Vitals module for an infusion system

Abstract

An infusion system with integrated vital signs monitoring including an infusion system configured to intravenously deliver a fluid and / or a medicament to a patient. The infusion system further includes a vitals module configured to acquire at least one patient physiological signal and to communicate that physiological signal to a processor and / or record that physiological signal within an EMR.

Description

[0001] VITALS MODULE FOR AN INFUSION SYSTEM

[0002] CROSS-REFERENCE TO RELATED APPLICATION(S) This application claims the benefit of U.S. Provisional Application No.

[0003] 63 / 762,485, filed February 24, 2025, and entitled “VITAL SIGN MODULE FOR INFUSION PUMP," the disclosure of which is hereby incorporated by reference in its entirety.

[0004] BACKGROUND

[0005] The present disclosure relates to an infusion system, and more particularly to a vitals module for an infusion system.

[0006] Infusion systems can deliver fluids and / or medicaments, including, for example, medications, blood, blood products, and any other IV fluid, into a patient’ s body in a controlled manner. Infusion systems are typically used in hospitals or clinics to deliver fluids and / or medicaments to patients in a controller manner over a predetermined period of time via intravenous infusion. Infusion systems can include a controller unit and a plurality of modules coupled to the controller unit and configurable to deliver fluids and / or medicaments to the patient. A healthcare provider can set the infusion rate, pumping function, and other programming using the controller unit and / or the plurality of modules. The controller unit and the plurality of modules can work together, using compatible power specifications, communication protocols, and mechanical interconnects.

[0007] SUMMARY

[0008] An infusion system with integrated vital signs monitoring including an infusion system configured to intravenously deliver a fluid and / or a medicament to a patient. The infusion system further includes a vitals module configured to acquire at least one patient physiological signal and to communicate that physiological signal to a processor and / or record that physiological signal within an EMR.

[0009] An attachable vitals module for an infusion system including an enclosure, electronics configured to acquire at least one patient physiological signal, and at least one interface configured to couple the vitals module to the infusion system to communicate data thereto.

[0010] BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 A is a front view of an infusion system including a plurality of pump modules.FIG. IB is a front view of the infusion system including a pump module, a syringe module, a patient-controlled analgesia module, and a respiratory monitoring module.

[0011] FIG. 2 is a front view of a vitals module.

[0012] FIG. 3 is a perspective view of a hemodynamic sensor for sensing hemodynamic data representative of arterial pressure of a patient.

[0013] FIG. 4 is a perspective view of a hemodynamic sensor for sensing hemodynamic data representative of arterial pressure of the patient.

[0014] FIG. 5 is a front view of the infusion system including the plurality of pump modules and the vitals module.

[0015] FIG. 6A is an isometric view of a first side of the vitals module.

[0016] FIG. 6B is an isometric view of a second side of the vitals module.

[0017] FIG. 7A is a front view of the vitals module.

[0018] FIG. 7B is a back view of the vitals module.

[0019] FIG. 7C is a side view of the first side of the vitals module.

[0020] FIG. 7D is a side view of the second side of the vitals module. FIG. 7E is a top view of the vitals module.

[0021] FIG. 7F is a bottom view of the vitals module.

[0022] FIG. 8A is an exploded view of the vitals module.

[0023] FIG. 8B is a back isometric view of the vitals module with the rear enclosure removed.

[0024] FIG. 9A is an assembled view of a manifold subassembly of the vitals module.

[0025] FIG. 9B is an exploded view of the manifold subassembly of the vitals module.

[0026] FIG. 9C is a cross sectional view of the vitals module taken along line 9C-9C of FIG. 7B.

[0027] FIG. 10 is a block diagram of the vitals module.

[0028] FIG. 11 is a block diagram of the infusion system.

[0029] FIG. 12 is a front view of an infusion system including an alternate embodiment of a vitals module displaying a representative blood pressure waveform.

[0030] FIG. 13 is a front view of an infusion system including the alternate embodiment of the vitals module displaying that a bolus is recommended.FIG. 14 is a front view of an infusion system including the alternate embodiment of the vitals module displaying that an insulin flow is being modified.

[0031] FIG. 15 is a front view of an infusion system including the alternate embodiment of the vitals module displaying that a sedation level is being adjusted.

[0032] FIG. 16 is a front view of a monitor displaying thresholds for stopping infusion.

[0033] FIG. 17 is a schematic view of a further alternate embodiment of a vitals module and sensors that can be coupled to the vitals module.

[0034] DETAILED DESCRIPTION FIG. 1 A is a front view of infusion system 10 including a plurality of pump modules 14. FIG. IB is a front view of infusion system 10 including pump module 14, syringe module 16, patient-controlled analgesia module 18, and respiratory monitoring module 20. FIGS. 1 A and IB will be discussed together. FIGS. 1A and IB show infusion system 10, including controller unit 12 and pump modules 14. FIG IB. shows syringe module 16, syringe 16A, patient-controlled analgesia module 18, syringe 18 A, patient controller 18B, respiratory monitoring module 20, and sensor 20A of infusion system 10.

[0035] Infusion system 10 can provide standardization and / or interoperability of infusion of fluids and / or medicaments. Infusion system 10 can also be referred to as a patient care system. Infusion system 10 is used to accurately deliver fluids and / or medicaments to a patient through intravenous or epidural routes. Infusion system 10 can deliver fluids and / or medicaments to a patient at any suitable rate, for example a rate between 0.1 and 999 mL / hr or higher. Infusion system 10 is a modular platform that includes controller unit 12 and one or more modules. Controller unit 12 can also be referred to as an interface unit, a PC unit, or a PCU. Controller unit 12 forms the base of infusion system 10 and the one or more modules can be attached to controller unit 12. Controller unit 12 can include a display and an interface (e.g., a keypad or a touch display) that a healthcare provider can use to program controller unit 12. Controller unit 12 can wirelessly transmit key drug and infusion therapy data to external devices, centralizing access to infusion and monitoring data. For example, controller unit 12 can be communicatively coupled to an EMR (electronic medical record).

[0036] The modules can include pump module 14, syringe module 16, patient-controlled analgesia module (PCA module) 18, and respiratory monitoring module (EtCO2 module) 20. Each of pump module 14, syringe module 16, patient-controlled analgesia module 18, and respiratory monitoring module 20 are coupled to, either directly orindirectly, and controlled via controller unit 12. Pump module 14 and syringe module 16 are configured to deliver fluids and / or medicaments to a patient. Pump module 14 and syringe module 16 can be programmed, via controller unit 12, to deliver a specific amount of fluid, one or more timing parameters for delivering the fluid, and other specific instructions.

[0037] Pump module 14 can also be referred to as a volume pump module. Pump module 14 allows for continuous or intermittent delivery of fluids and / or medicaments, including medications, blood, and blood products, to patients, including adult, pediatric, and neonatal patients. Pump module 14 can pump the fluids and / or medicaments from an IV bag or other fluid container through pump module 14 and into a patient via an IV or epidural. Tubing and / or other fittings extending from the IV bag or other fluid container can be positioned in and connected to pump module 14. Tubing and / or other fittings extending from pump module 14 can be connected to an IV or epidural of the patient. Pump module 14 can pump the fluid from the IV bag or other fluid container through pump module 14 and into the patient at a set rate.

[0038] Syring module 16 can also be referred to as a syringe pump module. Syringe module 16 allows for continuous or intermittent delivery of fluids and / or medicaments, including medications, blood, and blood products, to patients. Syring module 16 can pump the fluids and / or medicaments from syringe 16A into a patient via an IV or epidural. Syringe 16A can be connected to an IV or epidural of a patient via tubing and other fittings. Syringe 16A can be positioned in and connected to syringe module 16 so that syringe module 16 can deploy the plunger of syringe 16A to deliver the fluid to the patient at a set rate.

[0039] Patient-controlled analgesia module 18 allows a patient to control the delivery of analgesia on an as-needed basis. Patient-controlled analgesia module 18A can pump analgesia from syringe 18A into a patient via an IV or epidural. Syringe 18A can be connected to an IV or epidural of a patient via tubing and other fittings. Syringe 18A can be positioned in and connected to patient-controlled analgesia module 18 so that patient-controlled analgesia module 18 can deploy the plunger of syringe 18A to deliver the analgesia to the patient as needed. Patient-controlled analgesia module 18 further includes patient controller 18B connected to patient-controlled analgesia module 18 and extending to a patient to allow the patient to select when analgesia is delivered.

[0040] Respiratory monitoring module 20 can be integrated with patient-controlled analgesia module 18. Respiratory monitoring module 20 allows for continuous respiratorymonitoring (e.g., EtCCh) to reduce the risk of opioid-induced respiratory depression when used in connection with PCA module 18. Sensor 20A is connected to a port in respiratory monitoring module 20. Sensor 20A is then connected a patient to provide respiratory monitoring for the patient.

[0041] Any number of modules and any combination of modules can be coupled to controller unit 12. As shown in FIG. 1A, three pump modules 14 are coupled to controller unit 12 to form infusion system 10. As shown in FIG. IB, one pump module 14, one syringe module 16, one patient-controlled analgesia module 18, and one respiratory monitoring module 20 are coupled to controller unit 12 to form infusion system 10. The modules can be coupled to controller unit 12 in any suitable arrangement. In other examples, any number of pump modules 14, syringe modules 16, patient-controlled analgesia modules 18, and respiratory monitoring modules 20 can be coupled to controller unit 12.

[0042] Controller unit 12, pump module 14, syringe module 16, patient-controlled analgesia module 18, and respiratory monitoring module 20 include standard connectors that can be used to connect to one another. The standard connectors provide mechanical, power, and communication connections. The connectors can be referred to as inter-unit interface (IUI) connectors. An IUI connector integrates mechanical, power, and communication connections into a single connector, allowing the plurality of modules to be easily connected to controller unit 12 and / or other modules to couple each module to controller unit 12 and provide power thereto, as described in U.S. Pat. No. 7,553,291, filed Inly 10, 2006, entitled “Modular patient care system with interchangeable modules,” the disclosure of which is hereby incorporated by reference in its entirety.

[0043] FIG. 2 is a front view of vitals module 30. Vitals module 30 includes I / O connectors 32, display 34, and indicator 36.

[0044] Vitals module 30 is a module that can form part of an infusion system, for example infusion system 10 shown in FIGS. 1A-1B. Vitals module 30 can be coupled to controller unit 12, shown in FIGS. 1A and IB. Vitals module 30 senses hemodynamic data or other physiological data of the patient and can determine physiological parameters based on the sensed data. Further, vitals module 30 can display the sensed data, including as representative waveforms, and the physiological parameters. The terms hemodynamic data, data, physiological data, and physiological signals are used interchangeably throughout.

