Infusion device assembly

Abstract

To provide an injection device assembly.SOLUTION: A cassette for a drug delivery device may comprise a cassette base portion including a reservoir recess surrounded by an attachment surface. The attachment surface may include a reservoir outlet flow path recessed therein. The cassette may further comprise a reservoir film coupled to an attachment surface which, together with the reservoir recess, defines a flexible reservoir. A portion of the reservoir film may have a preformed shape which mimics a contour of the reservoir recess. The preform shape may cause the reservoir film to be disposed adjacent to a surface of reservoir recess when the reservoir is in an empty state. The cassette may further comprise at least one duct recessed into the surface of the reservoir recess. Each of the at least one duct may define a flow path which remains in fluid communication with the reservoir outlet flow path when the reservoir is in an empty state.SELECTED DRAWING: None

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 161,570 (Attorney Docket No. AA069), filed March 16, 2021, and entitled "Infusion Device Assembly," which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to fluid injection. More particularly, the present disclosure relates to a fluid injection device assembly. [Background technology]

[0003] Many potentially valuable drugs or compounds, including biologics, are not orally active due to poor absorption, liver metabolism, or other pharmacodynamic factors. In addition, some therapeutic compounds may be absorbed orally, but are sometimes required to be administered on a schedule that is often difficult for patients to maintain. In these cases, parenteral delivery is often employed or may be employed. Other drugs may be administered by routes other than parenteral, but the bioavailability of the drug varies over time from the ideal amount.

[0004] Effective parenteral routes of drug delivery and other fluids and compounds, such as subcutaneous injection, intramuscular injection, and intravenous (IV) administration, involve puncturing the skin with a needle or stylet. Insulin is an example of a therapeutic fluid that is self-injected by millions of diabetic patients. Users of parenterally delivered drugs would benefit from a wearable device that would automatically deliver the needed drug / compound over a period of time.

[0005] To this end, efforts have been made to set up portable devices for the controlled release of therapeutic agents. Such devices are known to have a reservoir, such as a cartridge, syringe, or bag, and to be electronically controlled. These devices suffer from several shortcomings, including a malfunction rate. Reducing the size, weight, and cost of these devices is also a continuing challenge. Summary of the Invention [Means for solving the problem]

[0006] According to an embodiment of the present disclosure, a cassette assembly for a drug delivery device may comprise a cassette base portion including a reservoir recess surrounded by a mounting surface. The mounting surface may include a reservoir outlet flow path recessed therein. The cassette assembly may further comprise a reservoir film coupled to the mounting surface which, together with the reservoir recess, may define a flexible reservoir. A portion of the reservoir film may have a preformed shape that mimics a contour of the reservoir recess. The preformed shape may cause the reservoir film to be positioned adjacent to a surface of the reservoir recess when the reservoir is in an empty state. The cassette assembly may further comprise at least one duct recessed into a surface of the reservoir recess. Each of the at least one duct may define a flow path that remains in fluid communication with the reservoir outlet flow path when the reservoir is in an empty state.

[0007] In some embodiments, the reservoir film may include an exposed area contained within the reservoir film. The exposed area may form a seal across the reservoir outlet flow path when the reservoir film is bonded to the mounting surface. In some embodiments, the reservoir film may include at least two layers. In some embodiments, the reservoir film may be thermally bonded to the mounting surface. In some embodiments, the cassette base portion may include a sidewall having a fill port that leads to the interior volume of the reservoir. In some embodiments, a basin may be recessed into the reservoir recess immediately downstream of the inlet that leads from the fill port to the interior volume of the reservoir. In some embodiments, at least one of the at least one duct may extend in communication with the basin. In some embodiments, the at least one duct may include a plurality of ducts that converge together at a junction. The junction may be located intermediate the reservoir outlet flow path and the duct. In some embodiments, the at least one duct may include a first duct and a second duct branching from the first duct. In some embodiments, the reservoir recess may include a wall extending from a bottom surface of the reservoir recess to the mounting surface, and the at least one duct includes a duct disposed along a portion of the circumference of the bottom surface adjacent the wall. In some embodiments, the duct disposed along a portion of the circumference may be disposed along a majority of the circumference. In some embodiments, the at least one duct may have a variable width. In some embodiments, the reservoir recess may include a wall extending from a bottom surface of the reservoir recess to the mounting surface, and the at least one duct may include a portion recessed into the bottom surface and a second portion recessed into the wall. In some embodiments, the first portion of the at least one duct may have a first width, and the second portion of the at least one duct has a variable width. In some embodiments, the width of the second portion of the at least one duct may taper from the first width to a second width that is smaller than the first width. In some embodiments, the first portion of the at least one duct may be of the second width.In some embodiments, the at least one duct may include a plurality of ducts extending from a junction region at regular angular intervals. The junction region may be disposed intermediate the plurality of ducts and the reservoir outlet flow path. In some embodiments, the reservoir outlet flow path may include an air trap. In some embodiments, the air trap may include at least one of a screen or a mesh.

[0008] According to another embodiment of the present disclosure, a cassette assembly for a drug delivery device may comprise a cassette base portion including a reservoir recess surrounded by a mounting surface. The cassette base portion may further comprise a welding surface along a portion of the periphery of the cassette base portion and a plurality of locating pins. The cassette assembly may further comprise a reservoir film coupled to the mounting surface which, together with the reservoir recess, may define a flexible reservoir. The cassette assembly may further comprise a cassette top portion including a number of locating pin receptacles and a peripheral energy director. The energy director may be aligned with the welding surface and a portion of the reservoir film is joined to the mounting surface when the locating pin is placed in the locating pin receptacle. The energy director may be welded to the welding surface and to the portion of the reservoir film.

[0009] In some embodiments, the energy director may comprise a triangular cross-section. In some embodiments, the energy director may be sonically welded to the weld surface and a portion of the reservoir film. In some embodiments, the energy director may be ultrasonically welded to the weld surface and a portion of the reservoir film. In some embodiments, the reservoir film may comprise at least two layers. In some embodiments, the cassette top portion may include a compartment including a number of retaining tabs. In some embodiments, the cassette assembly may further comprise a reservoir cover having a number of latch clips. The latch clips may be configured to cooperatively engage the retaining tabs of the compartments. The reservoir cover may be coupled to the cassette top portion when the latch clips cooperatively engage the retaining tabs.

[0010] According to another embodiment of the present disclosure, a cassette assembly for coupling to a reusable housing assembly of a drug delivery device may comprise a cassette base portion. The cassette assembly may further comprise a reservoir defined by a recess in the cassette base portion and a section of a reservoir film coupled to a mounting surface disposed around the recess. The cassette assembly may further comprise a cassette top portion including an inspection compartment covering the cassette base portion and disposed over the reservoir. The inspection compartment may include a number of coupling elements. The cassette assembly may further comprise a reservoir cover including a number of cooperating coupling elements configured to engage with the coupling elements of the inspection compartment and couple the reservoir cover into place within the inspection compartment. The reservoir may be accessible directly through the inspection compartment prior to disposition of the reservoir cover.

[0011] In some embodiments, the cassette base portion may be constructed from a transparent material. In some embodiments, the cassette base portion may be constructed from a clear material. The material may be sufficiently translucent to allow inspection by a machine or other mechanism during the filling process. In some embodiments, the cassette base portion may be constructed from a lightly colored material. In some embodiments, the reservoir cover may be a solid piece of material. In some embodiments, the coupling element may be a retaining tab and the cooperating coupling element may be a latch clip. In some embodiments, one of the latch clips may be disposed on a non-supported end of the cantilevered member of the reservoir cover. In some embodiments, the coupling element and the cooperating coupling element may be configured to engage via a snap fit. In some embodiments, the reservoir may be a pre-filled reservoir containing the drug. In some embodiments, the cassette may include a flow path extending from the reservoir to delivery tubing attached to the cassette. The cassette may further include an occluder assembly disposed in a section of the flow path. The occluder assembly may be operable between an occluded state and a flow-permitting state.

[0012] According to yet another embodiment of the present disclosure, a pre-filled cassette assembly for a drug delivery device may include a cassette base portion. The cassette may further include a reservoir defined by a recess in the cassette base portion and a reservoir film strip attached to the base portion at a mounting surface surrounding the recess. The reservoir may be filled with a drug. The cassette may further include a flow path extending from the reservoir to an outlet of the cassette. The flow path may be defined, at least in part, by a membrane cover along a section of the flow path. The cassette assembly may further include an occluder assembly operable between a flow permitting state and an occluded state in which the reservoir and a first portion of the flow path are isolated from a second portion downstream of the first portion of the flow path. The section of the flow path defined, at least in part, by the membrane cover may be part of the second portion of the flow path. The first portion of the flow path may be constructed from a material having long-term compatibility with the drug, and at least the membrane cover is constructed from a material having short-term compatibility with the drug.

[0013] In some embodiments, the reservoir film may be a layered film. In some embodiments, the second portion of the flow path may include at least one valve station. In some embodiments, the membrane cover may be coupled in place over the valve station to form a flow-tight seal. In some embodiments, the second portion of the flow path may include at least one pump chamber. In some embodiments, the membrane cover may be coupled in place over the valve station to form a flow-tight seal. In some embodiments, the occluder assembly may include an occluder diaphragm and an occluder actuator. In some embodiments, the cassette assembly may further include a threaded port, and in an occluded state, the occluder actuator may be threaded into the flow path, and the occluder diaphragm is actuated to occlude the flow path. In some embodiments, the cassette assembly may further include a threaded port configured to receive the occluder actuator, and the occluder assembly may be configured to transition from the occluded state to the flow-allowing state by removing the occluder actuator from the threaded port. In some embodiments, the occluder actuator may be configured to prevent mating of the cassette assembly and the reusable housing assembly when present in the cassette assembly. In some embodiments, at least a portion of the occluder diaphragm may be constructed from a material having long term compatibility with the drug. In some embodiments, the occluder assembly may be constructed from a material having long term compatibility with the drug. In some embodiments, at least a portion of the occluder assembly may be constructed from a material having long term compatibility with the drug. In some embodiments, the drug may be a drug for an endocrine disorder. In some embodiments, the drug may be treprostinil. In some embodiments, the drug may be selected from the group consisting of insulin and insulin analogs. In some embodiments, the drug may be proteinaceous. In some embodiments, the drug may include a polypeptide having a tertiary structure with at least one hydrophobic region.

[0014] According to an embodiment of the present disclosure, a pre-filled cassette assembly for a drug delivery device may include a housing. The cassette assembly may further include a reservoir containing a drug. The cassette assembly may further include a flow path extending from the reservoir to an outlet of the cassette assembly. The flow path may include several valve stations and a pump chamber. The cassette assembly may further include an occluder assembly including an occluder diaphragm and an occluder actuator in threaded engagement with a threaded port in the cassette assembly. The occluder assembly may have an occluded state in which the occluder actuator is in a first position in the threaded port and may urge the occluder diaphragm into sealing engagement with the occluder seat to occlude the flow path. The occluder assembly may have a flow allowing state in which the occluder actuator is unthreaded from the threaded port from the first position to at least a second position to relieve pressure on the occluder diaphragm.

[0015] In some embodiments, the reservoir may be defined by a recess in the cassette base portion and a piece of reservoir film attached to the base portion at a mounting surface surrounding the recess. In some embodiments, the occluder assembly may gate flow from the reservoir outlet flow path to the remainder of the flow path, including the pump chamber and the valve station. In some embodiments, the occluder diaphragm may be captured between the cassette base portion and the cassette top portion of the housing. In some embodiments, the occluder assembly may be contained within a recess or occluder seat in the face of the cassette base portion, and the occluder diaphragm may create a fluid seal about a periphery of the recess to form a sealed occluder volume. In some embodiments, the recess may include an occluder outlet. In some embodiments, the occluder outlet may be partially surrounded by a wall. The wall may extend from the recess for a distance greater than the height of the occluder assembly. In some embodiments, the occluder assembly may be a volcano-type arrangement. In some embodiments, the pump chamber and valve station, except for the occluder assembly, may be covered by a leaflet cover. In some embodiments, the housing may include a cassette base portion and a cassette top portion, and the leaflet cover may include an exposed area that forms a seal across at least one flow channel recessed into a face of the cassette base portion when the cassette base portion and the cassette top portion are coupled to one another. In some embodiments, the occluder actuator may include a knob and a rod protrusion from the rod. In some embodiments, the rod may include a number of bevel features disposed at a terminal end of the rod opposite the knob. The bevel features may have a pitch selected to cooperate with threads in the threaded port. In some embodiments, the bevel features may be disposed at uniform angular increments. In some embodiments, the threads in the threaded port include a shelf section. The bevel feature of the occluder actuator may be positioned on the shelf feature when the occluder actuator is in a first position.

[0016] According to another embodiment of the present disclosure, a cassette assembly for a drug delivery device may include a cassette base portion including a sidewall and a peripheral recess adjacent the sidewall. The cassette assembly may further include a cassette top portion coupled to the cassette base portion. The cassette assembly may further include a coupler consisting of a number of tabs protruding from the cassette top portion overhanging the peripheral recess and a number of rotational stops included on the cassette base portion and protruding into the recess. The rotational stops and tabs may cooperate to form a number of mating tracks. The cassette assembly may further include a collapsible reservoir. The cassette assembly may further include a fill port extending from the sidewall to the reservoir disposed within two of the mating tracks. The cassette assembly may be configured to mate with the reusable housing assembly upon introduction and rotation of mating fingers on the reusable housing assembly of the delivery device within each mating track.

[0017] In some embodiments, the tab may include a detent region. In some embodiments, the tab may include a beveled section. In some embodiments, the cassette top portion may include a sealing ring. In some embodiments, the cassette top portion may include a sealing ring and the tab may include a beveled section. The sealing ring may be configured to be compressed by the reusable housing assembly when a mating finger of the reusable housing assembly is rotated along the beveled section of the tab to releasably connect the cassette assembly to the reusable housing assembly. In some embodiments, the fill port may include a septum. In some embodiments, the fill port may include a protective wall adjacent the reservoir. In some embodiments, the protective wall may include an inlet that places the bore of the fill port in fluid communication with the interior volume of the reservoir. In some embodiments, the rotation stop may be disposed perpendicular to the tab. In some embodiments, the collapsible reservoir may include a reservoir recess in the cassette base portion and a piece of reservoir film that seals to be attached to the cassette base portion at a mounting surface surrounding the reservoir recess. In some embodiments, the reservoir recess may include a recessed basin immediately downstream of the fill port.

[0018] A cassette assembly for a drug delivery device according to an embodiment of the present disclosure may include a cassette base portion. The cassette assembly may further include a reservoir formed by a reservoir recess in the cassette base portion and a reservoir film strip attached to the cassette base portion at a mounting surface surrounding the reservoir recess. The cassette assembly may further include a valve leaflet cover. The cassette assembly may further include a channel film seal. The cassette assembly may further include a flow path extending from the reservoir to an outlet of the cassette assembly. The flow path may include a number of valve stations, at least one pump chamber, at least one channel recessed into each of a first face and an opposing second face of the cassette base portion, and a number of conduits extending through the cassette base portion connecting the channels on the first and second faces of the cassette base portion. The valve leaflet cover may form a seal around the number of valve stations and the at least one pump chamber. The channel film seal may seal at least one channel recessed into the second face of the cassette base portion. The at least one channel recessed into the first face of the cassette base portion may be sealed by at least one of the valve cover and the reservoir film.

[0019] In some embodiments, the reservoir film and the channel film seal may be constructed from the same material. In some embodiments, the reservoir film may be a multi-layer film. In some embodiments, the reservoir film may be heat bonded to the second side of the cassette assembly. In some embodiments, the reservoir film may be heat bonded to the mounting surface. In some embodiments, the at least one channel in the first side of the cassette base portion may include an air trap. In some embodiments, the at least one channel recessed into the first side of the cassette base portion may include a reservoir outlet channel recessed into the mounting surface. The reservoir film may form a seal over the reservoir outlet channel.

[0020] In some embodiments, the at least one channel recessed into the first face of the cassette base portion may include a channel that may be sealed over by an exposed area included in the leaflet cover. In some embodiments, the flow path may further include an occluder assembly. In some embodiments, the reservoir may be pre-filled by a manufacturer. In some embodiments, the at least one channel recessed into the second face of the cassette base portion and the channel film seal may be surrounded by a raised peripheral wall. In some embodiments, the cassette assembly may further include a cassette top portion coupled to the cassette base portion. The leaflet cover may be compressed between the cassette base portion and the cassette top portion to form a fluid-tight seal. In some embodiments, the cassette assembly may further include a cassette top portion coupled to the cassette base portion by sonic welding. At least a portion of the sonic welding may be formed between the cassette top portion and the reservoir film.

[0021] According to another embodiment of the present disclosure, a method of filling a reservoir for a cassette assembly of a drug delivery device may include actuating an occluder assembly of the cassette assembly to occlude a flow path leading from the reservoir to an outlet of the set. The method may further include loading fluid into the reservoir through a fill port. The method may further include imaging the reservoir. The method may further include determining whether the reservoir meets an acceptability criterion by analyzing at least one image of the reservoir. The method may further include disposing a reservoir cover within an inspection compartment providing visual access to the reservoir.

[0022] In some embodiments, imaging the reservoir may include photographing the reservoir through an inspection compartment. In some embodiments, determining whether the reservoir meets the acceptability criteria may include analyzing at least one image and determining whether particulates are present. In some embodiments, determining whether the reservoir meets the acceptability criteria may include analyzing at least one image and determining whether an amount of air above a predefined threshold is present. In some embodiments, actuating the occluder assembly may include disposing a removable occluder actuator within a port of the cassette assembly. In some embodiments, actuating the occluder assembly may include displacing an occluder diaphragm against the reservoir outlet valve to close off flow through the reservoir outlet valve. In some embodiments, disposing the reservoir cover within the inspection compartment may include coupling the reservoir cover to the cassette assembly via a snap fit.

[0023] According to another embodiment of the present disclosure, a cassette assembly for a drug delivery device may include a cassette base portion. The cassette assembly may further include a cassette top portion coupled to the cassette base portion. The cassette assembly may further include a collapsible reservoir. The cassette assembly may further include an outlet. The cassette assembly may further include a flow path extending from the collapsible reservoir to the outlet. The cassette assembly may further include a fill port extending from a sidewall of the cassette base portion to the reservoir, the fill port including at least one of an access restricting configuration and a reuse preventing configuration.

[0024] According to another embodiment of the present disclosure, a cassette assembly for a drug delivery device may include a cassette base portion. The cassette assembly may further include a reservoir defined by a reservoir recess in the cassette base portion and a reservoir film attached to the cassette base portion at a mounting surface surrounding the reservoir recess. The reservoir may be filled with a drug. The cassette assembly may further include a flow path extending from the reservoir to an outlet of the cassette assembly. The flow path may be defined, at least in part, by a membrane cover along a section of the flow path. The cassette assembly may further include an occluder assembly configured for operation between a flow permitting state and an occluded state in which the reservoir and a first portion of the flow path are isolated from a second portion downstream of the first portion of the flow path. The section of the flow path may be defined, at least in part, by a membrane cover that is part of the second portion of the flow path.

[0025] In some embodiments, the first portion of the flow path may be constructed from a material having long-term compatibility with the drug, and at least the membrane cover may be constructed from a material having short-term compatibility with the drug. In some embodiments, the reservoir film may be a layered film. In some embodiments, the second portion of the flow path may include at least one valve station. In some embodiments, the membrane cover may be coupled in place over the valve station to form a fluid-tight seal. In some embodiments, the second portion of the flow path may include at least one pump chamber. In some embodiments, the membrane cover may be coupled in place over the valve station to form a fluid-tight seal. In some embodiments, the occluder assembly may include an occluder diaphragm and an occluder actuator. In some embodiments, the cassette assembly may further include a threaded port, and in an occluded state, the occluder actuator may be threaded into the flow path, and the occluder diaphragm may be actuated to occlude the flow path. In some embodiments, the cassette assembly may further comprise a threaded port configured to receive an occluder actuator, and the occluder assembly may be configured to transition from the occluded state to the flow allowing state by removing the occluder actuator from the threaded port. In some embodiments, the occluder actuator may be configured to prevent mating of the cassette assembly and the reusable housing assembly when present in the cassette assembly. In some embodiments, at least a portion of the occluder diaphragm may be constructed from a material having long-term compatibility with drugs. In some embodiments, the occluder assembly may include an occluder actuator that is removable from the cassette assembly. The occluder assembly may be in the flow allowing state when the occluder actuator is removed from the cassette assembly. In some embodiments, the occluder assembly may include a rotatable occluder actuator. The occluder assembly is configured to transition from the occluded state to the flow allowing state in response to rotation of the occluder actuator.In some embodiments, the occluder assembly may include a displaceable occluder actuator. The occluder assembly may be configured to transition from an occluded state to a flow-permitting state in response to a translational displacement of the occluder actuator. In some embodiments, the occluder assembly may include an occluder shuttle disposed within the occluder channel. In some embodiments, the occluder shuttle may include at least one seal interface that generates a fluid seal against a wall of the occluder channel. In some embodiments, in the occluded state, the at least one seal interface may be disposed intermediate an opening of a first portion of the flow path to the occluder channel and an opening of a second portion of the flow path to the occluder channel. In some embodiments, the occluder shuttle may be covered by an occluder shuttle diaphragm. In some embodiments, the occluder shuttle may be compressible elastomer. In some embodiments, the occluder shuttle may be compressible and may include an enlarged section. The occluder channel may include a step between a wide section and a narrow section. The enlarged section of the occluder shuttle may be wider than the narrow section in a non-compressed state. In some embodiments, the occluder assembly may be constructed from a material that has long-term compatibility with drugs. In some embodiments, at least a portion of the occluder assembly may be constructed from a material having long-term compatibility with the drug. In some embodiments, the drug may be a medication for an endocrine disorder. In some embodiments, the drug may be selected from the group consisting of insulin and insulin analogs. In some embodiments, the drug may be treprostinil. In some embodiments, the drug may be proteinaceous. In some embodiments, the drug may include a polypeptide having a tertiary structure with at least one hydrophobic region. In some embodiments, the occluder assembly may include an occluder plug and a tapered port. The occluder plug may be retained within the tapered port via an interference fit. In some embodiments, the occluder assembly may include an occluder diaphragm.When retained within the tapered port, the obturator plug may compress and seal the obturator diaphragm against the reservoir exit opening, hi some embodiments, the obturator plug may be constructed from a compressible elastomer.

[0026] According to another embodiment of the present disclosure, a cassette assembly for a drug delivery device may include a cassette base portion. The cassette assembly may further include a cassette top portion coupled to the cassette base portion. The cassette assembly may further include a cassette shell. The cassette shell may be made of a material that is compatible with contact with a user's skin and resistant to body oils, sweat, and lotions that may be applied to the user's skin. The cassette shell may substantially cover the bottom and sides of the coupled cassette top and bottom portions while leaving the top open for attachment to the reusable housing assembly. The cassette shell may be attached to the coupled cassette base and top portions with a snap-fit ​​arrangement of tabs and slots. The cassette assembly may further include a collapsible reservoir defined by a recess in the cassette base portion and covered with a reservoir film. The cassette assembly may further include an outlet. The cassette assembly may further include a flow path extending from the collapsible reservoir to the outlet. The reservoir may have a fill port extending from a side of the cassette base portion. The reservoir may be filled with a drug and the fill port may be closed with a reservoir plug. The cassette shell may include a shell protrusion that covers the fill port and also helps hold the reservoir plug in place during shipping and use of the cassette assembly.

