Patent Application
20240238509
Field of Disclosure: This disclosure relates to fluid infusion. More specifically, this disclosure relates to fluid infusion device assemblies.
Many potentially valuable medicines or compounds, including biologicals, are not orally active due to poor absorption, hepatic metabolism or other pharmacokinetic factors. Additionally, some therapeutic compounds, although they can be orally absorbed, are sometimes required to be administered so often it is difficult for a patient to maintain the desired schedule. In these cases, parenteral delivery is often employed or could be employed. Other medicines can be administered by routes other than parenteral, but the bioavailability of the drug varies from an ideal amount over time.
Effective parenteral routes of drug delivery, as well as other fluids and compounds, such as subcutaneous injection, intramuscular injection, and intravenous (IV) administration include puncture of 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 needed drugs/compounds over a period of time.
To this end, there have been efforts to design portable devices for the controlled release of therapeutics. Such devices are known to have a reservoir such as a cartridge, syringe, or bag, and to be electronically controlled. These devices suffer from a number of drawbacks including the malfunction rate. Reducing the size, weight and cost of these devices is also an ongoing challenge.
In accordance with 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 an attachment surface. The attachment surface may include a reservoir outlet flow path recessed therein. The cassette assembly may further comprise a reservoir film coupled to the attachment surface that, together with the reservoir recess, may define a flexible reservoir. A portion of the reservoir film may have a preformed shape which mimics the contour of the reservoir recess. The preform shape may cause the reservoir film to be disposed adjacent the surface of reservoir recess when the reservoir is in an empty state. The cassette assembly 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.
In some embodiments, the reservoir film may comprise an outcrop region included in the reservoir film. The outcrop region may form a seal over the reservoir outlet flow path when the reservoir film is coupled to the attachment surface. In some embodiments, the reservoir film may include at least two layers. In some embodiments, the reservoir film may be heat bonded to the attachment surface. In some embodiments, the cassette base portion may include a side wall having a fill port leading to an interior volume of the reservoir. In some embodiments, a basin may be recessed into the reservoir recess directly downstream of an inlet leading to the interior volume of the reservoir from the fill port. In some embodiments, at least one of the at least one duct may extend into communication with the basin. In some embodiments, the at least one duct may include a plurality of ducts which converge together at a confluence. The confluence may be disposed intermediate the reservoir outlet flow path and the ducts. In some embodiments, the at least one duct may include a first duct and a second duct which furcates off of the first duct. In some embodiments, the reservoir recess may include a wall which extends from a bottom surface of the reservoir recess to the attachment surface and the at least one duct includes a duct which is disposed along a portion of a perimeter of the bottom surface adjacent the wall. In some embodiments, the duct disposed along a portion of the perimeter may be disposed along a majority of the perimeter. In some embodiments, the at least one duct may have a variable width. In some embodiments, the reservoir recess may include a wall which extends from a bottom surface of the reservoir recess to the attachment 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 a first width to a second width smaller than the first width. In some embodiments, the first portion of the at least one duct may be the second width. In some embodiments, the at least one duct may include a plurality of ducts which extend from a confluence region at regular angular intervals. The confluence 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 mesh.
In accordance with 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 an attachment surface. The cassette base portion may further include a weld 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 attachment 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 weld surface and a portion of the reservoir film bonded to the attachment surface when the locating pins are disposed within the locating pin receptacles. The energy director may be welded to the weld surface and the portion of the reservoir film.
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 the portion of the reservoir film. In some embodiments, the energy director may be ultrasonically welded to the weld surface and the portion of the reservoir film. In some embodiments, the reservoir film may include at least two layers. In some embodiments, the cassette top portion may include a bay including a number of retention 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 retention tabs of the bay. The reservoir cover may be coupled to the cassette top portion when the latch clips cooperatively engage the retention tabs.
In accordance with another embodiment of the present disclosure a cassette assembly for a 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 segment of reservoir film coupled to an attachment surface disposed around the recess. The cassette assembly may further comprise a cassette top portion covering the cassette base portion and including an inspection bay which is disposed over the entirety of the reservoir. The inspection bay may include a number of coupling elements. The cassette assembly may further comprise a reservoir cover including a number of cooperative coupling elements configured to engage with the coupling elements of the inspection bay to couple the reservoir cover in place within the inspection bay. The reservoir may be directly accessible through the inspection bay prior to installation of the reservoir cover.
In some embodiments, the cassette base portion may be constructed of a transparent material. In some embodiments, the cassette base portion may be constructed of a clear material. The material may be sufficiently translucent to allow for inspection by machine or other mechanisms during the filling process. In some embodiments, the cassette base portion may be constructed of a light colored material. In some embodiments, the reservoir cover may be a solid piece of material. In some embodiments, the coupling elements may be retention tabs and the cooperative coupling elements may be latch clips. In some embodiments, one of the latch clips may be disposed at an unsupported end of a cantilevered member of the reservoir cover. In some embodiments, the coupling elements and cooperative coupling elements may be configured to engage via a snap fit. In some embodiments, the reservoir may be a prefilled reservoir containing a 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 at a section of the flow path. The occluder assembly may be actuatable between an occluding state and a flow permitting state.
In accordance with yet another embodiment of the present disclosure a prefilled cassette assembly for a drug delivery device may comprise a cassette base portion. The cassette may further comprise a reservoir defined by a recess in the cassette base portion and a piece of reservoir film attached to based portion at an attachment surface surrounding the recess. The reservoir may be filled with a medicament. The cassette may further comprise 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 segment of the flow path. The cassette assembly may further include an occluder assembly actuatable between a flow permitting state and an occluding 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. The segment 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 of material having long term compatibility with the medicament and at least the membrane cover is constructed of material having short term compatibility with the medicament.
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 so as to form a fluid tight seal. In some embodiments, the second portion of the flow path may include at least one pumping chamber. In some embodiments, the membrane cover may be coupled in placed over the valve station so as 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 comprise a threaded port and in the occluding 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 comprise a threaded port configured to receive the occlude actuator and the occluder assembly may be configured to transition from the occluding state to the flow permitting state by extracting the occlude actuator from the threaded port. In some embodiments, the occlude actuator may be configured to prevent mating of the cassette assembly with a reusable housing assembly when present in the cassette assembly. In some embodiments, at least a portion of the occluder diaphragm may be constructed of material having long term compatibility with the medicament. In some embodiments, the occluder assembly may be constructed of material having long term compatibility with the medicament. In some embodiments, at least a portion of the occluder assembly may be constructed of material having long term compatibility with the medicament. In some embodiments, the medicament may be a drug for an endocrine disorder. In some embodiments the medicant may be treprostinil. In some embodiments, the medicament may be selected from a group consisting of insulin and an insulin analog. In some embodiments, the medicament may be proteinaceous. In some embodiments, the medicament may include a polypeptide having a tertiary structure with at least one hydrophobic region.
In accordance with an embodiment of the present disclosure a prefilled cassette assembly for a drug delivery device may comprise a housing. The cassette assembly may further comprise a reservoir containing a medicament. The cassette assembly may further comprise a flow path extending from the reservoir to an outlet of the cassette assembly. The flow path may include a number of valve stations and a pumping chamber. The cassette assembly may further comprise 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 occluding state in which the occluder actuator may be in a first position in the threaded port and presses the occlude diaphragm into sealing engagement with an occluder seat to occlude the flow path. The occluder assembly may have a flow permitting state in which the occlude actuator may be unthreaded out of the threaded port from the first position to at least a second position to relieve pressure against the occluder diaphragm.
In some embodiments, the reservoir may be defined by a recess in the cassette base portion and a piece of reservoir film attached to based portion at an attachment surface surrounding the recess. In some embodiments, the occluder assembly may gate flow from a reservoir outlet flow path to a remainder of the flow path including the pumping chamber and the valve stations. In some embodiments, the occluder diaphragm may be captured between a cassette base portion and a cassette top portion of the housing. In some embodiments, the occluder assembly may be included in a depression or occluder seat in a face of the cassette base portion and the occluder diaphragm may create a fluidic seal about a periphery of the depression so as to form a sealed occluder volume. In some embodiments, the depression may include an occluder outlet. In some embodiments, the occluder outlet may be partially surrounded by a wall. The wall may extend from the depression 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 pumping chamber and valve stations, with the exception of the occluder assembly, may be covered by a valve membrane cover. In some embodiments, the housing may include a cassette base portion and a cassette top portion and the valve membrane cover may include an outcrop region which forms a seal over at least one flow channel recessed into a face of the cassette base portion when the cassette base portion and cassette top portion are coupled to one another. In some embodiments, the occluder actuator may include a knob and a rod projection from the rod. In some embodiments, the rod may include a number of ramp features disposed at a terminal end of the rod opposite the knob. The ramp features may have a pitch selected to cooperate with threading in the threaded port. In some embodiments, the ramp features may be disposed at even angular increments. In some embodiments, the threading in the threaded port includes a shelf section. The ramp features of the occlude actuator may be parked on the shelf feature when the occluder actuator is in the first position.
