Hemodynamic management systems, devices and methods
By integrating infusion therapy information with physiological and hemodynamic data, the system addresses the challenges of complex data access and interpretation in current hemodynamic management systems, enabling more effective and efficient clinical decision-making.
Patent Information
- Application Number
- JP2024568068
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-05-18
- Filing Date
- 2023-05-18
- Publication Date
- 2025-06-05
AI Technical Summary
Current hemodynamic management systems face challenges in early detection of threats to favorable clinical outcomes due to complex and non-integrated point-of-care systems, leading to inefficient manual clinical tasks and difficulties in accessing and interpreting relevant data.
The system integrates infusion therapy information with physiological and hemodynamic data to provide a real-time or near real-time display at the patient's bedside, offering a comprehensive hemodynamic assessment and automated clinical decision support.
This integration enables clinicians to make more informed decisions by providing a unified view of patient data, reducing the burden of manual tasks, and enhancing the detection and management of hemodynamic instability.
Smart Images

Figure 2025517324000001_ABST
Abstract
Description
[Background technology]
[0001] Hemodynamics refers to the fluid dynamics of blood flow in a patient. In a normal circulatory system, the volume of blood returning to a patient's heart is approximately equal to the volume pumped. Hemodynamic monitoring detects when there is an imbalance between the volume of blood pumped and the volume of blood returned to the patient's heart. This monitoring is important for diagnosing cardiovascular disorders, post-operative trauma, sepsis, respiratory failure, and neurological injuries. Hemodynamic health is determined by several patient parameters, including blood pressure or mean arterial pressure ("MAP"), heart rate, arterial oxygen saturation ("SpO2"), body temperature, and / or fluid responsiveness. Other parameters of hemodynamic health that may be monitored or calculated include blood flow velocity, cardiac output ("CO"), arterial pressure, peripheral, total, or systemic vascular resistance ("SVR"), turbulence, wall tension, stroke volume ("SV"), stroke volume variation ("SVV"), and pulse pressure variation ("PPV").
[0002] In hemodynamically unstable patients, there is an imbalance in the volume of blood flowing into and out of the heart. This can result in a dramatic increase or decrease in blood pressure. This can lead to an increased or decreased heart rate, sepsis, or even respiratory problems. In many cases, hemodynamic instability during treatment can prolong or complicate recovery, lead to more serious health conditions, or even cause death. Thus, hemodynamic stability is often a critical goal for clinicians working in intensive care units ("ICUs").
[0003] While caring for hemodynamically unstable patients, clinicians are presented with a complex environment that does not foster early detection of threats to favorable clinical outcomes. Often, clinicians struggle to access and interpret relevant data points for clinical decision making. Even when accessed, relevant data can only be obtained through cumbersome, non-integrated point-of-care ("POC") systems that contain disparate data points. Coupling this unfavorable data access situation with a shortage of skilled clinicians and lack of standardization creates challenges in care coordination and delivery. This is especially true regarding hemodynamic therapy, where there are complex and highly taxing patient conditions that require rapid and accurate responses to address hemodynamic instability. Known systems require the use of highly inefficient, manual clinical tasks that must first be completed to hemodynamically stabilize the patient. Summary of the Invention [Means for solving the problem]
[0004] Exemplary systems, methods, and devices for hemodynamic management are disclosed. The exemplary systems, methods, and devices are configured to merge infusion therapy information with physiological and hemodynamic information into a single display device located at the patient's bedside. In some cases, the physiological information may include dialysis information, or other information indicative of fluids removed from the patient. Thus, the systems, methods, and devices provide hemodynamic information regarding the patient's net fluid balance in real time or near real time.
[0005] Exemplary systems, methods, and devices may also be configured to provide hemodynamic assessment that is integrated with infusion therapy information, physiological information, and hemodynamic information shown on a single display device. The hemodynamic assessment provides an indication of the patient's fluid responsiveness by inducing a reversible increase in cardiac preload. Displaying information related to hemodynamic assessment along with infusion therapy information, physiological information, and hemodynamic information provides a better clinician experience by integrating important patient information into one display device. Merging this information also allows the display device to execute one or more algorithms or protocols to provide automated clinical decision support. In comparison to known electronic medical record ("EMR") systems that are repositories of patient health information, the systems, methods, and devices disclosed herein are configured to provide real-time or near real-time personalized hemodynamic specific management and corresponding clinical decision support.
[0006] In some embodiments, the exemplary systems, methods, and devices are configured to manage the mapping of one or more infusion therapies to a patient's intravenous infusion sites. The systems, methods, and devices use a drug library file that specifies incompatibilities between drugs and / or drug access site types to determine when a planned infusion therapy may be harmful to the patient. The systems, methods, and devices may generate alerts indicating which drugs are incompatible and / or which drugs for an infusion site are incompatible. In some embodiments, the systems, methods, and devices may recommend one or more alternative infusion sites.
[0007] Aspects of the subject matter described herein may be useful alone or in combination with one or more other aspects described herein. Without limiting the foregoing, in a first aspect of the present disclosure, a hemodynamic management device includes a display interface screen, a memory device storing a patient identifier, and a processor communicatively coupled to the display interface screen and the memory device. The processor is configured to access a patient medical record in an electronic medical record database using the patient identifier and determine from the patient medical record a new infusion start event associated with an infusion pump fluidly connected to a patient corresponding to the patient medical record. The new infusion start event includes information indicating an infusion pump identifier, a name of the fluid to be infused, an infusion rate, a volume to be infused, a dose, a remaining volume, and a time when the new infusion start event was generated by the infusion pump. The processor is also configured to cause the display interface screen to display an infusion line mapping interface showing a graphical illustration of the human body and potential access sites, and to prompt for selection of an access site within the infusion line mapping interface. The processor is further configured to associate, in the memory device after receiving the selection of the access site, the infusion pump identifier with the selected access site. Additionally, the processor is configured to cause the display interface screen to display at least a portion of the information associated with the new infusion start event along with the selected access site shown in the infusion line mapping interface.
[0008] According to a second aspect of the disclosure, which may be used in combination with the first aspect, the memory device is configured to store a drug library that specifies incompatibilities between fluid types and access site types. Furthermore, the processor is further configured to, after receiving a selection of an access site, perform a check for fluid type and access site incompatibilities between the selected access site and the infused fluid name, and if there is an incompatibility, display a warning within the infusion line mapping interface and provide a prompt to change the access site for the infused fluid name associated with the infusion pump, and, after receiving a selection of a second access site, remove the warning and display at least a portion of the information associated with the new infusion start event with the selected second access site.
[0009] According to a third aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the processor is further configured to use the drug library to determine a compatible access site based on a fluid name to be infused, and cause the infusion line mapping interface to display a recommendation for fluidly connecting the infusion pump to the determined compatible access site.
[0010] According to a fourth aspect of the disclosure, which may be used in combination with any one or more of the preceding aspects, the processor is further configured to determine, from the patient medical record, a second new infusion start event associated with a second infusion pump fluidly connected to a patient corresponding to the patient medical record. The second new infusion start event includes information indicating a second infusion pump identifier, a second infused fluid name, a second dose, a second infusion rate, a second volume to be infused, a second remaining volume, and a second time at which the second new infusion start event was generated by the second infusion pump. The processor is also configured to cause the display interface screen to display an infusion line mapping interface, prompt a selection of a second access site within the infusion line mapping interface, and, after receiving the selection of the second access site, cause the display interface screen to display at least a portion of the second information associated with the second new infusion start event along with the selected second access site.
[0011] According to a fifth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the memory device is configured to store a drug library that specifies incompatibilities between fluid types for the access site. Furthermore, the processor is further configured to, after receiving a selection of the second access site, perform a check for incompatibilities between fluid types between the infused fluid name and the second infused fluid name, and if there is an incompatibility, display a warning within the infusion line mapping interface and provide a prompt to change the access site for the second infused fluid name associated with the second infusion pump, and, after receiving a selection of a third access site, remove the warning and display at least a portion of the second information associated with the second new infusion start event with the selected third access site.
[0012] According to a sixth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the processor is further configured to receive hemodynamic information indicative of cardiac stroke volume, cardiac output, cardiac index, heart rate, total peripheral resistive index ("TPRI"), or fluid responsiveness from the at least one sensor, and cause at least a portion of the hemodynamic information to be displayed together with the infusion line mapping interface or in a separate hemodynamic interface.
[0013] According to a seventh aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the processor is further configured to determine hemodynamic information indicative of cardiac stroke volume, cardiac output, cardiac index, heart rate, total peripheral resistive index ("TPRI"), or fluid responsiveness, and cause at least a portion of the hemodynamic information to be displayed together with the infusion line mapping interface or in a separate hemodynamic interface.
[0014] According to an eighth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the processor is further configured to combine the infusion flow rate of the infused fluid name with other infusion flow rates associated with a patient specified in the patient medical record to determine a fluid output flow rate specified in the patient medical record, the fluid output flow rate corresponding to at least one of dialysis, urine monitoring, or fluid drainage, determine a fluid balance as a difference between the combined infusion flow rate and the combined fluid output flow rate, and display at least the fluid balance within an interactive graphical interface or an infusion line mapping interface presented by the display interface screen.
[0015] According to a ninth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the processor is further configured to determine a new infusion event from the patient medical record, the new infusion event specifying a time when the new infusion event was generated by the infusion pump and indicating at least one of a modified infusion flow rate, a modified volume to be infused, or a modified remaining volume, and update the infusion line mapping interface based on information associated with the new infusion event.
[0016] According to a tenth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the processor is further configured to receive information indicative of an alarm event or determine the alarm event from the patient medical record and display a graphic or at least a portion of the information indicative of the alarm event, the alarm event including at least one of infiltration detected, a line obstruction, or information indicating that the fluid container is empty or nearly empty.
[0017] According to an eleventh aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the infusion line mapping interface is configured to display the name of the fluid being infused and the infusion flow rate, and to display a graphical icon indicating the remaining volume or a time indicating the remaining volume.
[0018] According to a twelfth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the processor is further configured to determine that the remaining volume or the time indicating the remaining volume is less than a threshold, display the remaining volume or the time indicating the remaining volume with a graphical icon, and change a color of the graphical icon and the selected access site.
[0019] According to a thirteenth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, selection of the graphical icon causes the processor to display at least an infusion pump identifier, an amount to be infused, an infusion flow rate, and a name of the fluid to be infused.
[0020] According to a fourteenth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, selection of the graphical icon causes the processor to transmit a message that causes the infusion pump to generate a sound or provide a visual indication.
[0021] According to a fifteenth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, a patient identifier is entered into a display interface screen, stored in a memory device, or determined from the patient medical record.
[0022] According to a sixteenth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the apparatus further includes an adapter for connection to a hub device, which is also connected to the infusion pump.