[0027] According to another embodiment of the present disclosure, a drug delivery system may include a dispensing assembly comprising a reusable housing assembly and a cassette assembly having a reservoir pre-filled with a fluid drug. The dispensing assembly further comprises a pump assembly and a pump controller for pumping the drug from the reservoir, through the flow path, to an outlet for final injection to a user. A method of use includes coupling the cassette assembly to the reusable housing assembly and initiating an auto-priming function, whereby the controller initiates a series of steps that operate the pump assembly and associated valve assembly to prime the pump assembly and the flow path. In a further embodiment, the dispensing assembly may include a volume sensor that is also primed by the auto-priming function. In yet another embodiment, the cassette assembly may include an occluder assembly for isolating the reservoir from the flow path until use, the method further including actuating the occluder from a closed state to an open state prior to initiating the auto-priming function. In yet another embodiment, the cassette assembly is packaged for transport within a packaging body. The occluder assembly further includes an occluder actuator whereby removal of the actuator transitions the occluder assembly from the closed state to the open state. The occluder actuator is tethered to the packaging body by an occluder tether. Removal of the cassette assembly from the packaging body stretches the occluder tether and removes the occluder actuator from the actuator assembly, thereby transitioning the occluder assembly from the closed state to the open state prior to coupling of the cassette assembly and the reusable housing assembly.

[0028] According to another embodiment of the present disclosure, a drug delivery system may include a dispensing assembly comprising a reusable housing assembly and a cassette assembly having a reservoir pre-filled with a fluid drug. The dispensing assembly further comprises a pump assembly and a pump controller for pumping the drug from the reservoir through the flow path to an outlet for final injection to a user. A method of use includes coupling the cassette assembly to the reusable housing assembly and initiating an auto-priming function, whereby the controller initiates a series of steps to operate the pump assembly and associated valve assembly to prime the pump assembly and the flow path. The pump assembly may have an inlet valve assembly, a pump assembly, and an outlet valve assembly. In some embodiments, the outlet valve assembly can be fluidly between the pump assembly and the volume sensor assembly, whereby the outlet valve assembly can also be a volume sensor valve assembly. The outlet valve assembly allows the auto-priming function to be biased to a closed position. Fluid pressure generated by the pump assembly in the fluid channel above a set amount will open the outlet valve assembly and allow fluid to flow downstream of the volume sensor assembly. During the auto-priming function, the outlet valve assembly may be opened by the valve drive assembly to allow auto-priming even when the fluid pressure is below a set amount.

[0029] According to another embodiment of the present disclosure, a cassette assembly of a dispensing system may be pre-filled and shipped to an end user. The cassette assembly includes an occluder assembly for isolating a pre-filled reservoir from a pump portion of the cassette assembly. The occluder assembly includes a bung that biases the occluder assembly to an occluded state. The cassette assembly is shipped in a package for holding the cassette assembly, and a tether further connects the package to the occluder bung. Removing the cassette assembly from the package stretches the tether, thereby retracting the occluder bung from the occluder assembly and transitioning the occluder assembly to a non-occluded state. The cassette assembly may then be coupled to a reusable housing assembly and an auto-priming feature may be initiated to prime a pump of the cassette assembly and prepare the dispensing system for infusion of fluid to an end user.

[0030] According to another embodiment of the present disclosure, the two-phase valve has a first mode in which the two-phase valve is biased to a closed state and opens, allowing fluid passage, when the fluid pressure on one side of the valve exceeds a predetermined threshold pressure. In a second mode of operation, the two-phase valve can open, allowing fluid flow, when the pressure falls below the threshold pressure. The two-phase valve has a valve actuator defining a valve face for sealing against a valve seat. The embodiment may further have a flexible diaphragm between the valve face and the valve seat. The valve actuator further defines a valve lift slot for receiving a valve lift pin. A valve spring biases the valve actuator to a closed position, where the valve face seals against the valve seat. The valve lift slot and the valve lift pin are configured to slidably engage the slot, whereby the valve actuator can fully seat the valve face within the valve seat. In a first mode of operation, when fluid pressure on the inlet side of the valve overcomes the bias of the valve spring, the valve opens and allows fluid flow until the pressure becomes insufficient to maintain the valve in the open position and the valve closes. Opening the valve moves the valve lift stop away from the valve lift pin. In a second mode, the valve lift pin is moved so that it engages the valve lift stop at the end of the valve lift slot, overcoming the bias of the valve spring and opening the valve. Returning the valve lift pin to its original position allows the valve spring to return the valve to the closed position. The valve lift pin may be moved by a bell crank shaped actuating arm that is pivoted by a shape memory actuator.

[0031] According to another embodiment of the present disclosure, a dual valve assembly is actuated by a common drive assembly having a first valve that is two-phase and a second valve that has at least a single mode. The first valve has a first mode in which the two-phase valve is biased to a closed state and opens, allowing fluid passage, when the fluid pressure on one side of the first valve exceeds a predetermined threshold pressure. In a second mode of operation, the second valve can be opened by the drive assembly to allow fluid flow when the pressure falls below the threshold pressure. The second valve can be opened and closed by the drive assembly independently of the first valve when the first valve is in the first mode. When the first valve is in the second mode, the second valve is also opened by the drive assembly. The first and second valves each have a valve actuator defining a valve face and a valve slot, the valve slot having a lift slot stop at one end, a valve seat for receiving the valve face and closing the valve, and a valve spring for biasing the valve to a closed position. The drive assembly moves a lift pin for each valve, the lift pin for each valve arranged for sliding engagement with each respective valve lift slot. The valve driver may have a bell crank shaped lift moved by a shape memory actuator, the lift pin and lift slot arranged such that when the valve driver is in a first position, the first and second valves are closed, whereby the first valve may open when in a first mode and fluid pressure exceeds a threshold value. In the second position, the valve actuator engages the lift pin of the second valve against the valve lift stop of the second valve to open the second valve, whereby the first valve continues to operate in the first mode whereby fluid pressure above a threshold opens the first valve. The actuator has a third position whereby the second valve is opened by engagement of the lift pin of the second valve against the valve lift slot stop of the second valve and the first valve is opened by engagement of the lift pin of the first valve against the lift slot stop of the first valve. The present invention provides, for example, the following: (Item 1) 20. A drug delivery device or any of the systems, methods and apparatus substantially as herein illustrated and described. (Item 2) 1. A cassette for a drug delivery device, comprising: a cassette base portion including a reservoir recess surrounded by a mounting surface, the mounting surface including a reservoir outlet flow path recessed therein, and a reservoir film coupled to the mounting surface and defining a flexible reservoir with the reservoir recess, a portion of the reservoir film having a preformed shape that mimics a contour of the reservoir recess, the preformed shape causing the reservoir film to be positioned adjacent a surface of the reservoir recess when the reservoir is in an empty condition; at least one duct recessed into a surface of the reservoir recess, each of the at least one duct defining a flow path that remains in fluid communication with the reservoir outlet flow path when the reservoir is in an empty state; A cassette comprising: (Item 3) Item 3. The cassette of item 2, wherein the reservoir film includes an exposed area that is contained within the reservoir film and forms a seal across the reservoir outlet flow path when the reservoir film is coupled to the mounting surface. (Item 4) 3. The cassette of claim 2, wherein the reservoir film comprises at least two layers. (Item 5) 3. The cassette of claim 2, wherein the reservoir film is thermally bonded to the mounting surface. (Item 6) 3. The cassette of claim 2, wherein the cassette base portion includes a sidewall having a fill port that leads to an interior volume of the reservoir. (Item 7) 7. The cassette of claim 6, wherein a basin is recessed into the reservoir recess immediately downstream of an inlet leading from the fill port to the interior volume of the reservoir. (Item 8) 8. The cassette of claim 7, wherein at least one of the at least one duct extends into communication with the basin. (Item 9) Item 3. The cassette of item 2, wherein the at least one duct comprises a plurality of ducts that converge together to a junction, the junction being disposed intermediate the reservoir outlet flow path and the duct. (Item 10) 3. The cassette of claim 2, wherein the at least one duct includes a first duct and a second duct branching off from the first duct. (Item 11) 3. The cassette of claim 2, wherein the reservoir recess includes a wall extending from a bottom surface of the reservoir recess to the mounting surface, and the at least one duct includes a duct disposed along a portion of a circumference of the bottom surface adjacent the wall. (Item 12) Item 12. The cassette of item 11, wherein the duct disposed along a portion of the circumference is disposed along a majority of the circumference. (Item 13) 3. The cassette of claim 2, wherein the reservoir recess includes a wall extending from a bottom surface of the reservoir recess to the mounting surface, and the at least one duct includes a portion recessed into the bottom surface and a second portion recessed into the wall. (Item 14) Item 14. The cassette of item 13, wherein a first portion of the at least one duct has a first width and a second portion of the at least one duct has a variable width. (Item 15) Item 14. The cassette of item 13, wherein a width of the second portion of the at least one duct tapers from a first width to a second width that is smaller than the first width. (Item 16) Item 14. The cassette of item 13, wherein a first portion of the at least one duct is of the second width. (Item 17) Item 3. The cassette of item 2, wherein the at least one duct includes a plurality of ducts extending from a junction region at regular angular intervals, the junction region being disposed intermediate the plurality of ducts and the reservoir outlet flow path. (Item 18) 3. The cassette of claim 2, wherein the reservoir outlet flow path includes an air trap. (Item 19) 1. A cassette for a drug delivery device, comprising: a cassette base portion including a reservoir recess surrounded by a mounting surface, the cassette base portion further including a weld surface along a portion of a periphery of the cassette base portion and a plurality of locating pins; a reservoir film coupled to the mounting surface and defining, together with the reservoir recess, a flexible reservoir; a cassette top portion including a number of locating pin receptacles and a peripheral energy director, the energy directors being aligned with the welding surface, a portion of the reservoir film being bonded to the mounting surface when the locating pins are placed within the locating pin receptacles, and the energy directors being welded to the welding surface and to the portion of the reservoir film; A cassette comprising: (Item 20) 20. The cassette of claim 19, wherein the energy director comprises a triangular cross-section. (Item 21) 20. The cassette of claim 19, wherein the energy director is sonically welded to the welding surface and a portion of the reservoir film. (Item 22) 20. The cassette of claim 19, wherein the energy director is ultrasonically welded to the welding surface and a portion of the reservoir film. (Item 23) 20. The cassette of claim 19, wherein the reservoir film comprises at least two layers. (Item 24) 20. The cassette of claim 19, wherein the cassette top portion includes a compartment including a number of retention tabs. (Item 25) Item 25. The cassette of item 24, wherein the cassette further comprises a cover having a number of latch clips configured to cooperatively engage retaining tabs on the compartments, the cover being coupled to the cassette top portion when the latch clips cooperatively engage the retaining tabs. (Item 26) 1. A cassette for coupling to a reusable housing assembly of a drug delivery device, comprising: A cassette base portion; a reservoir defined by a recess in the cassette base portion and a section of reservoir film bonded to a mounting surface disposed about the recess; a cassette top portion covering said cassette base portion and including an access compartment disposed throughout said reservoir, said access compartment including a number of coupling elements; a cover including a number of cooperating coupling elements configured to engage coupling elements of the access compartment and couple the cover into place within the access compartment; Equipped with The reservoir is accessible directly through the access compartment prior to placement of the cover of the cassette. (Item 27) 27. The cassette of claim 26, wherein the cassette base portion is constructed from a transparent material. (Item 28) 27. The cassette of claim 26, wherein the cassette base portion is constructed from a clear material. (Item 29) 27. The cassette of claim 26, wherein the cassette base portion is constructed from a light-colored material. (Item 30) 27. The cassette of claim 26, wherein the cover is a solid piece of material. (Item 31) 27. The cassette of claim 26, wherein the coupling element is a retaining tab and the cooperating coupling element is a latch clip. (Item 32) Item 32. The cassette of item 31, wherein one of the latch clips is disposed at a non-supported end of a cantilevered member of the cover. (Item 33) Item 27. The cassette of item 26, wherein the coupling element and the cooperating coupling element are configured to engage via a snap fit. (Item 34) 27. The cassette of claim 26, wherein the reservoir is a pre-filled reservoir containing the drug. (Item 35) 27. The cassette of claim 26, wherein the cassette includes a flow path extending from the reservoir to delivery tubing attached to the cassette, the cassette further including an occluder assembly disposed in a segment of the flow path, the occluder assembly being operable between an occluded state and a flow allowing state. (Item 36) 1. A pre-filled cassette for a drug delivery device, comprising: A cassette base portion; a reservoir defined by a recess in the cassette base portion and a piece of reservoir film attached to the base portion at a mounting surface surrounding the recess, the reservoir being filled with a drug; a flow path extending from the reservoir to an outlet of the cassette, the flow path being defined, at least in part, along a section of the flow path by a membrane cover; an occluder assembly operable between a flow permitting state and an occluded state in which the reservoir and a first portion of the flow path are isolated from a second portion of the flow path downstream of the first portion, the flow path compartment being defined, at least in part, by the membrane cover that is a part of the second portion of the flow path; Equipped with A cassette, wherein a first portion of the flow path is constructed from a material having long-term compatibility with the drug and at least the membrane cover is constructed from a material having short-term compatibility with the drug. (Item 37) 37. The cassette of claim 36, wherein the reservoir film is a layered film. (Item 38) Item 37. The cassette of item 36, wherein the second portion of the flow path includes at least one valve station. (Item 39) Item 39. The cassette of item 38, wherein the membrane cover is bonded in place over the valve station to form a fluid tight seal. (Item 40) Item 37. The cassette of item 36, wherein the second portion of the flow path includes at least one pump chamber. (Item 41) Item 41. The cassette of item 40, wherein the membrane cover is bonded in place over the valve station to form a fluid tight seal. (Item 42) Item 37. The cassette of item 36, wherein the occluder assembly includes an occluder diaphragm and an actuator. (Item 43) Item 43. The cassette of item 42, further comprising a threaded port, wherein in the occluded state, the actuator is threaded into the flow path and the occluder diaphragm is actuated to occlude the flow path. (Item 44) Item 43. The cassette of item 42, further comprising a threaded port configured to receive the actuator, the occluder assembly being configured to transition from the occluded state to the flow allowing state by removing the actuator from the threaded port. (Item 45) Item 43. The cassette of item 42, wherein the actuator, when present within the cassette, is configured to prevent interlocking of the cassette with a reusable housing assembly. (Item 46) Item 43. The cassette of item 42, wherein at least a portion of the diaphragm is constructed from a material having long term compatibility with the drug. (Item 47) Item 37. The cassette of item 36, wherein the occluder assembly is constructed from a material having long-term compatibility with the drug. (Item 48) Item 37. The cassette of item 36, wherein at least a portion of the occluder assembly is constructed from a material having long-term compatibility with the drug. (Item 49) 1. A pre-filled cassette for a drug delivery device, comprising: A housing and a reservoir containing a drug; a flow path extending from the reservoir to an outlet of the cassette, the flow path including a number of valve stations and a pump chamber; an occluder assembly including a diaphragm and an actuator in threaded engagement with a threaded port in the housing, the occluder assembly having an occluded state in which the actuator is in a first position within the threaded port and presses the diaphragm into sealing engagement with an occluder valve station of the valve station, the occluder assembly having a flow permitting state in which the actuator is unthreaded from the threaded port from the first position to at least a second position, relieving pressure on the diaphragm; A cassette comprising: (Item 50) 50. The cassette of claim 49, wherein the reservoir is defined by a recess in the cassette base portion and a piece of reservoir film attached to the base portion at a mounting surface surrounding the recess. (Item 51) 50. The cassette of claim 49, wherein the occluder valve station gates flow from a reservoir outlet flow path to the remainder of the flow path including the pump chamber and the remaining valve stations. (Item 52) 50. The cassette of claim 49, wherein the diaphragm is captured between a cassette base portion and a cassette top portion of the housing. (Item 53) Item 53. The cassette of item 52, wherein the occluder valve station is contained within a recess in a face of the cassette base portion, and the diaphragm creates a fluid seal about a periphery of the recess to form a sealed occluder volume. (Item 54) Item 54. The cassette of item 53, wherein the recess comprises an obturator outlet. (Item 55) Item 55. The cassette of item 54, wherein the obturator outlet is partially surrounded by a wall, the wall extending from the recess a distance that exceeds a height of the obturator valve station. (Item 56) 50. The cassette of claim 49, wherein the occluder valve station is a volcano-type valve station. (Item 57) 50. The cassette of claim 49, wherein the pump chambers and valve stations, except for the occluder valve station, are covered by a valve cover. (Item 58) Item 58. The cassette of item 57, wherein the housing includes a cassette base portion and a cassette top portion, and the valve cover includes an exposed area that forms a seal across at least one flow channel recessed into a face of the base area when the cassette base portion and the cassette top portion are coupled to one another. (Item 59) 50. The cassette of claim 49, wherein the actuator includes a knob and a rod projection from a rod. (Item 60) 60. The cassette of claim 59, wherein the rod includes a number of beveled features disposed on a terminal end of the rod opposite the knob, the beveled features having a pitch selected to cooperate with threads in the threaded port. (Item 61) Item 61. The cassette of item 60, wherein the beveled features are arranged at uniform angular increments. (Item 62) Item 61. The cassette of item 60, wherein the threads in the threaded port include a shelf section, and a ramp feature of the actuator rests on the shelf feature when the actuator is in the first position. (Item 63) 1. A cassette for a drug delivery device, comprising: a cassette base portion including a sidewall and a peripheral recess adjacent said sidewall; a cassette top portion coupled to said cassette base portion; a coupler comprising a number of tabs projecting from a top portion of the cassette overhanging the peripheral recess and a number of rotational stops included on a base portion of the cassette and projecting into the recesses, the rotational stops and tabs cooperating to form a number of mating tracks; a collapsible reservoir; a fill port extending from the sidewall to the reservoir, the fill port being disposed within two of the interlocking tracks; Equipped with The cassette is configured to mate with the reusable housing assembly of the delivery device upon introduction and rotation of mating fingers on the reusable housing assembly within respective mating tracks. (Item 64) Item 64. The cassette of item 63, wherein the tab includes a detent area. (Item 65) Item 64. The cassette of item 63, wherein the tab includes a beveled section. (Item 66) Item 64. The cassette of item 63, wherein the cassette top portion includes a sealing ring. (Item 67) Item 64. The cassette of item 63, wherein the cassette top portion includes a sealing ring, the tab includes a beveled section, and the sealing ring is configured to be compressed by the reusable housing assembly when a coupling finger of the reusable housing assembly is rotated along the beveled section of the tab. (Item 68) Item 64. The cassette of item 63, wherein the fill port comprises a septum. (Item 69) Item 64. The cassette of item 63, wherein the fill port includes a protective wall adjacent the reservoir. (Item 70) 70. The cassette of claim 69, wherein the protective wall includes an inlet that places the bore of the fill port in fluid communication with the interior volume of the reservoir. (Item 71) Item 64. The cassette of item 63, wherein the rotation stop is disposed perpendicular to the tab. (Item 72) Item 64. The cassette of item 63, wherein the collapsible reservoir comprises a recess in the cassette base portion and a piece of reservoir film that seals to the cassette base portion at a mounting surface surrounding the recess. (Item 73) 73. The cassette of claim 72, wherein the recess includes a recessed basin immediately downstream of the fill port. (Item 74) 1. A cassette for a drug delivery device, comprising: A cassette base portion; a reservoir formed by a recess in the cassette base portion and a piece of reservoir film attached to the cassette base portion at a mounting surface surrounding the recess; A valve cover; Film seal and a flow path extending from the reservoir to an outlet of the cassette, the flow path including a number of valve stations, at least one pump chamber, at least one channel recessed into each of a first side and an opposing second side of the cassette base portion, and a number of conduits extending through the cassette base portion connecting the channels on the first and second sides of the cassette base portion, the leaflet cover forming a seal around the number of valve stations and the at least one pump chamber, the film seal sealing at least one channel recessed into the second side of the cassette base portion, and at least one channel recessed into the first side of the cassette base portion being sealed by at least one of the leaflet cover and the reservoir film; A cassette comprising: (Item 75) 75. The cassette of item 74, wherein the reservoir film and film seal are constructed from the same material. (Item 76) 75. The cassette of claim 74, wherein the reservoir film is a multilayer film. (Item 77) Item 75. The cassette of item 74, wherein the film seal is thermally bonded to the second surface of the cassette. (Item 78) Item 75. The cassette of item 74, wherein the reservoir film is thermally bonded to the mounting surface. (Item 79) Item 75. The cassette of item 74, wherein at least one channel in a first face of the cassette base portion includes an air trap. (Item 80) Item 75. The cassette of item 74, wherein the at least one channel recessed into the first face of the cassette base portion includes a reservoir outlet channel recessed into the mounting surface, and the reservoir film forms a seal across the reservoir outlet channel. (Item 81) Item 75. The cassette of item 74, wherein the at least one channel recessed into the first face of the cassette base portion includes a channel sealed across an exposed area contained within the valve leaflet cover. (Item 82) Item 75. The cassette of item 74, wherein the flow path further comprises an occluder assembly. (Item 83) 75. The cassette of item 74, wherein the reservoir is pre-filled by the manufacturer. (Item 84) Item 75. The cassette of item 74, wherein the at least one channel recessed into the second face of the cassette base portion and the film seal are surrounded by a raised peripheral wall. (Item 85) Item 75. The cassette of item 74, wherein the cassette further comprises a cassette top portion coupled to the cassette base portion, the valve leaflet cover being compressed between the cassette base portion and the cassette top portion to form a fluid-tight seal. (Item 86) Item 75. The cassette of item 74, wherein the cassette further comprises a cassette top portion coupled to the cassette base portion by sonic welding, at least a portion of the sonic weld being formed between the cassette top portion and the reservoir film. (Item 87) 1. A method of filling a reservoir for a cassette of a drug delivery device, comprising: actuating an occluder assembly of the cassette to occlude a flow path leading from the reservoir to an outlet of the set; loading a fluid into the reservoir through a fill port; imaging the reservoir; and determining whether the reservoir meets acceptability criteria by analyzing at least one image of the reservoir; providing a cover within an access compartment providing visual access to said reservoir; A method comprising: (Item 88) Item 88. The method of item 87, wherein imaging the reservoir includes photographing the reservoir through the inspection compartment. (Item 89) 88. The method of claim 87, wherein determining whether the reservoir meets acceptability criteria comprises analyzing the at least one image and determining whether particulates are present. (Item 90) 88. The method of claim 87, wherein determining whether the reservoir meets acceptability criteria comprises analyzing the at least one image and determining whether an amount of air above a predefined threshold is present. (Item 91) Item 88. The method of item 87, wherein actuating the occluder assembly includes disposing a removable actuator within a port of the cassette. (Item 92) Item 88. The method of item 87, wherein actuating the occluder assembly includes displacing a membrane against a reservoir outlet valve to close off flow through the reservoir outlet valve. (Item 93) Item 88. The method of item 87, wherein disposing the cover within the access compartment includes coupling the cover to the cassette via a snap fit. (Item 94) 1. A cassette for a drug delivery device, comprising: A cassette base portion; a cassette top portion coupled to said cassette base portion; a collapsible reservoir; The exit, a flow path extending from the collapsible reservoir to the outlet; a fill port extending from a side wall of the cassette base portion to the reservoir, the fill port including at least one of an access restricting means and a reuse preventing means; A cassette comprising: (Item 95) 1. A cassette for a drug delivery device, comprising: A cassette base portion; a reservoir defined by a recess in the cassette base portion and a piece of reservoir film attached to the base portion at a mounting surface surrounding the recess, the reservoir being filled with a drug; a flow path extending from the reservoir to an outlet of the cassette, the flow path being defined, at least in part, along a section of the flow path by a membrane cover; an occluder assembly configured for operation between a flow permitting state and a closed state in which the reservoir and a first portion of the flow path are isolated from a second portion downstream of the first portion of the flow path, the flow path compartment being defined, at least in part, by the membrane cover that is a part of the second portion of the flow path; A cassette comprising: (Item 96) Item 96. The cassette of item 95, wherein a first portion of the flow path is constructed from a material having long-term compatibility with the drug and at least the membrane cover is constructed from a material having short-term compatibility with the drug. (Item 97) Item 96. The cassette of item 95, wherein the reservoir film is a layered film. (Item 98) Item 96. The cassette of item 95, wherein the second portion of the flow path includes at least one valve station. (Item 99) Item 99. The cassette of item 98, wherein the membrane cover is bonded in place over the valve station to form a fluid tight seal. (Item 100) Item 96. The cassette of item 95, wherein the second portion of the flow path includes at least one pump chamber. (Item 101) Item 101. The cassette of item 100, wherein the membrane cover is bonded in place over the valve station to form a fluid tight seal. (Item 102) Item 96. The cassette of item 95, wherein the occluder assembly includes an occluder diaphragm and an actuator. (Item 103) Item 103. The cassette of item 102, further comprising a threaded port, wherein in the occluded state, the actuator is threaded into the flow path and the occluder diaphragm is actuated to occlude the flow path. (Item 104) Item 103. The cassette of item 102, further comprising a threaded port configured to receive the actuator, the occluder assembly being configured to transition from the occluded state to the flow allowing state by removing the actuator from the threaded port. (Item 105) Item 103. The cassette of item 102, wherein the actuator, when present within the cassette, is configured to prevent interlocking of the cassette with a reusable housing assembly. (Item 106) Item 103. The cassette of item 102, wherein at least a portion of the diaphragm is constructed from a material having long-term compatibility with the drug. (Item 107) Item 96. The cassette of item 95, wherein the occluder assembly includes an actuator removable from the cassette, the occluder assembly being in a flow permitting state when the actuator is removed from the cassette. (Item 108) 96. The cassette of claim 95, wherein the occluder assembly includes a rotatable actuator, the occluder assembly configured to transition from the occluded state to the flow allowing state in response to rotation of the actuator. (Item 109) 96. The cassette of claim 95, wherein the occluder assembly includes a displaceable actuator, the occluder assembly configured to transition from the occluded state to the flow allowing state in response to translational displacement of the actuator. (Item 110) Item 96. The cassette of item 95, wherein the occluder assembly includes a shuttle disposed within the occluder channel. (Item 111) Item 111. The cassette of item 110, wherein the shuttle comprises at least one sealing interface that creates a fluid seal against a wall of the occluder channel. (Item 112) Item 112. The cassette of item 111, wherein in the occluded state, the at least one sealing interface is disposed intermediate an opening of a first portion of the flow path to the occluder channel and an opening of a second portion of the flow path to the occluder channel. (Item 113) Item 111. The cassette of item 110, wherein the shuttle is covered by a diaphragm. (Item 114) Item 111. The cassette of item 110, wherein the shuttle is a compressible elastomer. (Item 115) Item 96. The cassette of item 95, wherein the occluder assembly is constructed from a material having long-term compatibility with the drug. (Item 116) Item 96. The cassette of item 95, wherein at least a portion of the occluder assembly is constructed from a material having long-term compatibility with the drug. (Item 117) 96. The cassette of item 95, wherein the pharmaceutical agent is a drug for an endocrine disorder. (Item 118) 96. The cassette of item 95, wherein the drug is selected from the group consisting of insulin and insulin analogs. (Item 119) 96. The cassette of item 95, wherein the drug is proteinaceous. (Item 120) 96. The cassette of item 95, wherein the agent comprises a polypeptide having a tertiary structure with at least one hydrophobic region. (Item 121) Item 96. The cassette of item 95, wherein the occluder assembly includes a bung and a tapered port, the bung being retained within the tapered port via an interference fit. (Item 122) Item 122. The cassette of item 121, wherein the occluder assembly includes a diaphragm, and the plug, when retained in the tapered port, compresses and seals the diaphragm against the reservoir outlet opening. (Item 123) Item 122. The cassette of item 121, wherein the bung is constructed from a compressible elastomer. (Item 124) 1. A dual valve assembly comprising: a first valve assembly having a first mode in which the first valve assembly is biased to a closed position and fluid pressure opens the first valve assembly and a second mode in which the first valve is movable to an open position by an actuation assembly; a second valve assembly biased to a closed position and movable to an open position by a drive assembly; a common valve drive assembly for actuating the first valve assembly and the second valve assembly, the common valve drive assembly having a first position whereby the first valve assembly is in the first mode and the second valve assembly is in the closed position, a second position whereby the first valve assembly is in the first mode and the second valve assembly is in the open position, and a third position whereby the first valve assembly is in the second mode and in the open position and the second valve assembly is in the open position; A dual valve assembly comprising: (Item 125) Item 125. The dual valve assembly of item 124, wherein the valve drive assembly comprises a bell crank, the bell crank pivoting from the first position to the second position and to the third position. (Item 126) the first valve assembly and the second valve assembly each have a valve actuator, each valve actuator defining a valve slot and a valve slot stop; the valve drive assembly having a plurality of pins for slidably engaging the valve slot and contacting the valve slot stop to move the valve to the open position. Item 125. The dual valve assembly of item 124. (Item 127) Item 127. The dual valve assembly of item 126, wherein the valve drive assembly comprises a bell crank, the bell crank pivoting from the first position to the second position and to the third position. (Item 128) A biphasic valve, a valve actuator defining a valve face, a valve slot, and a valve slot stop; A valve seat; a valve spring for biasing the valve face against the valve seat to close the valve; a valve drive assembly having a pin for slidingly engaging within the valve stop, whereby in a first mode, fluid pressure within the valve above a pre-set threshold moves the valve face away from the valve seat to open the valve and the pin slides within the valve slot, and in a second mode, the drive assembly moves the pin to engage the valve slot stop, moving the valve face away from the valve seat to open the valve; A two-phase valve comprising: (Item 129) Item 129. The two-phase valve of item 128, further comprising a diaphragm between the valve face and the valve seat. (Item 130) Item 130. The bi-phase valve of item 129, further comprising a reusable pump housing and a cassette housing, the pump housing being releasably engageable with the cassette housing, the valve actuator, valve spring, and valve drive assembly being within the pump housing, and the valve seat and diaphragm being within the cassette housing. (Item 131) 3. The cassette of claim 2, wherein the at least one duct has a variable width. (Item 132) 37. The cassette of item 36, wherein the pharmaceutical agent is a drug for an endocrine disorder. (Item 133) 37. The cassette of item 36, wherein the drug is selected from the group consisting of insulin and insulin analogues. (Item 134) 37. The cassette of item 36, wherein the drug is proteinaceous. (Item 135) 37. The cassette of item 36, wherein the agent comprises a polypeptide having a tertiary structure with at least one hydrophobic region. (Item 136) Item 11. The cassette of item 110, wherein the shuttle is compressible and includes an enlarged section, the occluder channel includes a step between a wide section and a narrow section, the enlarged section of the shuttle being wider than the narrow section in an uncompressed state. [Brief description of the drawings]

