Fluid delivery system

Abstract

Provided herein are fluid delivery systems including a fluid delivery device. The fluid delivery device includes a reservoir assembly, a pumping assembly, an agent delivery assembly, and a drive assembly. The reservoir assembly stores an agent to be delivered to a patient. The pumping assembly includes: a barrel including a barrel lumen; a piston that translates and rotates within the barrel lumen; an inlet fluidly connecting the barrel lumen to the reservoir assembly; and an outlet fluidly connected to the barrel lumen. The agent delivery assembly includes a flow path that receives the agent from the outlet of the pumping assembly. The drive assembly causes the translation of the piston and the rotation of the piston. Rotation of the piston alternatingly connects the inlet and outlet to the barrel lumen. Translation of the piston propels the agent to the agent delivery assembly.

Description

[0001] Attorney Docket No. DYM-003-PCT

[0002] FLUID DELIVERY SYSTEM

[0003] RELATED APPLICATIONS

[0004]

[0001] This application claims the benefit of United States Provisional Application Serial Number 63 / 695,287 (Docket No. DYM-003-PR1), titled “Fluid Delivery System” filed September 16, 2024, the content of which is incorporated by reference in its entirety for all purposes.

[0005]

[0002] This application claims the benefit of United States Provisional 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 by reference in its entirety for all purposes.

[0006]

[0003] This application claims the benefit of United States Provisional Application Serial Number 63 / 766,169 (Docket No.: DYM-003-PR3), titled “Fluid Delivery System” filed March 3, 2025, the content of which is incorporated by reference in its entirety.

[0007]

[0004] This application is related to United States Provisional 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 by reference in its entirety for all purposes.

[0008]

[0005] This application is related to International PCT Patent Application Serial Number PCT / US2025 / 012907 (Docket No. DYM-001-PCT), titled “Fluid Delivery System” filed January 24, 2025, Publication Number WO 2025 / 160363, published July 31, 2025, the content of which is incorporated by reference in its entirety.

[0009]

[0006] This application is related to United States Provisional 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 by reference in its entirety for all purposes.

[0010] FIELD OF THE INVENTIVE CONCEPTS

[0011]

[0007] The present inventive concepts relate generally to systems, devices, and methods for the delivery of insulin or other agent to a patient.

[0012] BACKGROUND Attorney Docket No. DYM-003-PCT

[0013]

[0008] 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.

[0014]

[0009] There is a need for improved agent delivery systems, devices, and methods.

[0015] SUMMARY

[0016]

[0010] According to an aspect of the present inventive concepts, a fluid delivery system comprises a fluid delivery device comprising a reservoir assembly, an agent delivery assembly, and a pumping assembly. The reservoir assembly can be constructed and arranged to store an agent to be delivered to a patient. The pumping assembly can comprise a barrel including a barrel lumen, a piston configured to translate and rotate within the barrel lumen, an inlet fluidly connecting the barrel lumen to the reservoir assembly, and an outlet fluidly connected to the barrel. The agent delivery assembly can comprise a flow path constructed and arranged to receive the agent from the outlet of the pumping assembly. Rotation of the piston can alternatingly connect the inlet and outlet to the barrel lumen. Translation of the piston can propel the agent to the agent delivery assembly.

[0017] [Oi l] In some embodiments, the agent delivery assembly comprises a cannula configured to be inserted into the patient.

[0018]

[0012] In some embodiments, the agent delivery assembly comprises a fluid connector configured to fluidly attach to a patient access device. The agent delivery assembly can comprise a luer.

[0019]

[0013] In some embodiments, the fluid delivery system further comprises a drive assembly configured to perform the rotation and the translation of the piston. The drive assembly can comprise a rotary actuator and a cam mechanism. The rotary actuator can comprise a motor. The motor can comprise a stepper motor. The drive assembly can comprise an electromagnetic drive.

[0020]

[0014] In some embodiments, the barrel lumen comprises a diameter of at least 0.25mm and / or no more than 3mm, such as a diameter of approximately 0.7mm, 0.8mm, 0.9mm, and / or 1.0mm.

[0021]

[0015] In some embodiments, the barrel comprises a wall thickness of at least 0.05mm and / or no more than 2.0mm.

[0022]

[0016] In some embodiments, the pumping assembly comprises a variable volume chamber that comprises the volume within the barrel lumen between the distal end of the Attorney Docket No. DYM-003-PCT barrel lumen and the piston, and the piston is configured to be retracted to increase the volume of the variable volume chamber and advanced to decrease the volume of the variable volume chamber. The variable volume chamber can comprise a minimum volume comprising a volume of at least 0. lOpL and / or a volume of no more than 1.OOpL. The variable volume chamber can comprise a maximum volume comprising a volume of at least 0.56pL and / or a volume of no more than 2.46pL. Increasing the volume of the variable volume chamber can be configured to fill the chamber with a volume of the agent. The fill volume can comprise a volume of at least 0. lOpL and / or no more than 2.00pL. The piston can be configured to be retracted a distance of at least 0.2mm and / or no more than 2.0mm. The piston can be configured to be advanced a distance of at least 0.2mm and / or no more than 2.0mm. Increasing the volume of the variable volume chamber can be configured to fill the variable volume chamber with the agent, and wherein decreasing the volume of the variable volume chamber is configured to deliver the agent to the agent delivery assembly. The pumping assembly can be configured to fill the variable volume chamber in no less than 0.05 seconds and / or no longer than 1.00 seconds. The pumping assembly can be configured to deliver the agent from the variable volume chamber in no less than 0.05 seconds and / or no longer than 1.00 seconds. The pumping assembly can be configured to fill the variable volume chamber and deliver the agent from the variable volume chamber in no less than 0.15 seconds and / or no longer than 5.00 seconds.

[0023]

[0017] According to another aspect of the present inventive concepts, a fluid delivery system comprises a fluid delivery device. The fluid delivery device comprises: a reservoir assembly; a pumping assembly; an agent delivery assembly; and a drive assembly. The reservoir assembly is constructed and arranged to store an agent to be delivered to a patient. The pumping assembly comprises: a barrel including a barrel lumen; a piston configured to translate and rotate within the barrel lumen; an inlet fluidly connecting the barrel lumen to the reservoir assembly; and an outlet fluidly connected to the barrel lumen. The agent delivery assembly comprises a flow path constructed and arranged to receive the agent from the outlet of the pumping assembly. The drive assembly is constructed and arranged to cause the translation of the piston and to cause the rotation of the piston. Rotation of the piston alternatingly connects the inlet and outlet to the barrel lumen, and translation of the piston propels the agent to the agent delivery assembly Attorney Docket No. DYM-003-PCT

[0024]

[0018] In some embodiments, the drive assembly comprises: at least one force generating module; and at least one motion converting module. The at least one force generating module can comprise a rotary force generating module. The rotary force generating module can comprise a component selected from the group consisting of: arrangement of one or more coils and one or more magnets that can be collectively constructed and arranged to provide rotary motion; motor, such as a DC motor, an AC motor, a stepper motor, and / or a Lavet motor; a piezo motor; a squiggle motor; a torsional spring; and combinations thereof. The at least one motion converting module can comprise a rotary-to-linear motion converting module. The rotary-to-linear motion converting module can comprise a component selected from the group consisting of: a mating pin and slot arrangement; a rack and pinion assembly; a cam; a clicky-pen assembly; an arrangement of magnets with a multi-state linear bias based on rotational position; a living hinge; and combinations thereof. The at least one force generating module can comprise a linear force generating module. The linear force generating module can comprise a component selected from the group consisting of: an arrangement of one or more coils and one or more magnets that can be configured to provide translational motion; a voice coil; a solenoid; a piezo actuator; a squiggle motor; a magnetic linear drive; a shaped memory wire; and combinations thereof. The at least one motion converting module can comprise a linear-to-rotary motion converting module. The linear-to- rotary motion converting module can comprise a component selected from the group consisting of: a mating pin and slot arrangement; a rack and pinion assembly; a cam; a clicky- pen assembly; an arrangement of magnets with a multi-state linear bias based on rotational position; and combinations thereof.

[0025]

[0019] In some embodiments, the drive assembly comprises: a first force generating module; and a second force generating module, and the first force generating module is constructed and arranged to cause the translation of the piston, and the second force generating module is configured to cause the rotation of the piston.

[0026]

[0020] In some embodiments, the drive assembly comprises: a first force generating module; a second force generating module; and a first motion converting module. The first force generating module and the second force generating module each comprise a rotary force generating module, and the first motion converting module can comprise a rotary-to- linear motion converting module. The first force generating module and the second force generating module each comprise a linear force generating module, and the first motion converting module can comprise a linear-to-rotary motion converting module. Attorney Docket No. DYM-003-PCT

[0027]

[0021] In some embodiments, the drive assembly comprises: a first force generating module; a second force generating module; a first motion converting module; and a second motion converting module. The first force generating module can comprise a rotary force generating module, and the second force generating module can comprise a linear force generating module, and the first motion converting module can comprise a rotary-to-linear motion converting module, and the second motion converting module can comprise a linear- to-rotary motion converting module.

[0028]

[0022] In some embodiments, the drive assembly comprises: a first force generating module; and a first motion converting module, and the first force generating module is configured to cause the rotation of the piston and to apply a force to the first motion converting module to cause the translation of the piston. The first force generating module can comprise a motor and / or other rotary force generating module, and the first motion converting module can comprise a mating pin and slot arrangement. The first force generating module can comprise a motor and / or other rotary force generating module, and the first motion converting module can comprise a face cam arrangement. The first force generating module can comprise a motor and / or other rotary force generating module, and the first motion converting module can comprise a cam follower arrangement. The first force generating module can comprise a motor and / or other rotary force generating module, and the first motion converting module can comprise a rack and pinion arrangement. The drive assembly can further comprise a rotary decoupler. The drive assembly can further comprise a second motion converting module comprising a linear-to-rotary motion converter.

[0029]

[0023] In some embodiments, the drive assembly comprises: a first force generating module; and a first motion converting module, and the first force generating module is configured to cause the translation of the piston and to apply a force to the first motion converting module to cause the rotation of the piston. The first motion converting module can comprise a dicky pen arrangement. The first force generating module can comprise a piezo actuator. The drive assembly can comprise: a first magnet assembly operably attached to the piston; a second magnet assembly constructed and arranged to apply a first magnetic force to the first magnet assembly to cause the translation of the piston; and a third magnet assembly configured to apply a second magnetic force to the first magnet assembly to cause the rotation of the piston. The piston and barrel can collectively comprise a mating pin and slot arrangement configured to cause the piston to translate without significant rotation during a mid-portion of the translation of the piston. The piston can comprise the pin and the barrel Attorney Docket No. DYM-003-PCT can comprise the slot. The slot can comprise a proximal end and a distal end, and the slot can further comprise a tapered entry geometry on the proximal end, the distal end, or both. The second magnet assembly can comprise at least one electromagnet, and activation of the at least one electromagnet causes the translation of the piston. The second magnet assembly can comprise a first permanent magnet, and the drive assembly can further comprise a force generating module configured to cause the second magnet assembly to move between a first position and a second position, and the second magnet assembly can be configured to cause a forward translation of the piston when the second magnet assembly can be in the first position. The second magnet assembly can further comprise a second permanent magnet, and the second permanent magnet can be configured to cause a backward translation of the piston when the second magnet assembly can be in the second position. The third magnet assembly can comprise one or more electromagnets, and activation of the one or more electromagnets causes the rotation of the piston. The third magnet assembly can comprise one or more permanent magnets.

[0030]

[0024] In some embodiments, the drive assembly comprises a motor and / or other rotary force generating module and a motion modifying assembly comprising a rotation limiter, and the first motion converting module comprises a rotary-to-linear nut and gear assembly.

[0031]

[0025] In some embodiments, the drive assembly comprises: at least one force generating module; and at least one motion modifying module. The at least one motion modifying module can comprise a component constructed and arranged to amplify and / or de-amplify the motion provided by the at least one force generating module. The at least one motion modifying module can comprise a component constructed and arranged to amplify and / or deamplify the force provided by the at least one force generating module. The at least one motion modifying module can comprise a gear box. The gear box can comprise a clutch.

[0032] The at least one motion modifying module can comprise a non-360 degree tooth gear. The at least one motion modifying module can comprise a lever. The lever can be constructed and arranged to amplify the force delivered by the first force generating module and to de-amplify the distance delivered by the first force generating module. The at least one motion modifying module can comprise a clutch. The at least one motion modifying module can comprise a rotary-to-linear decoupler.

[0033]

[0026] In some embodiments, the fluid delivery device comprises a maximum height, and the piston comprises an outer diameter that is at least 10% of the maximum height. Attorney Docket No. DYM-003-PCT

[0034]

[0027] In some embodiments, the barrel lumen comprises a mating segment that slidingly interfaces with the piston, and the piston comprises an outer diameter that is at least 1%, 2%, and / or 3% larger than a diameter of the mating segment of the piston.

[0035]

[0028] In some embodiments, the pumping assembly comprises a sealing element positioned between the piston and the barrel, and the sealing element is constructed and arranged to provide a seal as the piston translates within the sealing element, and the barrel lumen comprises a diameter that is at least 1%, 2%, and / or 3% larger than the outer diameter of the segment of the piston that translates through the sealing element.

[0036]

[0029] In some embodiments, a segment of the piston and a segment of the barrel lumen overlap by at least 1mm, 2mm, and / or 3mm.

[0037]

[0030] In some embodiments, the drive assembly comprises a motor and / or other rotary force generator and a gear box, and the gear box has a gear ratio of at least 10: 1, 50: 1, 100: 1, and / or 125: 1.

[0038]

[0031] In some embodiments, the fluid delivery device further comprises a housing surrounding at least the pumping assembly and the drive assembly.

[0039]

[0032] In some embodiments, the piston comprises a diameter of at least 0.1mm, such as a diameter of at least 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, and / or 0.8mm.

[0040]

[0033] In some embodiments, the piston comprises a diameter of no more than 2.0mm, such as a diameter of no more than 1.9mm, 1.8mm, 1.7mm, 1.6mm, 1.5mm, 1.4mm, or 1.3mm.

[0041]

[0034] In some embodiments, the pumping assembly is constructed and arranged to translate the piston a translation distance of no more than 1.2mm, such as a translation distance of no more than 1.1mm, 1.0mm, 0.9mm, or 0.8mm.

[0042]

[0035] In some embodiments, the piston comprises a relief, and wherein the relief comprises a depth of at least 0.02mm, such as a depth of at least 0.03mm, 0.04mm and / or 0.05mm.

[0043]

[0036] In some embodiments, the piston comprises a relief, and the relief can comprise a depth of no more than 0.4mm, such as a depth of no more than 0.3mm and / or 0.2mm.

[0044]

[0037] In some embodiments, the piston comprises a diameter and a relief, and the relief can comprise a depth of no more than 50% of the diameter of the piston, such as no more than 40% and / or 30% of the diameter of the piston.

[0045]

[0038] In some embodiments, the inlet and / or outlet comprises a port diameter of no more than 0.8mm, such as a diameter of no more than 0.7mm, 0.6mm, 0.5mm, or 0.4mm. Attorney Docket No. DYM-003-PCT

[0046]

[0039] In some embodiments, the inlet and / or outlet comprises a port diameter of at least 0.1mm, such as a diameter of at least 0.2mm.

[0047]

[0040] In some embodiments, the inlet and / or outlet comprises a port diameter of no more than 80% of the diameter of the barrel lumen, such as no more than 70%, 60%, 50%, or 40%, of the diameter of the barrel lumen.

[0048]

[0041] In some embodiments, the pumping assembly comprises a housing with a proximal end and a distal end, and the inlet and / or outlet can comprise a port that is positioned at least 1mm, or at least 2mm from the proximal end, and / or the port can be positioned no more than 5mm, or no more than 4mm from the proximal end.

[0049]

[0042] In some embodiments, the pumping assembly comprises a housing with a proximal end and a distal end, and the inlet and / or outlet can comprise a port that is positioned at least 0.5mm, 0.75mm, or 1.0mm from the distal end, and / or the port can be positioned no more than 2.0mm, such as no more than 1.75mm and / or 1.5mm.

[0050]

[0043] In some embodiments, the drive assembly comprises a motor, and the motor can comprise a diameter of no more than 6mm, such as a diameter of no more than 5mm.

[0051]

[0044] In some embodiments, the fluid delivery device comprises a height, the drive assembly comprises a motor with a diameter, and the height can comprise a dimension equal to no more than the diameter of the motor plus at most 1.5mm, such as at most 1.4mm, 1.3mm, 1.2mm, and / or 1.1mm.

[0052]

[0045] In some embodiments, the drive assembly comprises a motor, and the motor can comprise a length of no more than 25mm, such as no more than 24mm, 23mm, 22mm, 21mm, 20mm, and / or 19mm.

[0053]

[0046] In some embodiments, the drive assembly comprises a cam assembly, and the cam assembly can comprise a diameter of no more than 10mm, such as no more than 9mm, 8mm, 7mm, 6mm, and / or 5mm.