[0023] According to a seventeenth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, a hemodynamic management method includes accessing, via a processor, a patient medical record in an electronic medical record database using a patient identifier, and determining, via a processor, from the patient medical record, a new infusion start event associated with an infusion pump fluidly connected to a patient corresponding to the patient medical record. The new infusion start event includes information indicating an infusion pump identifier, a name of the fluid to be infused, an infusion rate, a volume to be infused, a dose, a remaining volume, and a time when the new infusion start event was generated by the infusion pump. The method further includes causing, via the processor, a display interface screen to display an infusion line mapping interface showing a graphical illustration of the human body and potential access sites, and prompting, via the processor, for selection of an access site within the infusion line mapping interface, and after receiving the selection of the access site, associating, via the processor, the infusion pump identifier with the selected access site. The method further includes causing, via the processor, the display interface screen to display at least a portion of the information associated with the new infusion start event along with the selected access site shown within the infusion line mapping interface.
[0024] According to an eighteenth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the method further includes, after receiving the selection of an access site, performing, via the processor, a check for a fluid type and access site incompatibility between the selected access site and the infused fluid name using a drug library that specifies incompatibilities between fluid types and access site types, and if there is an incompatibility, displaying, via the processor, a warning in the infusion line mapping interface and providing a prompt to change the access site for the infused fluid name associated with the infusion pump, after receiving, via the processor, a selection of a second access site, removing the warning, and displaying, via the processor, at least a portion of information associated with the new infusion start event with the selected second access site.
[0025] According to a nineteenth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the method further includes, via the processor, using the drug library to determine a compatible access site based on a fluid name to be infused, and, via the processor, causing the infusion line mapping interface to display a recommendation for fluidly connecting the infusion pump to the compatible access site.
[0026] According to a twentieth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the method further includes combining, via a processor, an infusion flow rate for a name of a fluid to be infused with other infusion flow rates associated with a patient specified in a patient medical record; determining, via a processor, a fluid output flow rate specified in the patient medical record, the fluid output flow rate corresponding to at least one of dialysis, urine monitoring, or fluid drainage; determining, via the processor, a fluid balance as a difference between the combined infusion flow rate and the combined fluid output flow rate; and displaying, via the processor, at least the fluid balance within an interactive graphical interface or an infusion line mapping interface presented by a display interface screen.
[0027] According to a twenty-first aspect of the present disclosure, any of the structures and functions illustrated and described in connection with Figures 1-24 may be used in combination with any of the structures and functions illustrated and described in connection with any other of Figures 1-24 and any one or more of the aforementioned aspects.
[0028] Therefore, in light of the present disclosure and the above aspects, it is an advantage of the present disclosure to provide a hemodynamic management device and system that displays hemodynamic parameters in real time to provide hemodynamic assessment.
[0029] Another advantage of the present disclosure is that it provides infusion line management by showing the current infusion to the patient access site within a single display interface.
[0030] A further advantage of the present disclosure is that it provides a compatibility check of fluid type with fluid type and access site before a new injection can proceed.
[0031] Yet another advantage of the present disclosure is that it provides automated fluid balance monitoring.
[0032] Further features and advantages will be described in and will be apparent from the following detailed description and drawings. The features and advantages described herein are not all-inclusive, and in particular many further features and advantages will be apparent to those skilled in the art in view of the drawings and description. It is not necessary for any particular embodiment to have all the advantages enumerated herein, and it is expressly contemplated that each advantageous embodiment may be separately claimed. Furthermore, it should be noted that the language used in this specification has been selected primarily for ease of reading and explanation, and not to limit the scope of the inventive subject matter. [Brief description of the drawings]
[0033] [Figure 1]1 is a diagram of a hemodynamic management system including a hemodynamic management device according to an exemplary embodiment of the present disclosure.
[0034] [Diagram 2] FIG. 2 illustrates an example of a sensor in direct communication with the hemodynamic management device of FIG. 1 according to an exemplary embodiment of the present disclosure.
[0035] [Diagram 3] 2 is another diagram of the hemodynamic management system of FIG. 1 according to another exemplary embodiment of the present disclosure.
[0036] [Figure 4] FIG. 4 is a diagram of a hub device configured to connect to the hemodynamic management device of FIGS. 1-3 according to an exemplary embodiment of the present disclosure.
[0037] [Diagram 5] FIG. 5 is another view of the hub device of FIG. 4 with a hemodynamic management device disposed adjacent to the communications module in accordance with an exemplary embodiment of the present disclosure.
[0038] [Figure 6] FIG. 13 is another view of a hub device having a slim version of a hemodynamic management device according to an exemplary embodiment of the present disclosure.
[0039] [Figure 7] FIG. 1 illustrates a hemodynamic management device connected to a pole according to an exemplary embodiment of the present disclosure.
[0040] [Figure 8] FIG. 8 shows a flow diagram illustrating an exemplary procedure for configuring the hemodynamic management device of FIGS. 1-7 according to an exemplary embodiment of the present disclosure.
[0041] [Figure 9] FIG. 8 is a diagram of a registration interface for patient association displayed by the hemodynamic management device of FIGS. 1-7 according to an exemplary embodiment of the present disclosure.
[0042] [Figure 10] FIG. 8 shows a flow diagram illustrating an exemplary procedure for infusion line management performed by the hemodynamic management device of FIGS. 1-7 according to an exemplary embodiment of the present disclosure.
[0043] [Figure 11] FIG. 8 is a diagram of an exemplary infusion line mapping interface that may be displayed by a display interface screen of the hemodynamic management device of FIGS. 1-7 according to an exemplary embodiment of the present disclosure.
[0044] [Figure 12] 12 is a diagram of the infusion line mapping interface of FIG. 11 illustrating incompatibility between two infusions connected to the same access site according to an exemplary embodiment of the present disclosure.
[0045] [Figure 13] 8A-8C are diagrams illustrating different possible physiological data input into the hemodynamic management device of FIGS. 1-7 according to an exemplary embodiment of the present disclosure.
[0046] [Figure 14] FIG. 8 is a diagram of a hemodynamic dashboard interface displayed on a display interface screen by an application of the hemodynamic management device of FIGS. 1-7 according to an exemplary embodiment of the present disclosure.
[0047] [Figure 15] 8 shows a diagram of a fluid responsiveness interface that may be displayed by an application of the hemodynamic management device of FIGS. 1-7 according to an exemplary embodiment of the present disclosure. FIG.
[0048] [Figure 16] 13 illustrates a hemodynamic dashboard interface after a hemodynamic assessment has been performed according to an exemplary embodiment of the present disclosure.
[0049] [Figure 17]FIG. 13 is a diagram of an assessment interface showing the status of a bolus hemodynamic assessment according to an exemplary embodiment of the present disclosure.
[0050] [Figure 18] FIG. 13 is a diagram of a fluid responsiveness interface that may be presented by an application of a hemodynamic management device after a hemodynamic assessment has been performed or is in progress according to an exemplary embodiment of the present disclosure.
[0051] [Figure 19] FIG. 15 is a diagram of the hemodynamic dashboard interface of FIG. 14 with the infusion status section modified to show information indicative of an alarm or warning according to an exemplary embodiment of the present disclosure.
[0052] [Figure 20] 12 is a diagram of the infusion line mapping interface of FIG. 11 showing information indicating an alarm or warning regarding a nearly empty bag in accordance with an exemplary embodiment of the present disclosure.
[0053] [Figure 21] FIG. 15 is a diagram of the hemodynamic dashboard interface of FIG. 14 displaying a warning indication related to the detection of infiltration according to an exemplary embodiment of the present disclosure.
[0054] [Figure 22] 12 is a diagram of the infusion line mapping interface of FIG. 11 showing information indicating an alarm or warning regarding infiltration detection according to an exemplary embodiment of the present disclosure.
[0055] [Diagram 23] FIG. 1 is a diagram of a fluid balance interface according to an exemplary embodiment of the present disclosure.
[0056] [Figure 24] FIG. 13 is a detailed net fluid balance interface diagram according to an exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0057] The present disclosure generally relates to methods, systems, and apparatus for hemodynamic management. The methods, systems, and apparatus include a hemodynamic management device configured for use at a patient's bedside. The hemodynamic management device is configured to receive data from multiple medical devices. The data is compiled to provide a real-time or near real-time hemodynamic assessment along with a total fluid balance for the patient. The hemodynamic assessment may be performed via passive leg raising ("PLR"), an infusion bolus, and / or automatic detection of an infusion bolus. The hemodynamic assessment provides an indication of the patient's fluid responsiveness by inducing a reversible increase in cardiac preload.
[0058] As described herein, total fluid balance is the net gain or loss of fluid in a patient. The methods, systems, and apparatus are configured to aggregate data from medical devices to determine a cumulative fluid inflow rate and a cumulative fluid output rate. The cumulative fluid inflow rate and the output rate are subtracted to determine the net fluid gain / loss over a period of seconds, minutes, 10 minutes, etc. The net fluid gain / loss is trended over time to determine how much fluid the patient has lost or gained within a specified period of time, such as 1 hour, 4 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, etc. The total fluid balance and hemodynamic assessment together provide important information that allows for automatic or guided identification or prediction of hemodynamic instability in a patient. Such identification allows clinicians to more easily address detected or predicted onset hemodynamic instability before the patient's condition deteriorates.
[0059] The methods, systems, and devices disclosed herein are further configured to provide automatic mapping of fluid infusions. Some critically ill patients may receive as many as 15 simultaneous infusions. Each infusion is connected to a fluid container (such as an intravenous ("IV") bag). Fluid from the fluid container is pumped by a respective infusion pump through an IV tube or IV line. A separate IV line may be connected to the patient at each access site. However, to reduce the number of access sites used (reducing patient discomfort), several IV lines may be connected together upstream of the access site location. Rather than having the clinician perform manual compatibility checks and infusion line tracing, the methods, systems, and devices automatically perform compatibility checks to ensure that the infused fluid is compatible with a particular infusion access site, or is compatible with one or more other fluids at a particular infusion access site. Automatic mapping also enables the methods, systems, and devices to provide a real-time summary of the status of all infusions within a single display. This significantly reduces the burden on the clinician to have to individually check many different infusion pumps.
[0060] References are made herein to infusion access sites, intravenous access sites, or more generally, access sites. As described below, an access site is a location on a patient that receives an infused fluid. An access site is typically a vein, allowing for direct infusion of fluid into the patient's blood. For example, humans include numerous venous access sites, including the internal jugular vein, external jugular vein, left subclavian vein, superior vena cava, cephalic vein, basilic vein, cubital vein, cephalic vein, median antebrachial vein, median antebrachial vein, accessory cephalic vein, dorsal venous arch, metacarpal vein, and digital vein. However, it should be understood that the methods, systems, and devices disclosed herein may provide mapping to any patient access site.
[0061] As disclosed herein, hemodynamic management includes hemodynamic monitoring, vasoactive dosing / titration, fluid resuscitation, and tracking of urine volume / fluid balance. Exemplary methods, systems, and devices are configured to receive data from medical devices and one or more physiological sensors and use this data for hemodynamic management. The methods, systems, and devices include instructions that specify which data is relevant to hemodynamic management for selection or filtering. The instructions may also specify specific calculations to be performed to determine other hemodynamic parameters. Exemplary methods, systems, and devices may also include one or more instructions or algorithms for monitoring or analyzing trends or relationships between hemodynamic parameters for identification of fluid balance fluctuations, instabilities, and / or physiological changes. In some cases, the methods, systems, and devices may also include instructions or algorithms for predicting future hemodynamic instability of a patient by analyzing trends or relationships of hemodynamic parameters.
