Infusion device having adjustable safety features based on connected external safety devices - Patent Application 20070122997

Abstract

The infusion device includes a safety indicator sensor. The infusion device is configured to operate in a default safety mode, where operation in the default safety mode includes monitoring the infusion therapy for compliance with a safety indicator that characterizes an infusion pathway between the infusion container and the infusion administration site via the safety indicator sensor. The infusion device is also configured to connect to an external safety device configured to monitor the safety indicator while operating in the default safety mode. The infusion device is further configured to determine, based on the connection with the external safety device, that the external safety device is monitoring the safety indicator. The infusion device is further configured to switch from operating in the default safety mode to operating in an adjusted safety mode in response to determining that the external safety device is monitoring the safety indicator.

Description

[Background technology]

[0001] Many infusion therapies involve an external safety device (ESD) to monitor safety conditions, such as air bubbles and particle contamination, within the infusion line. Often, the monitored safety conditions are also monitored by the infusion pump delivering the therapy. This simultaneous monitoring occurs in parallel, without coordination or interaction between the ESD and the infusion pump, resulting in unnecessary alarms and wasted resources. Therefore, there is a need for an infusion pump that can interface with and respond to an ESD. Summary of the Invention [Means for solving the problem]

[0002] In accordance with various aspects of the present technology, an infusion device includes a safety metric sensor, a processor, and a non-transitory computer-readable medium storing instructions that, when executed by the processor, cause the infusion device to operate in a default safety mode. Operation in the default safety mode includes monitoring the infusion therapy for compliance with a safety metric characteristic of a fluid path between an infusion container and an infusion administration site via the safety metric sensor. The instructions also cause the infusion device to connect to an external safety device ("ESD") configured to monitor the safety metric while operating in the default safety mode. The instructions further cause the infusion device to determine, based on the connection with the ESD, that the ESD is monitoring the safety metric. The instructions further cause the infusion device to switch from operating in the default safety mode to operating in an adjusted safety mode in response to determining that the ESD is monitoring the safety metric. Operation in the adjusted safety mode includes suspending monitoring the infusion therapy for compliance with the safety metric via the safety metric sensor or monitoring the infusion therapy for compliance with the safety metric via the ESD.

[0003] In accordance with various aspects of the present technology, a method includes operating an infusion device and a safety indicator sensor. The method also includes operating the infusion device in a default safety mode. Operation in the default safety mode includes monitoring the infusion therapy for compliance with a safety indicator characteristic of an infusion pathway between an infusion container and an infusion administration site via the safety indicator sensor. The method further includes connecting the infusion device to an ESD configured to monitor the safety indicator while operating the infusion device in the default safety mode. The method further includes determining, based on the connection with the ESD, that the ESD is monitoring the safety indicator. The method further includes switching the infusion device from operation in the default safety mode to operation in an adjusted safety mode in response to determining that the ESD is monitoring the safety indicator. Operation in the adjusted safety mode includes suspending monitoring the infusion therapy for compliance with the safety indicator via the safety indicator sensor or monitoring the infusion therapy for compliance with the safety indicator via the ESD.

[0004] It is understood that other configurations of the present technology will become readily apparent to those skilled in the art from the following detailed description, which shows and describes, by way of illustration, various configurations of the present technology. As will be understood, the present technology is capable of other and different configurations, and its several details are capable of modification in various other respects, all without departing from the scope of the present technology. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

[0005] For a better understanding of the various implementations described, the following detailed description should be read in conjunction with the figures, in which like reference numerals refer to corresponding parts throughout the figures and description. [Brief explanation of the drawings]

[0006] [Figure 1A] FIG. 1 illustrates an exemplary patient care system including an infusion device and an external safety device (“ESD”), in accordance with aspects of the present technology. [Figure 1B]FIG. 1 illustrates an exemplary patient care system including an infusion device and an external safety device (“ESD”), in accordance with aspects of the present technology. [Figure 2A] FIG. 10 illustrates an exemplary user interface including information related to ESD, in accordance with aspects of the present technology. [Figure 2B] FIG. 10 illustrates an exemplary user interface including information related to ESD, in accordance with aspects of the present technology. [Figure 2C] FIG. 10 illustrates an exemplary user interface including information related to ESD, in accordance with aspects of the present technology. [Figure 3] FIG. 1 illustrates an exemplary process, in accordance with aspects of the present technique. [Figure 4A] FIG. 10 illustrates another exemplary process, in accordance with aspects of the present technique. [Figure 4B] FIG. 10 illustrates another exemplary process, in accordance with aspects of the present technique. [Figure 4C] FIG. 10 illustrates another exemplary process, in accordance with aspects of the present technique. [Figure 5] FIG. 1 is a conceptual diagram illustrating an exemplary electronic system, in accordance with aspects of the present technique. DETAILED DESCRIPTION OF THE INVENTION

[0007] Reference will now be made to implementations, examples of which are illustrated in the accompanying drawings. In the following description, numerous specific details are set forth in order to provide an understanding of the various implementations described. However, it will be apparent to those skilled in the art that the various implementations described may be practiced without these specific details. In some instances, well-known methods, procedures, components, circuits, and networks have not been described in detail so as not to unnecessarily obscure aspects of the implementations.

[0008] As discussed above, there is a need for an infusion pump that can interface with and respond to an external safety device (“ESD”). As used herein, an “ESD” refers to a safety device external to the infusion pump for monitoring the safety status of the infusion therapy being delivered by the infusion pump. For example, an ESD may include an air-in-line sensor for monitoring whether excess air is present in the infusion line of the infusion pump. Another ESD may include a particle sensor for detecting whether the infusion fluid flowing through the infusion line is contaminated (e.g., contains excessive particles). ESDs are distinguished from patient safety devices in that patient safety devices monitor the safety of the infusion therapy based on physiological measurements of the patient associated with the infusion pump, whereas ESDs monitor non-physiological aspects of the infusion, such as monitoring the administration set (e.g., tubing), fluid contents, fluid temperature, etc. For example, an ESD may measure safety indicators that are indicative of characteristics of the infusion pathway between the infusion container and the infusion administration site, rather than a specific patient response to the fluid administered along the infusion pathway.

[0009] Redundancy occurs when an infusion pump and an ESD simultaneously and independently monitor the same safety indicator (e.g., air in the line, particle contamination, etc.). Accordingly, the present disclosure relates to interoperability between an infusion pump and an ESD. For example, when an ESD is monitoring an infusion pump's safety indicator, the infusion pump may be able to adjust its operation to accommodate the safety monitoring provided by the ESD. The infusion pump may adjust its operation by, for example, including sensor data from the ESD in its safety assessment (e.g., including particle data from the ESD when assessing whether the infusion fluid is contaminated) and / or disabling or adjusting the monitoring frequency of other sensors that may be used to monitor similar safety indicators. Alternatively, the infusion pump may adjust its operation by disabling detection of a safe condition or adjusting the detection sensitivity of a safe condition to account for the ESD's monitoring of the safety condition.

[0010] 1A and 1B illustrate an exemplary patient care system 100 including an infusion device 102 and an external safety device (“ESD”) 110 in accordance with aspects of the present technology. Referring initially to FIG. 1A, patient care system 100 includes four fluid infusion pumps 132, 134, 136, and 138, each in operative engagement with a respective fluid administration set 122, 124, 126, and 128. In the illustrated example, the infusion pumps are connected to and controlled by a mainframe infusion controller 104. Fluid sources 112, 114, 116, and 118 can take a variety of forms, but in this instance are shown as bottles, suspended upside down above the pumps. Fluid sources 112, 114, 116, and 118 can also take the form of bags or other types of containers. Both the infusion device 102 and the infusion sources 112, 114, 116, and 118 are mounted on a roller stand or pole 108. The particular infusion sources 112, 114, 116, and 118 and their orientation within the care area (e.g., mounting location, mounting height, mounting type, etc.) may generate one or more interaction records. For example, an interaction record for a set may be generated in part by detecting a scannable code associated with the set or by detecting a physical structure on the set that encodes the set's identification information prior to use.

[0011] As shown in the exemplary implementation, each administration set 122, 124, 126, and 128 connects a respective fluid supply 112, 114, 116, and 118 to the patient 106, such that the patient 106 can receive the fluids in all of the fluid supplies 112, 114, 116, and 118. The administration sets may be identified actively, for example, by scanning by a clinician, or passively, for example, by wireless or optical detection of the administration set.