[0054]

[0047] In some embodiments, the drive assembly comprises a cam assembly comprising a ball bearing, and the ball bearing can comprise a diameter of no more than 2.5mm, such as a diameter of no more than 2.0mm.

[0055]

[0048] In some embodiments, the drive assembly comprises a cam assembly, and the cam assembly can comprise a ramp angle of no more than 50°, such as no more than 45°, 40°, 30°, and / or 20°.

[0056]

[0049] In some embodiments, the drive assembly comprises a cam assembly, and the cam assembly comprises a ramp angle of at least 5°, such as at least 10°, and / or at least 15°. Attorney Docket No. DYM-003-PCT

[0057]

[0050] In some embodiments, the drive assembly comprises a cam assembly with a 360° profile, and the cam assembly can further comprise one or more flat portions that comprise at least 90° of the 360° profile, such as at least 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, 190°, 200°, 210°, 220°, and / or 230° of the 360° profile.

[0058]

[0051] In some embodiments, the drive assembly comprises a cam assembly with a 360° profile, and wherein the cam assembly further comprises one or more flat portions that comprise no more than 320° of the 360° profile, such as no more than 300°, 280°, and / or 260° of the 360° profile.

[0059]

[0052] 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.

[0060] INCORPORATION BY REFERENCE

[0061]

[0053] 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.

[0062] BRIEF DESCRIPTION OF THE DRAWINGS

[0063]

[0054] Fig. 1 illustrates a block diagram of an embodiment of an agent delivery system, consistent with the present inventive concepts.

[0064]

[0055] Fig. 1A illustrates a block diagram of another embodiment of an agent delivery system, consistent with the present inventive concepts.

[0065]

[0056] Fig. 2 illustrates top and side views of a fluid delivery device, consistent with the present inventive concepts.

[0066]

[0057] Fig. 3 illustrates a schematic view of a fluid handling portion of a delivery device, consistent with the present inventive concepts. Attorney Docket No. DYM-003-PCT

[0067]

[0058] Figs. 3A, and 3B illustrate a perspective view of an embodiment of a fluid propulsion module, and a perspective view of a piston of the fluid propulsion module, respectively, consistent with the present inventive concepts.

[0068]

[0059] Figs. 4A-B illustrate a perspective view of an embodiment of a fluid propulsion module, and perspective view of a piston of the fluid propulsion module, respectively, consistent with the present inventive concepts.

[0069]

[0060] Fig. 5 illustrates a side sectional view of an embodiment of a pumping assembly including a portion of a sensor assembly, consistent with the present inventive concepts.

[0070]

[0061] Fig. 6 illustrates a perspective view of an embodiment of a pumping assembly including a tapered piston, consistent with the present inventive concepts.

[0071]

[0062] Fig. 7 illustrates a block diagram of an embodiment of a pumping assembly comprising a force generating module and a motion converting module, consistent with the present inventive concepts.

[0072]

[0063] Fig. 7A illustrates a perspective view of an embodiment of a pumping assembly comprising a rotary force generating module and a motion converting module comprising a pin and slot arrangement, consistent with the present inventive concepts.

[0073]

[0064] Fig. 7B illustrates a perspective view of an embodiment of a pumping assembly comprising a rotary force generating module and a motion converting module comprising a face cam arrangement, consistent with the present inventive concepts.

[0074]

[0065] Fig. 7C illustrates a side sectional view of a rotary force generator and a motion converting module comprising a cam follower arrangement, consistent with the present inventive concepts.

[0075]

[0066] Fig. 7D illustrates a perspective view of an embodiment of a pumping assembly comprising a rotary force generating module and a motion converting module comprising a rack and pinion arrangement, consistent with the present inventive concepts.

[0076]

[0067] Fig. 7E illustrates a perspective view of an embodiment of a pumping assembly comprising a linear force generating module and a motion converting module comprising a clicky-pen arrangement, consistent with the present inventive concepts.

[0077]

[0068] Fig. 7F illustrates a perspective view of an embodiment of a pumping assembly comprising a rotary force generating module and a motion converting module comprising a nut and gear assembly, consistent with the present inventive concepts.

[0078]

[0069] Fig. 8 illustrates a block diagram of an embodiment of a pumping assembly comprising two force generating modules, consistent with the present inventive concepts. Attorney Docket No. DYM-003-PCT

[0079]

[0070] Fig. 9 illustrates a block diagram of an embodiment of a pumping assembly comprising two force generating modules and a motion converting module, consistent with the present inventive concepts.

[0080]

[0071] Fig. 9A illustrates a perspective view of an embodiment of a pumping assembly comprising two linear force generating assemblies and a linear-to-rotary motion converting module, consistent with the present inventive concepts.

[0081]

[0072] Fig. 10 illustrates a block diagram of an embodiment of a pumping assembly comprising two force generating modules and two motion converting modules, consistent with the present inventive concepts.

[0082]

[0073] Fig. 11 illustrates a block diagram of an embodiment of a drive assembly comprising a force generating module and a motion modifying module, consistent with the present inventive concepts.

[0083]

[0074] Figs. 12A-C illustrate side sectional views of a drive assembly and fluid propulsion module with a piston in a retracted state, and advanced state, respectively, consistent with the present inventive concepts.

[0084]

[0075] Figs. 13A-B illustrate a top perspective view and bottom perspective view, respectively, of an embodiment of a fluid delivery device, consistent with the present inventive concepts.

[0085]

[0076] Figs. 14 and 14A illustrate a perspective view and a magnified view of an embodiment of a pumping assembly of a fluid delivery device, respectively, consistent with the present inventive concepts.

[0086]

[0077] Figs. 15A-H illustrate a series of perspective views of an embodiment of a pumping assembly positioned in various stages of a pumping cycle, consistent with the present inventive concepts.

[0087]

[0078] Fig. 16 illustrates a side sectional view of a fluid delivery device, consistent with the present inventive concepts.

[0088] DETAILED DESCRIPTION OF THE DRAWINGS

[0089]

[0079] 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 Attorney Docket No. DYM-003-PCT construed as including various modifications, equivalents, and / or alternatives of the embodiments described herein.

[0090]

[0080] 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.

[0091]

[0081] 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.

[0092]

[0082] 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.).

[0093]

[0083] 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; Attorney Docket No. DYM-003-PCT magnetism; mechanical linkages; light; sound such as ultrasound; and / or other materials and / or components.

[0094]

[0084] 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.

[0095]

[0085] 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.

[0096]

[0086] 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.

[0087] 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.

[0097]

[0088] 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. Attorney Docket No. DYM-003-PCT

[0098]

[0089] 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.

[0099]

[0090] 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.

[0100]

[0091] 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.

[0101]

[0092] 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.

[0102]

[0093] 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.

[0103]

[0094] As used herein, the terms “about” or “approximately” shall refer to ± 20% of a stated value.

[0104]

[0095] 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 Attorney Docket No. DYM-003-PCT 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.

[0105]

[0096] 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.

[0106]

[0097] 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.

[0107]

[0098] 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.

[0108]

[0099] 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. 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 Attorney Docket No. DYM-003-PCT 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.

[0109]

[0100] 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.

[0110]

[0101] 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. Attorney Docket No. DYM-003-PCT

[0111]

[0102] As used herein, the term “material” can refer to a single material, or a combination of two, three, four, or more materials.

[0112]

[0103] 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.

[0113]

[0104] The terms “data” and “information” are used interchangeably herein.

[0114]

[0105] 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.

[0115]

[0106] 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.

[0116]

[0107] 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. Attorney Docket No. DYM-003-PCT

[0117]

[0108] 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. A 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).

[0118]

[0109] 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 (e.g., a set of multiple delivery devices 100, such as a first delivery device 100a, a second delivery device 100b, a third delivery device 100c, and so on, as described herein). 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 some form of 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 (e.g., to be delivered to subcutaneous tissue of the patient). Attorney Docket No. DYM-003-PCT

[0119] 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 another agent (e.g., glucagon).

[0120]

[0110] 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.

[0121]

[0111] Delivery device 100 can include a reservoir assembly comprising one or more reservoirs for storing agent 20 (or other material), reservoir 110 shown. Reservoir 110 includes one or more internal voids, chamber 112, for storing agent 20. 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, reservoir 110 is positioned within a sealed portion of delivery device 100 (e.g., a portion at a pressure above or below atmospheric pressure). In some embodiments, reservoir 110 comprises a flexible wall portion, such as when reservoir 110 comprises a non-flexible portion and a flexible portion. Reservoir 110 can comprise a flexible bag-like construction.

[0122]

[0112] 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. Pumping assembly 130 can comprise a piston-driven pumping assembly, such as is described in reference to Figs. 3, 3A, 3B, 4A, 4B, and otherwise herein.

[0123]

[0113] Delivery device 100 can include tubes, lumens, conduits, manifolds, and / or other fluid pathways, fluid pathway 140 shown, that fluidly connect various components of delivery device 100. A distal portion of fluid pathway 140 can be fluidly attached to cannula assembly 180, as shown. Cannula assembly 180 can comprise one or more components (e.g., needles, catheters, or other cannulas, and / or a luer or other fluid pathway connector) which can be constructed and arranged to deliver agent 20 to an internal location of the patient (e.g., an agent 20 as received from reservoir 110, pumping assembly 130, and / or Attorney Docket No. DYM-003-PCT 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. Cannula assembly 180 can comprise a transcutaneously inserted fluid delivery element, cannula 185 shown (e.g., a needle, or soft cannula). Cannula 185 can be configured such that its distal end is positioned in subcutaneous tissue of the patient. In some embodiments, cannula 185 comprises a luer or other fluid connector (e.g., not a transcutaneous cannula), such as a luer that can be attached to an accessory device 300 comprising a patient access device, such as an infusion set (e.g., a subcutaneous infusion set), an intravenous line, an epidural access catheter, and / or other device for accessing an internal location of the patient.

[0124]

[0114] 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 (e.g., one or more rechargeable and / or non- rechargeable 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 (e.g., a rechargeable 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 nonelectrical energy to one or more components of delivery device 100.

[0125]

[0115] Delivery device 100 can include one or more casings 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.

[0126]

[0116] 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 Attorney Docket No. DYM-003-PCT 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 at a bottom portion 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 (e.g., a removable film) 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.

[0127]

[0117] 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 (e.g., provide one or more signals used to record one or more patient parameters, one or more system 10 parameters, or both). 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). In some embodiments, sensor 250 comprises a sensor configured to provide one or more signals used to: detect individual pulses of fluid delivery, detect an occlusion within a fluid delivery path, detect a leak of a fluid delivery path, or two or all three of these. In some embodiments, sensor 250 comprises a sensor (e.g., an air pressure or other pressure sensor, a force sensing resistor, a strain gauge, an accelerometer, and / or other sensor) that is configured to provide one or more signals used to measure one or more forces applied to a component of delivery device 100 (e.g., one or more forces applied to a component of pumping assembly 130, such as fluid propulsion module 1310 and / or drive module 1320, each as described herein).

[0128]

[0118] 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, and / or for the output of information from system 10 to a user. In Attorney Docket No. DYM-003-PCT 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). User device 700 can comprise one, two, or more similar or different electronic devices, such as one, two, or more devices selected from the group consisting of: cell phone such as a smart phone; tablet; laptop computer; desktop computer; voice-activated device; electronic assistant device; a smart watch; a handheld electronic device; a brain-machine interface; and combinations of these. User device 700 can comprise a user interface, user interface 760 shown.

[0129]

[0119] 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”.

[0130]

[0120] 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 herein.

[0131]

[0121] 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, and / 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.

[0132]

[0122] 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 Attorney Docket No. DYM-003-PCT comprising a non-tactile alert element, such as an indicator light, a speaker, and / or other output device that alerts the user to an alert condition.

[0133]

[0123] 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.

[0134]

[0124] 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, respectively, 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 can be 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 another system 10 component, such as to initiate, stop, and / or Attorney Docket No. DYM-003-PCT 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.

[0135]

[0125] 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, clinician, 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.

[0136]

[0126] 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. Attorney Docket No. DYM-003-PCT

[0137] 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.

[0138]

[0127] 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.

[0139]

[0128] In some embodiments, system 10 includes one or more servers, server 80 shown, that 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 “off-site” server (e.g., remotely located from the users of system 10), such as a server owned, maintained, Attorney Docket No. DYM-003-PCT and / or otherwise provided by the provider of system 10. Alternatively, or additionally, server 80 can comprise a cloud-based server.

[0140]

[0129] In some embodiments, at least a portion of system 10 comprises a temporary use and / or disposable component (“disposable”, “disposable component” and the like herein). For example, delivery device 100 can be configured as 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, and then to be replaced. 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 100a to a second delivery device 100b. In some embodiments, the multi-use disposable component is transferred to a third delivery device 100c, and so on, but the transfers are limited to a maximum number of transfers (e.g., less than 100, less than 50, or less than 20 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, and a second portion that is configured to be used for a second maximum period, 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 (e.g., a device that is used to deliver an agent for less than 7, 6, 5, 4, and / or 3 days).

[0141]

[0130] 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.

[0142]

[0131] 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 related to the delivery of agent 20 and / or other parameters related to the functionality of delivery device 100. Additionally, or alternatively, sensor 125 can comprise one, two, or more sensors that are configured to measure one or more fluid delivery Attorney Docket No. DYM-003-PCT parameters and / or other delivery device 100 parameters, such as to monitor for: an occlusion (e.g., via sensing of pressure, flow rate, and / or other parameter); a leak; an overheat condition; a low power condition; the encountering of an undesired shock; detachment of delivery device 100 from the patient’s skin; and / or other device 100 condition.

[0143]

[0132] In some embodiments, reservoir 110 is configured to be filled (e.g., filled with agent 20 using an aseptic technique) 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.

[0144]

[0133] 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. Transceiver 171 and other portions of communication module 170 can be configured to transmit data to, and / or receive data from user device 700 and / or another component of system 10.

[0145]

[0134] 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 elements 99, such as functional element 399 shown. In some embodiments, accessory device 300 Attorney Docket No. DYM-003-PCT comprises a glucose monitor and / or other patient physiologic information monitoring device (e.g., when accessory device comprises all or a portion of sensor assembly 200).

[0146]

[0135] 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 0. ImL, 0.2mL, and / or 0.3mL over a time period of no more than three days. In some embodiments, agent 20 stored in a first delivery device 100a can be transferred to another device, such as to a second delivery device 100b.

[0147]

[0136] System 10 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 one or more patient physiologic parameters, such as one, two, or more parameters that are monitored by sensor assembly 200. For example, closed-loop delivery of agent 20 comprising insulin can be based on the monitoring of blood glucose level of the patient (e.g., monitoring performed by a sensor assembly 200 configured to monitor blood glucose 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 (e.g., as determined by a sensor assembly 200 and / or by information provided by the patient via user interface 60). In some embodiments, closed-loop delivery can be based on a parameter of delivery device 100. For example, closed-loop delivery can be based on the available power level of power supply 160, and / or the volume of agent 20 available in reservoir 110 for delivery. 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).

[0148]

[0137] 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 Attorney Docket No. DYM-003-PCT 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, height 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 in reference to Fig. 2 herein. 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. In some embodiments, delivery device 100 comprises a major axis of no more than 51.5mm, 45mm, and / or 35mm.

[0149]

[0138] Delivery device 100 can comprise two or more different cross-sectional geometries along one of its axes (e.g., a varying cross-sectional geometry along an axis). For example, two or more cross-sectional geometries can vary along the length DL (e.g., a “sideview” of the device), and / or two or more cross-sectional geometries can vary 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 Attorney Docket No. DYM-003-PCT 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 (e.g., reservoir 110) 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).

[0150]

[0139] 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 Attorney Docket No. DYM-003-PCT 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 (e.g., when reservoir 110 comprises a collapsible bag-like construction). 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.

[0151]

[0140] 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.

[0152]

[0141] 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

[0153] 100 can similarly reduce in magnitude. In some embodiments, at least a portion of housing

[0154] 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.

[0155]

[0142] 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 ports, septum 151 shown. Septum 151 can be constructed and arranged to be piercingly accessed by a needle or other fluid transport element (e.g., a fluid delivery and / or a fluid removal element), such as a needle of accessory device 300 comprising a refill assembly. Septum 151 can be configured to be repeatedly Attorney Docket No. DYM-003-PCT accessed by a fluid transport element (e.g., a needle). 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 transport element.

[0156]

[0143] 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 100 has been positioned on the skin of the patient. In these embodiments, delivery device 100 can be configured for attachment to the skin of the patient no more than a single time.

[0157]

[0144] Internal volume RIV of reservoir 110 can comprise a volume of less than 3mL, 2mL, and / or ImL. 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 (e.g., a length) of no more than 51.5mm, 45mm, and / or 35mm. In some embodiments, reservoir 110 comprises a refillable reservoir (e.g., a reservoir configured to be refilled using an aseptic technique), 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 110 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.

