Delivery devices, systems, and methods

Abstract

A delivery device for delivering a medical agent to a barrier includes a body defining a containment area in a central region and including a peripheral region defined by a plurality of petals. The delivery device includes a reservoir including at least one delivery sharp, a main interior volume, and at least one septum in fluid communication with the main interior volume, the reservoir coupled to the body via a retention tab. The delivery device may also include an adhesive coupled to the body, and at least one biasing member disposed between the reservoir and a wall of the containment area.

Description

[Technical field]

[0001] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT This invention was made with Government support under Agreement W911NF-17-3-0003 awarded by ACC-APG-RTP. The Government has certain rights in this invention.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to drug delivery. More particularly, the present disclosure relates to dispensers for therapeutic drugs and other medical agents. [Background technology]

[0003] New pathogens pose a variety of public health challenges that are not easy to overcome immediately. From a medical perspective, the existing preventive health infrastructure is not well suited or well-suited for novel pathogens such as SARS, MERS, Zika, or SARS-CoV-2. Other pathogens for which herd immunity does not exist (such as Ebola) or are very dangerous pathogens that mutate quickly may pose similar challenges. Vaccines typically take years to produce, but once one exists, the prospect of rapidly producing billions of doses of the vaccine will almost certainly exceed current vaccine manufacturing capabilities. Without vaccination, other preventive measures such as testing, contact tracing, and personal protective equipment (PPE) become more important. However, again, these preventive measures can only provide as much benefit as the associated supply chains allow. Healthcare systems in the United States and around the world struggling to respond to the COVID-19 pandemic are struggling with shortages of PPE and test kits. In turn, the scale of the COVID-19 pandemic hampers the possibility of carrying out effective contact tracing, which is already a massive undertaking. Moreover, new pathogens can shift the focus of a health system away from its typical functions. Secondary effects often occur when a pandemic spreads and demands the medical community's attention. This can manifest in delayed surgeries, elective procedures, and routine doctor visits, but secondary effects can also be worse. As UNICEF's head of immunization noted, for example, during efforts to control the Ebola epidemic in the Democratic Republic of Congo in 2019, the number of deaths from measles was twice as high as the number of deaths from Ebola.

[0004] Novel pathogens also pose problems that are more psychological in nature. Simply put, such pathogens frighten people. With PPE and testing not readily available, people may choose to avoid visiting health care facilities and clinics for fear of exposure to the disease. Even if there is readily available PPE, certain individuals, such as those in high-risk demographics for certain pathogens, may still be apprehensive about visiting such facilities. Additionally, as is the case in the United States, some may vehemently oppose the use of PPE for a variety of reasons. This poses an additional public health challenge for systems attempting to deal with a pandemic. Solutions to novel pathogens must address and aim to avoid these challenges in order to be effective. Summary of the Invention

[0005] According to one embodiment of the present disclosure, a method of delivering a liquid to a biological barrier includes stretching the biological barrier. The method further includes piercing the stretched biological barrier with at least one delivery sharp. The method further includes moving the at least one delivery sharp along a non-linear path of movement within the biological barrier. The method further includes releasing and delivering a liquid from the at least one delivery sharp into the biological barrier.

[0006] In some embodiments, piercing the biological barrier may include moving the at least one delivery sharp in a generally vertical direction until it contacts the biological barrier. In some embodiments, the at least one delivery sharp may include at least one microneedle. In some embodiments, the path of movement may be arcuate. In some embodiments, moving the at least one delivery sharp may position the delivery sharp in an orientation closer to vertical to the biological barrier than the needle orientation when piercing the biological barrier. In some embodiments, stretching the biological barrier may include adhering a delivery device including the at least one delivery sharp to the biological barrier and unfolding and moving at least two portions of the delivery device. In some embodiments, unfolding and moving at least two portions of the delivery device may include applying a force to the delivery device in a direction perpendicular to the biological barrier. In some embodiments, expelling liquid from the at least one delivery sharp may include increasing a delivery pressure of liquid provided to the delivery sharp until liquid begins to be delivered from the at least one delivery sharp into the biological barrier. In some embodiments, moving the at least one delivery sharp along a non-linear path of travel may include driving an angled edge of the delivery sharp into the barrier. In some embodiments, moving the at least one delivery sharp along a non-linear path of travel may include moving a face of the at least one delivery sharp that includes an outlet of the delivery sharp away from a portion of the barrier that was contacted upon initial piercing.

[0007] According to an exemplary embodiment of the present disclosure, a method of a delivery device for delivering a liquid into a biological barrier includes adhering a delivery device including at least one delivery sharp to the biological barrier. The method further includes applying a force to a portion of the delivery device to move a reservoir assembly with the delivery sharp toward the biological barrier. The method further includes piercing the barrier with the at least one delivery sharp. The method further includes contacting a member protruding from one side of the reservoir assembly with the barrier to tilt the reservoir assembly and the at least one delivery sharp while continuing to move an opposite side of the reservoir assembly toward the barrier. The method further includes expelling liquid from an interior space of the reservoir assembly through the at least one delivery sharp.

[0008] In some embodiments, dispensing liquid from the internal volume of the reservoir assembly may include at least partially collapsing the internal volume of the reservoir assembly. In some embodiments, the internal volume of the reservoir assembly may include a first portion and a second portion proximal to the at least one delivery sharp. Dispensing liquid from the internal volume of the reservoir assembly may include increasing pressure in the second portion until at least the delivery sharp begins to deliver liquid to the biological barrier. In some embodiments, the at least one delivery sharp may include at least one microneedle. In some embodiments, tilting the reservoir assembly and the delivery sharp may include driving a beveled edge of the microneedle into the barrier. In some embodiments, the method may include transitioning a biasing member of the delivery device to a stressed state and applying a restoring force thereof against the reservoir assembly. In some embodiments, the method may include displacing at least two portions of the delivery device apart.

[0009] According to another embodiment of the present disclosure, a method of placing a delivery sharp within a biological barrier at a shallow depth includes stretching the biological barrier. The method further includes moving a holder of the delivery sharp toward the biological barrier. The method further includes moving at least one delivery sharp in a direction substantially perpendicular to the biological barrier to pierce the biological barrier. The method further includes contacting the biological barrier with at least one pivoting member protruding from one side of the holder. The method further includes continuing to move an opposite side of the holder (opposite the pivoting member) toward the barrier. The method further includes moving the at least one delivery sharp along a non-linear path within the skin.

[0010] In some embodiments, stretching the biological barrier may include spreading and displacing at least two portions of the delivery device, including the holder and at least one delivery sharp. In some embodiments, the at least one delivery sharp may be a microneedle. In some embodiments, moving the at least one delivery sharp along a non-linear path may include moving the delivery sharp along a curved path while moving the holder opposite the at least one rocking member toward the barrier. In some embodiments, the movement of the at least one delivery sharp may position the delivery sharp in a direction closer to perpendicular to the barrier than when the barrier was punctured. In some embodiments, moving the delivery sharp along a non-linear path may include moving the at least one delivery sharp through an arc of 3-5°.

[0011] According to another embodiment of the present disclosure, the fluid delivery assembly may include a delivery device. The delivery device may include a liquid holding portion and a coupling portion. The supply assembly may further include an adapter. The adapter may include an adapter coupling portion configured to connect with the coupling portion of the delivery device to form a liquid tight coupling. The adapter may further include an adapter body. The adapter may further include a sharps bearing body having an angled sidewall and at least one delivery sharp protruding from a surface thereof. The adapter body may be molded such that the material of the adapter body covers only a portion of the sidewall, thereby allowing the sharps bearing body and the adapter body to be coupled to one another.

[0012] In some embodiments, the delivery device may be a syringe. In some embodiments, the delivery device coupling and the adapter coupling may be cooperating luer lock couplings. In some embodiments, the at least one delivery sharp may be a microneedle. In some embodiments, the sharps holder and the at least one delivery sharp may be formed of silicon. In some embodiments, the at least one delivery sharp may include an array of microneedles. In some embodiments, the at least one delivery sharp may include microneedles having a height of 500 microns or more. In some embodiments, the at least one delivery sharp may have a flow lumen that communicates with a channel engraved on an outer surface of the microneedle. In some embodiments, the delivery sharp and the at least one delivery sharp may be formed as a single, integral structure.

[0013] According to another embodiment of the present disclosure, an adapter for a delivery device may include an adapter coupling configured to connect in fluid-tight relation with a mating coupling of a delivery device. The adapter may further include an adapter body. The adapter may further include a sharps retainer having an angled sidewall and at least one delivery sharp protruding from a surface thereof. The adapter body may be molded to cover only a portion of the sidewall to secure the sharps retainer to the adapter.

[0014] In some embodiments, the footprint of the sharps holder may expand as the distance from the surface increases. In some embodiments, the sharps holder may be formed of silicon. In some embodiments, the sharps holder and the at least one delivery sharp may be formed as a single integral component. In some embodiments, the at least one delivery sharp may be a microneedle. In some embodiments, the at least one delivery sharp may be a microneedle that is 500 microns or more in height. In some embodiments, the adapter coupling may be a luer lock coupling. In some embodiments, the at least one delivery sharp may include an array of microneedles. In some embodiments, the at least one delivery sharp may include a microneedle having a flow path that communicates with a channel engraved in the exterior surface.

[0015] According to another exemplary embodiment of the present disclosure, the delivery device may have a body including a central region and a peripheral region. The peripheral region may have a plurality of petals extending outward from the central region. The delivery device may further include a variable volume reservoir coupled to the body. The delivery device may further include a sharps retainer having at least one microneedle protruding from the surface and a sidewall disposed at an acute angle to the surface. A material of the rigid portion of the reservoir may be molded to cover only a portion of the sidewall, and the sharps retainer and the reservoir may be coupled. The delivery device may further include an adhesive disposed on at least a portion of the body.

[0016] In some embodiments, the central region may define a housing, with the top region and the base connected by a wall. The petals may extend from the base. In some embodiments, the reservoir may be at least partially disposed in the housing. In some embodiments, the delivery device may further include a biasing member in the housing disposed between the top and the reservoir. In some embodiments, the sharps retainer and the at least one microneedle may be a single, integral structure. In some embodiments, the sharps retainer and the at least one microneedle may be formed of silicon. In some embodiments, the reservoir may include a first portion and a second portion separated from each other by a flow restrictor. The second portion may be located more proximal to the at least one microneedle than the first portion.

[0017] According to another exemplary embodiment of the present disclosure, a method of forming a microneedle support may include etching a plurality of microneedles on a silicon wafer. The method may further include dicing a sharps support including at least one microneedle from the wafer. The cutting may form a sidewall of the sharps support such that a footprint of the sharps support increases with increasing distance from a surface on which the at least one microneedle is disposed. The method may further include molding a body to cover only a portion of the sidewall of the sharps support that is distal to the surface.

[0018] In some embodiments, the body may be part of a syringe. In some embodiments, the body may be an adapter for attachment to a delivery instrument. In some embodiments, the body may form part of a delivery device. In some embodiments, the body may be a stage projection of a reservoir of the delivery device. In some embodiments, the plurality of microneedles may each have a flow passage communicating with a channel engraved in the outer surface. In some embodiments, the sharp retainer may include an array of microneedles. In some embodiments, the sharp retainer may include a row of microneedles. Dicing the sharp retainer from the wafer may include using a dicing saw with a blade configured to form angled sidewalls. In some embodiments, etching the plurality of microneedles may include etching the microneedles to a height of 500 microns or more.

[0019] According to another exemplary embodiment of the present disclosure, a delivery device package may have a first portion formed of a rigid material including a plurality of wells, at least two of the wells being connected by a passageway. The package may further include a second portion removably coupled to an edge of the first portion. The package may further include a delivery device having a body with an adhesive covered by an adhesive liner. The adhesive liner may be adhered to a surface of the first well. When the body is removed from the well, the adhesive liner may be configured to peel from the adhesive and remain within the well.

[0020] In some embodiments, at least one of the first portion and the second portion may include a unique identifier. In some embodiments, the second portion may be configured to be permeable to the germicide. In some embodiments, the delivery device may include a pull tab extending from the body through the passageway to the second well. In some embodiments, the delivery device may include at least one delivery sharp and a delivery sharp cap covering the delivery sharp. In some embodiments, the cap may be connected to a surface of the first well and configured to remain in the well when the delivery device is removed from the well.

[0021] According to another exemplary embodiment of the present disclosure, a delivery device for delivering a liquid into a biological barrier may include a body. The delivery device may further include an adhesive attached to at least a portion of the body and used to adhere the delivery device to the biological barrier. The delivery device may further include a reservoir coupled to the body and may include at least one delivery sharp and at least one pivoting member. The body may be configured to transition from a first state to a second state. The reservoir may be configured to move toward the biological barrier when the body transitions from the first state to the second state, and the pivoting member may be configured to tilt the reservoir after it moves toward the biological barrier.

[0022] In some embodiments, the reservoir may be at least partially collapsible. In some embodiments, at least two adhesive portions of the body may be configured to expand as the body transitions from a first state to a second state. In some embodiments, the body may include a central region and a peripheral region having a plurality of petals extending outwardly from the central region. The central region may define a housing for housing at least a portion of the reservoir. In some embodiments, the reservoir may include at least one rigid portion and at least one flexible portion. In some embodiments, the at least one rocking member may be disposed along a periphery of the rigid portion of the reservoir. In some embodiments, the at least one rocking member may be a protrusion extending from the rigid portion of the reservoir. In some embodiments, the at least one delivery sharp may be attached to a stage protruding from the rigid portion of the reservoir. The at least one rocking member may be disposed closer to the periphery of the rigid portion than the stage. In some embodiments, the height of the at least one rocking member may be approximately the same as the height of the stage. In some embodiments, the at least one delivery sharp includes at least one microneedle, and the part of the at least one microneedle closest to the rocking member may be a cutting edge of the microneedle. In some embodiments, the at least one rocking member may be configured to tilt the reservoir such that the at least one delivery sharp swings through an arc of 3 to 5 degrees. In some embodiments, the at least one rocking member may be configured to tilt the reservoir only after the biological barrier is pierced by the at least one delivery sharp.

[0023] In accordance with yet another embodiment of the present disclosure, the delivery device can include a body including a central region and a peripheral region having a plurality of petals extending from the central region. The central region defines a housing and can have a top region and a base, which can be connected by a wall. The delivery device can further include a variable volume reservoir including at least one delivery sharp and at least one rocking member, the rocking member being closer to a periphery of the reservoir than the delivery sharp. The reservoir can be coupled to the body and at least partially disposed within the housing. Additionally, the delivery device can include an adhesive disposed on at least a portion of the body.

[0024] In some embodiments, the at least one delivery sharp may be a microneedle. In some embodiments, the rocking member may be a protrusion protruding from a rigid portion of the reservoir. In some embodiments, the at least one delivery sharp may include a microneedle, and the portion of the microneedle closest to the rocking member may be a cutting edge of the microneedle. In some embodiments, the rocking member may be disposed on a periphery of the reservoir. In some embodiments, the reservoir may include a planar body with a step protruding therefrom. The at least one delivery sharp may be attached to the step. In some embodiments, the delivery sharp may protrude from the step at an acute angle to a plane perpendicular to the plane of the planar body. In some embodiments, the rocking member may include a marking agent. In some embodiments, the body may be configured to transition from a first state to a second state when the body is adhered to a surface via an adhesive. The reservoir may be configured to move in a direction approximately perpendicular to the surface until the rocking member contacts the surface when the body transitions from the first state to the second state. The portion of the reservoir opposite the rocking member may be configured to continue to move toward the surface after the rocking member contacts the surface as the body transitions from the first state to the second state. In some embodiments, the at least one delivery sharp may be configured to pierce the surface as the reservoir moves in a direction substantially perpendicular to the surface, such that after the rocking member contacts the surface, the delivery sharp is tilted as the portion of the reservoir opposite the rocking member moves further toward the surface.

[0025] According to another exemplary embodiment of the present disclosure, a delivery device for delivering a liquid into a biological barrier may include a body. The delivery device may further include an adhesive disposed on at least a portion of the body and used to adhere the delivery device to the biological barrier. The delivery device may further include a reservoir coupled to the body, the reservoir including at least one delivery sharp. The reservoir may include a main interior volume for holding a fluid and a septum in fluid communication with the main interior volume. The body may be configured to transition between a first state and a second state. The reservoir may be configured to displace toward the biological barrier when the body transitions from the first state to the second state.

[0026] In some embodiments, the reservoir may further include a protrusion disposed closer to a periphery of the reservoir than the at least one delivery sharp. In some embodiments, the protrusion may be configured to tilt the reservoir when the body transitions from a first state to a second state. In some embodiments, the main interior volume may be at least partially collapsible. In some embodiments, at least two portions of the body in which the adhesive is disposed may be configured to displace to spread when the body transitions from a first state to a second state. In some embodiments, the body may include a central region and a peripheral region, the peripheral region having a plurality of petals extending outwardly from the central region. The central region may define a receiving section for receiving at least a portion of the reservoir. In some embodiments, the reservoir may include at least one rigid portion and at least one flexible portion. In some embodiments, the reservoir may include a guard for preventing a dispensing sharp that penetrates a septum from contacting a portion of the reservoir. In some embodiments, the guard may be formed at least in part by the septum and may establish a sharps receiving space within the reservoir. In some embodiments, the reservoir may include a flow path from the main interior volume to a septum. In some embodiments, the septum may include a plug portion disposed at an opening in the rigid portion of the reservoir. In some embodiments, the septum may include a plug portion and a standoff extending from the plug portion. The standoff may include two raised portions that sandwich a recessed channel. In some embodiments, the at least one delivery sharp may be attached to a step that protrudes from the rigid portion of the reservoir. In some embodiments, the at least one delivery sharp may include at least one microneedle. In some embodiments, the reservoir may further include at least one marking agent disposed on the raised portion of the reservoir. In some embodiments, the reservoir may further include a marking member.

[0027] According to another exemplary embodiment of the present disclosure, the delivery device may include a body including a central region and a peripheral region having a plurality of petals extending from the central region. The central region may define a housing, with a top region and a base connected by a wall. The delivery device may further include a variable volume reservoir including at least one delivery sharp and at least one septum in communication with a main interior volume of the reservoir. The delivery device may further include a variable volume reservoir including at least one delivery sharp and a main volume in communication with the septum, the reservoir may be coupled to the body and at least partially disposed within the housing. The delivery device may further include an adhesive disposed on at least a portion of the body.

[0028] In some embodiments, the reservoir may include a protruding member disposed closer to the periphery of the reservoir than the at least one delivery sharp. In some embodiments, the protruding member may extend from a rigid portion of the reservoir. In some embodiments, the at least one delivery sharp may be a microneedle. In some embodiments, the reservoir may include a planar body with a step protruding therefrom, and the at least one delivery sharp may be attached to the step. In some embodiments, the delivery sharp may protrude from the step at an acute angle to a plane perpendicular to the planar body. In some embodiments, the body may be configured to transition from a first state to a second state when the delivery device is adhered to a surface via an adhesive. The reservoir may be configured to be displaced primarily in a direction perpendicular to the surface as the body transitions from the first state to the second state. In some embodiments, the reservoir may include a guard. In some embodiments, the guard may be defined at least in part by a septum. In some embodiments, the reservoir may include a flow path from a main interior volume to the septum. In some embodiments, the septum may include a plug portion that forms a fluid-tight seal against an opening in the rigid portion. In some embodiments, the septum may include a first portion and a second portion extending from the first portion. The second portion may include two raised portions and a recessed channel therebetween. In some embodiments, the reservoir may further include a marking member. In some embodiments, the marking agent is retained in the marking member, and the marking member and the at least one delivery sharp may each extend away from the same side of the reservoir.

[0029] According to another exemplary embodiment of the present disclosure, a delivery device for delivering a medical agent to a biological barrier may include a body including a central region defining a receptacle, a peripheral region defined by a plurality of petals, and a series of retention tabs extending into the receptacle. The delivery device may further include a reservoir including at least one delivery sharp, a main interior volume, and at least one septum in communication with the main interior volume, the reservoir may be coupled to the body via the retention tabs. The delivery device may further include an adhesive coupled to the body. The delivery device may further include at least one biasing member disposed in the receptacle between the reservoir and a wall of the receptacle.

[0030] In some embodiments, the at least one biasing member may be a coil spring having an integral member in contact with the reservoir. In some embodiments, the body may be configured to transition between a first state and a second state. The reservoir may be configured to be displaced toward the biological barrier when the body transitions from the first state to the second state. In some embodiments, the biasing member may be configured to deform when the body transitions from the first state to the second state. The biasing member may be configured to exert a restoring force on the reservoir after being deformed by the body transitioning from the first state to the second state to force fluid out of the at least one delivery sharp. In some embodiments, the biasing member may be selected from the list consisting of a foam body, a rubber body, and an elastomeric body. In some embodiments, the main interior volume may be defined by a wall including at least one collapse promoter. In some embodiments, the at least one biasing member may be formed of an elastomeric material and may include at least one hollow portion. In some embodiments, the hollow portion may be defined by a passageway through the biasing member. In some embodiments, the biasing member is formed of an elastomeric material and may have a first and second stage, the stages having different areal footprints. In some embodiments, the reservoir may include a sharps receiving space. In some embodiments, the reservoir may include a guard formed at least in part by a septum. In some embodiments, a flow path from the main interior volume to the septum may be included within the reservoir. In some embodiments, the device further comprises a septum, the septum may include a plug portion disposed in fluid tight contact within an opening through the rigid portion of the reservoir. In some embodiments, the device further comprises a septum, the septum may include a portion disposed within the fluid-containing portion of the reservoir, the portion may have two ridges that sandwich a recessed channel. In some embodiments, the reservoir may include a rigid portion and a flexible portion coupled to the rigid portion.The delivery device may further comprise a septum, which may include a first portion disposed within the passageway through the rigid portion. The septum may include a second portion having a recessed channel and configured to prevent displacement of the flexible portion into the recessed channel. In some embodiments, the reservoir may be filled with an overdose intervention drug. In some embodiments, the reservoir may be filled with at least one vaccine. In some embodiments, the reservoir may be filled with a COVID-19 vaccine. In some embodiments, the reservoir may further comprise a protrusion closer to a periphery of the reservoir than the at least one delivery sharp. In some embodiments, the body may be configured to transition between a first state and a second state. The reservoir may be configured to displace toward a biological barrier as the body transitions from the first state to the second state. The protrusion may be configured to tilt the reservoir as the body transitions from the first state to the second state. In some embodiments, the body may be integrally formed with the retention tab in a side action free injection molding operation. In some embodiments, the body may include a set of stop members associated with the retention tabs.

[0031] According to another exemplary embodiment of the present disclosure, the delivery device may include a body including a central region and a peripheral region having a plurality of petals extending from the central region. The central region may define a housing, with a top and a base connected by a wall. The delivery device may further include a variable volume reservoir including at least one delivery sharp, the reservoir may be coupled to the body and at least partially disposed within the housing. The delivery device may further include an elastomeric body disposed within the housing between the top and the reservoir. The delivery device may further include an adhesive disposed on at least a portion of the body.

[0032] In some embodiments, the elastomeric body may include at least one hollow portion. In some embodiments, each hollow portion may be formed by a passageway at least partially through the elastomeric body. In some embodiments, the elastomeric body may have a stepped structure. In some embodiments, the reservoir may further include a septum. In some embodiments, the body may include a set of retention tabs extending into the housing. The reservoir may be configured to be coupled to the reservoir with a snap fit by passing through the retention tabs. In some embodiments, the reservoir may further include a protrusion closer to a periphery of the reservoir than the at least one delivery sharp. In some embodiments, the marking agent may be retained on the protrusion. In some embodiments, the body may be configured to transition between a first state and a second state. The reservoir may be configured to be displaced along a path as the body transitions from the first state to the second state. In some embodiments, the at least one delivery sharp may include an array of spaced apart microneedles. In some embodiments, a majority of each petal may be flat and disposed at an acute angle relative to a central axis of the delivery device. In some embodiments, the peripheral region may include an outermost portion that defines a periphery of the body. Each petal may define a portion of the periphery of the body. In some embodiments, the outermost portion of each petal may be arched along a radius having a center point along a central axis of the delivery device. In some embodiments, each petal may be separated by a slit in the peripheral region. The outermost portion of each petal may be disposed further away from the central region than the end of the slit that is furthest away. The outermost portion may narrow in width as it moves away from the central region.

[0033] According to yet another exemplary embodiment of the present disclosure, a method of delivering a medicament to an injection site may include attaching a delivery device to a skin patch at the injection site. The method may further include deforming at least two portions of the delivery device attached to the skin patch from an initial state to a deformed state, stretching the skin patch and displacing at least one delivery sharp into a piercing relationship with the skin patch. The method may further include dispensing a liquid from a reservoir of the delivery device to the injection site via the delivery sharp. The method may further include restoring the at least two portions of the delivery device attached to the skin patch from the deformed state to the initial state. The method may further include removing the delivery device from the skin patch.

[0034] In some embodiments, the at least one delivery sharp may be a microneedle. In some embodiments, the at least one delivery sharp may be an array of spaced apart microneedles. In some embodiments, the method may further include tilting the delivery sharp while the delivery sharp pierces the skin patch. In some embodiments, the method may further include compressing a biasing member of the delivery device against the reservoir. In some embodiments, deforming at least two portions of the delivery device affixed to the skin patch may include applying pressure to a surface of the delivery device. In some embodiments, restoring from the deformed state to the initial state may include releasing the pressure applied to the surface of the delivery device. In some embodiments, dispensing the fluid from the reservoir may include substantially inverting a portion of the delivery device and compressing a biasing member between the portion and the reservoir. In some embodiments, dispensing the fluid from the reservoir may include transitioning a portion of the delivery device from a protruding position to a recessed position and compressing a biasing member between the portion and the reservoir. In some embodiments, the at least two portions of the delivery device may be petal-shaped members coupled to a central region of the body. In some embodiments, dispensing of fluid from the reservoir may occur at least partially while the at least two portions of the delivery device are restored to their initial state, hi some embodiments, dispensing of fluid from the reservoir may continue after the at least two portions are restored to their initial state.

[0035] According to yet another exemplary embodiment of the present disclosure, a method of delivering a medicament may include attaching a delivery device to a surface, the delivery device including at least one delivery sharp coupled to a variable volume reservoir containing the medicament when the delivery device is in a first state. The method may further include applying and releasing pressure to the delivery device to transition the delivery device to a second state and causing the at least one delivery sharp to penetrate the surface and collapse the reservoir to force the medicament out of the delivery sharp.

[0036] In some embodiments, the method may further include stretching the skin as the delivery device transitions from the first state to the second state. In some embodiments, the method may further include tilting at least one delivery sharp after the delivery sharp penetrates the surface. In some embodiments, the method may further include contacting the surface with a protrusion from the reservoir after the delivery sharp penetrates the surface. In some embodiments, the method may further include creating a mark on the surface with the protrusion. In some embodiments, the method may further include filling the reservoir through a septum. In some embodiments, the at least one delivery sharp may be a microneedle. In some embodiments, the at least one delivery sharp may be an array of spaced apart microneedles. In some embodiments, the method may further include compressing the biasing member against the reservoir. In some embodiments, the method may further include compressing the elastomeric body against the reservoir. In some embodiments, the method may further include displacing at least two portions of the delivery device attached to the surface from an initial state with a spread. In some embodiments, applying and releasing pressure to the delivery device to transition to the second state may include moving at least two portions of the delivery device attached to the skin from a stored state, through an intermediate state, and at least partially back to a stored state. In some embodiments, applying and releasing pressure to the delivery device to transition to the second state may include moving at least two portions of the delivery device attached to the skin from a stored state to a maximally deformed state and at least partially elastically recovering from the state. In some embodiments, the at least two portions may be petal-shaped members extending from a central region of the body of the delivery device toward the periphery. In some embodiments, dispensing liquid from the reservoir may include substantially inverting a portion of the delivery device and compressing a biasing member between the portion and the reservoir.

[0037] According to yet another exemplary embodiment of the present disclosure, a method of delivering a medicament may include attaching a delivery device to a surface, the delivery device including at least one delivery sharp coupled to a variable volume reservoir containing the medicament. The method may further include applying pressure to the delivery device to transition first and second portions to respective deformed states and penetrating the surface with the at least one delivery sharp to initiate collapse of the reservoir and expel the medicament from the delivery sharp. The method may further include releasing the pressure applied to the delivery device to at least partially restore the first portion of the delivery device from its deformed state and lift the surface.

[0038] In some embodiments, transitioning the first portion to the deformed state may include displacing the segments of the first portion to splay relative to one another. In some embodiments, the method may further include tilting the at least one delivery sharp after the delivery sharp penetrates the surface. In some embodiments, the method may further include contacting the surface with a protrusion from the reservoir after the at least one delivery sharp penetrates the surface. In some embodiments, the collapse of the reservoir may continue while the first portion of the delivery device at least partially recovers from the deformed state. In some embodiments, the at least one delivery sharp may be a microneedle. In some embodiments, the at least one delivery sharp may be an array of spaced apart microneedles. In some embodiments, transitioning the second portion to the deformed state may include compressing the biasing member against the reservoir. In some embodiments, transitioning the second portion to the deformed state may include transitioning the second portion from the protruding state to the recessed state. In some embodiments, the first portion of the delivery device may include a plurality of petals extending from a central region of the body of the delivery device toward a periphery, and the second portion may be a portion of the central region. It can be translated as follows:

[0039] According to yet another exemplary embodiment of the present disclosure, a delivery device for delivering a liquid to a biological barrier may include a body having a peripheral region including a plurality of petals. The delivery device may further include a reservoir coupled to the body including at least one delivery sharp. The body may be configured to transition between a first state and a second state. The petals may be configured to deform from an initial state to an intermediate state and at least partially recover from the intermediate state as the body transitions from the first state to the second state.

[0040] In some embodiments, the delivery device may include an adhesive on at least a portion of the body for attaching the delivery device to the biological barrier. In some embodiments, the reservoir may further include at least one rocking member. In some embodiments, the reservoir may be configured to displace along a displacement path when the body transitions from a first state to a second state. In some embodiments, the reservoir may include a rigid portion having at least one protrusion. The protrusion may be configured to tilt the reservoir as it displaces along the displacement path. In some embodiments, the reservoir may be at least partially collapsible. In some embodiments, the petals may be at least partially covered with adhesive. The petals may be configured to displace with a spread when deforming from an initial state to an intermediate state. In some embodiments, the body may include a central region. The plurality of petals may be disposed in a direction extending outward from the central region. The central region may define a receiving portion for receiving at least a portion of the reservoir. In some embodiments, the reservoir may include at least one rigid portion and at least one flexible portion. In some embodiments, the flexible portion may include a reservoir wall having a collapse promoter. In some embodiments, a majority of each petal may be substantially flat. In some embodiments, a majority of each petal may extend at an angle to a central axis of the delivery device, and each petal may include a segment having a curve toward a central region of the body. In some embodiments, each petal may include an intermediate curved portion between a first substantially flat region and a second substantially flat region. In some embodiments, the at least one delivery sharp may be attached to a step that protrudes from a rigid portion of the reservoir. In some embodiments, the at least one delivery sharp may include at least one microneedle. In some embodiments, the periphery of the delivery device may be defined by the outermost edge of the petal.The outermost edge may bend along a path that is different from the path defined by a constant radius extending from a point along the central axis of the delivery device. In some embodiments, each petal may have an outermost region that narrows away from the central region. Each outermost region may include an outermost edge that is along a path that is different from the path defined by a constant radius extending from a point along the central axis of the delivery device. In some embodiments, the body may include a central region integrally formed with the peripheral region. The central region may include a portion configured to flip from a protruding state to a recessed state when the body transitions from the first state to the second state. In some embodiments, the delivery device may further include a biasing member disposed between the reservoir and the portion. The biasing member may be configured to deform when the portion flips to the recessed state. In some embodiments, the biasing member may be an elastomer. In some embodiments, the biasing member may be a graduated elastomeric body having a passageway at least partially therethrough. In some embodiments, the reservoir may further include a septum. [Brief description of the drawings]

[0041] These and other aspects will become more apparent from the following detailed description of various embodiments of the present disclosure, taken in conjunction with the drawings.

[0042] [Figure 1A] FIG. 1 is a block diagram of an exemplary delivery device in a stored state, in accordance with various aspects and embodiments of the present disclosure.

[0043] [Figure 1B] FIG. 1 is a block diagram of an exemplary delivery device in a delivery state, in accordance with various aspects and embodiments of the present disclosure.

[0044] [Diagram 2] FIG. 1 illustrates an exemplary microneedle according to various aspects and embodiments of the present disclosure.

[0045] [Figure 3A] 1A-1D are diagrams of an exemplary sharps holder incorporating microneedles, according to various aspects and embodiments of the present disclosure.

[0046] [Figure 3B] FIG. 1 illustrates an exemplary microneedle according to various aspects and embodiments of the present disclosure.

[0047] [Figure 4A] 1A-1D are diagrams of an exemplary sharps holder incorporating microneedles, according to various aspects and embodiments of the present disclosure.

[0048] [Figure 4B] FIG. 1 illustrates an exemplary microneedle according to various aspects and embodiments of the present disclosure.

