Delivery devices, systems, and methods

Abstract

The present disclosure relates to the delivery of medicaments. More particularly, it relates to dispensers for therapeutic and other medicinal agents.SOLUTION: The delivery device may comprise a body comprising a central region and a peripheral region. The central region may be shaped substantially like a thimble and may have a top surface and a base. The peripheral region may be defined by a plurality of petal members. The plurality of petal members can extend outwardly from the base. The delivery device may further comprise an adhesive coupled to at least a portion of the body. The delivery device may further comprise a collapsible reservoir coupled to the body and the at least one delivery sharp.SELECTED DRAWING: Figure 28

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, and more particularly to dispensers for therapeutic drugs and other medical substances. [Background technology]

[0003] New pathogens pose various public health challenges that are not easy to overcome immediately. From a medical perspective, existing preventive healthcare infrastructure is ill-suited and poorly suited to novel pathogens such as SARS, MERS, Zika, and COVID-19. Other pathogens for which herd immunity does not exist (e.g., Ebola) or highly dangerous pathogens that mutate rapidly may pose similar challenges. Vaccines typically take years to develop, but once a vaccine exists, the prospect of rapidly producing billions of doses will almost certainly exceed current vaccine manufacturing capacity. Without vaccination, other preventive measures, such as testing, contact tracing, and personal protective equipment (PPE), become increasingly 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 suffering from shortages of PPE and test kits. Second, the scale of the COVID-19 pandemic hinders the ability to carry out effective contact tracing, already a massive undertaking. Furthermore, new pathogens can shift the focus of health systems away from their 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 outbreak in the Democratic Republic of the Congo in 2019, measles deaths were twice as high as Ebola deaths.

[0004] Novel pathogens also pose problems that are more psychological in nature. Simply put, they frighten people. Without readily available PPE and testing, people may choose to avoid visiting medical facilities or clinics for fear of exposure to the disease. Even if readily available PPE were available, certain individuals, such as those belonging to high-risk demographics for certain pathogens, may still be apprehensive about visiting such facilities. Furthermore, as in the United States, some may vehemently oppose the use of PPE for a variety of reasons. This poses additional public health challenges for systems attempting to respond to pandemics. Solutions to novel pathogens must address and aim to avoid these challenges if they are to be effective. Summary of the Invention

[0005] According to an exemplary embodiment of the present disclosure, an exemplary delivery device may include a body including a central region and a peripheral region. The central region may be substantially thimble-shaped and may have an upper surface and a base. The peripheral region may be defined by a plurality of petal members and a plurality of first slots therebetween. The plurality of petal members may extend outward from the base. The delivery device may further include an adhesive bonded to at least a portion of the body. The delivery device may further include a collapsible reservoir bonded to the body and the at least one delivery sharp.

[0006] In some embodiments, the upper surface may be convex and may include a plurality of second slots therein. In some embodiments, the central region may include a plurality of fenestrations arranged in a ring around the periphery of the upper surface. In some embodiments, the delivery device may further include a sharps scaffold including at least one delivery sharp. In some embodiments, the at least one delivery sharp is a microneedle including a flow lumen with an elongated cross-section. The sharps scaffold may be coupled to a collapsible reservoir. The collapsible reservoir may be coupled to an inner surface of the central region. In some embodiments, when the delivery device is in a storage state, the collapsible reservoir may contain a fluid, and an adhesive may be attached to a pierceable surface of a member external to the delivery device. When the delivery device is in a delivery state, the pierceable surface may be stretched by the adhesive, the at least one delivery sharp may pierce the pierceable surface, and the foldable reservoir may be urged to at least partially collapse, allowing fluid to enter the member through the pierceable surface via the at least one delivery sharp. In some embodiments, an adhesive may be bonded to at least a portion of a side surface distal-most from the top surface of at least two of the plurality of petal members. In some embodiments, when the delivery device is in a storage state, the collapsible reservoir may contain a fluid, and the adhesive may be attached to a pierceable surface of a member external to the delivery device. When the delivery device is in a delivery state, the pierceable surface may be stretched by the adhesive, at least one delivery sharp may penetrate the pierceable surface, and the collapsible reservoir may be urged to at least partially collapse, allowing fluid to enter the member through the pierceable surface via the at least one delivery sharp. In some embodiments, the adhesive may be bonded to at least a portion of a side surface distal-most from the top surface of at least two of the plurality of petal members. In some embodiments, the top surface may be configured to transition from a storage state in which the top surface is convex to a delivery state in which the top surface is concave in response to pressure applied to the delivery device.In some embodiments, at least two of the plurality of petal members may be configured to curve in response to pressure applied to the upper surface when the delivery device transitions to the delivery state. In some embodiments, at least two of the plurality of petal members may be configured to curve with a substantially constant radius of curvature in response to pressure applied to the upper surface when the delivery device transitions to the delivery state. In some embodiments, at least a portion of a first petal member of the plurality of petal members may be configured to move further away from at least a portion of a corresponding portion of a second petal member of the plurality of petal members during at least a portion of the transition. Between the storage state and the delivery state, the first and second petal members are positioned opposite each other. In some embodiments, at least a portion of a first petal member of the plurality of petal members is configured to move further away from at least a portion of a corresponding portion of a second petal member of the plurality of petal members during at least a portion of the transition between the storage state and the delivery state to stretch the surface to which the delivery device is adhesively attached, and the first and second petal members are positioned opposite each other. In some embodiments, at least one delivery sharp may be a microneedle. In some embodiments, the delivery device may be an intradermal delivery device. In some embodiments, the reservoir may be divided into a first section and a second section. In some embodiments, the first section and the second section may be in fluid communication with each other via a flow restrictor. In some embodiments, the reservoir may include an orifice plate.

[0007] According to another exemplary embodiment of the present disclosure, an exemplary method of delivering a medication may include applying a delivery device to a skin surface, the delivery device including at least one delivery sharp coupled to a collapsible reservoir containing the medication, the delivery device being in a storage state. The method may further include applying pressure to the delivery device toward the skin surface to transition the delivery device to a delivery state, causing the at least one delivery sharp to penetrate the skin surface and collapse the reservoir, forcing the medication into the skin through the at least one delivery sharp.

[0008] In some embodiments, the method may further include stretching the skin surface when the delivery device transitions from the storage state to the delivery state. In some embodiments, the method may further include scratching the skin surface with at least one of the at least one delivery sharp. In some embodiments, the method may further include preventing reuse of the delivery device. In some embodiments, transitioning the delivery device to the delivery state may include at least partially inverting at least one region of the body of the delivery device. In some embodiments, transitioning the delivery device to the delivery state may include transforming the body of the delivery device from a first stable state to a second stable state. In some embodiments, collapsing the reservoir may include displacing a flexible wall of the reservoir relative to a rigid wall of the reservoir. In some embodiments, forcing the agent into the skin via the at least one delivery sharp may include transferring the agent from the reservoir to the skin through a respective flow lumen and channel in each of the at least one delivery sharp.

[0009] According to another exemplary embodiment of the present disclosure, an exemplary delivery device can include a body including a central region coupled to a peripheral region. The central region can be substantially thimble-shaped and can have an upper surface and a base. The peripheral region can surround the central region. The peripheral region can have an inner periphery and an outer periphery. The inner periphery can be coupled to the base such that the peripheral region extends outward from the base. The peripheral region can include a plurality of first slots extending inward from the outer periphery. The delivery device can further include an adhesive coupled to at least a portion of the body. The delivery device can further include a collapsible reservoir coupled to the body and the at least one delivery sharp.

[0010] In some embodiments, the upper surface is convex and can include a plurality of second slots therein. In some embodiments, the plurality of second slots can extend outward relative to a center point of the upper surface. In some embodiments, the central region can include a plurality of fenestrations disposed along the base. In some embodiments, the central region can include a plurality of fenestrations disposed along the periphery of the upper surface. In some embodiments, the delivery device can further include a sharps scaffold including at least one delivery sharp. The sharps scaffold can be coupled to the collapsible reservoir. The collapsible reservoir can be coupled to an inner surface of the central region. In some embodiments, adhesive can be coupled to at least a portion of a side of the peripheral region most distal from the upper surface. In some embodiments, the upper surface can be configured to transition from a storage state in which the upper surface is convex to a delivery state in which the upper surface is concave in response to pressure applied to the delivery device. In some embodiments, the body can have a footprint having an area and can be configured to increase in area during at least a portion of the transition between the storage state and the delivery state. In some embodiments, the body may have a footprint having an area that increases during at least a portion of a transition between the storage state and the delivery state, thereby expanding the surface to which the delivery device is affixed with the adhesive. In some embodiments, when the delivery device is in the storage state, the collapsible reservoir may contain a fluid, and the adhesive may be affixed to a pierceable surface of a member external to the delivery device. When the delivery device is in the delivery state, the pierceable surface may be stretched by the adhesive, at least one delivery sharp may penetrate the pierceable surface, and the collapsible reservoir may be urged to at least partially collapse, allowing fluid to enter the member through the pierceable surface via the at least one delivery sharp. In some embodiments, at least a portion of the side surface may include first and second regions between two pairs of adjacent first slots of the plurality of first slots. In some embodiments, the adhesive may be bonded to at least a portion of the side surface of the peripheral region most distal from the top surface.In some embodiments, at least a portion of the side surface may include first and second regions between two pairs of adjacent first slots of the plurality of first slots. In some embodiments, when the delivery device is in a storage state, the collapsible reservoir can contain a fluid, and an adhesive is affixed to a pierceable surface of the outer member of the delivery device. When the delivery device is in a delivery state, the pierceable surface can be stretched by the adhesive, at least one delivery sharp can penetrate the pierceable surface, and the collapsible reservoir can be urged to at least partially collapse to allow fluid to enter the member through the pierceable surface via the at least one delivery sharp. In some embodiments, the upper surface can be configured to transition from a storage state in which the upper surface is convex to a delivery state in which the upper surface is concave in response to pressure applied to the delivery device. In some embodiments, the body can have a footprint having an area, and the footprint can be configured to increase during at least a portion of the transition between the storage state and the delivery state. In some embodiments, the body may have a footprint having an area and may be configured to increase the footprint during at least a portion of the transition between the storage state and the delivery state, thereby stretching the surface to which the delivery device is adhesively affixed.

[0011] According to another exemplary embodiment of the present disclosure, an exemplary actuator assembly for inhibiting reuse of a drug delivery device can include a flexure including first and second members and a plurality of struts coupling the first and second members to one another. Each strut can have elasticity to resist displacement of the first and second members toward one another. The first member can include at least one first engagement member. The second member can include an engagement member cooperating with each of the first engagement members. The struts can be configured to deflect at least one of the first and second members to cause rotational movement when the first and second members are forced toward one another with a force exceeding a threshold force. The at least one first engagement member and each second engagement member can be configured to form a coupling when the distance between the first and second members decreases beyond a threshold distance.

[0012] According to another exemplary embodiment of the present disclosure, an exemplary delivery device may include a first portion at least partially covered with a first adhesive and including a cantilever arm. The delivery device may further include a second portion at least partially covered with a second adhesive and including at least one ramp element. The second portion may be coupled to the first portion via the first adhesive. The second portion may be configured to extend from a first state to an extended state. The delivery device may further include a collapsible reservoir including at least one delivery sharp. The reservoir may be coupled to the unsupported end of the cantilever arm.

[0013] The second portion may include one of a one-dimensional array of microneedles and a two-dimensional array of microneedles. In some embodiments, the second portion may include a delivery opening. The delivery opening may be misaligned with the at least one delivery sharp when the second portion is in the first state and may be aligned with the at least one delivery sharp when the second portion is in the extended state. In some embodiments, the second portion may include a folding region in the first state. The folding region may be configured to unfold when the second portion transitions to the extended state. In some embodiments, the second portion may include a folding region. A layer of the folding region may be bonded to the first adhesive. In some embodiments, each of the at least one ramp element may be disposed on a first side of the cantilever arm when the second portion is in the first state and on a second side of the cantilever arm when the second portion is in the second state. In some embodiments, the second portion may be at least partially elastic. In some embodiments, the second portion may include a pull tab. In some embodiments, the delivery device may further comprise a locking adhesive disposed on a portion of the first portion, and the delivery device may further comprise a tether having a first end coupled to the second portion. In some embodiments, the second end of the tether can be coupled to the locking adhesive and can cover the locking adhesive when the second portion is in the first state. The second end of the tether can be configured to at least partially separate from the locking adhesive to expose the locking adhesive when the second portion is in the extended state. In some embodiments, the second end of the tether can be coupled to the locking adhesive and the tether can be doubled over on itself when the second portion is in the first state. In some embodiments, the first adhesive and the second adhesive can be positioned a first distance from each other when the second portion is in the extended state, and the first and second adhesives can be positioned a second distance from each other when the second portion is in the extended state. The second distance can be greater than the first distance. In some embodiments, the at least one ramp element can be configured to elastically deflect the cantilever arm when the second portion transitions from the first state to the second state.

[0014] According to an exemplary embodiment of the present disclosure, an exemplary delivery device may include a body including first and second end blocks and a bridge separated by first and second side panels. The side panels and bridge may each include first and second opposing ends. The first ends may each be connected to the first end block via a respective first end living hinge. The second ends may each be connected to the second end block via a respective second end living hinge. The side panels and bridge may also each include a respective intermediate living hinge between their first and second ends. The delivery device may further include an adhesive at least partially covering the first side of the end block. The delivery device may further include a collapsible reservoir containing at least one delivery sharp. The reservoir may be coupled to an end of an arm member extending from the bridge toward the first side.

[0015] In some embodiments, each side panel can include at least one guard projection. In some embodiments, the first side panel can include a first guard projection extending toward the second side panel, and the second side panel can include a second guard projection extending toward the first side panel. In some embodiments, the first guard projection can include a latch projection, and the second side panel can include a latch catch. In some embodiments, the first side panel can include a third guard projection extending toward the second side panel, and the second guide panel can include a fourth guard projection extending toward the first side panel. In some embodiments, the bridge can include a first panel and a set of posts. The first panel can be connected to the posts via a mid-living hinge of the bridge. In some embodiments, an arm member can be disposed between the posts and extend from an end of the panel adjacent the mid-living hinge of the bridge. In some embodiments, the side panels can have a range of displacement from a bowed state to a substantially straight state, and the end blocks can be configured to displace away from each other when the side panels are displaced from the bowed state to the substantially straight state. In some embodiments, the side panels can be configured to transition from an outwardly curved state to a substantially straight state when a pinching force is applied to the side panels. In some embodiments, at least an intermediate living hinge of the bridge member can be configured to transition toward the first surface of the end block when the side panels transition from the outwardly curved state to a substantially straight state. In some embodiments, the side panels can have a range of transition from the outwardly curved state to a substantially straight state, and the bridge can be configured to allow the arm members to transition from a first position to a second position through which at least one arm member moves. The delivery sharp can be positioned below the first surface of the end block when the side panels transition from the outwardly curved state to a substantially straight state. In some embodiments, the side panels can have a range of transition from the outwardly curved state to a substantially straight state, and the body can include a latch protrusion and a latch catch.The latch protrusion can be configured to engage the latch catch when the side panel is displaced from the outwardly bent state to a substantially straight state. In some embodiments, the body can include multiple iris panels extending from the side panels to form a variable aperture. In some embodiments, the aperture can be configured to change size as the side panels are bent about the intermediate living hinge of each side panel.

[0016] According to another exemplary embodiment of the present disclosure, an exemplary delivery device can include a body including a pair of opposing end panels and at least two intermediate panels, wherein the panels can be separated from one another by a plurality of living hinges each extending across the body. The delivery device may further include adhesive covering at least a portion of the proximal side of each of the end panels. The delivery device may further include a foldable reservoir containing at least one delivery sharp. The reservoir may be coupled to the proximal side of one of the intermediate panels. The two intermediate panels may form a joint displaceable between a raised position and an over-center position when the two end panels are constrained in a plane. The first of the intermediate panels may extend along the plane when the joint is in the over-center position.

[0017] In some embodiments, the first end panel is substantially planar, and the second end panel may include a planar portion and an angled protrusion extending from the planar portion toward one of the intermediate links. In some embodiments, the second end panel may include a buttress extending from the planar portion to the angled protrusion. In some embodiments, the at least one delivery sharp may include an array of microneedles. In some embodiments, the delivery device may be configured to transition from a storage state to a delivery state. In some embodiments, the second intermediate panel may be at least partially covered on its proximal side with adhesive. In some embodiments, the end panels may be displaceable along the plane a first distance apart when the links are displaced from the raised position to the centered position, and displaceable toward each other a second distance less than the first distance when the links are displaced from the centered position to the over-centered position. In some embodiments, a reservoir may be disposed on the second intermediate panel adjacent to a living hinge of a plurality of living hinges between the first and second intermediate panels. In some embodiments, one of the panels may include a strain relief flexure. In some embodiments, at least a portion of the body can be configured to plastically deform when the linkage is displaced to the over-center position. In some embodiments, at least one of the living hinges can be configured to break when the linkage is displaced from the raised position to the over-center position and back again. In some embodiments, the linkage can at least partially reverse at the over-center position relative to the raised position. In some embodiments, the angle between the intermediate panels when the linkage is in the raised position can be an obtuse angle, and the angle between the intermediate panels when the linkage is over-center can be a reflex angle. In some embodiments, one of the intermediate panels can be parallel to the skin when the linkage is in the over-center position.

[0018] According to yet another exemplary embodiment of the present disclosure, an exemplary delivery device may include an actuator. The delivery device may further include a base including a threaded post. The actuator may be threadably engaged with the post and displaceable along the threaded post from a raised state in which the actuator is most distal to the base to a delivery state in which the actuator is more proximal to the base. The delivery device may further include a carriage disposed within the bore of the post. The carriage may include at least one first weakened portion and at least one second weakened portion supported on respective shelves defined within the bore. The delivery device may further include a delivery aid disposed within the bore. The delivery device may further include a collapsible reservoir disposed within the bore and including at least one delivery sharp. When the actuator is displaced from the raised state to the delivery state, a portion of the actuator may be configured to apply pressure to the carriage. The pressure may break at least one of the first weakened portions, freeing the carriage to be displaced within the bore, and may break at least one of the second weakened portions, allowing pressure to be applied to the reservoir via the carriage and the delivery aid. Displacement of the actuator to the delivery state may be further configured to displace the reservoir toward the base.

[0019] In some embodiments, the actuator may include a protrusion that may be aligned with the axis of the post. Pressure on the carriage may be applied via the protrusion. In some embodiments, the delivery aid may be coupled to the end of the protrusion closest to the base. In some embodiments, when the actuator is in at least one of the raised position and the delivery position, the protrusion can extend through at least a portion of the carriage. In some embodiments, the delivery aid can include a force-concentrating protrusion. In some embodiments, the base can include a delivery opening aligned with the bore of the post. In some embodiments, the at least one first weakened portion can include a set of weakened portions spaced at equal angular increments around the carriage. In some embodiments, the at least one second weakened portion can include a set of weakened portions spaced at equal angular increments around the carriage. In some embodiments, when the at least one first weakened portion is in a broken state, the carriage can have a range of displacement within the bore that is limited by a stop surface located at the end of the bore adjacent the base. In some embodiments, when the carriage abuts the stop surface such that the skin pressure body of the carriage is outside the bore, the carriage can extend through the delivery opening of the base. In some embodiments, a reservoir can be located within the bay of the carriage and retained therein by friction when pressure applied to the reservoir falls below a threshold. In some embodiments, the carriage, delivery aid, and reservoir can be configured to displace together within the bore as a unit after at least one first frangible portion is broken, hi some embodiments, the carriage delivery aid and reservoir can be configured to stop displacing together as a unit when at least one second frangible portion is broken.

[0020] According to another exemplary embodiment of the present disclosure, an exemplary microneedle can include a base including a first edge and a plurality of second edges. The microneedle can further include a plurality of sidewalls extending from the base in a substantially perpendicular direction. The microneedle can further include a face extending from the first end to an apex at an acute angle relative to the base. Two adjacent sidewalls of the plurality of sidewalls can define a lateral edge extending from the base to the apex in a substantially perpendicular direction relative to the base. The microneedle can further include a flow lumen extending through the microneedle from the base to an outlet at the face. The microneedle may further include a channel defined in the face and connected to the flow lumen.

[0021] In some embodiments, the flow lumen may have an elongated cross-sectional shape. In some embodiments, the in-face outlet may be located more proximal to the apex than the first edge. In some embodiments, the in-face outlet may be located more proximal to the first edge than the apex. In some embodiments, the in-face outlet may be located in a central region of the face intermediate a region near the apex and a region near the first edge. In some embodiments, the channel may extend from the in-face outlet in a direction toward the first edge. In some embodiments, the channel may include a first portion and a second portion. The first portion may extend from the in-face outlet in a direction toward the apex, and the second portion may extend from the in-face outlet in a direction toward the first edge. In some embodiments, the channel may have a variable width. In some embodiments, the channel may have a substantially constant width. In some embodiments, the end of the channel closest to the first end may be at least 50-200 microns from the base. In some embodiments, the microneedle may be constructed of silicon. In some embodiments, the height of the microneedles may be at least 600 microns.

[0022] According to another exemplary embodiment of the present disclosure, an exemplary microneedle can include a base including a first edge and multiple second edges. The microneedle can further include multiple sidewalls projecting from the second edges to an arcuate blade edge extending from a base apex formed by two of the second edges to a second apex spaced from the base. The microneedle can further include a face extending from the first end to the second apex. The microneedle can further include a flow lumen extending through the microneedle from the base to an outlet at the face.

[0023] In some embodiments, the blade edge may be a double-beveled blade. In some embodiments, the face outlet may have an elongated shape. In some embodiments, the first edge may be positioned such that a plane perpendicular to the base and including the first edge extends through a portion of the blade edge. In some embodiments, the first edge may be positioned such that a plane perpendicular to the base and including the first edge does not pass through the blade edge. In some embodiments, the outlet may be positioned such that at least one plane perpendicular to the base and passing through the outlet also passes through the blade edge. In some embodiments, the outlet may be positioned such that any plane perpendicular to the base and passing through the outlet also passes through the blade edge. In some embodiments, the dimension of the arc of the blade edge may be greater than 90°. In some embodiments, the dimension of the arc of the blade edge may be less than 90°.

[0024] According to yet another exemplary embodiment of the present disclosure, an exemplary delivery device can include a body including a peripheral region and a central region extending from the peripheral region. The peripheral region can have a top surface and a base. The peripheral region can include multiple bodies spaced apart by slits extending from the periphery of the peripheral region toward the central region. The delivery device can further include an adhesive coupled to at least a portion of the body. The delivery device can further include a collapsible reservoir coupled to the body and the at least one delivery sharp.

[0025] In some embodiments, the body can have a first state and a second state. The body may include at least one partially reversible region that has a first shape in the first state and that substantially inverts relative to the first shape across at least a portion of the reversible region in the second state. In some embodiments, the at least one partially reversible region may include a top surface. In some embodiments, the body may further include a static region that is substantially the same shape when the body is in the first state and the second state. In some embodiments, the static region may be included in a central region and may extend from the periphery of the top surface to the base. In some embodiments, the body may be configured such that at least two of the bodies in the peripheral region expand and displace when the body transitions from the first state to the second state. In some embodiments, the top surface may be convex in the first state. In some embodiments, the top surface may be concave in the second state. In some embodiments, the reservoir may be formed as an assembly including a holder to which the microneedle is coupled and a flexible body coupled to the holder. There may be an enclosed reservoir volume defined between a portion of the holder and a portion of the flexible body.

[0026] According to yet another exemplary embodiment of the present disclosure, an exemplary delivery device can include a body including a central region and a peripheral region having a plurality of petal members extending outward from the central region. The central region can define a receptacle and have a top region and a base connected by a wall. The delivery device can include a collapsible reservoir containing at least one delivery sharp. The reservoir can be coupled to the body and at least partially disposed within the receptacle. The delivery device can further include an adhesive disposed on at least a portion of the body.