[0062] Thus, the exemplary methods, systems, and devices disclosed herein provide clinicians with an immediate and complete picture of a patient's hemodynamic status within a single display or interface. The display of all relevant hemodynamic parameters in one interface allows clinicians to make more informed decisions at the point-of-care through early prediction and detection of hemodynamic problems. The exemplary systems disclosed herein also simplify and streamline hospital workflow by reducing the number of information sources and interfaces that clinicians must access to make informed decisions, thereby increasing clinician confidence and efficiency. Most importantly, the exemplary systems disclosed herein can provide more effective management of the hemodynamics of unstable patients in intensive care, resulting in better outcomes and shorter length of stay in the ICU or in the hospital more generally. It is understood that the methods, systems, and devices disclosed herein can be applied in other areas, including electrolyte replacement and renal function monitoring. The exemplary methods, systems, and devices can also be used for antibiotic management, glycemic management, infection monitoring and line tracing, and / or wound / drainage management.
[0063] (Hemodynamic Management System) 1 is a diagram of a hemodynamic management system 100 according to an exemplary embodiment of the present disclosure. The system 100 includes medical devices that operate in conjunction with a patient. The medical devices include, for example, an infusion pump 102 and a dialysis or renal failure therapy ("RFT") machine 104. The system 100 also includes a hemodynamic management device 106.
[0064] The exemplary infusion pump 102 may include any pump capable of delivering intravenous therapy to a patient via one or more intravenous line sets. Examples include syringe pumps, linear peristaltic pumps, large volume parenteral pumps, ambulatory pumps, multi-channel pumps, etc. The exemplary infusion pump 102 includes a display 108 and an interface 110 that allows a clinician to specify or program an infusion therapy. In addition to manual programming, the infusion pump 102 may receive electronic prescriptions from a hospital information system via the network 112 and gateway server 114. The infusion pump 102 may include one or more drug libraries that include specific restrictions based on care area, dose, variable flow rate, drug type, concentration, patient age, patient weight, etc.
[0065] The infusion pump 102 is configured to perform an infusion therapy on a patient, the infusion therapy including the infusion of one or more fluids, solutions, or drugs 111 to the patient. The infusion pump 102 operates according to an infusion prescription entered by a clinician at the pump's user interface 110 or received via the gateway server 114. The infusion pump 102 may compare the prescription to a drug library and provide a warning or alert if parameters of the prescription violate soft or hard limits. The infusion pump 102 is configured to monitor the progress of the therapy and periodically transmit infusion therapy progress data 116 to the gateway server 114. The infusion therapy progress data 116 may include, for example, infusion flow rate, dose, total volume infused, time remaining for therapy, fluid concentration, flow rate change, volume remaining in the drug container, fluid name, patient identifier, titration information, bolus information, care area identifier, timestamp when data was generated, alert conditions, warning conditions, events, etc. In some cases, the infusion therapy progress data 116 includes a new infusion start event that includes an infusion pump identifier, the name of the fluid being infused, the infusion rate, the volume to be infused, the dose, the volume remaining, and / or information indicating the time the new infusion start event was generated by the infusion pump. The infusion pump 102 may transmit the data 116 continuously, periodically (e.g., every 30 seconds, every minute, etc.), or upon request by the gateway server 114.
[0066] The exemplary RFT machine 104 of FIG. 1 may include any hemodialysis, hemofiltration, hemodiafiltration, continuous renal replacement therapy ("CRRT"), or peritoneal dialysis machine. CRRT is a dialysis modality typically used to treat critically ill hospitalized patients in intensive care units who develop acute kidney injury ("AKI"). Unlike chronic kidney disease, which occurs slowly over time, AKI often occurs in hospitalized patients and typically occurs over a period of hours to days. For example, a patient undergoing hemodialysis is connected to the RFT machine 104 and the patient's blood is pumped through the machine. The blood passes through a dialyzer in the machine 104, which removes waste, toxins, and excess water (e.g., ultrafiltrate) 117 from the blood. The cleansed blood is returned to the patient.
[0067] Hemodialysis is a kidney failure treatment in which waste products from the blood diffuse across a semipermeable membrane. During hemodialysis, blood is removed from a patient and flows through a semipermeable membrane assembly (dialyzer), where the blood generally flows countercurrent to a dialysis solution flowing on the other side of the semipermeable membrane. In the dialyzer, toxins from the blood migrate across the semipermeable membrane and exit the dialyzer into a spent dialysis solution (dialysate). The cleansed blood that has flowed through the dialyzer is then returned to the patient.
[0068] In a dialyzer, a pressure differential is created across a semipermeable membrane by removing dialysate at a flow rate greater than the flow rate used to introduce the dialysis solution into the dialyzer. This pressure differential pulls the fluid, including small, medium, and large molecule toxins, across the semipermeable membrane. Flow and volume measurements are used to control the amount of fluid removed (ultrafiltration). As noted above, a pump in a hemodialysis machine typically draws blood from the patient's arterial side and pushes it into, through the dialyzer, and through a drip chamber that separates the air before returning the dialyzed blood to the patient's venous side.
[0069] Alternatively, the RFT machine 104 can be a hemofiltration machine. Hemofiltration is another renal failure treatment similar to hemodialysis. During hemofiltration, the patient's blood passes through a semipermeable membrane (hemofilter) and fluid (including waste products) is pulled across the semipermeable membrane by a pressure difference. This convection brings molecular toxins and electrolytes of certain sizes (which are difficult to clean in hemodialysis) across the semipermeable membrane. During hemofiltration, substitution fluid is added to the blood to replace the fluid volume and electrolytes removed from the blood through the hemofilter. Hemofiltration in which substitution fluid is added to the blood before the hemofilter is known as predilution hemofiltration. Hemofiltration in which substitution fluid is added to the blood after the hemofilter is known as postdilution hemofiltration.
[0070] Alternatively, the RFT machine 104 can be a hemodiafiltration machine. Hemodiafiltration is a further renal failure treatment that uses hemodialysis in combination with hemofiltration. The blood is again pumped through a dialyzer, which unlike a hemofilter receives fresh dialysis fluid. However, in hemodiafiltration, like hemofiltration, a substitution fluid is delivered to the blood circuit. Thus, hemodiafiltration is a companion to hemodialysis and hemofiltration.
[0071] Alternatively, the RFT machine 104 may be a peritoneal dialysis machine. Peritoneal dialysis uses a dialysis solution, also called dialysate, which is infused into the patient's peritoneal cavity via a catheter. The dialysate contacts the peritoneal membrane of the patient's peritoneal cavity. Waste, toxins, and excess water pass from the patient's bloodstream through the peritoneal membrane and into the dialysate due to an osmotic gradient created by the solution. Spent dialysate is drained from the patient, removing the waste, toxins, and excess water from the patient. The cycle repeats.
[0072] The exemplary peritoneal dialysis machine 104 may perform various types of additional peritoneal dialysis therapies, including continuous cyclic peritoneal dialysis ("CCPD"), tidal automated peritoneal dialysis ("APD"), and continuous flow peritoneal dialysis ("CFPD"). APD machines perform drain, fill, and dwell cycles automatically, typically while the patient sleeps. APD machines free the patient or clinician from having to manually perform treatment cycles and from having to transport supplies during the day. The APD machine fluidly connects to an implanted catheter, a source or bag of fresh dialysate, and a fluid drain. The APD machine pumps fresh dialysate from the dialysate source through the catheter and into the patient's peritoneal cavity, allowing the dialysate to dwell in the cavity and allowing the transfer of waste, toxins, and excess water to occur. The source may be multiple sterile dialysate solution bags. The APD device pumps spent dialysate from the patient's peritoneal cavity through the catheter and into the drain. As with the manual process, several drain, fill, and dwell cycles occur during APD. A "last fill" occurs at the end of CAPD and APD, and it remains in the patient's peritoneal cavity until the next treatment.
[0073] CCPD therapy attempts to completely drain the patient at each drain. CCPD and / or APD can be batch-type systems that send spent dialysis fluid to a drain. A tide flow system is a modified batch system. In tide flow, instead of removing all the fluid from the patient over a longer period of time, a portion of the fluid is removed and replaced after shorter time increments.
[0074] The dialysis fluid for peritoneal dialysis may include a solution or mixture containing 0.5% to 10%, preferably 1.5% to 4.25% dextrose (or more commonly glucose). The dialysis fluid for peritoneal dialysis may include, for example, Dianeal®, Physioneal®, Nutrineal®, and Extraneal® dialysis fluids. The dialysis fluid may additionally or alternatively include a percentage of icodextrin. It should be appreciated that in some embodiments of the present disclosure, the dialysis fluid may be infused into the patient via the infusion pump 102 rather than the RFT machine 104.
[0075] Continuous flow, or CFPD, dialysis systems clean or regenerate used dialysate instead of discarding it. CFPD systems pump fluid in and out of the patient through a loop. Dialysate flows into the peritoneal cavity through one catheter lumen and flows out of another catheter lumen. Fluid leaving the patient passes through a reconstitution device that removes waste products from the dialysate, for example, via a urea removal column that uses urease to enzymatically convert urea to ammonia (e.g., ammonium cation). Ammonia is then removed from the dialysate by absorption prior to reintroduction of the dialysate into the peritoneal cavity. Additional sensors are used to monitor the removal of ammonia. CFPD systems are typically more complex than batch systems.
[0076] In both hemodialysis and peritoneal dialysis, "sorbent" technology can be used to remove uremic toxins from waste dialysate and reinfuse therapeutic agents (such as ions and / or glucose) into the treatment fluid, which can then be reused to continue dialysis for the patient. One commonly used sorbent is made from zirconium phosphate, which is used to remove ammonia generated from the hydrolysis of urea. Typically, large amounts of sorbent are needed to remove the ammonia produced during dialysis treatment.
[0077] Similar to the infusion pump 102, the RFT machine 104 may be locally programmed with a dialysis prescription or may receive a dialysis prescription via the gateway server 114. The RFT machine 104 is configured to perform a dialysis therapy on a patient, which includes removing ultrafiltration from the patient. In peritoneal dialysis, the RFT machine 104 infuses dialysate into the patient during a fill cycle. For any dialysis prescription, the RFT machine 104 may compare the parameters of the prescription to one or more limits and provide a warning or alert if the parameters of the prescription violate a soft or hard limit. The RFT machine 104 is configured to monitor the progress of the therapy and periodically transmit dialysis therapy progress data 119 to the gateway server 114. The dialysis therapy progress data 119 may include, for example, fill flow rate, dwell time, drain or fluid removal rate, blood flow rate, effluent volume, ultrafiltration removal rate, dialysate removal rate, total amount of dialysate infused, dialysate flow rate, pre-exchange flow rate, post-exchange flow rate, patient weight balance, return pressure, excess patient fluid indicator, filtration rate, remaining time, dialysate concentration, dialysate name, patient identifier, room identifier, care area identifier, timestamp when the data was generated, alarm conditions, warning conditions, events, etc. The RFT machine 104 may transmit the data continuously, periodically (e.g., every 30 seconds, every minute, etc.), or upon request by the gateway server 114.