[0032] These and other aspects will become more apparent from the following detailed description of various embodiments of the present disclosure, taken in conjunction with the drawings.

[0033] [Figure 1] FIG. 1 depicts a schematic diagram of an exemplary drug delivery system.

[0034] [Diagram 2] FIG. 2 depicts a schematic diagram of a flow path within an exemplary dispensing assembly.

[0035] [Diagram 3] 3-8 depict schematic diagrams of the flow path within an exemplary dispensing assembly. [Figure 4] 3-8 depict schematic diagrams of the flow path within an exemplary dispensing assembly. [Diagram 5] 3-8 depict schematic diagrams of the flow path within an exemplary dispensing assembly. [Figure 6] 3-8 depict schematic diagrams of the flow path within an exemplary dispensing assembly. [Figure 7] 3-8 depict schematic diagrams of the flow path within an exemplary dispensing assembly. [Figure 8] 3-8 depict schematic diagrams of the flow path within an exemplary dispensing assembly.

[0036] [Figure 9] FIG. 9 depicts a perspective view of an exemplary cassette assembly.

[0037] [Figure 10] FIG. 10 depicts an exploded view of an exemplary cassette assembly.

[0038] [Figure 11] FIG. 11 depicts a perspective view of the underside of an exemplary cassette assembly with an exemplary sealing wall exploded.

[0039] [Figure 12] FIG. 12 depicts a top-down view of an exemplary cassette assembly.

[0040] [Figure 13] FIG. 13 depicts a cutaway view of an exemplary cassette assembly, the cut being made as shown in FIG.

[0041] [Figure 14] FIG. 14 depicts a detailed view of the indicated area of ​​FIG.

[0042] [Figure 15] FIG. 15 depicts a cross-sectional view of an exemplary cassette assembly taken at the cutting plane shown in FIG.

[0043] [Figure 16] FIG. 16 depicts a detailed view of the area indicated in FIG.

[0044] [Figure 17] FIG. 17 depicts a top-down view of an exemplary cassette base portion of an embodiment of the cassette assembly.

[0045] [Figure 18] FIG. 18 depicts a perspective view of an exemplary cassette base portion of an embodiment of the cassette assembly.

[0046] [Figure 19] FIG. 19 depicts a cross-section of an exemplary cassette assembly taken at the cutting plane shown in FIG.

[0047] [Figure 20] FIG. 20 depicts a cross-section of an exemplary cassette assembly taken at the cutting plane shown in FIG.

[0048] [Figure 21] FIG. 21 depicts a detailed view of the indicated area of ​​FIG.

[0049] [Figure 22] FIG. 22 depicts a cross-section of an exemplary cassette assembly taken at the indicated cutting plane of FIG.

[0050] [Diagram 23] FIG. 23 depicts a detailed view of the indicated area of ​​FIG.

[0051] [Figure 24]FIG. 24 depicts a view of an exemplary cassette assembly with a top cover portion of the cassette assembly exploded from a cassette base portion of the cassette assembly.

[0052] [Diagram 25] FIG. 25 depicts a perspective view of an exemplary cassette assembly having a cassette top portion including a compartment in which a cover is disposed.

[0053] [Figure 26] FIG. 26 depicts an exploded view of the exemplary cassette assembly shown in FIG.

[0054] [Figure 27] FIG. 27 depicts a bottom view of an exemplary cassette assembly, with the sealing walls of the cassette assembly hidden.

[0055] [Figure 28] FIG. 28 depicts an exploded view of an exemplary cassette assembly.

[0056] [Figure 29] FIG. 29 illustrates a schematic diagram of an exemplary inspection system for a cassette assembly.

[0057] [Diagram 30] FIG. 30 shows a flow chart detailing some example actions that may be performed to service the cassette assembly.

[0058] [Diagram 31] FIG. 31 depicts a cutaway view of an exemplary cassette assembly including a cassette top portion with a compartment within which a cover is coupled.

[0059] [Diagram 32] FIG. 32 depicts a perspective view of an exemplary cassette assembly having a cassette top portion that includes a compartment in which a cover is disposed.

[0060] [Diagram 33] FIG. 33 depicts an exploded view of a portion of an occluder assembly that may be included within the cassette assembly.

[0061] [Diagram 34] FIG. 34 depicts a perspective view of the cassette assembly with the actuator of the occluder assembly removed therein.

[0062] [Diagram 35] FIG. 35 depicts a detailed view of the indicated area of ​​FIG.

[0063] [Diagram 36] FIG. 36 depicts a perspective view of the underside of the cassette top portion of an exemplary cassette assembly having an actuator of the occluder assembly disposed within a port contained within the cassette top portion.

[0064] [Figure 37] FIG. 37 depicts a detailed view of the indicated area of ​​FIG.

[0065] [Figure 38] FIG. 38 depicts a cross-sectional view taken at the cutting plane shown in FIG.

[0066] [Figure 39] FIG. 39 depicts a detailed view of the indicated area of ​​FIG.

[0067] [Diagram 40] FIG. 40 depicts a top-down view of an exemplary embodiment of a cassette assembly.

[0068] [Diagram 41] FIG. 41 depicts a cross-sectional view of an exemplary cassette assembly taken at the cutting plane shown in FIG.

[0069] [Diagram 42] FIG. 42 depicts a detailed view of the indicated area of ​​FIG.

[0070] [Diagram 43] FIG. 43 depicts a top-down view of an exemplary embodiment of a cassette assembly.

[0071] [Diagram 44] FIG. 44 depicts a cross-sectional view of an exemplary cassette taken at the cutting plane shown in FIG.

[0072] [Diagram 45] FIG. 45 depicts a detailed view of the indicated area of ​​FIG.

[0073] [Figure 46] FIG. 46 depicts a partially cut away isometric view of the plug of FIG.

[0074] [Figure 47] FIG. 47 depicts an exemplary cassette assembly and an exemplary loading fixture.

[0075] [Figure 48] FIG. 48 depicts a schematic diagram of an exemplary filling port and an exemplary interface portion of a filling fixture.

[0076] [Figure 49] FIG. 49 depicts a schematic diagram of an exemplary filling port and an exemplary interface portion of a filling fixture.

[0077] [Figure 50] FIG. 50 depicts a schematic diagram of an exemplary filling port and an exemplary interface portion of a filling fixture.

[0078] [Figure 51] FIG. 51 depicts a schematic diagram of an exemplary filling port and an exemplary interface portion of a filling fixture.

[0079] [Figure 52] FIG. 52 depicts a schematic diagram of an exemplary filling port and an exemplary interface portion of a filling fixture.

[0080] [Diagram 53] FIG. 53 depicts a schematic diagram of an exemplary filling port and an exemplary interface portion of a filling fixture.

[0081] [Figure 54] FIG. 54 depicts a schematic diagram of an exemplary filling port and an exemplary interface portion of a filling fixture.

[0082] [Figure 55] FIG. 55 depicts a schematic diagram of an exemplary filling port and an exemplary interface portion of a filling fixture.

[0083] [Figure 56] FIG. 56 depicts a schematic diagram of an exemplary filling port and an exemplary interface portion of a filling fixture.

[0084] [Figure 57] FIG. 57 depicts a schematic diagram of an exemplary filling port and an exemplary interface portion of a filling fixture.

[0085] [Figure 58] 58-60 depict schematic diagrams of an exemplary reuse prevention assembly that may be included within the fill port of the cassette assembly. [Figure 59] 58-60 depict schematic diagrams of an exemplary reuse prevention assembly that may be included within the fill port of the cassette assembly. [Figure 60] 58-60 depict schematic diagrams of an exemplary reuse prevention assembly that may be included within the fill port of the cassette assembly.

[0086] [Figure 61] 61-62 depict schematic diagrams of an exemplary filling port and an exemplary filling fixture. [Figure 62] 61-62 depict schematic diagrams of an exemplary filling port and an exemplary filling fixture.

[0087] [Figure 63] FIG. 63 depicts a schematic diagram of an exemplary cassette assembly and an exemplary loading fixture.

[0088] [Figure 64] FIG. 64 depicts a perspective view of an exemplary cassette assembly.

[0089] [Figure 65] FIG. 65 depicts an exploded view of the exemplary cassette assembly of FIG.

[0090] [Figure 66] 66 depicts a partial cutaway perspective view of a subassembly of the exemplary cassette assembly of FIG. 64.

[0091] [Figure 67] FIG. 67 depicts an enlarged view of a portion of the partially cut-away perspective view of FIG. 66 taken at 67.

[0092] [Figure 68] FIG. 68 depicts a rotated perspective view of the exemplary cassette assembly of FIG.

[0093] [Figure 69] FIG. 69 depicts an enlarged view of a portion of the exemplary cassette assembly of FIG. 68 taken at 69.

[0094] [Figure 70] FIG. 70 depicts a partial cutaway view of the exemplary cassette assembly of FIG.

[0095] [Figure 71] FIG. 71 depicts an enlarged view of a portion of the exemplary cassette assembly of FIG.

[0096] [Figure 72A] FIG. 72A depicts another embodiment of an enlarged view of a portion of the exemplary cassette assembly of FIG.

[0097] [Fig. 72B] FIG. 72B depicts another embodiment of an enlarged view of a portion of the exemplary cassette assembly of FIG.

[0098] [Figure 73] FIG. 73 depicts a perspective view of the occluder actuator.

[0099] [Figure 74] FIG. 74 depicts a cross-sectional view of the occluder actuator of FIG.

[0100] [Figure 75] FIG. 75 depicts a top perspective view of the occluder diaphragm.

[0101] [Figure 76] FIG. 76 depicts a bottom perspective view of the occluder diaphragm of FIG. 75.

[0102] [Figure 77] FIG. 77 depicts a top-down view of the exemplary cassette assembly of FIG.

[0103] [Figure 78] FIG. 78 depicts a cross-sectional view of the exemplary cassette assembly of FIG. 64, taken at BB in FIG. 77, with an occluder actuator inserted.

[0104] [Figure 79] FIG. 79 depicts an enlarged view of a portion of FIG. 78 taken at 79.

[0105] [Figure 80]FIG. 80 depicts a top-down view of the exemplary cassette assembly of FIG.

[0106] [Figure 81] FIG. 81 depicts a cross-sectional view of the exemplary cassette assembly of FIG. 64, taken at BB in FIG. 80, with the occluder actuator removed.

[0107] [Figure 82] FIG. 82 depicts an enlarged view of a portion of FIG. 81 taken at 82.

[0108] [Figure 83] FIG. 83 depicts a perspective view of the exemplary cassette assembly of FIG. 77 with an occluder actuator inserted, with a cross-sectional view at BB.

[0109] [Figure 84] FIG. 84 depicts an enlarged view of the cross-sectional view of FIG. 83 at D.

[0110] [Figure 85] FIG. 85 depicts a perspective view of the exemplary cassette assembly of FIG. 77 with the occluder actuator removed, with a cross-sectional view at BB.

[0111] [Figure 86] FIG. 86 depicts an enlarged view of the cross-sectional view of FIG. 85 at D.

[0112] [Figure 87] FIG. 87 depicts a front view of the lift assembly for the measurement valve assembly and the check valve assembly.

[0113] [Figure 88] FIG. 88 depicts a perspective left side view of the lift assembly of FIG. 87.

[0114] [Figure 89]FIG. 89 depicts a perspective right side view of the lift assembly of FIG. 87.

[0115] [Figure 90] FIG. 90 depicts a top view of the lift assembly of FIG. 87 with the check valve assembly open and the measurement valve assembly closed.

[0116] [Figure 91] FIG. 91 depicts a cross-sectional view of the lift assembly and check valve assembly of FIG. 90 taken at AA.

[0117] [Figure 92] FIG. 92 depicts a cross-sectional view of the lift assembly and measurement valve assembly of FIG. 90 taken at BB.

[0118] [Figure 93] FIG. 93 depicts a top view of the lift assembly of FIG. 87 with both the check valve assembly and the measurement valve assembly open.

[0119] [Figure 94] FIG. 94 depicts a cross-sectional view of the lift assembly and check valve assembly of FIG. 93 taken at AA.

[0120] [Figure 95] FIG. 95 depicts a cross-sectional view of the lift assembly and measurement valve assembly of FIG. 93 taken at BB.

[0121] [Figure 96] FIG. 96 is a graphical representation of power usage versus pump distance traveled.

[0122] [Figure 97] FIG. 97 is a perspective view of 64 cassette assemblies in a cassette package. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0123] Detailed Description 1, an exemplary drug delivery system 10 is shown. The exemplary drug delivery system 10 includes a dispensing assembly 100 that may be formed from a cassette assembly 102 and a reusable housing assembly 106. The dispensing assembly 100 may include a container or reservoir 118 and an access 120 (e.g., a pierceable member such as a septum). The cassette assembly 102 is coupled to the reusable housing assembly 106, which, in use, has a controller 108 and a mechanical actuation assembly 110 that may be controlled to selectively dispense fluid from the dispensing assembly 100 (in some embodiments, by acting on valves and pumping components included within the cassette assembly 102). As shown, the dispensing assembly 100 may be used in conjunction with an injection device 186 of the drug delivery system 10. The injection device 186 may be configured to be inserted into a patient and provide a flow path from the reservoir assembly 100 into the patient 104 (e.g., a subcutaneous layer of the skin of the patient 104). To facilitate establishment of a flow path into the skin 104 of the patient 104, the injection device 186 may include a needle or cannula 188. The injection device 186 may be fluidly connected to a length of tubing 184 and / or directly to the dispensing assembly 100. The outlet of the reservoir 118 may, in some embodiments, couple the dispensing assembly 100, directly or indirectly, to the tubing 184 or to the injection device 186. The dispensing assembly 100 may be controlled by a remote device 122 through wireless communication with the controller 108. The remote device 122 may be dedicated to communication with the dispensing assembly 100 or a more general device such as a cell phone or tablet that runs a specific application for the drug delivery system 10. The remote device 122 has a display for displaying information from the dispensing device 100, including status, warnings, alarms, etc. The remote device 122 may also be used to key in information for relay to the dispensing device, program injection rates, and initiate operations, functions, and modes of the dispensing assembly 100.

[0124] The various components described in connection with FIG. 1 may be incorporated in any of the following patent applications, including, but not limited to, U.S. Patent Publication No. US-2014-0107579 (Attorney Docket No. K40), filed March 7, 2013 and entitled "Infusion Pump Assembly," now U.S. Patent Publication No. US-2014-0107579, published April 17, 2014; U.S. Patent No. 8,491,570 (Attorney Docket No. G75), issued July 23, 2013 and entitled "Infusion Pump Assembly," U.S. Patent No. 8,414,522 (Attorney Docket No. E70), issued April 9, 2013 and entitled "Fluid Delivery Systems and Methods," U.S. Patent No. 8,414,522 (Attorney Docket No. E70), issued September 11, 2012 and entitled "Infusion Pump Assembly," now U.S. Patent Publication No. US-2014-0107579, published April 17, 2014; No. 8,262,616 (Attorney Docket No. F51), issued on December 11, 2007 and entitled “Loading Mechanism for Infusion Pump,” U.S. Patent No. 7,306,578 (Attorney Docket No. C54), filed on December 11, 2017 and entitled “Infusion Pump Assembly,” U.S. Provisional Application No. 62 / 597,246 (Attorney Docket No. P51), published on October 5, 2017 and entitled “Infusion Set and Inserter Assembly,” U.S. Publication No. 2015 / 0281863 (Attorney Docket No. U64), published on April 24, 2018 and entitled “Apparatus, System and Method for Fluid No. 15 / 961,238 (Attorney Docket No. X37), issued on April 11, 2017 and entitled “Apparatus, System and Method for Fluid Delivery,” U.S. Patent No. 9,617,020 (Attorney Docket No. M60), filed on February 22, 2019 and entitled “Infusion Set and Inserter Assembly Systems and Methods,” and U.S. Provisional Application No. 62 / 809,248 (Attorney Docket No. Y85), all of which are incorporated herein by reference in their entirety. The systems and methods described in any of the above-referenced applications and patents (including the cassette assemblies, reservoirs, filling aids, charging systems, volume sensing arrangements, control systems, inserter assemblies, etc.) may also be used in conjunction with the various embodiments shown and described herein. However, the embodiments shown and described herein are not limited to use therewith.

