Pump devices and methods for fluid infusion

Abstract

Described herein are pump devices capable of delivering fluids with a broad range of fluid infusion rates, a high degree of accuracy, and with low power consumption. The pump devices may have a small form factor and be configured for adjustment of the fluid infusion rate automatically or manually based on physiological parameters of the patient and / or information from other pumps. Systems and methods including the pump devices are also described herein.

Description

PUMP DEVICES AND METHODS FOR FLUID INFUSIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 672,581, filed on July 17, 2024, which is hereby incorporated by reference in its entirety.GOVERNMENT SUPPORT

[0002] This invention was made with government support under Department of Defense USA Medical Research Acquisition Activity grant W81XWH22C0044. The government has certain rights in the invention.FIELD

[0003] This application generally relates to pump devices capable of delivering fluids with a broad range of fluid infusion rates, a high degree of accuracy, and with low power consumption. The pumps may be configured for adjustment of the fluid infusion rate automatically or manually based on physiological parameters of the patient. Systems and methods including the pump devices are also described herein.BACKGROUND

[0004] Infusion pumps are medical devices used for the controlled delivery of fluids (e.g., colloids, crystalloids, medications, and / or blood products) intravenously or enterally. Infusion pumps may take several forms but are typically either peristaltic pumps or syringe pumps. Peristaltic pumps utilize rollers that squeeze a flexible tube, pushing the fluid forward in a wavelike motion. This is the most common form of infusion pump used for larger volumes, e.g., volumes over 50 ml. Syringe pumps, on the other hand, employ a motorized plunger that drives a syringe filled with a fluid such as medication. In the majority of syringe pumps, a syringe barrel preloaded with the medication is inserted into the pump, and the pump depresses the syringe plunger at a specified rate to achieve the desired flow of medication.

[0005] Other types of infusion pumps include linear actuator pumps, screw pumps, elastomeric pumps, and osmotic pumps. Linear actuator pumps rely on a linear motor that drives a piston or diaphragm forward, directly pushing the fluid in the desired direction. This type ofpumping mechanism may offer high accuracy but may not be suitable for very high flow rates. Screw pumps employ a rotating screw mechanism within a chamber. The threads of the screw create pockets of fluid that are progressively moved along the chamber, resulting in controlled flow. Screw pumps may offer a wider flow rate range compared to linear actuators but can be more complex to manufacture. With respect to elastomeric pumps, these pumps utilize a collapsible elastomeric reservoir (e.g., a stretchy pouch). Pressure from an external gas source or a spring compresses the reservoir, forcing the fluid out. Elastomeric pumps are simple and quiet but may not be ideal for long-term infusions due to material fatigue. Lastly, osmotic pumps rely on an osmotic pressure gradient created by a concentrated salt solution. This pressure difference draws water from the surrounding fluid reservoir into a compartment within the pump, displacing the medication or fluid out through a controlled outlet. Osmotic pumps are typically used for low-flow, continuous deliveries.

[0006] Across all pumping methodologies, it is generally important that the minimum and maximum infusion rate be balanced with the required precision around the rate. However, many pumps that are optimized for high flow rates lack accuracy and often cannot provide very low flow rates. Similarly, pumps designed for very low flow rates with high accuracy are incapable of providing very high flow rates. Commercially available pump architectures are generally also not optimized for autonomous or remote actuation. Most commercially available pumps must be programmed manually with physical inputs on the device itself. Thus, a purely automated closed-loop fluid delivery platform cannot be created by interconnecting other commercially available medical devices that measure a physiological parameter such as blood pressure, heart rate, and / or laboratory values such as lactate or pH.

[0007] Furthermore, current infusion pumps may not be suitable for military applications, e.g., in prolonged field care (PFC). In this environment, critically ill patients require continuous or intermittent infusion of fluids and medications with clinical grade infusion pumps, however, existing pumps are bulky and have high power requirements. Additionally, these pumps often require a specific physical orientation for proper functioning, with fluid / medication bags hung above the device on an IV pole for normal function. Moreover, clinical pumps may be prone to a host of mechanical malfunctions that result in interruption of the infusion. While these limitations complicate care in any environment, they may be particularly catastrophic during active patient transport, where resources and backup hardware is scarce. Many critically injuredpatients may also require rapid volume resuscitation with blood products or fluids, often in response to hemodynamic compromise. However, most infusion pumps have a maximum infusion rate of 1.0 liter per hour, which is well below what is needed for rapid resuscitation. This forces utilization of a separate rapid transfusion device or simply and imprecisely delivering fluids “wide open” on a pressure bag system. As soon as fluids and or blood are administered with pressure bags, the precision of the resuscitation is lost, and the ability to track the intervention within a closed loop and / or automated system is not possible. Because pressure bags are purely mechanical forms of fluid delivery, they may increase the risk of air embolism if not closely monitored. Tracking the volume administered may also be difficult and may lead to inadvertent fluid overload and inefficient use of finite resources.

[0008] During transport, patients may also require several medications to be delivered. However, the smaller compact infusion pumps generally used only include a single infusion channel, and thus can only deliver one medication at a time. Pumps configured to deliver multiple medications simultaneously are typically large and have large power requirements, making them unsuitable for use when patients are transported. While multiple smaller, single channel pumps may be used to simultaneously deliver several medications, these pumps are currently not able to infuse fluids with a high degree of accuracy, nor do they have the ability to communicate with each other or with other devices that measure a physiological parameter such that the infusion rate of one pump may be adjusted based on the infusion rate of one or more other pumps, or with a measured physiological parameter, respectively, and thus need to be adjusted manually.

[0009] Accordingly, it would be beneficial to have infusion pumps including new pumping mechanisms capable of delivering fluids and / or medications over a large range of infusion rates while maintaining accuracy across all flow rates. It would also be useful to have infusion pumps having a smaller form factor and lower power consumption than currently available pumps. Infusion pumps capable of coupling with other pumps and / or devices that measure physiologic data of a patient and automatically adjusting fluid and / or medication delivery based on the physiologic data would also be useful.SUMMARY

[0010] Described herein are pump devices, systems, and methods that may deliver fluids with a broad range of fluid infusion rates (e.g., from a few microliters per hour to thousands of milliliters per hour), a high degree of accuracy, and with low power consumption. The pumps may be configured for automated or manual adjustment of the fluid infusion rate. Adjustment of the fluid infusion rate may be based on one or more physiological parameters of the patient and / or when there has been a change in the type of medication administered. When the system employs multiple pumps, the fluid infusion rate of one pump may be adjusted based on the fluid infusion rate of another pump.

[0011] The fluids that may be delivered include without limitation, fluids for volume resuscitation to increase blood pressure, e.g., normal saline, D5W, lactated Ringer’s solution, Plasmalyte, plasma, albumin, blood, and / or a blood product, and one or more medications for adjusting blood pressure. For example, medications that may be delivered to increase blood pressure may include one or more of: norepinephrine, epinephrine, vasopressin, phenylephrine, dopamine, dobutamine, and angiotensin II. Exemplary medications that may be delivered to decrease blood pressure may include one or more of: cl evi dipine, nifedipine, labetalol, esmolol, fenoldopam, nitroglycerin, and nitroprusside. In some instances, the systems may include a plurality of pumps such that the systems may deliver both a fluid for volume resuscitation and a medication for blood pressure control. In other instances, the plurality of pumps may deliver one or more types of medications, or one or more types of fluid for volume resuscitation. In some variations, delivery of fluids may be automatically adjusted in a closed-loop fashion based on one or more physiological parameters of the patient. As mentioned above, when the system includes multiple pumps, each pump may be configured to communicate with one or more other pumps of the system and change its infusion rate based on the infusion rate of the one or more other pumps.

[0012] The pumps for fluid delivery may include at least a first chamber and a second chamber coupled to a housing, at least one actuator coupled to the first and second chambers, a drive mechanism operable to effect movement of the at least one actuator, and a valving system including one or more valves. In general, movement of the at least one actuator may simultaneously move a fluid into the first chamber and out of the second chamber, and the one or more valves may be configured to selectively direct the flow of a fluid into and out of each ofthe first and second chambers. The chambers may comprise barrels of various shape. For example, the barrels may be linear (i.e., straight) or curved. One or more of the pump chambers may be included on a cartridge configured for removable attachment to the housing. In some variations, a single cartridge may be removably attached to the housing. In other variations, two cartridges may be removably attached to the housing, e.g. one at each end of the housing. The cartridge may or may not be disposable. In some instances, the valving system may further be included on the cartridge. The pumps may also include one or more pressure sensors and / or an air bubble detector, as further described below.

[0013] The first chamber of the pumps may have a first volume, and the second chamber of the pumps may have a second volume. The first volume and the second volume may be the same or different. The volumes of fluid may be moved by a drive mechanism configured to effect rotational movement of at least one actuator. However, in some instances, the volumes of fluid may be moved by a drive mechanism configured to effect linear movement of at least one actuator. The drive mechanism may include one or more motors such as a stepper motor, brushed DC motor, or a brushless DC motor. The one or more motors may be coupled to a drive shaft or a drive screw. When the one or more motors is a stepper motor, the stepper motor may include one or more gears configured to deliver the fluid at a high accuracy rate. For example, the high accuracy rate may be an infusion rate within 0.5 pl of a preset infusion rate. The pumps described herein may also include one or more position sensors. The one or more position sensors may be configured to identify a position of at least one actuator (e.g., a plunger, piston, magnet). In some instances, the position sensors include optical sensors. One or more encoders may also be included in the pumps that are configured to track movement of the drive shaft.

[0014] A valving system in fluid communication with a reservoir of the fluid to be delivered may include one or more valves. The one or more valves may have a first orientation and a second orientation. When in the first orientation, at least one valve of the one or more valves may be configured to selectively direct the fluid to flow into the first chamber, and when in the second orientation, the at least one valve of the one or more valves may be configured to selectively direct the fluid to flow out of the first chamber. Similarly, when in the first orientation, at least one valve of the one or more valves is configured to selectively direct the fluid to flow out of the second chamber, and when in the second orientation, the at least one valve of the one or more valves may be configured to selectively direct the fluid to flow into thesecond chamber. Exemplary valves may be stopcock valves and solenoid valves. When a stopcock valve, the valve may be configured to prevent the fluid from moving into and out of each of the first and second chambers when rotated about 45 degrees.

[0015] The pumps described herein may include at least one actuator including at least one plunger or a magnet. The plungers may have a shape that corresponds to the shape of the pump chambers. For example, when the chambers are curved, the plungers may also be curved. In some instances, the plungers may have a C-shape. The first chamber and the second chamber may be operably coupled via the at least one plunger. Additionally, the plungers may include a component, e.g., a finger grip, configured to align the plungers with a drive shaft of the drive mechanism. When the at least one actuator includes a magnet, the magnet may include a polymer layer on an outer surface thereof. In some instances, the pumps include at least two actuators.

[0016] One or more controllers may also be included with the fluid delivery pumps. The one or more controllers may be disposed within the pump housing or external to the housing. The one or more controllers may be configured for automated and / or manual control of the fluid infusion rate. For example, the one or more controllers may be configured to switch from an automated mode of fluid infusion to a manual mode of fluid infusion, and vice versa. In some instances, the one or more controllers may be configured for wireless communication with a physiological monitoring device, and fluid infusion adjusted based on a physiological parameter measured by the physiological monitoring device. The fluid infusion rate may range from about 0.1 ml / hr to about 4,000 ml / hr, including all values and sub-ranges therein. For example, the fluid infusion rate may be about 0.1 ml / hr, about 0.2 ml / hr, about 0.3 ml / hr, about 0.4 ml / hr, about 0.5 ml / hr, about 1.0 ml / hr, 2.0 ml / hr, about 3.0 ml / hr, about 4.0 ml / hr, about 5.0 ml / hr, about 6.0 ml / hr, about 7.0 ml / hr, about 8.0 ml / hr, about 9.0 ml / hr, 10 ml / hr, about 20 ml / hr, about 30 ml / hr, about 40 ml / hr, about 50 ml / hr, about 60 ml / hr, about 70 ml / hr, about 80 ml / hr, about 90 ml / hr, about 100 ml / hr, about 125 ml / hr, about 150 ml / hr, about 175 ml / hr, about 200 ml / hr, about 225 ml / hr, about 250 ml / hr, about 275 ml / hr, about 300 ml / hr, about 325 ml / hr, about 350 ml / hr, about 375 ml / hr, about 400 ml / hr, about 425 ml / hr, about 450 ml / hr, about 475 ml / hr, or about 500 ml / hr. In some instances, the fluid infusion rate may range from about 10 ml / hr to about 4,000 ml / hr, or from about 0.1 ml / hr to about 500 ml / hr.

[0017] In some variations, the pumps for fluid delivery may include a first curved chamber, a second curved chamber, and a C-shaped plunger at least partially slidably received within the first and second curved chambers, where advancement of the plunger into the second curved chamber may simultaneously move a fluid into the first curved chamber and out of the second curved chamber. In these variations, the C-shaped plunger may have a first plunger end received within the first curved chamber and a second plunger end received within the second curved chamber. A valving system including one or more valves, e.g., one or more stopcock valves, may be configured to selectively direct the flow of a fluid into and out of each of the first and second curved chambers. The first curved chamber, the second curved chamber, and the plunger may be included on a cartridge configured for removable attachment to a housing of the pump. The cartridge may or may not be disposable. Furthermore, the C-shaped plunger may be coupled to a drive mechanism including a stepper motor operable to effect rotational movement thereof . Another stepper motor may be coupled to the stopcock valve to control fluid routing.

