Delivery devices, systems, and methods

Abstract

Regarding dispensers for therapeutic drugs and other medical medications. [Solution] The delivery device 10 may comprise a body 20 including a central region 28 and a peripheral region 340. The central region 28 may be substantially thimble in shape and may have a top surface 250 and a base. The peripheral region 340 may be defined by a plurality of petal members 42. The plurality of petal members 42 may extend outward from the base. The delivery device 10 may further comprise an adhesive bonded to at least a portion of the body 20. The delivery device 10 may further comprise a foldable reservoir bonded to the body 20 and at least one delivery sharp.

Description

Technical Field

[0001] Statement Regarding Research or Development Sponsored 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 a variety of public health challenges that are not easily overcome. From a medical standpoint, existing preventive healthcare infrastructure is not well-suited, or even very well-suited, to novel pathogens such as SARS, MERS, Zika, and COVID-19. Other pathogens for which herd immunity does not exist (such as Ebola) and rapidly mutating, highly dangerous pathogens could pose similar challenges. While vaccine production typically takes years, once a vaccine exists, the prospect of rapidly producing billions of doses would almost certainly exceed current vaccine production capacity. Without vaccination, other preventive measures such as testing, contact tracing, and personal protective equipment (PPE) become more crucial. However, again, these preventive measures can only provide benefits as far as the relevant supply chains allow. Healthcare systems in the US and around the world, struggling to respond to the COVID-19 pandemic, are suffering from shortages of PPE and testing kits. Secondly, the scale of the COVID-19 pandemic is hindering the possibility of implementing effective contact tracing, which is already a massive undertaking. Furthermore, new pathogens can divert the focus of healthcare systems away from their typical functions. Secondary effects often occur when a pandemic spreads and requires the medical community's attention. This can manifest as delays in surgery, selective treatment, and routine doctor visits, but secondary effects can also be more severe. As UNICEF's head of immunization pointed out, for example, when trying to contain the Ebola outbreak in the Democratic Republic of Congo in 2019, the number of deaths from measles was twice the number of deaths from Ebola.

[0004] New pathogens inherently raise more psychological issues. Simply put, such pathogens frighten people. Because PPE and testing are not readily available, people may choose to avoid visiting healthcare facilities and clinics for fear of exposure to the disease. Even if PPE is readily available, certain individuals, such as those belonging to demographic groups at high risk to a particular pathogen, may still feel anxious about visiting such facilities. Furthermore, as in the case of the United States, there may be people who are vehemently opposed to the use of PPE for a variety of reasons. This presents an additional public health challenge for systems trying to cope with a pandemic. For solutions to new pathogens to be effective, these challenges must be addressed and aimed at avoiding them. [Overview of the Initiative]