[0125] 2-8, an exemplary dispensing assembly or arrangement 500 is shown. An occluder assembly 9714 isolates the filled reservoir 118 from the remainder of the dispensing assembly 500. Opening of the occluder assembly 9714 allows fluid to flow into the remainder of the dispensing assembly 500. To effect delivery of the fluid in the reservoir 118 to a user, a controller 108, included within the dispensing assembly 100, may command energization of a shape memory actuator 112, which may be anchored at one end using a shape memory actuator anchor 604, and at the other end to a common connector 611 that is attached to the pump 105 and inlet valve assembly 614. The energization of the shape memory actuator 112 results in activation of the pump 105 and the reservoir valve assembly 614. The reservoir valve assembly 614 may include a reservoir valve actuator 614A and a reservoir valve seat 614B. Activation of the reservoir valve assembly 614 may result in a downward displacement of the reservoir valve actuator 614A closing against the reservoir valve seat 614B, resulting in a virtual isolation of the reservoir 118. The reservoir valve actuator 614A may press a membrane 124 contained within the cassette assembly 102 against the reservoir valve seat 614B to close the reservoir valve assembly 614. The pump 105 and the reservoir valve assembly 614 are arranged and connected by a connector 611, whereby the reservoir valve assembly 614 closes prior to the pump 105 pumping fluid. The pump 105 may include a pump plunger 105A and a pump chamber 105B. Activation of the pump 105 may result in the pump plunger 105A being displaced in a downward manner into the pump chamber 105B, leading to a displacement of fluid (in the direction of arrow 618 (see FIG. 4 )). A membrane 124 may be included between pump plunger 105A and pump chamber 105B. Pump chamber 105B is shaped to be substantially identical to the end of pump plunger 105A to substantially empty pump chamber 105B with each stroke of pump 105.

[0126] The check valve assembly or volume sensor valve assembly 612 may include a volume sensor valve actuator 612A and a volume sensor valve seat 612B. Referring again to FIG. 4, the volume sensor valve actuator 612A is maintained in a closed position via a volume valve spring assembly 612C acting against a spring anchor 6126 that provides a mechanical force to move the volume sensor valve actuator 612A against the volume sensor valve seat 612B and seal the volume sensor valve assembly 612. The volume sensor valve actuator 612A may press a membrane 124 included within the cassette assembly 102 against the volume sensor valve seat 614B to close the volume sensor valve assembly 614. However, when the pump 105 is activated, if the displaced fluid is of sufficient pressure to overcome the mechanical sealing force of the volume sensor valve assembly 612, a displacement of fluid may occur in the direction of arrow 618. This may result in the filling of a volume sensor chamber 620 included within the volume sensor assembly 148 (see FIG. 6). Through the use of a speaker assembly 622, a port assembly 624, a reference microphone 626, a spring diaphragm 628, and a variable volume microphone 630, the volume sensor assembly 148 may determine the volume of fluid in the volume sensor chamber 620. The operation of such a volume sensor assembly 148 may be, for example, as discussed in U.S. Patent No. 8,491,570 (Attorney Docket No. G75), issued July 23, 2013, and entitled "Infusion Pump Assembly," which is incorporated herein by reference in its entirety. Other suitable dispense volume sensors may also be used in other embodiments.

[0127] 6, a shape memory actuator 632 may be anchored (on a first end) to a shape memory actuator anchor 636. Additionally, the other end of the shape memory actuator 632 may be used to provide mechanical energy to the bell crank lift arm 708, which may activate the measurement valve assembly 610. Once the volume of fluid contained within the volume sensor chamber 620 has been calculated, the shape memory actuator 632 is energized, resulting in activation of the measurement valve assembly 610 to move it to an open position. The measurement valve assembly 610 may include a measurement valve actuator 610A and a measurement valve seat 610B. Once activated to lift the measurement valve actuator 610A from the measurement valve seat 610B due to mechanical energy imparted on the fluid within the volume sensor chamber 620 by the spring diaphragm 628, the fluid within the volume sensor chamber 620 may be displaced (in the direction of arrow 634) through the cannula 188 and into the body of the patient 104. The measurement valve actuator 610A may then press the membrane 124 contained within the cassette assembly 102 against the measurement valve seat 610B by de-energizing the shape memory actuator 632 and by the action of the measurement valve spring assembly 610C acting against the spring anchor 6106 to close the measurement valve assembly 610. In some embodiments, the membrane 124 contained across the reservoir valve seat 614B, the pump chamber 105B, the volume sensor valve seat 612B, and the measurement valve seat 610B may be formed within a single piece of material having an area covering each of these components.

[0128] 87, 88, and 89, a drive assembly or bellcrank assembly 638 has a generally L-shaped bellcrank body 700 with a bellcrank drive arm 702 for attachment to a shape memory actuator 632 by pivoting a bellcrank drive connector 704. The bellcrank drive connector 704 is attached to the bellcrank drive arm 702 by two pairs of bellcrank connector support arms 714, each pair supporting one cylindrical end of the bellcrank drive connector 704. The shape memory actuator 632 is affixed to the bellcrank drive connector 704 through actuator attachment holes 705. In operation, the pivoting bellcrank drive connector allows more linear motion and reduces the bending force of the shape memory actuator 632 as the shape memory actuator 632 pivots the bellcrank body 700 on the oppositely located bellcrank pivot pins 706. Bellcrank lift arm 708, generally perpendicular to bellcrank drive arm 702, has oppositely facing volume valve lift pin 712 and measurement valve lift pin 710. Volume valve lift pin 712 and measurement valve lift pin 710 are arranged to be generally parallel to the pivot axis of bellcrank pivot pin 706. Volume valve actuator 612A defines a hollow generally cylindrical cavity 612D and contains a volume valve spring assembly 612C. Volume valve spring assembly 612C extends between the bottom of cavity 612D and volume valve spring anchor 612G to hold volume sensor valve assembly 612 in a default closed position, where volume valve face 612F of volume valve actuator 612A is urged against volume valve seat 612B, using membrane 124 as a valve seal. During normal operation of the pump assembly for injection of fluid from the dispensing assembly 100, the volume valve spring assembly 612C is calibrated so that sufficient fluid pressure generated by the pump assembly 105 will overcome the spring force of the volume valve spring assembly 612C and allow the volume valve actuator 162A to move away from the volume valve seat 612C and permit fluid flow.

[0129] Measurement valve actuator 610A defines a hollow generally cylindrical cavity 610D and contains measurement valve spring assembly 610C. Measurement valve spring assembly 610C extends between a bottom of cavity 610D and measurement valve spring anchor 610G to hold measurement valve assembly 610 in a default closed position where measurement valve face 610F of measurement valve actuator 610A is biased against measurement valve seat 610B, using membrane 124 as a valve seal. During normal operation of the pump assembly for injection of fluid from dispensing assembly 100, measurement valve spring assembly is calibrated such that fluid pressure in volume sensor chamber 620 will be insufficient to overcome the spring force of measurement valve spring assembly 610C. The measurement valve assembly 610 is opened by energizing the shape memory actuator 632, which then shortens in length, thereby applying a force through the bell crank drive connector 704 to the bell crank assembly 638, causing the bell crank body to rotate on the bell crank pivot pin 706. The rotation of the bell crank body 700 lifts the bell crank lift arm 708. In operation, the measurement valve actuator 610A defines a measurement valve lift slot 610G generally parallel to the direction of motion of the measurement valve spring assembly 610C and the measurement valve actuator 610A. The measurement valve lift pin 710 of the bell crank assembly 638 slidably engages within the measurement valve lift slot 610G. When the measurement valve assembly 610 is in the closed position, the measurement valve lift pin 710 rests at or below a measurement valve lift stop 610G defined within the end of the measurement valve lift slot 610G. Lifting the bellcrank lift arm 708 engages the measurement valve lift pin 710 against the measurement valve lift stop 610G, thereby moving the measurement valve actuator 610A away from the measurement valve seat 610C and permitting fluid flow (see FIGS. 90, 91, 92). De-energizing the shape memory actuator 632 allows the measurement valve spring assembly 612C to return the measurement valve actuator 610A to the closed position and return the bellcrank assembly 638 toward the rest position.

[0130] In an automatic priming mode of the dispensing assembly 100, it may be advantageous to mechanically open the volume sensing valve assembly 612 even when there is insufficient pressure in the fluid channel to open in order to purge air from the dispensing assembly 100 and ensure that the fluid channel is fully primed for infusion of fluid to a user. With particular reference to FIGS. 93, 94, 95, the volume valve actuator 612A, in operation, defines a volume valve lift slot 612G generally parallel to the volume valve spring assembly 612C and generally parallel to the direction of movement of the volume valve actuator 612A. The volume valve lift pin 712 of the bell crank assembly 638 slidably engages within the volume valve lift slot 612G. When the volume sensor valve assembly 612 is in a closed position, the volume valve lift pin 712 rests at or below a volume valve lift stop 612G defined within the end of the volume valve lift slot 612G. Lifting the bellcrank lift arm 708 engages the volume valve lift pin 712 against the volume valve lift stop 612G, thereby moving the volume valve actuator 612A away from the volume valve seat 612C and allowing fluid flow. De-energizing the shape memory actuator 632 allows the volume valve spring assembly 612C to return the volume valve actuator 612A to the closed position and return the bellcrank assembly 638 towards the rest position.

[0131] The bell crank assembly 638 may have two modes: a normal pump operation mode, in which it operates only the measurement valve assembly 610, and an auto-priming mode, in which it operates both the measurement valve assembly 610 and the volume sensor valve assembly 612. In the normal pump operation mode, the bell crank assembly 638 is driven by the shape memory actuator 632 to a first position, whereby the measurement valve lift pin 710 engages the measurement valve lift stop 610H and lifts the measurement valve actuator 610A before the volume valve lift pin 712 engages the volume valve lift stop 612H (see Figs. 90, 91, 92). In the embodiment of Figs. 90, 91, 92, the measurement and volume lift slot stops 610H and 612H are at substantially the same elevation when both the measurement valve assembly 610 and the volume sensor valve assembly 612 are in the closed position. At a higher relative elevation, the measurement valve lift pin 710 is offset from the volume valve lift pin 712, whereby the measurement valve lift pin 710 opens the measurement valve assembly 610 while leaving the volume sensor valve assembly 612 in a closed position. Alternatively, the measurement and volume lift slots 610H and 612H may be offset instead, or the individual lift pins 710, 712 and lift stops 610H, 612H may both be offset to achieve the same result. In the auto-priming mode, the bell crank assembly 638 is rotated by the shape memory actuator 632 to a greater extent than in the normal pump mode. In the auto-priming mode, the bell crank assembly 638 is rotated to a first position, whereby the measurement valve lift pin 710 engages the measurement valve assembly 610 and moves it to an open position, and then continues to rotate to a second position, whereby the volume valve lift pin 712 engages the measurement valve assembly and then opens the volume valve lift assembly 612.

[0132] During the auto-priming operation, it is useful to sense the position of the pump plunger 105A, the measurement valve actuator 610A, and the volume valve actuator 612A. There are various devices that can be used to sense the position of the pump plunger 105A, the measurement valve actuator 610A, and the volume valve actuator 612A. These include, but are not limited to, one or more of the following: ultrasonic, optical (reflection, laser interferometer, camera, etc.), linear caliper, magnetic, mechanical contact switch, infrared light measurement, etc. However, in an exemplary embodiment, due to the small structure of the dispensing assembly 100, it is desirable to use small components to utilize a small space with the sensing components. Sensing distance can also be a consideration in various embodiments. For example, the displacement of one or more components, e.g., pump actuator 105A, measurement valve actuator 610A, and volume valve actuator 612A, may be very small (e.g., in an exemplary embodiment, the full displacement of pump actuator 105A may be about 1 mm and the full displacement of measurement valve actuator 610A may be about 0.2 mm). For example, a small reflective optical sensor assembly (hereinafter, "optical sensor") may be used that fits within the exemplary embodiment of reusable housing assembly 106 as shown and described herein. In some embodiments, at least one optical sensor is located within reusable housing assembly 106. The optical sensor, in various embodiments, has a sensing range that matches the components for which the optical sensor may sense the displacement of, e.g., pump actuator 105A, measurement valve actuator 610A, and volume valve actuator 612A. In exemplary embodiments, any optical sensor may be used, including but not limited to the Sharp GP2S60 manufactured by Sharp Electronics Corporation, a US subsidiary of Sharp Corporation, Osaka, Japan. In these embodiments, the optical sensor contains an infrared emitting diode and an infrared sensitive detector in a single component package. The light from the emitter is unfocused and bounces off the sensing surface, some of which is reflected back to the detector.3-8, optical pump sensor 640 is positioned to view behind pump actuator 105A, optical measurement valve sensor 644 is positioned to view behind measurement valve actuator 610A, and optical volume sensor 642 is positioned to view behind volume valve actuator 612A. Each optical sensor 640, 642, and 644 senses light reflected from a respective actuator 105A, 612A, and 610A. The material used in each actuator can be sufficiently reflective for sensor operation, for example, with the use of white DERLIN for actuators 105A, 612A, and 610A. If there is insufficient optical reflection, an additional layer of more reflective material can be added to the back of actuators 105A, 612A, and 610A to enable reliable optical sensor operation. Optical sensors 640, 642, and 644 are used to sense the initial movement and position of the individual actuators 105A, 612A, and 610A.

[0133] For an auto-priming operation, it may be preferable for the pump actuator 105 to be fully seated in the pump chamber 105B to remove all air from the pump chamber 105B. Referring to FIG. 96, the pump actuator 105A is controlled by the controller 108 by slowly incrementing the duty cycle of the energy applied to the shape memory actuator 112. Each time the duty cycle is increased, it is held constant until the pump actuator stops moving, as sensed by the pump sensor 640. For each position, the power is calculated from the duty cycle and the position is determined from the pump sensor 640 and added to a model of the pump actuator position vs. power. The position vs. power model will remain linear as the pump actuator 105A moves through the pump chamber 105B, but will flatten out when the pump actuator 105A hits the bottom of the pump chamber 105B. The stroke of the pump actuator 105A is stopped by the controller 108 when the model becomes linear and stops, as shown by line 646 in FIG. 96.

[0134] Because the pump actuator 105A moves fluid by displacement, the position of the pump actuator 105A sensed by the pump sensor 640 can be correlated with the amount / volume of fluid displaced / pumped and can be used by the controller 108 to determine the volume of fluid pumped. For the measurement valve actuator 610A, the measurement sensor 644 is used by the controller 108 to measure whether the measurement valve actuator 610A is in an open or closed position. For the volume valve actuator 612A, the volume sensor 642 is used by the controller 108 to measure whether the measurement valve actuator 612A is in an open or closed position. Furthermore, the position of the pump actuator 105A can be used by the controller 108 in controlling the energy applied to the shape memory actuator 112. The measured positions of the measurement valve actuator 610A and the volume valve actuator can be used by the controller 108 to control the amount of energy applied to the shape memory actuator 632.

[0135] In normal pumping operation, the measurement valve sensor 644 is used to control the energy applied by the controller 108 to the shape memory actuator 632. During auto-priming operation, the volume valve sensor 642 is used to ensure that the volume valve actuator 612A lifts and opens the volume valve assembly 612. The volume valve assembly 612 and the measurement valve assembly 610 are mechanically coupled by the drive assembly or bell crank assembly 638, and energizing the shape memory actuator 632 will at some point begin to lift the volume valve actuator 612A. However, due to mechanical tolerances, the point at which the strokes of the measurement valve actuator 610A and the volume valve actuator 612A will begin to move cannot be known. For example, the volume valve actuator 612A may begin to move when the measurement valve actuator 610A is lifted 0.015 inches, or may begin to move when the measurement valve actuator 610A is lifted 0.025 inches, which is a relatively large tolerance, assuming the check valve actuator 612A can be opened by lifting it 0.005 inches. Thus, using only the measurement valve sensor 644, the position of the volume valve actuator 612A cannot be known. Thus, the volume valve sensor 642 is used by the controller 108 to control the shape memory actuator 632 when the opening of the volume valve actuator 612A is of interest.

[0136] The auto-priming operation may be initiated by a user via a remote device by initiating the auto-priming function. In one embodiment, the user will remove the pre-filled cassette assembly 102 from the package (see below in connection with cassette package 8800). The cassette assembly 102 (or cassette assembly 8500, 9500) is then engaged to the reusable housing assembly 106. The reusable housing assembly is then turned on and enabled to receive instructions from the remote device 122. The user may then initiate the auto-priming function to prime the dispensing assembly 100, thereby purging air from the flow paths and allowing chemicals to fill the flow paths, making the dispensing assembly 100 ready for use. During the auto-priming function, the measurement valve assembly 610 and the volume sensor valve assembly 612 are opened by the bell crank assembly 638. The pump assembly 105 and the inlet valve assembly 614 are moved by the shape memory actuator 112. The inlet valve assembly 614 is initially closed and then the pump assembly is actuated to a full stroke, completely evacuating the air from the pump chamber 105B. The controller 108 measures the power consumption of the shape memory actuator 112 with respect to the travel length of the pump actuator 105A (see FIG. 94). The power consumption will generally be linear as the pump travels through the length of the stroke of the pump actuator 105A. When the pump actuator fully bottoms out in the pump chamber 105B, the power consumption will increase at a non-linear amount with respect to the previous travel. At the bottom stroke, the membrane 124 will be pushed fully into the pump chamber 105B, evacuating the air therein. The volume sensor valve assembly 612 will then be allowed to close by the bell crank assembly 638. The pump actuator 105A is allowed to return to its initial position and the inlet valve assembly 614 is opened. The membrane 124 has a natural resilience and will retract from the pump chamber once the pump actuator 105A is removed and the reservoir valve assembly 614 is opened.This return of the membrane 124 to the relaxed state creates a vacuum and draws fluid from the reservoir 118. This sequence of actions is then repeated. First, the measurement valve assembly 610 and the volume sensor valve assembly 612 are opened and the inlet valve assembly 614 is closed. A pump stroke of the pump actuator 105 of the pump assembly is initiated, whereby the pump actuator 105A travels a full stroke to the bottom of the pump chamber 105B. The inlet valve assembly 614 is opened, allowing the pump assembly to return to its initial position. These steps are repeated until the user is aware that fluid is being pumped from the tubing 184. The user can command the auto-priming function to stop by operation of the remote device 122. The auto-priming mode may have the additional step of counting the number of pump strokes and automatically stopping after completion of a predetermined number of strokes. This allows for automatic priming without draining the reservoir, even if the user forgets to notify the controller 108 that fluid is exiting tubing 184 .

[0137] 9, 10, and 11, various views of an exemplary cassette assembly 9500 are depicted. The cassette assembly 9500 includes a cassette base portion 9502. The cassette base portion 9502 may include a reservoir recess 9508, which may be integrally formed therein. The cassette base portion 9502 of a pre-filled cassette assembly 9500 may be formed from a long-term drug compatible material, such as, for example, a cyclic olefin polymer (COP) such as Zeonor® 1020R. If the cassette assembly 9500 is user-filled, the cassette base portion 9502 may be made from a cyclic olefin copolymer (COC) such as Topas® or a polyester such as Tritan®. The reservoir recess 9508 may be covered by a reservoir film piece 9516, which is bonded to the cassette base portion 9502. Together, the reservoir recess 9508 and the reservoir film 9516 may define a reservoir 9536 for holding a fluid (such as various drugs) within its interior volume (see, for example, FIG. 19). In an embodiment, the fluid may be a drug for an endocrine disorder. For example, the fluid may be a diabetes management drug, such as insulin. Short or fast acting insulins (e.g., regular human insulin, such as Aspart, Lispro, Glulisine, Velosulin, Novolin-R, or Humulin R) may be used, for example, but longer acting insulins (e.g., detemir, glargine, degludec, Toujeo) may also be used. Cardiovascular drugs may also be used. For example, vasodilators or antihypertensive agents, such as treprostinil, may be used. The fluid may also include analgesics, chemotherapy drugs, enzymes, pegylated proteins, small molecules, natural products, peptides, proteins, nucleic acids, carbohydrates, nanoparticulate suspensions, and associated pharma- ceutical acceptable carrier molecules.

[0138] The reservoir film 9516 may be affixed to the cassette base portion 9502 via adhesive, ultrasonic welding, heat sealing, etc., to create a fluid-tight seal between the cassette base portion 9502 and the reservoir film 9516. Alternatively, the reservoir film 9516 and the cassette base portion 9502 may be compressed and sandwiched together by the cassette top portion 9506 of the cassette assembly 9500 when the cassette top portion 9506 is coupled into the cassette assembly 9500. In some examples, as described further herein, the reservoir film 9516 may be affixed to the cassette base portion 9502 and the cassette top portion 9506, and the cassette top portion 9506 may be coupled in place within the cassette assembly 9500 by welding at least a portion of the cassette top portion 9506 onto the reservoir film 9516. The cassette top portion 9506 may be made from the same material as the cassette base portion 9502 for improved welding together. The reservoir film 9516 may be constructed from several layers of material, which may be selected to add various desirable features to the reservoir film 9516. If applicable, a tie layer may be used as well. In some embodiments, a drug compatibility layer, e.g., a long-term drug compatibility material, such as a cyclic olefin polymer (COP) such as Zeonor® 1020R, may form an interior volume facing the surface of the reservoir film 9516. A barrier layer, impermeable to gas or specific gases, may be included outwardly of the compatibility layer. The middle or tie layer may be ethylene vinyl alcohol (EVOH). The outer layer may be polychlorotrifluoroethylene ethylene (PCTFE), such as AClar®. If a layered film is used, the reservoir film 9516 may be a coextruded product. In alternative embodiments, the reservoir film 9516 may be constructed from nitrile, silicone, or chlorobutyl rubber.

[0139] In an exemplary embodiment, the reservoir film 9516 may include a preformed region 9536 (best shown in FIG. 10). The preformed region 9534 may be vacuum or thermoformed. In an exemplary embodiment, the preformed region 9534 is shown as a recess. The recess may be bowl-shaped and may mimic the shape of the reservoir recess 9508 contained within the cassette base portion 9502 of the cassette assembly 9500. When the reservoir film 9516 is coupled to the cassette assembly 9500, the preformed region 9534 may seat within the reservoir recess 9508 such that the reservoir film 9516 abuts the bottom surface of the reservoir recess 9508 and seats against the recess wall 9510. This may ensure that a minimum air volume is present within the reservoir 9536 prior to filling the reservoir 9536 (see, e.g., FIG. 19). In an exemplary embodiment, the reservoir recess 9508 includes various recessed ducts 9566 (described elsewhere herein (see, e.g., FIGS. 17-18)). The preformed region 9534 may not include corresponding features. When the reservoir 9536 is in an empty state, the reservoir film 9516 does not extend into the ducts 9566, which may aid in emptying substantially all of the fluid within the reservoir.

[0140] The reservoir film 9516 may include a peripheral edge region 9538. The peripheral edge region 9538 may be coupled to the cassette base portion 9502 at a mounting surface 9540 of the cassette base portion 9502, which may surround the reservoir recess 9508. In some embodiments, an exposure 9542 may be included in the peripheral edge region 9538. When the cassette top portion 9506 is welded onto the reservoir film 9516, the cassette top portion 9506 may include an energy director 9674 (see, e.g., FIG. 24 ), which aligns across the peripheral edge region 9538 when in place within the cassette assembly 9500. Thus, the cassette top portion 9506 may be welded onto a top surface of the peripheral edge region 9538 of the reservoir film 9516 to hold the cassette top portion 9506 in place within the cassette assembly 9500.