[0018] Methods for fluid delivery are also described herein. The methods may generally include reciprocating an actuator coupled to each of a first chamber and a second chamber of a pump to simultaneously move a fluid into and out of the first and second chambers, controlling one or more valves using a controller to selectively direct flow of the fluid into and out of the first and second chambers, and adjusting an infusion rate of the fluid to a patient using the controller. Exemplary fluids that may be delivered include without limitation, normal saline, D5W, lactated Ringer’s solution, plasma, albumin, blood, a blood product, and a medication. The fluids may be infused with a high degree of accuracy, for example, within 0.5 pl of a preset infusion rate.

[0019] In some instances, reciprocating the actuator of the pumps may include rotating the actuator about a longitudinal axis of a drive shaft. The drive shaft may also be rotated to effect rotation of the actuator. One or more encoders may be employed to track rotation of the drive shaft. Furthermore, one or more motors may be used to rotate the drive shaft, as previously stated. The one or more motors may be a stepper motor or a DC motor. In other instances, reciprocating the actuator may include linearly sliding the actuator within the first and second chambers of the pump. Sliding of the actuator in a linear manner may be effected by a magnetic actuation system. Some variations of the method may include identifying a position of theactuator using one or more position sensors. The one or more position sensors may be an optical sensor.

[0020] Each of the one or more valves of the valving system of the pumps has one or more orientations, and changing between each of the one or more orientations may adjust the flow of fluid from the pump. For example, when the one or more valves has a first orientation and a second orientation, changing between the first orientation to the second orientation may switch the flow of fluid entering the first chamber to exiting the first chamber, and the flow of fluid exiting the second chamber to entering the second chamber. In some instances, for example, when the one or move valves is a stopcock valve, rotating the stopcock valve about 45 degrees stops the flow of fluid from the pump.

[0021] The one or more controllers provided with the pumps may be configured for automated and / or manual control of the fluid infusion rate. For example, the one or more controllers may be configured to switch from an automated mode of fluid infusion to a manual mode of fluid infusion, and vice versa. One or more physiological parameters may be measured and wired or wirelessly communicated to the controller from a physiological monitoring device, and fluid infusion adjusted based on the one or more measured physiological parameters. The one or more physiological parameters may be a measurement of a patient’s heart rate, heart rate variability, blood pressure, oxygen saturation, respiratory rate, blood pH, carbon dioxide (e.g., pCCh or end tidal CO2), lactate, glucose, sodium, potassium, chloride, bicarbonate, creatinine, blood urea nitrogen, pressure within the CSF space, temperature, or a combination thereof.

[0022] The fluid infusion rate may range from about 0.1 ml / hr to about 4,000 ml / hr, including all values and sub-ranges therein. For example, the fluid infusion rate may be about 0.1 ml / hr, about 0.2 ml / hr, about 0.3 ml / hr, about 0.4 ml / hr, about 0.5 ml / hr, about 1.0 ml / hr, 2.0 ml / hr, about 3.0 ml / hr, about 4.0 ml / hr, about 5.0 ml / hr, about 6.0 ml / hr, about 7.0 ml / hr, about 8.0 ml / hr, about 9.0 ml / hr, 10 ml / hr, about 20 ml / hr, about 30 ml / hr, about 40 ml / hr, about 50 ml / hr, about 60 ml / hr, about 70 ml / hr, about 80 ml / hr, about 90 ml / hr, about 100 ml / hr, about 125 ml / hr, about 150 ml / hr, about 175 ml / hr, about 200 ml / hr, about 225 ml / hr, about 250 ml / hr, about 275 ml / hr, about 300 ml / hr, about 325 ml / hr, about 350 ml / hr, about 375 ml / hr, about 400 ml / hr, about 425 ml / hr, about 450 ml / hr, about 475 ml / hr, or about 500 ml / hr. In some instances, the fluid infusion rate may range from about 10 ml / hr to about 4,000 ml / hr, or from about 0.1 ml / hr to about 500 ml / hr.

[0023] The pumps described herein may deliver fluids for various indications. For example, the fluid may be delivered to treat hypotension in a patient, to treat hypertension in a patient, to increase a circulatory volume in a patient, for administration of a medication, and / or for administration of a blood product. The fluid will typically be received from an external fluid source, e.g., a bag containing the fluid. In some instances, the method may further include placing a pressure bag around the external fluid source. Pressure of the fluid flowing from the external fluid source to at least one of the first and second chambers may be measured using one or more pressure sensors. Additionally or alternatively, pressure of the fluid exiting at least one of the first and second chambers may be monitored using one or more pressure sensors.

[0024] Systems for delivering fluids are also described herein. The systems may include any one of the pumps described herein and an external source of the fluid. In some instances, the pump may be configured to infuse the fluid at a rate of about 10 ml / hr to about 4,000 ml / hr, including all values and sub-ranges therein. In other instances, the pump may be configured to infuse the fluid at a rate between about 0.1 ml / hr to about 500 ml / hr, including all values and sub-ranges therein. A pressure bag may be included in the systems, which may be configured to apply a compressive force around the external fluid source to further increase the fluid infusion rate. Adjusting the fluid infusion rate in this manner may help reduce the power consumed by the drive mechanism of the pump (e.g., the one or more motors) since it may reduce the force required by the drive mechanism to move the fluid. The fluid may include without limitation, normal saline, D5W, lactated Ringer’s solution, plasma, albumin, blood, a blood product, and a medication.

[0025] In some variations, the pump devices may include a plurality of pumps. In these variations, the pump devices may include a housing, a first pump at least partially within the housing and configured for delivery of a first fluid, a second pump at least partially within the housing and configured for delivery of a second fluid, and one or more controllers configured to adjust an infusion rate of at least one of the first and second fluids based on one or more of a physiological parameter of a patient or a pump parameter. The physiological parameter may be a heart rate, blood pressure, a lactate level, or an oxygen saturation of the patient, or a combination thereof. The pump parameter may be an infusion rate of one or more of the first fluid or the second fluid. A first cartridge for use with the first pump may be removably attached to the housing, and a second cartridge for use with the second pump may be removably attached to thehousing. Each of the first and second cartridges may comprise a first chamber and a second chamber, and an actuator and one or more valves configured to move the first and second fluids into and from the first chamber and the second chamber. For example, with respect to the first cartridge, movement of the actuator may simultaneously move the first fluid into the first chamber and out of the second chamber, and the one or more valves may be configured to selectively direct the flow of the first fluid into and out of each of the first and second chambers. Similarly, for the second cartridge, movement of the actuator may simultaneously move the second fluid into the first chamber and out of the second chamber, and the one or more valves may be configured to selectively direct the flow of the second fluid into and out of each of the first and second chambers. The first and second chambers may include a barrel having a curved shape, e.g., a C-shape. Additionally, the first pump may include a first motor set coupled to a first pulley subsystem, and the second pump may include a second motor set coupled to a second pulley subsystem to effectuate fluid delivery.BRIEF DESCRIPTION OF THE DRAWINGS

[0026] FIG. 1 A is a perspective view of an exemplary fluid delivery pump device including first and second curved chambers.

[0027] FIG. IB is an exploded view showing the interior components of the exemplary fluid delivery pump device shown in FIG. 1 A.

[0028] FIG. 1C is an exploded view of the components of the exemplary cartridge shown in FIGS. 1 A and IB.

[0029] FIG. ID is a front view of the exemplary cartridge shown in FIGS. 1 A and IB.

[0030] FIG. 2 is an exploded view of an exemplary clutch mechanism for engaging and disengaging a drive mechanism of the pump device.

[0031] FIG. 3 is an exploded view of another exemplary clutch mechanism for engaging and disengaging a drive mechanism of the pump device.

[0032] FIG. 4 illustrates an exemplary method for pumping fluids including a single valve.

[0033] FIG. 5 illustrates an exemplary method for pumping fluids using a plurality of valves.

[0034] FIG. 6 is a schematic of another exemplary pump device that uses a reciprocating piston in a linear chamber to pump fluids.

[0035] FIG. 7 is a schematic of a further exemplary pump device that uses a magnetic actuation system to move a piston within a linear chamber to pump fluids.

[0036] FIG. 8 is a schematic of yet another exemplary pump device in which a drive screw is used to control the piston within the linear chamber of the pump.

[0037] FIGS. 9A and 9B depict an exemplary pump device in which two pumps are employed.DETAILED DESCRIPTION

[0038] Described herein are pump devices capable of delivering fluids with a large range of fluid infusion rates (e.g., from less than about 0.5 ml / hr to several thousand ml / hr), a high degree of accuracy (e.g., within about 0.5 pl of a preset fluid infusion rate), and with low power consumption. The lower power consumption may extend the run time of the pumps and / or the number and / or size of the batteries used with the pump devices. The pump devices may include one or more controllers configured to adjust the fluid infusion rate automatically or manually. When adjusted automatically, the adjustment may be based on one or more physiological parameters of the patient that may be communicated to a controller of the pump device from other medical devices. For example, the delivery of medications and / or volume resuscitation fluids from the pump device may be automatically adjusted based on one or more physiological parameters of the patient. The pumps may be useful in a variety of settings, but may be especially useful for prolonged field care (PFC), where resources are often limited. Systems and methods including the pump devices are also described herein.PUMP DEVICES

[0039] In general, the pump devices for fluid delivery may include a pump having at least a first chamber and a second chamber coupled to a housing, at least one actuator coupled to the first and second chambers, a drive mechanism operable to effect movement of the at least one actuator, and a valving system including one or more valves. The first chamber, second chamber, and / or valving system may be included on a cartridge configured for releasable attachment to the housing. The one or more pump chambers may have any suitable shape. Forexample, the chambers may comprise barrels that are curved (e.g., arcuate in shape and / or resembling partial toroids) or linear (i.e., straight). Movement of the at least one actuator may simultaneously move a fluid into the first chamber and out of the second chamber, and the one or more valves may be configured to selectively direct the flow of a fluid into and out of each of the first and second chambers.

[0040] The pump devices may be used to deliver various types of fluids to a patient. For example, the fluids for delivery may include without limitation, fluids for volume resuscitation to increase blood pressure, e.g., normal saline, D5W, lactated Ringer’s solution, Plasmalyte, plasma, albumin, blood, and / or a blood product, and one or more medications for adjusting blood pressure. For example, medications that may be delivered to increase blood pressure may include one or more of: norepinephrine, epinephrine, vasopressin, phenylephrine, dopamine, dobutamine, and angiotensin II. Exemplary medications that may be delivered to decrease blood pressure may include one or more of: clevidipine, nifedipine, labetalol, esmolol, fenoldopam, nitroglycerin, and nitroprusside. When used for resuscitation, the pumps may be configured to deliver a large volume of fluid at a high infusion rate. When used to deliver a medication, the pumps may be configured to deliver small volumes of the medication at a lower infusion rate. While described in the context of controlling blood pressure using resuscitation fluids and / or medications, it should be appreciated that the pump devices described herein may be used for to deliver (e.g., in an automated fashion) any medically necessary or desirable fluids or medications. The pump devices may include a single pump, or an assembly of pumps comprising a plurality of pumps working together (e.g., 2, 3, 4, 5, 6, or more than 6 pumps working together).Housing

[0041] The pump devices may generally include a housing having a body and an interior that at least partially (e.g., fully) contains the primary components for moving fluid (e.g., actuators, drive mechanisms, sensors, fluid chambers). The housing may be reusable and made from non- biodegradable materials such as non-biodegradable polymers. Exemplary non-biodegradable polymers include, but are not limited to, polycarbonate, acrylonitrile butadiene styrene, polybutylene terephthalate, and co-polymers and blends thereof. The housing may include a door on one side of the housing body (e.g., front, side, back), which may be pivotally coupled to the housing body (e.g., via one or more hinges) and releasably latched thereto. The door may beopened to allow for attachment of a cartridge to the pump housing, and subsequently closed during use to protect the pump components from the external environment and / or prevent detachment of any associated cartridge from the pump. In some variations, the door may remain open during use of the pump. The housing may further include one or more connectors configured to attach the housing to another device, such as, for example, an IV pole or to a holder on an IV pole, or to a device that measures a physiological parameter of the patient.

[0042] The body of the housing may be variously sized and shaped. For example, the housing body may have one or more of a rectangular, square, ovular, or circular cross-sectional shape. A maximum cross-sectional dimension of the body may be about 10 cm to about 20 cm, including all values and sub-ranges therein. For example, the housing body may have a maximum cross- sectional dimension of about 10 cm, about 10.5 cm, about 11 cm, about 11.5 cm, about 12 cm, about 12.5 cm, about 13 cm, about 13.5 cm, about 14 cm, about 14.5 cm, about 15 cm, about 15.5 cm, about 16 cm, about 16.5 cm, about 17 cm, about 17.5 cm, about 18 cm, about 18.5 cm, about 19 cm, about 19.5 cm, or about 20 cm. In some variations, when comprising a rectangular or square cross-sectional shape, the housing body may be about 16.3 cm (about 6.4 inches) in height, about 10.9 cm (about 4.3 inches) in width, and about 8.9 cm (about 3.5 inches) in depth. However, it is understood that the housing body dimensions may be smaller or larger depending on such factors as the type and total volume of fluid being delivered and / or whether the pump is being used in a hospital, clinical, or PFC setting.

