WO2016118817A1

WO2016118817A1 - Fluid infusion device

Info

Publication number: WO2016118817A1
Application number: PCT/US2016/014448
Authority: WO
Inventors: Peter Botten; Lawrence Srnka; Gary Keefe; Anthony ALBANO; Richard Edwards; Michael Kolberg
Original assignee: Codonics, Inc.
Priority date: 2015-01-22
Filing date: 2016-01-22
Publication date: 2016-07-28

Abstract

Provided is an infusion device that includes a holder for supporting a supply of a substance to be administered to a patient, and a scale that monitors a weight of the supply of the substance supported by the holder during an infusion. A backup power circuit conveys, at least temporarily, electric power to maintain operation of the infusion device during an infusion from an alternate power supply other than a wall outlet in response to detecting an interruption of electric power from the wall outlet. A progress indicator provides an indication of a progression of the infusion at a time when the interruption of electric power occurred. And a drop counter monitors at least one of a quantity of the substance administered and a rate of administration.

Description

FLUID INFUSION DEVICE

BACKGROUND OF THE INVENTION

1. Field of the Invention

[0001] This application relates generally to a method and apparatus for administering a treatment to a patient and, more specifically, to an adaptable infusion device with at least one of an active power management mode and a diverse user interface.

2. Description of Related Art

[0002] A fluid infusion device, also known as an infusion pump or drug pump even though such devices do not actually incorporate a "pump" mechanism, is a medical device that delivers fluids, such as nutrients and medications, into a patient's body in controlled amounts. Infusion pumps can be used in clinical settings such as hospitals, nursing homes, and in the home.

[0003] In general, an infusion pump is to be operated by a trained user such as a clinician, who programs the rate and duration of fluid delivery through a built-in software interface. Infusion pumps offer significant advantages over manual administration of fluids, including the ability to deliver fluids in very small volumes, and the ability to deliver fluids at precisely programmed rates or automated intervals. They can deliver nutrients or medications, such as but not limited to insulin or other hormones, antibiotics, chemotherapy drugs, and pain relievers.

[0004] Examples of infusion pumps include large volume, patient-controlled analgesia (PCA), elastomeric, syringe, enteral, gravity fed devices and insulin pumps. Some are designed mainly for stationary use at a patient's bedside while others, called ambulatory infusion pumps, are designed to be portable or wearable.

[0005] The infusion pumps can be equipped with safety features, such as alarms or other operator alerts that are intended to activate in the event of a problem. For example, the pumps can be configured to alert users when air or another blockage is detected in the tubing that delivers fluid to the patient. According to alternate embodiments, the infusion pumps can be designed to issue an alert when the user sets the pump's parameters outside of specified safety limits. Information about medications, nutrients or fluids administered by such a pump can be encoded in a formulary that is sometimes called a drug database or drug library. The formulary is installed on the infusion pump and can incorporate information regarding the policies and procedures of a healthcare institution that are made available to the user by the infusion pump. However, conventional infusion pumps may have a limited ability to respond to unexpected conditions, and may be limited in the programming options via a conventional user interface.

BRIEF SUMMARY OF THE INVENTION

[0006] According to one aspect, the subject application involves an infusion device that includes a holder for supporting a supply of a substance to be administered to a patient, and a scale that monitors a weight of the supply of the substance supported by the holder during an infusion. A backup power circuit conveys, at least temporarily, electric power to maintain operation of the infusion device during an infusion from an alternate power supply other than a wall outlet in response to detecting an interruption of electric power from the wall outlet. A progress indicator provides an indication of a progression of the infusion at a time when the interruption of electric power occurred. An accessory life indicator issues a notification when a recommended useful life of an accessory to the infusion device is to be replaced or serviced. And a drop counter monitors at least one of a quantity of the substance administered and a rate of administration.

[0007] The above summary presents a simplified summary in order to provide a basic understanding of some aspects of the systems and/or methods discussed herein. This summary is not an extensive overview of the systems and/or methods discussed herein. It is not intended to identify key/critical elements or to delineate the scope of such systems and/or methods. Its sole purpose is to present some concepts in a simplified form as a prelude to the more detailed description that is presented later.

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWING [0008] The invention may take physical form in certain parts and arrangement of parts, embodiments of which will be described in detail in this specification and illustrated in the accompanying drawings which form a part hereof and wherein:

[0009] FIG. 1 schematically depicts an embodiment of an infusion pump in the form of an IV bag, large volume fluid infusion device; and

[0010] FIG. 2 schematically depicts an embodiment of an infusion pump in the form of pump fluid infusion device, or syringe pump.

DETAILED DESCRIPTION OF THE INVENTION

[0011] Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. Relative language used herein is best understood with reference to the drawings, in which like numerals are used to identify like or similar items.

Further, in the drawings, certain features may be shown in somewhat schematic form.

[0012] It is also to be noted that the phrase "at least one of, if used herein, followed by a plurality of members herein means one of the members, or a combination of more than one of the members. For example, the phrase "at least one of a first widget and a second widget" means in the present application: the first widget, the second widget, or the first widget and the second widget. Likewise, "at least one of a first widget, a second widget and a third widget" means in the present application: the first widget, the second widget, the third widget, the first widget and the second widget, the first widget and the third widget, the second widget and the third widget, or the first widget and the second widget and the third widget.