[0049] [Figure 5A] FIG. 1 is a perspective view of an exemplary sharps holder including a set of exemplary microneedles according to various aspects and embodiments of the present disclosure.

[0050] [Figure 5B] FIG. 1 is a perspective view of an exemplary sharps holder including a set of exemplary microneedles according to various aspects and embodiments of the present disclosure.

[0051] [Figure 6A] FIG. 1 is a perspective view of an exemplary sharps holder including a set of exemplary microneedles according to various aspects and embodiments of the present disclosure.

[0052] [Figure 6B] FIG. 6B is a top view of the exemplary sharps holder shown in FIG. 6A in accordance with various aspects and embodiments of the present disclosure.

[0053] [Figure 7A]FIG. 1 is a top view of an exemplary sharps holder including a set of exemplary microneedles according to various aspects and embodiments of the present disclosure.

[0054] [Figure 7B] FIG. 1 is a perspective view of an exemplary sharps holder including a set of exemplary microneedles according to various aspects and embodiments of the present disclosure.

[0055] [Figure 8A] FIG. 1 illustrates a top view of an exemplary sharps holder including a set of microneedles according to various aspects and embodiments of the present disclosure.

[0056] [Figure 8B] FIG. 1 is a perspective view of an exemplary sharps holder including a set of exemplary microneedles according to various aspects and embodiments of the present disclosure.

[0057] [Figure 8C] 8B is a cross-sectional view at the indicated cut plane of FIG. 8A according to various aspects and embodiments of the present disclosure.

[0058] [Figure 9A-9D] 1A-1D show various views of an exemplary microneedle with a side port according to various aspects and embodiments of the present disclosure.

[0059] [Figure 10A] FIG. 1 is a block diagram of a portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0060] [Figure 10B] FIG. 1 is a block diagram of a portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0061] [Figure 11] FIG. 1 is a block diagram of a portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0062] [Figure 12] FIG. 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0063] [Figure 13] FIG. 1 is a plan view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0064] [Figure 14] FIG. 1 is a side view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0065] [Figure 15] FIG. 1 is a plan view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0066] [Figure 16] FIG. 1 is a conceptual diagram of an exemplary delivery device in a delivery state, in accordance with various aspects and embodiments of the present disclosure.

[0067] [Figure 17] 1A-1D are diagrams of an exemplary delivery device in a stored state, in accordance with various aspects and embodiments of the present disclosure.

[0068] [Figure 18] FIG. 1 is a conceptual diagram of an exemplary delivery device in a delivery state, in accordance with various aspects and embodiments of the present disclosure.

[0069] [Figure 19] FIG. 1 is a side view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0070] [Figure 20] FIG. 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0071] [Figures 21A-21I] 1A-1C illustrate various exemplary embodiments of a body including different slot patterns and top openings, in accordance with various aspects and embodiments of the present disclosure.

[0072] [Figure 22] FIG. 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0073] [Figure 23] FIG. 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0074] [Figure 24] FIG. 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0075] [Diagram 25] 1 is a perspective view of an exemplary delivery device package according to various aspects and embodiments of the present disclosure. FIG.

[0076] [Figure 26] 1 illustrates a top view of an exemplary delivery device package with the delivery device removed, in accordance with various aspects and embodiments of the present disclosure. FIG.

[0077] [Figure 27] 1A-1D are diagrams of an exemplary delivery device in a stored state, in accordance with various aspects and embodiments of the present disclosure.

[0078] [Figure 28] FIG. 1 is a cross-sectional perspective view of a body of an exemplary delivery device in a stored state, according to various aspects and embodiments of the present disclosure.

[0079] [Figure 29A] FIG. 1 is a plan view of an exemplary delivery device showing example dimensions of one embodiment of a delivery device according to one embodiment of the present disclosure.

[0080] [Figure 29B] FIG. 1 is a side view of an exemplary delivery device showing example dimensions of one embodiment of a delivery device according to one embodiment of the present disclosure.

[0081] [Figure 30A] 1A-1C are schematic side views of an exemplary delivery device transitioning to a delivery state, in accordance with various aspects and embodiments of the present disclosure.

[0082] [Figure 30B] 1A-1C are schematic side views of an exemplary delivery device transitioning to a delivery state, in accordance with various aspects and embodiments of the present disclosure.

[0083] [Diagram 31] FIG. 1 is a perspective view conceptually illustrating an exemplary delivery device in a delivery state, in accordance with various aspects and embodiments of the present disclosure.

[0084] [Diagram 32] FIG. 32 is a side view of the exemplary delivery device of FIG. 31, in accordance with various aspects and embodiments of the present disclosure.

[0085] [Diagram 33] FIG. 32 is an exploded view of the delivery device shown in FIG. 31 in accordance with various aspects and embodiments of the present disclosure.

[0086] [Diagram 34] FIG. 32 is a plan view of the delivery device shown in FIG. 31 in accordance with various aspects and embodiments of the present disclosure.

[0087] [Diagram 35] FIG. 35 is a cross-sectional view of the delivery device shown in FIG. 33 taken at the cutting plane indicated in FIG. 34, according to various aspects and embodiments of the present disclosure.

[0088] [Diagram 36] 1A-1D show representative diagrams of an exemplary delivery device including a dispensing assembly according to various aspects and embodiments of the present disclosure.

[0089] [Figure 37] 1A-1D show representative diagrams of an exemplary delivery device including a dispensing assembly according to various aspects and embodiments of the present disclosure.

[0090] [Figure 38] 1A-1D show representative diagrams of an exemplary delivery device including a dispensing assembly according to various aspects and embodiments of the present disclosure.

[0091] [Figure 39] 1A-1D show perspective views of an exemplary delivery device and biasing member according to various aspects and embodiments of the present disclosure.

[0092] [Diagram 40] 1A-1D show perspective views of an exemplary biasing member that may be included in a delivery device according to various aspects and embodiments of the present disclosure.

[0093] [Diagram 41] 1 illustrates a cross-sectional view of a portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0094] [Diagram 42] 1 illustrates a cross-sectional view of a portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0095] [Diagram 43] 1 illustrates a perspective view of an exemplary push body that may be included in a delivery device according to various aspects and embodiments of the present disclosure.

[0096] [Diagram 44] 1 illustrates an exemplary depressor body and biasing member, with the biasing member in a stressed state, according to various aspects and embodiments of the present disclosure.

[0097] [Diagram 45] 1A-1D show cross-sectional views of an exemplary push body and biasing member, where the biasing member is in a stressed state, in accordance with various aspects and embodiments of the present disclosure.

[0098] [Figure 46A] FIG. 1 illustrates a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0099] [Figure 46B]1A-1D show perspective views of an exemplary stop member that may be included in a delivery device according to various aspects and embodiments of the present disclosure.

[0100] [Figure 46C] 1A-1D show perspective views of an exemplary delivery assembly and an exemplary stop member that may be included in a delivery device according to various aspects and embodiments of the present disclosure.

[0101] [Figure 46D] 1A-1D show perspective views of an exemplary biasing member and an exemplary pusher that may be included in a delivery device according to various aspects and embodiments of the present disclosure.

[0102] [Figure 47] 1A-1D show representative diagrams of an exemplary delivery device including a biasing member according to various aspects and embodiments of the present disclosure.

[0103] [Figure 48A] 1 illustrates a bottom view of an exemplary body that may be included in a delivery device according to various aspects and embodiments of the present disclosure.

[0104] [Figure 48B] 1A-1D show perspective views of an exemplary body and an exemplary biasing member that may be included in a delivery device according to various aspects and embodiments of the present disclosure.

[0105] [Figure 48C] 1A-1D show perspective views of an exemplary body and an exemplary biasing member that may be included in a delivery device according to various aspects and embodiments of the present disclosure.

[0106] [Figure 49A] FIG. 1 illustrates a side view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0107] [Figure 49B] 1 illustrates a cross-sectional view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0108] [Figure 50] 1 illustrates an exploded view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0109] [Figure 51] 51A and 51B show a portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure in a stored state and a delivery state, respectively.

[0110] [Figure 52] 1 illustrates a bottom view of a portion of an exemplary body and pusher of a delivery device according to various aspects and embodiments of the present disclosure.

[0111] [Figure 53A] FIG. 1 is a perspective view of an exemplary holder for a sharps holder according to various aspects and embodiments of the present disclosure.

[0112] [Figure 53B] FIG. 1 is a side view of an exemplary holder for a sharps holder according to various aspects and embodiments of the present disclosure.

[0113] [Figure 53C] FIG. 13 is a bottom plan view of an exemplary holder for a sharps holder according to various aspects and embodiments of the present disclosure.

[0114] [Fig. 53D] FIG. 1 is a perspective view of an exemplary holder for a sharps holder according to various aspects and embodiments of the present disclosure.

[0115] [Figure 54A] 1 illustrates a perspective view of an exemplary holder including a stepped protrusion according to various aspects and embodiments of the present disclosure.

[0116] [Figure 54B] 1 illustrates a perspective view of an exemplary holder including a stepped protrusion according to various aspects and embodiments of the present disclosure.

[0117] [Figure 54C] 1 illustrates a bottom view of an exemplary holder including a stepped protrusion according to various aspects and embodiments of the present disclosure.

[0118] [Figure 55A] 1 illustrates a side view of an exemplary holder including a stepped protrusion to which an exemplary sharps retainer is attached in accordance with various aspects and embodiments of the present disclosure. FIG.

[0119] [Figure 55B] 55B illustrates a detailed view of the indicated area of ​​FIG. 55A in accordance with various aspects and embodiments of the present disclosure.

[0120] [Figure 55C] 1 illustrates a cross-sectional view of an exemplary holder including a stepped protrusion to which an exemplary sharps retainer is attached in accordance with various aspects and embodiments of the present disclosure.

[0121] [Fig. 55D] 55C in accordance with various aspects and embodiments of the present disclosure.

[0122] [Figure 56A] 1A-1D are perspective views of an exemplary portion of a reservoir according to various aspects and embodiments of the present disclosure.

[0123] [Figure 56B] 1A-1D are side views of an exemplary portion of a reservoir according to various aspects and embodiments of the present disclosure.

[0124] [Figure 56C] 1A-1D are perspective views of an exemplary portion of a reservoir according to various aspects and embodiments of the present disclosure.

[0125] [Figure 56D] 1A-1D are plan views of exemplary portions of a reservoir according to various aspects and embodiments of the present disclosure.

[0126] [Figure 57]FIG. 1 illustrates a perspective view of an exemplary reservoir according to various aspects and embodiments of the present disclosure.

[0127] [Figure 58] FIG. 1 illustrates a perspective view of another exemplary reservoir according to various aspects and embodiments of the present disclosure.

[0128] [Figure 59] FIG. 1 is a block diagram of an exemplary reservoir assembly according to various aspects and embodiments of the present disclosure.

[0129] [Figure 60] FIG. 1 is a block diagram of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0130] [Figure 61A] FIG. 1 illustrates a block diagram of an exemplary reservoir assembly according to various aspects and embodiments of the present disclosure.

[0131] [Figure 61B] FIG. 1 illustrates a block diagram of an exemplary reservoir assembly according to various aspects and embodiments of the present disclosure.

[0132] [Figure 62] 1A-1D show representative diagrams of an exemplary delivery device including a reservoir divided into multiple portions according to various aspects and embodiments of the present disclosure.

[0133] [Figure 63A] FIG. 1 illustrates a block diagram of a delivery device with an example rocking member according to various aspects and embodiments of the present disclosure.

[0134] [Figure 63B] FIG. 1 illustrates a block diagram of a delivery device with an example rocking member according to various aspects and embodiments of the present disclosure.

[0135] [Fig. 64A] 1 illustrates a perspective view of a delivery device with an example of a rocking member according to various aspects and embodiments of the present disclosure.

[0136] [Figure 64B] 1 illustrates a perspective view of another example delivery device with multiple rocking members according to various aspects and embodiments of the present disclosure.

[0137] [Figure 65] 1 is a flowchart detailing some example actions that may be performed for drug delivery using a delivery device according to various aspects and embodiments of the present disclosure.

[0138] [Figure 66] 1 illustrates a diagram of an exemplary delivery device after being applied to a user in accordance with various aspects and embodiments of the present disclosure.

[0139] [Figure 67] 1A-1D show diagrams of an exemplary delivery device in the process of transitioning from a storage state to a delivery state in accordance with various aspects and embodiments of the present disclosure.

[0140] [Figure 68] 1A-1D show diagrams of an exemplary delivery device in the process of transitioning from a storage state to a delivery state in accordance with various aspects and embodiments of the present disclosure.

[0141] [Figure 69] 1 shows a diagram of a delivery device in a delivery state according to various aspects and embodiments of the present disclosure.

[0142] [Figure 70A] 1 illustrates an exemplary body that may be included in a delivery device according to various aspects and embodiments of the present disclosure.

[0143] [Figure 70B] 1 illustrates a side view of an exemplary body that may be included in a delivery device according to various aspects and embodiments of the present disclosure.

[0144] [Figure 71]1 illustrates a detailed view of a portion of an exemplary body according to various aspects and embodiments of the present disclosure.

[0145] [Figure 72A] 1A-1D show diagrams of an exemplary body that may be included in a delivery device according to various aspects and embodiments of the present disclosure.

[0146] [Fig. 72B] 1 illustrates a side view of an exemplary body that may be included in a delivery device according to various aspects and embodiments of the present disclosure.

[0147] [Figure 73A] 1 illustrates a front right top perspective view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0148] [Figure 73B] 1 illustrates a bottom plan view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0149] [Figure 73C] 1 illustrates a top view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0150] [Fig. 73D] 1 illustrates a front view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0151] [Figure 73E] 1 shows a right side view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0152] [Fig. 73F] 1 illustrates a rear view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0153] [Fig. 73G]1 illustrates a left side view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0154] [Fig. 74A] 1 illustrates a front right perspective view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0155] [Fig. 74B] 1 illustrates a top plan view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0156] [Fig. 74C] 1 illustrates a bottom plan view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0157] [Fig. 74D] 1 illustrates a front view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0158] [Fig. 74E] 1 illustrates a right side view of an exemplary portion of an exemplary delivery device, according to various aspects and embodiments of the present disclosure.

[0159] [Fig. 74F] 1 illustrates a rear view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0160] [Fig. 74G] 1 illustrates a left side view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0161] [Fig. 75A] 1 illustrates a front right perspective view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0162] [Fig. 75B]1 illustrates a top view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0163] [Fig. 75C] 1 illustrates a bottom view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0164] [Fig. 75D] 1 illustrates a front view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0165] [Fig. 75E] 1 illustrates a right side view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0166] [Fig. 75F] 1 illustrates a rear view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0167] [Fig. 75G] 1 illustrates a left side view of an exemplary portion of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0168] [Figure 76A] 1 illustrates a top view of an exemplary reservoir according to various aspects and embodiments of the present disclosure.

[0169] [Figure 76B] 1 illustrates a bottom view of an exemplary reservoir according to various aspects and embodiments of the present disclosure.

[0170] [Figure 77] FIG. 1 illustrates a perspective view of an exemplary septum according to various aspects and embodiments of the present disclosure.

[0171] [Figure 78] 1 illustrates a cross-sectional view of an exemplary reservoir including a septum according to various aspects and embodiments of the present disclosure.

[0172] [Figure 79] 1 illustrates a perspective view of an exemplary delivery device including a septum according to various aspects and embodiments of the present disclosure.

[0173] [Figure 80A] 1 illustrates a perspective cross-sectional view of an exemplary body including a retention tab according to various aspects and embodiments of the present disclosure.

[0174] [Figure 80B] 80B illustrates a detailed view of the indicated area of ​​FIG. 80A according to various aspects and embodiments of the present disclosure.

[0175] [Figure 81A] 1 illustrates a bottom view of an exemplary delivery device with an exemplary adhesive member according to various aspects and embodiments of the present disclosure.

[0176] [Fig. 81B] 13A-13D show bottom views of another exemplary delivery device with another exemplary adhesive member according to various aspects and embodiments of the present disclosure.

[0177] [Fig. 81C] 13A-13D show bottom views of another exemplary delivery device with another exemplary adhesive member according to various aspects and embodiments of the present disclosure.

[0178] [Fig. 82A] FIG. 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0179] [Fig. 82B] FIG. 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0180] [Figure 83A] FIG. 1 is a side view of an exemplary delivery device in a first state according to various aspects and embodiments of the present disclosure.

[0181] [Figure 83B] FIG. 2 is a side view of an exemplary delivery device in a second state according to various aspects and embodiments of the present disclosure.

[0182] [Figure 83C] FIG. 13 is a side view of an exemplary delivery device in a third state according to various aspects and embodiments of the present disclosure.

[0183] [Fig. 84A] 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0184] [Fig. 84B] 1A-1D are cross-sectional views of an exemplary flexure of a delivery device according to various aspects and embodiments of the present disclosure.

[0185] [Fig. 84C] FIG. 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0186] [Fig. 85A] FIG. 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0187] [Fig. 85B] FIG. 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0188] [Figure 86] FIG. 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0189] [Figure 87] FIG. 1 is a plan view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0190] [Fig. 88A] FIG. 1 is a side view of an exemplary delivery device in a first state, according to various aspects and embodiments of the present disclosure.

[0191] [Fig. 88B] FIG. 2 is a side view of an exemplary delivery device in a second state, according to various aspects and embodiments of the present disclosure.

[0192] [Fig. 88C] FIG. 13 is a side view of an exemplary delivery device in a third state, according to various aspects and embodiments of the present disclosure.

[0193] [Figure 89] 1A-1D are cross-sectional views of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0194] [Figure 90A] FIG. 1 is a block diagram of an exemplary delivery device in a stored state, in accordance with various aspects and embodiments of the present disclosure.

[0195] [Figure 90B] FIG. 1 is a block diagram of an exemplary delivery device in a delivery state, in accordance with various aspects and embodiments of the present disclosure.

[0196] [Figure 91] FIG. 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0197] [Figure 92] FIG. 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0198] [Figure 93] FIG. 1 is an exploded view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0199] [Figure 94] FIG. 1 is an exploded view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0200] [Figure 95A]FIG. 1 is a side view of an exemplary delivery device in a first state according to various aspects and embodiments of the present disclosure.

[0201] [Figure 95B] FIG. 95B is an enlarged view of the indicated area of ​​the delivery device of FIG. 95A according to various aspects and embodiments of the present disclosure.

[0202] [Figure 96A] FIG. 2 is a side view of an exemplary delivery device in a second state, according to various aspects and embodiments of the present disclosure.

[0203] [Figure 96B] FIG. 96B is an enlarged view of the indicated area of ​​the delivery device of FIG. 96A according to various aspects and embodiments of the present disclosure.

[0204] [Figure 97] FIG. 1 is a cross-sectional view of an exemplary delivery device in a first state according to various aspects and embodiments of the present disclosure.

[0205] [Figure 98] FIG. 2 is a cross-sectional view of an exemplary delivery device in a second state according to various aspects and embodiments of the present disclosure.

[0206] [Figure 99] 1 illustrates an exploded view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0207] [Figure 100] 1 illustrates an exploded view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0208] [Figure 101] FIG. 1 is a perspective view of an exemplary flexure that may be included as or as part of an actuation assembly of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0209] [Figure 102]FIG. 13 is a side view of an exemplary flexure that may be included as or as part of an actuation assembly of an exemplary delivery device in accordance with various aspects and embodiments of the present disclosure.

[0210] [Figure 103] FIG. 13 is a plan view of an exemplary flexure that may be included as or as part of an actuation assembly of an exemplary delivery device in accordance with various aspects and embodiments of the present disclosure.

[0211] [Figure 104] 1 illustrates a perspective view of an exemplary package for a delivery device according to various aspects and embodiments of the present disclosure.

[0212] [Figure 105] 1 illustrates a view of an exemplary body of a delivery device separated from an exemplary reservoir assembly that may be included in a delivery device according to various aspects and embodiments of the present disclosure.

[0213] [Fig. 106] 1 illustrates an exemplary delivery device being removed from a patient's skin, revealing marks formed on the skin by the delivery device according to various aspects and embodiments of the present disclosure.

[0214] [Figure 107] 1 shows an example of a thermal image of an injection site showing a blister due to the injection into the skin, in accordance with various aspects and embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0215] 1A and 1B show an embodiment of an exemplary delivery device 10. The exemplary delivery device 10 can be a low profile delivery device 10 that can be applied onto the skin of a patient. The exemplary delivery device 10 can be sized for handheld use and can be easily applied to a wide variety of injection sites on a patient's body. Additionally, the exemplary delivery device 10 can be designed to be used by a patient or an individual with relatively little or no training. Thus, a medical caregiver may not be required to use the delivery device 10.

[0216] Such a delivery device 10 may be used to administer a drug to a target site on a patient via one or more delivery sharps 72 from a reservoir 12 included as part of the delivery device 10. The reservoir 12 may be at least partially flexible and may have a variable volume that may decrease as fluid is dispensed from the reservoir 12. When the reservoir 12 is emptied, the reservoir 12 may at least partially collapse. In an exemplary embodiment, multiple delivery sharps 72 are included in the delivery device 10, although other embodiments may include only a single delivery sharp 72. The exemplary multiple delivery sharps 72 may be arranged in a one- or two-dimensional array and may extend from the reservoir 12. When multiple delivery sharps 72 are included, the delivery sharps 72 may be arranged in one or more rows and / or columns. Although FIG. 1A shows three delivery sharps 72 arranged in a row, multiple delivery sharps 72 may be arranged. The number and arrangement of the delivery sharps 72 may vary in alternative embodiments. Various examples may include any suitable number of rows and / or columns. In various embodiments, for example, there may be a single column array of delivery sharps 72 including up to five delivery sharps 72. Preferably, the delivery sharps 72 may be arranged to prevent skin penetration being hindered between users and delivery devices 10, or to prevent inconsistent bed of nails type situations. Bed of nails type scenarios may be arranged to prevent bed of nails type scenarios, which may occur if too many delivery sharps 72 are placed close to each other. Thus, this array may be referred to as a spaced array of delivery sharps 72.

[0217] The delivery sharps 72 can be selected based on the desired target delivery site of the patient. In certain embodiments, the target delivery site may be a transdermal location. For example, the target delivery site may be a subcutaneous delivery destination or an intramuscular delivery destination. Alternatively, the target delivery site may be a shallow delivery destination between the patient's stratum corneum and the patient's subcutaneous tissue. Such shallow destinations may be referred to herein as intradermal delivery destinations. Shallow delivery destinations may include target sites in the epidermis or dermis, for example, targeting the junction area between the epidermis and dermis, or the dermis and subcutaneous tissue. In an exemplary embodiment, the delivery sharps 72 are shown as microneedles. Such delivery sharps 72 may be present in a delivery device 10 having a shallow target delivery site (e.g., above the subcutaneous tissue). In alternative embodiments, for example, where the target delivery site is a subcutaneous or intramuscular location, a conventional delivery sharp (e.g., a 30 gauge needle) may be utilized.

[0218] In FIG. 2, microneedles are used, but the microneedles described herein may be polyhedral (e.g., pyramidal) silicon crystal microneedles fabricated with MEMS in certain embodiments. These microneedles may be 1 mm or less in height, e.g., 0.6 mm or 0.8 mm (although longer or shorter microneedles may also be used). At least some edges of the microneedle may be rounded or filleted, but such microneedles may still be referred to as polyhedral herein. In some examples, as shown in FIG. 2, the microneedles described herein may generally be in the shape of a heptagonal prism cut at an angle to form a heptagonal ramp or pointed wedge (although pentagonal, nonagonal, and other polygonal prisms may also be used as base shapes). In such embodiments, the heptagonal prism may be divided by a plane extending from the apex 14 of the top surface of the prism through the most distal side 15 of the base 17. At least two sides of the base of the microneedle may be parallel. The sidewall 19 may extend substantially perpendicularly from the base 17. The microneedle may be substantially symmetrical about a line of symmetry extending from the apex 14 to a point above a point on the center of the most distal side 15. In other embodiments, the microneedle may be conical. Any other suitable shape may be used. In this example, the apex 14 is shown as a point that forms the tip of the microneedle. In other embodiments, this portion of the microneedle may be rounded (although it may still be referred to herein as the apex 14, and such a microneedle may still be referred to as pointed). In such embodiments, the rear side edge 23 may be a rounded surface, or the rear side edge 23 and the adjacent sidewall 19 may be replaced by a rounded surface.

[0219] The tip or end of the microneedle may be solid, and the flow path 126 through the microneedle may be offset from the tip or end of the microneedle (wherein in FIG. 2 apex 14 forms the tip). Hollow-tipped microneedles may also be utilized, with the flow path 126 extending to the tip of the microneedle. In some embodiments, the microneedle may be a hollow microneedle, available from NanoPass Technologies Ltd., Golda Meir 3, Ness Ziona, Israel. It should be noted that microneedles described herein as being composed of silicon (or the substrate on which the microneedle is disposed), while still being considered to be composed of silicon, may have a surface layer of silicon dioxide (which may form, for example, due to exposure to air).

[0220] 3A-4B, in some embodiments, the microneedles may be constructed to include certain features that help reduce the pressure required to inject a fluid, such as a drug, into a patient's skin. In some instances, features common to insect stingers or biotoxin administration structures may be incorporated. These features may include various recesses or depressions formed in each microneedle or as part of at least one microneedle of the delivery device 10. These recesses or depressions may be in fluid communication with the flow channels 126 of the respective microneedles. In some embodiments, different microneedles of the delivery device 10 may include different recesses, or some microneedles may include multiple recesses that may (but need not) be different.

[0221] For example, as shown in Figures 4A-4B, the microneedle may include a channel or trough 200 on the outer inclined surface 21 from the flow channel 126 toward the distal side 15. The channel 200 allows the medical agent to flow along the outside of the microneedle through the channel 200 to find the path of least resistance, or weakest link, to the skin. In the illustrated embodiment, if the outlet of the flow channel 126 is inserted deeper than the depth of the weak area of ​​the skin, the channel 200 allows the agent to flow along the outside of the microneedle to the weak area of ​​the skin. The pellucida junction, which is the destination of intradermal delivery, is a weak link in the skin structure and is difficult to inject directly to consistently due to its relative thinness (typically about 40 nm thick). A microneedle including a channel 200 may allow the medical agent to flow to the pellucida junction, for example, when the pellucida junction passes the outlet of the flow channel 126. The channel 200 may facilitate distribution of the medical agent through a larger penetration or injection area. In some instances, incorporating the channels 200 into the microneedles can significantly reduce the pressure required to inject a drug into the skin. In certain instances, the pressure can be reduced by 600% or more (e.g., from 120 pounds per square inch (psi) to 18-20 psi in certain instances).

[0222] A suitable silicon etching technique (or mold in embodiments using polymer microneedles) can be used to create steeper side walls of the channel 200. This can help inhibit the skin from bending and blocking the channel 200. Etching techniques that can be used include, by way of non-limiting example, chemical etching techniques (e.g., acid). Suitable etching techniques include ion-based etching techniques (e.g., reactive ion etching). The etching process can be a wet etching process or a dry etching process. In some non-limiting embodiments, the channel 200 can have a side-to-side width in the range of 50-60 microns. In some non-limiting embodiments, the channel 126 can have a diameter of 50-60 microns. The channel 200 can have a width equal to the diameter or widest portion of the channel 126, or the channel 200 can have a width less than or greater than the width of the channel 126. The channel 200 can be about 5-10 percent of the height of the microneedle.

[0223] To avoid leakage of fluid from the channel 200, it may be desirable to ensure that the channel 200 terminates at least a certain distance below the surface of the skin when the microneedle is inserted into the skin, and also reaches the target skin layer (e.g., the pellucid plate junction). In some embodiments, the channel 200 extends from the flow path 126 to within up to 50 microns (e.g., 50-200 microns) of the base 17 of the microneedle. In some embodiments, the end of the channel 200 most proximal to the base 17 of the microneedle may be below at least the stratum corneum (and possibly one or more of the stratum lucidum, stratum granulosum, stratum spinosum, and stratum basale) when the microneedle is inserted into the skin. In some embodiments, the end of the channel 200 closest to the base 17 may be located below the epidermis (e.g., in the basement membrane) or within the epidermis.

[0224] The channel 200 does not have to be straight or shaped as shown and described in Figures 4A-4B. In some embodiments, the channel 200 may be a more tortuous flow path 200. For example, a curved flow path 200 may be used if the dimensions of the microneedle allow for it. Furthermore, there need not be only one channel 200. Two or more channels may be used if the structural integrity of the microneedle is taken into consideration.

[0225] The depth of the channel 200 may be about 25 microns or more (e.g., 25-50 microns) in certain examples. The depth of the channel 200 may be 5 percent or less of the height of the microneedle. The depth of the channel 200 may be constant along the length of the channel 200, but the depth of the channel 200 need not be constant along the length of the channel 200. Similarly, the width of the channel 200 need not be constant along the length of the channel 200 (see, e.g., FIG. 5B). The width of the channel 200 may be about 20-30 percent of the width of the distal side 15 of the microneedle at the narrowest point of the channel 200. In some embodiments, the width of the channel 200 may increase as the distance to the distal end 15 decreases. In some embodiments, the channel 200 may have a width at its widest that is 50% or more of the width of the distal side 15.

[0226] 5A and 5B, in other examples, the channel 200 may extend from the location of the flow passage 126 toward the tip or apex 14 of the microneedle (see, e.g., FIG. 5B). Additionally, in some examples, the channel 200 may extend from the location of the lumen 126 toward the apex 14 and toward the base 17. That is, the channel 200 may include a portion of both sides of the lumen 126 (see, e.g., FIG. 5A). As shown, the lumen 126 may be located substantially in the center of the inclined surface 21 of the microneedle. In such an embodiment, the channel 200 may extend toward the distal side 15 of the base 17, and the channel 200 may extend toward the tip or apex 14. In other embodiments, the lumen 126 may be positioned at (or near) the end of the channel 200 closest to the base 17.

[0227] Referring now to Figures 6A-6B, a sharp bearing body 26 is shown containing a number of microneedles. In certain embodiments, the channel 200 may not be included. Instead, the microneedle may include a flow passage 126 having an elongated cross section (at least at the outlet, see also Figures 7B and 8B). Microneedles with a channel 200 and an elongated lumen 126 are also possible. The elongated lumen 126 may be in fluid communication with, for example, multiple skin layers when placed in a predetermined position within the patient's body. Thus, thin and / or weak layers of skin may be easier to target when the microneedle is advanced into the patient's body. The elongated lumen 126 may also help to reduce the pressure required for injection. Such elongated flow passages 126 may have any suitable cross section. In some embodiments, the cross section may be oval or elliptical. Alternatively, a lumen 126 having an elliptical cross section may be used, as shown in Figures 6A and 6B. Polygonal cross-sectional shapes may also be used, such as, but not limited to, rectangular, trapezoidal, triangular, etc. In certain instances, the cross-sectional length (in the direction of elongation) of the lumen 126 may be up to 100-200 μm or more (although in certain instances it may be less). When an elongated lumen 126 is included, the end of the lumen 126 most proximal to the distal side 15 may be spaced at least a certain distance from the distal side 15. This spacing may be such that when the microneedle is inserted into the skin, the end of the lumen 126 most proximal to the distal side 15 may be at least below the stratum corneum (and possibly one or more of the stratum lucidum, stratum granulosum, stratum spinosum, and stratum basale). In some embodiments, it may be located below the epidermis (e.g., in the basement membrane) or within the epidermis.

[0228] 6A-6B, in certain embodiments, the inclined surface 21 of the microneedle may not extend to the base 17 of the microneedle. For example, there may be a vertical surface 13 that extends from the base 17 of the microneedle to the distal side 15. If a vertical surface 13 is included, the vertical surface 13 may be aligned with a side (e.g., distal side 15) of the sharps holder 26 and may form an extension thereof. The inclusion of such a vertical surface 13 may help reduce the size of the sharps holder 26 and help ensure consistent fluid delivery to the target site of delivery of a particular microneedle. As shown in FIGS. 6A-6B, any of the microneedles shown herein may be arranged with a vertical surface 13.

[0229] Additionally or alternatively, the microneedle may include a recess 202. The recess 202 may include first and second opposing apexes 204, 206. In some embodiments, the recess 202 may be (but is not necessarily) a rounded depression or a concave depression, as shown in Figures 3A-3B. The recess 202 may have a maximum depth at which the recess 202 is in fluid communication with the flow channel 126 of the microneedle. The recess 202 may thus form a side port for the microneedle through which fluid may be delivered to the patient. The side port may be the only outlet of the microneedle or may be in addition to the outlet of the lumen at the face 21 of the microneedle. When the microneedle is inserted into the skin surface, the fluid contained in the delivery device 10 may be delivered to the patient, at least in part, by being pumped into the recess 202. The recess 202 may be formed, for example, by cutting out material during the manufacture of the microneedle or may be formed during a molding operation. The cutting out of material may be accomplished by any known suitable process, such as, for example, etching (e.g., wet etching). In some embodiments, the recess 202 may be recessed into at least one sidewall 19 or edge of the microneedle (e.g., where two sidewalls 19 join). As shown in Figures 3A-3B, the recess 202 is formed in a substantially vertical back edge 23 of the microneedle that extends from the base 17 to the apex 14. This may establish or increase the vertical void volume created by the microneedle as it penetrates the skin. That is, such a recess 202 may establish an open space in the patient through which fluid may be easily delivered from the microneedle. Locating the recess 202 in the back edge 23 may provide a low resistance path for fluid to enter the skin penetrated by the microneedle. In embodiments where the microneedle includes at least one substantially vertical wall, the recess 202 may be recessed into the substantially vertical wall. In an exemplary embodiment, the maximum depth of the recess 202 may be about 130% to 110% of the distance from the back edge 23 to the flow channel 126.