In accordance with another embodiment of the present disclosure, a cassette assembly for a drug delivery device may comprise a cassette base portion including a side wall and a peripheral recess adjacent the side wall. The cassette assembly may further comprise a cassette top portion coupled to the cassette base portion. The cassette assembly may further comprise a coupling comprised of a number of tabs projecting from the cassette top portion overhanging the peripheral recess and a number of rotation stops included on the cassette base portion and projecting into the recess. The rotation stops and tabs may cooperate to form a number of mating tracks. The cassette assembly may further comprise a collapsible reservoir. The cassette assembly may further comprise a fill port extending from the side wall to the reservoir disposed in between two of the mating tracks. Upon introduction and rotation of a mating finger on a reusable housing assembly of the delivery device in each mating track, the cassette assembly may be configured to couple with the reusable housing assembly.
In some embodiments, the tabs may include a detent region. In some embodiments, the tabs may include a ramped 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 tabs may include a ramped section. The sealing ring may be configured to be compressed by the reusable housing assembly when the coupling fingers of the reusable housing assembly are rotated along the ramped section of the tabs 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 guard wall adjacent the reservoir. In some embodiments, the guard wall may include an inlet which places a bore of the fill port into fluid communication with an interior volume of the reservoir. In some embodiments, the rotation stops may be disposed perpendicularly to the tabs. In some embodiments, the collapsible reservoir may comprise a reservoir recess in the cassette base portion and a piece of reservoir film sealing attached to the cassette base portion at an attachment surface surround the reservoir recess. In some embodiments, the reservoir recess may include a recessed basin directly downstream of the fill port.
In accordance with an embodiment of the present disclosure a cassette assembly for a drug delivery device may comprise a cassette base portion. The cassette assembly may further comprise a reservoir formed by a reservoir recess in the cassette base portion and a piece of reservoir film attached to the cassette base portion at an attachment surface surrounding the reservoir recess. The cassette assembly may further comprise a valve membrane cover. The cassette assembly may further comprise a channel film seal. The cassette assembly may further comprise 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 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 face of the cassette base portion. The valve membrane cover may form a seal around the number of valve stations and the at least one pump chamber. The channel film seal may seal the 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 membrane cover and the reservoir film.
In some embodiments, the reservoir film and channel film seal may be constructed of the same material. In some embodiments, the reservoir film may be a multilayer film. In some embodiments, the reservoir film may be heat bonded to the second face of the cassette assembly. In some embodiments, the reservoir film may be heat bonded to the attachment surface. In some embodiments, the at least one channel in the first face of the cassette base portion may include an air trap. In some embodiments, the at least one channel recessed into the first face of the cassette base portion may include a reservoir outlet channel recessed into the attachment surface. The reservoir film may form a seal over the reservoir outlet channel.
In some embodiments, the at least one channel recessed into the first face of the cassette base portion may include a channel which may be sealed over by an outcrop region included in the valve membrane cover. In some embodiments, the flow path may further include an occluder assembly. In some embodiments, the reservoir may be prefilled by a manufacturer. In some embodiments, the at least one channel recessed into the second face of the cassette base portion as well as the channel film seal may be surrounded by a raised rim wall. In some embodiments, the cassette assembly may further comprise a cassette top portion coupled to the cassette base portion. The valve membrane cover may be compressed between the cassette base portion and cassette top portion to form a fluid tight seal. In some embodiments, the cassette assembly may further comprise a cassette top portion coupled to the cassette base portion by a sonic weld. At least a portion of the sonic weld may be formed between the cassette top portion and the reservoir film.
In accordance with another embodiment of the present disclosure, a method of filling a reservoir for a cassette assembly of a drug delivery device may comprise 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 comprise loading fluid into the reservoir through a fill port. The method may further comprise imaging the reservoir. The method may further comprise determining whether the reservoir meets acceptability criteria by analyzing at least one image of the reservoir. The method may further comprise installing a reservoir cover in an inspection bay which provides visual access to the reservoir.
In some embodiments, imaging the reservoir may comprise photographing the reservoir through the inspection bay. In some embodiments, determining whether the reservoir meets acceptability criteria may comprise analyzing the at least one image to determine if particulates are present. In some embodiments, determining whether the reservoir meets acceptability criteria may comprise analyzing the at least one image to determine if an amount of air greater than a predefined threshold is present. In some embodiments, actuating the occluder assembly may comprise installing a removable occluder actuator in a port of the cassette assembly. In some embodiments, actuating the occluder assembly may comprise displacing an occluder diaphragm against a reservoir outlet valve to close off flow through the reservoir outlet valve. In some embodiments, installing the reservoir cover in the inspection bay may comprise coupling the reservoir cover to the cassette assembly via snap fit.
In accordance with another embodiment of the present disclosure, a cassette assembly for a drug delivery device may comprise a cassette base portion. The cassette assembly may further comprise a cassette top portion coupled to the cassette base portion. The cassette assembly may further comprise a collapsible reservoir. The cassette assembly may further comprise an outlet. The cassette assembly may further comprise a flow path extending from the collapsible reservoir to the outlet. The cassette assembly may further comprise 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 restriction configuration and a reuse prevention configuration.
In accordance with another embodiment of the present disclosure a cassette assembly for a drug delivery device may comprise a cassette base portion. The cassette assembly may further comprise a reservoir defined by a reservoir recess in the cassette base portion and a reservoir film attached to the cassette base portion at an attachment surface surrounding the reservoir recess. The reservoir may be filled with a medicament. The cassette assembly may further comprise 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 segment of the flow path. The cassette assembly may further comprise an occluder assembly configured for actuation between a flow permitting state and an occluding 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. The segment of the flow path may define at least in part by the membrane cover being part of the second portion of the flow path.
In some embodiments, the first portion of the flow path may be constructed of material having long term compatibility with the medicament and at least the membrane cover may be constructed of material having short term compatibility with the medicament. 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 so as to form a fluid tight seal. In some embodiments, the second portion of the flow path may include at least one pumping chamber. In some embodiments, the membrane cover may be coupled in placed over the valve station so as 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 comprise a threaded port and in the occluding 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 the occluder actuator and the occluder assembly may be configured to transition from the occluding state to the flow permitting state by extracting the occluder actuator from the threaded port. In some embodiments, the occluder actuator may be configured to prevent mating of the cassette assembly with a reusable housing assembly when present in the cassette assembly. In some embodiments, at least a portion of the occluder diaphragm may be constructed of material having long term compatibility with the medicament. In some embodiments, the occluder assembly may include an occlude actuator which is removable from the cassette assembly. The occluder assembly may be in a flow permitting 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 configured to transition from the occluding state to the flow permitting state upon 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 the occluding state to the flow permitting state upon translational displacement of the occluder actuator. In some embodiments, the occluder assembly may include an occluder shuttle disposed in an occluder channel. In some embodiments, the occlude shuttle may comprise at least one sealing interface which generates a fluidic seal against the wall of the occluder channel. In some embodiments, in the occluding state the at least one sealing interface may be disposed intermediate an opening of the first portion of the flow path to the occluder channel and an opening of the 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 a compressible elastomer. In some embodiments, the occluder shuttle may be compressible and may include an enlarged segment. The occluder channel may include a step between a wide section and narrow section. The enlarged segment of the occluder shuttle may be wider than the narrow section in an uncompressed state. In some embodiments, the occluder assembly may be constructed of material having long term compatibility with the medicament. In some embodiments, at least a portion of the occluder assembly may be constructed of material having long term compatibility with the medicament. In some embodiments, the medicament may be a drug for an endocrine disorder. In some embodiments, the medicament may be selected from a group consisting of insulin and an insulin analog. In some embodiments the medicant may be treprostinil. In some embodiments, the medicament may be proteinaceous. In some embodiments, the medicament may include a polypeptide having a tertiary structure with at least one hydrophobic region. In some embodiments, the occluder assembly may include an occluder bung and a tapered port. The occluder bung may be retained in the tapered port via an interference fit. In some embodiments, the occluder assembly may include an occluder diaphragm. The occluder bung may compress and seal the occluder diaphragm against a reservoir outlet opening when retained in the tapered port. In some embodiments, the occluder bung may be constructed of compressible elastomer.