[0013] FIG. 1 schematically depicts an illustrative embodiment of a type of infusion pump referred to as an IV bag fluid infusion device. As shown, the IV Bag 12 containing the drug to be administered is hung from a lanyard or hook 14, which is optionally coupled to a scale 16 or other weight sensing device. The drug flows through the IV line 18 under the force of gravity to a drip chamber 20 equipped with a drop counter sensor 22 and drip counter light source 24 (e.g., LED, etc.) to sense each drop 26 emitted from the IV line 28, allowing the drops 26 to be counted by a processing circuit, optionally including a microprocessor device provided to the infusion device or "pump". The rate of delivery can be adjusted by the pump by controlling the degree to which the IV line 28 to the patient is constricted or "pinched" by a pinch mechanism 30 provided to the pump.

[0014] FIG. 2 schematically depicts another illustrative embodiment of a type of infusion pump referred to as a pump fluid infusion device, or syringe pump. According to the present embodiment, the infusion device receives a syringe 40 storing the drug to be delivered and a plunger feed mechanism 42 that inserts the plunger 44, and accordingly, administers the drug at a controlled rate through the IV line 46 to the patient according to the parameters programmed into the infusion device.

[0015] Although two types of infusion devices are shown in FIGs. 1 and 2 above and referenced herein for the sake of brevity and clarity, the present disclosure can encompass any other device for administering a fluid to a patient in a controlled manner.

[0016] POWER MANAGEMENT

[0017] Electrical power is required for the operation of most functions of the infusion pump. Therefore, it is important to maintain a continuous supply of electrical power to the pump. A connection to traditional power sources such as A/C line power is the most common method of supplying main electrical power to the infusion pump. One or more auxiliary power sources such as a battery backup, however, can also be used to ensure the functions of the infusion pump continue to operate when the main source of power is temporarily lost or disconnected. Additional methods that ensure the continuity of power to the infusion pump include, but are not limited to:

[0018] A. Circuit Isolation. The internal electrical circuits of the infusion pump that handle the different sources of electrical power will be separated and isolated from each other such that a failure in the circuitry that handles one power source will not affect the operation of other power sources in the same infusion pump.

[0019] B. Networked Power. An infusion pump can include an electrical power connection to a second infusion pump and receive its electrical power from the second pump. More than one pump can be daisy-chained together in this manner (e.g. connected end-to-end) and all pumps will receive their main operating power (e.g., AC line power from wall outlet supplied by an electrical utility, from a battery provided to one or more of the connected pumps, etc.) from the power supply of a single pump, which can be plugged into a wall outlet.

Accordingly, the power supply circuitry provided to one of the connected pumps can supply power to at least one, and optionally a plurality of other connected pumps in the event of a fault in the power supply of the one or plurality of other connected pumps occurs.

[0020] C. External Power Supply Components. More than one pump can be daisy- chained together (e.g. connected end-to-end, spoke and hub, etc.) with a single connection to a separate external electrical power supply such as a power supply mounted on the pole holding the pumps, for example. All pumps daisy-chained together will receive their operating power from the single external electrical power supply. A single external backup power supply such as a battery can also be used with pumps daisy-chained together to supply temporary power to the pumps daisy-chained together. This backup battery can be provided to one of the pumps daisy- chained together, separate from the pumps, but operatively connected to deliver backup power in the event power from the main supply is interrupted, or otherwise connected to at least one of the daisy-chained pumps.

[0021] D. Wireless Power. An infusion pump can receive wireless (e.g. inductive) power from an external power source for operating the pump and/or charging the temporary power supply of the pump.

[0022] E. Battery Power. A user replaceable battery that conforms to a standard can be used to supply temporary power to the pump.

[0023] F. Power Over a Connection Not Traditionally Used, or At Least Not Dedicated for Power Transmission. An infusion pump with a standard external port such as an Ethernet port or USB port can receive electrical power from that port as an alternative method to provide power to the pump. Electrical power received from an external port can be used as temporary power or as main power for the infusion pump.

[0024] G. Capacitive Storage. A super-capacitor can be used to store electrical energy and provide temporary electrical power to the pump during a relatively-short power interruption of disturbance. For example, electric power during momentary power interruptions (e.g., under 10 seconds, under 7 seconds, under 5 seconds, under 3 seconds, etc.) can be supplied by a capacitive storage device, avoiding the need to re-initialize the pump to resume an infusion. [0025] H. Reduced Power Consumption. An infusion pump can implement power- management functions that are controlled by software and/or hardware to reduce power consumption when primary electrical power sources such as A/C line power or external port power from an Ethernet or USB port, for example, are unavailable. These power management functions can include, but are not limited to:

[0026] 1. Reducing the frequency at which internal functions of the pump are performed such as checking sensors of the pump. This can include counting the fluid drips passing through a line, such as an IV line, or measuring the weight of the container or bag holding the fluid being delivered by the pump;

[0027] 2. Reducing the power allowed for some non-critical functions such as the brightness of displays and status indicators that are part of the infusion pump. This can include turning off such non-critical functions until the pump determines they are needed or they are activated by a user;

[0028] 3. Applying rules based on information encoded in the formulary stored on the pump that allows the software in the pump to control power management functions when the fluid being delivered by the pump includes an indication that power reduction procedures are permitted or not permitted for that fluid; and

[0029] 4. Calculating the amount of temporary power remaining, such as battery backup power, and calculating the estimated time to complete the current infusion operation and applying appropriate power management operations to extend the amount of remaining temporary power to complete the current infusion.