[0012] In the illustrated example, separate infusion pumps 132, 134, 136, and 138 are used to infuse each of the fluids from fluid sources 112, 114, 116, and 118 into patient 106. Infusion pumps 132, 134, 136, and 138 are flow control devices that act on respective tubing or infusion conduits of an infusion administration set to move fluid from the fluid sources, through the conduits, and to patient 106. Because separate infusion pumps 132, 134, 136, and 138 are used, each pump may be individually configured for the pumping or operating parameters needed to infuse a particular medical fluid from its respective fluid source into the patient at a particular rate prescribed for that fluid by a clinician.

[0013] The exemplary external safety device (“ESD”) 110 illustrated in the exemplary patient care system 100 may include an air trap, air detector, flow detector, particle detector, spectral analyzer, or another device configured to monitor a safety indicator associated with the infusion device 102. As illustrated, a downstream portion of the administration set 126 passes through the ESD 110. Additionally or alternatively, the ESD 110 may be located upstream of the infusion device 102. For example, the ESD 110 may analyze a safety indicator (e.g., an air-in-line indicator, a flow indicator, an in-line particle indicator, or a spectral indicator) of the infusion as it flows through the set 126. The indicator may measure the quantity or quality of a characteristic of interest, such as air bubbles, flow rate, particle levels, or light. The indicator may be measured at regular intervals or over a time series by sampling values ​​over time. When more than one value is collected for analysis, the indicator may reflect an average, a moving average, a maximum value over a period, a minimum value over a period, correspondence to a threshold or range, etc. The ESD 110 is also connected to the infusion device 102 via a wired connection 111. As described herein, the infusion device 102 (e.g., the mainframe infusion controller 104 or an attached infusion pump) may be configured to detect, receive signals from, or send signals to, and / or control the ESD 110. Furthermore, the infusion device 102 may be configured to adjust its own operation in response to the ESD 110. In some implementations, the ESD 110 may be connected to the infusion device 102 via a wireless connection (e.g., a Bluetooth connection, a Wi-Fi connection).

[0014] Typically, medical infusion administration sets have many more components than are shown in Figure 1A. Many medical infusion administration sets have check valves, drip chambers, valved ports, connectors, and other devices known to those skilled in the art. These other devices are not included in the drawing to maintain clarity.

[0015] FIG. 1B shows a close-up view of a portion of the infusion device 102 of FIG. 1A in accordance with various aspects of the present technology. One or more functions of the infusion device 102 may be configured or controlled based on the described ESD functions. FIG. 1B shows two infusion pumps 134 and 136 mounted on either side of a mainframe infusion controller 104, along with displays and control keys for each pump 134 and 136, which can be used to program each infusion pump 134, 136 (and infusion pumps 132 and 138, not shown). The infusion pump 136 includes a door 154 and a handle 156 that operates to lock the door 154 in a closed position for operation and to unlock and open the door 154 to access the internal pumping and sensing mechanisms and to load an administration set for the pump 136. When the door 154 is open, tubing can be connected to the pump 136. When the door 154 is closed, the tubing is in operative engagement with the pumping mechanism, upstream and downstream pressure sensors, and other components of the pump 136. In this embodiment, a display 142, such as an LED display, is prominently located on the door and may be used to visually communicate various information regarding the pump 136, such as warning indications (e.g., alarm messages). Control keys 144A-144D are present for programming and controlling the operation of the infusion pump as desired. In some implementations, the control keys 144A-144D may be displayed as interactive elements on the display 142 (e.g., a touchscreen display). The infusion device 102 and / or the infusion pump 136 may also include an audio alert device in the form of a speaker (not shown).

[0016] The mainframe infusion controller 104 of the infusion device 102 includes a display 182 for visually communicating various information, such as operating parameters of a connected pump and warning indications and messages, and control keys 184A-184C for selecting and / or setting control parameters and / or options for controlling the infusion device 102 and connected modules. The mainframe infusion controller 104 may also include a speaker for providing audible warnings. In some implementations, the display 182 may be implemented as a touchscreen display. In such implementations, the control keys 184A or 184B may be omitted or reduced in number by providing corresponding interactive elements via a graphical user interface presented via the display 182. In some implementations, each control key 184A-184C may select a corresponding option displayed on the display 182.

[0017] The mainframe infusion controller 104 may include a communications system (not shown) through which it may communicate with external devices, such as a medical facility server or other computers, and portable processors, such as handheld communications devices or laptop computers, or other information devices to which a clinician may need to transfer information and download drug libraries (e.g., to the infusion pump 136). The communications module may be used to transfer access and interaction information to a clinician connected to the mainframe infusion controller or a device coupled thereto (e.g., the pump 136, a bar code scanner). The communications system may include one or more of a radio frequency (RF) system, an optical system (e.g., infrared), a Bluetooth system, or other wired or wireless system. Alternatively, the bar code scanner and communications system may be included integrally with the infusion pump 136, such as when the mainframe infusion controller 104 is not used, or in addition to having the mainframe infusion controller 104. Furthermore, the information input device need not be hardwired to the medical instrument; information may be transferred via a wireless connection.

[0018] Additionally, other types of modules may be connected to the pump module or the mainframe infusion controller 104, such as a syringe pump module, a patient-controlled analgesia module, an external safety device (ESD) 110, or a patient safety device such as an end-tidal CO2 monitoring module or an oximeter monitoring module. Some ESDs may include, for example, an air trap, an air detector, a flow detector, a particle detector, or a spectrum analyzer. According to various implementations, the infusion device 102 (e.g., the mainframe infusion controller 104) may be configured to operate in one of several modes depending on whether an ESD is connected to the infusion device 102. For example, if the ESD 110 is not connected to the infusion pump 102, the infusion pump 102 may operate in a default safety mode (see operation 304). However, after successfully pairing or connecting the ESD 110 to the infusion pump 102, the infusion pump 102 may switch to operate in an adjusted safety mode (see operation 310), as described in more detail below.

[0019] In some embodiments, pressure measurements from the upstream and / or downstream pressure sensors are transmitted to a server or other coordinating device, and the methods disclosed herein are implemented on the server or other coordinating device. For example, more advanced, computationally intensive techniques such as machine learning may be implemented on the server (or on a PCU with greater memory and / or CPU resources). In some embodiments, machine learning is used to identify an empty condition based on the pressure signal received from the pump.

[0020] 2A-2C illustrate exemplary user interfaces 200, 230, and 260 containing information related to a connected ESD 110, in accordance with aspects of the present technology. In some implementations, the user interfaces 200, 230, and 260 are displayed on the display 182 of the main frame injection controller 104.

[0021] 2A , a user interface 200 indicates that a successful connection has been established between the infusion device 102 and the ESD 110. The illustrated user interface 200 includes a header region 202 configured to display a header notification (e.g., "Devices successfully paired") and an information region 204 configured to display notifications about the ESD 110, including the type of ESD (e.g., "Air Detector"), its sample rate (e.g., "10x / min"), and whether it includes an alarm (e.g., "Yes"). In some implementations, the information region 204 also displays the specific brand name or model number of the ESD 110, such as in the case of an infusion treatment requiring a specific brand or model of ESD 110.

[0022] The illustrated user interface 200 also includes a mute button 206, a threshold button 208, a sample button 210, and a start button 212. In some implementations, the mute button 206 mutes the infusion device's alarm when activated by a user. For example, if the infusion device 102 includes a safety indicator sensor (e.g., an air-in-line sensor) and the ESD 110 includes the same type of safety indicator sensor (e.g., an air-in-line sensor), both the infusion device 102 and the ESD 110 may simultaneously activate their respective alarms upon detecting a hazard associated with the safety indicator. Thus, a user may wish to mute the infusion device's 102 alarm by activating the mute button 206 (e.g., to avoid unnecessary alarms, avoid having to respond to two alarms, or to avoid the noise of two alarms).

[0023] In some implementations, the threshold button 208 adjusts the safety index threshold of the infusion device 102 when activated by a user. For example, if both the infusion device 102 and the ESD 110 include the same type of safety index sensor, the user may adjust the safety index threshold to reduce the likelihood of an infusion device alarm being triggered. For example, the user may increase the safety index threshold of the infusion device 102 so that the infusion device 102 does not trigger an alarm for the safety index unless a higher safety index threshold is met (e.g., to account for a faulty ESD 110). In some implementations, the threshold may be automatically adjusted based on the connection status with the ESD 110.

