Wearable medical infusion pump and method

By designing a pump system including a pumping syringe, an actuator, an inflow valve and an outflow valve, the wearable infusion pump in the prior art is solved in terms of accuracy and wearability, and the effect of high accuracy and long-term infusion is achieved.

CN119894550APending Publication Date: 2025-04-25BECTON DICKINSON & CO
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Patent Information

Application Number
CN202380064094.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-09-22
Filing Date
2023-09-21
Publication Date
2025-04-25

AI Technical Summary

Technical Problem

The existing wearable infusion pumps have shortcomings in accuracy and volume delivery, and the driving components are large in size, limiting the wearability of the pump and the feasibility of long-term infusion.

Method used

A pump system including a pumping syringe, an actuator, an inflow valve and an outflow valve is designed, which controls the delivery of fluid through the movement of the plunger in the cylinder, which moves the plunger through a linear actuator, and the valve ensures the direction of the fluid through a one-way check valve.

Benefits of technology

Higher flow rate accuracy is achieved, large amounts of fluid can be pumped over a longer period of time, and due to the design of the actuator, the pump is smaller in size and suitable for wearable use.

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Abstract

A pump for delivering fluid from a reservoir to a patient includes: at least one pumping syringe having a barrel and a plunger movable through the barrel; and at least one actuator for moving the plunger through the barrel to draw fluid from the reservoir into the barrel and to expel fluid from the barrel towards the patient. The pump further includes at least one inflow valve located between the reservoir and the barrel of the at least one pumping syringe, the at least one inflow valve opening when the plunger moves to draw fluid from the reservoir into the barrel; and at least one outflow valve located between the barrel of the at least one pumping syringe and the patient, the at least one outflow valve opening when the plunger moves to expel fluid from the barrel of the at least one pumping syringe toward the patient.
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Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. application No. 17 / 950,474, filed on September 22, 2022, and entitled “Wearable Medical Infusion Pump and Method,” the entire disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present invention generally relates to wearable injection and / or infusion devices, and more particularly to wearable pumps for administering medical fluids such as saline, therapeutic agents and / or total parenteral nutrition fluids to a patient in a continuous fluid flow, a substantially continuous fluid flow, a semi-continuous fluid flow, or an intermittent fluid flow. Background Art

[0004] Various types of automatic injection devices have been developed to allow drug solutions and other liquid therapeutic preparations to be applied by untrained personnel or for self-injection. Typically, these devices include a reservoir pre-filled with a liquid therapeutic preparation and a certain type of automatic needle injection mechanism that can be triggered by a user. When the volume of the fluid or drug to be applied exceeds 1 mL, the injection time will usually become longer, making it difficult for the patient to maintain contact between the device and the target area of ​​the patient's skin. In addition, as the volume of the drug to be applied becomes larger, it may be desirable to extend the time period for injection. The traditional method of slowly injecting therapeutic agents to the patient is to use an intravenous (intravenous, IV) bag, wherein the fluid is slowly transferred to the patient from the bag through a fluid conduit by gravity. This process is usually performed in a hospital or outpatient environment, because the IV bag is usually supported by a vertical rod or similar support, so that the IV bag remains above the injection site, thereby allowing the medical fluid to be discharged from the bag toward the patient by gravity.

[0005] Some devices allow self-injection or self-infusion in a home environment, and can gradually inject liquid therapeutic preparations into the patient's skin. In some cases, these devices (in terms of height and overall size) are small enough to allow non-bedridden patients to "wear" these devices when liquid therapeutic preparations are infused into the patient's body. These wearable injection and / or infusion devices generally include a pump or another type of discharge mechanism to force the liquid therapeutic preparation to flow out of the reservoir and flow into an injection needle or a vascular access kit. This device generally also includes a valve or flow control mechanism and an electrical and / or mechanical trigger mechanism, which is used to start the liquid therapeutic preparation at a selected flow rate at an appropriate time, and the electrical and / or mechanical trigger mechanism is used to start the injection.

[0006] One type of wearable infusion pump is an elastomeric infusion bag. Such elastomeric infusion bags provide a continuous flow of fluid to the patient; however, the accuracy of the flow rate may be poor because the elasticity of the bag material may change over time. As a result, such elastomeric bags may become less accurate and / or may not function as intended after the preferred or recommended shelf life of the bag device has expired. Changes in the elasticity of the bag material may also result in changes in the bag fill volume, as well as changes in the size (inner diameter) of the IV catheter lumen and / or changes in the IV line blockage rate (%) or flow restriction.

[0007] Another type of wearable infusion pump is an electromechanical peristaltic pump. Peristaltic pumps are generally slightly more accurate than elastomeric infusion bags. However, peristaltic pumps have poor flow rate accuracy compared to intravenous (IV) infusion syringe pumps. Therefore, it may not be recommended to use a wearable peristaltic pump to infuse medications that require high accuracy.

[0008] IV syringe pumps known in the prior art are the third fluid delivery solution. However, such IV syringe pumps have several disadvantages that make them unsuitable for use as wearable pumps. For example, IV syringe pumps are typically designed to hold large-sized syringes, up to 60 milliliters (mL) or 100 mL. In order to hold such large syringes, the size and weight of the IV syringe pump may be large because a linear actuator mechanism is required to drive the large syringe. The large size and weight of the drive components may limit the pump to be used at the bedside or mounted on an IV pole, rather than being wearable. In addition, if the patient requires a larger volume of medication or requires a long-term (several days) infusion of medication, the syringe needs to be frequently replaced during the infusion period. Compared with pumps that include smaller syringes or fluid reservoirs, the use of large-volume syringes can also result in lower accuracy in the infusion volume due to manufacturing tolerances and other factors.

[0009] In view of the limitations of currently available wearable pumps, there is a need for a wearable pump that can have more precise flow rate accuracy while having the ability to pump large amounts of fluid over an extended period of time. In addition, the pump drive components should be small enough to be wearable. There is also a need for a pump that is configured to provide continuous fluid flow, semi-continuous fluid flow, or intermittent fluid flow. The medical infusion pumps and related methods of the present disclosure are configured to address these limitations of existing infusion pump designs. Summary of the invention

[0010] According to one aspect of the present disclosure, a pump for delivering fluid from a reservoir to a patient includes: at least one pumping syringe having a barrel and a plunger movable through the barrel; and at least one actuator for moving the plunger through the barrel to draw fluid from the reservoir into the barrel and to discharge fluid from the barrel toward the patient. The pump also includes at least one inflow valve located between the reservoir and the barrel of the at least one pumping syringe, the at least one inflow valve opening when the plunger of the at least one pumping syringe moves to draw fluid from the reservoir into the barrel of the at least one pumping syringe; and at least one outflow valve located between the barrel of the at least one pumping syringe and the patient, the at least one outflow valve opening when the plunger moves to discharge fluid from the barrel of the at least one pumping syringe toward the patient.

[0011] According to another aspect of the present disclosure, a fluid infusion system comprises: a pump as described above; the reservoir, the reservoir being fluidically connected to the pump, the pump containing the fluid to be delivered to the patient; and at least one patient line, the at least one patient line being fluidically connected to the barrel of the at least one pumping syringe of the pump at a distal position of the at least one outflow valve. The patient line is configured to deliver the fluid from the pump to the patient's vascular system.

[0012] According to another aspect of the present disclosure, a method for infusing a fluid into a patient comprises: attaching the pump described above to a reservoir so that the reservoir is fluidically connected to the barrel of at least one pumping syringe of the pump. The method also includes placing the pump in communication with the patient's vascular system. The method also includes causing the at least one actuator of the pump to repeatedly move the plunger through the barrel of the at least one pumping syringe, thereby transferring the fluid from the reservoir to the barrel of the at least one pumping syringe, and from the barrel of the at least one pumping syringe to the patient.

[0013] Non-limiting illustrative examples of embodiments of the present disclosure will now be described in the following numbered items.

[0014] Article 1: A pump for delivering fluid from a reservoir to a patient, the pump comprising: at least one pumping syringe, the at least one pumping syringe comprising a barrel and a plunger movable through the barrel; at least one actuator, the at least one actuator being used to move the plunger through the barrel to draw fluid from the reservoir into the barrel and to expel fluid from the barrel toward the patient; at least one inlet valve, the at least one inlet valve being located between the reservoir and the barrel of the at least one pumping syringe, the at least one inlet valve opening when the plunger of the at least one pumping syringe moves to draw fluid from the reservoir into the barrel of the at least one pumping syringe; and at least one outflow valve, the at least one outflow valve being located between the barrel of the at least one pumping syringe and the patient, the at least one outflow valve opening when the plunger moves to expel fluid from the barrel of the at least one pumping syringe toward the patient.

[0015] Clause 2: The pump of clause 1, wherein the pump is a wearable pump worn by an ambulatory patient.

[0016] Clause 3: A pump according to clause 1 or 2, wherein the fluid comprises at least one of saline, liquid medication, or total parenteral nutrition solution.

[0017] Clause 4: The pump of any of Clauses 1 to 3, wherein the at least one actuator comprises a linear actuator that engages the plunger to move the plunger through the barrel.

[0018] Article 5: A pump according to any one of Articles 1 to 4, which further comprises a valve group connected to the at least one pumping syringe and the reservoir, the valve group comprising: a housing enclosing at least one fluid chamber; at least one inlet port, wherein fluid is transferred from the reservoir to the at least one fluid chamber through the at least one inlet port; at least one syringe port, which is fluidically connected to the interior of the barrel of the at least one pumping syringe, wherein fluid is transferred between the interior of the barrel and the at least one fluid chamber through the at least one syringe port; and at least one outflow port, wherein fluid is transferred from the at least one fluid chamber to a patient through the at least one outflow port.

[0019] Clause 6: The pump of Clause 5, wherein the at least one inlet valve is integral with the at least one inlet port.

