porting when placed in base station (inventory control, authentication and performance). The device can communicate performance result to EHR via secure connection (wireless whether directly or to middleware).

[000190] In some embodiments, the display screens on the pumping device are optimally low power consuming, visible and readable in varying light conditions ranging from a dark room to bright sunlight, and have enough resolution, contrast to display the content clearly. The displays can refresh with updating run information. Possible displays include monochrome screens and LCD and OLED color displays. Power Supply and Recharge stand

[000191] In some embodiments, the power supply for the device is a removable, rechargeable battery pack. This pack can contain one or more lithium-ion or lithium polymer batteries. The power supply can provide the device with a nominal 3.7V. Inside the device, various circuits and electronics can use 3.3V or lower to operate. In some embodiments, this is accomplished by a voltage regulator circuit built into the device control board. This circuit can supply power to much of the electronics, apart from the motor and pump, which can run straight off the battery pack. Additional components may need higher voltage, such as the indicator lights and display backlight. For this reason, an addition voltage regulator will be employed to provide the higher voltage for these devices.

[000192] The pumping device can have a custom recharging stand and a spare battery. The battery pack can be rechargeable through the unit and nesting into a cradle of the recharge stand. Electrical contact to the batteries may be via pogo pins to external battery contact points. Recharging can also be accomplished by attaching a micro-USB or other charging cable to the pumping device. The battery pack can be removable and replaceable. The recharge stand will also have a cradle for a spare battery recharging. This provides the ability to swap batteries as needed to ensure proper charge level of the device. If a pumping device runs out of batteries, there is no need to remove it from service to charge if spares are available.

[000193] This recharge stand could also be the portal for communication to the outside world including electronic health records (EHR) by including wired or wireless (e.g., Wi-Fi or Bluetooth) communication capability. When the device has finished a rapid infusion sequence and place in the cradle, the recharge stand could download all run information and send it to the EHR. This

communication could also include the use of the disposable that was identified by the NFC code. This will provide inventory information to the supplier that may allow automated restocking for used disposables.

[000194] Additional embodiments of the pressure vessel and pumping device configurations are provided below.

[000195] FIG. 29 illustrates another embodiment of a pressure vessel 2902 and a pumping device 2904. The pressure vessel 2902 comprises an IV pole hanger 2901. There is a fluid connection 2908 connecting the pressure vessel 2902 and the pumping device 2905. A catch sleeve on the pressure vessel also physically connects the pumping device 2904 to the pressure vessel 2902. The pressure vessel 2902 comprises a flap 2912 that can fold over to seal the IV bag within the pressure vessel 2902. A closure, such as adhesive 2914 can be used to seal the flap 2912. Other closures (e.g., buttons) are also possible.

[000196] As described above, the pumping device 2905 comprises an air pump and motor, a microprocessor, a self contained power supply (battery), multiple sensors including but not limited to pressure, temperature, accelerometer (positioning) optical or ultrasound sensors for flow rate or bubble detection, and audio/visual feedback and alarms, which include one or more light sources as well as a possible digital display to further communicate device status. [000197] An embodiment of a pumping device 3000 is shown in FIG. 30. Pumping device 3002 comprises an outer shell 3001 and an inner device 3014. The outer shell comprises a drop away battery sleeve 3010. The pumping device 3002 comprises an intake port 3002 and an atmospheric port 3004. At its tip (e.g., cone shaped nose), the pumping device 3006 comprises an outflow port 3006. The tip portion 3008 can also comprise a visual feedback region. For example, red, green, yellow, blue, etc. colored lights can be used to indicate system status to an operator. The inner device 3014 comprises a programmable input switch 3012. The inner device 3014 also comprises a first compartment 3016 that can comprise batteries. A second compartment 3018 can house the motor 3020 and pump 3022. The tip of the device 3014 comprises an outflow port 3024 that can comprise a threaded connector. A portion near the tip 3026 can be light transmissive to transmit visual feedback. Atmospheric port 3030 and intake port 3028 can be configured to line up to port 3004, and 3002, respectively. The device 3000 can comprise a logic circuit, sensors, and lighting, as described herein.

[000198] FIG. 31 shows device 3000 connecting to a traditional pressure bag 3102. The device 3000 can be connected to a 3-way stop cock 3104. The 3-way stop cock is also positioned to an inflation bulb 3016, which was previously used to inflate the bag 3102.

[0001991 FIGS. 32A and 32B show another embodiment of a pumping device 3202 comprising case 3212 and inner housing 3204. The device comprises discreet lighting 3206 for showing progression of infusion. Housing can comprise LEDs that are visible through case material. Intake 3208 and outflow 3208 atmospheric ports are positioned on device 3202. Outflow port 3210 of device comprises threads. Connectors 3322, 3342 described with respect to FIGS. 33C-H can be used with device 3202. The device 3202 comprises input switch 3212 on an end of the device. FIG. 32B shows a variation of outflow channel 3214 that can be used for pressure vessel decompression.

[000200] In some embodiments, the pressure vessel comprises a clear pliable material configured in an envelope format with an expansive internal air bladder and an integrated connector and sleeve. Additionally, possible sensors embedded in the pressure vessel are wired to the connector in order to communicate with Device.

[000201 ] The pumping device can be about 6.25 inches long and about 1.25 inches wide. The device 3000 can weight about 1 1 oz. including the weight of the batteries. In some embodiments, the pumping device 3000 is cylindrical, as shown in FIG. 30. Other configurations (e.g., not cylindrical shape of same dimensions) are possible. The device 3000 can comprise metal, or plastic composite. The device can comprise a combination of impact resistant, water repellant qualities and resistance to damage from common hospital cleaning agents. Due to the rapid paced environment of use for this device, the body should have a robust design that may include elastomer bumper on the ends or edges or other guards to protect certain sensitive areas of the device (e.g., from drops).

[000202] Unless specifically noted, all components subsequently described can be contained within the body of the pumping device (e.g., pumping device 900, pumping device, 3000, etc.). [000203J The pumping device can comprise a balanced weight along length of device, smooth surface for effective cleaning, a loss-less (non-removable) battery cover, and minimal shielded ports to body surface.

[000204] The device can comprise a user interface or other means of providing visual feedback by means of discrete and/or single-light-source multicolored light emitting diodes, in communication with the microprocessor, including but not limited to use of well known basic color combinations:

green=nominal function, yellow=warning, red=urgent warning. Flash patterns can also be used to convey level of importance. This light feedback may emanate from (but is not limited to) the proximal

(connection end) of the device via light transmissive connector. Secondary lighting emanating (from multiple discrete LEDs) from along the body of the device may be used to signal progression of infusion depending on mode selected. An example of this may be (but is not limited to) progressive lighting that signals to the user approximate or specific bolus volumes infused as determined by the device. Additional emanating colors may be used to signal additional device function. An example of this may be, but is not limited to, blue lighted feedback to signify "deflation mode" which the user will recognize as the microprocessor reverses the inflation process in order to decompress the pressure vessel. An additional example for the use of yellow color for a low battery warning while the device is functional. A concept drawing for the device body with the possible arrangements for light feedback to the user is shown in FIG. 32.

[000205] The device can comprise an audible sound generator, in communication with the microprocessor, that is configured to provide a concurrent method for communication to operator on status and functionality of device, complimenting visual feedback as described above. Length and frequency of sound generation is based on, but not limited to, discrete information that may be communicated in a specific fashion to alert the operator of the device function and/or warnings corresponding with afore- mentioned visual (light) feedback. A series of lights may indicate progress to complete IV bag delivery in run mode and show remaining battery life in a standby mode.