[0230] In certain examples, as shown next in Figures 7A and 7B, the microneedle may include a beveled surface 21 from which extends a lumen 126 extending through the microneedle. The microneedle may also include a rounded blade edge 31. In this example, the rounded blade edge 31 extends from a point 33 opposite the distal side 15 and extends in an arcuate path to the apex or tip 14 of the microneedle. In this example, the rounded blade edge 31 includes a double bevel, although other types of bevels may be used. The rounded blade edge 31 may be arced at a constant radius or may be arced at a variable radius. The rounded blade edge 31 may have an arc dimension less than 90°, or in certain examples, may have an arc dimension greater than 90° (see, e.g., Figures 8A-8C). The rounded blade edge 31 may aid in the introduction of the microneedle into the skin when the microneedle is inserted at a particular angle or over a variety of different angles.

[0231] In yet another embodiment, as shown in Figures 8A-8C, the lumen 126 may include a rounded blade edge 31 and a lumen exit surface 35. The lumen 126 may extend through the microneedle to the lumen exit surface 35, and may not be formed in a straight line through the microneedle. The lumen exit surface 35 may be angled from the apex 14 toward the distal side 15 to form an undercut. The distal edge 15 may be positioned such that a plane perpendicular to the base 17 passing through the distal edge 15 can also pass through the rounded or arcuate blade edge 31. Additionally, the outlet of the channel 126 at the lumen exit surface 35 may be positioned such that one or all planes perpendicular to the base 17 and passing through the outlet of the channel 126 can also pass through the blade edge 31. This need not be the case in all embodiments (see, for example, Figures 7A-7B). When a microneedle of the type shown in Figures 8A-8C is inserted, a vertical gap may result from the undercut. This may provide a low resistance path for fluid injection. Additionally, the undercut may help reduce the likelihood of the lumen 126 being blocked by the skin when the microneedle is inserted into the patient or when delivery occurs.

[0232] In yet other embodiments, as shown in Figures 9A-9D, the delivery sharp 72 may be or include a microneedle having a high aspect ratio shape. In some embodiments, the microneedle may be obelisk shaped. Such microneedles may be included in an array, such as any of the arrays described herein. When an obelisk shaped microneedle is used, the microneedle may include a base 17'. The base 17' may be any desired circular or polygonal shape. By way of example, Figures 9A-9D show a base 17' that is square or diamond shaped. The exemplary microneedle includes a set of sidewalls 19' that extend from the base 17' to an end region 25 of the microneedle. The sidewalls 19' may be disposed at an angle that is not perpendicular to the base 17'. Thus, the microneedle may taper to have a smaller cross-sectional area as the distance from the base 17' increases. The portion of the microneedle most distal to the base 17' may include a beveled tip 27. Such a tip 27 may facilitate piercing the skin and may help to increase the robustness of the end region 25. Any suitable bevel may be used, such as a single bevel or a double bevel.

[0233] In an embodiment of an obelisk-shaped microneedle, the microneedle may include at least one side port 29 that may function as an outlet for the microneedle. Such a side port 29 may be difficult to block in tissue that may be compressed during insertion of the microneedle into a patient. In an exemplary embodiment, the lumen 126 may extend through the base 17' of the microneedle and terminate closer to the end region 15 than the base 17'. The lumen 126 may have a relatively constant cross-section. The taper of the side wall 19' may be such that the end of the lumen 126 is wider than the cross-section of the corresponding region of the microneedle. Thus, the lumen 126 may form an opening in the side wall 19' that functions as the side port 29. In various examples, the lumen 126 may be centrally located, resulting in a symmetrical side port 29. In alternative embodiments, the lumen 126 need not be centrally located, and the side port 29 may not be symmetrical.

[0234] In various embodiments where silicon is not used to form the microneedles, the microneedles described herein may be made of glass (e.g., silica glass, borosilicate glass), ceramic (e.g., organically modified ceramics such as alumina, calcium sulfate dihydrate, calcium phosphate dihydrate, ormocer, etc.), polymer (e.g., polymethylmethacrylate or PMMA, polylactic acid or PLA, polylactic-co-glycolic acid or PLGA, polyglycolic acid or PGA, polycarbonate, cyclic olefin copolymer or COC, polyvinylpyrrolidone or PVP, polyvinyl alcohol PVA, polystyrene, polymethylvinylether-co-maleic anhydride), carbohydrate, or metal (e.g., stainless steel, titanium, alloys such as palladium, nickel, palladium-cobalt alloys, etc.). Any suitable microneedle structure may be used, including dissolvable microneedles. The microneedles and their features may be manufactured by one or more of, but are not limited to, molding processes, etching processes, ablation processes (e.g., laser ablation), or material addition processes (e.g., 3D printing). In various embodiments, it may be desirable for the microneedles to be constructed of a biocompatible, non-ductile, high Young's modulus material that has sufficient indentation hardness to allow penetration into the skin without breaking.

[0235] Referring again primarily to Figures 1A and 1B, the delivery device 10 described herein can deliver any of a variety of drugs or other medical agents to a patient. In certain embodiments, the reservoir 12 of the delivery device 10 may be filled with a vaccine. Such a delivery device 10 can deliver any suitable vaccine, but may be particularly well suited for vaccines against novel pathogens (e.g., SARS-CoV-2) or pathogens for which herd immunity does not exist (e.g., Ebola). Furthermore, such a delivery device 10 may be particularly useful in outbreaks of pathogens (e.g., measles, etc.) in communities that have chosen to forgo typical vaccinations. For example, such a delivery device 10 can be distributed without requiring patients to congregate in a hospital or other shared space. This may alleviate concerns about pathogen transmission associated with vaccination programs and alleviate potential concerns that may discourage people from reporting to get vaccinated. Instead, the delivery device 10 can be picked up and used by patients without violating social distancing, gathering size recommendations, or other safety guidelines. Alternatively, such a delivery device 10 could be distributed directly to a patient without the patient having to leave their residence or without the distributor having to interact with an individual who refuses to utilize the recommended PPE. The delivery device 10 could be loaded with a vaccine against a novel pathogen or with a vaccine typical of a regular vaccination schedule. In the latter case, such a delivery device 10 could help ensure that vaccination against known pathogens does not cease during a novel pathogen pandemic.

[0236] Any suitable vaccine may be delivered through such a delivery device 10. For example, the vaccine may be, but is not limited to, attenuated, inactivated virus, acellular, cellular, toxoid, heterotypic or Jenner, monovalent, polyvalent, nucleic acid (e.g., DNA, plasmid, mRNA), virus-like particle, recombinant vector (e.g., replicating, non-replicating), dendritic cell, T cell receptor peptide, chimeric, subunit, nanoparticle, recombinant protein, polysaccharide, and conjugate vaccines. Note that these are not necessarily mutually exclusive. For example, the vaccine may be a recombinant protein nanoparticle vaccine or other combinations of the above. Vaccine may also refer to combination vaccines (e.g., DTaP, MMR, MMRV, etc.) or vaccinal agents that target a single pathogen or multiple strains of a single pathogen. Examples of vaccines include, but are not limited to, vaccines for various coronaviruses, such as SARS-COV, SARS-COV-2, MERS-COV, HCoV-NL63, HCoV-229E, HCoV-OC43, and HKU1 (and variants and subspecies thereof). The delivery devices 10 described herein are also not limited to human use. Such delivery devices 10 may be used for livestock, pets, service animals, or other veterinary applications. In such cases, these delivery devices 10 may be loaded with a vaccine against at least one non-human pathogen. The delivery devices 10 described herein may also be useful for research applications.

[0237] When the delivery device 10 is filled with a vaccine, it may be desirable for the delivery site to be a shallow delivery destination. This may be particularly desirable when the amount of vaccine available is limited. For example, such a delivery device 10 may be well suited for use with new vaccines that are in high demand. Vaccines against novel pathogens (e.g., SARS-CoV-2 or other coronaviruses) may, for example, be well suited for use with the delivery device 10 described herein.

[0238] Evidence suggests that shallow delivery of vaccines may elicit a protective immune response with smaller amounts of vaccine antigen. This can result in dose savings allowing more people to be effectively vaccinated with the same amount of vaccine. Alternatively or additionally, it may be possible to save on injections. Shallow administration using a delivery device 10 as shown herein can allow for a single injection protocol where other routes of administration may require multiple injections over a period of time. Some vaccine formulations may include one or more adjuvants to further facilitate dose and injection savings, although it may also be possible to reduce the reliance on adjuvants when the vaccine is administered intradermally.

[0239] Particularly for new vaccines generated to combat the ongoing pandemic (e.g., a vaccine for SARS-CoV-2), the prospect of being able to rapidly produce billions of doses of the vaccine will almost certainly exceed current vaccine production capabilities. Due to the injection and dose-saving potential of the delivery device 10 described herein, such a delivery device 10 may facilitate vaccination of large numbers of people even when much-needed vaccines are in short supply. Furthermore, as a result of the potential dose and injection savings, the delivery device 10 as shown and described herein may be able to make injections more cost-effective. Furthermore, because a smaller amount of vaccine is required, the delivery device 10 can be made relatively small. This may simplify transportation and facilitate rapid distribution of the vaccine to the population. This may be particularly attractive for vaccines that require cold chain distribution, as packaging volume may become more critical.

[0240] Moreover, some studies suggest that shallow administration may be particularly useful in certain patient populations. For example, older adults may receive better protection with intradermal vaccination than with other routes. That said, the Mantoux technique typically used for intradermal administration can raise concerns about reliability and can be difficult to perform, especially without training. According to the World Health Organization, a major factor limiting the use of intradermal vaccination is the lack of an administration platform.

[0241] The delivery device 10 as illustrated and described herein can provide an attractive delivery platform for intradermal vaccination. As a result, the delivery device 10 as described and illustrated herein can help provide better protection to vulnerable populations and can help meet the large demand for vaccines, for example, against novel pathogens, by leveraging the dose / injection savings that may be possible with intradermal vaccination. Furthermore, the intradermal delivery device 10 described herein is painless or nearly painless, which may make the delivery device 10 described herein preferable to users over other types of injections. That being said, and as noted above, the delivery device 10 described herein is not limited to delivery via an intradermal route. The delivery device 10 can be configured, for example, as a transdermal (e.g., subcutaneous or intramuscular) delivery device 10.

[0242] Moreover, the exemplary delivery devices 10 shown herein are not limited to vaccine delivery devices. Such delivery devices 10 can fill many niches in the medical field. Other agents, such as diagnostic or testing agents, can be delivered via certain exemplary delivery devices 10. For example, allergens or potential allergens can be administered via the delivery device 10. Tuberculosis testing agents can be delivered via the delivery device 10. Such devices 10 can also be used to deliver agents for endocrine disorders. For example, insulin can be delivered using some exemplary delivery devices 10.

[0243] The delivery device 10 described and illustrated herein may also be suitable for administering an overdose countermeasure medication, such as an opioid antagonist (e.g., naloxone). The delivery device 10 described herein may be easily used at the scene of an overdose by bystanders without medical training. Alternatively, the delivery device 10 may be used by emergency medical services (EMS) personnel responding to an overdose. Such a delivery device 10 may provide rapid access to, for example, an overdose patient and deliver medication to a shallow site. This may provide rapid delivery of medication to an overdose patient and may also eliminate the need to establish intravenous access, which may be difficult, especially for intravenous drug users.

[0244] 1A-1B, the delivery device 10 may include a body 20. The body 20 may be a deformable body that may transition from a storage state (see FIG. 1A) to a delivery state (see FIG. 1B). In certain instances, the transition may be reversible, while in other embodiments, the transition may result in a permanent change to the body 20 and / or another portion of the delivery device 10. The body 20 may plastically deform such that it is permanently distorted and does not return to the storage state. In other instances, the delivery device 10 may include a weakened portion that may break as the body 20 transitions to the delivery state. Alternatively or additionally, a latch, lock, or other coupling may be engaged to hold the body 20 in the delivery state or prevent the body 20 from returning to the storage state. Release of such coupling may require destruction of a portion of the body 20 or a portion of the delivery device 10 engaged with the body 20, which may render the delivery device 10 inoperable. If a permanent change occurs upon transition to the delivery state, the permanent change may not only prohibit reuse but may also provide a perceptible (e.g., visual) indication to the user that the delivery device 10 has been used. The indication that a transition has occurred may also be generated by the delivery device 10. For example, an audible or tactile indication may be generated upon engagement of a latch or breaking of a frangible portion.

[0245] In various examples, the transition of the delivery device 10 from the storage state to the delivery state may be accomplished through bending, pivoting, or deformation of one or more regions of the body 20. In certain examples, the body 20 may include one or more hinges (e.g., living hinges, which help reduce part count) around which the body 20 may bend. In other embodiments, the body 20 may be or include a bi-stable element having a first stable state corresponding to the storage state and a second stable state corresponding to the delivery state. The body 20 may have one or more reversible regions that, for example, substantially or partially reverse in shape (e.g., from convex to concave) or at least partially reverse when the delivery device 10 transitions from the storage state to the delivery state. In some embodiments, the body 20 may include one or more reversible regions and may include one or more regions that distort and at least partially return to their original shape as the delivery device transitions to the delivery state.

[0246] The transition can be affected by the application of force throughout the entire transition. Alternatively, the transition may only require the application of force throughout a portion of the transition. For example, in some embodiments, a trigger force may be applied to initiate the transition, after which the transition may be completed without the application of an external force. For example, after application of the trigger force, the transition may be characterized by a snap-through buckling in which the body 20 rapidly transitions to the delivery state.

[0247] The body 20 may be at least partially covered with adhesive 22 on a first surface 24 of the body. The body 20 may serve to couple the body 20 to a skin surface at a patient's infusion or injection site. Thus, the first surface 24 may be a surface adjacent to the skin or a proximal (proximal and distal defined with respect to the patient) surface of the body 20. When the body 20 is in the storage state and is then transitioned to the delivery state, the body 20 may be adhered to the skin. When the transition occurs, at least two adhesive-bearing portions of the body 20 may be displaced relative to each other to stretch or widen the surfaces secured to the body 20 via the adhesive 22. When the portions are adhered to the skin surface, the skin may be stretched as the adhesive-bearing portions are displaced relative to each other. This may be desirable because the skin may be held taut to facilitate puncturing the skin by the delivery sharp 72 when the body 20 transitions to the delivery state. In certain examples, the adhesive-bearing portions may be positioned, for example, opposite each other. The displacement of the two adhesive-bearing portions may increase the distance between the two adhesive-bearing portions or may cause the two adhesive-bearing portions to spread apart. In other embodiments, the distance between the two adhesive-bearing portions may not increase or may even decrease while causing a stretching of the skin surface. This may occur, for example, when the transition pulls a flat portion of the skin around a curve or contour of the body 20 (see, for example, Figures 17 and 18). The displacement of the adhesive-bearing portions relative to each other (whether a positive or negative change in the distance between the adhesive-bearing portions) that results in a stretching of the adhered skin may be referred to as spreading displacement. The two adhesive-bearing portions so displaced may be referred to as being spreading displaced.

[0248] When the body 20 transitions to the delivery state, the delivery sharp 72 may also be displaced or lowered proximally toward and into the skin. In embodiments where the delivery sharp 72 is coupled to the reservoir 12, the reservoir 12 may also be displaced proximally. In some examples, the reservoir 12 may be compressed between the skin surface and a portion of the body 20 when the body 20 transitions from the storage state to the delivery state. Preferably, the delivery sharp 72 may be inserted into the skin before the reservoir 12 is substantially compressed. Compression of the reservoir 12 may help to expel fluid from the reservoir 12 and through the delivery sharp 72 to the target delivery site within the patient's body. In embodiments described herein, the delivery sharp 72 may be covered prior to use. A fluid communication path from the reservoir 12 out of the delivery sharp 72 may not be available prior to use.

[0249] In some embodiments, a collapsible pouch or packet 208 can be placed over the reservoir 12 in the delivery device 10, as shown in FIG. 10A. The packet 208 can include a substance that is at rest in a first state and transitions to a powered state in a second state. In one embodiment, the substance is at rest at a first temperature and a motive force can be applied to, for example, the reservoir 12 at a second temperature. In an exemplary embodiment, the first temperature can be lower than the second temperature. The first temperature can be a cold chain storage temperature for the vaccine. The second temperature can be room temperature or at least a temperature lower than the average body temperature of the patient (e.g., 98.6° F. for humans). In some embodiments, the substance can change volume when transitioning from the resting state to the powered state. Alternatively or additionally, the substance can change from one material state to another when transitioning from the resting state to the powered state. In an exemplary embodiment, the substance can change from a liquid to a gas during the transition from the resting state to the powered state.

[0250] In embodiments where the drug in the reservoir 12 of the delivery device 10 must be stored at very low temperatures, for example if the drug is a vaccine with such a requirement, the packet 208 may contain a liquid. For example, the vaccine may be stored and / or transported at commercial freezer temperatures, for example in the range of -18°C (or lower, e.g., -70°C or -20°C for certain vaccines). The liquid may have a boiling point higher than the storage temperature of the drug (e.g., vaccine) but lower than room temperature or another suitable temperature set point. While any suitable liquid may be used, one example of a suitable liquid is butane. The boiling point of butane is -1°C. Although the examples described herein refer to butane, one of ordinary skill in the art will appreciate that this description may be generalized to any suitable liquid.

[0251] The delivery device 10 can be affixed to the user's skin surface with the reservoir 12 containing the cryogenically stored / shipped vaccine and the packet 208 containing liquid butane (or any other suitable substance). When the ambient temperature is room temperature, e.g., about 20° C., the contents warm up (heat from the patient can help this). In an exemplary embodiment, the liquid butane boils and changes to a gas when it reaches its boiling point of −1° C. As the liquid boils and transitions to a gaseous state, the pressure in the packet 208 increases, causing the packet 208 to expand and exert a downward pressure on the reservoir 12 from above, as shown in FIG. 10B. For example, butane gas has a vapor pressure of 35.4 psi at 25° C. Thus, the final pressure of the reservoir 12 can be higher (e.g., about 38 psi) due to the transfer of heat from the patient to the packet 208. The body 20 of the delivery device 10 can be elastic enough not to deform under the pressure exerted by the packet 208. This can help direct the pressure towards the reservoir 12.

[0252] Such a configuration may also help provide visual evidence of whether the delivery device 10 has reached a temperature that is too high for the drug during storage or transport. For example, if a temperature exceeding the phase change temperature of the contents of the packet 208 is reached during storage, the pressure exerted from above by the packet 208 will emptie the delivery device 10. This may be visually noticeable to the user. The delivery device 10 may also self-destruct if exposed to certain temperature abuse scenarios. If the delivery device 10 is exposed to a temperature exceeding the phase change temperature of the contents of the packet 208, the delivery device 10 will emptie. As a result, the delivery device 10 will prevent itself from later administering the temperature abuse drug.

[0253] In some embodiments, it may be desirable for a significant downward pressure on the reservoir 12, for example, greater than 50 psi, to provide a force that collapses the reservoir 12 and forces the fluid therein through the delivery sharp 72 and into the user's skin. See Figures 1A and 1B. In such an embodiment, the packet 208 can be incorporated into a squeezable container 350, as shown in Figure 11. The container 350 can be made of squeezable plastic or any other suitable material, as will be appreciated by those skilled in the art. The container 350 can be formed by injection molding, thermoforming, or any other technique known to those skilled in the art. In addition to housing the packet 208, a first substance can be stored within the container 350. The packet 208 can hold a second substance. The first and second substances can be components of an expanding foam, for example. The first and second substances can be selected to expand and create pressure when they come into contact with each other. For example, a chemical reaction that produces a gas (such as baking soda or vinegar) can be used. Upon application of the delivery device 10 to the skin surface, a user may, for example, pinch, crush, squish or squeeze the container 350, causing the packet 208 therein to burst, thereby causing the first and second substances to interact and exert downward pressure on the reservoir 12 below.

[0254] In yet other embodiments, the packet 208 may be a vacuum packed biasing member (e.g., a foam spring). In the vacuum packed state, the biasing member may be in a compressed state. User interaction with the packet 208 may rupture the packet 208, allowing the biasing member to recover. When the biasing member recovers, pressure is applied to the reservoir 12, creating pressure for delivery.

[0255] In another embodiment, the packet 208 of FIG. 10A or 10B may be filled with contents that do not change phase when removed from refrigerated storage. For example, the packet 208 may be a gas bag that serves to prevent pressure from a user's finger applied to the top of the delivery device 10 from being applied directly to the reservoir 12. Such a gas bag may also serve to increase the applied pressure. An example of a suitable gas that may be used to fill such a packet 208 may be nitrogen. Any other suitable gas may be used.

[0256] In other embodiments, the packet 208 of FIG. 10A or FIG. 10B may be or include a biasing member. In some embodiments, the packet 208 may be a foam adhesive material located over the reservoir 12. In such an example, when the user presses down on the delivery device 10 (after the delivery device 10 is affixed to the skin surface), the foam adhesive may also facilitate an even distribution of pressure across the top of the reservoir 12. Assembly of the components described in connection with the above embodiments is described below with reference to FIGS. 49-61B and 12-29B.

[0257] With reference to Figures 12-14, an exemplary delivery device 10 is shown. The exemplary delivery device 10 is shown in a stored state in Figures 12-14. As shown, the delivery device 10 can include a body 20 and a reservoir 12. The reservoir 12 can include at least one delivery sharp 72. The delivery sharp 72 can be included on a sharps retainer 26 that can be coupled to a wall of the reservoir 12. The body 20 of the exemplary delivery device 10 can have a circular (e.g., circular) footprint and can include a central region 28 and a peripheral region 30. The central region 28 can be a raised region of the body. The body 20 and the peripheral region 30 can be substantially flat regions of the body 20 surrounding the central region 28. The thickness of the body 20 can be substantially uniform throughout the body 20. It can be formed as a thin sheet or disk of material that can be thermoformed to form the raised central region 28 and the flat peripheral region 30.

[0258] Alternatively, the body 20 may be injection molded, with the raised central region 28 and the flat peripheral region 30 formed during the molding operation. In various embodiments in which the delivery device 10 is or can be injection molded (e.g., the embodiments described in connection with Figures 12-35), the body 20 may be injection molded to be in either the stored or delivery state. The body 20 may be more easily transitioned from the reverse state to the molded state. Thus, to reduce the effort required to transition the delivery device 10 from the stored state to the delivery state, it may be desirable to mold the body 20 of the delivery device 10 into the shape of its delivery state. During assembly of the delivery device 10, the body 20 may be placed in its stored state configuration and remain in that configuration until use.

[0259] The central region 28 may be dome-shaped, which defines a housing 32 proximal to the body 20 within which the reservoir 12 may be disposed. The reservoir 12 may be bonded within the housing 32 via adhesive or another suitable method. The central region 28 may also include a series of fenestrations 34 that may form a fenestrated ring in the central region 28. In this example, the fenestrations 34 are equally spaced from one another and arranged in a circle approximately coaxial with the center. In alternative embodiments, the fenestrations 34 may be irregularly spaced or omitted. Additionally, in some embodiments, the fenestrations 34 may be replaced with a thinned region or ring of material in the body 20.

[0260] The body 20 can include a number of slots 36. The slots 36 can extend from a periphery 38 of the body 20 toward a center or midpoint of the body 20. In an exemplary embodiment, the slots 36 extend radially. The slots 36 can extend throughout the peripheral region 30. In some embodiments, as shown, the slots 36 can also extend through at least a portion of the central region 28. The fenestrations 34 in the central region 28 can be disposed radially inward of the ends 40 of each slot 36. Thus, the body 20 can include a central region 28 surrounded by a number of petals 42, which are spaced apart via the slots 36.

[0261] Referring to FIG. 15, a plan view of the proximal surface 24 of the body 20 is shown. As shown, adhesive 22 may be included on at least a portion of the proximal surface 24. The adhesive 22 may be a skin-compatible adhesive and may help to bond the delivery device 10 to the skin surface at the injection site. In an exemplary embodiment, the adhesive 22 may be included on the peripheral region 30 of the body 20. Although the adhesive 22 is shown to cover the entire surface of each petal 42 in the peripheral region 30, other embodiments may differ. For example, only certain petals 42 may include adhesive 22. In such an embodiment, the adhesive 22 may be included on at least one pair of petals 42 that are disposed oppositely (e.g., diametrically opposed in the exemplary embodiment). In some examples, only a portion (e.g., a majority of the surface area) of each petal 42 included in the peripheral region 30 may be covered with adhesive 22. Alternatively or additionally, the adhesive 22 may be different for each petal 42. Some petals 42 may be covered with a stronger adhesive 22 and other petals 42 may be covered with a less strong adhesive 22. In certain instances, the entire proximal surface 24 may be covered with adhesive 22. Additional adhesive members 22 are described elsewhere herein (see, e.g., FIGS. 81A-81C) and may be used with the delivery device 10.

[0262] Referring to FIG. 16, a conceptual representation of the body 20 of the delivery device 10 is shown in a delivery state. In the delivery state, at least the central region 28 of the body 20 can be substantially everted. The fenestrations 34 can facilitate this eversion by allowing increased flexure of the body 20 at the fenestrations 24. Thus, the central region 28 of the body 20 can assume a concave shape instead of a convex dome-like shape. When the peripheral region 30 is coupled to the central region 28, the peripheral region 30 can be displaced as a result of the eversion of the central region 28. In an exemplary embodiment, the entire body 20 assumes a bowl shape when transitioned to the delivery state. The peripheral region 30 can also be displaced extensively over at least a portion of the transition. The slots 36 of the body 20 can help facilitate the expansion displacement of the petals 42 as the transition occurs, thereby facilitating the stretching of the user's skin.

[0263] The body 20 may be a bistable element or may include at least one bistable region that may be stable in both the storage and delivery states. When the body 20 is in the storage state, an axial load acting on the central region 28 may cause the body 20 to deform into an unstable state. The body 20 may then exhibit a snap-through buckling action, causing the body 20 to rapidly transition to a stable delivery state similar to that shown in FIG. 16. Thus, only a trigger force may be applied to initiate the transition. The remaining changes between the storage and delivery states may be caused by the snap-through phenomenon.

[0264] FIG 17 shows the delivery device 10 in a retracted state and adhered to the skin 44 via the adhesive 22 on the proximal surface 24 of the body 20. FIG 18 is a conceptual diagram showing the delivery device 10 in a delivery state. As shown, the delivery device 10 may be applied to the skin 44 in the retracted state. The delivery device 10 may then transition to the delivery state. As the transition occurs, a spreading displacement of the opposing petals 42 of the body 20 may occur.

[0265] Two opposing points 46A, B located on the periphery of the proximal surface 24 are shown in Figs. 17 and 18. When the delivery device 10 is in the retracted state (Fig. 17), the shortest distance between the opposing points 46A, B is a straight line that does not pass through the proximal surface 24. This straight line is approximately parallel. However, in the delivery state, the shortest distance between the opposing points 46A, B is a straight line that passes through the proximal surface 24. If the skin 44 is secured to the body 20 via the adhesive 22 and cannot pass through the body 20, the skin 44 may be forced to conform to the curvature of the proximal surface 24. Thus, the length of the skin 44 surface between the two points 46A, B when the delivery device 10 is in the delivery state may be greater than the length of the skin 44 surface between the points 46A, B when the delivery device 10 is in the retracted state. The outer skin 44 may be placed under tension and stretched to accommodate this change in length. This stretching, in turn, may help facilitate puncturing the skin 44 by the delivery sharp 72.

[0266] When attempting to return to an unstretched state, due to the elasticity of the skin 44, the skin 44 can exert a restoring force against the proximal surface 24 of the body 20. The body 20 can resist this restoring force and maintain its bowl shape. However, the reservoir 12 can be compressed between the skin 44 and the body 20. This can help ensure that the delivery sharp 72 pierces the skin 44 and fluidly communicates with the target delivery site in the patient's body. Furthermore, because the reservoir 12 is collapsible, the restoring force exerted by the skin 44 can pressurize the reservoir 12 and allow fluid to be expelled from the reservoir 12 via the delivery sharp 72. The stretched skin 44 can help empty and collapse the reservoir 12.

[0267] As mentioned above, in certain instances, some petals 42 may not include adhesive 22 regions or may have proximal surfaces 24 at least partially covered with adhesive 22 that is less strong than the adhesive 22 on other petals 42. If some petals 42 are free of adhesive 22, this may help limit stretching of the skin 44. Similarly, petals 42 with less strong adhesive 22 may release the attached skin 44 patch if the force required to stretch the skin 44 exceeds a threshold value. The petals 42 themselves may be constructed such that at least one of the petals 42 includes a relief region (e.g., a thin or narrow region). For example, if the force required to stretch the skin 44 exceeds a threshold value, one or more of the petals 42 may bend or buckle at the relief region to relieve some of the tension on the skin 44.

[0268] This may be desirable as it may help reduce potential discomfort during injection due to excessive tension on the skin 44. Additionally, it may be helpful for certain patient populations as skin characteristics vary with age, hydration status, lifestyle (sun exposure, nutrition), etc. It may be desirable for loose or saggy skin to stretch more than skin that is more elastic. Thus, instead of providing a variety of delivery devices 10 with different adhesives 22 targeted to specific patient populations, the delivery device 10 may be made in a more generic manner.

[0269] 19 and 20, in another embodiment, the delivery device 10 may include a central region 28 having an upper surface 250 and a support structure 252 integral with the upper surface 250. The support structure 252 may have a circular, e.g., substantially circular, base. The peripheral region 30 may be approximately annular in shape and may include an inner periphery and an outer periphery or rim 38 that coincides with the base 262. The delivery device 10 may be constructed of Nycoa 2012 nylon or other similar nylon material and may be formed by injection molding. Any other suitable plastic may be used. The upper surface 250 may have a rounded footprint, e.g., approximately circular, or may be convex forming a dome shape. The upper surface 250 may have a periphery 340. The upper surface 250 may include a slot 254. The slot 254 may be a notch, hole, hole, opening, or void in various embodiments. The slots 254 can aid the delivery device 10 in transitioning from the stored state to the delivery state while relieving pressure from above. The slots 254 extend radially relative to the center point 256 of the upper surface 250, with respective first end points 258 surrounding an area that includes the center point 256 of the upper surface 250, and respective second end points 260 terminating at a fixed distance (e.g., the slots 254 are the same distance) from the periphery 340 of the upper surface 250. In embodiments that include slots 254, the slots 254 may be, but are not necessarily, spaced at regular angular intervals. In embodiments that include slots 254 described herein, the slots 254 do not necessarily have to be of equal length, but may be of equal length.

[0270] 21A-21I, various different body 20 embodiments are shown. The exemplary body 20 is shown in a flat state and can be thermoformed into a shape, such as that shown in FIG. 19. Although a thermoformable body 20 is shown, the features described with respect to a thermoformed body 20 may be included in a body 20 that is manufactured in any desired manner. As shown in FIGS. 21A-21I, the slot 254 can be provided in many different formats. Additionally, in some embodiments, the slot 254 may not be included.

[0271] In some embodiments, the slots 254 may be arranged so that they do not extend radially relative to the center point 256, as shown in FIG. 22. For example, the slots 254 may each extend at a common angle relative to the radial direction. In such embodiments, the slots 254 may be equally spaced around the top surface 250 and each may be of the same length. In other embodiments, the slots 254 may not all extend at a common angle relative to the radial direction. At least one (and possibly all) of the slots 254 may be arranged at a different angle relative to the radial direction. In some embodiments, the slots 254 may be relatively short and disposed around the periphery 340 of the top surface 250 and within an outer region of the top surface 250 (see, e.g., FIG. 21A). In other embodiments, the slots 254 may extend across the outer and middle regions of the top surface 250 (see, e.g., FIG. 21B). In yet other embodiments, the slots 254 may extend from the outer region of the top surface 250 into the middle region of the top surface 250 (see, e.g., FIG. 21C). The curved slot 254 may help to reduce the amount of pressure required to transition the delivery device 10 from the stored state to the delivery state. Positioning the slot 254 at a more acute angle relative to the radial direction may generally reduce this pressure. The width of the slot 254 may decrease slightly during at least a portion of the transition from the stored state to the delivery state.

[0272] In other embodiments, as shown primarily in FIG. 21E, at least one of the slots 254 may have a curvature. The curvature may be defined by a constant or variable radius. The curvature may only be present on a segment of the slot 254. In alternative embodiments, the slot 254 may include two or more sections that are angled from one another. In the exemplary embodiment shown in FIG. 1, FIG. 21E shows four curved slots 254, which are spaced apart at equal angular increments. The slots 254 are arcuate and include a first end 258 and a second end 260. Each exemplary slot 254 is oriented to initially begin extending from the first end 258 in a first direction and curve to extend in a second direction like a slot. The second direction may be closer to (or may be perpendicular to) the radial direction than the first direction.