[0020] Clause 7: The pump of clause 5 or 6, wherein the at least one outflow valve is integral with the at least one outflow port.

[0021] Clause 8: The pump of any one of Clauses 5 to 7, wherein the at least one inflow port, the at least one syringe port, and / or the at least one outflow port are removably connected to the housing.

[0022] Clause 9: The pump of any one of Clauses 1 to 8, wherein the at least one inlet valve and the at least one outlet valve are one-way check valves.

[0023] Clause 10: The pump of any one of Clauses 1 to 9, wherein the at least one inlet valve comprises an inlet check valve that automatically opens when fluid is drawn into the barrel of the at least one pumping syringe.

[0024] Clause 11: The pump of Clause 10, wherein the at least one outflow valve comprises an outflow check valve that automatically opens when fluid is expelled from the barrel of the at least one pumping syringe.

[0025] Clause 12: The pump according to Clause 11, wherein the opening pressure of the inflow check valve and / or the outflow check valve is greater than the atmospheric pressure to prevent the fluid from being siphoned out of the reservoir through the inflow check valve and the outflow check valve.

[0026] Clause 13: The pump of any one of Clauses 1 to 12, wherein the volume of the barrel of the at least one pumping syringe is about 3 mL to about 5 mL.

[0027] Clause 14: The pump of any one of Clauses 1 to 13, wherein the barrel of the at least one pumping syringe comprises an open proximal end, a distal end comprising a fluid port, and a cylindrical sidewall extending between the proximal end and the distal end.

[0028] Article 15: A pump according to Article 14, wherein the plunger includes a resilient stopper and a plunger rod, the resilient stopper sealing against the inner surface of the cylindrical side wall of the barrel, the plunger rod connected to the proximal end of the stopper for moving the stopper through the barrel to draw fluid into the barrel through the fluid port and to discharge fluid from the barrel through the fluid port.

[0029] Clause 16: The pump of Clause 15, wherein the at least one actuator engages the proximal end of the plunger rod and moves the plunger rod rearwardly through the barrel to draw fluid into the barrel and moves the plunger rod forwardly through the barrel to expel fluid from the barrel.

[0030] Clause 17: The pump of clause 16, wherein the actuator comprises a retainer engaged with the proximal end of the plunger rod, wherein the actuator moves the retainer back and forth along the track, thereby moving the resilient stop through the barrel.

[0031] Clause 18: The pump of any one of Clauses 1 to 17, further comprising a pump controller electrically coupled to the at least one actuator, the pump controller being configured to cause the at least one actuator to repeatedly move the plunger through the barrel of the at least one pumping syringe at a predetermined rate.

[0032] Clause 19: The pump of Clause 18, wherein the pump controller is configured to monitor the torque applied by the at least one actuator on the plunger to detect when the plunger approaches an end of stroke position.

[0033] Clause 20: The pump of clause 19, wherein the pump controller is configured to change the direction of the plunger when the torque increases above a threshold.

[0034] Article 21: A pump according to any one of Articles 18 to 20, which further includes at least one position sensor for detecting the position of the plunger in the barrel, wherein the pump controller is configured to cause the at least one actuator to change the direction of the plunger based on information detected by the at least one position sensor.

[0035] Clause 22: The pump of any of Clauses 19 to 21, wherein the pump controller is configured to receive input from a user and to adjust a rate at which the at least one actuator moves the plunger through the barrel based on the received input.

[0036] Article 23: A pump according to any one of Articles 18 to 22, further comprising a dose input button, wherein the pump controller is configured to receive an indication when a user presses the dose input button and cause the at least one actuator to increase the rate at which the plunger moves through the barrel for a predetermined duration to provide a dose of fluid to the patient.

[0037] Clause 24. The pump of any of Clauses 1 to 23, wherein the reservoir comprises a reservoir syringe comprising a barrel and a stopper for retaining fluid within the barrel.

[0038] Clause 25. The pump of Clause 24, wherein the barrel of the reservoir syringe comprises an open proximal end, a distal end, and a cylindrical sidewall extending therebetween, the distal end comprising a fluid port connected directly or indirectly to the at least one inlet valve.

[0039] Clause 26: The pump of any of Clauses 1 to 25, wherein the reservoir comprises an intravenous bag fluidly connected to the at least one inflow valve via at least one fluid conduit.

[0040] Clause 27: The pump of any one of Clauses 1 to 26, further comprising a closure that houses at least a portion of the at least one pumping syringe, the reservoir, the at least one inlet valve, and the at least one outlet valve.

[0041] Clause 28: The pump of Clause 27, wherein the closure comprises a sealed closure to restrict access to the fluid in the reservoir.

[0042] Clause 29: The pump of Clause 27 or 28, wherein the closure comprises a clamshell closure comprising a base and a cap pivotally connected to the base along a hinge.

[0043] Article 30: A pump according to any one of Articles 1 to 29, configured to provide continuous fluid delivery, semi-continuous fluid delivery, or intermittent fluid delivery to an ambulatory patient.

[0044] Clause 31. The pump of any one of Clauses 1 to 30, wherein the reservoir is removable from the remainder of the pump to allow replacement of the reservoir without interrupting operation of the at least one actuator and the at least one pumping syringe.

[0045] Article 32: A pump according to any one of Articles 1 to 31, wherein the at least one pumping syringe includes a first pumping syringe and a second pumping syringe, wherein the at least one actuator includes a first actuator and a second actuator, the first actuator moves the plunger of the first pumping syringe, and the second actuator moves the plunger of the second pumping syringe.

[0046] Clause 33. The pump of Clause 32, wherein fluid discharged from the first pumping syringe is transferred to a first patient line and fluid discharged from the second pumping syringe is transferred to a second patient line separate from the first patient line.

[0047] Clause 34: The pump of Clause 32 or 33, wherein the fluid discharged from the first pumping syringe and the fluid discharged from the second pumping syringe are transferred to the patient through a common patient line.

[0048] Article 35: A pump according to any one of Articles 32 to 34, wherein the at least one inlet valve comprises: a first inlet valve, which is located between the reservoir and the barrel of the first pumping syringe, and the first inlet valve opens when the plunger of the first pumping syringe moves to draw fluid from the reservoir into the barrel of the first pumping syringe; and a second inlet valve, which is located between the reservoir and the barrel of the second pumping syringe, and the second inlet valve opens when the plunger of the second pumping syringe moves to draw fluid from the reservoir into the barrel of the second pumping syringe.

[0049] Article 36: A pump according to Article 35, wherein the first inlet valve is closed when the plunger of the first pumping syringe moves to expel fluid from the barrel of the first pumping syringe, and the second inlet valve is closed when the plunger of the second pumping syringe moves to expel fluid from the barrel of the second pumping syringe.

[0050] Article 37: A pump according to Article 35 or 36, wherein the at least one outflow valve includes: a first outflow valve, which is located between the barrel of the first pumping syringe and the patient, and the first outflow valve opens when the plunger of the first pumping syringe moves to discharge the fluid from the barrel toward the patient; and a second outflow valve, which is located between the barrel of the second pumping syringe and the patient, and the second outflow valve opens when the plunger of the second pumping syringe moves to discharge the fluid from the barrel toward the patient.

[0051] Clause 38: The pump of Clause 37, wherein the first inlet valve and the second inlet valve, and the first outlet valve and the second outlet valve comprise one-way check valves.

[0052] Article 39: A pump according to Article 37 or 38, the pump also includes a valve group, which is connected to the first pumping syringe, the second pumping syringe and the reservoir, and the valve group includes: a housing, which encloses at least one fluid chamber; an inflow port, wherein fluid is transferred from the reservoir to the at least one fluid chamber through the inflow port; a first syringe port, the first syringe port is fluidly connected to the interior of the barrel of the first pumping syringe, wherein fluid is transferred between the interior of the barrel of the first pumping syringe and the at least one fluid chamber through the first syringe port; a second syringe port, the second syringe port is fluidly connected to the interior of the barrel of the second pumping syringe, wherein fluid is transferred between the interior of the barrel of the second pumping syringe and the at least one fluid chamber through the second syringe port; a first outflow port, wherein fluid is transferred from the barrel of the first pumping syringe toward the patient through the first outflow port; and a second outflow port, wherein fluid is transferred from the barrel of the second pumping syringe toward the patient through the second outflow port.

[0053] Article 40: The pump according to Article 39, wherein the first outflow valve and the second outflow valve are integrated with the first outflow port and the second outflow port, respectively.

[0054] Article 41: A pump according to any one of Articles 32 to 40, which also includes a pump controller electrically coupled to the first actuator and the second actuator, and the pump controller is configured to cause the plunger of the first pumping syringe and the plunger of the second pumping syringe to move in opposite directions substantially simultaneously.

[0055] Clause 42. The pump of Clause 41, wherein the pump controller is configured to cause the first actuator and the second actuator to repeatedly move the plunger back and forth through the barrel of the first pumping syringe and the barrel of the second pumping syringe.

[0056] Clause 43. The pump of Clause 42, wherein repeated simultaneous movement of the plungers in opposite directions causes fluid to be expelled from the pump toward the patient in a continuous stream or a substantially continuous stream.

[0057] Article 44: A pump according to any one of Articles 41 to 43, wherein the reservoir is removably connected to other parts of the pump so that the reservoir can be removed and replaced while the pump controller continues to cause the first actuator and the second actuator to move the plunger through the barrel of the first pumping syringe and the barrel of the second pumping syringe.

[0058] Article 45: A fluid infusion system, comprising: the pump described in any one of Articles 1 to 44; the reservoir, which is fluidly connected to the pump and contains the fluid to be delivered to the patient; and at least one patient line, which is fluidly connected to the barrel of the at least one pumping syringe at a distal position of the at least one outflow valve, wherein the at least one patient line is configured to deliver the fluid from the pump to the patient's vascular system.