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

[0006] In some embodiments, the top 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 top surface. In some embodiments, the delivery device may further comprise a sharp support including at least one delivery sharp. In some embodiments, the at least one delivery sharp is a microneedle including a flow lumen having an elongated cross-section. The sharp support may be coupled to a foldable reservoir. The foldable reservoir may be coupled to the inner surface of the central region. In some embodiments, when the delivery device is in storage, the foldable reservoir can contain fluid, and adhesive can be attached to a pierceable surface of an external member of the delivery device. When the delivery device is in delivery, the pierceable surface is stretched by the adhesive so that at least one delivery sharp penetrates the pierceable surface, and the foldable reservoir is prompted to collapse at least partially so that fluid can enter the member through the pierceable surface via at least one delivery sharp. In some embodiments, the adhesive may be bonded to at least a portion of the side surfaces furthest distal from the upper surfaces of at least two of the multiple petal members. In some embodiments, when the delivery device is in storage, the foldable reservoir can contain fluid, and the adhesive can be bonded to a pierceable surface of an external member of the delivery device. When the delivery device is in delivery, the pierceable surface is stretched by the adhesive, at least one delivery sharp penetrates the pierceable surface, and the foldable reservoir is encouraged to collapse at least partially, allowing fluid to enter the member through the pierceable surface via the at least one delivery sharp. In some embodiments, the adhesive may be bonded to at least a portion of the side surfaces furthest distal from the upper surfaces of at least two of the multiple petal members. In some embodiments, the upper surface may be configured to transition from a storage state where the upper surface is convex to a delivery state where the upper surface is concave, depending on the pressure applied to the delivery device.In some embodiments, at least two of the multiple petal members may be configured to curve in response to the pressure applied to the upper surface when the delivery device transitions to the delivery state. In some embodiments, at least two of the multiple petal members may be configured to curve to have a substantially constant radius of curvature in response to the pressure applied to the upper surface when the delivery device transitions to the delivery state. In some embodiments, at least a portion of the first petal member of the multiple petal members may be configured to move further away from at least a portion of the corresponding portion of the second petal member of the multiple petal members during at least a portion of the transition between the storage state and the delivery state, so that the delivery device stretches the surface to which the adhesive is attached, and the first and second petal members are positioned facing each other. In some embodiments, at least one delivery sharp may be a microneedle. In some embodiments, the delivery device may be an intradermal delivery device. In some embodiments, the reservoir may be divided into a first section and a second section. In some embodiments, the first section and the second section may be in fluid communication with each other via a flow limiter. In some embodiments, the reservoir may include an orifice plate.

[0007] According to another exemplary embodiment of the present disclosure, an exemplary method for delivering a drug may include the step of attaching a delivery device, which includes at least one delivery sharp coupled to a collapsible reservoir containing a drug, to a skin surface, with the delivery device in a stored state. The method may further include applying pressure to the delivery device toward the skin surface to transition the delivery device into a delivery state, which penetrates the skin surface with at least one delivery sharp, collapses the reservoir, and pushes the drug into the skin through at least one delivery sharp.

[0008] In some embodiments, this 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, this method may further include scratching the skin surface with at least one of the at least one delivery sharps. In some embodiments, this method may further include preventing the delivery device from being reused. In some embodiments, transitioning the delivery device to a delivery state may include at least partially inverting at least one area of ​​the body of the delivery device. In some embodiments, transitioning the delivery device to a 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 via at least one delivery sharp may include transferring the drug from the reservoir to the skin via the respective fl lumen and channel in each of the at least one delivery sharps.

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

[0010] In some embodiments, the top surface is convex and may include a plurality of second slots therein. In some embodiments, the plurality of second slots may extend outward relative to the center point of the top surface. In some embodiments, the central region may include a plurality of openings arranged along the base. In some embodiments, the central region may include a plurality of openings arranged along the periphery of the top surface. In some embodiments, the delivery device may further comprise a sharp support including at least one delivery sharp. The sharp support may be coupled to a foldable reservoir. The foldable reservoir may be coupled to the inner surface of the central region. In some embodiments, adhesive may be bonded to at least a portion of the side surface of the peripheral region furthest distal to the top surface. In some embodiments, the top surface may be configured to transition from a storage state where the top surface is convex to a delivery state where the top surface is concave in response to pressure applied to the delivery device. In some embodiments, the body may have a settling area, and the 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 have a mounting area of ​​a certain size, and the area may increase during at least part of the transition between the storage state and the delivery state, thereby widening the surface to which the delivery device is attached with adhesive. In some embodiments, when the delivery device is in the storage state, a collapsible reservoir can contain fluid, and adhesive can be attached to a pierceable surface of an external member of the delivery device. When the delivery device is in the delivery state, the pierceable surface is stretched by the adhesive, at least one delivery sharp penetrates the pierceable surface, and the collapsible reservoir is encouraged to collapse at least partially, so that fluid can enter the member through the pierceable surface via at least one delivery sharp. In some embodiments, at least part of the side surface may include first and second regions between two pairs of adjacent first slots of a plurality of first slots. In some embodiments, adhesive may be bonded to at least part of the side surface of the peripheral region furthest distal from the top surface.In some embodiments, at least a portion of the side surface may include first and second regions between two pairs of adjacent first slots among a plurality of first slots. In some embodiments, when the delivery device is in storage, a collapsible reservoir can contain fluid, and adhesive is applied to a pierceable surface of an outer member of the delivery device. When the delivery device is in delivery, the pierceable surface is stretched by the adhesive, at least one delivery sharp penetrates the pierceable surface, and the collapsible reservoir is encouraged to collapse at least partially so that fluid can enter the member through the pierceable surface via at least one delivery sharp. In some embodiments, the top surface may be configured to transition from a storage state where the top surface is convex to a delivery state where the top surface is concave, depending on the pressure applied to the delivery device. In some embodiments, the body may have a footprint of a certain area, and the footprint may be configured to increase during at least part of the transition between storage and delivery. In some embodiments, the body may have a mounting area of ​​a certain size, and the mounting area may increase during at least part of the transition between the storage state and the delivery state, thereby stretching the surface to which the delivery device is attached with adhesive.