In accordance with another embodiment of the present disclosure, a cassette assembly for a drug delivery device may comprise a cassette base portion. The cassette assembly may further comprise a cassette top portion coupled to the cassette base portion. The cassette assembly may further compromise a cassette shell. The cassette shell may be made of a material compatible with contact with a user's skin and resistant to body oils, sweat, and lotions that may be applied to a user's skin. The cassette shell may cover substantially the bottom and sides of the coupled cassette top portion and cassette bottom portion, leaving the top open for attachment to the reusable housing assembly. The cassette shell may attach to the coupled cassette base portion and cassette top portion with a snap fit arrangement of tabs and slots. The cassette assembly may further comprise a collapsible reservoir defined by a recess in the cassette base portion and covered with a reservoir film. The cassette assembly may further comprise an outlet. The cassette assembly may further comprise a flow path extending from the collapsible reservoir to the outlet. The reservoir may have a fill port extending from the side of the cassette base portion. The reservoir may be filled with medicant and the fill port may be closed with a reservoir plug. The cassette shell can cover the fill port and further comprise a shell projection that helps hold the reservoir plug in position during transport and use of the cassette assembly.
In accordance with another embodiment of the present disclosure, a drug delivery system may comprise a dispensing assembly comprising a reusable housing assembly and a cassette assembly having a reservoir prefilled with a fluid medicant. The dispensing assembly further comprises a pump assembly and a controller of the pump for pumping the medicant from the reservoir through a fluid path to an outlet for final infusion to a user. The method of use is to couple the cassette assembly to the reusable housing assembly, initiate an automatic prime function whereby the controller initiates a series of steps of operating the pump assembly and associated valve assemblies to prime the pump assembly and fluid path. In a further embodiment the dispensing assembly may include a volume sensor that is also primed by the automatic prime function. In a yet further embodiment, the cassette assembly may comprise an occluder assembly for isolating the reservoir from the fluid path until use, and the method further includes actuating the occluder from a closed state to an open state prior to initiating the automatic prime function. In a yet further embodiment, the cassette assembly is packaged for transport in a package body. The occluder assembly further comprises 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 package body by an occluder tether. The removal of the cassette assembly from the package body tensions 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 to the reusable housing assembly.
In accordance with another embodiment of the present disclosure, a drug delivery system may comprise a dispensing assembly comprising a reusable housing assembly and a cassette assembly having a reservoir prefilled with a fluid medicant. The dispensing assembly further comprises a pump assembly and a controller of the pump for pumping the medicant from the reservoir through a fluid path to an outlet for final infusion to a user. The method of use is to couple the cassette assembly to the reusable housing assembly, initiate an automatic prime function whereby the controller initiates a series of steps of operating the pump assembly and associated valve assemblies to prime the pump assembly and fluid 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 a volume sensor assembly, and thereby the outlet valve assembly can also be a volume sensor valve assembly. The outlet valve assembly in order to allow the automatic prime function is biased to a closed position. Fluid pressure created by the pump assembly in the fluid channel greater than a set amount will open the outlet valve assembly and allow fluid to flow downstream to the volume sensor assembly. During the automatic prime function, the outlet valve assembly may be opened by a valve drive assembly to allow for automatic priming even when fluid pressure is below the set amount.
In accordance with another embodiment of the present disclosure, the cassette assembly of a dispensing system may be pre-filled and shipped to the end user. The cassette assembly includes an occluder assembly for isolating the prefilled reservoir from the pump portion of the cassette assembly. The occluder assembly includes a bung biasing the occluder assembly to the occlude state. The cassette assembly is shipped in a package for holding the cassette assembly, and further a tether connects the package to the occluder bung. Removing the cassette assembly from the package tensions the tether whereby the occluder bung is pulled from the occluder assembly and the occluder assembly transitions to the non-occluded state. The cassette assembly may then be coupled to a reusable housing assembly, and an automatic priming function initiated to prime the pump of the cassette assembly to prepare the dispensing system for infusion of fluid to the end user.
In accordance with another embodiment of the present disclosure, a bi-modal valve having a first mode the bi-modal is biased to a closed state and opens to allow fluid passage when fluid pressure on one side of the valve exceeds a predetermined threshold pressure. In a second mode of operation the bi-modal valve can be opened to allow fluid flow below the threshold pressure. The bi-modal 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 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 wherein the valve face seals against the valve face. The valve lift slot and valve lift pin are configured so the slideably engages the slot where by the valve actuator can fully seat the valve face in the valve seat. In a first mode of operation, when fluid pressure on the inlet side of the valve overcomes the biasing force of the valve spring, the valve opens permitting fluid flow until the pressure is insufficient to maintain the valve in the open position and the valve closes. The opening of the valve moves the valve lift stop away from the valve lift pin. In the second mode, the valve lift pin is moved whereby the valve lift pin engages a valve lift stop at an end of the valve lift slot, overcomes the bias of the valve spring and opens the valve. Returning the valve lift pin to the 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 drive arm rotated on a pivot by a shape memory actuator.
In accordance with another embodiment of the disclosure, a dual valve assembly is actuated by a common drive assembly having a first valve being bi-modal and a second valve having at least a single mode. The first valve having a first mode wherein the bi-modal is biased to a closed state and opens to allow fluid passage when 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 below the threshold pressure. The second valve can be opened and closed by the drive assembly independent of the first valve when the first valve in the first mode. When the first valve in the second mode, the second valve is also opened by the drive assembly. The first and second valve each have; a valve actuator defining a valve face and a valve slot with the valve slot having a lift slot stop at one end thereof, a valve seat for receiving the valve face to close the vale, and a valve spring to bias the valve to the close 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 drive may have a bell crank shaped lift moved by a shape memory actuator, the lift pins and lift slots arranged so that when the valve drive is in the first position, the first and second valve are closed, and whereby the first valve is in the first mode and can open when fluid pressure exceeds a threshold. In a second position, the valve drive engages the lift pin of the second valve against a valve lift stop of the second valve to open the second valve, and whereby the first valve continues to operate in the first mode whereby fluid pressure above the threshold opens the first valve. The drive mechanism having 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 the engagement of the lift pin of the first valve against the lift slot stop of the first valve.