[000206] In some embodiments, the device comprises a water resistant programmable momentary switch in communication with the microprocessor. The multifunction switch will allow the operator to input multiple device selections/functions from one switch. These multiple selections can be defined by way of patterned pushes of the momentary switch, interpreted by the microprocessor to then activate discrete functions associated with predefined patterns. A combination of length of pushes as well as number of pushes can determine functions as monitored by microprocessor/workflow engine rules.

[000207] The switch can be oriented to, but not limited to, location at the distal end (heel) of device in order for accessibility by device operator (FIGS. 30 and 32). In some embodiments, this switch will be used for activation/deactivation, alarm acknowledgement, mode selection. Examples of these modes may be, but are not limited to, a single/short push to activate from sleep state, single/short push from nominal active state to deactivate, single/long push from dormant state to show remaining battery power, single/long push from active state to reverse inflation process, thereby and deflating the pressure vessel. A combination of length of pushes as well as number of pushes can determine additional functions, for example, two short pushes versus two long pushes to determine discrete function.

[000208] In some embodiments, individual user-selected functions may each be assigned to a discrete switch and multiple switches may be oriented along the device body or heel of device. In yet another embodiment a combination of multifunction and single function switches incorporated into the device may be used to select functions by the end user.

[000209] For additional user control features or feedback from the device, a single button, lights, and alarms for notice may not be enough. In this case, other user interfaces may be used including mobile smart phone-like touch screen control or a simpler monochrome LCD screen with multiple control buttons can be configured. FIG. 35 shows a possible configuration found suitable for a robust flashlight with GPS and text message capability. The monochrome screen and buttons would allow the user to toggle to different setting like a bolus administration and get specific feedback should an alarm go off.

[000210] A motor in communication with the power supply and microprocessor and mated with a rotary piston air pump to create air volume and pressure necessary for rapid inflation and subsequent maintenance of target pressure in connected pressure vessel. Pump and motor (FIG. 30) are entirely housed inside of device body. Speed and possible direction of rotation of motor are controlled by the microprocessor. Some embodiments use a simple brushed DC motor to actuate the air pump. Other embodiments utilize a brushless DC (BLDC) motor to provide improved speed control, thereby controlling the volume of air dispensed from the air pump more accurately. BLDC motors have a number of advantages over their brushed motors. They are more accurate in tracking position and counting revolutions. Relying on Hall effect position sensors for commutation, position of the motor can be related to cycles in the pump and thus air volume. They also require less and sometimes no maintenance due to the lack of brushes, which is important for robust product and a dependable product lifetime.

Measurement of the volume of air dispensed from the pump can be critical to the accuracy of the estimated volume of liquid dispensed from the bag. Measuring the current through a brushed DC motor can approximate the speed of the motor, providing a means to estimating the volume of air dispensed if a BLDC motor is not used. The pump may be a rotary piston or other suitable pump type to meet the performance, space and power usage requirements.

[000211] During inflation mode, the pump, in direct mechanical communication with the motor, can entrain air from the environment via the port along body device and directs that air, under pressure, first to internal pressure chamber of device and then to the pressure vessel via a connector. FIGS. 33A-H show possible designs for the pressure chamber and connectors to the pressure vessel. That internal chamber pressure generated within this sealed/airtight system can be, but is not limited to, nominal 300 torr (300 torr = 300 mmHg / 5.8 psi / .39 ATM). 300 torr is the medical standard of pressure applied to IV bags for rapid infusion. A pressure chamber (e.g., 3304, 3326, 3346 of FIGS. 33B, 33D, 33G) provides a dead space or volume of air that will smooth out the operation of the air pump. With extra air volume, the pump is not shutting on and off constantly trying to maintain a 300 torr control target. Also part of any dead space or pressure chamber is the line connecting the device to the pressure vessel (e.g., passage 3324 of FIG. 33D, tubing 3358 of FIG. 33H). That length and internal space of the tubing and connectors are additive to the volume of the internal pressure chamber in the device. During deflation mode, air could be evacuated from pressure vessel and pressure chamber to the environment by reversal of the same process, controlled by the microprocessor. In another embodiment, deflation is accomplished by means of an additional mechanical micro valve that is activated by the user from a secondary switch. In yet another embodiment, deflation is accomplished by means of an additional electronic micro valve that is activated by the user from a secondary switch or through some other user interface control.

[000212] A self-contained battery supply in direct communication with pump, motor, and microprocessor contains a single source for all power requirements. In some embodiments, batteries may be, but are not limited to, a current "standard" size (e.g., AAA), disposable when dead and held in place by a battery cage within device. The device may accept multiple types of battery technology including, but not limited to, Lithium Ion Polymer or Alkaline batteries. Additional battery technology (e.g., proprietary battery, rechargeable) can be used in exchangeable fashion within the device. In some embodiments, the battery cage is user-removable so that a rechargeable battery, having the same dimensions of the battery cage, can be utilized. Rechargeable batteries can be charged outside of the device. Power for the device can be swappable between the two technologies. In other embodiments, rechargeable batteries are not user accessible. The batteries recharge through the device's connection with an external charge. Charging/recharging of batteries in either of the above two embodiments can be accomplished through direct-contact or inductive charging. Charging the battery through a micro USB connector to an automobile cigarette lighter is also possible for mobile use of the device in an ambulance as an example. The microprocessor works, in conjunction with feedback methods described herein to alert the user to battery charge status.

[000213] In direct communication with the microprocessor, a barometric sensor of, but not limited to, dual/differential type or two separate sensors, can monitor the pressure vessel by means of monitoring the internal device pressure chamber in direct communication with pressure vessel. This function of pressure sensing can be regulated in frequency from multiple times (e.g., 1 -10, 10-50, 25-75,50-100) per minute to multiple times per second (e.g., 2-5, 5-10. 2-10) for accuracy and can read pressure during operation and non-operation of pump. Secondary pressure sensing of atmosphere is accomplished by way of communication to outside environment (atmosphere) via a port through device body. Comparison of these two pressures allows the device to compensate for environmental pressure changes and compensate for changes in order to accurately maintain target nominal pressures despite dynamic environmental pressure change from, for example, variations in elevation/altitude while using device.

[000214] In some embodiments, the device comprises a mechanical or electronic valve (e.g., valve 3308 of FIG. 33B). Placed in direct contact between device inner pressure chamber and outside environment, this valve compensates for sudden over-pressures (from nominal operating pressure) of pressure vessel. Interpreted by the microprocessor or by design of mechanical valve, sudden air volume causing over-pressure can be ported to environment, thus bringing pressure chamber and pressure vessel to a nominal operating range. When the pressure reading inside pressure chamber returns to the nominal range, the valve closes.

[000215] In some embodiments, three port electronic micro-valves (as example: Lee Company LHL Series Solenoid Valve LHLA051 1 1 1 1 H) incorporated into an air manifold positioned between, and in direct communication with, the pump intake and output ports and the internal pressure chamber, act in concert to reroute (reverse) airflow so that, controlled by the microprocessor, air can be actively pumped into the air vessel (inflation) or conversely, depending on preset conditions, actively pump air out of pressure vessel (deflation). Conditions include compensation for sudden over pressures by allowing the microprocessor to control deflation of the pressure vessel to nominal operating pressure, potentially alleviating the need for mechanical valve and over pressure alert). Additionally the microprocessor can control a user initiated "deflation mode", thereby eliminating the user-operated micro-valve (described subsequently), to partially or fully deflate the pressure vessel. In this instance, the mode can be visually represented by a discrete color alert and/or discrete audible signal.