[0045] Vitals module 30 can be coupled to one or more sensors for monitoring a patient's physiological state. Vitals module 30 can also be referred to as a vital sign module.Vitals module 30 includes I / O connectors 32 on the front side of vitals module 30. I / O connectors 32 allow sensors, including hemodynamic sensors, to be connected to vitals module 30 to provide data from a patient to vitals module 30. Vitals module 30 can also power the sensors in some embodiments. The sensors can include noninvasive, minimally invasive, and / or invasive sensors. I / O connectors 32 include two I / O connectors on the front side of vitals module 30 in the embodiment shown, but I / O connectors 32 can include any suitable number of I / O connectors in alternate embodiments. I / O connectors 32 are positioned on a front side of vitals module 30 in the embodiment shown, but I / O connectors 32 can be positioned on any side of vitals module 30 in alternate embodiments.

[0046] Vitals module 30 further includes display 34 to display the hemodynamic data from the patient. Display 34 can be a touch display, or touchscreen, that allows a healthcare provider to provide input to vitals module 30 via display 34. As shown in FIG.

[0047] 2, display 34 can display a waveform representative of a patient’s arterial pressure or any other suitable pressure. Display 34 can also display a patient’s physiological status. For example, as shown in FIG. 2, display 34 displays a patient’s blood pressure (e.g., mean arterial blood pressure (MAP), systolic blood pressure, and diastolic blood pressure), pulse rate, SpO2, and respiratory rate (RR). Indictor 36 is positioned at a top of display 34 and can serve as a visual alarm if the patient’s physiological status goes outside of predetermined thresholds.

[0048] Vitals module 30 can include a processor that can execute one or more algorithms stored in vitals module 30. The processor is a controller configured to perform an infusion safety shutoff of infusion system based on one or more vital-sign thresholds. One or more sensors can be connected to vitals module 30 to collect physiological data from the patient. Vitals module 30 can execute the algorithms using the data sensed from the one or more sensors to derive physiological parameters to determine a patient’s current or future physiological state. The derived physiological parameters can be based on data from one or more sensors and / or one or more sensors of different types. The physiological parameters can include one or more indices that reflect a patient’s physiological state or indicate a probability of a patient’s future physiological state. Vitals module 30 can include alarms, specifically visual alarms, for example indicator 36, for alerting a healthcare provider when physiological parameters are or are predicted to be outside of predetermined ranges or thresholds, indicating that a patient requires care. Vitals module 30 can also include audio alarms for alerting a healthcare provider when physiological parameters areor are predicted to be outside of predetermined ranges or thresholds. The alarms on vitals module 30 can be silenced on vitals module 30.

[0049] Advanced parameters can be derived from the physiological parameters. Such advanced parameters for continuous blood pressure readings can include, for example, respiration rate. An algorithm can be stored on vitals module 30 that can be executed to determine respiration rate using hemodynamic data (e.g., the blood pressure waveforms) collected by the sensors connected to vitals module 30. A patient’s respiration rate can be output in breaths per minute and updated on a regular interval, for example once every 20 seconds.

[0050] Examples of sensors that can coupled to vitals module 30 are shown in FIGS. 3 and 4 below.

[0051] FIG. 3 is a perspective view of hemodynamic sensor 50 for sensing hemodynamic data representative of arterial pressure of the patient. Hemodynamic sensor 50 is one example of a minimally invasive hemodynamic sensor that can be attached to the patient via, e.g., a radial arterial catheter inserted into an arm of the patient. In other examples, hemodynamic sensor 50 can be attached to the patient via a femoral arterial catheter inserted into a leg of the patient. Hemodynamic sensor 50 can be connected to vitals module 30 to provide hemodynamic data sensed by hemodynamic sensor 50 to vitals module 30.

[0052] As illustrated in FIG. 3, hemodynamic sensor 50 includes housing 52, fluid input port 54, catheter-side fluid port 56, and VO cable 58. Fluid input port 54 is configured to be connected via tubing or other hydraulic connection to a fluid source, such as a saline bag or other fluid input source. Catheter-side fluid port 56 is configured to be connected via tubing or other hydraulic connection to a catheter (e.g., a radial arterial catheter or a femoral arterial catheter) that is inserted into an arm of the patient (i.e., a radial arterial catheter) or a leg of the patient (i.e., a femoral arterial catheter). VO cable 58 is configured to connect to vitals module 30 via, e.g., one or more of VO connectors 32 (FIG. 2). Housing 52 of hemodynamic sensor 50 encloses one or more pressure transducers, communication circuitry, processing circuity, and corresponding electronic components to sense fluid pressure corresponding to arterial pressure of the patient that is transmitted to vitals module 30 (FIG. 2) via VO cable 58.

[0053] In operation, a column of fluid (e.g., saline solution) is introduced from a fluid source (e.g., a saline bag) through hemodynamic sensor 50 via fluid input port 54 to catheter-side fluid port 56 toward the catheter inserted into the patient. Arterial pressure iscommunicated through the fluid column to pressure sensors located within housing 52 which sense the pressure of the fluid column. Hemodynamic sensor 50 translates the sensed pressure of the fluid column to an electrical signal via the pressure transducers and outputs the corresponding electrical signal to vitals module 30 (FIG. 2) via I / O cable 58. Hemodynamic sensor 50 therefore transmits analog sensor data (or a digital representation of the analog sensor data) to vitals module 30 (FIG. 2) that is representative of substantially continuous beat-to-beat monitoring of the arterial pressure of the patient.

[0054] FIG. 4 is a perspective view of hemodynamic sensor 60 for sensing hemodynamic data representative of arterial pressure of the patient. Hemodynamic sensor 60 is one example of a non-invasive hemodynamic sensor that can be attached to the patient via one or more finger cuffs to sense data representative of arterial pressure of the patient. Hemodynamic sensor 60 can be connected to vitals module 30 to provide hemodynamic data sensed by hemodynamic sensor 60 to vitals module 30.

[0055] As illustrated in FIG. 4, hemodynamic sensor 60 includes inflatable finger cuff 62, heart reference sensor 64, and FO cable 66. Inflatable finger cuff 62 includes an inflatable blood pressure bladder configured to inflate and deflate as controlled by a pressure controller (not illustrated) that is pneumatically connected to inflatable finger cuff 62. Inflatable finger cuff 62 also includes an optical (c.g., infrared) transmitter and an optical receiver that are electrically connected to the pressure controller (not illustrated). The optical transmitter and the optical receiver can measure the changing volume of the arteries under the cuff in the finger. The optical transmitter and the optical receiver can be positioned to transmit and receive light therebetween through the inflatable blood pressure bladder.

[0056] In operation, the pressure controller continually adjusts pressure within the finger cuff to maintain a constant volume of the arteries in the finger (i.e., the unloaded volume of the arteries) as measured via the optical transmitter and optical receiver of inflatable finger cuff 62. The pressure applied by the pressure controller to continuously maintain the unloaded volume is representative of the blood pressure in the finger and is communicated by the pressure controller to vitals module 30 (FIG. 2) via FO cable 66. FO cable 66 is configured to connect to vitals module 30 via, e.g., one or more of FO connectors 32 (FIG. 2). Heart reference sensor 64 measures the hydrostatic height difference between the level at which the finger is kept and the reference level for the pressure measurement, which typically is heart level. Accordingly, hemodynamic sensor60 transmits sensor data that is representative of substantially continuous beat-to-beat monitoring of the arterial pressure waveform of the patient.

[0057] Hemodynamic sensor 50 and hemodynamic sensor 60 shown in FIGS. 3 and 4, respectively, are examples of sensors that can be connected to vitals module 30. Any other suitable sensor, including invasive, non-invasivc, or minimally invasive sensors, that collect physiological data of a patient can be connected to vitals module 30 in alternate embodiments. Examples of non-invasive sensors include blood pressure sensors, continuous blood pressure sensors (e.g., volume-clamp cuffs), continuous non-invasive blood pressure (CNIBP) sensors, pulse oximetry (SpO2) sensors, co-oximetry sensors, tissue oximetry sensors, respiratory sensors, EEG sensors, temperature sensors, galvanic skin sensors, electrocardiogram (ECG) sensors, electromyography (EMG) sensors, functional near-infrared spectroscopy (fNIRS) sensors, photoplethysmogram (PPG) sensors, accelerometers and gyroscopes for motion monitoring, magnetometers, heart rate variability (IIRV) sensors, skin conductance sensors, and end-tidal CO2 or capnography sensors (for measuring CO2 levels). Examples of invasive sensors include Swan-Ganz catheters, arterial line pressure sensors, intracranial pressure (ICP) sensors, central venous pressure (CVP) sensors, intravascular temperature sensors, microdialysis catheters (for monitoring biochemical parameters), implantable glucose sensors, and intravascular oxygen sensors.

[0058] The sensors can be in wired or wireless communication with vitals module 30. Vitals module 30 can include any hardware for operation of the sensors, such as any pneumatic pumps, valves, electrical connections, or other hardware. Vitals module 30 can automatically detect the sensors when they are connected to vitals module 30.

[0059] FIG. 5 is a front view of infusion system 10 including the plurality of pump modules 14 and vitals module 30. FIG. 5 shows infusion system 10, including controller unit 12, pump modules 14, and vitals module 30. Vitals modules 30 includes VO connectors 32, display 34, and indicator 36.

[0060] As shown in FIG. 5, vitals module 30 can form part of infusion system 10. Vitals module 30 can be connected to controller unit 12 to couple vitals module 30 to controller unit 12, as shown in FIG. 5. In alternate embodiments, vitals module 30 can be connected to pump module 14 (or any other of syringe module 16, patient-controlled analgesia module 18, or respiratory monitoring module 20 shown in FIG. IB) and coupled to controller unit 12 via the connections between the one or more modules and / or controller unit 12. Vitals module 30 includes connectors on the sides of the enclosure that areconfigured to connect vitals module 30 to controller unit 12 or another module. For example, vitals module 30 can include IUI connectors to provide mechanical, power, and communication connections in one connector. The connectors used on vitals module 30 can match the connectors used on controller unit 12 and the plurality of modules to allow vitals module 30 to be easily coupled to infusion system 10. The connectors also allow for the release of vitals module 30 from infusion system 10.

[0061] When vitals module 30 is coupled to infusion system 10, controller unit 12 will recognize vitals module 30. Controller unit 12 assigns a channel ID to each module connected to it. When vitals module 30 is coupled to infusion system 10, controller unit 12 will apply configuration settings (e.g., alarm limits) to vitals module 30. Controller unit 12 will display relevant alarms, faults, and other notifications from vitals module 30. Configuration settings, including alarms, can be set using controller unit 12 and / or vitals module 30.