[0024] In some implementations, the sample button 210, when activated by a user, may adjust the sample rate of the infusion device 102. Similar to the example above, if the infusion device 102 and the ESD 110 include the same type of safety indicator sensor, the user may desire to reduce the rate at which the infusion device 102 samples or monitors the safety indicator (e.g., to reduce the computational load associated with sampling the safety indicator frequently). In some implementations, the sampling rate may be automatically adjusted based on the status of the connection with the ESD 110.

[0025] In some implementations, the start button 212 begins an infusion therapy when activated by a user. For example, the start button 212 may initiate an infusion therapy in the infusion device 102 (e.g., via the infusion pump 136) while operating in an adjusted safety mode (e.g., as programmed by the user via the mute button 206, threshold button 208, or sample button 210). After the user selects the start button 212, connectivity with the ESD 110 may be re-verified (e.g., to ensure that the ESD is connected to the infusion device, is able to monitor safety indicators, and is able to activate alarms), as described in more detail below.

[0026] 2B, a user interface 230 indicates that the requested infusion therapy requires an ESD 110. The illustrated user interface 230 includes a header region 232 configured to display a header notification (e.g., "Error: External Device Required") and an information region 234 configured to display a notification regarding the ESD 110 (e.g., indicating that a particular brand or model of air detector ESD is required).

[0027] The illustrated user interface 230 also includes a connect button 236 and an override button 238. In some implementations, the connect button 236 initiates a connection to the ESD 110 when activated by a user (e.g., by displaying a series of connection instructions, by opening a pairing screen). In some implementations, the override button 238 overrides ESD requirements when activated by a user. For example, if the ESD 110 is connected to the infusion device 102 but the infusion device 102 does not recognize the connection, the user may override the ESD requirements by selecting the override button 238. As another example, if ESD is not available, the user may override the ESD requirements by activating the override button 238.

[0028] In some implementations, the user interface 230 does not include an override button 238. For example, if an ESD must be connected to the infusion pump 102 before infusion therapy (e.g., medically required, legally required), the user interface 230 may not allow the user to start infusion therapy without first connecting an ESD to the infusion pump.

[0029] 2C, user interface 260 indicates that ESD 110 has been disconnected. The illustrated user interface 260 includes a header region 262 configured to display a header notification (e.g., "Error: External Device Disconnected"). User interface 260 also includes an information region 264 configured to display notifications regarding ESD 110. In the illustrated implementation, the notification indicates that ESD 110 has been disconnected, infusion therapy has been paused, and that ESD 110 should be reconnected before therapy can continue.

[0030] User interface 260 also includes a connect button 266 and an override button 268. Connect button 266 and override button 268 may be similar to connect button 236 and override button 238 of user interface 230. For example, connect button 266 may initiate a reconnection to ESD 110 when activated by a user. Additionally, override button 268 may override an ESD requirement or recommendation (e.g., by resuming infusion therapy) when activated by a user. Similar to user interface 230, in some implementations, user interface 260 does not include override button 268 (e.g., when ESD 110 is required).

[0031] FIG. 3 illustrates an exemplary process 300 in accordance with aspects of the present technology. One or more blocks of the process 300 may be performed by one or more computing devices, such as, for example, the infusion device 102. In some implementations, one or more of the blocks may be performed based on one or more machine learning algorithms. In some implementations, one or more of the blocks may be performed by one or more different processors or devices, separate from the other blocks. Furthermore, for purposes of explanation, the blocks of the exemplary process 300 are described as occurring serially or linearly. However, multiple blocks of the exemplary process 300 may occur in parallel. Furthermore, the blocks of the exemplary process 300 need not be performed in the order shown, and one or more of the blocks of the exemplary process 300 need not necessarily be performed.

[0032] As shown, process 300 includes activating (302) an infusion device (e.g., infusion device 102) and a safety indicator sensor. The safety indicator sensor may include an air trap, an air-in-line sensor, a flow detector, a particle detector, a spectral detector, or other sensors for monitoring characteristics of the infusion provided by the infusion device. The infusion device may be configured to control and / or receive data from multiple safety indicator sensors, including other safety indicator sensors not mentioned herein.

[0033] The process 300 also includes operating (304) the infusion device in a default safety mode, which includes monitoring the infusion therapy for compliance with a safety indicator that characterizes the infusion pathway (e.g., including the administration set 126) between the infusion container (e.g., the infusion source 116) and the infusion administration site (e.g., of the patient 106) via a safety indicator sensor. For example, the safety indicator may be an air-in-line indicator, and the safety indicator sensor may be an air-in-line sensor. Thus, monitoring the infusion therapy for compliance with the safety indicator includes collecting air-in-line data from the air-in-line sensor and determining whether the air-in-line data complies with the air-in-line indicator (e.g., an air-in-line safety threshold).

[0034] Additionally, process 300 includes connecting 306 the injection device to an ESD configured to monitor safety metrics. For example, connecting 306 the injection device to the ESD may include plugging the ESD into the injection device (e.g., using wired connection 111). As another example, connecting the injection device to the ESD may include wirelessly connecting the injection device to the ESD (e.g., via Bluetooth, Wi-Fi). As yet another example, connecting the injection device to the ESD may include navigating a series of prompts or instructions (see, e.g., user interfaces 200, 230, and 260).

[0035] Further, process 300 includes determining (308) whether the ESD is monitoring the safety indicator. The determination may be made, for example, by the injection device 102 or the mainframe injection controller 104. Additionally, the determination may be based on receiving a message (or its content) from the ESD. In some implementations, the determination may monitor a message within a specific time interval (e.g., every 5 seconds) or a specific message (e.g., an “ESD connected” message). In response to determining (308-N) that the ESD is not monitoring the safety indicator, process 300 includes operating (304) the injection device according to a default safety mode (e.g., until it is determined that the ESD is monitoring the safety indicator or until another ESD is connected to the injection device).

[0036] However, process 300 includes, in response to determining that ESD is monitoring the safety indicator (308-Y), switching the injection device from operating in a default safety mode to operating in an adjusted safety mode (310). The injection device may not need to monitor the safety indicator while ESD is monitoring the safety indicator. In some implementations, operating in the adjusted safety mode includes suspending the injection device's monitoring of the safety indicator. In some cases, the injection device may reduce the level at which the safety indicator is monitored (e.g., activate the sensor less frequently or use a less resource-intensive analysis algorithm) while ESD is monitoring the safety indicator. In this regard, resources such as energy and computing power may be conserved. The injection device may disable the injection device's use of the safety indicator sensor upon detecting the presence of ESD.

[0037] In some implementations, operating in the adjusted safety mode includes monitoring the infusion therapy for compliance with a safety indicator and collecting safety indicator data via a safety indicator sensor. Furthermore, operating in the adjusted safety mode may include receiving additional safety indicator data from the ESD and determining whether the safety indicator meets a danger threshold based on the safety indicator data and the additional safety indicator data. For example, determining that the safety indicator meets the danger threshold may include determining that the safety indicator data or the additional safety indicator data meets the danger threshold. As another example, determining that the safety indicator meets the danger threshold may include determining that the safety indicator data and the additional safety indicator data meet a second threshold that is different from (e.g., lower than) the danger threshold.

[0038] In some implementations, process 300 includes pausing the infusion therapy in response to determining that the safety indicator meets a danger threshold. For example, pausing the infusion therapy may include displaying a notification indicating that the safety indicator meets a danger threshold. Additionally, the notification may include information regarding data (e.g., data from the infusion device or data from ESD) used in determining that the safety indicator meets the danger threshold (e.g., indicating that a danger was detected by the infusion device or by ESD). Similarly, in some implementations, process 300 includes activating a safety mode of the infusion device in response to determining that the safety indicator meets a danger threshold. For example, the safety mode may include steps to address the danger (e.g., pausing or slowing the infusion therapy, notifying the user, or activating an alarm).

[0039] In some implementations, operating in the default safety mode includes activating an alarm in response to detecting that the safety indicator meets a danger threshold. Accordingly, in some implementations, operating in the adjusted safety mode includes disabling the alarm. For example, as described with respect to the mute button 206 of the user interface 200, if the ESD also includes an alarm, the infusion device may disabling its own alarm. As another example, the infusion device may automatically disable the alarm while operating in the adjusted safety mode. Furthermore, in other implementations, operating in the adjusted safety mode includes activating an alarm in response to detecting that the safety indicator meets an adjusted danger threshold that is different from (e.g., higher than) the danger threshold.