[0043] The housing body may include a user interface configured to display information about one or more pumps of a pump device and / or their method of use. For example, the user interface may be configured to display information about pump parameters (e.g., fluid flow rates, etc.), pump status (power on / off status, power source information (e.g., identified power source, battery levels, etc.), cartridge information (e.g., attachment status, the type of cartridge attached), measured physiological parameters of the patient (e.g., blood pressure, heart rate, heart rate variability, etc.), information about other medical devices or pumps connected thereto, and / or information about the types of wired or wireless (such as Bluetooth, WI-FI, etc.) connections between the pump and other medical devices. When the pump devices include a plurality of pumps, the user interface may be configured to display any of the above-mentioned pump- related information for any of the plurality of pumps. In some variations, this information may be displayed simultaneously for all of the pumps in use. The user interface may also include atouch screen or features (e.g., buttons, tabs) configured to allow a user to input information to the pump and / or to control of the rate of fluid infusion. The user interface may be fixed to the housing body or configured to be releasably attached thereto so that it may be hand-held by the user. The user interface may also be a separate computing device (e.g., a smart phone, tablet or other device comprising a screen) that is not mechanically coupled to the pump but can communicate with the pump via wireless communication.

[0044] For example, referring to FIG. 1 A, an exemplary pump device (100) may include a housing (102) having a body (104) and a door (106) coupled to the housing body (104) for enclosing the pump components within the housing interior. A user interface (108) may be provided on one or more surfaces (110) of the housing body (104) (e.g., right side, left side, front, back). Furthermore, a cartridge (112) may be removably attached to the housing body (104). The pump (101) may further comprise one or more fluid chambers (e.g., first and second fluid chambers, 114 and 116 respectively). The fluid chambers 114, 116 may be disposed on or otherwise carried by the cartridge (112). As will be discussed in more detail herein, the fluid chambers may have a variety of shapes, including, as depicted, a curved shape. In some variations, the fluid chambers may have any suitable shape that allows for placement on a removably attachable cartridge. Thus, while the first and second fluid chambers (114 and 116, respectively) disposed on the cartridge (112) are shown as curved in shape, the shape of the fluid chambers is not so limited.Cartridges

[0045] The pumps described herein may be configured such that a cartridge including one or more pump components may be removably attached to the housing. For example, the cartridge may include one or more pump chambers and a valving system, such as, for example, at least two pump chambers. The cartridge may be configured to be disposable or reusable, and may be made from materials similar to that used to form the pump housing. The cartridge may have any suitable size and shape but will generally be sized and shaped to fit onto the pump housing and in a manner that allows the housing door to close around the cartridge. In some variations, the cartridge may have a height of about 15.5 cm (about 6.1 inches), a width of about 7.9 cm (about 3.1 inches), and a depth of about 2.8 cm (about 1.1 inches). Furthermore, the one or more pump chambers may have any suitable shape. As previously described, the chambers may comprisebarrels that are curved or linear (i.e., straight). The barrels may be rigid or include a bellowed structure.

[0046] When the cartridge includes a first chamber and a second chamber, the first chamber may have a first volume, and the second chamber may have a second volume. The first volume and the second volume may be the same or different. In some variations, the first and / or second chamber volume may be between about 0.3 ml to about 25 ml, including all values and subranges therein. For example, the first and / or second chamber volume may be about 0.3 ml, about 0.4 ml, about 0.5 ml, about 0.6 ml, about 0.7 ml, about 0.8 ml, about 0.9 ml, about 1.0 ml, about1.5 ml, about 2.0 ml, about 2.5 ml, about 3.0 ml, about 3.5 ml, about 4.0 ml, about 4.5 ml, about5.0 ml, about 5.5 ml, about 6.0 ml, about 6.5 ml, about 7.0 ml, about 7.5 ml, about 8.0 ml, about8.5 ml, about 9.0 ml, about 9.5 ml, about 10 ml, about 10.5 ml, about 11 ml, about 11.5 ml, about 12 ml, about 12.5 ml, about 13 ml, about 13.5 ml, about 14 ml, about 14.5 ml, about 15 ml, about 15.5 ml, about 16 ml, about 16.5 ml, about 17 ml, about 17.5 ml, about 18 ml, about18.5 ml, about 19 ml, about 19.5 ml, about 20 ml, about 20.5 ml about 21 ml, about 21.5 ml, about 22 ml, about 22.5 ml, about 23 ml, about 23.5 ml, about 24 ml, about 24.5 ml, or about 25 ml. In some variations, the volume of the first and / or second chamber may be about 0.32 ml, about 2.1 ml, about 2.8 ml, about 3.2 ml, about 4.4 ml, about 5.7 ml, about 7.3 ml, about 8.8 ml, about 10.8 ml, or about 12.8 ml. In one variation, each of the chamber volumes may be about 2.5 ml. Additionally, the cartridge may include at least one actuator that moves fluid (e.g., plunger, piston, magnet) coupled to the first and second chambers, a coupling mechanism to connect a portion of a drive mechanism operable to effect movement of the at least one actuator, and a valving system including one or more valves. The at least one actuator may be configured such that movement thereof may simultaneously move a fluid into the first chamber and out of the second chamber, and the one or more valves may be configured to selectively direct the flow of a fluid into and out of each of the first and second chambers.

[0047] The valving system included in the cartridge may generally be in fluid communication with a reservoir of the fluid to be delivered and may include one or more valves. The one or more valves may have a first orientation and a second orientation. When in the first orientation, at least one valve of the one or more valves may be configured to selectively direct the fluid to flow into a first chamber, and when in the second orientation, the at least one valve of the one or more valves may be configured to selectively direct the fluid to flow out of the first chamber.Similarly, when in the first orientation, at least one valve of the one or more valves is configured to selectively direct the fluid to flow out of a second chamber, and when in the second orientation, the at least one valve of the one or more valves may be configured to selectively direct the fluid to flow into the second chamber. Exemplary valves may include but are not limited to stopcock valves and solenoid valves. When a stopcock valve is used, the valve may have an open-flow configuration that allows the full flow of fluid from the first and second chambers to the patient, a partial flow configuration that allows partial flow of fluid from the first and second chambers to the patient, and a no-flow configuration that prevents the fluid from flowing from the first and second chambers to the patient when rotated about 45 degrees.

[0048] The cartridge may also include an identifier that provides information about the cartridge (e.g., serial number, the type of cartridge being attached to the pump housing (e.g., based on volume of the chambers included on the cartridge and / or type of actuator employed by the cartridge (e.g., plunger, piston, magnet)). For example, an RFID tag or an optical element such as QR code may be included on the cartridge. In some variations, this information may be used to prevent reuse of the cartridge (i.e., so that a cartridge may be used only once or only a predetermined number of times) and / or prevent the cartridge from being used with different drugs or with different patients.

[0049] In some variations, a heating element configured to heat the fluid before it is infused may be included in the pump, e.g., in the cartridge of the pump. The element may be configured to heat the fluid as it exits the cartridge, or the element may be configured to heat the entire cartridge so that as the fluid flows through the cartridge it is heated. For example, in some variations, the heating element may include one or more heating coils. In variations, the heating element may be integrated into one or more portions of the cartridge so that the entirety of the cartridge or only sections of the cartridge are heated. Heating may be turned on or off manually by the user or automatically (e.g., via an algorithm run by a processor of the controller). A temperature sensor configured to measure a temperature of the infusion fluid flowing into, within, or out of the cartridge may be utilized for closed loop feedback to control temperature. In some variations, the temperature sensor may also be included in the cartridge.Actuators and Drive Mechanisms

[0050] The pumps may include at least one actuator coupled to the one or more pump chambers. In some variations, the pumps may include at least two actuators. In one variation, the at least one actuator may include at least one plunger. The plunger may have a shape that corresponds to the shape of the pump chambers. For example, when the chamber is curved (e.g., arcuate in shape and / or resembling partial toroids), the plunger may also be curved. In some instances, the plunger may have a C-shape. In another example, when the chamber is linear, the plunger may also be linear. When the pump includes two chambers, the first chamber and the second chamber may be operably coupled via the at least one plunger. Additionally, the plunger may include a component, e.g., a finger grip, configured so that the user may align the plunger with a drive shaft of the drive mechanism.

[0051] In other variations, the at least one actuator may include a magnet. In some variations, the magnet may include a polymer layer or other type of coating, e.g., a rubber coating, on an outer surface thereof. In these variations, the polymer layer and / or other coatings may be configured to help protect the magnet from the fluid within the pump chamber and / or to provide lubricity to the magnet to aid in its reciprocation within the pump chamber. Exemplary polymers that may be used as a magnet coating include without limitation, polyvinylpyrrolidone (PVP), polyacrylic acid, polytetrafluoroethylene (PTFE), and silicone.

[0052] The drive mechanisms described herein may be configured to reciprocate the actuator, e.g., a plunger or a magnet, for movement of a fluid. In some variations, a volume of fluid may be moved by a drive mechanism configured to effect rotational movement of at least one actuator (e.g., rotation about a longitudinal axis of the drive shaft of the motor). However, in other instances, the volumes of fluid may be moved by a drive mechanism configured to effect linear movement of at least one actuator. The drive mechanism may include one or more motors such as, for example, a stepper motor and / or a DC motor. In some variations, the drive mechanism may include two motors configured to drive select components of the pump (e.g., one motor may drive movement of the actuator, and the other motor may be used to open / close the one or more valves). The one or more motors may include or be coupled to a drive shaft, such as, for example, via a drive screw extending therefrom, which may be configured to couple with the at least one actuator. In some variations, the one or more motors may include or be coupled to one or more gears (e.g., in a gearbox). The one or more gears may be configured toconnect to the at least one actuator on the cartridge and may, in some variations, facilitate delivery of the fluid at a high accuracy rate, such as, for example, an infusion rate within about 0.5 pl of a preset infusion rate. The use of stepper motors may be beneficial in the precise delivery of fluid.

[0053] The power source used to provide energy to the one or more motors may be from one or more batteries contained within the pump housing or a battery pack external to the housing configured for attachment to the housing. The batteries / battery pack may be rechargeable. Depending on the setting, e.g., hospital, clinic, PFC, a port for connection to wall power may be provided in the pump housing. In some variations, the one or more motors may be coupled to a mechanical component configured to assist with movement thereof in a manner that reduces the energy required by the motors. For example, the mechanical component may include a spring. The spring may be part a key-wound mechanism, similar to those found in mechanical clocks, where the mechanical energy stored in the spring may be used to reduce the electrical energy required by the motors. The reduction in power consumption may in turn decrease the size of the power source and / or extend the run time of the pump.

[0054] The pumps described herein may also include one or more position sensors configured to identify a position of at least one actuator (e.g., the plunger on the cartridge). In some variations, the one or more position sensors may include optical sensors. For example, the one or more position sensors may include an encoder configured for optical sensing. One or more encoders may be included in the pumps (e.g., on the drive shaft of the motor) that are configured to track movement of the drive shaft. The data obtained from the one or more position sensors or encoders may be input to a pump controller to adjust the fluid infusion rate. In some variations, the data obtained from the one or more position sensors or encoders may be input into a feedback loop to automatically change the speed of the motor to meet the appropriate fluid infusion rate.

[0055] Instead of changing the volume of the chambers based on the movement of an actuator (e.g., plunger, piston, magnet), when the chambers are configured as bellowed barrels, the volume may be changed using an external force on the bellowed barrels.Controllers

[0056] The pumps may include one or more controllers for regulating fluid infusion. The one or more controllers may be located within the pump housing or exterior to the pump housing. In some variations, the one or more controllers may include a processor configured for automated control of the fluid infusion rate. In other variations, the one or more controllers may include a processor configured for manual control of the fluid infusion rate. In further variations, the one or more controllers may include a processor configured to switch from an automated mode of fluid infusion to a manual mode of fluid infusion, and vice versa. In some instances, the one or more controllers may include one or more processors configured to communicate with a physiological monitoring device and / or sensor that collects data relating to a physiological parameter. The one or more controllers may include one or more processors that may be further configured to adjust infusion (e.g., start infusion, stop infusion, increase a fluid infusion rate, decrease a fluid infusion rate) based on the measured physiological parameter. In some variations, the controller may implement fluid infusion rates ranging from about 0.1 ml / hr to about 4,000 ml / hr, including all values and sub-ranges therein. For example, the fluid infusion rate may be about 0.1 ml / hr, about 0.2 ml / hr, about 0.3 ml / hr, about 0.4 ml / hr, about 0.5 ml / hr, about 1.0 ml / hr, 2.0 ml / hr, about 3.0 ml / hr, about 4.0 ml / hr, about 5.0 ml / hr, about 6.0 ml / hr, about 7.0 ml / hr, about 8.0 ml / hr, about 9.0 ml / hr, 10 ml / hr, about 20 ml / hr, about 30 ml / hr, about 40 ml / hr, about 50 ml / hr, about 60 ml / hr, about 70 ml / hr, about 80 ml / hr, about 90 ml / hr, about 100 ml / hr, about 125 ml / hr, about 150 ml / hr, about 175 ml / hr, about 200 ml / hr, about 225 ml / hr, about 250 ml / hr, about 275 ml / hr, about 300 ml / hr, about 325 ml / hr, about 350 ml / hr, about 375 ml / hr, about 400 ml / hr, about 425 ml / hr, about 450 ml / hr, about 475 ml / hr, or about 500 ml / hr. In some instances, the fluid infusion rate may range from about 10 ml / hr to about 4,000 ml / hr, or from about 0.1 ml / hr to about 500 ml / hr. In some variations, the controller may be configured to only control the fluid infusion rate of a single pump. In other variations, the controller may be configured to simultaneously control multiple fluid infusions at once (e.g. 2,3,4, or more than 4 infusions at the same time).