[0141] As shown, in certain examples, the mounting surface 9450 may include one or more features recessed therein. When mated in place in the cassette assembly 9500, the reservoir film 9516 may form a seal across these features. In an exemplary embodiment, a reservoir exit path 9544 is recessed into the mounting surface 9540. There is also an air trap housing 9546 disposed along the reservoir exit path 9544, shown in the exemplary embodiment as a recessed feature in the mounting surface 9540. The air trap housing 9546 may be a groove, which is oriented at an angle relative to a portion of the reservoir exit path 9544. In an exemplary embodiment, the air trap housing 9546 is approximately perpendicular to the reservoir exit path 9544. In some embodiments, an air trap 9547 may be located within the air trap housing 9546. The air trap 9547, in some embodiments, may be a piece of mesh or screen 9549 that is placed within the air trap housing 9546 and helps to entrain air bubbles and prevent them from progressing downstream. The exposed portion 9542 of the reservoir film 9516 may seal across the reservoir exit pathway 9544 within the air trap housing 9546 and the air trap 9547, forming an enclosed and leak-proof flow path out of the reservoir 9536 (see, e.g., FIG. 19).

[0142] A fill port 9524 may also be included within the cassette base portion 9502. In an exemplary embodiment, the fill port 9542 extends through a sidewall of the cassette base portion 9502. The fill port 9524 may extend directly to the reservoir 9536 (see, e.g., FIG. 19) or may be plugged with a septum 9522. The septum 9522 may be pierceable via a sharp 9586 (see, e.g., FIG. 47) on a fill instrument 9584 (see, e.g., FIG. 47) and self-seal upon removal of the sharp 9586 to fluidly seal the reservoir 9536 once it is loaded. As described elsewhere herein, the fill port 9524, the fill instrument 9584, or a combination of the two, may be configured to prevent reuse of the reservoir 9536 once a fill operation has been performed. Also, as described elsewhere herein, the fill port 9524, the fill fixture 9584, or a combination of the two, may also be configured to ensure that access to the reservoir 9536 is restricted to only the appropriate fill fixture 9584. Other portions of the cassette assembly 9500, such as the cassette top portion 9506 and the cassette base portion 9502, may include features for these purposes. In such embodiments, these features may cooperate with the fill fixture 9584 or interface with the fill port 9524 to prevent unintended access. The fill port 9524, in an exemplary embodiment, is positioned opposite the tubing 9518 extending from the cassette base portion 9502.

[0143] In the exemplary embodiment, the cassette assembly 9500 is arranged to mate with the reusable housing assembly 106 via a twist-lock type engagement and includes a portion of a rotational coupler to facilitate this. Other types of mating arrangements are also possible in other embodiments. In the exemplary embodiment, the cassette top portion 9506 of the cassette assembly 9500 includes several tabs 9548 (see, e.g., FIG. 9 ) that extend radially from the sides of the cassette top portion 9506. In the exemplary embodiment, the tabs 9548 are evenly spaced at regular angular intervals, however, in other embodiments, the spacing may vary. The cassette base portion 9502 may include a stop surface 9550 that prevents the reusable housing 106 from being twisted too far or in the wrong direction when the cassette 9500 and the reusable housing 106 are mated. The tabs 9548 and the stop surface 9550 may cooperate to form a mating track. The stop surface 9550 may be disposed generally perpendicular to the tab 9548, as shown. The tab 9548, which projects from the cassette top portion, may overhang a peripheral recess contained within the cassette base portion 9502 adjacent a side wall of the cassette base portion 9502. The stop surface 9550 may project into the peripheral recess.

[0144] During mating, a mating tab or finger of the reusable housing 106 may be passed through an opening 9551 between the stop surface 9550 and the tab 9548 and rotated under the tab 9548 along a twisting path until an appropriate stop surface 9550 is reached. The underside of each tab 9548 may include a beveled portion 9554, which may cause an environmental seal ring 9556 (which may be formed from an overmolded elastomer) included on the cassette top portion 9506 to compress against the reusable housing assembly 106 (to form a fluid seal) during mating of the cassette assembly 9500 and the reusable housing assembly 106 together. Each tab 9548 may include a detent area 9552 into which the mating tab on the reusable housing assembly 106 may seat once the stop surface 9550 is reached. When within the detent area 9552, the mating tab of the reusable housing assembly 106 may resist rotation unless a downward force is applied during the twisting motion.

[0145] The fill port 9524, in the exemplary embodiment, is located in a non-traversing region outside of the torsional path of either of the mating tabs of the reusable housing assembly 106. The fill port 9524 may be located, for example, between the non-traversing regions between two of the stop surfaces 9550. This may allow the fill port 9524 to be located in a sidewall of the cassette base portion 9502 while still allowing for a torsional lock type engagement between the cassette assembly 9500 and the reusable housing assembly 106.

[0146] The cassette assembly 9500 may further include a leaflet cover 9520. The leaflet cover 9520 (see, e.g., FIG. 10) may include several regions that seat over the pump chamber recess 9532 and valve features 9514 (such as those described in FIG. 2-8 above) contained within the cassette base portion 9502. In an embodiment, the valve features 9514 are shown as volcano-type valves. The leaflet cover 9520 may be constructed from a flexible material. Selected regions of the leaflet cover 9520 may be actuated toward and away from the valve features 9514 and pump chamber recess 9532 via pump and valve actuation components (such as those described in connection with FIG. 2-8 above) contained within the reusable housing 106. This may direct and control the flow of fluid being transferred from a reservoir 9536 (see, e.g., FIG. 19) toward the patient 104. The leaflet cover 9520 may be captured between the cassette base portion 9502 and the cassette top portion 9506 during assembly of the cassette assembly 9500. In some embodiments, the leaflet cover 9520 may be overmolded onto the cassette base portion 9502, compression sandwiched between the cassette base portion 9502 and the cassette top portion 9506, or affixed in place via adhesive, heat sealing, or another suitable process. A fluid-tight seal may be formed between the cassette base portion 9502 and the leaflet cover 9520 when the cassette assembly 9500 is assembled.

[0147] A volume sensor diaphragm assembly 9526 (see, e.g., FIG. 10), including a diaphragm 9528 and a frame 9530, may also be coupled into the cassette assembly 9500 between the cassette base portion 9502 and the cassette top portion 9506. The volume sensor diaphragm assembly 9526 may be mounted on a volume sensing station 9564 of the cassette base portion 9502. This may form a volume sensing chamber, which may be monitored to determine the volume of fluid being transferred through the cassette assembly 9500. Further description is provided in connection with FIG. 4 above.

[0148] The flow paths leading into and out of the valve feature 9514, pumping recess 9532, and volume sensing chamber may extend to flow channels 9558 (best shown in FIG. 11 ) defined on the opposing side of the cassette base portion 9502. These flow channels 9558 may allow the valve feature 9514 and the pump chamber recess 9532 to be in fluid communication with one another. As fluid is pumped from the reservoir 9536 towards the patient 104, the fluid may be transported and routed through these flow channels 9558. There may be additional recesses 9559 interspersed between the flow channels 9558. These recesses 9559 may help allow the cassette base portion 9502 to be molded with shorter mold cycle times and may help prevent any distortion of the flow channels 9558 during cooling.

[0149] A film sheet seal 9512 may be bonded onto the cassette base portion 9502 across the flow channels 9558 to form a seal across these flow channels 9558, which keeps fluid therein within the confines of the flow channels 9558. The film sheet seal 9512 may be attached to the cassette base portion 9502 in any suitable manner. In an embodiment, the film sheet seal 9512 may be bonded to the cassette base portion 9502 via a heat seal. The film sheet seal 9512 may be constructed from the same material used to create the reservoir film 9516, which may be a flexible material. In an exemplary embodiment, the flow channels 9558 are contained within a well 9562 defined by a surrounding wall or perimeter 9560 contained within the cassette base portion 9502. The perimeter 9560 may help protect the film sheet seal 9512 and may provide an alignment aid that may be used to position the film sheet seal 9512 during manufacture of the cassette assembly 9500. In alternative embodiments, the perimeter 9560 may not be included and other alignment aids, such as alignment pins or protrusions, may be utilized.

[0150] In some embodiments, a cover (not shown) may be included and may be bonded in place over the film sheet seal 9512. The cover may be bonded in place via a snap fit, an interference fit, a welding process, adhesives, solvent bonding, or the like. The cover may be constructed from a rigid or puncture resistant material and may act as a protector for the film sheet seal 9512. Preferably, the cover may be bonded to the cassette base portion 9502 in a manner that makes it difficult to remove by a user. The cover may be bonded to the cassette base portion 9502 similar to the manner in which the cover 9692 (see, e.g., FIGS. 31-32) described later herein may be bonded in place over the reservoir 9536. In some examples, a cover may not be used, however, the film sheet seal 9512 may be constructed from a thicker film than that used to construct the reservoir film 9516. The film sheet seal 9512 may also include one or more additional layers that add durability to the film sheet seal material 9512.

[0151] In alternative embodiments, the film sheet seal 9512 may not be used. Instead, another suitable sealing wall, such as a seal plate 9774 (see, e.g., FIG. 44), may be used. The seal plate 9774 may be laser welded across and seal across the flow channel 9558. In some examples where a plate 9774 is used, the flow channel 9558 may be defined in the plate 9774 as opposed to the cassette base portion 9502. However, depending on the embodiment, it may be advantageous to use a film sheet seal 9512. For example, if the plate 9774 is laser welded to the cassette base portion 9502 and seals the flow channel 9558, the plate 9774 may have a tight flatness tolerance (e.g., less than a thousandth of an inch variation from flat). Because the film sheet seal 9512 is flexible, these tolerance issues may be mitigated. With wider allowable tolerances, more flexibility in molding may be obtained as well.

[0152] Additionally, various embodiments may find it advantageous to include the flow channel 9558 in the cassette base portion 9502, as opposed to a plate 9774 (see, e.g., FIG. 44), regardless of whether a film sheet seal 9512 or a plate is used. Because the flow channel 9558 may be molded with the remainder of the cassette base portion 9502, it may be ensured that the flow paths leading into and out of the valve feature 9514, pumping recess 9532, volume sensing chamber, etc., are aligned with the flow channel 9558. Thus, the use of the film sheet seal 9512 may simplify the manufacture of the cassette assembly 9500 and may limit the number of different materials and manufacturing processes used in the production of the cassette assembly 9500. This in turn may help to reduce the compatibility testing burden placed on the cassette assembly 9500.

[0153] The use of film sheet seals 9512 may also allow the flow channels 9558 to be made smaller and arranged closer together in a denser layout. This may facilitate a more compact cassette assembly 9500, or the saved space may be used to allow a cassette assembly 9500 with a larger reservoir 9536 to be made without increasing the overall footprint of the cassette assembly 9500. For example, if the flow channels 9558 are contained within the cassette base portion 9502 and sealed by a laser welded plate 9774, the layout of the flow channels 9558 may need to be planned to accommodate melting of the cassette base portion material 9502 during laser welding. During welding, the laser may pass through the seal plate 9774 and the energy of the laser may be absorbed at the surface of the cassette base portion 9502. Thus, the resulting heating may be primarily within the cassette base portion 9502 in the area of ​​the flow channels 9558. Sufficient space may need to be included around the flow channels 9558 to ensure that melting of the cassette base portion 9502 does not distort, close, or otherwise plug the flow channels 9558. However, attaching the film sheet seal 9512 via a heat sealing process may minimize melting of the cassette base portion 9502. Heat during this process may be shifted away from the cassette base portion 9502 and instead applied from an external source through the film sheet seal 9512 material. Thus, the film sheet seal 9512 may be bonded to the cassette base portion 9502 with minimal melting of the cassette base portion 9502.

[0154] 13 (a perspective three-quarter view, cut away, as shown in FIG. 12) and FIG. 14 (a detailed view of area 14 in FIG. 13), the fill port 9524 may provide a direct path into the interior volume of the reservoir 9536. As shown, the fill port 9524 may have a bore 9568 within which a septum 9522 may be located. The septum 9522 may include one or more ribs 9570. The ribs 9570 may have a diameter (at its widest point) somewhat larger (e.g., 140-105%) than the diameter of the bore 9568. The fill port 9524 may also include a protective wall 9572. The protective wall 9572 may be located at the interior end of the bore 9568. The protective wall 9572 may block a user from extending a sharp object 9586 (e.g., a needle) past a certain point. This can prevent the reservoir film 9516 from being damaged by sharps 9586 (see, eg, FIG. 47) when the reservoir 9536 is filled.

[0155] 15 (a cross-sectional view taken at the indicated cutting plane in FIG. 12) and FIG. 16 (a detailed view of area 16 in FIG. 15), the protective wall 9572 may include an inlet 9574 to the reservoir 9536. A funnel region 9576, contained within the protective wall 9572, may surround the inlet 9574. The funnel region 9576 may help redirect any sharps 9586 toward the inlet 9574 so that they are long enough to reach the protective wall 9572. As shown, the reservoir recess 9508 may include a basin 9578, which is located downstream of the inlet 9574. The basin 9578 may be recessed deeper than the surrounding portions of the reservoir recess 9508. 14, due to pre-forming, the reservoir film 9516 may be positioned above a bottom surface of the basin 9578 when the reservoir 9536 is in an empty state. Thus, the basin 9758 may provide an open space through which a sharp 9586 may protrude without contacting the reservoir film 9536.

[0156] In some embodiments, the fill port 9524 may be arranged such that a fill tool 9584 (see, e.g., FIG. 47) for the reservoir 9536 includes a sharp 9586 (see, e.g., FIG. 47) that is not long enough to reach into the interior volume of the reservoir 9536. In such embodiments, the sharp 9586 may extend through the septum 9522 into a receiving volume in the bore 9568 of the fill port 9522, upstream of the protective wall 9572. Fluid may be delivered into the receiving volume and flow through an inlet 9574 in the protective wall 9572 into the reservoir 9536. This may prevent a user from contacting the sharp 9586 with the reservoir film 9516 during the filling operation. Preferably, any receiving volume, including within the fill port 9522, may be relatively small to minimize any dead space that may retain fluid as the reservoir 9536 is emptied.

[0157] In some embodiments, as described later herein, the fill port 9524 may include one or more features that may limit the ability to access the interior volume of the reservoir 9536. For example, the fill port 9524 may include one or more features that block access to the interior volume for a fill instrument 9584 (see, e.g., FIG. 47) that is not intended for use with the cassette assembly 9500. Additionally or alternatively, again as described later herein, the fill port 9524 may include one or more features that may prevent or limit reuse of the cassette assembly 9500. The fill port 9524 may include one or more features that may, for example, block access to or make it more difficult to access the interior volume of the reservoir 9536. This may help ensure that the cassette assembly 9500 is not used to exceed its intended usage life (which in some embodiments may be single use).

[0158] In some embodiments, or for a particular application, multiple cassette assembly 9500 types may be produced. In some embodiments, drugs for use with cassette assembly 9500 may be available in different concentrations. Using insulin as an example, cassette assemblies for U100 insulin and U200 insulin may be available. The filling instrument 9584, containing U200 insulin, may include a sharp 9586 that is of insufficient length to pierce through the septum 9522 of the U100 cassette assembly 9500. This may prevent the user from accidentally filling the reservoir 9536 with a higher concentration drug than intended.

[0159] 17 and 18, as mentioned above, the reservoir recess 9508 may include several recessed ducts 9566. These ducts 9566 may help prevent fluid from pooling in the collapsible reservoir 9536 as the reservoir 9536 is depleted and may help facilitate complete emptying of the reservoir 9536. The ducts 9566 may all extend to communicate with the reservoir outlet pathway 9544 of the cassette base portion 9502. In an exemplary embodiment, an outlet duct 9580, recessed into the reservoir recess wall 9510, leads into the reservoir outlet pathway 9544. A junction area 9582 may be present at the upstream end of the outlet duct 9580. Several ducts 9566 may branch off from the junction area 9582 into various portions of the reservoir recess 9508. In the exemplary embodiment, five ducts 9566 extend from the junction region 9582 and are spaced apart at regular angular intervals. These ducts extend in a generally straight path across the reservoir recess 9508 to the recessed wall 9510. Each, some, or at least one of these ducts 9566 may further branch into additional ducts 9566, which form tributaries for the parent duct 9566. Ducts 9566 extending along curved or at least partially curved paths are also possible. In the exemplary embodiment, a duct 9566 is included that is recessed around a majority of the circumference of the reservoir recess 9508 adjacent the recessed wall 9510. This duct 9566 may intersect the paths of other ducts 9566 contained within the cassette base portion 9502 and may extend to a basin region 9578 contained by an inlet 9574 to the reservoir 9536 .

[0160] The cross-sectional area of ​​the flow path created by the recessed ducts 9566 may be constant or may vary along at least a portion of the ducts 9566. In an exemplary embodiment, the recessed ducts 9566 increase in width as they extend to the recessed wall 9510. The depth of the ducts 9566 may remain approximately the same. This may allow the cassette assembly 9502 to be easily moldable.

[0161] 19 and 20-23, when the reservoir 9536 is depleted from the full state shown in FIG. 19 (cross section, taken at the indicated cutting plane in FIG. 12) to the empty state as shown in FIG. 20 (another cross section, taken at the indicated cutting plane in FIG. 12), the reservoir film 9516 may collapse onto the surface of the reservoir recess 9508. The vacuum created as fluid is pumped from the reservoir 9536 may not be sufficient to pull the reservoir film 9516 into the recessed duct 9566. As best shown in FIG. 21 (detailed view of the indicated area in FIG. 20), when the reservoir film 9516 is against the reservoir recess 9508 and recess wall 9510, the duct 9566 may remain open to fluid flow. Thus, the ducts 9566 can form a network of interconnected fluid channels that extend throughout the reservoir 9536 when the reservoir 9536 reaches an empty or near empty state. In an exemplary embodiment, the ducts 9566 have a depth that is approximately 25% (e.g., 20-35%) of the thickness of the cassette base portion 9502 material that defines the reservoir recess 9508.

[0162] As shown in FIG. 22 (cross-section taken at the indicated cutting plane in FIG. 12) and FIG. 23 (detailed view of the indicated area of ​​FIG. 22), the outlet duct 9580 and junction area 9582 may not be plugged by the reservoir film 9516 when the reservoir 9536 is empty or nearly empty. As a result, the reservoir outlet pathway 9544 (see, e.g., FIG. 10) may remain in fluid communication with the majority of the reservoir 9536 even when the reservoir film 9516 is drawn against the reservoir recess 9508 and recess wall 9510. This may help prevent fluid from becoming isolated in a recess that is out of communication with the reservoir outlet pathway 9544 as the reservoir 9536 is collapsed. In the exemplary embodiment, the outlet duct 9580 has a depth that is approximately ⅔ (eg, 50-70%) of the thickness of the cassette base portion 9502 material that defines the reservoir recess 9508.

[0163] By reducing the chances that fluid is sequestered away from the reservoir exit path 9544 as the reservoir 9536 collapses, the duct 9566 may ensure that the reservoir 9536 may be emptied more completely and consistently. A user, health system, or insurer may experience cost savings because much of the fluid loaded into the reservoir 9536 may be utilized. In addition, such a duct 9566 arrangement may increase the average therapy time that the reservoir 9536 may support, once filled. Another benefit may be an increased usefulness of the remaining reservoir volume determination made by components of the delivery system 10. Because the duct 9566 may help ensure that much of the fluid loaded into the reservoir 9536 may be used, the remaining volume determination may enable more robust scheduling of therapy events performed by the drug delivery system 10 based on the remaining volume determination. This may be especially true when the reservoir 9536 is nearly empty.

[0164] 23, for example, the cassette top portion 9506 of the cassette assembly 9500 may be affixed to the cassette assembly 9500 by mounting it, at least in some portions, on the reservoir film 9516. As shown, the cassette top portion 9506 may include an energy director 9674. The energy director 9674 may serve to focus sonic welding energy at an apex of the energy director 9674, which abuts the reservoir film 9516. The energy director 9674 shown may be of generally triangular cross-section and 0.5-0.7 mm high in one embodiment. The apex may be formed by a right angle, a 60° angle, or any other suitable angle.

[0165] 24, which is a view of the cassette assembly 9500 with the cassette top portion 9506 exploded and rotated to depict its underside, the energy director 9674 may be formed as a ring about the periphery of the bottom surface of the cassette top portion 9506. The energy director 9674 may seat over the reservoir film 9516, which is positioned on the mounting surface 9540 of the cassette base portion 9502. A welding surface 9681, disposed radially outwardly of the leaflet cover 9520, may also be included and may align with the energy director 9674 ring when the cassette top portion 9506 is in place. The reservoir film 9516 may be thin and compressible so that there is no significant step in the surface to which the cassette top portion 9506 will be welded. When the weld is formed, the cassette top portion 9506 may mate with the weld surface 9681 and form a seal at the location of the weld between the inner and outer portions of the weld surface 9681 of the cassette base portion 9502. Thus, when the reusable housing assembly 106 is mated to the cassette assembly 9500, there may be two redundant environmental seals that are generated (see also the description of the environmental seal ring 9556 in relation to FIG. 10 ).

[0166] Coupling the cassette top portion 9506 to the remainder of the cassette assembly 9500 in this manner may allow the cassette assembly 9500 to have a smaller footprint. It may also be advantageous because it may allow the reservoir 9536 to be made with a larger maximum volume without increasing the footprint of the cassette assembly 9500. This may be desirable, particularly if the cassette assembly 9500 is designed for use as part of a portable infusion device, such as an insulin pumping device. The size of such a device may be considered significantly more eye-catching to a user, as the user will either wear or carry the device (e.g., in a pocket or on a belt clip) throughout the day. Users may wish to cover or conceal such devices so as not to draw attention to them or to prevent them from getting in the way of daily activities. Smaller devices or devices that hold more drug volume without taking up more space may therefore be considered particularly attractive.

[0167] In an embodiment, one or more additional energy directors may be included within the occupied area of ​​the energy director 9674 ring. As shown, a second energy director 9676 is disposed within the energy director 9674 ring. The cassette base portion 9502 may include a weld recess 9678, which may receive the second energy director 9676. During welding, the sonic energy may melt the energy directors 9674, 9676 along with the material within the cassette base portion 9502 and the reservoir film 9516. The material may flow together and securely bond the parts together. The second energy director 9676 and weld recess 9678 may be positioned adjacent to the leaflet cover 9520, but radially inward. This may ensure that pressure is applied evenly against the leaflet cover 9520 to compressibly seal the leaflet cover 9520 to the cassette base portion 9502.

[0168] As shown, a number of locating pins 9680 and receptacles 9682 may also be included. In an embodiment, the locating pins 9680 may extend from the cassette base portion 9502 and be received within locating receptacles 9682 in the cassette top portion 9506. This may facilitate proper alignment of the cassette top portion 9506 prior to welding the cassette top portion 9506 to the remainder of the cassette assembly 9500.

[0169] 25 and 26, another exemplary cassette assembly 9500 is depicted. The cassette assembly 9500 includes a cassette base portion 9502. The depicted cassette base portion 9502 includes an integrally formed reservoir recess 9508. A reservoir film strip 9516, with a preformed region 9534 that mimics the shape of the reservoir recess 9508, may be bonded to the cassette base portion 9502 and define a reservoir 9536, which may be loaded with a drug, such as any of those described herein. In an exemplary embodiment, the reservoir recess 9508 includes various recessed ducts 9566 (described elsewhere herein (see, e.g., FIGS. 17-18)). The preformed region 9534 may not include a corresponding feature. When empty, the preformed area 9534 can seat within the reservoir recess 9508 such that the reservoir film 9516 abuts or is adjacent to the bottom surface of the reservoir recess 9508 and seats against the recess wall 9510 but does not extend into or block the flow through the duct 9566.