[0027] In some embodiments, the reservoir may include a rigid portion and a flexible portion coupled to the rigid portion. A sealed interior volume of the reservoir may be defined between the rigid portion and the flexible portion. At least one delivery sharp may be coupled to the rigid portion. In some embodiments, the rigid portion may include a stage protrusion. In some embodiments, the at least one delivery sharp may be coupled to the stage protrusion and protrude from the stage protrusion at an acute angle relative to the rigid portion. In some embodiments, the body may include a ridge adjacent to the receptacle. The ridge may form a mounting surface for the reservoir. In some embodiments, the delivery device may further include a packet disposed in the receptacle between the upper region and the reservoir. In some embodiments, the packet is a gas bag. In some embodiments, the packet may include means for applying pressure to the reservoir. In some embodiments, the packet may be configured to rupture when subjected to a pressure exceeding a threshold value. The packet may be disposed within a container and include a first substance. The container may include a second substance. The first and second substances may be configured to react when combined to expand the volume of the container. In some embodiments, the packet may be configured to burst when subjected to a pressure exceeding a threshold value. The packet may be disposed within a container and filled with a first substance. The container may contain a second substance. The first and second substances may be configured to participate in a chemiluminescent reaction when combined. In some embodiments, the delivery device may further include a biasing member disposed within a receptacle between the upper region and the reservoir. In some embodiments, the biasing member may be a conical spring. In some embodiments, the body may include a plurality of positioning protrusions capable of restraining the biasing member, and the biasing member may be coupled to the body. In some embodiments, the biasing member may be heat staked to the body. In some embodiments, the delivery device may further include a dispensing assembly including a pressing body, a reservoir interface member, and a biasing member, each at least partially disposed within a receptacle between the reservoir and the upper region. In some embodiments, the reservoir may be divided into a first portion and a second portion.In some embodiments, the first portion may be in fluid communication with the second portion through a flow restrictor.

[0028] According to another exemplary embodiment of the present disclosure, an exemplary delivery device may include a body including a central region and a peripheral region. The peripheral region may include a plurality of peripheral members extending outward from the central region. The central region may have a top region and a base connected by a wall. The delivery device may further include a reservoir portion including a reservoir with at least one delivery sharp. The reservoir portion may be removably coupled to the body and at least partially covered by the body. The delivery device may further include an indicator disposed on a portion of the reservoir portion covered by the body. The delivery device may further include a first adhesive disposed on at least a portion of the body. The delivery device may further include a second adhesive disposed on at least a portion of the reservoir portion. When the reservoir portion and the body are coupled, the body may obstruct a line of sight to the indicator.

[0029] In some embodiments, when the delivery device is applied to a surface, the second adhesive can be configured to maintain the reservoir portion against the surface such that a removal force applied to the body results in separation of the body and the reservoir portion. In some embodiments, the indicator is selected from the group consisting of a barcode, a data matrix, and a QR code. In some embodiments, the indicator can encode information related to the contents of the reservoir. In some embodiments, the body can be opaque. In some embodiments, the body can be translucent. In some embodiments, the reservoir portion can be bonded to the body via an adhesive. In some embodiments, the peripheral region can include a pull tab. In some embodiments, at least one of the peripheral members can define a pull tab. In some embodiments, the body can include a set of slots and the reservoir portion can include multiple tabs, each extending at least partially through a respective slot to releasably couple the reservoir portion and the body.

[0030] According to another exemplary embodiment, an exemplary delivery device may include 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 central region may define a receptacle and may have an upper region and a base connected by a wall. The delivery device may further include a collapsible reservoir containing at least one delivery sharp. The reservoir may be coupled to the body and at least partially disposed within the receptacle. The delivery device may further include a dispensing assembly at least partially disposed within the container between the reservoir and the upper region. The delivery device may further include an adhesive disposed on at least a portion of the body.

[0031] In some embodiments, the dispensing assembly can include a push body, at least one biasing member, and a reservoir interface member. In some embodiments, the push body can include a portion that protrudes through the opening in the upper region. In some embodiments, the push body can include a detent. In some embodiments, the portion of the push body can include at least one notch and can have a cross-sectional shape that is neither circular nor a regular polygon. In some embodiments, the biasing member can include at least one bow spring. In some embodiments, the biasing member can include a peripheral region and multiple biasing protrusions extending inward from the peripheral region. The body can include multiple slots. The biasing protrusions can extend through the slots into the receptacle. In some embodiments, the reservoir interface member can be integral with the push body. In some embodiments, the dispensing assembly can include a coil spring and can include a reservoir interface member. In some embodiments, the reservoir interface member can be formed by a terminal portion of the spring routed in a planar pattern adjacent to the ends of the coils of the spring. In some embodiments, the dispensing assembly may include a spring and may not contact the reservoir when the delivery device is in a storage state, hi some embodiments, the spring may be in an unstressed state when the delivery device is in a storage state.

[0032] In another exemplary embodiment, a delivery device system can include a package including an indicium. The system can further include a delivery device included in the package. The system may further include a database. The system can further include a reader including a user interface and a controller. The reader can be in data communication with the database and can be configured to obtain delivery device information from the indicium. The controller can be configured to check the delivery device information against associated data in the database. The controller can be configured to generate instructions for use on the user interface if the associated data in the database indicates the device is usable. The controller can prohibit use of at least one function of the reader until first information is collected by the reader and a first service is enabled on the reader.

[0033] In some embodiments, the indicium may be selected from the group consisting of a barcode, a data matrix, and a QR code. In some embodiments, the reader may be a smart device and may include an imaging device. In some embodiments, the at least one function may include use of the imaging device. In some embodiments, the first service may be a notification service. In some embodiments, the first service may be a location service. In some embodiments, the first information may be location information.

[0034] According to an exemplary embodiment of the present disclosure, an exemplary method of using a medical delivery device can include capturing device information using a reader from indicia on a package containing the medical delivery device. The method can further include applying the delivery device to a patient's skin. The method can further include establishing data communication between the reader and a database. The method can further include comparing the device information with associated device information stored in the database. The method can further include generating, using a controller of the reader, a set of usage instructions on a user interface of the reader if the comparison satisfies a usage criterion. The method can further include capturing data from the post-use indicia using the reader after the medical delivery device has been used. The method can further include updating the database to indicate that the post-use indicia of the delivery device have been captured by the reader.

[0035] In some embodiments, the method may further include removing a first portion of the medical delivery device to expose a post-use indicia on a second portion of the delivery device. In some embodiments, the method may further include applying a post-use indicia to the skin. In some embodiments, the method may further include generating a respective prompt on a user interface for each instruction in the instruction set and preventing display of the next instruction until user interaction with the prompt is registered by the controller. In some embodiments, the method may further include preventing use of at least one function of the reader until a notification service of the reader is enabled. In some embodiments, the at least one function may be use of an imaging device of the reader. In some embodiments, the method may further include generating a delivery confirmation for display on a user interface of the reader. In some embodiments, the reader may be a smartphone.

[0036] According to yet another exemplary embodiment of the present disclosure, a method of using a medical delivery device can include applying the delivery device to an injection site. The method can further include generating a set of instructions on a user interface of the reader using a controller of the reader. The method can further include delivering medication from the delivery device to the injection site. The method can further include capturing image data of the injection site using the reader, the image data including image data in a spectrum outside the visible spectrum. The method can further include analyzing the image data to determine whether the image data meets at least one criterion indicative of a proper injection.

[0037] In some embodiments, the method may further include establishing data communication between the reader and a database. In some embodiments, the method may further include updating the database to indicate results of the analysis. In some embodiments, the image data may include image data in the near-infrared spectrum. In some embodiments, the image data may include image data in the infrared spectrum. In some embodiments, the image data may include thermal image data. In some embodiments, analyzing the image data may include analyzing the thermal image data for the presence of a cold region at the injection site. In some embodiments, analyzing the image data may include analyzing the image data to determine the presence of at least one feature of interest. In some embodiments, the at least one feature of interest may include a feature indicative of an intradermal blister and a feature indicative of leakage. In some embodiments, the reader may be a smartphone.

[0038] According to another exemplary embodiment of the present disclosure, the microneedle may include a base including a first edge and a plurality of second edges. The microneedle may further include a plurality of sidewalls extending substantially perpendicularly from the base. The microneedle may further include a face extending from the first end to an apex at an acute angle relative to the base. Two adjacent sidewalls of the plurality of sidewalls may define a lateral edge extending from the base to the apex in a direction substantially perpendicular to the base. The microneedle may further include a flow lumen extending through the microneedle from the base to an outlet at the face. The flow lumen may have an elongated cross-section.

[0039] In some embodiments, the cross-sectional shape may be oval. In some embodiments, the cross-sectional shape may have an elongated length of up to 100 microns. In some embodiments, the cross-sectional shape may have an elongated length of up to 200 microns. In some embodiments, the cross-sectional shape may be polygonal. In some embodiments, the microneedles may be constructed of silicon. In some embodiments, the majority of the cross-sectional shape may have a constant width. In some embodiments, the microneedles may have a height of at least 600 microns. In some embodiments, the microneedles may have a height of up to 800 microns.

[0040] According to another exemplary embodiment of the present disclosure, an exemplary microneedle may include a base. The microneedle may further include a plurality of sidewalls extending from the base. The sidewalls may be angled such that the microneedle tapers to have a smaller cross-sectional area as the distance from the base increases. The microneedle may further include a flow lumen. The microneedle may further include a plurality of side ports in the sidewalls. The side ports may be in fluid communication with the flow lumen. The microneedle may further include a tip at an end of the sidewall opposite the base.

[0041] In some embodiments, the microneedles may have a high aspect ratio. In some embodiments, the microneedles may be substantially obelisk-shaped. In some embodiments, the base may be polygonal in shape, with a sidewall of the plurality of sidewalls extending from each side of the polygon of the base. In some embodiments, the base may have a quadrilateral in shape, with a sidewall of the plurality of sidewalls extending from each of the four sides of the base. In some embodiments, the flow lumen can have a substantially constant cross-section. In some embodiments, the flow lumen can extend from the base to a plane within the microneedle, and the cross-section of the flow lumen is wider than a portion of the cross-section of the microneedle. In some embodiments, the microneedle can be constructed of silicon, and the lumen can be etched into the microneedle. A side port can be formed as a result of etching the lumen. In some embodiments, the flow lumen can extend substantially along the long axis of the microneedle. In some embodiments, the tip can be beveled.

[0042] According to yet another exemplary embodiment of the present disclosure, a method for delivering a medical agent may include attaching a delivery device to a surface, the delivery device including at least one delivery sharp capable of fluidly communicating with an at least partially collapsible reservoir containing the agent while the delivery device is in a storage state. The method may further include pushing a portion of the delivery device toward the surface to transition the delivery device to a delivery state. The method may further include unfolding and displacing at least two portions of the delivery device to apply tension to the surface to which the delivery device is attached. The method may further include penetrating the surface with the at least one delivery sharp. The method may further include transferring fluid from the at least partially collapsible reservoir and transferring the fluid through the at least one delivery sharp until the reservoir is in a depleted state.

[0043] According to another exemplary embodiment of the present disclosure, a delivery device may include a body. The body may include a peripheral region having multiple petal members. The body may further include a central region extending from the peripheral region. The central region may have a top surface and a bottom surface. The delivery device may further include a foldable reservoir in fluid communication with at least one delivery sharp. The at least one delivery sharp may be configured to eject fluid from the reservoir in an ejection direction. The delivery device may further include an adhesive member including a central opening. The central opening may include an increased opening width portion aligned with the ejection direction.

[0044] In some embodiments, the reservoir may include a flexible portion and a rigid portion. An adhesive member may be affixed to the body and the rigid portion. In some embodiments, the reservoir may include a flexible portion and a rigid portion. The rigid portion may have a footprint with a first area. The central opening may surround a second area that is 60-100% of the first area. In some embodiments, the center of the central opening may be coaxial with the center of the reservoir. In some embodiments, the adhesive member may include at least one spoke that protrudes into the central opening from the periphery of the central opening. In some embodiments, the adhesive member may cover at least a portion of each of the petal members. In some embodiments, the at least one delivery sharp may include an array of spaced microneedles. In some embodiments, the body may have a first state and a second state. The body may include at least one partially reversible region that is in a first shape in the first state and that is substantially reversible relative to the first shape over at least a portion of the reversible region in the second state. In some embodiments, the body can be configured such that at least two of the petal members are displaced apart when the body transitions from the first state to the second state. In some embodiments, the at least one delivery sharp can be displaced into communication with the delivery destination when the body transitions from the first state to the second state. In some embodiments, the central opening can include at least one notch in the increased opening width portion extending outward from the periphery of the central opening through the adhesive member.

[0045] According to another exemplary embodiment of the present disclosure, a delivery device may include a main body. The main body may include a peripheral region having multiple petals. The main body may further include a central region extending from the peripheral region and having a top surface and a bottom surface. The delivery device may further include a collapsible reservoir coupled to the main body. The reservoir may be in fluid communication with at least one microneedle having a width, height, and length. The delivery device may further include an adhesive member. The adhesive member may include a central opening having an increased opening width portion aligned with the length dimension of the microneedle.

[0046] In some embodiments, the reservoir can include a flexible portion and a rigid portion. In some embodiments, an adhesive member can be affixed to the body and the rigid portion. In some embodiments, the reservoir can include a flexible portion and a rigid portion. The rigid portion can have a footprint with a first area. The central opening can surround a second area that is 60-100% of the first area. In some embodiments, the center of the central opening is coaxial with the center of the reservoir. In some embodiments, the adhesive member can include at least one spoke that protrudes from the periphery of the central opening into the central opening. In some embodiments, the adhesive member may cover at least a portion of each of the petal members. In some embodiments, the at least one delivery sharp may include an array of spaced microneedles. In some embodiments, the body may have a first state and a second state. The body may have a first shape in the first state and include at least one partially invertible region that is substantially inverted relative to the first shape over at least a portion of the invertible region in the second state. In some embodiments, the body may be configured such that at least two of the petal members are displaced apart when the body transitions from the first state to the second state. In some embodiments, the at least one delivery sharp may be displaced to communicate with the delivery destination when the body is displaced from the first state to the second state. In some embodiments, the central opening may include at least one notch in the increased opening width portion extending outward from the periphery of the central opening through the adhesive member.

[0047] According to yet another exemplary embodiment of the present disclosure, a delivery device may include a body. The body may include a peripheral region. The peripheral region may include multiple petals. The body may further include a central region. The central region may extend beyond the peripheral region. The central region may have an upper surface and a base. The delivery device may further include an adhesive bonded to at least a portion of the body. The delivery device may further include a reservoir including at least one flexible portion. The at least one flexible portion may include a cavity defined by a first wall including a disintegration promoter. The delivery device may further include at least one delivery sharp in fluid communication with the reservoir.

[0048] In some embodiments, the collapse-accelerating device can include a bellows. In some embodiments, the collapse-accelerating portion can include pleats extending spirally around the wall. In some embodiments, the collapse-accelerating portion can include at least one stepped region formed in the wall. In some embodiments, the first wall can extend from a flange coupled to the rigid portion of the reservoir. In some embodiments, the first wall can taper with increasing distance from the flange such that the cross-sectional area of ​​the cavity decreases with increasing distance from the flange. In some embodiments, the cavity can be defined by a second wall at an end of the cavity, the second wall forming a substantially flat surface. In some embodiments, the second surface can include a central recess. In some embodiments, the wall can extend from the flange or be integrally formed with the flange. In some embodiments, the cavity can be defined by the first wall and a second wall at an end of the cavity, the second wall being substantially parallel to the flange. In some embodiments, the at least one delivery sharp can include a microneedle. [Brief explanation of the drawings]

[0049] 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.

[0050] [Figure 1] FIG. 1 is a block diagram of an exemplary delivery device in a storage state, in accordance with various aspects and embodiments of the present disclosure.

[0051] [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.

[0052] [Figure 2] 1A-1D are diagrams of exemplary microneedles according to various aspects and embodiments of the present disclosure.

[0053] [Figure 3A] 1A-1C are diagrams of exemplary sharp scaffolds incorporating microneedles, according to various aspects and embodiments of the present disclosure.

[0054] [Figure 3B] 1A-1D are diagrams of exemplary microneedles according to various aspects and embodiments of the present disclosure.

[0055] [Figure 4A] 1A-1C are diagrams of exemplary sharp scaffolds incorporating microneedles, according to various aspects and embodiments of the present disclosure.

[0056] [Figure 4B] 1A-1D are diagrams of exemplary microneedles according to various aspects and embodiments of the present disclosure.

[0057] [Figure 5A] FIG. 1 is a perspective view of an exemplary sharp scaffold including a set of exemplary microneedles.

[0058] [Figure 5B] FIG. 1 is a perspective view of an exemplary sharp scaffold including a set of exemplary microneedles.

[0059] [Figure 6A] FIG. 1 is a perspective view of an exemplary sharp scaffold including a set of exemplary microneedles.

[0060] [Figure 6B] FIG. 6B is a top view of the exemplary sharp bearing shown in FIG. 6A.

[0061] [Figure 7A] FIG. 1 is a top view of an exemplary sharp scaffold including a set of exemplary microneedles.

[0062] [Figure 7B] FIG. 1 is a perspective view of an exemplary sharp scaffold including a set of exemplary microneedles.

[0063] [Figure 8A] FIG. 1 is a top view of an exemplary sharp scaffold containing a set of microneedles.

[0064] [Figure 8B] FIG. 1 is a perspective view of an exemplary sharp scaffold including a set of exemplary microneedles.

[0065] [Figure 8C] 8B is a cross-sectional view taken along the indicated cutting plane of FIG. 8A.

[0066] [Figures 9A-9D] 1A-1D show various views of an exemplary microneedle with a side port.

[0067] [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.

[0068] [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.

[0069] [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.

[0070] [Figure 12] 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0071] [Figure 13] FIG. 1 is a plan view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0072] [Figure 14]FIG. 1 is a side view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0073] [Figure 15] FIG. 1 is a plan view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0074] [Figure 16] FIG. 1 is a conceptual diagram of an exemplary delivery device in a delivery state, according to various aspects and embodiments of the present disclosure.

[0075] [Figure 17] 1A-1C are diagrams of an exemplary delivery device in a stored state, according to various aspects and embodiments of the present disclosure.

[0076] [Figure 18] FIG. 1 is a conceptual diagram of an exemplary delivery device in a delivery state, according to various aspects and embodiments of the present disclosure.

[0077] [Figure 19] FIG. 1 is a side view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0078] [Figure 20] 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0079] [Figures 21A-21I] 10A-10C 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.

[0080] [Figure 22] 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0081] [Figure 23] 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0082] [Figure 24] 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0083] [Figure 25] 1A-1C are diagrams of an exemplary delivery device in a stored state, according to various aspects and embodiments of the present disclosure.

[0084] [Figure 26] FIG. 1 is a cross-sectional perspective view of a body of an exemplary delivery device in a storage state, according to various aspects and embodiments of the present disclosure.

[0085] [Figure 27A] 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.

[0086] [Figure 27B] 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.

[0087] [Figure 28A] 1A-1C are side conceptual views of an exemplary delivery device transitioning to a delivery state, in accordance with various aspects and embodiments of the present disclosure.

[0088] [Figure 28B] 1A-1C are side conceptual views of an exemplary delivery device transitioning to a delivery state, in accordance with various aspects and embodiments of the present disclosure.

[0089] [Figure 29] FIG. 1 is a perspective view conceptually illustrating an exemplary delivery device in a delivery state, according to various aspects and embodiments of the present disclosure.

[0090] [Figure 30] FIG. 30 is a side view of the exemplary delivery device of FIG. 29, in accordance with various aspects and embodiments of the present disclosure.

[0091] [Figure 31] FIG. 30 is an exploded view of the delivery device shown in FIG. 29, according to various aspects and embodiments of the present disclosure.

[0092] [Figure 32] FIG. 30 is a plan view of the delivery device shown in FIG. 29, in accordance with various aspects and embodiments of the present disclosure.

[0093] [Figure 33] 33 is a cross-sectional view of the delivery device shown in FIG. 29 taken at the cutting plane indicated in FIG. 32 according to various aspects and embodiments of the present disclosure.

[0094] [Figure 34] 1 shows a representative diagram of an exemplary delivery device including a dispensing assembly.

[0095] [Figure 35] 1 shows a representative diagram of an exemplary delivery device including a dispensing assembly.

[0096] [Figure 36] 1 shows a representative diagram of an exemplary delivery device including a dispensing assembly.

[0097] [Figure 37] 1 shows a perspective view of an exemplary delivery device and biasing member.

[0098] [Figure 38] 1A and 1B show perspective views of exemplary biasing members that may be included in a delivery device.

[0099] [Figure 39] 1 illustrates a cross-sectional view of a portion of an exemplary delivery device.

[0100] [Figure 40] 1 illustrates a cross-sectional view of a portion of an exemplary delivery device.

[0101] [Figure 41]1 shows a perspective view of an exemplary push body that may be included in a delivery device.

[0102] [Figure 42] 1 illustrates an exemplary depressor body and biasing member, with the biasing member in a stressed state.

[0103] [Figure 43] 1 illustrates a cross-sectional view of an exemplary push body and biasing member, with the biasing member in a stressed state.

[0104] [Figure 44A] 1 shows a perspective view of an exemplary delivery device.

[0105] [Figure 44B] 1A and 1B show perspective views of an exemplary stop member that may be included in the delivery device.

[0106] [Figure 44C] 1A and 1B show perspective views of an exemplary delivery assembly and an exemplary stop member that may be included in the delivery device.

[0107] [Figure 44D] 1A and 1B show perspective views of an exemplary biasing member and an exemplary pusher that may be included in the delivery device.

[0108] [Figure 45] 1A-1C show representative views of an exemplary delivery device including a biasing member.

[0109] [Figure 46A] 1 shows a bottom view of an exemplary body that may be included in a delivery device.

[0110] [Figure 46B] 1A and 1B show perspective views of an exemplary body and an exemplary biasing member that may be included in a delivery device.

[0111] [Figure 46C] 1A and 1B show perspective views of an exemplary body and an exemplary biasing member that may be included in a delivery device.

[0112] [Figure 47] 1 is a perspective view of an exemplary holder for a sharp bearing according to various aspects and embodiments of the present disclosure. FIG.

[0113] [Figure 48] FIG. 1 is a side view of an exemplary holder for a sharp bearing according to various aspects and embodiments of the present disclosure.

[0114] [Figure 49] FIG. 10 is a bottom plan view of an exemplary holder for a sharp bearing according to various aspects and embodiments of the present disclosure.

[0115] [Figure 50] 1 is a perspective view of an exemplary holder for a sharp bearing according to various aspects and embodiments of the present disclosure. FIG.

[0116] [Figure 51A] 1 illustrates a perspective view of an exemplary holder including a stage protrusion.

[0117] [Figure 51B] 1 illustrates a perspective view of an exemplary holder including a stage protrusion.

[0118] [Figure 51C] 1 illustrates a bottom view of an exemplary holder including a stage protrusion.

[0119] [Figure 52A] 10 shows a side view of an exemplary holder including a stage protrusion to which an exemplary sharp bearing is attached.

[0120] [Figure 52B] FIG. 52B shows a detailed view of the indicated area of ​​FIG. 52A.

[0121] [Figure 52C] 10 shows a cross-sectional view of an exemplary holder including a stage protrusion to which an exemplary sharp bearing is attached.

[0122] [Figure 52D] FIG. 52D shows a detailed view of the indicated area of ​​FIG. 52C.

[0123] [Figure 53] FIG. 1 is a side view of an exemplary portion of a reservoir according to various aspects and embodiments of the present disclosure.

[0124] [Figure 54] 1A-1C are plan views of exemplary portions of reservoirs according to various aspects and embodiments of the present disclosure.

[0125] [Figure 55] 1A-1C are perspective views of exemplary portions of a reservoir according to various aspects and embodiments of the present disclosure.

[0126] [Figure 56] 1A-1C are perspective views of exemplary portions of a reservoir according to various aspects and embodiments of the present disclosure.

[0127] [Figure 57] 1 shows a perspective view of an exemplary reservoir.

[0128] [Figure 58] 1 shows a perspective view of another exemplary reservoir.

[0129] [Figure 59] FIG. 1 is a block diagram of an exemplary reservoir assembly according to various aspects and embodiments of the present disclosure.

[0130] [Figure 60] FIG. 1 is a block diagram of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0131] [Figure 61A] FIG. 1 shows a block diagram of an exemplary reservoir assembly.

[0132] [Figure 61B] FIG. 1 shows a block diagram of an exemplary reservoir assembly.

[0133] [Figure 62] 1 shows a representative diagram of an exemplary delivery device including a reservoir divided into multiple sections.

[0134] [Figure 63A] 1A-1C show bottom views of an exemplary delivery device with an exemplary adhesive member.

[0135] [Figure 63B] 10A-10C show bottom views of another exemplary delivery device with another exemplary adhesive member.

[0136] [Figure 63C] 10A-10C show bottom views of another exemplary delivery device with another exemplary adhesive member.

[0137] [Figure 64A] 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0138] [Figure 64B] 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0139] [Figure 65A] 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.

[0140] [Figure 65B] FIG. 1 is a side view of an exemplary delivery device in a second state, according to various aspects and embodiments of the present disclosure.