[0057] In some variations, the one or more controllers of the pump may connect wirelessly, e.g., via Bluetooth® technology Wi-Fi, Wixel, optical transmission, or otherwise, or via wires, to the physiological data inputs representing physiological parameters of the patient. In turn, the data inputs may be communicated to a local computer, tablet, other pump devices, or othermedical devices such as patient physiologic monitors. Exemplary data inputs may include without limitation, measurement of a patient’s heart rate, heart rate variability, blood pressure (e.g., arterial pressure or venous pressure), oxygen saturation, respiratory rate, blood pH, carbon dioxide (e.g., pCCh or end tidal CO2), lactate, glucose, sodium, potassium, chloride, bicarbonate, creatinine, blood urea nitrogen, pressure within the CSF space, temperature, or a combination thereof. Instead of being directly transmitted from the physiological monitoring device and / or sensor, the data inputs may first be transmitted to a central module for collection and then subsequently transmitted to the one or more controllers of the pump.

[0058] The one or more processors of the controller may be configured to run one or more algorithms operable to instruct the pump to automatically adjust the rate of medication or other fluid delivery based on the measured physiological parameter. The one or more algorithms may be rule based algorithms, random forest plots, Proportional Integral Derivative (PID) controllers, fuzzy logic, neural networks, logistic regression models, support vector machines, or a combination thereof. In some variations, the algorithm may be run in the cloud, or on another device with the output of the algorithm being transferred to the pump controller. This output may then cause the pump to change in function, e.g., increase or decrease a fluid infusion rate. In one variation, the output may be the actual change required, or in another variation, the output of the algorithm may be used by the controller to determine how the change in function should occur. The one or more processors may cause adjustments to fluid delivery at an individual pump level based on a measured physiological parameter, or when a plurality of pumps is employed, cause instructions to be sent to the plurality of pumps to adjust one or more of their fluid infusion rates.

[0059] When multiple pumps are employed, one or more processors of the controller may be configured to run one or more algorithms operable to instruct delivery of a first fluid from a first pump, delivery of a second fluid from a second pump, and / or specify a first pump parameter for each of the first and / or second pumps based on one or more physiological parameters of a patient and / or one or more other pump parameters of the first and / or second pump. As mentioned above, the physiological parameter may be a heart rate, blood pressure, a lactate level, or an oxygen saturation of the patient, or a combination thereof, and the first pump parameter may be an infusion rate of one or more of the first fluid and the second fluid. The one or more other pump parameters may include, for example, a rate of change in the infusion rateand an anticipated rate of change in the rate of infusion. For example, the controller may be configured to (e.g., an algorithm of the controller) instruct delivery of a first fluid from a first pump, delivery of a second fluid from a second pump, an infusion rate of fluid from the first pump, and / or an infusion rate of fluid from the second pump based on one or more physiological parameters and / or the infusion rate or rate of change of the infusion rate of the other pump. The data from a first pump may be used by a second pump to adjust the rate of infusion of a medication from the second pump in response to a current rate of infusion of the first pump and / or in response to an anticipated change in the rate of infusion in the first pump. The multiple pumps may be wirelessly connected or wired together to transmit and receive data, e.g., data related to the infusion rate of the first pump to the second pump, and / or a measured physiologic parameter of the patient to from the first pump to the second pump. In some variations, a single pump device may comprise the multiple pumps.

[0060] When the fluid is a medication, the one or more algorithms may be used to control blood pressure, e.g., medications that increase blood pressure or decrease blood pressure. In some variations, the one or more algorithms may control multiple pumps (e.g., turn them on / off and / or adjust an infusion rate), each of which may deliver a different medication for controlling blood pressure. For example, the pumps may deliver a medication to increase blood pressure that is long acting (such as epinephrine, norepinephrine, phenylephrine, or vasopressin) to raise the blood pressure over a target blood pressure, and then use a short-acting blood pressure medication (such as clevidipine, nifedipine, labetalol, esmolol, fenoldopam, nitroglycerin, or nitroprusside) to drive the blood pressure back down to a desired blood pressure. Alternatively, the pumps may be configured to provide a long-acting medication to decrease blood pressure and then a short acting blood pressure medication to increase the blood pressure to the desired blood pressure. While described herein in the context of blood pressure, it should be appreciated that the algorithms may be used to control other physiological parameters of a patient through delivery of medications that affect that physiological parameter and / or to otherwise deliver medications to treat conditions.

[0061] The one or more controllers may also include memory configured to store information about the pump, about the different types of cartridges that may be attached, about types of medication that may be used with the pump, and / or appropriate dose ranges for the pump. Insome instances, algorithms that may control the pump in response to measured physiological information may also be stored.Safety Features

[0062] The pumps described herein may include various safety features. For example, in some variations, the pump controller may be configured to include guardrails so that autonomous changes in infusion rates may only occur with a predetermined list of medicines or only when changes in a patient’s physiology are within a predetermined range of changes. In order to optimize safety, when the range changes or the changes in a patient’s physiology fall outside of these guardrails, the pump may include the capability to alert the user to the changes and may require the user to accept the next change in medication rate prior to enactment of that change.

[0063] Additionally, one or more pressure sensors may be included to detect the pressure in the fluid lines within the cartridge above and below the pumping architecture, an air bubble detector may be included below the pumping architecture, and / or a series of lights and or LEDs may be provided to indicate to the user any problem with the pump. In some variations, e.g., when a stepper motor is used, an independent checking circuit such as a Field Programmable Gated Array (FPGA) may verify that the number of steps on the stepper motor match the intended bolus volume and fluid infusion rate, and may disable the motor if incorrect movement is detected. In some variations, the independent checking circuit may also halt the stepper motor or rotate the stopcock to a non-flow position if various other errors are detected. These may include, for example, failure of the software to read the pressure sensors within a preset time limit (e.g., within about 5 milliseconds), failure of the encoder to report movement when the stepper motor is activated, steps being performed at a rate that is faster or slower than the automated or manually set rate, and / or incorrect actuator movement (e.g., the actuator moves in the wrong direction).

[0064] Another safety feature includes limit switches configured to detect the number of reciprocations of the actuator generated by stepper motor to create a full / empty state of the chambers. This number may be compared against the number reported by the encoder. If the measured number (as indicated by software), the encoder count, and the limit switch do not match, the software may conclude that one of the actuator or motor is not functioning correctly. Instead of limit switches, the pumps may also be configured to detect a current spike when thestepper motor pushes the actuator (e.g., plunger, piston) against an end of the chamber and / or the mechanical stops. This spike in the current may occur because the torque attempted by the stepper motor increases dramatically when the mechanical load increases, so the spike may be used as an additional method to detect that the chambers are full / empty.

[0065] A further safety feature may relate to the instance when the fluid reservoir (e.g., IV bag) pressure increases quickly, such as when the bag is dropped or stepped on. In this instance, an upstream pressure sensor may detect the pressure increase, and software may take several measures to prevent additional flow of fluid to the patient. For example, a hold current on the stepper motor may be increased. This may be performed quickly, e.g., in about 6 milliseconds if the upstream pressure is sampled every 5 milliseconds. Alternatively, the stopcock valve may be rotated at least about 25 degrees (but less than about 65 degrees) to completely block the flow of fluid.

[0066] Yet another safety feature may relate to the IV needle being removed from the patient. In this scenario, the pump may have software that instructs a mode in which the stopcock valve may be rotated to a position that prevents fluid flow. This mode may be triggered either through detection in a downstream pressure sensor or manually via the user interface. Further safety measures may be able to detect inconsistencies between the volume of fluid delivered by the pump and the amount of fluid remaining in the external fluid source (e.g., an IV bag). For example, the pump may include software operable to measure the amount of fluid pumped and compare it to the volume that should be in the IV bag. If an inconsistency is identified, the pump may be configured to warn a user about the inconsistency (e.g., via a visual or audible alert). Similar warnings can be provided for cases where the bag runs out before the amount listed for the IV bag has been pumped. The software, in some instances, may also prevent the pump from operating if improper attachment to the housing is detected.Exemplary Pumps

[0067] In one variation of the pump devices described herein, the pump device may be configured as shown in FIGS. 1 A-1D. The pump device may include a cartridge having a fluid flow path that enters at the top of the cartridge, splits into two channels to connect with various pump components, and then comes back together below the pump chambers before passing through an air bubble detector to exit the cartridge and flow to the patient. After the split, thetwo lines may pass through a stopcock valve that directs the flow of fluid to and from each of the pumping chambers. The pumping chambers may be curved and placed adjacent to each other so that the tops of the chambers are near the top of the cartridge and are typically upright when the pump is in use. However, the pumps (and pump devices) may deliver fluids when in other orientations, e.g., upside down or sideways. The fluid path may connect to each of the fluid chambers at the top of each chamber. The ends of a plunger may sit within both chambers at the bottom of each chamber. The shape of the plunger may also be curved or C-shaped.

[0068] Referring to FIG. 1 A, an exemplary pump device (100) may include a housing (102) having a body (104) and a door (106) coupled to the housing body (104) for enclosing the pump components within its interior. A user interface (108) may be provided on one surface (110) of the housing body (104). Furthermore, a cartridge (112) may be removably attached to the housing body (104). Although the first and second fluid chambers (114 and 116, respectively) disposed on the cartridge (112) are shown as curved in shape, the shape of the fluid chambers is not so limited and may be any suitable shape that allows for placement on a removably attachable cartridge, as previously mentioned.

[0069] The individual components of the pump device (100) are illustrated in further detail in FIG. IB. Referring to FIG. IB, the housing (102) may comprise a body having a first portion (118) and a second portion (120) with a user interface (108) disposed on a surface (110) of the first portion (118). A series of LEDs (122) may also be positioned on the first portion (118). The pump (100) may include two motors (124, 126) configured to drive select components of the pump. In FIGS. 1 A-1D, the first motor (124) may be a motor that drives rotation of a plunger (128) in a first direction and a second, opposite direction (bidirectional rotation), and the second motor (126) may drive the rotation of a stopcock valve (130). The first motor (124) may be connected to a first coupler (132) configured to attach the first motor (124) to the plunger (128) of the cartridge (134), and a second coupler (136) may be configured to attach the first motor (124) to the stopcock valve (130) of the cartridge (134). Additionally, a plunger position encoder (138) configured to allow for accurate tracking of the plunger (128) position throughout the cycle of the first motor (124) may be attached to the first coupler (132). A cartridge support plate (140) may be included to help provide support to the cartridge (134) when connected to the housing (102). An RFID reader (142) may further be incorporated into the housing (102) to read an RFID tag (not shown) on the cartridge (134) when the cartridge (134) is releasably attachedto the housing (102). An upstream occlusion detector (144), which may be a pressure sensor, may also be integrated into the pump (100) so that the fluid path within the cartridge (134) may connect to the upstream occlusion detection system (144). A downstream occlusion detector (146) and an air bubble detector (148) may be integrated below the plunger (128) within the cartridge (134). Limit switches (150) may be integrated into the pump architecture to indicate when the plunger (128) from the cartridge (134) rotates in either direction to the end of its travel. The pump (100) may also include a component (152) configured to enable wireless communication between the pump (100) and other devices.

[0070] Further details of the pump cartridge (134) are illustrated in FIG. 1C. Referring to FIG. 1C, the cartridge support plate (140) may include integrated fluid paths (154) that connect to a fluid inlet (156) and a fluid outlet (158). Flexible tubing (160) may be integrated into the cartridge (134) to allow for sensing of occlusion by an upstream occlusion detector (144) and a downstream fluid detector (146). A front plate (162) of the cartridge (134) may be connected to the support plate (140), sealing the fluid path (154) and the flexible tubing (160) therebetween. A stopcock valve (164), which may communicate with the fluid path (154) may be included on the front plate (162). The first and second chambers of the pump (100) may be a first curved barrel (166) and a second curved barrel (167), each of which may be in fluid communication with the fluid path (154) via the stopcock valve (164). The plunger (128) may include seals (168) on each end, which may be inserted into the first and second curved barrels (166, 167), so that as the plunger (128) rotates in either direction, fluid from one curved barrel (e.g., first curved barrel 166) may be ejected while the other barrel (e.g., second curved barrel 167) is filling with the fluid.

[0071] Alignment of the cartridge (134) with the motors (124, 126) of the pump (100) may be accomplished as illustrated in FIG. ID. A finger grip (170) of the stopcock valve (130) may be held and rotated by a user to allow the user to manually align the stopcock valve (130) so that it is in the correct position to connect the cartridge (134) to the pump housing (102). More specifically, a stopcock marker (172) (e.g., a colored marker) may be provided on the cartridge (134) to indicate to a user the position the finger grip (170) should be rotated to in order to properly align the stopcock valve (130) for a cartridge to motor connection. A plunger marker (174) (e.g., a colored marker) may also be included on the cartridge (134) to indicate proper alignment of the plunger (128) for connection to the pump housing (102).