[0273] 21D and 21F, the top surface may not include one or more slots 254, but may instead include at least one aperture 255. In the illustrated example, the aperture 255 is centrally located within the top surface 250. In some embodiments, the aperture 255 may surround substantially the entire top surface 250.

[0274] 21D and 21F, the slots 254 may be included in other regions of the body 20. In the exemplary embodiment, the regions of the body 20 that will become the support structures 252 (when the body 20 is thermoformed) include slots 254. These slots 254 may be straight, curved, angled (in terms of radial dimensions), or combinations thereof, similar to the patterns of slots 254 of the various top surfaces 250 described herein. As shown, the slots 254 are spaced at regular angular intervals and are spaced between the petals 42 of the body 20.

[0275] In yet other embodiments, the width of one or more slots 254 may vary over the length of the slot 254. Several embodiments including variable width slots 254 are shown in FIGS. 21G-21I. The slots 254 may vary in width continuously and may terminate at a pointed first or second end 258, 260. The variable width slots 254 may extend along a radial direction, but not necessarily in all embodiments. In an exemplary embodiment, each of the slots 254 is widest proximate a center point 256 of the top surface 250 and decreases in width continuously as the slots 254 extend distally toward the periphery 340 of the top surface 250. The top surface 250 shown in FIGS. 21G-21I may have slots 254 in a sunburst pattern. In other embodiments, the slots 254 do not necessarily increase or decrease in width continuously from one end to the other.

[0276] As shown in FIG. 22, the central region 28 may be monolithically formed with the petals 42, including the regions between each pair of slots 36 (see also FIGS. 12-18 and the examples and embodiments described above with respect thereto). The support structure 252 may extend upward from the petals 42 at an angle of 90° or at an angle greater than 90°, e.g., 100-105°, although the scale of the angle need not be limited to a range. The (vertical) distance from the base 262 of the support structure 252 to the periphery 340 of the top surface 250 may be long enough to provide the central region 28 with a housing for the reservoir 12 (see, e.g., FIG. 60), and in some embodiments, any packets 208 and / or containers 350 (see, e.g., FIGS. 10A-11), springs, or foam adhesive material. The housing may also be sized to house a portion of the actuation assembly or dispensing assembly 480 (see, e.g., FIG. 36). As described in more detail elsewhere herein, the packet 208 may include a gas bag, butane packet, or delivery force supply packet, and any associated containers 350, as described above with respect to FIGS. 10A-11. In some embodiments, the aforementioned distance may be about 0.3 inches (e.g., 0.315 inches). The slots 36 may extend from the periphery 38 of the delivery device 10 to the base 262 of the support structure 252, but may terminate at the base 262 and not extend into the support structure 252 itself. In such an embodiment, rather than the entire central region 28 substantially everting when pressure is applied from above (e.g., with a finger), only the upper surface 250 may evertate and assume a concave shape in the delivery state. In some embodiments, the support structure 252 may include fenestrations 264 evenly spaced around the base 262. The fenestrations 264 may facilitate manufacturing of the delivery device 10 in embodiments in which the body 20 is thermoformed.

[0277] In some embodiments, as shown in FIG. 23, at least one of the petals 42 may be made with an extended length such that an outer end of the petals 42 may be manipulated by a patient or healthcare provider as a pull tab 266. The pull tab 266 may be grasped by a user to remove the delivery device 10 from the skin after use. The pull tab 266 may be of any suitable shape. In one example, the pull tab 266 is approximately semicircular, has a first rounded end and a second end opposite the first end, and is attached to the petals 42. The second end may be attached to or formed integrally with the petals 42 by injection molding or other known techniques that allow the pull tab 266 to be sufficiently elevated from the skin surface to be held by a user.

[0278] As shown in FIG. 24, the pull tab 266 may also serve to facilitate a user to peel a release liner 265 from the bottom of the delivery device 10 before the delivery device 10 is applied to a skin surface via the adhesive 22. The release liner 265 may be removed in the same manner as a release liner is peeled off a bandage before application to the skin. An exemplary delivery device 10 having a pull tab 266 and including a release liner 265 and adhesive 22 is shown in FIG. 24. For purposes of illustration, the release liner 265 has been peeled off of the adhesive 22.

[0279] 25 and 26, an embodiment of a package 401 for a delivery device 10 is shown. In FIG. 25, the delivery device 10 is depicted housed within the package 401. The package 401 can include a first component 404 and a second component 406 (not shown in FIGS. 25-26, but see, for example, FIG. 104). The first component 404 can be a rigid component, such as plastic. The second component 406 can be a flexible component (e.g., an ethylene oxide (EtOx) permeable sheet) that can be peeled away from the first component 404 to access the delivery device 10. The interior of the package 401 can be a protected environment (e.g., an EtOx or other suitable sterile environment) until the second component 406 is removed from the first component. The second component 406 can be releasably coupled to a rim 403 included in the first component.

[0280] The first component 404 may include one or more wells 405. The delivery device 10 may be placed in one of these wells 405. The pull tab 266 of the delivery device 10 may protrude along a passageway 407 connecting two wells 405. To remove the delivery device 10, a user may reach into a well 405 in which the delivery device 10 is not placed and grasp the portion of the pull tab 266 that extends into that well 405. The delivery device 10 may then be easily lifted out of the package 401 by pulling the pull tab 266.

[0281] As shown in FIG. 26, a liner 265 for the adhesive 22 (e.g., see FIG. 24) may be bonded to one surface of the well 405. This may help limit movement of the delivery device 10 within the package 401 during shipping and handling. When the delivery device 10 is removed, the liner 265 may remain within the package 401. This may allow the delivery device 10 to be ready for use when removed from the package 401. A cap or cover 409 for the delivery sharps 72 of the delivery device 10 (e.g., a housing that surrounds the delivery sharps 72) may be included in some examples. The cover 409 may be bonded to the package 401 and may remain when the delivery device 10 is removed from the package 401. This may also help allow the delivery device 10 to be ready for use when removed from the package 401.

[0282] 27-28 and 30A-30B, in some embodiments, the delivery device 10 may include a central region 28 that is generally thimble or dome shaped, but has a relatively low height compared to certain other embodiments described herein. The (vertical) distance from the base 262 to the periphery 340 of the top surface 250 may be relatively short. In some embodiments, said distance may be approximately 0.15 inches.

[0283] Additionally or alternatively, the peripheral region 30 may not be a substantially flat annular shape. The peripheral region 30 may be defined by downwardly continuing curved petals 42 such that the periphery 38 is disposed away from the plane of the base 262 of the support structure 252 (e.g., approximately equal to or less than the distance from the base 262 to the periphery 340 of the upper surface 250). The periphery 38 may be disposed along a plane more distal to the periphery 340 of the upper surface 250 than the base 262. In FIG. 27, the delivery device 10 is shown in a retracted state. The delivery device 10 may include slots 36 that may be disposed between the petals 42, similar to other delivery device 10 embodiments described herein. An adhesive 22 (see, e.g., FIG. 24) may be affixed to at least a portion of at least two petals 42.

[0284] Referring to FIG. 28, which is a perspective cross-sectional view of the body 20 of the delivery device 10, the body 20 can include an internal ridge 290. The ridge 290 can be located at the base 262 of the support structure 252. The support structure 252 can be thickened in an area near the base 262 to form the ridge 290. This can facilitate the formation of the ridge 290, for example, in an injection molding operation that forms the remainder of the body 20. This can also provide additional rigidity to the support structure 252. The ridge 290 can provide a step, ledge, or other mounting surface to which a portion of the reservoir assembly 12 of the delivery device 10 can be attached. Such a ridge 290 can be included in any of the embodiments of the delivery device 10 described herein. The reservoir assembly 12 and the ridge 290 are further described elsewhere herein. Any of the embodiments that include the ridge 290 can instead include a retention tab 580 and a stop surface 582 as shown in FIGS. 79-80B.

[0285] 28A-28B, two conceptual representations of the delivery device 10 transitioning from a storage state to a delivery state are shown. When the delivery device 10 is affixed to the skin with the adhesive 22 and pressure is applied to the delivery device 10 from above, for example by a user's fingertip, the delivery device 10 may transition to the delivery state. When the petals 42 are pressed against the surface of the skin, the petals 42 may be displaced outward and at least some of the petals 42 may curl upwards due to the skin and / or the patient's body. The skin may then stretch as portions of the opposing petals 42, each secured to the skin surface by the adhesive 22 (shown only in FIG. 30A ), move away from each other or displaced. When the delivery device 10 transitions to the delivery state, at least a portion of each of the curved petals 42 may curve with a further or narrower radius of curvature. When the delivery state is reached, the curvature of the petals 42 may extend from the base 262 to the inflection point 360. The inflection point 360 is located in a plane spaced apart from the plane of the base 262 and may also be referred to as the lowest point in such embodiments. In such embodiments, the lowest point 360 may be in a plane more distal to the periphery 340 of the top surface 250 than the base 262. From the inflection point 360, the petals 42 may curve back upward to increasingly approach the plane in which the periphery 340 of the top surface 250 is located. The periphery 38 of the petals 42 may be located, for example, in the plane of the base 262 or at a point thereon (closer to the plane of the periphery 340 of the top surface 250). The petals 42 each have a constant radius of curvature from the inflection point 360 to the periphery 38, although this is not required. A constant radius of curvature returning upward may enhance the ability of the petals 42 to curl upward. This may facilitate stretching of the user's skin due to the spreading and displacement of points 360 on opposing petals 42 (each secured to the skin by adhesive 22). As noted elsewhere herein, the top surface 250 of the body 20 may also be inverted when the delivery device 10 transitions to the delivery state 10.

[0286] In some non-limiting examples, the delivery device 10, when in a stored state, can have dimensions and radii of curvature as shown in Figures 29A-29B. It should be understood that the dimensions shown are merely exemplary. Other delivery devices 10 of different sizes and having the same proportions are possible and contemplated. Additionally, delivery devices 10 having different dimensions and proportions are possible and contemplated.

[0287] 27-28 and 30A-30B, in some embodiments, the support structure 252 may not include fenestrations 264 (see, e.g., FIG. 19) evenly spaced about the base 262. The body 20 may be manufactured by injection molding. Those skilled in the art will readily appreciate that other manufacturing techniques may be used. The body 20 may be constructed from one monolithic piece of material such that the central region 28 and the peripheral region 30 are integral with one another. The body 20 may be constructed from a polymeric material. In some embodiments, the body 20 may be a nylon material, such as Nycoa 2012 nylon or other similar nylon material. In other embodiments, the body 20 may be made of a polypropylene material. The body 20 may be manufactured from a material that helps minimize water absorption or a material that helps maximize the ability to adhere to the adhesive 22. A material may be selected that accomplishes both of these objectives to the desired degree, respectively. These materials may be used for any of the bodies 20 described herein.

[0288] As further shown in FIGS. 27-28 and 30A-30B, the top surface 250 may have a rounded footprint, e.g., generally circular, or may be convex forming a dome shape (including the periphery 340). The top surface 250 may include slots 254. The slots 254 may be notches, openings, holes, apertures, or voids in various embodiments. The slots 254 may each have a first end 258 that encircles an area that includes the center point 256 of the top surface 250, and each have a second end 260 that each terminate at a distance from the periphery 340 of the top surface 250 (e.g., the slots 254 may each terminate at the same distance). In certain embodiments, the slots 254 may be disposed at regular angular increments and each be of equal length (although this need not be the case in all embodiments).

[0289] 27-28 and 30A-B, as described above with reference to FIG. 22, in alternative embodiments, the slots 254 may be positioned such that they do not extend radially relative to the center point 256. For example, the slots 254 may each extend at a common angle relative to the radial direction. In such embodiments, the slots 254 may be equally spaced about the top surface 250 and each may be the same length. In other embodiments, the slots 254 may not all extend at a common angle relative to the radial direction. At least one (and perhaps all) of the slots 254 may be positioned at a different angle relative to the radial direction.

[0290] Referring now primarily to Figures 33-35, several diagrams of conceptual representations of the delivery device 10 in a delivery state are shown. As explained above (and with reference to the embodiment of Figures 12-20), the delivery device 10 may transition from the storage state to the delivery state when downward pressure is applied to the upper surface 250. In this delivery state, the body 20 of the delivery device 10 is substantially or at least partially inverted. A user may remove the adhesive liner 265 (see, e.g., Figure 24) from the delivery device 10 and apply the delivery device 10 to the skin. The user may then press the upper surface 250 downward (i.e., toward the skin). This may cause the petals 42 to splay outward and displace and curl upward (at least over a portion thereof) and stretch the skin. The upper surface 250 may invert to press the delivery sharps 72 into the skin and remain inverted when the delivery device 10 reaches the delivery state. The peripheral region 20 may also assume an inverted shape due to the curling of the petals 42.

[0291] In various embodiments, certain regions of the body 20 of the delivery device 10 may remain stationary or may not evert. Thus, the body 20 may include everting regions and elastic regions. Although described as elastic regions, it should be understood that some degree of bending or deformation may still occur when pressure is applied. However, these regions may look generally similar or extend / protrude in generally the same direction in both the stored and delivery states. As shown, the peripheral region 30 and the top surface 250 may evert, while a portion of the central region 28 may resist this degree of deformation. The support structure 252 shown in other embodiments described herein (see, e.g., FIG. 19 or FIG. 27) may also be an elastic region. Thus, a particular delivery device 10 may include a body 20 with evertable regions separated from each other by elastic regions.

[0292] As further shown in Figures 33-35, the reservoir 12 may be formed as an assembly and include a reservoir portion 271 and a holder 270 (described in more detail below with reference to Figures 49-61B). The reservoir 12 may be compressed and / or at least partially crushed to deliver the agent contained therein when the delivery device 10 transitions to the delivery state. The user may then remove the delivery device 10 from the skin. The slots 254 may help the delivery device 10 transition from the storage state to the delivery state under reduced pressure from above. The fenestrations 34 may also facilitate the transition. As described above with reference to the embodiment of Figures 12-20, the central region 28 may have space for the reservoir 12 and the sharps retainer 26 (see additional description with reference to the embodiment of Figures 12-20 and Figures 49-61B). In some embodiments, the packet 208 and / or the container 350 (see, e.g., Figures 10A-11) and / or the foam adhesive material may also be contained within the central region 28. As described in more detail elsewhere herein, the packet 208 may include a gas bladder, butane packet, or delivery force supply packet and any associated containers 350 as described above with respect to Figures 10A-11. In some examples, one or more of the petals 42 may be constructed to incorporate a pull tab (not shown in Figures 33-35), such as the pull tab 266 described above with reference to Figure 23.

[0293] 36, a block diagram of an exemplary delivery device 10 is shown. As shown, the delivery device 10 can include a body 20 and a reservoir 12. The delivery device 10 can also include one or more biasing members 470. The one or more biasing members 470 can be included as part of a dispensing assembly 480 included in the delivery device 10. The dispensing assembly 480 can help apply pressure to the reservoir 12 and help expel fluid from the reservoir 12 during injection. In some embodiments, the dispensing assembly 480 can include a pressing body 472 that can be coupled or associated with at least one biasing member 470. A reservoir interface member 474 can also form part of the dispensing assembly 480 of the delivery device 10. In some examples, the reservoir interface member 474 can be omitted and the biasing member 470 can directly contact the reservoir 12.

[0294] In some embodiments, the biasing member 470 may be in an unstressed state when the associated delivery device 10 is in the storage state. A user's interaction with the delivery device 10 to transition the delivery device 10 to the delivery state may include applying pressure to the push body 472 of the dispensing assembly 480. This may displace the push body 472 toward the reservoir 12. The push body 472 may include an engagement mechanism (e.g., a catch or detent) that may engage with a retention mechanism (e.g., defined in the body 20) of the delivery device 10 to hold the push body 472 in the displaced position. The displacement of the push body 472 builds up a bias in the biasing member 470. When the delivery device 10 transitions to the delivery state, the biasing member 470 returns to its unstressed state. When the biasing member 470 returns, the reservoir interface member 474 of the dispensing assembly 480 may be biased against the reservoir 12 to collapse the reservoir 12 and pump fluid into the patient. Thus, for example, pressure can be applied to the reservoir 12 for a period of time sufficient to completely deliver the contents of the reservoir 12 (eg, five minutes in certain embodiments) without sustained manual pressure on the delivery device 10.

[0295] In other embodiments, the biasing member 470 may be in a stressed state when the associated delivery device 10 is in a stored state and may be coupled or associated with a push body 472 of the dispensing assembly 480. The push body 472 may contact a portion of the delivery device 10 (e.g., the body 20) to act to resist displacement under a restoring force generated by the biasing member 470. This may prevent the biasing member 470 from recovering from its stressed state. A catch or detent in the push body 472 may, for example, engage the body 20 when the delivery device 10 is in a stored state. User interaction with the delivery device 10 to transition the delivery device 10 to the delivery state may disengage the push body 472 so that it is free to move. Once the push body 472 is free to displace, the biasing member 470 may return to an unstressed state, or at least a less stressed state, and drive the reservoir interface member 474 of the dispensing assembly 480 against the reservoir 12. This causes the reservoir 12 to collapse and fluid to be expelled from the reservoir 12 into the patient's body.

[0296] 39-38, a representative example of a delivery device 10 including a biasing member 470 in an unstressed stored state is shown. The delivery device 10 may include a body 20 and a reservoir 12, similar to the various other delivery devices 10 described above. As shown, the pusher 472 of the dispensing assembly 480 may include an elongated member 476, such as a pin, that extends through the top surface 250 of the body 20. In some embodiments, the elongated member 476 may include a head 478 or other surface at the distal end of the elongated member 476. The head 478 may include a rounded or tapered portion to aid in the passage of the head 478 through an opening in the body 20 during assembly. Opposite the tapered or rounded portion, the head 478 may define a step or shelf. The shelf of the head 478 may limit the displacement of the elongated member 476 because the shelf cannot easily move back through the opening in the body 20. The end of the elongate member 476 opposite the head 478 may be coupled to one or more members. The reservoir interface member 474 may be coupled to one or more biasing members 470 such that the one or more biasing members 470 are disposed between the elongate member 476 and the reservoir interface member 474. In the illustrative embodiment, the one or more biasing members 470 are shown as a set of bow springs, although any suitable number of bow springs may be used. In alternative embodiments, other biasing members 470 (e.g., resilient foam, coil springs, bladders, rubber bodies, elastomeric bodies, etc.) may be used.

[0297] When pressure is applied to transition the delivery device 10 to the delivery state, the elongate member 476 may be displaced toward the reservoir 12. This may stress the biasing member 470. As shown, the elongate member 476 includes a detent or notch 482. The notch 482 may engage with the body 20 to hold the elongate member 476 in a depressed state. The engagement of the notch 482 with the body 20 may also serve to indicate that the delivery device 10 has been used.

[0298] With the elongate member 476 held in place, returning the biasing member 470 to a less stressed state may displace the reservoir interface member 474 into the reservoir 12. As discussed above, this causes the contents of the reservoir 12 to be directed out of the reservoir 12 and into the patient. It is noted that in various examples, at least some portions of the body 20 may be displaced and / or inverted extensively as the delivery device 10 transitions to the delivery state (see, e.g., FIG. 33). This is not shown in FIGS. 39-38 for ease of illustration.

[0299] 39 and 40, in certain embodiments, the delivery device 10 may include a biasing member 470 that is in a stressed state while the delivery device 10 is in a stored state. With reference to FIG. 40, the biasing member 470 (shown in an unstressed state) may include an outer enclosure 490. The outer enclosure 490 may be, for example, annular in shape, although any suitable shape may be used. A number of biasing projections 492 may extend from the outer enclosure 490 toward a center of the biasing member 470. The biasing projections 492 may extend radially inward from the outer enclosure 490 toward a center of the biasing member 470. In an exemplary embodiment, the biasing projections 492 may be spaced at equal angular increments, but this need not be the case in all embodiments. The outer enclosure 490 may be constructed of any suitable material, and in some examples, may be constructed of a resilient plastic or spring steel.

[0300] The body 20 of the delivery device 10 may include a number of passages 494 extending through the body 20. The passages 494 may be disposed in the support structure 252 of the body 20. The spacing of the passages 494 may correspond to the spacing of the biasing protrusions 492 on the biasing member 470. When the delivery device 10 is assembled, the biasing protrusions 492 may be introduced into and partially pass through each passage 494 in the body 20. The outer enclosure 490 may be mounted on a distal surface of the peripheral region 30 of the body 20 (see, e.g., FIG. 27 ).

[0301] 41-43, the delivery device 10 may include a push body 472. In the illustrated example, the push body 472 includes a reservoir interface member 474 at its proximal end. The push body 472 may be rotatably displaceable within an opening 496 in the body 20. The opening 496 may be disposed on the upper surface 250 of the body 20, for example, as shown in FIG. 41. The push body 472 may be rotated from a position or range of positions that limits translational displacement (see, for example, FIG. 41) to a position or range of positions that permits translational displacement (see, for example, FIG. 40). In the translational displacement limiting position, a retaining element of the push body 472 may engage with a cooperating lock defined in the body 20. In the translational displacement permitting position, the retaining element of the push body 472 may disengage from the lock of the body 20.

[0302] As best shown in FIG. 45, the exemplary push body 472 includes a stem 500 that extends through an opening 496 in the body 20 of the delivery device 10. The stem 500 may include a set of notches 498 or other recesses, each of which functions as a retention element. The cross-sectional shape of the stem 500 need not be circular or a regular polygon. Thus, one of the width and length dimensions of the cross-sectional shape of the stem 500 may be shorter than the other. In an exemplary embodiment, the cross-sectional shape of the stem is oval. In another example, other cross-sectional shapes may be used. The notch 498 may be disposed to be recessed into the widest portion of the stem 500. The opening 496 (see, for example, FIG. 39) may have a shape that corresponds to the cross-sectional shape of the stem 500, but may be slightly larger than the cross-sectional shape of the stem 500. The notch 498 may be recessed to a depth such that the push body 472 can rotate within the opening 496 when flush with the wall of the body 20 in which the opening 496 is formed.

[0303] The push body 472 is shown in a translational displacement limiting position in FIG. 41. In such a position, the rotational orientation of the push body 472 may be such that the notch 498 overhangs the portion of the body 20 in which the opening 496 is defined. As a result, the body 20 may provide mechanical interference with the translational displacement of the push body 472. Thus, the area of ​​the body 20 adjacent the opening 496 may act as a lock for the push body 472. When the push body 472 is rotated to a translational displacement-permitting position, as shown in FIG. 48, the rotational orientation of the push body 472 may be such that it may translate within a correspondingly shaped opening 496 in the body.

[0304] 48 and 43, the push body 472 can include an enlarged portion 502. The reservoir interface member 474 can form a proximal region of the enlarged portion 502. When the delivery device 10 is assembled, the biasing projection 492 of the biasing member 470 can push the enlarged portion 502 to capture or couple the enlarged portion within the biasing projection 492. Furthermore, the biasing member 470 can be substantially restrained from displacing as a whole because the biasing projection can be fed through a passage 494 in the body 20. If the biasing member 470 is constrained in place, the biasing projection 492 can deflect and become stressed when the depressor body 472 is lifted. When the push body 472 is lifted such that the notch 498 is flush with the portion of the body 20 in which the opening 496 is defined, the push body 472 can be rotated to a translational displacement limiting position (see, e.g., FIG. 41). Thus, the biasing member 470 can be held in a stressed state.

[0305] During actuation of the associated delivery device 10 from the storage state to the delivery state, the push body 472 may be rotated to a position that allows translational displacement. Once in this position, the push body 472 is free to translate and the biasing member 470 may translate the push body 472. When the biasing member 470 returns to a less stressed state, the reservoir interface member 474 may be driven against the reservoir 12 to force fluid out of the reservoir 12 and into the patient. The amount of the push body 472 that protrudes from the body 20 may change as the biasing member 470 returns to a less stressed state. Thus, the amount of the push body 472 that extends from the body 20 may serve as an indicator that the delivery device 10 has been used.

[0306] 48A-44D, in some examples, the biasing member 470 for the delivery device 10 may be entirely within the delivery device 10. Additionally, the push body 472 may not latch or engage a portion of the body 20 to prevent translation of the body 20. In some examples of such embodiments, a stop member 473 may be included in the delivery device 10. The push body 472 may include a recess 475 (or alternatively a set of notches 498, see e.g., FIG. 43), which may engage with the stop member 473 instead of the body 20. As shown in FIG. 48B, the stop member 473 may include an opening 496' having a shape corresponding to, but slightly larger than, the cross-sectional shape of the stem 500 of the push body 472. The recess 475 may be recessed to a depth such that the push body 472 can rotate within the opening 496' when flush with the opening 496'.

[0307] The stop member 473 can be rotated from a translation-limiting position to a translation-permitting position where the stop member 473 can be freely translated. In the translation-limiting position, the opening 496' can be arranged such that the stem 500 overhangs a portion of the body 479 of the stop member 473. As a result, the stop member 473 can provide mechanical interference with translational displacement of the stem 500. When the stop member 473 is rotated to a translation-permitting position, the stem 500 no longer overhangs the body 479 of the stop member 473. In this position, the push body 472 can translate within a correspondingly shaped opening 496' in the stop member 473. The stop member 473 can include ridges, knurling, ridges, grips, spokes, or other features to facilitate rotational displacement of the stop member 473 by interaction with a user's fingers.

[0308] As shown primarily in FIGS. 48C and 46D, the biasing member 470 may be a conical spring. When the delivery device 10 is in the stored state and the stop member 473 is in the translational displacement limiting position, the conical spring may be in stress (e.g., in a compressed state). When the stop member 473 moves to the translational displacement allowing position, the biasing member 470 is free to drive the displacement of the push body 472 against the reservoir 12, as described above with respect to FIGS. 44-45. When the push body 472 is displaced by relaxation of the biasing member 470, the stem 500 of the push body 472 may pass completely through the opening 496' of the stop member 473. Thus, the stop member 473 may be separated from the rest of the delivery device 10. The push body 472 may also be moved to a position where the recess 475 is inside the delivery device 10. Thus, the stop member 473 may be prevented from being reconnected to the push body 472. When the delivery device 10 is observed without the stop member 473, it can provide a visual indication that the particular delivery device 10 has already been used. Thus, the stop member 473 can also function as a communicating indicator that the particular delivery device 10 is ready for use.

[0309] Referring now to FIG. 47, a block diagram of another exemplary delivery device 10 is shown. As shown, the delivery device 10 can include a body 20 and a reservoir 12. The delivery device 10 can also include one or more biasing members 470. The one or more biasing members 470 can form the entire dispensing assembly 480. Additionally, the biasing members 470 can directly contact the reservoir 12 and can help apply pressure to the reservoir 12 to deliver fluid therefrom. In certain examples, a reservoir interface member 474 (see, e.g., FIG. 36) can be included. If included, the reservoir interface member 474 can be formed as part of, but is not necessarily required to be, and can be integral therewith, at least one biasing member 470. The reservoir interface member 474 can directly contact the reservoir 12. The at least one biasing member 470 may be or include a spring, a compression spring, a conical spring, a resilient foam, a bladder, any other suitable biasing member, other suitable biasing members, or any combination thereof.

[0310] As further shown in FIG. 47, the biasing member 470 may be in an unstressed state when the associated delivery device 10 is in a storage state. The storage state may not apply pressure to the reservoir 12. In certain examples, the at least one biasing member 470 (and any reservoir interface member 474) may not fully contact the reservoir 12 in the storage state (e.g., 0.05-2 mm). Alternatively, the biasing member 470 may contact but not press against the reservoir 12. When the delivery device 10 is used, the delivery device 10 may transition to a delivery state, as described elsewhere herein. As with various embodiments described herein, upon transition to the delivery state, at least a portion of the delivery device 10 may at least partially invert. For example, at least the domed upper surface 250 of the central region 28 may be inverted or partially inverted. The distance between the reservoir 12 and the inverted upper surface 250 in the delivery state may be less than the distance between the reservoir 12 and the upper surface 250 in the storage state. This results in a bias build-up in the biasing member 470. The at least one biasing member 470 may be compressed when the top surface 250 is inverted, in one example. Furthermore, when the at least one biasing member 470 is spaced apart from the reservoir 12 in the stored state, the at least one biasing member 470 or the reservoir interface member 474 (which may be part of the biasing member 470) may move into contact. The inverted top surface 250 may be strong enough to withstand any force exerted by the at least one biasing member 470 in the inverted state. When the at least one biasing member 470 is restored, it may push the at least one biasing member (and / or the reservoir interface member 474, if included) against the reservoir 12, collapsing the reservoir 12 and pumping fluid into the patient. Thus, for example, pressure can be maintained on the reservoir 12 for a period of time sufficient to completely deliver the contents of the reservoir 12 (e.g., 5 minutes in certain embodiments) without sustained manual pressure on the delivery device 10.

[0311] 48A-48B, an exemplary embodiment of the body 20 and the body 20 with the biasing member 470 are shown, respectively. FIG. 48A shows a bottom view of the body 20. FIG. 48B shows a perspective view of the body 20 and the biasing member 470. The body 20 is shown inverted top view for illustration purposes. As shown, the body 20 can include multiple positioning protrusions 471. In another embodiment, the positioning protrusions 471 can be replaced with circular or annular positioning walls. There can be a set of positioning protrusions 471 located in a central region of the top surface 250. A second set of positioning protrusions 471 can be spaced outwardly from the central region. In an exemplary embodiment, the second set of positioning protrusions 471 extend from the top surface 250. In another example, the positioning protrusions 471 can extend radially inward from the support structure 252 in the central region 28. The ends of the biasing member 470 are centered by the positioning protrusions 471 when the biasing member 470 is placed in the delivery device 10 assembly. In certain examples, the ends of the biasing member 470 can be bonded in place. For example, once the biasing member 470 is properly placed, the ends of the biasing member 470 adjacent the upper surface 250 can be heat staked (see, for example, FIG. 48C). When the delivery device 10 is fully assembled, the heat stakes can hold the biasing member 470 in place relative to the body 20. As a result, the biasing member 470 can be held out of contact with the reservoir 12 until the delivery device 10 is transitioned to the delivery state. The positioning protrusions 471 can also help ensure that the biasing member 470 transitions to the stressed state in a desired manner. For example, if a compression spring is used, the second set of positioning protrusions 471 can restrain the biasing member 470 such that the biasing member 470 is compressed substantially along the axis of the biasing member 470.

[0312] As shown now in FIG. 48C, in some examples, the biasing member 470 may be limited in displacement by one or more guide bodies 477. The one or more guide bodies 477 may extend from the support structure 252 in the central region 28 of the body 20 toward the zero axis of the biasing member 47. In the example shown in FIG. 48C, four guide bodies 477 are included and are spaced apart at equal angular increments. In other embodiments, the number of guide bodies 477 may be different and / or the guide bodies 477 may be irregularly spaced. The guide bodies 477 help ensure that the biasing member 470 compresses substantially along its axis and may help inhibit tilting of the biasing member 470 during use of the delivery device 10.

[0313] 48A-C, if the biasing member 470 is a compression spring, the end 481 of the biasing member 470 can form the reservoir interface member 474. The end 481 of the biasing member 470 can be wired in a manner that helps distribute pressure more evenly. The end 481 of the biasing member 470 can be wired in a direction or desired pattern. The end 481 can also be disposed substantially in a plane that is disposed in the same or adjacent position as the end of the biasing member 470. As shown in FIG. 48B, the coil end 481 is bent to extend between opposing points on the biasing member 470. In this example, the end 481 extends approximately diametrically across the end of the biasing member 470 proximal to the reservoir 12. In some embodiments, the end 481 of the biasing member 470 can be wired in a spiral or other pattern (see, for example, FIG. 48C).

[0314] 49A and 49B, in other examples, the biasing member 470 can be a block of compressible material (e.g., rubber or elastomer). The surface of the biasing member 470 adjacent the reservoir 12 serves as a reservoir interface member 474 and can be substantially flat or planar in some embodiments. Thus, various delivery devices 10 can include a flexible reservoir interface member 474. The delivery device 10 depicted in FIG. 49A and 49B shows a stored state. As shown in the figures, the delivery device 10 can include a push body 472 coupled to the top surface 250 of the body 20. The top surface 250 of the body 20 can have a funnel or trumpet shape in the stored state in some examples. Such a top surface 250 can also be included in various other embodiments described herein. As shown in the figures, the push body 472 includes a post 469. The post 469 may extend through the top surface 250 of the body 20 and be coupled to the top surface 250 (e.g., via heat caulking, adhesive, or a dogged central opening 459, etc.). The pusher 472 may further include a dished body 467 coupled to the post 469. The dished body 467 may be disposed on the top surface 250 of the body 20. The dished body 467 provides an ergonomic position for a user to press when transitioning the delivery device 10 to the delivery state. When the delivery device 10 transitions to the delivery state, the top surface 250 may be significantly inverted and the biasing member 470 may be compressed against the reservoir 12. This may encourage fluid to be expelled from the reservoir 12. In some embodiments, the biasing member 470 may be coupled to an end of the post 469 opposite the dished body 467. For example, the biasing member 470 may include a receiving recess 465 (e.g., see FIG. 50 ) into which the end of the post 469 fits. Although dish 467 is depicted as a concave dish, not all embodiments need to include a dish, for example, in some embodiments dish 467 may be replaced by a relatively flat body or plate.