[0040] In some implementations, operating in a default safety mode includes having the safety indicator sensor sample the safety indicator at a default sample rate. Thus, in some implementations, operating in an adjusted safety mode includes having the sensor sample the safety indicator at an adjusted sample rate that is different from the default sample rate. For example, if the ESD is already sampling the safety indicator, the injection device may not need to sample the safety indicator as frequently. This is described in more detail above with respect to the sample button 210 of the user interface 200.

[0041] In some implementations, process 300 also includes determining, based on the connection between the infusion device and the ESD, that the ESD is no longer monitoring the safety indicators (or that the ESD is no longer connected to the infusion device). In response to determining that the ESD is no longer monitoring the safety indicators (or is no longer connected to the infusion device), process 300 includes switching the infusion device from operating in an adjusted safety mode to operating in a default safety mode. In addition to switching to operating in the default mode, process 300 may also include notifying a user that the ESD is no longer monitoring the safety indicators (or is no longer connected to the infusion device). Alternatively, process 300 may include pausing the infusion therapy or informing a user that the ESD is no longer monitoring the safety indicators (or is no longer connected to the infusion device) in response to determining that the ESD is no longer monitoring the safety indicators (or is no longer connected to the infusion device). For an illustration of this, see the above description of user interface 260.

[0042] In some implementations, process 300 further includes receiving, at the infusion device, an infusion request indicating an infusion therapy and an ESD requirement specifying an ESD type. Process 300 may also include receiving, at the infusion device, an ESD type from the ESD. For example, the ESD type may indicate the brand or model of the ESD. As another example, the ESD type may indicate the ESD's safety indicator monitoring capabilities, such as whether the ESD monitors an air-in-line indicator. Accordingly, process 300 may include determining that the ESD type matches the specified ESD type. Furthermore, process 300 may include initiating an infusion therapy at the infusion device in response to determining that the ESD type matches the specified ESD type. For example, some infusion therapies may require a particular type of ESD (e.g., an ESD configured to monitor a particular safety indicator, or an ESD of a particular brand or model).

[0043] In some implementations, the ESD includes an air trap, an air detector, a flow detector, a particle detector, or a spectrum analyzer. Accordingly, in some implementations, the safety indicator includes an air-in-line indicator, a flow indicator, a particle-in-line indicator, or a spectral indicator. As previously described, the safety indicator may measure the quantity or quality of a characteristic of interest, such as air bubbles, flow rate, particle levels, or light. The indicator may be measured at regular intervals or as a time series by sampling values ​​over time. When more than one value is collected for analysis, the indicator may reflect an average, a moving average, a maximum value within a period, a minimum value within a period, correspondence to a threshold range, or the like. Furthermore, in some implementations, determining that the ESD is monitoring the safety indicator includes receiving additional safety indicator data from the ESD, including air-in-line data, flow data, particle-in-line data, or spectral data.

[0044] According to various implementations, data received from the ESD (e.g., regarding safety hazards) is provided to a machine learning model that is used to improve the safety indicator detection capabilities of the infusion device. For example, if the ESD identifies an air-in-line hazard that the infusion device was unable to detect, the machine learning model can be used to improve the detection capabilities of the infusion device (e.g., by adjusting the threshold for when the air-in-line hazard occurs).

[0045] In some implementations, this improvement may be achieved by combining ESD data with infusion device data. For example, a classification model may be trained to identify hazardous conditions based on historical ESD data and contemporaneous infusion device data. Once trained, the model may receive a set or series of values ​​from the ESD data and contemporaneous infusion device data (e.g., a safety index or a measurement derived therefrom) and generate an output indicative of the hazardous condition. The output may identify a specific hazardous condition, a degree of hazard, an alarm level appropriate for the input, and / or a confidence value indicating the likelihood that the modeled output reflects the actual infusion condition. As another example, the infusion device may change the hazard detection algorithm used based on connectivity with an ESD. When an ESD is connected, the infusion device may use a first algorithm to detect hazards based solely on information from the ESD or in combination with data generated by the infusion pump. When an ESD is not connected, the infusion device may use a different algorithm to detect hazards based on data generated by the infusion pump. In this way, resources are saved by utilizing potentially more advanced but resource-intensive algorithms when ESD information is indeed available, and changing to a different, potentially more resource-efficient algorithm when ESD is not available.

[0046] 4A-4C illustrate another exemplary process 400 in accordance with aspects of the present technology. Similar to process 300, one or more blocks of process 400 may be performed by one or more computing devices, such as, for example, infusion device 102. In some implementations, one or more of the blocks may be performed based on one or more machine learning algorithms. In some implementations, one or more of the blocks may be performed by one or more different processors or devices, separate from the other blocks. Furthermore, for purposes of explanation, the blocks of exemplary process 400 are described as occurring serially or linearly. However, multiple blocks of exemplary process 400 may occur in parallel. Furthermore, the blocks of exemplary process 400 need not be performed in the order shown, and one or more of the blocks of exemplary process 400 need not necessarily be performed.

[0047] 4A, process 400 includes receiving 402 infusion parameters. In some implementations, the infusion parameters are received at an infusion device (e.g., infusion device 102). For example, the infusion parameters may include a type of fluid (e.g., medication, saline), a type of IV set (e.g., a specified IV set length), a flow rate (e.g., 50 mL / hr), a total volume to be infused (e.g., 400 mL), an ESD requirement (e.g., a particle sensor ESD requirement), or an ESD recommendation (e.g., an air-in-line ESD recommendation).

[0048] Process 400 also includes determining (404) whether a special safety mode is associated with the infusion parameter. For example, a special safety mode may be associated with an infusion parameter if the infusion parameter poses a potential safety hazard. A high infusion flow rate is one example of an infusion parameter with which a special safety mode may be associated. When an infusion pump operates at a high speed, the likelihood of air entering the infusion line increases. Therefore, a special safety mode associated with a high flow rate may include requiring an ESD (e.g., an air trap ESD) to be connected to the infusion pump before initiating an infusion therapy. A drug that is prone to degradation is another example of an infusion parameter with which a special safety mode may be associated. To prevent particle contamination, a special safety mode may require an ESD (e.g., a particle detection ESD) to be connected to the infusion pump before initiating an infusion therapy of the IV fluid.

[0049] In some implementations, determining whether a special safety mode is associated with an infusion parameter includes determining whether a value or potential value of the infusion parameter (e.g., flow rate) meets a threshold (e.g., exceeds a high flow rate threshold). In some implementations, determining whether a special safety mode is associated with an infusion parameter includes searching a database for the infusion parameter (e.g., a drug susceptible to degradation) and checking whether a programmed special safety mode (e.g., a mode requiring particle detection ESD) is stored in the database and associated with the infusion parameter.

[0050] Process 400 includes initiating (412) an infusion therapy using the infusion module in response to determining (404-N) that a special safety mode is not associated with the infusion parameters. Initiating operation (412) is described in more detail below. Meanwhile, process 400 includes associating (406) with an ESD in response to determining (404-Y) that a special safety mode (e.g., ESD requirements) is associated with the infusion parameters. For example, associating (406) with the ESD may include establishing a physical (e.g., wired) or wireless (e.g., Bluetooth, Wi-Fi) connection with the ESD. Additionally, associating (406) with the ESD may include a handshake mode, security measures, or a verification process.

[0051] Process 400 further includes determining (408) whether the association was successful. Successful association may be based on one or more messages received by the infusion pump from the ESD. In some implementations, the messages may be part of a standards-based association protocol, such as a wireless pairing protocol. Process 400 may include error handling (e.g., notifying a user) if the association is unsuccessful (408-N). On the other hand, process 400 includes adjusting (410) the infusion module (e.g., infusion device 102) or the infusion pump (e.g., infusion pump 136) based on the ESD functionality if the association is successful (408-Y). For example, if the ESD functionality includes air-in-line detection, adjusting the infusion module or infusion pump may include disabling the air-in-line detection feature of the infusion module or infusion pump. For further description of how the infusion device may be modified in response to association with an ESD, see the above description of process 300.

[0052] 4B, process 400 also includes initiating 412 an infusion therapy using the infusion module. For example, initiating 412 an infusion therapy may include initiating the therapy while operating the infusion module or infusion pump according to an adjusted safety mode, as described above with respect to process 300.

[0053] Additionally, process 400 includes determining whether an ESD is associated (414). For example, determining whether an ESD is associated (414) may include performing a handshake with the ESD (e.g., in addition to the handshake performed when initially associating the ESD). As another example, determining whether an ESD is associated (414) may include attempting to send or receive data to or from the ESD.