[0072] In some variations, the one or more motors that drive the bidirectional rotating plunger may be disengaged so that the motor is no longer connected to a drive shaft of the one or more motors. This may occur through a variety of clutch mechanisms and at several points between the motor and its associated drive shaft. When the motor has been disengaged, the plunger may then be driven by other mechanisms, e.g., by pressurizing the fluid in the fluid reservoir (e.g., a medication bag). To drive the pump in these variations, the stopcock valve may be rotated back and forth to switch the emptying and filling of each of the pump chambers since the fluid being pushed into one chamber to fill it then drives the other chamber to empty. The rate of flow may be adjusted by the extent the stopcock valve is rotated to open the flow paths. Asymmetric flow paths or asymmetrical stopcock openings, either through the stopcock valve or in the flow paths themselves, may allow for partial opening of the flow paths to control the total filling rate and emptying rate of the chambers. Furthermore, by including an encoder on the drive shaft, the fluid infusion rate may be controlled. Feedback loops between the encoder and the controller may then continuously adjust the amount of opening of the stopcock to control flow. For example, as shown in FIG. 2, a worm gear (200) may be attached to a stepper motor (202) that actuates a plunger (not shown). A plunger motor mount (204) to which the stepper motor (202) is fixed, may generally be pushed against the worm gear (200) by a torsional spring (207). The motor mount (204) and a coupler link (208) may form a 4-bar linkage configured to rotate the stepper motor (202) and a worm (206) away from the worm gear (200) when a lever (210) is flipped. A spring -loaded locking shaft (212) may be configured to slide back and then forward to lock the lever (210) into position, thus keeping the motor disengaged from the worm gear (200).

[0073] In another variation, as shown in FIG. 3, a worm gear (300) may be attached to a stepper motor (302) that actuates a plunger (not shown). The plunger motor mount (304) to which the stepper motor (302) is fixed, may generally be pushed against the worm gear (306) by a torsional spring (308). The motor mount (304) may also be the follower for a cammed lever (310). The cammed lever (310) may be shaped such that as it is flipped, the motor mount (304) rotates an amount sufficient to engage and disengage the stepper motor (302) from the worm gear (306). In some variations, the cammed lever (310) may be shaped to have certain valleys, channels, indents, etc., configured to fit a corresponding structure on the motor mount (304) (e.g., pin 312) that locks the motor mount (304) in the engaged and disengaged positions independently.

[0074] In use, the pump devices (e.g., pump device 100) may generally deliver fluid as illustrated in FIG. 4. First, a fluid contained in a reservoir, e.g., a bag (400) may be connected to a cartridge of a pump (not shown). Downstream from the bag (400) there may be a pressure sensor (Pl) configured to measure pressure in the bag upstream of the pump. Fluid may flow through the stopcock valve (402) and to one of two curved chambers, while fluid flows from the other curved chamber back through the stopcock valve (402) of a valving system, past a second pressure sensor (P2) and then to the patient. The stopcock valve (402) may be configured with one or more orientations so that in a first orientation, e.g., orientation “A”, the fluid path “x” may flow from the bag (400) to the end of chamber 2 and the second fluid path “y” may flow from chamber 1 to the patient. When the stopcock valve (402) is rotated counterclockwise 90 degrees to a second orientation, e.g., orientation “B”, the fluid path “x” may connect the end of chamber 2 to the patient and the fluid path “y” may be connected to the end of cylinder 1 from the bag. With this configuration of stopcock valve (402), the pump may achieve fluid movement by rotating the stopcock valve (402) and the plunger. Thus, in orientation “A”, chamber 1 may be full of fluid and as the plunger rotates clockwise the fluid may be expelled through the tubing and fluid path “y” and out to the patient. While the fluid is being expelled from chamber 1, chamber 2 may be simultaneously filled by fluid flowing from the bag (400) through the stopcock valve (402) and fluid path “x” into chamber 1. The stopcock valve (402) may then be rotated counterclockwise to orientation “B”, which may also switch the direction of the plunger to rotate counterclockwise. In this orientation (orientation “B”), as the plunger rotates counterclockwise, the fluid is expelled from chamber 2 through pathway “x” in the stopcock valve (402) to the patient while chamber 1 is simultaneously filled from the bag (400) through fluid path “y”. One or more mechanical stops (MS) may be included on the cartridge and may be configured to prevent the plunger from over rotating.

[0075] In some variations, the stopcock valve may be configured to include a linear shaft having a longitudinal axis and a short axis perpendicular to the longitudinal axis, and two channels extending through the linear shaft parallel to the short axis. In these variations, channel selection to direct fluid flow may be controlled via a linear actuator that slides the linear shaft up and down. The linear shaft may include an additional channel that allows air bubbles to be purged.

[0076] In an alternative configuration, the valving system may include a plurality of valves coupled to the tubing lines instead of a stopcock valve so that the valves may be opened and closed to direct fluid flow into and out of the chambers. Opening and closing of the valves may be controlled by cams configured to rotate over portions of the flexible pump tubing so that the tubing is open to flow or closed to flow at different cam positions that may be timed to achieve open and closed flow paths. For example, referring to FIG. 5, a fluid contained in a reservoir, e.g., a bag (500) may be connected to a cartridge (506) of a pump and directed to chamber 1 (502) and chamber 2 (504) by opening and closing of valves VI, V2, V3, and V4 of a valving system and rotation of the plunger. More specifically, when valves V2 and V3 are open and valves VI and V4 are closed, and the plunger rotated clockwise, fluid is emptied from chamber 1 (502) while chamber 2 (504) may be simultaneously filled by the fluid from the bag (500). When opening and closing of the valves is switched, e.g., valves V2 and V3 are closed and valves VI and V4 are open, and the plunger rotated counterclockwise, fluid from the bag (502) fills chamber 1 (502) while fluid simultaneously exits chamber 2 (504). As described for FIG. 4, one or more mechanical stops (MS) configured to prevent the plunger from over rotating may be included on the cartridge (506). One or more pressure sensors may also be fluidically coupled to the valving system. For example, a pressure sensor (Pl) may be coupled to the flexible pump tubing to prevent over pressurization of the bag (500), and pressure sensor (P2) may be coupled to the pump tubing to detect occlusion of the tubing.

[0077] In some variations of the pump, the actuator may be linearly reciprocated instead of rotated to deliver fluid to a patient. For example, referring to FIG. 6, a piston (600) may be linearly reciprocated with chambers of a cylinder (602) to deliver the fluid (e.g., the fluid from the IV bag (604)). In these variations, fluid from the IV bag (604) may be pressurized to generate the power required to pump the fluid. Fluid leaving the bag (604) may first transit a pressure sensor (Pl) before a split in the fluid path transits to two different limbs (Limb “A” and Limb “B”) of the pump. Both Limb “A” and Limb “B” may include a valve with Limb “A” including valve VI and Limb “B” including valve V2. After flowing through the valves VI and V2, both limbs then branch with one branch flowing to the cylinder (602) and the other branch flowing to the patient after transiting through another set of valves, V3 in Limb “A” and V4 in Limb “B”, and merging. Prior to delivery to the patient, the fluid may pass another pressure sensor (P2). For this pump to work, the fluid in the IV bag (604) may first be pressurized, e.g., using a pressure bag (not shown) around the IV bag (604). In Limb “A” VI may be open and V3may be closed, and in Limb “B” V2 may be closed and V4 may be open. In this valve setting, fluid may flow out of the IV bag (604), through VI, and into the cylinder (602). This may push the piston “P” (also element (600)) across the cylinder (602) to empty that side of the cylinder (which may be a first chamber) out through V4 and to the patient. Once the piston (600) has moved across the entirety of the cylinder (602), the valves may change configuration so that VI is closed, V2 is open, V3 is open, and V4 is closed. With these valve configurations, pressurized fluid from the IV bag (604) may move through V2 and into a portion of the cylinder (which may be the first chamber). This pressurized fluid may then push the piston (600) back across the cylinder to empty the left side of the cylinder (which may be a second chamber) out through V3 and to the patient. By switching the valve configurations back and forth in this way the pressurized fluid may push the piston (600) back and forth between the first and second chambers of the cylinder (602) and to the patient.

[0078] Additionally, position sensors (not shown) may be positioned at various locations along the length of the cylinder, e.g., at either end of the cylinder (602) as shown in FIG. 6, so that the pump may identify when the piston (600) has fully moved across the cylinder (602). By knowing the size of the piston (600) and the duration it took to transit across the cylinder (602), the rate of fluid administration may be determined and continuously or periodically updated. In some variations, a continuous position sensor (606) may be mounted along the cylinder (602) (or, in some variations, several position sensors located along the cylinder) to track the movement of the piston (600) across the cylinder (602) and obtain continuous updates of the pump rate. In some variations, pump rates may be estimated based on the pressure in the IV bag, the pressure from the patient (e.g., using a venous pressure), and the known resistance of the fluid moving through the pump. The valves may be opened and closed for a duration of time that may either decrease or increase the rate of fluid flow. Alternatively, one or more of the valves (including all of the valves) VI, V2, V3, and V4 of the valving system may be partially closed to slow the fluid infusion rate or fully opened to allow flow of the fluid at a maximum fluid infusion rate. In one variation, the cylinder may be positioned between two solenoids, which may be configured to control opening and closing of the valves VI, V2, V3, and V4 similar to pinch valves. In this variation, the first solenoid may allow either VI or V2 to be open. The second solenoid may allow either V3 or V4 to be open.

[0079] As shown in FIG. 7, a further variation of the pump may include the same or similar valving system configuration as described for FIG. 6, but a magnetic actuation system may be used to reciprocate the piston and track piston movement within chambers of a cylinder. In this configuration, the piston (Ml) may contain a ferrous or other magnetic component so that it may be driven by a magnetic actuation system disposed external to the cylinder. The piston (Ml) may include a rubber coating. A stepper motor may be used to reciprocate the piston (Ml) back and forth by moving another magnet (M2) along a screw extending from the stepper motor. Thus, the rate of reciprocation of the piston (Ml) may be controlled by controlling the speed of the stepper motor moving the magnet (M2). The valves of the valving system may be opened in order to allow the piston (Ml) to move within the cylinder. For example, when valves VI and V4 are open, the magnetic actuation system may move the piston (Ml) from the left side of the cylinder (the first chamber of the cylinder) to the right side of the cylinder (the second chamber of the cylinder). When V2 and V3 are open, the magnetic actuation system may move the piston (Ml) from the right side of the cylinder (the second chamber of the cylinder) to the left side of the cylinder (the first chamber of the cylinder). The valving system may include pinch valves or a stopcock valve. Limit switches (S) at either end of the cylinder indicate when the piston has moved to either far end of the cylinder. In some instances, a continuous position sensor may also be included next to the cylinder to track the movement of the piston (Ml) within the cylinder. The pump of FIG. 7 may be helpful in maintaining pump sterility since no opening into the cylinder is needed to allow introduction of an actuator (e.g., push rod, drive screw).

[0080] FIG. 8 illustrates another exemplary pump drive mechanism that includes a drive screw (TS), stepper motor, and drive shaft (802) to reciprocate a piston (P) within chambers of a pump cylinder. This pump architecture may include a similar four valve system (VI, V2, V3, and V4) as described with respect to FIGS. 6 and 7. An optional adjustable pinch valve may be added prior to the first bifurcation (800) of the fluid path. Within the cylinder, the piston (P) may be connected to one end of a drive shaft (802). A stepper motor coupled to the other end of the drive shaft (802) via the drive screw (TS) may rotate the drive screw (TS) clockwise and counterclockwise to reciprocate the piston (P) back and forth within the cylinder. Instead of a stepper motor, some variations of the pump may employ a rack and pinion or a linear potentiometer as drive mechanisms for a drive shaft connected to a piston. A folding barrier may be included on the same side of the cylinder that the drive shaft (802) exits the cylinder. In use, when VI and V4 are open and V2 and V3 are closed, the drive mechanism may push the piston(P) from the left side of the cylinder (the first chamber of the cylinder) to the right side of the cylinder (the second chamber of the cylinder), which in turn may push the fluid out to the patient from the right side of the cylinder (the side of the cylinder that has valves V2 and V4). When VI and V4 are closed and V2 and V3 are open, the drive mechanism may pull the piston (P) from the right side of the cylinder (the second chamber of the cylinder) to the left side of the cylinder (the first chamber of the cylinder), which in turn may push the fluid out to the patient from the left side of the cylinder (the side of the cylinder that has valves VI and V3). Naturally, the drive shaft could be coming from the opposite side of the cylinder so pushing and pulling of the piston would be reversed. Similar to prior descriptions, limit sensors may be utilized to inform when the piston has moved all the way to one side of the cylinder or the other. A continuous position sensor may also be used to track the piston continuously throughout the cylinder.

[0081] In some variations, a single pump device may include a plurality of pumps. In order to maintain the small form factor of the pump device in these variations, the motors configured to actuate components of each of the plurality of pumps may be arranged in a vertically offset manner, and coupled to pulley subsystems. For example, when two pumps are included in a pump device, a first stopcock motor and a first plunger motor of the first pump may be vertically offset within the pump device housing, and a second stopcock motor and a second plunger motor of a second pump may also be vertically offset within the pump device housing. The first stopcock motor may be configured to actuate a stopcock valve of the first pump and the first plunger motor may be configured to move a plunger of the first pump. Similarly, the second stopcock motor may be configured to actuate a stopcock valve of the second pump and the second plunger motor may be configured to move a plunger of the second pump.