[0030] I. Mechanical Assistance. An infusion pump, such as a syringe based infusion pump, can incorporate mechanical design features such as a spring loaded plunger assist to provide a bias force against the plunger that reduces the amount of energy necessary to move a syringe plunger. Using a biasing force on the plunger allows a reduced amount of actuator force to move the syringe plunger which consumes less electrical power on the pump.

[0031] J. Low-Power Circuitry. An infusion pump can incorporate electrical design features such as low power components, displays (e.g. e-ink displays) and minimal component count including a reduction in use of higher power components and sharing of components on other infusion pumps to which the pump is connected (e.g. wireless network connections) to reduce overall power requirements.

[0032] K. Different Operational Modes. An infusion pump can have a "mobile mode" that is activated by the user or automatically when the main power source(s) are not present to implement power reduction strategies that extend the operational time of the pump when running on temporary power. In mobile mode, the pump can optionally implement rules and policies that are user configurable to maximize pump run time by disabling or substantially reducing some functions of the pump that require significant electrical power. Mobile mode rules can also disable, limit or cause the pump to ignore or otherwise not respond as it normally would (e.g., out of mobile mode) to some sensors or feedback from the pump that may provide inaccurate or false readings because of movement, noise, etc. when the pump is used in mobile situations such as in an ambulance, for example. Mobile mode rules and policies may require the user to perform more manual monitoring of the pump to compensate for reduced functions. The pump will include an indication that the mobile mode is enabled.

[0033] INFUSION CONTINUATION AFTER PUMP FAILURE

[0034] The present infusion pump can optionally continue the infusion of a fluid after an unrecoverable pump failure. Transferring the fluid container (e.g. syringe or IV bag) with the remaining fluid to a replacement pump is one method of handling this condition. Simplifying the transfer of information or settings that relate to the current infusion from the failed infusion pump to a replacement pump is important to reduce user errors associated with configuring the replacement pump and quickly restoring the flow of fluid to the patient. The methods to accomplish this can include, but are not limited to:

[0035] A. An infusion pump designed for a syringe can include a mechanical or digital indicator that shows the progress of the infusion. This could take the form of a mechanical indicator that travels along with the plunger as the pump pushes the plunger. It could also be a code or indicator on the pump display such as a numeric or alphanumeric display that indicates the progress of the infusion. The replacement pump will allow the user to enter the infusion progress indicator from the failed pump. The indicator will provide a portion or all of the information necessary to continue the infusion on the replacement pump. The pump can be configured to require the user confirm the information before the pump resumes the infusion. [0036] B. An infusion pump designed for IV bags can include a digital indicator that indicates the progress of the infusion. This could take the form of a code or codes on a display such as a numeric or alphanumeric display that indicates the progress of the infusion. The replacement pump will allow the user to enter the infusion progress indicator from the failed pump. The indicator will provide a portion or all of the information necessary to continue the infusion on the replacement pump. The pump can be configured to require the user confirm the information before the pump resumes the infusion.

[0037] C. An infusion pump can receive an identifier that is unique to the fluid being infused, such as an identifier from a barcode or RFID tag or other machine readable source on the fluid container or the fluid line, that allows the pump to transfer information regarding the progress of the infusion along with the unique identifier to another device across a

communication channel such as a server on the same communication network as the pump or memory device (e.g. writeable flash memory) or store the information in the machine readable identifier itself if the identifier allows it (e.g. a writeable RFID tag). If the fluid container is transferred to a replacement pump, the unique identifier on the fluid container can be used to retrieve the progress information associated with the infusion and use it to configure part or all of the settings of the replacement pump to complete the infusion. The pump can be configured to require the user confirm the information before the pump resumes the infusion.

[0038] D. An infusion pump can be associated with an identifier that is unique to the pump. Such as an identifier can be a barcode or RFID tag or other machine readable source affixed to or associated with the infusion pump. The pump can transfer information regarding the progress of the infusion along with the unique identifier of the pump to another device across a communication channel such as a server on the same communication network as the pump or memory device (e.g. writeable flash memory) or store the information in the machine readable identifier itself if the identifier allows it (e.g. a writeable RFID tag). If the fluid container is transferred to a replacement pump, the progress information associated with the unique identifier of the failed pump can be retrieved and used to configure part or all of the settings of the replacement pump to complete the infusion. The pump can be configured to require the user confirm the information before the pump resumes the infusion.

[0039] LINE IDENTIFICATION, INSTALLATION AND MONITORING [0040] The present infusion pump can use many different conduits such as IV lines, feeding lines and other type of lines to deliver fluids to the patient. These lines have properties such as the maximum amount of time a line can be used before they are required to be replaced, the type of fluid the line is intended to transport and other properties specific to the type of line. Proper identification and monitoring of lines used by the pump is important to properly manage infusions and the use of such lines for the benefit of the patient. The present infusion pump can include one or more of the following, and optionally other features to assist in managing lines:

[0041] A. An infusion pump can use physical properties of the line such as the line color, line diameter, line shape, and the shape of fittings on the line, and unique mechanical features of the line to identify the type of line or aid the user in the identification of the line. The pump can use the identification of the line along with the identification of the fluid to ensure delivery to the patient is using the correct route (e.g. ensuring nutrients are delivered to the patient using a feed line and not an IV line). Proper identification of the line can be used to set up the pump for operations such as counting fluid drips to ensure the correct flow rate of fluid to the patient. Line identification can also be used to reject lines not intended for use in the infusion pump or not intended for use with the type of fluid about to be administered.