[0158] 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, 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). Attorney Docket No. DYM-003-PCT

[0159]

[0145] 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 (e.g., to prevent refilling of reservoir 110 after delivery device 100 has been first attached to the skin of the patient). For example, a portion of fill port 150 can be located on the patient facing (skin-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).

[0160]

[0146] 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 100a is replaced with a second delivery device 100b). 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 Attorney Docket No. DYM-003-PCT 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.

[0161]

[0147] 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.

[0162]

[0148] 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 111 forms the barrel of a syringe-like construction. In some embodiments, a portion of housing 101 surrounds reservoir 110. Reservoir 110 can include one or more fluid propulsion elements, such as a plunger that translates within a syringe-barrel shaped housing 111. 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, a plunger of delivery device 100 comprises a spring-loaded plunger. For example, a spring-loaded plunger 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 Attorney Docket No. DYM-003-PCT expandable reservoir (e.g., reservoir 110 can comprise elastically biased walls) that is configured to exert a force (e.g., a pressure-generating force) 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.

[0163]

[0149] 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.

[0164]

[0150] 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 equal, 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). Attorney Docket No. DYM-003-PCT

[0165]

[0151] In some embodiments, such as when reservoir 110 comprises a refillable reservoir that is configured to be refilled while reservoir 110 is 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.

[0166]

[0152] In some embodiments, delivery device 100 can comprise multiple delivery devices, such as at least a first delivery device 100a and a second delivery device 100b, 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 100a and transferred to the second delivery device 100b (e.g., to reduce waste of agent 20).

[0167]

[0153] 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 desired (e.g., no longer safe, no longer efficacious, and / or otherwise no longer desirable) 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 Attorney Docket No. DYM-003-PCT 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).

[0168]

[0154] 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, and / or 6mm.

[0169]

[0155] In some embodiments, pumping assembly 130 includes a “MEMS pumping mechanism”, such as a micro-electromechanical system (MEMS) device that is configured to propel agent 20 (e.g., to propel agent 20 from reservoir 110 through cannula assembly 180 to the patient). Pumping assembly 130 can comprise a silicon-layered MEMS device, a metalalloy 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.

[0170]

[0156] Pumping assembly 130 can comprise a “piston-driven” pumping assembly, such as is described in reference to Figs. 3, 3 A, 3B, 4A, 4B, and otherwise herein.

[0171]

[0157] 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 through reservoir 110 to propel agent 20 through cannula assembly 180 to the patient.

[0172] 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 a plunger of delivery device 100 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.

[0173] Pumping assembly 130 and / or fluid pathway 140 can include one or more valves, such as Attorney Docket No. DYM-003-PCT 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 cannula assembly 180.

[0174]

[0158] A lead screw of pumping assembly 130 can be configured to disengage from a plunger, 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, a plunger of delivery device 100 can comprise a magnetic disengagement assembly that is configured to disengage the plunger from the leadscrew. In some embodiments, fill assembly 310 comprises a component that disengages the leadscrew from a plunger 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.

[0175]

[0159] 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. In some embodiments, delivery device 100 is configured to deliver a bolus of agent 20 within a maximum BDP, such as a maximum of 5 minutes, 4 minutes, and / or 3 minutes. Attorney Docket No. DYM-003-PCT

[0176]

[0160] Housing 101 of delivery device 100 can comprise two or more hinged portions (e.g., delivery device 100 comprises two or more hinged portions), 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 when device 100 is attached to the patient 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). 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.

[0177]

[0161] In some embodiments, system 10 comprises a set of two or more delivery devices 100, where at least a first device 100a and a second device 100b comprise two or more different geometric arrangements (e.g., the associated housings 101 or other device 100 components comprise different 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 or other factors of the patient at the time of use. For example, a first configuration (e.g., a delivery device 100a) 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 (e.g. a Attorney Docket No. DYM-003-PCT delivery device 100b) 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 (e.g., a delivery device 100c) 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). Attorney Docket No. DYM-003-PCT

[0178]

[0162] 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 reduce patient discomfort and / or increase 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 corners, for example when each convex portion of housing 101 (e.g., convex corner and / or edge of housing 101) comprises a soft portion.

[0179]

[0163] 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, system 10 comprises a set of housings 101 (e.g., a set of delivery devices 100) that are provided in a range of skin tone colors, for example such that a user (e.g., the patient or a clinician of the patient) can select a housing color to match the 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 100a prior to disposal of the first device and attached to a replacement delivery device (e.g., a second delivery device 100b). In some embodiments, the reusable portion comprises a color tone that is matched to (e.g., approximates) 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 covering with a decorative design and / or a covering that 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).

[0180]

[0164] As described herein, cannula assembly 180 can include one or more fluid delivery elements, such as cannula 185 shown. Cannula 185 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 pass through Attorney Docket No. DYM-003-PCT 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). Cannula 185 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, cannula 185 comprises at least two fluid delivery elements, such as at least a first fluid delivery element cannula 185a and a second fluid delivery element cannula 185b (e.g., where each cannula is configured to deliver the same agent 20 or a different agent 20). Cannula 185a can be configured to deliver agent 20 to the patient for a first time period, and cannula 185b can be configured to deliver agent 20 (e.g., the same or a different agent) to the patient for a subsequent, second time period. In some embodiments, cannula 185 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 cannula 185a can be configured to be inserted through the skin of the patient at a first skin location, and a second cannula 185b can be configured to be inserted through the skin of the patient at a second skin location that is at least 2mm, 4mm, and / or 6mm away from the first location. The two cannula 185 insertions can be performed at relatively the same time (e.g., on the same day), or at different times (e.g., at least 1 day, 2 days, and / or 3 days apart). In some embodiments, cannula assembly 180 includes an infusion set that includes cannula 185 (e.g., comprising a transcutaneous fluid delivery element), where cannula 185 is located at the distal portion of the infusion set. In some embodiments, all or a distal portion of cannula assembly 180 comprises the infusion set, and the infusion set is removably attachable to a more proximal portion of cannula assembly 180.

[0181]

[0165] In some embodiments, delivery device 100 comprises a single component 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 both propel fluid as well as provide a vibrational alert. For example, the single component can comprise a motor that is configured to both perform a fluid pumping operation (e.g., rotate a leadscrew, translate a piston or other fluid propulsion element, and the like) and also to cause a vibration (e.g., a motor or other transducer that can perform the fluid pumping operation without causing the vibration, and can cause the vibration without performing the fluid pumping operation). 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, Attorney Docket No. DYM-003-PCT 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 100, pumping assembly 130, and / or fluid pathway 140).

[0182]

[0166] 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 cannula assembly 180 is configured to deliver agent 20 under the patient’s skin without penetrating the patient’s skin. For example, cannula assembly 180 can be configured to deliver agent 20 to a location under the patient’s skin using high energy bursts that are configured to propel agent 20 through the skin of the patient (e.g., iontophoretic delivery of agent 20).

[0183]

[0167] In some embodiments, fluid pathway 140 includes one or more flow restrictors. For example, fluid pathway 140 can include 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. In some embodiments, the flow restrictor 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 restrictor 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 restrictor 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 restrictor 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.

[0184]

[0168] 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 Attorney Docket No. DYM-003-PCT 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 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 100a can comprise an in-use device, and a second delivery device 100b can comprise a replacement device configured to replace the first device. Subsequently, a third delivery device 100c can replace the second, and a fourth delivery device lOOd can replace the third, and so on. A first device can refer to any delivery device 100 that is in-use in the context of the various situations described herein.

[0185]

[0169] 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 cannula 185 from the skin of the patient), de-activate or otherwise prevent fluid delivery by device 100, alert the patient, and / or perform another function.

[0186]

[0170] 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 cannula 185, 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. Attorney Docket No. DYM-003-PCT

[0187]

[0171] In some embodiments, one or more dimensions, locations of components, geometric 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 configuration replaced with the first configuration or a third configuration, 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 allowing the SPL to be 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 100 that it is replacing, in a comparatively rotated orientation, such as a 180° orientation, such that the SPL of the replacement device is opposite the SPL of the used device.

[0188]

[0172] In some embodiments, delivery device 100 is configured to insert a portion of cannula assembly 180, such as at least a portion of cannula 185, to a depth of insertion, depth DOI. Depth DOI can comprise the distance from the surface of the skin at the SPS to the distal most portion of cannula 185. In some embodiments, cannula 185 comprises an insertable length, length IL. Canula 185 can be inserted into the skin at an angle, angle IA, for example where when angle IA equals 90°, cannula 185 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 cannula 185 is configured to be inserted in a straight trajectory that is perpendicular to the surface of Attorney Docket No. DYM-003-PCT the skin (e.g., where angle IA is 90°). Alternatively, in some embodiments, cannula 185 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 cannula 185 can be configured to be inserted with a non-straight trajectory, such as a curved trajectory, that can be (e.g., 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 cannula 185 is inserted with a non-straight trajectory, cannula 185 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°, cannula 185 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 cannula 185 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 cannula 185 is adjustable, and / or different configurations of delivery device 100 can comprise different angles I A and / or IO.

[0189]

[0173] System 10 can comprise a set of 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).

[0190]

[0174] 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, a power- associated time period PTP of power supply 160 is less than a usage time period UTP of the delivery device 100. 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 operably attach (e.g., electrically attach) power supply 160 to a recharging device, for example a USB charge port. Attorney Docket No. DYM-003-PCT

[0191] 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, and / or by the patient via user interface 60). 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 160a and a second power supply 160b. In these embodiments, the first power supply 160a can be configured to store electrical energy, such as a power supply comprising a battery and / or a capacitor, and the second power supply 160b 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.

[0192]

[0175] Sensor assembly 200 can include sensor 250, as described herein. For example, delivery device 100 can include a sensor assembly 120 that includes at least a portion of sensor assembly 200. Each sensor 250 (e.g., each sensor 125 of sensor assembly 120) can comprise one, two, or more sensors configured to produce one, two, or more signals that are related to one or more system 10 parameters and / or one or more patient parameters (e.g., to “monitor” and / or “record” a parameter and / or to “record” and / or “collect” parameter-related data herein). Sensor 250 can comprise 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 Attorney Docket No. DYM-003-PCT

[0193] 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 cannula 185 or other portion of cannula assembly 180. 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).

[0194]

[0176] In some embodiments, sensor 250 comprises an accelerometer. In these embodiments, processing unit 50 can be configured to monitor signals recorded from sensor 250 comprising an accelerometer to detect a fall and / or other high-impact event of a patient. 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 these embodiments, detection of a high-impact event by system 10 can cause an alert to be delivered to the patient (e.g., an alert to the patient to check to see if cannula 185 or other portions of delivery device 100 are properly inserted into and / or properly attached to the patient). Attorney Docket No. DYM-003-PCT

[0195]

[0177] In some embodiments, sensor assembly 200 (e.g., sensor assembly 120 of device 100) comprises a sleep detector that is configured to detect when the patient is asleep. In some embodiments, system 10 is configured to enter a “sleep mode” when patient sleep is detected (e.g., as detected by sensor assembly 200 and / or as entered by the patient via user interfaced 60). While in sleep mode, system 10 can be configured to adjust a function and / or enter a sleep-related function selected from the group consisting of: enter a sleep related alarm mode in which alerts are modified (e.g., volume increased, tactile sensations increased, or other alert modification); alert thresholds are modified (e.g., less-significant alert conditions are avoided until the patient is awake, and / or alerts thresholds are made more sensitive in order to wake the patient to assess their current condition); and combinations of one or more of these.

[0196]

[0178] Server 80 can be configured to receive data, data 85 described herein, from one, two or more patients and / or one, two, or more other (non-patient) users of system 10. Server 80 can receive data 85 from user device 700 (e.g., a cell phone), for example when device 700 comprises all or a portion of communication module 70, and module 70 is configured to transmit data 85 to server 80 via network 75. Additionally, or alternatively, 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 user device 700 and / or 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 user device 700, 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; Attorney Docket No. DYM-003-PCT 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.

[0197]

[0179] 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 bolus of agent 20 (e.g., initiate the deliveries of a limited number of boluses of agent 20).

[0198]

[0180] 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 between two or more components of system 10, for example between delivery device 100 and sensor assembly 200, between user device 700 and delivery device 100, between user device 700 and sensor assembly 200, between user device 700 and server 80, 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 user device 700 and / or to delivery device 100, via communication module 70.

[0199]

[0181] 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 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 one or more boluses 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 and / or another component of system 10 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 suggest a fill volume to be used in the filling of a future device 100, such as a suggestion that is based on the amount of Attorney Docket No. DYM-003-PCT agent 20 delivered to that patient by one or more previously used devices 100. 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 (e.g., 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 example 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.

[0200]

[0182] 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 cannula 185 of cannula assembly 180 is properly inserted into the patient; delivery device 100 is in a functional state (e.g., no alarm conditions are present); 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, via a user device 700 held by that individual or group) 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.

[0201]

[0183] 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 Attorney Docket No. DYM-003-PCT 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; if an adhesive securing one or more components of delivery device 100 has failed or is failing; and / or if the environment of the patient is unsafe or requires attention (e.g., a fire alarm or other alarm has been activated in the patient environment).

[0202]

[0184] 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.

[0203]

[0185] 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.

[0204]

[0186] 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).

[0205]

[0187] 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 Attorney Docket No. DYM-003-PCT 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.

[0206]

[0188] 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.

[0207]

[0189] 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, 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, reservoir 110 can include at least a portion of housing 101 that surrounds one or more agent storage areas, chamber 112 shown. Sensor Attorney Docket No. DYM-003-PCT assembly 120 can include one or more portions of housing 101 that surround portions of sensor 125. Pumping assembly 130 can include one or more portions of housing 101 that surround portions of the pumping assembly and / or provide fixation to one or more 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.

[0208]

[0190] 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 between the 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 and / or a housing of reservoir 110 can comprise one or more conduits that are routed within the walls such that the portion of the walls surrounding the conduits comprise the structural housing portions (e.g., tube walls) of one or more lumens of fluid pathway 140 (e.g., that portion of fluid pathway 140 is built into the walls of the housing). 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 a housing of reservoir 110). In Attorney Docket No. DYM-003-PCT some embodiments, pumping assembly 130 comprises a MEMS device that is at least partially built into the walls of a housing (e.g., housing 101).

[0209]

[0191] 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 outward facing walls of a housing of reservoir 110 comprise the portion of the walls of housing 101 in that region (e.g., the walls of housing 101 form a portion of the walls of a housing of reservoir 110, or reservoir 110 is built into housing 101).

[0210]

[0192] System 10 can comprise a tool, cannula insertion tool 320 shown, which can be configured to cause cannula 185 to penetrate the skin of the patient. In some embodiments, cannula insertion tool 320 comprises fill assembly 310.

[0211]

[0193] Delivery device 100 can be configured as a “miniaturized device”, such as when one or more assemblies or other components of device 100 (e.g., one or more components of pumping assembly 130) have a dimension threshold (e.g., a maximum dimension, a minimum dimension, or both) that enables device 100 to achieve various fluid delivery goals (e.g., requirements) while maintaining a low “body burden” (e.g., low height, length, and / or width, and / or a small mass of device 100) for the patient. In some embodiments, such as those in which device 100 is attached (e.g., adhesively attached) to the patient for a time period (e.g., at least 3 days), this low body burden achieved via these dimension thresholds provides a significant advantage for the patient (e.g. increased comfort due to reduced size and weight, improved cosmesis due to the reduced size, reduced likelihood of impacting a doorway or other object due to reduced height, and other similar advantages). Various dimension thresholds applicable to this miniaturized, low body-burden construction and arrangement of delivery device 100 and / or other system 10 component(s), are described in detail in reference to Figs. 3, 3A, 3B, 7A, 7B, and otherwise herein.

[0212]

[0194] 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 Attorney Docket No. DYM-003-PCT as the similar components described in reference to Fig. 1 and otherwise herein. Delivery device 100 can include length DL, and width DW, as shown. Delivery device 100 can also include height DH, as shown. In some embodiments, height DH comprises a height of no more than 8mm, such as a height of no more than 7.5mm, and / or no more than 7.0mm.

[0213]

[0195] Referring now to Fig. 3, a schematic view of a fluid handling portion of a delivery device is illustrated, consistent with the present inventive concepts. Pumping assembly 130 and / or other components of system 10 described in Fig. 3 can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1 A, and otherwise herein. Fig. 3 shows a schematic view of an embodiment of pumping assembly 130, that is fluidly connected to reservoir 110 and cannula assembly 180. Pumping assembly 130 can be fluidly attached to reservoir 100 and / or cannula assembly 180 via one or more tubes, channels, lumens, or other pathways of fluid pathway 140. For example, one or more fluid pathways, such as channel 141 shown, can fluidly connect reservoir 110 to pumping assembly 130. Additionally, or alternatively, one or more fluid pathways, channel 142 shown, can fluidly connect pumping assembly 130 to cannula assembly 180 (e.g., to cannula 185 of cannula assembly 180 that is configured to be inserted into the skin of a patient for delivery of agent 20, as described herein).