[0082] An exemplary single pump device including two pumps to deliver fluids is shown in FIGS. 9A and 9B. The pumps may deliver the same fluid or different fluids. For example, the first pump may deliver a fluid for volume resuscitation (e.g., normal saline, Ringer’s lactate) or to replace blood loss, and the second pump may deliver a medication (e.g., a medication that adjusts blood pressure). As another example, the first pump may deliver a first fluid for volume resuscitation or to replace blood loss and the second pump may deliver a second, different fluid for volume resuscitation or to replace blood loss. In a further example, the first pump may deliver a first medication (e.g., a medication that increases blood pressure) and the second pump may deliver a second, different medication (e.g., a medication that decreases blood pressure). Asmentioned above, this configuration of pumps may be beneficial when blood pressure regulation is accomplished using a closed feedback loop based on one or more measured physiological parameters of a patient and / or a pump parameter (e.g., an infusion rate) of one or both of the pumps. Each of the pumps may be configured similarly to the pump described in FIGS. 1 A-1D, and may have any of the features described herein with respect to FIGS. 1 A-1D. For example, the pumps may each include a cartridge having a fluid flow path that enters at the top of the cartridge, splits into two channels to connect with corresponding pump chambers and various other pump components, and then comes back together below the pump chambers to exit the cartridge. However, instead of an actuation mechanism including a worm and a worm gear, sets of longitudinally offset motors may be used to actuate the stopcock valves and plungers via pulley subsystems, as further described below. The stopcock valves may direct the flow of fluid to and from each of the pump chambers. The pump chambers may be curved or C-shaped and placed adjacent to each other so that the tops of the chambers are near the top of the cartridge and are typically upright when the pump is in use. However, the pumps (and pump devices) may deliver fluids when in other orientations, e.g., upside down or sideways. The fluid path may connect to each of the fluid chambers at the top of each chamber. The ends of a plunger may sit within both chambers at the bottom of each chamber. Additionally, the shape of the plunger may be curved or C-shaped.

[0083] Referring to FIG. 9A, the pump device (900) may generally include a housing (902) enclosing the pumps and may comprise a first chassis (908) and a second chassis (910) that may be secured together in various ways, e.g., snap-fit, friction fit, welding, soldering. The housing (902) may have a first door (904), which is shown in an open state and on the right side of the housing (902), and a second door (906), which is shown in a closed state and on the left side of the housing (902). The doors (904, 906) may be attached to the chassis (908, 910) of the housing (902) via hinges (912) and secured in the closed state to the chassis (908, 910) by one or more latches (914). The doors (904, 906) may be in their closed state when the pump device (900) is actively delivering fluids, and in their open state when the cartridge (916), which includes the pump chambers, e.g., C-shaped chambers (920, 922), C-shaped plunger (924), and stopcock valve (926), is being removed from the housing (908) and / or replaced. Both pumps may be controlled by a single user interface (918).

[0084] An exploded view illustrating the various components of the pump device (900) in more detail is shown in FIG. 9B. Referring to FIG. 9B, the first chassis (908) may provide support for a first printed circuit board (PCB) (928), a screen, e.g., LCD touch screen (930), and a first support (932) including switches and / or buttons configured to control first and second pumps of the pump device (900). The first pump, which is depicted on the right side of the pump device (900), may include a first motor set comprised of two motors that may be vertically aligned to more efficiently use the interior space of the housing (902) and maintain the small form factor of the pump device (900). The vertically aligned motors may be a first stopcock motor (905) and a first plunger motor (911). The first stopcock motor (905) (e.g., a stepper motor) may be attached to a motor mount (936) and configured to open and close the stopcock valve (926) using a stopcock pulley subsystem including a drive pulley (938a) and a driven pulley (938b) connected by a stopcock drive belt (940). For example, rotation of a drive shaft (903) of the first stopcock motor (905) coupled to the drive pulley (938a) rotates the stopcock drive belt (940), which in turn moves a shaft (944) of the stopcock valve (926) to open and close the stopcock valve (926). A zeroing disk (942) configured to track movement of the drive shaft (903) of the first stopcock motor (905) may be disposed on the drive shaft (903).

[0085] Still referring to FIG. 9B, a first plunger motor (911) (e.g., stepper motor) of the first motor set may also be attached to the motor mount (936). The first plunger motor (911) may be configured to drive the plunger (924). Similarly to stopcock valve actuation, a drive shaft (not shown) of the plunger motor (911) may be attached to a plunger pulley subsystem including a drive pulley (948a) and a driven pulley (948b) connected by a plunger drive belt (950). For example, rotation of a drive shaft (not shown) of the first plunger motor (911) coupled to the drive pulley (948a) rotates the plunger drive belt (950), which in turn rotates a shaft (952) to rotate the plunger (924). A plunger zeroing disk (954) configured to track movement of the shaft (952) of the first plunger motor (911) may be disposed on the shaft (952). Additionally, a sensor (e.g., an encoder (956)) may be attached to the shaft (952) of the plunger (924) to allow for tracking of the plunger zeroing disc (954). The pump device (900) may further include a first zeroing printed circuit board (PCB) (958) containing electronics to allow for zeroing the plunger (924) and the stopcock valve (926) and a first motor set PCB (960), which contains the electronics configured to control the first motor set. The first motor set PCB (960) may also include a first upstream occlusion detection sensor (962), a first RFID module (966), a first downstream occlusion sensor (964), and a first air in-line detector (968). A first plate (970), afirst plate gasket (972), and a first membrane (974) may also be included in the pump device (900) to ensure ingress protection to the right side of the pump device. A cartridge (976), which may be any one of the cartridges discussed above, may be attached to a first side (e.g., the right side) of the pump device (900). A first door position indicator (978) (e.g., a first LED membrane including LEDs) may be employed to visually indicate when the right door of the pump assembly is closed and / or locked properly. Batteries (980) may further be included to allow for powering the pump device (900) when the assembly is not plugged into an external power source.

[0086] The second pump may be disposed on the left side of the pump device (900), and may have an architecture that is the same or similar to that of the first pump disposed on the right side of the pump assembly (900). For example, the second pump may include a second motor set attached to the motor mount (936) comprised of two motors that may be vertically aligned to more efficiently use the interior space of the housing (902) and maintain the small form factor of the pump device (900). The vertically aligned motors may be a second stopcock motor (934) and a second plunger motor (946). The second stopcock motor (934) (e.g., a stepper motor) may be configured to open and close a stopcock valve of the second pump device using a stopcock pulley subsystem including a drive pulley (982a) and a driven pulley (982b) connected by a stopcock drive belt (984). For example, rotation of a drive shaft (not shown) of the second stopcock motor (934) coupled to the drive pulley (982a) rotates the stopcock drive belt (984), which in turn moves a shaft (981) of the stopcock valve to open and close the stopcock valve. A stopcock zeroing disk (988) configured to track movement of the shaft (981) of the second stopcock motor (934) may be disposed on the shaft (981).

[0087] The second plunger motor (946) (e.g., stepper motor) of the second motor set may be attached to the motor mount (936). The second plunger motor (946) may be configured to drive a plunger of the second pump. Similar to stopcock valve actuation, a drive shaft (not shown) of the second plunger motor (946) may be attached to a plunger pulley subsystem including a drive pulley (990a) and a driven pulley (990b) connected by a plunger drive belt (992). For example, rotation of a drive shaft (not shown) of the second plunger motor (946) coupled to the drive pulley (990a) rotates the plunger drive belt (992), which in turn rotates a shaft (994) to rotate the plunger. A plunger zeroing disk (996) configured to track movement of the shaft (994) of the second plunger motor (946) may be disposed on the shaft (994). Additionally, a second encoder(998) may be attached to the shaft (994) of the second plunger to allow for tracking of the plunger zeroing disc (996). The pump device (900) may further include a second zeroing PCB (1000) containing electronics to allow for zeroing the plunger and the stopcock valve, and a second motor set PCB (1002) containing the electronics configured to control the second motor set. The second motor set PCB (1002) may also include a second upstream occlusion detection sensor, a second RFID module, a second downstream occlusion sensor, and a second air in-line detector. A second side plate (1004), a second side plate gasket (1006), and a second side membrane (1008) may also be included in the pump device (900) to ensure ingress protection to the left side of the pump device. A cartridge (1010), which may be any one of the cartridges discussed above, may be attached to a second side (e.g., the left side) of the pump assembly (900). A second door position indicator (1012) (e.g., a second LED membrane including LEDs) may be employed to visually indicate when the left door of the pump assembly is closed and / or locked properly.SYSTEMS

[0088] Systems including any one or more of the aforementioned pumps and an external source of fluid (e.g., reservoir such as a bag) are also described herein. For example, the system may include a plurality of pumps working together (e.g., 2, 3, 4, 5, 6, or more than 6 pumps working together). In some variations, the systems may further include one or more devices configured to measure a physiological parameter of the patient. The fluid may include without limitation, normal saline, D5W, lactated Ringer’s solution, plasma, albumin, blood, a blood product, and a medication.

[0089] In one variation, the system may comprise a pump that may include at least a first chamber and a second chamber coupled to a housing, at least one actuator coupled to the first and second chambers, a drive mechanism operable to effect movement of the at least one actuator, and a valving system including one or more valves. In this variation, movement of the at least one actuator may simultaneously move a fluid into the first chamber and out of the second chamber, and the one or more valves may be configured to selectively direct the flow of a fluid into and out of each of the first and second chambers. The chambers may be variously sized and shaped. One or more of the pump chambers may be included on a cartridge configured for removable attachment to the housing. The cartridge may or may not be disposable. In some instances, the valving system may further be included on the cartridge. The pumps may alsoinclude one or more pressure sensors and / or an air bubble detector within the housing, on the cartridge, and / or fluid lines delivering fluid to the pump or from the pump to the patient.

[0090] In another variation, the system may comprise a pump including a first curved chamber and a second curved chamber coupled to a housing, and a plunger at least partially slidably received within the first and second curved chambers. In this variation, advancement of the plunger into to the second curved chamber may simultaneously move a fluid into the first curved chamber and out of the second curved chamber. The chambers may have various sizes and / or volumes. One or more of the curved pump chambers may be included on a cartridge configured for removable attachment to the housing. The cartridge may or may not be disposable. In some instances, a valving system may further be included on the cartridge. The pumps may also include one or more pressure sensors and / or an air bubble detector within the housing, on the cartridge, and / or fluid lines delivering fluid to the pump or from the pump to the patient.

[0091] In yet a further variation, the system may comprise a pump including a housing, a drive mechanism operable to effect movement of at least one actuator, and one or more valves, and a cartridge configured for removable attachment to the housing. The cartridge may include a first chamber and a second chamber, where movement of the at least one actuator may simultaneously move a fluid into the first chamber and out of the second chamber, and where the one or more valves may be configured to selectively direct the flow of a fluid into and out of each of the first and second chambers.

[0092] The systems may also include one or more controllers. The one or more controllers may be disposed within the pump housing (e.g., an internal controller) or external to the housing (e.g., an external controller). The one or more controllers may be configured for automated and / or manual control of the fluid infusion rate. For example, the one or more controllers may be configured to switch from an automated mode of fluid infusion to a manual mode of fluid infusion, and vice versa. In some instances, the one or more controllers may be configured for wireless communication with a physiological monitoring device, and fluid infusion adjusted based on a physiological parameter measured by the physiological monitoring device. The fluid infusion rate may range from about 0.1 ml / hr to about 4,000 ml / hr, including all values and subranges therein. For example, the fluid infusion rate may be about 0.1 ml / hr, about 0.2 ml / hr, about 0.3 ml / hr, about 0.4 ml / hr, about 0.5 ml / hr, about 1.0 ml / hr, 2.0 ml / hr, about 3.0 ml / hr, about 4.0 ml / hr, about 5.0 ml / hr, about 6.0 ml / hr, about 7.0 ml / hr, about 8.0 ml / hr, about 9.0ml / hr, 10 ml / hr, about 20 ml / hr, about 30 ml / hr, about 40 ml / hr, about 50 ml / hr, about 60 ml / hr, about 70 ml / hr, about 80 ml / hr, about 90 ml / hr, about 100 ml / hr, about 125 ml / hr, about 150 ml / hr, about 175 ml / hr, about 200 ml / hr, about 225 ml / hr, about 250 ml / hr, about 275 ml / hr, about 300 ml / hr, about 325 ml / hr, about 350 ml / hr, about 375 ml / hr, about 400 ml / hr, about 425 ml / hr, about 450 ml / hr, about 475 ml / hr, or about 500 ml / hr. In some instances, the fluid infusion rate may range from about 10 ml / hr to about 4,000 ml / hr, or from about 0.1 ml / hr to about 500 ml / hr.

[0093] In some variations, a pressure bag may be included in the systems, which may be configured to apply a compressive force around the external fluid source (e.g., an IV bag) to further increase the fluid infusion rate. Adjusting the fluid infusion rate in this manner may help reduce the power consumed by the drive mechanism of the pump (e.g., the one or more motors) since it may reduce the torque required by the drive mechanism (e.g., the motor) to move the fluid, as previously described. In other variations, the external fluid source (e.g., an IV bag) may be elevated to increase the fluid infusion rate in a manner that helps to reduce the torque on the motor and thus, the power consumed by the motor. Reducing power requirements may in turn reduce the size of any battery / battery pack included with the pump or disposed within the pump housing.