[0062] Accordingly, vitals module 30 can be powered by controller unit 12, which can include wired power and battery power that can be provided to vitals module 30. In some embodiments, vitals module 30 does not include a battery or other power source. In alternate embodiments, vitals module 30 can include an independent power supply, either a wired power or battery power, which can used alone or in combination with power provided by controller unit 12. Further, vitals module 30 can use the alarm management capabilities of controller unit 12, alerting a healthcare provider that a patient requires care by sounding an alarm on controller unit 12. As such, controller unit 12 can sound audible alarms based on alarm or fault conditions determined by vitals module 30. When vitals module 30 determines an alarm or fault condition is present, it can send a signal to controller unit 12 to provide the alarm to the healthcare provider. Vitals module 30 can also include alarms, including audio alarms and visual alarms that can be displayed on display 34 and indicator 36, that can be used to alert a healthcare provider that a patient requires care. The alarms on vitals module 30 can be silenced on vitals module 30 and / or on controller unit 12 and communicated to vitals module 30.

[0063] Vitals module 30 provides a hemodynamic channel for infusion system 10 that provides real-time patient monitoring, including blood pressure and hemodynamic monitoring or any other physiological monitoring. In some embodiments, vitals module 30 can provide continuous monitoring and / or non- or minimally-invasive monitoring. In some embodiments, the data sensed by vitals module 30 can be used to control the operation of infusion system 10.Vitals module 30 can also be coupled to a bedside monitor, which can ingest and display the data collected by the sensors coupled to vitals module 30. Vitals module 30 can be coupled to a bedside monitor using a DPT out port connector on vitals module 30. Further, data from vitals module 30 can be communicated to controller unit 12, which can export the data using a wired (c.g., a USB connection) or wireless connection to an external device, for example an EMR. Data from vitals module 30 can be communicated to infusion system 10 at a predetermined time interval, for example every 20 seconds. Further, the data from vitals module 30 and infusion data from infusion system 10 can be synced and exported using a wired or wireless connection to an external device, for example an EMR. Vitals module 30 can also communicate wirelessly with external devices. In one example, software updates can be provided to vitals module 30 using a wired (e.g., USB) or wireless connection.

[0064] FIG. 6A is an isometric view of a first side of vitals module 30. FIG. 6B is an isometric view of a second side of vitals module 30. FIG. 7A is a front view of vitals module 30. FIG. 7B is a back view of vitals module 30. FIG. 7C is a side view of the first side of vitals module 30. FIG. 7D is a side view of the second side of vitals module 30. FIG. 7E is a top view of vitals module 30. FIG. 7F is a bottom view of vitals module 30. FIG. 8A is an exploded view of vitals module 30. FIG. 8B is a back isometric view of vitals module 30 with rear enclosure 70 removed. FIGS. 6A-8B will be discussed together.

[0065] Vitals module 30 includes I / O connectors 32 (including I / O port 32A and I / O port 32B), display 34, indicator 36, front enclosure 68 (shown in FIGS. 6A, 6B, 7A, 7C, 7D, 7E, 7F, 8A, and 8B), rear enclosure 70 (shown in FIGS. 6A, 6B, 7B, 7C, 7D, 7E, 7F, and 8A), first IUI connector 72 (shown in FIGS. 6A, 7A, 7B, 7C, 7E, 7F, 8A and 8B), recess 74 (shown in FIGS. 6A, 7C, and 8A), latch receiver 76 (shown in FIGS. 6A, 7B, 7C, 7F, and 8A), second IUI connector 78 (shown in FIGS. 6B, 7A, 7B, 7D, 7E, 7F, and 8B), projection 80 (shown in FIGS. 6B, 7B, 7D, 7E, and 7F), latch 82 (shown in FIGS. 6B, 7A, 7B, 7D, 7E, 7F, and 8B), DPT out port 84 (shown in FIG. 7B and 8B), speaker 86 (shown in FIGS. 7F and 8B), manifold subassembly 88 (shown in FIGS. 8A and 8B) (showing mounts 89), and printed wiring board assemblies 90 (shown in FIGS. 8A and 8B).

[0066] I / O connectors 32 are on the front side of vitals module 30, as shown in FIGS. 6A, 6B, and 7A. I / O port 32A is a first I / O connector 32 positioned on the front side of vitals module 30 in the embodiment shown, but I / O port 32A can be positioned on any side of vitals module 30 in alternate embodiments. I / O port 32A can be a pressure controller connector. I / O port 32B can be a common I / O connector 32 positioned on thefront side of vitals module 30 in the embodiment shown, but I / O port 32B can be positioned on any side of vitals module 30 in alternate embodiments. I / O port 32A and I / O port 32B allow sensors, for example hemodynamic sensors, to be connected to vitals module 30 to provide physiological data of a patient to vitals module 30. For example, VO port 32B can receive hemodynamic data from a disposable pressure transducer, and VO port 32A can receive hemodynamic data from a non-invasive pressure sensor. Vitals module 30 can also power the sensors in some embodiments via VO port 32A and / or VO port 32B. The sensors can include noninvasive, minimally invasive, and / or invasive sensors.

[0067] Front enclosure 68 of vitals module 30 is at a front end of vitals module 30, and rear enclosure 70 of vitals module 30 is at a back end of vitals module 30 opposite front enclosure 68. Front enclosure 68 is connected to rear enclosure 70 to form the complete enclosure of vitals module 30. Display 34 and indicator 36 are positioned in front enclosure 68. Front enclosure 68 and rear enclosure 70 protect the inner components of vitals module 30 such that vitals module 30 is tamper proof. Front enclosure 68 and rear enclosure 70 also provide connection points for vitals module 30 to connect to other modules, such as modules of infusion system 10.

[0068] First IUI connector 72 is an inter-unit interface connector positioned on and connected to the first side of vitals module 30 in the embodiment shown. In alternate embodiments, first IUI connector 72 can be positioned on the second side of vitals module 30, which can include any number of first IUI connectors 72. First IUI connector 72 can extend through rear enclosure 70 and be connected to vitals module 30 via a gasket and fasteners. First IUI connector 72 is a plug, or projection, that extends outward from rear enclosure 70 and is configured to be received by another connector. First IUI connector 72 can include lead-in and chamfer to reduce the probably of dropping and off-axis insertion when vitals module 30 is being connected to another module or controller unit. First IUI connector 72 can be a mechanical, power, and / or communication connector. Example communication pathways of first IUI connector 72 include a module detection (MODDET) pathway configured to control power to vitals module 30 and other connected modules, transmit and receive (TxD and RxD) pathways configured to handle communication between vitals module 30 and other connected modules, Unit ID Detect pathways configured to allow vitals module 30 to determine when modules are attached, and Unit ID Enable pathways configured to control access to channels of vitals module 30 and other connected modules. First IUI connector 72 integrates the mechanical connections with power and communication connections into a single connector (e.g. a single plug), whichprovides simplicity of operation. As such, vitals module 30 is simpler to operate within an infusion system, such as infusion system 10 shown in FIGS. 1A, IB, and 5, as only one plug (or one receptable in other examples) provides all of the functionality required for physical and logical interoperation between vitals module 30 and the other various modules or connections of the infusion system. Additionally, first IUI connector 72 allows vitals module 30 to receive power from other connections, such as from controller unit 12 of infusion system 10 shown in FIGS. 1A, IB, and 5.

[0069] Recess 74 of vitals module 30 is a depression into rear enclosure 70 at the first side of vitals module 30 adjacent the back end of vitals module 30 in the embodiment shown. In alternate embodiments, recess 74 can be positioned on the second side of vitals module 30, which can include any number of recesses 74. Recess 74 is aligned with and sized and shaped to receive a projection of another module. Recess 74 helps align vitals module 30 with a module having a projection that fits within recess 74. Recess 74 allows vitals module 30 to be modular and easily configurable for patient needs.

[0070] Latch receiver 76 is a space within rear enclosure 70 at the first side of vitals module 30 adjacent the bottom of vitals module 30. In alternate embodiments, recess 74 can be positioned on the second side of vitals module 30. Latch receiver 76 is sized and shaped to receive a latch of another module. Latch receiver 76 includes a catch feature sized and shaped to connect to the latch of the other module to lock vitals module 30 to the other module. Latch receiver 76 connects vitals module 30 to a module having a latch. Latch receiver 76 allows vitals module 76 to be modular and easily configurable for patient needs.

[0071] Second IUI connector 78 is an inter-unit interface connector positioned on and connected to the second side of vitals module 30 in the embodiment shown. In alternate embodiments, second IUI connector 78 can be positioned on the first side of vitals module 30, which can include any number of second IUI connectors 78. Second IUI connector 78 can extend through rear enclosure 70 and be connected to vitals module 30 via a gasket and fasteners. Second IUI connector 78 is a receptable that extends inward from rear enclosure 70 and is configured to receive another connector. Second IUI connector 78 can include lead-in and chamfer to reduce the probably of dropping and off-axis insertion when vitals module 30 is being connected to another module or controller unit Second IUI connector 78 can be a mechanical, power, and / or communication connector. Example communication pathways of second IUI connector 78 include a module detection (MODDET) pathway configured to control power to vitals module 30 and other connectedmodules, transmit and receive (TxD and RxD) pathways configured to handle communication between vitals module 30 and other connected modules, Unit ID Detect pathways configured to allow vitals module 30 to determine when modules are attached, and Unit ID Enable pathways configured to control access to channels of vitals module 30 and other connected modules. Second IUI connector 78 integrates the mechanical connections with power and communication connections into a single connector (e.g. a single receptable), which provides simplicity of operation. As such, vitals module 30 is simpler to operate within an infusion system, such as infusion system 10 shown in FIGS.

[0072] 1A, IB, and 5, as only one receptable (or one plug in other examples) provides all of the functionality required for physical and logical interoperation between vitals module 30 and the other various modules or connections of the infusion system. Additionally, second IUI connector 78 allows vitals module 30 to receive power from other connections, such as from controller unit 12 of infusion system 10 shown in FIGS. 1A, IB, and 5.

[0073] Projection 80 of vitals module 30 is a projection that extends outward from rear enclosure 70 at the second side of vitals module 30 adjacent the back end of vitals module 30 in the embodiment shown. In alternate embodiments, projection 80 can be positioned on the first side of vitals module 30, which can include any number of projections 80. Projection 80 is aligned with and sized and shaped to fit within a recess of another module. Projection 80 helps align vitals module 30 with a module having a recess that receives projection 80. Projection 80 allows vitals module 30 to be modular and easily configurable for patient needs.

[0074] Latch 82 of vitals module 30 is a projection connected to and extending outward from rear enclosure 70 at the second side of vitals module 30 adjacent the bottom of vitals module 30. In alternate embodiments, latch 82 can be positioned on the first side of vitals module 30. Latch 82 is sized and shaped to fit within a latch receiver of another module. Latch 82 connects vitals module 30 to a module having a latch receiver. Latch 82 can be spring- loaded with a pre-load force sufficient to engage a catch feature on the latch receiver. Latch 82 allows vitals module 76 to be modular and easily configurable for patient needs.