[0042] B. An infusion pump can use machine readable identification on the line such as a barcode, RFID tag or other machine readable identifier associated with the line to identify the type of line.

[0043] C. Lines with machine readable identification that include identifiers unique to the line such as serial numbers can be used by the infusion pump to track the patient associated with the line to prevent cross-contamination with other patients and to track the amount of time a line has been in use to provide an indication of the time along with notifications regarding the replacement of the line to the user.

[0044] D. An infusion pump can be programmed to sense and track other information associated with the line including:

[0045] 1. Track how long a specific line has been in use and notify the clinician when line replacement is recommended based on hospital policy; [0046] 2. Track which specific line is being used for a specific patient and notify the clinician if a line was used on a different patient (cross-contamination);

[0047] 3. Track all fluids delivered on the line; and

[0048] 4. Track the current drug being delivered and provide information about the delivery status to a clinician or a second compatible pump device so the line and drug can be transferred to the second pump on the event of a failure of the first pump.

[0049] E. An infusion pump can use a mechanically activated switch on a cover or interlock mechanism that monitors when a line is inserted in the pump to control a timer that indicates when the line expires and needs to be changed.

[0050] F. The distance between the end of the line that connects to the fluid container (e.g. IV bag) and the part of the line that connects to the pump (e.g. drip bulb) can be made short enough to only allow a line from a container associated with a specific pump (e.g. hung from that pump) to be connected to that pump. Other pumps supported by a common structure or otherwise positioned near that pump will be spaced further apart from the IV bag such that the short line will not reach those other pumps, thereby limiting the likelihood that the IV bag or other fluid container will be connected to the wrong pump. This will increase patient safety by ensuring the fluid container and line is actually connected to the pump that is configured to deliver it to the patient.

[0051] G. The infusion pump can incorporate a light source (e.g. an LED) located at or near the point where the line makes contact with the pump that can illuminate the line. This allows the user to easily see the illuminated line and follow it back to the fluid source such as an IV bag. The line can incorporate properties such as fiber optic properties that aid in the transmission of light to extend the illumination effect from the pump along the line. This is particularly useful to improve safety when multiple pumps with different fluids are in use on a single patient and the pumps and fluid containers are in close proximity to each other.

[0052] FLUID IDENTIFICATION AND VERIFICATION

[0053] Proper identification of a fluid being used in the present infusion pump is required for effective treatment of patients. Encoding the fluid container (e.g., IV bag, syringe, etc.) with a machine readable identifier (e.g., barcode, RFID tag, etc.) representative of the fluid within the container is one method of transferring information about the fluid to the pump that reduces human error. Another method is determining the type of fluid being administered by analysis of the fluid. The goal is to ensure the correct fluid or pump setting are being

administered to the patient, and examples of methods to achieve this goal include, but are not limited to:

[0054] A. An infusion pump with a moveable, extendable RFID antenna or barcode reader that is positioned on the infusion pump to allow the user to read the machine readable identifier on a fluid container that is connected via a line set (e.g. IV line) to the pump. This can include allowing the user to change the orientation of the RFID antenna or barcode reader on the pump to optimize reading of the machine readable identifier on the fluid container. Optionally, the RFID antenna or barcode reader can be retained in the last position set by the user.

[0055] B. The infusion pump can include a digital weight scale with the necessary resolution and accuracy to determine the weight of a fluid container connected to the scale and calculate whether the fluid contained within the container is sufficient to administer the infusion based on the settings configured in the pump such as flow rate, time, total volume to be delivered, etc. (e.g. If the pump settings call for delivery of 1000 mL of fluid, but the weight registered by the pump scale suggests 500 mL in the fluid container, then the user is notified of the discrepancy. The reverse scenario of too much fluid in the container can trigger a notification of the user as the wrong fluid container may be connected to the pump). The formulary on the infusion pump can contain information necessary to calculate the weight of the fluid in the container.

[0056] C. An infusion pump can include a refractometer that allows a sample of the fluid being administered by the pump to be analyzed in real-time. The results of the fluid analysis can be compared to information stored in the formulary of the pump to correctly identify the fluid being administered or at a minimum, verify that the fluid matches the expected refraction index in the formulary. Multiple refractometer sensors with different analytic properties and/or sensitivity ranges can be used to increase the range of fluids that can be identified.

[0057] D. An infusion pump can include other types of sensors to analyze fluids such as a Raman spectrometer, IR spectrometer or other optical spectrometer, or camera array with light source. The resulting fluid analysis yields information that can be compared to information stored in the formulary of the pump to correctly identify the fluid being administered or at a minimum, verify that the fluid matches the expected values associated with the stored sensor values of that fluid in the formulary. The results of multiple sensors with varying properties of the same type or sensors of different types can be used to improve the accuracy of fluid analysis and identification.

