WO2025160363A1

WO2025160363A1 - Fluid delivery system

Info

Publication number: WO2025160363A1
Application number: PCT/US2025/012907
Authority: WO
Inventors: Ian Darisse; Christopher Hanson; Tyler A. REGISTER; William J. Gorman; R. Maxwell Flaherty; J. Christopher Flaherty
Original assignee: Dyme Medical Inc
Current assignee: Dyme Medical Inc
Priority date: 2024-01-24
Filing date: 2025-01-24
Publication date: 2025-07-31
Anticipated expiration: 2026-07-24

Abstract

Provided herein are systems, devices, and methods for delivering one or more agents to a patient. A fluid delivery system includes a fluid delivery device having a reservoir, a pumping assembly, a fluid pathway, a power supply, and a housing. The reservoir stores one or more agents to be delivered to a patient. The pumping assembly propels the agent. The fluid pathway has a distal portion having a delivery conduit, and the delivery conduit receives the agent from the reservoir and delivers the agent to the patient. The power supply provides energy to at least the pumping assembly. The housing surrounds at least the reservoir and the pumping assembly.

Description

FLUID DELIVERY SYSTEM

RELATED APPLICATIONS

[001] This application claims the benefit of United States Provisional Patent Application Serial Number 63/624,349 (Docket No.: DYM-001-PR1), titled "Fluid Delivery System", filed January 24, 2024, the content of which is incorporated herein by reference in its entirety for all purposes.

[002] This application is related to United States Provisional Patent Application Serial Number 63/694,287 (Docket No.: DYM-003-PR1), titled "Fluid Delivery System", filed September 16, 2024, the content of which is incorporated herein by reference in its entirety for all purposes.

[003] This application is related to United States Provisional Patent Application Serial Number 63/740,859 (Docket No.: DYM-003-PR2), titled "Fluid Delivery System", filed December 31, 2024, the content of which is incorporated herein by reference in its entirety for all purposes.

[004] This application is related to United States Provisional Patent Application Serial Number 63/734,417 (Docket No.: DYM-002-PR1), titled "Fluid Delivery System", filed December 16, 2024, the content of which is incorporated herein by reference in its entirety for all purposes.

FIELD OF INVENTIVE CONCEPTS

[005] The present inventive concepts relate generally to systems, devices, and methods for the delivery of insulin or other agent to a patient.

BACKGROUND

[006] Numerous drugs and other agents are used to treat patients suffering from one or more diseases and/or disorders. For some agents, administration of the agent by a pump or other fluid delivery system can provide numerous advantages.

[007] There is a need for improved agent delivery systems, devices, and methods.

SUMMARY [008] According to an aspect of the present inventive concepts, a fluid delivery system comprises one or more fluid delivery devices. Each fluid delivery device comprises: a reservoir constructed and arranged to store an agent to be delivered to a patient; a pumping assembly constructed and arranged to propel the agent; a fluid pathway having a distal portion comprising a delivery conduit, the delivery conduit being constructed and arranged to receive the agent from the reservoir and deliver the agent to the patient; a power supply configured to provide energy to at least the pumping assembly; and a housing surrounding at least the reservoir and the pumping assembly.

[009] In some embodiments, the system is configured to reduce waste of the agent. The system can be configured to reduce waste of at least 0. ImL, 0.2mL, and/or 0.3mL of the agent over a time period of no more than three days. The agent can comprise insulin.

[010] In some embodiments, the system is configured to operate in a closed-loop delivery mode. The closed-loop delivery mode can be based on a patient physiologic parameter. The patient physiologic parameter can comprise the glucose level of the patient. The closed-loop delivery mode can be based on a measured parameter of the fluid delivery device. The closed-loop delivery mode can be based on a patient activity.

[Oi l] In some embodiments, the system is configured to operate in an open-loop delivery mode.

[012] In some embodiments, the system is configured to operate in both an open-loop delivery mode and a closed-loop delivery mode. The change between modes and/or a change in a parameter of either mode can require an authorized confirmation (e.g., and password controlled) by a clinician user of the system.

[013] In some embodiments, the fluid delivery device comprises a volume of no more than 28,750mm³, such as no more than 25,000mm³, no more than 22,500mm³, and/or no more than 20,000mm³.

[014] In some embodiments, the fluid delivery device comprises a skin-contacting surface, such as when the skin-contacting surface comprises a surface area of no more than 1,983mm², 1,700mm², 1,500mm², 1,300mm², 1,000mm², 750mm², and/or 650mm².

[015] In some embodiments, the fluid delivery device comprises a skin-contacting surface that has a surface area that is less than the surface area of any parallel cross section at an elevation above the skin-contacting surface.

[016] In some embodiments, the fluid delivery device comprises a skin-contacting surface and a first surface opposite the skin-contacting surface, and the first surface has a surface area that is less than the surface area of any parallel cross section at an elevation below the first surface.

[017] In some embodiments, the fluid delivery device comprises a cross section with trapezoidal-shaped sides, slope-shaped sides, or both. In some embodiments, the fluid delivery device comprises a cross section with convex sides.

[018] In some embodiments, the fluid delivery device comprises a length of no more than 51.5mm, 45mm, and/or 35mm. In some embodiments, the fluid delivery device comprises a width of no more than 38.5mm, 32.5mm, and/or 27.5mm. In some embodiments, the fluid delivery device comprises a circular geometry with a diameter of no more than 51.5mm, 45mm, and/or 35mm. In some embodiments, the fluid delivery device comprises a height of no more than 14.5mm, 12mm, 10mm, 8mm, and/or 7mm.

[019] In some embodiments, the fluid delivery device comprises a mass, when the reservoir is empty, of no more than 26g, 23g, and/or 20g.

[020] In some embodiments, the fluid delivery device comprises a cross-section with a trapezoidal geometry. In some embodiments, the fluid delivery device comprises a crosssection with convex sides.

[021] In some embodiments, the fluid delivery device comprises a device volume, and the device volume can be constructed and arranged to reduce in magnitude over time. The reservoir can comprise a reservoir volume, and the reservoir volume can be constructed and arranged to reduce in magnitude over time. The reservoir can be constructed and arranged to collapse. The reservoir can comprise a balloon material and/or other stretchable material.

The power supply can comprise a power supply volume, and the power supply volume can be constructed and arranged to reduce in magnitude over time. The power supply can comprise multiple layers, and at least one layer of the multiple layers can be constructed and arranged to be removed from the fluid delivery device, thus reducing the device volume.

[022] In some embodiments, the fluid delivery device comprises a device height, and the device height can be constructed and arranged to reduce in magnitude over time. The reservoir can comprise a reservoir height, and the reservoir height can be constructed and arranged to reduce in magnitude over time. The reservoir can be constructed and arranged to collapse over time. The reservoir can comprise a balloon material and/or other stretchable material. The power supply can comprise a power supply height, and the power supply height can be constructed and arranged to reduce in magnitude over time. The power supply can comprise multiple layers, and at least one layer of the multiple layers can be constructed and arranged to be removed from the fluid delivery device, thus reducing the device height. [023] In some embodiments, the fluid delivery device comprises a first component and a second component, and the first component and the second component share a portion of a wall positioned between the first and second components. The first component can comprise the housing. The second component can comprise: the reservoir, the pumping assembly, the delivery conduit, and/or two, three, or four of these. The first component can comprise the reservoir and the second component can comprise the pumping assembly. The pumping assembly can comprise a MEMS device.

[024] In some embodiments, the fluid delivery device is configured to be used for more than 3 days. The fluid delivery device can be configured to be used for more than 6 days. [025] In some embodiments, the fluid delivery device comprises multiple fluid delivery devices. Each fluid delivery device can be replaced after a maximum duration of use. The maximum duration of use can comprise a time period of 3 days. A second fluid delivery device can be positioned to have a different skin penetration site than a first fluid delivery device used just prior to the second fluid delivery device. Each fluid delivery device can comprise an insertable transcutaneous fluid delivery element (e.g., a needle, cannula, tube, or catheter), and a second fluid delivery device can be configured to have a different depth of insertion of its transcutaneous fluid delivery element than the depth of insertion of a transcutaneous fluid delivery element of a first fluid delivery device used just prior to the second fluid delivery device. Each fluid delivery device can comprise an insertable transcutaneous fluid delivery element, and a second fluid delivery device can be configured to have a different angle of insertion of its transcutaneous fluid delivery element than the angle of insertion of a transcutaneous fluid delivery element of a first fluid delivery device used just prior to the second fluid delivery device. A first fluid delivery device can comprise a smaller volume than the volume of a second fluid delivery device. A first fluid delivery device can comprise a smaller length and/or a smaller width than the length and/or width of a second fluid delivery device. A first fluid delivery device can comprise a major axis with a smaller length than the length of a major axis of a second fluid delivery device. A first fluid delivery device can comprise a smaller height than the height of a second fluid delivery device.

[026] In some embodiments, the fluid delivery device comprises a first delivery conduit configured to be attached to a first port of the fluid delivery device, and a second delivery conduit configured to be attached to a second port of the fluid delivery device, and the first delivery conduit can deliver the agent for a first time period, and the second delivery conduit can deliver the agent for a second, subsequent time period.

[027] In some embodiments, the fluid delivery device comprises a single component that performs at least two functions. The single component can be configured to propel fluid and provide a vibrational alert. The single component can comprise a motor that can be configured to turn a leadscrew and to vibrate. The single component can be configured to propel fluid and measure flow of fluid. The single component can be configured to propel fluid and agitate fluid, such as to both propel and agitate the agent (e.g., simultaneously or sequentially).

[028] In some embodiments, the fluid delivery device comprises a fill port configured to allow a user to deliver the agent into the reservoir. The fill port can comprise one, two, or more access septa. The one, two, or more access septa can comprise at least one septum constructed and arranged to be piercingly accessed by a needle or other fluid delivery element. The fill port can be constructed and arranged to be non-piercingly accessed by a needle or other fluid delivery element. The fluid delivery device can comprise a bottom surface configured to be positioned on the skin of the patient, and the fill port can be positioned on the bottom surface.

[029] In some embodiments, the reservoir comprises a volume of less than 3mL, 2mL, and/or ImL.

[030] In some embodiments, the agent comprises insulin and/or other agent, and the reservoir is configured to store the insulin and/or other agent for at least 3 days, 14 days, and/or 30 days.

[031] In some embodiments, the reservoir comprises a refillable reservoir. The fluid delivery device can be configured such that the reservoir can be refilled while the fluid delivery device is positioned on the skin surface of the patient. The fluid delivery device can be configured such that the reservoir cannot be refilled while the fluid delivery device is positioned on the skin surface of the patient. The reservoir can be configured such that the reservoir can be refilled while the reservoir is positioned within the fluid delivery device. The reservoir can be configured such that the reservoir can be refilled while the reservoir is removed from the fluid delivery device.

[032] The system can further comprise a fill assembly comprising a valve configured to control flow of the agent into and/or out of the reservoir based on the pressure of the agent. The valve can comprise a one-way spring valve. The valve can comprise a valve selected from the group consisting of: ball valve; disc check valve; dual disc check valve; tilting disc check valve; piston check valve; swing check valve; piston check valve; ball check valve; silent check valve; nozzle check valve; wafer check valve; and combinations thereof. The fill assembly can comprise a semi -permeable membrane configured to propel the agent into the reservoir. The fill assembly can comprise a fluid injector and an agent cannister that can be configured to propel a predetermined volume of the agent into the reservoir. The fill assembly can comprise a docking module configured to operably attach to the fluid delivery device. The docking module can be configured to recharge the power supply of the fluid delivery device and/or can be configured to store the agent.

[033] In some embodiments, the reservoir is configured to be inserted into the fluid delivery device and not subsequently removed from the fluid delivery device.

[034] In some embodiments, the fluid delivery device includes a locking insertion mechanism constructed and arranged to prevent the reservoir from being removed from the fluid delivery device after insertion of the reservoir into the fluid delivery device.

[035] In some embodiments, the reservoir comprises multiple reservoirs, and a second reservoir is constructed and arranged to replace a first reservoir. A third reservoir can be constructed and arranged to replace the second reservoir.

[036] In some embodiments, the reservoir comprises a first reservoir and a second reservoir (e.g., where the fluid delivery device is constructed and arranged to include the first and second reservoirs simultaneously). The first reservoir can be configured to store a first agent, and the second reservoir can be configured to store a second agent that can be different than the first agent.

[037] In some embodiments, the fluid delivery device is configured to deliver a target volume of the agent, and the reservoir comprises a volume that is less than the target volume (i.e., the reservoir must be refilled and/or replaced at least one time during the use of the fluid delivery device in order to deliver the target volume). The reservoir can comprise a refillable reservoir and/or a replaceable reservoir.

[038] In some embodiments, the fluid delivery device is configured to be used for a first time period, and the reservoir comprises a reservoir volume that provides the agent for a second time period that is less than the first time period (i.e., the reservoir must be refilled and/or replaced at least one time during the use of the fluid delivery device). The first time period can comprise a time period of at least 3 days. [039] In some embodiments, the reservoir comprises at least a flexible portion. In some embodiments, the reservoir comprises at least a rigid portion. In some embodiments, the reservoir comprises a flexible portion and a rigid portion. In some embodiments, the reservoir comprises a bellows construction. In some embodiments, the reservoir comprises a thin-sheet construction. In some embodiments, the reservoir comprises a molded pouch construction. In some embodiments, the reservoir comprises a rolling diaphragm construction. In some embodiments, the reservoir comprises a syringe construction. The reservoir can comprise a spring-loaded plunger.

[040] In some embodiments, the reservoir comprises a reservoir that is pressurized above atmospheric pressure. The reservoir can comprise an elastically expandable reservoir which exerts pressure on the agent when expanded. The elastically expandable reservoir can comprise a near-linear stress-strain curve. The pressurized reservoir can be pressurized via a constant pressure cavity. The cavity can comprise freon or other material configured to maintain constant pressure by changing phase throughout the delivery of the agent.

[041] In some embodiments, the reservoir comprises a reservoir that is maintained at a pressure level below atmospheric pressure.

[042] In some embodiments, the reservoir comprises a hydraulic press construction. In some embodiments, the reservoir comprises a furlable tube and a torsion spring configured to exert a force on the furlable tube. In some embodiments, the reservoir comprises expanding foam.

[043] In some embodiments, the reservoir comprises a first reservoir and a second reservoir, and as the first reservoir empties the second reservoir fills, such as to maintain constant pressure in the first reservoir. The fluid delivery device can further comprise a fluid withdrawal element and a flow sensor, and the second reservoir can be filled via fluid captured by the fluid withdrawal element and based on flow as monitored by the flow sensor. [044] In some embodiments, the reservoir is configured to be filled and/or refilled with the agent, and the filling and/or refilling causes energy to be stored in the fluid delivery device. The fluid delivery device can be configured to recharge the power supply using the stored energy. The stored energy can be used to pressurize the reservoir. The stored energy can comprise phase-change energy. The stored energy can comprise energy in a form selected from the group consisting of: phase-change energy; mechanical energy; spring energy; hydraulic energy; pneumatic energy; electrical energy; chemical energy; and combinations thereof. [045] In some embodiments, the fluid delivery device comprises a first fluid delivery device including a first reservoir and a second fluid delivery device including a second reservoir, and the first reservoir can be configured to transfer fluid to the second reservoir. [046] In some embodiments, the pumping assembly comprises a volume of no more than 60mm³, 40mm³, and/or 20mm³. In some embodiments, the pumping assembly comprises a maximum cross-sectional area of no more than 100mm², 65mm², and/or 30mm². In some embodiments, the pumping assembly comprises a major axis with a length of no more than 10mm, 8mm, 6mm, 5mm, and/or 4mm.

[047] In some embodiments, the pumping assembly comprises a MEMS device (e.g., MEMS device that is piezo driven, motor driven, and/or shaped memory alloy driven). The MEMS device can comprise a silicon-layered MEMS device. The MEMS device can comprise a metal alloy MEMS device. The MEMS device can comprise a flexible polymer MEMS device.

[048] In some embodiments, the pumping assembly comprises a syringe driver. The syringe driver can comprise a plunger, leadscrew, and motive element, and the plunger and leadscrew can be positioned within the reservoir. Rotation of the leadscrew by the motive element can cause the plunger to translate within the reservoir. The leadscrew can be configured to disengage from the plunger, the motive element, or both (e.g.., to allow refilling of the reservoir). The leadscrew can comprise a magnetic disengagement assembly. Alternatively, or additionally, the plunger can comprise the magnetic disengagement assembly. The system can further comprise a fill assembly, and the fill assembly can comprise a magnet assembly configured to cause the leadscrew disengagement. The motive element can comprise a motor. The motive element can comprise at least one shaped memory component. The motive element can comprise at least one solenoid. The motive element can comprise a MEMS rotary actuator and/or other MEMS actuator. The motive element can comprise an inch-worm drive, such as when the plunger can comprise an inchworm drive. The motive element can comprise a rotary magnetic drive. The magnetic drive can be configured to provide a reciprocating motion. The pumping assembly can further comprise a gear attached to the leadscrew, a hook, and a ratchet and pawl assembly configured to rotate the gear via the reciprocating motion provided by the magnetic drive. The magnetic drive can comprise a set of one or more permanent magnets and a set of one or more electromagnets. Activation of each of the electromagnets can provide reciprocating motion, rotatory motion, or both. [049] In some embodiments, the pumping assembly is configured to deliver the agent in a series of discreet boluses, and each bolus can be delivered over a time period of at least 3, 6, 15, and/or 30 seconds.

[050] In some embodiments, the pumping assembly comprises a peristaltic assembly.

[051] In some embodiments, the pumping assembly comprises a check flow valve comprising at least one check flow valve. The pumping assembly can comprise a MEMS pumping assembly including an inlet and an outlet, and the check valve can comprise a first check valve that can be fluidly positioned between the reservoir and the inlet, and a second check valve that can be fluidly positioned between the outlet and a distal end of the delivery conduit.

[052] In some embodiments, the housing comprises a first portion, a second portion, and a hinge rotatably connecting the first portion to the second portion (e.g., the fluid delivery device comprises two or more hinged portions, such as to improve patient comfort).

[053] In some embodiments, the housing comprises at least one rigid portion and at least one flexible portion (e.g., such as to improve patient comfort).

[054] In some embodiments, the housing comprises one or more soft portions. The housing can comprise at least one soft corner. The housing can comprise at least three soft comers.

[055] In some embodiments, the housing comprises a housing volume, and the housing volume can be constructed and arranged to reduce in magnitude over time.

[056] In some embodiments, the housing comprises a skin-tone color. In some embodiments, the housing comprises a logo.

[057] In some embodiments, a distal portion of the delivery conduit comprises a transcutaneous fluid delivery element. The transcutaneous fluid delivery element can comprise a needle; a hollow microneedle; a catheter; and/or a cannula such as a hard cannula and or a soft cannula. The transcutaneous fluid delivery element can comprise at least two transcutaneous fluid delivery elements, and a first transcutaneous fluid delivery element can be configured to deliver the agent for a first time period and a second transcutaneous fluid delivery element can be configured to deliver the agent for a subsequent second time period. The transcutaneous fluid delivery element can comprise at least two transcutaneous fluid delivery elements, and the fluid delivery device can comprise (e.g., simultaneously comprise) a first transcutaneous fluid delivery element and a second transcutaneous fluid delivery element. The first transcutaneous fluid delivery element can be configured to be inserted through the skin of the patient at a first location, and the second transcutaneous fluid delivery element can be configured to be inserted through the skin of the patient (e.g., simultaneous with the insertion of the first delivery element, or at a time period of at least one, two, three, four, or five days later) at a second location that can be at least 2mm, 4mm, and/or 6mm away from the first location. The transcutaneous fluid delivery element can comprise a distal portion configured to remain under a skin surface of the patient for at least 3 days. The delivery conduit can comprise an infusion set that includes the transcutaneous fluid delivery element, and a distal portion of the infusion set can comprise the transcutaneous fluid delivery element. The infusion set can be removably attachable to a proximal portion of the fluid pathway. The transcutaneous fluid delivery element can be configured to deliver the agent to a location under the patient’s skin surface without the transcutaneous fluid delivery element penetrating the patient’s skin surface. The fluid delivery device can be configured to deliver the agent via high energy bursts.

[058] In some embodiments, the fluid pathway comprises a flow modifying element. The pumping assembly can comprise a MEMS-based pumping assembly. The flow modifying element can comprise a flow restricting element selected from the group consisting of: a duckbill valve; a flow-limiting orifice; a capillary tube and/or other small diameter tube; a mechanical restrictor; a solenoid valve; a distensible tube; a flow restricting channel, such as a channel constructed by welding two sheets of plastic together; and combinations of these. The flow modifying element can comprise a pressure attenuator. The pressure attenuator can comprise a component selected from the group consisting of: a diaphragm; a spring; a mechanical pressure attenuator; an electromechanical pressure attenuator; a bladder; a reservoir filled with a fluid; a positive-pressure-actuated attenuator; a negative-pressure-actuated attenuator; and combinations thereof. The flow modifying element can comprise a capillary tube with a known fluid resistance. The flow modifying element can comprise two sheets of plastic that can be welded together to include a flow- restricted fluid delivery channel between the welds. The flow modifying element can comprise a diaphragm with a pre-determined pressure on a first side and a fluid delivery channel on an opposite second side, such as when fluid must exceed the pre-determined pressure to pass through the fluid delivery channel.

[059] In some embodiments, the fluid delivery device is configured to be used for a first time period, and the power supply comprises an energy capacity that is configured to provide energy to the fluid delivery device for a second time period that is less than the first time period (i.e., the power supply must be recharged and/or replaced for the fluid delivery device to operate for the first time period). The first time period can comprise a time period of at least 3 days. The first time period can comprise a time period between 3 days and 28 days (e.g., a time period of at least 3 days and/or no more than 28 days).

[060] In some embodiments, the power supply comprises a rechargeable power supply. The power supply can be configured to be recharged via wireless transfer of energy. The power supply can comprise a USB charge port. The power supply can be configured to be recharged while the patient is asleep. The power supply can be configured to be recharged via patient movement. The power supply can be configured to be recharged via solar and/or other light energy. The power supply can be configured to be recharged via heat energy, such as heat energy extracted from the patient.

[061] In some embodiments, the power supply comprises a first power supply and a second power supply. The first power supply can comprise a battery, a capacitor, and/or another element configured to store electrical energy, and the second power supply can be configured to store non-electrical energy. The fluid delivery device can be configured to recharge the first power supply via energy provided by the second power supply.

[062] In some embodiments, the system can further comprise the agent. The agent can comprise insulin. The agent can further comprise a non-insulin agent. The insulin can comprise insulin at a concentration of: 100 units/mL, 200 units/mL, 300 units/mL, 400 units/mL, and/or 500 units/mL. The insulin can comprise insulin configured to be stored at: room temperature; body temperature; or both. The insulin can comprise insulin that includes a surfactant. The agent can further comprise glucagon.