These and other aspects will become more apparent from the following detailed description of the various embodiments of the present disclosure with reference to the drawings wherein:
Referring to
The various components described in relation to
Referring now to
A 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 also to
Referring also to
Referring now to
The measurement valve actuator 610A defines a hollow generally cylindrical cavity 610D to contain the measurement valve spring assembly 610C. The measurement valve spring assembly 610C expands between the bottom of the cavity 610D and the measurement valve spring anchor 610G to hold the measurement valve assembly 610 in a default closed position wherein a measurement valve face 610F of the measurement valve actuator 610A is urged against the measurement valve seat 610B to use the membrane 124 as a valve seal. In normal operation of the pump assembly for infusion of fluids from the dispensing assembly 100, the measurement valve spring assembly is calibrated that the fluid pressure in the volume sensor chamber 620 will be insufficient to overcome the spring force of the measurement valve spring assembly 610C. Measurement valve assembly 610 is opened by energizing the shape memory actuator 632 which then shortens in length, thereby applying a force to the bell crank assembly 638 through the bell crank drive connector 704, to rotate the bell crank body on the bell crank pivot pins 706. Rotation of the bell crank body 700 lifts the bell crank lift arm 708. The measurement valve actuator 610A defines a measurement valve lift slot 610G generally parallel to the measurement valve spring assembly 610C and the direction of the motion of the measurement valve actuator 610A in operation. The measurement valve lift pin 710 of the bell crank assembly 638 slideably engages in 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 at the end of the measurement valve lift slot 610G. Lifting the bell crank lift arm 708 engages the measurement valve lift pin 710 against the measurement valve lift stop 610G thereby causing the measurement valve actuator 610A to move away from the measurement valve seat 610C and permitting fluid flow. (See
In the auto-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, the opening advantageous in order to purge air from the dispensing assembly 100 and to ensure the fluid channel is fully primed for infusion of fluid to the user. With particular reference to
The bell crank assembly 638 may have two modes, a normal pump operation mode that operates only the measurement valve assembly 610, and an auto-prime mode where the bell crank assembly operates both the measurement valve assembly 610 and the volume sensor valve assembly 612. In normal pump operation mode, the bell crank assembly 638 is pivoted to a first position by the shape memory actuator 632 whereby the measurement valve lift pin 710 engages the measurement valve lift stop 610H to lift the measurement valve actuator 610A before the volume valve lift pin 712 engages the volume valve lift stop 612H (See
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 may 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 (reflective, laser interferometer, camera, etc.), linear caliper, magnetic, mechanical contact switch, infrared might measurement, etc. However, in the exemplary embodiment, due to the small structure of the dispensing assembly 100 it is desirable to use a small component so as to utilize a small space with the sensing component(s). Sensing distance may also be a consideration in various embodiments. For example, where the displacement of the one or more components, e.g., the pump actuator 105A, measurement valve actuator 610A and volume valve actuator 612A, it may be very small (for example, in the exemplary embodiment, a full displacement of the pump actuator 105A may be about 1 mm and a full displacement of the measurement valve actuator 610A may be about 0.2 mm). A small reflective optical sensor assembly (hereinafter “optical sensor”) that fits into the exemplary embodiments of the reusable housing assembly 106, as shown and described, for example, herein, may be used. In some embodiments, the at least one optical sensor is located in the reusable housing assembly 106. The optical sensor, in the various embodiments, has a sensing range that accommodates the components for which the optical sensor may be sensing, e.g., the displacements of the pump actuator 105A, measurement valve actuator 610A and volume valve actuator 612A. In the exemplary embodiment any optical sensor may be used, including, but not limited to a Sharp GP2S60, manufactured by Sharp Electronics Corporation which is a U.S. subsidiary of Sharp Corporation of Osaka, Japan. In these embodiments, this optical sensor contains an infra red emitting diode and infra red sensing detector in a single component package. Light from the emitter is unfocused and bounces off the sensing surface, some of which is reflected to the detector. With reference to
For auto-prime operation, it can be preferable for the pump actuator 105 to fully seat in the in the pump chamber 105B in order to remove all air from the pump chamber 105B. With reference to
Since the pump actuator 105A moves fluid by displacement, the position of the pump actuator 105A sensed by pump sensor 640 may be correlated with the amount/volume of fluid displaced/pumped and could be used by the controller 108 to determine the volume of fluid pumped. For the measurement valve actuator 610A, measurement sensor 644 is used by the controller 108 to measure if the measurement actuator 610A is in the open or closed position. For the volume valve actuator 612A, volume sensor 642 is used by the controller 108 to measure if the measurement valve actuator 612A is in the open or closed position. Further, the position of pump actuator 105A, can be used by the controller 108 in controlling the energy applied to the shape memory actuator 112. The position of measurement of the measurement valve actuator 610A and volume valve actuator can be used by the controller 108 to control the amount of energy applied to the shape memory actuator 632.
In normal pumping operation, the measurement valve sensor 644 is used by the controller 108 to control the energy applied to the shape memory actuator 632. During the auto-priming operation, the volume valve sensor 642 is used to ensure that the volume valve actuator 612A is lifting and opening the volume valve assembly 612. The volume valve assembly 612 and the measurement valve assembly 610 are mechanically linked by the drive assembly or bell crank assembly 638, and that energizing the shape memory actuator 632 will start lifting the volume valve actuator 612A at some point. However it may not be known at what point in the stroke of the measurement valve actuator 610A the volume valve actuator 612A will start moving due to mechanical tolerance. For example, the volume valve actuator 612A could start moving when the measurement valve actuator 610A has been lifted by 0.015″, or it could start moving when the measurement valve actuator 610A has been lifted by 0.025″, which is a relatively large tolerance given that the check valve actuator 612A may open by lifting 0.005″. Therefore, it may not be known the position of the volume valve actuator 612A using only the measurement valve sensor 644. Therefor 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.
The auto-prime operation may be initiated by the user via the remote device by starting an auto-prime function. In one embodiment, the used will remove the pre-filled cassette assembly 102 from packaging (See below with relation to cassette package 8800). The cassette assembly 102 (or cassette assemblies 8500, 9500) is then engaged to the reusable housing assembly 106. The reusable housing assembly is then turned on and is capable of receiving instructions from the remote device 122. The user then may initiate an auto-prime function to prime the dispensing assembly 100 whereby air is purged from the fluid pathways and medicant is fills the fluid pathways to ready the dispensing assembly 100 for use. During the auto-prime function, the measurement valve assembly 610 and volume sensor valve assembly 612 are opened by the bell crank assembly 638. The pump assembly 105 and inlet valve assembly 614 are moved by the shape memory actuator 112. The inlet valve assembly 614 is first closed, then the pump assembly is actuated a full stroke to completely evacuate air from the pump chamber 105B. The controller 108 measures the power consumption of the shape memory actuator 112 for the length of travel of the pump actuator 105A. (See
Referring now to
The reservoir film 9516 may be affixed to the cassette base portion 9502 via adhesive, ultrasonic welding, heat sealing, etc. to generate a fluid tight seal between the cassette base portion 9502 and the reservoir film 9516. Alternatively, the reservoir film 9516 and cassette base portion 9502 may be compressively pinched together by a 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, and as described further later in the specification, 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 in the cassette assembly 9500 by welding at least a portion of cassette top portion 9506 onto the reservoir film 9516. The cassette top portion 9506 may be made of the same material as the cassette base portion 9502 for improved welding together. The reservoir film 9516 may be constructed of a number of layers of materials which may be selected to add various desirable traits to the reservoir film 9516. Where applicable, tie layers may be used as well. In some embodiments, a drug compatible layer may form the interior volume facing surface of the reservoir film 9516, for example a long term drug compatible material such as a cyclic Olefin Polymer (COP), an example such as Zeonor® 1020R. A barrier layer which is impermeable to gas or specific gases may be included outward of the compatibility layer. The intermediate or tie layer may be an anethylene vinyl alcohol (EVOH). The outer layer may be polychlorotrifluoroethylene (PCTFE) such as Aclar®. Where layered film is used, the reservoir film 9516 may be a coextruded product. In alternative embodiments, the reservoir film 9516 may be constructed of nitrile, silicone, or chlorobuytl rubber.
In the example embodiment, the reservoir film 9516 may include a preform region 9536 (best shown in
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 an attachment surface 9540 of the cassette base portion 9502 which may surround the reservoir recess 9508. In some examples, an outcrop 9542 may be included in the peripheral rim region 9538. Where 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.
As shown, in certain examples, the attachment surface 9450 may include one or more features which are recessed therein. When coupled in place within the cassette assembly 9500, the reservoir film 9516 may form a seal over these features. In the example embodiment, a reservoir outlet path 9544 is recessed into the attachment surface 9540. An air trap housing 9546 disposed along the reservoir outlet path 9544 is also present and is shown as a recessed feature in the attachment surface 9540 in the example embodiment. The air trap housing 9546 may be a trench which is oriented at an angle with respect to a portion of the reservoir outlet path 9544. In the example embodiment, the air trap housing 9546 is substantially perpendicular to the reservoir outlet path 9544. In some embodiments, an air trap 9547 may be placed within the air trap housing 9546. The air trap 9547 may in some embodiments be a piece of mesh or screen 9549 placed in the air trap housing 9546 to help entrain air bubbles and prevent them from proceeding downstream. The outcrop 9542 of the reservoir film 9516 may seal over the reservoir outlet path 9544 and air trap 9547 within the air trap housing 9546 to form an enclosed and leak tight fluid pathway out of the reservoir 9536 (see, e.g.
A fill port 9524 may also be included in the cassette base portion 9502. In the example embodiment, the fill port 9542 extends through a side wall of the cassette base portion 9502. The fill port 9524 may extend directly to the reservoir 9536 (see, e.g.
In the example embodiment, the cassette assembly 9500 is arranged to mate with a reusable housing assembly 106 via a twist lock type engagement and includes part of a rotational coupling to facilitate this. Other types of coupling arrangements are possible in other embodiments. In the example embodiment, the cassette top portion 9506 of the cassette assembly 9500 includes a number of tabs 9548 (see, e.g.
During coupling, a coupling tab or finger of the reusable housing 106 may be passed through an opening 9551 between a stop surface 9550 and a tab 9548 and rotated under the tab 9548 along a twist path until reaching the appropriate stop surface 9550. The undersurface of each tab 9548 may include a ramped portion 9554 which may cause an environmental sealing ring 9556 (which may be formed of an overmolded elastomer) included on the cassette top portion 9506 to be compressed against the reusable housing assembly 106 (so as to form a fluid seal) during coupling together the cassette assembly 9500 and reusable housing assembly 106. Each tab 9548 may include a detent region 9552 into which the coupling tab on the reusable housing assembly 106 may seat once the stop surface 9550 has been reached. When in the detent region 9552, the coupling tab of the reusable housing 106 may resist rotation unless a downward force is applied during the twisting motion.