[0059] Article 46: A fluid infusion system according to Article 45, wherein the at least one pumping syringe includes a first pumping syringe and a second pumping syringe, wherein the at least one actuator includes a first actuator and a second actuator, the first actuator moves the plunger of the first pumping syringe, and the second actuator moves the plunger of the second pumping syringe.

[0060] Article 47: A fluid infusion system according to Article 46, wherein the at least one patient line includes a first patient line and a second patient line, the first patient line is configured to deliver fluid discharged from a first pumping syringe to a patient, and the second patient line is separate from the first patient line and configured to deliver fluid discharged from a second pumping syringe to a patient.

[0061] Clause 48: A fluid infusion system according to Clause 46 or 47, wherein the at least one patient fluid line comprises a common patient line configured to deliver fluid discharged from the first pumping syringe and from the second pumping syringe to the patient.

[0062] Clause 49: The fluid infusion system of Clause 48, wherein the at least one patient line comprises a central patient line.

[0063] Article 50: A fluid infusion system according to any one of Articles 45 to 49, wherein the reservoir comprises a reservoir syringe removably connected to the pump, wherein the reservoir syringe can be removed from the pump and replaced with another reservoir syringe while the at least one actuator causes the plunger to continue to move through the barrel of the at least one pumping syringe.

[0064] Clause 51. The fluid infusion system of any one of Clauses 45 to 50, wherein the reservoir comprises an intravenous bag fluidly connected to the pump via at least one fluid conduit.

[0065] Article 52: A method for infusing a fluid into a patient, the method comprising: attaching the pump described in any of Articles 1 to 44 to a reservoir so that the reservoir is in fluid communication with the barrel of at least one pumping syringe; placing the pump in fluid communication with the patient's vascular system; and causing the at least one actuator of the pump to repeatedly move the plunger through the barrel of the at least one pumping syringe, thereby transferring the fluid from the reservoir to the barrel of the at least one pumping syringe, and from the barrel of the at least one pumping syringe to the patient.

[0066] Clause 53: The method of clause 52, wherein the fluid is transferred from the pump toward the patient in a continuous flow, a substantially continuous flow, a semi-continuous flow, or an intermittent flow.

[0067] Clause 54: The method of clause 52 or 53, wherein placing the pump in fluid communication with the patient's vasculature comprises attaching the at least one outflow port of the pump to at least one patient line extending from a blood vessel of the patient.

[0068] Article 55: A method according to any one of Articles 52 to 54, wherein at least one pumping syringe of the pump includes a first pumping syringe and a second pumping syringe, and wherein placing the pump in fluid communication with the patient's vascular system includes attaching a first outlet of the pump that is fluidly connected to the first pumping syringe to a first patient line extending from the patient's blood vessel, and attaching a second outlet of the pump that is fluidly connected to the second pumping syringe to a second patient line extending from the patient's blood vessel.

[0069] Article 56: A method according to any one of Articles 52 to 55, wherein at least one pumping syringe of the pump includes a first pumping syringe and a second pumping syringe, and wherein placing the pump in fluid communication with the patient's vascular system includes attaching a first outlet of the pump that is fluidly connected to the first pumping syringe and a second outlet of the pump that is fluidly connected to the second pumping syringe to a common patient line extending from a blood vessel of the patient.

[0070] Clause 57: The method of any of Clauses 52-56, wherein attaching the pump to the reservoir comprises attaching the pump to at least one of a syringe and an intravenous bag.

[0071] Clause 58: The method of any of Clauses 52 to 57, further comprising removing the reservoir from the pump and replacing the reservoir with a new reservoir while the at least one actuator continues to move the plunger through the at least one pumping syringe. BRIEF DESCRIPTION OF THE DRAWINGS

[0072] Figure 1Ais a perspective view of a medical infusion pump according to one aspect of the present disclosure.

[0073] Figure 1B yes Figure 1A Cross-sectional view of a medical infusion pump.

[0074] Figure 1C It shows Figure 1A Schematic diagram of the electrical components of a medical infusion pump.

[0075] Figure 2A is a perspective view of another example of a medical infusion pump according to an aspect of the present disclosure.

[0076] Figure 2B yes Figure 2A Side view of a medical infusion pump.

[0077] Figure 2C yes Figure 2A Cross-sectional view of a medical infusion pump.

[0078] Figure 3A is a perspective view of an intravenous (IV) bag as is known in the art.

[0079] Figure 3B is a schematic diagram of a fluid infusion system according to one aspect of the present disclosure, the fluid infusion system including a medical infusion pump and an intravenous (IV) bag.

[0080] Figure 4A is a perspective view of another example of a medical infusion pump according to an aspect of the present disclosure.

[0081] Figure 4B yes Figure 4A Cross-sectional view of a medical infusion pump.

[0082] Figure 4C It shows Figure 4A A schematic diagram of electrical components of a medical infusion pump in a first configuration.

[0083] Figure 4D It shows Figure 4A A schematic diagram of electrical components of a medical infusion pump in a second configuration.

[0084] Figure 5 is a flow chart illustrating a method for delivering fluid to a patient with a medical infusion pump according to one aspect of the present disclosure. DETAILED DESCRIPTION

[0085] The following description is provided to enable those skilled in the art to make and use the described embodiments intended for implementing the present invention. However, various modifications, equivalents, variations and substitutes will still be apparent to those skilled in the art. Any and all such modifications, variations, equivalents and substitutes are intended to fall within the spirit and scope of the present invention.

[0086] Hereinafter, for the purpose of description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall relate to the present invention as oriented in the accompanying drawings. However, it should be understood that the present invention may employ alternative variations and step sequences unless expressly stated to the contrary. It should also be understood that the specific devices and processes shown in the drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0087] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0088] All numbers and ranges used in the specification and claims should be understood to be modified by the term "about" in all cases. "About" refers to plus or minus 25 percent of the stated value, such as plus or minus 10 percent of the stated value. However, this should not be regarded as a limitation on any numerical analysis under the doctrine of equivalents.

[0089] With reference to the accompanying drawings, the present disclosure is directed to a wearable injection and / or infusion device, such as a wearable medical infusion pump 10 , 110 , which is configured to deliver a medical fluid from a fluid reservoir to a patient through one or more patient fluid lines. Figures 1A to 4D Examples of pumps 10, 110 for delivering medical fluids to active (e.g., ambulatory) patients in hospital and home settings are shown. The medical infusion pumps 10 and 110 disclosed herein can be used in a variety of medical procedures and applications, such as Keep Vein Open (KVO) and drug infusion applications.

[0090] The pumps 10 and 110 of the present disclosure can be configured to provide a continuous flow of medical fluid, a substantially continuous flow of medical fluid, a semi-continuous flow of medical fluid, and / or an intermittent flow of medical fluid to a patient. As used herein, a "continuous" flow can refer to a fluid flow whose flow rate and / or flow volume remain unchanged throughout the duration of a fluid infusion process or event. A "substantially continuous flow" refers to a fluid flow whose flow rate and / or flow volume have only a small amount of change (e.g., a change of less than about 10%) during an infusion process or event. A "semi-continuous" flow can refer to a fluid flow that occurs continuously but is interrupted by a sustained pause (e.g., a drop in fluid flow rate and / or flow volume) during the duration of an infusion process. For example, when no fluid flows out of the pumps 10 and 110, the fluid can flow out of the pumps 10 and 110 in a series of equally spaced pulses separated by a duration. An "intermittent" fluid flow refers to a fluid flow that occurs at irregular intervals and is discontinuous or unstable. For example, as described in further detail herein, pumps 10 and 110 may include a bolus button that causes pumps 10 and 110 to initiate the flow of medical fluid to a patient. Fluid may be intermittently delivered to the patient only when the bolus button is pressed. At other times, pumps 10 and 110 may not deliver fluid to the patient.

[0091] Compared with traditional medical infusion pumps, the pumps 10 and 110 of the present disclosure can be configured to provide improved accuracy and smaller size. For example, the pumps 10 and 110 of the present disclosure can include a small volume (e.g., about 3mL to about 5mL) and a pumping syringe controlled by a micro syringe actuator and a flow control valve. Due to the small size of the pump components, the pumps 10 and 110 can be configured to be used to pump a dose of medical fluid from a reservoir such as an intravenous (IV) bag or a syringe to a patient's central or intravenous (IV) line, wherein the tolerance of the dose volume is strictly controlled. As is well known in the art, medical fluids can include any fluid that is usually delivered to a patient during a medical procedure and / or treatment of a chronic or acute medical condition. For example, pumps 10 and 110 can be used to deliver medical fluids, including fluids (e.g., saline) for flushing IV lines, liquid therapeutic agents or drugs, and / or total parenteral nutrition (TPN) liquids. In addition, as described in further detail herein, the small pumping syringes of pumps 10 and 110 do not limit the medical fluid to be injected into the patient. Instead, the medical fluid is contained in a separate reservoir, such as a separate syringe or intravenous (IV) bag connected to pumps 10 and 110. A small amount of medical fluid is extracted from a separate reservoir and immediately provided to the patient. In some examples, a separate reservoir can be removed from pumps 10, 110 and replaced with a new reservoir. For example, pumps 10, 110 can be configured to allow a user to remove an empty fluid reservoir from pumps 10, 110, and a new full reservoir is attached to pumps 10, 110. In some examples, the reservoir can be replaced while pumps 10, 110 continue to operate to provide medical fluids to patients. Therefore, removing and replacing the fluid reservoir will not interrupt the flow of medical fluids to the patient.