[063] In some embodiments, the system can further comprise a sensor configured to produce a signal related to one or more system parameters and/or one or more patient parameters. The sensor can comprise one or more sensors, and the signal can comprise one or more signals. The fluid delivery device can comprise the sensor. The sensor can comprise one or more physiologic sensors. The one or more physiologic sensors can comprise one, two, or more sensors selected from the group consisting of: glucose sensor; oxygen sensor such as oxygen saturation sensor; galvanic skin resistance sensor; ECG sensor; neural spike, local field potential, and/or EEG sensor; blood pressure sensor; heart rate sensor; oxygen sensor; respiration sensor; perspiration sensor; GPS sensor; and combinations thereof. The sensor can comprise at least one glucose sensor, such as at least one glucose sensor that is integral to the fluid delivery device. The sensor can comprise a glucose sensor and one, two, or more additional sensors selected from the group consisting of: oxygen sensor such as oxygen saturation sensor; galvanic skin resistance sensor; ECG sensor; neural spike, local field potential, and/or EEG sensor; blood pressure sensor; heart rate sensor; respiration sensor; perspiration sensor; and combinations thereof. The system can further comprise a sensor device, and the sensor device can comprise the sensor. One or more physiologic sensors of the fluid delivery device and/or a separate sensor device can comprise at least one glucose sensor. One or more physiologic sensors of the fluid delivery device and/or a separate sensor device can comprise one, two, or more sensors selected from the group consisting of: physiologic sensor; accelerometer; strain gauge; pressure sensor; flow sensor; optical sensor; temperature sensor; thermometer; RF and/or other electromagnetic sensor; impedance sensor; pH sensor; voltage sensor; current sensor; altitude sensor; sound sensor such as a microphone; ultrasound sensor; and combinations thereof. The sensor can comprise a sensor configured to monitor operation of the pumping assembly. The delivery conduit can comprise a needle, a catheter, a cannula, and/or other transcutaneous fluid delivery element, and the sensor can be configured to monitor deployment and/or position of the transcutaneous fluid delivery element. The sensor can comprise at least one accelerometer. The fluid delivery device can be configured to detect a fall of the patient based on signals received from the accelerometer. The fluid delivery device can be configured, based on a signal from an accelerometer or other sensor, to detect one or more parameters selected from the group consisting of: patient movement; patient position or position change; sleep state of the patient; proper operation of a vibrational transducer; proper operation of the pumping assembly; flow within the fluid pathway; and combinations of one, two, or more of these. The sensor can comprise at least one pressure sensor. The sensor can comprise at least one flow sensor. The sensor can comprise at least one occlusion sensor. The sensor can comprise at least one bubble detector. The sensor can comprise at least one temperature sensor. The sensor can comprise a sleep detector configured to detect when the patient is asleep. The system can be configured to allow a clinician to set one or more alert thresholds for a set of one or more monitored parameters (e.g., one or more sensor-monitored parameters), and the set of one or more monitored parameters can comprise one or more system parameters and/or one or more patient parameters, and the system can be configured to monitor the set of one or more system parameters based on the sensor signal. The sensor can be configured to produce a signal related to a patient environment parameter. The system can be configured to detect and/or confirm one or more system states and/or one or more patient states based on the sensor signal. The one or more system states and/or patient states can comprise one, two, or more states selected from the group consisting of: pump properly attached to body of patient; a fluid delivery element of the delivery conduit is properly inserted into the patient; pump is in a functional state; power supply is at an acceptable state; reservoir environment is at an acceptable level; patient condition is at an acceptable level; patient environment is at an acceptable level; patient activities are acceptable; and combinations thereof. The system can be configured to alert a non-patient user if an undesired system state and/or patient state can be detected based on the sensor signal. The system can be configured to detect if the agent stored in the reservoir is nearing the end of its useful life. The system can be configured to determine if the patient is maintaining a clinician-prescribed lifestyle plan based on the sensor signal. The system can be configured to monitor altitude of the patient based on the sensor signal, such as to adjust a parameter (e.g., a fluid delivery parameter) to maintain accurate delivery of the agent. The system can be configured to monitor sound in the vicinity of the fluid delivery device, and based on the sensor signal, the system can be further configured to determine: when delivery of the agent is occurring; if the reservoir is empty or otherwise below an acceptable level; if the fluid delivery device is not delivering the agent as intended; if the fluid delivery device is pumping air or other gas; when a priming procedure is complete; if the fluid delivery device is nearing an end-of-life condition; if the power supply is at an unacceptable level; if a component of the fluid delivery device is wearing (e.g., degrading) to an unacceptable state; if an adhesive securing one or more components of the fluid delivery device has failed or is failing; and combinations thereof. The system, based on the sensor signal, can be configured to detect a patient state selected from the group consisting of: talking; crying; awake; asleep; walking; running; sitting, standing; in a prone position; in a fetal position; or combinations thereof. The sensor can be configured to monitor use of the agent and/or a system component. The system can be configured to prevent use of the monitored agent and/or system component if use of the monitored agent and/or system component exceeds a time limit.

[064] In some embodiments, the system is configured to prevent, based on the sensor signal, undesired refilling of the reservoir and/or use of the fluid delivery device after undesired refilling of the reservoir.

[065] In some embodiments, the system can further comprise a communication module configured to transfer data between at least a first system component and at least a second system component. The first system component can comprise the fluid delivery device. The system can further comprise a glucose sensing device, and the second system component can comprise the glucose sensing device. The system can further comprise a smart phone and/or other cell phone, and the second system component can comprise the smart phone and/or other cell phone. The communication module can be configured to perform a data transfer via a wired connection. The communication module can be configured to perform a data transfer via a wireless connection, such as a Bluetooth connection, such as a Bluetooth low energy connection. The communication module can be configured to perform a data transfer via an acoustic signal such as an acoustic signal operating at frequencies outside of the auditory range of the patient. The fluid delivery device can comprise at least a first portion of the communication module. The system can further comprise a sensor device comprising a second portion of the communication module, and data can be transferred between the first portion and the second portion. The sensor device can comprise a glucose sensing device. [066] In some embodiments, the system further comprises a server. The server can be configured to receive data from the fluid delivery device and/or other system component. The data received can comprise: patient data; fluid delivery device data; or both. The system can be configured to perform trend analysis based on the data received by the server. The server can be configured to receive patient glucose data. The server can be configured to receive data selected from the group consisting of: operating settings such as basal rates, bolus volumes, and/or pre-configured extended bolus volumes; bolus calculator settings such as insulin-to-carbohydrate ratio data, insulin sensitivity data, and/or correction factor data; alarm threshold settings such as occlusion sensitivity data and/or reservoir volume warning level data; audio settings for alarms; and combinations thereof. The server can be configured to receive data selected from the group consisting of: sleep data; sleep schedule data; heart rate data; blood pressure data; exercise data; exercise schedule data; meal ingestion data; meal ingestion schedule data; and combinations thereof.

[067] In some embodiments, the system further comprises a user interface. The fluid delivery device can comprise at least a portion of the user interface. The at least a portion of the user interface included in the fluid delivery device can be configured to perform a limited set of functions, or a full set of instructions (e.g., as determined by a clinician of the patient). The limited set of functions can be limited to only a command to deliver a single bolus (e.g., one time, or repeatedly, such as when a continuous infusion rate, or “basal rate” cannot by modified). The system can further comprise a user device, and the user device can comprise at least a portion of the user interface. [068] In some embodiments, the system further comprises a processing unit comprising a processor and a memory storage element coupled to the processor, and the memory storage element can store instructions for the processor to perform an algorithm. The fluid delivery device can comprise at least a portion of the processing unit. The system can further comprise a sensor device comprising at least a portion of the processing unit. An algorithm can be configured to provide a suggestion comprising a suggested change to one or more agent delivery parameters. The suggested change can be the delivery of a bolus of the agent. The suggested change can be the modification of a continuous flow rate of the agent to be delivered. The algorithm can be configured to adjust the delivery of the agent based on patient sleep. The algorithm can be configured to monitor delivery of the agent and to adjust future delivery of the agent in order to minimize waste of the agent.

[069] In some embodiments, the system further comprises a functional element comprising one or more sensors, transducers, and/or other functional elements. In some embodiments, the functional element comprises at least one bubble trap, and the fluid pathway comprises the at least one bubble filter and/or other bubble trap.

[070] In some embodiments, the system can further comprise an alert assembly including at least one alert element, and the alert assembly can be configured to alert the user. The fluid delivery device can comprise the alert assembly. The at least one alert element can comprise two or more alert elements. The at least one alert element can comprise a first alert element and a second element, and the first alert element can be independently activatable. The at least one alert element can comprise a tactile alert element and a second alert element. [071] In some embodiments, the system further comprises an accessory device. The accessory device can comprise one, two, or more functional elements. The accessory device can comprise a bubble removal assembly. The bubble removal assembly can be configured to detachably and fluidly connect with the fluid pathway and remove a bubble from the fluid pathway. The accessory device can comprise a fill assembly constructed and arranged to deliver the agent into the reservoir. The accessory device can comprise a refill assembly constructed and arranged to refill the reservoir with the agent.

[072] In some embodiments, the system is configured in a closed-loop delivery mode, and delivery of the agent is based on both a patient parameter and a non-patient parameter. The patient parameter can comprise blood glucose level. The non-patient parameter can comprise a power level of the power supply, a volume level of the reservoir, or both. The closed-loop delivery can be biased toward underdelivery if a parameter exceeds a threshold. For example, the patient parameter can comprise a blood glucose level; and the non-patient parameter can comprise a volume level of the reservoir, and the closed-loop delivery can be configured such that: when a current blood glucose of the patient is at a level that correlates to a delivery of the agent at a volume X, a volume less than X is delivered when a current reservoir volume level is below a threshold. The closed-loop delivery can be biased toward overdelivery if a parameter exceeds a threshold. For example, the patient parameter can comprise a blood glucose level; and the non-patient parameter can comprise a power level of the power supply, and the closed-loop delivery can be configured such that: when a current blood glucose of the patient is at a level that correlates to a delivery of the agent at a volume X, a volume more than X is delivered when the power level of the power supply is below a threshold.

[073] According to another aspect of the present inventive concepts, a method of delivering an agent via a fluid delivery system is provided.

[074] The technology described herein, along with the attributes and attendant advantages thereof, will best be appreciated and understood in view of the following detailed description taken in conjunction with the accompanying drawings in which representative embodiments are described by way of example.

INCORPORATION BY REFERENCE

[075] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. The content of all publications, patents, and patent applications mentioned in this specification are herein incorporated by reference in their entirety. It will be clearly understood that, if a prior art publication is referred to herein, this reference does not constitute an admission that the publication forms part of the common general knowledge in the art in any country.

BRIEF DESCRIPTION OF THE DRAWINGS

[076] Fig. 1 illustrates a block diagram of an embodiment of an agent delivery system, consistent with the present inventive concepts. [077] Fig. 1A illustrates a block diagram of another embodiment of an agent delivery system, consistent with the present inventive concepts.

[078] Fig. 2 illustrates top and side views of a fluid delivery device, consistent with the present inventive concepts.

[079] Fig. 3 illustrates top and side views of two different sized fluid delivery devices, consistent with the present inventive concepts.

[080] Fig. 4 illustrates a side sectional view of a cannula assembly, consistent with the present inventive concepts.

[081] Figs. 4A-B illustrate sectional views of a cannula assembly positioned within an insertion tool, and a cannula assembly with the attached cannula inserted into the skin, respectively, consistent with the present inventive concepts.

[082] Fig. 5 illustrates a flow chart of a method of exchanging one or more devices used to provide therapy and/or monitor a patient, consistent with the present inventive concepts.

[083] Fig. 6 illustrates a flow chart of a method of exchanging a first sensor assembly for a second sensor assembly, consistent with the present inventive concepts.

DETAILED DESCRIPTION OF THE DRAWINGS

[084] Reference will now be made in detail to the present embodiments of the technology, examples of which are illustrated in the accompanying drawings. Similar reference numbers may be used to refer to similar components. However, the description is not intended to limit the present disclosure to particular embodiments, and it should be construed as including various modifications, equivalents, and/or alternatives of the embodiments described herein.

[085] It will be understood that the words "comprising" (and any form of comprising, such as "comprise" and "comprises"), "having" (and any form of having, such as "have" and "has"), "including" (and any form of including, such as "includes" and "include") or "containing" (and any form of containing, such as "contains" and "contain") when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.

[086] It will be further understood that, although the terms first, second, third, etc. may be used herein to describe various limitations, elements, components, regions, layers and/or sections, these limitations, elements, components, regions, layers and/or sections should not be limited by these terms. These terms are only used to distinguish one limitation, element, component, region, layer or section from another limitation, element, component, region, layer or section. Thus, a first limitation, element, component, region, layer or section discussed below could be termed a second limitation, element, component, region, layer or section without departing from the teachings of the present application.

[087] It will be further understood that when an element (also referred to as a “component” herein) is described as being "on", "attached", "connected" or "coupled" to another element, it can be directly on or above, or connected or coupled to, the other element, or one or more intervening elements can be present. In contrast, when an element is referred to as being "directly on", "directly attached", "directly connected" or "directly coupled" to another element, there are no intervening elements present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g. "between" versus "directly between," "adjacent" versus "directly adjacent," etc.).

[088] As used herein, the terms “operably attached”, “operably connected”, “operatively coupled” and similar terms related to attachment of components shall refer to attachment of two or more components that results in one, two, or more of: electrical attachment; fluid attachment; magnetic attachment; mechanical attachment; optical attachment; sonic attachment; and/or other operable attachment arrangements. The operable attachment of two or more components can facilitate the transmission between the two or more components of: power; signals; electrical energy; fluids or other flowable materials; magnetism; mechanical linkages; light; sound such as ultrasound; and/or other materials and/or components.

[089] It will be further understood that when a first element is referred to as being "in", "on" and/or "within" a second element, the first element can be positioned: within an internal space of the second element, within a portion of the second element (e.g. within a wall of the second element); positioned on an external and/or internal surface of the second element; and combinations of one or more of these.

[090] As used herein, the term “proximate”, when used to describe proximity of a first component or location to a second component or location, is to be taken to include one or more locations near to the second component or location, as well as locations in, on and/or within the second component or location. For example, a component positioned proximate an anatomical site (e.g. a blood or other fluid delivery location), shall include components positioned near to the anatomical site, as well as components positioned in, on and/or within the anatomical site.

[091] Spatially relative terms, such as "beneath," "below," "lower," "above," "upper", “under” and the like may be used to describe an element and/or feature's relationship to another element(s) and/or feature(s) as, for example, illustrated in the figures. It will be further understood that the spatially relative terms are intended to encompass different orientations of the device in use and/or operation in addition to the orientation depicted in the figures. For example, if the device in a figure is turned over, elements described as "below" and/or "beneath" other elements or features would then be oriented "above" the other elements or features. The device can be otherwise oriented (e.g. rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. [092] The terms “reduce”, “reducing”, “reduction” and the like, where used herein, are to include a reduction in a quantity, including a reduction to zero. Reducing the likelihood of an occurrence shall include prevention of the occurrence. Correspondingly, the terms “prevent”, “preventing”, and “prevention” shall include the acts of “reduce”, “reducing”, and “reduction”, respectively.

[093] The term "and/or" where used herein is to be taken as specific disclosure of each of the two specified features or components with or without the other. For example "A and/or B" is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.

[094] The term “one or more”, where used herein can mean one, two, three, four, five, six, seven, eight, nine, ten, or more, up to any number.

[095] The terms “and combinations thereof’ and “and combinations of these” can each be used herein after a list of items that are to be included singly or collectively. For example, a component, process, and/or other item selected from the group consisting of: A; B; C; and combinations thereof, shall include a set of one or more components that comprise: one, two, three or more of item A; one, two, three or more of item B; and/or one, two, three, or more of item C.

[096] In this specification, unless explicitly stated otherwise, “and” can mean “or”, and “or” can mean “and”. For example, if a feature is described as having A, B, or C, the feature can have A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A, B, and C, the feature can have only one or two of A, B, or C. [097] As used herein, when a quantifiable parameter is described as having a value “between” a first value X and a second value Y, it shall include the parameter having a value of: at least X, no more than Y, and/or at least X and no more than Y. For example, a length of between 1 and 10 shall include a length of at least 1 (including values greater than 10), a length of less than 10 (including values less than 1), and/or values greater than 1 and less than 10.

[098] The expression “configured (or set) to” used in the present disclosure may be used interchangeably with, for example, the expressions “suitable for”, “having the capacity to”, “designed to”, “adapted to”, “made to” and “capable of’ according to a situation. The expression “configured (or set) to” does not mean only “specifically designed to” in hardware. Alternatively, in some situations, the expression “a device configured to” may mean that the device “can” operate together with another device or component.

[099] As used herein, the terms “about” or “approximately” shall refer to ± 20% of a stated value.

[100] As used herein, the term “threshold” refers to a maximum level, a minimum level, and/or range of values correlating to a desired or undesired state. In some embodiments, a system parameter is maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and/or outside a threshold range of values, such as to cause a desired effect (e.g. efficacious therapy) and/or to prevent or otherwise reduce (hereinafter “prevent”) an undesired event (e.g. a device and/or clinical adverse event). In some embodiments, a system parameter is maintained above a first threshold (e.g. above a first temperature threshold to cause a desired therapeutic effect to tissue) and below a second threshold (e.g. below a second temperature threshold to prevent undesired tissue damage). In some embodiments, a threshold value is determined to include a safety margin, such as to account for patient, user, and/or operator variability, system variability, tolerances, and the like. As used herein, “exceeding a threshold” relates to a parameter going above a maximum threshold, below a minimum threshold, within a range of threshold values and/or outside of a range of threshold values.

[101] As described herein, “room pressure” shall mean pressure of the environment surrounding the systems and devices of the present inventive concepts. Positive pressure includes pressure above room pressure or simply a pressure that is greater than another pressure, such as a positive differential pressure across a fluid pathway component such as a valve. Negative pressure includes pressure below room pressure or a pressure that is less than another pressure, such as a negative differential pressure across a fluid component pathway such as a valve. Negative pressure can include a vacuum but does not imply a pressure below a vacuum. As used herein, the term “vacuum” can be used to refer to a full or partial vacuum, or any negative pressure as described hereabove.

[102] The term “diameter” where used herein to describe a non-circular geometry is to be taken as the diameter of a hypothetical circle approximating the geometry being described. For example, when describing a cross section, such as the cross section of a component, the term “diameter” shall be taken to represent the diameter of a hypothetical circle with the same cross sectional area as the cross section of the component being described.

[103] The terms “major axis” and “minor axis” of a component where used herein are the length and diameter, respectively, of the smallest volume hypothetical cylinder which can completely surround the component.

[104] As used herein, the term “functional element” is to be taken to include one or more elements constructed and arranged to perform a function. A functional element can comprise a sensor and/or a transducer (e.g., one, two, or more sensors, and/or one, two, or more transducers). In some embodiments, a functional element is configured to deliver energy. In some embodiments, a functional element is configured to treat tissue (e.g. a functional element configured as a treatment element). Alternatively or additionally, a functional element (e.g. a functional element comprising a sensor) can be configured to record one or more parameters, such as a patient physiologic parameter; a patient anatomical parameter (e.g. a tissue geometry parameter); a patient environment parameter; and/or a system parameter. In some embodiments, a sensor or other functional element is configured to perform a diagnostic function (e.g. to gather data used to perform a diagnosis). In some embodiments, a functional element is configured to perform a therapeutic function (e.g. to deliver therapeutic energy and/or a therapeutic agent). In some embodiments, a functional element comprises one or more elements constructed and arranged to perform a function selected from the group consisting of: deliver energy; extract energy (e.g. to cool a component); deliver a drug or other agent; manipulate a system component or patient tissue; record or otherwise sense a parameter such as a patient physiologic parameter or a system parameter; and combinations of one or more of these. A functional element can comprise a fluid and/or a fluid delivery system. A functional element can comprise a reservoir, such as an expandable balloon or other fluid-maintaining reservoir. A “functional assembly” can comprise an assembly constructed and arranged to perform a function, such as a diagnostic and/or therapeutic function. A functional assembly can comprise an expandable assembly. A functional assembly can comprise one or more functional elements.

[105] The term “transducer” where used herein is to be taken to include any component or combination of components that receives energy or any input, and produces an output. For example, a transducer can include an electrode that receives electrical energy, and distributes the electrical energy to tissue (e.g. based on the size of the electrode). In some configurations, a transducer converts an electrical signal into any output, such as: light (e.g. a transducer comprising a light emitting diode or light bulb), sound (e.g. a transducer comprising a piezo crystal configured to deliver ultrasound energy); pressure (e.g. an applied pressure or force); heat energy; cryogenic energy; chemical energy; mechanical energy (e.g. a transducer comprising a motor or a solenoid); magnetic energy; and/or a different electrical signal (e.g. different than the input signal to the transducer). Alternatively or additionally, a transducer can convert a physical quantity (e.g. variations in a physical quantity) into an electrical signal. A transducer can include any component that delivers energy and/or an agent to tissue, such as a transducer configured to deliver one or more of: electrical energy to tissue (e.g. a transducer comprising one or more electrodes); light energy to tissue (e.g. a transducer comprising a laser, light emitting diode and/or optical component such as a lens or prism); mechanical energy to tissue (e.g. a transducer comprising a tissue manipulating element); sound energy to tissue (e.g. a transducer comprising a piezo crystal); chemical energy; electromagnetic energy; magnetic energy; and combinations of one or more of these.

[106] As used herein, the term “fluid” can refer to a liquid, gas, gel, or any flowable material, such as a material which can be propelled through a lumen and/or opening.

[107] As used herein, the term “material” can refer to a single material, or a combination of two, three, four, or more materials.

[108] As used herein, the term “user interface” can comprise one or more interfaces, each interface comprising one or more components configured to receive an input from a user, “user input device” herein, and/or one or more components configured to provide output to a user, “user output device” herein. An input device can comprise one, two, three, or more components selected from the group consisting of: keyboard; a mouse; a button; a switch; a lever; a keypad such as a membrane keypad; a joystick; a touchscreen display; a microphone; a brain-machine-interface (e.g., a thought-control device); a camera, such as a camera with eye tracking, motion tracking, gesture identification, and/or other image processing capability configured to identify user input; a motion capture device, such as a camera and/or a device including one or more accelerometers; a virtual input device, such as a virtual device comprising ultrasonic, image capture, and/or motion-based sensing of user inputs; a physiologic input sensor, such as a sensor configured to provide an input signal based on a user action, such as flexure of a muscle proximate the sensor; a scent detector, such as a detector configured to identify a pheromone or other scent produced by the user; other input component; and combinations of these. An output device can comprise one, two, three, or more components selected from the group consisting of: a visual output component such as a light and/or a display such as a touchscreen display; an audible output component such as a buzzer and/or a speaker; a haptic output component such as a vibrational transducer and/or an ultrasonic device configured to produce a tactile output; a brain-machine-interface; an augmented reality (AR) and/or a virtual reality (VR) output device, such as glasses or a headset including a non-transparent display, a transparent display, and/or a “heads up” display where information is presented to the user in an overlay manner; a scent output device configured to produce an aromatic output, such as a computerized scent output; other output component; and combinations of these.

[109] The terms “data” and “information” are used interchangeably herein.

[110] It is appreciated that certain features of the inventive concepts, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the inventive concepts which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. For example, it will be appreciated that all features set out in any of the claims (whether independent or dependent) can be combined in any given way.

[111] It is to be understood that at least some of the figures and descriptions of the inventive concepts have been simplified to focus on elements that are relevant for a clear understanding of the inventive concepts, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the inventive concepts. However, because such elements are well known in the art, and because they do not necessarily facilitate a better understanding of the inventive concepts, a description of such elements is not provided herein.

[112] Terms defined in the present disclosure are only used for describing specific embodiments of the present disclosure and are not intended to limit the scope of the present disclosure. Terms provided in singular forms are intended to include plural forms as well, unless the context clearly indicates otherwise. All of the terms used herein, including technical or scientific terms, have the same meanings as those generally understood by an ordinary person skilled in the related art, unless otherwise defined herein. Terms defined in a generally used dictionary should be interpreted as having meanings that are the same as or similar to the contextual meanings of the relevant technology and should not be interpreted as having ideal or exaggerated meanings, unless expressly so defined herein. In some cases, terms defined in the present disclosure should not be interpreted to exclude the embodiments of the present disclosure.