[000216] In some embodiments, the device comprises a user operated micro valve. The valve can comprise a mechanical or electronic valve. Placed in direct contact between device inner pressure chamber and outside environment, a valve can be activated by operator on demand or by electronic or mechanical switch. When opened, this valve can allow the operator to decompress the pressure vessel of air in the event that the operator no longer wants force exerted onto the outside of the IV solution bag.

[000217] The connector (e.g., connector 3302 of FIG. 33A, connector 3322, of FIG. 33c, connector 33423 of FIG. 33F) acts as a mounting point for the device and port for inflation/deflation as well as communicates pressure from the pressure vessel directly to the device pressure chamber. In one embodiment (e.g., connector 3302), the connector is conical shaped and integrated into the device, positioned at the proximal end, made of impact resistant, light trans-missive plastic composite. A threaded base 3306 of connector 3302 can connect to the device. Inner pressure chamber 3304 is formed when the connector is connected to the device. Housed in the tip of the cone is a threaded hub 3310 and shorted male tapered fitting 3312 able to connect to standard intravenous port connections. This enables the connector and the device to mate with the air outflow port three-way-stopcock 3356 found in most commercially used pressure vessels. Once an airtight fit is made, the device is able to inflate the pressure vessel via the out- flow port 331 1. As a safety measure to avoid air embolus from accidental connection to intravenous tubing port, the shortened male tapered fitting inhibits penetration into the pliable seal found in standard intravenous tubing ports. Therefore, if the device is erroneously connected to an intravenous port by operator, the lack of penetration into the port seal and immediate high pressures recorded by the barometric sensor via the inner chamber of the device and interpreted by the microprocessor, the device will cease to function and alert the operator of the error by means of visual and audible alarm.

[000218] A connector design unique for the pumping device and pressure vessel is desirable. In this way the pressure lines for this system do not inadvertently become confused or mixed up with the IV and other medical lines. [000219] In another embodiment of the connector (e.g., connector 3322 of FIG. 33C), the connector is made of the same aforementioned material and is integrated into the structure of a pressure vessel. This connector acts as a mounting point for the device and a port for inflation/deflation as well as communicates air pressure from the pressure vessel directly to the device inner chamber 3326 formed by mating the device to the connector. The physical mating of the connector 3322 to the device can comprise about 1/4 turn to 1/2 turn thread or bayonet interface 3328, creating an airtight seal between the device and connector/pressure vessel. Lighted feedback, as previously described can be seen through the connector by way of its light transmissive properties. Connection point 3330 can comprise a flange with communicating air channel extending from the connector 3322 and forms a surface to which the layers of a pressure vessel can be fused. The connection point can be shaped to resist shearing forces of inflation.

[000220] Additional functionality can be enhanced by integration of a close proximity switch built into the connector that would enable automatic initiation of device simply by locking the device into the connector.

[000221] Other possible features of a pumping device include pressure vessel identification. This would allow the system to recognize whether a lOOOcc, 500cc or 250cc pressure vessel has been connected. This recognition could be from making an electrical connection from the pressure vessel to the pumping device sensing resistance or other variable unique to one size of the bag, or a mechanical or IR switch integrated into the connector that is engaged for one size bag but not another. RFID or Near Field, NFC, can create communication between a chip on the disposable pressure vessel and a reader in the pumping device. Another means to ID the bag type might be input using the simple LED display and control buttons. The switch in the connector could confirm the pressure vessel is connected and the LED and controls could toggle to the right bag size. Possible pressure vessel ID functions to the device are shown in FIGS. 34A-D.

[000222] In another embodiment of the connector (e.g., connector 3342 of FIGS. 33F-33H), the threaded hub found in the connector and shortened male tapered fitting (e.g., like that described with respect to FIGS. 33A) is replaced with a clip-on locking hub 3348 and shortened male tapered fitting 3344, as shown in FIGS. 33F-H. As with connector 3302, the user creates an airtight connection to/with the air outflow port three-way-stopcock 3356 (FIG. 33H); however the thread twist-on action may be replaced with a push click-lock action to connect. Once mated, the connector cannot be removed from the hub as the click-lock cannot be twisted off of the port. The device then mates to the connector 3342 in the same fashion as the connector 3322. Mating forms inner pressure chamber 3346. FIG. 33H shows the device connected to a stopcock 3356 which is connected to the pressure vessel 3352 and a pneumatic bulb 3354.

[000223] Additionally, connector 3322 can act as a communication/contact hub between the pressure vessel and device by means of physical small uniquely positioned contact points along the inner aspect of the connector (FIGS. 34A-D). As shown in FIG. 34E, multiple contact points 3404 within the connector cap 3412 can be uniquely positioned for predetermined sensors and circuit completion when put in proximity to corresponding contact points 3402 on the head of the device 3410. The device has corresponding contact points 3402, 3404 that allow, when paired, completion of circuits within the device, delivering valuable information that the microprocessor uses for functionality. The pins can be oriented vertically (FIG. 34A) or horizontally (FIG. 34B). FIGS. 34C and D show an embodiment where the device has a microswitch 3408 on the device side and a corresponding contact point 3408 on the connector side. FIG. 34D shows a view from inside the connector. The microswitch can be a mechanical or an electric contact switch. Examples of these contacts include automatic recognition of size of pressure vessel, orientation of the pressure vessel, completion of a capacitance sensor circuit (described subsequently).

[000224] In some embodiments, a wireless RF transmitter can be in communication with microprocessor, to include (but not limited to) low power Bluetooth, NFC, and/or Wi-Fi standards used for, but not limited to, populating electronic health records via standardized device integration standards. With this integration, any useable data collected can be utilized for record, including, but not limited to time intervals, pressure intervals, and infused volumes. This data may also be utilized to alert an operator of device status via linked secondary /handheld device, thereby allowing the user to, for instance, receive an end-of-bag warning prior to completion of infusion. The communication can be to a communication hub and from there goes into a network or alternatively the output could go to one fixed or mobile station.

[000225] In some embodiments, it is possible to place a weight sensor inside the pumping device. Conversely to the image shown in FIG. 29, the system can be configured for the device to hang directly from the IV pole and the pressure vessel, with the IV bag enclosed inside, is suspended from device. In this way, the device can sense weight changes to the pressure vessel and determine the quantity of fluid displaced for bolus delivery or end of bag situations. Should the user not be able to suspend the pressure vessel from the device for whatever reason, the microprocessor and control algorithm could ignore the weight sensor input and adapt to other means to estimate fluid dispensed.

[000226] FIG. 40 shows an embodiment of a schematic of the components of a pumping device system. In direct communication with power supply 4006, input selector switch 4020, motor 4004, barometric sensors 4022, 4024, feedback lights 4010, 4012, digital display 4008, accelerometer 4026 (e.g., 3-axis) secondary input switching 4016, communication circuit 4014, and audible alarms, the microprocessor 4002 accomplishes multiple functions by programmed workflow engine rules.