[0141] [Figure 65C] FIG. 10 is a side view of an exemplary delivery device in a third state, according to various aspects and embodiments of the present disclosure.

[0142] [Figure 66A] 1A-1C are cross-sectional views of an exemplary flexure of a delivery device according to various aspects and embodiments of the present disclosure.

[0143] [Figure 66B] 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0144] [Figure 66C] 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0145] [Figure 67A] 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0146] [Figure 67B] 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0147] [Figure 68] 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0148] [Figure 69] FIG. 1 is a plan view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0149] [Figure 70A] 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.

[0150] [Figure 70B] FIG. 1 is a side view of an exemplary delivery device in a second state, according to various aspects and embodiments of the present disclosure.

[0151] [Figure 70C] FIG. 10 is a side view of an exemplary delivery device in a third state, according to various aspects and embodiments of the present disclosure.

[0152] [Figure 71] 1A-1C are cross-sectional views of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0153] [Figure 72A] FIG. 1 is a block diagram of an exemplary delivery device in a storage state, in accordance with various aspects and embodiments of the present disclosure.

[0154] [Figure 72B] 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.

[0155] [Figure 73] 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0156] [Figure 74] 1 is a perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure. FIG.

[0157] [Figure 75] FIG. 1 is an exploded view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0158] [Figure 76] FIG. 1 is an exploded view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0159] [Figure 77A] 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.

[0160] [Figure 77B] FIG. 77B is an enlarged view of the indicated area of ​​the delivery device of FIG. 77A.

[0161] [Figure 78A]FIG. 1 is a side view of an exemplary delivery device in a second state, according to various aspects and embodiments of the present disclosure.

[0162] [Figure 78B] FIG. 78B is an enlarged view of the indicated area of ​​the delivery device of FIG. 78A.

[0163] [Figure 79] 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.

[0164] [Figure 80] FIG. 1 is a cross-sectional view of an exemplary delivery device in a second state, according to various aspects and embodiments of the present disclosure.

[0165] [Figure 81] 1 illustrates an exploded view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0166] [Figure 82] 1 illustrates an exploded view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0167] [Figure 83] 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.

[0168] [Figure 84] FIG. 10 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.

[0169] [Figure 85] FIG. 10 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 according to various aspects and embodiments of the present disclosure.

[0170] [Figure 86] 1 shows a perspective view of an exemplary package for a delivery device.

[0171] [Figure 87] 1A-1C show views of an exemplary body of a delivery device separated from an exemplary reservoir assembly that may be included in the delivery device.

[0172] [Figure 88] 10 illustrates an exemplary delivery device being removed from a patient's skin, revealing marks formed on the skin by the delivery device.

[0173] [Figure 89] An example of a thermal image of an injection site showing blisters from the injection into the skin is shown. DETAILED DESCRIPTION OF THE INVENTION

[0174] 1A and 1B illustrate an embodiment of an exemplary delivery device 10. The exemplary delivery device 10 may be a low-profile delivery device 10 that may be applied to a patient's skin. The exemplary delivery device 10 may be sized for handheld use and may be easily applied to a variety of injection sites on a patient's body. Additionally, the exemplary delivery device 10 may 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.

[0175] Such a delivery device 10 can be used to administer medication from a reservoir 12 included as part of the delivery device 10 to a target delivery destination in a patient via one or more delivery sharps 72. The reservoir 12 can be at least partially flexible and have a variable volume that can decrease as fluid is dispensed from the reservoir 12. When the reservoir 12 is emptied, the reservoir 12 can be at least partially collapsible. 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. While FIG. 1A shows three delivery sharps 72 arranged in a row, multiple delivery sharps 72 may also be arranged. The number and arrangement of 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 from being inhibited between users or delivery devices 10, or to prevent an inconsistent bed-of-nails type scenario. This may occur if too many delivery sharps 72 are placed close to one another. Thus, this array may be referred to as a spaced array of delivery sharps 72.

[0176] The delivery sharp 72 can be selected based on the patient's desired target delivery destination. In certain embodiments, the target delivery destination may be a transcutaneous location. For example, the target delivery destination may be a subcutaneous delivery destination or an intramuscular delivery destination. Alternatively, the target delivery destination 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 locations in the epidermis or dermis, and may target, for example, the junction between the epidermis and dermis, or the dermis and subcutaneous tissue. In an exemplary embodiment, the delivery sharp 72 is shown as a microneedle. Such a delivery sharp 72 may be present in a delivery device 10 having a shallow (e.g., above the subcutaneous tissue) target delivery destination. For example, in alternative embodiments where the target delivery destination is a subcutaneous or intramuscular location, a conventional delivery sharp (e.g., a 30-gauge needle) may be utilized.

[0177] While FIG. 2 uses microneedles, the microneedles described herein may, in certain embodiments, be polyhedral (e.g., pyramidal) silicon crystal microneedles fabricated with MEMS. 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, although 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 prism's top surface through the distal-most side 15 of the base 17. At least two sides of the microneedle's base may be parallel. The sidewalls 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 the center of the distal-most 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 microneedles 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.

[0178] The tip or tip of the microneedle may be solid, and the flow lumen 126 through the microneedle may be offset from the tip or tip of the microneedle (in FIG. 2, apex 14 forms the tip). Hollow-tipped microneedles may also be utilized, in which the flow lumen 126 extends to the tip of the microneedle. In some embodiments, the microneedle may be a hollow microneedle, such as those 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 considered to be composed of silicon, may have a surface layer of silicon dioxide (which may form, for example, due to exposure to air).

[0179] 3A-4B, in some embodiments, microneedles may be constructed to include certain features that help reduce the pressure required to inject a fluid, such as a medication, into a patient's skin. In some examples, features common to insect stingers or biotoxin administration structures may be incorporated. These features may include various recesses or indentations formed in each microneedle, or as part of at least one microneedle, of the delivery device 10. These indentations or indentations may be in fluid communication with the flow lumen 126 of the respective microneedle. In some embodiments, different microneedles of the delivery device 10 may include different indentations, or some microneedles may include multiple indentations that may (but need not) be different.

[0180] For example, as shown in Figures 4A-4B, the microneedle may include a channel or trough 200 on the outer sloping surface 21 from the flow lumen 126 toward the distal side 15. The channel 200 allows the medicinal agent to flow along the outside of the microneedle and through the channel 200, finding the path of least resistance or weakest link to the skin. In the illustrated embodiment, if the outlet of the flow lumen 126 is inserted deeper than the depth of the weak area of ​​the skin, the channel 200 allows the medicinal agent to flow along the outside of the microneedle to the weak area of ​​the skin. The lamina lucida junction, the destination of intradermal delivery, is a weak link in the skin structure and is difficult to inject consistently and directly due to its relative thinness (typically about 40 nm thick). A microneedle including the channel 200 may, for example, allow the medicinal agent to flow to the lamina lucida junction when it passes the outlet of the flow lumen 126. The channel 200 may facilitate distribution of the medicinal agent through a larger penetration or injection area. In some examples, incorporating the channel 200 into the microneedle can significantly reduce the pressure required to inject the medicinal agent into the skin. In certain examples, the pressure may be reduced by more than 600% (e.g., from 120 pounds per square inch (psi) to 18-20 psi in certain examples).

[0181] Steeper sidewalls of the channel 200 can be created using suitable silicon etching techniques (or molds in embodiments using polymer microneedles). This can help prevent 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 or 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 flow lumen 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 flow lumen 126, or the channel 200 can have a width that is smaller or larger than the width of the flow lumen 126. The channel 200 can be approximately 5-10 percent of the height of the microneedle.

[0182] To avoid leakage of fluid from channel 200, it may be desirable to ensure that 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 pellucida junction). In some embodiments, channel 200 extends from flow lumen 126 to within a maximum of 50 microns (e.g., 50-200 microns) of base 17 of the microneedle. In some embodiments, the end of channel 200 most proximal to 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 channel 200 closest to base 17 may be located below the epidermis (e.g., in the basement membrane) or within the epidermis.

[0183] The channel 200 does not have to be straight or have the shape shown and described in Figures 4A-4B. In some embodiments, the channel 200 may have 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.

[0184] The depth of the channel 200 may be approximately 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. While the depth of the channel 200 may be constant along the length of the channel 200, 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, for example, Figure 5B). The width of the channel 200 may be approximately 20-30 percent of the width of the distal side 15 of the microneedle at its narrowest point. 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 point that is 50% or more of the width of the distal side 15.

[0185] 5A and 5B, in other examples, the channel 200 may extend from the location of the lumen 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 beveled surface 21 of the microneedle. In such embodiments, 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.

[0186] 6A-6B, a sharp bearing body 26 containing multiple microneedles is shown. In certain embodiments, the channel 200 may not be included. Instead, the microneedle may include a flow lumen 126 having an elongated cross-section (at least at the outlet, see also FIGS. 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 positioned at a predetermined location within a patient's body. Thus, thin and / or weak layers of skin may be more likely to be targeted when the microneedle is advanced into the patient's body. The elongated lumen 126 can also help reduce the pressure required for injection. Such elongated flow lumen 126 can have any suitable cross-section. In some embodiments, the cross-section can be oval or elliptical. Alternatively, a lumen 126 having an elliptical cross-section can be used, as shown in FIGS. 6A and 6B. Polygonal cross-sectional shapes, such as, but not limited to, rectangular, trapezoidal, or triangular, can also be used. In certain instances, the cross-sectional length (in the elongated direction) of the lumen 126 can be up to 100-200 μm or greater (although in certain instances, it can be less). When an elongated lumen 126 is included, the end of the lumen 126 most proximal to the distal side 15 can be spaced from the distal side 15 by at least a certain distance. This spacing may be such that when the microneedle is inserted into the skin, the end most proximal to the distal side 15 of the lumen 126 may be below at least 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., within the basement membrane) or within the epidermis.

[0187] 6A-6B, in certain embodiments, the beveled surface 21 of the microneedle may not extend to the base 17 of the microneedle. For example, there may be a vertical surface 13 extending from the base 17 to the distal side 15 of the microneedle. If a vertical surface 13 is included, the vertical surface 13 may align with and form an extension of a side (e.g., distal side 15) of the sharp support 26. The inclusion of such a vertical surface 13 may help reduce the size of the sharp support 26 and may help ensure consistent fluid delivery to the target destination of a particular microneedle. As shown in FIGS. 6A-6B, any of the microneedles shown herein may be configured with a vertical surface 13.

[0188] 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 FIGS. 3A-3B. The recess 202 may have a maximum depth at which the recess 202 is in fluid communication with the flow lumen 126 of the microneedle. The recess 202 may thus form a side port for the microneedle through which fluid can be delivered to the patient. The side port may be the only outlet for 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, 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 removing material during the manufacturing of the microneedle or may be formed during a molding operation. Removal of material may be accomplished by any known suitable process, such as 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 FIGS. 3A-3B , the recess 202 is formed in the substantially vertical back edge 23 of the microneedle, which 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 approximately 130% to 110% of the distance from the back edge 23 to the flow lumen 126.

[0189] In certain examples, as shown in Figures 7A and 7B, the microneedle may include a beveled surface 21 from which a lumen 126 extending through the microneedle extends. 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 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 can be used. The rounded blade edge 31 may arc at a constant radius or may arc 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, for example, Figures 8A-8C). The rounded blade edge 31 can aid in the introduction of the microneedle into the skin when the microneedle is inserted at a specific angle or over a variety of different angles.

[0190] In yet another embodiment, as shown in Figures 8A-8C, the lumen 126 can 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 need 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 can be positioned so 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. Furthermore, the exit of the flow lumen 126 at the lumen exit surface 35 can be positioned so that one or all planes perpendicular to the base 17 and passing through the exit of the flow lumen 126 can also pass through the blade edge 31. This need not be true for all embodiments (see, e.g., Figures 7A-7B). When microneedles of the type shown in Figures 8A-8C are inserted, a vertical gap can 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.

[0191] In yet other embodiments, as shown in Figures 9A-9D, delivery sharp 72 may be or include a microneedle having a high aspect ratio shape. In some embodiments, the microneedles may be obelisk-shaped. Such microneedles may be included in an array, such as any of the arrays described herein. When obelisk-shaped microneedles are used, the microneedles 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' extending from the base 17' to an end region 25 of the microneedle. The sidewall 19' may be disposed at a non-perpendicular angle to the base 17'. Thus, the microneedle may be tapered 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 puncturing the skin and may help increase the robustness of the end region 25. Any suitable bevel, such as a single bevel or a double bevel, may also be used.

[0192] In obelisk-shaped microneedle embodiments, the microneedle may include at least one side port 29 that can function as an exit port for the microneedle. Such a side port 29 may be difficult to block due to 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 cause the end of the lumen 126 to be 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 need not be symmetrical.

[0193] In various embodiments in which 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), polymer (e.g., polymethyl methacrylate 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, polymethyl vinyl ether-co-maleic anhydride), carbohydrate, or metal (e.g., stainless steel, titanium, alloys such as palladium, nickel, palladium-cobalt alloy, 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.

[0194] Referring again primarily to FIGS. 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. While such a delivery device 10 can deliver any suitable vaccine, it 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 the event of a pathogen outbreak (e.g., measles) in a community that has chosen to forgo typical vaccinations. For example, such a delivery device 10 can be distributed without requiring patients to gather in a hospital or other shared space. This may alleviate concerns about pathogen transmission associated with vaccination programs and potentially discourage people from reporting to get vaccinated. Instead, the delivery device 10 can be picked up and used by the patient without violating social distancing, gathering size recommendations, or other safety guidelines. Alternatively, such a delivery device 10 may be distributed directly to the patient without the patient having to leave their residence or the distributor having to interact with individuals who refuse to utilize the recommended PPE. Delivery device 10 could be loaded with a vaccine against a novel pathogen, or with a vaccine typical of a regular vaccination schedule, in which case such a delivery device 10 could help prevent interruptions in vaccination against known pathogens during a pandemic of a novel pathogen.

[0195] Any suitable vaccine can be delivered through such a delivery device 10. For example, the vaccine can be, but is not limited to, an attenuated vaccine, an inactivated virus vaccine, an acellular vaccine, a cellular vaccine, a toxoid vaccine, a heterotypic or Jenner vaccine, a monovalent vaccine, a polyvalent vaccine, a nucleic acid vaccine (e.g., DNA, plasmid vaccine, mRNA), a virus-like particle vaccine, a recombinant vector vaccine (e.g., replicating, non-replicating), a dendritic cell vaccine, a T cell receptor peptide vaccine, a chimeric vaccine, a subunit vaccine, a nanoparticle vaccine, a recombinant protein vaccine, a polysaccharide vaccine, and a conjugate vaccine. Note that these are not necessarily mutually exclusive. For example, the vaccine can be a recombinant protein nanoparticle vaccine or other combinations of the above. Vaccine can also refer to combination vaccines (eg, 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. The delivery devices 10 described herein are also not limited to human use. Such delivery devices 10 can be used with livestock, pets, service animals, or other veterinary applications. In such cases, these delivery devices 10 can 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.

[0196] When the delivery device 10 is filled with a vaccine, a shallow target delivery destination may be desirable. 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), for example, may be well suited for use with the delivery device 10 described herein.

[0197] Evidence suggests that shallow delivery of a vaccine may elicit a protective immune response with a smaller amount 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 illustrated herein can enable 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.

[0198] Particularly for new vaccines developed to combat the ongoing pandemic (e.g., a vaccine for SARS-CoV-2), the prospect of rapidly producing billions of doses of 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, a delivery device 10 as shown and described herein may enable more cost-effective injections. 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 vaccines to the public. This may be particularly attractive for vaccines requiring cold-chain distribution, as packaging volume may become more important.

[0199] Furthermore, 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 reliability concerns 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.

[0200] 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 help meet the significant demand for vaccines, for example, against novel pathogens, by leveraging the dose / injection savings that intradermal vaccination can enable. Furthermore, because the intradermal delivery device 10 described herein is painless or nearly painless, the delivery device 10 described herein may be preferable to users over other types of injections. That said, and as noted above, the delivery device 10 described herein is not limited to delivery via the intradermal route. The delivery device 10 can be configured, for example, as a transdermal (e.g., subcutaneous or intramuscular) delivery device 10.

[0201] Furthermore, the exemplary delivery device 10 shown herein is not limited to vaccine delivery devices. Such a delivery device 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. A tuberculosis testing agent 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.

[0202] 1A-1B, delivery device 10 can include a body 20. Body 20 can be a deformable body that can transition from a storage state (see FIG. 1A) to a delivery state (see FIG. 1B). In certain instances, this transition can be reversible, while in other embodiments, the transition can result in a permanent change to body 20 and / or another portion of delivery device 10. The body 20 may be plastically deformed such that it is permanently distorted and cannot return to the storage state. In other examples, 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 connector may be engaged to hold the body 20 in the delivery state or to prevent the body 20 from returning to the storage state. Releasing such a 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, this permanent change may not only prohibit reuse but also provide a perceptible (e.g., visual) indication to the user that the delivery device 10 has been used. An 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 destruction of a frangible portion.

[0203] In various examples, the transition of the delivery device 10 from the storage state to the delivery state can be achieved through bending, pivoting, or deformation of one or more regions of the body 20. In certain examples, the body 20 can include one or more hinges (e.g., living hinges, which help reduce part count) through which the body 20 can bend. In other embodiments, the body 20 can be or include a bistable element having a first stable state corresponding to the storage state and a second stable state corresponding to the delivery state. The body 20 can have one or more reversible regions that, for example, substantially or partially reverse 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. The transition can be affected by applying a force throughout the entire transition. Alternatively, the transition can only require applying a force throughout a portion of the transition. For example, in some embodiments, a trigger force can be applied to initiate the transition, after which the transition can be completed without the application of an external force. For example, after application of a trigger force, the transition may be characterized by a snap-through buckling in which the body 20 rapidly transitions to the delivery state.

[0204] The body 20 may be at least partially covered with adhesive 22 on its first surface 24. This may serve to couple the body 20 to the skin surface at a patient's infusion or injection site. Thus, the first surface 24 may be the skin-adjacent or proximal (proximal and distal as defined with respect to the patient) surface of the body 20. When the body 20 is in the storage state and then transitioned to the delivery state, the body 20 may be adhered to the skin. When this transition occurs, at least two adhesive-bearing portions of the body 20 may be displaced relative to one another, stretching or widening the surfaces secured to the body 20 via the adhesive 22. When these portions are adhered to the skin surface, the skin may be stretched as the adhesive-bearing portions are displaced relative to one another. This may be desirable because it may hold the skin taut to facilitate puncture of 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 one another. The displacement of the two adhesive-bearing portions may increase the distance between the two adhesive-bearing portions or may increase the spacing between the two adhesive-bearing portions. In other embodiments, the distance between the two adhesive-bearing portions may not increase or may even decrease while causing stretching of the skin surface. This may occur, for example, when the transition pulls a flat portion of skin around the curve or contour of the body 20 (see, for example, Figures 17 and 18). The displacement of the adhesive-bearing portions relative to one another (whether a positive or negative change in the distance between the adhesive-bearing portions) that results in stretching of the adhered skin may be referred to as spreading displacement. Two adhesive-bearing portions that are so displaced may be referred to as being spread displaced.

[0205] As the body 20 transitions to the delivery state, the delivery sharp 72 may be displaced or lowered proximally toward or into the skin. In embodiments in which 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 as 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 force fluid out of the reservoir 12 and through the delivery sharp 72 to a target delivery destination 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 to the delivery sharp 72 may not be available prior to use.

[0206] In some embodiments, as shown in FIG. 10A , a collapsible pouch or packet 208 can be placed over the reservoir 12 within the delivery device 10. The packet 208 can contain a substance that is dormant in a first state and transitions to a powered state in a second state. In one embodiment, the substance is dormant at a first temperature and can be powered at a second temperature, for example, by applying a motive force to the reservoir 12. 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 a patient (e.g., 98.6°F for humans). In some embodiments, the substance can change volume when transitioning from the dormant state to the powered state. Alternatively or additionally, the substance can change from one material state to another when transitioning from the dormant state to the powered state. In an exemplary embodiment, the substance can change from a liquid to a gas during the transition from the dormant state to the powered state.

[0207] In embodiments where the medication in the reservoir 12 of the delivery device 10 must be stored at very low temperatures, for example, if the medication is a vaccine with such a requirement, the packet 208 can 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 above the storage temperature of the medication (e.g., vaccine) but below room temperature or another suitable temperature setpoint. While any suitable liquid can be used, one example of a suitable liquid is butane. The boiling point of butane is −1° C. While the examples described herein refer to butane, one skilled in the art will understand that this description can be generalized to any suitable liquid.

[0208] The delivery device 10 can be attached to a 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., approximately 20°C, the contents warm up (heat from the patient may assist in this). In an exemplary embodiment, the liquid butane boils and changes into a gas when it reaches its boiling point of -1°C. As the liquid boils and transitions to a gaseous state, pressure increases within the packet 208, causing it to expand and exert downward pressure on the reservoir 12, as shown in FIG. 10B. For example, butane gas has a vapor pressure of 35.4 psi at 25°C. Therefore, the final pressure of the reservoir 12 may be high (e.g., approximately 38 psi) due to heat transfer from the patient to the packet 208. The body 20 of the delivery device 10 may be sufficiently elastic so as not to deform under the pressure exerted by the packet 208. This may help direct the pressure toward the reservoir 12.

[0209] Such a configuration can 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 by the packet 208 from above will cause the delivery device 10 to empty. This can be visually noticeable to the user. The delivery device 10 can 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 empty. As a result, the delivery device 10 will prevent itself from later administering the temperature-abuse drug.

[0210] In some embodiments, it may be desirable to apply significant downward pressure to the reservoir 12, e.g., 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 FIGS. 1A and 1B. In such an embodiment, the packet 208 can be incorporated into a squeezable container 350, as shown in FIG. 11. The container 350 can be made of squeezable plastic or any other suitable material, as will be understood 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, for example, expanding foam components. 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 generates a gas (such as baking soda or vinegar) could be used. Upon applying the delivery device 10 to the skin surface, the user could, for example, pinch, crush, squish, or squeeze the container 350, causing the packet 208 therein to burst, thereby allowing the first and second substances to interact and exert downward pressure on the reservoir 12 below.

[0211] In yet another embodiment, 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 the pressure for delivery.

[0212] 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 fingers 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 also be used.

[0213] In other embodiments, packet 208 of FIG. 10A or 10B may be or include a biasing member. In some embodiments, packet 208 may be a foam adhesive material located above reservoir 12. In such an example, when a user presses down on delivery device 10 (after delivery device 10 is affixed to the skin surface), the foam adhesive may also facilitate an even distribution of pressure across the top of reservoir 12. Assembly of the components described in connection with the above embodiments is described below with reference to FIGS. 47-61B and 12-27B.

[0214] 12-14, an exemplary delivery device 10 is shown. The exemplary delivery device 10 is shown in a storage state in FIGS. 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 contained on a sharps support 26, which 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. The body 20 can be formed as a thin sheet or disc of material that can be thermoformed to form the raised central region 28 and the flat peripheral region 30.

[0215] Alternatively, the body 20 may be injection molded, with the raised central region 28 and 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 FIGS. 12-33), the body 20 may be injection molded to be in either the storage state or the delivery state. The body 20 may be more easily transitioned from the reverse state to the molded state. Therefore, to reduce the effort required to transition the delivery device 10 from the storage state to the delivery state, it may be desirable to mold the body 20 of the delivery device 10 into its delivery state shape. During assembly of the delivery device 10, the body 20 may be placed in its storage state configuration and remain in that configuration until use.

[0216] The central region 28 may be dome-shaped, forming a receptacle 32 proximal to the body 20 within which the reservoir 12 may be disposed. The reservoir 12 may be bonded within the receptacle 32 via adhesive or another suitable method. The central region 28 may also include a series of fenestrations 34, which 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 circular pattern generally 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.

[0217] The body 20 may include multiple slots 36. The slots 36 may 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 may extend across the entire peripheral region 30. In some embodiments, as shown, the slots 36 may also extend across at least a portion of the central region 28. The fenestrations 34 in the central region 28 may be located radially inward of the ends 40 of each slot 36. Thus, the body 20 may include a central region 28 surrounded by a plurality of petals 42, the petals 42 being spaced apart via the slots 36.

[0218] 15 , a plan view of the proximal surface 24 of the body 20 is shown. As shown, an 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. While adhesive 22 is shown covering the entire surface of each petal member 42 within the peripheral region 30, other embodiments may differ. For example, only certain petal members 42 may include adhesive 22. In such embodiments, adhesive 22 may be included on at least one pair of oppositely disposed petal members 42 (e.g., diametrically opposed in the illustrative embodiment). In some examples, only a portion (e.g., a majority of the surface area) of each petal member 42 included in the peripheral region 30 may be covered with adhesive 22. Alternatively or additionally, adhesive 22 may vary from petal member 42 to petal member 42. Some petal members 42 may be covered with a stronger adhesive 22, while other petal members 42 may be covered with a weaker adhesive 22. In certain examples, additional adhesive members 22, as described elsewhere herein (e.g., see Figures 63A-63C), may be used with the delivery device 10.