[113] Provided herein are systems, devices, and methods for delivery of one or more agents to a patient. A fluid delivery system can comprise one or more fluid delivery devices. Each fluid delivery device can comprise one or more of: a reservoir, a pumping assembly, a fluid pathway including a distal portion comprising a delivery conduit, a power supply, and a housing. The reservoir can be constructed and arranged to store an agent to be delivered to a patient. The pumping assembly can be constructed and arranged to propel the agent. The delivery conduit can be constructed and arranged to receive the agent from the reservoir and deliver the agent to the patient. The power supply can be configured to provide energy to at least the pumping assembly. The housing can surround at least the reservoir and the pumping assembly. The fluid delivery system can comprise multiple fluid delivery devices, such as when at least a portion of each fluid delivery device is used for a limited time period, and replaced with a new portion (e.g., a portion or the entire fluid delivery device is replaced on a regular basis, such as within 30 days, 7 days, or 3 days).

[114] Referring now to Fig. 1, a block diagram of an embodiment of an agent delivery system is illustrated, consistent with the present inventive concepts. System 10 can be configured to deliver one or more drugs or other agents to a patient, such as agent 20 shown. System 10 can be configured to deliver agent 20 to a human or other mammalian patient, “patient” herein. Additionally, or alternatively, system 10 can be configured to diagnose and/or monitor a patient (e.g., with or without delivery of an agent to the patient). System 10 includes one or more fluid delivery devices, delivery device 100 shown. System 10 and delivery device 100 can be prescribed by a clinician to deliver agent 20 to a patient. As used herein, a “user” of system 10 can refer to a doctor, nurse, and/or other healthcare professional, “clinician operator”, “clinician user”, or simply “clinician” herein, that manages or otherwise oversees the delivery of agent 20 to one or more patients via one or more delivery devices 100. The term “user” can also refer to one or more patients using system 10 to receive delivery of agent 20. The term “user” can also refer to a family member, friend, or other person with responsibility for a patient (e.g., when the patient is a juvenile). In some embodiments, system 10 is configured to diagnose, monitor, and/or treat a patient, such as a diabetic patient requiring an agent 20 comprising insulin to be delivered to a location under the skin of the patient. Agent 20 can comprise insulin at a concentration of 100 units/mL, 200 units/mL, 300 units/mL, 400 units/mL, 500 units/mL, and/or any insulin concentration. Agent 20 can comprise an insulin formulation configured to be stored at room temperature and/or body temperature, such as insulin comprising a surfactant. In some embodiments, agent 20 comprises a formulation including both insulin and glucagon.

[115] System 10 of Fig. 1 can include similar components, and can otherwise be of similar construction and arrangement to system 10 described in reference to Fig. 1 A and/or other figures described herein.

[116] Delivery device 100 can include one or more reservoirs for storing agent 20 (or other material), reservoir 110 shown. Reservoir 110 includes a housing, housing 111, which surrounds one or more internal voids, chamber 112, for storing agent 20. Housing 111 can comprise one or more flexible materials, one or more rigid materials, or both. In some embodiments, reservoir 110 comprises two or more reservoirs, for example when agent 20 comprises two or more agents, such as two or more different agents, and/or two or more agents comprising different concentrations (e.g., different dosages). In some embodiments, agent 20 comprises a first agent configured to provide a therapeutic benefit (e.g., insulin for a diabetic patient), and a second agent configured to reverse the effects of the first agent (e.g., dextrose or glucagon for reversing the effects of insulin toxicity).

[117] Delivery device 100 can include one or more material (e.g., fluid) transport mechanisms, pumping assembly 130 shown. Pumping assembly 130 can be configured to propel one or more materials (e.g., liquid or other flowable materials), such as agent 20. For example, pumping assembly 130 can pump agent 20 from reservoir 110 into the patient (e.g., into subcutaneous tissue, a blood vessel, and/or other location under the skin of the patient), such that agent 20 is infused or otherwise delivered (“delivered” herein) to the patient.

[118] Delivery device 100 can include tubes, lumens, conduits, manifolds, and/or other fluid pathways (also referred to as “flow pathways”, “fluid conduits”, and the like), fluid pathway 140 shown, that fluidly connect various components of delivery device 100. A distal portion of fluid pathway 140, delivery conduit 145 shown, is configured to deliver agent 20 to the patient (e.g., as received from reservoir 110, pumping assembly 130, and/or another component of delivery device 100). Fluid pathway 140 can comprise one or more fluid pathways that fluidly connect two or more components of delivery device 100, such as to fluidly connect reservoir 110 to pumping assembly 130.

[119] Delivery device 100 can include one, two, or more supplies of energy, power supply 160. Power supply 160 can be configured to provide electrical power and/or other energy (e.g., pressure and/or other stored potential mechanical energy) to delivery device 100. In some embodiments, power supply 160 comprises an electrical energy storage assembly, such as one or more batteries and/or capacitors. Additionally, or alternatively, power supply 160 can comprise a pressure source (e.g., a phase-change material configured to provide a constant pressure), a spring, and/or other stored energy source. In some embodiments, power supply 160 provides energy to pumping assembly 130, such as one or more forms of energy that are used by pumping assembly 130 to propel agent 20 (e.g., to deliver agent 20 to the patient). In some embodiments, power supply 160 is configured to provide electrical energy to one or more electronic components of delivery device 100. In some embodiments, power supply 160 is configured to provide non-electrical energy to one or more components of delivery device 100.

[120] Delivery device 100 can include one or more casings and/or other structural elements that at least partially enclose various components of the device, housing 101 shown. For example, housing 101 can surround at least a portion of reservoir 110 and pumping assembly 130. In some embodiments, housing 101 comprises two or more distinct housings, such as when delivery device 100 comprises two or more portions that are removably attachable to each other, for example as described herein. As used herein, housing 101 can refer to all and/or a portion of housing 111 of reservoir 110.

[121] System 10 can include attachment assembly 400 for temporarily attaching at least a portion of delivery device 100 to the skin of the patient. Attachment assembly 400 can comprise an adhesive attachment mechanism, such as an adhesive pad that temporarily adheres to the skin of the patient. In some embodiments, attachment assembly 400 is attached to device 100 (e.g., permanently or temporarily attached to delivery device 100 in a manufacturing process), such as when attached to housing 101 of delivery device 100. In some embodiments, attachment assembly 400 can comprise a layer of adhesive that is applied to a portion of housing 101 and is configured to temporarily adhere delivery device 100 to the skin of the patient. In these embodiments, the adhesive can be applied to housing 101 by a user prior to placing delivery device 100 on the skin of the patient. Alternatively, or additionally, an adhesive can be applied to housing 101 in a manufacturing process. In some embodiments, attachment assembly 400 includes a removable cover that can be removed to expose the skin-attaching adhesive portion of assembly 400. Alternatively, or additionally, attachment assembly 400 can include an activator configured to activate a pre-applied adhesive.

[122] System 10 can include one or more sensor assemblies, sensor assembly 200 shown. Sensor assembly 200 can include one, two, or more sensors, sensor 250 shown, such as one, two, or more sensors that are configured to record one or more patient parameters. For example, sensor assembly 200 can comprise a continuous glucose monitor (CGM) including a sensor 250 comprising a blood glucose sensor. Sensor assembly 200 can communicate (e.g., transfer data) with delivery device 100 and/or other components of system 10, as described herein. In some embodiments, delivery device 100 comprises sensor assembly 200 (e.g., when sensor 250 and/or at least a portion of sensor assembly 200 is integrated into delivery device 100).

[123] System 10 can include one or more user devices, user device 700 shown. User device 700 can provide a user interface for the input of commands and/or other information from a user of system 10 (e.g., commands sent to delivery device 100), and/or for the output of information from system 10 (e.g., data from delivery device 100) to a user. In some embodiments, one or more portions of user device 700 are integrated into delivery device 100 (e.g., when delivery device 100 is configured to receive input from and/or provide output to a user). Additionally, or alternatively, delivery device 100 can comprise user device 700 (e.g., when system 10 does not include a user device separate from delivery device 100). In some embodiments, user device 700 comprises a cell phone (e.g., a smart phone), or a handheld device that is configured as a cell phone. In some embodiments, user device 700 comprises a first user device 700p (e.g., a cell phone) for use by the patient (e.g., to deliver commands to and/or receive data from delivery device 100) and a second user device 700c (e.g., a cell phone, a laptop computer, and/or a desktop computer) for use by a clinician (e.g., to deliver commands to one or more system 10 components and/or to receive data from one or more system 10 components).

[124] System 10 can include one or more functional elements, such as functional element 99 shown. One or more components of system 10, such as delivery device 100, sensor assembly 200, and/or user device 700 can each include a functional element 99, such as when functional elements 199, 299, and/or 799, respectively, each shown, comprise a functional element 99. Singly or collectively, various functional elements described herein can individually or collectively be referred to as “functional element 99”.

[125] Referring additionally to Fig. 1A, a block diagram of another embodiment of an agent delivery system is illustrated, consistent with the present inventive concepts. In some embodiments, one or more components of system 10 of Fig. 1 A are of similar construction and arrangement to the similar components described in reference to Fig. 1 and/or otherwise herein.

[126] System 10 can include one or more assemblies that are configured to alert a user of system 10, alert assembly 40 shown. Alert assembly 40 can include one or more alert elements, alert element 49 shown, that provides a visible, audible, tactile, or other signal to a user to indicate a warning and/or other alert condition of system 10. All or a portion of one or more alert assemblies 40 can be integrated into one, two, or more of the various components of system 10, such as delivery device 100 and/or other component of system 10.

[127] In some embodiments, alert element 49 of alert assembly 40 comprises two or more alert elements. For example, alert assembly 40 can comprise a first alert element 49 and a second alert element 49. In some embodiments, the first and second alert elements 49 are independently activatable (e.g., to independently alert the user to different alert conditions of system 10). In some embodiments, alert assembly 40 comprises a first alert element 49 comprising a tactile alert element (e.g., a haptic transducer), and a second alert element 49 comprising a non-tactile alert element, such as a visible alert element (e.g., an indicator light), an audible alert element (e.g., a speaker or a buzzer), and/or other output device that alerts the user to an alert condition.

[128] System 10 can be configured to allow a user (e.g., a clinician, nurse, and/or other healthcare professional, “clinician” herein) to set one or more alert thresholds for a set of one or more parameters that are monitored by the system (e.g., one or more parameters that are monitored by sensor assembly 200, as described herein). When a threshold of a monitored parameter is exceeded, alert assembly 40 can be configured to alert the patient and/or another user of system 10, for example the patient’s clinician. In some embodiments, system 10 is configured to alert a non-patient user of system 10, for example the patient’s clinician, as described herein. [129] System 10 can include one or more data processing modules, processing unit 50 shown, that can be configured to perform and/or facilitate one or more of the functions of system 10 described herein. For example, processing unit 50 can perform and/or facilitate one or more processes, data collections, data analyses, data transfers, signal processing functions, agent deliveries, flow monitoring, monitoring of one or more patient parameters, and/or other functions of system 10 (“functions of system 10” or “system functions” herein). Processing unit 50 can comprise one or more electronic elements, electronic assemblies, and/or other electronic components, such as components selected from the group consisting of microprocessors; microcontrollers; state machines; memory storage components; analog-to-digital converters; rectification circuitry; filters and other signal conditioners; sensor interface circuitry; transducer interface circuitry; and combinations of one, two, or more of these. For example, processing unit 50 can include at least one processor and at least one memory storage component, such as processor 51 and memory 52, each shown. Memory 52 can be coupled to processor 51, and memory 52 can store one or more sets of computer instructions, instructions 53 shown. Instructions 53 can comprise instructions used by processor 51 to perform one or more algorithms of system 10. For example, system 10 can comprise one or more algorithms, algorithm 55 shown, that are performed by processor 51. Additionally, or alternatively, instructions 53 can comprise instructions for running one or more applications of system 10, for example application 56 shown. Processing unit 50 can be configured to “run” application 56, such that application 56 can initiate, modify, stop, and/or coordinate the performance of various functions of delivery device 100 and/or of system 10, such as to initiate, stop, and/or otherwise modify the delivery of agent 20 by delivery device 100. In some embodiments, application 56 is configured to receive input from a user of system 10, for example via a user interface (e.g., user interface 60 described herein). In some embodiments, algorithm 55 can comprise one or more machine learning, neural net, and/or other artificial intelligence algorithms (“Al algorithm” herein). All or a portion of one or more processing units 50 can be integrated into one, two, or more of the various components of system 10, such as delivery device 100, a server (e.g., server 80 described herein), and/or other component of system 10.

[130] System 10 can include one or more user interfaces, user interface 60 shown. User interface 60 can provide and/or receive information to and/or from a user of the system (e.g., a patient and/or other user of system 10). User interface 60 can include one or more user input components and/or output components. For example, user interface 60 can comprise a keyboard, mouse touchscreen, and/or other human interface or other input component (e.g., as described herein), user input device 61. In some embodiments, user interface 60 can comprise a speaker, indicator light, haptic transducer and/or other human interface or other output component (e.g., as described herein), user output device 62. In some embodiments, user output device 62 comprises a video output component, such as display 63 shown. Display 63 can comprise a touchscreen display, for example when user input device 61 and user output device 62 collectively comprise display 63. In some embodiments, processing unit 50 is configured to provide an interactive graphical interface, GUI 65, such as a graphical user interface provided by application 56. GUI 65 can be displayed (e.g., displayed to a user of system 10) via display 63. In some embodiments, user interface 60 and/or GUI 65 comprise a virtual reality and/or augmented reality interface. One or more components of system 10 can comprise one or more portions of a user interface 60, such as delivery device 100, sensor assembly 200, user device 700, and/or other components of system 10 described herein.

[131] System 10 can include one or more communication modules, communication module 70 shown. One or more devices of system 10 can comprise one or more portions of a communication module 70, such as delivery device 100, sensor assembly 200, user device 700, and/or other components of system 10 described herein. Communication module 70 can be configured to provide communication between (e.g., transfer commands, delivery information, patient information, and/or other data between) two or more components of system 10, such as via wired and/or wireless communication. For example, communication module 70 can include one or more transmitters and/or receivers, transceiver 71 shown. Transceiver 71 can comprise a wireless transceiver, such as a Bluetooth transceiver, a Near Field Communication (NFC) transceiver, a Wi-Fi transceiver, a cellular transceiver, a satellite-connected transceiver, and/or other short-range and/or long-range wireless transceiver. A wireless connection can include a short-range wireless connection, such as an NFC connection and/or a Bluetooth low energy (BLE) connection. In some embodiments, communication module 70 is configured to transfer data via an acoustic signal, such as an acoustic signal that is outside of the auditory range of the user. In some embodiments, communication module 70 is configured to communicate via one or more wired and/or wireless networks, such as network 75 shown. Network 75 can include a wireless network, such as cellular network, LAN, WAN, VPN, the Internet, and/or other wireless network connecting two or more devices. In some embodiments, network 75 comprises a wired network, and/or a network including wired and wireless devices.

[132] Communication module 70 can be configured to transfer data between at least a first component of system 10 and at least a second component of system 10, as described herein. In some embodiments, the first component of system 10 comprises delivery device 100. The second component can comprise another component of system 10, for example sensor assembly 200, such as a sensor assembly 200 comprising a glucose sensor, and/or user device 700, such as user device 700 comprising a smart device, such as a smartphone and/or a tablet.

[133] In some embodiments, system 10 includes one or more computers or systems that provide data, resources, programs, and/or services to other computers and/or other devices, server 80 shown. Server 80 can be configured to provide data storage and/or data processing for the providers of system 10 (e.g., the manufacturer and/or distributor of system 10) and/or the users of system 10. As used herein, data processing can refer to the receiving of data, processing of data, transmission of data (e.g., transmitting the results of data processing), and/or the storage of data. Server 80 can comprise one or more processing units 50.

Additionally, or alternatively, server 80 can include one or more data storage units for storing data collected by system 10, data 85 shown. In some embodiments, server 80 is configured to process data from various users of system 10, for example when the provider of system 10 maintains one or more servers 80 configured to process data for each (and/or a subset) of the users of system 10 (e.g., each of the patients, family members, clinicians and/or other healthcare professionals, and/or other users of system 10). Server 80 can comprise an “offsite” server (e.g., remotely located from the users of system 10), such as a server owned, maintained, and/or otherwise provided by the provider of system 10. Alternatively, or additionally, server 80 can comprise a cloud-based server.

[134] In some embodiments, at least a portion of system 10 comprises a temporary use and/or disposable (“disposable” herein) component. For example, delivery device 100 can be a disposable device, and/or device 100 can include one or more disposable components, each disposable portion configured to be used by a patient for a limited time period (e.g., no more than 30 days, 7 days, and/or 3 days), and then replaced with a similar component. In some embodiments, system 10 comprises one or more single use disposable components, and/or multi-use disposable components, wherein the multi-use components are transferred at least from a first delivery device 100 to a second delivery device 100. In some embodiments, the multi-use disposable component is transferred to a third delivery device 100, and so on, but the transfers are limited to a maximum (e.g., at least two, three, or four transfers, and/or no more than 100, 50, and/or 25 transfers). Additionally, or alternatively, system 10 can comprise one or more single and/or multi-use disposable components that are configured to be used for a maximum time period (e.g., as included in one, two, or more delivery devices 100). For example, delivery device 100 can comprise a first portion that is configured to be used for a first maximum time period (e.g., no more than 50 days, 30 days, or 14 days), and a second portion that is configured to be used for a second maximum period (e.g., no more than 7 days, or 3 days), where the second period is shorter than the first period, such as when the first portion is configured to work with two or more second portions (e.g., as the second portion is replaced). In some embodiments, the entire delivery device 100 comprises a disposable delivery device, as described herein.

[135] In some embodiments, delivery device 100 includes at least a portion of processing unit 50 and/or at least a portion of user interface 60, such as when delivery device 100 comprises processing unit 105 and/or user interface 106, respectively, each shown.

[136] In some embodiments, delivery device 100 comprises at least a portion of sensor assembly 200, sensor assembly 120 shown. For example, sensor assembly 120 can comprise one or more of sensors 250, sensor 125 shown. Sensor 125 can comprise one, two, or more sensors where each sensor can be configured to record (e.g., produce a signal related to) various parameters of the delivery of agent 20 and/or other parameters related to the functionality of delivery device 100.

[137] In some embodiments, reservoir 110 is configured to be filled (e.g., filled with agent 20) following a manufacturing process of delivery device 100 (e.g., filled by the manufacturer of system 10, or by a user, such as a patient, healthcare professional, family member, and/or other user of system 10). Delivery device 100 can include one or more fluid access ports, fill port 150 shown, that is fluidly connected to reservoir 110 and configured to receive agent 20 to fill reservoir 110. In some embodiments, reservoir 110 is insertable and/or removable from delivery device 100. For example, reservoir 110 can comprise a replaceable reservoir, such as a reservoir that is configured to be removed from delivery device 100 (e.g., when depleted) and replaced with a new (e.g., full and/or to be filled) reservoir. In some embodiments, delivery device 100 is provided to the user without an installed reservoir 110, and one or more reservoirs 110 are provided to the user to be inserted into delivery device 100 prior to use. In some embodiments, reservoir 110 is insertable and not removable, for example when delivery device 100 includes a locking insertion mechanism that prevents reservoir 110 from being removed after insertion.

[138] In some embodiments, delivery device 100 comprises at least a portion of communication module 70, communication module 170 shown. Communication module 170 can comprise one or more transceivers 71, transceiver 171 shown.

[139] System 10 can include one or more additional devices, such as accessory device 300 shown, that enable and/or otherwise assist the patient or other user in the use of system 10. For example accessory device 300 can include a device selected from the group consisting of: an applicator, such as an applicator for attaching delivery device 100 to the skin of the patient; a refill assembly, such as a device for filling and/or refilling reservoir 110 with agent 20; a safety device, such as a bubble removing assembly; an assembly tool, such as tool that attaches and/or detaches two portions of housing 101; and combinations of these. In some embodiments, accessory device 300 comprises one or more functional element 99, such as functional element 399 shown.

[140] In some embodiments, system 10 is configured to reduce the waste of agent 20 (e.g., insulin) that can occur during the use of an agent delivery system, for example, to reduce the amount of agent 20 that remains within reservoir 110 and/or fluid pathway 140 when the patient exchanges a used delivery device 100 for a replacement delivery device 100 (e.g., to reduce the discarded agent 20 remaining in the replaced device). In some embodiments, system 10 is configured to reduce the waste of agent 20 by at least O.lmL, 0.2mL, and/or 0.3mL over a time period of no more than three days.

[141] System 10 (e.g., via algorithm 55) can be configured to deliver agent 20 in a closed-loop-delivery mode (“closed-loop delivery” herein). In some embodiments, closed- loop delivery is based on a patient physiologic parameter, such as a parameter that is monitored by sensor assembly 200. For example, closed-loop delivery of agent 20 comprising insulin can be based on the blood glucose level and/or other physiologic parameter of the patient. Additionally, or alternatively, closed-loop delivery of an agent 20 comprising insulin or other agent can be based on patient activity, for example based on the activity level of the patient and/or the food intake of the patient. In some embodiments, closed-loop delivery can be based on a parameter of delivery device 100. In some embodiments, closed-loop delivery can be based on both a patient parameter (e.g., blood glucose level and/or other patient physiologic parameter), and a non-patient parameter (e.g., a delivery device 100 parameter and/or other system 10 component parameter). For example, closed-loop delivery performed by system 10 can be based on the available power level (e.g., energy content) of power supply 160, based on the volume of agent 20 available (e.g., currently available) in reservoir 110 for delivery to the patient, or both, such as when an amount of agent 20 delivered over time is based on one or both of these variables. In some embodiments, the amount of agent 20 delivered by delivery device 100 in a closed-loop arrangement of system 10 (e.g., as determined by algorithm 55) is based on a measurement of a patient physiologic parameter (e.g., blood glucose or other patient physiologic parameter) and one or both of energy content and/or other power level of power supply 160 and/or volume of agent 20 available in reservoir 110 for delivery to the patient. In these embodiments, algorithm 55 can comprise a bias, such as a bias toward underdelivery (e.g., slight underdelivery) of agent 20 (e.g., delivering less insulin than normally would be given based on a blood glucose reading due to a volume of insulin in reservoir 110 below a threshold, such as to “save” some insulin for a later delivery). Alternatively, or additionally, algorithm 55 can comprise a bias toward overdelivery (e.g., slight overdelivery) of agent 20 (e.g., delivering more insulin than normally would be given based on a blood glucose reading due to a limited amount of energy in power supply 160, such as to deliver an extra amount of insulin before the power supply is depleted). In some embodiments, system 10 can be configured to deliver agent 20 in an open-loop-delivery mode (“open-loop delivery” herein). In some embodiments, system 10 can be configured to deliver agent 20 in both open-loop and closed-loop delivery modes (e.g., where the two modes are performed simultaneously or sequentially). In some embodiments, changing between operating in open-loop and closed- loop mode can only be performed, or authorized, by a clinician of the patient using delivery device 100 to receive agent 20. For example, a user interface 60 of system 10 can require a clinician password or other authorization to change the status of any key parameter (e.g., system 10 requires the change to be “authorized” by a qualified clinician).