[0058] E. An infusion pump line set can include a chamber for analysis of fluid that is an integral part of the line. The analysis chamber, interchangeably referred to herein and in FIGs. 1 and 2 as the fluid sample chamber, can be a secondary chamber connected to the primary drip chamber or connected to some other part of the line. The analysis chamber can be incorporated in the function of another chamber such as the primary drip chamber of the line. The analysis chamber allows collection of a fluid sample for analysis by sensors without contaminating other fluid in the line or interfering with the delivery functions of the pump. The analysis chamber can be made of materials with optical properties that allow optical sensors used for analysis of the fluid to be located outside of the chamber. The analysis chamber shape and design will allow for convenient analysis of the fluid sample from outside of the chamber. The sensors for analyzing the fluid can be built-in to the infusion pump or be an add-on or external unit. External analysis units can be transported between pumps for quality control purposes allowing one unit to service many pumps. External analysis units can be designed to permit flexibility allowing the units to be utilized with generic fluid lines such as IV lines or custom designed lines or analysis chambers optimized for use with the external analysis unit.

[0059] F. When external analysis equipment is used to analyze a fluid sample, the formulary that is stored on the pump can be loaded on the external analysis device or accessed by the external analysis device using a wireless connection with the pump or other connections enabling information transfer to the external analysis equipment to extract the necessary information to analyze the fluid sample. Additional formulary information unique to the external analysis equipment may be required to perform the analysis.

[0060] G. Other properties of the fluid such as the unit weight of the fluid, viscosity, fluid density, surface tension, droplet size, pH and solubility can be analyzed and used to determine the type of fluid. Analysis of multiple properties can be combined to improve the accuracy of identification. Micro-capillary tubes can be used to determine surface tension or perform other analytic functions on the fluid. The analysis chamber can have one or more probes built-in that allow contact with the fluid. Externally accessible contacts to the probes that allow external analysis equipment to be connected outside of the chamber can be provided on the chamber. The contact points that allow access to the probes can be electrical or optical. In the case of optical, a fiber optic connection can be made to allow an optical measurement of the fluid from an external analysis device. Access to the probes can also be accomplished via a wireless connection such NFC (Near Field Communications), Bluetooth or other wireless methods. The formulary stored on the pump or in the external analysis device can include information required to identify a fluid from the results of the analysis process.

[0061] H. The analysis chamber can incorporate a seal that allows a sample of fluid to be collected in the chamber and isolated without contaminating other fluid in the line or interfering with the delivery functions of the pump.

[0062] I. The fluid sample can be extracted from a port on the fluid line or the analysis chamber by piercing the appropriate port or line with a needle. Other extraction methods that allow removal of the fluid including expressing fluid by squeezing or use of a vacuum to obtain a sample can be used.

[0063] J. The operation of the infusion pump can be configured to require feedback from the user and/or input from the analysis equipment that confirms the correct fluid was detected before the pump begin delivering the fluid to the patient. This configuration can be required of all fluids delivered by the pump or only specific fluids as specified by the formulary stored in the pump.

[0064] INHERITANCE OF PUMP INFORMATION

[0065] A plurality of the present infusion pumps can be used to treat a patient or within an area/ward of a healthcare institution. Some settings on these pumps are the same but the process of configuring each pump can be time consuming and prone to human error. When more than one pump is required and a first pump is already configured with information or settings required for the operation of the pump in that environment, a second pump can establish a connection with the first pump via a physical connection such as a communication or network cable, or a wireless connection such as Bluetooth or Wi-Fi for example. Once the connection is established, the second pump can receive a copy of the information from a first pump. This process is called inheritance. The receiving pump can be configured to require user confirmation of the information that is being inherited. Once the information is successfully copied from one device to another, the connection between devices is no longer required and either device can use the information. Examples of information that can be inherited include, but are not limited to: formulary information, device configuration information, hospital policy information (when to replace an IV line, etc), localization information (language, unit/measurement representation, etc.), patient information (Name, ID, DOB, Weight, Sex, etc.), and the like.

[0066] SHARING OF PUMP INFORMATION

[0067] Multiple infusion pumps are often used to treat a patient or within an area/ward of a healthcare institution. Some functions or information required by a pump are impractical or not cost effective to duplicate across multiple pumps. In these cases, sharing of information and resources between a plurality of the present pumps can facilitate improved convenience and cost effectiveness. When sharing of information or resources is required by one or more additional other pumps and a first pump has the resource or information to be shared, a second pump can establish a connection with the first pump via a physical connection such as a communication or network cable, or a wireless connection such as Bluetooth or Wi-Fi for example. Once the connection is established, the second pump can access or utilize information and resources on a first pump when the first pump is configured to enable such sharing. The second pump will have access to the shared information or resources as long as the connection between the pumps is maintained. Examples of resources or information that can be shared include, but are not limited to: formulary, device configuration, localization (language, unit/measurement representation, etc.), patient information (Name, ID, DOB, Weight, Sex, etc.), drug delivery status (current drug, flow rate, amount infused, amount remaining, completion time, completion status, attending clinician), network connections, physiologic data from patient sensors, user interface display and controls, and the like.