[0092] Wearable infusion pump with single pumping syringe

[0093] Figure 1A 2D shows an exemplary wearable medical infusion pump 10 for delivering, for example, a therapeutically effective dose of a medical fluid from a reservoir containing the fluid (e.g., a reservoir syringe 12 or an intravenous bag) to a patient through a patient line 14 (e.g., a vascular access device or an intravenous catheter) at a predetermined delivery rate. The pump 10 can be used with a fluid infusion system 2 that includes a reservoir syringe 12 and a patient line 14 for delivering the medical fluid to the patient.

[0094] As used herein, a "wearable" medical device refers to a portable device that can be attached to a patient and / or carried by a patient in a substantially hands-free manner. For example, a wearable device can be connected to a patient line or catheter via the skin and carried in clothing or a support structure, such as a pocket, a belt, a holster, a sling, a backpack, a waist bag, or another wearable support structure known in the art. In other examples, the wearable device may include an adhesive patch or sticker that can be adhered to the patient's skin. In some examples, the wearable device is an independent device that is not connected to any other structure or device, such as a fixed support frame, an external fixed power source, or a fixed fluid container. The patient can be a non-bedridden patient, meaning that the patient can move around (e.g., stand, walk, exercise, and / or perform other daily activities) while wearing the pump 10. For example, the wearable pump 10 can be configured for use in a home care environment or a hospital for patients who are not restricted to a bed and / or can move around independently.

[0095] like Figure 1A As shown in FIG. 2D , the fluid reservoir can be a syringe (referred to herein as a reservoir syringe 12) having a barrel 16, the barrel including an open proximal end 18, a distal end 20 including a nozzle, a fluid inlet / outlet, or a fluid port directly or indirectly connected to the pump 10, and a cylindrical sidewall 22 extending between the proximal end 18 and the distal end 20 of the barrel 16. The barrel 16 of the reservoir syringe 12 can have a large volume that accommodates, for example, a whole dose of medical fluid to be infused into a patient. For example, the barrel 16 can accommodate about 60 mL to about 100 mL or more of medical fluid for infusion. The reservoir syringe 12 can also include a plunger 26 or a stopper that is used to contain the medical fluid in the barrel 16 of the reservoir. In some examples, the reservoir syringe 12 can also include a plunger rod 28 extending proximally from the plunger 26. However, the plunger 26 or plunger rod 28 may not be required, as described in further detail herein, the pump 10 siphons the medical fluid through a nozzle or fluid port at the distal end 20 of the reservoir syringe 12, meaning that the user does not need to use the plunger rod 28 to manually advance the plunger 26 through the barrel 16 of the reservoir syringe 12.

[0096] As previously mentioned, the medical fluid contained in the reservoir syringe 12 may include, for example, saline, therapeutic agents, and / or TPN fluids, as well as any other medical fluids provided to a patient by infusion during a medical procedure and / or for the treatment of a chronic or acute condition as is known in the art. Exemplary therapeutic agents may include, for example, drugs, chemicals, biological substances, or biochemical substances that, when delivered to a patient in a therapeutically effective amount, achieve a desired therapeutic effect.

[0097] The infusion pump 10 also includes a pumping syringe 24, which includes a barrel 30 and a plunger 32 or stopper that can move through the barrel 30. The barrel 30 of the pumping syringe 24 can include an open proximal end 34, a distal end 36 including a nozzle or fluid port, and a cylindrical sidewall 38 extending between the proximal end 34 and the distal end 36 of the barrel 30 of the pumping syringe. The volume of fluid contained in the barrel 30 is significantly smaller than the volume of fluid contained in the reservoir syringe 12. For example, the pumping syringe 24 can contain about 3mL to about 5mL of fluid, while the reservoir syringe 12 contains about 60mL to 100mL or more of medical fluid to be infused to the patient. Advantageously, the relatively small size of the pumping syringe 24 means that the overall size of the pump 10 can be smaller than other infusion pumps known in the art, which typically include a reservoir that is large enough to contain the entire dose of fluid to be delivered to the patient.

[0098] In some examples, the plunger 32 of the pumping syringe 24 includes a resilient stopper 40 that seals against the inner surface 42 of the cylindrical sidewall 38. As is known in the art, the structure of the stopper 40 can be similar to the stoppers used in conventional syringes. Figure 1A and Figure 1B As shown, the stopper 40 may include a cylindrical body having one or more annular resilient ribs 44 extending around the body, the annular resilient ribs forming a seal with the inner surface 42 of the barrel 30. The plunger 32 may also include a plunger rod 46 connected to the proximal end of the stopper 40, the plunger rod being used to move the stopper 40 through the barrel 30 to draw the medical fluid into the barrel 30 through the nozzle or fluid port located at the distal end 36 of the barrel 30, and to discharge the medical fluid from the barrel 30 through the nozzle or fluid port. In some examples, the plunger rod 46 includes a grip or handle 48 at the proximal end of the rod 46, which is similar to the thumb press plate of a conventional syringe.

[0099] The medical infusion pump 10 also includes an actuator 50 for moving the plunger 32 through the barrel 30 of the pumping syringe 24 to draw the medical fluid from the reservoir syringe 12 into the barrel 30, and to discharge the medical fluid from the barrel 30 toward the patient. The actuator 50 can be an electromechanical device that includes mechanical components for moving the plunger 32 through the barrel 30 and an associated electrical circuit for controlling the movement of the plunger 32. For example, the actuator 50 can be a linear actuator that engages the plunger 32 to move the plunger 32 through the barrel 30. In some examples, the actuator 50 includes a bracket or connector for engaging the plunger rod 46, and a drive device or assembly for advancing and withdrawing the bracket or connector. For example, the actuator 50 can include a retainer 52 that is sized to accommodate and / or engage the handle 48 or handle of the plunger rod 46. The actuator 50 may also include a track 54 positioned below the plunger rod 46. The actuator 50 may be configured to move the retainer 52 back and forth along the track 54, thereby moving the resilient stopper 40 through the barrel 30 of the pumping syringe 24.

[0100] Continue to refer Figure 1A 2D , the wearable infusion pump 10 also includes a valve for controlling the flow of medical fluid from the reservoir syringe 12 to the pumping syringe 24, and from the pumping syringe 24 to the patient line 14. For example, the pump 10 may include an inflow valve 56 located between the reservoir syringe 12 and the barrel 30 of the pumping syringe, and an outflow valve 58 located between the barrel 30 of the pumping syringe and the patient. As is known in the art, the inflow valve 56 and the outflow valve 58 may be one-way check valves. As used herein, a "check valve" means a valve that automatically opens or closes in response to changes in fluid flow and / or fluid pressure. For example, the inflow valve 56 may be configured to open or close when the plunger 32 of the pumping syringe 24 moves in the proximal direction (e.g., Figure 1C The automatic opening of the Figure 1C The outflow valve 58 can be positioned to automatically close when the plunger 32 moves in the proximal direction through the barrel 30 of the pumping syringe 24. The outflow valve 58 is configured to close automatically when the plunger 32 moves in the distal direction (as shown). Figure 1C As shown by arrow D in the figure, it automatically opens when the pump moves to discharge the medical fluid from the barrel 30 of the pumping syringe 24. As shown by arrow A2 (as shown in the figure Figure 1C), the expelled fluid moves from the barrel 30 of the pumping syringe 24, moves through the open outflow valve 58, and moves toward the patient line 14 and the patient. In addition, moving the plunger 32 in the distal direction (as shown by arrow D) causes the inflow valve 56 to automatically close so that the fluid expelled from the barrel 30 of the pumping syringe 24 does not return to the reservoir syringe 12.

[0101] In some examples, the valves 56, 58 are joined together in a valve set 60 that is connected to the reservoir syringe 12, the pumping syringe 24, and / or the patient line 14. The valve set 60 may include, for example, a housing 62 that encloses a fluid chamber 64. The housing 62 may be a tubular closure, a fluid conduit, a pipe segment, or other structure that accommodates or removably connects to the inflow valve 56 and the outflow valve 58. In some examples, the valve set 60 includes an inflow port 66, a syringe port 68, and an outflow port 70. The ports 66, 68, 70 may be integral with the housing 62 or removably connected to the housing. The inflow port 66 may be positioned to allow medical fluid to be transferred from the reservoir syringe 12 to the fluid chamber 64 of the valve set 60 through the inflow port 66. The syringe port 68 may be fluidly connected to the interior of the barrel 30 of the pumping syringe 24, and is arranged to allow medical fluid to be transferred between the interior of the barrel 30 and the fluid chamber 64 through the syringe port 68. Outflow port 70 may be positioned to allow medical fluid to be transferred from fluid chamber 64 to a patient through outflow port 70 .

[0102] The ports 66, 68, 70 may include various connection structures, such as Luer connectors, threads, and / or press-fit connectors known in the art, for attaching the valve group 60 to the reservoir syringe 12, the pumping syringe 24, and the patient line 14. For example, the inflow port 66 and / or the syringe port 68 may be a female Luer connector sized to accommodate a nozzle or fluid port at the distal end 20 of the barrel 16 of the reservoir syringe 12 or the distal end 36 of the barrel 30 of the pumping syringe 24. The outflow port 70 may include a connector, such as a Luer connector sized to engage the proximal end of the patient line 14 or an intravenous catheter for attaching the pump 10 to the patient line 14 or catheter. In some examples, the inflow valve 56 is integrated with the inflow port 66 of the valve group 60. In other examples, the inflow valve 56 may be positioned in the valve group 60 so that fluid passes through the inflow port 66 and the fluid conduit of the valve group 60 to reach the inflow valve 56. In other examples, the inflow valve 56 can be a separate structure that is removably connected to the inflow port 66, so that the medical fluid from the reservoir syringe 12 passes through the inflow valve 56 before passing through the inflow port 66 into the valve block 60. Similarly, the outflow valve 58 can be integrated with the outflow port 70. Alternatively, the outflow valve 58 can be positioned in the valve block 60 so that the fluid passes from the fluid chamber 64, through the outflow valve 58, and through the outflow port 70. In other examples, the outflow valve 58 can be a separate structure that is directly or indirectly attached to the outflow port 70, so that the fluid passes from the fluid chamber 64 through the outflow port 70 and then through the outflow valve 58.