[142] In some embodiments, such as to enhance patient comfort and/or compliance, delivery device 100 comprises a minimized volume, mass, and/or overall size. For example, the internal components of delivery device 100 can be constructed and arranged such that the dimensions of housing 101 are minimized while enclosing the components necessary for delivery of agent 20 to the patient. In some embodiments, delivery device 100 comprises a volume DV. The dimensions of delivery device 100 can be equal to the dimensions of housing 101, for example volume HV of housing 101, described herein. In some embodiments, the dimensions of delivery device 100 stated herein include any portions of attachment assembly 400 that remain attached to the patient while delivery device 100 is attached to the patient (e.g., when attachment assembly 400 includes an adhesive pad with an area that is greater than the skin facing portion of housing 101). Alternatively, the dimensions of delivery device 100 stated herein do not include any additional height, width, length, mass, and/or volume of attachment assembly 400. Volume DV of delivery device 100 can comprise a volume of no more than 28,750mm³, such as no more than 25,000mm³, no more than 22,500mm³, and/or no more than 20,000mm³. The skin contacting surface area of delivery device 100 (e.g., the skin facing portion of housing 101) can comprise a surface area of no more than 1,983mm², 1,700mm², 1,500mm², 1,300mm², 1,000mm², 750mm², and/or 650mm². Delivery device 100 comprises a length along its major axis, DL, a width along its minor axis, DW, and a height from the skin contacting surface to the highest point on the top of housing 101, DH. In some embodiments, length DL is no more than 51.5mm, 45mm, and/or 35mm. In some embodiments, width DW is no more than 38.5mm, 32.5mm, and/or 27.5mm. In some embodiments, DH is no more than 14.5mm, 12mm, 10mm, 8mm, and/or 7mm. The dimensions DL, DW, and DH of delivery device 100 are shown and further described herebelow in reference to Fig. 2. In some embodiments, delivery device 100 comprises a mass, DM, of no more than 26g, 23g, and/or 20g (e.g., when reservoir 110 is empty). In some embodiments, delivery device 100 comprises a circular geometry, such as a circular geometry with a diameter of no more than 51.5mm, 45mm, and/or 35mm.

[143] Delivery device 100 can comprise one or more cross-sectional geometries, for example a cross-sectional geometry along the length DL (e.g., a “side-view” of the device), and a cross-sectional geometry along the width DW (e.g., an “end-view” of the device). In some embodiments, the top surface of delivery device 100 can comprise a length and/or a width that is different (e.g., less or more) than the corresponding length and/or width, respectively, of the bottom (skin facing) surface of delivery device 100, for example such that delivery device 100 comprises at least one cross-sectional geometry that is relatively trapezoidal and/or sloped (e.g., a trapezoidal and/or sloped geometry that reduces the likelihood of housing 101 or another portion of delivery device 100 “catching” on another object during patient ambulation or other patient movement). Various cross-sectional geometries of a single delivery device 100 can be similar or different, for example when the end-view geometry of delivery device 100 comprises a relatively rectangular geometry, and the side-view geometry of delivery device 100 comprises a relatively trapezoidal geometry. In some embodiments, housing 101 of delivery device 100 can comprise one or more flexible portions that are configured to expand and/or contract, such as one or more “bulging” portions (e.g., sides that are configured to bulge beyond the edges of the top and/or bottom portions of housing 101 when fully expanded). One or more bulging portions of housing 101 can be configured to contract as delivery device 100 is used, for example as the volume of one or more internal components of delivery device 100 is reduced in magnitude, as described herein. In some embodiments, one or more sides of housing 101 comprise a convex shape, for example where at least a portion of a side of housing 101 extends beyond the perimeter of the adjacent top and bottom surfaces of housing 101 (e.g., a convex geometry that reduces the likelihood of housing 101 or another portion of delivery device 100 “catching” on another object during patient ambulation or other patient movement). In some embodiments, one or more portions (e.g., sides) of housing 101 comprises flexible portions that are configured to transition between concave, flat, and/or convex geometries (e.g., where the sides of housing 101 are configured to expand to a convex geometry and/or collapse to a concave geometry). In some embodiments, a housing 101 comprises a sloped cross section that extends outward as the housing extends from its skin-contacting surface to the surface opposite the skin contacting surface (e.g., to minimize the surface area contacting the patient’s skin). Alternatively, housing 101 can comprise a sloped cross section that traverses inward as the housing extends from its skin-contacting surface to the surface opposite the skin contacting surface (e.g., to minimize the likelihood of housing 101 or another portion of delivery device 100 “catching” on another object during patient ambulation or other patient movement).

[144] Reservoir 110 comprises an internal volume RIV, and a total volume RTV. The volume RIV is the maximum volume of material (e.g., agent 20) that reservoir 110 can hold. The total volume RTV is defined by the outer surface of reservoir 110 (e.g., including the internal volume RIV of the reservoir as well as the volume of the walls or other portions of the reservoir). In some embodiments, total volume RTV of reservoir 110 is configured to reduce in magnitude over time (e.g., as agent 20 is delivered from reservoir 110 to the patient). For example, reservoir 110 can be configured to expand and/or collapse, such as when reservoir 110 is configured to expand when filled, and to collapse as the reservoir empties. In these embodiments, housing 101 can be configured to correspondingly expand and/or contract (e.g., at least contract) as reservoir 110 expands and/or contracts. In some embodiments, reservoir 110 comprises an elastic material, such as balloon material or other stretchable material.

[145] Power supply 160 comprises a volume PV. In some embodiments, volume PV is configured to reduce in magnitude over time, for example as the available power of power supply 160 is depleted during use of delivery device 100. In some embodiments, power supply 160 comprises multiple portions, such as multiple layers, where at least one of the portions (e.g., layers) is removable from delivery device 100, for example as the one or more portions are depleted of available power.

[146] In some embodiments, the volume DV of delivery device 100 is configured to reduce in magnitude over time (e.g., as agent 20 is delivered from reservoir 110 to the patient), for example as total volume RTV of reservoir 110 and/or volume PV of power supply 160 reduces in magnitude. In some embodiments, height DH of delivery device 100 can be configured to reduce in magnitude over time. For example, as the height of reservoir 110 and/or power supply 160 reduces in magnitude over time, height DH of delivery device

100 can similarly reduce in magnitude. In some embodiments, at least a portion of housing

101 comprises an elastic, flexible, or otherwise deformable portion that is configured to adjust (e.g., expand and/or contract) based on changes in the magnitude of volumes RTV and/or PV. For example, at least a portion of the sides of housing 101 can comprise an elastic portion that allows the height DH to increase from a resting position (e.g., an elastically biased geometry) to fit a fully expanded reservoir 110 and/or power supply 160, and to collapse as volumes RTV and/or PV decrease over time, thus decreasing height DH of delivery device 100.

[147] Fill port 150 can be configured to allow a user of system 10 to inject and/or otherwise deliver a material (e.g., agent 20) into reservoir 110. In some embodiments, fill port 150 includes one, two, or more access septa, septum 151 shown. Septum 151 can be constructed and arranged to be piercingly accessed by a needle or other fluid delivery element, such as a needle of accessory device 300 comprising a refill assembly. Septum 151 can be configured to be repeatedly accessed by a fluid delivery element. Alternatively, or additionally, fill port 150 can comprise an assembly of parts (e.g., including or not including septum 151) that can be non-piercingly accessed, such as via a fluid connector or other fluid delivery element.

[148] In some embodiments, fill port 150 is positioned on a bottom surface of delivery device 100 (e.g., a surface positioned against the skin of the patient during use), such as to prevent filling and/or refilling (either or both, “filling” herein) of delivery device 100 after delivery device has been positioned on the skin of the patient.

[149] Internal volume RIV of reservoir 110 can comprise a volume (e.g., a maximum volume of agent 20 to be delivered into reservoir 110) of less than 3mL, 2mL, and/or ImL. and/or a volume of at least 1ml, or at least 2ml. Reservoir 110 can comprise one or more cross-sectional areas, each with a maximum area of no more than 2000mm², 1500mm², 1000mm². Reservoir 110 can comprise a major axis with a major axis (e.g., a length) of no more than 51.5mm, 45mm, and/or 35mm. In some embodiments, reservoir 110 comprises a refillable reservoir, such as a reservoir that is configured to be initially filled by a user (e.g., the patient or other user receives delivery device 100 from the supplier with reservoir 110 empty), and/or a reservoir that is configured to be refilled by the user after an initial volume of agent 20 is depleted (e.g., delivered to the patient). As described herein, delivery device 100 can include multiple reservoirs 110, for example at least a first reservoir 110 and a second reservoir 110. In some embodiments, two or more reservoirs 110 are interchangeable, for example such that after a first reservoir 110 is depleted, a second reservoir 110 can replace the first. In some embodiments, subsequent reservoirs 110 can be interchanged, for example a third reservoir 110 that replaces the second after it is depleted. In some embodiments, a first reservoir 110 is configured to store a first agent 20, and a second reservoir 110 is configured to store a second agent 20. The first agent 20 can be similar or dissimilar to the second agent 20. For example, the first reservoir 110 can be configured to store a first agent 20 comprising insulin, and the second reservoir 110 can be configured to store a second agent 20 comprising glucagon. In some embodiments, agent 20 comprises insulin and/or a non-insulin agent, as described herein, for example when agent 20 comprises a single agent including both insulin and a non-insulin agent, or when agent 20 comprises a first agent comprising insulin, and a second agent comprising a non-insulin agent (e.g., a first and second agent that are stored in separate reservoirs 110 and delivered to the patient independently or in combination).

[150] In some embodiments, when reservoir 110 comprises a refillable reservoir, delivery device 100 can be configured such that reservoir 110 can be refilled while delivery device 100 is positioned on the skin of the patient (e.g., delivery device 100 does not have to be removed from the patient for reservoir 110 to be refilled). Alternatively, delivery device 100 can be configured such that reservoir 110 cannot be refilled while positioned on the skin of the patient. For example, a portion of fill port 150 can be located on the patient facing surface of housing 101, such that the fill port is not accessible when delivery device 100 is positioned on the skin of the patient. In some embodiments, when reservoir 110 comprises a removable and/or interchangeable reservoir, delivery device 100 can be configured such that reservoir 110 can be refilled while positioned within delivery device 100 (e.g., reservoir 110 does not have to be removed from the device to be refilled). Alternatively, delivery device 100 can be configured such that reservoir 110 cannot be refilled while positioned within delivery device 100. For example, reservoir 110 can comprise a fill port 150 where septum 151 is not accessible while reservoir 110 is positioned within delivery device 100. In some embodiments, reservoir 110 can be configured to be refilled while removed from delivery device 100 (e.g., while removed from within housing 101) and/or while positioned within delivery device 100 (e.g., while positioned within housing 101).

[151] In some embodiments, delivery device 100 is configured to deliver a target volume TV of agent 20 to the patient in a particular time period (e.g. a time period of expected use of delivery device 100, a time period such as one, two, or three days, or other time period). Target volume TV can comprise an intended volume, a maximum volume, and/or other known or otherwise pre-determined volume of agent 20 to be delivered to the patient in a particular time period. For example, delivery device 100 can comprise a disposable device that is configured to deliver volume TV to the patient before disposal of delivery device 100 (e.g., before a first delivery device 100 is replaced with a second delivery device 100). In some embodiments, the internal volume RIV of reservoir 110 is less than target volume TV. In these embodiments, reservoir 110 can comprise a refillable and/or interchangeable reservoir, such that additional volume of agent 20 needed to achieve target volume TV can be provided to delivery device 100. In some embodiments, delivery device 100 is configured to be used for a usage time period UTP, for example when delivery device 100 is configured to be removed and/or replaced after the period UTP has been reached for that delivery device 100. In some embodiments, usage time period UTP comprises a period of at least three days. For example, usage time period UTP can comprise a period of between three days and 28 days (e.g., no more than 28 days without the replacement of delivery device 100). Internal volume RIV of reservoir 110 can be sufficient to store a volume of agent 20 that is to be delivered over a delivery time period DTP. In some embodiments, delivery time period DTP is less than usage time period UTP. In these embodiments, reservoir 110 can comprise a refillable and/or interchangeable reservoir, such that additional volume of agent 20 can be provided to delivery device 100 to deliver agent 20 over usage time period UTP.

[152] In some embodiments, reservoir 110 comprises at least one flexible portion, at least one rigid portion, and/or at least one flexible portion and at least one rigid portion. Reservoir 110 can comprise a reservoir construction selected from the group consisting of: a bellows construction; a thin sheet construction; a rolling diaphragm construction; a molded pouch construction; and combinations of these. For example, reservoir 110 can comprise an expandable reservoir comprising an articulating “folded” portion, such as a reservoir with a “bellows-like” construction. Reservoir 110 can comprise a “thin sheet” construction, for example an expandable construction of two flexible and/or elastic sheets of material that are sealed along the edges to form an expandable chamber. Reservoir 110 can comprise a rolling diaphragm construction that is configured to roll-up and/or unfurl to decrease and/or increase, respectively, the available volume within the reservoir. In some embodiments, reservoir 110 comprises one or more flexible and/or hinged portions, such that a dimension of reservoir 110 (e.g., the height) changes as reservoir 110 empties. In these embodiments, a dimension of fluid delivery device 100 (e.g., a dimension of housing 101) can decrease as the reservoir 110 empties. For example, the height of delivery device 100 (e.g., the height of housing 101) can decrease as reservoir 110 empties.

[153] In some embodiments, reservoir 110 comprises a syringe-like construction for example when reservoir 110 comprises a syringe-barrel -type construction. In some embodiments, all or a portion of housing 101 forms the barrel of a syringe-like construction (e.g., a portion of housing 101 comprises housing 111 of reservoir 110). Reservoir 110 can include one or more fluid propulsion elements, plunger 113 shown. In some embodiments, reservoir 110 is configured to store agent 20 at a reservoir pressure, reservoir pressure RP, that is above the pressure of the environment of delivery device 100. Reservoir pressure RP can comprise a pressure of at least O. lpsi, 0.3psi, and/or 0.5psi (e.g. at least O.lpsi, 0.3psi, and/or 0.5psi above atmospheric pressure). In some embodiments, plunger 113 comprises a spring-loaded plunger. For example, a spring-loaded plunger 113 can be configured to provide a force (e.g., a constant and/or a variable force) to maintain reservoir pressure RP at or above a pressure threshold. Alternatively, or additionally, reservoir 110 can comprise an elastically expandable reservoir (e.g., reservoir 110 can comprise elastically biased walls) that is configured to exert a pressure on agent 20 when the reservoir is expanded. In some embodiments, an elastically expandable wall of reservoir 110 can comprise a near-linear stress-strain curve.

[154] In some embodiments, reservoir 110 is pressurized above atmospheric pressure via a constant pressure source, such as a chamber that is configured to provide a constant pressure to reservoir 110, for example a chamber that is hydraulically connected to (e.g., hydraulically interfaces with) reservoir 110, such as a chamber that comprises a compliant reservoir 110 that is positioned within and/or is otherwise in contact with reservoir 110. A constant pressure chamber can comprise a phase-change material, such as freon, that is configured to maintain a constant pressure due to a change of phase as the volume of the chamber increases (e.g., as agent 20 exits reservoir 110). In some embodiments, delivery device 100 is configured such that reservoir pressure RP comprises a pressure that is at a level below atmospheric pressure, such as to reduce the likelihood of unintended and/or undesired delivery of agent 20 outside of reservoir 110.

[155] In some embodiments, reservoir 110 comprises a hydraulic press construction. In some embodiments, reservoir 110 comprises a furlable tube and a force applying component, such as a torsion spring that is configured to exert a force on the furlable tube (e.g., to propel agent 20 from reservoir 110). In some embodiments, reservoir 110 includes an expanding element that is configured to provide reservoir pressure RP, such as an expanding foam used to propel fluid, pressurize fluid, or both. As described herein, reservoir 110 can comprise a multi-chamber construction. In some embodiments, reservoir 110 comprises a reservoir including a first chamber and a second chamber, where the first chamber is configured to store agent 20, and as the first chamber empties (e.g., as agent 20 is delivered to the patient), the second chamber is filled, such as to maintain constant pressure within reservoir 110. In some embodiments the two chambers are connected such that pressure between the two chambers is constant, but the materials within the two chambers are prevented from mixing. In some embodiments, delivery device 100 comprises a fluid withdrawal element and a flow sensor (e.g., functional element 199 comprises a fluid withdrawal element and a flow sensor), and the second chamber is filled with fluid that is captured by the fluid withdrawal element based on the flow of agent 20 as monitored by the flow sensor (e.g., such that the overall volume of fluid within reservoir 110 remains constant).

[156] In some embodiments, such as when reservoir 110 comprises a refillable reservoir that is configured to be refilled while positioned within delivery device 100, the delivery of agent 20 to reservoir 110 can be configured to provide energy to be stored by delivery device 100, for example electrical and/or other potential energy. In some embodiments, the stored energy can be used to charge power supply 160. Alternatively, or additionally, the stored energy can be used to pressurize reservoir 110 and/or otherwise reduce electrical power required to deliver agent 20 from reservoir 110. In some embodiments, the stored energy comprises phase-change energy (e.g., as described herein), for example when the refilling of reservoir 110 causes a phase-change material to compress (e.g., change phase to decrease the overall volume of the material), such that the material can provide pressure (e.g., a constant pressure) as it expands. In some embodiments the stored energy comprises energy in a form selected from the group consisting of: phase-change energy; mechanical energy; spring energy; hydraulic energy; pneumatic energy; electrical energy; chemical energy; and combinations of these.

[157] In some embodiments, delivery device 100 can comprise multiple delivery devices, such as at least a first delivery device 100 and a second delivery device 100, as described herein. Reservoir 110 can comprise one, two, or more reservoirs that are interchangeable between the multiple delivery devices. For example, reservoir 110 can be configured to be removed from the first delivery device 100 and transferred to the second delivery device 100 (e.g., to reduce waste of agent 20).

[158] Reservoir 110 can be configured to store agent 20 (e.g., agent 20 comprising insulin) for a storage time period STP of at least three days, such as at least 14 days, or at least 30 days. In some embodiments, storage time period STP comprises the “shelf life” of reservoir 110 and/or delivery device 100, for example the time period from the filling of reservoir 110 until it is no longer safe to deliver the stored agent 20 to the patient (e.g., due to degradation of agent 20 or otherwise). In some embodiments, reservoir 110 and/or other portion of delivery device 100 includes a functional element 199 that is configured to store information related to the time period STP and/or the condition of agent 20. For example, functional element 199 can comprise a memory storage device (e.g., an RF ID device) that is configured to store information and an identifier (e.g., identifying information) for the associated agent 20 (e.g., the associated reservoir 110 containing agent 20), and/or store information related to the date of filling of the reservoir 110 and the STP information. In some embodiments, processing unit 105 of delivery device 100 is configured to read identifying information from functional element 199 (e.g. of reservoir 110), and to prevent delivery of agent 20 from reservoir 110 if an undesirable condition of reservoir 110 and/or agent 20 is detected (e.g., time period STP has passed since the reservoir 110 was filled with agent 20).

[159] Pumping assembly 130 comprises a volume PAV comprising the total volume of the various components of pumping assembly 130. The volume PAV of pumping assembly 130 can comprise a volume of less than 60mm³, 40mm³, and/or 20mm³. Pumping assembly 130 can comprise one or more cross-sectional areas, each with a maximum area of no more than 100mm², 65mm², and/or 30mm². Pumping assembly 130 can comprise a major axis with a length of no more than 10mm, 8mm, 6mm, 5mm, and/or 4mm. In some embodiments, pumping assembly 130 includes a MEMS pumping mechanism, such as a MEMS device that is configured to propel agent 20 (e.g., to propel agent 20 from reservoir 110 through delivery conduit 145 to the patient). Pumping assembly 130 can comprise a silicon-layered MEMS device, a metal-alloy MEMS device, and/or a flexible polymer MEMS device. Pumping assembly 130 can comprise a MEMS device that includes a piezo actuator assembly, a micro electric motor, or shaped memory actuator.

[160] Pumping assembly 130 can include a syringe driving mechanism (“syringe driver” herein). For example, reservoir 110 can comprise a syringe-barrel-like construction (as described herein), and pumping assembly 130 can be configured to drive a plunger, such as plunger 113, through reservoir 110 to propel agent 20 through delivery conduit 145 to the patient. Pumping assembly 130 comprising a syringe driver can include a motive element and a lead screw that are configured to translate the plunger within reservoir 110. The motive element can comprise an element selected from the group consisting of a motor; at least one shaped memory component; at least one solenoid; a MEMS actuator, such as a MEMS rotary actuator; a spring; a source of pressure such as compressed air and/or a phase-change material; an inch-worm drive, such as when plunger 113 comprises an inch-worm drive; a magnetic drive, such as a rotary magnetic drive; and combination of these. In some embodiments, pumping assembly 130 comprises a peristaltic assembly. Pumping assembly 130 and/or fluid pathway 140 can include one or more valves, such as one, two, or more check flow valves that prevent retrograde flow of agent 20 (e.g., flow away from the patient toward reservoir 110). In some embodiments, pumping assembly 130 comprises a MEMS pumping assembly including an inlet and an outlet, and a first check valve (e.g., a functional element 199a comprising a check valve) is fluidly positioned (e.g., in the flow pathway) between reservoir 110 and the inlet, and a second check valve (e.g., a functional element 199b comprising a check valve) is fluidly positioned (e.g., in the flow pathway) between the outlet and a distal end of delivery conduit 145.

[161] A lead screw of pumping assembly 130 can be configured to disengage from a plunger (e.g., plunger 113), a motive element, and/or both the plunger and the motive element (e.g., to allow simplified filling and/or refilling of reservoir 110). In some embodiments, the leadscrew can include a magnetic disengagement assembly. For example, plunger 113 can comprise a magnetic disengagement assembly that is configured to disengage plunger 113 from the leadscrew. In some embodiments, fill assembly 310 comprises a component that disengages the leadscrew from the plunger 113 and/or the motive element, such as a magnetic assembly that activates the magnetic disengagement assembly of the lead screw. A motive element of pumping assembly 130 comprises a rotary drive, such as a magnetic rotary drive, that is configured to provide a reciprocating motion. Pumping assembly 130 can include a gear that is attached to a leadscrew, a hook, and a ratchet and pawl assembly that is configured to rotate the gear via the reciprocating motion. In some embodiments, a magnetic drive of pumping assembly 130 can comprise one or more permanent magnets and a set of one or more electromagnets. Activation of each of the electromagnets can be configured to provide reciprocating motion, rotatory motion, or both.

[162] In some embodiments, delivery device 100 is configured to deliver agent 20 (e.g., as propelled by pumping assembly 130) to the patient with a continuous flow rate over a period of time, and/or in a series of discrete boluses that are each delivered within a bolus delivery period BDP. The bolus delivery period BDP can comprise a minimum time period of at least 3 seconds, such as at least 6 seconds, 15 seconds, and/or 30 seconds, such as a minimum time period configured to reduce the power from a higher level that would be required to deliver the bolus over a shorter time period. For example, the force provided by pumping assembly 130 to deliver a bolus can be generated over a time period that is shorter than the associated bolus delivery period BDP.