[0068] COORDINATING ACTIONS ACROSS MULTIPLE PUMPS

[0069] The infusion pump can be used to deliver multiple fluids to a patient in a prescribed manner that requires coordination of the infusions between multiple pumps. For example, a patient may require 1000 mL of saline solution before administering a particular medication. Or, a fluid may be spread across a plurality of the present infusion pumps where one pump begins when another is complete. Methods to accomplish coordination of actions across multiple pumps include, but are not limited to:

[0070] A. Use of a time reference at the pump to coordinate the actions of the pump based on pre-programmed times. This can be based on actual date/time values (e.g. start tomorrow at 2AM) or relative time references (e.g. start in 45 minutes.) The time reference can be maintained by the pump as a function of the internal circuitry of the pump or received from an external source such as a network time source that the pump is configured to access.

[0071] B. Use of shared information between pumps in which a first pump can provide information about the status of an infusion to a second pump that establishes a connection with the first pump via a physical connection such as a communication or network cable, or a wireless connection such as Bluetooth or Wi-Fi for example. Once the connection is established, the second pump can receive information from the first pump that indicates when an infusion is should begin on the second pump. According to such an embodiment, the second pump can optionally lack programming specific to the coordinated delivery of fluids. For example, the first pump can be programmed to transmit a start signal in response to reaching a predetermined stage of fluid delivery (e.g., when the infusion via the first pump has been completed). The second pump receives the start signal and treats it as that second pump would a manually-input start signal to initiate fluid delivery via that second pump. According to alternate embodiments, the second pump can optionally be programmed or otherwise configured to expect a start signal (or other communication) from the first pump within a prescribed timeframe. Thus, the second pump can "follow up" with the first pump if the start signal is not received within that prescribed time period as a redundant check on the overall infusion process.

[0072] C. Use of multiple pump configuration instructions where a user configures a first pump with information regarding a series of infusions that includes part or all the information necessary for multiple connected pumps. The first pump makes that information available to the other pumps or actively transfers the information to them. The pumps can be configured to allow the user to confirm all instructions from the first pump or require

confirmation at each individual pump.

[0073] PUMP USER INTERFACE [0074] The present infusion pump may require several parameters and/or settings to be input to configure the pump for operation. The infusion pump also provides status information during an infusion so users can monitor the operation of the pump. The present pump improves the input and/or output of information via a user interface can include by, for example:

[0075] A. Use of analog display paradigms to augment or replace digital display values (e.g. dials, bar graphs, check boxes.).

[0076] B. Use of analog input devices that are physical or virtual representations of analog controls to replace or augment numeric input of digital values, (e.g. dials, sliders.).

[0077] C. Display enhancement using differential font sizes for important digital values. Values would be displayed with increased font size for digits that precede a decimal point (whole numbers) and decreased font size for digits that occur after a decimal point

(fractions of numbers). For example, if the number 12.25 was to be displayed, the "12" can be displayed with an increased font size and "25" would be displayed with decreased font size. The decimal point can be displayed or implied by the difference in font size.

[0078] D. Display enhancement using color for important digital values. Color differentiation can improve reading and recognition. Values would be displayed using one color for digits that precede a decimal point (whole numbers) and a different color for digits that occur after a decimal point (fractions of numbers). For example, if the number 12.25 was to be displayed, the "12" could be displayed in light blue and "25" could be displayed in dark blue. Any two colors can be assigned. The decimal point can be displayed or implied. Alternate colors for errors or warnings of digital values can be used to draw user attention to those values.

[0079] E. Information displayed on the pump can be formatted in such as way that it conforms to a standard such as ISO 26825, tallman lettering of drug names or other standards and conventions used in the medical industry. This can include the use of color, the layout or organization of information with respect to other information on the display, font size and other characteristics. The display of information can also conform to an institution or product specific standard that presents information in a manner that is familiar to the user. [0080] F. Rules can be incorporated in the pump or formulary to define information about how information is to be displayed. This can include country specific preferences such as use of commas or periods as numeric separators (e.g. 1,234.56 would be the U.S. representation while 1.234,56 is common in many European countries). The rules can also allow institutional or user preferences to be implemented.

[0081] G. A speaker that is part of the infusion pump or a shared resource of multiple pumps that are connected to share information can provide audible feedback using sounds of a "spoken" language (e.g. English, as opposed to simple beeps or tones) to provide important information using sound files (e.g. WAV, MP3) to improve safety. For example, if a user configures a pump to deliver a drug at 100 mg per hour but the usual dose is 10 mg per hour, the system can use spoken words to inform the user of this discrepancy and increase the likelihood the user will recognize the consequences of the action being requested. Spoken words from the pump can provide confirmation of actions, information about fluids being administrated such as the fluid names, concentration and other information, and positive or negative feedback regarding requested actions. The spoken files can also report information on the status of the infusion pump device.

[0082] H. The infusion pump can maintain a history of infusions including the user requesting the infusion, patient information, fluid information, date, time, location, formulary and other information relevant to the infusion. This information can be used for general analysis or identifying specifics about an infusion. The history information can also be used by the pump to compare new infusions for a patient with previous infusions of the same fluid for the same patient to identify differences that may indicate an incorrect setting was entered into the pump for one of the infusions. The pump can provide an indication to the user to verify the infusion pump settings before proceeding.