[0103] Specific reference Figure 1C In some examples, the pump 10 also includes a pump controller 72 electrically coupled to the actuator 50 for controlling the operation of the actuator 50. The pump controller 72 may include one or more computer processors and associated computer readable memory including instructions for operating the actuator 50. For example, the memory may include operating parameters for the actuator 50 to move the plunger 32 through the barrel 30 at a predetermined plunger speed to achieve a target flow rate and / or flow rate. The memory may also include information about a preferred operating routine for the pump 10. For example, for some infusions or therapies, the pump controller 72 may be configured to provide the medical fluid to the patient at a first flow rate for a period of time, and / or until a predetermined first volume of the medical fluid is delivered to the patient, and then provide the fluid to the patient at a different second flow rate for another period of time, or until a predetermined second volume of the medical fluid is delivered to the patient.

[0104] The pump controller 72 is also configured to monitor or detect the movement of the plunger 32 through the barrel 30 of the pumping syringe 24 to determine when to change the direction of the plunger 32. In this way, the pump controller 72 can control the plunger 32 to move back and forth through the barrel 30 so that the pump 10 provides a continuous flow of medical fluid, a substantially continuous flow of medical fluid, or a semi-continuous flow of medical fluid to the patient. In some examples, the pump controller 72 can be configured to monitor the torque applied by the actuator 50 to the plunger 32 to detect when the plunger 32 approaches the end of the stroke at the proximal end 34 or the distal end 36 of the barrel 30. For example, as the plunger 32 approaches the proximal end 34 and / or the distal end 36 of the barrel 30, the torque may increase. When the detected torque increases above a threshold, the pump controller 72 can cause the actuator 50 to change the direction of the plunger 32. For example, as the actuator 50 moves the plunger 32 in the distal direction to discharge the fluid from the pumping syringe 24 toward the patient, the torque applied by the actuator 50 increases. As the plunger 32 approaches the distal end 36 of the pumping syringe 24, which is near the syringe nozzle or fluid port, the measured torque increases to above the target torque value. When the measured torque is greater than the target value, the pump controller 72 causes the actuator 50 to change direction and cause the plunger 32 to begin moving in the proximal direction to draw fluid from the reservoir syringe 12 into the barrel 30 of the pumping syringe 24.

[0105] In some examples, the pump 10 may also include a sensor 74 (e.g., Figure 1C 34 ) to detect the position of the plunger 32 within the barrel 30 of the pumping syringe 24. For example, one or more position sensors 74 may be positioned proximate to the barrel 30 to detect when the plunger 32 approaches the proximal end 34 or the distal end 36 of the barrel 30 of the pumping syringe. The sensor 74 may be an optical sensor that detects an image of the plunger 32 and / or the plunger rod 46 to determine the position of the plunger 32. In other examples, the sensor 74 may be a distance sensor (e.g., a laser rangefinder) that detects, for example, the distance between the plunger 32 and the proximal end 34 of the barrel 30. In use, when the plunger 32 reaches the end-of-stroke position at the proximal end 34 or the distal end 36 of the barrel 30 as detected by the sensor 74, the pump controller 72 may cause the actuator 50 to change the direction of movement of the plunger 32 so that the plunger 32 continues to repeatedly move back and forth through the barrel 30 of the pumping syringe.

[0106] In some examples, the pump 10 may include an input, such as a button or a touch screen display, that allows a user (e.g., a caregiver or patient) to adjust or control the operation of the pump 10. For example, the user may manipulate the input to cause the pump controller 72 to adjust operating parameters of the pump 10, such as by starting an infusion program, pausing an infusion program, stopping an infusion program, and / or adjusting the flow rate and / or volume of the medical fluid delivered from the pump 10 to the patient. For example, the pump controller 72 may be configured to change the rate at which the actuator 50 moves the plunger 32 through the barrel 30 of the pumping syringe 24 based on information input by the caregiver or patient. In one example, the input button may be a dose input button 76 electrically coupled to the pump controller 72, which the user (e.g., a caregiver or patient) may press to cause the pump 10 to deliver a dose of the medical fluid from the pump 10 to the patient. The pump controller 72 can be configured to receive an indication when the user presses the dose input button 76 and can automatically cause the actuator 50 to increase the rate at which the plunger 32 moves through the barrel 30 within a predetermined duration to provide a dose of medical fluid to the patient (e.g., a short duration surge of medical fluid).

[0107] refer to Figure 2A To FIG. 2D, in some examples, the pump 10 can be completely or partially contained in a closure 78 or housing to protect the components of the pump 10 and / or make the pump 10 more convenient to wear or carry. For example, the pumping syringe 24 and the valve group 60 can be contained in the closure 78. In some examples, the entire reservoir syringe 12 can also be contained in the closure 78, while in other examples, a portion of the reservoir syringe 12 can be located outside the closure 78 so that the reservoir syringe 12 can be easily removed from the pump 10 and replaced when it is emptied. The closure 78 or housing can be formed of a rigid protective material, such as hard plastic. For example, the closure 78 can be formed of a high-density polyethylene or polycarbonate material. In other examples, the closure 78 can be made of glass, metal, ceramic material, or a combination thereof. The closure 78 can include a filler or an insulator that is used to protect the reservoir syringe 12 and other components of the pump 10 from damage when, for example, the pump 10 is dropped, shaken, or otherwise improperly operated.

[0108] In some examples, the wearable pump 10 can be used to deliver a therapeutic agent to a patient, which is a controlled substance, such as an opioid, a stimulant, a sedative, a hallucinogen, or an anabolic steroid. For such controlled substances, the pump 10 can be a controlled access device that prevents the patient from accessing the reservoir syringe 12 or obtaining a medical fluid exceeding the prescribed dose at one time. In order to control access to the pump 10, all components of the pump 10 (including the entire reservoir syringe 12) can be completely contained in the closure 78 or the housing so that the patient cannot remove the reservoir syringe 12 from the pump 10 to access the medical fluid contained in the reservoir syringe. For controlled substances, it may also be important to ensure that the therapeutic agent is released from the pump 10 only at the expected time and / or at the desired flow rate. In particular, it is important to ensure that the therapeutic agent cannot be siphoned out or discharged from the pump 10, thereby allowing the patient to obtain a large amount of medical fluid at one time. To prevent a patient from attempting to obtain a large amount of controlled access solution or medical fluid at one time, the opening pressure of the inflow valve 56 and / or the outflow valve 58 can be made greater than atmospheric pressure. As used herein, the "opening pressure" of a check valve refers to the minimum upstream pressure required to open the check valve, which allows detectable flow through the valve. Having the opening pressure of the inflow valve 56 and / or the outflow valve 58 greater than atmospheric pressure ensures that the valves 56, 58 cannot be forced open by, for example, a negative pressure provided at the outflow valve 58 that is sufficient to draw fluid from the syringe reservoir 12 through the valves 56, 58.

[0109] The closure 78 can have a variety of shapes and configurations depending, for example, on the size and shape of the components of the pump 10 and the degree of safety or security desired for the components of the pump 10. Figure 2A 2D, the closure 78 is a two-piece clam shell closure that includes a base 80 that includes a chamber or compartment sized to accommodate the reservoir syringe 12, the pumping syringe 24, and the valve assembly 60. The top 82 is connected to the base 80 along a hinge 84 for opening and closing the top 82. In some examples, the patient may be able to open the pump 10 to remove the empty reservoir syringe 12 and replace the empty reservoir syringe 12 with a full reservoir syringe 12. In this case, as Figure 2A As shown in FIG. 2D , the top 82 may be formed of a transparent or translucent material so that the patient can easily see when the reservoir syringe 12 is empty and should be replaced.

[0110] In other examples, particularly for controlled access devices (e.g., pumps 10 containing controlled substances, such as opioids or other narcotics), the base 80 and top 82 can be sealed or locked together, preventing the patient from opening the pump 10 to access the reservoir syringe 12 contained in the pump. In this case, a clinician, such as a prescribing physician or other medical practitioner, can have a key or other tool to unlock the pump 10 to replace an empty reservoir syringe 12. In other examples, the pump 10 can be a single-use device and can be discarded when the reservoir syringe 12 is empty. In this case, the closure 78 can be permanently closed during manufacturing, preventing any individual from accessing the reservoir syringe 12 or other components of the pump 10 to obtain the controlled substance contained in the reservoir syringe 12.

[0111] Fluid infusion system with intravenous bag and infusion pump

[0112] refer to Figure 3A and Figure 3B In some examples, as previously described, the reservoir syringe 12 of the pump 10 can be an intravenous (IV) bag 86. The intravenous (IV) bag 86 can be an expandable bag formed by one or more layers of polymer material (e.g., a multilayer polyolefin film). In other examples, the IV bag 86 can be made of other flexible plastic materials (e.g., polyethylene, natural rubber, or latex). The IV bag 86 may include a sealed or sealable port 90 that can be directly or indirectly connected to the pump 10. For example, the port 90 may include a self-sealing septum that is configured to be pierced by a needle cannula or another fluid conduit that is used to establish fluid communication between the IV bag 86 and the pump 10. In some examples, the IV bag 86 can be wearable (e.g., attached to the patient's upper arm) and is fluidly connected to the pump 10 via a flexible tube. For example, an exemplary infusion system including a wearable IV bag that can be used with the pump 10 described in the present disclosure is described in U.S. Patent Application Publication No. 2021 / 0085859, entitled "Medical Infusion Pump for Delivery of a Fluid," which is incorporated herein by reference. In other examples, the IV bag 86 can be connected to a stand or another portable or fixed support as is known in the art.