[0214]

[0196] Pumping assembly 130 can include one or more fluid propulsion modules, fluid propulsion module 1310 (also referred to as FPM 1310), that can be constructed and arranged to generate a force to: draw agent 20 from reservoir 110; to drive (e.g., propel) agent 20 through cannula 185 into the patient (e.g., for subcutaneous delivery of agent 20 to the patient); or both. Pumping assembly 130 can include one or more drive assemblies, drive module 1320 (also referred to as DM 1320) that can be constructed and arranged to generate forces that can be transferred to FPM 1310 to propel agent 20, as described herein. In some embodiments, pumping assembly 130 can include one or more physical and / or electromechanical linkages for transferring energy (e.g., kinetic energy) from drive module 1320 to FPM 1310, such as linkage 1330 shown.

[0215]

[0197] In some embodiments, linkage 1330 is configured to convert rotational motion to linear motion (e.g., and provide both linear motion and rotational motion), for example when linkage 1330 includes a cam mechanism. Alternatively, or additionally, linkage 1330 can be configured to convert linear motion into rotational motion (e.g., and provide both rotational and linear motion). In some embodiments, linkage 1330 comprises a fixed linkage, such as a linear connection between drive module 1320 and fluid propulsion module 1310. In some Attorney Docket No. DYM-003-PCT embodiments, linkage 1330 comprises a non-linear connection, such as a linkage that changes the direction of a force provided by drive module 1320, such as a linkage that provides at least a 90° change of direction, such as up to 180° change of direction of force. In some embodiments, linkage 1330 comprises a flexible linkage that is constructed and arranged to transfer energy (e.g., a motive force) from drive module 1320 to FPM 1310 in a non-fixed arrangement of drive module 1320 and FPM 1310. In some embodiments, linkage 1330 comprises a separable interface between drive module 1320 and FPM 1310.

[0216]

[0198] In some embodiments, drive module 1320 comprises a MEMS actuator, such as a MEMS actuator configured to provide rotation and translation (e.g., rotation and translation to a piston of fluid propulsion module 1310, as described herein).

[0217]

[0199] In some embodiments, drive module 1320 comprises a rotary actuator. For example, drive module 1320 can comprise a motor, such as a stepper motor, a servo, or other motor that is configured to rotate a drive shaft. In some embodiments, drive module 1320 comprises an electromagnetic drive module.

[0218]

[0200] Referring now to Figs. 3A-B, a perspective view of an embodiment of a fluid propulsion module, and a perspective view of a piston of the fluid propulsion module, respectively, are illustrated, consistent with the present inventive concepts. Pumping assembly 130 and / or other components of system 10 described in Figs. 3A-B can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1A, and otherwise herein. Fig. 3A shows a perspective view of a fluid propulsion module 1310 including barrel and piston construction, with the piston slidingly received within the barrel. For example, module 1310 can include barrel 1340 that slidingly receives piston 1350. Fig. 3B shows piston 1350 without barrel 1340. Barrel 1340 can include housing 1341 with lumen 1342 extending partially therethrough. Piston 1350 can comprise shaft 1351 with at least a proximal portion 1352 and distal portion 1353. At least a portion of shaft 1351 can include a surface that is coincident with the full circumference of piston 1350, FC surface 1354. Lumen 1342 can comprise a diameter, diameter DLM shown, and shaft 1351 can comprise a diameter, diameter DS shown. In some embodiments, a proximal portion of shaft 1351 comprises a smaller diameter than diameter DS of the distal portion of shaft 1351, as shown. Diameter DS and diameter DLM can comprise diameters such that FC surface 1354 creates a liquid tight seal with the inner surface of lumen 1342, such as when piston 1350 translates within lumen 1342 and otherwise. Shaft 1351 can include one or more Attorney Docket No. DYM-003-PCT cut-away portions (e.g., recessed portions), such as relief 1355 shown, wherein at least a portion of FC surface 1354 remains at the longitudinal portion of shaft 1351 coincident with relief 1355, such as FC surface 1354a shown.

[0219]

[0201] Propulsion module 1310 can comprise a variable volume chamber, chamber 1311 shown, that is defined by the empty volume within the distal portion of lumen 1342 when shaft 1351 is positioned within the lumen. The volume can include the volume of lumen 1342 between the distal end of the lumen and the distal end of shaft 1351 and the volume of relief 1355. Piston 1350 can be configured to translate proximally and distally within lumen 1342, varying the volume of chamber 1311 (e.g., increasing the volume and decreasing the volume, respectively).

[0220]

[0202] Barrel 1340 can include one or more inlet and / or outlet channels from chamber 1311, such as inlet 1343 and / or outlet 1344, each shown. Piston 1350 can be configured to rotate (e.g., in addition to translating) within lumen 1342. In some embodiments, relief 1355 longitudinally aligns with inlet 1343 and / or outlet 1344, such that as piston 1350 rotates within lumen 1342, relief 1355 can rotationally align with either inlet 1343, or outlet 1344 (i.e., but not align with both inlet 1343 and outlet 1344 simultaneously), such as to fluidly connect chamber 1311 to inlet 1343, or fluidly connect chamber 1311 to outlet 1344, based on the rotational orientation of relief 1355. When relief 1355 is not rotationally aligned with an inlet or outlet, FC surface 1354a can fluidly seal both inlet 1343 and outlet 1344. As used herein, FC Surface 1354a and the aperture of inlet 1343 can together be considered to form a valve, such as inlet valve 1345 shown. Similarly, FC surface 1354a and the aperture of outlet 1344 can form a valve, such as outlet valve 1346 shown.

[0221]

[0203] By piston 1350 rotating within lumen 1342 to vary the state of valves 1345 and 1346 and translating within lumen 1342 to vary the volume of chamber 1311, piston 1350 can draw fluid into chamber 1311 and expel fluid from chamber 1311. For example, starting from a distal position, with relief 1355 oriented toward inlet 1343 (e.g., such that valve 1345 is in an open state, and valve 1346 is in a closed state), piston 1350 can be retracted proximally within lumen 1342 (e.g., retracted by drive module 1320, such as when linkage 1330 fixedly attaches a translating element of drive module 1320 to piston 1350). Proximal motion of piston 1350 can cause an increase in the volume of chamber 1311, such as from an initial volume, volume VI, to a second volume greater than volume VI and related to the retracted position of piston 1350, volume VR. In some embodiments, when piston 1350 is located at a distal most location relative to barrel 1340, the volume of chamber 1311 Attorney Docket No. DYM-003-PCT comprises a minimum volume, volume VMIN. Similarly, when piston 1350 is located at a proximal most location relative to barrel 1340, the volume of chamber 1311 can comprise a maximum volume, volume VMAX. In some embodiments, the proximal most and distal most position of piston 1350 is defined by the maximum translation distances enabled by pumping assembly 130 (e.g., drive module 1320). Alternatively, or additionally, piston 1350 and / or barrel 1340 can include one or more physical “stops” (e.g., projections, surfaces, or other physically interfering elements) that define a distal most and / or proximal most position of piston 1350 relative to barrel 1340. For example, the distal most position of piston 1350 relative to barrel 1340 can comprise the position where the distal end of shaft 1351 abuts the distal end of lumen 1342.

[0222]

[0204] As described hereabove, when piston 1350 is retracted from a distal position to a proximal position, volume VI can increase to volume VR, where the change in volume defines a “shot size” volume, volume VS. Volume VS can be determined by the diameter of lumen 1342, diameter DLM, and the distance piston 1350 is retracted from the distal position to the proximal position (e.g., the retraction distance), distance DR. By retracting piston 1350 a distance DR with inlet valve 1345 in an open state (e.g., where inlet 1343 is fluidly connected to reservoir 110 holding agent 20), volume VS of agent 20 can be drawn into chamber 1311.

[0223]

[0205] Rotation of piston 1350 (e.g., while in a retracted position) can change the state of valves 1345 and 1346, for example to close inlet valve 1345 and / or to open valve 1346. In some embodiments, relief 1355 and / or the positioning of inlet 1343 and / or outlet 1344 relative to chamber 1311 are each constructed and arranged such that during rotation of piston 1350, valves 1345 and 1346 cannot both exist in a partially (or fully) open state (e.g., either valve must be fully closed before the other transitions to an open state). In some embodiments, relief 1355 comprises a relief that is constructed and arranged such that FC surface 1354a comprises more than a 180° circumferential portion of shaft 1351, for example such that at least when relief 1355 is oriented 90° away from both inlet 1343 and outlet 1344 (e.g., inlet and outlet positioned 180° apart), both valves 1345 and 1346 are in a closed state.

[0224]

[0206] From the retracted position, with volume VS of agent 20 drawn into chamber 1311 (as well as volume VI), and with piston 1350 rotated such that outlet valve 1346 is open, and inlet valve 1345 is closed, piston 1350 can be advanced distally an advancement distance, distance DA, such that a volume of agent 20 is expelled from chamber 1311 (e.g., delivered to the patient), volume VD. Volume VD (similar to volume VS) can be determined Attorney Docket No. DYM-003-PCT by diameter DLM and distance DA. If and / or while distance DA is less than distance DR (e.g., if piston 1350 is partially advanced to deliver a partial shot of agent 20, and / or at any point while piston 1350 is being advanced), a volume of agent 20 comprising a portion of volume VS, volume VP, remains within chamber 1311.

[0225]

[0207] In some embodiments, during a first cycle, while volume VP is greater than zero (e.g., distance DA is less than distance DR), a second cycle can be initiated, where the state of valves 1345 and 1346 are switched, and piston 1350 is retracted, such that volume VI of the second cycle includes volume VP from the first cycle. Volume VS of the second cycle can include volume VP of the first cycle (e.g., volume VS of the second cycle equals volume VI of the first cycle, plus volume VP of the first cycle, plus the volume defined by distance DR of the second cycle). In this embodiment, piston 1350 can be advanced a distance DA that is greater than distance DR of the second cycle, for example a distance equal to distance DR of the first cycle.

[0226]

[0208] To pump a single “shot” of agent 20, pumping assembly 130 can be configured to rotate and translate piston 1350, as described hereabove, to draw agent 20 through inlet 1343 and expel agent 20 via outlet 1344. To pump multiple shots, piston 1350 can be repeatedly cycled (e.g., rotated and translated as described hereabove). For a single shot, pumping assembly 130 can comprise a shot duration, duration TS, that includes a fill time, duration TF, that can include the time to close valve 1346, open valve 1345, and / or retract piston 1350, and a delivery time, duration TD, that can include the time to close valve 1345, open valve 1346, and advance piston 1350. Piston 1350 can be translated with a translation profile, profile PT. Piston 1350 can be rotated with a rotation profile, profile PR. The combined translation and rotation of piston 1350 can comprise a motion profile, profile PM. Pumping of agent 20 from pumping assembly 130 can be defined by a fluid delivery profile, profile PFD, that is defined at least in part by profiles PR, PT, and durations TS, TD, and / or TF. Delivery device 100 can comprise multiple profiles PFD, for example profiles configured to deliver various doses (e.g., volume per time) of agent 20 to a patient.

[0227]

[0209] In some embodiments, fluid delivery device 100 is constructed and arranged such that the various dimensions, volumes, durations, and / or other variables described herein are within maximum and / or minimum values, for example as shown in the table below: Attorney Docket No. DYM-003-PCT

[0228]

[0210] In some embodiments, diameter DS of piston 1350 comprises a diameter of at least 0.1mm, such as a diameter of at least 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, or 0.8mm, such as diameter of approximately 1.0mm. In some embodiments, diameter DS of piston 1350 comprises a diameter of no more than 2.0mm, such as a diameter of no more than 1.9mm, 1.8mm, 1.7mm, 1.6mm, 1.5mm, 1.4mm, or 1.3mm, such as a diameter of approximately 1.0mm. Piston 1350 can be configured to translate a “translation distance” (e.g., an advancement distance and a retraction distance) of no more than 1.2mm, such as a translation distance of no more than 1.1mm, 1.0mm, 0.9mm, or 0.8mm, such as a translation distance of approximately 0.64mm.

[0229]

[0211] In some embodiments, relief 1355 comprises a depth, depth RD shown, of at least 0.02mm, such as a depth of at least 0.03mm, 0.04mm or 0.05mm, such as a depth of approximately 0.10mm. Relief 1355 can comprise a depth of no more than 0.4mm, such as a depth of no more than 0.3mm or 0.2mm, such as a depth of approximately 0.10mm. Relief 1355 can comprise a depth equating to no more than 50% of the diameter DS of piston 1350, such as no more than 40% or 30% of diameter DS of piston 1350.

[0230]

[0212] Inlet 1343 and outlet 1344 can comprise similar or dissimilar port diameters. In some embodiments, inlet 1343 and / or outlet 1344 comprise a port diameter of no more than 0.8mm, such as a diameter of no more than 0.7mm, 0.6mm, 0.5mm, or 0.4mm, such as a diameter of approximately 0.3mm . Inlet 1343 and / or outlet 1344 can comprise a port diameter of at least 0.1mm, such as a diameter of at least 0.2mm, such as a diameter of approximately 0.3mm. In some embodiments, inlet 1343 and / or outlet 1344 comprise a port diameter of no more than 80% of the diameter of lumen 1342, such as no more than 70%, 60%, 50%, or 40%, of the diameter of lumen 1342, such as approximately 30% of the diameter of lumen 1342. Inlet 1343 and outlet 1344 can be positioned (e.g., the associated port can be positioned) at a similar or dissimilar distance from the distal end of lumen 1342 Attorney Docket No. DYM-003-PCT and / or from the proximal end of housing 1341. In some embodiments, inlet 1343 and / or outlet 1344 can be positioned a distance from the proximal end of housing 1341 of at least 1mm, such as at least 2mm, such as a distance of approximately 3mm from the proximal end of housing 1341. In some embodiments, inlet 1343 and / or outlet 1344 can be positioned a distance from the proximal end of housing 1341 of at most 5mm, such as at most 4mm, such as a distance of approximately 3mm. In some embodiments, inlet 1343 and / or outlet 1344 can be positioned a distance from the distal end of lumen 1342 of at least 0.5mm, such as at least 0.75mm, or 1.0mm, such as distance of approximately 1.125mm. In some embodiments, inlet 1343 and / or outlet 1344 can be positioned a distance from the distal end of lumen 1342 of at most 2.0mm, such as at most 1.75mm, or 1.5mm, such as a distance of approximately 1.125mm.

[0231]

[0213] Referring now to Figs. 4A-B, a perspective view of an embodiment of a fluid propulsion module, and perspective view of a piston of the fluid propulsion module are illustrated, respectively, consistent with the present inventive concepts. Pumping assembly 130 and / or other components of system 10 described in Figs. 4A-B are of similar construction and arrangement as the similar components described in reference to Figs. 3A-B. Piston 1350 can include one or more sensors, transducers, and / or other functional elements, functional element 1359 shown in Figs. 4A-B. Alternatively, or additionally, barrel 1340 can include one or more sensors, transducers, and / or other functional elements, functional element 1349 shown in Fig. 4A. Functional element 1359, functional element 1349, or both (e.g., collectively), can be configured to perform one or more functions, such as a function selected from the group consisting of: confirm proper translation, rotation, or both, of piston 1350; cause translation, rotation, or both, of piston 1350; control the translation, rotation, or both of piston 1350; and combinations of one or more of these. In some embodiments, functional element 1349 is positioned in another portion of device 100 (e.g., not in or on barrel 1340).

[0232]

[0214] In some embodiments, functional element 1359 comprises one or more magnets, and functional element 1349 comprises one or more electromagnets (or vice versa) that are configured to cause the translation, rotation, or both, of piston 1350. In these embodiments, functional element 1349 of barrel 1340 can comprise the one or more electromagnets for translating and / or rotating piston 1350 (e.g., barrel 1340 comprises at least a portion of drive module 1320). In some embodiments, functional element 199 comprises one or more Attorney Docket No. DYM-003-PCT electromagnets that are configured to translate and / or rotate piston 1350. In these embodiments, functional element 199 can comprise one or more electromagnets positioned in a first portion of delivery device 100 (e.g., a reusable portion configured to operably connect sequentially to multiple disposable portions of device 100), and piston 1350 is included in a second, mating portion of delivery device 100 (e.g., a disposable portion).

[0233]

[0215] In some embodiments, functional element 1359 comprises one or more markers, such as one or more markers selected from the group consisting of visible markers; ultrasonic markers; radiographic markers; infrared markers; and combinations of these. In these embodiments, functional element 1349 (e.g., positioned in barrel 1340 or another component of device 100) can comprise a functional element configured to detect the motion (e.g., by detecting the position) of a functional element 1359 comprising one or more markers detectable by functional element 1359. The detected position or motion can be used by drive module 1320 to confirm proper motion of piston 1350, to control the translation of piston 1350 (e.g., in a closed loop arrangement), or both.