Microprocessor functions include, but are not limited to, determination of input signals (not limited to multifunction input selector switch 4020 or switches and barometric sensors 4022, 4024, capacitance, infrared sensors and bubble or flow sensors 4018) as they relate to workflow engine, control of motor/pump activity, monitoring of battery level/power reserves, monitoring battery charging, feedback of status and functions to user via (but not limited to) light pulse and audible alerts, time event tracking with by internal timer/counter, control of a display and transmission of appropriate data (via wireless transmission) to populate electronic health records via standardized device integration standards.

[000227] The logic in the controller may benefit, in certain functions, from knowing the orientation of the pumping device and pressure vessel. This can be helpful for any capacitive sensors (to be described later) and interpretation of the bubbles sensors (explained later). It is also helpful to know the pressure vessel and the device are in the same orientation. Means to control to the system configuration is explained later. As is common with other mobile platforms like a smart phone, accelerometers, gyroscopes and other sensors can be added to the board supporting the microprocessor and provide orientation feedback to the control algorithm.

[000228] In direct communication with the pumping device via integration with a connector is the pressure vessel. This vessel is comprised of double layers of transparent material creating an air chamber or chambers that allows a balloon-effect when inflated with air by the device via the connector. The pressure vessel can be made in multiple sizes to accommodate a range of intravenous bag sizes, including, but not limited to, 500ml and 1000ml intravenous bags and standard blood administration bags.

Embodiments of the pressure vessel include, but are not limited to, a wrap-around sleeve (e.g., FIGS. 7B, 7C) and an envelope form with an adhesive sealing strip (e.g., FIG. 7D) made to fit tightly around an IV solution bag. When inflated, the internal chambers exert a force on that bag in order to physically force fluid from the bag. The envelope embodiment may be further described as side-loading (FIG. 29) or end- loading (FIG. 36). The properties of the vessel components include clear material so that contents within the sleeve/envelope may be visualized without distortion, and an outer layer of flexible yet relatively non elastic material so that the pressure from inflation is directed more efficiently inward towards the intravenous bag.

[000229] FIG. 36 illustrates an embodiment of an end-loading pressure vessel 3600. The pressure vessel 3600 is fused along the upper edge 3602 and side edges 3606 and open at the lower edge 3612 where the IV bag is to be inserted. The pressure vessel 3600 comprises a connector 3604 for connecting to a pumping device. Tabs 3608 positioned at the bottom of the pressure vessel 3602 can be configured to attach (e.g., adhere) to a side 3610 of the pressure vessel 3600. The pressure vessel 3600 can be used to surround an IV bag that has an IV line already attached or not. The pressure vessel 3600 can comprise a sleeve 3604 to support pressure vessel.

[000230] The pressure vessels can incorporate any of the features of the pressure vessel described herein e.g., with respect to FIGS. 1 A-8.

[000231] Another factor for the pressure vessel design is to make the pumping device easy to use and carry is a sleeve (e.g., sleeve 2906) built into the side of the vessel to accept the device. FIG. 29 and several other figures show a catch sleeve on the side of the pressure vessel. It could potentially be positioned on a flat face or on the bottom as well. The device can comprise a "mushroom cap", hook or other feature to prevent it from sliding through the sleeve. This catch sleeve should secure the device in the same orientation as the pressure vessel for interpretation by the orientation sensor and inclusion in the logic of the microprocessor. It is possible to place a switch on the device that is activated by placement in the sleeve to confirm to the microprocessor that the bag is aligned with the pressure vessel. Should the device with IV bag need to be moved away from a hanging IV pole, this configuration allows the user to grab the system like a football and move it as one assembly. Possible layout and steps in assembly of the device to the pressure vessel using the catch sleeve are shown in FIGS. 39A and B. FIG. 39A shows a fluid connector 3902 and sleeve 3904 attached to a pressure vessel (not shown). The device 3906 can be placed in placed in friction fit clamp 3904, which can comprise a rigid material, and then be connected to connector 3902. FIG. 39B shows a connector 3902 and a base 2908 connected to a pressure vessel (not shown). The device can be placed in the base 2908, and then aligned with the connector 3902. A turn (e.g., ¼ turn) can be used to lock the device in place, connected to the connector 3902.

[000232] In the aforementioned sleeve embodiment of the pressure vessel of FIGS. 7B and 7C, adhesive is used on the inner surface of the pressure vessel in order to have it effectively contact the intravenous bag and hold position through the process of inflation. Adhesive is present, but not limited to, the edges of the pressure vessel or the entire inner surface of the pressure vessel. In the aforementioned envelope embodiment of the pressure vessel, the layers of material are fashioned in such a way to create a pocket in which the intravenous fluid bag will be inserted from the direction of the side of the vessel, thereby allowing for previously attached intravenous tubing to clear the constraints of the pressure vessel. A side tab with adhesive can act as the seal of the envelope thereby securing the intravenous bag completely within the pressure vessel (FIG. 7D). In securing this tab tightly, the operator is able to compensate for space/gap between the outside of the intravenous bag and the inside of the pressure vessel and to compensate for slightly different designs from various manufacturers, thereby creating a more efficient, shorter inflation cycle, when inflated by the device.

[000233] Additionally, as shown in FIGS. 37 and 38, small sensor components can be permanently affixed into pressure vessel. These components, in direct communication with the device/microprocessor by way of circuit-completion contacts located in connector, can allow additional functionality of the system based on data sent to the device. An example of this is described in capacitance sensor for end-of- bag sensing, determining when a predefined bolus amount has been delivered and temperature sensor to enhance the microprocessor's accuracy of capacitance sensing.

[000234] Additionally, embedding a small heating device, or strip or grid of resistance wire in communication with the device will allow the device to send a high electrical current to the pressure vessel under pressure to blow a hole in the side of the bag if rapid pressure release is needed.

[000235] As noted above, sensors can be embedded into the pressure vessel and add additional functionality to the system. Capacitive sensors can be utilized for end-of-bag recognition. A series of one or more capacitive sensors positioned inside the pressure vessel and in communication with the outside of intravenous fluid bag, measure the impedance of the fluid as it drains from the bag under pressure. In one embodiment, with the capacitance sensors 3702 placed on opposing sides (e.g., front sensor 3704 and back sensor 3706) of the IV bag (FIG. 37), the impedance measures the distance between the sensors as the bag empties its contents. This distance can be used to estimate the volume dispensed from the bag. In another embodiment, with the capacitance sensors 3802 placed on one side of the IV bag (FIG. 38), the impedance measurement is used to determine when the fluid in the bag is gone, signaling an end of bag condition. The orientation of the device and bench data can be used to determine how the fluid will flow out of the compressed IV bag to support the programmed logic to use these sensors.

[000236] When the impedance reaches a designated threshold interpreted by the device microprocessor as end-of-bag, the device will alert the user. A second (or more) capacitive sensor placed in other optimal areas along the inside of the pressure vessel will enhance the device's calculation of relative volume/end-of-bag by providing information of the liquid content with information of the orientation of the bag. These placement positions include, but are not limited to top of vessel, bottom of vessel and center of vessel. A greater density of sensors, possibly an array, and sensors on opposing surfaces can provide even greater information on the volume of fluid remaining inside the IV bag, the orientation or position of the pressure vessel and the presence of air pockets within the bag or IV line. Adding capability in the system to determine orientation of the Device and Pressure Vessel will increase the accuracy of the calculations to determine volume dispensed and end of bag conditions as lab tests to determine which portion of the IV bag thins as the fluid is dispensed can be used to enhance the estimations of the volume dispensed.