[0219] Referring to FIG. 16 , a conceptual representation of the body 20 of the delivery device 10 is shown in the delivery state. In the delivery state, at least the central region 28 of the body 20 can substantially evertate. 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 may also be displaced extensively over at least a portion of the transition. The slots 36 in the body 20 may help facilitate the expansive displacement of the petal members 42 as the transition occurs, thereby facilitating the stretching of the user's skin.

[0220] 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 body 20 is in the storage state, an axial load acting on central region 28 may cause body 20 to deform and become unstable. Body 20 may then exhibit a snap-through buckling action, rapidly transitioning body 20 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.

[0221] Figure 17 shows the delivery device 10 in a storage state and adhered to the skin 44 via the adhesive 22 on the proximal surface 24 of the body 20. Figure 18 is a conceptual diagram showing the delivery device 10 in a delivery state. As shown, the delivery device 10 can be applied to the skin 44 in the storage state. The delivery device 10 can then be transitioned to the delivery state. As the transition occurs, a spreading displacement of the opposing petals 42 of the body 20 can occur.

[0222] 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 storage 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 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 adhesive 2 and cannot pass through the body 20, the skin 44 may be forced to conform to the curvature of the proximal surface 24. Therefore, 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 storage state. The skin 44 may be placed under tension and stretched to accommodate this change in length. This stretching, in turn, may help to facilitate puncture of skin 44 by delivery sharp 72 .

[0223] Due to the elasticity of the skin 44, when attempting to return to an unstretched state, 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 establishes fluid communication with the target delivery destination within the patient's body. Furthermore, because the reservoir 12 is collapsible, the restoring force exerted by the skin 44 can pressurize the reservoir 12, forcing fluid out of the reservoir 12 via the delivery sharp 72. The stretched skin 44 may help empty and collapse the reservoir 12 .

[0224] As mentioned above, in certain examples, some petal members 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 petal members 42. If some petal members 42 are free of adhesive 22, this may help limit stretching of the skin 44. Similarly, petal members 42 with less strong adhesive 22 may release the patch of skin 44 to which they are attached if the force required to stretch the skin 44 exceeds a threshold. The petal members 42 themselves may be constructed so that at least one of the petal members 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, one or more of the petal members 42 may bend or buckle at the relief region to relieve some of the tension on the skin 44.

[0225] This may be desirable because it may help reduce potential discomfort during injection due to excessive tension on the skin 44. Additionally, this may be helpful for certain patient populations because skin characteristics vary with age, hydration status, lifestyle (sun exposure, nutrition), etc. Loose or sagging skin may be more desirable to stretch than more elastic skin. 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.

[0226] 19 and 20 , in another embodiment, the delivery device 10 can 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 can have a circular, e.g., substantially circular, base. The peripheral region 30 can be generally annular in shape and can include an inner periphery and an outer periphery or rim 38 that coincide with the base 262. The delivery device 10 can be constructed of Nycoa 2012 nylon or other similar nylon material and formed by injection molding. Any other suitable plastic can also be used. The upper surface 250 can have a generally circular, rounded footprint, for example, or can be convex, forming a dome shape. The upper surface 250 can have a rim 340. The upper surface 250 can include a slot 254. The slot 254 can be a notch, hole, hole, opening, or void in various embodiments. The slots 254 can aid in the transition of the delivery device 10 from a storage state to a delivery state under vacuum from above. The slots 254 are spaced apart such that each first end point 258 surrounds an area that includes the center point 256 of the upper surface 250 and each second end point 260 extends a distance (in embodiments that include slots 254, the slots 254 may, but need not, be spaced at regular angular increments). In embodiments described herein that include slots 254, the slots 254 may each be (but need not be) the same length.

[0227] 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. While a thermoformable body 20 is shown, the features described with respect to a thermoformed body 20 may be included in a body 20 manufactured in any desired manner. As shown in FIGS. 21A-21I, slot 254 can be provided in many different formats. Additionally, in some embodiments, slot 254 may not be included.

[0228] In some embodiments, as shown in FIG. 22 , the slots 254 can be arranged so that they do not extend radially relative to the center point 256. For example, the slots 254 can each extend at a common angle relative to the radial direction. In such embodiments, the slots 254 can be equally spaced around the upper surface 250 and each can be the same length. In other embodiments, the slots 254 do not all extend at a common angle relative to the radial direction. At least one (and perhaps all) of the slots 254 can be arranged at a different angle relative to the radial direction. In some embodiments, the slots 254 can be relatively short, arranged around the periphery 340 of the upper surface 250, and located within an outer region of the upper surface 250 (see, e.g., FIG. 21A ). In other embodiments, the slots 254 can extend across the outer and middle regions of the upper surface 250 (see, e.g., FIG. 21B ). In still other embodiments, the slots 254 can extend from the outer region of the upper surface 250 into the central region of the upper surface 250 (see, e.g., FIG. 21C ). The angled slot 254 can help reduce the amount of pressure required to transition the delivery device 10 from the storage state to the delivery state. Positioning the slot 254 at a more acute angle relative to the radial direction can generally reduce this pressure. The width of the slot 254 can decrease slightly during at least a portion of the transition from the storage state to the delivery state.

[0229] In other embodiments, as shown primarily in FIG. 21E , at least one of the slots 254 may have a curvature. The curvature can be defined by a constant or variable radius. The curvature may exist only on a segment of the slot 254. In alternative embodiments, the slot 254 may include two or more sections that are angled relative to one another. In the exemplary embodiment shown in FIG. 1 , FIG. 21E shows four curved slots 254, 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 initially oriented to extend from the first end 258 in a first direction and then curve as it extends in a slot-like second direction. The second direction may be closer to (or even perpendicular to) the radial direction than the first direction.

[0230] 21D and 21F, the top surface may not include slots 254, but may instead include at least one aperture 255. In the illustrated example, aperture 255 is centrally located within top surface 250. In some embodiments, aperture 255 can surround substantially the entire top surface 250.

[0231] 21D and 21F, slots 254 may be included in other regions of body 20. In the exemplary embodiment, the region of body 20 that will become support structure 252 (when body 20 is thermoformed) includes slots 254. These slots 254 may be straight, curved, angled (in terms of the radial dimension), or a combination thereof, similar to the patterns of slots 254 in the various top surfaces 250 described herein. As shown, slots 254 are spaced at regular angular intervals and are spaced between petal members 42 of body 20.

[0232] In yet other embodiments, the width of one or more slots 254 may vary over the length of the slot 254. Some embodiments including variable-width slots 254 are shown in FIGS. 21G-21I. The slots 254 may vary continuously in width or may terminate in pointed first or second ends 258, 260. The variable-width slots 254 may extend radially, but not necessarily in all embodiments. In an exemplary embodiment, each of the slots 254 is widest proximate a center point 256 of the upper surface 250 and decreases continuously in width as the slot 254 extends distally toward the periphery 340 of the upper surface 250. The upper 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 continuously in width from one end to the other.

[0233] As shown in FIG. 22 , the central region 28 can be monolithically formed with the petal members 42, including the areas 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 can extend upward from the petal members 42 at an angle of 90° or greater, e.g., 100-105°, although the angle need not be limited to a certain range. The vertical distance from the base 262 of the support structure 252 to the periphery 340 of the top surface 250 can be long enough to provide a receptacle for the reservoir 12 (see, e.g., FIG. 60 ) in the central region 28, and in some embodiments, an optional packet 208 and / or container 350 (see, e.g., FIGS. 10A-11 ), spring, or foam adhesive material. The receptacle can also be sized to accommodate part of the actuation assembly or dispensing assembly 480 (see, e.g., FIG. 34 ). As described in more detail elsewhere herein, the packet 208 can include a gas bladder, butane packet, or delivery force supply packet, and any associated containers 350, such as those described above with respect to FIGS. 10A-11. In some embodiments, the aforementioned distance can be approximately 0.3 inches (e.g., 0.315 inches). The slots 36 can extend from the periphery 38 of the delivery device 10 to the base 262 of the support structure 252, but can terminate at the base 262 and not extend into the support structure 252 itself. In such embodiments, 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 can evertate and assume a concave shape in the delivery state. In some embodiments, the support structure 252 can include fenestrations 264 evenly spaced around the base 262. The fenestrations 264 can facilitate manufacturing of the delivery device 10 in embodiments in which the body 20 is thermoformed.

[0234] 23 , at least one of the petal members 42 may be made with an extended length so that the outer end of the petal member 42 can be manipulated by the patient or healthcare provider as a pull tab 266. The pull tab 266 can be grasped by the user to remove the delivery device 10 from the skin after use. The pull tab 266 can be 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 petal member 42. The second end may be attached to or integrally formed with petal member 42 by injection molding or other known techniques that allow pull tab 266 to be sufficiently lifted above the skin surface for a user to hold it.

[0235] As shown in FIG. 24 , the pull tab 266 can also serve to facilitate a user peeling 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 can be removed in the same manner as a release liner is peeled from 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 from the adhesive 22.

[0236] 25-26 and 28A-28B, in some embodiments, 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 base 262 to periphery 340 of top surface 250 may be relatively short. In some embodiments, said distance may be approximately 0.15 inches.

[0237] Additionally or alternatively, the peripheral region 30 does not have to be a substantially flat, annular shape. The peripheral region 30 may be defined by downwardly extending, curved petals 42 such that the periphery 38 is positioned away from the plane of the base 262 of the support structure 252 (e.g., approximately the same as or less than the distance from the base 262 to the periphery 340 of the upper surface 250). The periphery 38 may be positioned along a plane more distal to the periphery 340 of the upper surface 250 than to the base 262. In FIG. 25 , the delivery device 10 is shown in a stored state. The delivery device 10 may include slots 36 that may be positioned 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.

[0238] Referring to FIG. 26 , 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 forming 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 delivery device embodiments described herein. The reservoir assembly 12 and the ridge 290 are further described elsewhere herein.

[0239] Referring primarily to FIGS. 28A-28B, two conceptual representations of a 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 adhesive 22 and pressure is applied to the delivery device 10 from above, for example, by a user's fingertips, the delivery device 10 may transition to the delivery state. When the petals 42 are pressed against the surface of the skin, they may splay outward and displace, causing at least a portion of the petals 42 to curl upward 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 adhesive 22 (shown only in FIG. 28A ), move away from each other or splay outward and displace. As 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 tighter radius of curvature. Upon reaching the delivery state, 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, in such embodiments, may also be referred to as the lowest point. In such embodiments, the lowest point 360 may be in a plane more distal to the periphery 340 of the upper surface 250 than the base 262. From the inflection point 360, the petal members 42 may curve back upward to increasingly approach the plane in which the periphery 340 of the upper surface 250 is located. The periphery 38 of the petal members 42 may, for example, be located in the plane of the base 262 or at a point thereon (closer to the plane of the periphery 340 of the upper surface 250). The petal members 42 each have a constant radius of curvature from the inflection point 360 to the periphery 38. A constant radius of curvature returning upward can enhance the ability of the petal members 42 to curl upward. This may promote 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.

[0240] In some non-limiting examples, the delivery device 10, when in a storage state, can have the dimensions and radii of curvature shown in Figures 27A-27B. 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.

[0241] 25-26 and 28A-28B, in some embodiments, the support structure 252 may not include the fenestrations 264 (see, for example, FIG. 19) evenly spaced around 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 a single, 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 composed of 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 its ability to adhere to the adhesive 22. Materials may be selected that achieve both of these objectives to the desired degree. These materials may be used for any of the bodies 20 described herein.

[0242] As further shown in FIGS. 25-26 and 28A-28B, 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. In various embodiments, the slots 254 may be notches, openings, holes, apertures, or voids. Each first end point 258 of the slots 254 may surround an area that includes the center point 256 of the top surface 250, and each second end point 260 may terminate at a distance from the periphery 340 of the top surface 250 (e.g., each slot 254 may terminate at the same distance). In certain embodiments, the slots 254 may be disposed at regular angular increments and may each be of equal length (although this need not be the case in all embodiments).

[0243] 25-26 and 28A and 28B, as described above with reference to FIG. 22, in alternative embodiments, the slots 254 may be positioned so 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 may each 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.

[0244] Referring now primarily to Figures 29-33, several diagrams of conceptual representations of the delivery device 10 in a delivery state are shown. As described above (and with reference to the embodiment of Figures 12-20), the delivery device 10 can transition from a storage state to a 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 can 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 can then press the upper surface 250 downward (i.e., toward the skin). This causes the petals 42 to splay outward, displace, and curl upward (at least partially), stretching 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.

[0245] In various embodiments, certain regions of the body 20 of the delivery device 10 may remain stationary or may not evertip. Thus, the body 20 may include everting regions and elastic regions. While described as elastic regions, it should be understood that some bending or deformation may still occur when pressure is applied. However, these regions may appear generally similar or extend / protrude in generally the same direction in both the storage and delivery states. As shown, the peripheral region 30 and top surface 250 may evertip, 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, for example, Figures 19 or 25) 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.

[0246] As further shown in FIGS. 29-33, 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 FIGS. 47-61B). The reservoir 12 may be compressed and / or at least partially collapsed to deliver the agent contained therein when the delivery device 10 transitions to the delivery state. The user can then remove the delivery device 10 from the skin. The slots 254 can assist the delivery device 10 in transitioning from the storage state to the delivery state under reduced pressure from above. The fenestrations 34 can also facilitate the transition. As described above with reference to the embodiment of FIGS. 12-20, the central region 28 may provide space for the reservoir 12 and the sharp support 26 (see additional discussion with reference to the embodiment of FIGS. 12-20 and 47-61B). In some embodiments, a packet 208 and / or a container 350 (see, e.g., FIGS. 10A-11) and / or a foam adhesive material may also be contained within the central region 28. As described in more detail elsewhere herein, packet 208 includes a gas bladder, butane packet, or delivery force supply packet and any associated container 350 as described above with respect to Figures 10A-11. In some examples, one or more petal members 42 may be constructed to incorporate a pull tab (not shown in Figures 29-33), such as pull tab 266 described above with reference to Figure 23.

[0247] 34 , 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 push body 472 that can be coupled to 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.

[0248] In some such embodiments, the biasing member 470 may be in an unstressed state when the associated delivery device 10 is in the storage state. User 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, thereby displacing the push body 472 toward the reservoir 12. The push body 472 may include an engagement mechanism (e.g., a catch or detent) that can engage with a retention mechanism (e.g., defined on the body 20) of the delivery device 10 to retain 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. The return of the biasing member 470 biases the reservoir interface member 474 of the dispensing assembly 480 against the reservoir 12, collapsing the reservoir 12 and allowing fluid to be pumped into the patient. Thus, for example, pressure can be applied to reservoir 12 for a period of time sufficient to completely deliver the contents of reservoir 12 (eg, 5 minutes in certain embodiments) without sustained manual pressure on delivery device 10.

[0249] In other embodiments, the biasing member 470 may be in a stressed state when the associated delivery device 10 is in a storage 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) and 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 with the body 20 when the delivery device 10 is in the storage 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 returns to an unstressed, or at least less stressed, state and may drive the reservoir interface member 474 of the dispensing assembly 480 against the reservoir 12. This causes the reservoir 12 to collapse and the fluid to be expelled from the reservoir 12 into the patient's body.

[0250] 35-36 , a representative example of a delivery device 10 including a biasing member 470 in an unstressed 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, extending 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 the opening in the body 20 during assembly. Opposite the tapered or rounded portion, the head 478 may define a step or ledge. The ledge on the head 478 may limit the displacement of the elongated member 476 because the ledge cannot easily pass back through the opening in the body 20. The end of the elongate member 476 opposite the head 478 can be coupled to one or more biasing members 470. The reservoir interface member 474 can 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 can be used. In alternative embodiments, other biasing members 470 (e.g., resilient foam, coil springs, air bladders, etc.) can be used.

[0251] 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, which may stress the biasing member 470. As shown, the elongate member 476 includes a detent or notch 482. The notch 482 can engage with the body 20 to hold the elongate member 476 in a depressed position. The engagement of the notch 482 with the body 20 can also serve to indicate that the delivery device 10 has been used.

[0252] With the elongate member 476 held in place, returning the biasing member 470 to its unstressed state can 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. Note that in various examples, at least some portions of the body 20 can be displaced and / or inverted extensively as the delivery device 10 transitions to the delivery state (see, e.g., FIG. 29 ). This is not shown in FIGS. 35 and 36 for ease of illustration.

[0253] 37 and 38 , in certain embodiments, the delivery device 10 can include a biasing member 470 that is in a stressed state while the delivery device 10 is in a storage state. Referring to FIG. 38 , the biasing member 470 (shown in an unstressed state) can include an outer enclosure 490. The outer enclosure 490 can be, for example, annular in shape, although any suitable shape can be used. A number of biasing protrusions 492 can extend from the outer enclosure 490 toward the center of the biasing member 470. The biasing protrusions 492 can extend radially inward from the outer enclosure 490 toward the center of the biasing member 470. In an exemplary embodiment, the biasing protrusions 492 can be spaced at equal angular increments, although this need not be the case in all embodiments. The outer enclosure 490 can be constructed of any suitable material and, in some examples, can be constructed of a resilient plastic or spring steel.

[0254] The body 20 of the delivery device 10 may include multiple passages 494 extending therethrough. The passages 494 may be disposed within the support structure 252 of the body 20. The spacing between the passages 494 may correspond to the spacing between 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. 25 ).

[0255] 39-41 , the delivery device 10 can 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 can be rotatably displaceable within an opening 496 in the main body 20. The opening 496 can be located on the upper surface 250 of the main body 20, as shown in FIG. 39 , for example. The push body 472 can be rotated from a position or range of positions that restricts translational displacement (e.g., see FIG. 39 ) to a position or range of positions that allows translational displacement (e.g., see FIG. 38 ). In the translational displacement-restricting position, a retaining element of the push body 472 can engage with a cooperating lock defined on the main body 20. In the translational displacement-allowing position, the retaining element of the push body 472 can disengage from the lock on the main body 20.

[0256] As best shown in FIG. 41 , the exemplary pusher 472 includes a stem 500 extending 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 the exemplary embodiment, the cross-sectional shape of the stem is oval. In other examples, other cross-sectional shapes may be used. The notch 498 may be positioned to be recessed into the widest portion of the stem 500. The opening 496 (see, e.g., FIG. 37 ) may have a shape corresponding 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 pusher 472 can rotate within the opening 496 when flush with the wall of the body 20 in which the opening 496 is formed.

[0257] The push body 472 is shown in a translation-limiting position in FIG. 39 . In such a position, the rotation 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 region of the body 20 adjacent the opening 496 may function as a lock for the push body 472. When the push body 472 is rotated to a translation-permitting position, as shown in FIG. 40 , the rotation of the push body 472 may be such that it can translate within a correspondingly shaped opening 496 in the body.

[0258] 42 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 protrusion 492 of the biasing member 470 can press against the enlarged portion 502, capturing or coupling the enlarged portion therein. Furthermore, the biasing member 470 can be substantially restrained from displacement as a whole because the biasing protrusion can be fed through a passage 494 in the body 20. If the biasing member 470 is constrained in place, the biasing protrusion 492 can deflect and become stressed when the depressor body 472 is lifted. When the push body 472 is lifted so 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-limited position (see, for example, FIG. 39 ). Thus, the biasing member 470 can be held in a stressed state.

[0259] During actuation of the associated delivery device 10 from the storage state to the delivery state, the push body 472 can 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 can translate the push body 472. When the biasing member 470 returns to a less stressed state, the reservoir interface member 474 is driven against the reservoir 12, forcing fluid out of the reservoir 12 and into the patient. The amount of the push body 472 that protrudes from the body 20 can change as the biasing member 470 returns to a less stressed state. Thus, the amount of the push body 472 extending from the body 20 can serve as an indicator that the delivery device 10 has been used.

[0260] 44A-44D, in some examples, a biasing member 470 for a delivery device 10 may be entirely within the delivery device 10. Additionally, the push body 472 may not latch or engage with 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. 41 ), which may engage with the stop member 473 instead of the body 20. As shown in FIG. 44B, 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′.

[0261] The stop member 473 can be rotated from a translation-restricted position to a translation-allowed position, allowing free translation. In the translation-restricted position, the opening 496′ can be positioned 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-allowed 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 the 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 through interaction with a user's fingers.

[0262] As primarily shown in FIGS. 44C and 44D , the biasing member 470 may be a conical spring. When the delivery device 10 is in a storage state and the stop member 473 is in a translation-limiting position, the conical spring may be under stress (e.g., in a compressed state). When the stop member 473 is moved to the translation-allowing position, the biasing member 470 is free to drive the displacement of the push body 472 relative to the reservoir 12, as described above with respect to FIGS. 42-43 . When the push body 472 is displaced by relaxation of the biasing member 470, the stem 500 of the push body 472 can pass completely through the opening 496′ of the stop member 473. Thus, the stop member 473 can be separated from the rest of the delivery device 10. The push body 472 can also be moved to a position where the recess 475 is located within the delivery device 10. Thus, the stop member 473 can be prevented from reconnecting to the push body 472. When the delivery device 10 is observed without the stop member 473, it provides a visual indication that the particular delivery device 10 has already been used. Thus, the stop member 473 may also function as a communicating indicator that the particular delivery device 10 is ready for use.

[0263] Referring now to FIG. 45, 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 may also include one or more biasing members 470. The one or more biasing members 470 may form the entire dispensing assembly 480. Additionally, the biasing members 470 may directly contact the reservoirs 12 and help apply pressure to the reservoirs 12 to deliver fluid therefrom. In certain examples, a reservoir interface member 474 (see, e.g., FIG. 34 ) may be included. If included, the reservoir interface member 474 may be (but is not necessarily) formed as part of or integral with the at least one biasing member 470. The reservoir interface member 474 may directly contact the reservoirs 12. The at least one biasing member 470 may be or include a spring, a compression spring, a conical spring, a resilient foam, an air bladder, any other suitable biasing member, or some combination thereof.

[0264] As further shown in FIG. 45 , when the associated delivery device 10 is in a storage state, the biasing member 470 can be in an unstressed state. The biasing member 470 may not exert pressure on the reservoir 12 in the storage state. 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., by 0.05 to 2 mm). When the delivery device 10 is in use, the delivery device 10 can transition to a delivery state, as described elsewhere herein. Similar to various embodiments described herein, transitioning to the delivery state can result in at least a portion of the delivery device 10 being at least partially inverted. For example, at least the domed upper surface 250 of the central region 28 can be inverted or partially inverted. The distance between the reservoir 12 and the inverted upper surface 250 in the delivery state can be shorter than the distance between the reservoir 12 and the upper surface 250 in the storage state. This results in a bias being built up within the biasing member 470. In one example, the at least one biasing member 470 may be compressed when the upper surface 250 is inverted. Furthermore, when the at least one biasing member 470 is spaced apart from the reservoir 12 in the storage 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 upper 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, the at least one biasing member (and / or the reservoir interface member 474, if included) may press against the reservoir 12, collapsing the reservoir 12 and pumping fluid into the patient. Thus, for example, pressure may be maintained on the reservoir 12 for a period of time (e.g., 5 minutes in certain embodiments) sufficient to completely deliver the contents of the reservoir 12, even without sustained manual pressure on the delivery device 10.

[0265] 46A-46B, an exemplary embodiment of the body 20 and the body 20 with a biasing member 470 are shown, respectively. FIG. 46A shows a bottom view of the body 20. FIG. 46B shows a perspective view of the body 20 and the biasing member 470. The body 20 is shown inverted top view for illustrative purposes. As shown, the body 20 can include multiple positioning protrusions 471. There can be one set of positioning protrusions 471 located in a central region of the upper surface 250. A second set of positioning protrusions 471 can be spaced outward from the central region. In an exemplary embodiment, the second set of positioning protrusions 471 extend from the upper 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 positioned within 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 positioned, the ends of the biasing member 470 adjacent the upper surface 250 can be heat staked (see, e.g., FIG. 46C ). Once the delivery device 10 is fully assembled, heat stakes can hold the biasing member 470 in place relative to the body 20. As a result, the biasing member 470 can be kept 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 so that the biasing member 470 is compressed substantially along the axis of the biasing member 470.