[0315] Referring to FIG. 50, an exploded view of a delivery device 10 similar to that shown in FIG. 49B is shown. As shown in the figure, some delivery devices 10 may include a biasing member 470 that varies in width along its height and is constructed of an elastomeric material, such as silicone. For example, the biasing member 470 may have a stepped shape. In the example shown in the figure, the biasing member 470 may include two stages. Additionally, the biasing member 470 may include one or more hollow regions. In an example embodiment, the biasing member 470 includes a plurality of passages 463 that extend through the biasing member 470 to form a hollow region. The passages 463 extend through at least one stage, and in this embodiment, both are located in the first or base stage of the biasing member 470. The passages 463 are evenly spaced around the biasing member 470, and in the example shown, are arranged such that the biasing member 470 has a plane of symmetry. As previously described, the biasing member 470 may be compressed when the top surface 250 of the body 20 transitions from the storage state to the delivery state. As the biasing member 470 recovers from the compressed state, fluid may be expelled from the reservoir 12. The passageway 463 may provide a gentler, less abrupt initial application of force as the biasing member 470 exerts a force against the reservoir 12. This may allow the reservoir 12 to be more robust during use while at the same time ensuring that the reservoir 12 is substantially emptied during delivery.

[0316] 51A-52, various views of the body 20 and the push body 472 are shown. The push body 472 of the delivery device 10 may include a dished region 467' from which the skirt 461 extends. The skirt 461 may have a pair of ears 457 extending outwardly, as shown in FIG. 50. The ears 457 may be equally spaced apart. The dished region 467 may be shaped similarly to other dished bodies 467 described herein. The skirt 461 may be sized to fit into the support structure 252 of the body 20 when the delivery device 10 transitions from the storage state (FIG. 51A) to the delivery state (FIG. 51B). Thus, the support structure 252 may act as a guide to inhibit tilting of the push body 472 and ensure that the push body 472 is displaced along an axis when it is subjected to pressure. When fully transitioned to the delivery state, the end of the skirt 461 opposite the dished region 467' is close to the petals 42, but far enough away so as not to restrict movement of the petals 42. As best shown in FIG. 52, the pusher body may include a post 469. The post 469 may extend through a dog-shaped opening 459 in the central portion of the top surface 250 of the body 20. When the pusher body 472 is pulled away from the body 20, the dog of the dog-shaped opening 459 may rotate and bite into the post 469, preventing the pusher body 472 from being separated from the rest of the delivery device 10. When the delivery device 10 is assembled, the post 469 may project into a receiving recess 465 of the biasing member 470.

[0317] In some embodiments, as shown in FIGS. 53A-D (top, side, bottom, and underside perspective views, respectively, of the application surface of the delivery device 10, such as the skin surface), an exemplary holder 270 for a sharps retainer 26 (see, e.g., FIG. 33) including a delivery sharps 72 (see, e.g., FIG. 33) may be formed as a ring, or annular portion 272 integral with a rounded recess 274. The recess 274 may be centrally located. In one example, the rounded recess 274 may have the shape of a spherical segment. The annular portion 272 may have an inner edge, and the rounded recess 274 may have a perimeter. The inner edge of the annular portion 272 may coincide with the perimeter of the rounded recess 274. When the delivery device 10 incorporating the holder 270 is applied to the skin surface of a user, the rounded recess 274 extends below the plane of the annular portion 272 (see FIG. 53B). Thus, the rounded recess 274 may form a protrusion protruding from a proximal surface of the holder 270.

[0318] The round recess 274 may include a pocket 276 formed therein. The pocket 276 may be formed in the proximal surface of the holder 270 (e.g., in a protrusion). The pocket 276 may be located in the center of the round recess 274 and at the lowest point (with respect to the skin surface when the delivery device 10 is secured to the skin surface). The pocket 276 may be sized to fit and receive a sharps holder 26 having a delivery sharp 72 thereon, such as the sharps holder 26 including the delivery sharp 72 of FIG. 33. The sharps holder 26 including the delivery sharp 72 may be fitted into the pocket 276, for example, by injection molding or adhesive. The holder 270 may be overmolded around the sharps holder 26 to bond the components together. In various embodiments, the delivery device 10 may be positioned such that pressure from above (e.g., from a finger) on the delivery device 10 may be evenly distributed over the entire area of ​​the holder 270. In some embodiments, the recess 274 can function as a force concentrating protrusion from the holder 270, which ensures that the force applied to the delivery device 10 is concentrated on the delivery sharp 72 and aids in the insertion of the delivery sharp 72 into the skin.

[0319] In an exemplary embodiment, the width (e.g., diameter) of the holder 270 may be about 0.7 inches (e.g., 0.744 inches). The footprint of the exemplary holder 270 may be about 0.45 square inches (e.g., 0.44 square inches). The holder 270 may be manufactured by any technique known to one of ordinary skill in the art, including, for example, injection molding or thermoforming.

[0320] Another exemplary holder 270 is shown in 54A-54C. As shown, the holder 270 can include a disk body 275. The disk body 275 can be substantially flat and can include a number of circumferentially arranged tab projections 277. The tab projections 277 can be symmetrically arranged around the disk body 275 or can be spaced at regular angular intervals as shown in Figs. 54A-54C. In alternative embodiments, the tab projections 277 can be asymmetrically arranged around the base or can be spaced at irregular angular intervals. The tab projections 277 can engage with receiving slits 278 (see, e.g., Fig. 46A) located within the body 20 of the delivery device 10. Thus, the tab projections 277 can be used to couple the holder 270 to a predetermined position in the delivery device 10. The asymmetric or irregularly spaced tab projections 277 can couple the holder 270 to the body 20 in a predetermined orientation that is desirable in some instances.

[0321] 54A-54C, the holder 270 can include at least one stepped protrusion 279. The stepped protrusion 279 can be included in addition to or instead of the round recess 272 and spherical segment of the embodiment described above in connection with FIGS. 53A-53D. The stepped protrusion 279 can provide a well 281 on the distal side of the tab projection 277. The stepped protrusion 279 can extend proximally of the tab projection 277 by a height that in certain instances can be at least as high as the height of the microneedle 277 of the delivery device 10. The stepped protrusion 279 can extend at a generally perpendicular angle from the disk. The sidewall 283 of the stepped protrusion 279 can be chamfered to extend in a non-perpendicular direction relative to the proximal surface of the tab projection 277. The stepped protrusion 279 can include a pocket 276. The pocket 276 may be sized to matingly receive the sharps holder 26 with the delivery sharps 72, as described elsewhere herein.

[0322] 55A-55D, in some embodiments, the pocket 276 of the step projection 279 may be oriented non-parallel to the plane of the disk body 275. In FIG. 55D, when the sharps holder 26 is attached to the pocket 276, the orientation of the pocket 276 may ensure that the delivery sharps 72 (e.g., microneedles) extend at a predetermined angle to the disk body 275. In an exemplary embodiment, the pocket 276 may be oriented such that the delivery sharps 72 extend at an angle of 10-20° (e.g., 15°) to a plane perpendicular to the disk body 275. In other embodiments, the pocket 276 is oriented such that the delivery sharps 72 protrude at an angle of 45° or 60°, or an angle therebetween. Any suitable angle may be used. In alternative embodiments, the entire step projection 279 may protrude from the disk body 275 at a desired angle. Thus, the delivery sharps 72 may extend at that angle when coupled to the pocket 276.

[0323] The sharps holder 26 can be attached to any of the holders 270 described herein during the molding process or by using an adhesive. When the sharps holder 26 is attached to any of the holders 270 described herein during molding, a portion of material is molded over the sidewalls 27 of the sharps holder 26 and extends to the face of the delivery sharps 72 protruding from the sharps holder 26, thereby capturing the sharps holder 26. The sharps holder 26 may have a chamfer or angle that is not perpendicular to the face of the sharps holder 26. The footprint or cross-sectional area of ​​the sharps holder 26 may increase in area as the distance from the face containing the sharps increases. When the delivery sharps 72 are made of silicon, multiple sets of delivery sharps 72 are typically formed on a large wafer, and the sharps holder 26 containing a predetermined number of delivery sharps 72 are diced from the wafer. To form the chamfered sidewalls 27, a dicing saw may have an angled cutting edge, so that the dicing process creates the desired chamfer or angle in the sidewalls 27. In certain embodiments, sidewalls 27 with an angle of 30-60° (e.g., 45°) may be used. When a chamfered sidewall 27 is present, material may be molded onto only a portion of the sidewall 27 to bond the sharps retainer 26 to the holder 270. This allows the sharps retainer 26 to be captured by the holder 270 (or other molded parts, such as a part of a delivery device or a syringe adapter that connects to the delivery device via a luer lock or the like), while no material is molded onto the sharps-containing surface of the sharps retainer 26 (although this could be done if desired). Thus, the molded material acts as a standoff on the sharps retaining surface, preventing the entire length of the delivery sharps 72 from penetrating the skin.

[0324] In some embodiments, the reservoir portion 271 is shown as shown in FIGS. 56A-56D (respectively a top-down perspective view, a side view, a bottom-up perspective view, and a top view relative to an application surface of the delivery device 10, e.g., a skin surface). The reservoir portion 271 can be shaped to incorporate the dome-shaped portion 280, the tunnel or side channel 282, and the flange or annular portion 284 as a unitary structure. That is, these features can be included in a single monolithic piece of material. In some embodiments, the dome-shaped portion 280 can be shaped approximately as a hemisphere or other spherical segment, although any other suitable shape is possible. In examples where the reservoir portion 271 includes a rounded shape forming a cavity (e.g., the dome-shaped portion 280), the distal-most rounded portion of the flange 284 can include a plateau or flat surface. The flat surface can be generally parallel to the flange 284. In some examples, a central recess 267 (see, e.g., FIG. 57) can also be included in the flat surface. The tunnel 282 may be formed as a half pipe or half cylinder that may be formed from the annular portion 284 in some examples. In alternative embodiments, any suitable cross-sectional shape may be used. The side channel or tunnel 282 may communicate with the domed portion 280 via an arch 286 such that the combination of the domed portion 280 and the tunnel 282 forms an approximately igloo-like shaped structure. In some embodiments, the end of the tunnel 282 opposite the domed portion 280 may be flared or tapered outward to enhance ease of filling. The annular portion 284 may have an inner edge that coincides with the base perimeter 288 of the domed portion 280. The reservoir portion 271 may be manufactured, for example, by thermoforming a flat sheet of material (e.g., plastic or layers of various plastics or other materials). If a multi-layer sheet is used, the sheet may include a drug or agent compatible layer, a barrier layer, a tie layer, etc. In some embodiments, vacuum forming may be used to manufacture the reservoir portion 271. Other known techniques such as injection molding are also possible.The reservoir portion 271 may be formed of a polycarbonate material or other suitable material and may be coated with a cyclic olefin polymer (COP) or other suitable coating material. The dome-shaped portion 280 may collapse when pressure is applied.

[0325] 57, a perspective view of an exemplary reservoir portion 271 is shown. In certain examples, the reservoir portion 271 can include at least one cavity incorporating one or more collapse promoters. The collapse promoters can promote the collapse of the cavity in a predetermined manner and reduce the force required to collapse the cavity. The collapse promoters can also help ensure that the cavity collapses such that dead volume is minimized. Similarly, the inclusion of a collapse promoter can help reduce the possibility of trapping or pocketing of fluid contained in the reservoir 12 in areas of the reservoir 12 that are cut off from communication with the outlet during collapse of the cavity. Other reservoirs 12 described herein may include at least one collapse promoter.

[0326] The collapse promoter may be a pleated, bellows-like, accordion-like, creased, pleated, stepped, or bellows-like wall 261 extending upward from the flange 284. The wall 261 may extend beyond the flange 284 and may taper (e.g., continuously or stepwise) as the distance from the flange 284 increases. The top wall 263 may span the portion of the wall 261 most distal to the flange 284. Thus, the wall 261 and the top wall 263 may together form a cavity within the reservoir portion 271. The top wall 263 may be substantially planar and, in certain instances, extend parallel to the flange 284. The top wall 263 may include a central recess 267 in certain instances. The central recess 267 may function to aid in positioning the reservoir interface member 474 (see, e.g., FIG. 36) or a portion of the biasing members 470, 481 (see, e.g., FIGS. 37 and 48B, respectively). The flat top wall 263 and / or the central recess 267 may be included in other reservoirs 12 described herein. The cavity formed by the wall 261 and the top wall 263 may have a generally circular, circular, oval, elliptical, oval, or polygonal cross-section.

[0327] While any pleat, bellows, accordion, crease, or frill pattern may be used, in certain embodiments, the wall 261 may include at least one pleat 269 in a spiral pattern. The at least one spiral pleat 269 may extend from a point adjacent the flange 284 and terminate at a point adjacent the top wall 263. If the wall 261 tapers as the distance from the flange 284 increases, any spiral pleat 269 may have a conical shape corresponding to the taper. Any spiral pleat 269 may have a pitch such that each pleat 269 wraps around the wall 261 multiple times. In the exemplary embodiment shown in FIG. 57, the spiral pleat 269 wraps around the wall 261 approximately three times. Such pleats 269 may help aid in the collapse of the cavity while fluid is forced out of the reservoir 12 during operation of the delivery device 10. Thus, minimal force may be required to deform and deplete such a reservoir 12 during use. Furthermore, such pleats 269 may help ensure that little dead volume remains within the reservoir 12 after delivery is complete. The use of a flat top wall 263 may also aid in cavity collapse.

[0328] Referring to FIG. 58, the wall 261 may be stepped and include at least one stepped region 259. The cross-sectional area of ​​the cavity varies at each stepped region 259. In this example, the cross-sectional area of ​​the cavity is greatest adjacent the flange 284 and gradually decreases with increasing distance from the flange 284. In the example shown in FIG. 58, the wall 261 includes two stepped regions 259, but other embodiments may include any number. As with the previous example, this stepped wall 261 may help reduce the force required to collapse the cavity and direct the collapse in a predetermined manner. An example of a delivery device 10 including a reservoir 12 with such stepped walls 261 is shown in FIG. 49B. An example of a reservoir 12 with stepped walls 261 is shown in FIG. 78.

[0329] In one embodiment, the reservoir 12 may be formed by attaching the reservoir portion 271 to the holder 270, as shown in FIG. 59. In the illustrated example, the reservoir portion 271 may be disposed on the holder 270, and the lower surface area 285 of the annular portion 284 may be secured to the disk body 275 or the annular portion 272 or the upper surface area 273. For example, the reservoir portion 271 may be attached to the holder 270 by ultrasonic welding, although any form of welding or any other bonding technique known to those skilled in the art may be used. For example, the reservoir portion 271 and the holder 270 may be sealed with a double-sided adhesive. Other suitable techniques for sealing the reservoir portion 271 and the holder 270 together include, by way of non-limiting examples, the use of ultraviolet curable adhesives, heat staking, and laser welding.

[0330] An agent, such as a vaccine, can be inserted into reservoir 12 via side channel 282, which can then be sealed by any known technique, such as any known technique, such as sonic welding, heat staking, or any other suitable technique described herein. In another embodiment, reservoir 12 can include a septum 550 (see, e.g., FIGS. 76A-78) through which the agent is transferred into reservoir 12. In such an example, channel 282 can again be omitted and the periphery of flange 284 of reservoir portion 217 can be completely sealed to top surface 273.

[0331] A sharps holder 26 (see, e.g., FIG. 33) containing a delivery sharp 72 (see, e.g., FIG. 33) may be inserted into the pocket 276 and secured therein by any suitable technique, such as, for example, welding, prior to inserting the agent (e.g., vaccine) into the reservoir 12. Alternatively, as described above, a holder 270 may be formed around the sharps holder 26. As noted elsewhere herein, the delivery sharp 72 may be one or more microneedles in various examples.

[0332] In one exemplary embodiment, the reservoir 12 can hold approximately 2 microliters of vaccine or other medication. After the medical medication (e.g., vaccine) is inserted, the reservoir 12 may be placed separately in cold chain storage and then attached to the delivery device 10 immediately prior to use. This may help maximize the yield of vaccine doses per unit volume in the cold chain storage. The reservoir 12 may be inserted into the delivery device 10 along with a packet 208 and / or container 350 or foam adhesive (such as the packet or foam adhesive material described above with reference to FIGS. 10A-11). The packet 208 and / or container 350 or foam adhesive may be disposed between the reservoir 12 and the underside of the top surface 250 of the delivery device 10 when the delivery device 10 is fully assembled. Alternatively, as discussed above, when the reservoir 12 is installed, a distribution assembly 480 (see, e.g., FIG. 36) or at least one biasing member 470 (see, e.g., FIG. 47) may be positioned between the underside of the upper surface 250 and the reservoir 12.

[0333] 60, a reservoir 12 (e.g., a reservoir 12 as described above with reference to FIG. 59) may be secured inside a delivery device 10. While a representative example of a delivery device 10 is shown, the reservoir 12 may be similarly attached to the body 20 of any of the delivery device 10 embodiments described herein. The reservoir 12 may contain a drug (e.g., a vaccine) before being assembled into the delivery device 10. The reservoir 12 may be removed from refrigerated storage before being attached inside the body 20 of the delivery device 10.

[0334] 60, in one embodiment, a ridge 290 may be formed on the inner surface of the central region 28 of the delivery device 10, such that the ridge 290 may function as a seating structure on which or against which a section or region of the reservoir 12 is placed or bonded. In one example, the annular portion 272 or holder 270 may be adhered to the ridge 290 using an adhesive. Those skilled in the art will appreciate that any suitable bonding technique may be used. In other embodiments, the distal surface of the reservoir portion 271 may be attached to the proximal surface of the ridge 290. The distal surface of the reservoir portion 271 may be bonded to the ridge 290 of the body 20 of the delivery device 10, for example, as shown in FIG. 26. Alternatively or additionally, a tab projection 277 (see, e.g., FIG. 54A) may be used that bonds to a receiving slit 278 (see, e.g., FIG. 48A) defined in the body 20. Instead of the ridges 290, the body 20 may include retention tabs 580 and stop surfaces 582 (see, eg, FIGS. 79-80B) that may hold the reservoir 12 in place within the delivery device 10.

[0335] In certain embodiments, referring to FIGS. 61A-61B, the shape of the reservoir portion 271 can be adjusted to change the maximum cross-sectional area of ​​the reservoir portion 271. This can help achieve a desired delivery pressure. For example, in some embodiments, the reservoir portion 271 can be formed to have a balloon shape (as shown in FIGS. 61A-61B), a cylindrical shape, a polygonal prism shape, etc. The height of the reservoir portion 271 can be adjusted such that, given a preselected maximum cross-sectional area, a desired internal volume is obtained. As shown, the holder 270 can include at least one buttress 289. The at least one buttress 289 can at least partially surround the reservoir portion 271. The at least one buttress 289 can help hold the reservoir portion 271 in a desired position within the body. The at least one buttress 289 can also help guide the reservoir portion 271 in a collapsed direction as delivery occurs.

[0336] 61B, the body 20 can include a nesting projection 287. When the delivery device 10 transitions to a delivery state (see, e.g., FIG. 31), the nesting projection 287 can push against the reservoir portion 271. As delivery progresses, the nesting projection 287 can press the reservoir portion 271 against at least one buttress 289. In an exemplary embodiment, the nesting projection 287 can be disposed between the exemplary buttresses 289 and can help ensure that minimal dead space remains within the reservoir 12 after delivery is complete.

[0337] With reference to FIG. 62, in certain embodiments, it may be desirable for the delivery pressure to increase relatively slowly as the delivery device 10 transitions to the delivery state. For example, it may be desirable for the fluid injection to begin at a relatively low pressure, or at or near the lowest pressure at which injection is possible for a particular patient. The delivery pressure may be increased until this delivery start pressure is reached for a particular patient. By increasing the pressure slowly, it may be possible to reach the delivery start pressure for a wide variety of patients using the same design of the delivery device 10. Furthermore, once injection has begun, it may be desirable for the delivery pressure to be maintained at or near the delivery start pressure. Additionally, with reference to FIG. 62, in such embodiments, it may be desirable to use at least one biasing member 470 to facilitate delivery. For example, a compression spring made of hook-and-loop material may be used.

[0338] With reference to FIG. 62, in such an embodiment, the reservoir 12 may be divided into a first portion 520 and a second portion 522. The first portion 520 and the second portion 522 may be in fluid communication with one another via a flow restrictor 524 (see, e.g., FIG. 49B). The flow restrictor 524 may be disposed between a portion of the reservoir 12 proximal to the microneedle and a portion of the reservoir 12 distal to the microneedle. The flow restrictor 524 may be an orifice plate having one or more orifices extending therethrough in certain embodiments. In some embodiments, a flow restrictor 524 with an orifice of 15-25 microns may be included. In other embodiments, the orifice may be up to 100 microns in diameter (e.g., 70-80 microns or 75 microns). In some embodiments, the orifice may have a diameter of more than 100 microns. The size of the orifice may be selected based on considerations such as the viscosity and / or surface tension of the drug to be loaded into the reservoir, the desired injection rate, and how quickly it is desired to increase the injection pressure. The orifice plate may be an injection molded part, but may be formed in other suitable ways.

[0339] As further shown in FIG. 62, the first portion 520 of the reservoir 12 may include a majority of the reservoir 12. The second portion 522 of the reservoir 12 may be disposed proximal to the delivery sharp 72 relative to the first portion 520. The flow restrictor 524 may separate the larger first portion 520 from the smaller second portion 522 that is most proximal to the delivery sharp 72. The first portion 520 may have a volume substantially equal to the fill volume of the reservoir 12 in certain examples. The flow restrictor 524 may be disposed upstream of at least the pocket 276 (see, e.g., FIGS. 53A-54C) to which the sharps retainer 26 may be coupled. In an exemplary embodiment, the flow restrictor 524 may separate the round recess 274 (see, e.g., FIGS. 53A-53D) from the remainder of the reservoir 12. In such an embodiment, the flow restrictor 524 may be coupled to a distal face of the reservoir 12 above the round recess 274. In other examples, the flow restrictor 524 can separate the well 281 (see, e.g., FIGS. 54A-C) from the remainder of the reservoir 12. In such embodiments, the flow restrictor 524 can be coupled to a distal surface of the disk body 275 over the well 281 (see, e.g., FIGS. 54A-C).

[0340] In certain examples, the first portion 520 and the second portion 522 of the divided reservoir 12 may be filled with different fluids. For example, the first portion 520 may be filled with an agent (drug, vaccine, medical agent, etc.) that is desired to be delivered. The portion closer to the delivery sharp 72 may be filled with a gas (e.g., sterile or clean room air from the manufacturing environment, inert gas, etc.). The orifice may be sized such that the properties of the agent (e.g., surface tension, viscosity) prevent the agent from passing to the second portion 522 without applying pressure to the reservoir 12. Even though the first and second portions 520, 522 are in fluid communication, the second portion 522 may remain unwetted by any agent loaded into the reservoir 12 until use during manufacturing. When the delivery device 10 is used, there may be an incubation period during which fluid is forced from the first portion 520 into the second portion 522. The pressure in the second portion 522 may then increase to a pressure at which the patient's anatomy begins to receive delivery. Once delivery begins, the pressure may remain relatively stable (or at least not increase significantly).

[0341] When the delivery device 10 including the divided reservoir 12 transitions to the delivery state, pressure may be applied against the first portion 520 of the reservoir 12 by at least one biasing member 470 (e.g., conical spring, foam, rubber body, elastomeric body). In some embodiments, the at least one biasing member 470 may directly contact the reservoir 12 or may apply pressure via a reservoir interface member 474 (see, e.g., FIG. 36) or other components of the delivery assembly 280 (see, e.g., FIG. 36). The flow restrictor 524 may slowly increase the pressure of the fluid in the second portion 522 of the reservoir 512 to a pressure at which injection into the patient begins. The flow restrictor 524 may then limit the increase in pressure in the second portion 522 as the injection progresses. Thus, the injection tends to occur at or near the minimum pressure at which the patient will accept the delivery. This may facilitate the use of stronger springs and reduce discomfort associated with delivery. Additionally, it allows a single delivery device 10 design to be used for a broad patient population (e.g., any patient) or with a wide variety of different medications. Additionally, this can affect delivery blister formation. Delivery tends to occur more slowly and at lower pressures, resulting in a more diffuse, shallow (e.g., intradermal) injection. Adjusting the size of any orifice in the flow restrictor 524 can alter the duration of delivery and blister characteristics.

[0342] As shown in Figs. 63A and 63B, various delivery devices 10 described herein may include a reservoir 12 with at least one rocking member 526. When such a delivery device 10 is applied to a user and transitions to a delivery state, a portion of the delivery device 10 spreads and moves, stretching the skin, so that at least one delivery sharp 72 of the delivery device 10 penetrates the stretched skin. The movement of the delivery sharp 72 typically proceeds in a first direction that is approximately perpendicular to the surface of the skin, and the delivery sharp 72 penetrates downward into the skin. The rocking member 526 may cause the reservoir 12 to tilt or rock as the delivery device 10 transitions to the delivery state. The rocking member 526 may cause the delivery sharp 72 to move slightly in a second direction substantially opposite to the first direction when pressure is released from the delivery device 10. The movement in the second direction may occur simultaneously with the tilt.

[0343] In some embodiments, portions of the delivery device 10 may also be modified or adjusted to accommodate the sway of the reservoir 12. The tilt of the reservoir 12 may cause the delivery sharp 72 to move in a non-linear trajectory. For example, the delivery sharp 72 may rotate or swing along an arc-shaped trajectory, at least in part, as the delivery device 10 transitions to the delivery state. In some embodiments, the tilt may occur automatically as the delivery device 10 transitions to the delivery state. In some cases, no interlocking or linkage with a guide element is required to achieve the tilt. As an example, the presence of one or more rocking members 526 may cause the entire reservoir 12 to tilt as a unit. Such a tilt of the reservoir 12 may reduce the pressure at which injection begins and / or increase the delivery flow rate in certain delivery device 10 embodiments. The presence of the rocking members 526 may also affect the bleb formation characteristics of the delivery. Additionally, the tilt may help facilitate delivery when the delivery sharp 72 initially enters the skin approximately perpendicular to the skin.

[0344] 63A and 63B, the rocking member 526 may be a protrusion protruding from the proximal surface of the holder 270. In some examples, the rocking member 526 is disposed at or inside the periphery of the holder 270. The height of the rocking member 526 may be approximately the same as the height of the stepped protrusion 279 (see, for example, FIGS. 54A-55D). The height of the rocking member 526 may be shorter or longer. Alternatively, if the holder 270 includes a rounded recess 274 (see, for example, FIG. 53A), the rocking member 526 may be set to the same height as the protuberance corresponding to the rounded recess. In such an embodiment, a short or tall rocking member 526 may also be provided.

[0345] When the delivery device 10 including at least one rocking member 526 transitions to the delivery state, the rocking member 526 may contact the user and prevent further movement of the portion of the reservoir 12 including the rocking member 526. The opposing side may not have a rocking member 526 and may tilt or swing to continue moving toward the user. In certain examples, the delivery sharp 72 (e.g., microneedle) may tilt 3-5° (e.g., 4°) relative to the initial position. In other examples, the delivery sharp 72 may tilt more or less. The height of the rocking member 526 may change the point at which the delivery sharp 72 starts to rotate or swing when transitioning to the delivery state. A rocking member 526 with the same height as the step 279, for example, tends to start tilting after the delivery sharp 72 penetrates the skin.

[0346] In a particular example, the delivery sharp 72 may be a microneedle, as described herein. When the delivery sharp 72 is a microneedle, the rocking member 526 may be positioned on the side of the reservoir 12 closest to the back edge 23 of the microneedle. The rocking member 526 may be positioned such that the back edge 23 of the microneedle is the portion of the microneedle closest to the rocking member 526. As the reservoir 12 rocks, the back edge 23 of the microneedle may trace a path that penetrates the skin. The beveled surface may advance toward the back edge 23, which may facilitate cutting the skin when the microneedle is deployed. In this manner, the back edge 23 may become a cutting edge. Additionally, the surface on which the outlet of the flow channel 126 of each microneedle is located may move away from the skin that it contacts during initial insertion. For example, when using a microneedle as shown in FIG. 2, the lumen 126 may move away from the skin that the beveled surface 21 contacts during initial insertion. Such movement of the microneedle may help ensure that fluid easily flows from the lumen 126 to the skin as delivery occurs. Such movement may create a small receiving volume for fluid to be delivered from the lumen 126 to the skin. When the pressure applied to transition the delivery device 10 to the delivery state is released, the delivery sharp 72 may move slightly away from the patient. This creates a small receiving volume at the skin and may move the lumen 126 away from the skin where it was contacted during initial penetration. The rocking member 526 may help facilitate this movement.

[0347] As shown in Figs. 55A-D and 63B, in some examples, the delivery sharp 72 may be attached to a step 279 having a mounting surface (e.g., pocket 256) that is non-parallel to the disk body 275 of the holder 270. In such examples, the delivery sharp 72 may extend from the step 279 at a predetermined angle (e.g., 15°) with respect to a plane perpendicular to the disk body 275. When the delivery device 10 is first applied to a user, the disk body 275 and the skin are usually parallel, so the delivery sharp 72 may be angled with respect to a plane perpendicular to the skin. When the reservoir 12 is tilted, the delivery sharp 72 may move to a position close to a position perpendicular to the skin (e.g., 3-5°). Depending on the mounting angle of the delivery sharp 72, tilting the reservoir 12 may move the delivery sharp 72 to a position perpendicular or nearly perpendicular to the skin. In other embodiments, the delivery sharp 72 may be at a position 10° or more (e.g., 11-12°) away from the perpendicular direction.

[0348] With continued reference to FIGS. 63A-63B, in some examples, the reservoir 12 may include at least one marking member. The at least one marking member may contact or be pressed against the skin when the delivery device 10 delivers the medication to the user. In some embodiments, the rocking member 526 may also function as the marking member, although there may be a dedicated marking member. Marking members may also be used in embodiments that do not include the rocking member 526. When the delivery device 10 is used, the one or more marking members may leave a recognizable mark on the skin. The mark may be a temporary impression or indentation caused by the marking member pressing against the skin during delivery. Alternatively, or in addition, the marking member (e.g., the rocking member 526) may carry a marking agent (e.g., ink), a portion of which may be transferred to the skin when the delivery device 10 is used. If the size of the contact surface of the marking member is known, the recognizable mark may serve as a reference point. The delivery site may be imaged after the delivery device 10 is removed, and the image of the delivery site may be analyzed by the controller to identify a perceptible marking. In some cases, the image may need to be taken within a set time after the delivery device 10 is removed. The perceptible marking may help to verify that the delivery device 10 was used when identified in the image. Additionally, the perceptible marking may help to determine attributes related to delivery (e.g., the presence, size, area, and location of a bleb relative to the mark). For example, the controller may analyze an image region that is a certain distance from the marking to verify one or more attributes related to delivery or to verify that an attribute of interest meets an expected relationship with the mark (e.g., within a distance range from the mark). The mark left by the marking member or the placement of the marking member on the delivery device 10 may be selected to leave a perceptible mark having a particular pattern. Any suitable pattern may be used. The pattern may be selected to aid in image analysis or to provide a friendly delivery confirmation mark to the patient (e.g., a smiley face, etc.).

[0349] 64A and 64B, a bottom perspective view of the delivery device 10 including a rocking member 526 is depicted (with the adhesive member 22 hidden). As shown, the rocking member 526 can be a protrusion extending along the periphery of the disk body 275. While the rocking member 526 shown in the example of FIG. 64A is arc-shaped, the rocking member 526 can be linear, zigzag, wavy, serpentine, or extend along another path. In other examples, as shown in FIG. 64B, multiple rocking members 526 (two shown here, but more are possible) can be included. The rocking members 526 can be included as a set of bumps or protrusions protruding from the proximal surface of the disk body 275. The size and positioning of the rocking member 526 may be determined so that the rocking or tilting of the reservoir 12 occurs generally along a predetermined plane (e.g., a plane that includes or is parallel to the predetermined displacement path taken by one or more delivery sharps 72 of the delivery device 10 as the tilting occurs). The location and size of the rocking member 526 may affect the characteristics of the bleb formed during delivery of some delivery devices 10. For example, the rocking member 526 of FIG. 64A may promote a tendency for the bleb to spread left and right of the center of the rocking member 526.

[0350] 65, a flow chart 600 is depicted illustrating several exemplary operations that may be performed to deliver medication from the delivery device 10 to an injection site. As shown, at block 602, the adhesive backing 265 (see, e.g., Figs. 24 and 26) may be removed from the delivery device 10. Additionally, at block 602, a cover (e.g., cover 409 of Fig. 26) protecting the delivery sharps 72 may be removed from the delivery device 10. At block 604, the delivery device 10 may be positioned at a desired injection site.

[0351] 66, in block 606, pressure may be applied to the delivery device 10. In some examples, pressure may be applied to the top surface 250 of the body 20 of the delivery device 10. Or, as illustrated in the illustration of FIG. 66, pressure may be applied to the depressor 472 (e.g., dish 467) of the delivery device 10. Pressure may be applied manually, for example, by a single finger of the user.