[163] Housing 101 of delivery device 100 can comprise two or more hinged portions (e.g., delivery device 100 comprises two or more portions that are rotatably attached to each other via one or more hinges), for example two or more portions that rotate relative to each other to allow housing 101 to adjust to breathing, stretching, bending, and/or other body motion of the patient (e.g., to improve patient comfort by reducing forces applied to the patient by housing 101 during the body motion) and/or to allow housing 101 to transition between an expanded geometry and a collapsed geometry (e.g., such that volume DV of delivery device 100 can be increased and/or decreased). In some embodiments, housing 101 comprises two or more hinged portions that rotate as a component of delivery device 100 (e.g., reservoir 110) decreases in volume (e.g., reservoir 110 empties). Housing 101 comprises a volume HV. Volume HV can equal volume DV of delivery device 100. As described herein, housing 101 can include two or more portions, for example when delivery device 100 comprises two or more portions that are configured to be connected during agent 20 delivery and/or other operation of delivery device 100. Volume HV can include the volume of all portions of housing 101 that are connected when device 100 is in an operating configuration (e.g., excluding any exchangeable portions that are not connected in the operating configuration). In some embodiments the volume of a component of system 10 (e.g., total volume RTV of reservoir 110, volume DV of delivery device 100, and/or volume HV of housing 101) can comprise the volume of its convex hull, for example such that the volume of a component includes the volume of any concave recesses of the component. Alternatively, for example when a component is configured to collapse, the volume of the component can be defined by the actual volume of the component, excluding any concave portions. In some embodiments, volume HV of housing 101 can be configured to reduce in magnitude over time, for example as volume RTV and/or PV decrease over time, as described herein.

[164] In some embodiments, delivery device 100 comprises two or more geometric arrangements, such as two or more geometric arrangements comprising different dimensions, such as different volumes, different lengths, and/or different heights. Various geometric arrangements and/or other various configurations of delivery device 100 can be selected by the user for different uses and/or different situations, for example based on the priorities of the patient at the time. For example, a first configuration can comprise a reservoir 110 and/or power supply 160 with first volumes RTV and PV, respectively, and housing 101 with a first set of dimensions including a first volume HV, and a second configuration can comprise second volumes RTV, PV, and HV. The first configuration can include first volumes RTV, PV, and/or HV that are greater than respective second volumes RTV, PV, and/or HV of the second configuration (e.g., the first configuration is bigger than the second configuration). Delivery device 100 can further include a third configuration comprising third volumes RTV, PV, and/or HV, where the third volumes are less than respective second volumes RTV, PV, and/or HV of the second configuration (e.g., the third configuration is smaller than the second configuration). These first, second, and/or third configurations can comprise “extended use”, “standard”, and “slim” geometric arrangements, respectively, that can be selected by the user. For example, the extended use configuration of delivery device 100 can be selected for traveling or other situations where the patient does not wish to replace delivery device 100 as frequently as would be required with the standard configuration (e.g., UTP and/or DTP are longer for the extended use configuration than the standard configuration). Additionally, or alternatively, the slim configuration of delivery device 100 can be selected for situations where it may be desirable to have the least conspicuous configuration of delivery device 100, for example social situations such as parties and/or dating events (e.g., evenings out). The slim configuration would require replacement after a shorter period than the standard configuration (e.g., UTP and/or DTP are shorter for the slim configuration than the standard configuration). In some embodiments, various configurations of delivery device 100 are interchangeable, for example, a patient can use an extended use configuration for a five-day business trip, return home and replace the extended use delivery device 100 with a standard configuration device. The patient can replace the standard delivery device 100 (e.g., after the UTP of the standard device) with a slim configuration for a date night and replace the slim configuration delivery device 100 with a standard configuration device the following day. In some embodiments, housing 101 comprises at least one interchangeable portion that is configured to be selected to configure delivery device 100 in various configurations (e.g., for use with various configurations of reservoir 110 and/or power supply 160). System 10 can comprise a kit comprising various portions and/or configurations of components of delivery device 100 such that the user can assemble delivery device 100 in the desired configuration. In some embodiments, one or more portions and/or components of delivery device 100 are common to two or more (e.g., each) configurations of delivery device 100 (e.g., a portion of housing 101, pumping assembly 130, and/or fluid pathway 140).

[165] In some embodiments, housing 101 includes one or more “soft” portions. Soft portions of housing 101 can include portions of the housing that are atraumatic, smooth to the touch, rounded (e.g., not sharp, or pointy), compressible, flexible, padded, non-hard (e.g., comprise an elastic or other low-hardness material), and/or are otherwise configured to minimize patient discomfort and/or maximize patient comfort. For example, housing 101 can comprise at least one soft corner, such as a comer including a radius that avoids a sharp point. Housing 101 can comprise two, three, or more soft comers, for example when each convex portion of housing 101 (e.g., convex corner and/or edge of housing 101) comprises a soft portion. [166] In some embodiments, at least a portion (e.g., an outward facing and/or other visible portion) of housing 101 comprises a skin-tone color. In some embodiments, housing 101 is provided in a range of skin tone colors, for example such that a user can select a housing color to match the actual skin tone of the particular patient. In some embodiments, a portion of housing 101 (e.g., a cover portion) comprises a reusable portion, for example a portion that can be removed from a first delivery device 100 prior to disposal of the first device and attached to a replacement delivery device. In some embodiments, the reusable portion comprises a color tone that is matched to the skin-tone of the patient. Alternatively, or additionally, a portion of housing 101 (e.g., a reusable portion and/or a portion comprising a covering that can be applied and/or removed) can comprise a decorative design and/or can be decorated by a user. For example, the manufacturer of system 10 can provide portions of housing 101 featuring licensed designs (e.g., one or more logos that are embossed, printed, attached, and/or otherwise included on and/or in housing 101), for example designs licensed from Marvel Entertainment such as designs related to Iron Man, and/or designs related to the Bass Angler’s Sportsman Society and/or Major League Fishing. In some embodiments, portions of housing 101 can be provided in various colors, for example such that the user can select a color to match and/or best blend into clothing (e.g., to not be seen through clothing).

[167] Delivery conduit 145 of fluid pathway 140 can include one or more fluid delivery elements, fluid delivery element 1455 shown. The distal portion of delivery conduit 145 can comprise fluid delivery element 1455. Fluid delivery element 1455 can comprise a transcutaneous fluid delivery element, for example: a needle such as a hollow microneedle; a catheter; and/or a cannula such as a hard (e.g., rigid) and/or a soft cannula, that is configured to penetrate the skin surface of the patient such that agent 20 can be delivered to one or more locations within the patient (e.g. to the subcutaneous tissue, a blood vessel, and/or other internal location). Fluid delivery element 1455 can include at least a distal portion that is configured to remain under a skin surface of the patient for a minimum time period, such as at least three days. In some embodiments, fluid delivery element 1455 comprises at least two fluid delivery elements, such as at least a first fluid delivery element 1455a and a second fluid delivery element 1455b. The first fluid delivery element 1455a can be configured to deliver agent 20 to the patient for a first time period, and the second fluid delivery element 1455b can be configured to deliver agent 20 to the patient for a subsequent, second time period. In some embodiments, transcutaneous fluid delivery element 1455 comprises at least two transcutaneous fluid delivery elements, and delivery device 100 comprises each of the at least two fluid delivery elements simultaneously. In these embodiments, a first transcutaneous fluid delivery element 1455a can be configured to be inserted through the skin of the patient at a first location, and a second transcutaneous fluid delivery element 1455b can be configured to be inserted through the skin of the patient at a second location that is at least 2mm, 4mm, and/or 6mm away from the first location. In some embodiments, delivery conduit 145 includes an infusion set that includes fluid delivery element 1455 (e.g., comprising a transcutaneous fluid delivery element), where fluid delivery element 1455 is located at the distal portion of the infusion set. In some embodiments, all or a distal portion of delivery conduit 145 comprises the infusion set, and the infusion set is removably attachable to a more proximal portion of fluid pathway 140 (e.g., a more proximal portion of delivery conduit 145).

[168] In some embodiments, delivery device 100 comprises a single component (e.g., functional element 199 and/or other component of device 100) that is configured to perform at least two, three, or more functions. In some embodiments, delivery device 100 comprises a single component that is configured to provide both an audio alert and a vibrational alert. In some embodiments, delivery device 100 comprises a single component that is configured to both propel fluid as well as provide a vibrational alert. For example, the single component can comprise a motor that is configured to rotate a leadscrew and to vibrate (e.g., a motor that can rotate the leadscrew without vibrating, and can vibrate without rotating the leadscrew).

In some embodiments, delivery device 100 comprises a single component that is configured to both propel fluid (e.g., propel agent 20 within fluid pathway 140) as well as measure the flow of fluid (e.g. measure the flow of agent 20 within device 100). In some embodiments, delivery device 100 comprises a single component that is configured to both propel fluid (e.g. propel agent 20 within fluid pathway 140) as well as agitate fluid (e.g., agitate agent 20 within reservoir 110, pumping assembly 130, and/or fluid pathway 140). In some embodiments, delivery device 100 comprises a single component configured to both detect an occlusion and confirm the proper amount of agent 20 is being delivered (e.g., the proper amount of agent 20 is being propelled by pumping assembly 130).

[169] In some embodiments, delivery device 100 is configured to deliver agent 20 to the patient without any portion of the device penetrating the patient’s skin, for example when fluid delivery element 1455 is configured to deliver agent 20 under the patient’s skin without fluid delivery element 1455 penetrating the patient’s skin. For example, fluid delivery element 1455 can be configured to deliver agent 20 to the patient transdermally, such as by using high energy bursts that are configured to propel agent 20 through the skin of the patient.

[170] In some embodiments, fluid pathway 140 includes one or more flow restrictors, flow limiters, and/or other flow modifying component. For example, fluid pathway 140 can include a flow modifying component selected from the group consisting of a duckbill valve; a flow-limiting orifice; a capillary tube and/or other small diameter tube; a mechanical restrictor; a solenoid valve; a distensible tube; a flow restricting channel, such as a channel constructed by welding two sheets of plastic together; and combinations of these. In some embodiments, the flow modifying element can include a pressure attenuator, such as a pressure attenuator selected from the group consisting of a diaphragm; a spring; a mechanical pressure attenuator; an electromechanical pressure attenuator; a bladder; a reservoir filled with a fluid; a positive-pressure-actuated attenuator; a negative-pressure- actuated attenuator; and combinations of these. The flow modifying element can include a capillary tube with a known fluid resistance (e.g., a known resistance to the flow of agent 20). In some embodiments, the flow modifying element can comprise two or more sheets (e.g., flexible plastic sheets and/or sheets that include at least a flexible portion) that are joined (e.g., welded) together to form a flow-restricted fluid delivery channel. In some embodiments, the flow modifying element includes a valve comprising a diaphragm with a pre-determined pressure on a first side of the diaphragm, and a fluid delivery channel that is occluded by the second side of the diaphragm, where the pressure of the fluid must exceed the pre-determined pressure to pass through the fluid delivery channel.

[171] As described herein, a delivery device 100 can be configured to be used for a maximum usage time period UTP, for example when delivery device 100 comprises a disposable device that is intended to be replaced with a replacement delivery device 100 after the period UTP. As used herein, a “replacement” delivery device 100 can comprise a delivery device that replaces an “in-use” and/or “used” delivery device 100 that is to be removed and/or has been removed from the patient and is no longer used (e.g., discarded, recycled, and/or returned to the provider of system 10). System 10 can be configured to provide chronic treatment to a patient, for example where each in-use delivery device 100 is eventually replaced by a replacement delivery device 100 (e.g., following the UTP of the in- use device), and each replacement delivery device 100 is then subsequently replaced, such as for the duration of the chronic treatment (e.g., each replacement delivery device 100 can be referred to as an in-use and/or used device during and/or after the UTP of that device). Also as used herein, a first delivery device 100 can comprise an in-use device, and a second delivery device 100 can comprise a replacement device configured to replace the first device. Subsequently, a third device can replace the second, and a fourth device can replace the third, and so on. A first device can refer to any device that is in-use in the context of the various situations described herein.

[172] In some embodiments, usage time period UTP comprises a period of greater than three days (i.e., at least four days), such as a period that is greater than six days. In some embodiments, usage time period UTP comprises a maximum duration of use for delivery device 100. For example, an in-use delivery device 100 may be removed and/or replaced before the maximum duration of use has been reached, but after the maximum duration of use has been reached, the in-use delivery device 100 should (e.g., must) be removed and/or replaced. In some embodiments, after the maximum duration of use, an in-use delivery device 100 is configured to automatically disable one or more functions, such as to disable any agent delivery functionality of delivery device 100 (e.g., to prevent unwanted continued use of delivery device 100). Additionally, or alternatively, after the maximum duration of use, the in-use delivery device 100 can be configured to perform one or more functions, such as to automatically retract and/or otherwise remove any skin-penetrating components from the patient (e.g., to retract delivery element 1455 from the skin of the patient), alert the patient, and/or perform another function.

[173] Delivery device 100 can include one or more locations for a skin-penetrating component of device 100 to exit, location SPL, where each skin-penetrating component of delivery device 100, such as fluid delivery element 1455, exits housing 101 and penetrates the skin of the patient. Delivery device 100 can be positioned on the skin of the patient, such that location SPL aligns with a skin penetration site SPS. In some embodiments, a replacement delivery device 100 is positioned on the skin of the patient such that the SPS of the replacement delivery device 100 is different than the SPS of the used delivery device 100.

[174] In some embodiments, one or more dimensions, locations of components, orientation of components, and/or other parameters of delivery device 100 can be adjustable, user selectable, and/or can vary between devices 100 comprising different configurations. For example, system 10 can comprise various devices 100 comprising different configurations, such as a first configuration and a second configuration, where an in-use delivery device 100 comprising a first configuration can be replaced with a replacement delivery device 100 comprising a second configuration (e.g., and the second replaced with the first, and so on). Alternatively, or additionally, one or more of the characteristics of delivery device 100 can be adjusted (e.g., adjusted by the user and/or automatically adjusted) to vary between a used delivery device 100 and its replacement delivery device 100. For example, a first configuration of delivery device 100 can comprise a first skin penetration location SPL, and a second configuration of delivery device 100 can comprise a second skin penetration location SPL. The second SPL can be offset from the first SPL by at least 1mm, 3mm, 5mm, and/or 10mm. Different configurations of delivery device 100 can allow a replacement delivery device 100 to be placed in the same location on the skin of the patient as the used delivery device 100 it is replacing, while the SPL is varied. In some embodiments, the SPL of delivery device 100 is located in a non-symmetric location, such that rotation of delivery device 100 changes the relative location of the SPL. For example, delivery device 100 can comprise an elongate shape, where the SPL of delivery device 100 is located near an end of the elongate shape. A replacement delivery device 100 can be configured to be placed on the skin of the patient in the same (approximate) location as the used device it is replacing, in a rotated orientation, such as a 180° orientation, such that the SPL of the replacement device is opposite the SPL of the used device.

[175] In some embodiments, delivery device 100 is configured to insert a portion of delivery conduit 145, such as at least a portion of fluid delivery element 1455, to a depth of insertion DOI. Depth DOI can comprise the distance from the surface of the skin at the SPS to the distal most portion of fluid delivery element 1455. In some embodiments, fluid delivery element 1455 comprises an insertable length IL. Fluid delivery element 1455 can be inserted into the skin at an angle IA, for example where when angle IA equals 90°, fluid delivery element 1455 is inserted perpendicular to the surface of the skin (e.g., parallel to a surface normal of the skin at the SPS). In some embodiments, the insertable length IL is equal to the depth DOI, for example when fluid delivery element 1455 is configured to be inserted in a straight trajectory that is perpendicular to the surface of the skin (e.g., where angle IA is 90°). Alternatively, in some embodiments, fluid delivery element 1455 can be configured to be inserted in a straight trajectory that is not perpendicular to the surface of the skin (e.g., configured to be inserted at an angle IA that is less than 90°), and/or fluid delivery element 1455 can be configured to be inserted with a non-straight trajectory, such as a curved trajectory, that is initially perpendicular or non-perpendicular to the surface of the skin. In these embodiments, the length IL can be longer than the depth DOI. In some embodiments, for example when angle IA comprises an angle of less than 90°, and/or when fluid delivery element 1455 is inserted with a non-straight trajectory, fluid delivery element 1455 can be inserted with an insertion orientation IO. Orientation IO can comprise an angle relative to a top side of delivery device 100, for example when IO comprises an angle of 0°, fluid delivery element 1455 can be configured to exit housing 101 such that the insertion trajectory is directed toward the top side of delivery device 100. In some embodiments, the DOI and/or the IL of fluid delivery element 1455 is adjustable, and/or different configurations of delivery device 100 can comprise different depths DOI and/or lengths IL. In some embodiments, insertion angle IA and/or the IO of fluid delivery element 1455 is adjustable, and/or different configurations of delivery device 100 can comprise different angles IA and/or IO.

[176] System 10 can comprise multiple delivery devices 100, such as when delivery device 100 comprises multiple devices that are used for a limited time period, as described herein. In some embodiments, system 10 comprises multiple sets of one or more delivery devices 100, such as when each delivery device 100a of a first set of delivery devices is different than each delivery device 100b of a second set of delivery devices. System 10 can comprise delivery devices 100 that are of different sizes, as shown and described in reference to Fig. 3 herein. For example, a patient may use a smaller device 100 for special occasions (e.g., “date night”), such as a device 100 with a smaller reservoir 110 than reservoir 110 of a larger device 100 that is “normally” used (e.g., used more frequently).

[177] Power supply 160 comprises an energy capacity that is configured to provide energy to power delivery device 100 for a time period PTP. In some embodiments, power time period PTP is less than usage time period UTP of the delivery device 100 (as described herein). In these embodiments, power supply 160 can comprise a replaceable and/or a rechargeable power supply. Power supply 160 can comprise a rechargeable power supply that is configured to be wirelessly recharged. Alternatively, or additionally, delivery device 100 can include one or more connectors that are configured to attach power supply 160 to a recharging device, for example a USB charge port. In some embodiments, power supply 160 is configured to be recharged (e.g. via wireless and/or wired recharging) while the patient is asleep (e.g., as determined by system 10 as described herein). Power supply 160 can include an assembly for converting kinetic energy to charge power supply 160, for example such that power supply 160 can be recharged via patient movement. In some embodiments, power supply 160 is configured to be recharged via solar and/or other light energy. Alternatively, or additionally, power supply 160 can be configured to convert heat energy to charge power supply 160, such as to be charged by heat energy of the patient (e.g., as collected during attachment to the patient’s skin surface). In some embodiments, power supply 160 comprises two or more power supplies, such as at least a first power supply 160 and a second power supply 160. In these embodiments, the first power supply 160 can be configured to store electrical energy, such as a power supply comprising a battery and/or a capacitor, and the second power supply can be configured to store non-electrical energy. In some embodiments, the second power supply 160 is configured to convert stored non-electrical energy to electrical energy or other energy used to recharge the first power supply 160 with electrical energy.

[178] Sensor assembly 200 can include sensor 250, as described herein. In some embodiments, delivery device 100 can include a sensor assembly 200 sensor assembly 120 shown, which includes sensor 125. Each sensor 250 can comprise one or more sensors configured to produce one or more signals that are related to one or more system parameters and/or one or more patient parameters (e.g., to “monitor” and/or “record” a parameter and/or to “record” and/or “collect” data herein). Sensor 250 can comprise a patient physiologic sensor (also referred to as a “physiologic sensor”), such as a sensor selected from the group consisting of a glucose sensor; an oxygen saturation sensor; a skin resistance sensor, such as a galvanic skin resistance sensor; an ECG sensor; a neural spike, local field potential, and/or EEG sensor; a blood pressure sensor; a heart rate sensor; an oxygen sensor; a respiration sensor; a perspiration sensor; a GPS sensor; and combinations of these. Alternatively, or additionally, sensor 250 can comprise a sensor selected from the group consisting of a physiologic sensor; an accelerometer; a strain gauge; a pressure sensor; a flow sensor; an optical sensor; a temperature sensor; a thermometer; an RF and/or other electromagnetic sensor, such as an RF antenna configured to detect RF signals or other electromagnetic signals; an impedance sensor; a pH sensor; a voltage sensor; a current sensor; an altitude sensor; a Bluetooth sensor, such as an ultra-low energy or a low energy Bluetooth (BLE) sensor; and combinations of these. In some embodiments, sensor 250 comprises at least a glucose sensor and one, two, or more additional sensors, such as additional sensors selected from the group consisting of an oxygen sensor such as oxygen saturation sensor; a galvanic skin resistance sensor; an ECG sensor; a neural spike, local field potential, and/or EEG sensor; a blood pressure sensor; a heart rate sensor; a respiration sensor; a perspiration sensor; and combinations of these. Sensor 125 can be configured to monitor one or more parameters and or functions of delivery device 100. For example, sensor 125 can be configured to monitor the operation (e.g., fluid delivery) of pumping assembly 130. Sensor 125 can be configured to monitor the deployment and/or the position (e.g., the position over time) of fluid delivery element 1455. In some embodiments, sensor 125 is configured to monitor one or more parameters of the delivery of agent 20 to the patient, for example when sensor 125 comprises a pressure sensor, a flow sensor, an occlusion sensor, a bubble detecting sensor, a temperature sensor, and/or other sensor that is configured to monitor a parameter of agent 20, fluid pathway 140, and/or other component of delivery device 100 configured to deliver agent 20 to the patient. In some embodiments, sensor 125 comprises a glucose sensor that is integral to delivery device 100. In some embodiments, sensor 250 is configured to produce a signal related to an environmental parameter, for example a parameter of the patient’s current location, such as room pressure, temperature and/or humidity (e.g., pressure, temperature, and/or humidity of the environment in which the patient is currently located). In some embodiments, sensor 250 is configured to produce a signal such that delivery device 100 can deliver agent 20 in a closed-loop arrangement, such as when algorithm 55 uses data provided in the sensor 250 signal to determine flow rate, bolus volume, and/or other delivery parameters of device 100.

[179] In some embodiments, sensor 250 (e.g. sensor 125 or other sensor of system 100) comprises an accelerometer. Processing unit 50 (e.g., algorithm 55) can be configured to monitor signals recorded from sensor 250 (e.g., comprising an accelerometer or other sensor) to detect, monitor, and/or assess: an undesired patient movement such as a fall of a patient, a patient movement associated with a vehicular accident, a significant patient movement associated with participation in a sporting activity; patient movement; a position or position change of the patient (e.g., to determine whether standing, sitting, and/or lying down); a sleep state of the patient (e.g., via monitoring respiration, snoring, or other sleep-related parameter); operation of a vibrational transducer of device 100; operation of pumping assembly 130; flow within fluid delivery pathway 140; and combinations of these. For example, sensor 125 of delivery device 100 can comprise an accelerometer that can monitor the position and/or acceleration (and deceleration) of the patient when delivery device 100 is attached to the skin of the patient. Additionally, or alternatively, sensor assembly 200 can be configured to be worn by and/or otherwise attached to the patient, such that sensor 250 comprising an accelerometer can similarly be configured to monitor the patient. In some embodiments, sensor 250 comprises a sleep detector that is configured to detect when the patient is asleep. In some embodiments, sensor 125 comprises an accelerometer and system 10 (e.g., via algorithm 55) is configured to quantify patient activity, such as to determine an amount of agent 20 (e.g., insulin) to be delivered (e.g., in a closed-loop arrangement as described herein) based on at least the quantified patient activity (e.g., when also combined with food intake or other data). In some embodiments, sensor 125 comprises an accelerometer and system 10 (e.g., via algorithm 55) is configured to detect an undesired movement (e.g., a significant acceleration, such as might occur during a patient fall, a vehicular accident, and/or an impact during a sporting activity), where system 10 is further configured to enter an alarm state if the undesired movement (e.g., an undesired level of acceleration) exceeds a threshold. In some embodiments, sensor 125 comprises an accelerometer and system 10 is configured to detect an undesired movement (e.g., a significant acceleration, such as might occur during a patient fall, a vehicular accident, and/or an impact during a sporting activity), where system 10 is further configured to confirm proper operation of delivery device 100 (e.g., confirm all components are functioning properly, watertight compartments remain watertight, fluid delivery pathway 140 is intact and unobstructed and any cannula remain properly in place in the patient, electrical connections remain secure, and other proper operation is confirmed), and if confirmation is not confirmed, system 10 is further configured to enter an alarm state.