The fill port 9524 in the example embodiment is disposed in a non-traversed region outside of the twist path of any of the coupling tabs of the reusable housing assembly 106. The fill port 9524 may, for instance, be placed between a non-traversed region between two of the stop surfaces 9550. This may allow the fill port 9524 to be placed in a side wall of the cassette base portion 9502 while still allowing for a twist lock type engagement between a cassette assembly 9500 and reusable housing assembly 106.
The cassette assembly 9500 may further include a valve membrane cover 9520. The valve membrane cover 9520 (see, e.g.
A volume sensor diaphragm assembly 9526 (see, e.g.,
The flow pathways leading into and out of the valve features 9514, pumping recess 9532, and volume sensing chamber may extend to flow channels 9558 (best shown in
A film sheet seal 9512 may be coupled onto the cassette base portion 9502 over the flow channels 9558 so as to form a seal over 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 certain embodiments, the film sheet seal 9512 may be coupled to the cassette base portion 9502 via heat sealing. The film sheet seal 9512 may be constructed of the same material used to create the reservoir film 9516 and may be a flexible material. In the example embodiment, the flow channels 9558 are included within a well 9562 defined by a surrounding wall or rim 9560 included in the cassette base portion 9502. The rim 9560 may help protect the film sheet seal 9512 and may provide an alignment aid which may be used to locate the film sheet seal 9512 during manufacture of a cassette assembly 9500. In alternative embodiments, a rim 9560 may not be included and other alignment aids such as alignment pins or projections may be utilized.
In some embodiments, a cover (not shown) may be included and may couple in place above the film sheet seal 9512. This cover may couple in place via snap fit, interference fit, a welding process, adhesive, solvent bonding, etc. The cover may be constructed of a rigid or puncture resistant material and may serve as a protector for the film sheet seal 9512. Preferably, the cover may couple to the cassette base portion 9502 in a manner which makes the cover difficult to remove by a user. This cover may be coupled to the cassette base portion 9502 similarly to the manner in which cover 9692 described later in the specification (see, e.g.
In alternative embodiments, a film sheet seal 9512 may not be used. Instead, another suitable sealing wall such as a sealing plate 9774 (see, e.g.
Additionally, various embodiments may find it advantageous to include the flow channels 9558 in the cassette base portion 9502 as opposed to a plate 9774 (see, e.g.
Use of a film sheet seal 9512 may also allow for the flow channels 9558 to be made smaller or 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, where flow channels 9558 are included in a cassette base portion 9502 and sealed by a laser welded plate 9774, the layout of the flow channels 9558 may need to be planned so as to accommodate melting of the cassette base portion material 9502 during the laser weld. During welding, the laser may pass through the sealing plate 9774 and the laser's energy may be absorbed at the surface of the cassette base portion 9502. Thus, the heating which occurs may be predominantly in 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 obstruct the flow channels 9558. Attaching a film sheet seal 9512 via a heat sealing process, however, may minimize melting of cassette base portion 9502. Heating during in this process may be shifted away from the cassette base portion 9502 and instead may be applied from an external source through the film sheet seal 9512 material. Thus, the film sheet seal 9512 may be coupled to the cassette base portion 9502 with minimal melting of the cassette base portion 9502.
Referring now to
Referring now also to
In some embodiments, the fill port 9524 may be arranged such that the filling implement 9584 (see, e.g.,
In some embodiments, and as described later in the specification, the fill port 9524 may include one or more features which may restrict ability to access the interior volume of the reservoir 9536. For example, the fill port 9524 may include one or more feature which inhibits access to the interior volume for filling implements 9584 (see, e.g.,
In some embodiments or for particular applications, multiple cassette assembly 9500 types may be produced. In some embodiments, a drug for use with the 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. Filling implements 9584 containing U200 insulin may include a sharp 9586 which is of a length insufficient to pierce through the septum 9522 of a U100 cassette assembly 9500. This may prevent a user from accidentally filling the reservoir 9536 with a stronger concentration drug than intended.
Referring now to
The cross sectional area of the flow paths created by the recessed ducts 9566 may be constant or may change along at least a portion of the duct 9566. In the example embodiment, the recessed ducts 9566 increase in width as they extend up the recess wall 9510. The depth of the ducts 9566 may remain substantially the same. This may allow the cassette assembly 9502 to be easily moldable.
Referring now to
As shown in
By mitigating the chance for fluid to be isolated away from the reservoir outlet path 9544 as the reservoir 9536 is collapsed, the ducts 9566 may ensure that the reservoir 9536 can be more completely and consistently emptied. Since more of the fluid loaded into the reservoir 9536 may be utilized, the user, health systems, or insurers may experience a cost savings. Additionally, such a duct 9566 arrangement may increase the average therapy time a reservoir 9536 may support once filled. Another benefit may be an increase in the usefulness of a reservoir volume remaining determination made by a component of the delivery system 10. As the ducts 9566 may help to ensure that more of the fluid loaded into the reservoir 9536 can be used, the volume remaining determination may allow for more robust scheduling of therapeutic events executed by the drug delivery system 10 that are based on the volume remaining determination. This may be especially true when the reservoir 9536 is nearly empty.
As is also shown in
Referring now also to
Coupling the cassette top portion 9506 to the rest of the cassette assembly 9500 in this manner may allow of the cassette assembly 9500 to have a smaller footprint. It may also be advantageous as it may allow for the reservoir 9536 to be made with a greater maximum volume without increasing the footprint of the cassette assembly 9500. This may be particularly desirable where the cassette assembly 9500 is designed for use as part of an ambulatory infusion device such as an insulin pumping device. The size of such devices may be seen as a significant detractor for users as the user either wears or carries (e.g. in a pocket or on a belt clip) the device throughout the day. Users may want to cover or hide such a device so as to not draw attention to the device or have the device get in the way of quotidian activities. A smaller device or a device which holds more drug volume without taking up more space may thus be seen as especially attractive.
In certain embodiments, one or more additional energy director may be included within the footprint 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 welding recess 9678 which may accept the second energy director 9676. During welding, the sonic energy may cause the energy directors 9674, 9676 to melt along with material in the cassette base portion 9502 and reservoir film 9516. The materials may flow together and firmly couple the parts together. The second energy director 9676 and weld recess 9678 may be positioned adjacent, but radially inward of the valve membrane cover 9520. This may ensure that pressure is evenly applied against the valve membrane cover 9520 to compressibly seal the valve membrane cover 9520 against the cassette base portion 9502.
As shown, a number of locating pins 9680 and receptacles 9682 may also be included. In the example, the locating pins 9680 extend from the cassette base portion 9502 and may be received in locating receptacles 9682 of the cassette top portion 9506. This may facilitate proper alignment of the cassette top portion 9506 prior to welding of the cassette top portion 9506 to the rest of the cassette assembly 9500.
Referring now to
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 an attachment surface 9540 of the cassette base portion 9502 which may surround the reservoir recess 9508. An outcrop 9542 is also included in the shown peripheral rim region 9538. In the example embodiment, a reservoir outlet path 9544 is recessed into the attachment surface 9540. The outcrop 9542 of the reservoir film 9516 may seal over the reservoir outlet path 9544 to form an enclosed and leak tight fluid pathway out of the reservoir 9536.
A fill port 9524 may be included to provide fluid into the reservoir 9536. The fill port 9524 may extend directly to the interior volume of the reservoir 9536 through a side wall of the cassette base portion 9502. The fill port 9524 may be provided with a septum 9522. In some embodiments, the septum 9522 may be pierceable via a sharp 9586 (see, e.g.,
As described elsewhere herein, the fill port 9524, filling implement 9584, or a combination of the two may be configured to prevent reuse of the reservoir 9536 once a filling operation has been performed. Also as described elsewhere herein, the fill port 9524, filling implement 9584, or a combination of the two may also be configured to ensure access to the reservoir 9536 is restricted to only appropriate filling implements 9584. Other portions of a cassette assembly 9500 such as the cassette top portion 9506 and cassette base portion 9502 may include features for these purposes. The fill port 9524 in the example embodiment is disposed opposite the tubing 9518 extending from the cassette base portion 9502.
In the example embodiment, the cassette assembly 9500 is arranged to mate with a reusable housing assembly 106 via a twist lock type engagement (described elsewhere herein). The fill port 9524 in the example embodiment is disposed in a non-traversed region outside of the twist path of any of the coupling tabs of the reusable 106. The fill port 9524 may, for instance, be placed between a non-traversed region between two stop surfaces 9550. This may allow the fill port 9524 to be placed in a side wall of the cassette base portion 9502 while still allowing for a twist lock type engagement between a cassette assembly 9500 and reusable housing assembly 106.