[0170] The reservoir film 9516 may include a peripheral rim region 9538. The peripheral rim region 9538 may be coupled to the cassette base portion 9502 at a mounting surface 9540 of the cassette base portion 9502, which may surround the reservoir recess 9508. An exposed portion 9542 is also included within the shown peripheral rim region 9538. In an exemplary embodiment, a reservoir exit pathway 9544 is recessed into the mounting surface 9540. The exposed portion 9542 of the reservoir film 9516 may seal over the reservoir exit pathway 9544 to form an enclosed and leak-proof flow path out of the reservoir 9536.

[0171] A fill port 9524 may be included for providing fluid into the reservoir 9536. The fill port 9524 may extend directly through a sidewall of the cassette base portion 9502 into the interior volume of the reservoir 9536. The fill port 9524 may include a septum 9522. In some embodiments, the septum 9522 may be pierceable via a sharp 9586 (see, e.g., FIG. 47) on a fill instrument 9584 (see, e.g., FIG. 47) and self-seal upon removal of the sharp 9586 to fluidly seal the reservoir 9536 once it is loaded.

[0172] As described elsewhere herein, the fill port 9524, the fill fixture 9584, or a combination of the two, may be configured to prevent reuse of the reservoir 9536 once a fill operation has been performed. Also, as described elsewhere herein, the fill port 9524, the fill fixture 9584, or a combination of the two, may also be configured to ensure that access to the reservoir 9536 is restricted to only the appropriate fill fixture 9584. Other portions of the cassette assembly 9500, such as the cassette top portion 9506 and the cassette base portion 9502, may include features for these purposes. The fill port 9524, in an exemplary embodiment, is positioned opposite the tubing 9518, which extends from the cassette base portion 9502.

[0173] In the exemplary embodiment, the cassette assembly 9500 is arranged to mate with the reusable housing assembly 106 via a twist-lock type engagement (described elsewhere herein). The fill port 9524, in the exemplary embodiment, is located in a non-traversing region outside of the twist path of either of the mating tabs of the reusable housing assembly 106. The fill port 9524 may be located, for example, between the non-traversing regions between two of the stop surfaces 9550. This may allow the fill port 9524 to be located in a sidewall of the cassette base portion 9502 while still allowing for a twist-lock type engagement between the cassette assembly 9500 and the reusable housing assembly 106.

[0174] The cassette assembly 9500 may further include a valve cover 9520 including several areas that seat over the pump chamber recess 9532 and valve features 9514 (such as those described in Figures 2-8 above) contained within the cassette base portion 9502. A volume sensor diaphragm assembly 9526 including a diaphragm 9528 and a frame 9530 may also be coupled into the cassette assembly 9500 between the cassette base portion 9502 and the cassette top portion 9506. The volume sensor diaphragm assembly 9526 may be mounted on a volume sensing station 9564 of the cassette base portion 9502. This may form a volume sensing chamber that may be monitored to determine the volume of fluid being transferred through the cassette assembly 9500. Further description is provided in connection with Figure 4 above.

[0175] The cassette top portion 9506 of the cassette assembly 9500 may include a compliant member 9684, which may be attached thereto. In an embodiment, the compliant member 9684 may be disposed around a perimeter of a top surface of the cassette top portion 9506. The compliant member 9684 also includes a ring 9686, which surrounds the diaphragm 9528 when the cassette assembly 9500 is assembled. The exemplary ring 9686 is integral with the compliant member 9684 and is attached by a bridge 9688 that extends radially inward from the compliant member 9684. The compliant member 9684 and the ring 9686 may act as a gasket, which forms a fluid-tight seal when the reusable housing assembly 106 is attached to the cassette assembly 9500. The ring 9686 may form a sealed space connecting the volume sensing chamber and the volume sensing hardware within the reusable housing assembly 106. The compliant member 9684 may create an environmental seal that prevents the ingress of moisture, debris, etc. into the dispensing assembly 100 when the reusable housing assembly 106 and the cassette assembly 9500 are coupled to one another.

[0176] 27, the valve feature 9514, the pumping recess 9532, and the volume sensing chamber may be in fluid communication with one another via flow channels 9558 (see, e.g., FIG. 27) defined in opposing sides of the cassette base portion 9502. A film sheet seal 9512 (further described in connection with FIG. 11) may be coupled onto the cassette base portion 9502 across the flow channels 9558 to form a seal across these flow channels 9558 that retains fluid therein within the confines of the flow channels 9558.

[0177] 28, a flow channel 9756 may also be included on the same side of the cassette base portion 9502 as the valve feature 9514, pumping recess 9532, and volume sensing chamber. In the exemplary embodiment, a single flow channel 9756 is shown for purposes of example. The flow channel 9756 includes an air trap housing 9546. The air trap housing 9546 may retain an air trap 9547, which may be a screen or mesh insert as described elsewhere herein. In the exemplary embodiment, the leaflet cover 9520 includes an exposed area 9758, which may seal across the fluid channel 9756 when the cassette top portion 9506 is coupled in place within the cassette assembly 9500. As shown, the cassette top portion 9506 includes a sealing rib 9760, which mimics the shape of the fluid channel 9756 recess. When the cassette top portion 9506 is mated into the cassette assembly 9500, the sealing ribs 9760 may press against the exposed area 9758. The pressure provided by the sealing ribs 9760 may help create a robust fluid-tight seal around the flow channel 9756.

[0178] 25-26, in some embodiments, the cassette assembly 9500 may not be filled by the patient 104 close in time to its use. Instead, the cassette assembly 9500 may be provided to the patient 104 in a pre-filled state. For example, the patient 104 may receive the cassette assembly 9500 that has been filled by a manufacturer. Alternatively, a pharmacy may fill the cassette assembly 9500, which may be used to fill the patient's 104 prescription.

[0179] In embodiments in which the cassette assembly 9500 is provided to the patient 104 pre-filled, the cassette assembly 9500 may be constructed to facilitate performance of one or more quality checks associated with pre-filling the reservoir 9536. For example, the cassette assembly 9500 may include at least one fill verification feature. As shown, the cassette top portion 9506 of the cassette assembly 9500 may include a compartment 9690, which may receive a cover 9692. The reservoir 9536 of the cassette assembly 9500 may be filled prior to disposition of the cover 9692. In addition, other portions of the cassette assembly 9500 may be constructed from a light-colored (e.g., white opaque), translucent, transparent, or clear material. After filling, the cassette assembly 9500 may be inspected to verify that the fill operation was acceptable. Thus, the compartment 9690 may be referred to herein as an inspection compartment 9690. Such inspection may be performed manually, with a vision system, or both. The use of light or clear colors for the components of the cassette assembly 9500 may facilitate various imaging operations in embodiments in which a vision system is used. As shown, the cover 9692 is free of any holes or openings. When disposed, the cover 9692 may prevent the patient 104 from applying pressure against the reservoir 9536.

[0180] 29, in some embodiments, the cassette assembly 9500 may be inspected by at least one imager 9694 after it has been filled. The at least one imager 9694 may capture an image of the reservoir 9536. The image may be captured through an opening presented by a compartment 9690 in the cassette top portion 9506 to allow an unobstructed view of the reservoir 9536. The image processor 9696 may analyze the image and verify that the filling of the reservoir 9536 complies with various defined criteria. For example, analysis of the image by the image processor 9696 may determine whether the reservoir 9536 contains particles or air (e.g., above some threshold amount). The analysis may also check for other undesirable scenarios. For example, the analysis may check for haze, haze, or turbidity. The analysis may also include a distance meter, which verifies that the reservoir film 9516 is in a location that would be consistent with the desired fill volume. After it has been determined that the reservoir 9536 complies with the defined criteria, the cover 9692 may be placed in place over the reservoir 9536.

[0181] 30, a flow chart 9698 is shown depicting some example actions that may be performed to inspect the reservoir 9536. In block 9700, the cassette assembly 9500 may be assembled, except for the cover 9692. The reservoir 9536 of the cassette assembly 9500 may be filled in block 9702. One or more images of the reservoir 9536 may be taken in block 9704. The one or more images may be taken along a field of view that is unobstructed by components of the cassette assembly 9500. As noted above, an image or images of the reservoir 9536 may be captured through a window provided by the compartment 9690 of the cassette top portion 9506. The images may be analyzed in block 9706. If the acceptability criteria for the reservoir 9536 are violated at block 9708, a controller for the vision system may indicate that the cassette assembly 9500 is unacceptable at block 9710. If the cassette assembly complies with the acceptability criteria at block 9708, the cover 9692 may be coupled into the compartment 9690 at block 9712.

[0182] 31 , a perspective exploded view of an exemplary cassette assembly 9500 having a cover 9692 is shown. The compartments of the cassette top portion 9506 and the cover 9692 are exploded to illustrate the retention features for holding the cover 9692 in place within the compartment 9690 of the cassette top portion 9506. The cassette top portion 9506 includes a number of coupling members, in the exemplary embodiment, retention tabs 9716, which protrude from the walls of the compartment 9690. The exemplary cover 9692 includes a number of latch clips 9718. The exemplary latch clips 9718 are formed as "L" shaped extensions that extend from a bottom surface of the cover 9692. A first edge 9720 of the cover 9692 includes two latch clips 9718. A latch clip 9718 is also included opposite the first edge 9720 and is sandwiched between two notches (only one is shown in FIG. 31 ). The notches 9722 may allow the latch clip 9718 to be attached to the cover 9692 in a cantilevered manner such that the latch clip 9718 may resiliently flex during installation of the cover 9692. In an embodiment, the latch clip 9718 on the first edge 9720 may be displaced into position under its respective retaining tab 9716. The cover 9692 may then be rotated toward the cassette base portion 9502 until the bottom of the opposing latch clip 9718 contacts the top of its respective retaining tab 9716. Further pressure may cause the latch clip 9718 to resiliently deflect around its respective retaining tab 9716 and restore to an unstressed state under the retaining tab 9716. Thus, the cover 9692 can be assembled into the cassette assembly 9500 with little difficulty, but cannot be easily removed. As shown, the cover 9692 is a solid monolithic piece of material, with no openings or voids disposed within the side walls of the cover 9692. Thus, the cover 9692 can protect the reservoir 9536 against tampering, needle punctures, and accidental application of pressure.

[0183] In other embodiments, the cover 9692 may be attached to the cassette assembly 9500 in any of a variety of manners. For example, the cover 9692 may be bonded in place via solvent bonding, adhesive, or welding (heat staking or sonic welding). An interference fit, snap fit, threaded engagement, bayonet mount, or the like may also be used. In some embodiments, the cassette base portion 9502 or another portion of the cassette assembly 9500 may include slots or notches into which cooperating protrusions on the cover 9692 may be bonded to assemble the cover 9692 in place on the cassette assembly 9500. Preferably, once bonded in place, the cover 9692 may be difficult for a user to remove.

[0184] 32, a perspective view of an alternative embodiment of the cassette assembly 9500 is depicted. The cover 9692 is again shown as a solid protective body, which may be coupled in place over the reservoir 9536. In the example shown, the cover 9692 includes tabs 9770. The tabs 9770 of the cover 9692 may mate into receiving notches 9772 included in the cassette top portion 9506. In the exemplary embodiment, the notches 9772 are positioned as alignment bodies 9774, which extend protruding from an upper surface of the cassette top portion 9506. These alignment bodies 9774 may aid in coupling of the cassette assembly 9500 to the reusable housing assembly 106. The cover 9692 may be resiliently flexible to allow the cover 9692 to deflect as the tabs 9770 snap into the notches 9772.

[0185] 25-26 , the cassette assembly 9500 may include an occluder assembly 9714 in embodiments in which the reservoir 9536 is pre-filled prior to receipt by a user. The occluder assembly 9714 may fluidly isolate drug contact surfaces in a first portion of the cassette assembly 9500 from drug contact surfaces in a second portion of the cassette assembly 9500.

[0186] The first portion of the assembly 9500 may be constructed from materials that are compatible with any drug stored in the cassette assembly 9500 over an extended storage time frame. For example, the first portion may be constructed from materials that are compatible with the drug over a period of storage equivalent to several months to a year or more. The first portion may include the reservoir 9536 and the reservoir exit path 9544. The second portion may include materials that are compatible with the drug over a shorter time frame or have been tested to have acceptable compatibility with the drug over a shorter duration. In some embodiments, the materials of the second portion may only be in contact with the drug during therapy and related activities (e.g., priming the cassette assembly 9500). Depending on the embodiment, the reservoir 9536 may hold enough drug for a three-day therapy, after which the cassette assembly 9500 may be discarded and a new cassette assembly 9500 may take its place on the reusable housing assembly 106. The second portion may include all fluid contacting surfaces of the cassette assembly 9500 downstream of the occluder assembly 9714.

[0187] The occluder assembly 9714 may be constructed from a material having long-term compatibility. Given the small area of ​​the occluder assembly 9714 exposed to the drug or agent, the occluder assembly, particularly the diaphragm 9724, may be formed from halogenated butyl rubber, bromobutyl, or chlorobutyl. Alternatively, the portion of the occluder assembly 9714 that contacts the fluid in the first portion of the cassette assembly 9500 when the occluder assembly 9714 is in the occluded state may be constructed from a material having long-term compatibility. The fluid contacting components in the first portion of the cassette assembly 9500 may be selected to have long-term compatibility with the drug. The fluid contacting components downstream of the occluder assembly 9714 may be selected to have at least short-term compatibility with the drug. This may allow the drug to be stored for long periods of time without adverse effects, while also allowing a wider range of material options in other components of the cassette assembly 9500, such as the leaflet cover 9520. This may be particularly desirable for certain protein drugs, such as insulin.

[0188] The occluder assembly 9714 may establish multiple seals, which isolate the fluid in the reservoir 9536 and reservoir outlet path 9544 from the rest of the cassette assembly 9500. Each seal, independently, completely isolates the reservoir 9536 and reservoir outlet path 9544 from the rest of the cassette assembly 9500. At least two seals may be included, although a greater number of seals are also possible. This redundancy may help provide redundant assurance that fluid cannot leak through the occluder assembly 9714.

[0189] 33-37, prior to initiation of therapy, the occluder assembly 9714 or a portion thereof may be removed or placed in an unoccluded state. This may place a first portion of the cassette assembly 9500 in fluid communication with a second portion of the cassette assembly 9500. In some embodiments, the reusable housing assembly 106 may be prevented from mating with the cassette assembly 9500 when the occluder assembly 9714 is in the occluded state. Thus, the occluded state may also serve as an anti-mating state. For example, a portion of the occluder assembly 9714 may protrude from the remainder of the cassette assembly 9500. When a user attempts to attach the reusable housing assembly 106 to the cassette assembly 9500, the reusable housing assembly 106 may contact the protruding portion of the occluder assembly 9714 and be prevented from further displacement toward the cassette assembly 9500. The mating features of the cassette assembly 9500 and the reusable housing assembly 106 may disengage from one another when the reusable housing assembly 106 bottoms out of the protruding portion of the occluder assembly 9714 .

[0190] In an exemplary embodiment, as best shown in FIG. 33, the occluder assembly 9714 may include a diaphragm 9724 and an actuator 9726. The actuator 9726 may include a knob 9728. The knob 9728 may include several flutes 9730, which may facilitate grasping by the patient 104 or a removal tool. A rod 9732 may extend from the knob 9728 and may include two beveled features 9734, which may be located at a terminal end thereof. The beveled features 9734 are disposed radially opposite one another. In alternative embodiments, the number of beveled features 9734 may be greater and may be spaced about the rod 9732 in some predefined pattern. In some embodiments, the beveled features 9734 may be located at uniform angular increments from one another or may be disposed about the rod 9732 at irregular angular increments.

[0191] The diaphragm 9724 comprises a main body 9736. Tabletop regions 9738, 9740 may be included on the top and bottom sides of the main body 9736. The tabletop region 9740 on the top of the main body 9736 may align with the rod 9732 when assembled into the cassette assembly 9500. The tabletop region 9738 included on the bottom of the main body 9736 may provide a contact surface for sealing against one or more valves that gate flow between the first and second portions of the cassette assembly 9500. The diaphragm 9724 (or at least the tabletop region 9738) may be made from a compressible material that possesses long-term compatibility with the drug contained within the cassette assembly 9500. In some embodiments, the diaphragm 9724 and the septum 9522 may be constructed from the same material. In some embodiments, the material of the diaphragm 9724 may be chlorobutyl elastomer.

[0192] 35 (detailed view of the indicated area of ​​FIG. 34), the cassette assembly 9500 may include a threaded port 9742. The threaded port 9742 may be equipped with a set of threads 9744, which may have a pitch selected to cooperate with a bevel feature 9734 on the actuator 9726. The threaded port 9742 may be positioned over a section within the cassette base portion 9502 that includes one or more valves, as discussed above, that gate flow between portions of the cassette assembly 9500.

[0193] Referring primarily to FIG. 37 (detailed view of the indicated area of ​​the underside of the cassette top portion 9506 shown in FIG. 34), the actuator 9726 may be threaded into the threaded port 9742. As shown, threads 9744 within the threaded port 9742 may each guide a beveled portion 9734 of the actuator 9726 onto a respective retention area 9746. In the example shown, the retention area 9746 is a shelf-like extension that is continuous with the threads 9742. The retention area 9746 may include a detent in some embodiments and may serve to hold the actuator 9726 in place when fully threaded into the threaded port 9742. When the beveled portion 9734 is seated on the retention area 9746, the actuator 9726 may be in an occluded position or state. In this position, the actuator 9726 can push into the diaphragm 9724 and compress or bias the diaphragm 9724 against a valve seat located opposite the rod 9732 of the actuator 9726. Flow through the valve seat can be blocked when the diaphragm is pressed against the valve seat.

[0194] Referring now primarily to FIG. 38 (cross-section taken at the indicated plane in FIG. 27) and FIG. 39 (detailed view of the indicated area of ​​FIG. 38), a cross-sectional view of an exemplary occluder assembly 9714 is shown. The actuator 9726 is shown in an occluded position. The diaphragm 9724 is pressed against the reservoir outlet valve 9748, which gates flow from the reservoir outlet path 9544 (see, e.g., FIG. 26) to the remainder of the cassette assembly 9500. For ease of illustration, a portion of the actuator 9726 extends into the diaphragm 9724. In practice, the actuator 9726 would instead compress the diaphragm 9724. Thus, when deployed, the actuator 9726 can tightly close the reservoir outlet valve 9748.

[0195] The reservoir outlet valve 9748 is shown in the exemplary embodiment as a volcano-style valve. Specifically, the reservoir outlet valve 9748 is depicted as a dual volcano-style valve. When the actuator 9726 is in the occluded position, the diaphragm 9724 may be pressed against the reservoir outlet valve 9748 such that the diaphragm is compressed onto respective valve seats 9749A, B of the dual volcano valve. As a result, the occluder assembly 9714 may isolate a first portion of the cassette assembly 9500 from the remainder of the cassette assembly 9500 in multiple redundant seals.

[0196] Also, as shown, the diaphragm 9724 may be compressed into place between the cassette top portion 9506 and the cassette base portion 9502 in the cassette assembly 9500. This compression may create a seal between the diaphragm 9724, the cassette top portion, and the cassette base portion 9502. The diaphragm 9724 may be sealed, for example, around the periphery of the recess 9747 in which the reservoir outlet valve 9748 is located. In some embodiments, there may be a redundant seal around the periphery of the recess, similar to that created for the outlet valve seats 9749A,B. This may form a sealed occluder volume 9752 through which fluid may pass during therapy. Preferably, the occluder volume 9752 may be sized to be minimal so as to limit the amount of dead space in the flow path through the cassette assembly 9500.

[0197] When the actuator 9726 is unthreaded from the threaded port 9742, the diaphragm 9724 may recover from its compressed or deflected state. In its resting state, the diaphragm 9724 may be displaced away from the reservoir outlet valve 9748, causing the reservoir outlet valve 9748 to an open state. In the open state, fluid may flow through the occluder volume 9752 to the occluder outlet 9750, which is plumbed into a flow channel 9558 contained on the rear surface of the cassette assembly 9500. Thus, when the actuator 9726 is removed from the threaded port 9742, a first portion of the cassette assembly 9500 may be placed in fluid communication with a second portion of the cassette assembly 9500. The occluder assembly 9714 may transition to a flow allowing state when the actuator 9726 is unthreaded from the position shown in FIG. 39 to at least a second position. As noted above, depending on the embodiment, it may be necessary to completely remove the actuator 9726 in order to couple the cassette assembly 9500 to the reusable housing assembly 106 before initiating therapy.

[0198] As shown, one or more walls 9751 may be provided around a portion of the occluder outlet 9750. The walls 9751 may protrude from the recess 9747 beyond the valve seats 9749A,B of the reservoir outlet valve 9748. The walls 9751 may act as a restoring protrusion, which helps ensure that once the occluder assembly 9714 is brought to a non-occluded state, the diaphragm 9724 is pushed away from the reservoir outlet valve 9748, aiding in the opening of the reservoir outlet valve 9748. Additionally, the partial wall 9751 around the occluder outlet 9750 may ensure that the occluder outlet 9750 is less likely to be further blocked by the diaphragm 9724. Thus, the partial wall 9751 may ensure that flow through the occluder assembly 9714 is not impeded once the occluder assembly 9714 is brought to a non-occluded state.

[0199] 40-42, a diagram of an embodiment of the cassette assembly 9500 with an alternative occluder assembly 9714 is depicted. As shown, the occluder assembly 9714 is substantially identical to that shown in FIGS. 38-39, however, a bung 9800 type actuator for the occluder assembly 9714 is included instead of the actuator 9726. The bung 9800 may be constructed from a compressible elastomeric material. The bung 9800 may be pressed into the tapered port 9802 and may include a shoulder 9804, which prevents displacement of the bung 9800 into the tapered port 9802 beyond a certain point. The diameter of the bung 9800 may be larger than at least the smallest section of the tapered port 9802. Thus, an interference fit may be created when the bung 9800 is disposed, which helps to retain the bung 9800 in place within the tapered port 9802.

[0200] When pressed into the tapered port 9802, the plug 9800 may displace and compress the diaphragm 9724 against the reservoir outlet valve 9748, closing off flow therethrough. The end of the plug 9800 that contacts the diaphragm 9724 may also deform and bulge outwardly as it is advanced into the diaphragm 9724. This bulge may further help retain the plug 9800 in place within the tapered port 9802 during storage. The plug 9800 may include a nub 9806 on an exposed portion of the plug 9800, which may be grasped to remove the plug 9800. The plug 9800 may be manually removed or pulled out of the tapered port 9802 with a removal tool. As in FIG. 39, at least one wall 9751 may be provided around a portion of the occluder outlet 9750. The partial wall 9751 may help drive the diaphragm 9724 away from the reservoir outlet valve 9748 when the plug 9800 is removed.

[0201] 43-45, a diagram of an embodiment of the cassette assembly 9500 with another occluder assembly 9714 is depicted. Referring primarily to FIG. 45, the occluder assembly 9714 may include a shuttle body 9778, which acts as an actuator for the occluder assembly 9714. The shuttle body 9778 may be displaceable along an occluder channel 9782, which is in fluid communication with the reservoir exit pathway 9544 and the flow channel 9558 leading to a second portion of the cassette assembly 9500. In an example, the occluder assembly 9714 includes a diaphragm 9780, which is captured between the cassette base portion 9502 and the cassette top portion 9506 of the cassette assembly 9500. A seal plate 9774 (described in further detail in connection with FIG. 11 above), which may seal and / or partially define the flow channel 9558 of the cassette assembly 9550, may also define a portion of the occluder assembly 9714. As shown, the seal plate 9774 may include a well 9776. A channel 9780 is defined by a passage that extends through the well 9776, the diaphragm 9780, and the cassette base portion 9502, in the exemplary embodiment.