[180] Server 80 can be configured to receive data, data 85 described herein, from one or more patients and/or other users of system 10. Server 80 can receive data 85 from one or more delivery devices 100, for example when communication module 170 of delivery device 100 is configured to transmit data to server 80 via network 75. Data 85 transmitted from delivery device 100 can comprise patient data and/or delivery device 100 data. In some embodiments, patient data includes glucose data, such as data recorded from sensor 250 comprising a glucose sensor (e.g., a CGM). System 10 can be configured to perform a trend analysis of data 85, for example an analysis performed via a processing unit 50 of server 80. In some embodiments, server 80 is configured to receive (e.g., from delivery device 100, sensor assembly 200, accessory device 300, and/or other component of system 10) data selected from the group consisting of: operating settings such as basal rates, bolus volumes, and/or pre-configured extended bolus volumes; bolus calculator settings such as insulin-to- carbohydrate ratio data, insulin sensitivity data, and/or correction factor data; alarm threshold settings such as occlusion sensitivity data and/or reservoir volume warning level data; audio settings for alarms; and combinations of these. Alternatively, or additionally, server 80 can be configured to receive (e.g., from delivery device 100, sensor assembly 200, accessory device 300, and/or other component of system 10) data selected from the group consisting of: sleep data; sleep schedule data; heart rate data; blood pressure data; exercise data; exercise schedule data; meal ingestion data; meal ingestion schedule data; and combinations of these.

[181] As described herein, delivery device 100 can comprise at least a portion of a user interface 60, user interface 106 shown. In some embodiments, user interface 106 comprises a limited functionality and/or limited user input or output. For example, a user input device 61 of user interface 106 can be limited to a single input, such as a single button. A single input of user interface 106 can be configured to initiate a limited set of functions of delivery device 100, for example to allow the user to initiate the delivery of a single bolus of agent 20.

[182] As described herein, one or more devices of system 10 can comprise at least a portion of communication module 70, for example communication module 170 of delivery device 100 shown. Two or more portions of communication module 70 can be configured to transfer data 85 between two or more components of system 10, for example between delivery device 100 and sensor assembly 200, and/or between delivery device 100 and server 80. In some embodiments, sensor assembly 200 comprises a continuous glucose monitor (CGM) that is configured to transfer blood glucose data to delivery device 100 via communication module 70.

[183] Processing unit 50 (e.g., processing unit 105 of delivery device 100) can be configured to, via an algorithm 55 that is being executed by processor 51, monitor, record, and/or analyze data 85 collected by system 10. Algorithm 55 can be configured to determine one or more changes to an agent delivery parameter based on the data. Application 56 can be configured to present potential changes (e.g., “suggested” changes) identified by algorithm 55 to a user, such as via a GUI 65 that can be displayed on display 63 (e.g., of user interface 106). Suggested changes and/or actions can include the delivery of a bolus of agent 20 and/or a modification of a continuous flow rate of agent 20. Algorithm 55 can be configured to suggest a change in an agent delivery parameter based on a patient parameter, such as based on when the patient is asleep (e.g., when delivery device 100 detects that the patient is asleep as described herein). Algorithm 55 can be configured to monitor the delivery of agent 20 (e.g., to determine the amount of agent 20 remaining in reservoir 110), and to suggest a change to a future delivery of agent 20 to minimize waste of agent 20. Algorithm 55 can be configured to monitor the altitude of the patient and to adjust one or more parameters of delivery device 100 to maintain accurate delivery of agent 20. In some embodiments, algorithm 55 is configured (e.g., configured and enabled, such as when enabled to automatically make changes by a clinician or other user of system 10) to automatically perform an identified suggested change and or action, such as to automatically adjust the continuous flow rate of agent 20 when algorithm 55 detects that the patient has fallen asleep, and/or to automatically adjust delivery to minimize waste of agent 20. In some embodiments, algorithm 55 is configured and enabled to automatically deliver a bolus of agent 20, for example a bolus of agent 20 comprising an agent configured to provide lifesaving treatment in an emergency situation, for glucagon to prevent diabetic shock, adrenaline in the event of an allergic reaction, naloxone in the event of a drug exposure and/or overdose, and/or other bolus injections of agent 20.

[184] In some embodiments, system 10 is configured to detect and/or confirm one or more system states and/or one or more patient states based on signals provided by sensor 250. For example, one or more system and/or patient states can be selected from the group consisting of delivery device 100 properly attached to body of patient; a fluid delivery element 1455 of delivery conduit 145 is properly inserted into the patient; delivery device 100 is in a functional state; power supply 160 is at an acceptable state; reservoir 110 environment is at an acceptable level; patient condition is at an acceptable level; patient environment is at an acceptable level; patient activities are acceptable (e.g., activities are at an acceptable level); and combinations of these. In some embodiments, system 10 is configured to alert a non-patient user of system 10 (e.g., the patient’s clinician and/or a family member) to a condition of delivery device 100 and/or the patient, for example if an undesired system state and/or patient state is detected. In some embodiments, system 10 is configured to detect if agent 20 stored in reservoir 110 is nearing the end of its useful life. System 10 can be configured to determine if the patient is maintaining a clinician-prescribed lifestyle plan based on signals provided by sensor 250.

[185] In some embodiments, system 10 is configured to monitor sound in the vicinity of delivery device 100 and/or the patient. Based on signals related to the monitored sound, system 10 can be configured to determine: when delivery of agent 20 is occurring; if reservoir 110 is empty or otherwise below an acceptable level; if delivery device 100 is not delivering agent 20 as intended; if delivery device 100 is pumping air or other gas; when a priming procedure is complete; if delivery device 100 is nearing an end-of-life condition; if power supply 160 is at an unacceptable level; if a component of delivery device 100 is wearing to an unacceptable state; and/or if an adhesive securing one or more components of delivery device 100 has failed or is failing. [186] System 10 can be configured to detect a patient state, such as a patient state selected from the group consisting of talking; crying; awake; asleep; walking; running; sitting, standing; in a prone position; in a fetal position; or combinations of these. In some embodiments, system 10 is configured to monitor the use of a component of the system, for example the use of delivery device 100 by the patient, and/or the delivery of agent 20 to the patient. System 10 can be configured to prevent use of a component of the system if use of the component reaches a usage limit (e.g., a time limit and/or a fluid volume limit). In some embodiments, based on one or more signals from sensor 250, system 10 can be configured to prevent undesired refilling of reservoir 110 and/or to prevent the use of a delivery device 100 after undesired refilling of reservoir 110 has occurred.

[187] In some embodiments, functional element 199 of delivery device 100 comprises a bubble reducing element, such as a bubble trap or bubble filter that is configured to prevent (or at least reduce the likelihood of) gas bubbles from being propelled into the patient through fluid pathway 140. In some embodiments, fluid pathway 140 comprises functional element 199 configured as a bubble capture and/or other bubble-reducing element.

[188] In some embodiments, accessory device 300 comprises a bubble removal assembly. For example, accessory device 300 can include an assembly that fluidly and detachably connects to fluid pathway 140 and is configured to remove bubbles from the pathway. In some embodiments, accessory device 300 includes a fill assembly that fluidly and detachably connects to reservoir 110, such as via fill port 150, to deliver agent 20 into reservoir 110 (e.g., to initially fill reservoir 110). Additionally, or alternatively, accessory device 300 can include a refill assembly that fluidly and detachably connects to reservoir 110, such as via fill port 150, to deliver agent 20 into reservoir 110 (e.g., to refill reservoir 110).

[189] In some embodiments, accessory device 300 comprises a reservoir filling assembly, fill assembly 310 shown. In some embodiments, fill assembly 310 includes one or more flow control components, valve 311 shown. Valve 311 can be configured to control the flow of agent 20 into and/or out of reservoir 110. In some embodiments, valve 311 controls the flow of agent 20 based on the pressure of the agent, for example the pressure of agent 20 within reservoir 110, and/or the pressure of agent 20 within fill assembly 310. In some embodiments, valve 311 includes a one-way valve, such as a one-way spring valve. Valve 311 can comprise a valve selected from the group consisting of a ball valve; a disk check valve; dual disc check valve; tilting disc check valve; piston check valve; swing check valve; piston check valve; ball check valve; silent check valve; nozzle check valve; wafer check valve; and combinations of these. In some embodiments, fill assembly 310 includes a membrane, such as a semi -permeable membrane, that is configured to propel agent 20 into reservoir 110. For example, a membrane can include an elastic membrane surrounding a chamber that is filled with agent 20 (e.g., such that agent 20 is stored under the elastic pressure of the membrane), where when fill assembly 310 is fluidly connected to reservoir 110 (e.g., via fill port 150), the membrane propels agent 20 into reservoir 110. In some embodiments, fill assembly 310 includes a fluid injector and an agent canister that are configured to propel a predetermined volume of agent 20 into reservoir 110.

[190] In some embodiment, accessory device 300 comprises a “docking station”, such as a docking station configured to house one or more delivery devices 100 when not in use. In some embodiments, an accessory device 300 comprising a docking station can operably connect to delivery device 100. For example, accessory device 300 can be configured to electrically connect to delivery device 100, such as to charge power supply 160 (e.g., via a wired and/or a wireless connection). In some embodiments, accessory device 300 is configured to store agent 20 (e.g., when a docking station is configured to house one or more reservoirs 110). In some embodiments, accessory device 300 is configured to refrigerate agent 20 prior to use, for example agent 20 within a reservoir that is positioned within delivery device 100, and/or within a reservoir 110 that is not positioned within delivery device 100.

[191] Various components of delivery device 100 can comprise individual component housings or other structural components (“housings” and/or “housing components” herein). As used herein, housings can include one or more “walls” or “sides”, which can be used interchangeably. In some embodiments, and as described herein, one or more portions of housing 101 are “shared” by an internal component of delivery device 100, such as to reduce the overall volume of delivery device 100, volume DV. For example, at least a portion of housing 101 and at least a portion of housing 111 can comprise the same portion of housing (e.g., the two housings share one or more walls). Additionally, or alternatively, other components of delivery device 100 can comprise a portion of housing 101 (e.g., a housing portion or other portion of the component is a portion of housing 101). For example, housing 101 can comprise at least a portion of: sensor assembly 120; pumping assembly 130; fluid pathway 140; fill port 150; power supply 160; communication model 170; and/or other component of delivery device 100. In some embodiments, one or more portions of housing 101 are configured to provide fixation to one or more device 100 components, for example a motor mount configured to secure a motor of pumping assembly 130 within housing 101. Fill port 150 can include one or more portions of housing 101, such as a housing portion that surrounds septum 151. Power supply 160 can include one or more portions of housing 101 that surround portions of the power supply, for example insulative materials surrounding electrolytic components of a battery (e.g., when power supply 160 comprises a battery). Additionally, or alternatively, components of delivery device 100 can include various functional structural components of housing 101 (e.g., to reduce the overall volume DV). For example, fluid pathway 140 can include one or more lumens that are surrounded by one or more wall portions of housing 101. Processing unit 105, user interface 106, sensor assembly 120, power supply 160, communication module 170, functional element 199, and/or other electronic components of delivery device 100 can include one or more portions of housing 101, such as when circuit boards, antenna assemblies, screens (e.g., display screens), and/or other components comprise a portion of housing 101.

[192] In some embodiments, two or more components of delivery device 100 each comprising one or more housing components, can share a common housing component, for example a wall that is positioned and shared between two or more components. For example, a first component of delivery device 100 can include a housing with one or more walls, and a second component of delivery device 100 can include a housing with one or more walls, where at least one of the walls of the housing of the second component is also a wall of the housing of the first component (e.g., the wall is shared by the housings of the first and second components). Additionally, or alternatively, one or more portions of a component can be considered “built into” the housing of another component. For example, the walls of housing 101 (e.g., housing 111 of reservoir 110 and/or other portion of housing 101) can comprise one or more conduits (e.g., one or more lumens) that are routed within the thickness of the walls, such that the portion of the walls surrounding the conduits comprise structural housing portions of device 100. In some embodiments, where a first and a second component share a wall of a housing, the first component can include reservoir 110 and the second component can include pumping assembly 130 (e.g., reservoir 110 is adjacent to pumping assembly 130 and/or at least a portion of pumping assembly 130 is built into the walls of housing 111 of reservoir 110). In some embodiments, pumping assembly 130 comprises a MEMS device that is at least partially built into the walls of housing 111 or other portion of housing 101.

[193] Housing 101 of delivery device 100 can comprise a wall portion that is shared with a housing of one or more components of device 100. In some embodiments, portions of the walls of housing 101 can comprise portions of the walls of one, two, three, four, or more components of delivery device 100, such as reservoir 110, pumping assembly 130, fluid pathway 140, and/or other components of delivery device 100. For example, reservoir 110 can be located adjacent to a side of delivery device 100 (e.g., in a corner of delivery device 100 adjacent to multiple walls, such as two, three, and/or four walls of housing 101), such that the walls of housingl 11 comprise the portion of the outward facing walls of housing 101 in that region (e.g., the walls of housing 111 form a portion of the walls of housing 101, or reservoir 110 is built into housing 101).

[194] Referring now to Fig. 2, a top and a side view of a fluid delivery device are illustrated, consistent with the present inventive concepts. Delivery device 100 and/or other components of system 10 described in Fig. 2 can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and/or otherwise herein. Delivery device 100 can include length DL, and width DW, as shown. Delivery device 100 can also include height DH, as shown.

[195] Referring now to Fig. 3, top and side views of two different sized fluid delivery devices are illustrated, consistent with the present inventive concepts. As shown in Fig. 3, a first delivery device 100a can comprise a smaller volume, a smaller length (e.g., a smaller major axis), a smaller width, and/or smaller height than a second delivery device 100b, as shown. For example, delivery device 100a can comprise a smaller reservoir 110a than a reservoir 110b of delivery device 100b, such as when delivery device 100a is used only for special occasions (e.g., used for a limited time period as compared to use of device 100b) where reduced size is important to the patient (e.g., for reasons related to cosmesis).

[196] Referring now to Fig. 4, a side sectional view of a cannula assembly is illustrated, consistent with the present inventive concepts. Fluid pathway 140 and/or other components of delivery device 100 described in Fig. 4 can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1 A and/or otherwise herein. In some embodiments, fluid pathway 140 includes an assembly configured to enable the insertion of fluid delivery element 1455 into the tissue of the patient, such as cannula assembly 180 shown. Cannula assembly 180 can include one or more fluid delivery tubes, such as a fluid delivery tube configured as a fluid delivery element 1455, for example cannula 185 shown. Cannula 185 can extend from base 188, where base 188 comprises a structural member that can be configured to operably attach cannula assembly 180 to housing 101 of delivery device 100. Cannula assembly 180 can also include a fluid distribution element, manifold 182 shown, which includes a portion of fluid delivery conduit 145, chamber 1821 shown. Manifold 182 can further include one or more resealing access elements, such as septum 181 shown. Base 188 can comprise a fluid path, lumen 1881, that fluidly connects chamber 1821 to cannula 185. Cannula assembly 180 can include a skinpenetrating element, penetrator 186, that can be slidingly received through septum 181 and can be removably positioned within cannula 185. Penetrator 186 can be configured to be advanced into the skin of the patient (e.g., along with cannula 185) and subsequently removed from cannula 185, leaving cannula 185 inserted into the skin (e.g., for subcutaneous delivery of agent 20 through cannula 185, as described herein). Septum 181 can be positioned on the top and/or side of manifold 182, for example such that penetrator 186 can be inserted from the top and/or side. In some embodiments, fluid pathway 140 comprises two or more portions that are configured to be fluidly attached (e.g., in manufacturing and/or by the patient, such as during the of the process of filling and/or otherwise preparing delivery device 100 for use). For example, a first portion of fluid pathway 140 can be integral to a first portion of a two-piece delivery device 100, and a second portion of fluid pathway 140 can be integral to a second portion of the two-piece delivery device 100 (e.g., cannula assembly 180 can be integral to a base portion of delivery device 100). In these embodiments, the first portion of fluid pathway 140 can comprise a connector configured to fluidly attach to a mating connector of the second portion to complete the fluid path, such as a needle or other penetrator of the first portion of fluid pathway 140 configured to be inserted through septum 181 to form a fluid connection between the first portion and chamber 1821 of the second portion.

[197] Referring additionally to Figs. 4A and 4B, sectional views of a cannula assembly positioned within an insertion tool, and a cannula assembly with the attached cannula inserted into the skin, respectively, are illustrated, consistent with the present inventive concepts. Fluid pathway 140, accessory device 300, and/or other components of system 10 described in Figs. 4 A and 4B can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1 A, Fig. 4, and/or otherwise herein. Fig. 4A shows cannula assembly 180 positioned within insertion tool 320, with insertion tool 320 operably attached to housing 101 (e.g., a portion of housing 101 of a first portion of delivery device 100). Insertion tool 320 can include housing 321. Housing 321 can include one or more positioning, connection, and/or other alignment elements, such as alignment element 3211 shown. Alignment element 3211 can be constructed and arranged to operably engage with one or more portions of housing 101, such as alignment element 1013 shown. Cannula assembly 180 can be positioned within housing 321 such that cannula 185 aligns with an opening in housing 101, such as opening 1015 shown, enabling cannula 185 to be inserted into the skin of the patient through housing 101. Housing 101 can comprise a recess or other physical receptor, such as cannula assembly receptor 1012 shown, where receptor 1012 is constructed and arranged to slidingly receive and/or operably attach to base 188 of cannula assembly 180 (e.g., when cannula assembly 180 is brought into contact with housing 101 by insertion tool 320 as cannula 185 is inserted into tissue). In some embodiments, base 188 comprises an adhesive layer that causes cannula assembly 180 to adhere to housing 101. Alternatively, or additionally, base 188 and housing 101 can be configured to “snap” together and/or to otherwise fixedly attach.

[198] Insertion tool 320 can comprise an actuator, actuator 322 shown, that is constructed and arranged to drive cannula assembly 180 toward housing 101 and/or the skin of the patient. Actuator 322 can include a flange, flange 3221 shown, that applies a force to base 188. Actuator 322 can include a connector, connector 3222 shown, that fixedly attaches to penetrator 186, such as to apply a force to drive penetrator 186 into tissue and/or to retract penetrator 186 from cannula 185 after cannula 185 has been inserted. In some embodiments, insertion tool 320 includes one or more biasing elements, such as biasing element 323 shown, that are configured to assist with the deployment of cannula 185 into the tissue (e.g., insertion tool 320 comprises a “spring-loaded” actuation mechanism). Fig. 4B shows cannula assembly 180 fixedly attached to housing 101, with insertion tool 320 removed. Cannula 185 is shown inserted through the skin of the patient, with penetrator 186 removed from cannula 185 and septum 181.

[199] Referring now to Fig. 5, a flowchart of a method of exchanging one or more devices used to provide therapy and/or monitor a patient is illustrated, consistent with the present inventive concepts. Method 1000 of Fig. 5 comprises a method for replacing a first delivery device and/or a first sensor assembly with a second delivery device and/or second sensor assembly (respectively). Method 1000 can include an initialization of the replacement device, such as an initialization based on data from the device being replaced and/or another device of the system, as described herein. Method 1000 can be performed using system 10, and is described using system 10 components that are described in reference to Fig. 1, Fig. 1 A, and/or otherwise herein.

[200] To begin Method 1000, Step 1100 can be performed, where a first delivery device provides therapy to the patient, such as delivery device 100a (e.g., a fluid delivery device configured to deliver agent 20 comprising insulin to the patient to treat diabetes).

Additionally, or alternatively, in Step 1100, patient data can be recorded from a first sensor assembly, such as sensor assembly 200a (e.g., a continuous glucose monitor, CGM). As described herein, delivery device 100 and/or sensor assembly 200 can comprise temporary use, disposable devices, such as devices that are configured to be attached to the patient with a cannula or other component inserted into the skin of the patient for a period of no more than 30 days, 14 days, 7 days, and/or 3 days. All or just a portion of these devices can be configured to be removed from the patient (e.g., where all or a portion is removed, discarded, recycled, and/or at least partially refurbished by the manufacturer) and replaced periodically.

[201] Delivery device 100 can be configured to be removed and replaced at a first cadence, RC1 (e.g., each delivery device 100 is configured to be used up to a maximum time period), and sensor assembly 200 can be configured to be removed and replaced at a second cadence, RC2. In some embodiments, replacement cadences RC1 and RC2 comprise different cadences, for example when delivery device 100 is configured to be removed and replaced at least every 3 days and/or every 7 days, and sensor assembly 200 (e.g., a CGM) is configured to be removed and replaced at least every 7 days and/or every 14 days. In some instances, the replacement timing of delivery device 100 and sensor assembly 200 can synchronize ( “sync”), such that each device is due to be replaced at approximately the same time (e.g., on the same day). Otherwise, delivery device 100 and sensor assembly 200 are replaced separately (e.g., on different days). As described herebelow, when a device is replaced (e.g., delivery device 100 and/or sensor assembly 200), the new device can be initialized in part utilizing the other of the two devices not being replaced at that time. In some embodiments, when the replacement timing is concurrent, a first of the two devices to be replaced can be replaced (e.g., delivery device 100), and the second of the first two devices to be replaced can be replaced after some time period following replacement of the first, for example at least 1 hour, at least 2 hours, at least 4 hours, and/or at least 8 hours later. For example, if delivery device 100 and sensor assembly 200 are both to be replaced on the same day, the patient can replace sensor assembly 200 in the morning, and replace delivery device 100 in the evening, such as to benefit from the initialization of sensor assembly 200 using the existing delivery device 100, for example as described herein in reference to Method 2000 of Fig. 6.

[202] Method 1000 can include multiple path options from Step 1100, such as Path A and Path B, each shown. Path A can comprise steps for replacing a first delivery device, delivery device 100a, and Path B can comprise steps for replacing a first sensor assembly 200, sensor assembly 200a. As described hereabove, Path A and Path B can occur relatively simultaneously (e.g., when the patient replaces both delivery device 100a and sensor assembly 200a without synchronization and/or initiation, as described herein), and/or the replacement of delivery device 100a and the replacement of sensor assembly 200a can be performed at different times, for example due to asynchronous cadence of replacement and/or by being replaced at different times in the same day.

[203] Path A of Method 1000 can include an optional Step 1200, where a second delivery device 100, delivery device 100b, is initialized, such as to be used as a replacement for delivery device 100a. Delivery device 100b can be initialized based on one or more of: data from the delivery device being replaced, delivery device 100a; patient data recorded by the current sensor assembly, sensor assembly 200a; information related to the current state of the current sensor assembly, sensor assembly 200a; and combinations of these. Method 1000 can include Step 1250, where delivery device 100a is removed and replaced with delivery device 100b. One or more initialization actions of Step 1200 can occur before and/or after one or more steps of replacing delivery device 100a in Step 1250 (e.g., Step 1200 and Step 1250 can occur simultaneously and/or with various actions of each step interleaved to fully initialize delivery device 100b and replace the functionality of delivery device 100a, such that it can be removed and discarded). Following Step 1250, with second delivery device 100b functioning as a “current” device, and delivery device 100a removed and no longer used, Method 1000 can return to Step 1100, until Path A and/or Path B is performed again to replace a current device.