[0078] The hemodynamic management device 106 includes a processor 120, a memory device 122, and a display interface screen 124. The memory device 122 stores instructions that specify or define operations to be performed by an application 126. Execution of the instructions by the processor 120 causes the hemodynamic management device 106 to perform the operations discussed herein via the application 126. The processor 120 may include a controller, a logic device, an application specific integrated circuit ("ASIC"), a microcontroller, etc. The memory device 122 may include a flash drive, a solid state drive, or a hard disk drive.
[0079] The display interface screen 124 of the hemodynamic management device 106 is configured to display information related to hemodynamic monitoring and management. As described in further detail below, this includes fluid balance information, hemodynamic assessment information, hemodynamic parameters, and / or warnings regarding infiltration, infusion line occlusion, and / or near empty or empty fluid bags. The display interface screen 124 also displays information related to infusion line management. The display interface screen 124 may include a touch interface configured to receive touch gestures related to available displayed options or functions.
[0080] The memory device 122 may also be configured to store a data structure or file 127 that associates the infusion pumps 102 with their respective graphical icons displayed within the infusion line mapping interface 1100, as shown in FIG. 11. The data structure or file 127 may include an index that associates an infusion pump identifier or hardware address with an assigned graphical icon. As described in more detail below, the association occurs after a new infusion pump is added and a compatibility check is performed. The data structure or file 127 may also store at least some infusion therapy progress data 116, including fluid type / name, infusion flow rate, volume to be infused, and / or volume of fluid remaining in the fluid container. The application 126 is configured to retrieve the infusion therapy progress data 116 from the patient's EMR, the gateway server 114, and / or receive the data 116 directly from the infusion pump 102 when connected to the hub device 400 (described in more detail below).
[0081] The hemodynamic management device 106 is communicatively coupled to the gateway server 114 via a network 112. While Fig. 1 illustrates a wireless link, in other embodiments, the hemodynamic management device 106 is connected to the network 112 via a wired link, such as an Ethernet connection, as shown in Fig. 3. As described in more detail below, the hemodynamic management device 106 communicates with the gateway server 114 to receive information for display.
[0082] In some alternative embodiments (shown in FIGS. 4-6), the hemodynamic management device 106 is connected to the infusion pump 102 via a hub device. The hemodynamic management device 106 may communicate directly with the infusion pump 102 via the hub device without the need to use the network 112. The communication may be via a Universal Serial Bus ("USB") connection or a Controller Area Network ("CAN") connection. Reference is made herein to communication between the hemodynamic management device 106 and other medical devices, including the infusion pump 102. It is understood that the communication may occur via the network 112 and the gateway server 114. Alternatively, if a hub device is used, the communication may occur locally.
[0083] 1, the hemodynamic management device 106 is configured to receive physiological data 128 about the patient from one or more sensors 130. The sensors 130 may non-invasively monitor the patient for the physiological data 128 that provides hemodynamic monitoring. The sensors 130 may include, for example, a blood pressure sensor (e.g., a blood pressure cuff), a MAP sensor, a heart rate sensor, an SpO 2In some embodiments, the sensor 130 and / or the hemodynamic management device 106 may include a blood flow rate, a cardiac output ("CO"), an arterial pressure, peripheral, total, or systemic vascular resistance ("SVR"), turbulence, wall tension, stroke volume ("SV"), stroke volume variation ("SVV"), and / or pulse pressure variation ("PPV"). The sensor 130 and / or the hemodynamic management device 106 may also be configured to use the physiological data 128 to calculate a cardiac index ("CI"), a stroke volume index ("SVI"), and / or a total peripheral resistance index ("TPRI").
[0084] Although the sensors 130 are shown as communicatively coupled to the hemodynamic management device 106, in other embodiments, one or more of the sensors 130 are communicatively coupled to the infusion pump 102 and / or the RFT machine 104. Additionally or alternatively, one or more of the sensors 130 are configured to communicate with the gateway server 114 over the network 112. In these other embodiments, the hemodynamic management device 106 is configured to access or receive the physiological data 128 from the infusion pump 102, the RFT machine 104, and / or the gateway server 114 over the network 112.
[0085] In one example, the infusion pump 102 may be connected to a pulse oximetry sensor. The infusion pump 102 may be configured to integrate or otherwise include data from the pulse oximetry sensor in the infusion therapy progress data 116, or alternatively, transmit the pulse oximetry data separately to the gateway server 114. Similarly, the RFT machine 104 may be communicatively coupled to a blood pressure sensor, a patient scale, a glucose sensor, a cardiac monitor, etc. The RFT machine 104 may be configured to integrate or otherwise include data from the sensor in the dialysis therapy progress data 119, or alternatively, transmit the sensor data separately to the gateway server 114.
[0086] 2 illustrates an example of sensors 130a and 130b in direct communication with the hemodynamic management device 106 of FIG. 1 according to an exemplary embodiment of the present disclosure. In this example, the hemodynamic management device 106 includes a sensor module 202 communicatively coupled to the processor 120. The sensor module 202 is configured to receive physiological data 128a from the cardiac sensor 130a and convert the physiological data into hemodynamic parameters, such as SVI, TPRI, CI, CO, SV, etc. In some cases, the sensor module 202 includes an interactive interface integrated with the application 126 for displaying the hemodynamic parameters. Additionally, the sensor module 202 may be configured to receive one or more application commands from the processor 120 to perform a hemodynamic assessment.
[0087] In one example, the sensor module 202 adds fluid responsiveness monitoring to the application 126 of the hemodynamic management device 106. One or more chest patch sensors 130 are plugged into the sensor module 202, which is integrated into or otherwise connected to the device 106. The application 126 is configured to display an interface for monitoring stroke volume ("SV") and cardiac output ("CO") and to assess whether the patient would respond to additional IV fluids.
[0088] The sensor module 202 may include a Wi-Fi transceiver to enable wireless data communication with the cardiac sensor 130a. In other embodiments, the sensor module 202 and / or the hemodynamic management device 106 may include a Bluetooth transceiver. Additionally, the sensor module 202 may be operable with a communication interface 204 configured with a USB port, a micro USB port, an HDMI port, or other hardwire port for the cardiac sensor 130a.
[0089] 2 also shows that the hemodynamic management device 106 may communicate with an infiltration sensor 130b via a wired or wireless connection. The infiltration sensor 130b transmits physiological data 128b indicative of infiltration, which is leakage of fluid from a vein into surrounding tissue. The transceiver of the hemodynamic management device 106 is configured to receive the physiological data 128b to determine when to activate an alarm or alert indicating detection of infiltration. In some embodiments, the hemodynamic management device 106 allows the clinician to specify which IV line is associated with which infiltration sensor 130b, so that the appropriate line is highlighted on the display interface screen 124 when infiltration is detected.
[0090] Returning to FIG. 1 , the gateway server 114 includes controllers, processors, routers, switches, computers, etc. configured to communicate with the infusion pumps 102, the RFT machines 104, and the hemodynamic management devices 106 over the network 112 (e.g., a wide area network, a local area network, a wireless local area network, Ethernet, the Internet, a cellular network, or a combination thereof). The gateway server 114 may be communicatively coupled to multiple infusion pumps, RFT machines, and / or hemodynamic management devices. Additionally, the gateway server 114 may communicate with other medical devices, such as physiological sensors 130. The gateway server 114 is configured to provide bidirectional communication with the infusion pumps 102 for wired / wireless secure transfer of drug libraries, infusion prescriptions, and infusion therapy progress data 116. The gateway server 114 may also be configured to integrate with a hospital information system to transmit infusion therapy progress data 116 from the infusion pump 102 and / or dialysis therapy progress data 119 from the RFT machine 104 to a hospital electronic medical record ("EMR") managed by an EMR server 118.
[0091] The exemplary EMR server 118 is configured to manage patient EMRs stored in an EMR database 132. The EMR server 118 receives data 116 and 119 from medical devices 102 and 104, respectively, and uses machine and / or patient identifiers associated with the data to determine the corresponding patient EMR. The EMR server 118 is configured to write the data 116 and 119 to the appropriate patient EMR in the database 132, thereby providing a record accessible to the hemodynamic management device 106.
[0092] Additionally, the EMR server 118 is configured to store physiological data 128 from one or more sensors 130 in the patient's EMR. The physiological data 128 may be received directly from the sensors 130 and / or from one or more of the infusion pump 102, the RFT machine 104, and / or the hemodynamic management device 106. The EMR server 118 may also store infusion and / or RFT prescriptions in the appropriate patient EMR.
[0093] 1 also shows a clinician device 140 connected to the EMR server 118 and another clinician device 142 communicatively coupled to the network 142. The clinician device 140 may be located behind a firewall or gateway server 114 and access the EMR server 118 without authentication. The clinician device 142 may be located outside the hospital network 112 and may need to authenticate to communicate with the EMR server 118, the infusion pump 102, and / or the hemodynamic management device 106. The clinician devices 140 and 142 allow the clinician to enter infusion and / or dialysis / RFT prescriptions, which are transmitted to the EMR server 118 for storage in the patient's EMR. The electronic prescription is also transmitted by the gateway server 114 to the appropriate medical device 102, 104.
[0094] In some embodiments, the hemodynamic management device 106 is configured to provide access to the clinician devices 140, 142. During connection, the hemodynamic management device 106 may cause the clinician devices 140, 142 to display the current view shown on the display interface screen 124. Additionally or alternatively, the hemodynamic management device 106 may enable the clinician devices 140, 142 to select a desired interface screen to, for example, view trends of hemodynamic parameters over time, perform hemodynamic assessments remotely, and / or view the patient's fluid balance.
[0095] 3 is another diagram of the hemodynamic management system 100 according to another exemplary embodiment of the present disclosure. In this example, the RFT machine 104 is replaced with a fluid output sensor 302, which may include a urine sensor or a sensor measuring other fluid 306 discharged from the patient. The fluid output sensor 302 transmits fluid output data 304 to the gateway server 114 for routing to the EMR server 118, which stores the data 304 in the patient's EMR. The fluid output data 304 may indicate, for example, a total volume of fluid removed and / or a fluid removal rate. In other examples, the fluid output sensor 302 is communicatively coupled to the infusion pump 102 and / or the hemodynamic management device 106.
[0096] FIG. 3 also shows additional infusion pumps, such that both infusion pumps 102a and 102b are fluidly coupled to the patient. Infusion pump 102a is configured to infuse a first fluid 111a into the patient and transmit first infusion therapy progress data 116a to the gateway server 114 and / or hemodynamic management device 106. Additionally, infusion pump 102b is configured to infuse a second fluid 111b into the patient and transmit second infusion therapy progress data 116b to the gateway server 114 and / or hemodynamic management device 106. The fluid IV lines from infusion pumps 102a and 102b may be connected together such that only a single patient access site is required. Alternatively, the fluid IV lines from infusion pumps 102a and 102b may be connected to separate patient access sites.
[0097] The first and second fluids 111a and 111b may be different fluids and may include a drug or agent, such as dopamine. The first and second fluids 111a and 111b may also include saline, platelets, lipids, contrast media, dialysate, and / or parenteral nutrition. It should be understood that the fluids 111a and 111b may include any solution that can be infused into a patient.