[0234]

[0216] In some embodiments, functional element 1359, functional element 1349, or both, can be configured to detect a flow restriction (e.g., an occlusion) related to the flow of fluid intended to be caused by pumping assembly 130.

[0235]

[0217] In some embodiments, functional element 1359, functional element 1349, or both, are configured to detect an undesired substance (e.g., air, a contaminant, and the like) that is present (e.g., undesirably present) within a flow path of pumping assembly 130 or another component of device 100.

[0236]

[0218] Referring now to Fig. 5, a side sectional view of an embodiment of a pumping assembly including a portion of a sensor assembly is illustrated, consistent with the present inventive concepts. Pumping assembly 130, sensor assembly 120 and / or other components of system 10 described in Fig. 5 can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1 A, and otherwise herein. Fig. 5 shows a piston-driven embodiment of fluid propulsion module 1310 of pumping assembly 130, including barrel 1340 and piston 1350. In Fig. 5, shaft 1351 of piston 1350 is shown in a proximally retracted position and rotationally aligned within lumen 1342 of barrel 1340 such that FC surface 1354a is covering inlet 1343, such that inlet valve 1345 is closed (e.g., preventing agent 20 within chamber 1311 from exiting inlet 1343). From the orientation Attorney Docket No. DYM-003-PCT shown, piston 1350 can be advanced distally, such as to decrease the volume of chamber 1311, expelling agent 20 via outlet 1344.

[0237]

[0219] Sensor assembly 120 can comprise an assembly that is constructed and arranged to detect the pressure within chamber 1311. In some embodiments, sensor assembly 120 includes an assembly that moves and / or otherwise adjusts a measurable parameter of the assembly 120 based on the pressure within chamber 1311, pressure assembly 122 shown. Pressure assembly 122 can include a translating element and / or a biasing element, for example base plunger 1221 and biasing element 1222, respectively, each shown. Base plunger 1221 can be located within lumen 1342, slidingly received therein, and defining the distal end of chamber 1311 within lumen 1342 (e.g., the proximal surface of base plunger 1221 defines the distal wall of chamber 1311). Biasing element 1222 can comprise an elastic, spring, pneumatic, or other biasing element configured to provide a biasing force to base plunger 1221. Biasing element 1222 can be fixedly attached to barrel 1340, such as affixed to lumen 1342 and / or to a portion of housing 1341.

[0238]

[0220] In some embodiments, sensor assembly 120 includes sensor 125. Sensor 125 can be integral to, fixedly attached to, and / or otherwise located proximate barrel 1340. Sensor 125 can be configured to produce a signal related to the position of base plunger 1221 within lumen 1342 (e.g., to detect movement of base plunger 1221 within lumen 1342). Biasing element 1222 can be configured such that a signal from sensor 125 correlating to the position of base plunger 1221 can be used to determine the pressure within chamber 1311. For example, if base plunger 1221 is positioned distal to the neutral resting position of pressure assembly 122 (e.g., the position of base plunger 1221 when chamber 1311 is at a base pressure, such as atmospheric pressure), the pressure within chamber 1311 can be determined based on the position of base plunger 1221 and the biasing force applied by biasing element 1222. In some embodiments, biasing element 1222 is configured to prevent motion of base plunger 1221 unless the pressure within chamber 1311 is above a threshold (e.g., above a high-pressure threshold and / or below a low-pressure threshold). In these embodiments, motion (e.g., any motion) of base plunger 1221 can be correlated by sensor assembly 120 to a pressure within chamber 1311 exceeding a threshold (e.g., a binary sensor signal). Sensor 125 can comprise a magnetic sensor, such as when base plunger 1221 comprises a magnetic element and sensor 125 comprises a Hall effect sensor. In some embodiments, sensor 125 comprises a switch, for example a switch that is activated by base plunger 1221 when base plunger 1221 moves distally (e.g., when the pressure within chamber 1311 is above a Attorney Docket No. DYM-003-PCT threshold, such that biasing element 1222 is overcome, and base plunger 1221 moves distally).

[0239]

[0221] Referring now to Fig. 6, a perspective view of an embodiment of a pumping assembly including a tapered piston is illustrated, consistent with the present inventive concepts. Pumping assembly 130 and / or other components of system 10 described in Fig. 6 can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1 A, and otherwise herein. Fig. 6 shows an embodiment of fluid propulsion module 1310 comprising a piston-driven configuration. Piston 1350 can be slidingly positioned within lumen 1342 of barrel 1340. In some embodiments, lumen 1342 and / or piston 1350 comprise a tapered geometry. For example, as shown, the distal ends of lumen 1342 and piston 1350 can taper to a diameter that is smaller than the diameter of a more proximal portion.

[0240]

[0222] As described herein, pumping assembly 130 comprises barrel 1340 and piston 1350. Piston 1350 can comprise an OD that is slightly larger than the diameter of lumen 1342 of barrel 1340, such as when the OD of piston 1350 is at least 1%, 2%, and / or 3% larger than the diameter of lumen 1342. In this configuration, barrel 1340 can comprise a resiliently biased construction such that barrel 1340 can expand to slidingly and sealingly receive piston 1350.

[0241]

[0223] In some embodiments, pumping assembly 130 comprises barrel 1340, piston 1350, and a sealing element, seal 1390, not shown but positioned between piston 1350 and barrel 1340. Piston 1350 is configured to slide within seal 1390 while maintaining a fluid tight seal between seal 1390 and piston 1350, and between seal 1390 and barrel 1340. In some embodiments, lumen 1342 of barrel 1340 comprises a diameter that is at least 1%, 2%, and / or 3% larger than the portion of the outer diameter of piston 1350 that translates within lumen 1342 of barrel 1340.

[0242]

[0224] Figures 7-12B described herein include a drive module 1320 which can include one or more force generating modules, force generating module 3000 (also referred to as FGM 3000) as described herein. FGM 3000 can comprise a combination of one, two, or more components that are configured to provide rotary motion, herein referred to as a “rotary motion generator” or “RMG”. FGM 3000 can comprise an RMG selected from the group consisting of: arrangement of one or more coils and one or more magnets that are Attorney Docket No. DYM-003-PCT collectively constructed and arranged to provide rotary motion; motor, such as a DC motor, an AC motor, a stepper motor, and / or a Lavet motor; a piezo motor; a squiggle motor; a torsional spring; and combinations of one, two, or more of these. Alternatively or additionally, FGM 3000 can comprise a combination of one, two, or more components that are configured to provide linear motion, herein referred to as a “linear motion generator” or “LMG”. FMG 3000 can comprise an LMG selected from the group consisting of: an arrangement of one or more coils and one or more magnets that are configured to provide translational motion; a voice coil; a solenoid; a piezo actuator; a squiggle motor; a magnetic linear drive; a shaped memory wire; and combinations of one, two, or more of these. FMG 3000 can comprise: one or more RMGs; one or more LMGs; or a set of one, two, or more RMGs and a set of one, two, or more LMGs.

[0243]

[0225] Figures 7-12B described herein include a drive module 1320 which can include one or more motion converting modules, motion converting module 4000 (also referred to as MCM 4000), as described herein. MCM 4000 can comprise a rotary-to-linear motion converter, a linear-to-rotary motion converter, and / or one or more of each of these. MCM 4000 can comprise a rotary-to-linear motion converter selected from the group consisting of: a mating pin and slot arrangement; a rack and pinion assembly; a cam; a clicky-pen assembly; an arrangement of magnets with a multi-state linear bias based on rotational position; a living hinge; and combinations thereof. Alternatively, or additionally, MCM 4000 can comprise a linear-to-rotary motion converter selected from the group consisting of: a mating pin and slot arrangement; a rack and pinion assembly; a cam; a clicky-pen assembly; an arrangement of magnets with a multi-state linear bias based on rotational position; and combinations of one, two, or more of these.

[0244]

[0226] Referring now to Fig. 7, a block diagram of a pumping assembly is illustrated consistent with the present inventive concepts. As shown in Fig. 7, pumping assembly 130 comprises drive module 1320 and fluid propulsion module 1310, which are operatively attached by a linkage, linkage 1330 shown. Pumping assembly 130 and / or other components of fluid delivery device 100 or system 10 described in Fig. 7 can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Drive module 1320 of Fig. 7 comprises a force generating module, FGM 3000, and a motion converting module, MCM 4000, each as shown. In some embodiments, FGM 3000 Attorney Docket No. DYM-003-PCT comprises a single force generating module, and MCM 4000 comprises a single motion converting module.

[0245]

[0227] In some embodiments, pumping assembly 130 is constructed and arranged as described and illustrated in any one or more of Figs. 7A-7F.

[0246]

[0228] Referring now to Fig. 7A, a perspective view of a pumping assembly comprising a rotary force generator and a motion converting module comprising a pin and slot arrangement is illustrated, consistent with the present inventive concepts. Pumping assembly 130 of Fig. 7A comprises fluid propulsion module 1310 and drive module 1320, as shown. Drive module 1320 comprises an FGM 3000 comprising a motor, servo, and / or other rotational motion assembly, motor 3100, and an MCM 4000 comprising a motion converter, follower assembly 4100. Follower assembly 4100 comprises rotating body 4110 with slot 4111, and pin 4120.

[0247]

[0229] In some embodiments, MCM 4000 is configured to convert rotational motion from FGM 3000 into linear motion for actuating piston 1350 of fluid propulsion module 1310. Pin 4120 of follower assembly 4100 can be fixedly positioned (e.g., such that pin 4120 remains substantially stationary during operation relative to FGM 3000 and / or fluid propulsion module 1310). Slot 4111 of rotating body 4110 can be configured to slidingly receive pin 4120. As FGM 3000 rotates rotating body 4110, slot 4111 engages pin 4120. The interaction between pin 4120 and slot 4111 can cause rotating body 4110 to translate linearly along its axis of rotation, where such linear translation can be transferred to piston 1350 (e.g., to actuate piston 1350 within barrel 1340 for propulsion of agent 20). In some embodiments, the geometry of slot 4111 (e.g., the cam profile of slot 4111) determines the relationship between rotational input motion and linear output motion, such that controlled rotation of FGM 3000 produces controlled linear displacement of piston 1350.

[0248]

[0230] In some embodiments, motor 3100 can comprise a drive portion, drive 3110, such as an electromechanical drive portion comprising one or more coils and / or magnets, configured to rotate a first shaft of motor 3100. Additionally, or alternatively, motor 3100 can comprise a force modification portion (e.g., similar to MMM 5000 described herein), gearbox 3120, an arrangement of gears and / or other mechanical assembly that is configured to modify the rotational speed and / or torque applied to a second, output shaft of motor 3100. Gearbox 3120 can operably couple the first shaft of motor 3100 that is rotated by drive 3110 to the output shaft of motor 3100. Gearbox 3120 can comprise a gearhead configuration that Attorney Docket No. DYM-003-PCT is integral to motor 3100 (e.g., drive 3110 and gearbox 3120 can be integrated into a single housing of motor 3100, as shown in Fig. 7A).

[0249]

[0231] In some embodiments, motor 3100 comprises a diameter of no more than 6mm, such as no more than 5mm, such as a diameter of approximately 4mm. In some embodiments, motor 3100 comprises a diameter of at least 2mm, such as at least 3mm, such as a diameter of approximately 4mm. In some embodiments, height DH of delivery device 100 (shown in Fig. 2) comprises a dimension equal to no more than the diameter of motor 3100 plus at most 1.5mm, such as at most 1.4mm, 1.3mm, 1.2mm, or 1.1mm, such as approximately 1mm.

[0250]

[0232] In some embodiments, motor 3100 comprises a length of no more than 25mm, such as no more than 24mm, 23mm, 22mm, 21mm, 20mm, or 19mm, such as a length of approximately 18mm. In some embodiments, motor 3100 comprises a length of at least 5mm, such as at least 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, such as a length of approximately 18mm. The length of motor 3100 can be defined by the length of the housing of motor 3100, which can surround drive 3110 and gearbox 3120, as shown in Fig. 7A.

[0251]

[0233] Referring now to Fig. 7B, a perspective view of a pumping assembly comprising a rotary force generator and a motion converting module comprising a face cam arrangement is illustrated, consistent with the present inventive concepts. Pumping assembly 130 of Fig. 7B comprises fluid propulsion module 1310 and drive module 1320, as shown. Drive module 1320 comprises an FGM 3000 comprising a motor, motor 3100, and an MCM 4000 comprising cam assembly 4400. Cam assembly 4400 comprises cam 4410 and follower 4420.

[0252]

[0234] In some embodiments, cam 4410 comprises a “face cam” configuration, where the cam surface is oriented perpendicular to the rotational axis of motor 3100. Cam 4410 can comprise a profiled surface (e.g., a surface with varying axial height and / or contour) configured to convert rotational motion from motor 3100 into linear motion for driving piston 1350 of fluid propulsion module 1310. In some embodiments, follower 4420 can be operably coupled to piston 1350 and can be fixedly positioned relative to fluid propulsion module 1310. Cam assembly 4400 can be constructed and arranged such that follower 4420 maintains contact with the profiled surface of cam 4410 through a biasing force (e.g., spring bias, electromagnetic bias, magnetic bias and / or other biasing force). As motor 3100 rotates Attorney Docket No. DYM-003-PCT cam 4410, the varying cam profile can cause a reciprocating linear motion of cam 4410, which can be transmitted to piston 1350 to create the pumping action within barrel 1340 described herein. In some embodiments, cam 4410 is biased toward fluid propulsion module 1310 (and follower 4420) such as to maintain engagement of follower 4420 and cam 4410 throughout the rotation cycle. Follower 4420 can engage cam 4410, such that following the cam profile, cam 4410 translates linearly as follower 4420 opposes the biasing force applied to cam 4410.

[0253]

[0235] Referring now to Fig. 7C, a side sectional view of a pumping assembly comprising a rotary force generator and a motion converting module comprising a cam follower arrangement is illustrated, consistent with the present inventive concepts. Pumping assembly 130 of Fig. 7C comprises fluid propulsion module 1310 and drive module 1320, as shown. Drive module 1320 comprises an FGM 3000 comprising a motor, motor 3100, and an MCM 4000 comprising cam assembly 4400. Cam assembly 4400 comprises cam 4410 and follower 4420. In some embodiments, cam assembly 4400 includes a biasing element (e.g., a spring), such as biasing element 4430 shown. In some embodiments, sensor 250 is included (e.g., configured to provide a signal to monitor motion of one or more components of module 1310 and / or module 1320).

[0254]

[0236] In some embodiments, follower 4420 is fixed relative to drive module 1320 and / or fluid propulsion module 1310. Follower 4420 can be configured to contact the profile of cam 4410 as motor 3100 rotates cam 4410, such that cam 4410 linearly articulates relative to follower 4420. Cam 4410 can be operably coupled to piston 1350, such that piston 1350 translates in unison with cam 4410. As motor 3100 rotates cam 4410, the cam profile can push against the fixed follower 4420, causing cam 4410 (and piston 1350 attached thereto) to translate linearly relative to follower 4420. When the profile of cam 4410 extends distally toward fluid propulsion module 1310, cam 4410 is pushed away from fluid propulsion module 1310, retracting piston 1350 within barrel 1340. Conversely, when the profile of cam 4410 recedes proximally from the fluid propulsion module 1310, biasing element 4430 can bias cam 4410 toward fluid propulsion module 1310, advancing piston 1350 within barrel 1340. Biasing element 4430 can be configured to bias cam 4410 to maintain contact with follower 4420 throughout the rotation cycle, ensuring that follower 4420 accurately follows the cam contour to create controlled reciprocating motion of piston 1350 for delivering agent 20. In some embodiments, sensor 250 is configured to monitor the rotational and / or Attorney Docket No. DYM-003-PCT longitudinal position of cam 4410 (e.g., a sensor comprising optical or other sensor, such as a rotary and / or linear encoder). Sensor 250 can be configured to determine the rotational position of cam 4410, which can correspond to the linear position of piston 1350 within barrel 1340. Additionally, or alternatively, sensor 250 can be configured to monitor both rotational and longitudinal positions of cam 4410, providing feedback on both the angular orientation and axial displacement of cam 4410 during operation. Sensor 250 can provide position feedback signals to control the operation of motor 3100 in a closed loop manner.

[0255]

[0237] Referring now to Fig. 7D, a perspective view of a pumping assembly comprising a rotary force generator and a motion converting module comprising a rack and pinion arrangement is illustrated, consistent with the present inventive concepts. Pumping assembly 130 of Fig. 7D comprises fluid propulsion module 1310 and drive module 1320, as shown. Drive module 1320 comprises an FGM 3000 comprising a motor, motor 3100, and an MCM 4000. MCM 4000 comprises rack and gear assembly 4200 which includes worm gear 4211 and rack 4212, as shown. Pumping assembly 130 of Fig. 7D further comprises MMM 5000 which includes transmission assembly 5100. Transmission assembly 5100 comprises transmission 5110, gear 5121, and gear 5122, as shown.