[0075] DPT out port 84 of vitals module 30 is a connector on the back side of vitals module 30 that extends through rear enclosure 70, as shown in FIGS. 7B and 8B. DPT out port 84 can be positioned on any side of vitals module 30 in alternate embodiments. DPT out port 84 allows vitals module 30 to be connected to a monitor to provide a blood pressure waveform and / or other data from a patient to the monitor.Speaker 86 of vitals module 30 is on a botom of vitals module 30 connected to a bottom of rear enclosure 70, as shown in FIGS. 7F and 8B. Speaker 86 can be positioned on any side of vitals module 30 in alternate embodiments. Speaker 86 provides an audio indicator for vitals module 30. For example, speaker 86 can provide an audio indicator when vitals module 30 is receiving data from one or more sensors and / or can provide an audio alarm when the data exceeds predetermined thresholds. Further, one or more of the speaker apertures can also serve as an air inlet to an interior of front enclosure 68 and rear enclosure 70. Alternatively, another aperture (with optional filter) can be provided in the enclosure vital module for air ingress.

[0076] Manifold subassembly 80 of vitals module 30 is at a center of vitals module 30, enclosed between and protected by front enclosure 68 and rear enclosure 70. Manifold subassembly 88 includes mounts 89. Manifold subassembly 88 includes three mounts 89 in the embodiment shown in FIG. 8B. In alternate embodiments, manifold subassembly 88 can include any number of mounts 89.

[0077] A first printed wiring board assembly 90 of vitals module 30 is connected to a first side of manifold subassembly 80 and positioned between manifold subassembly 80 and rear enclosure 70. The first printed wiring board assembly 90 can be the main printed wiring board assembly 90 of vitals module 30. A second printed wiring board assembly 90 of vitals module 30 is connected to a second side of manifold subassembly 80 and positioned between manifold subassembly 80 and rear enclosure 70. The second printed wiring board assembly 90 can be a secondary printed wiring board assembly 90 of vitals module 30. Printed wiring board assemblies 90 can also be referred to as circuit boards. As shown in FIGS. 8A and 8B, printed wiring board assemblies 90 are adjacent the first side of vitals module 30 and the second side of vitals module 30, respectively. Manifold subassembly 80 and printed wiring board assemblies 90 provide electronic capabilities to vitals module 30, and mounts 89 connect components of manifold subassembly 88 to rear enclosure 70.

[0078] As shown in FIG. 5, vitals module 30 can be connected to and form part of an infusion system, such as infusion system 10. Vitals module 30 can be coupled to controller unit 12 and / or one or more of pump module 14, syringe module 16, patient-controlled analgesia module 18, and respiratory monitoring module 20 interchangeably. For example, the first side of vitals module 30 can be coupled to controller unit 12 and the second side of vitals module 30 can be coupled to pump module 14. Vitals module 30 can be positioned at a 45 -degree angle to, or tilted relative to, controller unit 12 and then rotatedtoward controller unit 12 to connect vitals module 30 to controller unit 12. First IUI connector 72 is inserted into a connector on controller unit 12 that has a receptable that couples to first IUI connector 72, providing a mechanical, power, and communication connection between vitals module 30 and controller unit 12. Vitals module 30 and controller unit 12 arc swung down to an almost parallel position. Recess 74 on the first side of vitals monitor 30 can line up with a projection on controller unit 12 to help align vitals module 30 with controller unit 12 and improves stability during vibration of the connected modules. The latch of controller unit 12 is pushed into latch receiver 76 of vitals module 30 until the latch snaps into place within latch receiver 76, connecting and locking vitals module 30 to controller unit 12. Vitals module 30 can be powered by controller unit 12 and can send and receive information to and from controller unit 12.

[0079] Pump module 14 can be positioned at a 45 -degree angle to, or tilted relative to, vitals module 30 and then rotated toward vitals module 30 to connect vitals module 30 to pump module 14. Second IUI connector 78 receives a connector on pump module 14 that has a plug that couples to second IUI connector 78, providing a mechanical, power, and communication connection between vitals module 30 and pump module 14. Vitals module 30 and pump module 14 are swung down to an almost parallel position. Projection 80 on the second side of vitals module 30 can line up with a recess on pump module 14 to help align vitals module 30 with pump module 14 and improves stability during vibration of the connected modules. Latch 82 of vitals module 30 is then pushed into a latch receiver of pump module 14 until latch 82 of vitals module 30 snaps into place within the latch receiver, connecting and locking vitals module 30 to pump module 14. Pump module 14 can also be connected to one or more additional pump modules 14, syringe modules 16, patient-controlled analgesia modules 18, and respiratory monitoring modules 20. Vitals module 30 can send and receive information to and from pump module 14 and any other modules connected to pump module 14.

[0080] A non-invasive pressure sensor can be plugged into VO port 32A on the front side of vitals module 30 to provide hemodynamic data about the patient to vitals module 30. The port 32A can be a hybrid connection that can deliver a pressurized fluid from an internal pump (described below) to a patient cuff and receive an electrical signal from said cuff. A disposable pressure transducer, for example, can be plugged into VO port 32B on the front side of vitals module 30 to provide hemodynamic data about the patient to vitals module 30. In other example, any sensor that can sense physiological data of the patient can be connected to vitals module 30. Vitals module 30 can present informationregarding the received hemodynamic data on display 34 and indicator 36 and speaker 86 on vitals module 30 can be activated to provide visual and / or audio alarms when the hemodynamic data exceeds predetermined thresholds. DPT out port 84 can receive a cable to connect vitals monitor 30 to a bedside monitor to provide an analog or digital blood pressure waveform of the patient to the monitor.

[0081] Vitals module 30 can be connected to an infusion system, such as infusion system 10, shown in FIGS. 1A, IB, and 5, to provide real-time continuous or intermittent patient monitoring, including blood pressure and hemodynamic monitoring, to infusion system 10. Vitals module 30 can instruct infusion system 10 based on the information received by vitals module 30 regarding the patient’s physiological state. For example, controller unit 12 of infusion system 10 can transmit drug and infusion therapy data to vitals module 30, which can use the infusion data along with the patient monitoring data to instruct one or more pump modules 14, syringe modules 16, patient-controlled analgesia modules 18, and / or respiratory monitoring modules 20 regarding the delivery of fluids and / or medicaments, including medications, blood, and / or blood products, to patients. A healthcare provider can also instruct infusion system 10 via display 34 of vitals module 30 based on information received by the healthcare provider via vitals module 30. As such, vitals module 30 can gather various patient data and sync the patient data, such as blood pressure data, with the infusion data to provide optimal treatments to the patient concurrently.

[0082] FIG. 9 A is an assembled view of manifold subassembly 88 of vitals module 30. FIG. 9B is an exploded view of manifold subassembly 88 of vitals module 30. FIG.

[0083] 9C is a cross sectional view of the vitals module taken along line 9C-9C of FIG. 7B. FIGS.

[0084] 9A-9C will be discussed together. In FIG. 9A, frame 92 is shown in transparent.

[0085] Vitals module 30 includes manifold subassembly 88. Manifold subassembly 88 includes mounts 89, frame 92, gasket 94, manifold chambers 95, cover 96, solenoid 98, pump housing 100 (which may include first pump housing 100 A and second pump housing 100B), pump 102, tubing connections 106, intake tube 108, fluid connection 108 A, outlet tube 110, fluid connection 110 A.

[0086] Manifold subassembly 88 can have a similar structure, design, and function as the pump manifold assemblies described in U.S. Application No. 19 / 366,311, filed October 22, 2025, and entitled “DISPLAY UNIT FOR A BLOOD PRESSURE MONITORING SYSTEM,” the disclosure of which is hereby incorporated by reference in its entirety.Frame 92 is a molded body of manifold subassembly 88. Frame 92 can also be referred to as a manifold. Frame 92 can be a multi-chamber manifold that includes a plurality of manifold chambers 95 formed in frame 92. Frame 92 provides support for components of manifold subassembly 88. Frame 92 can be attached to feet that extend from a bottom side of frame 92 to support frame 92. Gasket 94 of manifold subassembly 88 is connected to a front side of frame 92. Gasket 94 can include one or more openings 94A therethrough. Cover 96 of manifold subassembly 88 can be connected to a front side of frame 92 and can be positioned over gasket 94, such that gasket 94 is between frame 92 and cover 96. Cover 96 can be fastened to frame 92 to seal closed the chambers of frame 92. Cover 96 can include one or more channels within cover 96. The channels can align, variously, with openings 94A of gasket 94. Openings 94A can align with specific manifold chambers 95 of frame 92. When gasket 94 is assembled with cover 96, the channels and openings 94A can form pathways for fluid to flow between manifold chambers 95 of frame 92. Openings 94A can align with the channels of cover 96 and thereby enable fluid flow through gasket 94 and cover 96 that fluidly couple the plurality of manifold chambers 95 formed in frame 92. Gasket 94 and cover 96 of manifold subassembly 88 can have a similar structure, design, and function as described in Pat. Pub. No. W02025096860A1, filed October 31, 2024, and entitled “PUMP SYSTEM FOR PORTABLE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM,” the disclosure of which is hereby incorporated by reference in its entirety.

[0087] Solenoid 98 of manifold subassembly 88 is a solenoid connected to a back side of frame 92 of manifold subassembly 88. Pump housing 100 of manifold subassembly 88 is positioned within frame 92. Pump housing 100 is a rigid plastic part that is at least partially positioned around pump 102. As such, pump 102 is partially positioned within pump housing 100 and partially positioned within frame 92. Pump 102 is a pneumatic pump. Pump 102 has a pump intake and a pump outlet. Frame 92 is fluidly coupled to one or both the pump intake and the pump outlet of pump 102. Solenoid 98 controls an exhaust valve on pump 102 to release pressure within pump 102. Solenoid 98 may be used on shutdown of the system or pump. Second pump housing 100B of manifold subassembly 88 is a rigid plastic part that is at least partially positioned around pump 92 and is connected to first pump housing 100A. First pump housing 100 A and second pump housing 100B connect to, house, and protect pump 102. Second pump housing 100B is mounted to frame 92 at a back side of frame 92 via mounts 89 of manifold subassembly 88. Mounts 89 are connected to second pump housing 100B and frame 92 to connect second pump housing100B to frame 92, which connects pump 102 within first pump housing 100 A and second pump housing 100B to frame 92. As such, pump 102 is mounted within negative space 93 of frame 92, as shown in Figure 9C. Further, pump 102 is at least partially surrounded by at least one of the manifold chambers formed in frame 92. Mounts 89 are made of elastic material, allowing movement of mounts 89 along with movement of first pump housing 100A and second pump housing 100B due to pump 102. As a result, vibration from pump 102 is at least partially mechanically decoupled from the rest of manifold subassembly 88 and vibrations produced during operation of pump 102 are dampened.