[0098] 3 also shows that the system 100 includes a drug library server 310 and corresponding database 312. The drug library server 310 is configured to manage a drug library file 314 that specifies, for example, hard and soft infusion limits for a particular fluid. The drug library file 314 is provided to the infusion pumps 102a and 102b via the drug library server 310 to ensure that the infusion parameters of the infusion prescription (or the infusion parameters entered at the pump) are within clinically acceptable limits. In some embodiments, the drug library file 314 specifies different limits based on a patient's weight, gender, ethnicity, age, area of care, etc.
[0099] In some embodiments, the drug library file 314 also specifies incompatibilities between fluid types and / or between fluid types and access sites. Incompatibilities between fluid types may specify, for example, fluids that cannot be infused into a patient during the same treatment or within a certain time period of each other. Incompatibilities between fluid types may also specify fluids that cannot be combined together via IV tubing upstream of an access site. For example, the drug library file 314 may specify that dopamine and sodium bicarbonate cannot be combined together for a common access site. In another example, incompatibilities between fluid types and access sites may specify that saline should not be administered into a particular vein, e.g., a finger vein. Incompatibilities may be based on the Intensive Care Intravenous Drug Administration Guide and / or Y-site IV compatibility guidelines.
[0100] In the illustrated embodiment, the drug library file 314 may also be transmitted by the drug library server 310 to the hemodynamic management device 106 via the gateway server 114. Alternatively, the hemodynamic management device 106 may use a known address of the drug library server 310 to obtain the drug library file 314. As described in more detail below, the hemodynamic management device 106 is configured to use the drug library file 314 to perform incompatibility checks between fluid types and / or between fluid types and access sites as part of infusion line management. (Embodiments for mounting the hemodynamic management device)
[0101] As described above in connection with FIG. 3, the hemodynamic management device 106 may physically connect to a hub device housing one or more infusion pumps 102. FIG. 4 is a diagram of a hub device 400 configured to connect to the hemodynamic management device 106 and infusion pumps 102 of FIGS. 1-3 according to an exemplary embodiment of the present disclosure. In the illustrated example, the hub device 400 is a rack for supporting the hemodynamic management device 106 along with the infusion pumps 102a, 102b, 102c, and 102d. The hub device 400 may be configured to stand on a floor or tabletop. Alternatively, the hub device 400 may be connected to a patient's bed or pole via at least one clamp.
[0102] The hub device 400 includes a communication module 402 communicatively coupled to the hemodynamic management device 106 and the infusion pumps 102a, 102b, 102c, and 102d via a CAN connection, a USB connection, and / or a local wireless connection such as Wi-Fi or Bluetooth. In the illustrated example, the pumps 102a-102d are syringe pumps. In other embodiments, the hub device 400 may connect to a large volume pump, a syringe pump, or a combination of a syringe pump and a large volume pump. Thus, the hub device 400 is configured to allow different combinations of pumps 102 to be connected based on a patient's predetermined infusion schedule. Additionally, while four pumps 102a-102d are shown in FIG. 4, the hub device 400 may include as few as one pump and as many as a dozen pumps, for example.
[0103] The exemplary pumps 102a-102d are connected to the hub device 400 via respective shelves. The hemodynamic management device 106 may be connected to the hub device 400 using an adapter that is positioned on one or more shelves. The adapter is configured to slide over, for example, two shelves to provide improved support for the hemodynamic management device 106. The illustrated embodiment allows a hemodynamic management device 106 having an 8-inch to 12-inch display interface screen 124 to be positioned above or between a stack of infusion pumps 102. The relatively large size of the display interface screen 124 allows for more data to be displayed for infusion line management and hemodynamic management.
[0104] 5 is another view of the hub device 400 of FIG. 4 with the hemodynamic management device 106 located adjacent to the communications module 402 according to an exemplary embodiment of the present disclosure. In this example, the communications module 402 includes an adapter or stage 502 for receiving the hemodynamic management device 106. Locating the hemodynamic management device 106 at the top of the hub device 400 allows for more pumps 102a-102c to be connected in a stack and improves visibility of the display interface screen 124.
[0105] In some embodiments, the communication module 402 is configured to provide local communication between the hemodynamic management device 106 and the infusion pump 102. The hub device 400 may include a communication port that is individually addressed to each shelf location. When a hemodynamic management device 106 or an infusion pump 102 is connected to the hub device 400, the communication module 402 is configured to associate a pump identifier (e.g., a media access control address ("MAC")) with the communication port. This association allows the hub device 400 to determine which infusion pump 102 is located on which shelf or module. Furthermore, the processor 120 of the hemodynamic management device 106 is configured to register or pair with the communication module 402 using the corresponding communication port. Registration of the hemodynamic management device 106 with the communication module 402 causes the communication module 402 to transmit infusion therapy progress data 116 (e.g., messages and events) received from the infusion pump 102 to the hemodynamic management device 106. The communications coupling also enables the processor 120 of the hemodynamic management device 106 to transmit commands, such as commands to perform a bolus, to the appropriate infusion pump 102 directly or via the communications module 402 .
[0106] The exemplary communications module 402 is also configured to be communicatively coupled to the gateway server 114 via the network 112. Infusion therapy progress data 116 from the infusion pump 102 is transmitted to the gateway server 114 for storage in the appropriate patient's medical record in the EMR database 132. Additionally, the hemodynamic management device 106 may communicate with the gateway server 114 via the communications module 402 of the hub device 400. In this manner, the communications module 402 is configured as a network access point and router / switch for the infusion pump 102 and the hemodynamic management device 106.
[0107] 6 is another view of the hub device 400 with a slim version of the hemodynamic management device 106 according to an exemplary embodiment of the present disclosure. In the illustrated example, the hemodynamic management device 106 includes a smaller display interface screen that allows the hemodynamic management device 106 to fit within the shelf of the hub device 400 without the need for special adapters. The hemodynamic management device 106 is configured to occupy approximately the same space as the infusion pump 102.
[0108] In some embodiments, the hemodynamic management device 106 includes a wireless transceiver 602 that communicates with the processor 120. The wireless transceiver 602 may include a Wi-Fi transceiver, a Bluetooth transceiver, or the like. The wireless transceiver 602 is configured to communicatively couple to the clinician devices 140, 142, which may have relatively large screens. The clinician devices 140, 142 may communicate directly with the hemodynamic management device 106 or indirectly via the network 112. Such a configuration allows the clinician devices 140, 142 to display one or more interfaces managed by the application 126 of the hemodynamic management device 106. Additionally, the clinician devices 140, 142 may transmit commands, such as commands to perform a bolus injection for hemodynamic assessment and / or commands to remotely cause the hemodynamic management device 106 to command the appropriate pump 102 to perform the commanded injection. The clinician devices 140, 142 may also allow the clinician to remotely change infusion parameters or remotely silence alerts / alarms using a line management interface.
[0109] 7 is a diagram of a hemodynamic management device 106 connected to a pole 700 according to an exemplary embodiment of the present disclosure. In this embodiment, the pole 700 is configured to separately support the hemodynamic management device 106. The pole 700 can be floor mounted or set on a tabletop. The hemodynamic management device 106 can be communicatively coupled to the infusion pump 102, the RFT machine 104, and / or the fluid output sensor 302 via the gateway server 114 and / or the network 112.
[0110] (Configuration embodiment of hemodynamics management device) 8 shows a flow diagram illustrating an example procedure 800 for configuring the hemodynamic management device 106 of FIGS. 1-7 in accordance with an example embodiment of the present disclosure. The example procedure 800 may be performed, for example, by the application 126 and / or the processor 120 described in connection with FIGS. 1-3. Although the procedure 800 is described in connection with the flow diagram shown in FIG. 8, it should be understood that many other ways of performing the operations associated with the procedure 800 may be used. For example, the order of many of the blocks may be changed, certain blocks may be combined with other blocks, and many of the described blocks are optional.
[0111] The procedure 800 begins with an entry point where the hemodynamic management device 106 is provided to the patient (block 802). This may include attaching the hemodynamic management device 106 to the hub device 400 or moving the hemodynamic management device 106 to a room. The hemodynamic management device 106 then has the clinician execute a patient setup routine for patient association (block 804). This step may include scanning a patient wristband using a barcode scanner, entering a patient identifier into a registration interface of the hemodynamic management device 106, or searching for the patient in the EMR database 132 using a search interface of the application 126 (block 806).
[0112] Regarding the embodiment of barcode scanning, a barcode scanner may be connected to the hemodynamic management device 106. In this case, the hemodynamic management device 106 prompts the patient to scan the patient barcode or wristband, which causes the hemodynamic management device 106 to associate the scanned patient identifier with the processor 120. Alternatively, the barcode scanner may be attached to a separate computer on a wheel or other device. In these embodiments, the hemodynamic management device 106 is configured to display a barcode or a quick response ("QR") on the display interface screen 124. The code indicates the identifier of the hemodynamic management device 106. The hemodynamic management device 106 may prompt the clinician to also scan the code in addition to the barcode on the patient wristband. Scanning the code on the display interface screen 124 and the patient wristband causes the computer on a wheel or other device to write both the hemodynamic management device 106 and the patient's scanned identifier to the patient's EMR in the EMR database 132. The processor 120 of the hemodynamic management device 106 then reads the EMR in the database 132 and searches for its identifier. After the processor 120 finds the identifier of the hemodynamic management device 106, the processor 120 reads the associated patient identifier. At this point, the processor 120 has associated the hemodynamic management device 106 with the patient and determined the EMR to which the data 116 and / or 119 should be written by the medical devices 102 and 104.
[0113] It should be understood that patient identification is not necessarily required if the hemodynamic management device 106 is connected to the same hub device 400 as the infusion pump 102. In this case, the infusion therapy progress data 116 transmitted by the infusion pump 102 in the hub device 400 is automatically routed to the hemodynamic management device 106 without relying on patient identification matching. Instead, the common connection to the hub device 400 indicates that the hemodynamic management device 106 and the infusion pump 102 are associated with the same patient. However, patient identification may still be required to enable the hemodynamic management device 106 to write to the patient's EMR in the database 132.
[0114] In another embodiment, the hemodynamic management device 106 is configured to display a registration interface, such as the registration interface 900 shown in FIG. 9. As shown, the registration interface 900 is displayed on the display interface screen 124 by the application 126 and prompts the clinician to enter a patient identifier, age, sex, height, weight, and body mass index. Entering the patient identifier causes the application 126 (or, more generally, the processor 120) to search the EMR database 132 for a corresponding patient EMR. If the patient identifier is not known, the registration interface 900 may include an option to search for the patient identifier in the EMR database 132 using, for example, the patient's name, room number, date of birth, social security number, etc.
[0115] Returning to FIG. 8, at this point the hemodynamic management device 106 is associated with a particular patient. The application 126 of the hemodynamic management device 106 then displays a dashboard that allows the clinician to set up or configure a sensor 130 for fluid / hemodynamic management and / or add an infusion pump 102 for line management (block 808). Once the sensor option is selected, the application 126 executes a sensor setup routine (block 810). This routine may include pairing with one or more sensors 130 as described above. In some embodiments, the sensor module 202 is used to set up or configure the sensor 130.