The cassette assembly 9500 may further include a valve membrane cover 9520 including a number of regions which seat over a pumping chamber recess 9532 and valve features 9514 (such as those described above in
The cassette top portion 9506 of the cassette assembly 9500 may include a compliant member 9684 which may be attached thereto. In the example, the compliant member 9684 may be disposed along a perimeter of the 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 example ring 9686 is integral with the compliant member 9684 and attached by a bridge 9688 which extends radially inward from the compliant member 9684. The compliant member 9684 and ring 9686 may serve as gaskets which form fluid tight seals 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 with volume sensing hardware in the reusable housing assembly 106. The compliant member 9684 may generate an environmental seal which inhibits ingress of moisture, detritus, etc. into the dispensing assembly 100 when a reusable housing assembly 106 and cassette assembly 9500 are coupled to one another.
Referring now also to
Referring now also to
Referring again primarily to
In embodiments where the cassette assembly 9500 is provided to a patient 104 in a prefilled state, the cassette assembly 9500 may be constructed to facilitate execution of one or more quality checks related to the prefilling of 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 bay 9690 which may receive a cover 9692. The reservoir 9536 of the cassette assembly 9500 may be filled prior to installation of the cover 9692. Additionally, other portions of the cassette assembly 9500 may be constructed of 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 filling operation was acceptable. Thus, the bay 9690 may be referred to herein as an inspection bay 9690. Such inspection may be performed manually, with a vision system, or both. Using a light or clear color for portions of the cassette assembly 9500 may facilitate various image processing operations in embodiments where a vision system is used. As shown, the cover 9692 is free from any holes or openings. When installed, the cover 9692 may prevent a patient 104 from exerting pressure against the reservoir 9536.
Referring now also to
Referring now to
Referring now primarily to
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 coupled into place via solvent bonding, adhesive, or welding (heat staking or sonic welding). Interference fits, snap fits, threaded engagements, bayonet mounts, etc. 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 protuberances on the cover 9692 may be coupled to assembly the cover 9692 in place on the cassette assembly 9500. Preferably, once coupled into place, the cover 9692 may be difficult for a user to remove.
Referring now to
Referring again primarily to
The first portion of the assembly 9500 may be constructed of materials which are compatible with any drug stored in the cassette assembly 9500 over long term storage timeframes. For example, the first portion may be constructed of materials compatible with the drug over several months to a year or more worth of storage. The first portion may include the reservoir 9536 and the reservoir outlet path 9544. The second portion may include of materials which are compatible with the drug for a shorter timeframe or tested to have an acceptable compatibility with the drug over a shorter duration. In some embodiments, the material of the second portion may only be in contact with the drug during a therapy and related activities (e.g. priming of the cassette assembly 9500). Depending on the embodiment, a reservoir 9536 may hold enough drug for a three day therapy whereafter the cassette assembly 9500 may be discarded and a new cassette assembly 9500 may take its place on a reusable housing assembly 106. The second portion may include all fluid contacting surfaces of the cassette assembly 9500 downstream of the occluder assembly 9714.
The occluder assembly 9714 may be constructed of materials having long term compatibility. Given the small area of the occluder assembly 9714 exposed to a drug or medicant, the occluder assembly, particularly the diaphragm 9724 may be formed from a halogenated butyl rubber, bromobutyl or a chlorobutyl. Alternatively, portions of the occluder assembly 9714 in contact with fluid in the first portion of the cassette assembly 9500 when the occluder assembly 9714 is in an occluding state may be constructed of materials having long term compatibility. Fluid contacting components in the first portion of the cassette assembly 9500 may be chosen to have long term compatibility with the drug. 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 for the drug to be stored for long periods of time without ill effect while also allowing for a wider range of material choices in other components of the cassette assembly 9500 such as the valve membrane cover 9520. This may be particularly desirable for certain proteinaceous medicaments such as insulin.
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 may independent completely isolate the reservoir 9536 and reservoir outlet path 9544 from the rest of the cassette assembly 9500. At least two seals may be included, though greater numbers of seals are also possible. This redundancy may help to provide extra assurance that fluid may not leak through the occluder assembly 9714.
Referring now also to
In the example embodiment, and as best shown in
The diaphragm 9724 includes a main body 9736. Plateau regions 9738, 9740 may be included on the top and bottom side of the main body 9736. The plateau region 9740 on the top of the main body 9736 may align with the rod 9732 when assembled into the cassette assembly 9500. The plateau region 9738 included on the bottom of the main body 9736 may provide a contact face for sealing against one or more valve gating flow between the first and second portion of the cassette assembly 9500. The diaphragm 9724 (or at least the plateau region 9738) may be made of a compressible material which 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 of the same material. In some embodiments, the material of the diaphragm 9724 may be chlorobutyl elastomer.
Referring now primarily to
Primarily referring to
Referring now primarily to
The reservoir outlet valve 9748 is shown as a volcano type valve in the example embodiment. Specifically, the reservoir outlet valve 9748 is depicted as a double volcano type valve. When the actuator 9726 is in the occluding position, the diaphragm 9724 may be pressed against the reservoir outlet valve 9748 such that the diaphragm is compressed upon each valve seat 9749A, B of the double volcano valve. As a result, the occluder assembly 9714 may isolate the first portion of the cassette assembly 9500 from the rest of the cassette assembly 9500 at a multiplicity of redundant seals.
Also as shown, the diaphragm 9724 may be compressed in place between the cassette top portion 9506 and cassette base portion 9502 within the cassette assembly 9500. This compression may create seals between the diaphragm 9724, the cassette top portion, and the cassette base portion 9502. The diaphragm 9724 may, for example, be sealed around the periphery of a depression 9747 in which the reservoir outlet valve 9748 is disposed. In some embodiments, redundant seals similar to those created against the outlet valve seats 9749A, B may be present around the periphery of the depression. 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 within the flow path through the cassette assembly 9500.
When the actuator 9726 is threaded out of the threaded port 9742, the diaphragm 9724 may restore from its compressed or deflected state. In its resting state, the diaphragm 9724 may displace away from the reservoir outlet valve 9748 bringing the reservoir outlet valve 9748 into an open state. In the open state, fluid may flow through the occluder volume 9752 to an occluder outlet 9750 which is plumbed into the flow channels 9558 included on the backside of the cassette assembly 9500. Thus, when the actuator 9726 is extracted from the threaded port 9742, the first portion of the cassette assembly 9500 may be placed into fluid communication with the second portion of the cassette assembly 9500. The occluder assembly 9714 may transition to a flow permitting state when the actuator 9726 has been unthreaded from the position shown in
As shown, one or more wall 9751 may be provided around a portion of the occluder outlet 9750. The wall(s) 9751 may be more proud of the depression 9747 than the valve seats 9749A, B of the reservoir outlet valve 9748. The wall(s) 9751 may act as a restoring projection which helps to ensure that once the occluder assembly 9714 is brought to a non-occluding state, the diaphragm 9724 is pushed away from the reservoir outlet valve 9748 aiding in opening of the reservoir outlet valve 9748. Additionally, the partial wall(s) 9751 around the occluder outlet 9750 may ensure that the occluder outlet 9750 is unlikely to ever be blocked off by the diaphragm 9724. Thus, the partial wall(s) 9751 may ensure that flow through the occluder assembly 9714 is unimpeded once the occluder assembly 9714 is brought into a non-occluding state.
Referring now to
When pressed into the tapered port 9802, the bung 9800 may displace and compress the diaphragm 9724 against the reservoir outlet valve 9748 closing off flow therethrough. The end of the bung 9800 which contacts the diaphragm 9724 may also deform and bulge outward when advanced into the diaphragm 9724. This bulging may further aid in retaining the bung 9800 in place within the tapered port 9802 during storage. The bung 9800 may include a nub 9806 on an exposed portion of the bung 9800 which may be grasped in order to remove the bung 9800. The bung 9800 may be manually removed or pulled out of the tapered port 9802 with a removal tool. As in
Referring now to
The cassette base portion 9502 may include at least one rib 9786 which may surround the occluder channel 9782. In the example embodiment a set of ribs 9786 is included. The cassette top portion 9506 may include compression projections 9798 which may align 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 seals 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 the other occluder assembly 9714 embodiments (e.g. that shown in
Referring now also to
Referring primarily to
When the user is preparing the cassette assembly 9500 for use, the user may press on the diaphragm 9780 to displace the shuttle body 9778 into a flow permitting state. Pressing may be accomplished manually (e.g. via a thumb or other digit) or via a tool such as a priming and/or filling aid. Examples of such aids are described in U.S. Pat. No. 10,080,704, Issued Sep. 25, 2018, entitled Apparatus, System and Method for Fluid Delivery, to Lanigan et al., Attorney Docket No. M62 which is hereby incorporated by reference herein in its entirety. Alternatively, the reusable housing assembly 106 may include an actuator which may be powered to displace the shuttle body 9778. In some embodiments, a reusable housing assembly 106 may include a feature (e.g. a ramped projection) which depresses (e.g. as it is swept passed) the shuttle body 9778 as the reusable housing assembly 106 is coupled to the cassette assembly 9500. When in a flow permitting state, the shuttle body 9778 may be disposed such that the sealing interface(s) 9784 are within the well 9776 so as to place the reservoir outlet path 9544 into communication with the fluid channel 9558 leading from the well 9776.