[0083] I. An infusion pump that is part of multiple pumps delivering multiple fluids to the same patient can exchange information with the other pumps to detect infusions of fluids that may have interactions or may have similar settings that could be an indication that the user should verify the settings on this pump and possibly other pumps to ensure no swaps of fluid containers (e.g. IV bags) or infusion settings occurred. The pump can provide an indication to the user to verify the fluids being administered and infusion pump settings before proceeding. [0084] PUMP CALIBRATION AND MAINTENANCE

[0085] The present infusion pump requires consistency of operation and accuracy to ensure the proper amount of fluid is delivered to the patient in the specific time. Mechanical variations in components of the pump and fluid line sets can require calibration of the pump to those specific components and line sets, for example. The calibration can be unit specific or apply to all pumps using similar components or fluid line sets. The following methods and techniques are examples of the calibration and maintenance of the present pumps:

[0086] A. Calibration of the drip volume of a fluid line set can be performed using a deterministic amount of a fluid (e.g., a pre-measured volume such as 100 mL) and counting the number of drips as the fluid flows through the fluid line set. Information about the total drip count and volume of fluid passed through the drip chamber of the fluid line can be entered into the pump by a user or received by the pump as part of an automated calibration cycle for that type of line set.

[0087] B. Calibration of the drip sensor(s) and associated light source(s) (e.g. LED) that are used to count the drips of fluid passing though the fluid line can be calibrated to ensure the drip sensor detects all drips even if lighting conditions, fluid type or the characteristics of the line or drip chamber vary. The brightness of the lights source and the sensitivity of the sensor (e.g. signal gain) can be adjusted to determine the high, low and optimal settings to ensure reliable detection and counting of drips. A multi-color light source (e.g. RGB LED) can be used and the color frequency of the emitted light adjusted using software control in the pump during the calibration cycle to improve drip detection. Alternating multiple colors of light by strobing different colors in rapid succession such that all colors are cycled at least once during a single drip allows for greater dynamic range and safety margin when detecting drips with different types of fluid lines and fluids. The software in the pump can optionally select the optimum light source color(s) and sensor sensitivity automatically during pump set up or during administration of an infusion. Although the embodiments described in this paragraph make use of a multi-color light source and a corresponding sensor, alternate embodiments can utilize a plurality of single- color (e.g., each of a different color) light sources and a separate, dedicated sensor corresponding to each different light source. [0088] C. The line pinch mechanism that regulates the rate of flow of fluid through the pump is self-calibrating based on the drip volume calculation described in paragraph (a) of this section. The pinch mechanism can reduce the flow of fluid or increase the flow of fluid in increments that allow a sufficient flow range to handle the administration needs of fluids to a patient. When a flow rate setting is entered into the pump, the number of drips per unit-time are calculated based on the drip volume to achieve the flow rate setting and line pinch mechanism is adjusted incrementally to achieve the desired drip rate. An initial gross calibration of the pinch mechanism can be performed by the factory to ensure that full flow and no flow of the fluid can be achieved on the pump with the necessary incremental steps to properly control fluid flow during an infusion.

[0089] D. Calibration of the weight scale can take into account the weight of the fluid container and fluid line and provide this information to improve the calculation of the weight of fluid in the container.

[0090] E. Calibration values can be stored in factory assigned non-volatile memory in the infusion pump, or in the formulary or global configuration setting stored in, or otherwise made accessible to the pump by the institution using the pump, or pump specific non-volatile memory based on on-site calibrations by users. A hierarchy is established in the pump by the facility or other suitable party (e.g., OEM that produces the pump) authorized to configure the pump to define which setting to select when multiple settings for the same calibration exist.

[0091] F. The calibration process for any setting can be performed multiple times and the pump can optionally average the results to improve accuracy. The pump can also notify the user when a calibration result exceeds expected ranges or is significantly different from previous results.

[0092] G. Preventative maintenance and required maintenance requests can be generated by the pump software and an indication of such maintenance provided to the user or facility owning the pumps using the pump display or via a network connected to the pump (e.g. Wifi or Ethernet.) A required maintenance request can result in the software of the pump refusing to accept new infusion requests for safety reasons until the maintenance is performed. Preventative maintenance requests will not interfere with the operation of the pump but may become required maintenance in some instances if the maintenance is not performed in a reasonable amount of time. Maintenance requests and/or pump status and pump log information can be aggregated together and provided via network to a designated set of users (e.g. a hospital medical equipment maintenance department) using email or other means to assist hospital staff in analyzing and resolving operational issues involving infusion pumps.

[0093] PUMP SENSORS

[0094] The present infusion pump can use sensors to improve convenience and performance during operation. The sensors can be integrated as part of the pump itself, and/or added-on as an optional, separate component or an external module that can be used with multiple pumps. Sensors can interact with pump electrically, mechanically and via software. Design considerations such as sensor placement, orientation and relationship to other

components are often important to ensure the proper operation of the sensor. The following methods to implement or improve sensors used by the pump can include, but are not limited to:

[0095] A. Use of sensors, such as accelerometers, gyroscopes, tilt switches or other motion detection devices, can be employed to detect motion of the pump including a change in pump orientation or tilting of the pump. This can provide an indication that a patient or clinician is moving the pump. These indications can be used to trigger an alert to the user or a warning to the person triggering the sensor.

[0096] B. Use of sensors can determine the location of a pump. These can include GPS (Global Positioning System), IPS (Internal Positioning System), accelerometers, gyroscopes or other wireless receivers that can determine the location of the device with sufficient accuracy to allow the configuration of the pump, including the formulary, patient information or other configurable information used by the pump, to be changed based on the location. Techniques such as triangulation and trilateralization can be used external sensors in the facility housing the pumps to locate and identify the pump and transfer the location information to the pump using a network such as a wireless network (e.g. IEEE 802.11, commonly referred to as Wifi).