[0054] Process 400 includes continuing the infusion therapy if it is determined that the ESD is no longer associated with the infusion module or infusion pump (414-N). Additionally, process 400 may include pausing the infusion therapy or notifying the user that the ESD is no longer associated if it is determined that the ESD is no longer associated (414-N). Examples of this are described above with respect to user interface 260.

[0055] However, if it is determined that the ESD is still associated with the infusion module or infusion pump (414-Y), process 400 includes determining whether the association is active (416). For example, an active association may mean that the ESD is actively monitoring (or generating) safety indicators. As another example, an active association may mean that the ESD periodically sends information (e.g., safety indicator data, activity instructions) to the infusion module or infusion pump.

[0056] In response to determining that the association is no longer active (416-N), process 400 includes adjusting the infusion module or infusion pump to activate on-board safety or suspend the infusion (424). Whether the on-board safety mode is activated or the infusion is suspended may depend, for example, on the type of drug being infused, patient demographics (e.g., the patient's medical condition), or other infusion parameters. Further, other adjustment examples are described above with respect to process 300. Alternatively, process 400 includes receiving ESD data from the ESD (418) if it is determined that the association is still active (416-Y). For example, the data may include air-in-line safety indicator data (e.g., number of air bubbles counted, volume of air detected) or particle safety indicator data (e.g., amount of particles detected, size of detected particles, mass of particles). As another example, the data may include a hazard warning (e.g., indicating an air-in-line hazard, a particle-in-line hazard).

[0057] Additionally, process 400 includes generating 420 a safety indicator based on the infusion pump data. In some implementations, the safety indicator is also generated 420 based on the ESD data. For example, if the ESD includes an air-in-line sensor and the ESD includes air-in-line data, generating the safety indicator may include comparing the air-in-line data and the air-in-line data collected by the infusion pump against an air-in-line threshold.

[0058] The process further includes determining whether it is safe to continue the infusion therapy (422). For example, if the safety indicators indicate that an air-in-line risk exists, it may be unsafe to continue the infusion therapy. Thus, in response to determining that it is unsafe to continue (422-N), the process 400 includes adjusting the infusion module of the infusion pump to activate an on-board safety or suspend the infusion therapy (424), as described above. In addition to the above, activating the on-board safety may include issuing an alarm and / or indicating the reason for the alarm (e.g., indicating the type of safety risk, whether the infusion pump or ESD detected a safety risk). However, if it is determined that it is safe to continue the infusion therapy (422-Y), the process 400 includes continuing the infusion therapy (e.g., after ensuring that the ESD is still engaged and notifying the operator that it is safe to continue the infusion therapy).

[0059] Returning to the associating operation (406), FIG. 4C illustrates an example sub-method of method 400, particularly relating to the associating operation (406) and the determination (408) as to whether the association was successful. As shown, the associating operation (406) includes associating (406A) an infusion module and fluid (e.g., medication, saline) with the patient. The associating operation (406) also includes receiving (406B) a message identifying the ESD associated with the patient. For example, an ESD may be associated with the patient if the patient has a medical need (e.g., an allergy to a medication) that requires an ESD.

[0060] Further, the associating operation (406) includes receiving input (406C) to associate the ESD with the infusion module and the medication. Further, the associating operation (406) includes determining (406D) whether the ESD is connectable to the infusion pump. For example, if the ESD requires a physical (e.g., wired) connection, determining (406D) whether the ESD is connectable to the infusion pump may include determining whether the ESD can be physically connected to the infusion pump (e.g., via a particular cable). As another example, determining (406D) whether the ESD is connectable to the infusion pump may include determining whether the ESD can be wirelessly connected to the infusion pump.

[0061] If it is determined (406D-N) that the ESD is not connectable to the infusion pump, the associating operation (406) includes receiving manual confirmation of the association (406H). For example, if the ESD operates independently of the infusion pump (e.g., without handshake, without pairing), the associating operation (406) may include receiving manual confirmation (e.g., from a user) (e.g., at the infusion pump) that the ESD is associated with the infusion pump (e.g., monitoring safety indicators of the infusion therapy performed by the infusion pump). Alternatively, if it is determined (406D-Y) that the ESD is connectable to the infusion pump, the associating operation (406) includes pairing (406E) the ESD with the infusion pump or infusion module (e.g., physically, wirelessly).

[0062] Additionally, the association operation (406) includes determining (406F) whether the infusion pump can automatically confirm association with the ESD. For example, the infusion pump may be able to automatically confirm association with the ESD via a handshake or data exchange. If it is determined (406F-N) that the infusion pump cannot automatically confirm association with the ESD, the association is unsuccessful (i.e., proceeding to 408-N of process 400). However, if it is determined (406F-Y) that the infusion pump can automatically confirm association with the ESD, the association operation (406) further includes determining (406G) whether the association is confirmed. If the association is confirmed (406G-Y), the association is successful (i.e., proceeding to 408-Y of process 400); otherwise (406G-N), the association is unsuccessful (i.e., proceeding to 408-N).

[0063] FIG. 5 is a conceptual diagram illustrating an exemplary electronic system 500 in accordance with aspects of the present technology. The electronic system 500 may be implemented by a computing device for executing software associated with portions or steps of processes 300 and 400 or the components and methods provided by FIGS. 1-4. In this regard, the electronic system 500 may include the infusion device 102. The electronic system 500 may include a specially configured personal computer or a mobile device for infusion, such as a smartphone, tablet computer, laptop, PDA, augmented reality device, wearable such as a watch or band or glasses, or a combination thereof, or other touch screen or television incorporating or coupled with one or more processors, or any other computer-related electronic device with network connectivity.

[0064] The electronic system 500 may include various types of computer-readable media and interfaces for various other types of computer-readable media. In the illustrated example, the electronic system 500 includes a bus 508, a processing unit 512, a system memory 504, a read-only memory (ROM) 510, a persistent storage device 502, an input device interface 514, an output device interface 506, and a network interface 516. In some implementations, the electronic system 500 may include or be integrated with other computing devices or circuits for operation of the various components and methods described above.

[0065] Bus 508 collectively refers to all system, peripheral, and chipset buses that communicatively connect the various internal devices of electronic system 500. For example, bus 508 communicatively connects processing unit 512 to ROM 510, system memory 504, and persistent storage device 502.

[0066] Processing unit 512 retrieves instructions to execute and data to process from these various memory units in order to perform the processes of the present disclosure. Processing unit 512 can be a single processor or a multi-core processor in different implementations.

[0067] The ROM 510 stores static data and instructions required by the processing unit 512 and other modules of the electronic system. The persistent storage device 502, on the other hand, is a read-write memory device. This device is a non-volatile memory unit that stores instructions and data even when the electronic system 500 is powered off. Some implementations of the present disclosure use mass storage devices (such as magnetic or optical disks and their corresponding disk drives) as the persistent storage device 502. Other implementations use removable storage devices (such as floppy disks, flash drives, and their corresponding disk drives) as the persistent storage device 502.

[0068] Like the persistent storage device 502, the system memory 504 is a read-and-write memory device. However, unlike the storage device 502, the system memory 504 is a volatile read-and-write memory, such as random-access memory (RAM). The system memory 504 stores some of the instructions and data needed by the processor during execution. In some implementations, the processes of the present disclosure are stored in the system memory 504, the persistent storage device 502, and / or the ROM 510. The processing unit 512 retrieves instructions to execute and data to process from these various memory units in order to execute the processes of some implementations.

[0069] Bus 508 also connects to input device interface 514 and output device interface 506. Input device interface 514 allows a user to communicate information and selected commands to the electronic system. Input devices used with input device interface 514 include, for example, an alphanumeric keyboard and a pointing device (also called a "cursor control device"). Output device interface 506 allows, for example, the display of images generated by electronic system 500. Output devices used with output device interface 506 include, for example, a printer and a display device such as a cathode ray tube (CRT) or a liquid crystal display (LCD). Some implementations include devices that function as both input and output devices (e.g., a touchscreen).

[0070] Additionally, bus 508 also couples electronic system 500 to a network (not shown) via network interface 516. Network interface 516 may include, for example, a wireless access point (e.g., Bluetooth or Wi-Fi) or radio circuitry for connecting to a wireless access point. Network interface 516 may also include hardware (e.g., Ethernet hardware) for connecting the computer to a network of computers, such as a local area network (LAN), a wide area network (WAN), a wireless LAN, an intranet, or part of a network of networks, such as the Internet. Any or all components of electronic system 500 can be used in conjunction with the present disclosure if specifically configured to have one or more of the described functions.