[0202] The cassette base portion 9502 may include at least one rib 9786, which may surround the occluder channel 9782. In an exemplary embodiment, a set of ribs 9786 is included. The cassette top portion 9506 may include compression protrusions 9798, which may match over the ribs 9786 when the cassette top portion 9506 is coupled to the cassette base portion 9502. These ribs 9786 may form a layer of redundant sealing between the diaphragm 9780 and the cassette base portion 9502 when the diaphragm 9780 is captured and compressed between the cassette base portion 9502 and the cassette top portion 9506. Such an arrangement may also be included in other occluder assembly 9714 embodiments (e.g., those shown in FIG. 39 or FIG. 42).

[0203] 46, a perspective view of the shuttle body 9778 is shown. The shuttle body 9778 may include at least one seal interface 9784. In the exemplary embodiment, two seal interfaces 9784 are included, shown as protruding ridges on the shuttle body 9778. The seal interface 9784 is included in one of the enlarged end sections 9788 of the shuttle body 9778. The seal interface 9784 may fluidly seal against the walls of the occluder channel 9782 and may also generate an adhesion force that resists unintentional displacement of the shuttle body 9778. In the exemplary embodiment, the entire shuttle body 9778 is a monolithic piece, which may be constructed, for example, from molded chlorobutyl elastomer (the diaphragm 9780 may also be made from this material). In other embodiments, the seal interface 9784 may be an O-ring, which is assembled onto the shuttle body 9778 during manufacture of the disposable housing assembly 9500.

[0204] 45-46, the cassette assembly 9500 may be packaged with a shuttle body 9778 in a closed position (shown in FIG. 45). In the closed position, the shuttle body 9778 may be positioned such that a seal interface 9784 of the shuttle body 9778 prevents flow from the reservoir exit pathway 9544 to the flow channel 9558 in the second portion of the cassette assembly 9500. In an exemplary embodiment, the seal interface 9784 seals against a wall of the occluder channel 9582 midway between the entry point of the reservoir exit pathway 9544 and the fluid channel 9558 into the occluder channel 9582. As shown, the two seal interfaces 9784 provide redundant seals in an exemplary embodiment, which isolate the fluid pre-filled in the reservoir 9536 from the second portion of the cassette assembly 9500.

[0205] When a user prepares the cassette assembly 9500 for use, the user may press on the diaphragm 9780 to displace the shuttle body 9778 to the flow-permitting state. Pressing may be accomplished manually (e.g., via a thumb or other finger) or via a tool, such as a priming and / or filling aid. An example of such an aid is described in “Apparatus, System and No. 10,080,704 to Lanigan et al., entitled "Method for Fluid Delivery," Attorney Docket No. M62, which is incorporated herein by reference in its entirety. Alternatively, the reusable housing assembly 106 may include an actuator that can be powered to displace the shuttle body 9778. In some embodiments, the reusable housing assembly 106 may include a feature (e.g., a beveled protrusion) that depresses the shuttle body 9778 as the reusable housing assembly 106 is coupled to (e.g., swept through) the cassette assembly 9500. When in the flow permitting state, the shuttle body 9778 may be positioned such that the seal interface 9784 is within the well 9776 to place the reservoir outlet pathway 9544 in communication with the fluid channel 9558 leading from the well 9776.

[0206] As best shown in FIG. 46, the shuttle body 9778 includes an enlarged central region 9790 in addition to the enlarged end regions 9587. The enlarged central region 9790 may include a recess 9792 that extends into an axle portion 9794 of the shuttle body 9778. The recess 9792 may provide a flow path for fluid to flow through the enlarged central region 9790. The enlarged central region 9790 may be sized to be captured against a step 9796 (see, e.g., FIG. 45 ), contained within the occluder channel 9782. Thus, the enlarged central region 9790 may help to hold the shuttle body 9778 in an occluded state during storage. Because the shuttle body 9778 may be made from a compressible material, sufficient pressure on the diaphragm 9780 may allow the enlarged central region 9790 to deform and overcome the step 9796 during actuation to the flow permitting state. The enlarged central region 9790 may also fill space within the occluder channel 9782, which may help limit dead space within the occluder assembly 9714.

[0207] 45, in some embodiments, the diaphragm 9780 and the shuttle body 9778 may be unitary with one another. When the shuttle body 9778 is moved to the flow-permitting state, the diaphragm 9780 may be advanced toward the well 9776. Thus, when the shuttle body 9778 is displaced, the amount of open volume above the shuttle body 9778 may be reduced. This may help maximize usage of the fluid preloaded into the reservoir 9536 because dead volume in the occluder assembly 9514 may be minimized.

[0208] While the exemplary embodiment is depicted with a seal plate 9774, it is also contemplated that a similar occluder assembly 9714 in the cassette assembly 9500 could be included that uses a film sheet seal 9512 instead of the seal plate 9774. In such an embodiment, the film sheet seal 9512 would close the bottom end of the occluder channel 9782. The thickness of the cassette base portion 9502 could be increased in area of ​​the occluder channel 9782 such that the length of the occluder channel 9782 could remain approximately the same. In addition, the width of the occluder channel 9782 adjacent the film sheet seal 9512 could be increased to a size that provides a gap around the seal interface 9784 of the shuttle body 9778. This could allow fluid communication to be established between the reservoir outflow flow path 9544 and the second portion of the cassette assembly 9500 when the shuttle body 9778 is placed in a flow-permitting state.

[0209] 47, as discussed above, the fill port 9524 may include one or more features that may prevent reuse of the cassette assembly 9500 or limit access to the fill port 9524 by an improper fill instrument 9584. This may be accomplished through the use of various wedging features incorporated into the fill port 9524, the fill instrument 9584, and / or other components of the cassette assembly 9500. The fill instrument 9584 may include portions that mate with the fill port 9524, features of the cassette base portion 9502, the top cover 9506, or combinations thereof, once filling of the reservoir 9536 is performed. An interface portion 9588 of the fill instrument 9584 may, for example, engage into or mate around the fill port 9524. The sharps 9586 of the filling instrument 9584 may be unable to establish fluid communication with the interior volume of the reservoir 9536 (e.g., may be too short) unless an interface portion 9588 of the filling instrument 9584 is properly mated with the fill port 9524 and / or other portions of the cassette assembly 9500. If the interface portion 9588 of the filling instrument 9584 is not configured to mate with the fill port 9524 and / or other portions of the cassette 9500, a user may be prevented from filling the reservoir 9536.

[0210] By limiting the loading tool 9584 that may be used with the cassette assembly 9500, several potential advantages may be possible. For example, a user may be prevented from using a loading tool 9584 with an excessively long sharp 9586. This may reduce any chance that the tip of the sharp 9586 may come into contact with the reservoir film 9516 and cause damage. In addition, the loading tool 9584 may ensure that it contains an appropriate volume of fluid for the particular cassette assembly 9500 that is being loaded with fluid. For example, a user may be prevented from using a syringe that holds more than the maximum volume of the reservoir 9536 and is capable of overfilling the cassette assembly 9500. The loading tool 9584 may also be designed to be specific to a particular drug type or a particular concentration of a drug. Using insulin as an example, the drug may be available for injection in U100 and U200 concentrations. The cassette assembly 9500 and loading fixture 9584 may be constructed to be specific to each concentration, so that loading of an improper concentration into the cassette assembly 9500 may be prevented.

[0211] In the example shown in FIG. 47, the filling device 9584 is depicted as a syringe. It should be understood that any of a wide variety of filling devices 9584 may alternatively be used. For example, a pen delivery device, a pump, a syringe, a gravity feed system, a pressurized ampule or vial, or the like may be used. In some examples, an intervening adapter between the filling device 9584 and the cassette assembly 9500 may also be used. As shown, the filling device 9584 includes a round interface portion 9588, which is not intended for use with the cassette assembly 9500 depicted in FIG. 47. The filling port 9524 of the cassette assembly 9500 includes a polygonal (in the example, rectangular, although any suitable shape is contemplated) bore 9590. At least one dimension of the polygonal bore 9590 may be sized to prevent the interface portion 9588 of the filling device 9584 from properly engaging the filling port 9524. Thus, an improper filling instrument 9584 may be prevented from gaining access to the reservoir 9536. However, a filling instrument 9584 having a rectangular interface portion 9588 may be able to fit within the polygonal bore 9590 and access the interior volume of the reservoir 9536.

[0212] In other embodiments, the interface portion 9588 may also be polygonal in cross-section, but sized to fit only within a particular type of cassette assembly 9500. For example, the interface portion 9588 may have a triangular or star-shaped cross-section, which is incompatible with the polygonal bore 9590 shown. However, the polygonal interface portion 9588 may cooperatively engage with the fill port 9584 of a different cassette assembly type 9500, perhaps intended for use with different drug concentrations. In some embodiments, the bore in the fill port 9524 may be round, while still having at least one dimension (e.g., diameter, minor axis, or other axis of symmetry, etc.) that prevents interfacing with an inappropriate fill fixture 9584. In general, the bore of the fill port 9524 may be a negative version of the interface portion 9588 of a suitable fill fixture 9584, creating a lock-and-key arrangement. Cooperating round, polygonal, oval, or any other cooperating geometric shapes may be used to impart the fill port 9524 and fill fixture 9584 interface portion 9588 pair.

[0213] When different types of cassette assemblies 9500 are used, the cassette assemblies 9500 may include other differentiating features that may help a user quickly determine the type of cassette assembly 9500 they are looking for. In some embodiments, a first type of cassette assembly 9500 may be clear, translucent, or light colored (e.g., white), while a second type of cassette assembly 9500 may be opaque or dark (e.g., black).

[0214] 48, in another embodiment, access to the interior volume of the reservoir 9536 may be restricted by a cooperating arrangement of protrusions 9592 and receptacles 9594 included on the fill port 9536, the fill fixture 9584, and / or another portion of the cassette assembly 9500 (such as the cassette base portion 9502 or the cassette top portion 9506). The fill fixture 9584 may include at least one protrusion 9592, a receptacle 9594, or some combination of both. The cassette assembly 9500 may include cooperating protrusions 9592 and / or receptacles 9594 that may mate with those on the fill fixture 9584 if an appropriate fill fixture 9584 is used. An inappropriate fill fixture 9584 may not include an arrangement of protrusions 9592 and / or receptacles 9594 that are capable of properly interfacing with those on the cassette assembly 9500. The protrusions 9592 may extend in a direction that is generally parallel to the axis of the sharp 9586. Any cross-sectional shape protrusion 9592 may be used. In some embodiments, the cross-sectional shape of the protrusion 9592 may change or taper as the distance from its attachment point to the loading device 9584 increases. For example, a rounded nub may be used in one example. The receptacle 9594 may be formed as a negative of its respective protrusion 9592.

[0215] As shown in FIG. 48 , the fill port 9524 is depicted and includes a receptacle 9594. Although a fill port 9524 is shown, the receptacle 9594 may be included on any suitable portion of the cassette assembly 9500. In other embodiments, the receptacle 9594 may be included on the cassette base portion 9502 or the cassette top portion 9506. The fill port 9524 shown in FIG. 48 is intended to engage with a fill fixture 9584 having a single protrusion 9592 that is sized to fit within the receptacle 9594. An interface portion 9588 of an unsuitable fill fixture 9584 is shown in FIG. 48. The exemplary interface portion 9588 includes two protrusions 9592. 48 with the example interface portion 9588, shown in FIG. 48, the protrusion 9592 will not fit within the receptacle 9594 of the fill port 9524. As a result, the user will not be able to access the reservoir 9536 in the cassette assembly 9500.

[0216] In some embodiments, it may be desirable for the cassette assembly 9500 to include at least one protrusion 9592. By including a protrusion 9592 on the cassette assembly 9500, an improper filling instrument 9584 may be held away from the cassette assembly 9500 if a user attempts to introduce an incorrect filling instrument 9584. As a result, the sharps 9586 of the improper filling instrument 9584 may not be able to extend into communication with the interior volume of the reservoir 9536.

[0217] 49-50, in an embodiment, the filling instrument 9584 may include a removable member or assembly 9596. The removable member 9596 may be held in place on the filling instrument 9584 by a frangible type connection, a friction fit, or any other suitable connection. When the interface portion 9588 of the filling instrument 9584 is mated with the cassette assembly 9500, the removable member 9596 may be disassociated with the filling instrument 9584 and left behind when the filling instrument 9584 is removed. The removable member 9596 may be retained by the cassette assembly 9500 such that its removal is difficult. While retained by the cassette assembly 9500, the removable member 9596 may present a mechanical interference to a subsequent filling instrument 9584 attached thereto. Because the space within the cassette assembly 9500 for the removable member 9596 included on the subsequent loading device 9584 is already occupied, the subsequent loading device 9584 may not be able to mate with the cassette assembly 9500. Thus, the removable member 9596 may prevent reuse of the cassette assembly 9500.

[0218] In certain examples, the removable member 9596 may be a sleeve-type member that surrounds the sharp 9586 of the loading instrument 9584. Such a removable member 9596 may fit within and plug the fill port 9524 of the cassette assembly 9500 when the loading instrument 9584 is mated with and removed from the cassette assembly 9500. A small orifice may still be present within the fill port 9524 when the removable member 9596 is retained therein. This may make access through the fill port 9524 difficult and may require very precise aiming by the user. Depending on the embodiment, the fill port 9524 may include a barb 9598. The barb 9598 may fit within a recess 9600 included on the removable member 9596 when the loading instrument 9584 is mated with the cassette assembly 9500. The recesses 9600 may be present around the entire circumference of the removable member 9596 to allow the filling instrument 9584 to be displaced into the fill port 9524 in any rotational orientation. In other embodiments, the recesses 9600 may be present on only a portion of the radial surface of the removable member 9596 to require a specific rotational orientation or range of orientations to access the reservoir 9536. By using barbs 9598 that are coupled into the recesses 9600, the removable member 9596 may be retained within the fill port 9524. The sleeve-type removable member 9596 may be allowed to advance only a predefined distance into the fill port 9524 before bottoming out. As a result, the removable member 9596 may also act as an insertion depth limiter.

[0219] In some embodiments, the bore 9602 of the removable member 9596 may decrease in cross-sectional area, close, or be blocked when the loading instrument 9584 and the removable member 9596 are separated. For example, the bore 9602 may include a compliant material that is compressed when the sharp 9586 is present therein. The compliant material may return to its resting state when the loading instrument 9584 is disassociated from the removable member 9596. This may close the bore 9602 and prevent further access to the reservoir 9536. Alternatively, the removable member 9596 may include a cantilevered arm that is biased toward the bore 9602. During manufacturing, the cantilevered arm may be displaced to allow the sharp 9586 to be extended through the bore 9602. When the removable member 9596 and the filling instrument are separated, the cantilevered arms may be biased into the bore 9602 to block the bore 9602 from further access. In some embodiments, the bore 9602 may include a protrusion that, when the removable member 9596 is retained within the bore 9602, may bias against such arms and prevent them from moving out of the obstructing position.

[0220] In certain examples, the removable member 9596, such as a sleeve as in the embodiments described above, may include geometric features similar to those described in connection with FIG. 47. Thus, the removable member 9596 may help to ensure only the use of the intended cassette assembly 9500 with the filling instrument 9584 on which it is contained. The removable member 9596 may also include geometric features that may be captured on a restrictor member present in an improper cassette assembly 9500. When the geometric feature is captured by the restrictor, the sharp 9586 may be prevented from displacing further along the fill port 9524. This may prevent a user from gaining access to the cassette assembly 9500 if an improper filling instrument 9584 is employed.

[0221] 51-54, in some embodiments, the interface portion 9588 of the fill instrument 9584 may be twisted as it is introduced into mating arrangement with the fill port 9524 or other portions of the cassette assembly 9500. The fill instrument 9584 may not be able to fully mate for loading of the reservoir 9536 into the cassette assembly 9500 unless such twisting occurs. When the fill port 9524 cooperates with the interface portion 9588 of the fill instrument 9584, the fill port 9524 may resist twisting during mating if an improper fill instrument 9584 is presented.

[0222] In an embodiment, the fill fixture 9584 and the fill port 9524 may include cooperating track features that may define a particular displacement path during mating. For example, the fill fixture 9584 may include a protrusion or slot on its interface portion 9588 that cooperates with a channel recessed into the wall of the fill port 9524 bore 9568 or a rail extending radially inward from the wall of the fill port 9524 bore 9586. When multiple types of cassette assemblies 9500 are used (e.g., U100 type and U200 type), the track features present in each cassette assembly 9500 type may be different. A dedicated fill fixture 9584 for use with each cassette assembly 9500 type may be used and may not be able to be displaced along the displacement path of an inappropriate cassette assembly 9500.

[0223] As shown in FIG. 51, the fill port 9524 and the interface portion 9588 are depicted. The fill port 9524 and the interface portion 9588 shown in FIG. 51 are intended for use with one another. The fill tool 9584 interface portion 9588 includes several protrusions 9604. The bore 9568 of the fill port 9524 may include several channels 9606A-C. The spacing, size, number, location, etc. of the channels 9606A-C may be selected to cooperate with a particular interface portion 9588 design while preventing other interface portions 9588 from operably coupling with the cassette assembly 9500. As shown, the protrusions 9604 of the interface portion 9588 shown in FIG. 51 may enter the channels 9606A first when the interface portion 9588 is first introduced into the fill port 9606A. The protrusions 9604 may be displaced along the channel 9606A from their initial entry point to a stop abutment position where one of the protrusions 9604 may collide with a wall forming an end of the first channel 9606A. At the stop abutment position, further translational displacement of the interface portion 9588 may be prevented, but the protrusions 9604 may align with the twisted channel 9606B. The interface portion 9588 may be twisted from the stop abutment position to a final channel entry position where the protrusions 9604 enter the final channel 9606C. In an exemplary embodiment, the rotational displacement required to enter into the final channel 9606C is about 180°. The amount of rotational displacement may be different in alternative embodiments. Once the protrusion 9604 reaches the final channel entry position, the interface portion 9588 may continue to be translated into a loading position in which the sharp 9866 (not shown in FIG. 51) communicates with the reservoir 9536 .

[0224] 52, the fill port 9524 of FIG. 51 is shown with an improper interface portion 9588 of the fill instrument 9584. The protrusion 9604 of the interface portion 9588 may be unable to align with or pass through at least one of the channels 9606A-C defined in the bore 9568. In an embodiment, the twist channel 9606B would be unable to align with the protrusion 9604 of the interface portion 9588 in FIG. 52. As a result, a sharp 9586 (not shown) contained on the interface portion 9588 would be prevented from accessing the interior volume of the reservoir 9536.

[0225] 53, the interface portion 9588 of FIG. 52 is shown with its cooperating fill port 9524. As shown in FIG. 53, when the interface portion 9588 is introduced and the protrusion 9604 reaches a stop abutment position in the first channel 9606A, the protrusion 9604 may align with the twist channel 9606B contained within the bore 9568. The protrusion on the interface portion 9588 may be rotated into a final channel entry position and the interface portion 9588 may be further introduced into the fill port 9524 to reach a loading position.

[0226] 54, the interface portion 9588 of FIG. 51 is depicted along with the fill port 9524 of FIG. 53. As in FIG. 52, the depicted components are not intended for use in conjunction with one another. At least one of the protrusions 9604 of the interface portion 9588 may not be able to align with the twist channel 9606B. As a result, a user would not be able to gain access to the interior volume of the reservoir 9536 using the interface portion 9588.

[0227] 55, in some embodiments, a door 9608 may be included within the fill port 9524. The door 9608 may be held in place by one or more catches 9610. The door 9608 may include a latch protrusion 9612 for each catch 9610. When the latch protrusions are engaged with the catches 9610, the door 9608 may be held in place and block access to the interior volume of the reservoir 9536. When a fill instrument 9584 is introduced into the fill port 9524, an interface portion 9588 of the fill instrument 9584 may disengage the catch 9610 from the latch protrusion 9612 on the door 9608. In the example shown in FIG. 55, the fill instrument 9584 includes a blunt cannula 9614 instead of a sharp 9586. Once the catch 9610 is disengaged, the blunt cannula 9614 can press against the door 9608, unhinging the door 9608 out of the blocked orientation and allowing access to the interior volume of the reservoir 9536 for filling. Once the filling instrument 9584 is removed, the door 9608 can be biased back to its closed configuration via the biasing member 9616.

[0228] If multiple types of cassette assemblies 9500 are used, the fill port 9524 in each may be different. This may allow each type of cassette assembly 9500 to be accessible only through the fill fixture 9584 intended for that cassette assembly 9500. The diameter (or another dimension) of the interface portion 9588 of each fill fixture 9584 may be selected such that the interface portion 9588 can only actuate the door 9608 in the cassette assembly 9500 for which it is intended. For example, a fill fixture 9584 inappropriate for the fill port 9524 depicted in FIG. 55 may have a diameter that is smaller than the shortest distance between the two catches 9610. As a result, it would be impossible to actuate the catch 9610 and unlatch the door 9608. The diameter of the fill port 9524 for another cassette assembly 9500 may be too small to accept the interface portion 9588 shown in FIG. 55. As a result, the interface portion 9588, shown in FIG. 55, would not be able to attach to the door 9608 contained therein.

[0229] 56, in another embodiment, the fill port 9524 may include a stopcock assembly 9618. The stopcock assembly 9618 may be provided to prevent reuse of the cassette assembly 9500. As shown, the stopcock assembly 9618 may include a barb 9620, which may engage with a notch 9622 included in an arm 9624 on the interface portion 9588 when the fill instrument 9584 is introduced into the fill port 9524. A tab 9626 may be included to prevent rotation of the valve rotor 9628 of the stopcock assembly 9618 as the fill instrument 9584 is inserted into the fill port 9524. The tab 9626 may engage a recess in the valve rotor 9628 to prevent this rotation. After loading of the reservoir 9536 is complete, the user may remove the fill instrument 9584. As the filling instrument 9584 is removed, the notches 9522 may impart a force against the return 9620, which causes rotation of the valve rotor 9628. As the valve rotor 9628 rotates, the flow path 9630 through the valve rotor 9628 may be displaced to a position where the flow path to the interior volume of the reservoir 9536 is broken. The pawls 9626 engage another recess in the valve rotor 9528, preventing the valve rotor 9628 from re-establishing the flow path to the interior volume of the reservoir 9536.

[0230] 57, in another embodiment, a stopcock assembly 9618 may be included in the cassette assembly 9500 to limit access to the interior volume of the reservoir 9536. In such an embodiment, the valve rotor 9628 may include a pinion portion 9632. The interface portion 9588 of the fill instrument 9584 may include a rack member 9634, which may engage with the pinion portion 9632 of the stopcock assembly 9618. During introduction of the interface portion 9588 of the fill instrument 9584, the valve rotor 9628 may be rotated from the blocking orientation to the access allowing orientation. After the reservoir 9536 is loaded, removal of the fill instrument 9584 may rotate the valve rotor 9628 back to the blocking orientation. If an improper fill instrument 9584 is utilized by the user, the valve rotor 9628 will not be rotated and the flow path to the interior volume of the reservoir 9536 may remain blocked. As a result, the rack 9634 and pinion 9632 arrangement may limit access to the reservoir 9536 when an improper filling instrument 9584 is employed.