[0088] Pump 102 is fluidly connected with manifold assembly 88 by intake tube 108 and outlet tube 110. Air can enter manifold assembly 88 through an inlet (not shown). The air can be filtered (e.g., with an internal filter within frame 92 or cover 96). The air can pass through one or more of manifold chambers 95 of frame 92. The air may pass through gasket 94 and / or cover 96. One or more of manifold chambers 95 can be within cover 96. The air can then reach intake tube 108 that extends from cover 96 through or around frame 92 to pump housing 100. Intake tube 108 can be connected at fluid connection 108 A at pump 102 (e.g., on housing 100) and at tubing connections 106A at cover 96. Pump 102 can pressurize the air and the air can delivered back to manifold subassembly 88 through outlet tube 110. Outlet tube 110 can be connected at fluid connection 110A at pump 102 (e.g., on housing 100) and at tubing connections 106B at cover 96. The pressurized air can proceed through one or more of manifold chambers 95 of frame 92. The pressurized air may pass through gasket 94 and / or cover 96. One or more of manifold chambers 95 can be within cover 96. The pressurized air can then be delivered to I / O port 32A. A tube (not shown) can connect outlet 96A of cover 96 with a fluid port of I / O port 32A. I / O port 32A can include a pneumatic socket in fluid communication with an outlet of pump 102.

[0089] Tubing 108 and tubing 110 allow for air exchange around pump 102. Additionally, a length of intake tube 108 and a length of outlet tube 110 and the travel path along manifold chambers 95 on both inlet and outlet side are great enough to create a fluid path that reduces oscillations in the fluid traveling through intake tube 108 and outlet tube 110 to further decouple any vibration of pump 102 from the rest of manifold subassembly 88. Further intake tube 108 and outlet tube 110 110 are not very rigid to decouple vibration of intake tube 108 and outlet tube 110 from the rest of manifold subassembly 88, providing additional vibration isolation. Manifold chambers 95 can be sized and tuned to dampen oscillations within the pressurized air coming from the outlet side of pump 102.Manifold subassembly 88 has pump 92 connected to frame 92 via elastic mounts 89 to mechanically decouple the vibration of pump 92 from the rest of manifold subassembly 88, providing vibration isolation. First pump housing 100A and second pump housing 100B form an enclosure around pump 102 and provide noise isolation. Additionally, manifold subassembly 88 is lighter-weight and docs not require machined metals.

[0090] FIG. 10 is a block diagram of vitals module 30 connected to modules Ml and M2 of an infusion system, first sensor SI, second sensor S2, and patient monitor M. Vitals module 30 includes I / O port 32A, I / O port 32B, display 34, user interface 35, first IUI connector 72, second IUI connector 78, DPT out port 84, USB 112, pneumatic subsystem 114, DPT out port sub-system 116, processor 118, and storage 120. Also shown in FIG. 10 is module Ml, module M2, first sensor SI, second sensor S2, patient monitor M, and electronic medical record EMR.

[0091] Vitals module 30 can be connected to an infusion system, such as infusion system 10 shown in FIGS. 1A, IB, and 5. Module Ml can be a controller of an infusion system, such as controller unit 12 of infusion system 10 shown in FIGS. 1A, IB, and 5, or another module of an infusion system, such as pump module 14, syringe module 16, patient-controlled analgesia module 18, or respiratory monitoring module 20 of infusion system 10 shown in FIGS. 1 A, IB, and 5. Module Ml is connected to first IUI connector 71 of vitals module 30. First IUI connector 71 is also connected to second IUI connector 78. Module M2 can be a controller of an infusion system, such as controller unit 12 of infusion system 10 shown in FIGS. 1 A, IB, and 5, or another module of an infusion system, such as pump module 14, syringe module 16, patient-controlled analgesia module 18, or respiratory monitoring module 20 of infusions system 10 shown in FIGS. 1A, IB, and 5. Module M2 is connected to second IUI connector 78 of vitals module 30.

[0092] First sensor S 1 can be a non-invasive pressure sensor, such as hemodynamic sensor 60 shown in FIG. 4. Second sensor S2 is connected to VO port 32B of vitals module 30. Second sensor S2 can be a hemodynamic sensor or any other type of sensor. Second sensor S2 can be a disposable pressure transducer, such as hemodynamic sensor 50 shown in FIG. 3. First sensor SI is connected to I / O port 32A of vitals module 30. In alternate embodiments first sensor SI and second sensor S2 can be any sensor capable of sending physiological data from the patient. Patient monitor M can be a bedside patient monitor. Patient monitor M is connected to DPT out port 84 of vitals module 30.Vitals module 30 has USB 112 on a side of vitals module 30. USB 112 is a port configured to provide a wired connection to vitals module 30. Pneumatic sub-system 114 of vitals module 30 is a system enclosed within vitals module 30 that is connected to I / O port 32B and configured to receive information from I / O port 32B. DPT out port subsystem 116 of vitals module 30 is a system enclosed within vitals module 30 that is connected to DPT out port 84 and configured to receive information from DPT out port 84. DPT out port sub-system 116 can also output information, such as an analog BP signal, from vitals module 30 to patient monitor M. Processor 118 of vitals module 30 is enclosed within vitals module 30. Processor 118 communicates information to and / or receives information from I / O port 32A, USB 112, pneumatic sub-system 114, and DPT out port sub-system 116. Processor 118 also communicates information to and / or receives information from storage 120, which is also enclosed within vitals module 30. Storage 120 stores information within vitals module 30. For example, storage 120 can store sensed data, algorithms that can be executed by vitals module 30, or any other suitable information. Processor 118 additionally communicates information to and / or receives information from first IUI connector 72 and second IUI connector 78. As such, processor 118 is in communication with module Ml and module M2. Processor 118 can send and receive information to and from display 34 of vitals module 30. For example, a user can make selections (e.g. adjust thresholds or accept or reject recommendations, such as an adjustment of fluid, made by vitals module 30 based on the received data) with user interface 35 on display 34, which are subsequently communicated to processor 118. Display 34 can been a screen, including a touchscreen, and is operatively coupled to processor 118. As such, vitals module 30 is compatible with various data gathering systems, display systems, and infusion systems and can display and relay physiological data.

[0093] Processor 118 is a hardware processor configured to receive data, execute algorithms stored on vitals module 30, and communicate data and / or signals. Examples of processor 118 can include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or other equivalent discrete or integrated logic circuitry.

[0094] Storage 120 can be configured to store information within vitals module 30 during operation. Storage 120, in some examples, is described as computer-readable storage media. In some examples, a computer-readable storage medium can include a non-transitory medium. The term “non-transitory” can indicate that the storage medium is notembodied in a carrier wave or a propagated signal. In certain examples, a non-transitory storage medium can store data that can, over time, change (e.g., in RAM or cache). Storage 120 can include volatile and non-volatile computer-readable memories. Examples of volatile memories can include random access memories (RAM), dynamic random access memories (DRAM), static random-access memories (SRAM), and other forms of volatile memories. Examples of non-volatile memories can include, e.g., magnetic hard discs, optical discs, flash memories, or forms of electrically programmable memories (EPROM) or electrically erasable and programmable (EEPROM) memories.

[0095] Display 34 can be a liquid crystal display (LCD), a light-emitting diode (LED) display, an organic light-emitting diode (OLED) display, or other display device suitable for providing information to users in graphical form. User interface 35 can include graphical and / or physical control elements that enable user input to interact with vitals module 30 and / or other components of infusion system 10. In some examples, user interface 35 can take the form of a graphical user interface (GUI) that presents graphical control elements presented at, e.g., a touch-sensitive and / or presence sensitive display screen of display 34. In such examples, user input can be received in the form of gesture input, such as touch gestures, scroll gestures, zoom gestures, or other gesture input. In certain examples, user interface 35 can take the form of and / or include physical control elements, such as a physical buttons, keys, knobs, or other physical control elements configured to receive user input to interact with components of infusion system 10.

[0096] User interface 35 is configured to allow a user, i.e., a healthcare provider, to: calibrate a signal from a cable attached to vitals module 30; set one or more of the patient safety protocols; adjust operation of one or more sensors attached to vitals module 30; enter demographic information related to a patient the one or more of the sensors is attached to; and / or accept or deny a proposed change to operation of infusion system 10. The proposed change in the operation of infusion system 10 can include a change in a titration level, initiating delivery of a bolus of fluid or other medicament with infusion system 10, start a measurement session using vitals module 30, stop the measurement session using vitals module 30, and select from a list the type of sensor attached to vitals module 30.

[0097] First IUI connector 71 provides mechanical, power, and communication connection between module Ml and vitals module 30. Module Ml can power vitals module 30. First IUI connector 71 can send and receive power and communication signals to and from second IUI connector 78 and processor 118. Second IUI connector 78 providesmechanical, power, and communication connection between module M2 and vitals module 30. Module M2 can power vitals module 30. Second IUI connector 78 can send and receive power and communication signals to and from first IUI connector 72 and processor 118. As such, module Ml and module M2 are integrated into vitals module 30 and are connected to each other via vitals module 30. Module Ml, vitals module 30, and module M2 can communicate among each other.

[0098] Module Ml is shown as being coupled to electronic medical record EMR in the embodiment shown in FIG. 10, however any of module Ml, vitals module 30, or module M2 can be coupled to electronic medical record EMR in alternate embodiments. Module Ml can be a controller unit of infusion system 10 and can be coupled to electronic medical record EMR via a wired or wireless connection. Data sensed by vitals module 30 can be communicated to electronic medical record EMR via module Ml. Processor 118 can communicate the sensed data, and any other information, such as physiological parameters determined by vitals module 30, to electronic medical record EMR via module Ml.

[0099] I / O port 32A receives information from first sensor SI. For example, I / O port 32A can be a hybrid electrical and pneumatic connection that receives hemodynamic data from a non-invasivc pressure sensor. I / O port 32A can have a similar structure, design, and function as the receptacles configured to receive pressure controller connectors as described in Pat. Pub. No. WO2024192046A1, filed March 12, 2024, and entitled “SYSTEMS AND DEVICES HAVING MULTIFUNCTIONAL CONNECOTRS FOR HYBRID APPLICATIONS AND PRESSURE MONITORING,” the disclosure of which is hereby incorporated by reference in its entirety. Pressurized fluid can be delivered via a cable plugged into I / O port 32A, and a blood pressure signal can be received back by I / O port 32B. I / O port 32A can send the hemodynamic data from second sensor S2 to pneumatic sub-system 114, where the hemodynamic data is processed and sent to processor 118. For example, pneumatic sub-system 114 can provide continuous non-invasive blood pressure (CNIBP) monitoring control.

[0100] Storage 120 provides additional information to processor 118 (for example, algorithms to be executed by processor 118), which gathers and integrates the information from all sources. For example, processor 118 gathers hemodynamic data from I / O port 32B and pneumatic sub-system 114 and processes the hemodynamic data, for example by executing algorithms to derive physiological parameters or advanced parameters of the patient to determine the patient’s current or future physiological state. USB 112 can sendinformation, such as software updates or additional downloaded data, to processor 118. As such USB 112 allows for the direct download of system updates and data into vitals module 30.