[0011] According to another exemplary embodiment of the present disclosure, an exemplary actuator assembly for preventing reuse of a drug delivery device may comprise a deflection portion including first and second members and a plurality of struts connecting the first and second members to each other. Each strut may have elasticity to resist displacement of the first and second members in the direction of the relationship between them. The first member may include at least one first engaging member. The second member may include engaging members cooperating with each of the first engaging members. The struts may be configured to deflect at least one of the first and second members, causing rotational motion, when the first and second members are pressed toward each other by a force exceeding a threshold force. At least one first engaging member and each of the second engaging members may 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, the exemplary delivery device may comprise a first part comprising a cantilever arm, at least partially covered with a first adhesive. The delivery device may further comprise a second part comprising at least partially covered with a second adhesive, comprising at least one ramp element. The second part may be bonded to the first part via the first adhesive. The second part may be configured to extend from a first state to an extended state. The delivery device may further comprise a foldable reservoir comprising at least one delivery sharp. The reservoir may be bonded to the unsupported end of the cantilever arm.

[0013] The second portion may include one of a one-dimensional array of microneedles and one of a two-dimensional array of microneedles. In some embodiments, the second portion may include a delivery opening. The delivery opening does not have to be aligned with at least one delivery sharp part when the second portion is in the first state, but may be aligned with at least one delivery sharp part when the second portion is in the extended state. In some embodiments, the second portion may include a folded region in the first state. The folded region may be configured to unfold when the second portion transitions to the extended state. In some embodiments, the second portion may include a folded region. Layers of the folded region may be bonded to the first adhesive. In some embodiments, each of at least one ramp element may be positioned on the first side of the cantilever arm when the second portion is in the first state, and on the second side of the cantilever arm when the second portion is in the second state. In some embodiments, the second portion may be at least partially elastic. In some embodiments, the second portion may include a pull tab. In some embodiments, the delivery device may further comprise a locking adhesive positioned within a portion of the first part, and the delivery device may further comprise a tether having a first end that is coupled to a second part. In some embodiments, the second end of the tether is bonded to the locking adhesive and can cover the locking adhesive when the second portion is in the first state. The second end of the tether may be configured to at least partially separate from the locking adhesive and expose the locking adhesive when the second portion is in the extended state. In some embodiments, the second end of the tether may be bonded to the locking adhesive and the tether may be doubled over itself when the second portion is in the first state. In some embodiments, when the second portion is in the first state, the first and second adhesives may be positioned at a first distance from each other, and when the second portion is in the extended state, the first and second adhesives may be positioned at a second distance from each other. The second distance may be greater than the first distance. In some embodiments, at least one ramp element may be configured to elastically flex the cantilever arm when the second portion transitions from the first state to the second state.