[0231] 58-60, in certain embodiments, the fill port 9524 may include a disk 9636 that is rotatable about a pivot 9640 and is disposed at least partially within a bore 9568 of the fill port 9524. The disk 9636 may prevent reuse of the cassette assembly 9500. The disk 9636 may include an opening 9638 that may align with a channel that leads to an interior volume of the reservoir 9536. In some embodiments, the disk 9636 may be rotatably held in place by a catch 9642 that may engage with a notch 9644 included in the disk 9636. The disk 9636 may also include a protrusion 9646. In some embodiments, a portion of the biasing member 9648 may apply a biasing force against the protrusion 9646 when the opening 9638 is aligned with the channel. The catch 9642 may prevent the disk 9636 from rotating under the force of the biasing member 9648. When the interface portion 9588 of the filling instrument 9584 is introduced into the filling port 9524, the interface portion 9588 may push the disk 9636, which may be translated into the bore 9568 of the filling port 9524. This may disengage the notch 9644 from the fastener 9642. A blunt cannula 9614 or sharp 9586 may be present in the opening 9638 to hold the disk 9636 in its rotational orientation against the force of the biasing member 9648 while the reservoir 9536 is loaded with fluid. Once the filling instrument 9584 is removed, the biasing force applied by the biasing member 9648 against the protrusion 9646 may rotate the disk 9636 to an orientation in which the opening 9638 is out of alignment with the channel to the reservoir 9536. Further attempts to fill reservoir 9536 may be blocked by the walls of disc 9636 and the user may be prevented from reusing cassette assembly 9500.

[0232] In some embodiments, now referring to FIGS. 61-62, the fill port 9524 may include a needleless connector assembly 9650. The needleless connector assembly 9650 may eliminate the use of a needle (and any risk of an inadvertent needle stick) when filling the cassette assembly 9500. Such an arrangement may also prevent a user from establishing a flow path through the fill port 9524 to the internal volume of the reservoir 9536 if they attempt to access the reservoir 9536 with a general-purpose syringe or needle. Thus, the needleless connector assembly 9650 may also act as a needle-use prevention arrangement. Any of a variety of needleless connector assemblies 9650 may be used. For example, a positive, negative, or neutral displacement needleless connector assembly 9650 may be used. A split septum type needleless connector assembly may be used. A needleless connector assembly 9650 having an internal valve other than a split septum may also be used. The internal valve may be, for example, a fluid pressure actuated or mechanical valve with a moving component. The needleless connector assembly 9650 may seal the fill port 9524 when not in use and may be opened once a fill instrument 9584 is introduced or coupled to the fill port 9524. In some embodiments, the needleless connector assembly 9650 may be luer actuated and open once a luer connection between the fill instrument 9584 and the fill port 9524 is established.

[0233] If different types of cassette assemblies 9500 may be used, the needleless connector assembly 9650 included on each type may be configured to work only with the appropriate filling instrument 9584. An inappropriate filling instrument 9584 may not open or be unable to engage with the incorrect needleless connector assembly 9650. Using insulin as an example, there may be a needleless connector assembly 9650 specific to U100 insulin and a different needleless connector assembly 9650 specific to U200 insulin. A U100 filling instrument 9584 or cassette assembly 9500 may be inoperable with a respective U200 cassette assembly 9500 or filling instrument 9584. This may be accomplished through size differences, geometric differences, or otherwise ensured by the design of the needleless connector assembly 9650.

[0234] In the exemplary embodiment (see FIGS. 61-62), the needleless connector assembly 9650 includes an internal blunt cannula 9652, which includes an opening 9654. A portion of the internal blunt cannula 9652 may be surrounded by a displaceable closure member 9656. A biasing member 9658 may be included to bias the closure member 9656 toward a closed position in which a seal is formed around the opening 9654 in the blunt cannula 9652. Upon connection to an appropriate loading instrument 9584, the closure member 9656 may be urged away from a closed state and to an access allowing state. As shown, the cassette assembly 9500 and the loading instrument 9584 include cooperating coupler fittings 9660, 9662. Luer fittings or barbed fittings may be used, for example. When the fill instrument 9584 coupler fitting 9660 is threaded into engagement with the cassette assembly 9500 coupler fitting 9662, the outlet port 9664 of the fill instrument 9584 may actuate the displaceable closure member 9656 to an access allowing state. A portion of the blunt cannula 9652 may sealingly engage the outlet port 9664 of the fill instrument 9584 and fluid may be delivered into the interior volume of the reservoir 9536. In response to disengagement of the fill instrument 9584 and the fill port 9524, the closure member 9656 may be biased by the biasing member 9658 to return to the closed state.

[0235] 63, in some embodiments, a "smart" filling tool 9584 and cassette assembly 9500 may be used. One of the filling tool 9584 and cassette assembly 9500 may include a radio frequency identification tag 9666 (e.g., RFID, NFC, UHF, HF, etc.) and the other may include an interrogator 9668. Typically, as shown, the tag 9666 may be included within the cassette assembly 9500. The tag 9666 used may be a passive tag, which does not include an on-board power source. In other embodiments, an active tag 9666 is also possible. The tag 9666 may be encoded with information identifying the type of cassette assembly 9500 (e.g., U100 or U200, using insulin as an example), the size of the reservoir 9536, the refill interval, etc.

[0236] As noted above, the filling instrument 9584 may include an interrogator 9668. The interrogator 9668 may check a tag 9666 included as part of the cassette assembly 9500. A controller 9670 included within the filling instrument 9584 may verify that the tag 9666 indicates that the cassette assembly 9500 is suitable for use with the filling instrument 9584. If the tag 9666 is for a cassette assembly 9500 that is not intended for use with that filling instrument 9584, the controller 9670 may not command fluid to be dispensed from the filling instrument 9584. Alternatively, the filling instrument 9584 may be communicatively linked to another component of the delivery system 10 (e.g., the reusable housing assembly 106) and may receive data therefrom related to the therapy to be administered. If the therapy program defines a cassette assembly 9500 type that does not match the tag 9666, the controller 9670 may prevent any fluid from being output by the filling instrument 9584.

[0237] In embodiments where the cassette assembly 9500 is not intended for reuse, the controller 9670 may check to determine if the tag 9666 belongs to a cassette assembly 9500 that has been previously used. For example, the controller 9670 may query a memory (not shown) of the fill instrument 9584 to determine if the unique identifier encoded in the tag 9666 matches any identifier previously scanned by the interrogator 9668. If an attempt is made to reuse the cassette assembly 9500, the fill instrument 9584 may not allow the dispensing of fluid. In other embodiments, a remote database (e.g., a cloud server) may be communicatively linked to the fill instrument 9584. The fill instrument 9584 may perform an anti-reuse check by determining if the unique identifier on the cassette assembly 9500 is listed in the database as having been previously used. In embodiments where reuse is permitted, the fill instrument 9584 may check the error history associated with the unique identifier of the cassette assembly 9500. If previous use of the cassette assembly 9500 is associated with an error or pattern of errors (e.g., a detected leak, occlusion, repeated occlusion, or discontinuance of therapy following such types of errors), the filling instrument 9584 may prevent the loading of fluid into the reservoir 9536 of the cassette assembly 9500. If the controller 9670 determines that an acceptable cassette assembly 9500 is presented, the controller 9670 may command or allow fluid to be filled into the reservoir 9536.

[0238] In the exemplary embodiment, the filling instrument 9584 is depicted with a pump 9672. Any type of pump 9672 may be used. The filling instrument 9584 may command, via the pump 9672, to dispense a defined volume of fluid into the reservoir 9536. The defined volume of fluid may be encoded in the tag 9666, or alternatively, may be a pre-set volume appropriate for the cassette assembly 9500 being used. The volume dispensed into the reservoir 9536 may be communicated by the filling instrument 9584 to other components of the delivery system 10. For example, the filling instrument 9584 may communicate the volume to be filled into the reservoir 9536 to the reusable housing assembly 106. This volume may then be used to determine the volume remaining in the reservoir 9536 as a therapy is performed by the drug delivery system 10.

[0239] In alternative embodiments, the tag 9666 may be replaced by indicia (printed indicia, barcode, QR code, data matrix, vocode, digimark, etc.). The filling fixture 9584 may include a reader (e.g., camera, barcode scanner, etc.) which may read the indicia. The controller 9670 may use data from the indicia as described above to help ensure that fluid in the filling fixture 9584 is dispensed only into the appropriate cassette assembly 9500. Additionally, in some embodiments, the interrogator 9668 or reader may not be included within the filling fixture 9584. Instead, the interrogator 9668 or reader may be included within another component of the delivery system 10, such as the reusable housing assembly 106 or a communicatively linked device 124, such as a smartphone.

[0240] 64, 65, various views of an exemplary disposable cassette assembly 8500 are depicted. The cassette assembly is releasably engageable with the reusable housing 106. The cassette assembly 8500 includes a cassette base portion 8502. The base cassette base portion 8502 may include a reservoir recess 8508, which may be integrally formed therein. The cassette base portion 8502 of a pre-filled cassette assembly 8500 may be formed from a long-term drug compatible material, such as, for example, a cyclic olefin polymer (COP) such as Zeonor® 1020R. If the cassette assembly 8500 is user-filled, the cassette base portion 8502 may be made from a cyclic olefin copolymer (COC) such as Topas® or a polyester such as Tritan®. The reservoir recess 8508 may be covered by a reservoir film piece 8516, which is bonded to the base cassette base portion 8502. Together, the reservoir recess 8508 and the reservoir film 8516 may define a reservoir 8536 for holding a fluid (such as various drugs) within its interior volume. In an embodiment, the fluid may be a drug for an endocrine disorder. For example, the fluid may be a diabetes management drug, such as insulin. A short or fast acting insulin (e.g., regular human insulin, such as Aspart, Lispro, Glulisine, Velosulin, Novolin-R, or Humulin R) may be used, for example, but longer acting insulin (e.g., detemir, glargine, degludec, Toujeo) may also be used. Cardiovascular drugs may also be used. For example, vasodilators or antihypertensive agents, such as treprostinil, may be used. The fluid may also include analgesics, chemotherapy drugs, enzymes, pegylated proteins, small molecules, natural products, peptides, proteins, nucleic acids, carbohydrates, nanoparticulate suspensions, and associated pharma- ceutical acceptable carrier molecules.

[0241] The reservoir film 8516 may be affixed to the cassette base portion 8502 via adhesive, ultrasonic welding, heat sealing, etc., to create a fluid-tight seal between the cassette base portion 8502 and the reservoir film 8516. Alternatively, the reservoir film 8516 and the cassette base portion 8502 may be compressed and sandwiched together by the cassette top portion 8506 of the disposable cassette assembly 8500 when the cassette top portion 8506 is coupled into the cassette assembly 8500. In some examples, as described further herein, the reservoir film 8516 may be affixed to the cassette base portion 8502 and the cassette top portion 8506, and the cassette top portion 8506 may be coupled in place within the cassette assembly 8500 by welding at least a portion of the cassette top portion 8506 onto the reservoir film 8516. The cassette top portion 8506 may be made from the same material as the cassette base portion 8502 for improved welding together. The reservoir film 8516 may be constructed from several layers of material, which may be selected to add various desirable features to the reservoir film 8516. If applicable, a tie layer may be used as well. In some embodiments, a drug compatibility layer, e.g., a long-term drug compatibility material, such as a cyclic olefin polymer (COP) such as Zeonor® 1020R, may form an interior volume facing the surface of the reservoir film 8516. A barrier layer, impermeable to gas or specific gases, may be included outwardly of the compatibility layer. The middle or tie layer may be ethylene vinyl alcohol (EVOH). The outer layer may be polychlorotrifluoroethylene ethylene (PCTFE), such as AClar®. If a layered film is used, the reservoir film 8516 may be a coextruded product. In alternative embodiments, the reservoir film 9516 may be constructed from nitrile, silicone, or chlorobutyl rubber.

[0242] In an exemplary embodiment, the reservoir film 8516 may include a preformed region 8536 (best shown in FIG. 65). The preformed region 8534 may be vacuum or thermoformed. In an exemplary embodiment, the preformed region 8534 is shown as a recess. The recess may be bowl-shaped and may mimic the shape of the reservoir recess 8508 contained within the cassette base portion 8502 of the disposable cassette assembly 8500. When the reservoir film 8516 is coupled to the disposable cassette assembly 8500, the preformed region 8534 may seat within the reservoir recess 8508 such that the reservoir film 8516 abuts the bottom surface of the reservoir recess 8508 and seats against the recess wall 8510. This may ensure that a minimum air volume is present within the reservoir 8536 prior to filling the reservoir 8536 (see, e.g., FIG. 19). In the exemplary embodiment, the reservoir recess 8508 includes a series of indentations 8567 molded into the reservoir bottom. The indentations 8567 extend into the reservoir cavity and may keep the reservoir film 8515 from completely adhering to the bottom and sides of the reservoir recess 8508, thereby creating channels and allowing fluid to flow therebetween and allowing the reservoir to empty more completely.

[0243] A fill port 8524 may also be included in the cassette base portion 8502. In an exemplary embodiment, the fill port 8542 extends through a side wall of the cassette base portion 8502. The fill port 8524 may extend directly to the reservoir 8536 (see, e.g., FIG. 70) and may be sealed with a plug 8525 (see FIGS. 66-67). The plug 8525 can be made from a material compatible with long-term drug storage. The area of ​​the plug 8525 exposed to the drug is small, therefore the plug can be formed from halogenated butyl rubber, bromobutyl, or chlorobutyl.

[0244] The reservoir film 8516 may include a peripheral edge region 8538. The peripheral edge region 8538 may be coupled to the cassette base portion 8502 at a mounting surface 8540 of the cassette base portion 8502, which may surround the reservoir recess 8508. In some embodiments, an exposure 8542 may be included in the peripheral edge region 8538. The cassette top portion 8506 is welded onto the reservoir film 8516.

[0245] The cassette assembly 8500 has a cassette shell 8200 attached to a cassette base portion 8502. The cassette shell 8200 forms a base for contact with the user. The cassette shell 8200 may be made from an extruded material, such as plastic, that is compatible with contact with the user's skin. The cassette shell 8200 can be made from an acrylonitrile butadiene styrene (ABS), such as Lustran® 348. The use of the cassette shell 8200 allows the cassette base portion 8502 and the cassette top portion 8506 to be made from a material that is long-term drug compatible, while the cassette shell 8200 can be made from a material that is resistant to sweat, body oils, lotions, and other materials that may be present on the human body. The cassette shell 8200 has a bottom portion 8202 and a circumferential shell wall 8204. The cassette shell 8200 may define a series of standoffs 8206 around the inside of the cassette shell to position the cassette base portion 8502 and the cassette top portion 8506 away from the shell bottom 8202 and shell walls 8204. The cassette shell walls 8204 may define cutouts 8208 for extension of luers or tubing 184 from the cassette base portion 8502. Tabs 8210 may extend from the inside of the shell walls 8204 for snap-fit ​​engagement with slots 8503 defined in the cassette base portion 8502 (see FIGS. 68, 69). The cassette shell 8200 is sufficiently resiliently deformable to allow the tabs 8210 to fit within the slots 8503, thereby securing the cassette shell 8200 to the cassette base portion 8502. Additionally, the cassette shell 8200 may define a reservoir plug stop 8212 to aid in securing the reservoir plug 8525 within the reservoir opening 8524. The reservoir plug stop 8212 is positioned adjacent to or in contact with the reservoir plug opening 8524 when the cassette shell 8200 is secured to the cassette base portion 8502 (see FIG. 71 ).In a further embodiment, the reservoir plug stop 8212 may define a plug cover extension 8214 that extends into the reservoir fill bore 8568 and contacts the reservoir plug 8525 (see FIG. 72A). The reservoir plug stop 8212 provides an additional means for securing the reservoir plug in place for transport of the pre-filled cassette assembly 8500 from a fill location to an end user. In another embodiment (see FIG. 72B), which may be intended for refilling or user filling, the cassette shell 8200 defines a reservoir plug opening 8213 opposite the reservoir plug opening 8524. The reservoir plug opening is blocked by a septum 8527, which permits the use of a sharp 9586 of a fill instrument 9584 to puncture the septum 8527 and fill the reservoir 8536.

[0246] The cassette assembly 8500 further includes a valve membrane 9520 and a volume sensor diaphragm assembly 9526 as described above with respect to the cassette assembly 9500. Referring to FIGS. 73-86, the occluder assembly 8714 has an occluder diaphragm 8724 and a bung or occluder actuator 8726. The occluder diaphragm 8724 can be made from a material compatible with long-term drug storage. The area of ​​the occluder diaphragm 8724 exposed to the drug is small, and therefore the diaphragm can be formed from halogenated butyl rubber, bromobutyl, or chlorobutyl. The cassette base portion 8502 defines an inlet fluid passageway 8728 from the reservoir 118 to the occluder chamber 8731. The cassette base portion 8502 further defines a second outlet fluid passageway 8742 from the occluder chamber 8731 to the inlet valve assembly 614. The occluder fluid inlet opening 8729 is surrounded by a pair of annular sealing ridges 8730. A circumferential and closed occluder chamber wall 8732 formed by the cassette base portion 8502 surrounds the occluder chamber 8731 and has an upper surface for sealing with the occluder diaphragm 8724. The occluder diaphragm 8724 is captured between the cassette base portion 8502 and the cassette top portion 8506. The cassette top portion defines an annular occluder actuator opening 8734 for receiving the occluder actuator 8726. With particular reference to FIGS. 75 and 76 , the occluder diaphragm 8724 has an upper surface with an occluder diaphragm extension 8736 for contact with the occluder actuator 8726. When the occluder diaphragm 8724 is captured between the cassette base portion 8502 and the cassette top portion 8506, the occluder diaphragm extension 8736 is aligned with the occluder actuator opening 8734. A bottom surface of the occluder diaphragm 8724 has an outer wall seal surface 8738 for sealing with a top surface of the occluder chamber wall 8732. The thickness of the occluder diaphragm 8724 is sufficient such that the wall seal surface 8738 forms a fluid tight seal for the occluder chamber 8731 with the occluder chamber wall 8732 when the occluder diaphragm 8724 is captured between the cassette base portion 8502 and the cassette top portion 8506.The bottom of the obturator diaphragm 8724 defines an inner inlet opening sealing surface 8740 for sealing with the sealing ridges 8730. The obturator diaphragm 8724 may further have a pair of positioning ridges 8739 for positioning the obturator diaphragm over the obturator chamber 8731 during the assembly process of the top cassette portion 8506 and the cassette bottom portion 8502.

[0247] A plug or occluder actuator 8726 (see FIGS. 73, 74) is radially formed from a resiliently deformable material and has an occluder actuator head portion 8744, an occluder actuator upper reduced diameter portion 8746, an occluder actuator lower reduced diameter portion 8748, and a lower occluder actuator catch portion 8750. When the occluder assembly 8714 is in a closed position, occluding fluid flow, the occluder actuator 8726 is positioned within the occluder actuator opening 8734. The catch portion 8750 contacts the occluder diaphragm extension 8736 and deforms the occluder diaphragm such that the inlet opening sealing surface is brought into contact with the sealing ridge 8730 forming a flow-tight seal, thereby fluidly isolating the reservoir from the downstream fluid passageway within the cassette assembly 8500 (see FIGS. 79 and 84). The use of multiple annular permanent rings for the seal ridge 8730 provides multiple seals to improve sealing during transport of the cassette assembly 8500. The occluder actuator catch portion 8750 has a diameter that is sufficiently larger than the occluder actuator opening 8734 whereby the occluder actuator 8726 may be deformed and inserted through the occluder actuator opening 8734, but also large enough that the force of the deformable occluder diaphragm 8724 wanting to return to its resting state is insufficient to drive the occluder actuator from the occluder actuator opening 8734. The catch portion 8750 may further be shaped with a flat annular surface perpendicular to the axis of the occluder actuator 8726 to improve contact with a peripheral area of ​​the occluder actuator opening 8734. The occluder actuator lower reduced diameter portion is generally of a similar or smaller diameter than the occluder actuator opening 8734.

[0248] The occluder actuator upper reduced diameter portion 8746 defines a reduced diameter area having a diameter less than the diameter of the head portion 8744. A tether 8760 may be secured to the upper reduced diameter portion, looped around the circumference of the upper reduced diameter portion 8746, or otherwise secured. The tether 8760 is a flexible filament. The tether 8760 is used to retract and remove the occluder actuator 8726 from the occluder actuator opening 8734. Upon removal of the occluder actuator 8726, the occluder diaphragm 8724 returns to an undeformed state, thereby releasing the seal with the seal ridge 8730 and placing the occluder assembly 8714 in an open state, whereby fluid may enter from the reservoir into other fluid passageways of the cassette assembly 8500 (see FIGS. 82 and 86 ). The occluder actuator head portion 8726 may additionally be of sufficient size to interfere with engagement of the cassette assembly 8500 and the reusable housing 106 when the occluder actuator 7826 is within the occluder actuator opening 8734. This interference can be used to prevent an end user from inadvertently attempting to use the drug delivery system 10 without first removing the occluder actuator 7826, thereby enabling the reservoir to provide fluid to the drug delivery system 10 for injection into the user.

[0249] The cassette assembly 8500 may be pre-filled and shipped to a user in a cassette package 8800 (see FIG. 97). The cassette package 8800 defines a cassette package opening 8802 to receive and securely hold the cassette assembly 8500. A first end of the tether 8760 is secured to the occluder actuator 8726 and a second end of the tether 8760 is secured to a tether anchor 8804 on the cassette package 8800. In use, an end user removes the cassette assembly 8500 from the cassette package 8800. Removal tensions the tether 8760 and pulls the occluder actuator 7826 from the occluder actuator opening 8734, moving the occluder assembly 8714 from a closed state to an open state. The cassette assembly is then engaged to the reusable housing 106 and the auto-priming function is initiated and other necessary steps may be taken to initiate drug delivery to the user.

[0250] It should be noted that the various access restriction and re-use prevention arrangements described herein are not mutually exclusive of each other. One or more of the concepts presented herein may be used together in a single embodiment. Access may be controlled and re-use may be prevented by any desired combination of the above.

[0251] Various alternatives and modifications may be devised by those skilled in the art without departing from the present disclosure. Therefore, the present disclosure is intended to encompass all such alternatives, modifications, and differences. In addition, although some embodiments of the present disclosure are shown in the drawings and / or discussed herein, the present disclosure is not intended to be limited thereto, and the present disclosure is intended to be read as broadly as the art will permit, as well as the present specification. Therefore, the above description should not be interpreted as limiting, but merely as exemplification of specific embodiments. Also, those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto. Other elements, steps, methods, and techniques that are substantially different from those described above and / or in the appended claims are also intended to be within the scope of the present disclosure.

[0252] The embodiments shown in the drawings are presented only to demonstrate certain examples of the present disclosure. Also, the drawings described are illustrative only and not limiting. In the drawings, the size of some of the elements may be exaggerated and not drawn to a particular scale for illustrative purposes. In addition, elements shown together in the drawings having the same number may be the same elements or similar elements, depending on the context.

[0253] When the term "comprising" is used in the present description and claims, it does not exclude other elements or steps. When referring to a singular noun, where an indefinite or definite article is used, e.g., "a", "an", or "the", this also includes the plural of that noun, unless some description specifically states otherwise. Thus, the term "comprising" should not be construed as being limited to the items listed thereafter, i.e., it does not exclude other elements or steps, and thus the scope of the expression "a device comprising items A and B" should not be limited to a device consisting of components A and B only.

[0254] Moreover, the terms "first," "second," "third," and the like, whether used in the description or claims, are provided only to distinguish between similar elements and not necessarily to describe a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances (unless expressly disclosed otherwise) and that the embodiments of the disclosure described herein are capable of operating in sequences and / or arrangements other than those described or illustrated herein.

Claims

[Claim 1] The invention described in this specification.

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