As shown best in
Though not shown in
Though the example embodiment is depicted with a sealing plate 9774, it is also possible to include a similar occluder assembly 9714 in cassette assemblies 9500 that use a film sheet seal 9512 instead of a sealing plate 9774. In such embodiments, the film sheet seal 9512 would close a bottom end of the occluder channel 9782. The thickness of the cassette base portion 9502 may be increased in the area of the occluder channel 9782 such that the length of the occluder channel 9782 may remain substantially the same. Additionally, the width of the occluder channel 9782 adjacent the film sheet seal 9512 may be increased to a size which provides clearance around the sealing interface(s) 9784 of the shuttle body 9778. This may allow for fluidic communication to be established between the reservoir outlet flow path 9544 and second portion of the cassette assembly 9500 when the shuttle body 9778 is actuated to a flow permitting state.
Referring now to
By restricting the filling implements 9584 which may be used with a cassette assembly 9500 a number of potential advantages may be possible. For example, the user may be prevented from using a filling implement 9584 having a sharp 9586 which is excessively long. This may mitigate any opportunity that the tip of the sharp 9586 may come into contact with the reservoir film 9516 and cause damage. Additionally, it may ensure that filling implements 9584 contain an appropriate volume of fluid for the particular cassette assembly 9500 about to be loaded with fluid. For example, a user may be prevented from using a syringe capable of holding more than the maximum volume of the reservoir 9536 and overfilling the cassette assembly 9500. The filling implement 9584 may also be designed so as to be specific to specific drug types or specific concentrations of certain drugs. Using insulin as an example, the drug may be available for injection in U 100 and U 200 concentrations. Cassette assemblies 9500 and filling implements 9584 may be constructed to be specific to each concentration and loading of the improper concentration into a cassette assembly 9500 may be prevented.
In the example shown in
In other embodiments, the interfacing portion 9588 may also be polygonal in cross section, but dimensioned so as to only fit within a particular type of cassette assembly 9500. For example, the interfacing portion 9588 may have a triangular or star shaped cross section which is incompatible with the polygonal bore 9590 shown. The polygonal interfacing portion 9588 may, however, cooperatively engage with the fill port 9584 of a different cassette assembly type 9500 which may perhaps be intended for use with a different drug concentration. 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 inappropriate filling implements 9584. In general, the bore of a fill port 9524 may be a negative version of the interfacing portion 9588 of the appropriate filling implement 9584 so as to generate a lock and key type arrangement. Cooperating round, polygonal, oblong, or any other cooperating geometries may be used for a given fill port 9524 and filling implement 9584 interfacing portion 9588 pair.
Where different types of cassette assemblies 9500 are used, the cassette assemblies 9500 may include other differentiating features. These may help a user quickly determine the type of cassette assembly 9500 they are looking at. In some examples a first type of cassette assembly 9500 may be clear, translucent, or light in color (e.g. white) while a second type of cassette assembly 9500 may be opaque, or dark in color (e.g. black).
Referring now to
As shown in
In some embodiments, it may be desirable that the cassette assembly 9500 include at least one projection 9592. By including a projection 9592 on the cassette assembly 9500, inappropriate filling implements 9584 may be held away from the cassette assembly 9500 in the event a user attempts to introduce the wrong filling implement 9584. As a result, the sharp 9586 of an inappropriate filling implement 9584 may not be able to extend into communication with the interior volume of the reservoir 9536.
Referring now to
In certain examples, a detachable member 9596 may be a sleeve type member which surrounds the sharp 9586 of a filling implement 9584. Such a detachable member 9596 may fit within and plug the fill port 9524 of the cassette assembly 9500 when a filling implement 9584 is mated with the cassette assembly 9500 and removed. A small orifice may still be present in the fill port 9524 when the detachable member 9596 is retained therein. This may make access through the fill port 9524 difficult and may require very precise aim by the user. Depending on the embodiment, the fill port 9524 may include a barb 9598. This barb 9598 may couple into a recess 9600 included on the detachable member 9596 when the filling implement 9584 is mated with a cassette assembly 9500. The recess 9600 may be present around the entire circumference of the detachable member 9596 so as to allow the filling implement 9584 to be displaced into the fill port 9524 in any rotary orientation. In other embodiments, the recess 9600 may only be present on a portion of the radial face of the detachable member 9596 so as to require a specific rotary orientation or range of orientations in order to access the reservoir 9536. With the barb 9598 coupled into the recess 9600, the detachable member 9596 may be held within the fill port 9524. A sleeve type detachable member 9596 may be capable of only advancing a predefined distance into a fill port 9524 before bottoming out. As a result, a detachable member 9596 may also act as an insertion depth limiter.
In some embodiments, the bore 9602 of the detachable member 9596 may decrease in cross-sectional area, close, or be blocked off when the filling implement 9584 and detachable member 9596 are separated. For example, the bore 9602 may include a complaint material which is compressed when a sharp 9586 is present therein. The compliant material may restore to its resting state when the filling implement 9584 is disassociated with the detachable member 9596. This may close off the bore 9602 and inhibit further access to the reservoir 9536. Alternatively, the detachable member 9596 may include a cantilevered arm which is biased toward the bore 9602. During manufacture, the cantilevered arm may be displaced so as to allow for the sharp 9586 to be extended through the bore 9602. When the detachable member 9596 and filling implement are separated, the cantilevered arm may be urged into the bore 9602 so as to block off the bore 9602 from further access. In some embodiments, the bore 9602 may include a projection which may press against such an arm to prevent the arm from moving out of an obstructing position when the detachable member 9596 is retained in the bore 9602.
In certain examples, a detachable member 9596 such as the sleeve like embodiment described above may include geometric features similar to those described in relation to
Referring now to
In certain embodiments, a filling implement 9584 and fill port 9524 may include cooperative track features which may prescribe a particular displacement path during coupling. For example, the filling implement 9584 may include protuberances or slots on its interfacing portion 9588 which cooperate with channels recessed into the wall of a fill port 9524 bore 9568 or rails extending radially inward from the wall of the fill port 9524 bore 9586. Where multiple types of cassette assemblies 9500 are used (e.g. a U100 type and a U200 type), the track features present in each cassette assembly 9500 type may differ. Filling implements 9584 dedicated for use with each cassette assembly 9500 type may be used and may be incapable of being displaced along the displacement path of the inappropriate cassette assembly 9500.
As shown in
With reference to
Referring now to
Referring now to
Referring now to
Where multiple types of cassette assemblies 9500 are used, the fill port 9524 in each may differ. This may allow for each type of cassette assembly 9500 to only be accessible through a filling implement 9584 intended for that cassette assembly 9500. The diameters (or another dimension) of the interfacing portion 9588 of each filling implement 9584 may be selected so that an interfacing portion 9588 may only actuate a door 9608 in a cassette assembly 9500 for which it is intended. For example, an inappropriate filling implement 9584 for the fill port 9524 depicted in
Referring now to
Referring now to
Referring now to
In some examples, and referring now to
Where 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 an appropriate filling implement 9584. An inappropriate filling implement 9584 may not open or be able to engage with the wrong 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 implement 9584 or cassette assembly 9500 may not be operable with the respective U200 cassette assembly 9500 or filling implement 9584. This may be accomplished via size differences, geometry differences, or otherwise ensured by the design of the needleless connector assembly 9650.
In the example embodiment, (See
Referring now to
As mentioned above, the filling implement 9584 may include an interrogator 9668. The interrogator 9668 may check the tag 9666 included as part of the cassette assembly 9500. A controller 9670 included in the filling implement 9584 may verify that the tag 9666 indicates that the cassette assembly 9500 is appropriate for use with the filling implement 9584. In the event that the tag 9666 is for a cassette assembly 9500 not intended for use with that filling implement 9584, the controller 9670 may not command fluid to be dispensed from the filling implement 9584. Alternatively, the filling implement 9584 may be communicatively linked with another component of the delivery system 10 (e.g. the reusable housing assembly 106) and may receive data related to the therapy about to be conducted therefrom. In the event that 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 implement 9584.