[0256]

[0238] In some embodiments, motor 3100 provides both rotational positioning and linear actuation of piston 1350 through transmission assembly 5100 and rack and gear assembly 4200. Worm gear 4211 can be operably coupled to rack 4212, where rack 4212 can be configured to drive linear translation of piston 1350 within barrel 1340 as worm gear 4211 rotates. Gear 5122 can comprise a width configured to allow continuous meshing engagement with gear 5121 throughout the range of motion of piston 1350, such that gear 5121 and gear 5122 remain in mesh as piston 1350 translates back and forth. In some embodiments, transmission assembly 5100 is configured to provide time-coordinated actuation, for example where rotational positioning occurs rapidly before substantial linear motion begins. For example, transmission 5110 can be configured such that when motor 3100 initiates rotation, transmission assembly 5100 first engages gear 5121 and gear 5122 to rapidly rotate piston 1350 approximately 180 degrees with minimal linear displacement.

[0257] Following the rotational positioning phase, transmission 5110 can be configured to disengage the rotational drive path and engage the linear drive path, allowing motor 3100 to drive worm gear 4211 and rack 4212 for linear translation of piston 1350. In some embodiments, transmission 5110 comprises a slip-clutch mechanism, a programmable engagement system, Attorney Docket No. DYM-003-PCT and / or a directional coupling configured to mechanically coordinate the rotational and linear motion phases. Alternatively, or additionally, transmission 5110 can be configured such that upon motor direction reversal, piston 1350 again rapidly provides 180-degree rotation before engaging linear motion in the opposite direction, allowing motor 3100 to provide both rapid rotational positioning and controlled linear actuation for delivering agent 20.

[0258]

[0239] Referring now to Fig. 7E, a perspective view of a pumping assembly comprising a linear force generator and a motion converting module comprising a “dicky pen” arrangement is illustrated, consistent with the present inventive concepts. Pumping assembly 130 of Fig. 7E comprises fluid propulsion module 1310 and drive module 1320, as shown. Drive module 1320 comprises an FGM 3000 comprising a linear drive assembly, piezo 3200, and an MCM 4000. MCM 4000 comprises dicky pen assembly 4500, which comprises housing 4501, first cam 4511, second cam 4512, pin 4513, channel 4502, and biasing element 4520.

[0259]

[0240] In some embodiments, dicky pen assembly 4500 operates as a bistable cam mechanism configured to convert linear actuations from piezo 3200 into discrete linear positioning of piston 1350. Pin 4513 can be operably attached to second cam 4512, where pin 4513 is configured to travel within channel 4502 of housing 4501. Channel 4502 can comprise a shaped constraint path (e.g., such as a slot with linear segments and perpendicular segments) configured to control the motion of second cam 4512 by constraining pin 4513 to follow a predetermined path. In some embodiments, the dicky pen mechanism is configured to operate through coordinated linear and rotational constraints provided by channel 4502 and pin 4513. For example, during a first actuation phase, pin 4513 can be positioned within a linear portion of channel 4502, where the channel geometry prevents second cam 4512 from rotating despite rotational forces applied through cam interaction with first cam 4511. When piezo 3200 provides sufficient linear force, pin 4513 can advance through channel 4502 until reaching a perpendicular segment, where channel 4502 permits second cam 4512 to rotate. The rotational motion continues until pin 4513 encounters a mechanical stop or constraint within channel 4502, locking second cam 4512 in a rotated position. During a subsequent action, pin 4513 can be freed from the constraint, allowing biasing element 4520 to drive second cam 4512 through another rotational segment of channel 4502 until pin 4513 re-enters a linear constraint portion, completing the bistable cycle. This mechanism allows piezo 3200 to apply both linear force and rotational force simultaneously through the cam interaction, Attorney Docket No. DYM-003-PCT where channel 4502 controls the sequence and timing of linear versus rotational motion to provide predictable discrete positioning of piston 1350 for controlled delivery of agent 20.

[0260]

[0241] Alternatively, or additionally, first cam 4511 and second cam 4512 can be configured to interact with each other through angled cam surfaces (e.g., such as surfaces oriented at approximately 45 degrees), where each linear actuation from piezo 3200 can cause relative rotation between the cams. Housing 4501 can include guide features (e.g., such as guide pins, channels, and / or tracks) configured to constrain the motion of first cam 4511 and second cam 4512, such as to define stable positions for the cam assembly. In some embodiments, biasing element 4520 can comprise a spring, such as a spring configured to provide return force and maintain engagement between the cam surfaces during operation. In some embodiments, the dicky pen mechanism operates in a two-stroke cycle, such as a cycle similar to a retractable pen mechanism cycle. For example, during a first actuation, piezo 3200 can drive the cam assembly distally, causing first cam 4511 and second cam 4512 to rotate relative to each other (e.g., such as approximately 180 degrees). When piezo 3200 returns to its initial position, biasing element 4520 can urge the cam assembly back toward its starting position, where the rotated cam configuration can lock piston 1350 in an extended position within barrel 1340. During a subsequent activation, the cam assembly can again rotate and reposition, such that upon return piston 1350 is locked in a retracted position. This bistable operation can allow piezo 3200 to provide discrete, controlled linear positioning of piston 1350 for precise fluid delivery of agent 20, where each actuation of piezo 3200 toggles piston 1350 between extended and retracted states.

[0261]

[0242] Referring now to Fig. 7F, a perspective view of a pumping assembly comprising a rotary force generator and a motion converting module comprising a nut and gear assembly is illustrated, consistent with the present inventive concepts. Pumping assembly 130 of Fig. 7F comprises fluid propulsion module 1310 and drive module 1320, as shown. Drive module 1320 comprises an FGM 3000 comprising a motor, motor 3100, and an MCM 4000. MCM 4000 comprises nut and gear assembly 4600. Pumping assembly 130 of Fig. 7F further comprises MMM 5000 which includes rotation limiting assembly 5200.

[0262]

[0243] In some embodiments, nut and gear assembly 4600 comprises a threaded lead screw configuration operably coupled to piston 1350. The lead screw can be configured to translate piston 1350 linearly within barrel 1340 based on rotational drive from motor 3100. Rotation limiting assembly 5200 can be configured to provide positional control by Attorney Docket No. DYM-003-PCT selectively constraining rotational motion of piston 1350 and / or components of nut and gear assembly 4600. In some embodiments, the mechanism operates in a two-phase actuation cycle. During a first phase, motor 3100 can rotate in a first direction, causing piston 1350 to rotate until piston 1350 contacts rotation limiting assembly 5200 (e.g., such as a mechanical stop or constraint), preventing further rotation of piston 1350. With piston 1350 rotationally constrained, continued rotation of motor 3100 can drive the threaded engagement between the lead screw and piston 1350, causing piston 1350 to translate linearly distally (e.g., extending piston 1350 within barrel 1340 to expel agent 20). During a second phase, motor 3100 can reverse direction, again causing piston 1350 to rotate until it contacts rotation assembly 5200 in the opposite position (e.g., after 180 degrees of rotation). With piston 1350 again rotationally constrained, the reversed rotation of motor 3100 can drive piston 1350 to translate linearly proximally (e.g., retracting piston 1350 within barrel 1340). Rotation limiting assembly 5200 can comprise an anti-backlash feature configured to provide greater frictional or mechanical resistance than the torque required to rotate piston 1350, such that piston 1350 rotates to the mechanical stop before the threads engage to drive linear translation. This configuration can provide positional control piston 1350, while minimizing backlash and ensuring consistent fluid delivery performance.

[0263]

[0244] Referring now to Fig. 8, a block diagram of a pumping assembly is illustrated consistent with the present inventive concepts. As shown in Fig. 8, pumping assembly 130 comprises drive module 1320 and fluid propulsion module 1310, which are operatively attached by a linkage, linkage 1330 shown. Pumping assembly 130 and / or other components of fluid delivery device 100 or system 10 described in Fig. 8 can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Drive module 1320 of Fig. 8 comprises a first force generating module, FGM 3000T, which is configured to translate piston 1350 of FPM 1310, and a second force generating module, FGM 3000R which is configured to rotate piston 1350.

[0264]

[0245] Referring now to Fig. 9, a block diagram of a pumping assembly is illustrated consistent with the present inventive concepts. As shown in Fig. 9, pumping assembly 130 comprises drive module 1320 and fluid propulsion module 1310, which are operatively attached by a linkage, linkage 1330 shown. Pumping assembly 130 and / or other components of fluid delivery device 100 or system 10 described in Fig. 9 can be of similar construction Attorney Docket No. DYM-003-PCT and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Drive module 1320 of Fig. 9 comprises a first force generating module, FGM 3000aR which comprises a rotary force generating module (e.g., a motor or the like) and a second force generating module, FGM 3000bR, which also comprises a rotary force generating module (e.g., a motor or the like). Drive module 1320 of Fig. 9 further comprises a motion converting module 4000R2T, which is configured to convert rotary motion to translational motion. FGM 3000aR can be configured to rotate piston 1350, and FGM 3000bR can be configured, via 4000R2T, to translate piston 1350.

[0265]

[0246] Referring now to Fig. 9A, a perspective view of an embodiment of a pumping assembly comprising two linear force generating assemblies and a linear-to-rotary motion converting module is illustrated, consistent with the present inventive concepts. Pumping assembly 130 of Fig. 9A comprises fluid propulsion module 1310 and drive module 1320, as shown. Drive module 1320 comprises an FGM 3000 comprising a linear drive assembly, piezo 3200 and magnetic assembly 3300. Drive module 1320 further comprises MCM 4000, which comprises rack and gear assembly 4700. Magnetic assembly 3300 can comprise magnet 3310a, magnet 3310b, and magnet 3320.

[0266]

[0247] In some embodiments, pumping assembly 130 is configured to operate through coordinated linear actuation and magnetic force switching. Rack and gear assembly 4700 can be configured to convert linear motion from piezo 3200 into rotational motion of piston 1350, where piston 1350 can be rotated approximately 180 degrees with each actuation cycle. Magnetic assembly 3300 can comprise one, two, or more magnetic elements, such as magnets 3310a and 3310b shown, fixedly positioned relative to barrel 1340. In some embodiments, piston 1350 includes one or more magnetic elements, magnet 3320 shown, configured to interact with the stationary magnets of magnetic assembly 3300 (e.g., magnets 3310a and / or 3310b). In some embodiments, the magnetic switching mechanism operates based on rotational positioning of piston 1350. For example, when piston 1350 is in a first rotational position, magnet 3320 can be aligned with and attracted to magnet 3310a (as shown), such that the magnetic force draws piston 1350 in a first linear direction (e.g., distally) within barrel 1350. When rack and gear assembly 4700 rotates piston 1350 by approximately 180 degrees (e.g., through actuation by piezo 3200), magnet 3320 becomes aligned with magnet 3310b, which is positioned approximately 180 degrees from magnet 3310a. The magnetic attraction between magnet 3320 and magnet 3310b draws piston 1350 in a second linear Attorney Docket No. DYM-003-PCT direction (e.g., proximally, opposite to the first direction) within barrel 1340. The alternating magnetic attraction between magnet 3320 and the stationary magnets (magnet 3310a and magnet 3310b), combined with the 180-degree rotational positioning provided by rack and gear assembly 4700, creates reciprocating linear motion of piston 1350 for controlled delivery of agent 20. The magnetic forces can provide the primary linear driving force, while piezo 3200 and rack and gear assembly 4700 can provide the rotational positioning that switches the magnetic field alignment between magnet 3320 and the stationary magnets 3310a, b of magnetic assembly 3300.

[0267]

[0248] Referring now to Fig. 10, a block diagram of a pumping assembly is illustrated consistent with the present inventive concepts. As shown in Fig. 10, pumping assembly 130 comprises drive module 1320 and fluid propulsion module 1310, which are operatively attached by a linkage, linkage 1330 shown. Pumping assembly 130 and / or other components of fluid delivery device 100 or system 10 described in Fig. 10 can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Drive module 1320 of Fig. 10 comprises a first force generating module, FGM 3000a, and a second force generating module, FGM 3000b. Drive module 1320 of Fig. 10 further comprises a first motion converting module, MCM 4000a, which converts the motion of FGM 3000a, and a second motion converting module, MCM 4000b, which converts the motion of FGM 3000b.

[0268]

[0249] FGM 3000a and FRM 3000b can each comprise a linear force generator, a rotary force generator, or both. MCM 4000a and MCM 4000b can each comprise a rotary-to-linear motion converter, a linear-to-rotary motion converter, or both.

[0269]

[0250] Referring now to Fig. 11, a block diagram of a pumping assembly comprising a force generating module and a motion modifying module is illustrated, consistent with the present inventive concepts. Each force generating module 3000 of the present inventive concepts can be combined with one or more motion modifying modules, motion modifying module 5000 (also referred to as MMM 5000), as shown in Fig. 11. For example, FGM 3000 of Figs. 7, 7A-E, 8, 9, and / or 10 can comprise a MMM 5000 (e.g., a gear box or other motion modifying module). Attorney Docket No. DYM-003-PCT

[0270]

[0251] MMM 5000 can comprise an assembly or other component constructed and arranged to amplify, de-amplify, or both amplify and de-amplify the motion provided by the at least one force generating module 3000.

[0271]

[0252] MMM 5000 can comprise an assembly or other component constructed and arranged to amplify, de-amplify, or both amplify and de-amplify the force provided by the at least one force generating module 3000.

[0272]

[0253] MMM 5000 can comprise a gear box, such as a gear box comprising a clutch. In some embodiments, MMM 5000 comprises a gear box with a gear box ratio of at least 10: 1, 50: 1, 100: 1, and / or 125: 1 (a gear box configured to amplify force by at least 10: 1, 50: 1, 100: 1, and / or 125: 1).

[0273]

[0254] MMM 5000 can comprise a non-360 degree tooth gear (e.g., a gear with teeth that do not fill a full 360 degree circumference, such as when one or more circumferential portions are void of teeth).

[0274]

[0255] MMM 5000 can comprise a lever, such as a lever constructed and arranged to amplify force provided by an FGM 3000 (e.g., while de-amplifying the distance delivered by FGM 3000).

[0275]

[0256] MMM 5000 can comprise a clutch.

[0276]

[0257] MMM 5000 can comprise a rotary-to-linear decoupler.

[0277]

[0258] The pumping assemblies 130 described in reference to Figs. 7-12C and otherwise herein can be configured such that piston 1310 is translated in a controlled matter, such as to: translate a minimum distance, translate a maximum distance, or both; translate at a velocity above a minimum translational velocity threshold, below a maximum translational velocity threshold, or both; translate at an acceleration above a minimum translational acceleration threshold, below a maximum translational acceleration threshold, or both; or combinations of these.

[0278]

[0259] The pumping assemblies 130 described in reference to Figs. 7-12C and otherwise herein can be configured such that piston 1350 is rotated in a controlled manner, such as to: rotate a minimum distance, rotate a maximum distance, or both; rotate at a velocity above a minimum rotational velocity threshold, below a maximum rotational velocity threshold, or both; rotate at an acceleration above a minimum rotational acceleration threshold, below a maximum rotational acceleration threshold, or both; or combinations of these. Attorney Docket No. DYM-003-PCT

[0279]

[0260] Referring now to Fig. 12A through 12C side sectional views of an embodiment of a drive assembly and fluid propulsion module with a piston in a retracted state, and advanced state, respectively, is illustrated, consistent with the present inventive concepts. Pumping assembly 130 and / or other components of fluid delivery device 100 or system 10 described in reference to Figs. 12A through 12C can be of similar construction and arrangement to the similar components described in reference to Fig. 1, Fig. 1 A and otherwise herein. Figs. 12A and 12B show pumping assembly 130 comprising fluid propulsion module 1310 and drive assembly 1320 in various states of translation and rotation of piston 1350. Drive assembly 1320 can comprise shuttle 1324, forward drive magnet 1326, retraction magnet 1327, and / or slot 1322. Magnetic assembly 3300 can comprise plunger drive magnet 3310, plunger rotate magnet 3315, proximal rotation magnet 3322, and / or distal rotation magnet 3324. Fig. 12C shows barrel 1340 including slot 1348.

[0280]

[0261] In some embodiments, drive module 1320 is configured to limit the velocity, the acceleration, or both, of piston 1350. For example, magnetic assembly 3300 can be configured to limit the force applied to piston 1350 (e.g., force limited to the magnetic attraction), such as to limit the velocity and / or acceleration of piston 1350, and / or to limit the drive force applied to piston 1350. In some embodiments, fluid propulsion module 1310, drive module 1320, or both, are configured to limit the velocity, the acceleration, or both, of fluid (e.g. agent 20) as the fluid travels through inlet 1343, lumen 1342, outlet 1344, and / or other flow pathway of delivery device 100 (e.g., such as to prevent damage or other undesired changes to agent 20).