[0113] Figure 3A An exemplary intravenous (IV) bag 86 is shown that may be used with the pump 10 and fluid infusion system 2 disclosed herein. Figure 3B A fluid infusion system 2 for delivering medical fluid from an IV bag 86 to a patient is shown, the fluid infusion system including an infusion pump 10. Figure 3B As shown, the IV bag 86 is connected to the inflow port 66 of the pump 10 by a conduit 88, such as a length of flexible medical tubing extending from the inflow port 66 to a port 90 of the IV bag 86. As in the previous examples, the patient line 14 extends from the outflow port 70 of the pump 10 to the patient. As in the previous examples, the medical fluid flows from the reservoir (IV bag 86) to the pump 10 when the plunger 32 of the pumping syringe 24 moves in the proximal direction to draw the medical fluid into the barrel 30 of the pumping syringe 24. As the plunger 32 moves in the distal direction, the medical fluid is discharged from the barrel 30 of the pumping syringe 24.

[0114] Medical infusion pump with dual pumping syringe

[0115] FIG. 4A to FIG. 4D A fluid infusion system 102 is shown that includes a wearable medical infusion pump 110 for delivering medical fluid from a fluid reservoir (e.g., a reservoir syringe 112) to a patient having dual pumping syringes 114, 116. As in the previous examples, the reservoir may be a reservoir syringe 112 (e.g., a reservoir syringe 112). FIG. 4A to FIG. 4C as shown), IV bags, or other containers known in the art for holding medical fluids. FIG. 4A to FIG. 4C The pump 110 is not shown as having a closure, housing, or casing. However, it should be understood that within the scope of the present disclosure, some or all of the components of the pump 110 may be disposed in a casing or closure, such as Figure 2A 2D to protect the components of the pump 110 and to ensure that the medical fluid in the reservoir syringe 112 is not damaged or improperly discharged from the pump 110.

[0116] In some examples, the pump 110 includes a first pumping syringe 114 and a second pumping syringe 116. As in the previous examples, each pumping syringe 114, 116 includes a barrel 118 and a plunger 120 or stopper that can move through the barrel 118. The barrel 118 can include an open proximal end 122, a distal end 124 including a nozzle or fluid port, and a cylindrical sidewall 126 extending between the proximal end and the distal end. The pump 110 also includes an actuator for moving the plunger 120 of the first pumping syringe 114 and the plunger 120 of the second pumping syringe 116 through the barrel 118 to draw medical fluid from the reservoir syringe 112 into the barrel 118, and to discharge medical fluid from the barrel 118 toward the patient. For example, the pump 110 may include a first actuator 128 for moving the plunger 120 of the first pumping syringe 114, and a second actuator 130 for moving the plunger 120 of the second pumping syringe 116. As in the previous examples, the actuators 128, 130 may be electromechanical devices that include a retainer 132 for engaging the plungers 120 of the pumping syringes 114, 116, and circuitry for causing the retainer 132 to move the plungers 120 in a proximal direction and a distal direction through the barrel 118. As described in further detail below, the actuators 128, 130 may be configured to move the plungers 120 of the first pumping syringe 114 and the plungers 120 of the second pumping syringe 116 simultaneously, but in opposite directions, which enables a continuous flow of fluid, or a substantially continuous flow of fluid, to be discharged from the pump 110 toward the patient.

[0117] The pump 110 also includes an inlet valve and an outlet valve for directing fluid flow through the pump 110. As in the previous example, the inlet valve and the outlet valve can be one-way check valves. In addition, the inlet valve and the outlet valve can be part of a valve block that can be removably connected to the pumping syringes 114, 116 and / or the reservoir syringe 112. FIG. 4A to FIG. 4D As shown, the inlet valve is positioned between the reservoir syringe 112 and the barrel 118 of the pumping syringes 114, 116. For example, the pump 110 may include a first inlet valve 134 located between the reservoir syringe 112 and the barrel 118 of the first pumping syringe 114, when the plunger 120 of the first pumping syringe 114 moves in the proximal direction (e.g., Figure 4C The first inlet valve is opened to draw the medical fluid from the reservoir syringe 112 into the barrel 118 of the first pumping syringe 114. Specifically, the drawn fluid is drawn as shown by arrow A3 (in Figure 4C When the plunger 120 of the first pumping syringe 114 is in the distal direction (by Figure 4DWhen the first inlet valve 134 moves (as shown by the arrow D in FIG. 1 ), the first inlet valve 134 is closed to discharge the fluid from the barrel 118 of the first pumping syringe 114.

[0118] The pump 110 may further include a second inlet valve 136 located between the reservoir syringe 112 and the barrel 118 of the second pumping syringe 116, which is activated when the plunger 120 of the second pumping syringe 116 moves in the proximal direction (eg, Figure 4D The second inlet valve is opened to draw fluid from the reservoir syringe 112 into the barrel 118 of the second pumping syringe 116 (as shown by arrow P in FIG. 1 ). The flow of fluid from the reservoir syringe 112 to the barrel 118 of the second pumping syringe 116 is indicated by arrow A5 (in FIG. Figure 4D The second inlet valve 136 is configured to be ... Figure 4D Closes when discharged in the patient direction (center).

[0119] The pump 110 also includes an outflow valve located between the barrels 118 of the pumping syringes 114, 116 and the patient. For example, the pump 110 may include a first outflow valve 138 located between the barrel 118 of the first pumping syringe 114 and the patient, and the first outflow valve opens when the plunger 120 of the first pumping syringe 114 moves to discharge the medical fluid from the barrel 118 toward the patient, such as Figure 4C When the plunger 120 of the first pumping syringe 114 moves in the proximal direction to draw fluid into the barrel 118 of the first pumping syringe 114, the first outflow valve 138 is closed.

[0120] The pump 110 may further include a second outflow valve 140 located between the barrel 118 of the second pumping syringe 116 and the patient, the second outflow valve opening when the plunger 120 of the second pumping syringe 116 moves to discharge the medical fluid from the barrel 118 toward the patient, such as Figure 4D When the plunger 120 of the second pumping syringe 116 moves in the proximal direction to draw fluid into the barrel 118 of the second pumping syringe 116, the second outflow valve 140 is closed.

[0121] In some examples, the inflow valves 134, 136 and the outflow valves 138, 140 are components of a valve block 142 that are connected to the pumping syringes 114, 116 and the reservoir syringe 112. As in the previous examples, the valve block 142 for the dual syringe pump 110 may include a housing 144 that encloses a fluid chamber 146 and an inflow port 148 that is positioned to allow fluid from the reservoir syringe 112 to pass through the inflow port 148 to the fluid chamber 146. The valve block 142 also includes a first syringe port 150 that is fluidly connected to the interior of the barrel 118 of the first pumping syringe 114 and a second syringe port 152 that is fluidly connected to the interior of the barrel 118 of the second pumping syringe 116. The medical fluid is transferred between the interior of the barrel 118 of the first pumping syringe 114 and the fluid chamber 146 through the first syringe port 150. In a similar manner, the medical fluid is transferred between the interior of the barrel 118 of the second pumping syringe 116 and the fluid chamber 146 through the second syringe port 152. The valve group 142 also includes a first outflow port 154 and a second outflow port 156. The medical fluid is transferred from the barrel 118 of the first pumping syringe 114 toward the patient through the first outflow port 154. In a similar manner, the fluid is transferred from the barrel 118 of the second pumping syringe 116 toward the patient through the second outflow port 156. In some examples, the outflow valves 138, 140 are integrated with the outflow ports 154, 156. In other examples, the outflow valves 138, 140 and the outflow ports 154, 156 can be separate structures that are directly connected together or indirectly connected by one or more pipe segments.

[0122] In some examples, as is known in the art, medical fluid is discharged from the pump 110 to one or more patient fluid lines (e.g., an intravenous catheter) through the outflow ports 154, 156. For example, there may be a first patient fluid line 158 connected to the first outflow port 154 and a second patient fluid line 160 connected to the second outflow port 156. In some examples, the patient lines 158, 160 may be completely separate, such that fluid discharged from the first outflow port 154 passes through the first patient fluid line 158 to the vasculature of the patient at a first location, and fluid discharged from the second outflow port 156 passes through the second patient fluid line 160 to the vasculature of the patient at a second location different from the first location. Including two separate patient lines 158, 160 means that even if one of the outflow ports 154, 156 or the patient lines 158, 160 is blocked, fluid can continue to be delivered to the patient. Fluid flow through the separate patient lines 158, 160 is semi-continuous, meaning that when the plunger 120 of the first pumping syringe 114 is moved in the distal direction (eg, Figure 4CAs the fluid moves through the first patient fluid line 158, and as the plunger 120 of the second pumping syringe 116 moves in the distal direction (as indicated by the arrow D in FIG. Figure 4D As the medical fluid moves (as indicated by arrow D in FIG. 1 ), it passes through the second patient fluid line 160 .

[0123] In other examples, the patient fluid lines 158, 160 extending from the first outflow port 154 and the second outflow port 156 can be joined together before reaching the patient. For example, the first patient fluid line 158 and the second patient fluid line 160 can form a common patient line 162 that extends from the intersection 164 toward the vasculature of the patient. The fluid flow through the common patient line 162 can be a continuous flow or a substantially continuous flow, meaning that the fluid flow continues when the plunger 120 of the first pumping syringe 114 moves in the distal direction and when the plunger 120 of the second pumping syringe 116 moves in the distal direction.