[0101] I / O port 32B receives information from second sensor S2. For example, I / O port 32B receives hemodynamic data from a disposable pressure transducer. I / O port 32B sends the hemodynamic data from second sensor S2 to processor 118. Processor 118 of vitals module 30 can receive at least one physiological signal representing physiological data for patient monitoring. Processor 118 can send the data to DPT out port sub-system 116 where the data is further processed to provide the data, for example a blood pressure waveform, to patient monitor M via DPT out port 84. Patient monitor M displays the data, for example the blood pressure waveform, from vitals module 30. Processor 118 can send the data to display 34 to visually display the data on vitals module 30. Processor 118 can also send the data to USB 112, which allows the data to be exported from vitals module 30.

[0102] Processor 118 of vitals module 30 can also send information to module Ml via first IUI connector 72 and / or module M2 via second IUI connector 78. Module Ml and / or module M2 can activate based on the data sensed or parameters determined by vitals module 30. For example, processor 118 can send instructions to pump module 14 to direct pump module 14 regarding the delivery of fluids and / or medicaments, including medications, blood, and / or blood products, to controller unit 12 to display relevant alarms, faults, or other notifications. Further, processor 118 can send a signal to controller unit 12 to perform an infusion safety shutoff of the infusion system based on one or more vital-sign thresholds. Processor 118 of vitals module 30 can also receive information from first module Ml and / or second module M2 that can be used in conjunction with the data received by processor 118 of vitals module 30. For example, processor 118 can receive configuration settings, such as alarm limits, from controller unit 12 and display alarms on display 34. The connection between vitals module 30 and module Ml and / or module M2 enables real-time data sharing among various systems.

[0103] Vitals module 30 provides a hemodynamic channel for infusion system 10 that provides real-time patient monitoring, including blood pressure and hemodynamic monitoring, which allows for more accurate operation of infusion system 10. Vitals module 30 also provides hemodynamic information to patient monitor M, such as a bedside monitor, where real-time hemodynamic data (e.g. blood pressure, arterial waveforms, etc.) and / or fluid infusion information can be displayed.FIG. 11 is a block diagram of infusion system 10. Infusion system 10 includes controller unit 12, pump module 14, syringe module 16, vitals module 30, and sensors S. Pump module 14 includes flow probe 130 and flow controller 132. Syringe module 16 includes flow probe 140 and flow controller 140. FIG. 11 further shows patient P.

[0104] Infusion system 10 has the general configuration and function as described above with respect to FIGS. 1-10. As shown in FIG. 11, pump module 14 includes flow probe 130 and syringe module 16 includes flow probe 140. Flow probe 130 and flow probe 140 are configured to measure flow-related data of one or more fluids and provide the measured flow-related data to infusion system 10. For example, flow probe 130 and flow probe 140 can measure flow-related data of a first fluid that is configured to alter or maintain a hemodynamic state of a subject and a second fluid that is configured to alter or maintain a level of anesthesia of a subject. For example, the first fluid can include a vasopressor, a substantially pure saline solution (free of other vasoactive drugs), or an inotrope, and the second fluid can include at least one of: a pain medication, a sedative, or a muscle relaxant. As further shown in FIG. 11, pump module 14 includes flow controller 132 and syringe module 16 includes flow controller 142. Flow controller 132 and flow controller 142 arc configured to control a flow of one or more fluid being administered to patient P, for example the first fluid and the second fluid.

[0105] Incorporating vitals module 30 into infusion system 10 allows for closed-loop operation of infusion system 10. The hemodynamic data from vitals module 30 can be used to adjust the delivery (e.g., timing, rate or volume) of fluids and / or medicament to a patient through either pump module 14 or syringe module 16. One or more algorithms can be executed by the controller on vitals module 30, a controller on infusion system 10 (specifically controller unit 12), an EMR, or on a cloud-based system to determine whether any adjustment may be necessary to the delivery of fluids and / or medicament by infusion system 10. The algorithms can calculate the adjustments to maintain physiological stability for patient P. The adjustments to the delivery of medicaments can be based on a single physiological parameter or multiple parameters. One goal can be to maintain one or more physiological parameters of patient P within desired ranges or thresholds. The ranges or thresholds themselves may be based on patient data and / or physiological data, such as an autoregulation range for one or more organs. In other implementations, vitals module 30 can be used to automate hospital protocols for drug delivery, such as the delivery of vasoactive drugs based on blood pressure. In other implementations, vitals module 30 canbe used to enforce safety shutoffs of the delivery of medicaments based on the physiological parameters.

[0106] To determine whether to modify the flow of the first and second fluids administered to the patient can include determining that the hemodynamic data of the patient arc outside a preset range or predicted to be outside of a preset range within a time frame, generating a recommendation of a modification of the flow of the first and second fluids, and receiving, via a user interface, a user selection configured to approve modifying the flow of the first and second fluids.

[0107] The processor is configured to execute computer executable instructions to generate an alert based on modifying the flow of the first and second fluids administered to the patient. The alert can include an indication of the hemodynamic data, an indication of an initial flow of the first or second fluids, or an indication of a modified flow of the first or second fluids. The processor is further configured to execute computer executable instructions in order to obtain second hemodynamic data of the patient, determine that second hemodynamic data exceeds a safety threshold associated with the patient, and reduce, using the flow controller and based on the second hemodynamic data of the patient, the flow of at least one of the first or second fluids administered to the patient. The processor is also configured to execute computer executable instructions in order to generate an alert based on reducing the flow of the at least one of the first or second fluids administered to the subject.

[0108] In one implementation, any adjustments to the delivery of medicaments can be automatic without human intervention (closed- loop control). In another implementation, any adjustments to the delivery of medicaments can require human intervention (semi-closed-loop control). In another implementation, certain adjustments to the delivery of medicaments can require human intervention while others can be automatic. In certain examples, adjustments within a pre-determined range (e.g., timing, rate, volume or physiological parameter) can be automated while adjustments outside of that range can require human approval. Vitals module 30 can include alarms (e.g., visual alarms) and infusion system 10 can include alarms (e.g., audible alarms) for alerting a clinician when delivery parameters are or are predicted to be outside of predetermined ranges or thresholds.

[0109] FIG. 12 is a front view of infusion system 210 including vitals module 230 displaying a representative blood pressure waveform. FIG. 13 is a front view of infusion system 210 including vitals module 230 displaying that a bolus is recommended. FIG. 14 is a front view of infusion system 210 including vitals module 230 displaying that an insulinflow is being modified. FIG. 15 is a front view of infusion system 210 including vitals module 230 displaying that a sedation level is being adjusted. FIGS. 12-15 will be discussed together. FIGS. 12-15 show infusion system 210, controller unit 212, pump modules 214, vitals module 230, VO connectors 232, and display 234.

[0110] Infusion system 210 has the same structure, design, and function as infusion system 10 discussed above with respect to FIGS. 1A-11. Infusion system 210 includes controller unit 212, three pump modules 214, and vitals module 230 in the configuration shown in FIGS. 12-15, but can include any number of pump modules 214 or any other module as discussed above in alternate configurations.

[0111] Vitals module 230 has the same general structure, design, and function as vitals module 30 discussed above with respect to FIGS. 3-11. However, vitals module 230 includes three VO connectors 232 on the front of vitals module 230 in FIGS. 12-14 and two VO connectors 232 on the front of vitals module 230 in FIG. 15.

[0112] As shown in FIG. 12, display 234 of vitals module 230 is displaying hemodynamic data of the patient, including a representative waveform, blood pressure, and other hemodynamic data. Infusion system 210 can include a vasopressor control system that automatically adjusts vasopressor dosage based on hemodynamic (e.g., blood pressure) data sensed by vitals module 230. As shown in FIG. 12, infusion system 210 is modifying norepinephrine, a vasopressor, based on blood pressure data sensed by vitals module 230.

[0113] As shown in FIG. 13, display 234 of vitals module 230 is displaying hemodynamic data of the patient, including MAP over time, blood pressure, and other hemodynamic data. Display 234 also shows at reference numeral A that a bolus of fluid is suggested based on a patient’ s current or predicted hemodynamic status, specifically the blood pressure data. A healthcare provider can deliver a bolus of fluid based on the suggestion from vitals module 230. Further, in some embodiments, infusion system 210 can automatically deliver a bolus of fluid based on a signal sent from vitals module 230 to controller unit 212.

[0114] As shown in FIG. 14, display 234 of vitals module 230 is displaying hemodynamic data of the patient, including a representative waveform and blood pressure. Display 234 also shows at reference numeral B that infusion system 210 is modifying a flow of medicament to the patient based on at least one of the blood pressure and / or the arterial waveform of the patient. Fhe hemodynamic data from vitals module 230 can be communicated to controller unit 212 to automatically modify the pain delivery based on the hemodynamic data.As shown in FIG. 15, display 234 of vitals module 230 is displaying sedation levels of the patient. The hemodynamic data from vitals module 230 can be communicated to controller unit 212 of infusion system 210 to automatically adjust a sedation level being delivered to the patient based on the hemodynamic data.

[0115] FIG. 16 is a front view of monitor 300 displaying thresholds for stopping infusion. Monitor 300 includes display 302.

[0116] Monitor 300 can be coupled to an infusion system, for example infusion system 10 shown in FIGS. 1 A-l 1 or infusion system 210 shown in FIGS. 12-15. In a first embodiment, monitor 300 can be coupled to a vitals module, for example vitals module 30 shown in FIGS. 2-11 or vitals modules 230 shown in FIGS. 12-15, that forms part of the infusion system and receives data from the vitals module. In a second embodiment, monitor 300 can sense data using sensors attached to monitor 300 and can send the data to the infusion system, including a controller unit of the infusion system or a vitals module of the infusion system.

[0117] Monitor 300 includes display 302 on a front of monitor 300. Display 302 can be a touchscreen display in some embodiments. Display 302 can display data received in or sensed by monitor 300. As shown in FIG. 16, display 302 of monitor 300 can also display thresholds for stopping infusion. Monitor 300 can send a signal to the infusion system to automatically stop infusions when safety parameters are not met, improving patient safety. For example, the infusion system may reduce (e.g., stop) a flow of fluid to the patient based on sensed hemodynamic data.

[0118] If a patient is being infused with a vasopressor, a patient’ s blood pressure (BP) can be used to determine whether an infusion should be stopped. If the patient’s systolic blood pressure (SYS BP) drops below 90 mmHg or a mean arterial pressure (MAP) drops below 65 mmHg, the infusion can be stopped. This helps to prevent inadequate perfusion.