[0071] These functions described above may be implemented in computer software, firmware, or hardware. The techniques may be implemented using one or more computer program products. The programmable processor and programmable computer may be included in or packaged as a mobile device. Processes and logic flows may be executed by one or more programmable processors and by programmable logic circuitry. General-purpose and special-purpose computing and storage devices may be interconnected via a communications network.

[0072] Some implementations include electronic components such as a microprocessor, storage, and memory that store computer program instructions in a machine-readable or computer-readable medium (also called a computer-readable storage medium, machine-readable medium, or machine-readable storage medium). Some examples of such computer-readable media include RAM, ROM, read-only compact discs (CD-ROMs), recordable compact discs (CD-Rs), rewritable compact discs (CD-RWs), read-only digital versatile discs (e.g., DVD-ROMs, dual-layer DVD-ROMs), various recordable / rewritable DVDs (e.g., DVD-RAMs, DVD-RWs, DVD+RWs, etc.), flash memory (e.g., SD cards, mini-SD cards, micro-SD cards, etc.), magnetic and / or solid-state hard drives, read-only and recordable Blu-Ray® discs, ultra-high density optical discs, other optical or magnetic media, and floppy disks. A computer-readable medium can store a computer program executable by at least one processing unit and including a set of instructions for performing various operations. Examples of computer programs or computer code include machine code, such as produced by a compiler, and files containing higher-level code that are executed by a computer, electronic component, or microprocessor using an interpreter.

[0073] Although the above description primarily refers to microprocessors or multi-core processors executing software, some implementations are performed by one or more integrated circuits, such as application specific integrated circuits (ASICs) or field programmable gate arrays (FPGAs). In some implementations, such integrated circuits execute instructions stored on the circuitry itself.

[0074] As used herein and in any claims of this application, the terms "computer," "server," "processor," and "memory" all refer to an electronic or other technological device specifically configured to have one or more of the above functions. These terms exclude a person or group of people. For purposes of this specification, the terms "display" or "displaying" mean displaying on an electronic device. As used herein and in any claims of this application, the terms "computer-readable medium" and "computer-readable media" are strictly limited to tangible, physical objects that store information in a form readable by a computer. These terms exclude wireless signals, wired download signals, and any other transitory signals.

[0075] To provide for user interaction, implementations of the subject matter described herein may be implemented on a computer having a display device, e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor, for displaying information to the user, and a keyboard and pointing device, e.g., a mouse or trackball, by which the user can provide input to the computer. Other types of devices may also be used to provide for user interaction. For example, feedback provided to the user may be any form of sensory feedback (e.g., visual feedback, auditory feedback, haptic feedback), and input from the user may be received in the form of acoustic input, speech input, gesture input, or tactile input, etc. Additionally, the computer may interact with the user by sending and receiving documents to and from devices used by the user (e.g., by sending a web page to a web browser on the user's client device in response to a request received from the web browser).

[0076] Implementations of the subject matter described herein may be implemented in a specially configured computing system that includes back-end components (e.g., data servers), or includes specially configured middleware components (e.g., application servers), or includes specially configured front-end components (e.g., a client computer having a graphical user interface or web browser that allows a user to interact with an implementation of the subject matter described herein), or any combination of one or more such back-end, middleware, or front-end components. The components of the system may be interconnected by one or more forms or media of digital data communication, such as a communications network. Examples of communications networks include LANs and WANs, internetworks (e.g., the Internet), and peer-to-peer networks (e.g., ad hoc peer-to-peer networks).

[0077] A computing system may include specially configured clients and servers. Clients and servers are generally remote from each other and may interact through a communications network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other. In some implementations, a server sends data (e.g., HTML pages) to client devices (e.g., to display the data to and receive user input from a user interacting with the client device). Data generated at the client device (e.g., the result of user interaction) may be received from the client device by the server.

[0078] Those skilled in the art will understand that the various illustrative blocks, modules, elements, components, methods, and algorithms described herein may be implemented as electronic hardware, computer software, or a combination thereof. To illustrate this interchangeability of hardware and software, the various illustrative blocks, modules, elements, components, methods, and algorithms have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends on the particular application and design constraints imposed on the overall system. The described functionality may be implemented in various ways for each particular application. The various components and blocks may be arranged differently (e.g., arranged in a different order or divided in a different way), all without departing from the scope of the present technology.

[0079] It is understood that the specific order or hierarchy of steps in the processes disclosed is a description of example approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Some of the steps may be performed simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not intended to be limited to the specific order or hierarchy presented.

[0080] Examples of clauses of this technology: Various examples of aspects of the present disclosure are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and are not intended to limit the present technology. Figure and reference number identification is provided below for illustration and explanation purposes only, and the clauses are not limited by those identifications.

[0081] Clause 1. An infusion device comprising a safety indicator sensor, a processor, and a non-transitory computer-readable storage medium storing instructions, which, when executed by the processor, cause the infusion device to: operate in a default safety mode, including monitoring an infusion therapy for compliance with a safety indicator characteristic of an infusion pathway between an infusion container and an infusion administration site via the safety indicator sensor; connect to an external safety device ("ESD") configured to monitor the safety indicator while operating in the default safety mode; determine, based on the connection with the ESD, that the ESD is monitoring the safety indicator; and, in response to determining that the ESD is monitoring the safety indicator, switch from operation in the default safety mode to operation in an adjusted safety mode, wherein operation in the adjusted safety mode includes suspending monitoring of the infusion therapy for compliance with the safety indicator via the safety indicator sensor or monitoring the infusion therapy for compliance with the safety indicator via the ESD.

[0082] Clause 2. The injection device of clause 1, wherein the non-transitory computer-readable storage medium further stores instructions that, when executed by a processor, cause the injection device to determine that the ESD is no longer monitoring a safety indicator based on a connection (e.g., lack of connection) with the ESD, and, in response to determining that the ESD is no longer monitoring the safety indicator, switch from operating in an adjusted safety mode to operating in a default safety mode.

[0083] Clause 3. An injection device as described in clause 1 or 2, wherein the non-transitory computer-readable storage medium further stores instructions that, when executed by a processor, cause the injection device to receive injection parameters, determine based on characteristics of the injection parameters that the injection therapy should be monitored via an ESD, and prompt a user of the injection device to connect an ESD to the injection device.

[0084] Clause 4. An injection device as described in any one of clauses 1 to 3, wherein operation in the adjusted safety mode includes monitoring the injection therapy for compliance with a safety indicator, collecting safety indicator data via a safety indicator sensor, receiving additional safety indicator data from the ESD, and determining whether the safety indicator meets a danger threshold based on the safety indicator data and the additional safety indicator data.

[0085] Clause 5. The infusion device of clause 4, wherein operating in the adjusted safety mode further includes pausing the infusion therapy or activating a safety mode of the infusion device in response to determining that the safety indicator meets a danger threshold.

[0086] Clause 6. An injection device as described in any one of clauses 1 to 5, wherein operation in the default safety mode includes activating an alarm in response to detecting that a safety indicator meets a danger threshold, and operation in the adjusted safety mode includes deactivating the alarm.

[0087] Clause 7. An injection device as described in any one of clauses 1 to 5, wherein operation in a default safety mode includes activating an alarm in response to detecting that a safety indicator meets a danger threshold, and operation in an adjusted safety mode includes activating an alarm in response to detecting that a safety indicator meets an adjusted danger threshold that is different from the danger threshold.

[0088] Clause 8. An injection device as described in any one of clauses 1 to 7, wherein operation in a default safety mode includes causing the safety indicator sensor to sample the safety indicator at a default sample rate, and operation in an adjusted safety mode includes causing the safety indicator sensor to sample the safety indicator at an adjusted sample rate that is different from the default sample rate.

[0089] Clause 9. An injection device as described in any one of clauses 1 to 8, wherein the non-transitory computer-readable storage medium further stores instructions that, when executed by a processor, cause the injection device to perform the following: receive an injection request instructing an injection therapy and an ESD requirement specifying a type of ESD; receive an ESD type from the ESD; determine that the ESD type matches the specified ESD type; and initiate the injection therapy in response to determining that the ESD type matches the specified ESD type.

[0090] Clause 10. An injection device described in any one of clauses 1 to 9, wherein the ESD includes an air trap, an air detector, a flow detector, a particle detector, or a spectral analyzer, and the safety indicator includes an in-line air indicator, a flow indicator, an in-line particle indicator, or a spectral indicator, and determining that the ESD is monitoring the safety indicator includes receiving additional safety indicator data from the ESD including in-line air data, flow data, in-line particle data, or spectral indicator data.