[0124] Specific reference Figure 4C and Figure 4D As in the previous example, the pump 110 may also include a pump controller 166. The pump controller 166 may be a computer device and / or one or more computer processors electrically coupled to the first actuator 128 and the second actuator 130. The pump controller 166 may be configured to cause the plunger 120 of the first pumping syringe 114 and the plunger 120 of the second pumping syringe 116 to move in opposite directions substantially simultaneously. For example, the pump controller 166 may be configured to cause the first actuator 128 to move in a proximal direction (e.g., Figure 4C The plunger 120 is moved (as indicated by the arrow P in the figure) to draw the medical fluid into the barrel 118 of the first pumping syringe 114, while the second actuator 130 is simultaneously moved in the distal direction (as indicated by the arrow P in the figure). Figure 4C The plunger 120 of the second pumping syringe 116 is moved (as indicated by arrow D in FIG. 1 ) to expel any medical fluid from the barrel 118 of the second pumping syringe 116 toward the patient. Once the plunger 120 reaches its end-of-stroke position (e.g., the most proximal position of the plunger 120 of the first pumping syringe 114 and the most distal position of the plunger 120 of the second pumping syringe 116), the actuators 128, 130 reverse the plunger 120, which means that the medical fluid is expelled from the barrel 118 of the first pumping syringe 114 and the medical fluid is drawn into the barrel 118 of the second pumping syringe 116, as shown in FIG. Figure 4D shown.

[0125] As in the previous example, the pump controller 166 can cause the actuators 128, 130 to continuously move the plunger 120 back and forth through the syringe barrel 118 throughout the infusion process or event. Moving the plunger 120 continuously through the syringe barrel 118 (but in opposite directions) causes the fluid to be discharged from the pump 110 toward the patient in a continuous stream or a substantially continuous stream. As in the previous example, the reservoir syringe 112 can be removably connected to the rest of the pump 110 so that the reservoir 112 can be removed and replaced while the pump controller 166 continues to cause the first actuator 128 and the second actuator 130 to move the plunger 120 through the barrel 118 of the first pumping syringe 114 and the barrel 118 of the second pumping syringe 116. Thus, an empty reservoir syringe 112 may be replaced with a full reservoir syringe 112 without interrupting operation of the pump controller 166 and / or actuators 128 , 130 , or interrupting continuous or substantially continuous flow of medical fluid to the patient.

[0126] Fluid infusion method

[0127] The pumps 10, 110 of the present disclosure are used to infuse medical fluids into a patient through, for example, one or more patient lines 14, 158, 160 and / or one or more intravenous catheters. Figure 5 The method includes step 210, which is to connect a wearable medical infusion pump (e.g., including a single pumping syringe 24 (e.g., Figures 1A to 3B ) or an infusion pump 10 including dual pumping syringes 114, 116 (as shown FIG. 4A to FIG. 4D As previously described, the reservoir may be a reservoir syringe 12, 112 (such as Figures 1A to 2C , FIG. 4A to FIG. 4C In other examples, the reservoir may be an IV bag 86 (eg, Figure 3A and Figure 3B 10, 110) or any other convenient container for containing medical fluids, such as a bottle, can, box, or other container for medical fluids known in the art. Attaching the reservoir to the pump 10, 110 places the interior of the reservoir in fluid communication with the interior of the barrel 16, 118 of one or more pumping syringes 24, 114, 116.

[0128] At step 212, the method also includes placing the pump 10, 110 in fluid communication with the patient's vascular system. For example, placing the pump 10 in fluid communication with the patient's vascular system can include attaching the outflow port 70 of the pump 10 to a patient line 14 connected to the patient's vascular fluid. As is known in the art, the patient line 14 can be an intravenous catheter or a similar infusion tool. For the dual syringe pump 110, placing the pump 110 in fluid communication with the patient's vascular system includes attaching a first patient line 158 to the first outflow port 154, and attaching a second patient line 160 to the second outflow port 156 of the pump 110. As previously described, in some examples, the patient lines 158, 160 are separated along their entire length. In other examples, the patient lines 158, 160 can be connected together to form a common patient line 162. After attaching one or more outflow ports 70, 154, 156 of the pump 10, 110 to one or more patient lines 14, 158, 160, the pump 10, 110 can be secured to the patient. For example, as previously described, the pump 10, 110 can be a wearable pump that remains outside the patient's body. In some examples, the wearable pump 10, 110 can be adhered to the patient's skin by an adhesive patch or adhesive member (e.g., a sticker or tape). In other examples, the pump 10, 110 can be placed in a wearable carrier or support structure, such as a pocket, belt, vest, waist bag, or backpack.

[0129] At step 214, the method further includes causing one or more actuators 50, 128, 130 of the pump 10, 110 to repeatedly move one or more plungers 32, 120 through one or more barrels 30, 118 of one or more pumping syringes 24, 114, 116 to move the medical fluid from the reservoir (e.g., reservoir syringe 12, 112) into one or more barrels 30, 118 of the one or more pumping syringes 24, 114, 116, and from one or more barrels 30, 118 of the one or more pumping syringes 24, 114, 116 to the patient. For example, for a pump 10 having a single pumping syringe 24 (e.g., Figure 1A 2D ), when the actuator 50 moves the plunger 32 in the proximal direction (e.g., toward the proximal end 34 of the pumping syringe barrel 30) through the barrel 30 of the pumping syringe 24, the inlet valve 56 opens in the direction of arrow A1 (e.g., Figure 1C1 (shown) draws medical fluid from the reservoir syringe 12 through the inlet valve 56 to the interior of the barrel 30 of the pumping syringe 24. When the actuator 50 moves the plunger 32 in the distal direction toward the distal end 36 of the pumping syringe barrel 30, the inlet valve 56 is closed and the outflow valve 58 is opened. When the outflow valve 58 is open, the medical fluid is expelled from the pumping syringe barrel 30, moves through the outflow valve 58, and moves to the patient line 14 extending from the pump 10.

[0130] For a pump 110 having a dual pumping syringe (eg FIG. 4A to FIG. 4D ), the first actuator 128 and the second actuator 130 move the plungers 120 of the first pumping syringe 114 and the second pumping syringe 116 simultaneously, but in opposite directions. For example, the first actuator 128 can move the plunger 120 of the first pumping syringe 114 in the proximal direction, as shown by arrow P (at Figure 4C ), and the second actuator 130 moves the plunger 120 of the second pumping syringe 116 in the distal direction, as shown by arrow D (in Figure 4C In this case, the first inlet valve 134 is opened and the first outlet valve 138 is closed, which prevents the fluid from being transferred from the pump 110 toward the patient. The medical fluid is directed to the patient at arrow A3 (in Figure 4C The medical fluid is drawn from the reservoir syringe 112 through the first inlet valve 134 to the barrel 118 of the first pumping syringe 114 in the direction of the first pumping syringe 114. The second inlet valve 136 is closed to prevent the medical fluid from flowing to the barrel 118 of the second pumping syringe 116.

[0131] Once the plunger 120 reaches the end-of-stroke position (e.g., the plunger 120 of the first pumping syringe 114 reaches its most proximal position, and the plunger 120 of the second pumping syringe 116 reaches its most distal position), the direction of movement of the plunger 120 is reversed. Specifically, the first actuator 128 causes the plunger 120 of the first pumping syringe 114 to move in the distal direction (by Figure 4D The second actuator 130 moves the plunger 120 of the second pumping syringe 116 as shown by the arrow P ( Figure 4D When the plunger 120 moves in these directions, the first inlet valve 134 is closed and the first outlet valve 138 is opened. In addition, the second inlet valve 136 is opened and the second outlet valve 140 is closed. The medical fluid in the barrel 118 of the first pumping syringe 114 is discharged from the barrel 118 to the patient line through the opened first outlet valve 138, as shown by arrow A4 (in FIG. Figure 4D While the medical fluid is being discharged from the barrel 118 of the first pumping syringe 114, the medical fluid is discharged from the reservoir syringe 112 through the opened second inlet valve 136 in the direction of arrow A5 (in Figure 4D) is drawn into the barrel 118 of the second pumping syringe 116.

[0132] Once the plunger 120 reaches the end position (e.g., the plunger 120 of the first pumping syringe 114 reaches its most distal position, and the plunger 120 of the second pumping syringe 116 reaches its most proximal position), the direction of movement of the plunger 120 is reversed again. Figure 4C As shown by arrow A6 in FIG. 1 , the medical fluid in the barrel 118 of the second pumping syringe 116 is discharged from the second pumping syringe 116 through the second outflow valve 140. While the medical fluid is being discharged from the second pumping syringe 116, additional medical fluid is drawn from the reservoir syringe 112 into the barrel 118 of the first pumping syringe 114, as shown in FIG. Figure 4C 14 and 15. As shown by arrow A3 in FIG. During the duration of the medical infusion process or infusion event, the first actuator 128 and the second actuator 130 continue to repeatedly move the plunger 120 in opposite directions through the barrels 118 of the pumping syringes 114, 116 simultaneously. This repeated movement causes the medical fluid to be discharged from the pump 110 in a continuous stream or a substantially continuous stream, alternating between discharging fluid from the barrel 118 of the first pumping syringe 114 and discharging fluid from the barrel 118 of the second pumping syringe 116.

[0133] At step 216, the medical fluid discharged from the pump 110 is delivered to the patient's vasculature through the patient line. For example, the medical fluid can be discharged from the pump 10, 110 through the outflow port 70, 154, 156 and enter the patient line 14, 158, 160 for delivery to the patient's vasculature. For a pump 10 with a single pumping syringe 24, the medical fluid can be delivered to the patient's vasculature by moving the plunger 32 of the single pumping syringe 24 in the distal direction (e.g., Figure 1CThe semi-continuous fluid flow that exists when the pump 110 (as shown by arrow D in FIG. 1 ) moves through the barrel 30 passes through the single pump outflow port 70 to the patient line 14. For a pump 110 with dual pumping syringes 114, 116, a first patient line 158 extends from the first outflow port 154 and a second patient line 160 extends from the second outflow port 156. The medical fluid is discharged from the pump 110 to the patient lines 158, 160 through the outflow ports 154, 156. As previously described, in some examples, the patient lines 158, 160 are separated along their entire length. In this case, the fluid discharged from the pump 110 into the first patient line 158 passes through the first patient line 158 to the vasculature of the patient at the first location. The medical fluid discharged from the pump 110 into the second patient line 160 passes through the second patient line 160 to the vasculature of the patient at the second location. In other examples, the first patient line 158 and the second patient line 160 are connected together at a junction 164 to form a common patient line 162. Fluid passing through each of the patient lines 158, 160 is transferred to the common patient line 162 where it is delivered to the patient's vasculature in a continuous fluid stream or a substantially continuous fluid stream.