[0116] After the sensor 130 is configured, the application 126 allows the clinician to start a new hemodynamic assessment (block 812). The options include selecting an assessment type (block 814), such as a PLR assessment, a bolus assessment, or an auto-bolus assessment (block 816). If a PLR assessment is selected, the application 126 determines a PLR baseline using the physiological data 128 from the sensor 130. The application 126 then prompts the clinician to start a PLR assessment and records the corresponding physiological data 128 from the sensor 130. If a bolus assessment is selected, the application 126 determines a bolus baseline using the physiological data 128 from the sensor 130. The application 126 then prompts the clinician to start a bolus assessment and records the corresponding physiological data 128 from the sensor 130. In the case of an auto-bolus, the application 126 may automatically transmit a command to the appropriate infusion pump 102 with instructions and parameters to perform a bolus.
[0117] Returning to block 808, once the clinician selects the infusion management option, the application 126 is configured to display a line management interface that allows the clinician to add a pump. This operation includes displaying one or more line management interfaces (block 820) and associating at least a portion of the infusion therapy progress data 116 with the designated pump graphic or icon. The procedure for adding an infusion pump is described in more detail in connection with FIG. 10. After configuration of the hemodynamic management device 106, the exemplary procedure 800 ends.
[0118] In some embodiments, the application is configured to automatically add the infusion pump when the hemodynamic management device 106 and the infusion pump 102 are connected to the hub device 400. In these embodiments, as each infusion pump 102 is programmed, the pump transmits the infusion therapy progress data 116 (including the start event) to the hub device 400, which is routed to the processor 120 of the hemodynamic management device 106. The application 126 uses at least some of the information in the infusion therapy progress data 116 to create a graphic or icon of the infusion pump 102 showing, for example, the name / type of fluid, the infusion rate, the dose, and / or information indicating the remaining amount to be infused or the estimated remaining time until the fluid container is empty. In this embodiment, the application 126 only prompts the clinician to specify the patient's access site. Alternatively, the application 126 may also automatically determine the access site information when the infusion pump 102 includes access site programming parameters, which may be included in the infusion therapy progress data 116.
[0119] In some examples of these embodiments, the application 126 is configured to arrange the graphical representation of the infusion pumps within the line management interface based on their stack location within the hub device 400. In these examples, the communications module 402 may show a shelf position or stack height for each infusion pump 102 based on the known communications port to which each pump is connected. Such a configuration provides a graphical layout of the infusion pumps 102 that matches their actual location within the hub device 400, making it easier for clinicians to quickly identify a particular infusion pump 102, such as an infusion pump associated with an alarm or alert. In these examples, the display interface screen 124 may show the infusion pump (or container) icon relative to the graphic of the hub device 400 or relative to each other based on its location within the hub device 400.
[0120] FIG 10 illustrates a flow diagram illustrating an exemplary procedure 1000 for infusion line management performed by the hemodynamic management device 106 of FIGS. 1-7 in accordance with an exemplary embodiment of the present disclosure. The exemplary procedure 1000 may be performed, for example, by the application 126 and / or the processor 120 described in connection with FIGS. 1-3. Although the procedure 1000 is described in connection with the flow diagram shown in FIG 10, it should be understood that many other ways of performing the operations associated with the procedure 1000 may be used. For example, the order of many of the blocks may be changed, certain blocks may be combined with other blocks, and many of the described blocks are optional.
[0121] The exemplary procedure 1000 begins when the hemodynamic management device 106 is associated with a patient, as described in connection with procedure 800 of FIG. 8. At this point, a clinician may configure the infusion pump 102 to deliver an infusion therapy. Configuration includes ordering fluids via the patient's EMR in database 132, causing the order to be filled, and causing a fluid container associated with the order to be hung adjacent to the infusion pump 102 in the patient's room. Configuration also includes connecting an IV tubing or IV line set to the fluid container and priming the IV tubing or IV line set. The IV line set or IV tubing is then loaded into the infusion pump 102 and connected to the patient's access site. The clinician then programs the infusion pump 102 to deliver the therapy. Programming may include manually entering infusion parameters, such as fluid name, dose, volume to be infused, and / or infusion rate into interfaces 108, 110 at the infusion pump 102. Programming may also include scanning a label or barcode on a fluid container that contains the programming parameters to be automatically programmed into the infusion pump. The programming may further include scanning a pump barcode and / or a patient barcode so that the electronic prescription in the patient's EMR is transmitted to the infusion pump 102. After programming, the infusion pump 102 compares the programmed parameters to the limits in the drug library file 314 and generates an alert / alarm when at least one limit is exceeded. In some embodiments, after programming, the infusion pump 102 transmits the infusion therapy progress data 116, including a new infusion start event, to the EMR server 118 for storage in the patient's EMR. The new infusion start event may include information indicating the infusion pump identifier, the name of the fluid being infused, the infusion rate, the volume to be infused, the dose, the volume remaining, and the time the new infusion start event was generated by the infusion pump 102.
[0122] The procedure 1000 then continues by the hemodynamic management device 106 using the patient association to access the patient's EMR to determine that a new infusion start event has occurred (block 1002). The hemodynamic management device 106 may be further configured to scan the patient's EMR or listen for new start events via the hub device 400. The hemodynamic management device 106 may use the event's timestamp to determine that the event is new and that the infusion pump 102 is ready to start (or has started) the infusion. Alternatively, the new infusion start event may be transmitted to the hemodynamic management device 106 via the hub device 400.
[0123] The hemodynamic management device 106 then displays an infusion line mapping interface (block 1004). FIG. 11 is a diagram of an exemplary infusion line mapping interface 1100 that may be displayed by the display interface screen 124 of the hemodynamic management device 106. The infusion line mapping interface 1100 displays a graphical illustration of the human body along with graphical diagrams or icons 1102 of fluids infused into the patient via a line set. Each icon 1102 indicates the amount of fluid remaining in a fluid container or an estimated time remaining until the fluid container is empty, as reported by the corresponding infusion pump 102 via the infusion therapy progress data 116. Each icon 1102 also includes a fluid name, an infusion rate, and a dose. Each icon 1102 may be associated with a corresponding infusion pump identifier.
[0124] In the illustrated example, an icon 1102 is created for display after the hemodynamic management device 106 detects a new infusion start event. As shown in FIGURE 10, the infusion line mapping interface 1100 prompts the clinician to specify an access site for the infusion (block 1006). This may include displaying a drop-down list of possible access sites or displaying the possible access sites for selection on a graphical illustration of a person within the interface 1100.
[0125] After receiving the access site selection, the hemodynamic management device 106 is configured to perform an infusion site suitability check (block 1008). This may include using the fluid type access site list in the drug library file 314 to determine whether the specified fluid type is permitted to be infused into the patient at the selected access site. In some embodiments, the hemodynamic management device 106 uses the fluid type access site suitability check in the drug library file 314 to proactively perform the suitability assessment by filtering possible access sites for selection based on known fluid types.
[0126] 10, if there is a compatibility issue, the hemodynamic management device 106 displays a warning and prompts the clinician for selection of an alternative access site in the infusion line mapping interface 1100 (block 1010). The hemodynamic management device 106 then receives a selection of a second, different access site (block 1012). The hemodynamic management device 106 may perform another compatibility check for the second access site.
[0127] The hemodynamic management device 106 also determines when multiple fluids are to be infused into the access site (block 1014). As shown in FIG. 11, furosemide, lipids, platelets, dexmedetomedine, and midazolam are fluidly connected to the same access site. To make the fluid connections, the clinician may use a series of Y-connectors or T-connectors. When there is more than one fluid to be infused into the access site, the hemodynamic management device 106 is configured to perform an incompatibility check between fluid types (block 1016). It should be appreciated that the incompatibility check determines whether certain fluid types can be mixed before infusion into the patient. The drug library file 314 also provides a general fluid type incompatibility list that specifies which fluid types cannot be infused into the patient at the same time or within a certain time period, regardless of the use of different access sites. It should be appreciated that the hemodynamic management device 106 is configured to perform both access site specific compatibility checks and general fluid checks.
[0128] To check an access site for multiple fluid compatibility, the hemodynamic management device 106 is configured to determine other fluid types associated with the given access site. The hemodynamic management device 106 then determines whether the other determined fluid types are listed in an incompatibility section for the given fluid type in the drug library file 314. If there is an access site specific compatibility issue, the hemodynamic management device 106 displays a warning and prompts the clinician for selection of an alternative access site in the infusion line mapping interface 1100 (block 1010). The warning may include showing the incompatible infusion with a red or yellow icon 1102, as shown in FIG. 12. The hemodynamic management device 106 then receives a selection of a second, different access site (block 1012). In some embodiments, the hemodynamic management device 106 may proactively determine an access site that is compatible with the new fluid type and provide a recommendation via the infusion line mapping interface 1100. In some embodiments, the hemodynamic management device 106 is configured to first search for access sites that already have an infusion connection. If a compatible currently in use access site is not found, the hemodynamic management device 106 is configured to identify an access site requiring a new needle access. The hemodynamic management device 106 may perform other compatibility checks for the second access site selected by the user when another fluid type is being infused into the second access site.
[0129] To perform the general fluid compatibility specific check, the hemodynamic management device 106 is configured to determine the other fluid types specified in the infusion line mapping interface 1100. The hemodynamic management device 106 may also check the patient's EMR for past infusions. The hemodynamic management device 106 then determines whether the other determined fluid types are listed in the incompatibilities section for the given fluid type in the drug library file 314. If there is a general fluid type compatibility issue, the hemodynamic management device 106 is configured to display a warning indicating that the selected fluid type cannot be administered for the other fluid being administered. The warning may indicate the specific fluid causing the patient incompatibility. The hemodynamic management device 106 may also specify the reason why the incompatibility exists. In some cases, the hemodynamic management device 106 transmits a warning or alert to the corresponding infusion pump 102, thereby preventing the infusion pump 102 from performing the therapy. Additionally, the hemodynamic management device 106 may transmit a warning or alert to the clinician device 140, 142.
[0130] As shown in FIG. 10, the hemodynamic management device 106 is configured to associate the selected access site in a given infusion pump when the compatibility check does not indicate an incompatibility issue (block 1018). The hemodynamic management device 106 may update a table or other data structure (e.g., data structure 127) that associates the access site with the icon 1102 and the infusion pump. The table or data structure 127 may be stored in the memory device 122 of the hemodynamic management device 106 and provides a correspondence between the infusion, the fluid type, and the access site. After the association, the hemodynamic management device 106 displays information associated with the new infusion start event at the selected access site in the infusion line mapping interface 1100 (block 1020). As shown in FIG. 11, this includes displaying the icon 1102 with information indicating the remaining amount of fluid in the fluid container, a graphic indicating the connection between the icon 1102 and the access site, the fluid type name, the infusion rate, and the dose. In some embodiments, an identifier for the infusion pump may also be displayed. If a given fluid type is connected to other fluid types at the access site, the infusion line mapping interface 1100 shows the infusion lines as connected to each other before a single line to the access site. The clinician may then press the "start" button on the newly added infusion pump to begin therapy. Alternatively, the hemodynamic management device 106 may transmit a message to the newly added infusion pump 102 indicating that infusion therapy may begin. Returning to FIG. 10, the exemplary procedure 1000 continues when another infusion start event is detected (or received) by the hemodynamic management device 106.