[0091] Clause 11. A computer-implemented method comprising the steps of: activating an infusion device and a safety indicator sensor; operating the infusion device in a default safety mode, wherein operation in the default safety mode includes monitoring the infusion therapy for compliance with a safety indicator characteristic of an infusion pathway between an infusion container and an infusion administration site via the safety indicator sensor; connecting the infusion device to an external safety device ("ESD") configured to monitor the safety indicator while operating the infusion device in the default safety mode; determining, based on the connection with the ESD, that the ESD is monitoring the safety indicator; and, in response to determining that the ESD is monitoring the safety indicator, switching the infusion device from operation in the default safety mode to operation in an adjusted safety mode, wherein operation in the adjusted safety mode includes suspending monitoring of the infusion therapy for compliance with the safety indicator via the safety indicator sensor or monitoring the infusion therapy for compliance with the safety indicator via the ESD.

[0092] Clause 12. The computer-implemented method of clause 11, further comprising: determining that the ESD is no longer monitoring the safety indicator based on a connection (e.g., lack of connection) between the injection device and the ESD; and, in response to determining that the ESD is no longer monitoring the safety indicator, switching the injection device from operating in an adjusted safety mode to operating in a default safety mode.

[0093] Clause 13. The computer-implemented method of clause 11 or 12, further comprising the steps of receiving injection parameters, determining based on characteristics of the injection parameters that the injection therapy should be monitored via an ESD, and prompting a user of the injection device to connect an ESD to the injection device.

[0094] Clause 14. The computer-implemented method of any one of clauses 11 to 13, wherein operating in the adjusted safety mode includes monitoring the infusion therapy for compliance with a safety indicator, collecting safety indicator data via a safety indicator sensor, receiving additional safety indicator data from the ESD, and determining whether the safety indicator meets a danger threshold based on the safety indicator data and the additional safety indicator data.

[0095] Clause 15. The computer-implemented method of clause 14, wherein operating in the adjusted safety mode further comprises pausing the infusion therapy or activating a safety mode of the infusion device in response to determining that the safety indicator meets a danger threshold.

[0096] Clause 16. The computer-implemented method of any one of clauses 11 to 15, wherein operation in the default safety mode includes activating an alarm in response to detecting a safety metric meeting a danger threshold, and operation in the adjusted safety mode includes disabling the alarm.

[0097] Clause 17. The computer-implemented method of any one of clauses 11 to 15, wherein operation in the default safety mode includes issuing an alarm in response to detecting that the safety indicator meets a danger threshold, and operation in the adjusted safety mode includes issuing an alarm in response to detecting that the safety indicator meets an adjusted danger threshold that is different from the danger threshold.

[0098] Clause 18. The computer-implemented method of any one of clauses 11 to 17, wherein operating in the default safety mode includes causing the safety indicator sensor to sample the safety indicator at a default sample rate, and operating in the adjusted safety mode includes causing the safety indicator sensor to sample the safety indicator at an adjusted sample rate that is different from the default sample rate.

[0099] Clause 19. The computer-implemented method of any one of clauses 11 to 18, further comprising the steps of: receiving, at the injection device, an injection request indicating an injection therapy and an ESD requirement specifying an ESD type; receiving, at the injection device, an ESD type from the ESD; determining that the ESD type matches the specified ESD type; and initiating injection therapy at the injection device in response to determining that the ESD type matches the specified ESD type.

[0100] Clause 20. The computer-implemented method of any one of clauses 11 to 19, wherein the ESD includes an air trap, an air detector, a flow detector, a particle detector, or a spectral analyzer, and the safety indicator includes an in-line air indicator, a flow indicator, an in-line particle indicator, or a spectral indicator, and determining that the ESD is monitoring the safety indicator includes receiving additional safety indicator data from the ESD, the additional safety indicator data including in-line air data, flow data, in-line particle data, or spectral indicator data.

[0101] Further considerations: It is understood that the specific order or hierarchy of steps in the processes disclosed is a description of example approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Some of the steps may be performed simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not intended to be limited to the specific order or hierarchy presented.

[0102] The foregoing description is provided to enable any person skilled in the art to practice the various aspects described herein. The foregoing description provides various examples of the technology, and the technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

[0103] Accordingly, the claims are not limited to the embodiments set forth herein, but are to be accorded the full scope consistent with the language of the claims. For example, reference to an element in the singular is intended to mean "one or more," not "one," unless otherwise specified. Further, the term "some" refers to one or more, unless otherwise specified. Masculine pronouns (e.g., his) include feminine and neuter forms (e.g., her and its), and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention(s) described herein.

[0104] The terms "configured to," "operable to," and "programmed to" do not imply any particular tangible or intangible modification of the subject matter, but rather are intended to be used interchangeably. For example, a processor configured to monitor and control operations or components may also mean that the processor is programmed to monitor and control operations or that the processor is operable to monitor and control operations. Similarly, a processor configured to execute code may be interpreted as a processor programmed to execute code or operable to execute code.

[0105] As used herein, the term "automatic" may include performance by a computer or machine without user intervention, e.g., by instructions in response to a predicated action by a computer or machine or other initiation mechanism. The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs.

[0106] The use of a phrase such as "aspect" does not imply that such aspect is essential to the technology or that such aspect applies to all configurations of the technology. Disclosure regarding an aspect may apply to all configurations or one or more configurations. An aspect may provide one or more examples. A phrase such as "aspect" may refer to one or more aspects, and vice versa. A phrase such as "implementation" does not imply that such implementation is essential to the technology or that such implementation applies to all configurations of the technology. Disclosure regarding an implementation may apply to all implementations or one or more implementations. An implementation may provide one or more examples. A phrase such as "implementation" may refer to one or more implementations, and vice versa. A phrase such as "configuration" does not imply that such configuration is essential to the technology or that such configuration applies to all configurations of the technology. Disclosure regarding a configuration may apply to all configurations or one or more configurations. A configuration may provide one or more examples. A phrase such as "a configuration" may refer to one or more configurations, and vice versa.

[0107] As used herein, a "user interface" (also referred to as an interactive user interface, graphical user interface, or UI) may refer to a network-based interface that includes data fields or other control elements for receiving input signals or providing electronic information, or for providing information to a user in response to any received input signals. Control elements may include dials, buttons, icons, selectable areas, or other recognizable indicators presented via the UI that, when interacted with (e.g., clicked, touched, selected, etc.), initiate a data exchange for the device presenting the UI. A UI may be implemented in whole or in part using technologies such as hyper-text markup language (HTML), FLASH™, JAVA™, .NET™, C, C++, web services, or rich site summaries (RSS). In some implementations, a UI may be included in a standalone client (e.g., a thick client, a fat client) configured to communicate (e.g., send or receive data) according to one or more of the described aspects. The communication may be between the medical devices or a server in communication therewith.

[0108] As used herein, the terms "determine" or "determining" encompass a wide variety of actions. For example, "determining" may include calculating, computing, processing, deriving, generating, obtaining, looking up (e.g., looking up in a table, database, or another data structure), ascertaining, etc., via a hardware element without user intervention. Also, "determining" may include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), etc., via a hardware element without user intervention. "Determining" may include resolving, selecting, choosing, establishing, etc., via a hardware element without user intervention.

[0109] As used herein, the terms "providing" or "providing" encompass a wide variety of actions. For example, "providing" may include storing a value at a location on a storage device for later retrieval, transmitting a value directly to a recipient via at least one wired or wireless communication medium, transmitting or storing a reference to a value, etc. "Providing" may also include encoding, decoding, encrypting, decrypting, verifying, verifying, etc. via a hardware element.

[0110] As used herein, the term "message" encompasses a wide variety of formats for communicating (e.g., sending or receiving) information. A message may include a collection of machine-readable information, such as an XML document, a fixed-field message, a comma-separated message, JSON, a custom message, etc. A message, in some implementations, may include a signal utilized to transmit one or more representations of information. While stated in the singular, it is understood that a message may be created, sent, stored, received, etc., in multiple parts.

[0111] As used herein, the terms "selectively" or "selective" encompass a wide variety of actions. For example, a "selective" process may include determining one option from multiple options. A "selective" process may include one or more dynamically determined, pre-configured, or user-initiated inputs for making the decision. In some implementations, an n-input switch may be included to provide selective functionality, where n is the number of inputs used to make the selection.