[0134] At step 218, the method also includes removing the empty reservoir syringe 12, 112 from the pump 10, 110 and replacing the reservoir with a new full reservoir syringe 12, 112. In some examples, the empty reservoir syringe 12, 112 may be replaced while the one or more actuators 50, 128, 130 continue to move the one or more plungers 32, 120 through the one or more barrels 30, 118 of the one or more pumping syringes 24, 114, 116. Thus, the medical fluid in the one or more pumping syringes 24, 114, 116 may continue to be delivered to the patient even while the reservoir syringe 12, 112 is being replaced. Thus, it may not be necessary to shut down the pump 10, 110 or the one or more actuators 50, 128, 130 when replacing an empty reservoir 12, 112, as long as the replacement can be performed quickly. After replacing the reservoir syringe 12, 112 with a full reservoir 12, 112, medical fluid may continue to be delivered to the patient for the remaining duration of the medical infusion procedure or event.

[0135] Although examples of pumps, fluid infusion systems, and methods are shown in the accompanying drawings and described in detail above, other examples will be apparent to and readily made by those skilled in the art without departing from the scope and spirit of the invention. Therefore, the above description is intended to be illustrative rather than limiting. The invention described above is defined by the appended claims, and all changes to the invention that fall within the equivalent meaning and equivalent range of the claims will be included within the scope of the claims.

Claims

1. A pump for delivering a fluid from a reservoir to a patient, the pump comprising: at least one pump syringe comprising a barrel and a plunger movable through the barrel; at least one actuator for moving the plunger through the barrel to draw the fluid from the reservoir into the barrel and to expel the fluid from the barrel toward the patient; at least one inlet valve located between the reservoir and the barrel of the at least one pumping syringe, the at least one inlet valve opening when the plunger of the at least one pumping syringe moves to draw the fluid from the reservoir into the barrel of the at least one pumping syringe; as well as At least one outflow valve is located between the barrel of the at least one pumping syringe and the patient, and the at least one outflow valve opens when the plunger moves to expel the fluid from the barrel of the at least one pumping syringe toward the patient.

2. The pump according to claim 1, wherein The pump is a wearable pump worn by an ambulatory patient, wherein the fluid comprises at least one of saline, liquid medication, or total parenteral nutrition solution.

3. The pump of claim 1 , further comprising a valve assembly connected to the at least one pumping syringe and the reservoir, the valve assembly comprising: a housing enclosing at least one fluid chamber; at least one inflow port, wherein the fluid is transferred from the reservoir to the at least one fluid chamber through the at least one inflow port; at least one syringe port fluidly connected to the interior of the barrel of the at least one pumping syringe, wherein the fluid is transferred between the interior of the barrel and the at least one fluid chamber through the at least one syringe port; and at least one outflow port, wherein the fluid is transferred from the at least one fluid chamber to the patient through the at least one outflow port.

4. The pump according to claim 1, wherein The at least one inflow valve comprises an inflow check valve that automatically opens when the fluid is drawn into the barrel of the at least one pumping syringe, Wherein, the at least one outflow valve comprises an outflow check valve, which automatically opens when the fluid is discharged from the barrel of the at least one pumping syringe.

5. The pump according to claim 4, wherein The opening pressure of the inflow check valve and / or the outflow check valve is greater than the atmospheric pressure to prevent the fluid from being siphoned out of the reservoir through the inflow check valve and the outflow check valve.

6. The pump according to claim 1, wherein The barrel of the at least one pumping syringe has a volume of from about 3 mL to about 5 mL.

7. The pump of claim 1 , further comprising a pump controller electrically coupled to the at least one actuator, the pump controller being configured to cause the at least one actuator to repeatedly move the plunger through the barrel of the at least one pumping syringe at a predetermined rate.

8. The pump according to claim 7, wherein The pump controller is configured to monitor the torque applied by the at least one actuator on the plunger to detect when the plunger approaches an end of stroke position, and to change the direction of the plunger when the torque increases above a threshold.

9. The pump of claim 7, further comprising at least one position sensor for detecting the position of the plunger within the barrel, wherein: The pump controller is configured to cause the at least one actuator to change the direction of the plunger based on information detected by the at least one position sensor.

10. The pump of claim 1 further comprising a sealed closure comprising at least a portion of the at least one pumping syringe, the reservoir, the at least one inlet valve, and the at least one outlet valve to restrict access to the fluid in the reservoir.

11. The pump according to claim 1, wherein The reservoir is removable from the rest of the pump to allow replacement of the reservoir without interrupting operation of the at least one actuator and the at least one pumping syringe.

12. The pump according to claim 1, wherein The at least one pumping syringe comprises a first pumping syringe and a second pumping syringe, The at least one actuator includes a first actuator that moves a plunger of the first pumping syringe and a second actuator that moves a plunger of the second pumping syringe.

13. The pump according to claim 12, wherein Fluid discharged from the first pumping syringe is transferred to a first patient line, and fluid discharged from the second pumping syringe is transferred to a second patient line that is separate from the first patient line.

14. The pump according to claim 12, wherein Fluid discharged from the first pumping syringe and fluid discharged from the second pumping syringe are transferred to the patient through a common patient line.

15. The pump according to claim 12, wherein: The at least one inlet valve comprises: a first inlet valve located between the reservoir and the barrel of the first pumping syringe, the first inlet valve opening when the plunger of the first pumping syringe moves to draw the fluid from the reservoir into the barrel of the first pumping syringe; and a second inlet valve located between the reservoir and the barrel of the second pumping syringe, the second inlet valve opening when the plunger of the second pumping syringe moves to draw the fluid from the reservoir into the barrel of the second pumping syringe, Wherein, when the plunger of the first pumping syringe moves to discharge the fluid from the barrel of the first pumping syringe, the first inlet valve is closed, and when the plunger of the second pumping syringe moves to discharge the fluid from the barrel of the second pumping syringe, the second inlet valve is closed.

16. The pump according to claim 12, wherein: The at least one outflow valve includes: a first outflow valve, which is located between the barrel of the first pumping syringe and the patient, and the first outflow valve opens when the plunger of the first pumping syringe moves to discharge the fluid from the barrel toward the patient; and a second outflow valve, which is located between the barrel of the second pumping syringe and the patient, and the second outflow valve opens when the plunger of the second pumping syringe moves to discharge the fluid from the barrel toward the patient.

17. The pump of claim 12, further comprising a valve assembly connected to the first pumping syringe, the second pumping syringe, and the reservoir, the valve assembly comprising: a housing enclosing at least one fluid chamber; an inflow port, wherein the fluid is transferred from the reservoir to the at least one fluid chamber through the inflow port; a first syringe port fluidly connected to an interior of a barrel of the first pumping syringe, wherein the fluid is transferred between the interior of the barrel of the first pumping syringe and the at least one fluid chamber through the first syringe port; a second syringe port fluidly connected to an interior of a barrel of the second pumping syringe, wherein the fluid is transferred between the interior of the barrel of the second pumping syringe and the at least one fluid chamber through the second syringe port; a first outflow port, wherein the fluid is transferred from the barrel of the first pumping syringe toward the patient through the first outflow port; and A second outflow port, wherein the fluid is transferred from the barrel of the second pumping syringe toward the patient through the second outflow port.

18. The pump of claim 12, further comprising a pump controller electrically coupled to the first actuator and the second actuator, the pump controller being configured to cause the plunger of the first pumping syringe and the plunger of the second pumping syringe to move in opposite directions substantially simultaneously, which causes fluid to be discharged from the pump toward the patient in a continuous stream or a substantially continuous stream.

19. A fluid infusion system, comprising: The pump according to claim 1; the reservoir, the reservoir being fluidly connected to the pump, the pump containing the fluid to be delivered to the patient; as well as At least one patient line is fluidly connected to the barrel of the at least one pumping syringe at a location distal to the at least one outflow valve, wherein the patient line is configured to deliver the fluid from the pump to the vasculature of the patient.

20. A method for infusing a fluid into a patient, the method comprising: A pump is provided, the pump comprising: at least one pump syringe comprising a barrel and a plunger movable through the barrel, at least one actuator for moving the plunger through the barrel to draw the fluid from a reservoir into the barrel and to expel the fluid from the barrel toward the patient; at least one inlet valve located between the reservoir and the barrel of the at least one pumping syringe, the at least one inlet valve opening when the plunger of the at least one pumping syringe moves to draw the fluid from the reservoir into the barrel of the at least one pumping syringe; and at least one outflow valve located between the barrel of the at least one pumping syringe and the patient, the at least one outflow valve opening when the plunger moves to expel the fluid from the barrel of the at least one pumping syringe toward the patient; attaching the pump to the reservoir so that the reservoir is in fluid communication with the barrel of the at least one pumping syringe; placing the pump in fluid communication with the patient's vasculature; and The at least one actuator of the pump repeatedly moves the plunger through the barrel of the at least one pumping syringe, thereby transferring the fluid from the reservoir into the barrel of the at least one pumping syringe and from the barrel of the at least one pumping syringe to the patient.