[0266] As shown in FIG. 46C , 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 axis of the biasing member 470. In the example shown in FIG. 46C , four guide bodies 477 are included and spaced at equal angular increments. In other embodiments, the number of guide bodies 477 may vary and / or the guide bodies 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.

[0267] Further referring to FIGS. 46A-C, if the biasing member 470 is a compression spring, the terminal end 481 of the biasing member 470 can form the reservoir interface member 474. The terminal end 481 of the biasing member 470 can be wired in a manner that helps distribute pressure more evenly. The terminal end 481 of the biasing member 470 can be wired in a direction or desired pattern. The terminal end 481 can also be positioned substantially in the same plane as or adjacent to the end of the biasing member 470. As shown in FIG. 46B, the coil terminal end 481 is bent to extend between opposing points on the biasing member 470. In this example, the terminal end 481 extends approximately diametrically across the end of the biasing member 470 proximal to the reservoir 12. In some embodiments, the terminal end 481 of the biasing member 470 can be wired in a spiral or other pattern (see, for example, FIG. 46C).

[0268] In some embodiments, as shown in FIGS. 47-50 (which are top, side, bottom, and bottom perspective views, respectively, of the application surface of the delivery device 10, such as the skin surface), an exemplary holder 270 for a sharps bearing 26 (see, e.g., FIG. 31 ) including a delivery sharps 72 (see, e.g., FIG. 31 ) 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 an outer perimeter. The inner edge of the annular portion 272 may coincide with the outer perimeter of the rounded recess 274. When the delivery device 10 incorporating the holder 270 is applied to a user's skin surface, the rounded recess 274 extends below the plane of the annular portion 272 (see FIG. 48 ).

[0269] The rounded recess 274 can include a pocket 276 formed therein. The pocket 276 can be formed on the proximal surface of the holder 270. The pocket 276 can be located at the center of the rounded recess 274 and at its lowest point (with respect to the skin surface when the delivery device 10 is secured to the skin surface). The pocket 276 can be sized to fit over and receive a sharps bearing 26 having a delivery sharp 72 thereon, such as the sharps bearing 26 including the delivery sharp 72 of FIG. 31 . The sharps bearing 26 including the delivery sharp 72 can be fitted into the pocket 276 by, for example, injection molding or adhesive. The holder 270 can be overmolded around the sharps bearing 26 to bond the components together. In various embodiments, the delivery device 10 can be positioned so that pressure from above (e.g., from a finger) on the delivery device 10 can be evenly distributed throughout the 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.

[0270] In an exemplary embodiment, the width (e.g., diameter) of the holder 270 may be approximately 0.7 inches (e.g., 0.744 inches). The footprint of the exemplary holder 270 may be approximately 0.45 square inches (e.g., 0.44 square inches). The holder 270 may be manufactured by any technique known to those skilled in the art, including, for example, injection molding or thermoforming.

[0271] Another exemplary holder 270 is shown in FIGS. 51A-51C. As shown, the holder 270 can include a disk body 275. The disk body 275 can be substantially flat and include multiple circumferentially spaced tab protrusions 277. The tab protrusions 277 can be symmetrically spaced about the disk body 275 or can be spaced at regular angular intervals, as shown in FIGS. 51A-51C. In alternative embodiments, the tab protrusions 277 can be asymmetrically spaced about the base or at irregular angular intervals. The tab protrusions 277 can engage with receiving slits 278 (see, e.g., FIG. 44A) located within the body 20 of the delivery device 10. The tab protrusions 277 can thus be used to couple the holder 270 in a predetermined position in the delivery device 10. Asymmetric or irregularly spaced tab protrusions 277 can allow the holder 270 to be coupled to the body 20 in a desired predetermined orientation in some instances.

[0272] 51A-51C, the holder 270 can include at least one stage protrusion 279. The stage protrusion 279 can be included in addition to or instead of the rounded recess 272 and spherical segment of the embodiment described above in connection with FIGS. 47-50. The stage protrusion 279 can provide a well 281 on the distal side of the disk body 277. The stage protrusion 279 can extend proximally from the disk body 277 by a height that, in certain instances, can be at least equal to the height of the microneedles 277 of the delivery device 10. The stage protrusion 279 can extend generally at a perpendicular angle from the disk. The sidewalls 283 of the stage protrusion 279 can be chamfered to extend in a non-perpendicular direction relative to the proximal surface of the disk body 279. The stage protrusion 279 can include a pocket 276. The pocket 276 can be sized to fit and receive the sharp bearing 26 with the delivery sharp 72, as described elsewhere herein.

[0273] 52A-52D, in some embodiments, the pocket 276 of the stage protrusion 279 may be oriented non-parallel to the plane of the disk body 275. In FIG. 52D, when the sharps support 26 is attached to the pocket 276, the orientation of the pocket 276 can ensure that the delivery sharps 72 (e.g., microneedles) extend at a predetermined angle relative to the disk body 275. In an exemplary embodiment, the pocket 276 can be oriented such that the delivery sharps 72 extend at an angle of 10-20° (e.g., 15°) relative to the plane of 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 can be used. In alternative embodiments, the entire stage protrusion 279 can protrude from the disk body 275 at a desired angle. Thus, the delivery sharps 72 can extend at that angle when coupled to the pocket 276.

[0274] In some embodiments, reservoir portion 271 is shown as shown in FIGS. 53-56 (side view, top view, top-down perspective view, and bottom perspective view, respectively, relative to the application surface of delivery device 10, e.g., the skin surface). Reservoir portion 271 can be shaped to incorporate dome-shaped portion 280, tunnel or gutter 282, and 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, dome-shaped portion 280 can be shaped approximately like a hemisphere or other spherical segment, although any other suitable shape is possible. In examples where reservoir portion 271 includes a rounded shape forming a cavity (e.g., dome-shaped portion 280), the distal-most portion of the rounded shape of flange 284 can include a plateau or flat surface. The flat surface can be generally parallel to 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, which 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 dome-shaped portion 280 via an arch 286, such that the combination of the dome-shaped portion 280 and the tunnel 282 forms an approximately igloo-shaped structure. In some embodiments, the end of the tunnel 282 opposite the dome-shaped portion 280 may be flared or tapered to enhance ease of filling. The annular portion 284 may have an inner edge that coincides with the base perimeter 288 of the dome-shaped 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 can be formed of a polycarbonate material or other suitable material and can be coated with a cyclic olefin polymer (COP) or other suitable coating material. The dome-shaped portion 280 can collapse when pressure is applied.

[0275] Referring now to FIG. 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 so that dead volume is minimized. Similarly, the inclusion of a collapse promoter can help reduce the likelihood 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 cavity collapse. Other reservoirs 12 described herein may include at least one collapse promoter.

[0276] The collapse promoter may be a pleated, bellows-like, accordion-like, wrinkled, 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 upper wall 263 may span the portion of the wall 261 most distal to the flange 284. Thus, the wall 261 and the upper wall 263 may together form a cavity within the reservoir portion 271. The upper wall 263 may be substantially planar and, in certain examples, extend parallel to the flange 284. The upper wall 263, in certain examples, may include a central recess 267. The central recess 267 may function to aid in positioning the reservoir interface member 474 (see, e.g., FIG. 34) or a portion of the biasing members 470, 481 (see, e.g., FIGS. 35 and 46B, 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 substantially circular, circular, oval, elliptical, oval, or polygonal cross-section.

[0277] While any pleat, bellows, accordion, fold, or ruffle 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 with increasing distance from the flange 284, 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 to aid in cavity collapse while fluid is expelled from the reservoir 12 during operation of the delivery device 10. Thus, minimal force is required to deform and deplete such a reservoir 12 during use. Furthermore, such pleats 269 can help ensure that a small amount of dead volume remains within the reservoir 12 after delivery is complete. The use of a flat top wall 263 can also aid in cavity collapse.

[0278] As shown here in Figure 58, wall 261 is stepped and can include at least one step region 259. The cross-sectional area of ​​the cavity can vary at each step region 259. In this example, the cross-sectional area of ​​the cavity is greatest adjacent the flange and decreases in a stepwise manner as the distance from flange 284 increases. In the example shown in Figure 58, wall 261 includes two step regions 259, although alternative embodiments can include any suitable number. As in the previous example, the stepped wall 261 helps to lower the force required to collapse the cavity and helps to direct the collapse in a predetermined manner.

[0279] In one embodiment, the reservoir 12 may be formed by attaching a reservoir portion 271 to a 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 region 285 of the annular portion 284 may be secured to the disk body 275 or the annular portion 272 or the upper surface region 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 joining 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 example, the use of ultraviolet-curable adhesives, heat staking, and laser welding.

[0280] 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 sonic welding or any other suitable technique described herein. A sharps bearing 26 (see, e.g., FIG. 31 ) containing a delivery sharp 72 (see, e.g., FIG. 31 ) can be inserted into pocket 276 and secured therein by any suitable technique, such as welding, prior to inserting the agent (e.g., vaccine) into reservoir 12. Alternatively, as described above, holder 270 can be formed around sharps bearing 26. As noted elsewhere herein, delivery sharps 72 can be one or more microneedles in various examples.

[0281] 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 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, once the reservoir 12 is installed, a dispensing assembly 480 (see, e.g., FIG. 34) or at least one biasing member 470 (see, e.g., FIG. 45) may be positioned between the underside of the upper surface 250 and the reservoir 12.

[0282] 60, a reservoir 12 (e.g., a reservoir 12 as described above with reference to FIG. 59) can be secured inside the delivery device 10. While a representative example of a delivery device 10 is shown, the reservoir 12 can similarly be attached to the body 20 of any of the delivery device 10 embodiments described herein. The reservoir 12 can contain a drug (e.g., a vaccine) before being assembled into the delivery device 10. The reservoir 12 can be removed from refrigerated storage before being attached inside the body 20 of the delivery device 10.

[0283] Referring to FIG. 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 can serve as a seating structure onto which or against which a section or region of the reservoir 12 is placed or coupled. 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 coupling 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 coupled to the ridge 290 on the body 20 of the delivery device 10, for example, as shown in FIG. 26 . Alternatively or additionally, a tab protrusion 277 (see, e.g., FIG. 51A ) may be used that couples to a receiving slit 278 (see, e.g., FIG. 44A ) defined in the body 20.

[0284] 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-like shape (as shown in FIGS. 61A-61B), a cylindrical shape, a polygonal prism shape, or the like. The height of the reservoir portion 271 can be adjusted as follows: Given a preselected maximum cross-sectional area, a desired internal volume is achieved. 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 during delivery.

[0285] As shown in FIG. 61B, the body 20 can include a nesting protrusion 287. When the delivery device 10 transitions to the delivery state (see, for example, FIG. 29 ), the nesting protrusion 287 can press against the reservoir portion 271. As delivery progresses, the nesting protrusion 287 can press the reservoir portion 271 against at least one buttress 289. In an exemplary embodiment, the nesting protrusion 287 can be positioned between the exemplary buttresses 289 and can help ensure minimal dead space remains within the reservoir 12 after delivery is complete.

[0286] Referring 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 to begin fluid injection 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 delivery device 10 design. Furthermore, once injection has begun, it may be desirable for the delivery pressure to be maintained at or near the delivery start pressure. Further, referring 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.

[0287] Referring 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 each other via a flow restrictor 524. 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, in certain embodiments, be an orifice plate having one or more orifices extending therethrough. In some embodiments, the flow restrictor 524 may include an orifice having a diameter of 15-25 microns. 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 greater than 100 microns. The size of the orifice may be selected based on considerations such as the viscosity and / or surface tension of the agent being loaded into the reservoir, the desired injection rate, and how quickly the injection pressure is desired to increase. The orifice plate may be an injection molded part, but may also be formed in other suitable ways.

[0288] As further shown in FIG. 62 , the first portion 520 of the reservoir 12 can comprise a majority of the reservoir 12. The second portion 522 of the reservoir 12 can be disposed proximal to the delivery sharp 72 relative to the first portion 520. A flow restrictor 524 can separate the larger first portion 520 from the smaller second portion 522, which is most proximal to the delivery sharp 72. The first portion 520 can, in certain examples, have a volume substantially equal to the fill volume of the reservoir 12. The flow restrictor 524 can be disposed upstream of at least the pocket 276 (see, e.g., FIGS. 47-51C ) to which the sharp bearing 26 can be coupled. In an exemplary embodiment, the flow restrictor 524 can separate the rounded recess 274 (see, e.g., FIGS. 47-50 ) from the remainder of the reservoir 12. In such an embodiment, the flow restrictor 524 can be coupled to the distal surface of the reservoir 12 above the rounded recess 274. In other examples, the flow restrictor 524 can separate the well 281 (see, e.g., FIGS. 51A-51C) from the rest of the reservoir 12. In such embodiments, the flow restrictor 524 can be coupled to a distal surface of the disk body 275 on the well 281 (see, e.g., FIGS. 51A-51C).

[0289] In certain examples, the first and second portions 520, 522 of the divided reservoir 12 may be filled with different fluids. For example, the first portion 520 may be filled with a desired agent (e.g., a drug, vaccine, medical agent, etc.) 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, an inert gas, etc.). The orifice may be sized such that the agent's properties (e.g., surface tension, viscosity) prevent the agent from passing to the second portion 522 without applying pressure to the reservoir 12. Despite the first and second portions 520, 522 being 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 within the second portion 522 may then build up 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).

[0290] When a delivery device 10 including a divided reservoir 12 transitions to a delivery state, pressure may be applied to the first portion 520 of the reservoir 12 by at least one biasing member 470 (e.g., a conical spring). 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. 34) or other component of the delivery assembly 280 (see, e.g., FIG. 34). 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 can then limit the increase in pressure within the second portion 522 as the injection progresses. Thus, the injection tends to occur at or near the lowest pressure at which the patient will accept delivery. This can facilitate the use of a stronger spring, potentially reducing discomfort associated with delivery. Furthermore, it allows a single delivery device 10 design to be used for a broad range of patient populations (e.g., any patient) or with a wide variety of different medications. This can also affect blebbing due to delivery. Because delivery tends to occur relatively slowly and at relatively low pressures, a more diffuse, shallow (e.g., intradermal) injection tends to result. Adjusting the size of any orifice within the flow restrictor 524 can alter the duration of delivery and bleb characteristics.

[0291] 63A-63C, 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 may leave certain petal members 42 devoid of adhesive. As shown, each adhesive member 22 may include multiple slits 43 extending radially inward from the periphery of the adhesive member 22 to form petal portions that align with the petal members 42 of the main 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.

[0292] 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 specific shallow deliveries or shallow delivery to skin with specific 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 that allows at least a portion of the adhesive member 22 to be 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 be in the range of 0.13 square inches to 0.5 square inches (e.g., approximately 0.3 square inches).

[0293] Additionally, it may be desirable for the central opening 49 to be wider in certain directions relative to other directions. For example, each delivery sharp 72 (e.g., one or more microneedles) may tend to distribute fluid in an ejection direction extending from the outlet of the respective delivery sharp 72 (e.g., along the axis of the lumen of the 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 a relatively wider portion) of the central opening 49 may be along a direction parallel to a plane containing 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.

[0294] Referring now primarily to FIG. 63A , the central opening 49 may be a generally round (e.g., circular) opening, except for numerous inwardly extending teeth or spokes 51 in 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. While the central opening 49 can have a relatively large width in this direction, this does not preclude other wide regions of equal, narrower, or possibly wider widths. In the illustrated example, the central opening 49 has approximately the same width as measured perpendicular to the anterior-posterior direction of the microneedle. In certain examples, the spokes 51 can aid in attachment to a holder 270 or other rigid reservoir 12 portion. This can, for example, provide a robust attachment of the adhesive member 22 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 .

[0295] 63B-C, in certain examples, central opening 49 may include a notch 53 extending outward from the periphery of the remainder of central opening 49. Notch 53 may be included to widen central opening 49 if desired. While this example includes a rectangular notch 53, in alternative embodiments, the notch may be shaped differently. Notch 53 may be any suitable polygonal shape, or may be circular, for example.

[0296] 64A and 64B, 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 bearing 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 the exemplary embodiment, the body 20 includes multiple living hinges 50 that are integrally formed with the remainder of the body 20. Each living hinge 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.

[0297] 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 end panels 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 the 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 .

[0298] 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 the end of the raised protrusion 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 connection 60 between the end panels 52A, D.

[0299] As shown in FIGS. 65A-65C, the connector 60 may be displaceable through a raised position (see FIG. 65A), a centered position (see FIG. 65B), and then to a center-over-center position (see FIG. 65C). The connector 60 may be in the raised position when the delivery device 10 is in a storage state. In the raised position, the intermediate panel 52B connected to the raised protrusion 56 may extend from the raised protrusion 56 at an angle 62 (angles 62, 64, 66) measured between the proximal surfaces 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 protrusion 56 increases. In the illustrated example, the angle 62 is an obtuse angle when the connector 60 is in the raised position. The intermediate panels 52B, 52C may be disposed at an angle 64 relative 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.

[0300] The delivery device 10 can be applied to the skin 44 over the injection site in a storage state with the connector 60 in the raised position. This secures the end panels 52A, D so that they are substantially constrained to the plane of the skin patch to which they are adhered. Applying downward pressure to the connector 60 can displace the connector 60 from the raised position toward the center position. As this occurs, the angle 64 between the two intermediate panels 52B, C can increase. The angle 62 between the raised protrusion 56 and the intermediate panel 52B and the angle 66 between the end panel 52D and the intermediate panel 52C can decrease. To accommodate the change in angle 64 between the two intermediate panels 52B, C, the end panels 52A, D can widen. When the connector 60 reaches the center position (see FIG. 65B), the angle 64 is 180° and the end panels 52A, D can be at their maximum distance from each other. The skin 44 can be stretched and taut as the end panels 52A, D are displaced apart.

[0301] As the connector 60 is further displaced, it may assume an over-center position. 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 connector 60 is displaced through the center position, it may automatically displace to an over-center position at the end of the connector 60's displacement range. Once the connector 60 is displaced to this over-center position, the delivery device 10 may transition to the delivery state. As the connector moves to the over-center position shown in FIG. 65C, 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 connector 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 approximately 90° (e.g., 80° to 110°). The angle 64 between the intermediate panels 52B, C may be a reflex angle. Thus, the link 60 can be partially inverted relative to its position in the raised position. The angle 66 between the middle panel 52C and the end panel 52D can be substantially 180°. As shown, when the link 60 reaches an over-center position at the end of its range of displacement, the proximal surface of the middle panel 52C can contact the skin 44.

[0302] When the delivery device 10 is in the delivery state (see FIG. 65C), 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. 65C) can be selected so that the delivery sharp 72 pierces the skin 44 at a predetermined angle (e.g., 45° to 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. 65C) to the length of the intermediate panel 52B within a desired range. When the delivery device 10 is in the delivery state, the reservoir 12 may be pressed against the skin 44 . This pressurizes the reservoir 12 and may 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.

[0303] In some embodiments, the proximal surface of the intermediate panel 52C may be at least partially covered with adhesive 22 (see, e.g., FIG. 65C). When the connector 60 reaches an over-center position at the end of its displacement range, the adhesive 22 can 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, 52D 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. As the flexure flexes, the connector 60 may snap through the center position into an over-center position, stopping the stretching of the skin 44. This may be desirable because it can help reduce potential discomfort during injection due to excessive tension on the skin 44. Similarly, this may be helpful in certain patient populations, as skin characteristics vary widely among potential patients.

[0304] In one embodiment, one of 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). Applying sufficient pressure to the biasing member may overcome the biasing member and cause the deflection. Thus, intermediate panels 52B, 52C may be formed to have a variable length that decreases when the force exceeds a predetermined threshold.

[0305] Intermediate panel 52C (although any intermediate panel 52B, 52C may include such a feature) may be implemented as or may include at least one lattice-structured flexure 290, as shown in FIGS. 66A-66B. Flexure 290 may be formed by injection molding. Intermediate panel 52C may include a first member 296 adjacent the connection of the living hinge 50 to the other intermediate panel 52B. 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 first member 296 to second member 298 of intermediate panel 52C. Second member 298 may be adjacent the connection of the living hinge 50 to end panel 52D. Second member 298 may be positioned parallel to and opposite 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 can be positioned substantially parallel to and extend between a respective pair of four support arms 300A-D. Each of the two arms 302A-B can 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 positioned on either side of the respective arm 302A-B. In this example, each of the two arms 302A, B is connected to a respective associated support arm 302A-B. For ease of illustration, only six of the twelve buttresses 304A-F are shown in FIG. 66A. Applying 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 in 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.

[0306] 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 can 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. 67A-67B, the exemplary flexure 292 may be generally 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 during the injection molding process that forms the body 20 of the delivery device 10.

[0307] In some embodiments, at least a portion of the body 20 can 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 if 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 can be irreversible, preventing reuse of the delivery device 10. In some examples, the adhesive 22 can be selected to bond more aggressively to the skin 44 than the material forming the body 20. Thus, the adhesive 22 can peel from the delivery device 10 upon removal of the delivery device 10. In embodiments described herein in which the adhesive 22 is peeled from the delivery device 10, the adhesive 22 may include a pull tab or similar mechanism to facilitate subsequent removal from the skin 44.

[0308] 68-69, 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 support 26 that includes a linear 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 can change from a first polygonal shape (e.g., hexagonal) to a second polygonal shape (e.g., rectangular) when the delivery device 10 transitions from a storage state to a delivery state.

[0309] The main body 20 may include first and second end blocks 70A, B. The end blocks 70A, B may be positioned opposite each other. The end blocks 70A, B may be spaced apart and connected to each other by a pair of side panels 71A, B and a bridge 76. Each of the side panels 71A, B may have a first end connected to the first end block 70A by a hinge 74A. Each of the side panels 71A, 71B may 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 positioned in an intermediate region of the side panel 71A, B between the first and second ends of each side panel 71A, B.

[0310] 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 and second ends of the bridge 76. The bridge 76 may include a panel body 78 and a pair of support members 80A, B. The support 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 support members 80A, B and extend toward the proximal faces of the end blocks 70A, B. In the exemplary embodiment, the arm member 82 extends from the end of the panel body 78 adjacent to the intermediate hinge 74F of the bridge 76. The reservoir 12 may be coupled to the proximal face of the arm member 82 at the end of the arm member 82 opposite the panel member 78 .

[0311] 68-69, 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 coupled together via hinges 74A-F. In yet other examples, body 20 may be comprised of at least two components. Instead of using hinges to couple the components, two or more components of body 20 may be coupled by welding, heat bonding, solvent bonding, etc.

[0312] 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 storage state (shown in FIGS. 68-69) and a delivery state. In the storage state, the side panels 71A, 71B of the delivery device 10 may be in an outwardly bent 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 bent position. 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 also occurs, allowing the side panels 71A, B to be positioned in the outwardly bent position.

[0313] A clamping force can be applied to the side panels 71A, 71B to push the side panels 71A, 71B toward each other, displacing the side panels 71A, 71B from an outwardly curved position to a straight position. Note that the straight position does not necessarily have to be a position in which the side panels 71A, 71B each extend along a straight line. In some examples, the straight position can be a position in which the side panels 71A, 71B are less outwardly curved than their outwardly curved positions.

[0314] The bridge 76 may also be displaceable through a range of displacement to transition the delivery device 10 between a storage state (shown in FIGS. 68-69) and a delivery state. In the storage state, the bridge 76 may be in a raised state in which at least the dispensing sharp portion 72 of the reservoir 12, coupled to the arm members 82, is positioned above the proximal faces of the endblocks 70A,B. The bridge 76 may be bent at the intermediate hinge 74F so that the panel body 78 and the posts 80A,B extend upward from the endblocks 70A,B and away from the proximal faces of the endblocks 70A,B. Some pivoting of the hinges 74D,E connecting the bridge 76 to the endblocks 70A,B and the posts 80A,B may also occur, allowing the bridge to assume the raised position. A force perpendicular to the proximal faces of the endblocks 70A,B can 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.

[0315] 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 bent state to a straight state can transition the delivery device 10 from the storage state to the delivery state. Because the bridge 76 and the side panels 71A, B are coupled to one another via the 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.

[0316] Whether actuation of the side panels 71A, B or the bridge 76 is used to transition the delivery device 10 may be up to the user. 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 applies more pressure to the arm members 82, which can aid in reliable penetration of the delivery sharp 72 into the skin. Therefore, 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.

[0317] As shown in FIGS. 70A-70C, when the side panels 71A, B are in an outwardly bent position and the bridge 76 is in a raised position (see FIG. 70A), 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 toward a lowered position (see FIGS. 70B-70C), 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 expansion of the end blocks 70A, B may stretch and taut the skin 44. This may help facilitate puncturing the skin 44 with the delivery sharp 72 contained in the reservoir 12. As shown in FIG. 70C, when the side panels 71A, B reach the straight position and the bridge 76 reaches the lowered position, the delivery sharp 72 punctures the skin 44, and the delivery device 10 may be in a delivery state. The reservoir 12 can 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 can collapse as delivery occurs.