[0352] Referring primarily to FIG. 65 and FIG. 67, in block 608, the skin may be stretched when the delivery device 10 is adhered to the skin via the adhesive 22. At least two portions of the delivery device 10 may deform and spread from an initial state, pulling and stretching the skin. For example, this may occur when the petals 42 of the body 20 are deformed by applying pressure to the delivery device 10. As described herein, as the petals 42 deform, the reservoir 12 and delivery sharps 72 coupled thereto move toward the skin. In block 610, the delivery sharps 72 may penetrate the skin and optionally tilt (e.g., due to the presence of the rocking member 526, see FIGS. 63A-64B and associated description). As shown in FIG. 67, the top surface 250 of the delivery device 10 may resist deformation, at least during the initial spread of the petals 42.

[0353] The petals 42 may be configured to have a selected stiffness to allow this movement to occur. For example, the petals 42 may be substantially flat and protrude from the rest of the delivery device 10 at an angle (see Figs. 70A-70B). This allows the petals 42 to flex relatively easily when pressure is applied to the delivery device 10. In another embodiment, the petals 42 may be curved in at least some areas. The curvature of the petals 42 may be selected so that at least a predetermined amount of deformation occurs in the petals 42 before the upper surface 250 is deformed. In a preferred embodiment, the body 20 is configured such that the petals 42 deform sufficiently to stretch the skin and allow the delivery sharp 72 to pierce the skin before the upper surface 250 is substantially deformed.

[0354] Referring primarily to FIG. 65 and FIG. 68, in block 612, the top surface 250 of the body 20 may change or invert from a protruding state to a concave state. In block 612, liquid may be expelled from the reservoir 12. As described herein, when the top surface 250 is inverted, the biasing member 470 may be compressed. When the biasing member 470 returns to its original (less altered) shape, liquid is delivered from the reservoir 12 through the delivery sharp 72 to the injection site. As shown in FIG. 68, in an embodiment including a pusher 472 having a dish 467, the dish 467 may abut an edge of the support structure 252 when the top surface 250 is inverted. When the top surface 250 is inverted, the dish 467 may block the view of the top surface 250, which may provide a visual cue that the delivery device 10 has been used (see also FIG. 69).

[0355] 65 and 69, in block 614, pressure may be removed from the delivery device 10 and a predetermined time may be waited for. This time may be set to be at least equal to, and preferably longer than, the expected delivery time. In some instances, the wait time is between 1 and 5 minutes.

[0356] As shown in FIG. 69, when pressure is removed, a portion of the delivery device 10 may at least partially return from the deformed state to its original shape. Thus, the body 20 may have at least one reversible region, at least one elastic region, and at least one region that elastically deforms as the delivery device 10 transitions to the delivery state. The at least one region that elastically deforms may deform from an initial state to an intermediate state and then at least partially return from the intermediate state to its original shape during the transition to the delivery state. The intermediate state may be a state in which the region is maximally deformed. From this state, the region may return to its initial state. For example, the petals 42 may at least partially return to their original shape. Because the petals 42 of the delivery device 10 are adhered to the skin via the adhesive 22 of the delivery device 10, the skin may be pulled away from the underlying anatomical structures as the petals 42 return to their original shape. As the petals 42 return to their original shape, the reservoir 12 may also move slightly away from the skin (the rocking member 526 may assist in this, see, e.g., the discussion of Figs. 63A-64B). If adhesive 22 is present on a portion of the reservoir 12 (e.g., the holder 270), the skin may also be pulled away from the underlying anatomical structures as the reservoir 12 moves. This may relieve some of the pressure on the injection site and prevent the anatomical structures at the injection site from compressing. This reduction in pressure at the injection site may allow the liquid to move more easily from the delivery sharp 72 to the delivery destination. Additionally, depending on the orientation of the delivery sharp 72, the delivery sharp 72 may pull up the skin that it penetrates, which may result in the skin being pulled away from the underlying anatomical structures. Again, this may reduce compression of the anatomical structures at the delivery destination and facilitate delivery. The shape of the petals 42 and the materials used in the construction of the body 20 may be selected to encourage the petals 42 to at least partially return to their original shape when pressure is removed.

[0357] At block 616, the delivery device 10 may be removed from the injection site. In some examples, at block 618, the delivery may be verified. In some embodiments, this verification may be performed manually. Vaccination site or clinic staff may visually verify the presence of a bleb after injection and that there is no leakage. In other embodiments, an image of the injection site may be taken, analyzed, and documented in an electronic record (as described elsewhere). Image analysis may be performed, for example, to determine whether expected markings are present at the injection site or whether the image exhibits characteristics of interest (or has a desired relationship to a fiducial marking). In other examples, the image may be analyzed to verify the presence of a cold area on the skin (see, e.g., FIG. 107 and related discussion).

[0358] 70A-70B and 72A-72B, two exemplary bodies 20 for use in the various delivery devices 10 described herein are shown, respectively. When the delivery device 10 is injection molded, portions of the body 20 may be injection molded in a stored or delivery state. Portions of the body 20 may be prone to transitioning to or returning to the molded state easily. Such portions may also have a tendency to remain in the molded state. In the example of FIGS. 70A-70B, the top surface 250 is molded in a delivery state position. The petals 42 are molded in a storage state position. Upon assembly of the delivery device 10, various portions of the body 20 may be placed in a storage state and remain in that state until use. Molding the top surface 250 in the delivery state may reduce the effort required to transition the delivery device 10 from the storage state to the delivery state. Similarly, molding the petals 42 in the storage state may facilitate the petals 42 returning to the storage state when pressure is released from the delivery device 10 during use (see FIG. 69 and related discussion).

[0359] As mentioned above, in certain embodiments, the petals 42 may be relatively uncurved. For example, the petals 42 may be substantially flat and / or extend at an angle from other portions of the body 20. This may result in a relatively low force being required to deflect the petals 42 when pressure is applied to the delivery device 10, which may facilitate the spreading displacement of the petals 42 and help ensure that the delivery sharps 72 penetrate the skin before the top surface 250 of the body 20 is deformed.

[0360] As shown in FIGS. 70A-70B, the petals 42 of the exemplary body 20 each include a first region 620 adjacent the support structure 252 and a second region 622 forming a more peripheral portion of the petals 42. As shown in the figures, the first region 620 may be arcuate like the adjacent portion of the support structure 252. The second region 622 may be disposed at an angle relative to the central axis A1 of the body 20. The second region 622 may form a majority of the petals 42. In some instances, the petals 42 may be primarily flat, while having curved regions or surfaces. In various embodiments, a small curved transition 621 may be included between the first and second regions 620, 622 of the petals 42 (see, e.g., FIG. 71).

[0361] A living hinge may be formed at the transition between the first and second regions 620, 622. When pressure is applied to the top surface 250 of the body 20, the living hinge allows the second region 622 of the petals 42 to move relative to the first region 620. The first region 620 may deform less than the second region 622 while the delivery device 10 transitions to the delivery state. In some instances, the first region 620 may resist significant deformation and remain substantially undeformed during the transition. Thus, the first region 620 may act as a stop and help limit the spreading displacement of the petals 42 after a desired amount of spreading displacement has been achieved. The curved transition 621 may be included to facilitate at least partial return of the petals 42 after pressure applied to the delivery device 10 is released. In examples including petals 42 such as those in FIGS. 70A-70B, in the stored state, it may be desirable for the base of the stepped protrusion 279 to be approximately the same height as the edge of the second region 622 of the petals 42 closest to the central region 28.

[0362] The body 20 may have a rounded, generally circular footprint, as shown in FIGS. 70A-70B. The portion of each petal 42 at the periphery 38 of the body 20 may be arched along a radius extending radially from the n-axis A1 of the body 20. In various examples, as shown in FIGS. 72A-72B, the portions of the petals 42 forming the periphery 38 may narrow as they move away from the central portion 28 of the body 20. For example, the portions of the petals 42 forming the periphery 38 of the body 20 may not be arched along a radius extending from a center point within the central axis A1 of the body 20. For example, the radius defining the periphery of each petal 42 may extend from a center point within the corresponding petal 42 or the second region 622 thereof. The outermost region of each petal 42 is disposed farther from the central portion 28 than the end of the slit 36 ​​furthest from the central portion 28. The outermost regions may narrow as they move away from the central portion 28. In some instances, the portion forming the periphery 38 of each petal 42 may be tapered or rounded, as shown in Figures 72A-72B.

[0363] This may facilitate easier removal by reducing the surface area of ​​adhesive that the user must peel from the skin during the initial removal action when removing the delivery device 10. Although each petal 42 is described as being the same shape, at least one petal 42 may be included that has a slightly different shape to include a pull tab 266 (see, e.g., FIG. 72B) that may be included to aid in removal of the delivery device 10.

[0364] Various views of a portion of an exemplary delivery device 10 are shown in FIGS. 73A-73G. Various views of an exemplary delivery device 10 are also shown in FIGS. 74A-75G. As shown, in comparison to a typical syringe or needle-based injection, a delivery device 10 of the type shown here can be decorative, which can make it, for example, more approachable. This can be particularly useful for needle-phobic populations, such as children. In some examples, a portion of the delivery device 10 can be shaped or colored to look like a flower (e.g., a daisy). The push-down body 472 (and possibly at least a portion of the central portion 28 of the body 20) can have a first appearance (e.g., color, material, pattern), and at least the petal-like members 42 of the body 20 can have a second appearance (e.g., color, material, pattern) that is different from the first appearance. The push-down body 472 can look like, for example, the central portion of a flower. The petal-like members 42 can have a petal-like appearance. As shown in dotted lines in FIGS. 73A-75G, certain features may vary or may be omitted, but the delivery device 10 and portions thereof may include decorative elements. Additionally, the delivery device 10 and portions thereof shown and described in connection with FIGS. 73A-75G may have decorative elements in isolation (e.g., the hold-down body 472, the body 20, the periphery 30 of the body 20, the petals 42, the set of petals 42). Additionally, the delivery device 10 and portions thereof shown and described in connection with FIGS. 73A-75G may be modified, for example, to add or remove the number of petals 42. In some implementations, the petals 42 are separated by slits in the periphery 30 as shown in FIGS. 73A-75G, but the size of the petals 42 may vary to accommodate the desired number of petals 42. In such instances, the petals 42 have the same cross-sectional shape as shown in the figures, but the cross-sectional shape may rotate along a larger or smaller arc depending on the number of petals 42. The gaps between the petals 42 formed by the slits in the periphery 30 may be wider or narrower in alternative embodiments.

[0365] 76A-76B, top and bottom views of an exemplary reservoir 12 are depicted. The exemplary reservoir 12 may be included in any of the exemplary delivery device 10 embodiments described above, for example. As shown, various exemplary reservoirs 12 may include at least one septum 550. The septum 550 may be located in an off-center position adjacent to the rocking member 526 in the reservoir 12, in certain examples. When the reservoir 12 is assembled, a first portion of the septum 550 may be fluidly connected with the interior volume of the reservoir 12. The septum 550 may also include an externally accessible portion. In some embodiments, the reservoir 12 includes a flow path, which is fluidly connected with the main fluid-holding volume of the reservoir 12, but is sealed from the external environment by the septum 550. The flow path may extend from a space adjacent to the first portion of the septum 550 to the main fluid-holding volume of the reservoir 12. The flow path may be defined by a portion of the disk body 275 and the reservoir portion 271. The reservoir 12 may be filled (e.g., using a dispensing sharp 570) through the septum 550, and fluid may flow through the flow path into the interior space of the reservoir 12. Although shown with respect to the embodiment shown in Figures 76A-76B, the septum 550 may also be included in other exemplary reservoirs 12 described herein.

[0366] The exemplary reservoir 12 includes a reservoir portion 271 with a wall 261 having a structure that promotes collapse (see, e.g., FIGS. 57-58). In the exemplary embodiment, the wall 261 includes a plurality of stepped regions 259, as described in connection with FIG. 58, such that the wall 261 has a stepped appearance. The interior main volume of the exemplary reservoir 12 has a stepped pyramid or ziggurat shaped volume. The reservoir 12 is shown in a filled state. The holder 270 includes a stepped projection 279 (further described in connection with FIGS. 55A-D) and a rocking member 526 (further described in connection with FIGS. 63A-64B).

[0367] In the example shown, the side channel 282 of the reservoir portion 271 is sealed by heat staking the material of the reservoir portion 271 to the holder 270. The portion of the side channel 282 at the periphery of the flange 284 is sealed to the holder 270, with the remainder of the side channel 282 remaining open. In alternative embodiments, the reservoir portion 271 may not include the side channel 282. The entire periphery of the flange 284 may be bonded to the disk body 275 during manufacture. In certain examples, the walls 261 forming the cavity in the reservoir portion 271 may include branches or nodes that extend away from the main portion of the cavity.

[0368] As shown in FIGS. 76A-76B, the reservoir 12 including the septum 550 may be shipped unfilled. The reservoir 12 may be filled at a pharmacy, hospital, doctor's office, vaccination site, or other patient care location. Alternatively, the reservoir 12 may be filled at a local distribution center and then distributed to the surrounding population. The reservoir 12 may be filled immediately prior to use of the delivery device 10. Thus, the drug may only be stored in the delivery device 10 for a short period of time (e.g., minutes to weeks). This allows the reservoir 12 and delivery device 10 to be shipped without the need for a cold chain distribution network, further limiting long-term drug compatibility testing and allowing for a faster response to public health crises.

[0369] 77-78, an exemplary reservoir 12 can be filled by establishing a fluid connection between the interior fluid holding volume of the reservoir 12 and a filling instrument (not shown). In various examples, a filling instrument such as a syringe is used and may include a dispensing sharp 570. The dispensing sharp 570 passes through a septum 550 and fluid is transferred from the filling instrument through the dispensing sharp 570 to the interior volume of the reservoir 12. The adhesive member 22 on the delivery device 10 (see, e.g., FIGS. 81A-C) may include an open area to allow access to the septum 550 through the dispensing sharp 570 or may be bonded to the delivery device 10 after filling. After the desired amount of fluid has been transferred to the reservoir 12, the dispensing sharp 570 is withdrawn from the septum 550. The septum 550 is constructed of a self-sealing material such that after the dispensing sharp 570 is withdrawn, the septum 550 provides a tight seal between the interior volume of the reservoir 12 and the outside environment. In some examples, a vacuum may be pulled on the reservoir 12 through the filling instrument (e.g., by pulling the plunger of a syringe) prior to transferring fluid to the reservoir 12. The dispensing sharp 570 is removed from the septum 550 and gas drawn from the reservoir 12 is vented through the filling instrument, thereby minimizing the amount of gas present in the reservoir 12 prior to filling.

[0370] In some examples, the reservoir 12 may include a guard that prevents contact between the tip 572 of the dispensing sharp 570 and the reservoir portion 271. The guard helps to keep the reservoir portion 271 away from the dispensing sharp 570 when filling the reservoir 12. The guard may, for example, prevent a portion of the reservoir portion 271 from migrating into the sharp-receiving area where the tip 572 of the dispensing sharp 570 is located during filling.

[0371] Referring primarily to FIG. 77, an exemplary septum 550 is depicted. As shown, the septum 550 includes a plug portion 552 and a standoff 554, which may function as a guard. The plug portion 552 includes a first end 556 and a second end 558, which are connected by a stem body 562. The stem body 562 may be narrower (e.g., smaller in diameter) than either the first end 556 or the second end 558. The first end 556 may be wider (e.g., larger in diameter) than the second end 558. The standoff 554 protrudes from the second end 558. In the illustrated example, the standoff 554 is generally hemispherical and includes a recessed channel 564. The recessed channel 564 forms a canyon-like feature in the standoff 554 and extends along the width of the standoff 554.

[0372] Referring primarily to FIG. 78, the holder 270 includes an opening 560 that extends through the disk body 275 of the holder 270. A septum 550 may provide a fluid-tight plug for the opening 560 when the reservoir 12 is assembled. For example, the septum 550 is attached to the reservoir 12 with a standoff 554 and a first end 556 passing through the opening 560. The standoff 554 may have a shape (e.g., a spherical piece) that helps guide the septum 550 into the opening 560. When attached, the stem body 562 is disposed within the bore of the opening 560. The first end 556 is disposed against a face of the holder 270 from which the stepped protrusion 279 extends. The second end 558 is disposed within the side channel 282 (or within a branch or node that protrudes from the main cavity of the interior volume of the reservoir 12). Thus, the plug portion 552 can establish a fluid-tight seal between the external environment and the interior volume of the reservoir 12. The stem body 562 of the septum 550 can have a width (e.g., diameter) slightly larger than the diameter of the opening 560 so that the septum 550 is compressed when the septum 550 is attached to the reservoir 12.

[0373] When installed within the reservoir 12, the side channel 282 (or branch or node from the main cavity of the reservoir 12) formed in the reservoir portion 271 may be prevented from moving into the recessed channel 564 by the remaining portion of the standoff 554. The portion of the standoff 554 adjacent to the recessed channel 564 may hold the reservoir portion 271 above the recessed channel 564. In this manner, the recessed channel 564 forms a sharps receiving space within the reservoir 12. The tip 572 of the dispensing sharp 570 may be kept clear of the material forming the reservoir portion 271 as it travels into the recessed channel 564.

[0374] In some embodiments, an adapter 566 may be used with any suitable filling tool to prevent the dispensing sharp 570 from advancing more than a certain distance into the septum 550. The adapter 566 may be coupled, for example, to a filling tool or to a hub 568 to which the dispensing sharp 570 is attached. The adapter 566 may extend along a portion of the dispensing sharp 570 to shorten the exposed length of the dispensing sharp 570. The adapter 566 may contact or bottom out against the reservoir 12 when the dispensing sharp 570 is inserted into the septum 550, preventing the dispensing sharp 570 from advancing further into the septum 550. The adapter 566 may limit the movement of the tip 572 of the dispensing sharp 570 out of the recessed channel 564. In alternative embodiments, the adapter 566 may be omitted. The dispensing sharp 570 may have an exposed length (e.g., extending from the hub 568) that is less than the height of the septum 550, but greater than the distance between the first end 556 of the septum 550 and the nearest point of the recessed channel 564. Thus, upon insertion, the tip 572 of the dispensing sharp 570 may be disposed within the recessed channel 564.

[0375] 79, the exemplary reservoir 12 of FIGS. 76A-78 is shown incorporated into an exemplary delivery device 10. In some embodiments, the reservoir 12 may be filled while attached to the delivery device 10, or may be filled and then attached to the delivery device 10. If the reservoir 12 is filled separately from the delivery device 10, a user may attach the reservoir 12 to the delivery device 10 after filling, and then couple the adhesive member 22 to the delivery device 10. If the delivery device 10 is filled at a pharmacy or the like, a tool may be provided to assist in positioning when coupling the adhesive member 22 to the delivery device 10.

[0376] 80A-80B, the body 20 of the delivery device 10 may include one or more retention tabs 580. The retention tabs 580 may form a ledge extending from an inner sidewall of the body 20 and spaced apart from each stop surface 582 on the respective retention tab 580. In various examples, the body 20 may be formed as a single monolithic body including the retention tabs 580 and the stop surfaces 582 in a single molding operation without the use of a side operation of the mold. The retention tabs 580 may be created by incorporating a bypass shutoff in the mold. The retention tabs 580 may allow the reservoir 12 to be coupled to the body 20 with a snap fit. To attach the reservoir 12 to the delivery device 10, the reservoir 12 may be pressed against the underside of the retention tabs 580 (the side closest to the patient when the delivery device 10 is in use) and toward the top surface 250 of the body 20. The retention tab 580 may flex to allow the disk body 275 of the reservoir 12 to pass over the retention tab 580 and impact with the stop surface 582. The retention tab 580 resiliently bounces back to secure the reservoir 12 within the delivery device 10. The retention tab 580 and stop surface 582 may be incorporated into various delivery devices 10 described herein (e.g., any of those described above). The embodiment including the ridge 290 (see, e.g., FIG. 28) may be modified to include the retention tab 580 and stop surface 528 in place of the ridge 290. Referring now to FIGS. 81A-81C, multiple exemplary adhesive members 22 are shown on an exemplary delivery device 10. As shown, a single adhesive member 22 is included on each of the exemplary delivery devices 10. In alternative embodiments, the adhesive member 22 may be broken down or destroyed into multiple individual adhesive members 22. This may facilitate the use of different adhesives or leave certain petals 42 devoid of adhesive. As shown, each adhesive member 22 may include a plurality of slits 43 extending radially inward from the periphery of the adhesive member 22 to form petal portions that align with the petal-like members 42 of the body 20. The adhesive member 22 may include a central opening 49 through which the delivery sharps 72 of the delivery device 10 can access the patient.

[0377] The shape and size of the central opening 49 may affect blister formation resulting from delivery when the delivery device 10 is used. Additionally, the shape and size of the central opening 49 may help facilitate a particular shallow delivery, or shallow delivery to skin with particular characteristics. In various exemplary delivery devices 10, it may be desirable for the central opening 49 to have a cross-sectional area that is 60-100% of the footprint of the holder 270. It may be preferable for the central opening 49 to have a shape such that at least a portion of the adhesive member 22 is attached to a portion of the holder 270 or other rigid portion of the reservoir 12. In certain examples, the cross-sectional area of ​​the central opening 49 may be greater than 0.13 square inches. In certain examples, the cross-sectional area of ​​the central opening 49 may range from 0.13 square inches to 0.5 square inches (e.g., about 0.3 square inches).

[0378] Additionally, it may be desirable for the central opening 49 to be wider in certain directions than in other directions. For example, each delivery sharp 72 (e.g., one or more microneedles) may tend to distribute fluid in an ejection direction (e.g., along the axis of the lumen of the delivery sharp 72) extending from the outlet of the respective delivery sharp 72. It may be desirable for the central opening 49 to have a greater or increased width in a direction that coincides with or substantially coincides with the ejection direction. For example, the maximum width (or at least the relatively wider width portion) of the central opening 49 may be along a direction parallel to a plane that includes the ejection direction. By using a delivery device 10 including one or more microneedles similar to that shown in FIG. 2, the increased width portion of the central opening 49 may be aligned with the anterior-posterior (from the distal side 15 to the rear end 23, also referred to herein as the length) direction or line of symmetry of the microneedle. For example, the central opening 49 may be oval shaped and widest in a direction parallel to the anterior-posterior direction of the microneedle. This may help create a more diffused, shallow (e.g., intradermal) injection as opposed to a concentrated blister. This may be desirable as it may help increase the effectiveness of the injection: for example, injecting the vaccine more widely intradermally may expose more immune-related cells in the intradermal area to the vaccine, enhancing the immune response.

[0379] Referring now primarily to FIG. 81A, the central opening 49 may be a generally round (e.g., circular) opening, except for a number of inwardly extending teeth or spokes 51 of the adhesive member 22 material. In this exemplary embodiment, the adhesive member 22 includes a central opening 49 with four spokes 51 spaced at regular angular increments from one another. In certain examples, the number of spokes 51 may vary, and the spacing of the spokes 51 may be irregular. The spokes 51 may be arranged such that the central opening 49 has a relatively large width in a direction along the ejection direction. The central opening 49 may have a relatively large width in this direction, but this does not exclude other wide areas of equal, narrower, or possibly wider widths. In the illustrated example, the central opening 49 is approximately equal in width as measured in a direction perpendicular to the front-to-rear direction of the microneedle. In certain examples, the spokes 51 may aid in attachment to a holder 270 or other rigid reservoir 12 portion. This may, for example, allow the adhesive member 22 to be rigidly attached to both the body and the holder 270. In certain instances, the spokes 51 may be the only portion of the adhesive member 22 that is adhered to the holder 270 .

[0380] 81B-C, in certain examples, the central opening 49 may include a notch 53 that extends outwardly from the periphery of the remaining portion of the central opening 49. The notch 53 may be included to widen the central opening 49 if desired. While this example includes a rectangular notch 53, in alternative embodiments the notch may be shaped differently. The notch 53 may be any suitable polygonal shape, for example, circular.

[0381] As described above, various bodies 20, petals 42, central regions 28, top surfaces 250, ridges 290, and retention tabs 580 have been described. It should be understood that the various delivery devices 10 described herein are exemplary. Any of the bodies 20 described herein may be used with any of the delivery devices 10 described above. Similarly, any of the features of the bodies 20 described herein may be incorporated into the body 20 described above. Any of the adhesive members 22 described herein may be used with any of the delivery devices 10 described above. Any of the delivery sharps 72 and sharps retainers 26 described herein may be used with any of the delivery devices 10 described above. Additionally, any of the dispensing assemblies 480 or portions thereof (e.g., biasing member 470, depressor 474) described herein may be used with any of the delivery devices 10 described above. Additionally, the reservoir 12 and its features (eg, holder 270, rocker member 526, reservoir portion 271, reservoir wall 261, stepped protrusion 279, flow restrictor 524) described above may also be used in the delivery device 10 described above.

[0382] 82A and 82B, another exemplary embodiment of the delivery device 10 is shown. As shown, the delivery device 10 includes a body 20 and a reservoir 12. The reservoir 12 includes a sharps holder 26 that includes a one-dimensional array of three delivery sharps 72. Other embodiments may include any suitable number of delivery sharps 72 arranged in any pattern. The body 20 of the delivery device 10 may have a polygonal (e.g., rectangular) footprint and may generally be formed as a strip of material to which the reservoir 12 is attached. In an exemplary embodiment, the body 20 includes multiple living hinges 50 that are integrally formed with the remainder of the body 20. Each of the living hinges 50 may extend across a portion of the body 20 and divide the body 20 into multiple panels 52A-D. The body 20 may be injection molded.

[0383] The panels 52A-D may include a pair of opposing end panels 52A,D. Each of the end panels 52A,D may include a planar portion 54. The planar portions 54 may be parallel or coplanar. In this example, the planar portions 54 are coplanar. One of the ends 52A may include an angled protrusion 56 extending from the planar portion 54. The angled protrusion may extend from the planar portion 54 such that an obtuse angle is formed between a distal surface of the planar portion 54 and the angled protrusion 56. The angled protrusion 56 may be resilient and resist deflection or bending such that it extends at an angle relative to the planar portion 54. In some examples, a buttress 58 may be included and may extend from the planar portion 54 to the angled protrusion. Each planar portion may have a proximal surface at least partially covered with adhesive 22.

[0384] The panels 52A-D may also include at least two intermediate panels 52B,C that may extend between and join the end panels 52A,D. One of the panels 52B may be joined to an end of the raised projection 56 via one of the living hinges 50. The other of the intermediate panels 52C may be joined to the planar end panel 52D via another one of the living hinges 50. Each of the intermediate panels 52B,C may be joined to one another via a living hinge 50 to form a joint 60 between the end panels 52A,D.

[0385] As shown now in FIGS. 83A-83C, the connector 60 may be displaceable through a raised position (see FIG. 83A), a centered position (see FIG. 83B), and up to a center-on position (see FIG. 83C). When the delivery device 10 is in a stored state, the connector 60 may be in the raised position. In the raised position, the intermediate panel 52B connected to the raised projection 56 may extend from the raised projection 56 at an angle 62 (angles 62, 64, 66) measured between the proximal faces of the listed components. The angle 62 may be selected such that the intermediate panel 52B gradually moves away from the plane of the planar portion 54 as the distance from the raised projection 56 increases. In the illustrated example, when the connector 60 is in the raised position, the angle 62 is an obtuse angle. The intermediate panels 52B, C may be disposed at an angle 64 to one another. This angle 64 is also an obtuse angle in the exemplary embodiment when the connector 60 is in the raised position. The middle panel 52C and the end panel 52D may form a reflex angle 66 with respect to one another when the connector 60 is in the raised position. Additionally, in the raised position, each of the end panels 52A,D may be at their closest distance to one another.

[0386] The delivery device 10 may be applied to the skin 44 over the injection site in a retracted state with the connector 60 in the elevated position. This may secure the end panels 52A,D such that they are substantially constrained to the plane of the skin patch to which they are adhered. Applying downward pressure to the connector 60 may displace the connector 60 from the elevated position toward the center position. As this occurs, the angle 64 between the two middle panels 52B,C may increase. The angle 62 between the raised protrusion 56 and the middle panel 52B, and the angle 66 between the end panel 52D and the middle panel 52C may decrease. To accommodate the change in angle 64 between the two middle panels 52B,C, the end panels 52A,D may widen. When the connector 60 reaches the center position (see FIG. 83B), the angle 64 is 180° and the end panels 52,D may be at a maximum distance from each other. The skin 44 may stretch and become taut as the end panels 52A,D are displaced apart.

[0387] As the link 60 is displaced further, it may be in an over-center state. The elasticity of the stretched skin 44 may exert a restoring force that tends to drive the end panels 52A, D toward each other. Thus, as the link 60 is displaced through the center position, it may automatically be displaced to an over-center position at the end of the link 60's displacement range. Once the link 60 is displaced to this over-center position, the delivery device 10 may transition to the delivery state. As the link moves to the over-center position shown in FIG. 83C, the distance between the end panels 52A, D may decrease. However, the distance between the end panels 52A, D may still be greater than the distance between the end panels 52A, D when the link 60 is in the raised position. In the over-center position at the end of the displacement range, the angle 62 between the raised protrusion 56 and the intermediate panel 52B may be about 90° (e.g., 80°-110°). The angle 64 between the intermediate panels 52B, C may be a reflex angle. Thus, the connector 60 may be partially inverted relative to its position in the raised position. The angle 66 between the middle panel 52C and the end panel 52D may be substantially 180°. As shown, when the connector 60 reaches an over-center position at the end of its range of displacement, the proximal surface of the middle panel 52C may contact the skin 44.

[0388] When the delivery device 10 is in the delivery state (see FIG. 83C), the delivery sharp 72 can be pressed into the skin 44 to puncture the skin 44 and establish fluid communication with a delivery destination within the patient's body. The angle 64 between the intermediate panels 52B,C in the over-center delivery position (see FIG. 83C) can be selected so that the delivery sharp 72 pierces the skin 44 at a predetermined angle (e.g., 45°-45° relative to the surface of the skin 44). The angle 64 can be selected to be within a range of 30° to 60°. Alternatively, the angle 64 can be established by setting the ratio of the shortest distance between the angle 62 and the surface of the skin 44 in the over-center delivery position (see FIG. 83C) and the length of the intermediate panel 52B within a desired range. When the delivery device 10 is in the delivery state, the reservoir 12 can be pressed against the skin 44. This can pressurize the reservoir 12 and force fluid from the reservoir 12 through the delivery sharp 72 and into the patient. The restoring force created by the stretched skin 44 may provide continuous pressure against the reservoir 12 and help ensure that the reservoir 12 is completely emptied as delivery occurs.

[0389] In some embodiments, the proximal surface of the intermediate panel 52C may be at least partially covered with adhesive 22 (see, e.g., FIG. 83C). When the connector 60 reaches an over-center position at the end of the displacement range, the adhesive 22 may hold the connector 60 in place. Additionally, in some embodiments, the body 20 may include at least one force limiter. For example, at least one of the panels 52A,D may include a strain relief flexure. In an exemplary embodiment, this flexure may flex if the force required to stretch the skin 44 exceeds a threshold value. As the flexure flexes, the connector 60 may snap through the center position into an over-center position and the stretching of the skin 44 may stop. This may be desirable as it may help to reduce potential discomfort during injection due to excess tension on the skin 44. Similarly, this may be helpful in certain patient populations as skin characteristics vary widely between potential patients.

[0390] In one embodiment, one of the intermediate panels 52B, 52C, for example, intermediate panel 52C, may be implemented as a flexure or to include at least one flexure incorporating a gap and at least one biasing member. The gap may be biased to an expanded state by a biasing member (which in some embodiments may be integrally formed of the same material as panels 52B, C). Upon application of sufficient pressure to the biasing member, the biasing member may be overcome and a deflection may occur. Thus, intermediate panels 52B, 52C may be formed to have a variable length that decreases when the force exceeds a predetermined threshold.

[0391] The intermediate panel 52C (although any intermediate panel 52B, 52C may include such features) may be implemented as or include at least one lattice structured flexure 290, as shown in FIGS. 84A-84B. The flexure 290 may be formed by injection molding. The intermediate panel 52C may include a first member 296 adjacent the connection of the living hinge 50 to the other intermediate panel 52B. The first member 296 may have at least one support arm 300. In the illustrated example, there are four support arms 300A-D extending at a substantially 90° angle from the first member 296 to a second member 298 of the intermediate panel 52C. The second member 298 may be adjacent the connection of the living hinge 50 to the end panel 52D. The second member 298 may be disposed parallel and opposite to the first member 296 and may have at least one arm 302. In the illustrated example, there are two arms 302A-B extending from the second member 298 toward the first member 296 at a substantially 90° angle. Each of the two arms 302A-B may be disposed substantially parallel to and extending between a respective pair of four support arms 300A-D. Each of the two arms 302A-B may be coupled by at least one buttress 304 (e.g., three buttresses 304) to at least one of two associated support arms 300A-B, 300C-D disposed on either side of the respective arm 302A-B. In this example, each of the two arms 302A,B is connected to each of the associated support arms 302A-B. Only six of the twelve buttresses 304A-F are shown in FIG. 84B for ease of illustration. Application of pressure above a threshold level at least partially closes the gaps between first and second members 296, 298, support arms 300A-D, arms 302A-B, and buttresses 304A-F. The number of buttresses 304A-F can be varied to adjust the threshold at which flexure 290 gives away. Additionally or alternatively, the amount or thickness of material of buttresses 340A-F can be adjusted for this purpose.Buttresses 304A-F may be disposed substantially parallel to one another and extend from respective arms 302A-B at an acute angle relative to first member 296. Buttresses 304A-F may be coupled to respective support arms 300A-D at an obtuse angle. Flexures 290 are shown by way of non-limiting example and may be incorporated using any suitable shape, angle, and / or configuration and / or number of parts.