[000237] Additionally infrared emitter detectors may be utilized in conjunction with, or in replacement of capacitive sensing to determine end-of-bag.

[000238] An embodiment of the device provides pressure monitoring and control of the pressure vessel to assure consistent and timely evacuation of the entrained liquid bag. An additional embodiment provides for a method of determining the amount of liquid dispensed for population of the electronic health record, possible bolus amounts, end of bag detection, bag size, and timed infusions. Volume measurement or flow rate measurements over time provide the basis of the dispensed liquid measurement. Possible methods include air flow metering, and ultrasonic flow rate sensors, discussed below.

[000239] As discussed above, air flow metering uses the volume of air dispensed by the pump, the nominal volume of the pressure sleeve, and the Ideal Gas Law to determine the volume of liquid dispensed. Possible embodiments of the air flow metering method include a brushed DC motor with current monitoring, a BLDC motor operating at a constant speed, any motor with a speed sensor or encoder device and an air flow sensor connected to the inlet or outlet of the air pump. Adding a temperature sensor to the control board will sharpen the ideal gas law calculations and possibly be a critical feature should the device be used outside the typical hospital environment. Also contributing to precision of this calculation is a tight fit of the pressure vessel to the IV bag as a loose fit will cause an unknown extra volume of air to fill the vessel. In any case the amount of air used in the initial fill of the pressure vessel can be used to estimate the dead space or volume of the pressure chamber and fill line. The repeated refills to 300 torr as the air pump goes on and off can estimate the IV volume displaced by the air in the expanding chamber for the pressure vessel.

[000240] Additional device functionality can be enhanced by the inclusion of a secondary component, which, in wired-contact with the device, is attached (clamped) onto the outside of the intravenous tubing. These sensors typically have a channel or slot that the IV tubing 4104 fits into and the sensing capability is in the walls of the slot. Shown in FIG. 41 , this attachment 4102 provides a flow/bubble sensor and also possible actuator/clamp. Air bubbles in IV fluids entering the patient have potential to cause serious harm or even death if large enough. There is, however, a size and number of bubbles threshold below which a small volume is clinically insignificant. Bubble sensors and the control algorithm would ideally not set off alarms or clamp the IV tubing for those insignificant bubbles. [000241] This sensor can also be located on a dongle or cord 4106 from the base unit 4108 that is clamped on to the IV line to the patient (FIG. 41 ). Placement of the clamped sensor further upstream on the IV line can provide more warning to the attendant that a bubble or dangerous flow condition has occurred and needs correction.

[000242] An alternate placement is to position the sensor 4202 at one end or along the side of the device 4204. This would avoid possible loss or damage to a sensor on a cord loose from the base.

Assuming the pressure vessel, IV bag and base unit are hanging from an IV pole, the IV tubing could be routed through the sensor slot and then on to the patient (FIG. 42). FIG. 42B shows an activation 4106 button on a bottom of the pump 4104 of FIG. 42A. FIG. 42C shows an open slot 4108 running horizontally to accept the IV tubing. The slot 4108 can comprise a vertical rise and catch 41 10 to work the tubing over for a secure holding. FIG. 42D shows a hinged door 41 12 that can open to accept IV tubing. FIG. 42E shows a vertically oriented slot 41 14 to accept the IV tubing positioned on a side of the device. FIG. 42F shows a door 41 16 that can be twisted to open and close. The door 41 16 can be used with a vertical tubing slot

[000243] The sensors described with respect to FIGS. 10A-10F are contemplated. Sensors can include infrared emitter/detector pair, capacitive sensor, acoustic sensor and optical sensors. These sensors are also capable of determining or approximating the size of the bubble and the system microprocessor can be tuned for allowable sizes of bubble. Optical sensors allow a simple way to detect a change in the fluid/air interface in the tube to detect a bubble. An example of an optical sensor is provided by Panasonic and their BE-A series of sensors. Acoustic or ultrasound sensors provide the ability to detect air bubbles of various sizes through opaque tubes and liquids. Examples of these sensors are offered by Moog, Introtek and Sonotek. Capacitance sensors provide changes in impedance with the ratio of fluid and air passing through the sensors electric field. In communication with the microprocessor, if the device senses an air bubble in the flow of fluid through the tubing, it actuates a clamp within the secondary component attached to the IV tubing, that pinches tubing, obstructing flow, while alert the user to this potential patient safety issue. Possible clamp configurations that are automatically activated by the bubble sensor are shown in FIGS. 43A, 43B, and 43C. FIG. 43A shows an IV bag 4304 inserted within a pressure vessel 4306. The pressure vessel 4306 is connected to a pumping device 4308. A clamp housing 4302 is tethered 4310 to the pumping device. In some embodiments, the housing 4302 can have a wireless connection to the pumping device. The clamp housing 4302 can provide an automatic pincher. In some embodiments, the housing 4302 includes other features. Flow sensing allows the device to calculate flow volume of intravenous fluid through the tubing, using this measurement with pressure/time values to determine amount of volume infused. FIG. 43C illustrates another embodiment of a clamp. The clamps are configured to exert direct pressure against standard tubing.

[000244] Should the device have no clamping function, other options for automatically slowing the flow include: turning off the air pump, activating the relief valve to drop all pressure applied to the IV bag from the pressure vessel or activating a self destruct mechanism described earlier of a heater strip in the pressure envelope that blows a hole. Height of the IV bag relative to the patient then becomes the sole driving force to move the fluid.

[000245] Workflow Engine Rules (WER) are defined as the preprogrammed instruction set that translates input from operator and other sensors into actionable routines based on context. The purpose of these rules is efficient performance of device as well as intuitive interaction with operator including simplistic feedback, easily understood actions and removal of complexity of setup and maintenance of device. Descriptions of workflow engine rules include, but are not limited to the following examples:

[000246] Translation of Operator Input (via selector switch action): Multiple actions can be initiated by use of an input selector switch. This section assumes the pumping device has a single input switch and feedback to the user is provided by lighted feedback from the LED. (Later descriptions will offer multiple input switches and interfaces.) Minimal discrete actions can be tied to specific conditions as interpreted by device. Programming of action may be changed to create most efficient, intuitive workflow engine rules based on validation studies by end users of device in practice. Examples of this include, but are not limited to the examples shown in Table 2.

Table 2

[000247] Signaling battery level when device is inactive: With device uncoupled from pressure vessel or with device coupled to deflated pressure vessel around an IV bag via airtight connection with coupler, operator pushes momentary switch (i.e.: single/long action). In contrast to the displayed feedback during a normal inflation operation, the battery level may be displayed by (but not limited to) means of lighted secondary LEDs previously described in this document. A time-out function will turn off this display and return to "inactive status" after a preprogrammed amount of time, awaiting further input. Inactive status prior to displaying battery level may be determined by (but not limited to) last task performed by the device or analysis of pressure variations, which may confirm stage of function.

[000248] Signaling battery status as part of various start-up/activity modes: With activation of device by operator (via momentary/selector switch action), microprocessor measures battery status as voltage (but not limited to a sole method of measure such as voltage) as it compares to preprogrammed voltage ranges. The battery status is relayed to the operator. This can be (but is not limited to) a combination of successive visible/audible signals to re-late remaining power in reserve. This process may be further defined to "no-warning" above 50%, appropriate visible/audible signals at less-than 50%, escalated visible/audible signals at less than 25% and continuous visible/audible signals when power falls below requirement for effective device performance in addition to inhibiting activation of device. In addition to signaling the user via feedback lighting displayed via the proximal connector, the degree of remaining power can be displayed via the secondary LEDs as described above, by means of (but not limited to) each of the four secondary LEDs representing 25% remaining power. The function currently is related to start-up, however is not limited to this phase of use.