[0281]

[0262] In some embodiments, the multi -magnetic drive system of Figs. 12A through 12C operates through coordinated linear and rotational magnetic forces controlled by the positioning of shuttle 1324. Fig. 12A illustrates a configuration where forward drive magnet 1326 is positioned adjacent to plunger drive magnet 3310, creating a repulsive magnetic force due to matching magnetic polarity. This repulsive force drives piston 1350 distally within barrel 1340 (e.g., advancing the piston to expel agent 20). Fig. 12B illustrates a configuration where shuttle 1324 has moved such that retraction magnet 1327 is positioned adjacent to plunger drive magnet 3310, creating an attractive magnetic force due to opposite magnetic polarity. This attractive force draws piston 1350 proximally within barrel 1340 (e.g., retracting the piston to draw agent 20 into the pumping chamber). In Fig. 12A, magnetic assembly 3300 is shown in a state where shuttle 1324 has been actuated, such that piston 1350 is to be advanced, driven by the magnetic forces between forward drive magnet 1326 Attorney Docket No. DYM-003-PCT and plunger drive magnet 3310. After advancement, plunger rotate magnet 3315 will enter the magnetic field of distal rotation magnet 3324, causing a 180 degree rotation of piston 1350. In Fig. 12B, magnetic assembly 3300 is shown in a state where shuttle 1324 has be actuated, such that piston 1350 is to be retracted, drawn by the magnetic forces between retraction magnet 1327 and plunger drive magnet 3310. After retraction, plunger rotate magnet 3315 will enter the magnetic field of proximal rotation magnet 3322, causing a 180 degree rotation of piston 1350, as described herein.

[0282]

[0263] In some embodiments, plunger rotate magnet 3315 is operably attached to piston 1350 and configured to interact with proximal rotation magnet 3322 and / or distal rotation magnet 3324 to drive rotational positioning of piston 1350. As piston 1350 translates between retracted and advanced positions, plunger rotate magnet 3315 experiences magnetic forces from the rotation magnets that cause piston 1350 to rotate approximately 180 degrees. The rotational motion is evidenced by the position of pin 1356 which appears pointing towards the viewer in Fig. 12A and pointing away from the viewer (shown dashed) in Fig. 12B due to the 180-degree rotation.

[0283]

[0264] In some embodiments, mating slot 1348 (shown in Fig. 12C) comprises a helical, serpentine, linear stepwise, or other path configured to constrain pin 1356 to follow a predetermined motion path that combines both linear translation and rotational motion. Mating slot 1348 can include linear segments where pin 1356 translates without rotation, and transition segments where pin 1356 can rotate approximately 180 degrees while maintaining substantially the same linear position. The constraint provided by mating slot 1348 can ensure that piston 1350 follows the same motion pattern during each actuation cycle, where pin 1356 travels linearly in one direction, rotates 180 degrees at the end of travel, then travels linearly in the opposite direction before rotating again to complete the cycle. The magnetic rotation ensures that plunger drive magnet 3310 alternates its orientation relative to forward drive magnet 1326 and retraction magnet 1327, enabling the system to switch between repulsive (advancing) and attractive (retracting) linear forces based on the position of shuttle 1324 and the rotational state of piston 1350 as constrained by mating slot 1348.

[0284]

[0265] Referring now to Figs. 13A and 13B, a top perspective view and bottom perspective view, respectively, of an embodiment 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 Figs. 13 A and 13B can be of similar construction and arrangement Attorney Docket No. DYM-003-PCT as the similar components described in reference to Fig. 1 and otherwise herein. Fig. 13A shows perspective view from the top side of an embodiment of delivery device 100 with a portion of housing 101 removed for illustrative clarity to reveal components located within the housing. Fig. 13B shows a perspective view from the bottom side of delivery device 100.

[0285]

[0266] Delivery device 100 can include pumping assembly 130. Pumping module 130 can include drive module 1320, which can include motor 3100 (e.g., a DC or other motor operably connected to a gear box, such as a gear box with a ratio of at least 100: 1, or 200: 1) that is operably attached to fluid propulsion module 1310 in the arrangement shown. Motor 3100 can comprise a motor and a gear box with a maximum diameter of no more than 7mm, such as no more than 6.5mm, 6.0mm, and / or 5.5mm. Drive module 1320 can include cam assembly 4400, as described herein. Pumping assembly 130 can be configured to propel fluid (e.g., agent 20) from reservoir 110 into the patient, such as via fluid pathway 140 and cannula 185. Cannula 185 can be configured to be inserted subcutaneously, as described herein.

[0286] Delivery device 100 can include canula assembly 180, for example an assembly configured to insert cannula 185 into the patient, as described herein. In some embodiments, delivery device 100 includes an assembly for filling reservoir 110, fill port assembly 150 shown e.g., an assembly comprising a resealable septum for access via a needle). As shown in Fig. 13B, housing 101 can include one or more openings, recesses, and / or other features for accessing the interior of the housing 101, such as an opening for accessing fill port assembly 150.

[0287]

[0267] Power supply 160 can include a battery and / or other energy storage device, such as an assembly comprising both a battery and a capacitor. In some embodiments, power supply 160 comprises a battery that has a height that is at least 50% of the height of delivery device 100, such as a height that is at least 60%, 65%, 70%, and / or 75% of the height of delivery device 100. Delivery device 100 can include a set of one or more circuit board or other electronic assemblies, assembly PCB shown. Reservoir 110 can take up at least 20% of the volume of delivery device 100 (as shown), such as at least 25%, 30%, 35%, and / or 40% of the volume of delivery device 100.

[0288]

[0268] Referring now to Figs. 14 and 14A, a perspective view and a magnified view of an embodiment of a pumping assembly of a fluid delivery device are illustrated, respectively, consistent with the present inventive concepts. Delivery device 100 and / or other components of system 10 described in Figs. 14 and 14A can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Fig. 14 shows Attorney Docket No. DYM-003-PCT a perspective view of an embodiment of pumping assembly 130 of delivery device 100. Pumping assembly 130 can include fluid propulsion module 1310, cam assembly 4400, and drive module 1320, as shown. Fig. 14A shows a magnified view of pumping assembly 130, with a portion of fluid propulsion module 1310 shown as semi-transparent for illustrative clarity to reveal components of the assembly not shown in Fig. 14.

[0289]

[0269] Motor 3100 (e.g., a DC or other motor operably connected to a gear box, such as a gear box with a ratio of at least 100: 1, or 200: 1) of pumping assembly 130 can be operably attached to cam assembly 4400, that is operably attached to piston 1350 of fluid propulsion module 1310. Motor 3100 can comprise a motor and a gear box with a maximum diameter of no more than 7mm, such as no more than 6.5mm, 6.0mm, and / or 5.5mm. Motor 3100 can be configured to rotate cam assembly 4400 and piston 1350 in unison. As cam assembly 4400 rotates, the face of the cam can ride along a bearing, such as ball bearing 4440 shown. The interaction between the ball bearing and the face of cam assembly 4400 causes the axial translation of cam assembly 4400, and piston 1350 that is attached thereto. Piston 1350 can translate and rotate within chamber 1311 fluid propulsion module 1310 (e.g., within barrel 1340) as described herein, which can draw fluid from a reservoir (e.g., reservoir 110), through channel 141 into chamber 1311 via inlet 1343, and out of chamber 1311 via outlet 1344, through channel 142 (e.g., to cannula assembly 180). Fluid pathway 140 can extend from reservoir 110 (not shown but described herein), to cannula assembly 180 (also not shown but described herein), including the fluid flow pathway through fluid propulsion module 1310.

[0290]

[0270] In some embodiments, housing 1341 of barrel 1340 comprises a housing including one or more structures that are configured to form and / or support additional features of delivery device 100. For example, at least a portion of fill port assembly 150 can be integrated into housing 1341, as shown. Housing 1341 can comprise a chamber that is sealed with a septum, as shown, and fluidly attached to a lumen extending through the housing, the reservoir inlet 1411 shown, that is fluidly attached to reservoir 110. Housing 1341 can comprise a lumen configured as channel 141, such as reservoir outlet 1412 shown that fluidly attaches reservoir 110 to chamber 1311.

[0291]

[0271] Drive module 1320 can include one or more bearing assemblies positioned between motor 3100 and cam assembly 4400, such as the two bearings 4450a and 4450b shown. Cam assembly 4400 can include one or more biasing elements 4430, such as a spring Attorney Docket No. DYM-003-PCT shown. The spring can be configured to maintain contact between the face of cam assembly 4400 and ball bearing 4440.

[0292]

[0272] In some embodiments, cam assembly 4400 comprises a diameter of no more than 10mm, such as no more than 9mm, 8mm, 7mm, 6mm, or 5mm, such as approximately 4mm. In some embodiments, cam assembly 4400 comprises a diameter of at least 2mm, such as at least 3mm, such as approximately 4mm. In some embodiments, cam assembly 4400 comprises a height of no more than the height of motor 3100. In some embodiments, ball bearing 4440 comprises a diameter of no more than 2.5mm, such as no more than 2.0mm, such as approximately 1.5mm. In some embodiments, the profile of cam assembly 4400 (e.g., the bearing surface of cam assembly 4400 configured to oppose ball bearing 4440) comprises a maximum ramp angle of no more than 50°, such as no more than 45°, 40°, 30°, or 20°, such as approximately 18.5°. In some embodiments, the profile of cam assembly 4400 comprises a maximum ramp angle of at least 5°, such as at least 10°, or 15°, such as approximately 18.5°. In some embodiments, the profile of cam assembly 4400 comprises one or more flat portions (e.g., portions where cam assembly 4400 is not causing linear translation of piston 1350 during a 360° rotation of cam assembly 4400), such as one or more flat portions that comprise at least 90° of the 360° profile, such as at least 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, 190°, 200°, 210°, 220°, or 230° of the 360° profile, such as approximately 240° of the 360° profile. In some embodiments, the profile of cam assembly 4400 comprises one or more flat portions that comprise no more than 320° of the 360° profile, such as no more than 300°, 280°, or 260° of the 360° profile, such as approximately 240° of the 360° profile.

[0293]

[0273] Referring now to Figs. 15A through 15H, a series of perspective views of an embodiment of a pumping assembly positioned in various stages of a pumping cycle are illustrated, consistent with the present inventive concepts. Delivery device 100 and / or other components of system 10 described in Figs. 15A and 15H can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Drive module 1320 of pumping assembly 130 can include motor 3100 (e.g., a DC or other motor operably connected to a gear box, such as a gear box with a ratio of at least 100: 1, or 200: 1) that is operably attached to cam assembly 4400, as described herein. Motor 3100 can comprise a motor and a gear box with a maximum diameter of no more than 7mm, such as no more than 6.5mm, 6.0mm, and / or 5.5mm. Drive module 1320 can be configured to translate Attorney Docket No. DYM-003-PCT and rotate piston 1350 of fluid propulsion module 1310, as described herein. Figs. 15A through 15H show various rotational positions of cam assembly 4400, with piston 1350 in various rotational and longitudinal positions within barrel 1340. Below, the orientation of piston 1350 is described referencing the orientation of relief 1355 as cam assembly 4400 rotates through at 360° rotation, and the longitudinal position of piston 1350 within barrel 1340.

[0294]

[0274] In Fig. 15A, relief 1355 is shown positioned straight “down” (e.g., 0°), with both the inlet and outlet of barrel 1340 blocked by the body of piston 1350.

[0295]

[0275] In Fig. 15B, piston 1350 has been rotated, such that relief 1355 is oriented toward the inlet of barrel 1340, such that as piston 1350 is retracted, fluid can be pulled into fluid propulsion module 1310.

[0296]

[0276] In Fig. 15C, piston 1350 has been retracted, as relief 1355 is oriented toward the inlet, drawing fluid into fluid propulsion module 1310.

[0297]

[0277] In Fig. 15D, relief 1355 is shown positioned straight “up” (e.g., 180° from Fig. 15 A), with both the inlet and outlet of barrel 1340 blocked by the body of piston 1350.

[0298]

[0278] Fig. 15E shows pumping assembly 130 from the opposite angle. Piston 1350 has been rotated such that relief 1355 is oriented toward the outlet of barrel 1340, such that as piston 1350 is readvanced (e.g., as allowed by cam assembly 4400, and biased by the spring of the cam assembly), fluid is pushed from fluid propulsion module 1310.

[0299]

[0279] In Fig. 15F, piston 1350 has been advanced, as relief 1355 is oriented toward the outlet, pushing fluid from fluid propulsion module 1310.

[0300]

[0280] In Fig. 15G, piston 1350 has been further advanced and rotated, such that the fluid from within fluid propulsion assembly 130 has been expelled, and the body of piston 1350 blocks the outlet of barrel 1340.

[0301]

[0281] In Fig. 15H, piston 1350 has been fully rotated (e.g., rotated 360° back to 0° position), and is oriented as shown in Fig. 15 A.

[0302]

[0282] Referring now to Fig. 16, a side sectional view of a fluid delivery device is illustrated, consistent with the present inventive concepts. Delivery device 100 and / or other components of system 10 described in Fig. 16 can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Fig. 16 illustrates reservoir 110 and power supply 160, with a surrounding housing 101 of a delivery device 100. Reservoir 110 and power supply 160 (e.g., a battery) can be configured to “fill” Attorney Docket No. DYM-003-PCT

[0303] (e.g., optimally and / or maximally fill) a chamber portion of delivery device 100. In Fig. 16, reservoir 110 has been filled with agent 20 (e.g., insulin or other agent to be delivered by device 100). Reservoir 110 can comprise a flexible material, such as a flexible material configured to expand as filled with agent 20, and reservoir 110 can be further configured to conform around the periphery of power supply 160, such as to minimize “dead space”, as shown in Fig. 16. In some embodiments, when reservoir 110 is in a full state, reservoir 110 and power supply 160 collectively occupy at least 80%, 85%, 90% and / or 95% of the cross- sectional area of one or more cross sections of delivery device 100. In some embodiments, reservoir 110 comprises one or more pleats, or recesses, to enhance the ability of reservoir 110 to conform around power supply 160. In some embodiments, reservoir 110 is configured to have a fill volume of at least 1.2ml, such as at least 1.5ml, 1.8ml, and / or 2.0ml. In these embodiments, delivery device 100 can comprise a maximum height of no more than 9mm, such as no more than 8mm, 7.5mm, 7.0mm, and / or 6.0mm, such as when power supply 160 comprises one, two, or more batteries located under reservoir 110 (e.g., power supply 160 and reservoir 110 are located in the same cross section of device 100), as shown in Fig. 16.

[0304]

[0283] 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

Attorney Docket No. DYM-003-PCTWHAT IS CLAIMED IS:

1. A fluid delivery system comprising: a fluid delivery device comprising: a reservoir assembly constructed and arranged to store an agent to be delivered to a patient; a pumping assembly comprising: a barrel including a barrel lumen; a piston configured to translate and rotate within the barrel lumen; an inlet fluidly connecting the barrel lumen to the reservoir assembly; and an outlet fluidly connected to the barrel lumen; and an agent delivery assembly comprising a flow path constructed and arranged to receive the agent from the outlet of the pumping assembly, wherein rotation of the piston alternatingly connects the inlet and outlet to the barrel lumen, and wherein translation of the piston propels the agent to the agent delivery assembly.

2. The fluid delivery system of claim 1 and / or any one or more other claims herein, wherein the agent delivery assembly comprises a cannula configured to be inserted into the patient.

3. The fluid delivery system of claim 1 and / or any one or more other claims herein, wherein the agent delivery assembly comprises a fluid connector configured to fluidly attach to a patient access device.Attorney Docket No. DYM-003-PCT4. The fluid delivery system of claim 3 and / or any one or more other claims herein, wherein the agent delivery assembly comprises a luer.

5. The fluid delivery system of claim 1 and / or any one or more other claims herein, wherein the pumping assembly further comprises a drive assembly configured to perform the rotation and the translation of the piston.

6. The fluid delivery system of claim 5 and / or any one or more other claims herein, wherein the drive assembly comprises a rotary actuator and a cam mechanism.

7. The fluid delivery system of claim 6 and / or any one or more other claims herein, wherein the rotary actuator comprises a motor.

8. The fluid delivery system of claim 7 and / or any one or more other claims herein, wherein the motor comprises a stepper motor.

9. The fluid delivery system of claim 5 and / or any one or more other claims herein, wherein the drive assembly comprises an electromagnetic assembly.

10. The fluid delivery system of claim 1 and / or any one or more other claims herein, wherein the barrel lumen diameter and / or the piston diameter comprises a diameter of at least 0.25mm and / or no more than 3mm, such as a diameter of approximately 0.7mm, 0.8mm, 0.9mm, and / or 1.0mm.

11. The fluid delivery system of claim 1 and / or any one or more other claims herein, wherein the barrel comprises a wall thickness of at least 0.05mm and / or no more than 2.0mm.

12. The fluid delivery system of claim 1 and / or any one or more other claims herein, wherein the pumping assembly comprises a variable volume chamber thatAttorney Docket No. DYM-003-PCT comprises the volume within the barrel lumen between the distal end of the barrel lumen and the piston, and wherein the piston is configured to be retracted to increase the volume of the variable volume chamber and advanced to decrease the volume of the variable volume chamber.