[204] Path B of Method 1000 can include an optional Step 1300, where a second sensor assembly 200, sensor assembly 200b, is initialized, such as to be used as a replacement for sensor assembly 200a. Sensor assembly 200b can be initialized based on one or more of: data from the current delivery device, delivery device 100a; patient data recorded by the sensor assembly being replaced, sensor assembly 200a; information related to the current state of the current delivery device, delivery device 100a; and combinations of these. Method 1000 can include Step 1350, where sensor assembly 200a is removed and replaced with sensor assembly 200b. One or more initialization actions of Step 1300 can occur before and/or after one or more steps of replacing sensor assembly 200a in Step 1350 (e.g., Step 1300 and Step 1350 can occur simultaneously and/or with various actions of each step interleaved to fully initialize sensor assembly 200b and replace the functionality of sensor assembly 200a, such that it can be removed and discarded). Following Step 1350, with second sensor assembly 200b functioning as a “current” device, and sensor assembly 200a removed and no longer used, Method 1000 can return to Step 1100, until Path A and/or Path B is performed again to replace a current device.

[205] Referring now to Fig. 6, a flowchart of a method of exchanging a first sensor assembly for a second sensor assembly, each for use with a delivery device, is illustrated, consistent with the present inventive concepts. Method 2000 of Fig. 6 comprises a method for replacing a first sensor assembly with a second sensor assembly, and assessing the function of the second sensor assembly before discontinuing use of the first. Method 2000 can be performed using system 10, and is described using system 10 components that are described in reference to Fig. 1, Fig. 1 A, and/or otherwise herein.

[206] To begin Method 2000, Step 2100 can be performed, where patient data is recorded from a first sensor assembly, such as sensor assembly 200a (e.g., a continuous glucose monitor, CGM). In Step 2100, delivery device 100 can provide therapy (e.g., delivery of one or more agents to the patient, such as an agent 20 comprising insulin). In some embodiments, therapy provided by delivery device 100 is provided in a closed-loop arrangement, such as a closed-loop arrangement based at least in part on patient data recorded from sensor assembly 200a.

[207] After completion of Step 2100, Method 2000 can include Step 2200, where use of a second sensor assembly begins, such as sensor assembly 200b. Use of sensor assembly 200a can continue after the initial use of assembly 200b, such that patient data is recorded from first sensor assembly 200a and second sensor assembly 200b simultaneously. Method 2000 can include Step 2300 after Step 2200, where patient data recorded from sensor assemblies 200a and 200b are compared, for example by an algorithm of system 10 (e.g., algorithm 55 running on processing unit 105 of delivery device 100 and/or another processor of system 10).

[208] After completion of Step 2300, Method 2000 can include Step 2400, where system 10 is configured to assess the functionality of second sensor assembly 200b. For example, an algorithm of system 10 (e.g. algorithm 55) can be configured to assess the functionality of second sensor assembly 200b by comparing the patient data recorded by sensor assembly 200b to patient data recorded by first sensor assembly 200a. In some embodiments, the algorithm assesses the functionality of second sensor assembly 200b based on: (1) patient data that was recorded by first sensor assembly 200a prior to the use of second sensor assembly 200b; and/or (2) current patient data recorded by first sensor assembly 200a, such as patient data recorded simultaneously to the patient data recorded by second sensor assembly 200b. For example, blood glucose levels recorded by a second CGM (e.g., a new CGM intended to replace a current CGM nearing its end of useful life) can be compared to blood glucose levels recorded simultaneously by a first CGM (e.g., the current CGM to be replaced by the new CGM). The algorithm can be biased to assume patient data recorded by first sensor assembly 200a is accurate, and to assess the functionality of second sensor assembly 200b based on comparison of the patient data recorded from each. Alternatively, or additionally, the algorithm can be configured to assess the functionality of both first sensor assembly 200a and second sensor assembly 200b based on the comparison of the data, for example, if the data does not match, both assemblies can be considered “non-functional”. Method 2000 can include a step comprising a decision, Step 2450, where Method 2000 continues based on the functionality assessment performed in Step 2400.

[209] Method 2000 can comprise Step 2500, where the use of first sensor assembly 200a is discontinued, and second sensor assembly 200b becomes the “current” sensor assembly (e.g., the only and/or primary sensor assembly recording data for closed-loop delivery of agent 20). For example, if the function of sensor assembly 200b is confirmed in Step 2400, Step 2450 can direct Method 2000 to Step 2500. Discontinued use of first sensor assembly 200a and continued use of sensor assembly 200b can include a change in the patient data source used in calculation of closed-loop delivery by delivery device 100. For example, in the embodiment of sensor assemblies 200 comprising CGM devices, the closed-loop delivery of insulin from delivery device 100 can switch from delivery based on blood glucose levels recorded from the first CGM to levels recorded by the second CGM, after functionality of the second CGM is assessed and confirmed. In some embodiments, Step 2400 continues for a first time period, TPc, such as a ramp-up period where data recorded by sensor assembly 200b is stabilizing and/or otherwise varying (e.g., due to algorithmic or other changes) and may be outside desired accuracy limits of the sensor. If the functionality of second sensor assembly 200b can be confirmed (e.g., the recorded data stabilizes and/or otherwise falls within desired accuracy limits when compared to data recorded by first sensor assembly 200a, such as when determined by algorithm 55) within the first time period TPc (e.g., the allotted time threshold for confirming functionality), Method 2000 can continue to Step 2500 as described herein.

[210] Method 2000 can comprise Step 2460, where second sensor assembly 200b is replaced with a third sensor assembly 200c. If the functionality of second sensor assembly 200b cannot be confirmed in Step 2400, for example confirmation of accuracy cannot be achieved within the first time period TPc, Step 2450 can direct Method 2000 to Step 2460 in which second sensor assembly 200b is replaced with a third sensor assembly 200c. After completion of Step 2460, Method 2000 can return to Step 2200 through 2450, where data is recorded and the assessment of sensor assembly 200c is performed (e.g., compared to sensor assembly 200a), as described herein. After a functioning replacement sensor assembly 200 is successfully initiated and use of the previous sensor assembly discontinued (e.g., after completion of Step 2500 of Method 2000), Method 2000 can return to and continue Step 2100. Step 2200 can be initiated when the current sensor assembly 200 is nearing the end of its functional life cycle and needs to be replaced.

[211] The above-described embodiments should be understood to serve only as illustrative examples; further embodiments are envisaged. Any feature described herein in relation to any one embodiment may be used alone, or in combination with other features described, and may also be used in combination with one or more features of any other of the embodiments, or any combination of any other of the embodiments. Furthermore, equivalents and modifications not described above may also be employed without departing from the scope of the inventive concepts, which are defined in the accompanying claims.

Claims

WHAT IS CLAIMED IS:

1. A fluid delivery system comprising: a fluid delivery device comprising: a reservoir constructed and arranged to store an agent to be delivered to a patient; a pumping assembly constructed and arranged to propel the agent; a fluid pathway having a distal portion comprising a delivery conduit, wherein the delivery conduit is constructed and arranged to receive the agent from the reservoir and deliver the agent to the patient; a power supply configured to provide energy to at least the pumping assembly; and a housing surrounding at least the reservoir and the pumping assembly.

2. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to reduce waste of the agent.

3. The system according to claim 2 and/or any one or more other claims herein, wherein the system is configured to reduce waste of at least O.lmL, 0.2mL, and/or 0.3mL of the agent over a time period of no more than three days.

4. The system according to claim 2 and/or any one or more other claims herein, wherein the agent comprises insulin.

5. The system as claimed in any one or more claims herein, wherein the system is configured to operate in a closed-loop delivery mode.

6. The system according to claim 5 and/or any one or more other claims herein, wherein the closed-loop delivery mode is based on a patient physiologic parameter.

7. The system according to claim 6 and/or any one or more other claims herein, wherein the patient physiologic parameter comprises the glucose level of the patient.

8. The system according to claim 5 and/or any one or more other claims herein, wherein the closed-loop delivery mode is based on a measured parameter of the fluid delivery device.

9. The system according to claim 5 and/or any one or more other claims herein, wherein the closed-loop delivery mode is based on a patient activity.

10. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to operate in an open-loop delivery mode.

11. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to operate in both an open-loop delivery mode and a closed- loop delivery mode, and wherein the change between modes and/or a change in a parameter of either mode requires an authorized confirmation by a clinician user of the system.

12. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a volume of no more than 28,750mm³, such as no more than 25,000mm³, no more than 22,500mm³, and/or no more than 20,000mm³.

13. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a skin-contacting surface, and wherein the skincontacting surface comprises a surface area of no more than 1,983mm², 1,700mm², 1,500mm², 1,300mm², 1,000mm², 750mm², and/or 650mm².

14. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a skin-contacting surface that has a surface area that is less than the surface area of any parallel cross section at an elevation above the skin-contacting surface.

15. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a skin-contacting surface and a first surface opposite the skin-contacting surface, wherein the first surface has a surface area that is less than the surface area of any parallel cross section at an elevation below the first surface.

16. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a cross section with trapezoidal-shaped sides, slope-shaped sides, or both.

17. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a cross section with convex sides.

18. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a length of no more than 51.5mm, 45mm, and/or 35mm.

19. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a width of no more than 38.5mm, 32.5mm, and/or 27.5mm.

20. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a circular geometry with a diameter of no more than 51.5mm, 45mm, and/or 35mm.

21. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a height of no more than 14.5mm, 12mm, 10mm, 8mm, and/or 7mm.

22. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a mass of no more than 26g, 23g, and/or 20g when the reservoir is empty.

23. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a cross-section with a trapezoidal geometry.

24. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a cross-section with one or more convex sides.

25. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a device volume, and wherein the device volume is constructed and arranged to reduce in magnitude over time.

26. The system according to claim 25 and/or any one or more other claims herein, wherein the reservoir comprises a reservoir volume, and wherein the reservoir volume is constructed and arranged to reduce in magnitude over time.

27. The system according to claim 26 and/or any one or more other claims herein, wherein the reservoir is constructed and arranged to collapse.

28. The system according to claim 26 and/or any one or more other claims herein, wherein the reservoir comprises a balloon material and/or other stretchable material.

29. The system according to claim 25 and/or any one or more other claims herein, wherein the power supply comprises a power supply volume, and wherein the power supply volume is constructed and arranged to reduce in magnitude over time.

30. The system according to claim 29 and/or any one or more other claims herein, wherein the power supply comprises multiple layers, and wherein at least one layer of the multiple layers is constructed and arranged to be removed from the fluid delivery device.

31. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a device height, and wherein the device height is constructed and arranged to reduce in magnitude over time.

32. The system according to claim 31 and/or any one or more other claims herein, wherein the reservoir comprises a reservoir height, and wherein the reservoir height is constructed and arranged to reduce in magnitude over time.

33. The system according to claim 32 and/or any one or more other claims herein, wherein the reservoir is constructed and arranged to collapse over time.

34. The system according to claim 32 and/or any one or more other claims herein, wherein the reservoir comprises a balloon material and/or other stretchable material.

35. The system according to claim 31 and/or any one or more other claims herein, wherein the power supply comprises a power supply height, and wherein the power supply height is constructed and arranged to reduce in magnitude over time.

36. The system according to claim 35 and/or any one or more other claims herein, wherein the power supply comprises multiple layers, and wherein at least one layer of the multiple layers is constructed and arranged to be removed from the fluid delivery device.

37. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a first component and a second component, and wherein the first component and the second component share a portion of a wall positioned between the first and second components.

38. The system according to claim 37 and/or any one or more other claims herein, wherein the first component comprises the housing.

39. The system according to claim 38 and/or any one or more other claims herein, wherein the second component comprises: the reservoir, the pumping assembly, the delivery conduit, and/or two, three, or four of these.

40. The system according to claim 37 and/or any one or more other claims herein, wherein the first component comprises the reservoir and wherein the second component comprises the pumping assembly.

41. The system according to claim 40 and/or any one or more other claims herein, wherein the pumping assembly comprises a MEMS device.

42. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device is configured to be used for more than 3 days.

43. The system according to claim 42 and/or any one or more other claims herein, wherein the fluid delivery device is configured to be used for more than 6 days.

44. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises multiple fluid delivery devices.

45. The system according to claim 44 and/or any one or more other claims herein, wherein each fluid delivery device is replaced after a maximum duration of use.

46. The system according to claim 45 and/or any one or more other claims herein, wherein the maximum duration of use comprises a time period of 3 days.

47. The system according to claim 44 and/or any one or more other claims herein, wherein a second fluid delivery device is positioned to have a different skin penetration site than a first fluid delivery device used just prior to the second fluid delivery device.

48. The system according to claim 44 and/or any one or more other claims herein, wherein each fluid delivery device comprises an insertable transcutaneous fluid delivery element, and wherein a second fluid delivery device is configured to have a different depth of insertion of its transcutaneous fluid delivery element than the depth of insertion of a transcutaneous fluid delivery element of a first fluid delivery device used just prior to the second fluid delivery device.

49. The system according to claim 44 and/or any one or more other claims herein, wherein each fluid delivery device comprises an insertable transcutaneous fluid delivery element, and wherein a second fluid delivery device is configured to have a different angle of insertion of its transcutaneous fluid delivery element than the angle of insertion of a transcutaneous fluid delivery element of a first fluid delivery device used just prior to the second fluid delivery device.

50. The system according to claim 44 and/or any one or more other claims herein, wherein a first fluid delivery device comprises a smaller volume than the volume of a second fluid delivery device.

51. The system according to claim 44 and/or any one or more other claims herein, wherein a first fluid delivery device comprises a smaller length and/or a smaller width than the length and/or width of a second fluid delivery device.

52. The system according to claim 44 and/or any one or more other claims herein, wherein a first fluid delivery device comprises a major axis with a smaller length than the length of a major axis of a second fluid delivery device.

53. The system according to claim 44 and/or any one or more other claims herein, wherein a first fluid delivery device comprises a smaller height than the height of a second fluid delivery device.

54. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a first delivery conduit configured to be attached to a first port of the fluid delivery device, and a second delivery conduit configured to be attached to a second port of the fluid delivery device, and wherein the first delivery conduit delivers the agent for a first time period, and wherein the second delivery conduit delivers the agent for a second, subsequent time period.

55. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a single component that performs at least two functions.

56. The system according to claim 55 and/or any one or more other claims herein, wherein the single component is configured to propel fluid and provide a vibrational alert.

57. The system according to claim 56 and/or any one or more other claims herein, wherein the single component comprises a motor that is configured to turn a leadscrew and to vibrate.

58. The system according to claim 55 and/or any one or more other claims herein, wherein the single component is configured to propel fluid and measure flow of fluid.

59. The system according to claim 55 and/or any one or more other claims herein, wherein the single component is configured to propel fluid and agitate fluid.

60. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a fill port configured to allow a user to deliver the agent into the reservoir.

61. The system according to claim 60 and/or any one or more other claims herein, wherein the fill port comprises one, two, or more access septa.

62. The system according to claim 61 and/or any one or more other claims herein, wherein the one, two, or more access septa comprises at least one septum constructed and arranged to be piercingly accessed by a needle or other fluid delivery element.

63. The system according to claim 60 and/or any one or more other claims herein, wherein the fill port is constructed and arranged to be non-piercingly accessed by a needle or other fluid delivery element.

64. The system according to claim 60 and/or any one or more other claims herein, wherein the fluid delivery device comprises a bottom surface configured to be positioned on the skin of the patient, and wherein the fill port is positioned on the bottom surface.

65. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir comprises a volume of less than 3mL, 2mL, and/or ImL.

66. The system according to claim 1 and/or any one or more other claims herein, wherein the agent comprises insulin and/or other agent, and wherein the reservoir is configured to store the insulin and/or other agent for at least 3 days, 14 days, and/or 30 days.

67. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir comprises a refillable reservoir.

68. The system according to claim 67 and/or any one or more other claims herein, wherein the fluid delivery device is configured such that the reservoir can be refilled while the fluid delivery device is positioned on the skin surface of the patient.

69. The system according to claim 67 and/or any one or more other claims herein, wherein the fluid delivery device is configured such that the reservoir cannot be refilled while the fluid delivery device is positioned on the skin surface of the patient.

70. The system according to claim 67 and/or any one or more other claims herein, wherein the reservoir is configured such that the reservoir can be refilled while the reservoir is positioned within the fluid delivery device.

71. The system according to claim 67 and/or any one or more other claims herein, wherein the reservoir is configured such that the reservoir can be refilled while the reservoir is removed from the fluid delivery device.

72. The system according to claim 67 and/or any one or more other claims herein, further comprising a fill assembly comprising a valve configured to control flow of the agent into and/or out of the reservoir based on the pressure of the agent.

73. The system according to claim 72 and/or any one or more other claims herein, wherein the valve comprises a one-way spring valve.

74. The system according to claim 72 and/or any one or more other claims herein, wherein the valve comprises a valve selected from the group consisting of: ball valve; disc check valve; dual disc check valve; tilting disc check valve; piston check valve; swing check valve; piston check valve; ball check valve; silent check valve; nozzle check valve; wafer check valve; and combinations thereof.

75. The system according to claim 72 and/or any one or more other claims herein, wherein the fill assembly comprises a semi-permeable membrane configured to propel the agent into the reservoir.

76. The system according to claim 72 and/or any one or more other claims herein, wherein the fill assembly comprises a fluid injector and an agent cannister that are configured to propel a predetermined volume of the agent into the reservoir.

77. The system according to claim 72 and/or any one or more other claims herein, wherein the fill assembly comprises a docking module configured to operably attach to the fluid delivery device.

78. The system according to claim 77 and/or any one or more other claims herein, wherein the docking module is configured to recharge the power supply of the fluid delivery device and/or is configured to store the agent.

79. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir is configured to be inserted into the fluid delivery device and not subsequently removed from the fluid delivery device.

80. The system according to claim 79 and/or any one or more other claims herein, wherein the fluid delivery device includes a locking insertion mechanism constructed and arranged to prevent the reservoir from being removed from the fluid delivery device after insertion of the reservoir into the fluid delivery device.

81. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir comprises multiple reservoirs, and wherein a second reservoir is constructed and arranged to replace a first reservoir.

82. The system according to claim 81 and/or any one or more other claims herein, wherein a third reservoir is constructed and arranged to replace the second reservoir.

83. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir comprises a first reservoir and a second reservoir.

84. The system according to claim 83 and/or any one or more other claims herein, wherein the first reservoir is configured to store a first agent, and wherein the second reservoir is configured to store a second agent that is different than the first agent.

85. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device is configured to deliver a target volume of the agent, and wherein the reservoir comprises a volume that is less than the target volume.

86. The system according to claim 85 and/or any one or more other claims herein, wherein the reservoir comprises a refillable reservoir and/or a replaceable reservoir.

87. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device is configured to be used for a first time period, and wherein the reservoir comprises a reservoir volume that provides the agent for a second time period that is less than the first time period.

88. The system according to claim 87 and/or any one or more other claims herein, wherein the first time period comprises a time period of at least 3 days.

89. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir comprises at least a flexible portion.

90. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir comprises at least a rigid portion.

91. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir comprises a flexible portion and a rigid portion.

92. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir comprises a bellows construction.

93. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir comprises a thin-sheet construction.

94. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir comprises a molded pouch construction.

95. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir comprises a rolling diaphragm construction.

96. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir comprises a syringe construction.

97. The system according to claim 96 and/or any one or more other claims herein, wherein the reservoir comprises a spring-loaded plunger.

98. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir comprises a reservoir that is pressurized above atmospheric pressure.

99. The system according to claim 98 and/or any one or more other claims herein, wherein the reservoir comprises an elastically expandable reservoir which exerts pressure on the agent when expanded.

100. The system according to claim 99 and/or any one or more other claims herein, wherein the elastically expandable reservoir comprises a near- linear stress-strain curve.

101. The system according to claim 98 and/or any one or more other claims herein, wherein the pressurized reservoir is pressurized via a constant pressure cavity.

102. The system according to claim 101 and/or any one or more other claims herein, wherein the cavity comprises freon or other material configured to maintain constant pressure by changing phase throughout the delivery of the agent.

103. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir comprises a reservoir that is maintained at a pressure level below atmospheric pressure.

104. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir comprises a hydraulic press construction.

105. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir comprises a furlable tube and a torsion spring configured to exert a force on the furlable tube.

106. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir comprises expanding foam.

107. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir comprises a first reservoir and a second reservoir, and wherein as the first reservoir empties the second reservoir fills, such as to maintain constant pressure in the first reservoir.

108. The system according to claim 107 and/or any one or more other claims herein, wherein the fluid delivery device further comprises a fluid withdrawal element and a flow sensor, and wherein the second reservoir is filled via fluid captured by the fluid withdrawal element and based on flow as monitored by the flow sensor.

109. The system according to claim 1 and/or any one or more other claims herein, wherein the reservoir is configured to be filled and/or refilled with the agent, and wherein the filling and/or refilling causes energy to be stored in the fluid delivery device.

110. The system according to claim 109 and/or any one or more other claims herein, wherein the fluid delivery device is configured to recharge the power supply using the stored energy.

111. The system according to claim 109 and/or any one or more other claims herein, wherein the stored energy is used to pressurize the reservoir.

112. The system according to claim 109 and/or any one or more other claims herein, wherein the stored energy comprises phase-change energy.

113. The system according to claim 109 and/or any one or more other claims herein, wherein the stored energy comprises energy in a form selected from the group consisting of phase-change energy; mechanical energy; spring energy; hydraulic energy; pneumatic energy; electrical energy; chemical energy; and combinations thereof.

114. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device comprises a first fluid delivery device including a first reservoir and a second fluid delivery device including a second reservoir, and wherein the first reservoir is configured to transfer fluid to the second reservoir.

115. The system according to claim 1 and/or any one or more other claims herein, wherein the pumping assembly comprises a volume of no more than 60mm³, 40mm³, and/or 20mm³.

116. The system according to claim 1 and/or any one or more other claims herein, wherein the pumping assembly comprises a maximum cross-sectional area of no more than 100mm², 65mm², and/or 30mm².

117. The system according to claim 1 and/or any one or more other claims herein, wherein the pumping assembly comprises a major axis with a length of no more than 10mm, 8mm, 6mm, 5mm, and/or 4mm.

118. The system according to claim 1 and/or any one or more other claims herein, wherein the pumping assembly comprises a MEMS device.

119. The system according to claim 118 and/or any one or more other claims herein, wherein the MEMS device comprises a silicon-layered MEMS device.

120. The system according to claim 118 and/or any one or more other claims herein, wherein the MEMS device comprises a metal alloy MEMS device.

121. The system according to claim 118 and/or any one or more other claims herein, wherein the MEMS device comprises a flexible polymer MEMS device.

122. The system according to claim 1 and/or any one or more other claims herein, wherein the pumping assembly comprises a syringe driver.

123. The system according to claim 122 and/or any one or more other claims herein, wherein the syringe driver comprises a plunger, leadscrew, and motive element, wherein the plunger and leadscrew are positioned within the reservoir, and wherein rotation of the leadscrew by the motive element causes the plunger to translate within the reservoir.

124. The system according to claim 123 and/or any one or more other claims herein, wherein the leadscrew is configured to disengage from the plunger, the motive element, or both.

125. The system according to claim 124 and/or any one or more other claims herein, wherein the leadscrew comprises a magnetic disengagement assembly.

126. The system according to claim 125 and/or any one or more other claims herein, wherein the plunger comprises the magnetic disengagement assembly.

127. The system according to claim 125 and/or any one or more other claims herein, further comprising a fill assembly, wherein the fill assembly comprises a magnet assembly configured to cause the leadscrew disengagement.

128. The system according to claim 123 and/or any one or more other claims herein, wherein the motive element comprises a motor.

129. The system according to claim 123 and/or any one or more other claims herein, wherein the motive element comprises at least one shaped memory component.

130. The system according to claim 123 and/or any one or more other claims herein, wherein the motive element comprises at least one solenoid.