[000249] Signaling and achieving nominal pressure of pressure vessel: With the device connected to deflated pressure vessel around an IV bag via airtight connection with coupler, the operator pushes momentary switch (single/short action). The device can measure and communicate the battery status to the operator. If power requirements are met, the device can measure inner chamber pressure and environmental/atmospheric pressure to (1) determine if pressure vessel is functionally empty, and to (2) determine altitude. The device can provide normal function visual feedback (green light). The device can send test pressure (preprogrammed RPM) to determine patency of line. If there is no sudden pressure elevation (comparison to preprogrammed parameters), the device can continue to pump air and increases motor RPM for maximal speed of inflation. The device can continue to inflate to nominal pressure, monitoring and recording barometric pressures as frequently as multiple times per second during inflation, comparing to nominal parameter (which can be, but is not limited to 300 torr) at which point, the motor/pump is stopped by the microprocessor. The device feedback to operator can continue to show normal function visual feedback, under these conditions. The device can continuously monitors the pressure vessel and restart the motor/pump when the pressure falls to a preprogrammed threshold (for example 275 torr) in order to re-inflate to nominal pressure. An example flow and control schematic is shown in FIGS. 44A-44C and possible pressure and time control pattern is shown in FIG. 45

[000250] FIGS. 44A-C show embodiments of an air manifold comprising microvalves that can be used. FIG. 44A shows a motor and pump 4402. Pump comprises an intake port 4404 and an output 4406. The pump is connected to an air manifold 4410 comprising to tandem 3-port, bi-stable electronic valves 4412, 4414. Pump intake 4404 is connected to valve 4412. Pump outlet 4406 is connected to valve 4414. P2 connected to an internal pressure chamber 4418 of a pumping device. PI connects to the external atmosphere 4420. FIG. 44B shows the system in inflation mode, pulling air from the external port to inflate a connected pressure vessel. PI is shown closing off valve 4414, sending external air 4420 to the intake 4404 of the pump 4402. P2 is shown closing off valve 4412, sending pair to the pressure chamber 4418. Fig. 44C, shows the system in deflation mode, pulling air from the pressure vessel and actively routing it to the external port to deflate the pressure vessel. P2 is shown closing off valve 4414, sucking air from pressure chamber 4418. PI is shown closing off valve 4412, sending the air from the pressure chamber 4418 to the atmosphere 4420.

1000251] Signaling and achievement of one or more successive boluses from same IV bag: In a variation of nominal pressure inflation, that being continuous pressure monitoring and frequent re- inflation as necessary to keep the pressure vessel at maximum nominal operating pressure (described previously as 280-300 torr range), the user can select a "bolus mode" defined by programming of microprocessor to accept another variation of input from momentary switch. This mode will, upon initiation of system as previously described, inflate the pressure vessel to maximum nominal pressure (e.g., 300 torr) and then continue to monitor decreasing pressure variation without frequent re-inflation as described above, over time, until reaching a target pressure that directly reflects the loss of a specific volume of infusate from intravenous bag. The accepted standard for boluses may be, but is not limited to, 250ml of infusate. Once the target pressure is achieved, signifying the bolus has completed, the device can relay this information to the operator by means of activating one secondary LED to represent each bolus (average of four boluses per 1000ml intravenous infest bag, with four discrete corresponding secondary light signals/ LEDs). As described earlier, a tight fit of the pressure vessel to the IV bag and known temperature of the environment can provide added precision to calculations.

[000252] The device can relay continued activity/function via the primary visual feedback (LEDS) as seen through the light-transmissive connector/coupler and immediately re-pressurize the pressure vessel to max nominal pressure and repeats the process, adding successive completion signals through the progression of boluses, until the operator interrupts this mode. Additional volume accuracy can be obtained by including one or more combinations of capacitive sensing and acoustic flow-metering for comparison in calculation algorithm.

[000253] Signaling and achieving decompression of pressure vessel: With the device connected to a pressure vessel around an IV bag via airtight connection with a connector, and the device in nominal pressure mode signified to user by corresponding visual feedback (e.g., green light), the operator can push the momentary switch with a single, long action. The device microprocessor can confirm active function by internal chamber pressure/environmental pressure differential compared to workflow engine rules. The device microprocessor can then actuate tandem three port micro-valves, which are housed with the previously described air manifold, to each valve's opposite position, thereby reversing airflow through the manifold, evacuating air and thereby decompressing the pressure vessel (FIG. 44C). The action can halt and the mode reset when pressure is equalized between inner chamber and environment. A feedback method to signal decompression mode can be, but is not limited to, all lights signaling a discrete color only used for "decompression" mode, after which device transitions to "inactive" mode. An alternative to this process/methodology is an operator controlled valve (described previously), electronic or mechanical, that opens when activated in order to passively allow air to escape from the pressure vessel.

[000254] Signaling and compensating for sudden overpressure: With the device connected to a pressure vessel around an IV bag via airtight connection with connector, and the device in nominal pressure mode signified to user by green feedback light (whether or not motor/pump is currently active), the device, as previously described, can continuously monitor internal chamber pressure. If the microprocessor determines a sudden increase in pressure (as preprogrammed parameter of pressure and time), the device can stop active inflation, and alert the operator of "out of range" pressure by means of lighted and audible feedback including, but not limited to, red flashing light with corresponding audible alarm. This alarm may continue until operator addresses underlying issue or condition self corrects.

Inclusion of a mechanical micro-valve in communication between the device inner pressure chamber and atmosphere (previously described) preset to open at pressures above device nominal inflation pressure (above 300 torr) will port excess air volume from circuit until nominal pressure is again achieved. The device can determine this as the microprocessor continuously monitors the pressure, even during alarm, to see if conditions are met to continue with nominal function. In an alternative embodiment, the inclusion of the previously mentioned tandem, three position, micro-valve air manifold would allow the device microprocessor to control direction of air. Sudden overpressures could signal the microprocessor to automatically evacuate air volume from the system until nominal inflation pressure is regained.

Communication of alerts with the operator then may be minimized with this added feature of active volume correction.

[000255] Signaling sudden under-pressure: With the device connected to a pressure vessel around an IV bag via airtight connection with the connector, and the device in nominal pressure mode signified to user by green feedback light (whether or not motor/pump is currently active), the device, as previously described, can continuously monitor internal chamber pressure. If the micro-processor determines a sudden decrease in pressure (as preprogrammed parameter of pressure and time), the device can stop active inflation, and alert the operator of "out of range" pressure by means of lighted and audible feedback including, but not limited to, red flashing light with sounded alarm.