[0014] According to exemplary embodiments of the present disclosure, an exemplary delivery device may comprise a body including first and second end blocks and a bridge, spaced apart by first and second side panels. The side panels and bridge may each include first and second opposing ends. Each first end may be connected to a first end block via its respective first end living hinge. Each second end may be connected to a second end block via its respective second end living hinge. The side panels and bridge may also each include its respective intermediate living hinge between their first and second ends. The delivery device may further comprise an adhesive that at least partially covers the first side of the end blocks. The delivery device may further comprise a foldable reservoir including at least one delivery sharp. The reservoir may be coupled to the 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 projection. In some embodiments, the first side panel may include a first guard projection extending toward the second side panel, and the second side panel may include a second guard projection extending toward the first side panel. In some embodiments, the first guard projection may include a latch projection, and the second side panel may include a latch catch. In some embodiments, the first side panel may include a third guard projection extending toward the second side panel, and the second guide panel may include a fourth guard projection extending toward the first side panel. In some embodiments, the bridge may include a first panel and a pair of posts. The first panel may be connected to the posts via an intermediate living hinge of the bridge. In some embodiments, arm members may be positioned between the posts and extend from the end of the panel adjacent to the intermediate living hinge of the bridge. In some embodiments, the side panels may have a displacement range from an outwardly curved state to a substantially straight state, and the end blocks may be configured to displace away from each other when the side panels are displaced from an outwardly curved state to a substantially straight state. In some embodiments, the side panel may be configured to displace from an outwardly curved 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 toward the first surface of the end block when the side panel is displaced from an outwardly curved state to a substantially straight state. In some embodiments, the side panel may have a displacement range from an outwardly curved state to a substantially straight state, and the bridge may be configured so that the arm members are displaced from a first position to a second position to which at least one arm member moves. The delivery sharp is positioned beneath the first surface of the end block when the side panel is displaced from an outwardly curved state to a substantially straight state. In some embodiments, the side panel may have a displacement range from an outwardly curved state to a substantially straight state, and the body may include a latch projection and a latch catch.The latch projection may be configured to engage with the latch catch when the side panel is displaced from an outwardly curved state to a substantially straight state. In some embodiments, the body may include a plurality of iris panels extending from the side panel to form a variable opening. In some embodiments, the opening may be configured to change size as the side panel is bent around an intermediate living hinge of each side panel.

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

[0017] In some embodiments, the first end panel is substantially planar, and the second end panel may include a planar portion and an inclined projection extending from the planar portion toward one of the intermediate connecting portions. In some embodiments, the second end panel may include a buttress extending from the planar portion toward the inclined projection. In some embodiments, at least one delivery sharp may include an array of microneedles. In some embodiments, the delivery device may be configured to transition from a storage state to a delivery state. In some embodiments, the second intermediate panel may be at least partially covered on its proximal side with adhesive. In some embodiments, the end panels may be displaced apart by a first distance along the plane when the connecting portion is displaced from an elevated position to a centered position, and may be displaced toward each other by a second distance shorter than the first distance when the connecting portion is displaced from a centered position to an overcentered position. In some embodiments, a reservoir may be located on the second intermediate panel adjacent to a living hinge among a plurality of living hinges between the first and second intermediate panels. In some embodiments, one of the panels may include a tension-relieving deflection portion. In some embodiments, at least a portion of the body may be configured to plastically deform when the connecting portion is displaced to the overcenter position. In some embodiments, at least one of the living hinges may be configured to break when the connecting portion is displaced from the raised position to the overcenter position and then returns to its original position. In some embodiments, the connecting portion can be at least partially inverted in the overcenter position relative to the raised position. In some embodiments, the angle between the intermediate panels when the connecting portion is in the raised position may be obtuse, and the angle between the intermediate panels when the connecting portion is overcenter may be a reflection angle. In some embodiments, when the connecting portion 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 may comprise an actuator. The delivery device may further comprise a base comprising a threaded post. The actuator may screw-engage with the post and be displaceable along the threaded post from a raised state where the actuator is furthest from the base to a delivered state where the actuator is closer to the base. The delivery device may further comprise a carriage disposed within a bore of the post. The carriage may include at least one first weak point and at least one second weak point, supported on each of the shelves defined within the bore. The delivery device may further comprise a delivery aid disposed within the bore. The delivery device may further comprise a foldable reservoir disposed within the bore and including at least one delivery sharp. When the actuator is displaced from the raised state to the delivered state, a portion of the actuator may be configured to apply pressure to the carriage. The pressure may break at least one of the first weak points, freeing the carriage and allowing it to be displaced within the bore, and may also break at least one of the second weak points, allowing pressure to be applied to the reservoir via the carriage and the delivery aid. The displacement of the actuator to the delivery state may be further configured to displace the reservoir toward the base.

[0019] In some embodiments, the actuator may include a projection that can be aligned with the axis of the post. Pressure on the carriage may be applied through the projection. In some embodiments, the delivery aid may be coupled to the end of the projection closest to the base. In some embodiments, when the actuator is in at least one of the raised and delivery positions, the projection may extend through at least a portion of the carriage. In some embodiments, the delivery aid may include a projection for concentrating force. In some embodiments, the base may include a delivery opening aligned with the bore of the post. In some embodiments, at least one first weak point may include a pair of weak points spaced around the carriage at equal angular increments. In some embodiments, at least one second weak point may include a pair of weak points spaced around the carriage at equal angular increments. In some embodiments, when at least one first weak point is in a broken state, the carriage may have a range of displacement within the bore limited by a stop surface located at the end of the bore adjacent to the base. In some embodiments, when the carriage is in contact with the stop surface such that the skin press body of the carriage is outside the bore, the carriage may extend through the delivery opening of the base. In some embodiments, a reservoir may be located within the carriage bay and held therein by friction when the pressure applied to the reservoir falls below a threshold. In some embodiments, the carriage, delivery aid, and reservoir may be configured to displace together as a unit in the bore after at least one first weak point has broken. In some embodiments, the carriage, delivery aid, and reservoir may be configured to stop displacing together as a unit when at least one second weak point has broken.

[0020] According to another exemplary embodiment of the present disclosure, an exemplary microneedle may comprise a base including a first edge and a plurality of second edges. The microneedle may further comprise a plurality of sidewalls extending substantially perpendicularly from the base. The microneedle may further comprise a plane extending acutely with respect to the base to the apex. Two adjacent sidewalls of the plurality may define a side edge extending from the base to the apex in a direction substantially perpendicular to the base. The microneedle may further comprise a flow lumen extending through the microneedle from the base to the exit of the plane. The microneedle may further comprise a channel defined in the plane and connected to the flow lumen.

[0021] In some embodiments, the flow lumen may have an elongated cross-sectional shape. In some embodiments, the in-plane exit may be located closer to the vertex than to the first edge. In some embodiments, the in-plane exit may be located closer to the first edge than to the vertex. In some embodiments, the face exit may be located in a central region of the face, intermediate between the region near the vertex and the region near the first edge. In some embodiments, the channel may extend in the direction from the in-plane exit toward the first edge. In some embodiments, the channel may extend in the direction from the in-plane exit toward the vertex. In some embodiments, the channel may include a first portion and a second portion. The first portion may extend in the direction from the face exit toward the vertex, and the second portion may extend in the direction from the face exit toward the first edge. In some embodiments, the channel may have a variable width. In some embodiments, the channel may have a substantially constant width. In some embodiments, the end of the channel closest to the first end may be at a distance of at least 50 to 200 microns from the base. In some embodiments, the microneedle may 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 may comprise a base including a first edge and a plurality of second edges. The microneedle may further comprise a plurality of side walls projecting from the second edges to an arcuate blade edge (cutting edge) extending from a base apex formed by two of the second edges to a second apex spaced apart from the base. The microneedle may further comprise a surface extending from the first end to the second apex. The microneedle may further comprise a flow lumen extending through the microneedle from the base to the exit of the surface.