[0119] If a patient is being infused for fluid resuscitation, a patient’s stroke volume variation (SVV) can be used to determine whether an infusion should be stopped. If the patient’s stroke volume variation (SVV) drops below 15%, the infusion can be stopped. This helps to prevent fluid overload.

[0120] If a patient is being infused with a diuretic, a patient’s blood pressure (BP) and / or stroke volume (SV) can be used to determine whether an infusion should be stopped. If the patient’s systolic blood pressure (SYS BP) drops below 90 mmHg and / or their strokevolume (SV) drops below 2.5 L / min, the infusion can be stopped. This helps to prevent hypotension and dehydration.

[0121] If a patient is being infused with a sedative, a patient’s blood pressure (BP) and / or respiratory rate (RR) can be used to determine whether an infusion should be stopped. If the patient’s systolic blood pressure (SYS BP) drops below 90 mmHg and / or their respiratory rate (RR) drops below 8 breaths / min, the infusion can be stopped. This helps to prevent respiratory depression.

[0122] If a patient is being infused with an antipyretic, a patient’s temperature (TEMP) can be used to determine whether an infusion should be stopped. If the patient’s temperature (TEMP) drops below 36°C, the infusion can be stopped. This helps to prevent hypothermia.

[0123] If a patient is being infused with an antibiotic, a patient’s heart rate (HR) can be used to determine whether an infusion should be stopped. If the patient’s heart rate (HR) drops below 120 bpm (beats per minute), the infusion can be stopped. This helps to prevent potential sepsis or reaction.

[0124] If a patient is being infused with an inotropic agent, a patient’s cardiac output (CO) can be used to determine whether an infusion should be stopped. If the patient’s cardiac output (CO) drops below 4 L / min, the infusion can be stopped. This helps to prevent worsening cardiac function.

[0125] If a patient is being infused with a nitroglycerin, a patient’s blood pressure (BP) can be used to determine whether an infusion should be stopped. If the patient’s systolic blood pressure (SYS BP) drops below 90 mmHg, the infusion can be stopped. This helps to prevent hypotension.

[0126] If a patient is being infused with an opioid, a patient’s respiratory rate (RR) and / or oxygen saturation (SpO2) can be used to determine whether an infusion should be stopped. If the patient’s respiratory rate (RR) drops below 8 breaths / min and / or the oxygen saturation (SpO2) drops below 92%, the infusion can be stopped. This helps to prevent respiratory depression.

[0127] The above thresholds are provided as examples, but other hemodynamic parameters could be used to determine to stop infusions and other thresholds can be set to determine to stop infusions.

[0128] Further, while the thresholds are shown on display 302 of monitor 300, the same thresholds can be stored in a vitals module, for example vitals module 30 shown in FIGS. 2-11 or vitals modules 230 shown in FIGS. 12-15, that forms a part of an infusionsystem. The vitals module can determine if an infusion should be stopped and send a signal to other components of the infusion system to stop an infusion, for example a controller module, a pump module, or a syringe module. Monitor 300 or the vitals module can automatically select the appropriate threshold from a look up table based on the fluid and / or medicament being delivered by the infusion system and the sensors attached to monitor 300 or the vitals module.

[0129] FIG. 17 is a schematic view of vitals module 430 and sensors that can be coupled to vitals module 430. Vitals module 430 includes L / O connectors 432 (including VO port 432A, VO port 432B, and I / O port 432C), display 434, and DPT out port 484. FIG.

[0130] 17 further shows hemodynamic sensor 450, hemodynamic sensor 460, EEG sensor 470, and monitor 480.

[0131] Vitals module 430 has the same general structure, design, and function as vitals module 30 discussed above with respect to FIGS. 3-11. However, vitals module 430 includes three VO connectors 432 on the front of vitals module 430 and DPT out port 484 on the front of vitals module 430.

[0132] VO port 432A is a first I / O connector 432 positioned on the front side of vitals module 430 in the embodiment shown, but VO port 432A can be positioned on any side of vitals module 430 in alternate embodiments. VO port 432A can be pressure controller connector. As shown in FIG. 17, hemodynamic sensor 460 can be connected to VO port 432A. Hemodynamic sensor 460 can be a noninvasive sensor, for example a blood pressure cuff, for measuring blood pressure of the patient.

[0133] VO port 432B is a second VO connector 432 positioned on the front side of vitals module 430 in the embodiment shown, but VO port 432B can be positioned on any side of vitals module 430 in alternate embodiments. VO port 432B can be a common connector. As shown in FIG. 17, hemodynamic sensor 450 can be connected to I / O port 432B. Hemodynamic sensor 450 can be a minimally invasive sensor, for example a disposable pressure transducer, for measuring hemodynamic data representative of arterial pressure of the patient.

[0134] VO port 432C is a third VO connector 432 positioned on the front side of vitals module 430 in the embodiment shown, but VO port 432C can be positioned on any side of vitals module 430 in alternate embodiments. VO port 432C can be an EEG sensor connector. As shown in FIG. 17, EEG sensor 470 can be connected to VO port 432C. EEG sensor 470 can be a noninvasive sensor for measuring an EEG of the patient.I / O port 432A, I / O port 432B, and I / O port 432C allow sensors to be connected to vitals module 430 to provide data of a patient to vitals module 430. For example, VO port 432A can receive hemodynamic data from a disposable pressure transducer, VO port 432B can receive hemodynamic data from a non-invasive pressure sensor, and VO port 432C can receive EEG data from a non-invasive EEG sensor.

[0135] Vitals module 430 also includes DPT out port 484 on the front side of vitals module 430. DP I out port 484 can be positioned on any side of vitals module 430 in alternate embodiments. DPT out port 484 allows vitals module 430 to be connected to monitor 480 to provide a blood pressure waveform, hemodynamic data, and / or EEG data from a patient to monitor 480.

[0136] Vitals module 430 is another example of a module that can be coupled to an infusion system, for example infusion system 10 shown in FIGS. 1 A-l 1 or infusion system 210 shown in FIGS. 12-15. Vitals modules 430 can be coupled to both hemodynamic sensor 450 and hemodynamic sensor 460, as well as EEG sensor 470. This is a representative example of the types of sensors that can be coupled to vitals module 430. In alternate embodiments, any suitable sensor can be coupled to vitals module 430. Any other suitable sensor, including invasive, non-invasive, or minimally invasive sensors, that collect data of a patient can be connected to vitals module 430 in alternate embodiments. Examples of non-invasive sensors include blood pressure sensors, continuous blood pressure sensors (e.g., volume-clamp cuffs), pulse oximetry sensors, co-oximetry sensors, tissue oximetry sensors, respiratory sensors, EEG sensors, temperature sensors, galvanic skin sensors, electrocardiogram (ECG) sensors, electromyography (EMG) sensors, functional near-infrared spectroscopy (fNIRS) sensors, photoplethysmogram (PPG) sensors, accelerometers and gyroscopes for motion monitoring, magnetometers, heart rate variability (HRV) sensors, skin conductance sensors, and end-tidal CO2 or capnography sensors (for measuring CO2 levels). Examples of invasive sensors include Swan-Ganz catheters, arterial line pressure sensors, intracranial pressure (ICP) sensors, central venous pressure (CVP) sensors, intravascular temperature sensors, microdialysis catheters (for monitoring biochemical parameters), implantable glucose sensors, and intravascular oxygen sensors.

[0137] Discussion of Possible Embodiments

[0138] The following are non-exclusive descriptions of possible embodiments of the present invention.An infusion system with integrated vital signs monitoring includes an infusion system configured to intravenously deliver a fluid and / or a medicament to a patient and a vitals module configured to acquire at least one patient physiological signal and to communicate that physiological signal to a processor.

[0139] The infusion system of the preceding paragraph can optionally include, additionally and / or alternatively, any one or more of the following features, configurations, and / or additional components listed below.

[0140] Wherein the processor communicates the physiological signal to an EMR in communication with the infusion pump.

[0141] Wherein the processor is a controller configured to perform an infusion safety shutoff of the infusion system based on one or more vital-sign thresholds.

[0142] Wherein the vitals module comprises a pneumatic pump having a pump intake and a pump outlet.

[0143] The infusion system further includes a multi-chamber manifold fluidly coupled to one or both of the pump intake and the pump outlet.

[0144] The infusion system further includes a frame disposed within an enclosure. Wherein manifold chambers are formed within the frame.

[0145] Wherein the pump is mounted within a negative space of the frame and is partially surrounded by at least one of the manifold chambers.

[0146] Wherein the pump is mounted to the frame using elastic mounts configured to dampen vibrations produced during pump operation.

[0147] The infusion system further includes a gasket mounted on a side of the frame, the gasket providing fluid couplings between the manifold chambers of the frame.

[0148] The infusion system further includes one or more circuit boards mounted between the enclosure and the frame.

[0149] The infusion system further includes a pneumatic socket in fluid communication with the pump outlet.

[0150] Wherein the pneumatic socket is on a front face of the vital sign module same as the user interface.

[0151] The infusion system further includes a connector on a front face of the vitals module that is configured to be coupled to a sensor to receive the at least one patient physiological signal from the sensor.Wherein the at least one physiological signal comprises one or more of invasive or non-invasive blood pressure (BP, CNIBP), EEG, respiration, heart rate, SpO?, ECG, and temperature.

[0152] The infusion system further includes a disposable pressure transducer (DPT) out port on the vitals module.

[0153] The infusion system further includes a speaker disposed at a bottom of the vitals module, wherein one or more of the speaker apertures also serve as an air inlet to an interior of an enclosure of the vitals module.

[0154] The infusion system further includes a display including a user interface operatively coupled to the processor of the vitals module.

[0155] Wherein the user interface is configured to allow a user to: calibrate a signal from a cable attached to the vitals module; set one or more of the patient safety protocols; adjust operation of one or more sensors attached to the vitals module; enter demographic information related to a patient the one or more of the sensors is attached to; and / or accept or deny a proposed change to operation of the infusion system.

[0156] Wherein the proposed change to operation of the infusion system can include: changing a titration level; initiating a delivery of a bolus of fluid and / or medicament with the infusion system; starting a measurement session using the vitals module; stopping the measurement session using the vitals module; and / or selecting from a list a type of sensor attached to the vitals module.

[0157] An attachable vitals module for an infusion system includes an enclosure, electronics configured to acquire at least one patient physiological signal, and at least one interface configured to couple the vitals module to the infusion system to communicate data thereto.

[0158] The hemodynamic monitoring and infusion delivery system of the preceding paragraph can optionally include, additionally and / or alternatively, any one or more of the following features, configurations, and / or additional components listed below.

[0159] Wherein the processor communicates the physiological signal to an EMR in communication with the infusion pump.

[0160] Wherein the processor is a controller configured to perform an infusion safety shutoff of the infusion system based on one or more vital-sign thresholds.

[0161] Wherein the vitals module comprises a pneumatic pump having a pump intake and a pump outlet.The infusion system further includes a multi-chamber manifold fluidly coupled to one or both of the pump intake and the pump outlet.