[000256] Signaling for non-patent connection of device to pressure vessel: With the device connected to a deflated pressure vessel around an IV bag via airtight connection with connector, the operator can push a momentary switch (single/short action). The device can measure and communicate battery status to operator. If power requirements are met, the device can measure inner chamber pressure and environmental/atmospheric pressure to (1 ) determine if pressure vessel is functionally empty, and (2) determine altitude. The device can turn on normal function visual feedback (green light). The device can send a test pressure (preprogrammed RPM) to determine patency of line (assuring the line is not blocked or kinked in a way that would inhibit air flow to the Pressure Vessel). If the microprocessor determines a sudden increase in pressure (as pre- programmed parameter of pressure and time), the device can stop active inflation, and alert the operator of "out of range" pressure by means of lighted and audible feedback, including, but not limited to, red flashing light with sounded alarm. [000257] Erroneous activation of unconnected device by operator: While not connected to the pressure vessel by any of the aforementioned means, the operator can erroneously activate the device into normal inflation mode (e.g., single/short action or momentary input selector switch). Normal startup process is initiated as described previously (power sensing, mode initiation, barometric pressure sensing and comparison, test motor activation and pressure confirmation). As with normal function, over a predefined period of time, for example, but not limited to two minutes, the device continually measures pressure changes at predefined intervals, in anticipation of pressure changed during pressure vessel inflation. If there is no internal/comparative pressure variations (i.e.: lack of pressure increase in internal chamber, reflective of absent pressure vessel inflation), the device will alarm for a preprogrammed period of time and then return to sleep mode to conserve battery power.

Examples of Use of the Rapid Infusion Device

[000258] The Paramedic is often the most advanced-trained clinician in the prehospital arena. Paramedics bring advance life support protocols to the field. Paramedics are often paired with a caregiver of lesser skill. This means that advanced life support, including IV access and IV fluid therapy, can only be performed by Paramedics, not their lesser trained associates. This leaves multiple skills that only the Paramedic can perform in a finite period of time before transfer of care to hospital personnel. In the prehospital setting, administration of IV fluids are utilized with hemodynamically unstable patients (read: shock), whether from blood loss from trauma, blood loss from gastrointestinal bleed, neurological event, cardiac event, cardiac arrest, sepsis, anaphylaxis, dehydration, or other significant underlying condition.

[000259] A Paramedic is preparing to rapidly infuse a portion of a full liter IV fluid bag for a hemodynamically unstable end-stage renal disease patient that may have been over dialyzed and now suffers from symptomatic hypotension. The Paramedic knows that the patient will benefit from isotonic crystalloid fluid infused intravenously, but is aware that this patient can quickly become fluid overloaded from too much IV fluid. The Paramedic knows that the IV equipment at his/her disposal is lOOOmL 0.9% Saline IV bags and a manual pressure sleeve. The Paramedic will have to repeatedly inflate the IV pressure bag, a distracting manual process, in order to effectively administer IV fluid rapidly. He or She will also have to deflate the manual pressure sleeve in order to visually estimate the amount of fluid infused, then re-inflate to nominal pressure in order to continue the infusion. Additionally, the attention of the Paramedic is often taken by other logistics of treatment and transport which can lead to inaccurate administration of fluid (either under-delivery or over-delivery of fluids) negatively affecting the treatment of the patient. By utilizing the device disclosed herein, the Paramedic can quickly edit device settings to initiate a partial-bag-volume rapid infusion treatment (250mL of the 1 OOOmL IV fluid bag), confident that the device will administer the infusion, clamp the infusion after preprogrammed volume delivery and then alert the care provider of completion. Additionally, during the infusion, the device will monitor infusion rate and alert the Paramedic of any deviation from target rate of administration.

[000260] A Paramedic is preparing to bolus a full liter of IV fluid for a patient found in Pulseless Electrical Activity (a type of cardiac arrest) while rendering numerous Advanced Life Support (ALS) tasks simultaneously in support of the patients unstable hemodynamic state with the goal of treating and transporting as quickly as possible to definitive care (hospital). The logistics in this case are immense.

The Paramedic has to assess the situation, render ALS care (CPR, IV access, medications, fluid therapy) and orchestrate care from additional personnel with varying levels of training and skill, while transporting to the hospital. The situation is stressful and often chaotic. Simple tasks such as inflating and re-inflating a manual pressure bag may be carried out less proficiently in this case as there are many distractions in this situation. By utilizing the pumping device disclosed herein, the Paramedic can initiate an infusion of the standard 1 OOOmL bag of IV fluid. The quick-start mode utilizes an algorithm and multiple sensors to identify a new pressure vessel & IV bag and will initiate the infusion of the entire bag at the maximum nominal pressure to rapidly deliver volume while the Paramedic continues with other ALS tasks. The device will alert the Paramedic of completion of delivery, as well as any deviation from target flow rate of administration, during the infusion.

[000261] The Physician is the medical authority for the treatment of patients in any prehospital, hospital, or intra-facility arena. The Physician utilizes advanced training to directly render care or guide other clinicians to render care to the patient in need. Workflows of Physicians vary greatly by therapy, department and the specialty role that the Physician performs. The care rendered by Physicians is often in a continuum of care initiated in another area before patient contact (i.e., the Emergency Physician assumes care of patients treated in the prehospital setting by Paramedics under the direction of the EMS Medical Director; the Intensivist Physician accepts patients from the Emergency Physician into the Critical Care Department; the Surgeon accepts patients for procedural intervention and then returns care to the Intensivist/Hospitalist Physician after the task has been performed or he/she continues caring for the patient on surgical service. The Anesthesiologist Physician provides procedural sedation, airway control and hemodynamic monitoring/treatment while in the peri-operative arena. Best-practice standards guide Physicians to the most efficient rendering of care regardless of roll or environment in which they function.

[000262] In the Labor & Delivery Setting, an Anesthesiologist frequently initiates pain control for labor by administering continuous regional anesthesia via a spinal catheter (spinal epidural). While this often reduces or eliminates pain for the patient during contractions, a significant side effect is hypotension secondary to blockage of the cardiac sympathetic nerve. As a means to combat this side effect, in addition to close monitoring and titration of anesthesia, a bolus of isotonic crystalloid IV fluid prior or post procedure is utilized. If all tasks are performed by the Anesthesiologist, the workflows would not be concurrent, as one person cannot manipulate a non-sterile item during a sterile procedure. By utilizing the pumping device, the Anesthesiologist can initiate an infusion of the standard 1 OOOmL bag of IV fluid whether a fractional bolus or entire volume. The pumping system will rapidly infuse, clamp at completion and alert the Anesthesiologist to completion without repeated intervention by the clinician in order to maximize delivery, thereby allowing the Anesthesiologist to set up and perform additional tasks concurrently.

[000263] In the operating suite, an Anesthesiologist moves definitively to bolus a patient with 500mL of isotonic crystalloid IV fluid because of sudden hemodynamic instability. The Anesthesiologist initiated the IV catheter access in the preoperative setting and knows that the IV is small, positional, and the patient has fragile veins. This being the only access at the time, the Anesthesiologist is well aware that despite the need for rapid infusion, initiation of full pressure and maximum flow may, in fact, infiltrate the IV and thereby create failure of IV access. The IV bag is currently full. By utilizing the pumping device, the Anesthesiologist can initiate an infusion of 500mL from the 1 OOOmL IV fluid bag. He or She can not only quickly edit the settings to have the device deliver 1/2 of the volume of the full bag before clamping and alerting, but is also able to adjust the pressure to a lower level, to l OOmmHg for instance, in order to still rapidly infuse, but at a lower force as to maintain the integrity of the IV site.