[0131] In some embodiments, the infusion line mapping interface 1100 allows a clinician to quickly identify which infusion pump is associated with each infusion represented by a respective graphical icon. For example, selection of the graphical icon 1102 may cause the application 126 to display additional information regarding the infusion pump 102 and / or the infusion. The additional information may include an infusion pump identifier, the volume to be infused, the infusion rate, and / or the name of the fluid being infused. The additional information may also include an option to ping the infusion pump 102. Selection of the ping option causes the application 126 to transmit a message to the infusion pump 102, which causes the infusion pump 102 to emit a sound, flash the display screen 108, or display a graphical / visual indication that the pump has been selected. The message may be transmitted directly to the infusion pump via the hub device 400 or may be transmitted to the infusion pump 102 via the gateway server 114.
[0132] 11 also illustrates that the application 126 may be configured to calculate a cumulative infusion rate. The application 126 sums each of the infusion rates shown in the interface 1100. The cumulative infusion rate may then be displayed to indicate the patient's total fluid intake. The interface 1100 includes hemodynamic parameters including SVI, CO, and heart rate. The parameters may be determined from physiological data 128 transmitted by one or more sensors 130 coupled to the hemodynamic management device 106. Thus, the infusion line mapping interface 1100 provides infusion line management in addition to displaying information indicative of fluid balance or intake and hemodynamic information.
[0133] (Exemplary Hemodynamic Modalities) 13 is a diagram illustrating different types of physiological data 128 input into the hemodynamic management device 106 of FIGS. 1-7 in accordance with an exemplary embodiment of the present disclosure. The physiological data 128 corresponds to the hemodynamic parameters displayed by the hemodynamic management device 106. In some embodiments, the physiological data 128 is processed by the hemodynamic management device 106 to determine other hemodynamic parameters, such as CI, SVI, and / or TPRI.
[0134] Physiological data 128 may be received from one or more of the sensors 130. As illustrated, the physiological data 128 may include cardiac output, stroke volume, blood pressure cuff measurements, SpO2 values, heart rate, heart rate variability, patient temperature, arterial line measurements including MAP, SVV, and / or PPV, ECG lead 2 measurements, ECG lead 3 measurements, respiratory rate, EtCO2 measurements, tidal volume, infiltration detection signals, thoracic fluid volume measurements, PVP and / or bioimpedance fluid status, urine volume measurements, intra-abdominal pressure values, continuous non-invasive blood pressure, continuous glucose and / or lactate measurements, continuous electrolyte measurements, continuous hematocrit measurements, central venous pressure measurements, blood gas measurements, ejection fraction measurements, ultrafiltration measurements or estimates, and / or fluid drainage measurements.
[0135] The exemplary hemodynamic management device 106 is configured to use the physiological data 128 within one or more hemodynamic modalities provided by the application 126. As shown in FIG. 12, the modalities can include hemodynamic assessment including PLR, bolus, and / or auto-bolus. The modalities also include display and trending of hemodynamic parameters, total fluid balance management, and / or guided hemodynamic therapy related to vasopressors, inotropes, and / or CRRT fluid removal. These modalities also include providing early detection of sepsis, acute kidney injury ("AKI"), and hemodynamic instability. With respect to infusion management, the modalities include infiltration detection, patient association, IV line management, relay control, drug timer management, and infusion layer management.
[0136] FIG. 14 is an illustration of a hemodynamic dashboard interface 1400 displayed on the display interface screen 124 by the application 126 of the hemodynamic management device 106 of FIGS. 1-7 in accordance with an exemplary embodiment of the present disclosure. The hemodynamic dashboard interface 1400 includes sections for fluid responsiveness / assessment, infusion status, and fluid balance. The fluid responsiveness section indicates that a hemodynamic bolus assessment was last performed 4 hours and 15 minutes ago, and that the ASYI has increased by 12.3% since the assessment. The infusion status indicates the total infusion flow rate, along with an indication that a new infusion line has been detected. The fluid balance section indicates a 12-hour fluid balance of +120 milliliters ("mL") and a recent change of +60 mL within the past hour. Selection of a section causes the application 126 to open another interface, as described in more detail below. The hemodynamic dashboard interface 1400 also includes sections for hemodynamic parameters including heart rate, CO, SVI, and TPRI. The SVI and TPRI parameter values may be determined from one or more calculations or comparisons of the physiological data 128. It should be understood that in other embodiments, additional or fewer hemodynamic parameters may be displayed within the dashboard interface 1400. Thus, the hemodynamic dashboard interface 1400, and more generally the hemodynamic management device 106, provides safer, more effective personalized therapy during a patient's hospital stay by integrating hemodynamic and therapy monitoring for hospitalized patients.
[0137] Fluid Responsive Embodiments 15 shows diagrams of fluid responsiveness interfaces 1502, 1504, 1506, and 1508 that may be displayed by the application 126 of the hemodynamic management device 106 in accordance with an exemplary embodiment of the present disclosure. The fluid responsiveness interfaces 1502, 1504, 1506, and 1508 are configured to provide hemodynamic assessment along with display of hemodynamic parameters including, for example, SVI, CI, and heart rate.
[0138] After the clinician selects the fluid responsiveness section of the dashboard interface 1400 of FIG. 14 and then selects to perform a PLR assessment, a first fluid responsiveness interface 1502 may be displayed. The fluid responsiveness interface 1502 includes a prompt to perform a PLR. After the patient is positioned, selection of the "next" option causes the application 126 to start a timer during which the PLR assessment is in progress, as shown in the fluid responsiveness interface 1504. Prior to the PLR assessment, the application 126 may store baseline hemodynamic parameter values, and then after the assessment begins, the application 126 aggregates or tracks new hemodynamic parameter values. The application 126 continues the assessment, as shown in the fluid responsiveness interface 1506, until the timer expires. The application 126 then displays a fluid responsiveness interface 1508 showing information indicative of fluid responsiveness as determined from the measured or calculated hemodynamic parameters.
[0139] This includes, for example, the rate of change for the SVI for the assessment, fluid flow rate, and fluid type. In this manner, the application 126 of the hemodynamic management device 106 provides real-time clinical decision support regarding the patient's fluid responsiveness. Figure 16 shows a hemodynamic dashboard interface 1400 after a hemodynamic assessment has been performed. The fluid responsiveness section shows the time since the last assessment and the option to perform a new assessment via PLR or bolus.
[0140] For example, it should be understood that if the bolus option is selected in the hemodynamic dashboard interface 1400, the application performs similar operations for bolus hemodynamic assessment. In some cases, the application 126 includes a prompt for the clinician to indicate when the bolus has started. Alternatively, the application 126 is configured to detect a bolus start event via the infusion line mapping interface 1100 and corresponding data structures, which triggers the display of the assessment interface and hemodynamic assessment trace. In yet another embodiment, the application 126 may transmit instructions for a designated infusion pump 102 to administer a bolus via the hub device 400 or gateway server 114. The instructions may identify the infusion pump, the bolus start command, and the duration of the bolus. In this manner, the application 126 itself initiates the hemodynamic assessment of fluid responsiveness.
[0141] 17 is an illustration of an evaluation interface 1700 showing a status of a bolus hemodynamic evaluation according to an exemplary embodiment of the present disclosure. The evaluation interface 1700 includes bolus duration, completion percentage, fluid type, and fluid flow rate. The application 126 may receive information indicative of the completion percentage, fluid type, and / or flow rate from the infusion therapy progress data 116 generated by the corresponding infusion pump 102.
[0142] FIG. 18 is an illustration of a fluid responsiveness interface 1800 that may be shown by the application 126 of the hemodynamic management device 106 after a hemodynamic assessment has been performed or is in progress according to an exemplary embodiment of the present disclosure. The fluid responsiveness interface 1800 shows trends in SVI, CI, and heart rate over time, including the baseline prior to the hemodynamic assessment. It is understood that the fluid responsiveness interface 1800 may include additional or fewer hemodynamic parameters. The fluid responsiveness interface 1800 also highlights a section of the trend data corresponding to the hemodynamic assessment highlighting how the hemodynamic parameters responded to the assessment. The fluid responsiveness interface 1800 further includes functionality that allows the clinician to change the timescale of the trend data between 15 minutes, 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, etc. Thus, the fluid responsiveness interface 1800 may provide real-time continuous information regarding heart rate, cardiac index, cardiac output, stroke volume index, stroke volume, and / or total peripheral resistance.
[0143] 18 illustrates hemodynamic parameters, it is understood that the application 126 is configured to provide an interface that displays other physiological data 128 values and / or physiological trends that may be displayed along with the infusion or fluid balance trends. For example, heart rate, SVI, and blood pressure may be displayed along with a specific infusion flow rate or volume, a cumulative infusion fluid flow rate / volume, and / or a net fluid balance flow rate / volume.
[0144] (Embodiment of the injected state) The hemodynamic dashboard interface 1400 shown in FIG. 14 also includes an infusion status section. The application 126 is configured to detect an alarm and / or warning in the infusion therapy progress data 116 or the physiological data 128. The alarm or warning may indicate an infiltration, a line occlusion, a pump or IV line leak, an empty or nearly empty bag, or the physiological data 128 exceeding one or more physiological limits (e.g., a heart rate exceeding 125 beats per minute). When the application 126 detects an alarm and / or warning, the application 126 is configured to update the hemodynamic dashboard interface 1400. FIG. 19 is an illustration of a hemodynamic dashboard interface 1400 in which the infusion status section has been modified to show information indicative of an alarm or warning according to an exemplary embodiment of the present disclosure.
[0145] Specifically, in this embodiment, the infusion status section indicates that at least one bag or fluid container is nearly empty. The clinician may select the infusion status section of the hemodynamic dashboard interface 1400, which causes the application 126 to display the infusion line mapping interface 1100, as shown in FIG. 20. The application 126 highlights the IV line and the graphical icon 2002 associated with the bag nearly empty alert. In some embodiments, the application 126 provides the highlighting by changing the color from blue / gray to yellow. Bag empty may be indicated in red. The graphical icon 2002 is also changed to indicate the estimated amount of fluid remaining in the fluid container or the estimated time until the fluid container is empty. The application 126 may also display a value indicating the time remaining. Selection of the graphical icon 2002 causes the application 126 to transmit a command to the corresponding infusion pump 202, which may cause the corresponding infusion pump 202 to emit an audible sound, or flash a light or screen, or display some other indication as to which infusion pump 202 corresponds to the alert / alarm. In other examples, the display 108 of the infusion pump 102 may already be displaying information indicating a warning / alarm. The warning / alarm may be removed by changing the bag and having the barcode scanner scan a new bag or input that a new bag has been added. Thus, the application 126 detects the bag change in the corresponding event data of the infusion therapy progress data 116 stored in the patient's EMR in the database 132 or transmitted to the hemodynamic management device 106 via the hub device 400.
[0146] FIG. 21 is an illustration of a hemodynamic dashboard interface 1400 displaying an indication of an alert associated with the detection of an infiltration. The application 126 may detect the infiltration based on the physiological data 128b from the sensor 130b of FIG. 2. The alert may identify the access site associated with the corresponding infiltration or infusions. In this example, the alert in the hemodynamic dashboard interface 1400 indicates that an infiltration was detected at a right antecubital access site. Selection of the infusion status section of the hemodynamic dashboard interface 1400 causes the application 126 to display the infusion line mapping interface 1100, as shown in FIG. 22. Here, the application highlights the IV line connected to the access site in question and indicates an infiltration alert. The alert may be removed by the clinician securing the access site connection or clearing the alert after determining that an infiltration has not occurred.