[0318] Referring now to FIG. 71, which is a cross-sectional view of the delivery device 10 of FIGS. 68-69, in certain examples, 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 opening 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, 71B in a direction toward the opposite side panel 71A, 71B. In an exemplary embodiment, two iris panels 86A-D extend from each side panel 71A, 71B and are disposed on either side of the intermediate hinges 74C, 74D of each side panel 71A, 71B. As the side panels 71A, 71B are displaced from their outwardly bowed positions to their straight positions, the iris panels 86A-D adjust the opening 88 so that the opening provides an opening for the delivery sharp 72 of the reservoir 12 to pass through. As shown in FIG. 71, when the delivery device 10 is in a storage state, the opening 88 can be substantially closed. Such an iris assembly 84 may therefore function as a guard to help prevent inadvertent contact with the delivery sharps 72 during handling of the delivery device 10 .

[0319] In the 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 sloped. Thus, when the iris panels 86A and 86B are displaced toward each other, the iris panel 86B deflects and can ride up the sloped surface of the latch protrusion 90 (see, for example, FIG. 70B). When the latch catch 92 aligns with the latch protrusion 90, the iris panel 86B, including the latch catch 92, returns to its undeflected state, allowing the latch catch 92 to snap into engagement with the latch protrusion 90. This secures the delivery device 10 in the delivery state. The snapping action of the iris panels 86B can generate a tactile sensation perceptible, for example, through the user's fingertips. Alternatively or additionally, the snapping may produce 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, when the delivery device 10 is removed, the adhesive 22 can become detached from the delivery device 10. This can also help prevent reuse of the delivery device 10.

[0320] 72A-72B, another exemplary embodiment of a 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 storage state (see FIG. 72A) to a delivery state (see FIG. 72B). 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 examples, 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 can be engaged to retain 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 together when the delivery device 10 is transitioned to the storage state. Once the delivery device 10 is transitioned to the delivery state, breaking or releasing the coupling between the first portion 100 and the second portion 102 may require breaking a portion of the delivery device 10. This breaking may render the delivery device 10 inoperable. This not only prohibits reuse but may also provide a perceptible (e.g., visual) indication to the user that the delivery device 10 has been used.

[0321] The proximal surface of each of the first and second portions 100, 102 may be at least partially covered with adhesive 22. The adhesive 22 may function to bond the first and second portions 110, 102 to the skin surface at the 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 and facilitate puncture of the skin by at least one delivery sharp 72 of the reservoir 12 included in the delivery device 10.

[0322] Transitioning of the delivery device 10 to the delivery state may also cause the delivery sharp 72 to displace or descend proximally toward or into the skin. In embodiments in which 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 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 a target delivery destination within the patient's body. Additionally, in some embodiments, at least one of an audible or tactile indication may be generated when the delivery sharp 72 is displaced toward the skin.

[0323] 73-74, 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 so that the proximal portion 110, or at least a portion of the proximal portion, can stretch. The distal portion 112 may be rigid. The proximal surfaces of both the proximal portion 110 and the distal portion 112 may have at least one region covered with adhesive 22. The proximal portion 110 may be bonded to the distal portion 112 via adhesive 22 on the proximal surface of the distal portion 110. Such an embodiment may be desirable because the delivery device 10 is suitable for mass production via a reel-to-reel manufacturing process.

[0324] 75-76 , the proximal portion 110 and the distal portion 112 may be coupled 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 coupled at a first end to the proximal portion 110 of the delivery device 10 and at a second, opposite end to the locking adhesive 116 on the distal portion 112. The tether member 118 may be heat staked, welded, or otherwise fixedly coupled to the proximal portion 110 while being relatively lightly coupled to the locking adhesive 116. In some embodiments, the tether member 118 may be comprised of an adhesive liner or adhesive backing material, but may be easily peeled from the locking adhesive 116. As shown, the tether member 118 may be at least partially doubled when the delivery device 10 is in a storage state.

[0325] Proximal portion 110 may include a pull tab 120, which may be disposed at a first end of proximal portion 110. Pull tab 120 may be an enlarged or widened portion of proximal portion 110. In some embodiments, pull tab 120 may include a roughened surface, ridges, or the like to facilitate gripping. In alternative embodiments, pull tab 120 may include a notch to form a pull ring.

[0326] 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 upon itself multiple times. In this example, the fold region 122 is folded upon 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 dispenses material. The number of folds in the fold region 122 can be adjusted to vary the amount of stretch the proximal portion 110 undergoes 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.

[0327] As shown in FIG. 75 , the delivery device 10 may include a reservoir 12 that may contain 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 support 26 coupled to the reservoir 12. The reservoir 12 may be disposed on a resilient cantilever arm 130 defined in the 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 storage state, the delivery opening 124 may be misaligned 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 storage 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.

[0328] 77A-78B, 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 the proximal surface of the distal portion 112. Thus, the distal portion 112 of the delivery device 10 can be substantially stationary when 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 expand to extend the proximal portion 110 as the pull tab 120 is pulled. Furthermore, in certain embodiments, the proximal portion 110 can stretch to allow for further elongation. A segment of the proximal portion 110 including 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 the first state to the elongated state. 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.

[0329] As the folding region 122 unfolds, material in the proximal portion 110 is expelled, causing the proximal portion 110 to extend and displacing the delivery opening 124 into alignment with the delivery sharp 72. The at least one ramp element 128 may be displaced 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 relative to the proximal portion 110 as the proximal portion 110 transitions to the extended state. As the at least one ramp element 128 is further displaced, 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.

[0330] Once at least one ramp element 128 has passed the cantilever arm 130, the cantilever arm 130 can return to an undeflected state, as shown in FIGS. 78A and 78B. The delivery device 10 can 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 can be displaced through the delivery opening 124 and puncture the skin 44, thereby establishing fluid communication between the delivery sharp 72 and the patient's target delivery destination. Additionally, the reservoir 12 can be compressed between the skin 44 and the cantilever arm 130 as the cantilever arm 130 returns to its undeflected state. This compression can act to expel fluid from the reservoir 12 and pump it through the delivery sharp 72 and into the patient. Compression can also help ensure that the reservoir 12 is completely emptied during delivery.

[0331] As shown, 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. Once 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 may then adhere to the proximal portion 110, adhering the proximal portion 110 in place. The locking adhesive 116 may positively adhere to the proximal portion 110. Attempts to separate the proximal portion 110 and the locking adhesive 116 may damage one of the components of the delivery device 10. This may help ensure the transition of the delivery device 10. Returning the delivery device 10 to the delivery state is irreversible. The locking adhesive 116 may also inhibit the proximal portion 110 from crumpling due to the restoring force exerted by stretched skin. Thus, the locking adhesive 116 may hold the adhesive 22 on the proximal portion 110 in place while the proximal portion 110 is in a stretched state, ensuring that the skin remains stretched when the user releases the pull tab 120.

[0332] 79-82, another exemplary embodiment of the delivery device 10 is shown. FIG. 79 shows the exemplary delivery device 10 in a storage state. FIG. 80 shows the exemplary delivery device 10 in a delivery state. FIGS. 81 and 82 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 serve to 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 those skilled in the art. Those skilled in the art will understand that the top 306 need not be limited to any particular shape, so long as it can be twisted by a user.

[0333] As shown, the exemplary top 306 rests on a base body 309. The top 306 engages 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 body 309. Those skilled in the art will appreciate that other materials and manufacturing techniques may be used.

[0334] 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 before attaching the adhesive liner 265 to any of the delivery devices 10 described herein. In some examples, the user may peel the adhesive liner 265 off in a manner similar to peeling a liner off a bandage before applying it. 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.

[0335] After affixing the delivery device 10 to the skin, a user can twist the top 306 of the delivery device 10 to advance the top 306 proximally (e.g., toward the skin) along the threads of the screw 310. The threaded screw 310 can contain a frangible material, or weakened portion 314. The weakened portion 314 can prevent displacement of the top 306 and other components of the delivery device 10 until a sufficient force is applied to the top 306. This can help prevent the delivery device 10 from transitioning to the delivery state during storage.

[0336] In the exemplary embodiment, the weakened portion 314 is provided as at least one tab protruding from the carriage 315, which 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 ledge 319 for supporting at least one of the weakened portions 314, and preferably a ledge 319 for supporting each of the weakened portions 314. When the weakened portions 314 rest on the ledge 319, the carriage 315 may be prevented from displacing within the bore 317, preventing torsional movement of the top portion 306. In certain examples, the ledges 319 may each be the end of a track or rail (best shown in FIG. 81 ) disposed within the bore 317, which may help guide the displacement of the carriage 315 within the bore 317.

[0337] 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 threaded downward or proximally toward the skin surface, the protrusion 318 may force the frangible portions 314 against their respective ledges 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 skilled in the art will appreciate that breaking the frangible portions 314 may inhibit reuse of the delivery device 10.

[0338] 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 its proximal displacement upon contacting the ledge 321.

[0339] The top 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 top 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 prevent displacement of the top 306. Further actuation of the top exerts 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 ledge 321). One skilled in the art will appreciate that breaking weakened portion 325 may inhibit the delivery device 10 from being reused.

[0340] 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 from 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 medication (e.g., a vaccine), and incorporates on its underside a sharps support 26 (see, e.g., FIG. 31 ) that includes at least one delivery sharp 72 (see, e.g., FIG. 31 ).

[0341] 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 within the carriage 315. The reservoir 12 may be held within the opening in the carriage 315 by a friction fit or a slip fit, as shown. In some examples, a weak adhesive may hold the reservoir 12 in place within the opening. In other embodiments, the friction fit may be augmented by a gasket member (e.g., an O-ring) positioned between the side of the reservoir 12 and the opening in the carriage 315.

[0342] 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 in which the delivery aid 320 rests on a shelf within the carriage 315, a portion of the delivery aid 320 may deform or break, allowing it to move beyond the shelf. As the tip 306 continues to advance along the post 310, the delivery aid 320 and reservoir 12 may move downward. The force exerted by the tip 306 may be sufficient to overcome 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. 31 ) 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. 80 . As the tip 306 continues to displace proximally, pressure from the delivery aid 320 builds within the reservoir 12, forcing the fluid contained within the reservoir 12 through the delivery sharp 72 and into the patient. At that point, the tip 306 may have stopped twisting and reached the end of its displacement range. At the end of its displacement range, the tip 306 may abut the base body 309, which may provide mechanical interference against further displacement. Once the tip 306 stops moving, the user can remove the delivery device 10 from the skin.

[0343] 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 includes an actuation assembly that may include first and second displaceable members. These members may be displaceable relative to one another from a separated state to a proximal state. 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 the members from separating and maintain the members in the proximal state.

[0344] 83-85, 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 a unitary 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 positioned above the second body 320B or in a different plane. In the exemplary embodiment, the first and second bodies 320A, 320B 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 connected by at least two flexible struts 322 integral with the flexure. While six such flexible struts 322 are shown in this example, 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 angles that are not perpendicular to the bodies 320A, 320B.

[0345] At least one hook 324 may be included integral with one of the bodies 320A, 320B. The other of the bodies 320A, 320B may include at least one catch 326. In the exemplary embodiment, the first body 320A includes multiple hooks 324 extending downward 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 evenly 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 upward from the second body 320B toward the first body 320A. While 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."

[0346] As the first body 320A is displaced toward the second body 320B, at least one of the bodies 320A, 320B may also rotate. If one of the bodies 320A, 320B is rotationally constrained, only the other of the bodies 320A, 320B may rotate as the bodies 320A, 320B are displaced toward each other. Pressing down on the first body 320A from above while the second body 320B is rotationally constrained may cause the flexible strut 322 to bend. The hook 324 may rotate and displace (around an axis passing through the center points of the bodies 320A, 320B). 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 its 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. The use of a single-piece flexure (e.g., formed by injection molding) allows the delivery device 10 to be manufactured at a relatively low cost. The hook 324 engaging the catch 326 may also help prevent the delivery device 10 from being reused, including the flexure. The engaged hook 324 may also help maintain pressure on the reservoir 12 of the delivery device 10, necessary to reliably deliver a medical agent (e.g., a vaccine) into a patient via one or more delivery sharps 72 (see, e.g., FIG. 31 ).

[0347] The rotational displacement of one of the bodies 320A,B may be a harness that assists in driving the delivery sharp (see, e.g., FIG. 31) 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. 31) may be constrained to move in conjunction with the first body 320A. Thus, the delivery sharp (see, e.g., FIG. 31) rotates as it moves relative to the skin.

[0348] Referring now to FIG. 86, an exemplary package 400 is shown. The package 400 can house the delivery device 10 during distribution and transport. The package 400 may also include other components, such as printed instructions and / or medical wipes, that can be used to prepare the injection site. The package 400 can hold the delivery device 10 and possibly other contents in place during delivery and can help prevent premature or inadvertent activation of the delivery device 10. The package 400 can include an internal cavity that can have one or more receivers 402 for the delivery device 10 (parts of the package 400 are shown transparent in FIG. 86). The receivers 402 can restrain the delivery device 10 within the package 400 to prevent excessive movement or violent impact during handling. The package 400 can also protect the delivery device 10 from exposure to the ambient environment. In some embodiments, the package 400 and delivery device 10 can be sterilized (e.g., with EtOx), and the package 400 can maintain the delivery device 10 in this state until immediately prior to use.

[0349] The package 400 itself may be constructed from a first component 404 and a second component 406. The first component 404 may be a rigid base. The rigid base may include a well in which the delivery device 10 (e.g., similar to that shown in FIG. 25) may be housed. The rigid base may be a plastic part. The second component 406 may be a peelable cover that may be bonded to a face of the first component 404. The peelable cover may be removed by the user to access the delivery device 10 immediately prior to use.

[0350] As shown, the package 400 may include at least one unique identifier 408. In other embodiments, the unique identifier 408 may instead or additionally be included on the delivery device 10 or a component thereof. Any suitable unique identifier 408 and combinations thereof may be used. In some embodiments, RFID may be used. In other examples, the unique identifier 408 may be implemented as a printed indicia, such as a barcode, data matrix, QR code, or the like. The unique identifier 408 may encode various information regarding the delivery device 10 or the contents of the reservoir 12 of the delivery device 10. For example, the unique identifier 408 may include product identification information, product lot information, product serial number, dose size information, etc.

[0351] The unique identifier 408 is read by a reader 410. The reader 410 may be a dedicated reader or, in some embodiments, a device such as a smartphone, tablet, smart device, laptop, or other portable device. When a smartphone or the like is utilized, a dedicated delivery device app may run on the smartphone. When a smartphone or the like is utilized, the reader 410 may include multiple hardware pieces (e.g., one or more front-facing imagers and one or more rear-facing imagers) that may be used to read the unique identifier 408. The reader 410 used may depend on whether the delivery device 10 is intended for home use by an individual user or for use in a clinical environment (e.g., a vaccination center, hospital, clinic, or other care facility). A smartphone may be convenient to use as the reader 410 when delivery via the delivery device 10 is self-administered by the patient (e.g., at home).

[0352] The reader 410 can communicate with the database 412 (e.g., via the internet, other networks, cloud platforms, etc.). Prior to using the delivery device 10, a user can read the unique identifier 408 with the reader 410. The identifier 408 of the delivery device 10 can be checked against a database 412 to verify that the unique identifier 408 is not associated with a delivery device 10 that has already been used, is being recalled, has expired, etc. The database 412 can also be updated to indicate that the delivery device 10 associated with the unique identifier 408 has been used. Thus, the reader 410 and database 412 can assist in inventory control. Other usage information can also be stored. In some embodiments, geolocation data indicating the location of the package 400 when the unique identifier 408 is read can also be stored in the database 412.

[0353] Depending on the available infrastructure, the data may be stored offline in the memory of the reader 410 until a robust connection to the Internet or another suitable network is made. The data may then be uploaded to the database 412. Alternatively, the data may be transmitted to the database 412 as it is acquired by the reader 410.

[0354] In some embodiments, a patient may be required to pre-register to receive the delivery device 10. In some embodiments, the reader 410 may be used to perform the registration (e.g., when an app on a smartphone is used). If the reader 410 uses a smartphone app, the smartphone app may prohibit use of the reader 410 for delivery if certain services are not enabled. Such an app may generate a unique identifier or code if predefined required services (e.g., location tracking, push notifications, etc.) are enabled. This code may be provided to the database 412 and may also be referred to as a registration code. The patient may be required to provide the code to receive the delivery device 10. The code may be entered into the dispenser or provided to a distributor and checked against the database 412. If the code matches the registration code stored in the database 412, the delivery device 10 may be provided to the patient. In other embodiments, the controller 416 of the reader 410 may generate a manual entry screen to collect desired information if the user chooses not to enable one or more services or chooses not to provide desired user information. For example, if location tracking is not enabled, the app may generate a location data entry screen. Such screens may require input of information before the code is generated and provided to database 412.

[0355] In some embodiments, once the unique identifier 408 on the package 400 is read, the controller 416 of the reader 410 can generate instructions on the user interface 414 of the reader 410. The instructions may include text, images, animations, videos, etc., detailing how to use the delivery device 10. The instructions can guide the user step-by-step from opening the package 400 to disposing of the delivery device 10 after use. In some embodiments, after each step in the set of instructions, a prompt may be generated on the user interface 414 via the controller 416. The user may need to interact with the prompt to proceed to the next set of instructions. User interactions may be recorded and stored in the database 412. This may help verify that a particular delivery device 10 has not only been received by the patient, but also applied and used. In some embodiments, the controller 416 can generate a notification (e.g., visual, tactile, audio, or a combination thereof) if all steps have not been completed. In other embodiments, one or more messages may be generated if the user does not respond to a prompt. For example, when a smartphone or the like is used, the message may be a push notification generated by an app on the delivery device 10.

[0356] In other embodiments, at least one message generator 418 in data communication with the database 412 generates, for example, a text message, email, or phone call (e.g., an automated message or connecting the user to a human operator), which may be sent to a user-provided phone number or email address. If a delay of more than a predetermined period occurs since the previous prompt was interacted with the user, the message generator 418 may send a communication to the patient. If no response is received after a communication is sent by the message generator 418, the type of communication triggered may escalate (escalate). The communication may initially be a text message or push notification. In some embodiments, if cellular service is unacceptable or below a threshold, a push message may be sent, preferably or instead of a text message. If no user interaction is received after a predetermined escalation period, the message generator 418 may generate a more intrusive communication (e.g., a phone call). Any suitable number of escalation tiers may be used.

[0357] In some embodiments, the patient can also provide additional data via the reader 410. This data is stored in the database 412 and analyzed (e.g., via a cloud analytics tool or toolset). For example, a user can report a problem with a delivery device 10 via the reader 410. This data can be matched with data associated with other delivery devices 10 from the same lot. If a lot is deemed to contain more than a predetermined threshold of problematic delivery devices 10, the lot can be flagged for investigation and prevented from distribution or use. Alternatively or additionally, the patient can be prompted to provide specific post-injection information via the reader 410. For example, the patient can be requested to complete a side effect questionnaire or other form, which can be generated by the controller 416 of the reader 410 on the user interface 414. Side effect data can be analyzed to identify patterns common to particular patient types or delivery devices 10 (e.g., delivery devices 10 from the same lot or delivery devices 10 holding the same contents). The analysis can be performed via a cloud analytics tool or toolset.

[0358] In certain examples, as shown in FIG. 87 , the delivery device 10 may include a manifestation indicator 450 or identifier that is hidden when the delivery device 10 is in storage. The manifestation indicator 450 may become accessible during or after use of such a delivery device 10. The manifestation indicator 450 may then be scanned by the reader 410, and confirmation of the scan or scan data captured during the scan may be transmitted to the database 412. The manifestation indicator 450, in certain examples, may encode a unique identifier (e.g., a barcode, QR code, data matrix, etc.) specific to the delivery device 10. Thus, the manifestation indicator 450 may serve as confirmation that delivery was performed using a specific delivery device 10. In some examples, the database 412 or specific data within the database 412 may be accessible via a payment provider (e.g., a government agency, an insurance company, etc.). Reimbursement or payment may be associated with the scanning of the manifestation identifier 450 to ensure that the manifestation identifier 450 is scanned and document-delivered via the delivery device 10. For example, the payment service may query the database 412 to determine the usage status of the delivery device 10 and authorize payment only if the delivery device 10 has been used. An indication in the database 412 that the manifestation indicator 450 has been scanned may flag the delivery device 10 as used.

[0359] Referring now to FIG. 87 , in some examples, the delivery device 10 may include a first portion and a second portion that can be separated when the user removes the delivery device 10 from the skin. In this exemplary embodiment, a delivery device 10 is shown that includes a body 20 and a reservoir assembly 12 similar to those shown in FIG. 25 , for example. The reveal indicator 450 may be included in other delivery device 10 embodiments described herein. In the example shown in FIG. 87 , the exemplary first portion is the reservoir assembly 12 (see, e.g., FIG. 59 ), and the exemplary second portion is the body 20. In such examples, the reveal indicator 450 may be located distal to the reservoir. When the first and second portions are coupled, the view of the reveal indicator 450 may be obstructed by the body 20 (which may be opaque or at least sufficiently translucent). As shown, when the body 20 and reservoir assembly 12 are separated, the reveal indicator 450 becomes visible and may be scanned to help confirm that the delivery device 10 has been used.

[0360] In some examples, the holder 270 of the reservoir assembly 12 (see, e.g., FIGS. 47-50 and 51A-51C) can include an adhesive on at least a portion of the proximal surface of the holder 270. If the reservoir assembly 12 of the holder 270 includes a tab 277 (see, e.g., FIG. 51B) that couples to a slit in the body 20, the tab 277 can disengage from a slit 278 in the body 20 (see, e.g., FIG. 45) when the user attempts to remove the delivery device 10 from the skin. The bond between the adhesive on the holder 270 and the skin can be sufficient to overcome or disengage the bond between the tab 277 and the body 20 when the patient pulls on the body 20 to remove the delivery device 10. That is, the adhesive can withstand any force applied to separate the body 20 from the rest of the delivery device 10 when the user pulls on the body 20. Thus, the reservoir portion 12 may remain adhered to the skin, and the body 20 may be removed. The reveal indicator 450 included on the reservoir 12 becomes visible and may be scanned by the reader 410 (see, e.g., FIG. 86 ). The reservoir assembly 12 may then be peeled from the skin by the patient. In instances where the reservoir assembly 12 is adhered to the body 20, the adhesive connection between the skin and the reservoir assembly 12 may be stronger than the adhesive connection between the reservoir assembly 12 and the body 20. Thus, when the patient pulls on the body 20, the body 20 may separate from the reservoir assembly 12, exposing the reveal indicator 450.

[0361] In other embodiments, as shown in FIG. 88 , the delivery device 10 may provide a mark 510 on the skin when the delivery device 10 is applied, or at least after it has been applied for a predetermined period of time. In some embodiments, a marking agent, such as ink, may be included on the portion of the delivery device 10 adjacent to the skin 512. Alternatively, the marking agent may be manufactured into a skin-compatible adhesive for bonding the delivery device 10 to the skin during use. In instances where a pressure-sensitive adhesive is used, pressure applied when the delivery device 10 is used may activate the adhesive and also release the marking agent. The marking agent may at least partially migrate to the skin 512 when the delivery device 10 is applied or otherwise mark the skin 512. Alternatively, the delivery device 10 may apply a temporary tattoo during injection. In some embodiments, the mark 510 created may have a pattern that encodes specific information about the delivery device 10. In the exemplary embodiment, a series of “X”s is shown, but any suitable mark 510 may be created. As indicated by injection blister 514 , mark 510 may become visible after the injection is completed and delivery device 10 is removed from skin 512 .

[0362] When the delivery device 10 is removed, a mark 510 left on the skin 512 may be imaged by the reader 410 (see, e.g., FIG. 86). This mark 510 may help confirm that an injection was administered to the patient by the delivery device 10. In some embodiments, the controller 416 of the reader 410 (see, e.g., FIG. 86) may analyze the image to determine whether the mark 510 is present. If the controller 416 determines that the appropriate mark 510 is present, the database 412 (see, e.g., FIG. 86) may be updated to indicate that the delivery device 10 associated with the previously scanned unique identifier 408 was used. It should be understood that in embodiments described herein where the controller 416 is described as performing image analysis or other analysis, this need not be the case. For example, the image may be communicated by the reader 410 to the database 412, and cloud analysis tools may be utilized to verify that the image indicates that delivery occurred. Regardless of where the analysis is performed, the image may be uploaded to the database 412.