[000264] In an adjacent operating suite, an Anesthesiologist prefers to control the IV infusion manually, By inflating the standard manual pressure vessel to 300mmHg and using the roller clamp to speed up and slow down the continual infusion of 1 OOOmL, the Anesthesiologist can adapt the IV flow to the situation at hand. Unfortunately, as with this inefficient manual process, the Anesthesiologist is unable to accurately estimate the flow rate and amount of fluid infused at any given time. Additionally, with other tasks demanding the attention of the Anesthesiologist, he/she may become distracted and not attend to the maintenance of the manual system. By utilizing the pumping device, the anesthesiologist can initiate an infusion of the 1 OOOmL (or a fraction thereof), and maintain optimal pressure at any setting level desired while still controlling the flow rate manually with the IV roller clamp. The device will continue to accurately calculate the outflow of the fluid, despite the manual roller clamp affecting the flow rate and give an amount infused. Additionally, the Anesthesiologist can be alerted by the device for a significant rate change as a measure of safety during the delivery of IV.

[000265] The Registered Nurse (RN) is, for all intents and purposes, the clinician tasked with best- practice execution of Physicians' orders and patient care in any of the environments listed above.

Working alone or in teams, but often with limited resources, the RN is tasked with basic and advanced life support tasks, following complex protocols in an effort to care for patients with various illnesses and levels of instability. The RN is tasked with physical assessment, plan of care, coordination of healthcare team, vascular access, medication administration, airway and hemodynamic interventions and basic and advanced needs of the patient. Each RN's assignment includes, in most cases, multiple patients that require care simultaneously.

[000266] An Emergency Department (ED) RN, on a normally busy evening in a high-volume urban ED, has received two acutely ill patients concurrently, one brought in by ambulance with one via walk-in triage, in additional to his/her existing patient. The new patients are immediately assessed and found to both screen positive for suspected sepsis. A significantly abnormal point-of-care serum lactate is found for each and, while only one of the two patients presents with significant hypotension, according to best practice protocol, both are to receive 30mL/Kg of 0.9% isotonic crystalloid solution intravenously. The IV access for each were difficult to gain because of various obstacles, and the significant IV infusion volumes need to be given as soon as possible to increase the likelihood of a positive outcome. Each patient is to receive 3000mL of 0.9% Normal Saline. The RN is tasked with administering those 3 liters to each patient in two adjacent beds of the same ED bay simultaneously and be finished within the expected 30 min as ordered. There are a significant number of additional tasks for these two patients as well, distracting the caregiver. The RN goes about the manual process of infusion utilizing the standard manual pressure bag. Unfortunately the task is too great for one person and the infusions take longer than expected. By utilizing the pumping device for each patient, the Registered Nurse can initiate an rapid infusion of the standard 1 OOOmL bag of IV fluid. The quick-start mode utilizes algorithm and multiple sensor to identify a new pressure vessel & IV bag and will initiate the infusion of the entire bag at the maximum nominal pressure to rapidly deliver volume, thereby allowing the RN to divide time between his/her patients and those patients' additional needs. The device will alert the RN of completion of delivery of each bag, as well as any deviation from target flow rate of administration during infusion, allowing the RN to superimpose the next IV fluid bag was soon as possible to continue the process of rapid infusion as expediently as possible. The RN, at a glance, can determine the status of the device from a distance by lighted color alerts, and with additional valuable real-time run data when in visual range of the device decision support display. Audible alerts assist timely recognition of a situation that needs the clinician's intervention, alleviating the delays that are often experienced with the current manual workflow.

[000267] A Labor and Delivery RN is given orders to initiation of massive transfusion protocol for a delivery with hemorrhage complications. The department's only automatic rapid infuser is currently in use with another patient. The RN is tasked with using the standard pressure bags in order to give four (4) units of universal-donor O Negative Packed Red Blood Cells (PRBC). The RN has access to two in-line IV fluid warmers. The fluid warmers are functional to 200mL/minute, or 3.3mL/second, before losing targeted thermal output. The RN does not know if the unit of blood, under 300mmHg pressure will infuse beyond the target rate for effective thermal control to the potential detriment of the patient. By utilizing the pumping device and a 500mL Pressure Vessel, the Registered Nurse can not only quickly edit the settings to have the device deliver the volume unique to a bag of PRBC (generally 325-375mL) before clamping and alerting, but is also able to adjust the pressure to a lower level, to maintain an infusion rate compatible with the in-line fluid warmer. The decision support display not only communicates the realtime volume infused and estimated time-to-completion, but in this case, also the mL/sec in order to confirm a comparable flow rate and maintain targeted thermal output.

[000268] A Critical Care Registered Nurse is currently caring for a complex, critical care patient. As part of the plan of care, an arterial catheter is inserted for continuous invasive blood pressure monitoring. The RN is tasked with maintaining the integrity of this line in the standard configuration and workflow: a manual pressure vessel over a 500mL or 1 OOOmL flush bag connected at the distal end of an arterial catheter/transducer which, in turn, is connected to patient's arterial access (proximal end). The manual pressure vessel has been found by staff to be inefficient not only in the manual inflation process, but in pressure accuracy as the visual indicator sticker on the manometer was found to be inaccurately placed and the bag integrity is compromised by the material of which it is made, causing an appreciable leak of approximately ten (10) mmHg inflation per minute. By utilizing the pumping system in transducer mode, the Registered Nurse can automatically compensate for the shortcomings of the manual system by maintaining target pressure efficiently, and at a reduced power consumption from rapid infusion modes, so that the device will operate for significant amount of time (hours) without recharge. Maintenance of the device in this mode is minimal, allowing for the clinician to focus on other tasks. The device can be interrupted so that the clinician can obtain an arterial blood sample, flush and reinitiate the device without negatively affecting the current workflow.

[000269] The Combat Medic is a military role equivalent to civilian EMT II/Paramedic with a unique focus on the care of trauma patients within the battlefield environment. Combat medics are often tasked with rendering lifesaving medical care and extrication of one or more unstable trauma patients simultaneously while in an unrelenting combat arena. Stabilization of the patient(s) is difficult, often compound by limited resources and difficult egress from the battlefield that often includes ground and air transport modalities.

[000270] An Air Force Pararescue Jumper (PJ) team has arrived to transport a single category alpha trauma (single victim combatant with life-threatening injuries) to the nearest Combat Support Hospital (CSH) for immediate treatment. The landing zone has been determined to be safe to land, and the combat medic attached to the squad has been able to control the victim's bleeding limb with little time for other treatment. The victim is agitated, a sign of poor perfusion in trauma patients. With a rapid trauma assessment performed, the PJ determines that the victim needs blood replacement immediately while en route to the CSH. With a single failed attempt at gaining vascular access, the PJ determines that the next option would be to gain intraosseous (IO) access in order to transfuse two (2) units of universal donor O Negative PRBC. The PJ inserts an IO access at the victim's right humeral head. The PJ knows that an IO infusion is slow because of resistance of infusing blood through the bone marrow cavity to the systemic circulation. The victim would benefit from pressure infusion, but the manual process is distracting the medic from continuing other necessary assessment and treatment. By utilizing the pumping device disclosed herein and a 500mL Pressure Vessel, the Pararescue Jumper can not only quickly edit the device settings to have the device deliver the volume unique to a bag of PRBC (generally 325-375mL) before clamping and alerting, but also infuse at maximal pressure of 300mmHg to overcome the resistance associated with intraosseous access. Additionally, altitude changes will not interfere with the automated infusion as the pumping system monitors atmospheric pressure as well as device pressure in order to compensate for dynamic changes in altitude during infusion.