131. The system according to claim 123 and/or any one or more other claims herein, wherein the motive element comprises a MEMS rotary actuator and/or other MEMS actuator.

132. The system according to claim 123 and/or any one or more other claims herein, wherein the motive element comprises an inch-worm drive, such as when the plunger comprises an inch-worm drive.

133. The system according to claim 123 and/or any one or more other claims herein, wherein the motive element comprises a rotary magnetic drive.

134. The system according to claim 133 and/or any one or more other claims herein, wherein the magnetic drive is configured to provide a reciprocating motion.

135. The system according to claim 134 and/or any one or more other claims herein, wherein the pumping assembly further comprises a gear attached to the leadscrew, a hook, and a ratchet and pawl assembly configured to rotate the gear via the reciprocating motion provided by the magnetic drive.

136. The system according to claim 133 and/or any one or more other claims herein, wherein the magnetic drive comprises a set of one or more permanent magnets and a set of one or more electromagnets.

137. The system according to claim 136 and/or any one or more other claims herein, wherein activation of each of the electromagnets provides reciprocating motion, rotatory motion, or both.

138. The system according to claim 1 and/or any one or more other claims herein, wherein the pumping assembly is configured to deliver the agent in a series of discreet boluses, and wherein each bolus is delivered over a time period of at least 3, 6, 15, and/or 30 seconds.

139. The system according to claim 1 and/or any one or more other claims herein, wherein the pumping assembly comprises a peristaltic assembly.

140. The system according to claim 1 and/or any one or more other claims herein, wherein the pumping assembly comprises a check flow valve comprising at least one check flow valve.

141. The system according to claim 140 and/or any one or more other claims herein, wherein the pumping assembly comprises a MEMS pumping assembly including an inlet and an outlet, and wherein the check valve comprises a first check valve that is fluidly positioned between the reservoir and the inlet, and a second check valve that is fluidly positioned between the outlet and a distal end of the delivery conduit.

142. The system according to claim 1 and/or any one or more other claims herein, wherein the housing comprises a first portion, a second portion, and a hinge rotatably connecting the first portion to the second portion, and/or wherein the housing comprises at least one rigid portion and at least one flexible portion.

143. The system according to claim 1 and/or any one or more other claims herein, wherein the housing comprises one or more soft portions.

144. The system according to claim 143 and/or any one or more other claims herein, wherein the housing comprises at least one soft comer.

145. The system according to claim 143 and/or any one or more other claims herein, wherein the housing comprises at least three soft corners.

146. The system according to claim 1 and/or any one or more other claims herein, wherein the housing comprises a housing volume, and wherein the housing volume is constructed and arranged to reduce in magnitude over time.

147. The system according to claim 1 and/or any one or more other claims herein, wherein the housing comprises a skin-tone color.

148. The system according to claim 1 and/or any one or more other claims herein, wherein the housing comprises a logo.

149. The system according to claim 1 and/or any one or more other claims herein, wherein a distal portion of the delivery conduit comprises a transcutaneous fluid delivery element.

150. The system according to claim 149 and/or any one or more other claims herein, wherein the transcutaneous fluid delivery element comprises a needle; a hollow microneedle; a catheter; and/or a cannula such as a hard cannula and or a soft cannula.

151. The system according to claim 149 and/or any one or more other claims herein, wherein the transcutaneous fluid delivery element comprises at least two transcutaneous fluid delivery elements, wherein a first transcutaneous fluid delivery element is configured to deliver the agent for a first time period and a second transcutaneous fluid delivery element is configured to deliver the agent for a subsequent second time period.

152. The system according to claim 149 and/or any one or more other claims herein, wherein the transcutaneous fluid delivery element comprises at least two transcutaneous fluid delivery elements, and wherein the fluid delivery device comprises a first transcutaneous fluid delivery element and a second transcutaneous fluid delivery element.

153. The system according to claim 152 and/or any one or more other claims herein, wherein the first transcutaneous fluid delivery element is configured to be inserted through the skin of the patient at a first location, and wherein the second transcutaneous fluid delivery element is configured to be inserted through the skin of the patient at a second location that is at least 2mm, 4mm, and/or 6mm away from the first location.

154. The system according to claim 149 and/or any one or more other claims herein, wherein the transcutaneous fluid delivery element comprises a distal portion configured to remain under a skin surface of the patient for at least 3 days.

155. The system according to claim 149 and/or any one or more other claims herein, wherein the delivery conduit comprises an infusion set that includes the transcutaneous fluid delivery element, wherein a distal portion of the infusion set comprises the transcutaneous fluid delivery element.

156. The system according to claim 155 and/or any one or more other claims herein, wherein the infusion set is removably attachable to a proximal portion of the fluid pathway.

157. The system according to claim 149 and/or any one or more other claims herein, wherein the transcutaneous fluid delivery element is configured to deliver the agent to a location under the patient’s skin surface without the transcutaneous fluid delivery element penetrating the patient’s skin surface.

158. The system according to claim 157 and/or any one or more other claims herein, wherein the fluid delivery device is configured to deliver the agent via high energy bursts.

159. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid pathway comprises a flow modifying element.

160. The system according to claim 159 and/or any one or more other claims herein, wherein the pumping assembly comprises a MEMS-based pumping assembly.

161. The system according to claim 159 and/or any one or more other claims herein, wherein the flow modifying element comprises a flow restricting element selected from the group consisting of a duckbill valve; a flow-limiting orifice; a capillary tube and/or other small diameter tube; a mechanical restrictor; a solenoid valve; a distensible tube; a flow restricting channel, such as a channel constructed by welding two sheets of plastic together; and combinations of these.

162. The system according to claim 159 and/or any one or more other claims herein, wherein the flow modifying element comprises a pressure attenuator.

163. The system according to claim 162 and/or any one or more other claims herein, wherein the pressure attenuator comprises a component selected from the group consisting of a diaphragm; a spring; a mechanical pressure attenuator; an electromechanical pressure attenuator; a bladder; a reservoir filled with a fluid; a positive-pressure-actuated attenuator; a negative-pressure-actuated attenuator; and combinations thereof.

164. The system according to claim 159 and/or any one or more other claims herein, wherein the flow modifying element comprises a capillary tube with a known fluid resistance.

165. The system according to claim 159 and/or any one or more other claims herein, wherein the flow modifying element comprises two sheets of plastic that are welded together to include a flow-restricted fluid delivery channel between the welds.

166. The system according to claim 159 and/or any one or more other claims herein, wherein the flow modifying element comprises a diaphragm with a predetermined pressure on a first side and a fluid delivery channel on an opposite second side, wherein fluid must exceed the pre-determined pressure to pass through the fluid delivery channel.

167. The system according to claim 1 and/or any one or more other claims herein, wherein the fluid delivery device is configured to be used for a first time period, and wherein the power supply comprises an energy capacity that is configured to provide energy to the fluid delivery device for a second time period that is less than the first time period.

168. The system according to claim 167 and/or any one or more other claims herein, wherein the first time period comprises a time period of at least 3 days.

169. The system according to claim 167 and/or any one or more other claims herein, wherein the first time period comprises a time period between 3 days and 28 days.

170. The system according to claim 1 and/or any one or more other claims herein, wherein the power supply comprises a rechargeable power supply.

171. The system according to claim 170 and/or any one or more other claims herein, wherein the power supply is configured to be recharged via wireless transfer of energy.

172. The system according to claim 170 and/or any one or more other claims herein, wherein the power supply comprises a USB charge port.

173. The system according to claim 170 and/or any one or more other claims herein, wherein the power supply is configured to be recharged while the patient is asleep.

174. The system according to claim 170 and/or any one or more other claims herein, wherein the power supply is configured to be recharged via patient movement.

175. The system according to claim 170 and/or any one or more other claims herein, wherein the power supply is configured to be recharged via solar and/or other light energy.

176. The system according to claim 170 and/or any one or more other claims herein, wherein the power supply is configured to be recharged via heat energy of the patient.

177. The system according to claim 1 and/or any one or more other claims herein, wherein the power supply comprises a first power supply and a second power supply.

178. The system according to claim 177 and/or any one or more other claims herein, wherein the first power supply comprises a battery, a capacitor, and/or another element configured to store electrical energy, and wherein the second power supply is configured to store non-electrical energy.

179. The system according to claim 178 and/or any one or more other claims herein, wherein the fluid delivery device is configured to recharge the first power supply via energy provided by the second power supply.

180. The system according to claim 1 and/or any one or more other claims herein, further comprising the agent.

181. The system according to claim 180 and/or any one or more other claims herein, wherein the agent comprises insulin.

182. The system according to claim 181 and/or any one or more other claims herein, wherein the agent further comprises a non-insulin agent.

183. The system according to claim 181 and/or any one or more other claims herein, wherein the insulin comprises insulin at a concentration of: 100 units/mL, 200 units/mL, 300 units/mL, 400 units/mL, and/or 500 units/mL.

184. The system according to claim 181 and/or any one or more other claims herein, wherein the insulin comprises insulin configured to be stored at: room temperature; body temperature; or both.

185. The system according to claim 181 and/or any one or more other claims herein, wherein the insulin comprises insulin that includes a surfactant.

186. The system according to claim 181 and/or any one or more other claims herein, wherein the agent further comprises glucagon.

187. The system according to claim 1 and/or any one or more other claims herein, further comprising a sensor configured to produce a signal related to one or more system parameters and/or one or more patient parameters, wherein the sensor comprises one or more sensors, and wherein the signal comprises one or more signals.

188. The system according to claim 187 and/or any one or more other claims herein, wherein the fluid delivery device comprises the sensor.

189. The system according to claim 187 and/or any one or more other claims herein, wherein the sensor comprises one or more physiologic sensors.

190. The system according to claim 189 and/or any one or more other claims herein, wherein the one or more physiologic sensors comprise one, two, or more sensors selected from the group consisting of: glucose sensor; oxygen sensor such as oxygen saturation sensor; galvanic skin resistance sensor; ECG sensor; neural spike, local field potential, and/or EEG sensor; blood pressure sensor; heart rate sensor; oxygen sensor; respiration sensor; perspiration sensor; GPS sensor; and combinations thereof.

191. The system according to claim 189 and/or any one or more other claims herein, wherein the sensor comprises at least one glucose sensor.

192. The system according to claim 191 and/or any one or more other claims herein, wherein the at least one glucose sensor is integral to the fluid delivery device.

193. The system according to claim 189 and/or any one or more other claims herein, wherein the sensor comprises a glucose sensor and one, two, or more additional sensors selected from the group consisting of: oxygen sensor such as oxygen saturation sensor; galvanic skin resistance sensor; ECG sensor; neural spike, local field potential, and/or EEG sensor; blood pressure sensor; heart rate sensor; respiration sensor; perspiration sensor; and combinations thereof.

194. The system according to claim 187 and/or any one or more other claims herein, further comprising a sensor device, wherein the sensor device comprises the sensor.

195. The system according to claim 194 and/or any one or more other claims herein, wherein the one or more physiologic sensors comprise at least one glucose sensor.

196. The system according to claim 187 and/or any one or more other claims herein, wherein the sensor comprises one, two, or more sensors selected from the group consisting of: physiologic sensor; accelerometer; strain gauge; pressure sensor; flow sensor; optical sensor; temperature sensor; thermometer; RF and/or other electromagnetic sensor; impedance sensor; pH sensor; voltage sensor; current sensor; altitude sensor; sound sensor such as a microphone; ultrasound sensor; and combinations thereof.

197. The system according to claim 187 and/or any one or more other claims herein, wherein the sensor comprises a sensor configured to monitor operation of the pumping assembly.

198. The system according to claim 187 and/or any one or more other claims herein, wherein the delivery conduit comprises a needle, a catheter, a cannula, and/or other transcutaneous fluid delivery element, and wherein the sensor is configured to monitor deployment and/or position of the transcutaneous fluid delivery element.

199. The system according to claim 187 and/or any one or more other claims herein, wherein the sensor comprises at least one accelerometer.

200. The system according to claim 199 and/or any one or more other claims herein, wherein the fluid delivery device is configured to detect: a fall of the patient: patient movement; patient position or position change; sleep state of the patient; proper operation of a vibrational transducer; proper operation of the pumping assembly; and/or flow within the fluid pathway, based on signals received from the accelerometer.

201. The system according to claim 187 and/or any one or more other claims herein, wherein the sensor comprises at least one pressure sensor.

202. The system according to claim 187 and/or any one or more other claims herein, wherein the sensor comprises at least one flow sensor.

203. The system according to claim 187 and/or any one or more other claims herein, wherein the sensor comprises at least one occlusion sensor.

204. The system according to claim 187 and/or any one or more other claims herein, wherein the sensor comprises at least one bubble detector.

205. The system according to claim 187 and/or any one or more other claims herein, wherein the sensor comprises at least one temperature sensor.

206. The system according to claim 187 and/or any one or more other claims herein, wherein the sensor comprises a sleep detector configured to detect when the patient is asleep.

207. The system according to claim 187 and/or any one or more other claims herein, wherein the system is configured to allow a clinician to set one or more alert thresholds for a set of one or more monitored parameters, wherein the set of one or more monitored parameters comprises one or more system parameters and/or one or more patient parameters, and wherein the system is configured to monitor the set of one or more system parameters based on the sensor signal.

208. The system according to claim 187 and/or any one or more other claims herein, wherein the sensor is configured to produce a signal related to a patient environment parameter.

209. The system according to claim 187 and/or any one or more other claims herein, wherein the system is configured to detect and/or confirm one or more system states and/or one or more patient states based on the sensor signal.

210. The system according to claim 209 and/or any one or more other claims herein, wherein the one or more system states and/or patient states comprises one, two, or more states selected from the group consisting of pump properly attached to body of patient; a fluid delivery element of the delivery conduit is properly inserted into the patient; pump is in a functional state; power supply is at an acceptable state; reservoir environment is at an acceptable level; patient condition is at an acceptable level; patient environment is at an acceptable level; patient activities are acceptable; and combinations thereof.

211. The system according to claim 187 and/or any one or more other claims herein, wherein the system is configured to alert a non-patient user if an undesired system state and/or patient state is detected based on the sensor signal.

212. The system according to claim 187 and/or any one or more other claims herein, wherein the system is configured to detect if agent stored in the reservoir is nearing the end of its useful life.

213. The system according to claim 187 and/or any one or more other claims herein, wherein the system is configured to determine if the patient is maintaining a clinician -prescribed lifestyle plan based on the sensor signal.

214. The system according to claim 187 and/or any one or more other claims herein, wherein the system is configured to monitor altitude of the patient based on the sensor signal and to adjust a parameter to maintain accurate delivery of the agent.

215. The system according to claim 187 and/or any one or more other claims herein, wherein the system is configured to monitor sound in the vicinity of the fluid delivery device, and wherein based on the sensor signal, the system is further configured to determine: when delivery of the agent is occurring; if the reservoir is empty or otherwise below an acceptable level; if the fluid delivery device is not delivering the agent as intended; if the fluid delivery device is pumping air or other gas; when a priming procedure is complete; if the fluid delivery device is nearing an end-of-life condition; if the power supply is at an unacceptable level; if a component of the fluid delivery device is wearing to an unacceptable state; if an adhesive securing one or more components of the fluid delivery device has failed or is failing; and combinations thereof.

216. The system according to claim 187 and/or any one or more other claims herein, wherein the system, based on the sensor signal, is configured to detect a patient state selected from the group consisting of talking; crying; awake; asleep; walking; running; sitting, standing; in a prone position; in a fetal position; or combinations thereof.

217. The system according to claim 187 and/or any one or more other claims herein, wherein the sensor is configured to monitor use of the agent and/or a system component.

218. The system according to claim 217 and/or any one or more other claims herein, wherein the system is configured to prevent use of the monitored agent and/or system component if use of the monitored agent and/or system component exceeds a time limit.

219. The system according to claim 187 and/or any one or more other claims herein, wherein the system is configured to prevent, based on the sensor signal, undesired refilling of the reservoir and/or use of the fluid delivery device after undesired refilling of the reservoir.

220. The system according to claim 1 and/or any one or more other claims herein, further comprising a communication module configured to transfer data between at least a first system component and at least a second system component.

221. The system according to claim 220 and/or any one or more other claims herein, wherein the first system component comprises the fluid delivery device.

222. The system according to claim 221 and/or any one or more other claims herein, further comprising a glucose sensing device, wherein the second system component comprises the glucose sensing device.

223. The system according to claim 221 and/or any one or more other claims herein, further comprising a smart phone and/or other cell phone, and wherein the second system component comprises the smart phone and/or other cell phone.

224. The system according to claim 220 and/or any one or more other claims herein, wherein the communication module is configured to perform the data transfer via a wired connection.

225. The system according to claim 220 and/or any one or more other claims herein, wherein the communication module is configured to perform the data transfer via a wireless connection, such as a Bluetooth connection, such as a Bluetooth low energy connection.

226. The system according to claim 220 and/or any one or more other claims herein, wherein the communication module is configured to perform the data transfer via an acoustic signal such as an acoustic signal operating at frequencies outside of the auditory range of the patient.

227. The system according to claim 220 and/or any one or more other claims herein, wherein the fluid delivery device comprises at least a first portion of the communication module.

228. The system according to claim 227 and/or any one or more other claims herein, wherein the system further comprises a sensor device comprising a second portion of the communication module, and wherein data is transferred between the first portion and the second portion.

229. The system according to claim 228 and/or any one or more other claims herein, wherein the sensor device comprises a glucose sensing device.

230. The system according to claim 1 and/or any one or more other claims herein, further comprising a server.

231. The system according to claim 230 and/or any one or more other claims herein, wherein the server is configured to receive data from the fluid delivery device.

232. The system according to claim 231 and/or any one or more other claims herein, wherein the data received comprises: patient data; fluid delivery device data; or both.

233. The system according to claim 231 and/or any one or more other claims herein, wherein the system is configured to perform trend analysis based on the data received by the server.

234. The system according to claim 230 and/or any one or more other claims herein, wherein the server is configured to receive patient glucose data.

235. The system according to claim 230 and/or any one or more other claims herein, wherein the server is configured to receive data selected from the group consisting of operating settings such as basal rates, bolus volumes, and/or preconfigured extended bolus volumes; bolus calculator settings such as insulin-to- carbohydrate ratio data, insulin sensitivity data, and/or correction factor data; alarm threshold settings such as occlusion sensitivity data and/or reservoir volume warning level data; audio settings for alarms; and combinations thereof.

236. The system according to claim 230 and/or any one or more other claims herein, wherein the server is configured to receive data selected from the group consisting of sleep data; sleep schedule data; heart rate data; blood pressure data; exercise data; exercise schedule data; meal ingestion data; meal ingestion schedule data; and combinations thereof.

237. The system according to claim 1 and/or any one or more other claims herein, further comprising a user interface.

238. The system according to claim 237 and/or any one or more other claims herein, wherein the fluid delivery device comprises at least a portion of the user interface.

239. The system according to claim 238 and/or any one or more other claims herein, wherein the at least a portion of the user interface included in the fluid delivery device is configured to perform a limited set of functions.

240. The system according to claim 239 and/or any one or more other claims herein, wherein the limited set of functions comprises only a command to deliver a single bolus.

241. The system according to claim 237 and/or any one or more other claims herein, further comprising a user device, wherein the user device comprises at least a portion of the user interface.

242. The system according to claim 1 and/or any one or more other claims herein, further comprising a processing unit comprising a processor and a memory storage element coupled to the processor, wherein the memory storage element stores instructions for the processor to perform an algorithm.

243. The system according to claim 242 and/or any one or more other claims herein, wherein the fluid delivery device comprises at least a portion of the processing unit.

244. The system according to claim 242 and/or any one or more other claims herein, further comprising a sensor device comprising at least a portion of the processing unit.

245. The system according to claim 242 and/or any one or more other claims herein, wherein the algorithm is configured to provide a suggestion comprising a suggested change to one or more agent delivery parameters.

246. The system according to claim 245 and/or any one or more other claims herein, wherein the suggested change is the delivery of a bolus of the agent.

247. The system according to claim 245 and/or any one or more other claims herein, wherein the suggested change is the modification of a continuous flow rate of the agent to be delivered.

248. The system according to claim 242 and/or any one or more other claims herein, wherein the algorithm is configured to adjust the delivery of the agent based on patient sleep.

249. The system according to claim 242 and/or any one or more other claims herein, wherein the algorithm is configured to monitor delivery of the agent and to adjust future delivery of the agent in order to minimize waste of the agent.

250. The system according to claim 1 and/or any one or more other claims herein, further comprising a functional element comprising one or more sensors, transducers, and/or other functional elements.

251. The system according to claim 250 and/or any one or more other claims herein, wherein the functional element comprises at least one bubble trap, and wherein the fluid pathway comprises the at least one bubble filter and/or other bubble trap.

252. The system according to claim 1 and/or any one or more other claims herein, further comprising an alert assembly including at least one alert element, wherein the alert assembly is configured to alert the user.

253. The system according to claim 252 and/or any one or more other claims herein, wherein the fluid delivery device comprises the alert assembly.

254. The system according to claim 252 and/or any one or more other claims herein, wherein the at least one alert element comprises two or more alert elements.

255. The system according to claim 254 and/or any one or more other claims herein, wherein the at least one alert element comprises a first alert element and a second element, and wherein the first alert element is independently activatable.

256. The system according to claim 254 and/or any one or more other claims herein, wherein the at least one alert element comprises a tactile alert element and a second alert element.

257. The system according to claim 1 and/or any one or more other claims herein, further comprising an accessory device.

258. The system according to claim 257 and/or any one or more other claims herein, wherein the accessory device comprises one, two, or more functional elements.

259. The system according to claim 257 and/or any one or more other claims herein, wherein the accessory device comprises a bubble removal assembly.

260. The system according to claim 259 and/or any one or more other claims herein, wherein the bubble removal assembly is configured to detachably and fluidly connect with the fluid pathway and remove a bubble from the fluid pathway.

261. The system according to claim 257 and/or any one or more other claims herein, wherein the accessory device comprises a fill assembly constructed and arranged to deliver the agent into the reservoir.

262. The system according to claim 257 and/or any one or more other claims herein, wherein the accessory device comprises a refill assembly constructed and arranged to refill the reservoir with the agent.

263. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured in a closed-loop delivery mode, and wherein delivery of the agent is based on both a patient parameter and a non-patient parameter.

264. The system according to claim 263 and/or any one or more other claims herein, wherein the patient parameter comprises a blood glucose level.

265. The system according to claim 263 and/or any one or more other claims herein, wherein the non-patient parameter comprises a power level of the power supply, a volume level of the reservoir, or both.

266. The system according to claim 263 and/or any one or more other claims herein, wherein the closed-loop delivery is biased toward underdelivery if a parameter exceeds a threshold.

267. The system according to claim 266 and/or any one or more other claims herein, wherein: the patient parameter comprises a blood glucose level; and the non-patient parameter comprises a volume level of the reservoir, and wherein the closed-loop delivery is configured such that: when a current blood glucose of the patient is at a level that correlates to a delivery of the agent at a volume X, a volume less than X is delivered when a current reservoir volume level is below a threshold.

268. The system according to claim 263 and/or any one or more other claims herein, wherein the closed-loop delivery is biased toward overdelivery if a parameter exceeds a threshold.

269. The system according to claim 268 and/or any one or more other claims herein, wherein: the patient parameter comprises a blood glucose level; and the non-patient parameter comprises a power level of the power supply, and wherein the closed-loop delivery is configured such that: when a current blood glucose of the patient is at a level that correlates to a delivery of the agent at a volume X, a volume more than X is delivered when the power level of the power supply is below a threshold.