[0094] Some variations of the systems described herein may include devices comprising an elongate body (e.g., a catheter) with one or more sensors configured for monitoring one or more physiological parameters during a medical procedure and / or for monitoring patient physiology over prolonged periods of time during routine and critical medical care. In some instances, these systems may include blood flow control devices. In some variations, the devices may be used to measure pH and / or an analyte, e.g., a lactate level, an oxygen level, or a carbon dioxide level. For example, the devices may be configured to perform arterial monitoring and include one or more the sensors on an arterial catheter (to measure, e.g., pH, a lactate level, an oxygen level, or a carbon dioxide level). In other variations, the devices may be used to measure (or monitor) blood pressure. In these variations, the devices may be configured to measure blood pressure at any location within the body. For example, the devices may be placed in the central arterial vasculature (e.g., aorta, pulmonary artery) or central venous vasculature (e.g., vena cava), or the peripheral arterial vasculature (e.g., femoral artery, radial artery) or peripheral venous vasculature (e.g. femoral vein, radial vein) and used to measure blood pressure therein. In onevariation, the devices may measure blood pressure in the aorta. In other variations, the devices may measure blood pressure in the radial artery. The pressure measurements may or may not be made using devices that include an expandable member, e.g., an expandable balloon.METHODS

[0095] Methods for fluid delivery are also described herein. The methods may generally include attaching one or more pump cartridges to the pump housing, reciprocating an actuator coupled to each of a first chamber and a second chamber on the cartridge to simultaneously move a fluid into and out of the first and second chambers, controlling one or more valves using a controller to selectively direct flow of the fluid into and out of the first and second chambers, and adjusting an infusion rate of the fluid to a patient using the controller. When the cartridge is connected to housing, one of the motors may be used to open and close one or more of the valves (e.g., a stopcock valve) and the second motor may be used to move the actuator (e.g., plunger, piston). Alignment of one or more motors of the pump to the cartridge may also be performed prior to delivering fluid from the pump. Exemplary fluids that may be delivered include without limitation, normal saline, D5W, lactated Ringer’s solution, plasma, albumin, blood, a blood product, and a medication. The fluids may be infused with a high degree of accuracy, for example, within about 0.5 pl of a preset infusion rate.

[0096] In some instances, reciprocating the actuator of the pumps may include rotating the actuator about a longitudinal axis of a drive shaft. The drive shaft may also be rotated to effect rotation of the actuator. One or more sensors (e.g., encoders) may be employed to track rotation of the drive shaft. Furthermore, one or more motors may be used to rotate the drive shaft, as previously stated. The one or more motors may be a stepper motor or a DC motor (brushed or brushless).

[0097] In other instances, reciprocating the actuator may include linearly sliding the actuator within the first and second chambers of the pump, as illustrated in FIGS. 6 and 8. Sliding of the actuator in a linear manner may be effected by a magnetic actuation system, as illustrated by FIG. 7. Some variations of the method may include identifying a position of the actuator using one or more position sensors. The one or more position sensors may be an optical sensor.

[0098] Each of the one or more valves of the valving system of the pumps has one or more orientations, and changing between each of the one or more orientations may adjust the flow of fluid from the pump. For example, as illustrated in FIG. 4, when the one or more valves has a first orientation and a second orientation, changing between the first orientation to the second orientation may switch the flow of fluid entering the first chamber to exiting the first chamber, and the flow of fluid exiting the second chamber to entering the second chamber. In some instances, for example, when the one or move valves is a stopcock valve, rotating the stopcock valve about 45 degrees may stop the flow of fluid from the pump.

[0099] In some variations, e.g., when a stepper motor (e.g., a stopcock motor) and stopcock valve are employed, the pump may achieve fluid delivery by moving the stepper motor and switching the direction of the stepper motor when one chamber is full and the other is empty. The switch may be performed at the point when one chamber is completely empty and the other chamber is completely full, or when both chambers are partially full (e.g., half -way full). Prior to switching directions, the stopcock valve may be rotated about 90 degrees to allow for the change in the fluid path. More specifically, prior to rotation of the stopcock valve, the pressure in the filled chamber will be higher than the pressure in the empty chamber so that rotation of the stopcock valve by about 90 degrees may cause a small spurt of fluid into the patient from the higher pressure filled chamber. To prevent this, the stopcock valve may first be rotated about 45 degrees (which results in no open flow path to either chamber), and the stepper motor moved a few steps such that the pressure in the filled chamber matches the pressure in the fluid line to the patient. Given that the time required to rotate the stopcock may be non-zero, the rate at which the chambers are emptied may be adjusted to be higher than the desired pumping rate. For example, if the time to rotate the stopcock valve is about 5% of the time to empty one of the pumping chambers, the rotation rate of the stepper motor that moves the actuator (e.g., plunger, piston) may be increased by about 5% to result in a net pumping rate that meets the desired rate.

[0100] Rotation of the stopcock valve to adjust and / or direct fluid flow may be accomplished in various ways. For example, the stopcock valve may always be rotated in the same direction (such as clockwise or counterclockwise). However, depending on the motor used, it may be more convenient to rotate the stopcock valve back and forth by about 90 degrees. This arrangement may provide additional safety mechanisms through the addition of mechanical stops that prevent movement of the stopcock valve past 90 degrees.

[0101] The fluid infusion rate of the pumps may be automatically or manually controlled using one or more controllers. For example, the one or more controllers may be configured to switch from an automated mode of fluid infusion to a manual mode of fluid infusion, and vice versa. One or more physiological parameters may be measured and wireless communicated to the controller from a physiological monitoring device, and fluid infusion adjusted based on the one or more measured physiological parameters. The one or more physiological parameters may be a measurement of a patient’s heart rate, heart rate variability, blood pressure, oxygen saturation, respiratory rate, blood pH, carbon dioxide (e.g., pCCh or end tidal CO2), lactate, glucose, sodium, potassium, chloride, bicarbonate, creatinine, blood urea nitrogen, pressure within the CSF space, temperature, or a combination thereof.

[0102] The fluid may be infused at a rate ranging from about 0.1 ml / hr to about 4,000 ml / hr, including all values and sub-ranges therein. For example, the fluid infusion rate may be about 0.1 ml / hr, about 0.2 ml / hr, about 0.3 ml / hr, about 0.4 ml / hr, about pml / hr, about 1.0 ml / hr, 2.0 ml / hr, about 3.0 ml / hr, about 4.0 ml / hr, about 5.0 ml / hr, about 6.0 ml / hr, about 7.0 ml / hr, about 8.0 ml / hr, about 9.0 ml / hr, 10 ml / hr, about 20 ml / hr, about 30 ml / hr, about 40 ml / hr, about 50 ml / hr, about 60 ml / hr, about 70 ml / hr, about 80 ml / hr, about 90 ml / hr, about 100 ml / hr, about 125 ml / hr, about 150 ml / hr, about 175 ml / hr, about 200 ml / hr, about 225 ml / hr, about 250 ml / hr, about 275 ml / hr, about 300 ml / hr, about 325 ml / hr, about 350 ml / hr, about 375 ml / hr, about 400 ml / hr, about 425 ml / hr, about 450 ml / hr, about 475 ml / hr, or about 500 ml / hr. In some instances, the fluid infusion rate may range from about 10 ml / hr to about 4,000 ml / hr, or from about 0.1 ml / hr to about 500 ml / hr.

[0103] The pump devices described herein may deliver fluids for various indications. For example, the fluid may be delivered to treat hypotension and / or hypertension in a patient, to increase a circulatory volume in the patient, for administration of a medication, and / or for administration of a blood product. The fluid will typically be received from an external fluid source, e.g., a bag containing the fluid. In some instances, the method may further include placing a pressure bag around the external fluid source. Pressure of the fluid flowing from the external fluid source to at least one of the first and second chambers may be measured using one or more pressure sensors. Additionally or alternatively, pressure of the fluid exiting at least one of the first and second chambers may be monitored using one or more pressure sensors. In some instances, the pressure in the bag may be used to drive the movement of fluid within thechambers, e.g., infusing fluid into one chamber while expelling fluid from the other chamber, thereby decreasing the power requirements of the pump.

[0104] In some variations, the pump may require priming with the fluid. During priming, the air that is present in the first and second pump chambers must be replaced by the fluid. The general goal of priming is to remove all air bubbles. During the priming sequence, the actuator of the pump (e.g., the plunger) may be moved such that first chamber is full (of air) and the second chamber is empty. The external fluid source (e.g., an IV bag) may then be connected and the actuator moved to draw in fluid into the first chamber. When the valving system includes a stopcock valve, the stopcock valve may be rotated to empty the first chamber and fill the second chamber. The actuator and stopcock valve may also be “rocked” (small movements) to agitate the fluid and dislodge any small bubbles.

[0105] In another variation, the fluid may be heated within the pump prior to delivery to a patient. The fluid may be heated when exiting the pump or heating may be provided by heating of the entire cartridge. Heating could be turned on or off by the user or via the algorithm. A temperature sensor may be used (e.g., could be built into the cartridge) for closed loop feedback for temperature control.

[0106] When multiple pumps are employed (in the same pump device, in separate pump devices), fluid delivery may include delivering a first fluid from a first pump, delivering a second fluid from a second pump, and controlling the infusion rate of at least one of the first and second fluids based on one or more of a physiological parameter of a patient and a pump parameter. As mentioned above, the physiological parameter may be a heart rate, blood pressure, a lactate level, or an oxygen saturation of the patient, or a combination thereof, and the pump parameter may be, e.g., an infusion rate of one or more of the first fluid and the second fluid, a rate of change in the infusion rate, and an anticipated rate of change in the rate of infusion. The multiple pumps may be wirelessly connected or wired together to transmit and receive data, e.g., data related to the infusion rate of the first pump to the second pump, and / or a measured physiologic parameter of the patient to from the first pump to the second pump.

[0107] As previously mentioned, the first and second fluids for delivery may include without limitation, fluids for volume resuscitation to increase blood pressure, e.g., normal saline, D5W, lactated Ringer’s solution, Plasmalyte, plasma, albumin, blood, and / or a blood product, and oneor more medications for adjusting blood pressure. For example, medications that may be delivered to increase blood pressure may include one or more of: norepinephrine, epinephrine, vasopressin, phenylephrine, dopamine, dobutamine, and angiotensin II. Exemplary medications that may be delivered to decrease blood pressure may include one or more of: clevidipine, nifedipine, labetalol, esmolol, fenoldopam, nitroglycerin, and nitroprusside. When used for resuscitation, the pumps may be configured to deliver a large volume of fluid at a high infusion rate. When used to deliver a medication, the pumps may be configured to deliver small volumes of the medication at a lower infusion rate. While described in the context of controlling blood pressure using resuscitation fluids and / or medications, it should be appreciated that the pump devices described herein may be used to deliver (e.g., in an automated fashion) any medically necessary or desirable fluids or medications.

[0108] The foregoing description, for purposes of explanation, used specific nomenclature to provide a thorough understanding of the invention. However, it will be apparent to one skilled in the art that specific details are not required in order to practice the invention. Thus, the foregoing descriptions of specific embodiments of the invention are presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed; obviously, many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to explain the principles of the invention and its practical applications, they thereby enable others skilled in the art to utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated.

Claims

CLAIMS1. A pump device for fluid delivery comprising: a first chamber and a second chamber coupled to a housing; at least one actuator coupled to the first and second chambers; a drive mechanism operable to effect movement of the at least one actuator; and a valving system comprising one or more valves, wherein movement of the at least one actuator simultaneously moves a fluid into the first chamber and out of the second chamber, and wherein the one or more valves is configured to selectively direct the flow of a fluid into and out of each of the first and second chambers.

2. The pump device of claim 1, wherein at least one of the first and second chambers is included on a cartridge configured for removable attachment to the housing.

3. The pump device of claim 2, wherein the cartridge is disposable.

4. The pump device of claim 2, wherein the valving system is further included on the cartridge.

5. The pump device of claim 1, wherein the fluid comprises normal saline, D5W, lactated Ringer’s solution, plasma, albumin, blood, a blood product, or a medication.

6. The pump device of claim 1, wherein the first chamber has a first volume and the second chamber has a second volume.

7. The pump device of claim 6, wherein the first volume and the second volume are the same.

8. The pump device of claim 6, wherein the first volume and the second volume are different.

9. The pump device of claim 1, wherein each of the first and second chambers comprises a barrel having a curved shape.

10. The pump device of claim 1, wherein the first and second chambers are disposed within a linear barrel.

11. The pump device of claim 1, wherein the drive mechanism is configured to effect rotational movement of the at least one actuator.

12. The pump device of claim 1, wherein the drive mechanism is configured to effect linear movement of the at least one actuator.

13. The pump device of claim 1, wherein the drive mechanism comprises one or more motors.

14. The pump device of claim 13, wherein the one or more motors comprises a stepper motor.

15. The pump device of claim 14, wherein the stepper motor comprises one or more gears configured to deliver the fluid at a high accuracy rate.

16. The pump device of claim 15, wherein the high accuracy rate is an infusion rate within 0.5 pl of a preset infusion rate.

17. The pump device of claim 13, wherein the one or more motors comprises a DC motor.

18. The pump device of claim 13, wherein each of the one or more motors is coupled to a drive shaft.

19. The pump device of claim 18, wherein each of the one or more motors is further coupled to a drive screw.

20. The pump device of claim 1, wherein the pump further comprises one or more position sensors.

21. The pump device of claim 20, wherein the one or more position sensors is configured to identify a position of the at least one actuator.