[0147] (Embodiment of Fluid Balance) The hemodynamic dashboard interface 1400 of FIG. 14 also includes a section for fluid balance. Selection of that section causes the application 126 to display a fluid balance interface 2300, as shown in FIG. 23. The fluid balance interface 2300 provides a summary of infused and detected fluids removed for a specified time period, such as 1 hour, 4 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, etc. The infused fluid is determined by summing or combining the individual infusion rates shown in the infusion line mapping interface 1100. The removed fluid may be determined from the RFT machine 104, the fluid output sensor 302, and / or any other sensor 130 configured to measure fluid removed from the patient. The application 126 is also configured to determine fluid output data from the patient's EMR in the database 132. In some embodiments, the fluid balance interface 2300 may allow the clinician to manually input fluid inflow or fluid outflow. Additionally, in the illustrated embodiment, the fluid balance interface 2300 provides a display of a fluid assessment for the fluid balance.
[0148] FIG. 24 is an illustration of a detailed net fluid balance interface 2400 according to an exemplary embodiment of the present disclosure. The net fluid balance interface 2400 provides a detailed list of each fluid entered for the patient as determined from the infusion line mapping interface 1100 and / or manually entered by the clinician. Additionally, the net fluid balance interface 2400 provides a list of fluids removed as detected by different sources including the RFT machine 104, the fluid output sensor 302, and the drainage sensor. Additionally, the clinician may manually enter information indicating that fluid has been removed. The net fluid balance interface 2400 allows monitoring of total fluids entering and leaving along with current infusion information. Additionally, the net fluid balance interface 2400 consolidates infusion therapy information to provide a comprehensive view on one screen, thereby improving the clinician's experience.
[0149] (Conclusion) It will be understood that all of the disclosed methods and procedures described herein can be implemented using one or more computer programs, or components. These components can be provided as a series of computer instructions on any conventional computer-readable medium, including RAM, ROM, flash memory, magnetic or optical disks, optical memory, or other storage media. The instructions can be configured to be executed by a processor, which, upon executing the series of computer instructions, performs (or facilitates the execution of) all or a portion of the disclosed methods and procedures.
[0150] It should be understood that various changes and modifications to the exemplary embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. Accordingly, such changes and modifications are intended to be covered by the appended claims.
[0151] It is understood that 35 U.S.C. § 112(f) or 35 U.S.C. § 112, paragraph 6 is not intended to be invoked unless the terms "means" or "step" are expressly recited in a claim, and thus the claims are not meant to be limited to the corresponding structures, materials, or acts described in the specification, or equivalents thereof.
Claims
1. A hemodynamic management device, comprising: a display interface screen; a memory device storing a patient identifier; a processor communicatively coupled to the display interface screen and to the memory device; Equipped with The processor, accessing a patient medical record in an electronic medical record database using the patient identifier; determining from the patient medical record a new infusion start event associated with an infusion pump fluidly connected to a patient corresponding to the patient medical record, the new infusion start event including information indicative of an infusion pump identifier, a name of the fluid being infused, an infusion rate, a volume to be infused, a dose, a remaining volume, and a time when the new infusion start event was generated by the infusion pump; displaying on said display interface screen an infusion line mapping interface showing a graphical illustration of the human body and potential access sites; prompting for selection of an access site within the infusion line mapping interface; after receiving a selection of an access site, associating in the memory device the infusion pump identifier with the selected access site; displaying at least a portion of the information associated with the new infusion start event on the display interface screen along with the selected access site shown in the infusion line mapping interface; The hemodynamic management device is configured to:
2. The memory device is configured to store a drug library specifying incompatibilities between fluid types and access site types, and the processor: after receiving the selection of the access site, performing a check for a fluid type and access site incompatibility between the selected access site and the name of the fluid to be injected; If there is any incompatibility, displaying a warning within the infusion line mapping interface and providing a prompt to change the access site for the infused fluid name associated with the infusion pump; removing the alert after receiving a selection of a second access site; displaying the at least a portion of the information associated with the new infusion start event along with the selected second access site; and The hemodynamic management device of claim 1 , further configured to:
3. The processor, determining a suitable access site based on the infused fluid name using the drug library; displaying, on the infusion line mapping interface, recommendations for fluidly connecting the infusion pump to the determined suitable access site; The hemodynamic management device of claim 2 , further configured to:
4. The processor, determining from the patient medical record a second new infusion start event associated with a second infusion pump fluidly connected to the patient corresponding to the patient medical record, the second new infusion start event including second information indicating a second infusion pump identifier, a second infused fluid name, a second dose, a second infusion rate, a second volume to be infused, a second remaining volume, and a second time at which the second new infusion start event was generated by the second infusion pump; displaying the infusion line mapping interface on the display interface screen; prompting for selection of a second access site within the infusion line mapping interface; after receiving a selection of the second access site, displaying on the display interface screen at least a portion of the second information associated with the second new infusion start event along with the selected second access site; The hemodynamic management device of claim 1 , further configured to:
5. The memory device is configured to store a drug library specifying incompatibilities between fluid types for an access site, and the processor is further configured to: performing a check for a fluid type incompatibility between the infused fluid name and the second infused fluid name after receiving the selection of the second access site; If there is any incompatibility, displaying a warning within the infusion line mapping interface and providing a prompt to change an access site for the second infused fluid name associated with the second infusion pump; removing the alert after receiving a selection of a third access site; displaying at least a portion of the second information associated with the second new infusion start event along with the selected third access site; The hemodynamic management device of claim 4 , further configured to:
6. The processor, receiving hemodynamic information from at least one sensor indicative of cardiac stroke volume, cardiac output, cardiac index, heart rate, total peripheral resistive index ("TPRI"), or fluid responsiveness; causing at least a portion of the hemodynamic information to be displayed together with the infusion line mapping interface or in a separate hemodynamic interface; The hemodynamic management device of claim 1 , 3 or 5 , further configured to:
7. The processor, determining hemodynamic information indicative of cardiac stroke volume, cardiac output, cardiac index, heart rate, total peripheral resistive index ("TPRI"), or fluid responsiveness; causing at least a portion of the hemodynamic information to be displayed together with the infusion line mapping interface or in a separate hemodynamic interface; The hemodynamic management device of claim 1 , 3 or 5 , further configured to:
8. The processor, combining the infusion rate of the infused fluid with other infusion rates associated with the patient specified in the patient medical record; determining a fluid output flow rate specified in the patient medical record, the fluid output flow rate corresponding to at least one of dialysis, urine monitoring, or fluid drainage; determining a fluid balance as the difference between the combined inlet flow rate and the combined outlet fluid flow rate; displaying at least the fluid balance within an interactive graphical interface presented by the display interface screen or within the infusion line mapping interface; The hemodynamic management device of claim 1 , 3 or 5 , further configured to:
9. The processor, determining a new infusion event from the patient medical record, the new infusion event specifying a time when the new infusion event was generated by the infusion pump and indicating at least one of a changed infusion rate, a changed volume to be infused, or a changed remaining volume; updating the infusion line mapping interface based on information associated with the new infusion event; The hemodynamic management device of claim 1 , 3 or 5 , further configured to:
10. The processor, receiving information indicative of an alarm event or determining an alarm event from the patient medical record; displaying a graphic or at least a portion of the information indicative of the alarm event; [0023] 20. The method according to claim 1, further comprising: The hemodynamic management device of claim 1 , 3 or 5 , wherein the alarm event includes at least one of an infiltration detection, a line occlusion, or an indication that a fluid container is empty or nearly empty.
11. The infusion line mapping interface includes: Displaying the name of the fluid to be injected and the injection rate; displaying a graphical icon indicative of said remaining volume or a time indicative of said remaining volume; The hemodynamic management device of claim 1 , 3 or 5 , configured to:
12. The processor, determining that the remaining volume or a time indicative of the remaining volume is less than a threshold; displaying the remaining volume or the time indicative of the remaining volume together with the graphical icon; changing the color of said graphical icon and said selected access site; The hemodynamic management device of claim 11, further configured to:
13. The hemodynamic management device of claim 11, wherein the selection of the graphical icon causes the processor to display at least the infusion pump identifier, the amount to be infused, the infusion rate, and the name of the fluid to be infused.
14. 12. The hemodynamic management device of claim 11, wherein the selection of the graphical icon causes the processor to transmit a message, the message causing the infusion pump to generate a sound or provide a visual indication.
15. 6. The hemodynamic management device of claim 1, 3, or 5, wherein the patient identifier is entered into the display interface screen, stored in the memory device, or determined from the patient medical record.
16. 10. The hemodynamic management device of claim 1, 3 or 5, further comprising an adapter for connection to a hub device that is also connected to the infusion pump.
17. 1. A method for hemodynamic management, the method comprising: accessing, via the processor, a patient medical record in an electronic medical record database using the patient identifier; determining, using the processor, from the patient medical record, a new infusion start event associated with an infusion pump fluidly connected to a patient corresponding to the patient medical record, the new infusion start event including information indicative of an infusion pump identifier, a name of the fluid being infused, an infusion rate, a volume to be infused, a dose, a remaining volume, and a time when the new infusion start event was generated by the infusion pump; displaying, via said processor, an infusion line mapping interface on a display interface screen showing a graphical illustration of the human body and potential access sites; prompting, via the processor, for selection of an access site within the infusion line mapping interface; after receiving a selection of an access site, associating, via the processor, the infusion pump identifier with the selected access site; displaying, via the processor, at least a portion of the information associated with the new infusion start event on the display interface screen along with the selected access site shown in the infusion line mapping interface; A method for hemodynamic management comprising:
18. The method comprises: after receiving the selection of the access site, performing, via the processor, a check for fluid type and access site incompatibility between the selected access site and the name of the fluid to be infused using a drug library that specifies fluid type and access site type incompatibility; If there is any incompatibility, displaying, via the processor, a warning within the infusion line mapping interface and providing a prompt to change an access site for the infused fluid name associated with the infusion pump; removing the alert after receiving, via the processor, a selection of a second access site; and displaying, via the processor, the at least a portion of the information associated with the new infusion start event along with the selected second access site.
20. The hemodynamic management method of claim 17, further comprising:
19. The method comprises: determining, via said processor, a suitable access site based on said infused fluid name and using said drug library; causing, via the processor, the infusion line mapping interface to display recommendations for fluidly connecting the infusion pump to the compatible access site.
20. The hemodynamic management method of claim 18, further comprising:
20. The method comprises: combining, via the processor, the infusion rate of the infused fluid name with other infusion rates associated with the patient specified in the patient medical record; determining, via the processor, a fluid output flow rate specified in the patient medical record, the fluid output flow rate corresponding to at least one of dialysis, urine monitoring, or fluid drainage; determining, via the processor, a fluid balance as the difference between the combined inlet fluid flow rate and the combined outlet fluid flow rate; displaying, via the processor, at least the fluid balance within an interactive graphical interface presented by the display interface screen or within the infusion line mapping interface; 20. The hemodynamic management method of claim 17, further comprising: