Delivery device, system, and method

Abstract

To provide a dispenser for therapeutic medicine and other medicine.SOLUTION: A delivery device 10 includes a body including a center region 28 and a peripheral region. The center region may be shaped substantially in a thimble-like shape, and may have an upper face and base face. The peripheral region may be defined by a plurality of petal members. The plurality of petal members may extend from the base part outwardly. The delivery device further includes an adhesive agent adhered to at least a part of the body. The delivery device further includes a foldable reservoir coupled to the body and at least one delivery sharp.SELECTED DRAWING: Figure 28

Description

Technical Field

[0001] Statement Regarding Research or Development Supported by the Federal Government 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] This disclosure relates to drug delivery. More specifically, this disclosure relates to dispensers for therapeutic and other medical agents.

Background Art

[0003] New pathogens pose various public health challenges that are not easily overcome. From a medical perspective, the existing preventive healthcare infrastructure is not suitable, or less suitable, for new pathogens such as SARS, MERS, Zika fever, and COVID-19. Other pathogens without herd immunity (such as Ebola hemorrhagic fever) or highly dangerous pathogens that mutate rapidly can also cause similar problems. Although vaccine production usually takes several years, once a vaccine exists, the prospect of rapidly producing billions of doses of the vaccine will almost certainly exceed the current vaccine production capacity. Without vaccination, the importance of other preventive measures such as testing, contact tracing, and personal protective equipment (PPE) increases. However, as repeated, these preventive measures can only provide benefits as far as the relevant supply chain allows. Healthcare systems in the United States and around the world struggling to respond to the COVID-19 pandemic are troubled by shortages of PPE and testing kits. Next, the scale of the COVID-19 pandemic has hindered the possibility of implementing effective contact tracing, which has already become a large-scale operation. Furthermore, new pathogens may cause the focus of the healthcare system to deviate from its typical functions. Secondary effects often occur when a pandemic spreads and medical attention is required. This may appear in the form of delayed surgeries, elective treatments, regular doctor visits, etc., but secondary effects may also worsen. As pointed out by the UNICEF's immunization chief, for example, when trying to contain the Ebola hemorrhagic fever epidemic in the Democratic Republic of the Congo in 2019, the number of deaths from measles was twice the number of deaths from Ebola hemorrhagic fever.

[0004] New pathogens also essentially cause more psychological problems. Simply put, such pathogens scare people. Due to the unavailability of PPE and testing, people may choose to avoid visiting medical facilities and clinics for fear of being exposed to the disease. Even if readily available PPE exists, certain individuals, such as those belonging to a high-risk demographic for a particular pathogen, may still be anxious about visiting such facilities. Additionally, as in the case of the United States, there may be people who strongly oppose the use of PPE for various reasons. This poses an additional public health challenge to the system trying to address the pandemic. To be effective in solving the problems posed by new pathogens, it is necessary to address and avoid these issues.

Summary of the Invention

[0005] According to an exemplary embodiment of the present disclosure, an exemplary delivery device can include a body having a central region and a peripheral region. The central region may be substantially in the shape of a thimble and may have an upper surface and a base. The peripheral region can be defined by a plurality of petal members and a plurality of first slots therebetween. The plurality of petal members can extend outwardly from the base. The delivery device can further include an adhesive coupled to at least a portion of the body. The delivery device can further include a foldable reservoir coupled to the body and 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 openings arranged in a ring shape along the periphery of the upper surface. In some embodiments, the delivery device can further include a sharp support including at least one delivery sharp. In some embodiments, the at least one delivery sharp is a micro needle including a flow lumen having an elongated cross-section. The sharp support can be coupled to a foldable reservoir. The foldable reservoir can be coupled to the inner surface of the central region. In some embodiments, when the delivery device is in a storage state, the foldable reservoir can contain fluid and the adhesive can be attached to a penetrable surface of a member external to the delivery device. When the delivery device is in a delivery state, the penetrable surface is stretched by the adhesive, the at least one delivery sharp penetrates the penetrable surface, and the foldable reservoir is urged to at least partially collapse to allow fluid to enter the member through the penetrable surface via the at least one delivery sharp. In some embodiments, the adhesive can be coupled to at least a portion of the most distal side surface from the upper surfaces of at least two of the plurality of petal members. In some embodiments, when the delivery device is in a storage state, the foldable reservoir can contain fluid and the adhesive can be attached to a penetrable surface of a member external to the delivery device. When the delivery device is in a delivery state, the penetrable surface is stretched by the adhesive, the at least one delivery sharp penetrates the penetrable surface, and the foldable reservoir is urged to at least partially collapse to allow fluid to enter the member through the penetrable surface via the at least one delivery sharp. In some embodiments, the adhesive can be coupled to at least a portion of the most distal side surface from the upper surfaces of at least two of the plurality of petal members. In some embodiments, the upper surface can be configured to transition from a storage state where the upper surface is convex to a delivery state where the upper surface is concave in response to pressure applied to the delivery device.In some embodiments, at least two of the plurality of flap 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 flap members may be configured to curve to have 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 flap member of the plurality of flap members may be configured to move further away from at least a portion of a corresponding portion of a second flap member of the plurality of flap members during at least a portion of the transition. The first flap member and the second flap member are disposed opposite each other between the storage state and the delivery state. In some embodiments, at least a portion of a first flap member of the plurality of flap members is configured to move further away from at least a portion of a corresponding portion of a second flap member of the plurality of flap members during at least a portion of the transition between the storage state and the delivery state, so as to stretch the surface to which the delivery device is adhered with an adhesive, and the first and second flap members are disposed opposite each other. In some embodiments, at least one delivery sharp may be a micro needle. 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 drug can include applying a delivery device including at least one delivery sharp coupled to a foldable reservoir containing the drug to a skin surface, the delivery device being in a storage state. The method can further include applying pressure to the delivery device toward the skin surface to transition the delivery device to a delivery state, penetrating the skin surface with the at least one delivery sharp, and collapsing the reservoir to push the drug through the at least one delivery sharp into the skin.

[0008] In some embodiments, the method may further include the step of stretching the skin surface when the delivery device transitions from a storage state to a 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 deforming the body of the delivery device from a first stable state to a second stable state. In some embodiments, folding the reservoir may include displacing the flexible wall of the reservoir relative to the rigid wall of the reservoir. In some embodiments, pushing the drug into the skin through the at least one delivery sharp may include transferring the drug from the reservoir to the skin through respective flow lumens and channels 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 having a central region coupled to a peripheral region. The central region may be substantially finger-nail shaped and may have an upper surface and a base. The peripheral region may surround the central region. The peripheral region can have an inner circumference and an outer circumference. The inner circumference can be coupled to the base such that the peripheral region extends outwardly from the base. The peripheral region can include a plurality of first slots extending inwardly from the outer circumference. The delivery device can further include an adhesive coupled to at least a portion of the body. The delivery device can further include a foldable 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 outwardly with respect to the central point of the upper surface. In some embodiments, the central region can include a plurality of openings disposed along the base. In some embodiments, the central region can include a plurality of openings disposed along the perimeter of the upper surface. In some embodiments, the delivery device can further include a sharp support including at least one delivery sharp. The sharp support can be coupled to a foldable reservoir. The foldable reservoir can be coupled to the inner surface of the central region. In some embodiments, the adhesive can be coupled to at least a portion of the side surface of the peripheral region that is the 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 an installation area having an area and can be configured such that the area increases during at least a portion of the transition between the storage state and the delivery state. In some embodiments, the body can have an installation area having an area, the area can increase during at least a portion of the transition between the storage state and the delivery state, thereby expanding the surface to which the delivery device is attached by the adhesive. In some embodiments, when the delivery device is in the storage state, the foldable reservoir can contain fluid and the adhesive can be attached to the penetrable surface of a member external to the delivery device. When the delivery device is in the delivery state, the penetrable surface is stretched by the adhesive, at least one delivery sharp penetrates the penetrable surface, and the foldable reservoir can be urged to at least partially collapse to allow fluid to enter the member through the penetrable surface via at least one delivery sharp. In some embodiments, at least a portion of the side surface can include first and second regions between two pairs of adjacent first slots of the plurality of first slots. In some embodiments, the adhesive can be coupled to at least a portion of the side surface of the peripheral region that is the most distal from the upper 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 among the plurality of first slots. In some embodiments, when the delivery device is in a storage state, the foldable reservoir can contain fluid, and the adhesive is attached to the penetrable surface of a member outside the delivery device. When the delivery device is in a delivery state, the penetrable surface is stretched by the adhesive, at least one delivery sharp penetrates the penetrable surface, and the foldable reservoir is urged to at least partially collapse so that fluid can enter the member through the penetrable surface via the at least one delivery sharp. In some embodiments, the upper surface may be configured to transition from a convex storage state to a concave delivery state in response to pressure applied to the delivery device. In some embodiments, the body may have an installation area having a certain area, and the installation area may 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 be an installation area having a certain area, and the installation area may increase 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 attached with the adhesive.

[0011] According to another exemplary embodiment of the present disclosure, an exemplary actuator assembly for prohibiting reuse of a drug delivery device can include a flexure portion including first and second members and a plurality of struts coupling the first and second members to each other. Each strut may have an elasticity that resists displacement of the first and second members in a mutual direction. The first member can include at least one first engagement member. The second member can include engagement members that cooperate 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 a rotational movement when the first and second members are pressed against each other 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 member and the second member decreases beyond a threshold distance.

[0012] According to another exemplary embodiment of the present disclosure, an exemplary delivery device can include a first portion that is at least partially covered with a first adhesive and includes a cantilever arm. The delivery device can further include a second portion that is at least partially covered with a second adhesive and includes at least one lamp element. The second portion can be coupled to the first portion via the first adhesive. The second portion can be configured to extend from a first state to an extended state. The delivery device can further include a foldable reservoir that includes at least one delivery tip. The reservoir can be coupled to the unsupported end of the cantilever arm.

[0013] It can include one of a one-dimensional array of microneedles and a two-dimensional array of microneedles. In some embodiments, the second portion can include a delivery opening. The delivery opening may not be aligned with at least one delivery tip when the second portion is in the first state, and may be aligned with at least one delivery tip when the second portion is in the extended state. In some embodiments, the second portion can include a folding region in the first state. The folding region can be configured to expand when the second portion transitions to the extended state. In some embodiments, the second portion can include a folding region. The layer of the folding region can be coupled to the first adhesive. In some embodiments, each of the at least one lamp element can 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 can be at least partially elastic. In some embodiments, the second portion can include a pull tab. In some embodiments, the delivery device may further include a lock adhesive disposed on a part of the first portion, and the delivery device may further include a tether having a first end coupled to the second portion. In some embodiments, the second end of the tether can be coupled to a lock adhesive and can cover the lock 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 lock adhesive to expose the lock adhesive when the second portion is in the extended state. In some embodiments, the second end of the tether can be coupled to the lock adhesive, and when the second portion is in the first state, the tether can be doubled over itself. In some embodiments, when the second portion is in the first state, the first adhesive and the second adhesive can be disposed at a first distance from each other, and when the second portion is in the extended state, the first and second adhesives can be disposed at a second distance from each other. The second distance can be greater than the first distance. In some embodiments, at least one lamp element can be configured to elastically flex 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 can include a body including first and second end blocks and a bridge separated by first and second side panels. The side panels and the bridge can each include first and second opposing ends. The first ends can each be connected to the first end block via respective first end living hinges. The second ends can each be connected to the second end block via respective second end living hinges. The side panels and the bridge can each also include respective intermediate living hinges between their first and second ends. The delivery device can further include an adhesive that at least partially covers a first side of the end block. The delivery device can further include a foldable reservoir including at least one delivery sharp. The reservoir can be coupled to an end of an arm member extending from the bridge toward the first side.

[0015] In some embodiments, each side panel may include at least one guard protrusion. In some embodiments, the first side panel may include a first guard protrusion extending towards the second side panel, and the second side panel may include a second guard protrusion extending towards the first side panel. In some embodiments, the first guard protrusion may include a latch protrusion, and the second side panel may include a latch catch. In some embodiments, the first side panel may include a third guard protrusion extending towards the second side panel, and the second guide panel may include a fourth guard protrusion extending towards the first side panel. In some embodiments, the bridge may include a first panel and a set of struts. The first panel can be connected to the struts via an intermediate living hinge of the bridge. In some embodiments, the arm member may be disposed between the struts and extend from an end of the panel adjacent to the intermediate living hinge of the bridge. In some embodiments, the side panel may have a displacement range from a bent-outward state to a substantially straight state, and the end blocks may be configured to displace away from each other when the side panel displaces from a bent-outward state to a substantially straight state. In some embodiments, the side panel may be configured to displace from a bent-outward state to a substantially straight state when a clamping force is applied to the side panel. In some embodiments, at least the intermediate living hinge of the bridge member may be configured to displace towards the first surface of the end block when the side panel displaces from a bent-outward state to a substantially straight state. In some embodiments, the side panel may have a displacement range from a bent-outward state to a substantially straight state, and the bridge may be configured to be displaceable from a first position where the arm member is located to a second position where at least one arm member moves. The delivery sharp is disposed under the first surface of the end block when the side panel displaces from a bent-outward state to a substantially straight state. In some embodiments, the side panel may have a displacement range from a bent-outward state to a substantially straight state, and the body may 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 a state where it is bent outward to a substantially straight state. In some embodiments, the body can include a plurality of iris panels extending from the side panel to form a variable aperture. In some embodiments, the aperture can be configured to change in size as the side panel is bent around 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 having a set of opposing end panels and at least two intermediate panels. The panels can be separated from each other by a plurality of living hinges each extending across the body. The delivery device may further include an adhesive covering at least a portion of the proximal side of each of the end panels. The delivery device can further include a foldable reservoir including at least one delivery tip. The reservoir can be coupled to the proximal side of one of the intermediate panels. The two intermediate panels can form a connection 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 can extend along the plane when the connection is in an over-center position.

[0017] In some embodiments, the first end panel may be substantially planar, and the second end panel may include a planar portion and an inclined protrusion extending from the planar portion toward one of the intermediate connections. In some embodiments, the second end panel may include a bevel extending from the planar portion to the inclined protrusion. In some embodiments, at least one delivery tip 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 proximal side of the second intermediate panel may be at least partially covered with an adhesive. In some embodiments, the end panels can be displaced apart by a first distance along a plane when the connection is displaced from a raised position to a centered position, and can be displaced toward each other by a second distance shorter than the first distance when the connection is displaced from the centered position to an overcenter position. In some embodiments, the reservoir can be disposed on the second intermediate panel adjacent to a living hinge of a plurality of living hinges between the first intermediate panel and the second intermediate panel. In some embodiments, one of the panels may include a tension-relieving flexure. In some embodiments, at least a portion of the body may be configured to plastically deform when the connection is displaced to an overcenter position. In some embodiments, at least one of the living hinges may be configured to break when the connection is displaced from a raised position to an overcenter position and back again. In some embodiments, the connection can be at least partially inverted at the overcenter position relative to the raised position. In some embodiments, the angle between the intermediate panels when the connection is in the raised position may be obtuse, and the angle between the intermediate panels when the connection is at overcenter may be reflex. In some embodiments, when the connection is in the overcenter position, one of the intermediate panels may be parallel to the skin.

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

[0019] In some embodiments, the actuator can include a protrusion that can be aligned with the axis of the post. The pressure on the carriage may be applied via the protrusion. In some embodiments, the delivery aid can 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 may include a protrusion that concentrates force. In some embodiments, the base can include a delivery opening that is aligned with the bore of the post. In some embodiments, the at least one first frangible portion can include a set of frangible portions spaced at equal angular increments around the carriage. In some embodiments, the at least one second frangible portion can include a set of frangible portions spaced at equal angular increments around the carriage. In some embodiments, when the at least one first frangible portion is in a damaged state, the carriage can have a displacement range within the bore that is limited by a stop surface disposed at an end of the bore adjacent to the base. In some embodiments, the carriage can extend through the delivery opening of the base when the carriage is in contact with the stop surface such that the skin pressing body of the carriage is outside the bore. In some embodiments, the reservoir is disposed within the bay of the carriage and can be held therein by friction when the pressure applied to the reservoir is below a threshold. In some embodiments, the carriage, the delivery aid, and the reservoir can be configured to displace together within the bore as a unit after at least one first frangible portion is broken. In some embodiments, the carriage delivery aid and the reservoir can be configured to stop displacing together as a unit when at least one second frangible portion is damaged.

[0020] According to another exemplary embodiment of the present disclosure, an exemplary microneedle can comprise a base having a first edge and a plurality of second edges. The microneedle can further comprise a plurality of sidewalls extending in a direction substantially perpendicular to the base. The microneedle can further comprise a face extending from a first end to a vertex at an acute angle with respect to the base. Two adjacent sidewalls of the plurality of sidewalls can define a side edge extending from the base to the vertex in a direction substantially perpendicular to the base. The microneedle can further comprise a flow lumen extending through the microneedle from the base to an exit of the face. The microneedle may further comprise 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 exit in the face can be disposed closer to the vertex than to the first edge. In some embodiments, the exit in the face can be disposed closer to the first edge than to the vertex. In some embodiments, the exit in the face can be disposed in a central region of the face intermediate a region near the vertex and a region near the first edge. In some embodiments, the channel can extend in a direction from the exit in the face toward the first edge. In some embodiments, the channel can extend in a direction from the exit in the face toward the vertex. In some embodiments, the channel can comprise a first portion and a second portion. The first portion can extend in a direction from the exit of the face toward the vertex, and the second portion can extend in a direction from the exit of the face toward the first edge. In some embodiments, the channel can have a variable width. In some embodiments, the channel can have a substantially constant width. In some embodiments, the end of the channel closest to the first end can be at a distance of at least 50 to 200 microns from the base. In some embodiments, the microneedle can be constructed of silicon. In some embodiments, the height of the microneedle can be at least 600 microns.

[0022] According to another exemplary embodiment of the present disclosure, an exemplary microneedle can comprise a base having a first edge and a plurality of second edges. The microneedle can further comprise a plurality of sidewalls that project from the second edges to an arcuate blade edge (cutting edge) that extends from the second edges to a second apex spaced from the base at a base apex formed by two of the second edges. The microneedle can further comprise a surface that extends from a first end to the second apex. The microneedle can further comprise a flow lumen that extends through the microneedle from the base to an outlet of the surface.

[0023] In some embodiments, the blade edge may be a double bevel edge. In some embodiments, the outlet of the surface may have an elongated shape. In some embodiments, the first edge can be arranged such that a plane perpendicular to the base and including the first blade extends through a portion of the blade edge. In some embodiments, the first edge can be arranged 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 can be arranged 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 can be arranged 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 size 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 comprise a body including a peripheral region and a central region that projects and extends from the peripheral region. The peripheral region can have an upper surface and a base. The peripheral region can include a number of bodies separated by slits that extend from the periphery of the peripheral region toward the central region. The delivery device can further comprise an adhesive coupled to at least a portion of the body. The delivery device can further comprise a foldable reservoir coupled to the body and at least one delivery sharp.

[0025] In some embodiments, the body can have a first state and a second state. The body can include at least one partially invertible region that is in a first shape in the first state and that substantially inverts relative to the first shape over at least a portion of the invertible region in the second state. In some embodiments, the at least one partially invertible region can include an upper surface. In some embodiments, the body can further include a stationary 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 can be included in a central region and can extend from around the upper surface to a base. In some embodiments, the body can be configured such that when the body transitions from the first state to the second state, at least two of the bodies in the peripheral region expand and displace. In some embodiments, the upper surface can be convex in the first state. In some embodiments, the upper surface can be concave in the second state. In some embodiments, the reservoir can be formed as an assembly that includes a holder to which the microneedle is coupled and a flexible body coupled to the holder. There may be a sealed 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 having a central region and a peripheral region extending outwardly from the central region and having a plurality of petal members. The central region can define a receptacle and can have an upper region and a base connected by a wall. The delivery device can include a foldable reservoir that includes at least one delivery sharp. The reservoir can be coupled to the body and can be 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 comprise a rigid portion and a flexible portion coupled to the rigid portion. The sealed internal volume of the reservoir may be defined between the rigid portion and the flexible portion. At least one delivery tip may be coupled to the rigid portion. In some embodiments, the rigid portion may include a stage protrusion. In some embodiments, at least one delivery tip is coupled to the stage protrusion and can protrude from the stage protrusion at an acute angle with respect to the rigid portion. In some embodiments, the body may include a ridge adjacent to the receptacle. The ridge can form the mounting surface of the reservoir. In some embodiments, the delivery device may further comprise a packet disposed within 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 is disposed within a container and can contain a first substance. The container may contain 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 rupture when subjected to a pressure exceeding a threshold value. The packet is disposed within a container and can be 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 comprise a biasing member disposed within the 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 can be coupled to the body. In some embodiments, the biasing member may be heat caulked to the body. In some embodiments, the delivery device may further comprise a dispensing assembly including a pressing body, a reservoir interface member, and a biasing member, each at least partially disposed within the 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 via a flow restrictor.

[0028] According to another exemplary embodiment of the present disclosure, an exemplary delivery device can include a body including a central region and a peripheral region. The peripheral region can include a plurality of peripheral members extending outwardly from the central region. The central region can have an upper region and a base connected by a wall. The delivery device can further include a reservoir portion including a reservoir with at least one delivery tip. The reservoir portion can be removably coupled to the body and at least partially covered by the body. The delivery device can further include an indicator disposed on a portion of the reservoir portion covered by the body. The delivery device can further include a first adhesive disposed on at least a portion of the body. The delivery device can further include a second adhesive disposed on at least a portion of the reservoir portion. When coupling the reservoir portion and the body, the body can obstruct the 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 the removal force applied to the body results in the separation of the body and the reservoir portion. In some embodiments, the indicator can be 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 coupled 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 a plurality of tabs, each tab extending at least partially through a respective slot to removably couple the reservoir portion and the body.

[0030] According to another exemplary embodiment, the exemplary delivery device can comprise a body including a central region and a peripheral region. The peripheral region may have a plurality of petal members extending outwardly from the central region. The central region can define a receptacle and can have an upper region and a base connected by a wall. The delivery device can further comprise a foldable reservoir including at least one delivery tip. The reservoir can be coupled to the body and can be at least partially disposed within the receptacle. The delivery device can further comprise a dispensing assembly at least partially disposed within a container between the reservoir and the upper region. The delivery device can further comprise an adhesive disposed on at least a portion of the body.

[0031] In some embodiments, the dispensing assembly can include a pressing body, at least one biasing member, and a reservoir interface member. In some embodiments, the pressing body can include a portion that protrudes through an opening in the upper region. In some embodiments, the pressing body can include a detent. In some embodiments, the portion of the pressing body may include at least one notch and may have a cross-sectional shape that is neither circular nor regular polygonal. In some embodiments, the biasing member can include at least one arcuate spring. In some embodiments, the biasing member can include a peripheral region and a plurality of biasing protrusions extending inwardly from the peripheral region. The body can include a plurality of slots. The biasing protrusions can extend through the slots into the receptacle. In some embodiments, the reservoir interface member may be integral with the pressing body. In some embodiments, the dispensing assembly may include a coil spring and may 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 pattern in a plane adjacent to an end of the coil 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. In some embodiments, when the delivery device is in a storage state, the spring may be in a stress-free state.

[0032] In another exemplary embodiment, the delivery device system can comprise a package that includes an authentication seal. The system can further comprise a delivery device contained within the package. The system may further comprise a database. The system can further comprise a reader that includes a user interface and a controller. The reader can communicate data with the database and can be configured to obtain delivery device information from the authentication seal. The controller can be configured to check the delivery device information against related data in the database. The controller can be configured to generate instructions for use on the user interface if the related data in the database indicates that the device is available for use. The controller can prohibit the use of at least one function of the reader until the first information is collected by the reader and the first service is enabled on the reader.

[0033] In some embodiments, the authentication seal can 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, at least one function can include the 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 an indicium on a package containing the medical delivery device. The method may further include applying the delivery device to a patient's skin. The method may further include establishing data communication between the reader and a database. The method can further include comparing the device information with related device information stored in the database. The method may further include, when usage criteria are met by the comparison, generating a set of instructions on a user interface of the reader using a controller of the reader. The method may further include, after the medical delivery device has been used, capturing data from a post - use indicium using the reader. The method can further include updating the database to indicate that the post - use indicium of the delivery device has 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 mark on a second portion of the delivery device. In some embodiments, the method may further include applying a post - use indicium to the skin. In some embodiments, the method may further include generating respective prompts on the user interface for each instruction of the set of instructions, and preventing display of the next instruction until a 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 may further include generating a set of instructions on a user interface of the reader using a controller of the reader. The method may further include delivering a drug from the delivery device to the injection site. The method may further include capturing image data of the injection site using the reader, the image data including image data of 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 indicating an appropriate 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 the result of the analysis. In some embodiments, the image data can include image data of the near-infrared spectrum. In some embodiments, the image data can include image data of the infrared spectrum. In some embodiments, the image data can include thermal image data. In some embodiments, analyzing the image data may include analyzing the thermal image data for the presence of a low-temperature region at the injection site. In some embodiments, analyzing the image data can 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 can include a feature indicating an intradermal blister and a feature indicating leakage. In some embodiments, the reader may be a smartphone.

[0038] According to another exemplary embodiment of the present disclosure, the microneedle can comprise a base having a first edge and a plurality of second edges. The microneedle can further comprise a plurality of sidewalls extending in a direction substantially perpendicular to the base. The microneedle can further comprise a surface extending from a first end to a tip at an acute angle with respect to the base. Two adjacent sidewalls of the plurality of sidewalls can define a side edge extending from the base to the tip in a direction substantially perpendicular to the base. The microneedle can further comprise a flow lumen extending through the microneedle from the base to an outlet of the surface. The flow lumen may have an elongated cross-sectional shape.

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

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

[0041] In some embodiments, the microneedle may have a high aspect ratio. In some embodiments, the microneedle may be substantially in the shape of an obelisk. In some embodiments, the base may be polygonal in shape, and the sidewalls among the plurality of sidewalls may extend from each side of the polygon of the base. In some embodiments, the base may have a quadrilateral shape, and the sidewalls among the plurality of sidewalls may extend from each of the four sides of the base. In some embodiments, the flow lumen may have a substantially constant cross-section. In some embodiments, the flow lumen may extend from the base to a plane within the microneedle, and the cross-section of the flow lumen is wider than the portion of the cross-section of the microneedle. In some embodiments, the microneedle can be composed of silicon, and the lumen can be formed in the microneedle by etching. The side ports can be formed as a result of the etching of the lumen. In some embodiments, the flow lumen can extend substantially along the long axis of the microneedle. In some embodiments, the tip may be chamfered.

[0042] According to yet another exemplary embodiment of the present disclosure, a method of delivering a medical agent can include attaching a delivery device including at least one delivery sharp that can be in fluid communication with at least a partially foldable reservoir that houses the agent while the delivery device is in a storage state to a surface. The method may further include pushing a part of the delivery device toward the surface to transition the delivery device to a delivery state. The method may further include spreading 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 at least one delivery sharp. The method may further include transferring fluid from the at least partially foldable reservoir and transferring the fluid through at least one delivery sharp until the reservoir is depleted.

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

[0044] In some embodiments, the reservoir can include a flexible portion and a rigid portion. The adhesive member may be attached to the body and the rigid portion. In some embodiments, the reservoir can include a flexible portion and a rigid portion. The rigid portion may have an installation area with a first region. The central opening can surround a second region that is 60-100% of the first region. In some embodiments, the center of the central opening may be coaxial with the center of the reservoir. In some embodiments, the adhesive member can include at least one spoke that protrudes from around 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, at least one delivery tip can include an array of spaced micro needles. In some embodiments, the body can have a first state and a second state. The body may include at least one partially invertible region that is in a first shape in the first state and substantially inverts with respect to the first shape over at least a portion of the invertible region in the second state. In some embodiments, the body can be configured such that at least two of the petal members spread and displace when the body transitions from the first state to the second state. In some embodiments, at least one delivery tip can be displaced to communicate with a delivery site when the body is displaced from the first state to the second state. In some embodiments, the central opening can include at least one notch that extends outwardly from around the central opening through the adhesive member to an increased opening width portion.

[0045] According to another exemplary embodiment of the present disclosure, the delivery device can include a body. The body can include a peripheral region having a number of flap members. The body can further include a central region that projects and extends from the peripheral region and has a top surface and a bottom surface. The delivery device can further include a foldable reservoir coupled to the body. The reservoir can be in fluid communication with at least one microneedle having a certain width, height, and length. The delivery device can further include an adhesive member. The adhesive member can 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, the adhesive member can be attached 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 an installation area with a first region. The central opening can surround a second region that is 60 to 100% of the first region. 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 projects from around 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, at least one delivery sharp may include an array of spaced micro-needles. In some embodiments, the body can have a first state and a second state. The body may include at least one partially invertible region that is in a first shape in the first state and substantially inverts with respect 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 spread and displace when the body transitions from the first state to the second state. In some embodiments, at least one delivery sharp can be displaced to communicate with a delivery site when the body is displaced from the first state to the second state. In some embodiments, the central opening can include at least one notch that extends outwardly through the adhesive member from around the central opening to an increased opening width portion.

[0047] According to yet another exemplary embodiment of the present disclosure, the delivery device can include a body. The body may include a peripheral region. The peripheral region can include a plurality of petal members. The body can further include a central region. The central region may protrude and extend from the peripheral region. The central region can have an upper surface and a base. The delivery device may further include an adhesive coupled to at least a portion of the body. The delivery device can further include a reservoir that includes at least one flexible portion. The at least one flexible portion can include a cavity defined by a first wall that includes a disintegration promoting portion. The delivery device can further include at least one delivery sharp in fluid communication with the reservoir.

[0048] In some embodiments, the disintegration promoting device can include a bellows. In some embodiments, the disintegration promoting portion may include pleats that extend helically around the wall. In some embodiments, the disintegration promoting 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 a rigid portion of the reservoir. In some embodiments, the first wall can taper as the distance from the flange increases such that the cross-sectional area of the cavity decreases as the distance from the flange increases. In some embodiments, the cavity may be defined by a second wall at an end of the cavity, and the second wall forms a substantially flat surface. In some embodiments, the second surface can include a central recess. In some embodiments, the wall may extend from the flange or may be integrally formed with the flange. In some embodiments, the cavity can be defined by a first wall and a second wall at an end of the cavity, and the second wall is substantially parallel to the flange. In some embodiments, at least one delivery sharp can include a micro needle.

Brief Description of the Drawings

[0049] These and other aspects will become more apparent from the following detailed description of various embodiments of the disclosure with reference to the drawings.

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DETAILED DESCRIPTION OF THE INVENTION

[0174] Figures 1A and 1B show an embodiment of an exemplary delivery device 10. The exemplary delivery device 10 can be a low profile delivery device 10 that can be applied on a patient's skin. The exemplary delivery device 10 can be sized for hand-held use and can be easily applied to a variety of injection sites on a patient's body. Further, the exemplary delivery device 10 can be designed to be used by a patient, or an individual who is relatively untrained or has received minimal training. Thus, a healthcare provider may not be necessary for the use of the delivery device 10.

[0175] Such a delivery device 10 can be used to administer a drug from a reservoir 12 included as part of the delivery device 10 to a target delivery destination of a patient via one or more delivery sharps 72. The reservoir 12 may be at least partially flexible and may have a variable volume that can decrease as fluid is dispensed from the reservoir 12. When the reservoir 12 is emptied, the reservoir 12 may at least partially collapse. In an exemplary embodiment, a plurality of delivery sharps 72 are included in the delivery device 10, although other embodiments may include only a single delivery sharp 72. The exemplary plurality of delivery sharps 72 may be arranged in a one-dimensional or two-dimensional array and may extend from the reservoir 12. When a plurality of delivery sharps 72 are included, the delivery sharps 72 may be arranged in one or more rows and / or columns. FIG. 1A shows three delivery sharps 72 arranged in a single column, although a plurality of delivery sharps 72 may be arranged. The number and arrangement of the delivery sharps 72 may vary in alternative embodiments. Various examples may include any suitable number of rows and / or columns. In various embodiments, for example, there may be a single column array of delivery sharps 72 that includes up to five delivery sharps 72. Preferably, the delivery sharps 72 can be arranged to prevent penetration of the skin from being inhibited between the user and the delivery device 10 or to prevent an inconsistent bed of nails type situation. It can be arranged to prevent a scenario where the bed of nails penetrates. This can occur when too many delivery sharps 72 are arranged in close proximity to each other. Thus, this array may be referred to as a spaced-apart array of delivery sharps 72.

[0176] The delivery sharp 72 can be selected based on a desired target delivery site of a patient. In certain embodiments, the target delivery destination may be a percutaneous location. For example, the target delivery site may be a subcutaneous delivery site or an intramuscular delivery site. Alternatively, the target delivery site may be a shallow delivery site between the stratum corneum of the patient and the subcutaneous tissue of the patient. Such a shallow destination may sometimes be referred to herein as an intradermal delivery destination. The shallow delivery destination may include a target location in the epidermis or dermis, or, for example, may target a junction region between the epidermis and dermis, or between 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 within a delivery device 10 having a shallow (e.g., over subcutaneous tissue) target delivery destination. For example, in an alternative embodiment 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] In FIG. 2, micro-needles are used, and the micro-needles described in this specification may, in certain embodiments, be silicon crystal micro-needles in the form of polyhedra (e.g., pyramids) fabricated by MEMS. These micro-needles may have a height of 1 mm or less, for example 0.6 mm or 0.8 mm (although longer or shorter micro-needles may also be used). At least some edges of the micro-needles may be rounded or filleted, but such micro-needles may still be referred to as polyhedra in this specification. In some examples, as shown in FIG. 2, the micro-needles described in this specification may generally be in the shape of a heptagonal prism that has been cut obliquely to form a heptagonal ramp or a sharp wedge (although pentagonal, nonagonal, and other prisms may also be used as the basic shape). In such an embodiment, the heptagonal prism may be divided by a plane extending through the apex 14 of the upper surface of the prism to the most distal side 15 of the base 17. At least two sides of the base of the micro-needle may be parallel. The side walls 19 may extend substantially perpendicular to the base 17. The micro-needle may be substantially symmetric with respect to a line of symmetry extending from the apex 14 to a point above the center of the most distal side 15. In other embodiments, the micro-needle may be conical. Any other suitable shape may also be used. In this example, the apex 14 is shown as the point forming the tip of the micro-needle. In other embodiments, this portion of the micro-needle may be rounded (although it may still be referred to as the apex 14 in this specification and such micro-needles may still be referred to as being sharp). In such an embodiment, the back side edge 23 may be a rounded surface or the side wall 19 adjacent to the back side edge 23 may be replaced with a rounded surface.

[0178] The tip or tips of the microneedles may be solid, and the flow lumen 126 through the microneedle may be offset from the tip or tips of the microneedle (in FIG. 2, vertex 14 forms the tip). A microneedle with a hollow tip where the flow lumen 126 extends to the tip of the microneedle may also be utilized. In some embodiments, the microneedle may be a hollow microneedle available from NanoPass Technologies Ltd., Ness Ziona, Israel, named after Golda Meir 3. It should be noted that the microneedles (or the substrate on which the microneedles are disposed) described herein as being composed of silicon may still have a surface layer of silicon dioxide (e.g., which may be formed by exposure to air) while still being considered to be composed of silicon.

[0179] Referring to FIGS. 3A - 4B, in some embodiments, the microneedles can be constructed to include certain features that help reduce the pressure required to inject a fluid such as a drug into the patient's skin. In some examples, features common to insect needles or biotoxin delivery structures may be incorporated. These features can include various recesses or depressions formed as part of each microneedle or at least a portion of at least one microneedle of the delivery device 10. These recesses or depressions can 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 recesses, or some microneedles may include a plurality of recesses that can be different (although not necessarily so).

[0180] For example, as shown in FIGS. 4A - 4B, the microneedle can include a channel or trough 200 on the outer inclined surface 21 facing distally 15 from the flow lumen 126. The channel 200 allows the medical agent to flow along the outside of the microneedle through the channel 200 to find the path of least resistance or the weakest connection to the skin. In the illustrated embodiment, when the outlet of the flow lumen 126 is inserted to a depth deeper than the depth of the delicate area of the skin, the drug can flow along the outside of the microneedle through the channel 200 to the delicate area of the skin. The transparent layer junction, which is the destination of intradermal delivery, is a weak connection of the skin structure, and due to its relatively thin thickness (usually about 40 nm), it is consistently difficult to directly inject. The microneedle including the channel 200 can enable, for example, a medical agent to flow to the transparent plate junction when the transparent plate junction passes through the outlet of the flow lumen 126. The channel 200 can facilitate the distribution of the medical agent through a larger penetration or injection area. In some examples, by incorporating the channel 200 into the microneedle, the pressure required to inject the drug into the skin can be significantly reduced. In certain examples, the pressure can be reduced by more than 600% (e.g., from 120 pounds per square inch (psi) to 18 - 20 psi in certain examples).

[0181] Appropriate silicon etching techniques (or molds in embodiments using polymer microneedles) can be used to create the steeper sidewalls of the channel 200. This can help prevent the skin from bending and blocking the channel 200. Etching techniques that can be used include, as non - limiting examples, chemical etching techniques (e.g., acids). Appropriate etching techniques include ion - based etching techniques (e.g., reactive ion etching). The etching process can be a wet etching process or a dry etching process. In some non - limiting embodiments, the channel 200 may have a left - right width in the range of 50 - 60 microns. In some non - limiting embodiments, the flow lumen 126 may have a diameter of 50 - 60 microns. The channel 200 may have a width equal to the diameter or the widest part of the flow lumen 126, or alternatively, the channel 200 may have a width smaller or larger than the width of the flow lumen 126. The channel 200 can be about 5 - 10 percent of the height of the microneedle.

[0182] To avoid leakage of fluid from channel 200, when the micro-needle is inserted into the skin, it is desirable to ensure that channel 200 ends at least a certain distance below the surface of the skin and further reaches the target skin layer (e.g., the stratum lucidum junction). In some embodiments, channel 200 extends from flow lumen 126 to within a maximum of 50 microns (e.g., 50 - 200 microns) of the base 17 of the micro-needle. In some embodiments, the end of channel 200 closest to base 17 of the micro-needle may be beneath at least the stratum corneum (and possibly one or more of the stratum lucidum, stratum granulosum, stratum spinosum, and stratum basale) when the micro-needle is inserted into the skin. In some embodiments, the end of channel 200 closest to base 17 may be disposed beneath (e.g., within the basement membrane) or within the epidermis.

[0183] Channel 200 need not be straight nor of the shape shown and described in FIGS. 4A - 4B. In some embodiments, channel 200 may be a more serpentine flow path 200. For example, a curved flow path 200 can be used if the dimensions of the micro-needle are compatible. Further, there need not be only one channel 200. Two or more channels can be used if the structural integrity of the micro-needle is considered.

[0184] The depth of the channel 200 can be, in certain examples, greater than or equal to about 25 microns (e.g., 25 - 50 microns). The depth of the channel 200 can be less than or equal to 5 percent of the height of the micro - needle. The depth of the channel 200 may be constant along the length of the channel 200, but the depth of the channel 200 need not be constant along the length of the channel 200. Similarly, the width of the channel 200 need not be constant along the length of the channel 200 (see, e.g., FIG. 5B). The width of the channel 200 can be about 20 - 30 percent of the width of the distal side 15 of the micro - needle at the narrowest point of the channel 200. In some embodiments, the width of the channel 200 can increase as the distance to the distal end 15 decreases. In some embodiments, the channel 200 can have a width that is 50% or more of the width of the distal side 15 at its widest point.

[0185] Referring now to FIGS. 5A and 5B, in other examples, the channel 200 can extend from the location of the lumen 126 towards the tip or apex 14 of the micro - needle (see, e.g., FIG. 5B). Further, in some examples, the channel 200 can extend from the location of the lumen 126 towards the apex 14 and towards the base 17. That is, the channel 200 can include a portion on both sides of the lumen 126 (see, e.g., FIG. 5A). As shown, the lumen 126 can be located substantially at the center of the inclined surface 21 of the micro - needle. In such an embodiment, the channel 200 extends towards the distal side 15 of the base 17 and the channel 200 can extend towards the tip or apex 14. In other embodiments, the lumen 126 can be positioned at (or near) the end of the channel 200 closest to the base 17.

[0186] Referring now to FIGS. 6A-6B, a sharp bearing body 26 including a number of microneedles is shown. In certain embodiments, the channel 200 may not be included. Instead, the microneedles may include a flow lumen 126 having an elongated cross-section (at least at the outlet, see also FIGS. 7B and 8B). Microneedles with both a channel 200 and an elongated lumen 126 are also possible. The elongated lumen 126, when placed at a predetermined location within a patient's body, may be in fluid communication with, for example, multiple skin layers. Thus, when the microneedles are advanced into the patient's body, thin and / or weak layers of the skin may be more likely to be targeted. The elongated lumen 126 can also help reduce the pressure required for injection. Such an elongated flow lumen 126 can have any suitable cross-section. In some embodiments, the cross-section may be oval or elliptical. Alternatively, as shown in FIGS. 6A and 6B, a lumen 126 having an elliptical cross-section can also be used. Without limitation, polygonal cross-sectional shapes such as rectangular, trapezoidal, triangular, etc. can also be used. In a particular example, the length (elongation direction) of the cross-section of the lumen 126 can be up to 100-200 μm or greater (although in particular examples it may be smaller). When an elongated lumen 126 is included, the end of the lumen 126 closest to the distal side 15 can be spaced apart from the distal side 15 by at least a certain distance. This spacing can be such that when the microneedle is inserted into the skin, the end of the lumen 126 closest to the distal side 15 can be beneath 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 can be placed beneath (e.g., within the basement membrane) or within the epidermis.

[0187] Referring to FIGS. 6A-6B, in certain embodiments, the inclined surface 21 of the microneedle may not extend to the base 17 of the microneedle. For example, there may be a vertical surface 13 that extends from the base 17 of the microneedle to the distal side 15. When the vertical surface 13 is included, the vertical surface 13 can be aligned with the side surface (e.g., the distal side surface 15) of the sharp support 26 and can form an extension thereof. Including such a vertical surface 13 can help reduce the size of the sharp support 26 and can 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 can be arranged 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 vertices 204, 206. In some embodiments, the recess 202 may be a rounded or concave depression (although it need not necessarily be so), as shown in FIGS. 3A - 3B. The recess 202 may have a maximum depth such that the recess 202 is in fluid communication with the flow lumen 126 of the microneedle. Thus, the recess 202 can form a side port for the microneedle through which fluid can be delivered to the patient. The side port may be the sole outlet of the microneedle or may be added to the outlet of the lumen in the face 21 of the microneedle. When the microneedle is inserted into the skin surface, the fluid contained in the delivery device 10 can be at least partially delivered to the patient by being pumped into the recess 202. The recess 202 may be formed, for example, by removing material during the manufacture of the microneedle or during a shaping operation. The removal of material can be accomplished by any suitable known process, such as etching (e.g., wet etching). In some embodiments, the recess 202 may be recessed in at least one sidewall 19 or edge of the microneedle (e.g., where two sidewalls 19 meet). As shown in FIGS. 3A - 3B, the recess 202 is formed in a substantially vertical backside edge 23 of the microneedle that extends from the base 17 to the apex 14. Thereby, the vertical void volume created by the microneedle as the microneedle penetrates the skin can be established or increased. That is, such a recess 202 can establish an open space in the patient through which fluid can be easily delivered from the microneedle. By disposing the recess 202 in the backside edge 23, a low - resistance path for fluid to enter the skin penetrated by the microneedle can be provided. In embodiments where the microneedle includes at least one substantially vertical wall, the recess 202 may be recessed within the substantially vertical wall. In an exemplary embodiment, the maximum depth of the recess 202 may be from about 130% to 110% of the distance from the backside edge 23 to the flow lumen 126.

[0189] In a particular example, as shown next in FIGS. 7A and 7B, the microneedle can include an inclined surface 21 through 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 extends in an arcuate path to the apex or tip 14 of the microneedle. In this example, the rounded blade edge 31 includes a double bevel, although other types of bevels can also be used. The rounded blade edge 31 may trace an arc with a constant radius or may trace an arc with a variable radius. The rounded blade edge 31 may have an arc dimension of less than 90° or, in a particular example, may have an arc dimension of greater than 90° (see, e.g., FIGS. 8A-8C). The rounded blade edge 31 can assist in the introduction of the microneedle into the skin when the microneedle is inserted at a particular angle or over a variety of different angles.

[0190] In yet another embodiment, as shown in FIGS. 8A - 8C, the lumen 126 may include a round blade edge 31 and a lumen exit surface 35. The lumen 126 may extend through the micro - needle to the lumen exit surface 35 and may not be formed along a straight line passing through the micro - needle. The lumen exit surface 35 may be angled distally 15 from the apex 14 so as to form an undercut. The distal edge 15 may be arranged such that a plane perpendicular to the base 17 passing through the distal edge 15 can also pass through the round or arcuate blade edge 31. Further, the exit of the flow lumen 126 at the lumen exit surface 35 is arranged such that one or all planes perpendicular to the base 17 passing through the exit of the flow lumen 126 can also pass through the blade edge 31. This need not apply to all embodiments (see, e.g., FIGS. 7A - 7B). When a micro - needle of the type shown in FIGS. 8A - 8C is inserted, a vertical void may be created by the undercut. This may provide a low - resistance path for fluid injection. Further, the undercut may help reduce the likelihood that the lumen 126 will be occluded by the skin when the micro - needle is inserted into the patient or when delivery is performed.

[0191] In yet other embodiments, as shown in FIGS. 9A - 9D, the delivery sharp 72 may be or may include a micro - needle having a high aspect ratio shape. In some embodiments, the micro - needle may be in the shape of an obelisk. Such a micro - needle can be included in an array such as any of the arrays described herein. When an obelisk - type micro - needle is used, the micro - needle may include a base 17'. The base 17' may be of any desired circular or polygonal shape. By way of example, FIGS. 9A - 9D show a base 17' that is square or rhombus - shaped. An exemplary micro - needle includes a set of side walls 19' that extend from the base 17' to the end region 25 of the micro - needle. The side wall 19' may be arranged at an angle that is not perpendicular to the base 17'. Thus, the microneedle can be tapered to have a smaller cross-sectional area as the distance from the base 17' increases. The most distal portion of the microneedle of the base 17' may include a chamfered tip 27. Such a tip 27 can facilitate skin penetration and can help enhance the robustness of the end region 25. Any suitable chamfer, such as a single chamfer or a double chamfer, can also be used.

[0192] In an embodiment of the obelisk-shaped microneedle, the microneedle may include at least one side port 29 that can function as an exit for the microneedle. Such a side port 29 may be difficult to block with tissue that may be compressed during insertion of the microneedle into the patient. In an exemplary embodiment, the lumen 126 may extend through the base 17' of the microneedle and may have a terminus 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' can be such that the terminus of the lumen 126 is wider than a portion of the cross-section of the corresponding region of the microneedle. Thus, the lumen 126 can form an opening that functions as the side port 29 in the side wall 19'. In various examples, the lumen 126 can be centrally located and can provide symmetric side ports 29. In alternative embodiments, the lumen 126 need not be centrally located and the side ports 29 may not be symmetric.

[0193] In various embodiments where silicon is not used to form the microneedles, the microneedles described herein are made of glass (e.g., silica glass, borosilicate glass), ceramic (e.g., alumina, calcium sulfate dihydrate, calcium phosphate dihydrate, organically modified ceramics such as ormosil), polymer (e.g., polymethyl methacrylate or PMMA, polylactic acid or PLA, polylactic acid - co - glycolic acid or PLGA, polyglycolic acid or PGA, polycarbonate, cyclic olefin copolymer or COC, polyvinyl pyrrolidone or PVP, polyvinyl alcohol PVA, polystyrene, polymethyl vinyl ether - co - maleic anhydride), carbohydrate, or metal (e.g., alloys such as stainless steel, titanium, palladium, nickel, palladium - cobalt alloy, etc.). Any suitable microneedle structure including dissolvable microneedles can be used. The microneedles and their features can be manufactured by one or more of a molding process, an etching process, an ablation process (e.g., laser ablation), or a material addition process (e.g., 3D printing), but are not limited thereto. In various embodiments, the microneedles may desirably be composed of a biocompatible, non - ductile, high Young's modulus material having sufficient push - in hardness to allow penetration into the skin without breaking.

[0194] Referring again mainly to FIGS. 1A and 1B, the delivery device 10 described herein can deliver any of a variety of drugs or other pharmaceutical agents to a patient. In certain embodiments, the reservoir 12 of the delivery device 10 may be filled with a vaccine. Such a delivery device 10 can deliver any suitable vaccine, but may be particularly well-suited for vaccines against novel pathogens (e.g., SARS-CoV-2) or pathogens for which there is no herd immunity (e.g., Ebola hemorrhagic fever). Further, such a delivery device 10 may be particularly useful in the event of an outbreak of a pathogen (e.g., measles, etc.) in a community that has elected to forego typical vaccination. For example, such a delivery device 10 can be distributed without the patient having to gather at a hospital or other shared space. This can reduce concerns about the spread of pathogens associated with vaccination programs and can reduce potential concerns that people may hesitate to get vaccinated. Instead, the patient can pick up and use the delivery device 10 without violating social distancing, recommendations regarding the size of gatherings, or other safety guidelines. Alternatively, such a delivery device 10 can also be distributed directly to the patient without the patient having to leave their residence or interact with individuals who decline to use the recommended PPE. The delivery device 10 could be filled with a vaccine against a novel pathogen or a vaccine typical of a normal vaccination schedule. In the latter case, such a delivery device 10 could help to ensure that vaccinations against known pathogens do not lapse 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 heterologous vaccine or a Jennerian vaccine, a monovalent vaccine, a multivalent 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. It should be noted that these are not necessarily mutually exclusive. For example, the vaccine can be a recombinant protein nanoparticle vaccine or other combinations as described above. The vaccine may also refer to a combination vaccine (e.g., DTaP, MMR, MMRV, etc.) or a vaccine inoculant targeting a single pathogen or multiple strains of a single pathogen. Examples of vaccines include, but are not limited to, vaccines against various coronaviruses such as SARS-COV, SARS-COV-2, MERS-COV, HCoV-NL63, HCoV-229E, HCoV-OC43, and HKU1. The delivery device 10 described herein is also not limited to human use. Such a delivery device 10 can be used for livestock, pets, service animals, or other veterinary applications. In such cases, these delivery devices 10 can be filled with a vaccine against at least one non-human pathogen. The delivery device 10 described herein may also be useful for research purposes.

[0196] When the delivery device 10 is filled with a vaccine, it may be desirable for the target delivery site to be a shallow delivery site. This is particularly desirable when the amount of available vaccine is limited. For example, such a delivery device 10 may be well suited for use with new vaccines in high demand. Vaccines against novel pathogens (e.g., SARS-CoV-2 or other coronaviruses) may, for example, be well suited for use with the delivery device 10 described herein.

[0197] There is evidence suggesting that shallow delivery of vaccines may elicit a protective immune response with a smaller amount of vaccine antigen. As a result, it is possible to save on dosage and effectively vaccinate more people with the same amount of vaccine. Alternatively or additionally, it may be possible to save on injections. Shallow administration using the delivery device 10 as shown herein can enable a single injection protocol when other administration routes may require multiple injections over a period of time. Some vaccine formulations may include one or more adjuvants to further facilitate dosage and injection savings, but it is also possible to reduce the dependence on adjuvants when the vaccine is administered intradermally.

[0198] In particular, in the case of new vaccines generated to fight an ongoing pandemic (e.g., a SARS-CoV-2 vaccine), the prospect of being able to rapidly produce billions of doses of vaccine will almost certainly exceed current vaccine production capacity. Due to the injection and dosage savings potential of the delivery device 10 described herein, such a delivery device 10 can facilitate vaccination of a large number of people even when there is a shortage of much-needed vaccines. Furthermore, as a result of potential dosage and injection savings, the delivery device 10 as shown and described herein may be able to make injections more cost-effective. Additionally, since less vaccine is required, the delivery device 10 can be made relatively small. This can simplify transportation and facilitate the rapid distribution of vaccines to the population. This can be particularly attractive for vaccines that require cold chain distribution as the importance of packaging volume may increase.

[0199] Furthermore, some studies have suggested that shallow administration may be particularly useful in certain patient populations. For example, the elderly may receive better protection from intradermal vaccination than from other routes. However, the Mantoux technique commonly used for intradermal administration can raise concerns about reliability and may be difficult to perform without training. According to the World Health Organization, a major factor limiting the use of intradermal vaccination is the lack of a delivery platform.

[0200] Delivery device 10 as illustrated and described herein can provide an attractive delivery platform for intradermal vaccination. As a result, the delivery device 10 described and illustrated herein can help provide better protection to vulnerable populations and can help meet a large demand for vaccines against, for example, new pathogens, by taking advantage of dose / injection savings that can be achieved with intradermal vaccination. Furthermore, since the intradermal delivery device 10 described herein is painless or nearly painless, the delivery device 10 described herein can be more preferable to the user than other types of injections. That being said, also as described 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 assay agents, can be delivered via a particular exemplary delivery device 10. For example, allergens or potential allergens can be administered via the delivery device 10. Tuberculosis assay agents can be delivered via the delivery device 10. Such a device 10 can also be used to deliver agents for endocrine disorders. For example, insulin can be delivered using some exemplary delivery devices 10.

[0202] Referring further to FIGS. 1A - 1B, the delivery device 10 may include a main body 20. The main body 20 may be a deformable main body that can transition from a storage state (see FIG. 1A) to a delivery state (see FIG. 1B). In a particular example, this transition may be reversible, but in other embodiments, the transition may result in a permanent change to the main body 20 and / or another part of the delivery device 10. The main body 20 may be plastically deformed so as to be permanently distorted and unable to return to the storage state. In other examples, a weak part included in the delivery device 10 may break when the main body 20 transitions to the delivery state. Alternatively or additionally, it can engage with a latch, lock, or other connector to hold the main body 20 in the delivery state or prevent the main body 20 from returning to the storage state. To release such a connection, it may be necessary to break a part of the main body 20 or a part of the delivery device 10 engaged with the main body 20, and this breakage may render the delivery device 10 inoperable. If a permanent change occurs during the transition to the delivery state, this permanent change can not only prohibit reuse but also provide a perceptible (e.g., visual) indication to the user that the delivery device 10 has been used. The indication that the transition has occurred can also be generated by the delivery device 10. For example, an audible or tactile indication can be generated upon engagement of the latch or breakage of the weak part.

[0203] In various examples, the transition of the delivery device 10 from a storage state to a delivery state can be achieved via bending, pivoting, or deformation of one or more regions of the main body 20. In a particular example, the main body 20 may include one or more hinges (e.g., a living hinge (integral hinge) that helps reduce the number of parts) through which the main body 20 can bend. In other embodiments, the main body 20 may be or may 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 main body 20 may have one or more invertible regions that, for example, substantially or partially invert in shape (e.g., from convex to concave) or at least partially invert when the delivery device 10 transitions from the storage state to the delivery state. The transition may be affected by applying a force throughout the transition. Alternatively, the transition may only require applying a force to part or all of the transition. For example, in some embodiments, a trigger force is applied to initiate the transition, and then the transition may complete without an external force being applied. For example, after the application of the trigger force, the transition may be characterized by snap-through buckling in which the main body 20 rapidly transitions to the delivery state.

[0204] The body 20 may be at least partially covered with an adhesive 22 on a first face 24 of the body. The body 20 can serve to couple the body 20 to the skin surface of a patient's infusion or injection site. Thus, the first face 24 may be the face of the body 20 adjacent to the skin or the proximal (proximal and distal as defined with respect to the patient) face. When the body 20 is in a storage state and then transitions to a delivery state, the body 20 may be adhered to the skin. When the transition occurs, at least two adhesive-bearing portions of the body 20 can displace relative to each other to stretch or expand a surface secured to the body 20 via the adhesive 22. When these portions are adhered to the skin surface, the skin can be stretched as the adhesive-bearing portions displace relative to each other. This may be desirable because when the body 20 transitions to the delivery state, the skin can be tensed so as to facilitate piercing of the skin by the delivery sharp 72. In a particular example, the adhesive-bearing portions can be arranged, for example, opposite to each other. Displacement of the two adhesive-bearing portions can increase the distance between the two adhesive-bearing portions or spread 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 can occur, for example, when a flat portion of the skin is pulled around the curve or contour of the body 20 by the transition (see, for example, FIGS. 17 and 18). The displacement of the adhesive-bearing portions relative to each other that results in stretching of the adhered skin (regardless of a positive or negative change in the distance between the adhesive-bearing portions) may be referred to as a spreading displacement. The two adhesive-bearing portions so displaced may be referred to as being spread and displaced.

[0205] When the body 20 transitions to the delivery state, the delivery sharp 72 may be displaced or lowered proximally into the skin towards the skin. In embodiments where the delivery sharp 72 is coupled to the reservoir 12, the reservoir 12 can also be displaced proximally. In some examples, the reservoir 12 can be compressed between the skin surface and a portion of the body 20 when the body 20 transitions from the storage state to the delivery state. Preferably, the delivery sharp 72 can be inserted into the skin before the reservoir 12 is substantially compressed. Compression of the reservoir 12 can help to expel fluid from the reservoir 12 and cause it to flow through the delivery sharp 72 and into the target delivery destination within the patient's body. In the embodiments described herein, the delivery sharp 72 may be covered prior to use. The fluid communication path from the reservoir 12 to the outside of the delivery sharp 72 may not be available prior to use.

[0206] In some embodiments, as shown in FIG. 10A, a foldable pouch or packet 208 can be disposed over the reservoir 12 within the delivery device 10. The packet 208 may contain a substance that is in a resting state in a first state and transitions to a powered state upon application of power in a second state. In one embodiment, the substance is in a resting state at a first temperature and can apply motive power to the reservoir 12, for example, at a second temperature. In an exemplary embodiment, the first temperature may be lower than the second temperature. The first temperature may be the cold chain storage temperature of a vaccine. The second temperature can be room temperature, or at least a temperature lower than the average body temperature of the patient (e.g., 98.6°F for a human). In some embodiments, the substance can change in volume when transitioning from the resting state to the powered state. Alternatively or additionally, the substance can change from one substance state to another when transitioning from the resting state to the powered state. In an exemplary embodiment, the substance can change from a liquid to a gas during the transition from the resting state to the powered state.

[0207] In an embodiment where the drug in the reservoir 12 of the delivery device 10 must be stored at a very low temperature, for example, if the drug is a vaccine having such requirements, the packet 208 can contain a liquid. For example, the vaccine can be stored and / or transported at a commercial freezer temperature in the range of, for example, -18 °C (or below, for example, -70 °C or -20 °C for certain vaccines). The liquid can have a boiling point higher than the storage temperature of the drug (e.g., the vaccine), but lower than room temperature or another appropriate temperature setting. Any suitable liquid can be used, and an example of a suitable liquid is butane. The boiling point of butane is -1 °C. Although the examples described herein refer to butane, those 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 the skin surface of the user together with the reservoir 12 containing the cryopreserved / shipped vaccine and the packet 208 containing liquid butane (or any other suitable substance). When the ambient temperature is room temperature, for example, about 20 °C, the contents will warm up (heat from the patient may help with this). In an exemplary embodiment, the liquid butane boils and changes to a gas when it reaches its boiling point of -1 °C. When the liquid boils and transitions to the gaseous state, the pressure inside the packet 208 increases, the packet 208 expands, and a downward pressure is applied to the reservoir 12 from above as shown in FIG. 10B. For example, butane gas has a vapor pressure of 35.4 psi at 25 °C. Thus, the final pressure in the reservoir 12 can be higher due to heat transfer from the patient to the packet 208 (e.g., about 38 psi). The body 20 of the delivery device 10 may have sufficient elasticity so as not to deform under the pressure applied from the packet 208. This can help direct the pressure towards the reservoir 12.

[0209] Such a configuration can also help provide visible evidence as to whether the delivery device 10 has reached a temperature that is too high for the drug during storage or transportation. For example, if during storage the temperature reaches above the phase change temperature of the contents of packet 208, the delivery device 10 will empty due to the pressure applied from above by the packet 208. This can be visually recognized by the user. The delivery device 10 can also self-destruct when exposed to certain temperature abuse scenarios. When the delivery device 10 is exposed to a temperature above the phase change temperature of the contents of packet 208, the delivery device 10 will empty. As a result, the delivery device 10 will prevent itself from administering the temperature-abused drug later.

[0210] In some embodiments, it may be desirable to provide a substantial downward pressure on reservoir 12, for example, a substantial downward pressure exceeding 50 psi, to provide a force to crush reservoir 12 and push the fluid therein through delivery cannula 72 into the user's skin. Refer to FIGS. 1A and 1B. In such embodiments, packet 208 can be incorporated within a squeezable container 350 as shown in FIG. 11. Container 350 can be made of a squeezable plastic or any other suitable material, as would be understood by one of ordinary skill in the art. Container 350 can be formed by injection molding, thermoforming, or any other technique known to those skilled in the art. In addition to housing packet 208, a first substance can be stored within container 350. Packet 208 can hold a second substance. The first and second substances can be, for example, components of an expanding foam. The first and second substances can be selected such that they expand and create pressure when they contact each other. For example, a chemical reaction that generates gas (such as baking soda and vinegar) can also be used. When the delivery device 10 is applied to the skin surface, the user can, for example, squeeze, crush, compress, or squeeze container 350. This causes the packet 208 therein to rupture, thereby causing the first substance and the second substance to interact and apply a downward pressure on the underlying reservoir 12.

[0211] In yet other embodiments, 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. Due to the user's interaction with packet 208, packet 208 may be destroyed and the biasing member may be able to recover. When the biasing member recovers, pressure is applied to reservoir 12, generating pressure for delivery.

[0212] In another embodiment, packet 208 of FIGS. 10A or 10B may be filled with contents that do not change phase when removed from a refrigerated storage. For example, packet 208 may be a gas bag that serves to prevent pressure from the user's finger applied to the top of delivery device 10 from being directly applied to reservoir 12. Such a gas bag may also help to increase the applied pressure. An example of a suitable gas that may be used to fill such a packet 208 may be nitrogen. Any other suitable gas may be used.

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

[0214] Referring to FIGS. 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 main body 20 and a reservoir 12. The reservoir 12 can include at least one delivery lancet 72. The delivery lancet 72 can be included on a lancet support 26 that can be coupled to the wall of the reservoir 12. The main body 20 of the exemplary delivery device 10 can have a circular (e.g., round) installation area and can include a central region 28 and a peripheral region 30. The central region 28 can be a raised region of the main body. The main body 20 and the peripheral region 30 can be a substantially flat region of the main body 20 surrounding the central region 28. The thickness of the main body 20 can be substantially uniform throughout the main body 20. It can be formed as a thin sheet or disk of material that can be thermoformed to form the raised central region 28 and the flat peripheral region 30.

[0215] Alternatively, the main body 20 can be injection molded to form the raised central region 28 and the flat peripheral region 30 during the molding operation. In various embodiments in which the delivery device 10 is injection molded or can be injection molded (e.g., the embodiments described in connection with FIGS. 12 - 33), the main body 20 can be injection molded to be in a storage state or a delivery state. The main body 20 can more easily transition from the reverse state to the molded state. Thus, it may be desirable to mold the main body 20 of the delivery device 10 into its delivery state shape to reduce the effort required to transition the delivery device 10 from the storage state to the delivery state. During assembly of the delivery device 10, the main body 20 can be configured in its storage state and can remain in that configuration until used.

[0216] The central region 28 may be dome-shaped, and due to its dome shape, a receptacle 32 can be formed on the proximal side of the body 20, and the reservoir 12 can be disposed therein. The reservoir 12 can be coupled within the receptacle 32 via an adhesive or by another suitable method. The central region 28 can also include a series of openings 34 that can form a fenestrated ring in the central region 28. In this example, the openings 34 are equally spaced from each other and are arranged in a circular shape that is substantially coaxial with the center. In alternative embodiments, the openings 34 may be arranged at irregular intervals or omitted. Further, in some embodiments, instead of the openings 34, the material of the body 20 can be replaced with a thinner region or ring.

[0217] The body 20 can include a number of slots 36. The slots 36 can extend from the periphery 38 of the body 20 towards the 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 further extend across at least a portion of the central region 28. The openings 34 in the central region 28 can be disposed radially inward of the ends 40 of each slot 36. Thus, the body 20 can include a central region 28 surrounded by a plurality of petal members 42, which are spaced apart via the slots 36.

[0218] Referring to FIG. 15, a plan view of the proximal surface 24 of the body 20 is shown. As shown, the adhesive 22 may be included in at least a portion of the proximal surface 24. The adhesive 22 may be a skin-compatible adhesive and can serve to couple the delivery device 10 to the skin surface of the injection site. In an exemplary embodiment, the adhesive 22 may be included on the peripheral region 30 of the body 20. Although the adhesive 22 is shown as covering the entire surface of each petal member 42 within the peripheral region 30, other embodiments may vary. For example, only certain petal members 42 may include the adhesive 22. In such embodiments, the adhesive 22 may be included in at least one pair of petal members 42 that are disposed opposite each other (e.g., directly opposite in the exemplary 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 by the adhesive 22. Alternatively or additionally, the adhesive 22 may vary from petal member 42 to petal member 42. One petal member 42 may be covered with a stronger adhesive 22, and another petal member 42 may be covered with a less strong adhesive 22. In certain examples, additional adhesive members 22 are described elsewhere herein (e.g., see FIGS. 63A - 63C) and can 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 be substantially inverted. The aperture 34 can facilitate this inversion by allowing an increase in the flexure of the body 20 at the aperture 24. Thus, the central region 28 of the body 20 can take on a concave shape instead of the convex dome - like shape. When the peripheral region 30 is coupled to the central region 28, the peripheral region 30 may be displaced as a result of the inversion of the central region 28. In the exemplary embodiment, the entire body 20 takes on a bowl shape when shifted to the delivery state. The peripheral region 30 can also be displaced extensively over at least a portion of the transition. The slots 36 in the body 20 serve to facilitate the expansion displacement of the petal members 42 when the transition occurs, thereby facilitating the stretching of the user's skin.

[0220] The body 20 may be a bistable element or may include at least one bistable region that can be stable in both the storage state and the delivery state. When the body 20 is in the storage state, if an axial load acts on the central region 28, the body 20 may deform and become unstable. Next, the body 20 exhibits a snap-through buckling effect and can be rapidly shifted to a stable delivery state similar to that shown in FIG. 16. Therefore, only a trigger force can be applied to initiate the transition. The remaining change between the storage state and the delivery state can be caused by the snap-through phenomenon.

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

[0222] Two opposing points 46A, B disposed at 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 straight line is substantially 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 fixed to the body 20 via the 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 can 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 outer skin 44 is placed under tension and may be stretched to accommodate this change in length. This stretching can in turn help facilitate the piercing of the skin 44 by the delivery sharp 72.

[0223] When attempting to return to the unextended state, due to the elasticity of the skin 44, the skin 44 can exert a restoring force on 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 is in fluid communication with the target delivery destination within the patient's body. Further, since the reservoir 12 is foldable, the restoring force exerted by the skin 44 can pressurize the reservoir 12 and cause fluid to be discharged from the reservoir 12 through the delivery sharp 72. The extended skin 44 can help collapse and empty the reservoir 12.

[0224] As described above, in certain examples, some of the petal members 42 may not include the adhesive 22 region or may have a proximal surface 24 that is at least partially covered with an adhesive 22 that is not stronger than the adhesive 22 on other petal members 42. If there is no adhesive 22 on some of the petal members 42, this can help limit the stretching of the skin 44. Similarly, petal members 42 having a less strong adhesive 22 can release the patch of the attached skin 44 if the force required to stretch the skin 44 exceeds a threshold. The petal members 42 themselves may be constructed such 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 can bend or buckle in the relief region to relieve some of the tension applied to the skin 44.

[0225] This may be desirable as it can help reduce the potential discomfort during injection due to excessive tension of the skin 44. Further, since the characteristics of the skin vary with age, hydration status, lifestyle (exposure to sunlight, nutrition), etc., it can be useful for certain patient populations. Sagging or loose skin may desirably stretch more than elastic skin. Thus, instead of providing various delivery devices 10 with different adhesives 22 for specific patient populations, the delivery device 10 can be fabricated in a more general-purpose manner.

[0226] Referring to FIGS. 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, for example, substantially circular base. The peripheral region 30 may be of a generally annular shape and may include an inner and outer circumference or periphery 38 that coincides with the base 262. The delivery device 10 may be constructed of Nycoa 2012 nylon or other similar nylon materials and may be formed by injection molding. Any other suitable plastic may be used. The upper surface 250 may, for example, have a generally circular, rounded footprint and may be a convex surface forming a dome shape. The upper surface 250 can have a periphery 340. The upper surface 250 may include slots 254. The slots 254 can be, in various embodiments, notches, holes, apertures, openings, or voids. The slots 254 can assist the delivery device 10 in transitioning from a storage state to a delivery state under reduced pressure from above. The slots 254 each have a first end point 258 that surrounds a region including the center point 256 of the upper surface 250, and each second end point 260 is at a respective distance (in embodiments including the slots 254, the slots 254 can be arranged at regular angular increments (although this is not necessary). In embodiments described herein including the slots 254, the slots 254 may each be of the same length (although this is not necessarily required).

[0227] Referring to FIGS. 21A - 21I, various different embodiments of the body 20 are shown. The exemplary body 20 is shown in a flat state and can be thermoformed into a shape as shown in, for example, FIG. 19. Although a thermoformable body 20 is shown, the features described with respect to the thermoformed body 20 may be included in a body 20 manufactured in any desired method. As shown in FIGS. 21A - 21I, the slots 254 can be provided in many different formats. Further, in some embodiments, the slots 254 may be absent.

[0228] In some embodiments, as shown in FIG. 22, the slots 254 can be arranged so as not to extend radially with respect to the center point 256. For example, each of the slots 254 can extend at a common angle with respect to the radial direction. In such embodiments, the slots 254 can be arranged equidistantly around the upper surface 250 and can each have the same length. In other embodiments, not all of the slots 254 need extend at a common angle with respect to the radial direction. At least one (and perhaps all) of the slots 254 may be arranged at different angles with respect to the radial direction. In some embodiments, the slots 254 are relatively short and are arranged around the periphery 340 of the upper surface 250 and can be arranged within the outer region of the upper surface 250 (see, for example, FIG. 21A). In other embodiments, the slots 254 may extend across the outer region and the intermediate region of the upper surface 250 (see, for example, 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, for example, FIG. 21C). The angled slots 254 can help reduce the amount of pressure required to transition the delivery device 10 from the storage state to the delivery state. Placing the slots 254 at a more acute angle with respect to the radial direction generally may reduce this pressure. The width of the slots 254 can decrease slightly during at least a portion of the transition from the storage state to the delivery state.

[0229] In other embodiments, at least one of the slots 254 may have a curvature, mainly as shown in FIG. 21E. The curvature can be defined by a constant or variable radius. The curvature may exist only on segments of the slot 254. In alternative embodiments, the slot 254 may include two or more sections that are angled with respect to each other. In the exemplary embodiment shown in FIG. 1, in FIG. 21E, four curved slots 254 are shown, which are spaced apart at equal angular increments. The slot 254 is arcuate and includes a first end 258 and a second end 260. Each exemplary slot 254 is initially oriented to extend in a first direction from the first end 258 and then curve to extend in a second direction, like a slot. The second direction may be closer to perpendicular (or perpendicular) to the radial direction than the first direction.

[0230] In some examples, next, mainly as shown in FIGS. 21D and 21F, the upper surface may not include the slot 254, but instead may include at least one opening 255. In the illustrated example, the opening 255 is disposed centrally within the upper surface 250. In some embodiments, the opening 255 can surround substantially the entire upper surface 250.

[0231] As shown in FIGS. 21D and 21F, the slot 254 may be included in other regions of the body 20. In an exemplary embodiment, the region of the body 20 that becomes the support structure 252 (when the body 20 is thermoformed) includes the slot 254. These slots 254 may be straight, curved, angled (with respect to the radial dimension), or combinations thereof, similar to the patterns of the slots 254 on the various upper surfaces 250 described herein. As shown, the slots 254 are spaced apart at regular angular intervals and are spaced between the petal members 42 of the 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 have a continuously varying width or may terminate in pointed first or second ends 258, 260. The variable-width slots 254 may extend along a radial direction, but need not do so in all embodiments. In an exemplary embodiment, each of the slots 254 is widest proximal to the central point 256 of the upper surface 250 and the width continuously decreases 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 a sunburst pattern of slots 254 that radiate outward like rays of light emitted by the sun. In other embodiments, the slots 254 need not necessarily have a continuously increasing or decreasing width from one end to the other.

[0233] As shown in FIG. 22, the central region 28 can be formed monolithically with a petal member 42 that includes the region between each pair of slots 36 (see also FIGS. 12-18 and the examples and embodiments described above in connection therewith). The support structure 252 may extend upwardly from the petal member 42 at an angle of 90° or greater than 90°, such as 100-105°, although the measure of the angle need not be limited to a range. The (vertical) distance from the base 262 of the support structure 252 to the periphery 340 of the upper surface 250 is such that in some embodiments, a receptacle for the reservoir 12 in the central region 28 (see, e.g., FIG. 60), any packet 208 and / or container 350 (see, e.g., FIGS. 10A-11), spring, or foamed adhesive material can be provided with sufficient length. The receptacle may also be sized to accommodate a portion 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 bag, butane packet, or delivery force supply packet, and any associated container 350 as described above with respect to FIGS. 10A-11. In some embodiments, the aforementioned distance can be about 0.3 inches (e.g., 0.315 inches). The slots 36 may extend from the periphery 38 of the delivery device 10 to the base 262 of the support structure 252, but may terminate at the base 262 and not extend into the support structure 252 itself. In such embodiments, when pressure is applied from above (e.g., with a finger), not the entire central region 28 substantially flips, but only the upper surface 250 flips and can take on a concave shape in the delivery state. In some embodiments, the support structure 252 may include openings 264 spaced equidistantly around the base 262. The openings 264 can facilitate the manufacture of the delivery device 10 in embodiments where the body 20 is thermoformed.

[0234] In some embodiments, as shown in FIG. 23, at least one of the flap members 42 may be made with an extended length such that the outer end of the flap member 42 can be operated as a pull tab 266 by the patient or healthcare provider. 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 of any suitable shape. In one example, the pull tab 266 is generally semi-circular, having a first rounded end and a second end opposite the first end, and is attached to the flap member 42. The second end can be attached to the flap member 42 or formed integrally with the flap member 42 by injection molding or other known techniques that allow the pull tab 266 to be lifted sufficiently from the skin surface for the user to hold.

[0235] As shown in FIG. 24, the pull tab 266 can also help facilitate the user in peeling the release liner 265 from the bottom of the delivery device 10 before the delivery device 10 is applied to the skin surface via the adhesive 22. The release liner 265 can be removed in the same manner as peeling a release liner from a bandage before applying it to the skin. An exemplary delivery device 10 having the pull tab 266 and including the release liner 265 and the adhesive 22 is shown in FIG. 24. For purposes of illustration, the release liner 265 has been peeled from the adhesive 22.

[0236] Referring to FIGS. 25 - 26 and FIGS. 28A - 28B, in some embodiments, the delivery device 10 may include a central region 28 that is generally fingerless or dome-shaped but has a relatively low height compared to certain other embodiments described herein. The (vertical) distance from the base 262 to the periphery 340 of the upper surface 250 may be relatively short. In some embodiments, the aforementioned distance may be about 0.15 inches.

[0237] Further, or alternatively, the peripheral region 30 may not be of a substantially flat annular shape. The peripheral region 30 may be defined by a downwardly extending curved flap member 42 such that the peripheral edge 38 is disposed 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 peripheral edge 340 of the upper surface 250). The peripheral edge 38 may be disposed along a plane that is more distal with respect to the peripheral edge 340 of the upper surface 250 than the base 262. In FIG. 25, the delivery device 10 is shown in a stored state. The delivery device 10 may include a slot 36 that can be disposed between the flap members 42, similar to other embodiments of the delivery device 10 described herein. An adhesive 22 (e.g., see FIG. 24) may be attached to at least a portion of at least two of the flap members 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 disposed on the base 262 of the support structure 252. The support structure 252 may be thickened in the region near the base 262 so as to form the ridge 290. Thereby, for example, in an injection molding operation for forming the remainder of the body 20, the ridge 290 can be easily formed. Thereby, additional rigidity can also be imparted to the support structure 252. The ridge 290 can provide a step, projection, or other attachment surface to which a portion of the reservoir assembly 12 of the delivery device 10 can be attached. Such a ridge 290 can be included in any of the embodiments of the delivery device described herein. The reservoir assembly 12 and the ridge 290 will be further described elsewhere in this specification.

[0239] Referring mainly to FIGS. 28A - 28B here, two conceptual representations of the delivery device 10 transitioning from a storage state to a delivery state are shown. When the delivery device 10 is attached to the skin with the adhesive 22 and pressure is applied to the delivery device 10 from above, for example, by the user's fingertip, the delivery device 10 can transition to the delivery state. When the flap member 42 is pressed against the surface of the skin, the flap member 42 spreads outward and displaces, and at least a part of the flap member 42 can curl upward by the skin and / or the patient's body. Next, as a part of the opposing flap members 42 fixed to the skin surface by the adhesive 22 (shown only in FIG. 28A) move away from each other or spread and displace, the skin may stretch. When the delivery device 10 transitions to the delivery state, at least a part of each of the curved flap members 42 can curve further or with a smaller radius of curvature. When the delivery state is reached, the curvature of the flap member 42 can be made to extend from the base 262 to the inflection point 360. The inflection point 360 is located in a plane spaced from the plane of the base 262 and in such an embodiment may also be referred to as the lowest point. In such an embodiment, the lowest point 360 may be in a plane more distal to the peripheral edge 340 of the upper surface 250 than the base 262. From the inflection point 360, the flap member 42 may curve upward and back so as to get closer and closer to the plane in which the peripheral edge 340 of the upper surface 250 is disposed. The peripheral edge 38 of the flap member 42 can be disposed, for example, in the plane of the base 262 or at a point above it (closer to the plane of the peripheral edge 340 of the upper surface 250). The flap member 42 does not necessarily have to, but each has a constant radius of curvature from the inflection point 360 to the peripheral edge 38. The constant radius of curvature returning upward can enhance the ability of the flap member 42 to curl upward. Thereby, as the points 360 on the opposing flap members 42 (each fixed to the skin by the adhesive 22) spread and displace, the stretching of the user's skin can be promoted. As described elsewhere in this specification, the upper surface 250 of the main body 20 can also invert when the delivery device 10 transitions to the delivery state 10.

[0240] In some non-limiting examples, when in the stored state, the delivery device 10 can have the dimensions and radii of curvature as shown in FIGS. 27A-27B. It should be understood that the dimensions shown are merely exemplary. Other delivery devices 10 having the same ratio but different sizes are also possible and contemplated. Further, delivery devices 10 having different dimensions and ratios are possible and contemplated.

[0241] Referring to FIGS. 25-26 and FIGS. 28A-28B, in some embodiments, the support structure 252 may not include the openings 264 (see, e.g., FIG. 19) that are equally spaced around the base 262. The body 20 can be manufactured by injection molding. One of ordinary skill in the art will readily understand that other manufacturing techniques can be used. The body 20 can be constructed from a single monolithic piece of material such that the central region 28 and the peripheral region 30 are integral with each other. 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 materials. In other embodiments, the body 20 may be made of a polypropylene material. The body 20 may be manufactured from a material that helps to minimize water absorption or a material that helps to maximize the ability to adhere to the adhesive 22. A material that achieves both of these objectives to the desired degree can be selected. These materials can be used for any of the bodies 20 described herein.

[0242] Further, as shown in FIGS. 25-26 and FIGS. 28A-28B, the upper surface 250 may have a round installation area, such as a substantially circular shape, and may be a convex surface forming a dome shape (including the peripheral edge 340). The upper surface 250 may include slots 254. The slots 254 can be notches, openings, holes, apertures, or voids in various embodiments. Each slot 254 may surround a region including the center point 256 of the upper surface 250 at its respective first end point 258, and may each terminate at a distance from the peripheral edge 340 of the upper surface 250 at its respective second end point 260 (e.g., the slots 254 may each terminate at the same distance). In certain embodiments, the slots 254 may be arranged at regular angular increments and may each be of equal length (although this need not apply to all embodiments).

[0243] Referring further to FIGS. 25-26 and FIGS. 28A and 28B, in an alternative embodiment, as described above with reference to FIG. 22, the slots 254 may be arranged so as not to extend radially with respect to the center point 256. For example, each slot 254 may extend at a common angle with respect to the radial direction. In such an embodiment, the slots 254 can be arranged equidistantly around the upper surface 250 and can each be of the same length. In other embodiments, not all of the slots 254 need extend at a common angle with respect to the radial direction. At least one (and perhaps all) of the slots 254 may be arranged at different angles with respect to the radial direction.

[0244] Referring mainly to FIGS. 29 - 33 here, several diagrams of the conceptual representation of the delivery device 10 in the delivery state are shown. As described above (and referring to the embodiments of FIGS. 12 - 20), when a downward pressure is applied to the upper surface 250, the delivery device 10 can transition from the storage state to the delivery state. In this delivery state, the main body 20 of the delivery device 10 is substantially or at least partially inverted. The user can remove the adhesive liner 265 (e.g., referring to FIG. 24) from the delivery device 10 and apply the delivery device 10 to the skin. Next, the user can push the upper surface 250 downward (i.e., towards the skin). Thereby, the petal member 42 spreads outward and is displaced, curls upward (at least over a part of it), and can stretch the skin. The upper surface 250 can be inverted to push the delivery sharp 72 into the skin, and may remain inverted when the delivery device 10 reaches the delivery state. The peripheral region 20 can also take an inverted shape due to the curling of the petal member 42.

[0245] In various embodiments, certain regions of the main body 20 of the delivery device 10 may remain stationary or may not invert. Thus, the main body 20 can include an inversion region and an elastic region. Although described as an elastic region, it should be understood that some bending or deformation may still occur when pressure is applied. However, these regions may appear substantially the same or extend / project in substantially the same direction in both the storage state and the delivery state. As shown, the peripheral region 30 and the upper surface 250 may invert, but a part of the central region 28 may resist this degree of deformation. The support structure 252 (e.g., referring to FIG. 19 or FIG. 25) shown in other embodiments described herein may also be an elastic region. Thus, a particular delivery device 10 can include a main body 20 with invertible regions separated from each other by elastic regions.

[0246] Further, as shown in FIGS. 29 - 33, the reservoir 12 may be formed as an assembly and may 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 crushed to deliver the drug 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 slot 254 can assist the delivery device 10 in transitioning from the storage state to the delivery state under reduced pressure from above. The opening 34 can also facilitate the transition. As described above with reference to the embodiments of FIGS. 12 - 20, there may be space in the central region 28 for the reservoir 12 and the sharp support 26 (see additional description with reference to the embodiments of FIGS. 12 - 20 and FIGS. 47 - 61B). In some embodiments, the packet 208 and / or the container 350 (e.g., see FIGS. 10A - 11) and / or the foam adhesive material may also be housed within the central region 28. As described in more detail elsewhere in this specification, the packet 208 includes a gas bag, a butane packet, or a delivery force supply packet, and any associated container 350 as described above with respect to FIGS. 10A - 11. In some examples, one or more flap members 42 may be constructed to incorporate a pull tab such as the pull tab 266 described above with reference to FIG. 23 (not shown in FIGS. 29 - 33).

[0247] Referring now to FIG. 34, a block diagram of an exemplary delivery device 10 is shown. As illustrated, 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 discharge fluid from the reservoir 12 during injection. In some embodiments, the dispensing assembly 480 can include a pusher 472 that can be coupled or associated with at least one biasing member 470. A reservoir interface member 474 can also form part of the dispensing assembly 480 of the delivery device 10.

[0248] In some such embodiments, when the associated delivery device 10 is in a storage state, the biasing member 470 may be in a stress-free state. User interaction with the delivery device 10 to transition the delivery device 10 to a delivery state can include the step of applying pressure to the pusher 472 of the dispensing assembly 480. Thereby, the pusher 472 can be displaced in the direction of the reservoir 12. The pusher 472 can include an engagement mechanism (e.g., a catch or detent) that can engage with a holding mechanism (e.g., defined in the body 20) of the delivery device 10 to hold the pusher 472 in the displaced position. Due to the displacement of the pusher 472, a bias is accumulated in the biasing member 470. When the delivery device 10 transitions to the delivery state, the biasing member 470 returns to a stress-free state. When the biasing member 470 returns, the reservoir interface member 474 of the dispensing assembly 480 is biased 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 the reservoir 12 over a time sufficient to completely deliver the contents of the reservoir 12 (e.g., 5 minutes in certain embodiments) without continuous manual pressure on the delivery device 10.

[0249] In other embodiments, the biasing member 470 may be in a stressed state even when the associated delivery device 10 is in a stored state and may be coupled or associated with the pusher 472 of the dispensing assembly 480. The pusher 472 can act in contact with a part of the delivery device 10 (e.g., the body 20) to resist displacement under the restoring force generated by the biasing member 470. Thereby, the biasing member 470 can be prevented from restoring from its stressed state. A catch or detent in the pusher 472 can engage the body 20, for example, when the delivery device 10 is in a stored state. The user's interaction with the delivery device 10 to move the delivery device 10 to the delivery state can disengage the pusher 472 so that the pusher 472 can move freely. When the pusher 472 is free to displace, the biasing member 470 returns to a stress-free state or at least a state with less stress and can drive the reservoir interface member 474 of the dispensing assembly 480 against the reservoir 12. Thereby, the reservoir 12 collapses and fluid is discharged from the reservoir 12 into the patient's body.

[0250] Next, referring to FIGS. 35 - 36, a representative example of the delivery device 10 including the biasing member 470 with no stress applied in the storage state is shown. The delivery device 10 may include the main body 20 and the reservoir 12, similar to the various other delivery devices 10 described above. As shown, the pressing body 472 of the dispensing assembly 480 can include an elongated member 476 such as a pin extending through the upper surface 250 of the main body 20. In some embodiments, the elongated member 476 can 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 assist the head 478 in passing through the opening of the main body 20 during assembly. Opposite the tapered or rounded portion, the head 478 can define a step or shelf (protrusion). The shelf of the head 478 can limit the displacement of the elongated member 476 because the shelf cannot easily pass back through the opening of the main body 20. The end of the elongated member 476 opposite the head 478 can be coupled to one or more members. The reservoir interface member 474 can be coupled to one or more biasing members 470 such that one or more biasing members 470 are disposed between the elongated member 476 and the reservoir interface member 474. In an exemplary embodiment, the one or more biasing members 470 are shown as a set of arcuate springs, but any suitable number of arcuate springs can be used. In alternative embodiments, other biasing members 470 (e.g., elastic foam, coil spring, airbag, etc.) may be used.

[0251] When pressure is applied to transition the delivery device 10 to the delivery state, the elongated member 476 can be displaced toward the reservoir 12. Thereby, stress can be applied to the biasing member 470. As shown, the elongated member 476 includes a detent or notch 482. The notch 482 can engage with the main body 20 to hold the elongated member 476 in the depressed state. The engagement between the notch 482 and the main body 20 can also help indicate that the delivery device 10 has been used.

[0252] With the elongated member 476 held in place, if the biasing member 470 is returned to a state of low stress, the reservoir interface member 474 may displace into the reservoir 12. As described above, this causes the contents of the reservoir 12 to move from the reservoir 12 into the patient. Note that in various examples, when the delivery device 10 transitions to the delivery state, at least some portions of the body 20 may displace and / or invert over a wide range (see, for example, FIG. 29). This is not shown in FIGS. 35 and 36 for ease of explanation.

[0253] Referring to FIGS. 37 and 38, in certain embodiments, the delivery device 10 may include a biasing member 470 in a stressed state while the delivery device 10 is in the 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 may be, for example, annular in shape, but 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, but this is not necessary in all embodiments. The outer enclosure 490 can be constructed of any suitable material and, in some examples, can be constructed of an elastomeric plastic or spring steel.

[0254] The body 20 of the delivery device 10 can include a number of passages 494 that extend through the body 20. The passages 494 can be disposed within the support structure 252 of the body 20. The spacing of the passages 494 can correspond to the spacing of the biasing protrusions 492 on the biasing member 470. When the delivery device 10 is assembled, the biasing protrusions 492 can be introduced into and partially pass through their respective passages 494 within the body 20. The outer enclosure 490 can be placed on the distal surface of the peripheral region 30 of the body 20 (see, for example, FIG. 25).

[0255] Referring now to FIGS. 39-41, the delivery device 10 can include a pressing body 472. In the illustrated example, the pressing body 472 includes a reservoir interface member 474 at its proximal end. The pressing body 472 can be rotationally displaceable within an opening 496 of the body 20. The opening 496 can be disposed on the upper surface 250 of the body 20, for example as shown in FIG. 39. The pressing body 472 can be rotated from a position or range of positions that limit translational displacement (e.g., see FIG. 39) to a position or range of positions that permit translational displacement (e.g., see FIG. 38). In the translational displacement limiting position, the retaining element of the pressing body 472 can engage a cooperating lock defined in the body 20. In the translational displacement permitting position, the retaining element of the pressing body 472 can disengage from the lock of the body 20.

[0256] As best shown in FIG. 41, an exemplary pressing body 472 includes a stem 500 that extends through an opening 496 in the body 20 of the delivery device 10. The stem 500 can include a set of notches 498 or other recesses that each function as a retaining element. The cross-sectional shape of the stem 500 need not be circular or regular polygonal. Thus, one of the width dimension and the length dimension of the cross-sectional shape of the stem 500 can be shorter than the other. In an exemplary embodiment, the cross-sectional shape of the stem is oval. In another example, other cross-sectional shapes can be used. The notches 498 can be disposed so as to recess into the widest part of the stem 500. The opening 496 (e.g., see FIG. 37) can have a shape corresponding to the shape of the cross-section of the stem 500, but can be slightly larger than the shape of the cross-section of the stem 500. The notches 498 can be recessed to a depth such that the pressing body 472 can rotate within the opening 496 when the opening 496 is at the same height as the wall of the body 20 in which the opening 496 is formed.

[0257] The pressing body 472 is shown in the translational displacement limiting position in FIG. 39. In such a position, the rotational direction of the pressing body 472 may be such that the notch 498 projects into the portion of the main body 20 where the opening 496 is defined. As a result, the main body 20 may mechanically interfere with the translational displacement of the pressing body 472. Therefore, the region of the main body 20 adjacent to the opening 496 can function as a lock for the pressing body 472. As shown in FIG. 40, when the pressing body 472 rotates to a position that allows translational displacement, the rotational direction of the pressing body 472 can be such that it can perform translational displacement within the opening 496 of the corresponding shape of the main body.

[0258] Referring to FIGS. 42 and 43, the pressing body 472 can include an enlarged portion 502. The reservoir interface member 474 can form a proximal region of the enlarged portion 502. When the delivery device 10 is assembled, the biasing projection 492 of the biasing member 470 can push the enlarged portion 502 to capture or engage the enlarged portion within the biasing projection 492. Further, since the biasing projection of the biasing member 470 can be supplied through the passage 494 in the main body 20, the biasing member 470 can be substantially suppressed from displacing as a whole. When the biasing member 470 is constrained in a predetermined position, when the depressor body 472 is lifted, the biasing projection 492 may bend and stress may be applied. When the pressing body 472 is lifted such that the notch 498 becomes the same as the portion of the main body 20 where the opening 496 is defined, the pressing body 472 can be rotated to the translational displacement limiting position (see, for example, FIG. 39). Therefore, the biasing member 470 can be held in a stressed state.

[0259] During the operation of the related delivery device 10 from the storage state to the delivery state, the pressing body 472 can be rotated to a position that allows translational displacement. When this position is reached, the pressing body 472 can freely undergo translational displacement, and the biasing member 470 can cause the pressing body 472 to undergo translational displacement. When the biasing member 470 returns to a state with less stress, the reservoir interface member 474 is driven relative to the reservoir 12, and the fluid can be extruded from the reservoir 12 and pushed into the patient. The amount of the pressing body 472 protruding from the main body 20 can change as the biasing member 470 returns to a state with less stress. Therefore, the amount of the pressing body 472 extending from the main body 20 can function as an indicator indicating that the delivery device 10 has been used.

[0260] Referring now to FIGS. 44A - 44D, in some examples, the biasing member 470 for the delivery device 10 may be entirely within the delivery device 10. Further, the pressing body 472 may latch or engage with a part of the main body 20 and not prevent the translation of the main body 20. In some examples of such embodiments, a stop member 473 may be included in the delivery device 10. The pressing body 472 may include a recess 475 (or alternatively a set of notches 498, see FIG. 41 for example). This may engage with the stop member 473 instead of the main body 20. As shown in FIG. 44B, the stop member 473 can include an opening 496' having a shape corresponding to, but slightly larger than, the cross-sectional shape of the stem 500 of the pressing body 472. The recess 475 may be recessed to a depth such that the pressing body 472 can rotate within the opening 496' when at the same height as the opening 496'.

[0261] The stop member 473 can rotate from the translational displacement limit position to the translational displacement allowable position where it can freely undergo translational displacement. At the translational displacement limit position, the opening 496' can be arranged such that the stem 500 projects from a part of the main body 479 of the stop member 473. As a result, the stop member 473 may mechanically interfere with the translational displacement of the stem 500. When the stop member 473 rotates to the position allowing translational displacement, the stem 500 no longer projects from the main body 479 of the stop member 473. At this position, the pressing body 472 can translate within the opening 496' having a corresponding shape of the stop member 473. The stop member 473 may include a ridge, knurling, bulge, grip, spoke, or other features to facilitate the rotational displacement of the stop member 473 by interaction with the user's finger.

[0262] As mainly shown in FIGS. 44C and 44D, the biasing member 470 may be a conical spring. When the delivery device 10 is in the storage state and the stop member 473 is in the translational displacement limit position, the conical spring may be under stress (e.g., in a compressed state). When the stop member 473 moves to the translational displacement allowable position, the biasing member 470 can freely drive the displacement of the pressing body 472 with respect to the reservoir 12 as described above with respect to FIGS. 42 - 43. When the pressing body 472 is displaced by the relaxation of the biasing member 470, the stem 500 of the pressing body 472 can completely pass 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. Also, the pressing body 472 can move to a position where the recess 475 is inside the delivery device 10. Thus, the reconnection of the stop member 473 to the pressing body 472 can be prevented. When the delivery device 10 is observed without the stop member 473, it can visually indicate that a particular delivery device 10 has already been used. Thus, the stop member 473 can also function as an indicator communicating that a particular delivery device 10 is available 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 can also include one or more biasing members 470. The one or more biasing members 470 can form the entire dispensing assembly 480. Further, the biasing member 470 can contact the reservoir 12 directly and can assist in applying pressure to the reservoir 12 to deliver fluid from the reservoir 12. In certain examples, a reservoir interface member 474 (see, e.g., FIG. 34) can be included. If included, the reservoir interface member 474 can be formed as (but need not necessarily be) part of at least one biasing member 470 and can be integrated therewith. The reservoir interface member 474 can contact the reservoir 12 directly. The at least one biasing member 470 can be a spring, a compression spring, a conical spring, an elastic foam, an air bladder, any other suitable biasing member, other suitable biasing members, or some combination thereof, or can include them.

[0264] As further shown in FIG. 45, when the associated delivery device 10 is in a storage state, the biasing member 470 may be in a state where it is not subjected to stress. In the storage state, it may not be necessary to apply pressure to the reservoir 12. In a particular example, at least one biasing member 470 (and any reservoir interface member 474) may not be in complete contact with the reservoir 12 in the storage state (e.g., 0.05 to 2 mm). When the delivery device 10 is used, the delivery device 10 can transition to a delivery state as described elsewhere herein. Similar to the various embodiments described herein, when transitioning to the delivery state, at least a portion of the delivery device 10 can at least partially invert. For example, at least the domed upper surface 250 of the central region 28 can invert or partially invert. The distance between the reservoir 12 and the inverted upper surface 250 in the delivery state may be shorter than the distance between the reservoir 12 and the upper surface 250 in the storage state. As a result, a bias will accumulate within the biasing member 470. In one example, at least one biasing member 470 may be compressed when the upper surface 250 is inverted. Further, if at least one biasing member 470 is spaced from the reservoir 12 in the storage state, at least one biasing member 470 or reservoir interface member 474 (which may be part of the biasing member 470) can move into contact. The inverted upper surface 250 can have sufficient strength to withstand any force exerted by at least one biasing member 470 in the inverted state. When at least one biasing member 470 returns to its original state, at least one biasing member (and / or reservoir interface member 474 if included) can press against the reservoir 12 to crush the reservoir 12 and deliver fluid into the patient. Thus, for example, pressure can be continuously applied to the reservoir 12 for a sufficient time (e.g., 5 minutes in a particular embodiment) to completely deliver the contents of the reservoir 12 without the need for continuous manual pressure on the delivery device 10.

[0265] Referring now to FIGS. 46A-46B, an exemplary embodiment of the body 20, and the body 20 with the 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 with the top surface inverted for purposes of illustration. As shown, the body 20 can include a number of positioning protrusions 471. There can be a set of positioning protrusions 471 disposed in the central region of the top surface 250. A second set of positioning protrusions 471 can be spaced outwardly from the central region. In an exemplary embodiment, the second set of positioning protrusions 471 extends from the top surface 250. In other examples, the positioning protrusions 471 can extend radially inwardly from the support structure 252 of the central region 28. The ends of the biasing member 470 are centered by the positioning protrusions 471 when the biasing member 470 is disposed within the delivery device 10 assembly. In a particular example, the ends of the biasing member 470 can be coupled to a predetermined position. For example, once the biasing member 470 is properly positioned, the end of the biasing member 470 adjacent to the top surface 250 can be heat staked (see, e.g., FIG. 46C). When the delivery device 10 is fully assembled, the heat stake can hold the biasing member 470 in a predetermined position relative to the body 20. As a result, the biasing member 470 can be held so as not to contact the reservoir 12 until the delivery device 10 transitions 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 constrain the biasing member 470 such that the biasing member 470 is compressed substantially along the axis of the biasing member 470.

[0266] As shown here in FIG. 46C, in some examples, the biasing member 470 can have its displacement restricted by one or more guide bodies 477. The one or more guide bodies 477 can extend from the support structure 252 in the central region 28 of the body 20 towards the 0-axis of the biasing member 47. In the example shown in FIG. 46C, four guide bodies 477 are included and are spaced at equal angular increments. In other embodiments, the number of guide bodies 477 may be different and / or the guide bodies may be at irregular intervals. The guide bodies 477 can help ensure that the biasing member 470 compresses substantially along its axis and can help suppress tilting of the biasing member 470 during use of the delivery device 10.

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

[0268] In some embodiments, as shown in FIGS. 47 - 50 (a perspective view from above, a side view, a bottom view, and a perspective view from below, respectively, of the application surface of the delivery device 10 such as the skin surface), an exemplary holder 270 for a sharp support 26 (see, e.g., FIG. 31) that includes a delivery sharp 72 (see, e.g., FIG. 31) can be formed as a ring or an annular portion 272 integral with a round recess 274. The recess 274 may be disposed centrally. In one example, the round recess 274 may have the shape of a spherical segment. The annular portion 272 has an inner edge, and the round recess 274 may have a perimeter. The inner edge of the annular portion 272 may coincide with the perimeter of the round recess 274. When the delivery device 10 incorporating the holder 270 is affixed to the user's skin surface, the round recess 274 extends below the plane of the annular portion 272 (see FIG. 48).

[0269] The round 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 round recess 274 and at the lowest point (with respect to the skin surface when the delivery device 10 is fixed to the skin surface). The pocket 276 can be sized to receive and fit a sharp support 26 having a delivery sharp 72 thereon, such as the sharp support 26 including the delivery sharp 72 of FIG. 31. The sharp support 26 including the delivery sharp 72 can be fitted into the pocket 276, for example, by injection molding or an adhesive. The holder 270 may be overmolded around the sharp support 26 to couple the components to each other. In various embodiments, the delivery device 10 can be arranged such that pressure applied from above (e.g., from a finger) to the delivery device 10 can be evenly distributed across the area of the holder 270. In some embodiments, the recess 274 can function as a force concentration 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 about 0.7 inches (e.g., 0.744 inches). The installation area of the exemplary holder 270 can be about 0.45 square inches (e.g., 0.44 square inches). The holder 270 can 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 at 51A - 51C. As shown, the holder 270 can include a disk body 275. The disk body 275 can be substantially flat and can include a number of tab protrusions 277 arranged circumferentially. The tab protrusions 277 can be arranged symmetrically around the disk body 275 and can be spaced at regular angular intervals, as shown in FIGS. 51A - 51C. In an alternative embodiment, the tab protrusions 277 may be arranged asymmetrically around the base or may be arranged at irregular angular intervals. The tab protrusions 277 can engage with a receiving slit 278 (see, for example, FIG. 44A) arranged within the body 20 of the delivery device 10. Thus, the tab protrusions 277 can be used to couple the holder 270 in a predetermined position in the delivery device 10. The asymmetric or irregularly spaced tab protrusions 277 can, in some examples, couple the holder 270 to the body 20 in a desired predetermined direction.

[0272] Referring further to FIGS. 51A - 51C, the holder 270 can include at least one stage protrusion 279. The stage protrusion 279 may be included in addition to, or instead of, the round recess 272 and the spherical segment of the embodiments 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 protruding from the proximal side of the disk body 277 by a height that can be, in a particular example, at least the same as the height of the micro - needle 277 of the delivery device 10. The stage protrusion 279 can typically extend at an angle perpendicular to the disk. The side wall 283 of the stage protrusion 279 may be chamfered to extend in a non - perpendicular direction with respect to the proximal surface of the disk body 279. The stage protrusion 279 may include a pocket 276. The size of the pocket 276 can be such as to fit and receive the sharp support 26 with the delivery sharp 72 as described elsewhere in this specification.

[0273] Referring now to FIGS. 52A - 52D, in some embodiments, the pocket 276 of the stage protrusion 279 may have an orientation non - parallel to the plane of the disk body 275. In FIG. 52D, when the sharp support 26 is attached to the pocket 276, the orientation of the pocket 276 can ensure that the delivery sharp 72 (e.g., a micro - needle) extends at a predetermined angle with respect to the disk body 275. In an exemplary embodiment, the pocket 276 can be oriented such that the delivery sharp 72 extends at an angle of 10 - 20° (e.g., 15°) with respect to the plane of the disk body 275. In other embodiments, the pocket 276 can be oriented such that the delivery sharp 72 protrudes at an angle of 45° or 60°, or an angle therebetween. Any suitable angle can be used. In an alternative embodiment, the entire stage protrusion 279 can protrude from the disk body 275 at a desired angle. Thus, the delivery sharp 72 can extend at that angle when coupled to the pocket 276.

[0274] In some embodiments, as shown in FIGS. 53 - 56 (side view, top view, perspective view looking down from above, and perspective view from below, respectively, for example, of the application surface of the delivery device 10 such as the skin surface), a reservoir portion 271 is shown. The reservoir portion 271 can be shaped as an integral structure incorporating a dome - shaped portion 280, a tunnel or side groove 282, and a flange or annular portion 284. That is, these features can be included in a single monolithic piece of material. In some embodiments, the dome - shaped portion 280 may be shaped like a substantially hemisphere or other spherical segment, but any other suitable shape is also possible. In an example where the reservoir portion 271 includes a rounded shape forming a cavity (for example, the dome - shaped portion 280), a plateau or flat surface may be included in the most distal rounded - shaped portion of the flange 284. The flat surface may generally be parallel to the flange 284. In some examples, a central recess 267 (see, for example, FIG. 57) may also be included in the flat surface. The tunnel 282 can be formed as a semi - pipe or semi - cylinder that can be formed from the annular portion 284 in some examples. In alternative embodiments, any suitable cross - sectional shape can be used. The side channel or tunnel 282 can 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 a structure shaped somewhat like an igloo. In some embodiments, the end of the tunnel 282 on the opposite side of the dome - shaped portion 280 may flare outwards or taper in order to facilitate filling. The annular portion 284 may have an inner edge that coincides with the base outer perimeter 288 of the dome - shaped portion 280. The reservoir portion 271 may be manufactured, for example, by thermo - forming a flat sheet of material (such as plastic or a layer of various plastics or other materials). When a multi - layer sheet is used, the sheet can include a drug or agent - compatible layer, a barrier layer, a bonding layer, and the like. In some embodiments, vacuum forming can 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 be folded when pressure is applied.

[0275] Referring now to FIG. 57, a perspective view of an exemplary reservoir portion 271 is shown. In a particular example, the reservoir portion 271 can include at least one cavity incorporating one or more collapse promoters. The collapse promoters can facilitate the collapse of the cavity in a predetermined manner and can reduce the force required to collapse the cavity. The collapse promoters can also help ensure that the cavity collapses such that the dead volume is minimized. Similarly, including collapse promoters can help reduce the likelihood that fluid contained in the reservoir 12 becomes trapped or pocketed in areas of the reservoir 12 where communication with the outlet is blocked during cavity collapse. Other reservoirs 12 described herein may include at least one collapse promoter.

[0276] The breakdown promoting part may be a pleated, bellows-shaped, accordion-shaped, wrinkled, pleated, stepped, or bellows-shaped wall 261 that extends upward from the flange 284. The wall 261 may protrude and extend from the flange 284 and may taper (e.g., continuously or stepwise) as the distance from the flange 284 increases. The upper wall 263 can span the portion of the wall 261 that is the most distal from the flange 284. Thus, the wall 261 and the upper wall 263 can together form a cavity within the reservoir portion 271. The upper wall 263 is substantially planar and, in certain examples, can extend parallel to the flange 284. The upper wall 263 can, in certain examples, include a central recess 267. The central recess 267 can function to assist in positioning a 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 upper 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 upper wall 263 may have a substantially circular, circular, oval, elliptical, oblong, or polygonal cross-section.

[0277] Any pleats, bellows, accordion, folds, or frill patterns can be used, but in certain embodiments, wall 261 can include at least one pleat 269 in a spiral pattern. At least one spiral pleat 269 can extend from a point adjacent to flange 284 and can end at a point adjacent to upper wall 263. If wall 261 tapers as the distance from flange 284 increases, any spiral pleat 269 can have a conical shape corresponding to its taper (tapering). Any spiral pleat 269 can have a pitch such that each pleat 269 wraps around wall 261 multiple times. In the exemplary embodiment shown in FIG. 57, the spiral pleat 269 wraps around wall 261 approximately three times. Such pleats 269 can help assist in the collapse of the cavity while fluid is being extruded from reservoir 12 during operation of delivery device 10. Thus, the force required to deform and deplete such a reservoir 12 during use can be minimal. Further, such pleats 269 can help ensure that a small dead volume remains within reservoir 12 after delivery is complete. The use of a flat upper wall 263 can also assist in the collapse of the cavity.

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

[0279] In one embodiment, the reservoir 12 can 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 top of the holder 270, and the lower surface region 285 of the annular portion 284 may be fixed to the upper surface region 273 of the disk body 275 or the annular portion 272. For example, the reservoir portion 271 can be attached to the holder 270 by ultrasonic welding, but any form of welding or any other joining technique known to those skilled in the art can be used. For example, the reservoir portion 271 and the holder 270 may be sealed with a two-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 caulking, and laser welding.

[0280] Agents such as vaccines, for example, can be inserted into the reservoir 12 through the side channel 282, and then the side channel 282 can be sealed by any known technique such as any well-known technique such as sonic welding or any other suitable technique described herein. A sharp support 26 (see, for example, FIG. 31) including a delivery sharp 72 (see, for example, FIG. 31) can be inserted into the pocket 276 and fixed therein by any suitable technique such as welding, for example, before inserting the agent (e.g., vaccine) into the reservoir 12. Alternatively, as described above, the holder 270 can be formed around the sharp support 26. As described elsewhere herein, the delivery sharp 72 can be one or more microneedles in various examples.

[0281] In one exemplary embodiment, reservoir 12 can hold approximately 2 microliters of vaccine or other agent. After the medical agent (e.g., vaccine) is inserted, reservoir 12 may be placed separately in a cold chain storage and subsequently attached to delivery device 10 immediately prior to use. This can help maximize the yield of vaccine doses per unit volume in the cold chain storage. Reservoir 12 can be inserted into delivery device 10 together with packet 208 and / or container 350 or a foam adhesive (such as the packet or foam adhesive material described above with reference to FIGS. 10A - 11). Packet 208 and / or container 350 or the foam adhesive can be disposed between reservoir 12 and the underside of the upper surface 250 of delivery device 10 when delivery device 10 is fully assembled. Alternatively, as discussed above, when reservoir 12 is attached, dispensing assembly 480 (e.g., see FIG. 34) or at least one biasing member 470 (e.g., see FIG. 45) may be disposed between the underside of upper surface 250 and reservoir 12.

[0282] Referring to FIG. 60, reservoir 12 (e.g., reservoir 12 as described above with reference to FIG. 59) can be fixed inside delivery device 10. Although a representative example of delivery device 10 is shown, reservoir 12 can similarly be attached to the body 20 of any embodiment of delivery device 10 described herein. Reservoir 12 may contain an agent (e.g., vaccine) before being assembled into delivery device 10. Reservoir 12 may be removed from a refrigerated storage before being attached inside body 20 of delivery device 10.

[0283] Referring to FIG. 60, in one embodiment, the raised portion 290 may be formed on the inner surface of the central region 28 of the delivery device 10, such that as a result, the ridge 290 may function as a seating structure on which or against which a section or region of the reservoir 12 is disposed or coupled. In one example, the annular portion 272 or the holder 270 may be adhered to the raised portion 290 using an adhesive. Those skilled in the art will understand that any suitable coupling technique can be used. In other embodiments, the distal surface of the reservoir portion 271 may be attached to the proximal surface of the raised portion 290. The distal surface of the reservoir portion 271 may be coupled, for example, to the ridge 290 of the body 20 of the delivery device 10 shown in FIG. 26. Alternative or additional tab projections 277 (see, for example, FIG. 51A) that couple to a receiving slit 278 (see, for example, FIG. 44A) defined in the body 20 can be used.

[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 to achieve a desired delivery pressure. For example, in some embodiments, the reservoir portion 271 may be formed to have a balloon-like shape (shown in FIGS. 61A-61B), a cylindrical shape, a polygonal prism shape, and the like. The height of the reservoir portion 271 may be adjusted as follows. Given a preselected maximum cross-sectional area, a desired internal volume is obtained. As shown, the holder 270 can include at least one buttress 289. The at least one buttress 289 can at least partially surround the reservoir portion 271. The at least one buttress 289 can help to hold the reservoir portion 271 in a desired position within the body. The at least one buttress 289 can also help to direct the reservoir portion 271 in a direction to be collapsed during delivery.

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

[0286] Referring to FIG. 62, in certain embodiments, it may be desirable for the delivery pressure to rise relatively slowly when the delivery device 10 transitions to the delivery state. For example, fluid injection may desirably start at a relatively low pressure, or at or near the lowest pressure at which injection is possible for a particular patient. The delivery pressure can be increased until it reaches this delivery start pressure for a particular patient. By slowly increasing the pressure, it may be possible to reach the delivery start pressure for a wide variety of patients using the same design of delivery device 10. Further, once injection begins, 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 a hook material may be used.

[0287] Referring to FIG. 62, in such an embodiment, the reservoir 12 can 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 can be disposed between a portion of the reservoir 12 near the micro needle and a portion of the reservoir 12 distal to the micro needle. The flow restrictor 524 may be an orifice plate having one or more orifices extending therethrough in certain embodiments. In some embodiments, the flow restrictor 524 may include orifices of 15 to 25 microns. In other embodiments, the orifice may have a diameter of up to 100 microns (e.g., 70 to 80 microns or 75 microns). In some embodiments, the orifice may have a diameter greater than 100 microns. The size of the orifice can be selected based on considerations such as the viscosity and / or surface tension of the drug filled in the reservoir, the desired injection rate, and how fast it is desirable to increase the injection pressure. The orifice plate may be an injection molded part, but can also be formed by other suitable methods.

[0288] Furthermore, as shown in FIG. 62, the first portion 520 of the reservoir 12 may include most of the reservoir 12. The second portion 522 of the reservoir 12 may be disposed proximal to the delivery stylet 72 relative to the first portion 520. The flow restrictor 524 can separate the large first portion 520 from the small second portion 522 that is closest to the delivery stylet 72. The first portion 520 may have a volume that is substantially equal to the filling volume of the reservoir 12 in a particular example. The flow restrictor 524 may be disposed upstream of at least the pocket 276 (see, e.g., FIGS. 47-51C) to which the stylet support 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 may be coupled to the distal surface of the reservoir 12 over the rounded recess 274. In other examples, the flow restrictor 524 can separate the well 281 (see, e.g., FIGS. 51A-51C) from the remainder of the reservoir 12. In such an embodiment, the flow restrictor 524 may be coupled to the distal surface of the disk body 275 over the well 281 (see, e.g., FIGS. 51A-51C).

[0289] In certain examples, the first portion 520 and the second portion 522 of the divided reservoir 12 may be filled with different fluids. For example, the first portion 520 may be filled with a drug (medicine, vaccine, medical agent, etc.) that is desired to be delivered. The portion close to the delivery sharp 72 may be filled with a gas (e.g., sterilized air or clean room air from the manufacturing environment, an inert gas, etc.). The orifice can be sized such that, due to the properties of the drug (e.g., surface tension, viscosity), the drug is prevented from passing into the second portion 522 without applying pressure to the reservoir 12. Even though the first and second portions 520, 522 are in fluid communication, the second portion 522 may remain non-wetted by any drug filled in the reservoir 12 until use during manufacturing. When the delivery device 10 is used, there may be a latency period during which fluid is pushed from the first portion 520 into the second portion 522. Thereafter, the pressure within the second portion 522 can rise to the pressure at which the patient's anatomical structure begins to receive delivery. Once delivery is initiated, the pressure may remain relatively stable (or at least not rise significantly).

[0290] When the delivery device 10 including the 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 contact the reservoir 12 directly, or may apply pressure via a reservoir interface member 474 (see, e.g., FIG. 34) or other components of the delivery assembly 280 (see, e.g., FIG. 34). The flow restrictor 524 can slowly raise the pressure of the fluid within the second portion 522 of the reservoir 512 to the pressure at which injection into the patient begins. Thereafter, the flow restrictor 524 can limit the increase in pressure within the second portion 522 as the injection proceeds. Thus, the injection tends to be performed at or near the minimum pressure that the patient can accept for delivery. This facilitates the use of a stronger spring and can reduce the discomfort associated with delivery. Further, the design of the single delivery device 10 can be made to be used for a wide range of patient populations (e.g., any patient) or with a wide variety of different drugs. Further, this can affect blister formation due to delivery. Since the delivery tends to be performed relatively slowly and at relatively low pressures, a more diffused and shallow (e.g., intradermal) injection tends to result. Adjusting the size of any orifice within the flow restrictor 524 can change the duration of delivery and the characteristics of the blisters.

[0291] Referring now to FIGS. 63A - 63C, a number of exemplary adhesive members 22 are shown on an exemplary delivery device 10. As shown, a single adhesive member 22 is included with each of the exemplary delivery devices 10. In an alternative embodiment, the adhesive member 22 may be disassembled or broken into a plurality of individual adhesive members 22. This facilitates the use of different adhesives or may leave an adhesive missing from a particular flap member 42. As shown, each adhesive member 22 may include a plurality of slits 43 extending radially inwardly from the periphery of the adhesive member 22 to form a flap portion that aligns with the flap member 42 of the body 20. The adhesive member 22 may include a central opening 49 through which the delivery sharp 72 of the delivery device 10 can access the patient.

[0292] The shape and size of the central opening 49 can affect blister formation resulting from delivery when the delivery device 10 is used. Further, the shape and size of the central opening 49 can serve to facilitate certain shallow deliveries, or shallow deliveries to skin having certain 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 to 100% of the mounting area of the holder 270. The central opening 49 may preferably have a shape such that at least a portion of the adhesive member 22 is attached to a portion of the holder 270 or another 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., about 0.3 square inches).

[0293] Furthermore, in some cases it may be desirable for the central opening 49 to be wider in a particular direction compared to other directions. For example, each delivery sharp 72 (e.g., one or more microneedles) may tend to distribute fluid in a release direction extending from the outlet of each 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 is substantially coincident with the discharge direction. For example, the maximum width (or at least a relatively wide width portion) of the central opening 49 may be along a direction parallel to the plane including the discharge direction. By using a delivery device 10 that includes one or more microneedles similar to those shown in FIG. 2, the widened portion of the width of the central opening 49 may be aligned with the front-to-back (from the distal end 15 to the back end 23, also referred to herein as the length) direction of the microneedle or the line of symmetry. For example, the central opening 49 may be oval and widest in a direction parallel to the front-to-back direction of the microneedle. This may help to create a more diffuse shallow (e.g., intradermal) injection as opposed to a concentrated blister. This may be desirable as it may help to enhance the effectiveness of the injection. For example, injecting a vaccine more widely intradermally exposes more immune-related cells in the intradermal region to the vaccine and may enhance the immune response.

[0294] Referring mainly to FIG. 63A here, the central opening 49 may be a generally round (e.g., circular) opening except for a number of inwardly extending teeth or spokes 51 of the adhesive member 22 material. In this exemplary embodiment, the adhesive member 22 includes a central opening 49 with four spokes 51 spaced at regular angular increments from each other. In a particular example, the number of spokes 51 may be different, 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 discharge direction. The central opening 49 can have a relatively large width in this direction, but this does not exclude other wide regions of equal, narrower, or in some cases wider width. In the illustrated example, the central opening 49 has a width that is approximately equal when measured in a direction perpendicular to the longitudinal direction of the microneedle. In a particular example, the spokes 51 can assist in attaching to the holder 270 or other rigid reservoir 12 portion. Thereby, for example, the adhesive member 22 can be firmly attached to both the body and the holder 270. In a particular example, the spokes 51 may be the only part of the adhesive member 22 that is adhered to the holder 270.

[0295] Referring mainly to FIGS. 63B - C here, in a particular example, the central opening 49 may include a notch 53 that extends outward from the periphery of the remainder of the central opening 49. The notch 53 may be included to widen the central opening 49 if desired. This example includes rectangular notches 53, but in alternative embodiments the shape of the notch may be different. The notch 53 may be any suitable polygon or, for example, circular.

[0296] Referring now to FIGS. 64A and 64B, another exemplary embodiment of the delivery device 10 is shown. As illustrated, the delivery device 10 includes a body 20 and a reservoir 12. The reservoir 12 includes a sharp support 26 that includes a one-dimensional array of three delivery sharps 72. Other embodiments may include any suitable number of delivery sharps 72 arranged in any pattern. The body 20 of the delivery device 10 may have a polygonal (e.g., rectangular) footprint and may generally be formed as a strip of material to which the reservoir 12 is attached. In an exemplary embodiment, the body 20 includes a number of living hinges 50 that are integrally formed with the remainder of the body 20. Each of the living hinges 50 extends across a portion of the body 20 and may divide the body 20 into a number of 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 can be parallel or coplanar. In this example, the planar portions 54 are coplanar. One of the ends 52A may include an angled protrusion 56 that extends 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 is elastic and can resist deflection or bending so as to extend at a constant angle with respect to the planar portion 54. In some examples, a battress 58 may be included and may extend from the planar portion 54 to the angled protrusion. Each planar portion may have a proximal surface that is at least partially covered with an adhesive 22.

[0298] Panels 52A - D may also include at least two intermediate panels 52B, C that extend between and couple the end panels 52A, D. One of the panels 52B can be coupled to the end of the raised protrusion 56 via one of the living hinges 50. The other of the intermediate panels 52C can be coupled to the planar end panel 52D via another one of the living hinges 50. Each of the intermediate panels 52B, C can be coupled to each other via the living hinge 50 to form a connection portion 60 between the end panels 52A, D.

[0299] As shown here in FIGS. 65A - 65C, the connection portion 60 can be displaceable from a raised position (see FIG. 65A), through a central position (see FIG. 65B), to a centered - up position (see FIG. 65C). When the delivery device 10 is in a storage state, the connection portion 60 may be in the raised position. In the raised position, the intermediate panel 52B connected to the raised protrusion 56 can extend from the raised protrusion 56 at an angle 62 (angles 62, 64, 66) measured between the proximal surfaces of the recited components. The angle 62 can be selected such that as the distance from the raised protrusion 56 increases, the intermediate panel 52B gradually moves away from the plane of the planar portion 54. In the illustrated example, the angle 62 is an obtuse angle when the connection portion 60 is in the raised position. The intermediate panels 52B, C may be arranged at an angle 64 to each other. This angle 64 is also an obtuse angle in the exemplary embodiment when the connection portion 60 is in the raised position. The intermediate panel 52C and the end panel 52D can form an angle 66 that is a reflex angle with respect to each other when the connection portion 60 is in the raised position. Further, in the raised position, each of the end panels 52A, D may be at the closest distance to each other.

[0300] The delivery device 10 can be applied to the skin 44 over the injection site in a storage state where the connection portion 60 is in the raised position. Thereby, the end panels 52A, D can be fixed so as to be substantially constrained to the plane of the skin patch to which the end panels 52A, D are adhered. When a downward pressure is applied to the connection portion 60, the connection portion 60 can be displaced from the raised position toward the central position. When this occurs, the angle 64 between the two intermediate panels 52B, C can increase. The angle 62 between the raised projection 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 the angle 64 between the two intermediate panels 52B, C, the end panels 52A, D may spread. When the connection portion 60 reaches the central position (see FIG. 65B), the angle 64 becomes 180°, and the end panels 52, D can be at the maximum distance from each other. The skin 44 can become stretched and taut when the end panels 52A, D are displaced apart.

[0301] When the connecting portion 60 is further displaced, the connecting portion 60 can be in an over-center state. The elasticity of the stretched skin 44 can exert a restoring force that tends to drive the end panels 52A and D towards each other. Thus, when the connecting portion 60 is displaced through the central position, the connecting portion 60 can automatically displace to an over-center position at the end of the displacement range of the connecting portion 60. When the connecting portion 60 is displaced to this over-center position, the delivery device 10 can shift to a delivery state. When the connecting portion moves to the over-center position shown in FIG. 65C, the distance between the end panels 52A and D can decrease. However, the distance between the end panels 52A and D may still be greater than the distance between the end panels 52A and D when the connecting portion 60 is in the raised position. At the over-center position at the end of the displacement range, the angle 62 between the raised protrusion 56 and the intermediate panel 52B can be about 90° (e.g., 80° - 110°). The angle 64 between the intermediate panels 52B and C can be a reflection angle. Thus, the connecting portion 60 can partially invert with respect to its position in the raised position. The angle 66 between the intermediate panel 52C and the end panel 52D can be substantially 180°. As shown, when the connecting portion 60 reaches the over-center position at the end of its displacement range, the proximal surface of the intermediate 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 pushed into the skin 44 to make a hole in the skin 44 and establish fluid communication with the delivery site in the patient's body. The angle 64 between the intermediate panels 52B and C at the over-center delivery position (see FIG. 65C) can be selected such that the delivery sharp 72 penetrates the skin 44 at a predetermined angle (e.g., 45° - 45° with respect to the surface of the skin 44). The angle 64 can be selected to be within the range of 30° to 60°. Alternatively, the angle 64 may be established by setting the ratio of the shortest distance between the angle 62 at the over-center delivery position (see FIG. 65C) and the surface of the skin 44 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. As a result, the reservoir 12 is pressurized and fluid can be pushed from the reservoir 12 through the delivery tip 72 into the patient. The restoring force generated by the stretched skin 44 can supply a continuous pressure to the reservoir 12 and help ensure that the reservoir 12 is completely emptied when delivery occurs.

[0303] In some embodiments, the proximal surface of the intermediate panel 52C may be at least partially covered with the adhesive 22 (see, e.g., FIG. 65C). When the connection portion 60 reaches the over-center position at the end of the displacement range, the adhesive 22 can hold the connection portion 60 in place. Further, in some embodiments, the body 20 can include at least one force limiter. For example, at least one of the panels 52A, D may include a tension-relieving flexure portion. In an exemplary embodiment, this flexure portion can bend when the force required to stretch the skin 44 exceeds a threshold value. When the flexure portion bends, the connection portion 60 snaps through the central position and enters the over-center position, and the elongation of the skin 44 can stop. This may be desirable because it can help reduce potential discomfort during injection due to excessive tension in the skin 44. Similarly, this may be useful in certain patient populations because of the potentially large differences in skin characteristics among patients.

[0304] In one embodiment, one of the intermediate panels 52B, 52C, for example the intermediate panel 52C, can be implemented to include a flexure portion or at least one flexure portion incorporating a gap and at least one biasing member. The gap can be biased in an expanded state by the biasing member (which can be integrally formed of the same material as the panels 52B, C in some embodiments). When sufficient pressure is applied to the biasing member, the biasing member can be overcome and flexure can occur. Thus, the intermediate panels 52B, 52C can be formed to have a variable length that decreases when the force exceeds a predetermined threshold value.

[0305] The intermediate panel 52C (although any intermediate panels 52B, 52C may include such features) can be implemented as, or include, at least one flexure portion 290 of a lattice structure, as shown in FIGS. 66A - 66B. The flexure portion 290 can be formed by injection molding. The intermediate panel 52C can include a first member 296 adjacent to the connection of the living hinge 50 to another intermediate panel 52B. The first member 296 may have at least one support arm 300. In the illustrated example, there are four support arms 300A - D that extend at a substantially 90° angle from the first member 296 towards a second member 298 of the intermediate panel 52C. The second member 298 can be adjacent to the connection of the living hinge 50 to the end panel 52D. The second member 298 can be arranged parallel and opposite to the first member 296 and can have at least one arm 302. In the illustrated example, there are two arms 302A - B that extend at a substantially 90° angle from the second member 298 towards the first member 296. Each of the two arms 302A - B is arranged substantially parallel to a respective pair of the four support arms 300A - D and can extend therebetween. Each of the two arms 302A - B can be coupled to at least one of the associated two support arms 300A - B, 300C - D arranged on both sides of the respective arm 302A - B by at least one battress 304 (e.g., three battresses 304). In this example, each of the two arms 302A, B is connected to a respective one of the associated support arms 302A - B. In FIG. 66A, only six of the twelve battresses 304A - F are shown for ease of explanation. When pressure exceeding a threshold level is applied, the gaps between the first and second members 296, 298, the support arms 300A - D, the arms 302A - B, and the battresses 304A - F close at least partially. The number of battresses 304A - F can be changed to adjust the threshold at which the flexure portion 290 gives away. Additionally, or alternatively, the amount or thickness of the material of the battresses 340A - F can be adjusted for this purpose.The battless 304A - F can be arranged substantially parallel to each other and extend from their respective arms 302A - B at an acute angle with respect to the first member 296. The battless 304A - F can be coupled to their respective support arms 300A - D at an obtuse angle. The flexure part 290 is shown as a non - limiting example and can be incorporated using any suitable shape, angle, and / or structure and / or number of components.

[0306] In other embodiments, at least one flexure part 292, which may be in the form of a crushable body that can deform when a threshold force applied to the body is exceeded, may be incorporated into the intermediate panel 52C. In one embodiment, the flexure part 292 may be round and hollow. Referring to FIGS. 67A - 67B, an exemplary flexure part 292 may have a substantially cylindrical shape. The illustrated flexure part 292 is one of many possible examples and need not be limited to the illustrated structure or shape. The flexure part 292 may be integral with the intermediate panel 52C or may be formed in an injection molding process that forms the body 20 of the delivery device 10.

[0307] In some embodiments, after the delivery device 10 transitions from a storage state to a delivery state, at least a part of the body 20 can undergo plastic deformation. For example, one of the living hinges 50 may be plastically deformed. Alternatively, if an attempt is made to return the delivery device 10 from the delivery state to the storage state, one or more of the living hinges 50 may be damaged. Thus, the transition from the storage state to the delivery state can be made irreversible, preventing reuse of the delivery device 10. In some examples, the adhesive 22 can be selected to bind more actively to the skin 44 than the material forming the body 20. Thus, when the delivery device 10 is removed, the adhesive 22 can be peeled off from the delivery device 10. In the embodiments described herein where the adhesive 22 is peeled off from the delivery device 10, the adhesive 22 may include a pull tab or a similar mechanism to facilitate subsequent removal from the skin 44.

[0308] Referring now to FIGS. 68 - 69, another exemplary embodiment of the delivery device 10 is shown. As illustrated, the delivery device 10 includes a body 20 and a reservoir 12. The reservoir 12 includes a cartridge support 26 that includes a one - dimensional array of delivery needles 72. Other embodiments may include any suitable number of delivery needles 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 body 20 can include first and second end blocks 70A, B. The end blocks 70A, B can be arranged opposite to each other. The end blocks 70A, B can be spaced apart and connected to each other by a set of side panels 71A, B and a bridge 76. Each of the side panels 71A, B can have a first end connected to the first end block 70A by a hinge 74A. Each of the side panels 71A, 71B can have a second end opposite the first end that is connected to the second end block 70B by a hinge 74B. Each of the side panels 71A, B can also include an intermediate hinge 74C that can be disposed 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 can 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 set 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 can also include an arm member 82. The arm member 82 is disposed between the two support members 80A, B and can extend toward the proximal surfaces of the end blocks 70A, B. In an exemplary embodiment, the arm member 82 extends from an end of the panel body 78 adjacent to the intermediate hinge 74F of the bridge 76. The reservoir 12 can be coupled to the proximal surface of the arm member 82 at an end of the arm member 82 opposite the panel member 78.

[0311] In the exemplary embodiments shown in FIGS. 68 - 69, the hinges 74A - F are shown as living hinges. In alternative embodiments, at least one of the hinges 74A - F may be a conventional hinge, and the body 20 may be constructed as an assembly of a plurality of components coupled to each other via the hinges 74A - F. In still other examples, the body 20 may be composed of at least two components. Instead of using hinges to couple the components, two or more components of the body 20 may be joined by welding, thermal bonding, solvent bonding, etc.

[0312] The side panels 71A and 71B of the delivery device 10 can be displaceable over a displacement range to shift the delivery device 10 between a storage state (shown in FIGS. 68 to 69) and a delivery state. In the storage state, the side panels 71A and 71B of the delivery device 10 may be in a position bent outward. The side panels 71A and 71B can be bent at the intermediate hinges 74C of the respective side panels 71A and 71B so that the side panels 71A and 71B can take this position bent outward. Some pivotal movement of the side panels 71A and B also occurs at the hinges 74A and B connecting the side panels 71A and B to the end blocks 70A and B, enabling the side panels 71A and B to be arranged in a position bent outward.

[0313] By applying a clamping force to the side panels 71A and 71B that pushes the side panels 71A and 71B toward each other, the side panels 71A and 71B can be displaced from the position bent outward to a straight position. Note that the straight extended position does not necessarily have to be a position where the side panels 71A and B extend along a straight line respectively. In some examples, the straight position may be a position with less outward bending than the position where the side panels 71A and B are bent outward.

[0314] Bridge 76 may also be displaceable over a displacement range to move the delivery device 10 between a storage state (shown in FIGS. 68 - 69) and a delivery state. In the storage state, bridge 76 may be in a raised state where at least the delivery sharp portion 72 of reservoir 12 coupled to arm member 82 is disposed above the proximal surfaces of end blocks 70A, B. Bridge 76 may be bent at intermediate hinge 74F such that panel body 78 and struts 80A, B extend upwardly from end blocks 70A, B and away from the proximal surfaces of end blocks 70A, B. Also, some pivoting of FIGS. 78 and struts 80A, B occurs at hinges 74D, E that connect bridge 76 to end blocks 70A, B, enabling the bridge to assume a raised position. A force perpendicular to the proximal surfaces of end blocks 70A, B can be applied to bridge 76 to displace the bridge from the raised position to a lowered position at the opposite end of the displacement range of bridge 76.

[0315] In various embodiments, when bridge 76 operates over its displacement range, delivery device 10 can transition from the storage state to the delivery state. Further, actuating side panels 71A, B from a bent - out state to a straight state can cause delivery device 10 to transition from the storage state to the delivery state. Since bridge 76 and side panels 71A, B are coupled to each other via end blocks 70A, B, actuating bridge 76 over its displacement range causes side panels 71A, B to displace over their displacement ranges. The displacement of side panels 71A, B over their displacement ranges can result in the displacement of bridge 76 over its displacement range.

[0316] Whether to use the actuation of side panels 71A, B or bridge 76 for the transition of the delivery device 10 may be left to the user. Alternatively, whether the bridge 76 is actuated or the side panels 71A, B are actuated may depend on the patient population to which the user belongs. For example, by actuating the bridge 76, a greater pressure will be applied to the arm member 82. This can assist in ensuring the puncture of the delivery sharp 72 into the skin. Thus, for a patient population with specific skin characteristics, it may be desirable to instruct the delivery device 10 to be actuated via the bridge rather than the side panels 71A, B.

[0317] As shown here in FIGS. 70A - 70C, when the side panels 71A, B are in the outwardly bent position and the bridge 76 is in the raised position (see FIG. 70A), the end blocks 70A, B may be at a first distance from each other. As the side panels 71A, B displace towards the straight position and the bridge 76 displaces to the lowered position (see FIGS. 70B - 70C), the end blocks 70A, B can displace away from each other. Since the delivery device 10 is attached to the skin 44 via the adhesive 22 contained in the end blocks 70A, B, the spreading of the end blocks 70A, B can cause the skin 44 to be stretched and tensed. This can help facilitate the piercing of the skin 44 by 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 pierces the skin 44 and the delivery device 10 can be in the delivery state. The reservoir 12 is compressed between the skin 44 and the arm member 82 and can push the fluid from the reservoir 12 into the patient. The reservoir 12 may be crushed when the delivery is performed.

[0318] Referring to FIG. 71, which is a cross-sectional view of the delivery device 10 of FIGS. 68 - 69, in a particular example, the delivery device 10 may include an iris assembly 84. The iris assembly 84 can include a set of iris panels 86A - D that can define an aperture 88 whose size is variable from a closed state to a fully open state. The iris panels 86A - D can extend in a direction from each of the side panels 71A, B toward the opposite side panels 71A, B. In an exemplary embodiment, two iris panels 86A - D extend from each side panel 71A, B and are disposed on either side of the intermediate hinges 74C, D of each side panel 71A, 71B. When the side panels 71A, 71B are displaced from the outwardly curved position to the straight position, the iris panels 86A - D adjust the aperture 88 to provide an opening for the delivery tip 72 of the reservoir 12 to pass through. As shown in FIG. 71, when the delivery device 10 is in the storage state, the aperture 88 can be substantially closed. Thus, such an iris assembly 84 can function as a guard that helps prevent inadvertent contact with the delivery tip 72 during handling of the delivery device 10.

[0319] In an exemplary embodiment, one of the iris panels 86A includes a latch protrusion 90. Another panel 86B of the iris panel 86B includes a latch catch 92 that can be formed as a notch in the iris panel 86B. The latch protrusion 90 is inclined. Thus, when the iris panels 86A and B are displaced toward each other, the iris panel 86B can be deflected and ride on the inclined surface of the latch protrusion 90 (see, for example, FIG. 70B). When the latch catch 92 is aligned with the latch protrusion 90, the iris panel 86B including the latch catch 92 returns to an undeflected state, and the latch catch 92 can snap-engage with the latch protrusion 90. Thereby, the delivery device 10 in the delivery state can be fixed. The snap operation of the iris panel 86B can generate a tactile sensation perceptible, for example, through the fingertips of the user. Alternatively or additionally, a snap may generate an audible click or slapping sound. Thus, the delivery device 10 can provide an auditory and / or tactile indication that the delivery device 10 has transitioned to the delivery state. The engagement between the latch protrusion 90 and 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 actively to the skin 44 than the material forming the body 20. Thus, when the delivery device 10 is removed, the adhesive 22 may peel off from the delivery device 10. This can also help prevent reuse of the delivery device 10.

[0320] Referring now to FIGS. 72A-72B, another exemplary embodiment of the delivery device 10 is shown. The delivery device 10 can include a first portion 100 and a second portion 102. One of the first portion 100 and the second portion 102 can be displaced translationally relative to the other of the first portion 100 and the second portion 102 to move 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 displaced translationally relative to the other. For example, one of the first portion 100 or the second portion 102 can be extended and / or stretched. In a particular example, the transition to the delivery state can be reversible, although in other embodiments the transition can be an irreversible one-way transition. For example, a latch, lock, or other coupling can be engaged to hold the first and second portions 100, 102 in the delivery state or to prevent the first and second portions 100, 102 from returning to the storage state. Alternatively, the first portion 100 and the second portion 102 may be coupled to each other when the delivery device 10 transitions to the storage state. When the delivery device 10 transitions to the delivery state, destruction of a portion of the delivery device 10 may be required to release or uncouple the first portion 100 and the second portion 102 from each other. This destruction can render the delivery device 10 inoperable. This can not only prohibit reuse, but also provide a user-perceivable (e.g., visual) indication that the delivery device 10 has been used.

[0321] The proximal surfaces of each of the first and second portions 100, 102 may be at least partially covered with an adhesive 22. The adhesive 22 may function to couple the first and second portions 110, 102 to the skin surface of 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 may then be transitioned to a delivery state. When the transition occurs, the adhesive-carrying portion of the first portion 100 may be displaced relative to the adhesive-carrying portion of the second portion 102. Accordingly, the distance between these adhesive support sections may increase to stretch or expand the underlying skin. This may be desirable to facilitate piercing of the skin by at least one delivery sharp 72 of the reservoir 12 included in the delivery device 10 with the skin taut.

[0322] Upon transition of the delivery device 10 to the delivery state, the delivery sharp 72 may also be displaced proximally or lowered into the skin towards the skin. In embodiments where the delivery sharp 72 is coupled to the reservoir 12, the reservoir 12 may also be displaced proximally. In some examples, the reservoir 12 may be compressed between the skin surface and 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 serve to expel fluid from the reservoir 12 and cause it to flow through the delivery sharp 72 into the target delivery destination within the patient's body. Further, in some embodiments, at least one of an audible or tactile indication may be generated when the delivery sharp 72 is displaced towards the skin.

[0323] Referring now to FIGS. 73-74, an exemplary delivery device 10 is shown. As illustrated, the delivery device 10 may be a substantially planar, thin and lightweight assembly. The delivery device 10 may include a proximal portion 110 and a distal portion 112. The proximal portion 110 may be formed of a flexible material and, in some embodiments, may be elastic such that the proximal portion 110 or at least a portion of the proximal portion can be stretched. 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 an adhesive 22. The proximal portion 110 may be coupled to the distal portion 112 via the adhesive 22 on the proximal surface of the distal portion 110. Such embodiments are desirable because the delivery device 10 is suitable for mass production by a reel-to-reel manufacturing process, if desired, for a baal.

[0324] Referring now to FIGS. 75-76, the proximal portion 110 and the distal portion 112 may be coupled together via an adhesive fixation assembly 114. As shown, the adhesive fixation assembly 114 may include a region of a lock adhesive 116, which may be disposed on a portion of the proximal surface of the distal portion 112. The adhesive fixation assembly 114 may include a tether member 118. The tether member 118 may be coupled to the proximal portion 110 of the delivery device 10 at a first end and to the lock adhesive 116 on the distal portion 112 at a second, opposite end. The tether member 118 may be fixedly coupled to the proximal portion 110 by heat staking, welding, or other means while being relatively lightly coupled to the lock adhesive 116. In some embodiments, the tether member 118 may be composed of an adhesive liner or an adhesive support material, but can be easily peeled from the lock adhesive 116. As shown, when the delivery device 10 is in a storage state, the tether member 118 may be at least partially doubled over.

[0325] The proximal portion 110 may include a pull tab 120 that may be disposed at the first end of the proximal portion 110. The pull tab 120 may be an enlarged or widened portion of the proximal portion 110. In some embodiments, the pull tab 120 may include a rough surface or may include a protrusion or the like to facilitate gripping. In an alternative embodiment, the pull tab 120 may include a notch to form a pull ring.

[0326] The proximal portion 110 may also include at least one lamp element 128 and a folding region 122 at the end of the proximal portion 110 opposite the pull tab 120. In an exemplary embodiment, the proximal portion 110 includes two lamp elements 128 arranged side by side. The folding region 122 can be folded over itself multiple times. In this example, the folding region 122 is folded twice over itself. Thus, when a tensile force is applied to the pull tab 120, the folding region 122 can expand, winding up the material of the proximal portion 110 so that the proximal portion 110 can extend. The at least one lamp element 128 can also move when the folding region 122 feeds out the material. The number of folds of the folding region 122 can be adjusted to vary the amount by which the proximal portion 110 extends when transitioning to the 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 towards the rounded end. The layer of the folding region 112 closest to the distal portion 112 is substantially immovable and can be fixed in place by the adhesive 22 of the distal portion 112 when the folding region 122 expands.

[0327] As shown in FIG. 75, the delivery device 10 can include a reservoir 12 that can include at least one delivery lancet 72. Any suitable number of delivery lancets 72 can be included in any desired number of rows and / or columns. Any of the delivery lancets 72 described herein can be used. The delivery lancet 72 may be included on a lancet support 26 coupled to the reservoir 12. The reservoir 12 may be disposed on an elastic cantilever arm 130 defined within the distal portion 112 of the delivery device 10. The folding region 122 of the proximal portion 110 can include a delivery opening 124. As shown, when the delivery device 10 is in a storage state, the delivery opening 124 may not be aligned with the delivery lancet 72. Thus, the proximal portion 110 can cover the delivery lancet 72 and prevent or protect against inadvertent contact with the delivery lancet 72 when the delivery device 10 is in a storage state. However, the delivery opening 124 can allow the delivery lancet 72 of the delivery device 10 to access the user's skin through the delivery opening 124 when the delivery device 10 transitions to a delivery state.

[0328] Referring now to FIGS. 77A - 78B, a pulling force can be applied to the pull tab 120 to transition the delivery device 10 from a stored state to a 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 may remain substantially stationary when the transition occurs. The proximal portion 110 can transition from a first state to an extended state as the delivery device 10 transitions from a stored state to a delivery state. As shown, the folding region 122 of the proximal portion 110 can expand such that the proximal portion 110 extends when the pull tab 120 is pulled. Further, in certain embodiments, the proximal portion 110 can stretch to allow for further extension. A segment of the proximal portion 110 that includes the adhesive 22 can be displaced relative to the distal portion 112 of the delivery device 10 when the pull tab 120 is pulled. The adhesives 22 on the proximal portion 110 and the distal portion 112 may displace away from each other when the proximal portion 110 is pulled from the first state to the extended 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 can be stretched to facilitate piercing and can become taut.

[0329] As the folding region 122 expands, material of the proximal portion 110 is fed out, and as a result, the proximal portion 110 can extend and the delivery opening 124 can be displaced to align with the delivery sharp 72. At least one ramp element 128 can be displaced in the direction of the pull tab 120. The at least one ramp element 128 can keep the cantilever arm 130 slightly deflected towards the distal portion 112 as the proximal portion extends. This can prevent the delivery sharp 72 of the reservoir 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 can ride up on the inclined region of the at least one ramp element 128 and can be further deflected towards the distal portion 112 of the delivery device 10. As the folding region 122 continues to expand, the at least one ramp element 128 can move beyond the cantilever arm 130.

[0330] When at least one lamp element 128 passes through the cantilever arm 130, the cantilever arm 130 can return to a non-deflected state as shown in FIGS. 78A and 78B. When the delivery device 10 is such that the cantilever arm 130 is separated from at least one lamp element 128 and returns to its non-deflected state, it can enter the delivery state. When the cantilever arm 130 springs back to a non-deflected state, the delivery sharp 72 may be displaced through the delivery opening 124 and puncture the skin 44. Thereby, fluid communication between the delivery sharp 72 and the patient's target delivery site can be established. Further, the reservoir 12 may be compressed between the skin 44 and the cantilever arm 130 when the cantilever arm 130 returns to a non-deflected state. This compression can serve to discharge fluid from the reservoir 12 and deliver it to the patient via the delivery sharp 72. Also, the compression may help ensure that the reservoir 12 is completely emptied during delivery.

[0331] As shown, the tether member 118 can be peeled from the lock adhesive 116 when the delivery device 10 transitions from the storage state to the delivery state. When the delivery device 10 reaches the delivery state, the tether member 118 can be at least partially separated from the lock adhesive 116. The exposed lock adhesive 116 can then adhere to the proximal portion 110 and secure the proximal portion 110 in place. The lock adhesive 116 can actively adhere to the proximal portion 110. Attempting to separate the proximal portion 110 from the lock adhesive 116 can damage one of the components of the delivery device 10. This can help ensure the transition of the delivery device 10. Returning the delivery device 10 to the delivery state is irreversible. The lock adhesive 116 can also prevent the proximal portion 110 from wrinkling due to the restoring force exerted by the stretched skin. Thus, the lock adhesive 116 can hold the adhesive 22 on the proximal portion 110 in a predetermined position such that the proximal portion 110 is in an extended state and the skin remains stretched when the user releases the pull tab 120.

[0332] Next, referring to FIGS. 79-82, another exemplary embodiment of the delivery device 10 is shown. FIG. 79 shows an exemplary delivery device 10 in a storage state. FIG. 80 shows an exemplary delivery device 10 in a delivery state. FIGS. 81 and 82 are exploded views of the exemplary delivery device 10. As illustrated, the exemplary delivery device 10 may include an actuator. In some embodiments, the actuator can form a top 306 or cap having at least one recess or recess 308 therein (although three such recesses 308 are shown, it will be understood that the number need not be three). The recess 308 can serve to facilitate twisting of the top 306 by the 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. One of ordinary skill in the art will understand that the top 306 need not be limited to any particular shape as long as it can be twisted by the user.

[0333] As illustrated, the exemplary top 306 is placed 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. One of ordinary skill in the art will understand that other materials and manufacturing techniques may be used.

[0334] In an exemplary embodiment, the user can 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 is, in some embodiments, attached to cover the delivery device 10 and maintain a pre-sterilized state. Such a state can be created before attaching the adhesive liner 265 to any of the delivery devices 10 described herein. In some examples, the user can remove the adhesive liner 265 in a manner similar to peeling the liner from a bandage before applying the bandage. Once the liner 265 is removed, the user can 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 can be ultrasonically welded to the delivery device 10. Those skilled in the art will understand that other suitable techniques for attaching the adhesive pad 312 to the delivery device 10 may be used.

[0335] After applying the delivery device 10 to the skin, the user can advance the top 306 in a proximal direction (e.g., toward the skin) along the threads of the screw 310 by twisting the top 306 of the delivery device 10. The threaded screw 310 can accommodate a breakable material, or a weak portion 314. The weak portion 314 can prevent displacement of the top 306 and other components of the delivery device 10 until 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 an exemplary embodiment, the frangible portion 314 is provided as at least one tab protruding from a carriage 315 that can be disposed within a bore 317 of the threaded post 310. In some embodiments, the carriage 315 can include a set of three frangible portions 314. The bore 317 can include a shelf 319 for supporting at least one of the frangible members 314, and preferably can include a shelf 319 for supporting each frangible portion 314. When the frangible portion 314 is seated on the shelf 319, displacement of the carriage 315 within the bore 317 can be prevented, and torsional movement of the top 306 can be impeded. In a particular example, each of the shelves 319 can be an end of a track or rail (best shown in FIG. 81) disposed within the bore 317, which can serve to guide displacement of the carriage 315 within the bore 317.

[0337] The top 306 can incorporate a central protrusion 318 (e.g., a post or stepped post as shown) that is seated on a portion of the carriage 315. When the top 306 is screwed downward or proximally toward the skin surface, the protrusion 318 can press each frangible portion 314 against its respective shelf 319. The pressure applied to the frangible portion 314 causes the frangible portion 314 to break, enabling the carriage 315 to move proximally within the bore 317. The carriage 315 is displaced proximally, and ultimately the second end of the carriage 315 (opposite the first end from which the frangible portion 314 protrudes) can contact the skin surface. One of ordinary skill in the art will understand that when the frangible portion 314 breaks, reuse of the delivery device 10 can be prohibited.

[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 a predetermined position relative to the delivery device 10 in the region of the central opening 323. Thus, if the carriage 315 continues to be displaced in the proximal direction, the skin in this region can be pushed and stretched when displaced by the carriage 315. As a result, the skin aligned with the central opening 323 can be in a taut state. The base body 309 can include a shelf 321 that extends into the bore 317 at the proximal end of the bore 317 and functions as a stop surface. The carriage 315 can stop its displacement in the proximal direction when it contacts the shelf 321.

[0339] The top 306 can be at an intermediate point of its movement along the post 310 when the carriage 315 contacts the shelf 321. As shown, the carriage 315 can include a second frangible portion 325 or a set of frangible portions 325. In some embodiments, there may be three second frangible portions 325 equally angularly spaced around the carriage 315. The first frangible portion 314 may be weaker (e.g., thinner) than the second frangible portion 325. Thus, the second frangible portion 325 can break only after the first frangible portion 314 has broken. The protrusion 318 from the top 306 can contact the second frangible portion 325 when the carriage 315 is abutting against the stop provided by the shelf 321. The second frangible portion 325 can prevent displacement of the top 306. Further actuation of the top can apply a force to the second frangible portion 325, as a result of which the second frangible portion 325 can be broken. When the second frangible portion 325 is broken, the top 306 can move freely in the proximal direction while the carriage 315 remains stationary (against the stop provided by the shelf 321). One skilled in the art will understand that when the frangible portion 325 breaks, reuse of the delivery device 10 may be prohibited.

[0340] As shown in the illustration, the delivery device 10 may also include a delivery aid 320. The delivery aid 320 may be, as shown in the example, a flat plate from which a pillar extends. The delivery aid 320 may be made from a plastic material formed by injection molding. One skilled in the art will understand that other materials and manufacturing techniques can be used to construct the delivery aid 320. The delivery aid 320 is disposed on top of a reservoir 12 containing a fluid such as, for example, a drug (such as a vaccine), and on the lower side, a sharp support 26 (see, for example, FIG. 31) including at least one delivery sharp 72 (see, for example, FIG. 31) is incorporated.

[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 be placed on a shelf within the carriage 315. The reservoir 12 may be held within the opening of the carriage 315 by friction fit or slip fit as shown in the illustration. In some examples, a weak adhesive can hold the reservoir 12 in a predetermined position within the opening. In other embodiments, the friction fit may be enhanced by a gasket member (such as an O-ring) disposed between the side surface of the reservoir 12 and the opening of the carriage 315.

[0342] When the second weak point 325 breaks, the delivery aid 320 can concentrate the force generated when the top 306 acts on the reservoir 12 of the delivery device 10. In an embodiment where the delivery aid 320 is placed on a shelf within the carriage 315, a portion of the delivery aid 320 may deform or break to allow movement over the shelf. As the top 306 continues to advance along the post 310, the delivery aid 320 and the reservoir 12 may move downward. The force exerted by the top 306 may be sufficient to overcome the friction or adhesive holding the reservoir 12 in place. As the delivery aid 320 moves downward, the reservoir 12 may move downward until the delivery sharp 72 (see, e.g., FIG. 31) penetrates the skin surface. At this point, as shown in FIG. 80, the reservoir 12 may be sandwiched between the skin and the protrusion 318 of the top 306. As the top 306 continues to displace in the proximal direction, pressure from the delivery aid 320 accumulates within the reservoir 12, and the fluid contained within the reservoir 12 is sent to the patient through the delivery sharp 72. At that point, the top 306 may stop twisting and may have reached the end of its displacement range. The top 306 may abut against the base body 309 at the end of the displacement range, and the base body 309 may provide mechanical interference against further displacement. When the movement of the top 306 stops, the user can remove the delivery device 10 from the skin.

[0343] As described above, it may be desirable to prevent reuse of the delivery device 10. Also, it may be desirable to provide a delivery device 10 that scratches the skin surface before the delivery lancet 72 penetrates the skin surface. In one embodiment, the delivery device 10 can include an actuation assembly that can include first and second displaceable members. These members may be displaceable relative to each other from a separated state to a proximate state. The members can transition from a 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 can include cooperating coupling mechanisms that can engage with each other when the members approach or reach the proximal state. When the cooperating coupling mechanisms engage, the coupling mechanisms can prevent separation of the members and maintain the members in the proximal state.

[0344] Referring to FIGS. 83-85, an exemplary embodiment of such a portion of the actuation assembly 327 for the delivery device 10 is shown. The delivery device 10 may comprise an integral or integrally formed bend. The bend may be formed as a pair of first and second bodies 320A, 320B spaced apart in a vertical direction such that the first body 320A is located above or in a different plane than the second body 320B. In an exemplary embodiment, the first and second bodies 320A, B are concentric circular bodies and are specifically shown as circles. The bend can 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 can be joined by at least two flexible struts 322 integral with the bend. In this example, six such flexible struts 322 are shown, but it will be understood that the number need not be six. The struts 322 may be arranged at equal angular increments, but need not be so in all embodiments. The struts 322 can extend between the bodies 320A, 320B at an angle that is not perpendicular to the bodies 320A, 320B.

[0345] At least one hook 324 integrated with one of the bodies 320A, B may be included. The other of the bodies 320A, B may include at least one catch 326. In an exemplary embodiment, the first body 320A includes a number of hooks 324 that extend downwardly therefrom towards the second body 320B. Six such hooks 324 are shown, but it will be understood that the number need not be six. In this example, the hooks 324 are equally spaced around the first circle 320A, but this need not necessarily 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 a hook 324 of the first body 320A. The catches 326 in this example extend upwardly from the second body 320B towards the first body 320A. Six such catches 326 are shown, but it will be understood that the number need not be six. The catches 326 can be spaced at equal angular increments around the second body 320B. The catches 326 can be arranged such that each catch 326 engages with a hook 324 when the flexure portion is actuated. The flexure portion can be actuated, for example, by applying pressure to the flexure portion via a part of the delivery device 10 in which the flexure portion is incorporated. The catches 326 can be formed substantially in the shape of an inverted Latin letter "U".

[0346] As the first body 320A is displaced toward the second body 320B, at least one of the bodies 320A,B may also rotate. If one of the bodies 320A,B is rotationally constrained, only the other of the bodies 320A,B may rotate as the bodies 320A,B are displaced toward each other. If the first body 320A is pressed down from above while the second body 320B is rotationally constrained, the flexible post 322 may bend. The hook 324 may rotate and displace (around an axis passing through the center points of the bodies 320A,B). The hook 324 and the first body 320A may also translate as the first body 320A approaches the second body 320B. The hook may translate relative to the catch 326 until the hook 324 contacts the catch 326. The hook 324 may deflect around the catch and then resiliently return to engagement with the catch 326. Thus, when the strut 322 attempts to resiliently return to an undeflected state, the first body 320A and the second body 320B may be held together by the engagement of the hook 324 and the catch 326. By using a single piece flexure (e.g., formed by injection molding), the delivery device 10 may be manufactured at a relatively low cost. The hook 324 engaging the catch 326 may also help prevent reuse of the delivery device 10 that includes the flexure. The engaged hook 324 may also help maintain pressure on the reservoir 12 of the delivery device 10 necessary to ensure delivery of a medical agent (e.g., a vaccine) into a patient via one or more delivery sharps 72 (see, e.g., FIG. 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. Package 400 can accommodate the delivery device 10 during distribution and transportation. Package 400 may also include printed instructions and / or other components such as medical wipes that can be used in preparing the injection site. Package 400 can hold the delivery device 10 and possibly other contents in place during delivery and can help prevent premature or inadvertent actuation of the delivery device 10. Package 400 can include an internal cavity that may have one or more receivers 402 for the delivery device 10 (in FIG. 86, a portion of package 400 is shown transparently). The receiver 402 can restrain the delivery device 10 within the package 400 so that the delivery device 10 does not move excessively or collide violently during handling. Package 400 can also protect the delivery device 10 from exposure to the surrounding environment. In some embodiments, package 400 and the delivery device 10 can be sterilized (e.g., by EtOx), and package 400 can maintain the delivery device 10 in this state until immediately prior to use.

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

[0350] As shown, package 400 may include at least one unique identifier 408. In other embodiments, alternatively or additionally, the unique identifier 408 may be included in the delivery device 10 or its components. Any suitable unique identifiers 408 and combinations thereof can 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, etc. The unique identifier 408 may encode various information regarding the contents of the delivery device 10 or the reservoir 12 of the delivery device 10. For example, the unique identifier 408 can include product identification information, product lot information, product serial numbers, dosage size information, and the like.

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

[0352] The reader 410 can communicate with a database 412 (e.g., via the Internet, other networks, cloud platforms, etc.). Before using the delivery device 10, the user can read the unique identifier 408 with the reader 410. The identifier 408 of the delivery device 10 can be compared with the database 412 to confirm that the unique identifier 408 is not associated with a delivery device 10 that has already been used, is a recall target, 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 the database 412 can assist in inventory management. Other usage information can also be stored. In some embodiments, geographical location data indicating the position 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, data can be stored offline in the memory of the reader 410 until a robust connection to the Internet or another suitable network is formed. Thereafter, the data can be uploaded to the database 412. Alternatively, the data can be transmitted to the database 412 when it is acquired by the reader 410.

[0354] In some embodiments, a patient may need to pre-register to receive the delivery device 10. In some embodiments, a reader 410 may be used to register (e.g., if an app on a smartphone is used). If the reader 410 uses a smartphone app, the smartphone app may prohibit the 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 essential services (such as location tracking, push notifications, etc.) are enabled. This code can be provided to the database 412 and can also be called a registration code. A patient may need to provide the code to receive the delivery device 10. The code may be entered into the dispenser or provided to the distributor and compared with 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 input screen for collecting the desired information if the user selects not to enable one or more services or selects not to provide the desired user information. For example, if location tracking is not enabled, the app may generate a location data input screen. Input of information into such a screen may be required before the code is generated and provided to the database 412.

[0355] In some embodiments, when 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. that detail how to use the delivery device 10. The instructions can guide the user step by step from opening the package 400 to discarding the delivery device 10 after use. In some embodiments, a prompt may be generated on the user interface 414 via the controller 416 after each step of the set of instructions. The user may need to interact with the prompt to proceed to the next series of instructions. The user interaction can be recorded and stored in the database 412. This can help confirm that a particular delivery device 10 has not only been received by a patient, but also applied and used. In some embodiments, the controller 416 can generate a notification (e.g., visual, tactile, audible, or a combination thereof) if all steps have not been completed. In other embodiments, one or more messages can be generated if the user does not respond to the prompt. For example, when using a smartphone or the like, the message may be a push notification generated by the app of the delivery device 10.

[0356] In other embodiments, at least one message generator 418 that communicates with the database 412 generates, for example, text messages, emails, phone calls (e.g., automated messages or connecting the user to a human operator), which can be sent to the phone number or email address provided by the user. If a delay exceeding a predetermined period occurs after the previous prompt has interacted with the user, the message generator 418 can send a communication to the patient. If no response is received after the communication has been sent by the message generator 418, the type of communication triggered can increase gradually (escalation). The communication can initially be a text message or a push notification. In some embodiments, if cellular service is unavailable or below a threshold, it is preferable to send a push message or it may be sent instead of a text message. If no user interaction is received after a predetermined escalation period, the message generator 418 can generate a more intrusive communication (e.g., a phone call). Any suitable number of escalation layers can be used.

[0357] In some embodiments, the patient may also provide additional data via the reader 410. This data is stored in the database 412 and analyzed (e.g., via a cloud analysis tool or toolset). For example, the user may be able to notify the delivery device 10 that a problem has occurred via the reader 410. This data can be compared with data related to other delivery devices 10 of the same lot. If a delivery device 10 with a problem exceeding a predetermined threshold is considered to be present within the lot, the lot may be flagged for investigation and distribution or use may be blocked. Alternatively or additionally, the patient may be prompted to provide specific post-injection information via the reader 410. For example, the patient may be requested to fill out a side effect questionnaire or other form that may be generated by the controller 416 of the reader 410 on the user interface 414. The side effect data can be analyzed to identify patterns common to a particular patient type or delivery device 10 (e.g., delivery devices 10 of the same lot or delivery devices 10 holding the same contents). The analysis can be performed via a cloud analysis tool or toolset.

[0358] In certain examples, as shown in FIG. 87, the delivery device 10 may include an activation indicator 450 or identifier that is hidden when the delivery device 10 is in a storage state. Upon or after use of such a delivery device 10, access to the activation indicator 450 may be enabled. Next, the activation indicator 450 may be scanned by a reader 410, and the scan confirmation or scan data captured during the scan may be transmitted to a database 412. The activation indicator 450, in certain examples, can encode a unique identifier specific to the delivery device 10 (e.g., barcode, QR code, data matrix, etc.). Thus, the activation indicator 450 may function as confirmation that delivery was performed using a particular 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., government agency, insurance company, etc.). To ensure that the activation identifier 450 is scanned and document delivery occurs via the delivery device 10, reimbursement or payment can be associated with the scan of the activation identifier 450. For example, a payment service can query the database 412 to determine the usage status of the delivery device 10 and permit payment only if the delivery device 10 has been used. The indication within the database 412 that the activation indicator 450 has been scanned may set a used flag for the delivery device 10.

[0359] Referring now to FIG. 87, in some examples, the delivery device 10 can 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 that shown, for example, in FIG. 25. A manifestation indicator 450 may be included in other embodiments of the delivery device 10 described herein. In the example shown in FIG. 87, the exemplary first portion is the reservoir assembly 12 (see, for example, FIG. 59), and the exemplary second portion is the body 20. In such an example, the exposure indicator 450 can be disposed distally of the reservoir. When the first portion and the second portion are coupled, the visibility of the exposure indicator 450 can be blocked by the body 20 (the body 20 can be opaque or at least sufficiently translucent). As shown, when the body 20 and the reservoir assembly 12 are separated, the manifestation indicator 450 becomes visible and may be scanned to assist in confirming 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. When 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 the slit 278 (see, e.g., FIG. 45) in the body 20 when a 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 remainder of the delivery device 10 when the user pulls on the body 20. Accordingly, the reservoir portion 12 can remain adhered to the skin and the body 20 can be removed. The visualization indicator 450 included on the reservoir 12 can become visible and can be scanned by the reader 410 (see, e.g., FIG. 86). Next, the reservoir assembly 12 can be peeled from the skin by the patient. In an example where the reservoir assembly 12 is adhered to the body 20, the adhesive connection between the skin and the reservoir assembly 12 can 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 can separate from the reservoir assembly 12 to expose the exposure 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 applied for a predetermined period. In some embodiments, a marking agent such as ink may be included in a portion of the delivery device 10 adjacent to the skin 512. Alternatively, the marking agent may be manufactured into a skin-compatible adhesive for attaching the delivery device 10 to the skin during use. In an example where a pressure-sensitive adhesive is used, the adhesive may be activated by the pressure applied when the delivery device 10 is used, and the marking agent may also be released. The marking agent may at least partially migrate to the skin 512 or otherwise mark the skin 512 when the delivery device 10 is applied. Alternatively, the delivery device 10 may apply a temporary tattoo during injection. In some embodiments, the mark 510 created can have a pattern that encodes specific information about the delivery device 10. In an exemplary embodiment, a series of "X"s are shown, but any suitable mark 510 can be created. As indicated by the injection blister 514, the mark 510 may become visible after the injection is complete and the delivery device 10 is removed from the skin 512.

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

[0363] Referring now mainly to FIG. 89, in certain embodiments, the reader 410 (see, for example, FIG. 86) can include at least one image sensor that is sensitive to one or more wavelengths outside the visible spectrum. The non-visible spectrum wavelength or the spectrum sensed by the image sensor can be a wavelength that has a greater depth of penetration into the skin than light in the visible spectrum. The reader 410 can include at least one image sensor that is 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 capable sensors within the reader 410 may not include an IR filter (e.g., IR blocking film) commonly applied to typical consumer imaging devices. The sensor may be associated with a filter that blocks visible light. In some embodiments, the imaging device may be a thermography or thermal imaging device. A plurality of imaging devices that capture images in different non-visible spectra 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 has been used, at least one image of the injection site can be captured using the reader 410. The at least one image can be acquired or generated based on light other than in 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 (see, e.g., FIG. 86) can generate a prompt (e.g., within an app) for capturing 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 may be automated or may be performed by a human operator who views the images via a network connection to the database 412 (see, e.g., FIG. 86). Since light outside the visible spectrum has greater penetration into the skin, using such light for imaging purposes enables or makes it easier to identify certain subsurface features of the skin. This can, for example, help facilitate the detection of blisters 514. Further, the temperature of the injected drug can be different from that of the patient. There may be regions that can be identified as having a different temperature from the area around the patient. The injection site can, for example, be cooler than the area around the patient. For example, FIG. 89 shows a thermal image of an arm after injection. As shown, a cold region (dark gray) can be identified within the image and corresponds to the location of the blister 514 on the skin.

[0366] If the image includes the characteristics of the blister 514, delivery can be actually performed using the delivery device 10 and it can be concluded that it was successful. In some embodiments, the image may be required to conform to at least one predetermined target characteristic. For example, in a particular implementation, the blister 514 may be detected and may be required to be of a particular size (e.g., with respect to the marking 510). Further, the image may be required to not include features indicating an inappropriate injection. For example, when a thermal imaging device is used, a low-temperature region corresponding to the blister 514 having one or more adjacent low-temperature regions, or a low-temperature region 514 or a size exceeding a particular limit may be flagged as having leakage characteristics. In such an example, the analysis may indicate that the delivery from the delivery device 10 has failed.

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

[0368] In an example where the leader 410 is a smartphone, any app being used may generate a confirmation that an injection by the delivery device 10 has been performed in response to a user request. The controller 416 of the leader 410 may generate an option (e.g., a display button) that can be interacted with by the user to display a confirmation notice regarding the injection. When the delivery device 10 is used to perform a vaccination, the app may provide a vaccination certificate or 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 leader 410, or may be stored in a database 412 (e.g., see FIG. 86) accessible via the leader 410 (or may be stored in multiple locations). Thus, the leader 410 may be used to provide evidence of the injection as needed. For example, the leader 410 can be used to prove vaccination to gain access to a particular space (restaurant, stadium, workplace, other venue, airplane or airport, ship, public transportation, etc.).

[0369] In yet other embodiments, a container 350 that houses the packet 208 may be included in the delivery device 10 as described elsewhere herein (e.g., see FIG. 11). One of the packet 208 and the container 250 may contain a first chemical substance and the other may contain a second chemical substance. 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 rupture and the first and second chemical substances may be mixed. These chemicals may react to produce a visually recognizable effect. A chemiluminescent reaction may be initiated, for example, when the first and second chemical substances are mixed. In an example of such an embodiment, the chemicals commonly used in glow sticks may be filled into, for example, the container 350 and the packet 208.

[0370] Delivery device 10 may include one or more windows (e.g., slots 254 or apertures 255 in body 20 as in the examples shown in FIGS. 21A - 21I) through which light generated by the reaction can be perceived. A reader 410 (e.g., see FIG. 86) can image delivery device 10 during injection, and a controller 416 (e.g., see FIG. 86) can analyze the image to confirm the presence of light from the reaction. When controller 416 determines that a chemiluminescent reaction is recorded in the image, controller 416 can communicate with database 412 and update database 412 to indicate that 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 delivery device 10 during injection. The first and second chemicals may interact by the time injection is complete, resulting in, for example, a color change to a color indicating delivery. An image of the injection site can be taken by reader 410 and analyzed (e.g., locally by controller 416 or via a cloud analysis tool after the image is uploaded to database 412) to confirm the presence of the color indicating delivery. If the color change is recorded in the image, database 412 can be updated to indicate that delivery device 10 has been used.

[0372] Those skilled in the art can devise various alternatives and amendments without departing from the present disclosure. Therefore, the present disclosure is intended to embrace all such alternatives, modifications, and variations. Further, although some embodiments of the present disclosure are shown in the drawings and / or discussed herein, the present disclosure is not intended to be limited thereto, and the present disclosure is intended to be as broad as permitted in the art, and the same applies to the specification. Therefore, the above detailed description of the invention should not be construed as a limitation, but should be construed as merely an exemplification of specific 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 substantially different from those described in the detailed description of the invention and / or the appended claims are also considered to be within the scope of the present disclosure.

[0373] Embodiments are presented only for the purpose of illustrating specific examples of the present disclosure. Also, the drawings described are merely illustrative and not restrictive. In the drawings, for illustrative purposes, the sizes of some elements may be exaggerated and may not be drawn to a specific scale. Further, elements shown within the same drawing having the same number may, depending on the context, be the same element or similar elements.

[0374] When the term "comprising" is used in this specification and the 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", "the", etc., unless otherwise specified, this also includes the plural form of that noun. Therefore, the term "comprising" should not be construed as being limited to the items listed thereafter. Since 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 only of components A and B.

[0375] Furthermore, terms such as "first", "second", and "third" are provided to distinguish like elements whether used in the specification or in the claims and are not necessarily provided to describe a sequential or chronological order. Such terms may be interchangeable under appropriate circumstances (unless there is a separate clear disclosure), and it should be understood that the embodiments of the disclosure described herein can operate in a sequence and / or arrangement different from 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 having an upper surface spaced apart from a base and 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 coupled 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, the upper surface including a plurality of second slots therein.

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

4. 10. The delivery device of claim 1, further comprising a sharps bearing comprising at least one delivery sharp, the sharps bearing 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 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 foldable reservoir is urged to at least partially collapse to allow 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 petal members that is 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 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 foldable reservoir is urged to at least partially collapse to allow 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 curve 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 a transition between the storage state and the delivery state, and the first petal member and the second petal member are disposed 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 a transition between the storage state and the delivery state, thereby stretching a surface to which the delivery device is attached with the adhesive, and wherein the first petal member and the second petal member 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 of the plurality of petal members 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 thereon.

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

20. 1. A method of 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 against the skin surface to pierce the skin surface with the at least one delivery sharp, collapsing the reservoir and forcing the medical agent through the at least one delivery sharp and into the skin; 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 having 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 first plurality of slots extending inwardly from the outer periphery; an adhesive coupled to at least a portion of the body; a collapsible reservoir coupled to the body and to 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 outwardly 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 a perimeter 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 thereon.

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 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 penetrates the pierceable surface, and the foldable reservoir is urged to at least partially collapse to allow the fluid to enter the member through the pierceable surface via the at least one delivery sharp.

35. 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 includes a first region and a second region 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 penetrates the pierceable surface, and the foldable reservoir is urged to at least partially collapse to allow 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 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.

40. 40. The delivery device of claim 39, 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.

41. 41. The delivery device of claim 40, wherein the body has a footprint having an area, and 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 each other, each strut having a resilience that resists displacement of the first member and the second member relative to each other; 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 bias 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 exceeding a threshold value, 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 comprising: 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; a collapsible reservoir containing at least one delivery sharp, the reservoir being coupled to the unsupported end of the cantilever 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 widen 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, the delivery device further comprising a tether having a first end coupled to the second portion.

52. 52. The delivery device of claim 51 , wherein a 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 wherein 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 a first end block and a second end block spaced apart by a bridge, each of the side panels and the bridge including first and second opposed ends, each of the first ends being connected to the first end block via a respective first end living hinge and each of the second ends being connected to the second end block via a respective second end living hinge, each of the side panels and the bridge also 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 being 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. 60. 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 posts, the first panel being connected to the posts 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 the intermediate living hinge 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 one another 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 condition to the substantially straight condition 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 curved state to a substantially straight state, and the bridge is configured such that when the side panels are displaced from the outwardly curved 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 opening is 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 opposed 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 one 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 projection 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 central position and are displaced toward each other a second distance less than the first distance as the connectors are displaced from the central 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 intermediate panels adjacent a living hinge between the first and second intermediate panels of the plurality of living hinges.

78. 71. The delivery device of claim 70, wherein one of the panels comprises a strain relieved 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 link 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 including 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, which pressure breaks at least one first weakened portion, freeing the carriage to displace within a bore, and breaks 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 that aligns with an axis of the post, and 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 projection closest to the base.

87. 86. The delivery device of claim 85, wherein the projection 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 in a substantially perpendicular direction from the base; a surface extending from the first edge to an apex at an acute angle relative to the base, wherein two adjacent sidewalls of the plurality of sidewalls 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 face; 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 face 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 a region adjacent the apex and a region adjacent 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 towards the apex.

103. 98. The microneedle of claim 97, wherein the channel includes a first portion and a second portion, the first portion extending in a direction from an outlet on the surface toward the apex, and the second portion extending in a direction from an 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 least 50-200 microns away 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 microneedle has a height of 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 edges 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 face; A microneedle comprising:

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

112. 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 such 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 such 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 dimension of the arc 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 a number of bodies spaced apart by slits extending from a periphery of the peripheral region toward the central region; an adhesive coupled to at least a portion of the body; a collapsible reservoir coupled to the body and to 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, the body including at least one partially invertible region, wherein in the first state the body is a first shape and in the second state the body is substantially inverted relative to the first shape in at least a portion of the invertible region.

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 stationary 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 in the central region and extends from a periphery of the top surface to the base.

124. 121. The delivery device of claim 120, wherein the body is configured to spread and displace at least two bodies in the peripheral region 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 including 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 is defined between the rigid portion and the flexible portion, and the at least one delivery sharp is 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 comprising a first substance, the container comprising a second substance, the first substance and the second substance being configured to react when combined to expand a 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, further comprising 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 push body, a reservoir interface member, and a biasing member, each of which is at least partially disposed within the receptacle between the reservoir and the upper region.

142. 129. The delivery device of claim 128, wherein the interior 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 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 being removably coupled to 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 bar code, 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 including at least one delivery sharp, the reservoir coupled to the body and at least partially disposed within the receptacle; a dispensing assembly disposed at least partially 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 pusher includes a portion that protrudes through an opening in the upper region.

160. 160. The delivery device of claim 159, wherein the pusher 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 projections extending inwardly therefrom, the body includes a number of slots, the biasing projections extending through the slots into the receptacle.

164. 158. The delivery device of claim 157, wherein the reservoir interface member is integral with the push 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 in a plane adjacent an end of the coil 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 stored 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 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: obtaining device information from indicia on a package containing the delivery device using a reader; applying the delivery device to the skin of a patient; establishing data communication between the reader and a database; comparing said equipment 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 satisfies a usage criterion; 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 after-use indicia on a second portion of the delivery device.

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

179. 177. The method of claim 176, further comprising: generating a respective prompt on the user interface for each instruction manual in the set of instructions; and preventing 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 a notification service of the reader is 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 in a substantially perpendicular direction from the base; a surface extending from the first edge to an apex at an acute angle relative to the base, wherein two adjacent sidewalls of the plurality of sidewalls 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 face, 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. 185. 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 as the distance from the base increases; Flow Lumen and a plurality of side ports in the side wall, 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 in the shape of an obelisk.

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. 200. 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. 200. The microneedle of claim 193, wherein the microneedle is constructed 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 an 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; and capturing image data of the injection site with the reader, the image data including image data outside the visible spectrum; and 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 comprises image data in the infrared spectrum.

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

209. 204. The method of claim 203, wherein analyzing the image data comprises 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 pharmaceutical agent, comprising: attaching a delivery device to a surface, the delivery device including at least one delivery sharp in fluid communication with an at least partially collapsible reservoir containing a medicament while the delivery device is in a storage state; pushing a portion of the delivery device towards the surface to transition the delivery device to a delivery state; displacing at least two portions of the delivery device to apply tension to a surface to which the delivery device is attached; piercing said 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 expelling 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 having 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 protruding from a 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, the body including at least one partially invertible region, wherein in the first state the body is a first shape and in the second state the body is substantially inverted relative to the first shape in at least a portion of the invertible region.

222. 222. The delivery device of claim 221, wherein the body is configured such that at least two of the petal members spread 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 in the increased opening width portion that extends through the adhesive member outwardly from a periphery of the central opening.

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 affixed 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 having 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 protruding from a 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, the body including at least one partially invertible region, wherein in the first state the body is a first shape and in the second state the body is substantially inverted relative to the first shape in at least a portion of the invertible region.

233. 233. The delivery device of claim 232, wherein the body is 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.

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 outwardly from a 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 a top surface and a base; an adhesive coupled 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 promoter 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 a 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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