22. The pump device of claim 21, wherein the one or more position sensors comprises an optical sensor.

23. The pump device of claim 18, wherein the pump further comprises one or more encoders.

24. The pump device of claim 23, wherein the one or more encoders is configured to track movement of the drive shaft.

25. The pump device of claim 1, wherein the drive mechanism comprises a magnetic actuation system.

26. The pump device of claim 1, wherein the valving system is in fluid communication with a reservoir of the fluid.

27. The pump device of claim 1, wherein each of the one or more valves has a first orientation and a second orientation.

28. The pump device of claim 27, wherein, in the first orientation, at least one valve of the one or more valves is configured to selectively direct the fluid to flow into the first chamber, and wherein, in the second orientation, the at least one valve of the one or more valves is configured to selectively direct the fluid to flow out of the first chamber.

29. The pump device of claim 27, wherein, in the first orientation, at least one valve of the one or more valves is configured to selectively direct the fluid to flow into the second chamber, and wherein, in the second orientation, the at least one valve of the one or more valves is configured to selectively direct the fluid to flow out of the first second chamber.

30. The pump device of claim 1, wherein the one or more valves is a stopcock valve.

31. The pump device of claim 30, wherein the stopcock valve is configured to prevent the fluid from moving into and out of each of the first and second chambers when rotated about 45 degrees.

32. The pump device of claim 1, wherein the one or move valves is a solenoid valve.

33. The pump device of claim 1, wherein the at least one actuator comprises at least one plunger.

34. The pump device of claim 33, wherein the at least one plunger has a C-shape.

35. The pump device of claim 33, wherein the plunger comprises a finger grip configured to align the plunger with a drive shaft of the drive mechanism.

36. The pump device of claim 33, wherein the first chamber and the second chamber are operably coupled via the at least one plunger.

37. The pump device of claim 1, wherein the at least one actuator comprises a magnet.

38. The pump device of claim 37, wherein the magnet comprises a polymer layer on an outer surface thereof.

39. The pump device of claim 1, wherein the pump comprises at least two actuators.

40. The pump device of claim 1, wherein the pump further comprises a controller within the housing configured to control an infusion rate of the fluid to a patient.

41. The pump device of claim 40, wherein the controller is configured for automated control of the infusion rate.

42. The pump device of claim 40, wherein the controller is configured for wireless communication with a physiological monitoring device.

43. The pump device of claim 40, wherein the controller is configured for manual control of the infusion rate.

44. The pump device of claim 40, wherein the infusion rate is between about 10 ml / hr to about 4,000 ml / hr.

45. The pump device of claim 40, wherein the infusion rate is between about 0.1 ml / hr to about 500 ml / hr.

46. The pump device of claim 1, further comprising one or more pressure sensors.

47. The pump device of claim 1, wherein the pump further comprises an air bubble detector.

48. The pump device of claim 1, wherein the housing comprises a user interface.

49. A pump device for fluid delivery comprising: a first curved chamber; a second curved chamber; and a plunger at least partially slidably received within the first and second curved chambers, wherein advancement of the plunger into the second curved chamber simultaneously moves a fluid into the first curved chamber and out of the second curved chamber.

50. The pump device of claim 49, wherein the plunger has a first plunger end and a second plunger end, and the first plunger end is received within the first curved chamber and the second plunger end is received within the second curved chamber.

51. The pump device of claim 49, wherein the plunger is C-shaped.

52. The pump device of claim 49, further comprising a valving system comprising one or more valves, wherein the one or more valves is configured to selectively direct the flow of a fluid into and out of each of the first and second curved chambers.

53. The pump device of claim 52, wherein the one or more valves is a stopcock valve.

54. The pump device of claim 49, wherein the first curved chamber, the second curved chamber, and the plunger are included on a cartridge configured for removable attachment to a housing of the pump.

55. The pump device of claim 54, wherein the cartridge is disposable.

56. The pump device of claim 49, wherein the plunger is coupled to a drive mechanism operable to effect rotational movement thereof.

57. The pump device of claim 56, wherein the drive mechanism comprises a stepper motor.

58. The pump device of claim 49, wherein the pump further comprises a controller configured to control an infusion rate of the fluid to a patient.

59. The pump device of claim 58, wherein the controller is configured for automated control of the infusion rate.

60. The pump device of claim 58, wherein the controller is configured for wireless communication with a physiological monitoring device.

61. The pump device of claim 58, wherein the controller is configured for manual control of the infusion rate.

62. The pump device of claim 58, wherein the infusion rate is between about 10 ml / hr to about 4,000 ml / hr.

63. The pump device of claim 58, wherein the infusion rate is between about 0.1 ml / hr to about 500 ml / hr.

64. The pump device of claim 49, wherein the fluid comprises normal saline, D5W, lactated Ringer’s solution, plasma, albumin, blood, a blood product, or a medication.

65. A method of delivering fluids comprising: reciprocating an actuator coupled to each of a first chamber and a second chamber of a pump to simultaneously move a fluid into and out of the first and second chambers; and controlling one or more valves using a controller to selectively direct flow of the fluid into and out of the first and second chambers; and adjusting an infusion rate of the fluid to a patient using the controller.

66. The method of claim 65, wherein reciprocating the actuator comprises rotating the actuator about a longitudinal axis of a drive shaft.

67. The method of claim 66, wherein rotating the actuator is effected by rotating the drive shaft.

68. The method of claim 67, wherein one or more motors is used to rotate the drive shaft.

69. The method of claim 68, wherein the one or more motors is a stepper motor.

70. The method of claim 69, wherein the infusion rate is within 0.5 pl of a preset infusion rate.

71. The method of claim 68, wherein the one or more motors is a DC motor.

72. The method of claim 66, further comprising tracking rotation of the drive shaft using one or more encoders.

73. The method of claim 65, wherein reciprocating the actuator comprises linearly sliding the actuator within the first and second chambers of the pump.

74. The method of claim 73, wherein linearly sliding the actuator is effected by a magnetic actuation system.

75. The method of claim 65, wherein each of the one or more valves has one or more orientations, and changing between each of the one or more orientations adjusts the flow of fluid from the pump.

76. The method of claim 75, wherein the one or more valves has a first orientation and a second orientation, and changing between the first orientation to the second orientation switches the flow of fluid entering the first chamber to exiting the first chamber, and the flow of fluid exiting the second chamber to entering the second chamber.

77. The method of claim 65, wherein the infusion rate is between about 10 ml / hr to about 4,000 ml / hr.

78. The method of claim 65, wherein the infusion rate is between about 0.1 ml / hr to about 500 ml / hr.

79. The method of claim 65, wherein the controller is configured to automatically adjust the infusion rate based on one or more physiological parameters of the patient.

80. The method of claim 79, wherein the one or more physiological parameters is wireless communicated to the controller.

81. The method of claim 79, wherein the one or more physiological parameters comprises a heart rate, blood pressure, or oxygen saturation of the patient, or a combination thereof.

82. The method of claim 65, wherein the controller is configured for manual adjustment of the infusion rate.

83. The method of claim 65, wherein the fluid comprises normal saline, D5W, lactated Ringer’s solution, plasma, albumin, blood, a blood product, or a medication.

84. The method of claim 65, wherein the fluid is delivered to treat hypotension in the patient.

85. The method of claim 65, wherein the fluid is delivered to increase a circulatory volume in the patient.

86. The method of claim 65, further comprising receiving the fluid from an external fluid source.

87. The method of claim 86, further comprising placing a pressure bag around the external fluid source.

88. The method of claim 65, further comprising monitoring pressure of the fluid flowing from the external fluid source to at least one of the first and second chambers using one or more pressure sensors.

89. The method of claim 65, further comprising monitoring pressure of the fluid exiting at least one of the first and second chambers using one or more pressure sensors.

90. The method of claim 65, further comprising identifying a position of the actuator using one or more position sensors.

91. The method of claim 90, wherein the one or more position sensors comprises an optical sensor.

92. A system for delivering fluids comprising: the pump device of claim 1; and an external source of the fluid.

93. The system of claim 92, further comprising a pressure bag configured to apply a compressive force around the external source of the fluid.

94. The system of claim 92, wherein the pump is configured to infuse the fluid at a rate of about 10 ml / hr to about 4,000 ml / hr.

95. The system of claim 92, wherein the pump is configured to infuse the fluid at a rate between about 0.1 ml / hr to about 500 ml / hr.

96. The system of claim 92, wherein the fluid comprises normal saline, D5W, lactated Ringer’s solution, plasma, albumin, blood, a blood product, or a medication.

97. A system for delivering fluids comprising: the pump device of claim 49; and an external source of the fluid.

98. The system of claim 97, wherein the pump is configured to infuse the fluid at a rate of about 10 ml / hr to about 4,000 ml / hr.

99. The system of claim 97, wherein the pump is configured to infuse the fluid at a rate between about 0.1 ml / hr to about 500 ml / hr.

100. The system of claim 97, wherein the fluid comprises normal saline, D5W, lactated Ringer’s solution, plasma, albumin, blood, a blood product, or a medication.

101. A system for delivering fluids comprising: a pump, the pump comprising a housing, a drive mechanism operable to effect movement of at least one actuator, and one or more valves; and a cartridge configured for removable attachment to the housing, the cartridge comprising a first chamber and a second chamber, wherein movement of the at least one actuator simultaneously moves a fluid into the first chamber and out of the second chamber, and wherein the one or more valves is configured to selectively direct the flow of a fluid into and out of each of the first and second chambers.

102. A pump device comprising: a housing; a first pump at least partially within the housing and configured for delivery of a first fluid; a second pump at least partially within the housing and configured for delivery of a second fluid; and one or more controllers configured to adjust delivery of the first and second fluids based on one or more of a physiological parameter of a patient and a pump parameter.

103. The pump device of claim 102, wherein the first pump comprises a first cartridge configured for removable attachment to the housing, and the second pump comprises a second cartridge configured for removable attachment to the housing.

104. The pump device of claim 103, wherein the first and second cartridges comprise first and second actuators, one or more valves, and first and second and third and fourth chambers, respectively.

105. The pump device of claim 104, wherein for the first cartridge, movement of the first actuator simultaneously moves the first fluid into the first chamber and out of the second chamber, and wherein the one or more valves of the first cartridge is configured to selectively direct the flow of the first fluid into and out of each of the first and second chambers.

106. The pump device of claim 104, wherein for the second cartridge, movement of the second actuator simultaneously moves the second fluid into the third chamber and out of the fourth chamber, and wherein the one or more valves of the second cartridge is configured to selectively direct the flow of the second fluid into and out of each of the third and fourth chambers.

107. The pump device of claim 104, wherein each of the first, second, third, and fourth chambers comprises a barrel having a curved shape.

108. The pump device of claim 102, wherein the first fluid comprises normal saline, D5W, lactated Ringer’s solution, plasma, albumin, blood, or a blood product.

109. The pump device of claim 102, wherein the second fluid comprises a medication.

110. The pump device of claim 109, wherein the medication is a blood pressure medication that increases or decreases blood pressure.

111. The pump device of claim 102, wherein the first fluid and the second fluid each comprise a medication.

112. The pump device of claim 102, wherein the physiological parameter comprises one or more of a heart rate, blood pressure, a lactate level, or an oxygen saturation of the patient.

113. The pump device of claim 102, wherein the pump parameter is an infusion rate of one or more of the first fluid or the second fluid.

114. The pump device of claim 102, wherein the first pump comprises a first motor set coupled to a first pulley subsystem, and the second pump comprises a second motor set coupled to a second pulley subsystem.

115. The pump device of claim of claim 114, wherein the first motor set comprises a first stopcock motor and a first plunger motor.

116. The pump device of claim 114, wherein the first pulley subsystem comprises one or more drive pulleys, one or more driven pulleys, and one or more drive belts.

117. The pump device of claim 114, wherein the first motor set and the first pulley subsystem are configured to actuate a stopcock valve of the first pump.

118. The pump device of claim 114, wherein the first motor set and the first pulley subsystem are configured to move a plunger of the first pump.

119. The pump device of claim 114, wherein the second motor set comprises a second stopcock motor and a second plunger motor.

120. The pump device of claim 114, wherein the second pulley subsystem comprises one or more drive pulleys, one or more driven pulleys, and one or more drive belts.

121. The pump device of claim 114, wherein the second motor set and the second pulley subsystem are configured to actuate a stopcock valve of the second pump.

122. The pump device of claim 114, wherein the second motor set and the second pulley subsystem are configured to move a plunger of the second pump.

123. The pump device of claim 102, wherein the one or more controllers is disposed within the housing.

124. A method of delivering fluids comprising: delivering a first fluid from a first pump of a pumping device; delivering a second fluid from a second pump of the pumping device; and controlling the infusion rate of at least one of the first or second fluids based on one or more of a physiological parameter of a patient or a pump parameter.

125. The method of claim 124, wherein the first fluid comprises normal saline, D5W, lactated Ringer’s solution, plasma, albumin, blood, or a blood product.

126. The method of claim 124, wherein the second fluid comprises a medication.

127. The method of claim 126, wherein the medication is a blood pressure medication that increases or decreases blood pressure.

128. The method of claim 124, wherein the first fluid and the second fluid each comprise a medication.

129. The method of claim 124, wherein the physiological parameter comprises one or more of a heart rate, blood pressure, a lactate level, or an oxygen saturation of the patient.

130. The method of claim 124, wherein the pump parameter is an infusion rate of one or more of the first fluid or the second fluid.

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