[0392] In other embodiments, the intermediate panel 52C may incorporate at least one flexure 292, which may be in the form of a crushable body that may deform when a threshold force is applied to the body. In one embodiment, the flexure 292 may be round and hollow. With reference to FIGS. 85A-85B, the exemplary flexure 292 may be approximately cylindrical in shape. The illustrated flexure 292 is one of many possible examples and need not be limited to the illustrated configuration or shape. The flexure 292 may be integral with the intermediate panel 52C or may be formed in the injection molding process that forms the body 20 of the delivery device 10.

[0393] In some embodiments, at least a portion of the body 20 may be plastically deformed after the delivery device 10 transitions from the storage state to the delivery state. For example, one of the living hinges 50 may be plastically deformed. Alternatively, one or more of the living hinges 50 may break when an attempt is made to return the delivery device 10 from the delivery state to the storage state. Thus, the transition from the storage state to the delivery state may be made irreversible, preventing reuse of the delivery device 10. In some examples, the adhesive 22 may be selected to bond more aggressively to the skin 44 than the material forming the body 20. Thus, the adhesive 22 may peel off from the delivery device 10 upon removal of the delivery device 10. In embodiments described herein in which the adhesive 22 is peeled off from the delivery device 10, the adhesive 22 may include a pull tab or similar mechanism to facilitate subsequent removal from the skin 44.

[0394] 86-87, another exemplary embodiment of a delivery device 10 is shown. As shown, the delivery device 10 includes a body 20 and a reservoir 12. The reservoir 12 includes a sharps holder 26 that includes a one-dimensional array of delivery sharps 72. Other embodiments may include any suitable number of delivery sharps 72 arranged in any pattern. The body 20 of the delivery device 10 may have a polygonal footprint that may change from a first polygonal shape (e.g., hexagonal) to a second polygonal shape (e.g., rectangular) as the delivery device 10 transitions from a stored state to a delivery state.

[0395] The body 20 may include first and second end blocks 70A,B. The end blocks 70A,B may be disposed opposite one another. The end blocks 70A,B may be disposed in a spaced apart relationship and connected to one another by a pair of side panels 71A,B and a bridge 76. The side panels 71A,B may each have a first end connected to the first end block 70A by a hinge 74A. The side panels 71A,71B may each have a second end opposite the first end connected to the second end block 70B by a hinge 74B. Each of the side panels 71A,B may also include an intermediate hinge 74C that may be disposed in an intermediate region of the side panels 71A,B between the first and second ends of each side panel 71A,B.

[0396] Similar to the side panels 71A,B, the bridge 76 may have a first end connected to the first end block 70A by a hinge 74D and a second end opposite the first end connected to the second end block 70B by another hinge 75E. The bridge 76 may further include an intermediate hinge 74F disposed between the first end and the second end of the bridge 76. The bridge 76 may include a panel body 78 and a pair of strut members 80A,B. The strut members 80A,B may be connected to the panel body 78 via the intermediate hinge 74F of the bridge 76. The bridge 76 may also include an arm member 82. The arm member 82 may be disposed between the two strut members 80A,B and extend toward the proximal face of the end blocks 70A,B. In an exemplary embodiment, the arm member 82 extends from an end of the panel body 78 adjacent the intermediate hinge 74F of the bridge 76. The reservoir 12 may be coupled to a proximal face of the arm member 82 at the end of the arm member 82 opposite the panel member 78 .

[0397] In the exemplary embodiment shown in Figures 86-87, hinges 74A-F are shown as living hinges. In alternative embodiments, at least one of hinges 74A-F may be a conventional hinge, and body 20 may be constructed as an assembly of multiple components that are coupled together via hinges 74A-F. In yet other examples, body 20 may be constructed from at least two components. Instead of using hinges to couple the components, two or more components of body 20 may be coupled by welding, thermal bonding, solvent bonding, etc.

[0398] The side panels 71A, 71B of the delivery device 10 may be displaceable through a range of displacement to transition the delivery device 10 between a stored state (shown in FIGS. 86-87) and a delivery state. In the stored state, the side panels 71A, 71B of the delivery device 10 may be in an outwardly bowed position. The side panels 71A, 71B may be bent at an intermediate hinge 74C of each side panel 71A, 71B to enable the side panels 71A, 71B to assume this outwardly bowed position. There may also be some pivoting of the side panels 71A, B at the hinges 74A, B connecting the side panels 71A, B to the end blocks 70A, B to enable the side panels 71A, B to be disposed in the outwardly bowed position.

[0399] A clamping force can be applied to the side panels 71A, 71B pushing the side panels 71A, 71B towards each other to displace the side panels 71A, 71B from their outwardly curved positions to their straight positions. Note that the straight positions do not necessarily have to be positions in which the side panels 71A, B each extend along a straight line. In some examples, the straight positions may be positions in which the side panels 71A, B are less outwardly curved than their outwardly curved positions.

[0400] The bridge 76 may also be displaceable through a range of displacement to transition the delivery device 10 between a stored state (as shown in Figs. 86-87) and a delivery state. In the stored state, the bridge 76 may be in a raised state in which at least the delivery sharps 72 of the reservoir 12 coupled to the arm members 82 are disposed above the proximal faces of the endblocks 70A,B. The bridge 76 may be bent at the intermediate hinges 74F such that the panel bodies 78 and the posts 80A,B extend upwardly from the endblocks 70A,B and away from the proximal faces of the endblocks 70A,B. There may also be some pivoting of the bridge 76 at the hinges 74D,E connecting the bridge 76 to the endblocks 70A,B and the posts 80A,B to allow the bridge to assume a raised position. A force perpendicular to the proximal faces of the endblocks 70A,B may be applied to the bridge 76 to displace it from the raised position to a lowered position at the opposite end of the bridge 76's range of displacement.

[0401] In various embodiments, actuation of the bridge 76 through its range of displacement can transition the delivery device 10 from the storage state to the delivery state. Additionally, actuation of the side panels 71A,B from an outwardly bowed state to a straight state can transition the delivery device 10 from the storage state to the delivery state. Because the bridge 76 and side panels 71A,B are coupled to one another via end blocks 70A,B, actuation of the bridge 76 through its range of displacement can result in displacement of the side panels 71A,B through their range of displacement. Displacement of the side panels 71A,B through their range of displacement can result in displacement of the bridge 76 through its range of displacement.

[0402] It may be up to the user to decide whether to use actuation of the side panels 71A,B or the bridge 76 to transition the delivery device 10. Alternatively, whether the bridge 76 or the side panels 71A,B are actuated may depend on the patient population to which the user belongs. For example, actuation of the bridge 76 may result in more pressure being applied against the arm members 82, which may aid in reliable penetration of the delivery sharp 72 into the skin. Thus, it may be desirable for patient populations with certain skin characteristics to be instructed to actuate the delivery device 10 via the bridge rather than the side panels 71A,B.

[0403] As shown now in Figs. 88A-88C, when the side panels 71A,B are in an outwardly bent position and the bridge 76 is in a raised position (see Fig. 88A), the end blocks 70A,B may be at a first distance from each other. When the side panels 71A,B are displaced toward a straight position and the bridge 76 is displaced to a lowered position (see Figs. 88B-88C), the end blocks 70A,B may be displaced away from each other. Because the delivery device 10 is attached to the skin 44 via the adhesive 22 contained in the end blocks 70A,B, the spreading of the end blocks 70A,B may stretch and taut the skin 44. This may help to facilitate puncturing the skin 44 by the delivery sharp 72 contained in the reservoir 12. When the side panels 71A,B reach a straight position and the bridge 76 reaches a lowered position, the delivery sharp 72 may puncture the skin 44 and the delivery device 10 may be in a delivery state, as shown in Fig. 88C. The reservoir 12 may be compressed between the skin 44 and the arm members 82 to force fluid out of the reservoir 12 and into the patient. The reservoir 12 may collapse as delivery occurs.

[0404] Referring now to FIG. 89, which is a cross-sectional view of the delivery device 10 of FIGS. 86-87, in a particular example, the delivery device 10 can include an iris assembly 84. The iris assembly 84 can include a pair of iris panels 86A-D that can define an aperture 88 that is variable in size from a closed position to a fully open position. The iris panels 86A-D can extend from each of the side panels 71A,B in a direction toward the opposite side panel 71A,B. In an exemplary embodiment, two iris panels 86A-D extend from each side panel 71A,B and are disposed on either side of the intermediate hinges 74C,D of each side panel 71A,71B. As the side panels 71A,71B are displaced from their outwardly bent positions to their straight positions, the iris panels 86A-D adjust the aperture 88 so that the aperture 88 provides an opening for the delivery sharp 72 of the reservoir 12 to pass through. 89, when the delivery device 10 is in the stored state, the opening 88 may be substantially closed. Such an iris assembly 84 may thus function as a guard to help prevent inadvertent contact with the delivery sharps 72 during handling of the delivery device 10.

[0405] In an exemplary embodiment, one of the iris panels 86A includes a latch protrusion 90. Another of the iris panels 86B includes a latch catch 92, which may be formed as a notch in the iris panel 86B. The latch protrusion 90 is inclined. Thus, when the iris panels 86A,B are displaced toward each other, the iris panel 86B can deflect and ride up the inclined surface of the latch protrusion 90 (see, for example, FIG. 88B). When the latch catch 92 is aligned on the latch protrusion 90, the iris panel 86B including the latch catch 92 returns to an undeflected state, and the latch catch 92 can snap into engagement with the latch protrusion 90. This can secure the delivery device 10 in the delivery state. The snapping action of the iris panels 86B can generate a tactile sensation perceptible, for example, via the user's fingertips. Alternatively or additionally, the snapping can generate an audible clicking or slapping sound. Thus, the delivery device 10 can provide an audible and / or tactile indication that the delivery device 10 has transitioned to the delivery state. The engagement of the latch protrusion 90 with the latch catch 92 can also help prevent reuse. As described in connection with other embodiments herein, the adhesive 22 can be selected to bond more aggressively to the skin 44 than the material forming the body 20. Thus, upon removal of the delivery device 10, the adhesive 22 can become detached from the delivery device 10. This can also help prevent reuse of the delivery device 10.

[0406] 90A-90B, another exemplary embodiment of the delivery device 10 is shown. The delivery device 10 can include a first portion 100 and a second portion 102. One of the first portion 100 and the second portion 102 can be translationally displaced relative to the other of the first portion 100 and the second portion 102 to transition the delivery device 10 from a stored state (see FIG. 90A) to a delivery state (see FIG. 90B). In some embodiments, only a portion of the first portion 100 or the second portion 102 can be translationally displaced relative to the other. For example, one of the first portion 100 or the second portion 102 can elongate and / or stretch. In certain instances, the transition to the delivery state can be reversible, while in other embodiments, the transition can be an irreversible one-way transition. For example, a latch, lock, or other coupling may be engaged to hold the first and second portions 100, 102 in the delivery state or to prevent the first and second portions 100, 102 from returning to the storage state. Alternatively, the first portion 100 and the second portion 102 may be coupled to one another as the delivery device 10 transitions to the storage state. Once the delivery device 10 transitions to the delivery state, breaking the coupling or coupling between the first portion 100 and the second portion 102 may require destruction of a portion of the delivery device 10. This destruction may render the delivery device 10 inoperable. This may not only prohibit reuse, but may also provide a perceptible (e.g., visual) indication to the user that the delivery device 10 has been used.

[0407] The proximal surface of each of the first and second portions 100, 102 may be at least partially covered with an adhesive 22. The adhesive 22 may function to bond the first and second portions 110, 102 to a skin surface at a patient's injection site. The delivery device 10 may be adhered to the skin when the delivery device 10 is in a storage state and then transitioned to a delivery state. When the transition occurs, the adhesive-bearing portion of the first portion 100 may be displaced relative to the adhesive-bearing portion of the second portion 102. Thus, the distance between these adhesive-bearing sections may increase to stretch or widen the underlying skin. This may be desirable to hold the skin taut to facilitate puncturing the skin by at least one delivery sharp 72 of the reservoir 12 included in the delivery device 10.

[0408] The transition of the delivery device 10 to the delivery state may also cause the delivery sharp 72 to displace or descend proximally toward and into the skin. In embodiments in which the delivery sharp 72 is coupled to the reservoir 12, the reservoir 12 may also displace proximally. In some examples, the reservoir 12 may be compressed between the skin surface and one of the first and second portions 100, 102 when the delivery device 10 transitions from the storage state to the delivery state. Compression of the reservoir 12 may help force fluid out of the reservoir 12 and through the delivery sharp 72 to the target delivery site within the patient's body. Additionally, in some embodiments, at least one of an audible or tactile indication may be generated as the delivery sharp 72 displaces toward the skin.

[0409] 91-92, an exemplary delivery device 10 is shown. As shown, the delivery device 10 may be a substantially planar, thin, low profile assembly. The delivery device 10 may include a proximal portion 110 and a distal portion 112. The proximal portion 110 may be formed of a flexible material and in some embodiments may be elastic such that the proximal portion 110 or at least a portion of the proximal portion may be stretchable. The distal portion 112 may be rigid. The proximal surface of both the proximal portion 110 and the distal portion 112 may have at least one area covered with adhesive 22. The proximal portion 110 may be bonded to the distal portion 112 via the adhesive 22 on the proximal surface of the distal portion 110. Such an embodiment may be desirable when the delivery device 10 is suitable for mass production by a reel-to-reel manufacturing process.

[0410] 93-94, the proximal portion 110 and the distal portion 112 may be bonded together via an adhesive fastening assembly 114. As shown, the adhesive fastening assembly 114 may include a region of locking adhesive 116, which may be disposed on a portion of the proximal surface of the distal portion 112. The adhesive fastening assembly 114 may include a tether member 118. The tether member 118 may be bonded at a first end to the proximal portion 110 of the delivery device 10 and at a second, opposing end to the locking adhesive 116 on the distal portion 112. The tether member 118 may be heat staked, welded, or otherwise fixedly bonded to the proximal portion 110 while being relatively lightly bonded to the locking adhesive 116. In some embodiments, the tether member 118 may be constructed of an adhesive liner or adhesive backing material, but is easily peelable from the locking adhesive 116. As shown, when the delivery device 10 is in the stored state, the tether member 118 can be at least partially doubled.

[0411] The proximal portion 110 may include a pull tab 120, which may be disposed at a first end of the proximal portion 110. The pull tab 120 may be an enlarged or widened portion of the proximal portion 110. In some embodiments, the pull tab 120 may include a roughened surface, ridges, or the like to facilitate gripping. In alternative embodiments, the pull tab 120 may include a notch to form a pull ring.

[0412] The proximal portion 110 may also include at least one ramp element 128 and a fold region 122 at an end of the proximal portion 110 opposite the pull tab 120. In an exemplary embodiment, the proximal portion 110 includes two ramp elements 128 aligned with one another. The fold region 122 can be folded on itself multiple times. In this example, the fold region 122 is folded on itself twice. Thus, when a pulling force is applied to the pull tab 120, the fold region 122 can unfold and take up material of the proximal portion 110, allowing the proximal portion 110 to stretch. The at least one ramp element 128 can also move as the fold region 122 pumps out material. The number of folds in the fold region 122 can be adjusted to vary the amount the proximal portion 110 stretches as it transitions to an extended state. The folding region 122 may taper from a wider width to a smaller width over at least a portion of the folding region 122. In an exemplary embodiment, the layer of the folding region 122 closest to the distal portion 112 tapers toward a rounded end. The layer of the folding region 112 most proximal to the distal portion 112 may be substantially stationary and secured in place by the adhesive 22 of the distal portion 112 as the folding region 122 unfolds.

[0413] As shown in FIG. 93, the delivery device 10 may include a reservoir 12 that may include at least one delivery sharp 72. Any suitable number of delivery sharps 72 may be included in any desired number of rows and / or columns. Any delivery sharp 72 described herein may be used. The delivery sharp 72 may be included on a sharps holder 26 coupled to the reservoir 12. The reservoir 12 may be disposed on a resilient cantilever arm 130 defined in a distal portion 112 of the delivery device 10. The folding region 122 of the proximal portion 110 may include a delivery opening 124. As shown, when the delivery device 10 is in a stored state, the delivery opening 124 may not be aligned with the delivery sharp 72. Thus, the proximal portion 110 may cover the delivery sharp 72 and prevent or protect against inadvertent contact with the delivery sharp 72 when the delivery device 10 is in a stored state. However, the delivery opening 124 may allow the delivery sharps 72 of the delivery device 10 to pass through the delivery opening 124 and access the user's skin when the delivery device 10 is transitioned to the delivery state.

[0414] 95A-96B, a pulling force can be applied to the pull tab 120 to transition the delivery device 10 from the storage state to the delivery state. The distal portion 112 of the delivery device 10 can be secured to the skin 44 via an adhesive on a proximal surface of the distal portion 112. Thus, the distal portion 112 of the delivery device 10 can be substantially stationary as the transition occurs. The proximal portion 110 can transition from a first state to an elongated state as the delivery device 10 transitions from the storage state to the delivery state. As shown, the folded region 122 of the proximal portion 110 can widen such that the proximal portion 110 stretches as the pull tab 120 is pulled. Additionally, in certain embodiments, the proximal portion 110 can stretch to allow for further elongation. A segment of the proximal portion 110 that includes the adhesive 22 can be displaced relative to the distal portion 112 of the delivery device 10 as the pull tab 120 is pulled. The adhesive 22 on the proximal portion 110 and the distal portion 112 may be displaced apart when the proximal portion 110 is pulled from a first condition to an elongated condition. As a result, the skin 44 between the adhesive 22 on the proximal portion 110 and the adhesive 22 on the distal portion 112 may be stretched and taut to facilitate puncture.

[0415] As the folding region 122 unfolds, material in the proximal portion 110 is expelled, which may result in the proximal portion 110 extending and displacing the delivery opening 124 into alignment with the delivery sharp 72. The at least one ramp element 128 may displace toward the pull tab 120. The at least one ramp element 128 may keep the cantilever arm 130 slightly biased toward the distal portion 112 as the proximal portion extends. This may prevent the reservoir delivery sharp 72 from being dragged against the proximal portion 110 as the proximal portion 110 transitions to the extended state. As the at least one ramp element 128 further displaces, the cantilever arm 130 may ride up the sloped region of the at least one ramp element 128 and be further deflected toward the distal portion 112 of the delivery device 10. As the folding region 122 continues to unfold, the at least one ramp element 128 may advance past the cantilever arm 130.

[0416] Once at least one ramp element 128 has passed the cantilever arm 130, the cantilever arm 130 may return to an undeflected state, as shown in FIGS. 96A and 96B. The delivery device 10 may enter a delivery state when the cantilever arm 130 clears the at least one ramp element 128 and returns to its undeflected state. As the cantilever arm 130 bounces back to its undeflected state, the delivery sharp 72 may be displaced through the delivery opening 124 and pierce the skin 44. This may establish fluid communication between the delivery sharp 72 and the patient's delivery target site. Additionally, the reservoir 12 may be compressed between the skin 44 and the cantilever arm 130 as the cantilever arm 130 returns to its undeflected state. This compression may act to expel fluid from the reservoir 12 and pump it through the delivery sharp 72 and into the patient. Compression may also help ensure that the reservoir 12 is completely emptied during delivery.

[0417] As illustrated, the tether member 118 can peel away from the locking adhesive 116 when the delivery device 10 transitions from the storage state to the delivery state. When the delivery device 10 reaches the delivery state, the tether member 118 can be at least partially separated from the locking adhesive 116. The exposed locking adhesive 116 can then adhere to the proximal portion 110 to adhere the proximal portion 110 in place. The locking adhesive 116 can aggressively adhere to the proximal portion 110. Any attempt to separate the proximal portion 110 and the locking adhesive 116 can damage one of the components of the delivery device 10. This can help ensure the transition of the delivery device 10. Returning the delivery device 10 to the delivery state is irreversible. The locking adhesive 116 can also inhibit the proximal portion 110 from crumpling due to the restoring force exerted by the stretched skin. Thus, the locking adhesive 116 can hold the adhesive 22 on the proximal portion 110 in place such that the proximal portion 110 is in a stretched state and the skin remains stretched when the user releases the pull tab 120.

[0418] 97-100, another exemplary embodiment of the delivery device 10 is shown. FIG. 97 shows the exemplary delivery device 10 in a stored state. FIG. 98 shows the exemplary delivery device 10 in a delivery state. FIG. 99 and FIG. 100 are exploded views of the exemplary delivery device 10. As shown, the exemplary delivery device 10 may include an actuator. In some embodiments, the actuator may form a top 306 or cap having at least one recess or indentation 308 therein (though three such indentations 308 are shown, it will be understood that the number need not be three). The indentation 308 may help facilitate twisting of the top 306 by a user by placing a fingertip therein. The top 306 may be hooded or convex and may be made of plastic formed by injection molding or any other suitable technique known to one of skill in the art. One of skill in the art will appreciate that the top 306 need not be limited to any particular shape, so long as it can be twisted by a user.

[0419] As shown, the exemplary top 306 rests on a base body 309. The top 306 engages with a threaded post or screw 310 that is included as part of the base body 309. In some non-limiting examples, the screw 310 may be made of a plastic material formed by injection molding and may be integrally formed with the remainder of the base 309. One skilled in the art will appreciate that other materials and manufacturing techniques may be used.

[0420] In an exemplary embodiment, the user may first remove the adhesive liner 265 (see, e.g., FIG. 24) from the delivery device 10. In addition to covering the adhesive bearing pad 312 of the delivery device 10, the adhesive liner 265, in some embodiments, is attached to cover the delivery device 10 and maintain a pre-sterilized condition. Such a condition may be created prior to attaching the adhesive liner 265 to any of the delivery devices 10 described herein. In some examples, the user may peel off the adhesive liner 265 in a manner similar to peeling a liner from a bandage before applying a bandage. Once the liner 265 is removed, the user may apply the delivery device 10 to the skin. As in the illustrated example, the adhesive pad 312 may be annular in shape. In some embodiments, the adhesive pad 312 may be ultrasonically welded to the delivery device 10. Those skilled in the art will appreciate that other suitable techniques for adhering the adhesive pad 312 to the delivery device 10 may be used.

[0421] After affixing the delivery device 10 to the skin, a user can twist the apex 306 of the delivery device 10 to advance the apex 306 proximally (e.g., toward the skin) along the threads of the screw 310. The threaded screw 310 can house a frangible material, or weakened portion 314. The weakened portion 314 can prevent displacement of the apex 306 and other components of the delivery device 10 until a sufficient force is applied to the apex 306. This can help prevent the delivery device 10 from transitioning to a delivery state during storage.

[0422] In an exemplary embodiment, the weakened portion 314 is provided as at least one tab protruding from the carriage 315 that may be disposed within the bore 317 of the threaded post 310. In some embodiments, the carriage 315 may include a set of three weakened portions 314. The bore 317 may include a shelf 319 for supporting at least one of the weakened portions 314, and preferably may include a shelf 319 for supporting each of the weakened portions 314. When the weakened portions 314 rest on the shelf 319, the carriage 315 may be prevented from displacing within the bore 317 and may prevent twisting motion of the top 306. In certain examples, the shelves 319 may each be an end of a track or rail (best shown in FIG. 99) disposed within the bore 317, which may help guide the displacement of the carriage 315 within the bore 317.

[0423] The top 306 may incorporate a central protrusion 318 (e.g., a post or stepped post as shown) that rests on a portion of the carriage 315. When the top 306 is screwed downward or proximally toward the skin surface, the protrusion 318 may force the frangible portions 314 against their respective shelves 319. Pressure applied to the frangible portions 314 may cause the frangible portions 314 to break, allowing the carriage 315 to move proximally within the bore 317. The carriage 315 may be displaced proximally until a second end of the carriage 315 (opposite the first end from which the frangible portions 314 protrude) contacts the skin surface. One of ordinary skill in the art will appreciate that breaking the frangible portions 314 may inhibit reuse of the delivery device 10.

[0424] The adhesive pad 312 of the delivery device 10 can have a central opening 323 through which a portion of the carriage 315 can extend. The skin may not be held in place relative to the delivery device 10 in the area of ​​the central opening 323. Thus, as the carriage 315 continues to displace proximally, the skin in this area may be pushed and stretched as it is displaced by the carriage 315. This may cause the skin aligned with the central opening 323 to become taut. The base body 309 may include a ledge 321 that extends into the bore 317 at the proximal end of the bore 317 and acts as a stop surface. The carriage 315 may stop displacing proximally when it contacts the ledge 321.

[0425] The apex 306 may be at the midpoint of its travel along the post 310 when the carriage 315 contacts the shelf 321. As shown, the carriage 315 may include a second weakened portion 325 or set of weakened portions 325. In some embodiments, there may be three second weakened portions 325 spaced equiangularly around the circumference of the carriage 315. The first weakened portion 314 may be weaker (e.g., thinner) than the second weakened portion 325. Thus, the second weakened portion 325 may break only after it has been broken. The protrusion 318 from the apex 306 may abut the second weakened portion 325 when the carriage 315 abuts against the stop provided by the shelf 321. The second weakened portion 325 may impede displacement of the apex 306. Further actuation of the apex may exert a force against the second weakened portion 325, which may result in the second weakened portion 325 breaking. When second weakened portion 325 is broken, top portion 306 is free to move proximally while carriage 315 remains stationary (against the stop provided by shelf 321). One skilled in the art will appreciate that breaking of weakened portion 325 may inhibit reuse of delivery device 10.

[0426] As shown, the delivery device 10 may also include a delivery aid 320. The delivery aid 320 may be a flat plate with a post extending therefrom, as shown in the example. The delivery aid 320 may be made of a plastic material formed by injection molding. Those skilled in the art will appreciate that other materials and manufacturing techniques may be used to construct the delivery aid 320. The delivery aid 320 is positioned above the reservoir 12 containing a fluid, such as a drug (e.g., a vaccine), and incorporates on its underside a sharps holder 26 (see, e.g., FIG. 33) that includes at least one delivery sharps 72 (see, e.g., FIG. 33).

[0427] In some embodiments, the delivery aid 320 may be attached to the proximal end of the protrusion 318 via an adhesive. In some embodiments, the delivery aid 320 may rest on a shelf in the carriage 315. The reservoir 12 may be held in the opening of the carriage 315 by a friction fit or a slip fit as shown. In some instances, a weak adhesive may hold the reservoir 12 in place in the opening. In other embodiments, the friction fit may be augmented by a gasket member (e.g., an O-ring) disposed between the side of the reservoir 12 and the opening of the carriage 315.

[0428] When the second weakened portion 325 breaks, the delivery aid 320 can concentrate the force generated when the tip 306 acts against the reservoir 12 of the delivery device 10. In embodiments where the delivery aid 320 rests on a shelf in the carriage 315, a portion of the delivery aid 320 may deform or break, allowing it to move past the shelf. As the tip 306 continues to advance along the post 310, the delivery aid 320 and the reservoir 12 may move downward. The force exerted by the tip 306 may be sufficient to overcome the friction or adhesive holding the reservoir 12 in place. As the delivery aid 320 moves downward, the reservoir 12 may move downward until the delivery sharp 72 (see, e.g., FIG. 33) penetrates the skin surface. At this point, the reservoir 12 may be pinched between the skin and the protruding portion 318 of the tip 306, as shown in FIG. 98. As the apex 306 continues to displace proximally, pressure from the delivery aid 320 builds up in the reservoir 12, forcing the fluid contained therein through the delivery sharps 72 to the patient. At that point, the apex 306 may have stopped twisting and reached the end of its displacement range. At the end of its displacement range, the apex 306 may abut the base body 309, which may provide a mechanical interference against further displacement. Once the movement of the apex 306 has stopped, the user may remove the delivery device 10 from the skin.

[0429] As mentioned above, it may be desirable to prevent the delivery device 10 from being reused. It may also be desirable to provide a delivery device 10 that scratches the surface of the skin before the delivery sharp 72 penetrates the skin surface. In one embodiment, the delivery device 10 may include an actuation assembly that may include first and second displaceable members. The members may be displaceable from a separated state to a proximal state relative to one another. The members may transition from the separated state to a proximal state when the delivery device 10 is actuated and / or when the delivery device 10 delivers its contents. The members may include cooperating coupling mechanisms that may engage with one another when the members approach or reach the proximal state. When the cooperating coupling mechanisms are engaged, the coupling mechanisms may prevent separation of the members and maintain the members in the proximal state.

[0430] 101-103, an exemplary embodiment of such a portion of an actuation assembly 327 for a delivery device 10 is shown. The delivery device 10 may include an integral or integrally formed flexure. The flexure may be formed as a pair of vertically spaced first and second bodies 320A, 320B such that the first body 320A is located above the second body 320B or in another plane. In an exemplary embodiment, the first and second bodies 320A, B are concentric round bodies, specifically shown as circles. The flexure may be made of a bendable plastic formed by injection molding or other suitable techniques known to those skilled in the art. The bodies 320A, 320B may be joined by at least two flexible struts 322 integral with the flexure. In this example, six such flexible struts 322 are shown, but it will be understood that the number need not be six. The struts 322 may be, but need not be, spaced at equal angular increments in all embodiments. The struts 322 can extend between the bodies 320A, 320B at an angle that is not perpendicular to the bodies 320A, 320B.

[0431] At least one hook 324 may be included integral with one of the bodies 320A,B. The other of the bodies 320A,B may include at least one catch 326. In an exemplary embodiment, the first body 320A includes a number of hooks 324 extending downwardly therefrom toward the second body 320B. While six such hooks 324 are shown, it will be understood that the number need not be six. In this example, the hooks 324 are equally spaced around the first circle 320A, but this need not be the case in all embodiments. This exemplary embodiment also shows at least one catch 326 integral with the second body 320B. Each of the catches 326 is located at a point on the second body 320B that is not directly below the hook 324 of the first body 320A. The catches 326 in this example extend upwardly from the second body 320B toward the first body 320A. Although six such catches 326 are shown, it will be understood that the number need not be six. The catches 326 may be spaced at equal angular increments around the second body 320B. The catches 326 may be positioned such that upon actuation of the flexure, each catch 326 and hook 324 engages with one another. The flexure may be actuated, for example, by applying pressure to the flexure via a portion of the delivery device 10 in which the flexure is incorporated. The catches 326 may be formed substantially in the shape of an upside-down Latin letter "U."

[0432] As the first body 320A is displaced toward the second body 320B, at least one of the bodies 320A,B may also rotate. If one of the bodies 320A,B is rotationally constrained, only the other of the bodies 320A,B may rotate as the bodies 320A,B are displaced toward each other. If the first body 320A is pressed down from above while the second body 320B is rotationally constrained, the flexible post 322 may bend. The hook 324 may rotate and displace (around an axis passing through the center points of the bodies 320A,B). The hook 324 and the first body 320A may also translate as the first body 320A approaches the second body 320B. The hook may translate relative to the catch 326 until the hook 324 contacts the catch 326. The hook 324 may deflect around the catch and then resiliently return to engagement with the catch 326. Thus, when the strut 322 attempts to resiliently return to an undeflected state, the first body 320A and the second body 320B may be held together by the engagement of the hook 324 and the catch 326. By using a single piece flexure (e.g., formed by injection molding), the delivery device 10 may be manufactured at a relatively low cost. The hook 324 engaging the catch 326 may also help prevent reuse of the delivery device 10 that includes the flexure. The engaged hook 324 may also help maintain pressure on the reservoir 12 of the delivery device 10 necessary to ensure delivery of a medical agent (e.g., a vaccine) into a patient via one or more delivery sharps 72 (see, e.g., FIG. 33).

[0433] The rotational displacement of one of the bodies 320A,B may be a harness that helps drive the delivery sharp (see, e.g., FIG. 33) across the skin surface to scratch the skin before piercing the skin. In the exemplary embodiment described above, the delivery sharp 72 (see, e.g., FIG. 33) may be constrained to move in conjunction with the first body 320A. Thus, the delivery sharp (see, e.g., FIG. 33) rotates as it moves relative to the skin.

[0434] Referring now to FIG. 104, an exemplary package 400 is shown. The package 400 can house the delivery device 10 during distribution and transportation. The package 400 may also include other components, such as printed instruc...

Claims

1. 1. A delivery device for delivering a medicament to a barrier, comprising: a body including a central region defining a receptacle, a peripheral region defined by a plurality of petals, and a set of retention tabs extending into the receptacle; a reservoir including at least one delivery sharp, a main interior volume, and at least one septum in fluid communication with the main interior volume, the reservoir coupled to the body via the retention tab; an adhesive bonded to the body; at least one biasing member located in the housing between the reservoir and a wall of the housing; A delivery device comprising:

2. The delivery device of claim 1 , wherein the at least one biasing member is a coil spring having an integrated reservoir interface member.

3. 2. The delivery device of claim 1, wherein the body is configured to transition from a first state to a second state, and the reservoir is configured to displace toward the barrier as the body transitions from the first state to the second state.