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

[0024] According to yet another exemplary embodiment of the present disclosure, an exemplary delivery device may comprise a body including a peripheral region and a central region extending outward from the peripheral region. The peripheral region may have a top surface and a base. The peripheral region may include a number of bodies spaced apart by slits extending from the periphery of the peripheral region toward the central region. The delivery device may further comprise an adhesive bonded to at least a portion of the body. The delivery device may further comprise a foldable reservoir bonded 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 the base. In some embodiments, the body can be configured such that at least two of the bodies in the peripheral region expand and displace when the body transitions from the first state to the second state. In some embodiments, the 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 flap 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 sharp may be coupled to the rigid portion. In some embodiments, the rigid portion may include a stage projection. In some embodiments, at least one delivery sharp may be coupled to the stage projection and project from the stage projection at an acute angle to the rigid portion. In some embodiments, the body may include a protrusion adjacent to the receptacle. The protrusion may form a mounting surface for 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. The packet is disposed within a container and may 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. The packet may be placed in a container and filled with a first substance. The container may contain a second substance. The first and second substances may be configured to participate in a chemiluminescent reaction when combined. In some embodiments, the delivery device may further include a biasing member located in a receptacle between an upper region and a reservoir. In some embodiments, the biasing member may be a conical spring. In some embodiments, the body may include a plurality of positioning protrusions that can restrain the biasing member, and the biasing member may be coupled to the body. In some embodiments, the biasing member may be heat-crimped to the body. In some embodiments, the delivery device may further include a distribution assembly including a press, a reservoir interface member, and a biasing member, each at least partially located in a receptacle between a reservoir and an upper region. In some embodiments, the reservoir may be divided into a first part and a second part.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 can be 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 a removal force applied to the body results in 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 may comprise a body including a central region and a peripheral region. The peripheral region may have a plurality of petal members extending outward from the central region. The central region may define a receptacle and may have an upper region and a base connected by a wall. The delivery device may further comprise a foldable reservoir including at least one delivery sharp. The reservoir may be coupled to the body and at least partially located within the receptacle. The delivery device may further comprise a distribution assembly at least partially located within a container between the reservoir and the upper region. The delivery device may further include an adhesive placed on at least a portion of the main body.

[0031] In some embodiments, the distribution assembly may include a press, at least one biasing member, and a reservoir interface member. In some embodiments, the press may include a portion projecting through an opening in the upper region. In some embodiments, the press may include a retaining element. In some embodiments, the portion of the press may include at least one notch and may have a cross-sectional shape that is neither circular nor polygonal. In some embodiments, the biasing member may include at least one arc-shaped spring. In some embodiments, the biasing member may include a peripheral region and a plurality of biasing projections extending inward from the peripheral region. The body may include a plurality of slots. The biasing projections may extend into the receptacle through the slots. In some embodiments, the reservoir interface member may be integral with the press. In some embodiments, the distribution assembly may include a coil spring and may include a reservoir interface member. In some embodiments, the reservoir interface member may be formed by the end portion of the spring routed in a plane adjacent to the end of the coil of the spring. In some embodiments, the distribution assembly may include a spring that does not need to be in contact with the reservoir when the delivery device is in storage. In some embodiments, the spring may be unstressed when the delivery device is in storage.

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

[0033] In some embodiments, the mark may be selected from the group consisting of barcodes, data matrices, and QR codes. In some embodiments, the reader may be a smart device and may include an imaging device. In some embodiments, at least one function may include the use of an 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 exemplary embodiments of the present disclosure, an exemplary method of using a medical delivery device may include the step of retrieving device information using a reader from a mark on a package containing the medical delivery device. This method may further include applying the delivery device to the patient's skin. This method may further include establishing data communication between the reader and a database. This method may further include comparing the device information with related device information stored in the database. This method may further include generating a set of instructions for use on the reader's user interface using the reader's controller if the comparison satisfies usage criteria. This method may further include the step of retrieving data from a post-use mark using a reader after the medical delivery device has been used. This method may further include updating the database to indicate that the post-use mark of the delivery device has been captured by the reader.