[0097] C. Use of a weight scale, such as a load sensor, can be employed to determine the amount of fluid in a container attached to the pump. As the fluid is administered, the weight of the container will change and the scale and register such changes. Information from a formulary can be used augment and verify the calculation of the amount of fluid in the container and the unit weight of the fluid to register changes in the container as fluid is administered. [0098] D. Use of a weight scale on a pump can require protection of the associated sensor from accidental impact or damage. Since the connection point of the weight scale to a drug container is likely to be on an outer surface of the pump, providing protection in the form a guard, shield or protruding structure around the connection point of the scale sensor is one method of protecting the sensor. The drug container can be connected the weight scale inside the protected area helping to protect the sensor. Alternately, or in addition to the protected area, a supporting cable such as a lanyard, chain or cord that only allows tension and not compression and extends downward from the weight sensor can be utilized to protect the device from compression damage resulting from a potential impact to the area of the pump with the weight sensor.

[0099] E. Use of a camera of other imaging device to read machine readable codes such as barcodes that can be used to configure functions of the pump including infusion parameters, fluid information, patient information and other information necessary for the functioning of the pump. The camera can also provide monitoring of the patient or pump user and capture images that can be used for record-keeping or device logging purposes, especially when the pump configuration is being set up or changed.

[00100] F. Use of a weight scale on the pump to monitor the weight of the fluid container attached to the pump can provide an indication of the remaining fluid that is displayed on the pump. The indication can be displayed on the pump with a visual representation to make it easy for a user to determine the amount of fluid and/or time remaining in the infusion or determine that the infusion will soon be complete. The indication can also be provided over a network such as a wireless network (e.g. wifi) or hardwired network (e.g. Ethernet) to external monitoring equipment such as a terminal at a nursing station. This can include notifying a user when the remaining fluid is nearly empty based on the weight of the attached container.

[00101] USER INTERFACE EXTERNAL TO PUMP

[00102] The present infusion pump can be designed with small size as a design feature. Eliminating the user display and most user controls can help minimize the size of the pump. The following are examples of methods that can be used to reduce the size of the pump, without limiting the operational ability of the pump to administer a substance to a patient: [00103] A. Use minimal status indications (e.g. a single, discrete multi-color LED) that provides a simple indication of the pump statues (e.g. Green=normal operation, Yellow=alert, non-critical attention required, Red=fault, critical attention required). This method can optionally involve the omission of a liquid-crystal display device or other dynamic display device capable of displaying text and/or graphics to convey information to a user from the body of the pump itself. In other words, the pump itself would not have an on-board, built-in .

[00104] B. Use of network communications (e.g. Wifi, Ethernet, etc.) to send status and alerts messages to an external interface such as a nursing station terminal. The terminal can also be used to configure the pump for an infusion, although user interaction with the pump can be required to start the infusion.

[00105] C. Use of a portable display device (e.g. smartphone, tablet) to communicate with the pump over a network (e.g. Wifi.) The portable device can use NFC (Near Field

Communication), Bluetooth or other local methods of identifying devices including a machine readable code affixed to the pump such as a barcode or RFID tag to select the pump when the portable device is in the vicinity so the pump and portable device and pump can establish a point-to-point communication channel for exchange of information.

[00106] D. Use of an indicator on the pump (e.g. a flashing light or LED) that is only active when a connection to a remote device such as a nursing terminal or portable device is active. This will provide additional feedback to the user that the expected pump is the connected to the remote device.

[00107] E. Establishing a connection between a remote device such as a nursing terminal or portable device and a pump in the process of infusing a fluid will provide status information about the pump that would typically be shown on a display that is integrated as part of a pump with similar capabilities that includes a display.

[00108] Illustrative embodiments have been described, hereinabove. It will be apparent to those skilled in the art that the above devices and methods may incorporate changes and modifications without departing from the general scope of this invention. It is intended to include all such modifications and alterations within the scope of the present invention.

Furthermore, to the extent that the term "includes" is used in either the detailed description or the claims, such term is intended to be inclusive in a manner similar to the term "comprising" as "comprising" is interpreted when employed as a transitional word in a claim.

Claims

CLAIM(S) What is claimed is:

1. An infusion device comprising: a holder for supporting a supply of a substance to be administered to a patient; a backup power circuit for conveying, at least temporarily, electric power to the infusion device during an infusion from an alternate power supply other than a wall outlet in response to detecting an interruption of electric power from the wall outlet; a progress indicator that provides an indication of a progression of the infusion at a time when the interruption of electric power occurred; an accessory life indicator that issues a notification when a recommended useful life of an accessory to the infusion device is to be replaced or serviced; a drop counter to monitor at least one of a quantity of the substance administered and a rate of administration; and a scale that monitors a weight of the supply of the substance supported by the holder during the infusion.

2. The infusion device of claim 1 further comprising a power outlet for transmitting the electric power delivered to the infusion device to another infusion device.

3. The infusion device of claim 1 further comprising a computer-readable code reader that interrogates a computer-readable code provided to the supply of the substance to identify at least one parameter governing the infusion of the substance to the patient, and transmits a signal to a controller provided to the infusion device to program the infusion device with the at least one operational parameter.