4. 4. The delivery device of claim 3, wherein the biasing member is configured to deform when the body transitions from the first state to the second state, and the biasing member is configured to return to the reservoir after being deformed by the body transitioning from the first state to the second state, and to push fluid out of the at least one delivery sharp.

5. The delivery device of claim 1 , wherein the biasing member is selected from the group consisting of a foam body, a rubber body, and an elastomeric body.

6. The delivery device of claim 1 , wherein the main interior volume is defined by a wall comprising at least one disintegration enhancing agent.

7. The delivery device of claim 1 , wherein the at least one biasing member is formed from an elastomeric material and includes at least one hollow portion.

8. The delivery device of claim 7 , wherein the at least one hollow portion is defined by a passageway through the biasing member.

9. The delivery device of claim 1 , wherein the biasing member is formed of an elastomeric material and has first and second layers having different areas of print.

10. The delivery device of claim 1 , wherein the reservoir comprises a sharps receiving space.

11. The delivery device of claim 1 , wherein the reservoir includes a guard defined at least in part by a septum.

12. The delivery device of claim 1 , wherein the reservoir includes a fluid path from the main interior volume to a septum.

13. The delivery device of claim 1 , further comprising a septum including a plug portion disposed in a fluid-tight manner within an opening through the rigid portion of the reservoir.

14. 10. The delivery device of claim 1, comprising a septum including a portion disposed within a fluid-containing portion of the reservoir, the fluid-containing portion being formed with two raised portions sandwiching a recessed channel.

15. 2. The delivery device of claim 1, wherein the reservoir includes a rigid portion and a flexible portion coupled to the rigid portion, and the delivery device further includes a septum including a first portion disposed within a passageway through the rigid portion and a second portion having a recessed channel, the septum configured to prevent displacement of the flexible portion into the recessed channel.

16. The delivery device of claim 1 , wherein the reservoir is filled with an overdose intervention drug.

17. The delivery device of claim 1 , wherein the reservoir is filled with at least one vaccine.

18. The reservoir is filled with a COVID-19 vaccine.

10. The delivery device of claim 1.

19. The reservoir further comprises a protrusion closer to a periphery of the reservoir than the at least one delivery sharp.

10. The delivery device of claim 1.

20. 20. The delivery device of claim 19, wherein the body is configured to transition between a first state and a second state, the reservoir is configured to displace toward the barrier as the body transitions from the first state to the second state, and the protrusion is configured to tilt the reservoir as the body transitions from the first state to the second state.

21. The delivery device of claim 1 , wherein the body is integrally formed with the retention tab in an injection molding operation without lateral motion.

22. The delivery device of claim 1 , wherein the body includes a series of stops associated with the retention tabs.

23. 1. A delivery device for delivering a fluid into a barrier, comprising: The main body, an adhesive disposed on at least a portion of the body for attaching the delivery device to the barrier; a reservoir coupled to the body and containing at least one delivery sharp, the reservoir including a main interior volume for holding a fluid and a septum in fluid communication with the main interior volume; wherein the body is configured to transition between a first state and a second state, and the reservoir is configured to displace toward the barrier as the body transitions from the first state to the second state.

24. 24. The delivery device of claim 23, wherein the reservoir further comprises a protrusion closer to a periphery of the reservoir than the at least one delivery sharp.

25. 25. The delivery device of claim 24, wherein the protrusion is configured to tilt the reservoir when the body transitions from the first condition to the second condition.

26. 24. The delivery device of claim 23, wherein the main interior volume is at least partially collapsible.

27. 24. The delivery device of claim 23, wherein at least two portions of the body having the adhesive disposed thereon are configured to displace and spread when the body transitions from the first state to the second state.

28. 24. The delivery device of claim 23, wherein the body includes a central region and a peripheral region having a plurality of petals extending outwardly from the central region, the central region defining a receiving portion for receiving at least a portion of the reservoir.

29. 24. The delivery device of claim 23, wherein the reservoir comprises at least one rigid portion and at least one flexible portion.

30. 24. The delivery device of claim 23, wherein the reservoir includes a guard to protect a portion of the reservoir from contact with a dispensing sharp pierced through the septum.

31. 31. The delivery device of claim 30, wherein the guard is defined at least in part by the septum and forms a sharps receiving space within the reservoir.

32. 24. The delivery device of claim 23, wherein the reservoir includes a flow path from the main interior volume to the septum.

33. 24. The delivery device of claim 23, wherein the septum includes a plug portion disposed within an opening in a rigid portion of the reservoir.

34. 24. The delivery device of claim 23, wherein the septum includes a plug portion and a standoff extending from the plug portion, the standoff being configured with two raised portions sandwiching a recessed channel.

35. 24. The delivery device of claim 23, wherein the at least one delivery sharp is attached to a step that protrudes from a rigid portion of the reservoir.

36. 24. The delivery device of claim 23, wherein the at least one delivery sharp comprises at least one microneedle.

37. 24. The delivery device of claim 23, wherein the reservoir further comprises at least one marking agent disposed on a raised portion of the reservoir.

38. 24. The delivery device of claim 23, wherein the reservoir further comprises a marking material.

39. 1. A delivery device comprising: a body including a central region and a peripheral region having a plurality of petals extending from the central region, the central region defining a receptacle, the body having a top region and a base connected by a wall; a variable volume reservoir including at least one delivery sharp and at least one septum communicating with a main interior volume of the reservoir, the variable volume reservoir being coupled to the body and at least partially disposed within the housing; an adhesive disposed on at least a portion of the body; A delivery device comprising:

40. 40. The delivery device of claim 39, wherein the reservoir further comprises at least one protruding member closer to a periphery of the reservoir than the at least one delivery sharp.

41. 41. The delivery device of claim 40, wherein the protruding member extends from a rigid portion of the reservoir.

42. 40. The delivery device of claim 39, wherein the at least one delivery sharp is a microneedle.

43. 40. The delivery device of claim 39, wherein the reservoir comprises a planar body with a step protruding therefrom, and the at least one delivery sharp is attached to the step.

44. 44. The delivery device of claim 43, wherein the at least one delivery sharp protrudes from the step at an acute angle relative to a plane perpendicular to the plane of the planar body.

45. 40. The delivery device of claim 39, wherein the body is configured to transition from a first state to a second state when attached to a surface via the adhesive, and the reservoir is configured to be primarily displaced in a direction approximately perpendicular to the surface as the body transitions from the first state to the second state.

46. 40. The delivery device of claim 39, wherein the reservoir includes a guard.

47. 47. The delivery device of claim 46, wherein the guard is defined at least in part by a septum.

48. 40. The delivery device of claim 39, wherein the reservoir includes a flow path from the main interior volume to the septum.

49. 40. The delivery device of claim 39, wherein the septum includes a plug portion that forms a fluid-tight seal with an opening in a rigid portion of the reservoir.

50. 40. The delivery device of claim 39, wherein the septum includes a first portion and a second portion extending from the first portion, the second portion being configured with two raised portions sandwiching a recessed channel.

51. 40. The delivery device of claim 39, wherein the reservoir further comprises a marking material.

52. 40. The delivery device of claim 39, wherein a marking material is carried by the marking material, and the marking material and the at least one delivery sharp each extend away from the same side of the reservoir.

53. 1. A delivery device comprising: a body including a central region and a peripheral region having a plurality of petals extending from the central region, the central region defining a receptacle, the central region having a top region and a base connected by a wall; a variable volume reservoir containing at least one delivery sharp, said reservoir coupled to said body and at least partially disposed within said housing; an elastomeric body positioned within said housing between said upper region and said reservoir; an adhesive disposed on at least a portion of the body; A delivery device comprising:

54. 54. The delivery device of claim 53, wherein the elastomeric body includes at least one hollow portion.

55. 55. The delivery device of claim 54, wherein each of the at least one hollow portion is formed by a passageway that extends at least partially through the elastomeric body.

56. 54. The delivery device of claim 53, wherein the elastomeric body is layered.

57. 54. The delivery device of claim 53, wherein the reservoir further comprises a septum.

58. 54. The delivery device of claim 53, wherein the body includes a set of retention tabs that extend into the receiver and are configured to be coupled to the reservoir by a snap fit by passing the reservoir past the retention tabs.

59. 54. The delivery device of claim 53, wherein the reservoir further comprises a protrusion closer to a periphery of the reservoir than the at least one delivery sharp.

60. 60. The delivery device of claim 59, wherein the protrusions carry a marking agent.

61. 54. The delivery device of claim 53, wherein the body is configured to transition between a first state and a second state, and the reservoir is configured to displace along a path as the body transitions from the first state to the second state.

62. 54. The delivery device of claim 53, wherein the at least one delivery sharp comprises an array of spaced apart microneedles.

63. 54. The delivery device of claim 53, wherein each of the petals is mostly flat and disposed at an acute angle relative to a central axis of the delivery device.

64. 54. The delivery device of claim 53, wherein the peripheral region includes an outermost portion defining a periphery of the body, and each of the petals defines a portion of the periphery.

65. 54. The delivery device of claim 53, wherein an outermost portion of each of the petals defines a portion of a periphery of the body, and wherein the outermost portion of each of the petals arc along a radius having a center point along a central axis of the delivery device.

66. 54. The delivery device of claim 53, wherein the outermost portion of each petal defines a portion of a periphery of the body, and the outermost portion of each petal arcs along a radius having a center point within each petal.

67. 54. The delivery device of claim 53, wherein each petal is separated by a slit in the peripheral region, each petal includes an outermost region disposed further from the central region than an end of the slit furthest from the central region, the outermost regions narrowing in width away from the central region.

68. 1. A method of delivering a medication to an injection site, comprising: affixing a delivery device to a skin patch at the injection site; deforming at least two portions of the delivery device affixed to the skin patch from an initial state to a deformed state such that the skin patch is stretched and at least one delivery sharp of the delivery device is displaced into a skin-piercing relationship; Dispensing fluid from a reservoir of the delivery device to the injection site via the delivery sharp; returning at least two portions of the delivery device attached to the skin patch from the deformed state toward the initial state; removing the delivery device from the skin patch; The method includes:

69. 69. The method of claim 68, wherein the at least one delivery sharp is a microneedle.

70. 69. The method of claim 68, wherein the at least one delivery sharp is an array of spaced apart microneedles.

71. 70. The method of claim 68, further comprising tilting the at least one delivery sharp while the at least one delivery sharp is in piercing relationship with the skin.

72. 70. The method of claim 68, further comprising compressing a biasing member of the delivery device against the reservoir.

73. 70. The method of claim 68, wherein deforming at least two portions of the attached delivery device comprises applying pressure to a surface of the delivery device.

74. 69. The method of claim 68, wherein returning at least two portions of the delivery device attached to the skin patch from the deformed state toward the initial state comprises releasing pressure applied to a surface of the delivery device.

75. 69. The method of claim 68, wherein dispensing fluid from the reservoir comprises compressing a biasing member between a portion of the delivery device and the reservoir by substantially everting a portion of the delivery device.

76. 76. The method of claim 75, wherein dispensing fluid from the reservoir comprises transitioning a portion of the delivery device from a protruding orientation to a concave orientation to compress a biasing member between the portion of the delivery device and the reservoir.

77. 69. The method of claim 68, wherein the at least two portions of the delivery device are petals of the body joined to a central region of the body.

78. 69. The method of claim 68, wherein dispensing liquid from the reservoir occurs at least partially while at least two portions of the delivery device return to the initial state.

79. 1. A method of delivering a pharmaceutical agent, comprising: while the delivery device is in a first state, securing a delivery device to a surface, the delivery device including at least one delivery sharp coupled to a collapsible reservoir containing a medicament; applying pressure to the delivery device and releasing the pressure to transition the delivery device to a second state, causing the at least one delivery sharp to pierce the surface, collapse the reservoir, and force medicament out of the at least one delivery sharp.

80. 80. The method of claim 79, further comprising stretching the skin as the delivery device transitions from the first state to the second state.

81. 80. The method of claim 79, further comprising tilting the at least one delivery sharp after the at least one delivery sharp penetrates the surface.

82. 80. The method of claim 79, further comprising contacting a protrusion from the reservoir with the surface after the at least one delivery sharp has penetrated the surface.

83. 83. The method of claim 82, further comprising marking the surface with the protrusions.

84. 80. The method of claim 79, wherein the at least one delivery sharp is a microneedle.

85. 80. The method of claim 79, wherein the at least one delivery sharp is an array of spaced apart microneedles.

86. 80. The method of claim 79, further comprising compressing a biasing member against the reservoir.

87. 80. The method of claim 79, further comprising compressing an elastomeric body against the reservoir.

88. 80. The method of claim 79, further comprising deforming at least two portions of the delivery device secured to the surface from an initial state to a displaced, divergent state.

89. 80. The method of claim 79, wherein applying pressure and releasing pressure to transition the delivery device to a second state includes deforming at least two portions of the delivery device secured to the skin from a stored state, through an intermediate state, and at least partially back to the stored state.

90. 80. The method of claim 79, wherein applying pressure and releasing pressure to transition the delivery device to a second state includes deforming at least two portions of the delivery device secured to the skin from a stored state to a maximally deformed state and at least partially elastically recovering from that state.

91. 91. The method of claim 90, wherein the at least two portions are petals extending outwardly from a central region of a body of the delivery device.

92. 80. The method of claim 79, wherein dispensing fluid from the reservoir comprises substantially inverting a portion of the delivery device to compress a biasing member between the portion of the delivery device and the reservoir.

93. 80. The method of claim 79, further comprising filling the reservoir through a septum.

94. 1. A method of delivering a pharmaceutical agent, comprising: affixing a delivery device to a surface, the delivery device including at least one delivery sharp coupled to a collapsible reservoir containing a medicament; applying pressure to the delivery device to transition the first and second portions of the delivery device to respective deformed states to penetrate the surface with the at least one delivery sharp and initiate collapse of the reservoir to expel medicament from the at least one delivery sharp; releasing pressure on the delivery device to at least partially restore the first portion of the delivery device from the deformed state and lift the surface; A method comprising:

95. 95. The method of claim 94, wherein transitioning the first portion to the deformed state comprises displacing a plurality of segments of the first portion splayed relative to one another.

96. 95. The method of claim 94, further comprising tilting the at least one delivery sharp after the at least one delivery sharp penetrates the surface.

97. 95. The method of claim 94, further comprising contacting a protrusion from the reservoir with the surface after the at least one delivery sharp penetrates the surface.

98. 98. The method of claim 97, further comprising marking the surface with the protrusions.

99. 95. The method of claim 94, wherein the collapse of the reservoir continues while the first portion of the delivery device at least partially recovers from the deformed state.

100. 95. The method of claim 94, wherein the at least one delivery sharp is a microneedle.

101. 95. The method of claim 94, wherein the at least one delivery sharp is an array of spaced apart microneedles.

102. 95. The method of claim 94, wherein transitioning the second portion to a deformed state comprises compressing a biasing member against the reservoir.

103. 95. The method of claim 94, wherein transitioning the second portion to a deformed state includes transitioning the second portion from a protruding state to a recessed state.

104. 95. The method of claim 94, wherein the first portion of the delivery device comprises a plurality of petals extending circumferentially from a central region of a body of the delivery device, and the second portion of the delivery device is a portion of the central region.

105. 1. A delivery device for delivering a fluid to a barrier, comprising: a body including a peripheral region having a plurality of petals; a reservoir coupled to the body and containing at least one delivery sharp; wherein the body is configured to transition between a first state and a second state, and wherein the petals are configured to transform from an initial state to an intermediate state and at least partially recover from the intermediate state as the body transitions from the first state to the second state.

106. 106. The delivery device of claim 105, further comprising an adhesive disposed on at least a portion of the body for affixing the delivery device to the barrier.

107. 106. The delivery device of claim 105, wherein the reservoir further comprises at least one rocking member.

108. 106. The delivery device of claim 105, wherein the reservoir is configured to displace along a displacement path when the body transitions from the first state to the second state.

109. 109. The delivery device of claim 108, wherein the reservoir includes a rigid portion having at least one protrusion configured to tilt the reservoir as it is displaced along the displacement path.

110. 106. The delivery device of claim 105, wherein the reservoir is at least partially collapsible.

111. 106. The delivery device of claim 105, wherein the petals are at least partially covered with an adhesive and configured to spread and displace as the petals transform from the initial state to the intermediate state.

112. 106. The delivery device of claim 105, wherein the body includes a central region, the plurality of petals extending outwardly from the central region, the central region defining a recess for receiving at least a portion of the reservoir.

113. 106. The delivery device of claim 105, wherein the reservoir comprises at least one rigid portion and at least one flexible portion.

114. 114. The delivery device of claim 113, wherein the flexible portion comprises a reservoir wall comprising a disintegration promoter.

115. 106. A delivery device according to claim 105, wherein a majority of each petal is substantially flat.

116. 106. The delivery device of claim 105, wherein a majority of each petal extends at an angle relative to a central axis of the delivery device, and the petals include portions having a curvature that extend to a central region of the body.

117. 106. The delivery device of claim 105, wherein each petal includes a curved portion intermediate the first and second generally flat regions of each petal.

118. 106. The delivery device of claim 105, wherein the at least one delivery sharp is attached to a step that protrudes from a rigid portion of the reservoir.

119. 106. The delivery device of claim 105, wherein the at least one delivery sharp comprises at least one microneedle.

120. 106. The delivery device of claim 105, wherein the periphery of the delivery device is defined by the outermost edges of the petals, the outermost edges being curved along a path other than a path defined by a constant radius extending from a point along a central axis of the delivery device.

121. 106. The delivery device of claim 105, wherein each petal has an outermost region that narrows with increasing distance from a central region of the delivery device, and each outermost region includes an outermost edge that follows a path that is different from a path defined by a constant radius extending from a point along a central axis of the delivery device.

122. 106. The delivery device of claim 105, wherein the body includes a central region integrally formed with the peripheral region, the central region including a portion configured to flip from a protruding state to a recessed state when the delivery device transitions from the first state to the second state.

123. 123. The delivery device of claim 122, further comprising a biasing member positioned between the reservoir and the portion, the biasing member configured to deform when the portion inverts to the concave state.

124. 123. The delivery device of claim 122, wherein the biasing member is an elastomer.

125. 123. The delivery device of claim 122, wherein the biasing member is a layered elastomeric body having at least one passageway at least partially therethrough.

126. 106. The delivery device of claim 105, wherein the reservoir further comprises a septum.

127. 1. A method of delivering a fluid to a barrier, comprising: stretching the barrier; and puncturing the stretched barrier using at least one delivery sharp; displacing at least one delivery sharp along a non-linear displacement path within the barrier; Dispensing fluid from the at least one delivery sharp into a barrier; The method includes:

128. 128. The method of claim 127, wherein piercing the barrier comprises displacing the at least one delivery sharp in a substantially vertical direction until it contacts the barrier.

129. 128. The method of claim 127, wherein the at least one delivery sharp comprises at least one microneedle.

130. 128. The method of claim 127, wherein the non-linear displacement path is curved.

131. 128. The method of claim 127, wherein displacing the at least one delivery sharp places the at least one delivery sharp in an orientation closer to a perpendicular orientation to the barrier than the orientation of the at least one delivery sharp when the barrier is punctured.

132. 128. The method of claim 127, wherein stretching the barrier comprises affixing a delivery device including the at least one delivery sharp to the barrier and displacing at least two portions of the delivery device apart.

133. 133. The method of claim 132, wherein displacing at least two portions of the delivery device apart comprises applying a force to the delivery device in a direction perpendicular to the barrier.

134. 128. The method of claim 127, wherein dispensing fluid from the at least one delivery sharp comprises increasing a delivery pressure of fluid supplied to the at least one delivery sharp until delivery from the at least one delivery sharp to the barrier is initiated.

135. 128. The method of claim 127, wherein displacing the at least one delivery sharp along a non-linear displacement path comprises driving a beveled surface of the at least one delivery sharp through a portion of a barrier.

136. 128. The method of claim 127, wherein displacing the at least one delivery sharp along a non-linear displacement path comprises displacing a face of the at least one delivery sharp including an outlet of the at least one delivery sharp away from a portion of the barrier that it contacted upon initial puncture of the barrier.

137. 1. A method of delivering a fluid to a barrier, comprising: adhering a delivery device to the barrier, the delivery device including at least one delivery sharp; applying a force to a portion of the delivery device to displace a reservoir assembly having the at least one delivery sharp toward the barrier; piercing the barrier with the at least one delivery sharp; tilting the reservoir assembly and the at least one delivery sharp by further displacing an opposite side of the reservoir assembly toward the barrier while a member protruding from one side of the reservoir assembly contacts the barrier; pumping fluid from an interior volume of the reservoir assembly through the at least one delivery sharp; The method includes:

138. 138. The method of claim 137, wherein pumping fluid from the internal volume of the reservoir assembly comprises at least partially collapsing the internal volume of the reservoir assembly.

139. 138. The method of claim 137, wherein the internal volume of the reservoir assembly includes a first portion and a second portion proximal to the at least one delivery sharp relative to the first portion, and pumping fluid from the internal volume of the reservoir assembly includes increasing pressure of the drug in the second portion until delivery is initiated from the at least one delivery sharp to the barrier.

140. 138. The method of claim 137, wherein the at least one delivery sharp comprises a microneedle.

141. 128. The method of claim 127, wherein tilting the reservoir assembly and the at least one delivery sharp comprises penetrating a bevel of the microneedle through the barrier.

142. 138. The method of claim 137, further comprising transitioning a biasing member of the delivery device into a stressed state and exerting a restoring force of the biasing member against the reservoir assembly.

143. 138. The method of claim 137, further comprising displacing at least two portions of the delivery device apart.

144. 1. A method of positioning at least one delivery sharp for shallow delivery within a barrier, comprising: stretching the barrier; and displacing a holder holding the at least one delivery sharp toward the barrier; piercing the barrier by displacing the at least one delivery sharp in a direction generally perpendicular to the barrier; contacting at least one member protruding from one side of the holder with the barrier; further displacing the opposite side of the holder toward the barrier; displacing the at least one delivery sharp along a non-linear path within the barrier; The method includes:

145. 145. The method of claim 144, wherein stretching the barrier comprises displacing at least two portions of a delivery device including the holder and the at least one delivery sharp apart.

146. 145. The method of claim 144, wherein the at least one delivery sharp is a microneedle.

147. 145. The method of claim 144, wherein displacing at least one delivery sharp along a non-linear path comprises displacing the at least one delivery sharp along a curved displacement path as the opposite side of the holder is displaced further toward the barrier.

148. 145. The method of claim 144, wherein displacing the at least one delivery sharp positions the at least one delivery sharp in an orientation closer to a perpendicular orientation to the barrier than the orientation of the at least one delivery sharp when it penetrates the barrier.

149. Displacing the at least one delivery sharp along a non-linear path includes oscillating the at least one delivery sharp along an arc of approximately 3-5 degrees. The method of claim 144.

150. 1. A fluid delivery assembly comprising: a delivery device including a fluid holding portion and a coupling portion; An adapter, the adapter comprising: an adapter coupling configured to engage a coupling of the delivery device to form a fluid-tight coupling; The adapter body, and 1. A fluid delivery assembly comprising a sharps retainer having a chamfered sidewall and at least one delivery sharp protruding from a surface thereof, the adapter body being molded such that the material of the adapter body covers only a portion of the sidewall to bond the sharps retainer and the adapter body to one another.

151. 151. The fluid delivery assembly of claim 150, wherein the delivery device is a syringe.

152. 151. The fluid delivery assembly of claim 150, wherein the delivery instrument coupling and the adapter coupling are cooperating luer lock couplings.

153. 151. The fluid delivery assembly of claim 150, wherein the at least one delivery sharp is a microneedle.

154. 151. The fluid delivery assembly of claim 150, wherein the sharps holder and the at least one delivery sharp are formed of silicone.

155. 151. The fluid delivery assembly of claim 150, wherein the at least one delivery sharp comprises an array of microneedles.

156. 151. The fluid delivery assembly of claim 150, wherein the at least one delivery sharp comprises a microneedle having a height of at least 500 microns.

157. 151. The fluid delivery assembly of claim 150, wherein the at least one delivery sharp comprises a microneedle having a flow passage, the flow passage communicating with a channel recessed in an outer surface of the microneedle.

158. 151. The fluid delivery assembly of claim 150, wherein the sharps holder and the at least one delivery sharp are formed as a unitary structure.

159. 1. A delivery device adaptor comprising: an adapter coupling configured to fluid-tightly engage a corresponding coupling of a delivery device; The adapter body, a sharps holder having a chamfered side wall and at least one delivery sharp protruding from the chamfered side; wherein the adapter body is molded to cover only a portion of the side wall to secure the sharps retainer to the adapter.

160. 160. The delivery instrument adaptor of claim 159, wherein the footprint of the sharps retainer increases as the distance from the surface increases.

161. 160. The delivery instrument adaptor of claim 159, wherein the sharps retainer is formed from silicone.

162. 160. The delivery instrument adaptor of claim 159, wherein the sharps holder and the at least one delivery sharp are formed as a single, integral structure.

163. 160. The delivery instrument adapter of claim 159, wherein the at least one delivery sharp is a microneedle.

164. 160. The delivery instrument adaptor of claim 159, wherein said at least one delivery sharp is a microneedle having a height of greater than 500 microns.

165. 160. The delivery instrument adaptor of claim 159, wherein the adaptor coupling is a luer lock coupling.

166. 160. The delivery instrument adaptor of claim 159, wherein the at least one delivery sharp comprises an array of microneedles.

167. 160. The delivery instrument adaptor of claim 159, wherein the at least one delivery sharp has a flow path that communicates with a channel recessed in an outer surface of the microneedle.

168. 1. A delivery device comprising: a body including a central region and a peripheral region having a plurality of petals extending outwardly from the central region; a variable volume reservoir coupled to the body; a sharps retainer having at least one microneedle protruding from a surface thereof and a sidewall disposed at an acute angle to said surface, wherein material of the rigid portion of said reservoir is molded to cover only a portion of said sidewall to couple said sharps retainer to said reservoir; an adhesive disposed on at least a portion of the body; A delivery device comprising:

169. 169. The delivery device of claim 168, wherein the central region defines a receptacle and includes an upper region and a base connected by a wall, and the petals extend from the base.

170. 170. The delivery device of claim 169, wherein the reservoir is at least partially disposed within the housing.

171. 169. The delivery device of claim 168, further comprising a biasing member disposed within a receiving portion between the upper region and the reservoir.

172. 169. The delivery device of claim 168, wherein the sharps holder and the at least one microneedle are of unitary construction.

173. 169. The delivery device of claim 168, wherein the sharps holder and the at least one microneedle are formed of silicone.

174. 169. The delivery device of claim 168, wherein the reservoir comprises a first portion and a second portion separated from one another by a flow restrictor, the second portion being located closer to the at least one microneedle than the first portion.

175. 1. A method of forming a microneedle holder, comprising: Etching a plurality of microneedles on a silicon wafer; dicing a sharps holder including at least one microneedle from the wafer such that sidewalls of the sharps holder are angled and the footprint of the sharps holder increases with increasing distance from the surface on which the at least one microneedle is disposed; The method includes molding a body onto only a portion of a side wall of the sharps retainer distal to the face.

176. 176. The method of claim 175, wherein the body is part of a syringe.

177. 176. The method of claim 175, wherein the body is an adapter for attachment to a delivery device.

178. 176. The method of claim 175, wherein the body forms part of a delivery device.

179. 176. The method of claim 175, wherein the body is a stepped protrusion of a reservoir of a delivery device.

180. 176. The method of claim 175, wherein the plurality of microneedles includes a flow passage that communicates with a channel recessed in an outer surface of the microneedle.

181. The method of claim 175, wherein the sharp holder comprises an array of microneedles.

182. The method of claim 175, wherein the sharp holder comprises an array of microneedles.

183. 176. The method of claim 175, wherein dicing the sharp retainer from the wafer includes using a dicing saw with a blade configured to form angled sidewalls.

184. 176. The method of claim 175, wherein etching the plurality of microneedles comprises etching a plurality of microneedles having a height of greater than 500 microns.

185. 1. A delivery device package comprising: a first portion formed of a rigid material and including a plurality of wells, at least two of the wells being connected by a passage; a second portion removably coupled to the rim of the first portion; a delivery device having a body with an adhesive covered with an adhesive liner, the adhesive liner being bonded to a surface of a first well; wherein when the body is removed from the well, the adhesive liner is configured to peel away from the adhesive and remain within the well.

186. 186. The delivery device package of claim 185, wherein at least one of the first portion and the second portion includes a unique identifier.

187. 186. The delivery device package of claim 185, wherein the second portion is permeable to a sterilant.

188. 186. The delivery device package of claim 185, wherein the delivery device comprises a pull tab that extends from the body, through the passage and into a second well.

189. 186. The delivery device package of claim 185, wherein the delivery device comprises at least one delivery sharp and a delivery sharps cap surrounding the at least one delivery sharp.

190. 190. The delivery device package of claim 189, wherein the delivery sharps cap is bonded to a surface of the first well and configured to remain within the well when the delivery device is removed from the well.

191. 1. A delivery device for delivering a fluid to a barrier, comprising: The main body, an adhesive disposed on at least a portion of the body for attaching the delivery device to the barrier; a reservoir coupled to the body and including at least one delivery sharp and at least one rocking member; wherein the body is configured to transition between a first state and a second state, the reservoir is configured to be displaced toward the barrier as the body transitions from the first state to the second state, and the pivot member is configured to facilitate tilting of the reservoir after it has displaced a certain distance toward the barrier.

192. 192. The delivery device of claim 191, wherein the reservoir is at least partially collapsible.

193. 192. The delivery device of claim 191, wherein at least two portions of the body on which the adhesive is disposed are configured to expand and displace when the body transitions from the first state to the second state.

194. 192. The delivery device of claim 191, wherein the body includes a central region and a peripheral region having a plurality of petals extending outwardly from the central region, the central region defining a receiving portion for receiving at least a portion of the reservoir.

195. 192. The delivery device of claim 191, wherein the reservoir comprises at least one rigid portion and at least one flexible portion.

196. 192. The delivery device of claim 191, wherein the at least one rocking member is disposed along a periphery of a rigid portion of the reservoir.

197. 192. The delivery device of claim 191, wherein the at least one rocking member is a protrusion extending from a rigid portion of the reservoir.

198. 192. A delivery device as described in claim 191, wherein the at least one delivery sharp is attached to a step protruding from a rigid portion of the reservoir, and the at least one rocking member is positioned at a position closer to the periphery of the rigid portion than the step.

199. 200. The delivery device of claim 198, wherein the height of the at least one rocking member is approximately the same as the height of the step.

200. 200. The delivery device of claim 198, wherein the at least one delivery sharp comprises at least one microneedle, and the portion of the at least one microneedle closest to the at least one rocking member is a cutting blade of the microneedle.

201. 192. The delivery device of claim 191, wherein the at least one rocking member is configured to tilt the reservoir such that the at least one delivery sharp rocks along an arc of approximately 3-5 degrees.

202. 192. The delivery device of claim 191, wherein the at least one pivot member is configured to tilt the reservoir only after the barrier has been pierced by at least one delivery sharp.

203. 1. A delivery device comprising: a body including a central region and a peripheral region having a plurality of petals extending outwardly from the central region, the central region defining a receptacle and having a top region and a bottom region connected by a wall; a variable volume reservoir including at least one delivery sharp and at least one rocking member disposed closer to a periphery of the reservoir than the at least one delivery sharp, the reservoir being coupled to a body and at least partially disposed within the housing; an adhesive disposed on at least a portion of the body; A delivery device comprising:

204. 204. The delivery device of claim 203, wherein the at least one delivery sharp is a microneedle.

205. 204. The delivery device of claim 203, wherein the rocking member is a protrusion protruding from a rigid portion of the reservoir.

206. 204. The delivery device of claim 203, wherein the at least one delivery sharp comprises a microneedle, and the portion of the microneedle closest to the rocking member is a cutting edge of the microneedle.

207. 204. The delivery device of claim 203, wherein the rocking member is disposed on a periphery of the reservoir.

208. 204. The delivery device of claim 203, wherein the reservoir includes a planar body with a step protruding therefrom, and the at least one delivery sharp is attached to the step.

209. 209. The delivery device of claim 208, wherein the at least one delivery sharp protrudes from the step at an acute angle relative to a plane perpendicular to the plane of the planar body.

210. 204. The delivery device of claim 203, wherein the rocking member is supported by a marking agent.

211. 204. The delivery device of claim 203, wherein the body is configured to transition from a first state to a second state when attached to a surface via an adhesive, the reservoir is configured to displace in a direction approximately perpendicular to the surface until the rocking member contacts the surface as the body transitions from the first state to the second state, and a portion of the reservoir located on the opposite side of the rocking member is configured to continue to displace toward the surface as the body transitions from the first state to the second state after the rocking member contacts the surface.

212. 212. The delivery device of claim 211, wherein the at least one delivery sharp is configured to puncture the surface as the reservoir is displaced in a direction approximately perpendicular to the surface, and then tilt as a portion of the reservoir located opposite the rocking member is further displaced toward the surface after the rocking member contacts the surface.

213. Any of the systems, methods, and apparatus described herein.

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