[0162] The infusion system further includes a frame disposed within an enclosure. Wherein manifold chambers are formed within the frame.

[0163] Wherein the pump is mounted within a negative space of the frame and is partially surrounded by at least one of the manifold chambers.

[0164] Wherein the pump is mounted to the frame using elastic mounts configured to dampen vibrations produced during pump operation.

[0165] The infusion system further includes a gasket mounted on a side of the frame, the gasket providing fluid couplings between the manifold chambers of the frame.

[0166] The infusion system further includes one or more circuit boards mounted between the enclosure and the frame.

[0167] The infusion system further includes a pneumatic socket in fluid communication with the pump outlet.

[0168] Wherein the pneumatic socket is on a front face of the vital sign module same as the user interface.

[0169] The infusion system further includes a connector on a front face of the vitals module that is configured to be coupled to a sensor to receive the at least one patient physiological signal from the sensor.

[0170] Wherein the at least one physiological signal comprises one or more of invasive or non-invasive blood pressure (BP, CNIBP), EEG, respiration, heart rate, SpCh, ECG, and temperature.

[0171] The infusion system further includes a disposable pressure transducer (DPT) out port on the vitals module.

[0172] The infusion system further includes a speaker disposed at a bottom of the vitals module, wherein one or more of the speaker apertures also serve as an air inlet to an interior of an enclosure of the vitals module.

[0173] The infusion system further includes a display including a user interface operatively coupled to the processor of the vitals module.

[0174] Wherein the user interface is configured to allow a user to: calibrate a signal from a cable attached to the vitals module; set one or more of the patient safety protocols; adjust operation of one or more sensors attached to the vitals module; enter demographic information related to a patient the one or more of the sensors is attached to; and / or accept or deny a proposed change to operation of the infusion system.Wherein the proposed change to operation of the infusion system can include: changing a titration level: initiating a delivery of a bolus of fluid and / or medicament with the infusion system; starting a measurement session using the vitals module; stopping the measurement session using the vitals module; and / or selecting from a list a type of sensor attached to the vitals module.

[0175] A hemodynamic monitoring and infusion delivery system includes a hemodynamic data sensor configured to sense hemodynamic data of a subject, and a flow probe configured to measure a flow-related data of first and second fluids and to provide the measured flow-related data. The first fluid is configured to alter or maintain a hemodynamic state of a subject, and the second fluid is configured to alter or maintain a level of anesthesia of a subject. A flow controller is configured to control a flow of the first and second fluids administered to the subject. A computer readable medium stores software modules including computer executable instructions, and one or more hardware processors is in communication with the computer readable medium. The one or more hardware processors is configured to execute a user interface module of the software modules in order to obtain hemodynamic data of the subject, and modify, using the flow controller and based on the hemodynamic data of the subject, the flow of the first and second fluids administered to the subject.

[0176] The hemodynamic monitoring and infusion delivery system of the preceding paragraph can optionally include, additionally and / or alternatively, any one or more of the following features, configurations, and / or additional components listed below.

[0177] Wherein the one or more hardware processors are further configured to execute the computer executable instructions in order to generate an alert based on modifying the flow of the first and second fluids administered to the subject.

[0178] Wherein the alert comprises at least one of an indication of the hemodynamic data, an indication of an initial flow of the first or second fluids, or an indication of a modified flow of the first or second fluids.

[0179] Wherein the one or more hardware processors are further configured to execute the computer executable instructions in order to obtain second hemodynamic data of the subject, determine that second hemodynamic data exceed a safety threshold associated with the subject, and reduce, using the flow controller and based on the second hemodynamic data of the subject, the flow of at least one of the first or second fluids administered to the subject.Wherein the one or more hardware processors are further configured to execute the computer executable instructions in order to generate an alert based on reducing the flow of the at least one of the first or second fluids administered to the subject.

[0180] Wherein the hemodynamic data sensor comprises a blood pressure cuff configured to sense a continuous blood pressure of the subject.

[0181] Wherein the hemodynamic data sensor comprises an arterial catheter configured to sense an arterial waveform of the subject.

[0182] Wherein the first fluid comprises a vasopressor, a substantially pure saline solution (free of other vasoactive drugs), or an inotrope.

[0183] Wherein the second fluid comprises at least one of: a pain medication, a sedative, or a muscle relaxant.

[0184] Wherein modifying the flow of the first and second fluids administered to the subject comprises determining that the hemodynamic data of the subject are outside a preset range or predicted to be outside of a preset range within a time frame, generating a recommendation of a modification of the flow of the first and second fluids, and receiving, via a user interface, user selection configured to approve the modifying the flow of the first and second fluids.

[0185] Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.

Claims

CLAIMS:

1. An infusion system with integrated vital signs monitoring, comprising:an infusion system configured to intravenously deliver a fluid and / or a medicament to a patient; anda vitals module configured to acquire at least one patient physiological signal and to communicate that physiological signal to a processor.

2. The infusion system of claim 1 wherein the processor communicates the physiological signal to an EMR in communication with the infusion pump.

3. The infusion system of claims 1 or 2, wherein the processor is a controller configured to perform an infusion safety shutoff of the infusion system based on one or more vital-sign thresholds.

4. The infusion system of claim 1 , wherein the vitals module comprises a pneumatic pump having a pump intake and a pump outlet.

5. The infusion system of claim 4, further comprising a multi-chamber manifold fluidly coupled to one or both of the pump intake and the pump outlet.

6. The infusion system of claim 4, further comprising a frame disposed within an enclosure.

7. The infusion system of claim 6, wherein manifold chambers arc formed within the frame.

8. The infusion system of claim 7, wherein the pump is mounted within a negative space of the frame and is partially surrounded by at least one of the manifold chambers.

9. The infusion system of any of claims 6-8, wherein the pump is mounted to the frame using elastic mounts configured to dampen vibrations produced during pump operation.

10. The infusion system of any of claims 6-9, further comprising a gasket mounted on a side of the frame, the gasket providing fluid couplings between the manifold chambers of the frame.

11. The infusion system of any of claims 6-10, further comprising one or more circuit boards mounted between the enclosure and the frame.

12. The infusion system of any of claims 5-10, further comprising a pneumatic socket in fluid communication with the pump outlet.

13. The infusion system of claim 12, wherein the pneumatic socket is on a front face of the vital sign module same as the user interface.

14. The infusion system of any of claims 1-13, further comprising a connector on a front face of the vitals module that is configured to be coupled to a sensor to receive the at least one patient physiological signal from the sensor.

15. The infusion system of claim 14, wherein the at least one physiological signal comprises one or more of invasive or non-invasivc blood pressure (BP, CNIBP), EEG, respiration, heart rate, SpCh, ECG, and temperature.

16. The infusion system of any of claims 1-15, further comprising a disposable pressure transducer (DPT) out port on the vitals module.

17. The infusion system of any of claims 1-16, further comprising a speaker disposed at a bottom of the vitals module, wherein one or more of the speaker apertures also serve as an air inlet to an interior of an enclosure of the vitals module.

18. The infusion system of any of claims 1-17, further comprising display including a user interface operatively coupled to the processor of the vitals module.

19. The infusion system of claim 18, wherein the user interface is configured to allow a user to:calibrate a signal from a cable attached to the vitals module;set one or more of the patient safety protocols;adjust operation of one or more sensors attached to the vitals module;enter demographic information related to a patient the one or more of the sensors is attached to; and / oraccept or deny a proposed change to operation of the infusion system.

20. The infusion system of claim 19, wherein the proposed change to operation of the infusion system can include:changing a titration level;initiating a delivery of a bolus of fluid and / or medicament with the infusion system; starting a measurement session using the vitals module;stopping the measurement session using the vitals module; and / orselecting from a list a type of sensor attached to the vitals module.

21. An attachable vitals module for an infusion system, the vitals module comprising:an enclosure;electronics configured to acquire at least one patient physiological signal; and at least one interface configured to couple the vitals module to the infusion system to communicate data thereto.

22. The infusion system of claim 21 wherein the processor communicates the physiological signal to an EMR in communication with the infusion pump.

23. The infusion system of claims 21 or 22, wherein the processor is a controller configured to perform an infusion safety shutoff of the infusion system based on one or more vital-sign thresholds.

24. The infusion system of claim 21, wherein the vitals module comprises a pneumatic pump having a pump intake and a pump outlet.

25. The infusion system of claim 24, further comprising a multi-chamber manifold fluidly coupled to one or both of the pump intake and the pump outlet.

26. The infusion system of claim 24, further comprising a frame disposed within an enclosure.

27. The infusion system of claim 26, wherein manifold chambers are formed within the frame.

28. The infusion system of claim 27, wherein the pump is mounted within a negative space of the frame and is partially surrounded by at least one of the manifold chambers.

29. The infusion system of any of claims 26-28, wherein the pump is mounted to the frame using elastic mounts configured to dampen vibrations produced during pump operation.

30. The infusion system of any of claims 26-29, further comprising a gasket mounted on a side of the frame, the gasket providing fluid couplings between the manifold chambers of the frame.

31. The infusion system of any of claims 26-30, further comprising one or more circuit boards mounted between the enclosure and the frame.

32. The infusion system of any of claims 25-30, further comprising a pneumatic socket in fluid communication with the pump outlet.

33. The infusion system of claim 32, wherein the pneumatic socket is on a front face of the vital sign module same as the user interface.

34. The infusion system of any of claims 21-33, further comprising a connector on a front face of the vitals module that is configured to be coupled to a sensor to receive the at least one patient physiological signal from the sensor.

35. The infusion system of claim 34, wherein the at least one physiological signal comprises one or more of invasive or non-invasive blood pressure (BP, CNIBP), EEG, respiration, heart rate, SpCh. ECG, and temperature.

36. The infusion system of any of claims 21-35, further comprising a disposable pressure transducer (DPT) out port on the vitals module.

37. The infusion system of any of claims 21-36, further comprising a speaker disposed at a bottom of the vitals module, wherein one or more of the speaker apertures also serve as an air inlet to an interior of an enclosure of the vitals module.

38. The infusion system of any of claims 21-37, further comprising display including a user interface operatively coupled to the processor of the vitals module.

39. The infusion system of claim 38, wherein the user interface is configured to allow a user to:calibrate a signal from a cable attached to the vitals module;set one or more of the patient safety protocols:adjust operation of one or more sensors attached to the vitals module;enter demographic information related to a patient the one or more of the sensors is attached to; and / oraccept or deny a proposed change to operation of the infusion system.

40. The infusion system of claim 39, wherein the proposed change to operation of the infusion system can include:changing a titration level;initiating a delivery of a bolus of fluid and / or medicament with the infusion system; starting a measurement session using the vitals module;stopping the measurement session using the vitals module; and / orselecting from a list a type of sensor attached to the vitals module.

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