[0112] As used herein, the terms "correspond" or "corresponding" encompass a structural, functional, quantitative, and / or qualitative correlation or relationship between two or more objects, data sets, information, etc., and preferably, the correspondence or relationship may be used to render one or more of the two or more objects, data sets, information, etc., so that they appear identical or equivalent. Correspondence may be evaluated using one or more of thresholds, value ranges, fuzzy logic, pattern matching, machine learning evaluation models, or combinations thereof.

[0113] In some implementations, generated or detected data can be transferred to a “remote” device or location, where “remote” means a location or device other than the location or device where the program is executed. For example, a remote location could be another location in the same city (e.g., an office, a lab, etc.), another location in a different city, another location in a different state, or another location in a different country. Thus, when an item is described as being “remote” from another item, this means that the two items may be in the same room but apart, or at least in different rooms or different buildings, and that the two items may be at least 1 mile, 10 miles, or at least 100 miles apart. “Communicating” information refers to transmitting data representing that information as electrical signals over a suitable communications channel (e.g., a private or public network). "Transmitting" an item refers to any means of moving the item from one location to another, whether by physically transporting the item or (if possible) otherwise, and includes, at least in the case of data, physically transporting the medium carrying the data or communicating that data. Examples of communication media include radio or infrared transmission channels, as well as network connections to another computer or networked device, and the Internet, or the transmission of email, information stored on a website, etc.

Claims

1. a safety indicator sensor; a processor; a non-transitory computer-readable storage medium storing instructions; wherein the instructions, when executed by the processor, operating in a default safety mode, the default safety mode including monitoring, via the safety indicator sensor, an infusion therapy for conformance with a safety indicator characteristic of an infusion pathway between an infusion container and an infusion administration site; connecting an external safety device ("ESD") configured to monitor the safety indicator while operating in the default safety mode; determining, based on the connection with the ESD, that the ESD is monitoring the safety indicator; and switching from operating in the default safety mode to operating in an adjusted safety mode in response to determining that the ESD is monitoring the safety indicator, wherein operating in the adjusted safety mode comprises: suspending monitoring of the infusion therapy for compliance with the safety indicator via the safety indicator sensor; or monitoring the infusion therapy for compliance with the safety parameters via the ESD; Including switching and The injection device causes the injection device to perform the steps of:

2. The non-transitory computer-readable storage medium, when executed by the processor, determining, based on the connection with the ESD, that the ESD is no longer monitoring the safety indicator; switching from operating in the adjusted safety mode to operating in the default safety mode in response to determining that the ESD is no longer monitoring the safety indicator; The injection device of claim 1 , further storing instructions that cause the injection device to perform the following:

3. The non-transitory computer-readable storage medium, when executed by the processor, receiving injection parameters; determining, based on the characteristics of the injection parameter, that the injection therapy should be monitored via the ESD; prompting a user of the injection device to connect the ESD to the injection device; 3. The injection device of claim 1, further comprising instructions for causing the injection device to perform the following:

4. said adjusted safety mode operation comprising: monitoring said infusion therapy for compliance with said safety parameters; collecting safety indicator data via the safety indicator sensor of the infusion device; receiving additional safety indicator data from the ESD; and determining whether the safety index meets a danger threshold based on the safety index data and the additional safety index data; 4. An injection device according to claim 1, comprising:

5. operating in the adjusted safety mode in response to determining that the safety metric meets the danger threshold; Suspending infusion therapy, or activating a safety mode of the infusion device. The injection device of claim 4 further comprising:

6. operating in the default safety mode includes issuing an alarm in response to detecting that the safety metric meets a danger threshold; 6. An injection device according to claim 1, wherein operating in the adjusted safety mode comprises disabling the alarm.

7. operating in the default safety mode includes issuing an alarm in response to detecting that the safety metric meets a danger threshold; 6. The injection device of claim 1, wherein operation in the adjusted safety mode includes activating an alarm in response to detecting that the safety indicator meets an adjusted danger threshold that is different from the danger threshold.

8. operating in the default safety mode includes causing the safety indicator sensor of the infusion device to sample the safety indicator at a default sample rate; 8. The injection device of claim 1, wherein operating in the adjusted safety mode comprises causing the safety indicator sensor to sample the safety indicator at an adjusted sample rate that is different from the default sample rate.

9. The non-transitory computer-readable storage medium, when executed by the processor, receiving an infusion request indicating an infusion therapy and an ESD requirement specifying a type of ESD; receiving the ESD type from the ESD; determining that the type of ESD matches the specified ESD type; initiating the infusion therapy in response to determining that the type of ESD matches the specified ESD type.

9. An injection device according to claim 1, further comprising instructions for causing the injection device to perform the following:

10. the ESD comprises an air trap, an air detector, a flow detector, a particle detector, or a spectrum analyzer; the safety index comprises an air-in-line index, a flow index, an in-line particle index, or a spectral index; 10. The injection device of claim 1, wherein determining that the ESD is monitoring the safety indicator comprises receiving additional safety indicator data from the ESD, including in-line air data, flow data, in-line particle data, or spectral indicator data.

11. activating the infusion device and the safety indicator sensor; operating the infusion device in a default safety mode, the default safety mode operation including monitoring, via the safety indicator sensor, an infusion therapy for compliance with a safety indicator characteristic of an infusion pathway between an infusion container and an infusion administration site; connecting the injection device to an external safety device ("ESD") configured to monitor the safety parameters while operating the injection device in the default safety mode; determining, based on the connection with the ESD, that the ESD is monitoring the safety indicator; in response to determining that the ESD is monitoring the safety indicator, switching the injection device from operating in the default safety mode to operating in an adjusted safety mode, wherein operating in the adjusted safety mode comprises: suspending monitoring of the infusion therapy for compliance with the safety indicator via the safety indicator sensor; or monitoring the infusion therapy for compliance with the safety parameters via the ESD; Including steps and 20. A computer-implemented method comprising:

12. determining, based on the connection between the injection device and the ESD, that the ESD is no longer monitoring the safety indicator; in response to determining that the ESD is no longer monitoring the safety indicator, switching the injection device from operating in the adjusted safety mode to operating in the default safety mode. The computer-implemented method of claim 11 further comprising:

13. receiving injection parameters; determining, based on the characteristics of the injection parameters, that the injection therapy should be monitored via the ESD; prompting a user of the injection device to connect the ESD to the injection device; 13. The computer-implemented method of claim 11 or 12, further comprising:

14. said adjusted safety mode operation comprising: monitoring said infusion therapy for compliance with said safety parameters; collecting safety indicator data via the safety indicator sensor; receiving additional safety indicator data from the ESD; and determining whether the safety index meets a danger threshold based on the safety index data and the additional safety index data; 14. The computer-implemented method of any one of claims 11 to 13, comprising:

15. operating in the adjusted safety mode in response to determining that the safety metric meets the danger threshold; Suspending infusion therapy, or activating a safety mode of the infusion device. The computer-implemented method of claim 14 further comprising:

16. operating in the default safety mode includes issuing an alarm in response to detecting that the safety metric meets a danger threshold; 16. The computer-implemented method of claim 11, wherein operating in the adjusted safety mode includes disabling the alarm.

17. operating in the default safety mode includes issuing an alarm in response to detecting that the safety metric meets a danger threshold; 16. The computer-implemented method of claim 11, wherein operating in the adjusted safety mode includes issuing an alarm in response to detecting that the safety indicator meets an adjusted danger threshold that is different from the danger threshold.

18. operating in the default safety mode includes causing the safety indicator sensor to sample the safety indicator at a default sample rate; operating in the adjusted safety mode includes causing the safety indicator sensor to sample the safety indicator at an adjusted sample rate that is different from the default sample rate.

18. A computer-implemented method according to any one of claims 11 to 17.

19. receiving, at the infusion device, an infusion request indicating an infusion therapy and an ESD requirement specifying a type of ESD; receiving, at the injection device, the type of ESD from the ESD; determining that the type of ESD matches the specified ESD type; initiating the infusion therapy at the infusion device in response to determining that the type of ESD matches the specified ESD type; 19. The computer-implemented method of claim 11, further comprising:

20. the ESD comprises an air trap, an air detector, a flow detector, a particle detector, or a spectrum analyzer; the safety index comprises an air-in-line index, a flow index, an in-line particle index, or a spectral index; 20. The computer-implemented method of claim 11, wherein determining that the ESD is monitoring the safety indicator comprises receiving additional safety indicator data from the ESD, including in-line air data, flow data, in-line particle data, or spectral indicator data.

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