[0363] Referring now primarily to FIG. 89, in certain embodiments, the reader 410 (see, e.g., FIG. 86) may include at least one image sensor sensitive to one or more wavelengths outside the visible spectrum. The non-visible spectrum wavelengths, or spectrum the image sensor is sensitive to, may be wavelengths that penetrate deeper into the skin than light in the visible spectrum. The reader 410 may include at least one image sensor sensitive to various wavelengths in the infrared spectrum (e.g., near-infrared). A CCD or CMOS image sensor may be included in various embodiments. Such a capable sensor in the reader 410 may not include an IR filter (e.g., IR-blocking film) commonly applied to typical consumer imaging devices. The sensor may have an associated filter that blocks visible light. In some embodiments, the imager may be a thermographic or thermal imager. Multiple imagers capturing images in different non-visible spectrums may be included (e.g., at least one for near-infrared and at least one for longer infrared wavelengths).

[0364] After the delivery device 10 is used, the reader 410 can be used to capture at least one image of the injection site. The at least one image can be acquired or generated based on light other than the visible spectrum. In some embodiments, image data in the visible spectrum can also be captured. The controller 416 (see, e.g., FIG. 86) of the reader 410 can generate a prompt (e.g., in an app) to capture an image. In certain embodiments, the controller 416 can also automatically open an image capture program. The controller 416 may enable image capture by an appropriate imaging device of the reader 410 (e.g., if multiple imaging devices are included in the reader 410).

[0365] The image data can be analyzed to determine the presence of blisters 514 formed within the skin during delivery. The analysis can be automated or performed by a human operator viewing the images via a network connection to database 412 (see, e.g., FIG. 86). Because light outside the visible spectrum has greater penetration into the skin, using such light for imaging purposes can identify or more easily identify certain subsurface features of the skin. This can help, for example, to facilitate the detection of blisters 514. Additionally, the temperature of the injected agent can be different from that of the patient. Areas that are different in temperature from the surrounding areas of the patient may be identifiable. The injection site may, for example, be cooler than the surrounding areas of the patient. For example, FIG. 89 shows a thermal image of an arm after injection. As shown, cooler areas (dark gray) are identifiable in the image, corresponding to the location of blisters 514 on the skin.

[0366] If the image includes characteristics of a blister 514, it can be concluded that delivery was indeed performed using the delivery device 10 and was successful. In some embodiments, the image may be required to conform to at least one predetermined characteristic of interest. For example, in certain implementations, a blister 514 may be detected and required to be a certain size (e.g., with respect to the markings 510). Additionally, the image may be required to not include characteristics indicative of an improper injection. For example, if a thermal imager is used, a cold region corresponding to a blister 514 with one or more adjacent cold regions, or a cold region 514 or size exceeding a certain limit, may be flagged as having characteristics of a leak. In such an example, the analysis may indicate that delivery from the delivery device 10 failed.

[0367] The analysis may be performed by the controller 416 (e.g., see FIG. 86) of the reader 410 (e.g., see FIG. 86). Alternatively, the analysis may be performed on a network server, such as a cloud server. As noted above, human analysis may be used. The results of the analysis and optionally the image may be provided to and stored in at least one database 412 (e.g., see FIG. 86). If the image indicates improper delivery or no delivery, a notification to the user may be generated (e.g., by the controller 416, see FIG. 86). If proper delivery is documented, confirmation that the injection was successful may be generated.

[0368] In examples where the reader 410 is a smartphone, any app used may generate confirmation that an injection was performed by the delivery device 10 upon the user's request. The controller 416 of the reader 410 may generate an option (e.g., a display button) that the user can interact with to display a confirmation notification regarding the injection. When the delivery device 10 is used to perform a vaccination, the app may provide proof of vaccination or a virtual vaccination record or card into which various information regarding the user's vaccination is automatically entered. The vaccination record may be stored in the memory of the reader 410 or in a database 412 (e.g., see FIG. 86 ) accessible via the reader 410 (or may be stored in multiple locations). Thus, the reader 410 may be used to provide proof of injection as needed. For example, the reader 410 may be used to prove vaccination for access to certain spaces (e.g., restaurants, stadiums, workplaces, other venues, airplanes or airports, ships, public transportation, etc.).

[0369] In yet other embodiments, a container 350 containing the packet 208 may be included in the delivery device 10 as described elsewhere herein (see, e.g., FIG. 11 ). One of the packet 208 and the container 250 may contain a first chemical, and the other may contain a second chemical. A dye may also be included in one of the container 350 and the packet 208. When pressure is applied to the delivery device 10 to transition the delivery device from a storage state to a delivery state, the packet 208 may burst, causing the first and second chemicals to mix. These chemicals may react to produce a visually discernible effect. A chemiluminescent reaction may be initiated, for example, when the first and second chemicals are mixed. In an example of such an embodiment, chemicals commonly used in glow sticks may be loaded into the container 350 and the packet 208, for example.

[0370] The delivery device 10 may include one or more windows (e.g., slots 254 or openings 255 in the body 20, such as the examples shown in FIGS. 21A-21I) through which the light produced by the reaction can be perceived. A reader 410 (see, e.g., FIG. 86) can image the delivery device 10 during injection, and a controller 416 (see, e.g., FIG. 86) can analyze the image to confirm the presence of light from the reaction. When the controller 416 determines that a chemiluminescent reaction has been recorded in the image, the controller 416 can communicate with the database 412 and update the database 412 to indicate that the delivery device 10 has been used.

[0371] In some alternative embodiments, where two (or more) chemicals are combined to produce a visible effect, the first chemical or chemicals may be included in a medical wipe. The user may wipe the injection site during preparation, and some of the first chemical may adhere to the skin surface. The second chemical may be carried or released by the delivery device 10 during injection. The first and second chemicals may interact by the time the injection is complete, resulting in, for example, a color change to a color indicative of delivery. Images of the injection site may be taken by the reader 410 and analyzed (e.g., locally by the controller 416 or via a cloud analysis tool after the image is uploaded to the database 412) to confirm the presence of a color indicative of delivery. If a color change is recorded in the image, the database 412 may be updated to indicate that the delivery device 10 has been used.

[0372] Those skilled in the art may devise various alternatives and modifications without departing from the present disclosure. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications, and variations. Moreover, while several embodiments of the present disclosure have been shown in the drawings and / or discussed herein, the disclosure is not intended to be limited thereto, but is intended to be as broad as permitted by the art, and the same applies to the specification. Accordingly, the above detailed description of the invention should not be construed as limiting, but merely as exemplification of particular embodiments. And, those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto. Other elements, steps, methods, and techniques that differ substantially from those described in the detailed description of the invention and / or the appended claims are also intended to be within the scope of the present disclosure.

[0373] The embodiments are presented only to illustrate particular examples of the present disclosure. Also, the drawings described are for illustration purposes only and not for limitation. In the drawings, the size of some elements may be exaggerated and not drawn to a particular scale for illustrative purposes. Furthermore, elements shown in the drawings with the same number may be identical or similar elements, depending on the context.

[0374] When the term "comprises" is used in the present specification and claims, it does not exclude other elements or steps. When an indefinite or definite article is used to refer to a singular noun, such as "a," "an," or "the," this also includes the plural of that noun, unless otherwise stated. Thus, the term "comprises" should not be construed as being limited to the items listed thereafter. Because it does not exclude other elements or steps, the scope of the expression "a device comprising items A and B" should not be limited to a device consisting of only parts A and B.

[0375] Furthermore, terms such as "first," "second," "third," etc., whether used in the specification or the claims, are provided to distinguish between like elements and not necessarily to describe a sequential or chronological order. Terms so used are interchangeable under appropriate circumstances (unless expressly disclosed otherwise), and it should be understood that the disclosed embodiments described herein can operate in other sequences and / or arrangements than those described or illustrated herein.

Claims

1. 1. A delivery device comprising: a body including a central region and a peripheral region, the central region being spaced apart from a base and having an upper surface connected to the base, the peripheral region being defined by a plurality of petal members and a plurality of first slots therebetween, the plurality of petal members extending outwardly from the base; an adhesive bonded to at least a portion of the body; a collapsible reservoir coupled to at least one delivery sharp; A delivery device comprising:

2. The delivery device of claim 1 , wherein the upper surface is convex and includes a plurality of second slots therein.

3. The delivery device of claim 1 , wherein the central region includes a plurality of fenestrations arranged annularly around the periphery of the upper surface.

4. 10. The delivery device of claim 1, further comprising a sharps scaffold containing at least one delivery sharp, the sharps scaffold being coupled to the collapsible reservoir, the collapsible reservoir being coupled to an inner surface of the central region.

5. 5. The delivery device of claim 4, wherein when the delivery device is in a storage state, the collapsible reservoir contains a fluid, the adhesive is affixed to a pierceable surface of a member external to the delivery device, and when the delivery device is in a delivery state, the pierceable surface is stretched by the adhesive, the at least one delivery sharp penetrates the pierceable surface, and the collapsible reservoir is urged to at least partially collapse, allowing fluid to enter the member through the pierceable surface via the at least one delivery sharp.

6. The delivery device of claim 4 , wherein the adhesive is bonded to at least a portion of a side surface of at least two of the plurality of petals most distal from the top surface.

7. 7. The delivery device of claim 6, wherein when the delivery device is in a storage state, the collapsible reservoir contains a fluid, the adhesive is affixed to a pierceable surface of a member external to the delivery device, and when the delivery device is in a delivery state, the pierceable surface is stretched by the adhesive, the at least one delivery sharp penetrates the pierceable surface, and the collapsible reservoir is urged to at least partially collapse, allowing fluid to enter the member through the pierceable surface via the at least one delivery sharp.

8. 5. The delivery device of claim 4, wherein the at least one delivery sharp is a microneedle including a flow lumen having an elongated cross section.

9. The delivery device of claim 1 , wherein the interior volume of the reservoir is divided into a first section and a second section.

10. The delivery device of claim 9 , wherein the first section and the second section are in fluid communication with each other via at least one flow restrictor.

11. The delivery device of claim 9 , wherein the first section has a variable internal volume and the second section has a fixed internal volume that is smaller than the variable internal volume.

12. 12. The delivery device of claim 11, wherein the fixed internal volume is closer to at least one delivery sharp than the variable internal volume.

13. 10. The delivery device of claim 9, wherein at least two of the plurality of petal members are configured to bend in response to pressure applied to the upper surface as the delivery device transitions to the delivery state.

14. 14. The delivery device of claim 13, wherein at least two of the plurality of petal members are configured to curve with a substantially constant radius of curvature in response to pressure applied to the upper surface as the delivery device transitions to the delivery state.

15. 10. The delivery device of claim 9, wherein at least a portion of a first petal member of the plurality of petal members is configured to move further away from at least a corresponding portion of a second petal member of the plurality of petal members during at least a portion of the transition between the storage state and the delivery state, and the first petal member and the second petal member are positioned opposite one another.

16. 10. The delivery device of claim 9, wherein at least a portion of a first petal member of the plurality of petal members moves further away from at least a corresponding portion of a second petal member of the plurality of petal members during at least a portion of the transition between the storage state and the delivery state, thereby stretching the adhesively attached surface of the delivery device, and wherein the first and second petal members are positioned opposite one another.

17. The delivery device of claim 1 , wherein the adhesive is bonded to at least a portion of a side surface of at least two petals of the plurality of petals that is most distal from the top surface.

18. 10. The delivery device of claim 1, wherein the upper surface is configured to transition the delivery device from a storage state in which the upper surface is convex to a delivery state in which the upper surface is concave in response to pressure applied thereto.

19. The delivery device of claim 1 , wherein the reservoir comprises an orifice plate.

20. 1. A method for delivering a medical agent, comprising: applying to a skin surface a delivery device comprising at least one delivery sharp coupled to a collapsible reservoir containing the medical agent, the delivery device being in a storage state; and transitioning the delivery device to a delivery state and applying pressure to the delivery device toward the skin surface to pierce the skin surface with the at least one delivery sharp, collapsing the reservoir and forcing the medical agent into the skin through the at least one delivery sharp; A method comprising:

21. 21. The method of claim 20, further comprising stretching the skin surface as the delivery device transitions from the storage state to the delivery state.

22. 22. The method of claim 21, wherein the method further comprises scratching the skin surface with at least one of the at least one delivery sharp.

23. 21. The method of claim 20, further comprising preventing reuse of the delivery device.

24. 1. A delivery device comprising: a body including a central region coupled to a peripheral region, the central region having a substantially thimble shape with a top surface and a base, the peripheral region surrounding the central region and having an inner periphery and an outer periphery, the inner periphery being coupled to the base such that the peripheral region extends outwardly from the base, the peripheral region including a plurality of first slots extending inwardly from the outer periphery; an adhesive bonded to at least a portion of the body; a collapsible reservoir coupled to the body and at least one delivery sharp; A delivery device comprising:

25. 25. The delivery device of claim 24, wherein the upper surface is convex and includes a plurality of second slots therein.

26. 26. The delivery device of claim 25, wherein the plurality of second slots extend outward relative to a center point of the upper surface.

27. 25. The delivery device of claim 24, wherein the central region includes a plurality of fenestrations disposed along the base.

28. 25. The delivery device of claim 24, wherein the central region includes a plurality of fenestrations disposed along the periphery of the upper surface.

29. 25. The delivery device of claim 24, further comprising a sharps scaffold containing the at least one delivery sharp, the sharps scaffold being coupled to the collapsible reservoir, the collapsible reservoir being coupled to an inner surface of the central region.

30. 30. The delivery device of claim 29, wherein the adhesive is bonded to at least a portion of a side of the peripheral region most distal from the top surface.

31. 31. The delivery device of claim 30, wherein the upper surface is configured to transition the delivery device from a storage state in which the upper surface is convex to a delivery state in which the upper surface is concave in response to pressure applied thereto.

32. 32. The delivery device of claim 31, wherein the body has a footprint having an area, the area being configured to increase during at least a portion of a transition between the storage state and the delivery state.

33. 32. The delivery device of claim 31 , wherein the body has a footprint having an area, and wherein the area is configured to increase during at least a portion of a transition between the storage state and the delivery state to stretch a surface to which the delivery device is adhesively affixed.

34. 31. The delivery device of claim 30, wherein when the delivery device is in the storage state, the collapsible reservoir contains a fluid, the adhesive is affixed to a pierceable surface of a member external to the delivery device, and when the delivery device is in the delivery state, the pierceable surface is stretched by the adhesive, the at least one delivery sharp pierces the pierceable surface, and the collapsible reservoir is urged to at least partially collapse, allowing the fluid to enter the member through the pierceable surface via the at least one delivery sharp.

35. 31. The delivery device of claim 30, wherein at least a portion of the side surface includes a first region and a second region between two adjacent pairs of first slots of the plurality of first slots.

36. 25. The delivery device of claim 24, wherein the adhesive is bonded to at least a portion of a side of the peripheral region most distal from the top surface.

37. 37. The delivery device of claim 36, wherein at least a portion of the side surface includes first and second regions between two adjacent pairs of first slots of the plurality of first slots.

38. 37. The delivery device of claim 36, wherein when the delivery device is in the storage state, the collapsible reservoir contains a fluid, the adhesive is affixed to a pierceable surface of a member external to the delivery device, and when the delivery device is in the delivery state, the pierceable surface is stretched by the adhesive, the at least one delivery sharp pierces the pierceable surface, and the collapsible reservoir is urged to at least partially collapse, allowing the fluid to enter the member through the pierceable surface via the at least one delivery sharp.

39. 25. The delivery device of claim 24, wherein the upper surface is configured to transition the delivery device in response to pressure applied thereto from a storage state in which the upper surface is convex to a delivery state in which the upper surface is concave.

40. 40. The delivery device of claim 39, wherein the body has a footprint having an area, and is configured to increase the area during at least a portion of a transition between the storage state and the delivery state.

41. 41. The delivery device of claim 40, wherein the body has a footprint having an area, and wherein the area is configured to increase during at least a portion of a transition between the storage state and the delivery state to stretch a surface to which the delivery device is adhesively affixed.

42. 1. An actuator assembly for inhibiting reuse of a drug delivery device, comprising: a flexure including a first member and a second member; a plurality of struts connecting the first member and the second member to one another, each strut having elasticity that resists displacement of the first member and the second member relative to one another; wherein the first member includes at least one first engagement member, the second member includes an engagement member cooperating with each of the first engagement members, the plurality of struts are configured to deflect at least one of the first member and the second member to cause rotational movement when the first member and the second member are urged toward one another with a force above a threshold, and the at least one first engagement member and each second engagement member are configured to form a coupling when a distance between the first member and the second member decreases beyond a threshold distance.

43. A delivery device a first portion at least partially covered with a first adhesive and including a cantilever arm; a second portion at least partially covered with a second adhesive and including at least one lamp element, the second portion coupled to the first portion via the first adhesive, the second portion configured to extend from a first state to an extended state; and a collapsible reservoir containing at least one delivery sharp, the reservoir being coupled to the unsupported end of the cantilevered arm; A delivery device comprising:

44. 44. The delivery device of claim 43, wherein the at least one delivery sharp comprises one of a one-dimensional array of microneedles and a two-dimensional array of microneedles.

45. 44. The delivery device of claim 43, wherein the second portion includes a delivery opening that is not aligned with the at least one delivery sharp when the second portion is in the first state, but is aligned with the at least one delivery sharp when the second portion is in the extended state.

46. 44. The delivery device of claim 43, wherein the second portion includes a folding region in the first state, the folding region configured to unfold as the second portion transitions to the extended state.

47. 44. The delivery device of claim 43, wherein the second portion includes a folding region, a layer of the folding region being bonded to the first adhesive.

48. 44. The delivery device of claim 43, wherein each of the at least one ramp element is disposed on a first side of the cantilever arm when the second portion is in the first state and is disposed on a second side of the cantilever arm when the second portion is in the second state.

49. 44. The delivery device of claim 43, wherein the second portion is at least partially elastic.

50. 44. The delivery device of claim 43, wherein the second portion comprises a pull tab.

51. 44. The delivery device of claim 43, wherein the delivery device further comprises a locking adhesive disposed on a portion of the first portion, and wherein the delivery device further comprises a tether having a first end coupled to the second portion.

52. 52. The delivery device of claim 51 , wherein the second end of the tether is configured to be coupled to and cover the locking adhesive when the second portion is in the first state, and the second end of the tether is configured to at least partially disengage from the locking adhesive to expose the locking adhesive when the second portion is in the extended state.

53. 52. The delivery device of claim 51, wherein a second end of the tether is coupled to the locking adhesive, and the tether doubles back on itself when the second portion is in the first state.

54. 44. The delivery device of claim 43, wherein when the second portion is in the first state, the first adhesive and the second adhesive are positioned a first distance apart from one another, and when the second portion is in the extended state, the first adhesive and the second adhesive are positioned a second distance apart from one another, the second distance being greater than the first distance.

55. 44. The delivery device of claim 43, wherein the at least one ramp element is configured to resiliently deflect the cantilever arm when the second portion transitions from the first state to the second state.

56. 1. A delivery device comprising: a body including first and second side panels and first and second end blocks spaced apart by a bridge, the side panels and bridges each including first and second opposite ends, each first end connected to the first end block via a respective first end living hinge and each second end connected to the second end block via a respective second end living hinge, the side panels and bridges also each including a respective intermediate living hinge between their first and second ends; an adhesive at least partially covering a first side of the end blocks; a collapsible reservoir containing at least one delivery sharp, the reservoir coupled to an end of an arm member extending from the bridge toward the first side; A delivery device comprising:

57. 57. The delivery device of claim 56, wherein the side panels each include at least one guard projection.

58. 57. The delivery device of claim 56, wherein the first side panel includes a first guard projection extending toward the second side panel, and the second side panel includes a second guard projection extending toward the first side panel.

59. 59. The delivery device of claim 58, wherein the first guard projection includes a latch projection and the second side panel includes a latch catch.

60. 59. The delivery device of claim 58, wherein the first side panel includes a third guard projection extending toward the second side panel, and the second side panel includes a fourth guard projection extending toward the first side panel.

61. 57. The delivery device of claim 56, wherein the bridge includes the first panel and a set of struts, the first panel connected to the struts via a mid-living hinge of the bridge.

62. 62. The delivery device of claim 61, wherein the arm members are disposed between the posts and extend from ends of the panels adjacent intermediate living hinges of the bridge.

63. 57. The delivery device of claim 56, wherein the side panels have a range of displacement from an outwardly bowed state to a substantially straight state, and the end blocks are configured to displace away from each other as the side panels displace from the outwardly bowed state to the substantially straight state.

64. 64. The delivery device of claim 63, wherein the side panels are configured to transition from the outwardly bowed state to the substantially straight state upon application of a clamping force to the side panels.

65. 65. The delivery device of claim 64, wherein at least an intermediate living hinge of the bridge member is configured to displace toward the first surface of the end block when the side panel displaces from the outwardly bowed condition to the substantially straight condition.

66. 57. The delivery device of claim 56, wherein the side panels have a range of displacement from an outwardly bowed state to a substantially straight state, and the bridge is configured such that when the side panels are displaced from the outwardly bowed state to the substantially straight state, the arm members are displaced from a first position to a second position in which the at least one delivery sharp is disposed below a first surface of the endblock.

67. 57. The delivery device of claim 56, wherein the side panels have a range of displacement from an outwardly bowed state to a substantially straight state, and the body includes a latch protrusion and a latch catch, the latch protrusion configured to engage with the latch catch when the side panels are displaced from the outwardly bowed state to the substantially straight state.

68. 57. The delivery device of claim 56, wherein the body includes a plurality of iris panels extending from the side panels to form a variable aperture.

69. 69. The delivery device of claim 68, wherein the openings are configured to change size as the side panels are bent about an intermediate living hinge of each side panel.

70. 1. A delivery device comprising: a body including a pair of opposing end panels and at least two intermediate panels, the panels being separated from one another by a plurality of living hinges each extending across the body; an adhesive covering at least a portion of the proximal side of each end panel; a collapsible reservoir containing at least one delivery sharp, the reservoir being coupled to a proximal side of one of the intermediate panels; wherein the two intermediate panels form a joint that is displaceable between a raised position and an over-center position when the two end panels are constrained in a plane, and wherein a first of the intermediate panels extends along the plane when the joint is in the over-center position.

71. 71. The delivery device of claim 70, wherein a first one of the end panels is substantially planar and a second one of the end panels includes a planar portion and an angled protrusion extending from the planar portion toward one of the intermediate links.

72. 72. The delivery device of claim 71, wherein a second one of the end panels includes a buttress extending from the planar portion to the angled projection.

73. 71. The delivery device of claim 70, wherein the at least one delivery sharp comprises an array of microneedles.

74. 71. The delivery device of claim 70, wherein the delivery device is configured to transition from a storage state to a delivery state.

75. 71. The delivery device of claim 70, wherein a second one of the intermediate panels is at least partially covered with adhesive on a proximal side thereof.

76. 71. The delivery device of claim 70, wherein the end panels are displaced along the plane a first distance apart as the connectors are displaced from the raised position to the center position and are displaced toward each other a second distance less than the first distance as the connectors are displaced from the center position to the over-center position.

77. 71. The delivery device of claim 70, wherein the reservoir is disposed on a second intermediate panel of the plurality of living hinges adjacent to a living hinge between the first and second intermediate panels.

78. 71. The delivery device of claim 70, wherein one of the panels comprises a strain relief flexure.

79. 71. The delivery device of claim 70, wherein at least a portion of the body is configured to plastically deform when the link is displaced to an over-center position.

80. 71. The delivery device of claim 70, wherein at least one of the living hinges is configured to break upon reciprocal displacement of the linkage from the raised position to the over-center position.

81. 71. The delivery device of claim 70, wherein the linkage is at least partially inverted in the over-center position relative to the raised position.

82. 71. The delivery device of claim 70, wherein the angle between the intermediate panels when the connector is in the raised position is an obtuse angle, and the angle between the intermediate panels when the connector is over-center is a reflex angle.

83. 71. The delivery device of claim 70, wherein one of the intermediate panels is parallel to the skin when the connector is in the over-center position.

84. 1. A delivery device comprising: An actuator; a base including a threaded post, the actuator being in threaded engagement with the post and displaceable along the post from a raised state in which the actuator is most distal relative to the base to a delivered state in which the actuator is more proximal relative to the base; a carriage disposed within the bore of the post, the carriage including at least one first weakened portion and at least one second weakened portion supported on respective shelves defined within the bore; a delivery aid disposed within the bore; a collapsible reservoir disposed within the bore and containing at least one delivery sharp; wherein when the actuator is displaced from the raised state to the delivery state, a portion of the actuator is configured to apply pressure against the carriage, the pressure breaking at least one first weakened portion, freeing the carriage to be displaced within a bore, and breaking at least one second weakened portion, causing pressure to be applied against the reservoir via the carriage and the delivery aid, and wherein displacement of the actuator to the delivery state is further configured to displace the reservoir towards the base.