In embodiments where the cassette assembly 9500 is not intended for reuse, the controller 9670 may check to determine whether the tag 9666 belongs to a cassette assembly 9500 which has been previously used. For example, the controller 9670 may query a memory (not shown) of the filling implement 9584 to determine whether a unique identifier encoded in the tag 9666 matches any identifiers previous scanned by the interrogator 9668. In the event that reuse of a cassette assembly 9500 is attempted, the filling implement 9584 may not permit dispensation of fluid. In other embodiments, a remote database (e.g. cloud server) may be communicatively linked to the filling implement 9584. The filling implement 9584 may perform a reuse prevention 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 filling implement 9584 may check an error history associated with the unique identifier of the cassette assembly 9500. In the event that a previous usage of the cassette assembly 9500 was associated with certain errors or patterns of errors (e.g. leak detected, occlusion, repeated occlusions, or such types of errors followed by a discontinuation of therapy), the filling implement 9584 may prevent loading of fluid into the reservoir 9536 of the cassette assembly 9500. In the event that the controller 9670 determines an acceptable cassette assembly 9500 has been presented, the controller 9670 may command or allow fluid to be filled into the reservoir 9536.
In the example embodiment, the filling implement 9584 is depicted with a pump 9672. Any type of pump 9672 may be used. The filling implement 9584 may command dispensing of a specified volume of fluid into the reservoir 9536 via the pump 9672. The specified volume of fluid may be encoded in the tag 9666 or alternatively may be a preset volume appropriate for the cassette assembly 9500 being used. The volume dispensed into the reservoir 9536 may be communicated by the filling implement 9584 may be communicated to other components of the delivery system 10. For example, the filling implement 9584 may communicate the volume filled into the reservoir 9536 to a reusable housing assembly 106. This volume may then be used to determine volume remaining in the reservoir 9536 as a therapy is executed by the drug delivery system 10.
In alternative embodiments, the tag 9666 may be replaced by an indicium (printed indicium, barcode, QR code, data matrix, bokode, digimarc, etc.). The filling implement 9584 may include a reader (e.g. camera, barcode scanner, etc.) which may read the indicium. The controller 9670 may use data from the indicia as described above to help ensure that fluid in the filling implement 9584 is only dispensed into appropriate cassette assemblies 9500. Additionally, in some embodiments, the interrogator 9668 or reader may not be included in the filling implement 9584. Instead, the interrogator 9668 or reader may be included in another component of the delivery system 10 such as the reusable housing assembly 106 or communicatively linked device 124 such as a smart phone.
Referring now to
The reservoir film 8516 may be affixed to the cassette base portion 8502 via adhesive, ultrasonic welding, heat sealing, etc. to generate a fluid tight seal between the cassette base portion 8502 and the reservoir film 8516. Alternatively, the reservoir film 8516 and cassette base portion 8502 may be compressively pinched 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, and as described further later in the specification, 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 in the cassette assembly 8500 by welding at least a portion of cassette top portion 8506 onto the reservoir film 8516. The cassette top portion 8506 may be made of the same material as the cassette base portion 8502 for improved welding together. The reservoir film 8516 may be constructed of a number of layers of materials which may be selected to add various desirable traits to the reservoir film 8516. Where applicable, tie layers may be used as well. In some embodiments, a drug compatible layer may form the interior volume facing surface of the reservoir film 8516, for example a long term drug compatible material such as a cyclic Olefin Polymer (COP), an example such as Zeonor® 1020R. A barrier layer which is impermeable to gas or specific gases may be included outward of the compatibility layer. The intermediate or tie layer may be an anethylene vinyl alcohol (EVOH). The outer layer may be polychlorotrifluoroethylene (PCTFE) such as Aclar®. Where layered film is used, the reservoir film 9516 may be a coextruded product. In alternative embodiments, the reservoir film 8516 may be constructed of nitrile, silicone, or chlorobuytl rubber.
In the example embodiment, the reservoir film 8516 may include a preform region 8536 (best shown in
A fill port 8524 may also be included in the cassette base portion 8502. In the example embodiment, the fill port 8542 extends through a sidewall of the cassette base portion 8502. The fill port 8524 may extend directly to the reservoir 8536 (see, e.g.
The reservoir film 8516 may include a peripheral rim region 8538. The peripheral rim region 8538 may be coupled to the cassette base portion 8502 at an attachment surface 8540 of the cassette base portion 8502 which may surround the reservoir recess 8508. In some examples, an outcrop 8542 may be included in the peripheral rim region 8538. Where the cassette top portion 8506 is welded onto the reservoir film 8516.
The cassette assembly 8500 has a cassette shell 8200 that attaches to the cassette base portion 8502. The cassette shell 8200 forms a base for contact with the user. The cassette shell 8200 may be made of an extruded material such as plastic compatible with contact with the user skin and body oils, lotions and other materials. The cassette shell 8200 can be made of an Acrylonitrile Butadiene Styrene (ABS) such as Lustran® 348. The use of a cassette shell 8200 allows the cassette base portion 8502 and cassette top portion 8506 to be made of materials that are long term drug compatible while the cassette shell 8200 can be made of materials resistant to sweat, body oils, lotions and other materials that may be present on the human body. The cassette shell 8200 has a bottom 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 for positioning the cassette base portion 8502 and cassette top portion 8506 away from the shell bottom 8202 and shell wall 8204. The cassette shell wall 8204 may define a cutout 8208 for extension of a lure or tubing 184 from the cassette base portion 8502. From the inside of the shell wall 8204 may extend tabs 8210 for snap fit engagement with slots 8503 defined in the cassette base portion 8502. (See
Cassette assembly 8500 further includes a valve membrane 9520 and volume sensor diaphragm assembly 9526 as described above for cassette assembly 9500. With reference to
The bung or occluder actuator 8726 (See
The occluder actuator upper neck portion 8746 defines a neck area having a diameter less than the diameter of the head portion 8744. A tether 8760 may be secured to the upper neck portion, looping the circumference of the upper neck portion 8746 or otherwise secured. The tether 8760 is a flexible filament. The tether 8760 is used to pull and remove the occluder actuator 8726 from the occluder actuator opening 8734. On removal of the occluder actuator 8726, the occluder diaphragm 8724 returns to the undeformed state, thereby releasing the seal of with the sealing ridges 8730 and placing the occluder assembly 8714 in the open state whereby fluid may from the reservoir into the other fluid passages of the cassette assembly 8500. (See
The cassette assembly 8500 maybe prefilled and shipped to the user in a cassette package 8800. (See
It should be noted that various access restricting and reuse prevention arrangements described herein are not mutually exclusive of one another. One or more of the concepts shown herein can be used together in a single embodiment. Access may be controlled and reuse may be prevented by any desired combination of the above.
Various alternatives and modifications can be devised by those skilled in the art without departing from the disclosure. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications and variances. Additionally, while several embodiments of the present disclosure have been shown in the drawings and/or discussed herein, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. And, 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 insubstantially different from those described above and/or in the appended claims are also intended to be within the scope of the disclosure.
The embodiments shown in drawings are presented only to demonstrate certain examples of the disclosure. And, the drawings described are only illustrative and are non-limiting. In the drawings, for illustrative purposes, the size of some of the elements may be exaggerated and not drawn to a particular scale. Additionally, elements shown within the drawings that have the same numbers may be identical elements or may be similar elements, depending on the context.
Where the term “comprising” is used in the present description and claims, it does not exclude other elements or steps. Where an indefinite or definite article is used when referring to a singular noun, e.g. “a” “an” or “the”, this includes a plural of that noun unless something otherwise is specifically stated. Hence, the term “comprising” should not be interpreted as being restricted to the items listed thereafter; it does not exclude other elements or steps, and so the scope of the expression “a device comprising items A and B” should not be limited to devices consisting only of components A and B.
Furthermore, the terms “first”, “second”, “third” and the like, whether used in the description or in the claims, are provided for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances (unless clearly disclosed otherwise) and that the embodiments of the disclosure described herein are capable of operation in other sequences and/or arrangements than are described or illustrated herein.
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 63/161,570 filed Mar. 16, 2021, entitled Infusion Device Assembly (Attorney Docket No. AA069), which is incorporated herein by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US22/71158 | 3/15/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63161570 | Mar 2021 | US |