13. The fluid delivery system of claim 12 and / or any one or more other claims herein, wherein the variable volume chamber comprises a minimum volume comprising a volume of at least 0. lOpL and / or a volume of no more than l.OOpL.

14. The fluid delivery system of claim 12 and / or any one or more other claims herein, wherein the variable volume chamber comprises a maximum volume comprising a volume of at least 0.56pL and / or a volume of no more than 2.46pL.

15. The fluid delivery system of claim 12 and / or any one or more other claims herein, wherein increasing the volume of the variable volume chamber is configured to fill the chamber with a volume of the agent.

16. The fluid delivery system of claim 15 and / or any one or more other claims herein, wherein the fill volume comprises a volume of at least O.lOpL and / or no more than 2.00pL.

17. The fluid delivery system of claim 12 and / or any one or more other claims herein, wherein the piston is configured to be retracted a distance of at least 0.2mm and / or no more than 2.0mm.

18. The fluid delivery system of claim 12 and / or any one or more other claims herein, wherein the piston is configured to be advanced a distance of at least 0.2mm and / or no more than 2.0mm.

19. The fluid delivery system of claim 12 and / or any one or more other claims herein, wherein increasing the volume of the variable volumeAttorney Docket No. DYM-003-PCT chamber is configured to fill the variable volume chamber with the agent, and wherein decreasing the volume of the variable volume chamber is configured to deliver the agent to the agent delivery assembly.

20. The fluid delivery system of claim 19 and / or any one or more other claims herein, wherein the pumping assembly is configured to fill the variable volume chamber in no less than 0.05 seconds and / or no longer than 1.00 seconds.

21. The fluid delivery system of claim 19 and / or any one or more other claims herein, wherein the pumping assembly is configured to deliver the agent from the variable volume chamber in no less than 0.05 seconds and / or no longer than 1.00 seconds.

22. The fluid delivery system of claim 19 and / or any one or more other claims herein, wherein the pumping assembly is configured to fill the variable volume chamber and deliver the agent from the variable volume chamber in no less than 0.15 seconds and / or no longer than 5.00 seconds.

23. A fluid delivery system comprising: a fluid delivery device comprising: a reservoir assembly constructed and arranged to store an agent to be delivered to a patient; a pumping assembly comprising: a barrel including a barrel lumen; a piston configured to translate and rotate within the barrel lumen; an inlet fluidly connecting the barrel lumen to the reservoir assembly;Attorney Docket No. DYM-003-PCT an outlet fluidly connected to the barrel lumen, and a drive assembly constructed and arranged to cause the translation of the piston and to cause the rotation of the piston; and an agent delivery assembly comprising a flow path constructed and arranged to receive the agent from the outlet of the pumping assembly, and wherein rotation of the piston alternatingly connects the inlet and outlet to the barrel lumen, and wherein translation of the piston propels the agent to the agent delivery assembly.

24. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the drive assembly comprises: at least one force generating module; and at least one motion converting module.

25. The fluid delivery system of claim 24 and / or any one or more other claims herein, wherein the at least one force generating module comprises a rotary force generating module.

26. The fluid delivery system of claim 25 and / or any one or more other claims herein, wherein the rotary force generating module comprises a component selected from the group consisting of: arrangement of one or more coils and one or more magnets that are collectively constructed and arranged to provide rotary motion; motor, such as a DC motor, an AC motor, a stepper motor, and / or a Lavet motor; a piezo motor; a squiggle motor; a torsional spring; and combinations thereof.Attorney Docket No. DYM-003-PCT27. The fluid delivery system of claim 25 and / or any one or more other claims herein, wherein the at least one motion converting module comprises a rotary-to-linear motion converting module.

28. The fluid delivery system of claim 27 and / or any one or more other claims herein, wherein the rotary-to-linear motion converting module comprises a component selected from the group consisting of: a mating pin and slot arrangement; a rack and pinion assembly; a cam; a dicky -pen assembly; an arrangement of magnets with a multi-state linear bias based on rotational position; a living hinge; and combinations thereof.

29. The fluid delivery system of claim 25 and / or any one or more other claims herein, wherein the at least one force generating module comprises a linear force generating module.

30. The fluid delivery system of claim 29 and / or any one or more other claims herein, wherein the linear force generating module comprises a component selected from the group consisting of: an arrangement of one or more coils and one or more magnets that are configured to provide translational motion; a voice coil; a solenoid; a piezo actuator; a squiggle motor; a magnetic linear drive; a shaped memory wire; and combinations thereof.

31. The fluid delivery system of claim 25 and / or any one or more other claims herein, wherein the at least one motion converting module comprises a linear-to-rotary motion converting module.

32. The fluid delivery system of claim 31 and / or any one or more other claims herein, wherein the linear-to-rotary motion converting module comprises a componentAttorney Docket No. DYM-003-PCT selected from the group consisting of: a mating pin and slot arrangement; a rack and pinion assembly; a cam; a clicky-pen assembly; an arrangement of magnets with a multi-state linear bias based on rotational position; and combinations thereof.

33. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the drive assembly comprises: a first force generating module; and a second force generating module, wherein the first force generating module is constructed and arranged to cause the translation of the piston, and wherein the second force generating module is configured to cause the rotation of the piston.

34. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the drive assembly comprises: a first force generating module; a second force generating module; and a first motion converting module.Attorney Docket No. DYM-003-PCT35. The fluid delivery system of claim 34 and / or any one or more other claims herein, wherein the first force generating module and the second force generating module each comprise a rotary force generating module, and wherein the first motion converting module comprises a rotary -to-linear force generating motion converting module.

36. The fluid delivery system of claim 34 and / or any one or more other claims herein, wherein the first force generating module and the second force generating module each comprise a linear force generating module, and wherein the first motion converting module comprises a linear-to-rotary motion converting module.

37. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the drive assembly comprises: a first force generating module; a second force generating module; a first motion converting module; and a second motion converting module.

38. The fluid delivery system of claim 37 and / or any one or more other claims herein, wherein the first force generating module comprises a rotary force generating module,Attorney Docket No. DYM-003-PCT wherein the second force generating module comprises a linear force generating module, wherein the first motion converting module comprises a rotary -to-linear motion converting module, and wherein the second motion converting module comprises a linear-to- rotary motion converting module.

39. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the drive assembly comprises: a first force generating module; and a first motion converting module, wherein the first force generating module is configured to cause the rotation of the piston and to apply a force to the first motion converting module to cause the translation of the piston.

40. The fluid delivery system of claim 39 and / or any one or more other claims herein, wherein the first force generating module comprises a motor and / or other rotary force generating module, and wherein the first motion converting module comprises a mating pin and slot arrangement.

41. The fluid delivery system of claim 39 and / or any one or more other claims herein, wherein the first force generating module comprises a motor and / or other rotary force generating module, and wherein the first motion converting module comprises a face cam arrangement.

42. The fluid delivery system of claim 39 and / or any one or more other claims herein, wherein the first force generating module comprises a motor and / or other rotary force generating module, and wherein the first motion converting module comprises a cam follower arrangement.Attorney Docket No. DYM-003-PCT43. The fluid delivery system of claim 39 and / or any one or more other claims herein, wherein the first force generating module comprises a motor and / or other rotary force generating module, and wherein the first motion converting module comprises a rack and pinion arrangement.

44. The fluid delivery system of claim 43 and / or any one or more other claims herein, wherein the drive assembly further comprises a rotary decoupler.

45. The fluid delivery system of claim 43 and / or any one or more other claims herein, wherein the drive assembly further comprises a second motion converting module comprising a linear-to-rotary motion converter.

46. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the drive assembly comprises: a first force generating module; and a first motion converting module, wherein the first force generating module is configured to cause the translation of the piston and to apply a force to the first motion converting module to cause the rotation of the piston.

47. The fluid delivery system of claim 46 and / or any one or more other claims herein, wherein the first motion converting module comprises a dicky pen arrangement.

48. The fluid delivery system of claim 47 and / or any one or more other claims herein, wherein the first force generating module comprises a piezo actuator.Attorney Docket No. DYM-003-PCT49. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the drive assembly comprises: a first magnet assembly operably attached to the piston; a second magnet assembly constructed and arranged to apply a first magnetic force to the first magnet assembly to cause the translation of the piston; and a third magnet assembly configured to apply a second magnetic force to the first magnet assembly to cause the rotation of the piston.

50. The fluid delivery system of claim 49 and / or any one or more other claims herein, wherein the piston and barrel collectively comprise a mating pin and slot arrangement configured to cause the piston to translate without significant rotation during a mid-portion of the translation of the piston.

51. The fluid delivery system of claim 50 and / or any one or more other claims herein, wherein the piston comprises the pin and wherein the barrel comprises the slot.

52. The fluid delivery system of claim 50 and / or any one or more other claims herein, wherein the slot comprises a proximal end and a distal end, and wherein the slot further comprises a tapered entry geometry on the proximal end, the distal end, or both.

53. The fluid delivery system of claim 49 and / or any one or more other claims herein, wherein the second magnet assembly comprises at least one electromagnet, and wherein activation of the at least one electromagnet causes the translation of the piston.

54. The fluid delivery system of claim 49 and / or any one or more other claims herein, wherein the second magnet assembly comprises a first permanent magnet, wherein the drive assembly further comprises a forceAttorney Docket No. DYM-003-PCT generating module configured to cause the second magnet assembly to move between a first position and a second position, and wherein the second magnet assembly is configured to cause a forward translation of the piston when the second magnet assembly is in the first position.

55. The fluid delivery system of claim 54 and / or any one or more other claims herein, wherein the second magnet assembly further comprises a second permanent magnet, and wherein the second permanent magnet is configured to cause a backward translation of the piston when the second magnet assembly is in the second position.

56. The fluid delivery system of claim 49 and / or any one or more other claims herein, wherein the third magnet assembly comprises one or more electromagnets, and wherein activation of the one or more electromagnets causes the rotation of the piston.

57. The fluid delivery system of claim 49 and / or any one or more other claims herein, wherein the third magnet assembly comprises one or more permanent magnets.

58. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the drive assembly comprises a motor and / or other rotary force generating module and a motion modifying assembly comprising a rotation limiter, and wherein the first motion converting module comprise a rotary-to- linear nut and gear assembly.

59. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the drive assembly comprises: at least one force generating module; and at least one motion modifying module.Attorney Docket No. DYM-003-PCT60. The fluid delivery system of claim 59 and / or any one or more other claims herein, wherein the at least one motion modifying module comprises a component constructed and arranged to amplify and / or deamplify the motion provided by the at least one force generating module.

61. The fluid delivery system of claim 59 and / or any one or more other claims herein, wherein the at least one motion modifying module comprises a component constructed and arranged to amplify and / or deamplify the force provided by the at least one force generating module.

62. The fluid delivery system of claim 59 and / or any one or more other claims herein, wherein the at least one motion modifying module comprises a gear box.

63. The fluid delivery system of claim 62 and / or any one or more other claims herein, wherein the gear box comprises a clutch.

64. The fluid delivery system of claim 59 and / or any one or more other claims herein, wherein the at least one motion modifying module comprises a non-360 degree tooth gear.

65. The fluid delivery system of claim 59 and / or any one or more other claims herein, wherein the at least one motion modifying module comprises a lever.

66. The fluid delivery system of claim 65 and / or any one or more other claims herein, wherein the lever is constructed and arranged to amplify the force delivered by the first force generating module and to de-amplify the distance delivered by the first force generating module.Attorney Docket No. DYM-003-PCT67. The fluid delivery system of claim 59 and / or any one or more other claims herein, wherein the at least one motion modifying module comprises a clutch.

68. The fluid delivery system of claim 59 and / or any one or more other claims herein, wherein the at least one motion modifying module comprises a rotary-to-linear decoupler.

69. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the fluid delivery device comprises a maximum height, and wherein the piston comprises an outer diameter that is at least 10% of the maximum height.

70. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the barrel lumen comprises a mating segment that slidingly interfaces with the piston, and wherein the piston comprises an outer diameter that is at least 1%, 2%, and / or 3% larger than a diameter of the mating segment of the piston.

71. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the pumping assembly comprises a sealing element positioned between the piston and the barrel, wherein the sealing element is constructed and arranged to provide a seal as the piston translates within the sealing element, and wherein the barrel lumen comprises a diameter that is at least 1%, 2%, and / or 3% larger than the outer diameter of the segment of the piston that translates through the sealing element.

72. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein a segment of the piston and a segment of the barrel lumen overlap by at least 1mm, 2mm, and / or 3mm.

73. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the drive assembly comprises a motor and / or other rotary forceAttorney Docket No. DYM-003-PCT generator and a gear box, and wherein the gear box has a gear ratio of at least 10: 1, 50: 1, 100: 1, and / or 125: 1.

74. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the fluid delivery device further comprises a housing surrounding at least the pumping assembly and the drive assembly.

75. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the piston comprises a diameter of at least 0.1mm, such as a diameter of at least 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, and / or 0.8mm.

76. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the piston comprises a diameter of no more than 2.0mm, such as a diameter of no more than 1.9mm, 1.8mm, 1.7mm, 1.6mm, 1.5mm, 1.4mm, or 1.3mm.

77. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the pumping assembly is constructed and arranged to translate the piston a translation distance of no more than 1.2mm, such as a translation distance of no more than 1.1mm, 1.0mm, 0.9mm, or 0.8mm.

78. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the piston comprises a relief, and wherein the relief comprises a depth of at least 0.02mm, such as a depth of at least 0.03mm, 0.04mm and / or 0.05mm.

79. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the piston comprises a relief, and wherein the relief comprises a depth of no more than 0.4mm, such as a depth of no more than 0.3mm and / or 0.2mm.Attorney Docket No. DYM-003-PCT80. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the piston comprises a diameter and a relief, and wherein the relief comprises a depth of no more than 50% of the diameter of the piston, such as no more than 40% and / or 30% of the diameter of the piston.

81. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the inlet and / or outlet comprises a port diameter of no more than 0.8mm, such as a diameter of no more than 0.7mm, 0.6mm, 0.5mm, or 0.4mm.

82. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the inlet and / or outlet comprises a port diameter of at least 0.1mm, such as a diameter of at least 0.2mm.

83. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the inlet and / or outlet comprises a port diameter of no more than 80% of the diameter of the barrel lumen, such as no more than 70%, 60%, 50%, or 40%, of the diameter of the barrel lumen.

84. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the pumping assembly comprises a housing with a proximal end and a distal end, and wherein the inlet and / or outlet comprise a port that is positioned at least 1mm, or at least 2mm from the proximal end, and / or the port can be positioned no more than 5mm, or no more than 4mm from the proximal end.

85. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the pumping assembly comprises a housing with a proximal end and a distal end, and wherein the inlet and / or outlet comprise a port that is positioned at least 0.5mm, 0.75mm, or 1.0mm from the distal end, and / or the port can be positioned no more than 2.0mm, such as no more than 1.75mm and / or 1.5mm.Attorney Docket No. DYM-003-PCT86. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the drive assembly comprises a motor, and wherein the motor comprises a diameter of no more than 6mm, such as a diameter of no more than 5mm.

87. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the fluid delivery device comprises a height, wherein the drive assembly comprises a motor with a diameter, and wherein the height comprises a dimension equal to no more than the diameter of the motor plus at most 1.5mm, such as at most 1.4mm, 1.3mm, 1.2mm, and / or 1.1mm.

88. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the drive assembly comprises a motor, and wherein the motor comprises a length of no more than 25mm, such as no more than 24mm, 23mm, 22mm, 21mm, 20mm, and / or 19mm.

89. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the drive assembly comprises a cam assembly, and wherein the cam assembly comprises a diameter of no more than 10mm, such as no more than 9mm, 8mm, 7mm, 6mm, and / or 5mm.

90. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the drive assembly comprises a cam assembly comprising a ball bearing, and wherein the ball bearing comprises a diameter of no more than 2.5mm, such as a diameter of no more than 2.0mm.

91. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the drive assembly comprises a cam assembly, and wherein the cam assembly comprises a ramp angle of no more than 50°, such as no more than 45°, 40°, 30°, and / or 20°.

92. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the drive assembly comprises a cam assembly, and wherein theAttorney Docket No. DYM-003-PCT cam assembly comprises a ramp angle of at least 5°, such as at least 10°, and / or at least 15°.

93. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the drive assembly comprises a cam assembly with a 360° profile, and wherein the cam assembly further comprises one or more flat portions that comprise at least 90° of the 360° profile, such as at least 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, 190°, 200°, 210°, 220°, and / or 230° of the 360° profile.

94. The fluid delivery system of claim 23 and / or any one or more other claims herein, wherein the drive assembly comprises a cam assembly with a 360° profile, and wherein the cam assembly further comprises one or more flat portions that comprise no more than 320° of the 360° profile, such as no more than 300°, 280°, and / or 260° of the 360° profile.

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