85. 85. The delivery device of claim 84, wherein the actuator includes a protrusion aligned with an axis of the post, and wherein pressure on the carriage is applied via the protrusion.

86. 86. The delivery device of claim 85, wherein the delivery aid is coupled to an end of the protrusion closest to the base.

87. 86. The delivery device of claim 85, wherein the protrusion extends through at least a portion of the carriage when the actuator is in at least one of the raised state and the delivery state.

88. 85. The delivery device of claim 84, wherein the delivery aid device comprises a force concentrating protrusion.

89. 85. The delivery device of claim 84, wherein the base includes a delivery opening aligned with the bore of the post.

90. 85. The delivery device of claim 84, wherein the at least one first weakened portion comprises a set of weakened portions spaced at equal angular increments relative to the carriage.

91. 85. The delivery device of claim 84, wherein the at least one second weakened portion comprises a set of weakened portions spaced at equal angular increments relative to the carriage.

92. 85. The delivery device of claim 84, wherein when the at least one first weakened portion is in a broken state, the carriage has a range of displacement within the bore that is limited by a stop surface located at an end of the bore adjacent the base.

93. 93. The delivery device of claim 92, wherein the carriage extends through a delivery opening in the base when the carriage is against the stop surface such that a skin pressure member of the carriage is outside the bore.

94. 85. The delivery device of claim 84, wherein the reservoir is disposed within a bay of the carriage and frictionally retained therein when pressure applied to the reservoir is below a threshold value.

95. 85. The delivery device of claim 84, wherein the carriage, the delivery aid, and the reservoir are configured to be displaced together within the bore as a unit after at least one first weakened portion is broken.

96. 96. The delivery device of claim 95, wherein the carriage, the delivery aid, and the reservoir are configured to stop displacement together as a unit when at least one second weakened portion is broken.

97. A microneedle, a base including a first edge and a plurality of second edges; a plurality of side walls extending substantially perpendicularly from the base; a surface extending from the first edge to an apex at an acute angle relative to the base, wherein two adjacent side walls of the plurality of side walls define a side edge extending from the base to the apex in a direction substantially perpendicular to the base; a flow lumen extending through the microneedle from the base to an outlet at the surface; a channel defined in the surface and connected to the flow lumen; A microneedle comprising:

98. 98. The microneedle of claim 97, wherein the outlet of the surface is located more proximal to the apex than the first edge.

99. 98. The microneedle of claim 97, wherein the outlet of the face is located more proximal to the first edge than the apex.

100. 98. The microneedle of claim 97, wherein the outlet of the surface is located in an intermediate region of the surface intermediate the region adjacent to the apex and the region adjacent to the first edge.

101. 98. The microneedle of claim 97, wherein the channel extends in a direction from an outlet on the surface toward the first edge.

102. 98. The microneedle of claim 97, wherein the channel extends in a direction from an outlet on the face toward the apex.

103. 98. The microneedle of claim 97, wherein the channel comprises a first portion and a second portion, the first portion extending in a direction from the outlet on the surface toward the apex, and the second portion extending in a direction from the outlet on the surface toward the first edge.

104. 98. The microneedle of claim 97, wherein the channel has a variable width.

105. 98. The microneedle of claim 97, wherein the channel has a substantially constant width.

106. 98. The microneedle of claim 97, wherein the end of the channel closest to the first end is at a distance of at least 50 to 200 microns from the base.

107. 98. The microneedle of claim 97, wherein the microneedle is made of silicon.

108. 98. The microneedle of claim 97, wherein the height of the microneedle is at least 600 microns.

109. 98. The delivery device of claim 97, wherein the flow lumen has an elongated cross-sectional shape.

110. A microneedle, a base including a first edge and a plurality of second edges; a plurality of sidewalls projecting from the second edge to an arcuate blade edge extending from a base apex formed by two of the plurality of second edges to a second apex spaced from the base; a surface extending from the first edge to the second vertex; a flow lumen extending through the microneedle from the base to an outlet at the surface; A microneedle comprising:

111. 111. The microneedle of claim 110, wherein the blade edge is a double bevel blade.

112. 111. The microneedle of claim 110, wherein the outlet of said surface has an elongated shape.

113. The microneedle of claim 110, wherein the first edge is perpendicular to the base and is positioned such that a plane containing the first edge extends through a portion of the blade edge.

114. The microneedle of claim 110, wherein the first edge is perpendicular to the base and is positioned so that a plane containing the first edge does not pass through the blade edge.

115. 111. The microneedle of claim 110, wherein the outlet is positioned such that at least one plane perpendicular to the base and passing through the outlet also passes through the blade edge.

116. 111. The microneedle of claim 110, wherein the outlet is positioned so that any plane perpendicular to the base and passing through the outlet also passes through the blade edge.

117. 111. The microneedle of claim 110, wherein the arc dimension of the blade edge is greater than 90°.

118. 111. The microneedle of claim 110, wherein the arc dimension of the blade edge is less than 90°.

119. 1. A delivery device comprising: a body including a peripheral region and a central region extending beyond the peripheral region and having a top surface and a base, the peripheral region including multiple bodies spaced apart by slits extending from a periphery of the peripheral region toward the central region; an adhesive bonded to at least a portion of the body; a collapsible reservoir coupled to the body and at least one delivery sharp; A delivery device comprising:

120. 120. The delivery device of claim 119, wherein the body has a first state and a second state, and the body includes at least one partially invertible region, wherein the body is in a first shape in the first state and is substantially inverted relative to the first shape in at least a portion of the invertible region in the second state.

121. 121. The delivery device of claim 120, wherein the at least one partially invertible region comprises the upper surface.

122. 121. The delivery device of claim 120, wherein the body further comprises a rest region that is substantially the same shape when the body is in the first state and the second state.

123. 123. The delivery device of claim 122, wherein the rest region is contained within the central region and extends from the periphery of the top surface to the base.

124. 121. The delivery device of claim 120, wherein the body is configured to cause at least two bodies in the peripheral region to expand and displace when the body transitions from the first state to the second state.

125. 121. The delivery device of claim 120, wherein the upper surface is convex in the first state.

126. 121. The delivery device of claim 120, wherein the upper surface is concave in the second state.

127. 120. The delivery device of claim 119, wherein the reservoir is formed as an assembly including a holder to which the microneedle is coupled and a flexible body coupled to the holder, with a sealed reservoir volume defined between a portion of the holder and a portion of the flexible body.

128. 1. A delivery device comprising: a body including a central region and a peripheral region having a plurality of petal members extending outwardly from the central region, the central region defining a receptacle, the body having a top region and a base connected by a wall; a collapsible reservoir containing at least one delivery sharp, said reservoir coupled to said body and at least partially disposed within said receptacle; an adhesive disposed on at least a portion of the body; A delivery device comprising:

129. 129. The delivery device of claim 128, wherein the reservoir comprises a rigid portion and a flexible portion coupled to the rigid portion, a sealed internal volume of the reservoir being defined between the rigid portion and the flexible portion, and the at least one delivery sharp being coupled to the rigid portion.

130. 130. The delivery device of claim 129, wherein the rigid portion comprises a stage protrusion.

131. 131. The delivery device of claim 130, wherein the at least one delivery sharp is coupled to the stage protrusion and protrudes therefrom at an acute angle relative to the rigid portion.

132. 129. The delivery device of claim 128, wherein the body includes a raised portion adjacent the receptacle, the raised portion forming a mounting surface for the reservoir.

133. 129. The delivery device of claim 128, further comprising a packet disposed within the receptacle between the upper region and the reservoir.

134. 134. The delivery device of claim 133, wherein the packet is a gas bag.

135. 134. The delivery device of claim 133, wherein the packet includes means for applying pressure to the reservoir.

136. 134. The delivery device of claim 133, wherein the packet is configured to burst when subjected to a pressure exceeding a threshold pressure, the packet being disposed within a container and containing a first substance, the container containing a second substance, the first substance and the second substance being configured to react when combined to expand the volume of the container.

137. 134. The delivery device of claim 133, wherein the packet is configured to burst when subjected to a pressure above a threshold pressure, the packet is disposed within a container and filled with a first substance, the container containing a second substance, and the first substance and the second substance are configured to participate in a chemiluminescent reaction when combined.

138. 129. The delivery device of claim 128, wherein the delivery device further comprises a biasing member disposed within the receptacle between the upper region and the reservoir.

139. 139. The delivery device of claim 138, wherein the biasing member is a conical spring.

140. 139. The delivery device of claim 138, wherein the body includes a plurality of positioning protrusions that restrain the biasing member, the biasing member being coupled to the body.

141. 129. The delivery device of claim 128, further comprising a dispensing assembly including a pressure body, a reservoir interface member, and a biasing member, each at least partially disposed within the receptacle between the reservoir and the upper region.

142. 129. The delivery device of claim 128, wherein the internal volume of the reservoir is divided into a first portion and a second portion.

143. 143. The delivery device of claim 142, wherein the first portion and the second portion are in fluid communication via at least one flow restrictor.

144. 143. The delivery device of claim 142, wherein the first portion and the second portion are in fluid communication through at least one orifice in an orifice plate separating the first portion and the second portion.

145. 143. The delivery device of claim 142, wherein the first portion has a variable internal volume and the second portion has a substantially fixed internal volume, the second portion being adjacent to the at least one delivery sharp.

146. 129. The delivery device of claim 128, wherein the at least one delivery sharp comprises an array of spaced apart microneedles.

147. 1. A delivery device comprising: a body including a central region and a peripheral region including a plurality of peripheral members extending outwardly from the central region, the central region having a top region and a base connected by a wall; a reservoir portion including a reservoir with at least one delivery sharp, the reservoir portion removably coupled to the body and at least partially covered by the body; an indicator disposed in a section of the reservoir portion covered by the body; a first adhesive disposed on at least a portion of the body; a second adhesive disposed on at least a portion of the reservoir portion; wherein when the reservoir portion and the body are coupled, the body blocks a line of sight to the indicator.

148. 148. The delivery device of claim 147, wherein the second adhesive is configured to maintain the reservoir portion against the surface such that when the delivery device is applied to a surface, a removal force applied to the body results in separation of the body and the reservoir portion.

149. 148. The delivery device of claim 147, wherein the indicator is selected from the group consisting of a barcode, a data matrix, and a QR code.

150. 148. The delivery device of claim 147, wherein the indicator encodes information related to the contents of the reservoir.

151. 148. The delivery device of claim 147, wherein the body is opaque.

152. 148. The delivery device of claim 147, wherein the body is translucent.

153. 148. The delivery device of claim 147, wherein the reservoir portion is coupled to the body via an adhesive.

154. 148. The delivery device of claim 147, wherein the peripheral region comprises a pull tab.

155. 148. The delivery device of claim 147, wherein at least one of the peripheral members defines a pull tab.

156. 148. The delivery device of claim 147, wherein the body includes a set of slots and the reservoir portion includes a number of tabs, each of the tabs extending at least partially through a respective slot to releasably couple the reservoir portion and the body.

157. 1. A delivery device comprising: a body including a central region and a peripheral region having a plurality of petal members extending outwardly from the central region, the central region defining a receptacle, the body having a top region and a base connected by a wall; a collapsible reservoir containing at least one delivery sharp, the reservoir coupled to the body and at least partially disposed within the receptacle; a dispensing assembly at least partially disposed within the receptacle between the reservoir and the upper region; an adhesive disposed on at least a portion of the body; A delivery device comprising:

158. 158. The delivery device of claim 157, wherein the dispensing assembly includes a push body, at least one biasing member, and a reservoir interface member.

159. 158. The delivery device of claim 157, wherein the pressure body includes a portion that protrudes through an opening in the upper region.

160. 160. The delivery device of claim 159, wherein the push body includes a detent.

161. 160. The delivery device of claim 159, wherein the portion of the push body includes at least one notch and has a cross-sectional shape that is neither circular nor a regular polygon.

162. 158. The delivery device of claim 157, wherein the biasing member comprises a bow spring.

163. 158. The delivery device of claim 157, wherein the biasing member includes a peripheral region and a number of biasing protrusions extending inwardly therefrom, the body includes a number of slots, and the biasing protrusions extend through the slots into the receptacle.

164. 158. The delivery device of claim 157, wherein the reservoir interface member is integral with the pressure body.

165. 158. The delivery device of claim 157, wherein the dispensing assembly includes a coil spring and a reservoir interface member.

166. 166. The delivery device of claim 165, wherein the reservoir interface member is formed by a terminal portion of the spring routed in a pattern within a plane adjacent the ends of the coils of the spring.

167. 158. The delivery device of claim 157, wherein the dispensing assembly includes a spring and the dispensing assembly is not in contact with the reservoir when the delivery device is in a storage state.

168. 168. The delivery device of claim 167, wherein the spring is in an unstressed state in the storage state.

169. 1. A delivery device system comprising: a package including an indicia; a delivery device contained within the package; A database, 1. A delivery device system comprising: a reader including a user interface and a controller, the reader configured to be in data communication with the database and to obtain delivery device information from the indicia; the controller configured to check the delivery device information against associated data in the database; the controller configured to generate instructions for use on the user interface if the associated data in the database indicates that the device is usable; and the controller configured to prevent use of at least one function of the reader until first information is collected by the reader and a first service is enabled on the reader.

170. 170. The system of claim 169, wherein the indicium is selected from the group consisting of a bar code, a data matrix, and a QR code.

171. 170. The system of claim 169, wherein the reader is a smart device and includes an imaging device, and the at least one function includes use of the imaging device.

172. 170. The system of claim 169, wherein the reader comprises a plurality of imaging devices.

173. 170. The system of claim 169, wherein the first service is selected from the group consisting of a notification service and a location service.

174. 170. The system of claim 169, wherein the delivery device comprises a reservoir in fluid communication with one or more microneedles.

175. 170. The system of claim 169, wherein the first information is location information.

176. 1. A method of using a medical delivery device, comprising: using a reader to obtain device information from indicia on a package containing said delivery device; applying the delivery device to the skin of a patient; establishing data communication between the reader and a database; comparing said device information with related device information stored in said database; generating, using a controller of the reader, a set of usage instructions on a user interface of the reader if the comparison indicates that a usage criterion is met; acquiring data from an after-use indicia using the reader after use of the delivery device; updating the database to indicate that a post-use indicia of the delivery device was captured by the reader; A method comprising:

177. 177. The method of claim 176, wherein the method further comprises removing a first portion of the delivery device to expose the use-after indicia on a second portion of the delivery device.

178. 177. The method of claim 176, further comprising marking the after-use indicia on the skin.

179. 177. The method of claim 176, wherein the method further comprises generating a respective prompt on the user interface for each instruction manual in the set of instructions, and preventing the display of the next instruction manual until the controller registers a user interaction with the prompt.

180. 177. The method of claim 176, further comprising preventing use of at least one feature of the reader until notification services of the reader are enabled.

181. 181. The method of claim 180, wherein the at least one function is use of an imaging device of the reader.

182. 177. The method of claim 176, further comprising generating a confirmation of delivery for display on a user interface of the reader.

183. 177. The method of claim 176, wherein the reader is a smartphone.

184. A microneedle, a base including a first edge and a plurality of second edges; a plurality of side walls extending substantially perpendicularly from the base; a surface extending from the first edge to an apex at an acute angle relative to the base, wherein two adjacent side walls of the plurality of side walls define a side edge extending from the base to the apex in a direction substantially perpendicular to the base; a flow lumen extending through the microneedle from the base to an outlet at the surface, the flow lumen having an elongated cross section; A microneedle comprising:

185. The microneedle of claim 184, wherein the cross-sectional shape is oval.

186. A microneedle as described in claim 184, wherein the length of the cross-sectional shape in the extension direction is 100 microns or less.

187. A microneedle as described in claim 184, wherein the length of the cross-sectional shape in the extension direction is 200 microns or less.

188. The microneedle of claim 184, wherein the cross-sectional shape is polygonal.

189. The microneedle of claim 184, wherein the microneedle is made of silicon.

190. 185. The microneedle of claim 184, wherein the majority of the cross-sectional shape has a constant width.

191. 185. The microneedle of claim 184, wherein the microneedle has a height of at least 600 microns.

192. 185. The microneedle of claim 184, wherein the microneedle has a height of 800 microns or less.

193. A microneedle, A base and a plurality of side walls extending from the base and angled to taper such that the needle has a smaller cross-sectional area with increasing distance from the base; Flow Lumen and a plurality of side ports in the sidewall, the side ports being in fluid communication with the flow lumen; a tip at an end of the side wall opposite the base; A microneedle comprising:

194. 194. The microneedle of claim 193, having a high aspect ratio.

195. 194. The microneedle of claim 193, which is obelisk-shaped.

196. 194. The microneedle of claim 193, wherein the base is polygonal in shape and a side wall of the plurality of side walls extends from each side of the polygon of the base.

197. 194. The microneedle of claim 193, wherein the base has a rectangular shape and a side wall of the plurality of side walls extends from each of the four sides of the base.

198. 194. The microneedle of claim 193, wherein the flow lumen has a substantially constant cross-section.

199. 200. The microneedle of claim 198, wherein the flow lumen extends from the base to a plane within the microneedle, and the cross section of the flow lumen is wider than a portion of the cross section of the microneedle.

200. 194. The microneedle of claim 193, wherein the microneedle is made of silicon, the lumen is etched into the microneedle, and the side port is formed as part of the etching of the lumen.

201. 194. The microneedle of claim 193, wherein the flow lumen extends substantially along the longitudinal axis of the microneedle.

202. 194. The microneedle of claim 193, wherein the tip is beveled.

203. 1. A method of using a medical delivery device, comprising: applying a delivery device to the injection site; generating, using a controller of the reader, a set of instructions on a user interface of the reader; delivering a medication from the delivery device to an injection site; capturing image data of the injection site with the reader, the image data including image data in a spectrum outside the visible spectrum; analyzing the image data to determine whether the image data meets at least one criterion indicative of a proper injection; A method comprising:

204. 204. The method of claim 203, further comprising establishing data communication between the reader and the database.

205. 205. The method of claim 204, further comprising updating the database to indicate the results of the analysis.

206. 204. The method of claim 203, wherein the image data includes image data in the near-infrared spectrum.

207. 204. The method of claim 203, wherein the image data includes image data in the infrared spectrum.

208. 204. The method of claim 203, wherein the image data includes thermal image data.

209. 204. The method of claim 203, wherein analyzing the image data includes analyzing thermal image data for the presence of a cold region at the injection site.

210. 204. The method of claim 203, wherein analyzing the image data includes analyzing the image data to determine the presence of at least one feature of interest.

211. 211. The method of claim 210, wherein the at least one feature of interest includes a feature indicative of an intradermal blister and a feature indicative of leakage.

212. 204. The method of claim 203, wherein the reader is a smartphone.

213. 1. A method of delivering a drug, comprising: attaching a delivery device to a surface while the delivery device is in a storage state, the delivery device including at least one delivery sharp in fluid communication with an at least partially collapsible reservoir containing the medicament; pressing a portion of the delivery device toward the surface to transition the delivery device to a delivery state; spreading and displacing at least two portions of the delivery device to apply tension to a surface to which the delivery device is attached; piercing the surface with at least one delivery sharp; transferring fluid at least partially out of a collapsible reservoir and through the at least one delivery sharp until the reservoir is depleted; A method comprising:

214. 1. A delivery device comprising: a peripheral region having a plurality of petal members; a central region having a top surface and a base and extending beyond the peripheral region; a collapsible reservoir in fluid communication with at least one delivery sharp, the collapsible reservoir configured to expel fluid from the reservoir in an expulsion direction; an adhesive member including a central opening having an increased opening width portion aligned with the ejection direction; a delivery device.

215. 215. The delivery device of claim 214, wherein the reservoir comprises a flexible portion and a rigid portion, and the adhesive member is affixed to the body and the rigid portion.

216. 215. The delivery device of claim 214, wherein the reservoir comprises a flexible portion and a rigid portion, the rigid portion having a footprint with a first area, and the central opening encircles a second area that is 60-100% of the first area.

217. 215. The delivery device of claim 214, wherein the center of the central opening is coaxial with the center of the reservoir.

218. 215. The delivery device of claim 214, wherein the adhesive member includes at least one spoke that protrudes from the periphery of the central opening into the central opening.

219. 215. The delivery device of claim 214, wherein the adhesive member covers at least a portion of each of the petal members.

220. 215. The delivery device of claim 214, wherein the at least one delivery sharp comprises an array of spaced apart microneedles.

221. 215. The delivery device of claim 214, wherein the body has a first state and a second state, and the body includes at least one partially invertible region, wherein the body is in a first shape in the first state and is substantially inverted relative to the first shape in at least a portion of the invertible region in the second state.

222. 222. The delivery device of claim 221, wherein the body is configured such that at least two of the petal members spread apart and displace when the body transitions from the first state to the second state.

223. 224. The delivery device of claim 223, wherein the at least one delivery sharp is displaced into communication with a delivery destination when the body is displaced from the first state to the second state.

224. 215. The delivery device of claim 214, wherein the central opening includes at least one notch extending through the adhesive member outward from the periphery of the central opening in the increased opening width portion.

225. 1. A delivery device comprising: a body including a peripheral region having a plurality of petal members and a central region extending from the peripheral region and having an upper surface and a base; a collapsible reservoir coupled to the body and in fluid communication with at least one microneedle having a width, a height, and a length; an adhesive member including a central opening having an increased width portion aligned with a length dimension of the microneedle; A delivery device comprising:

226. 226. The delivery device of claim 225, wherein the reservoir comprises a flexible portion and a rigid portion, and the adhesive member is attached to the body and the rigid portion.

227. 226. The delivery device of claim 225, wherein the reservoir comprises a flexible portion and a rigid portion, the rigid portion having a footprint with a first area, and the central opening encircles a second area that is 60-100% of the first area.

228. 226. The delivery device of claim 225, wherein the center of the central opening is coaxial with the center of the reservoir.

229. 226. The delivery device of claim 225, wherein the adhesive member includes at least one spoke that protrudes from the periphery of the central opening into the central opening.

230. 226. The delivery device of claim 225, wherein the adhesive member covers at least a portion of each of the petal members.

231. 226. The delivery device of claim 225, wherein the at least one delivery sharp comprises an array of spaced apart microneedles.

232. 226. The delivery device of claim 225, wherein the body has a first state and a second state, and the body includes at least one partially invertible region, wherein the body is in a first shape in the first state and is substantially inverted relative to the first shape in at least a portion of the invertible region in the second state.

233. 233. The delivery device of claim 232, wherein the body is configured such that at least two of the petal members spread apart and displace when the body transitions from the first state to the second state.

234. 234. The delivery device of claim 233, wherein the at least one delivery sharp is displaced into communication with a delivery destination when the body is displaced from the first state to the second state.

235. 226. The delivery device of claim 225, wherein the central opening includes at least one notch extending through the adhesive member outward from the periphery of the central opening in the increased opening width portion.

236. 1. A delivery device comprising: a body including a peripheral region having a plurality of petal members and a central region extending from the peripheral region and having an upper surface and a base; an adhesive bonded to at least a portion of the body; a reservoir including at least one flexible portion, the at least one flexible portion including a cavity defined by a first wall including a collapse promoter; at least one delivery sharp in fluid communication with said reservoir; A delivery device comprising:

237. 237. The delivery device of claim 236, wherein the collapse promoting portion comprises a bellows.

238. 237. The delivery device of claim 236, wherein the collapse promoter comprises pleats extending spirally around the wall.

239. 237. The delivery device of claim 236, wherein the collapse promoter comprises at least one stepped region formed in the wall.

240. 237. The delivery device of claim 236, wherein the first wall extends from a flange coupled to a rigid portion of the reservoir.

241. 241. The delivery device of claim 240, wherein the first wall tapers such that the cross-sectional area of ​​the cavity decreases with distance from the flange as the distance from the flange increases.

242. 237. The delivery device of claim 236, wherein the cavity is also defined by a second wall at an end of the cavity, the second wall forming a substantially flat surface.

243. 243. The delivery device of claim 242, wherein the second surface comprises a central recess.

244. 237. The delivery device of claim 236, wherein the wall extends from and is integrally formed with a flange, the cavity being defined by the first wall and a second wall at an end of the cavity, the second wall being substantially parallel to the flange.

245. 237. The delivery device of claim 236, wherein the at least one delivery sharp comprises a microneedle.

246. Any of the systems, methods, or apparatus shown or described herein.

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