[0035] In some embodiments, the method may further include the step of 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 the step of applying a post-use mark to the skin. In some embodiments, the method may further include the steps of generating a corresponding prompt on the user interface for each instruction manual in the instruction manual set, and preventing the display of the next instruction manual until a user interaction with the prompt is registered by the controller. In some embodiments, the method may further include preventing the use of at least one function of the reader until the reader's notification service is enabled. In some embodiments, the at least one function may be the use of the reader's imaging device. In some embodiments, the method may further include generating a delivery confirmation for display on the reader's user interface. 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 may include applying the delivery device to an injection site. This method may further include generating a set of instructions for use on the reader's user interface using the reader's controller. This method may further include the step of delivering a drug from the delivery device to the injection site. This method may further include the step of capturing image data of the injection site using the reader, the image data including image data of the spectrum outside the visible spectrum. This method may further include the step of analyzing the image data to determine whether the image data meets at least one criterion indicating a proper injection.

[0037] In some embodiments, the method may further include establishing data communication between a reader and a database. In some embodiments, the method may further include updating the database to indicate the results of the analysis. In some embodiments, the image data may include near-infrared spectral image data. In some embodiments, the image data may include infrared spectral image data. In some embodiments, the image data may include thermal image data. In some embodiments, analyzing the image data may include analyzing the thermal image data for the presence of a low-temperature region at the injection site. In some embodiments, analyzing the image data may include analyzing the image data to determine the presence of at least one feature of interest. In some embodiments, at least one feature of interest may 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, a microneedle may comprise a base including a first edge and a plurality of second edges. The microneedle may further comprise a plurality of sidewalls extending substantially perpendicularly from the base. The microneedle may further comprise a face extending acutely from the first end to the apex with respect to the base. Two adjacent sidewalls of the plurality may define a side edge extending from the base to the apex in a direction substantially perpendicular to the base. The microneedle may further comprise a flow lumen extending through the microneedle from the base to the exit of the face. The flow lumen may have an elongated cross-section.

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

[0040] According to another exemplary embodiment of the present disclosure, the exemplary microneedle may comprise a base. The microneedle may further comprise a plurality of side walls extending from the base. The side walls may be angled to taper so 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 may further comprise a plurality of side ports in the side walls. The side ports may be in fluid communication with the flow lumen. The microneedle may further comprise a tip at the end of the side wall opposite the base.

[0041] In some embodiments, the microneedle may have a high aspect ratio. In some embodiments, the microneedle may be substantially obelisk-shaped. In some embodiments, the base may be polygonal, and the sidewalls of the multiple 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 of the multiple 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 may be wider than a portion of the cross-section of the microneedle. In some embodiments, the microneedle may be made of silicon, and the lumen may be formed by etching into the microneedle. Side ports may be formed as a result of etching the lumen. In some embodiments, the flow lumen may 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 for delivering a medical drug may include the step of attaching a delivery device to a surface, which includes at least one delivery sharp that can fluidly communicate with at least a partially foldable reservoir containing a drug while the delivery device is in storage. The method may further include the step of pushing a portion of the delivery device toward the surface to transition the delivery device into 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 the step of penetrating the surface with at least one delivery sharp. The method may further include the step of transferring fluid from at least a 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 may comprise a body. The body may comprise a peripheral region having a number of petal members. The body may further comprise a central region extending from the peripheral region. The central region may comprise a top surface and a bottom surface. The delivery device may further comprise a foldable reservoir in fluid communication with at least one delivery sharp. At least one delivery sharp may be configured to discharge fluid from the reservoir in a discharge direction. The delivery device may further comprise an adhesive member including a central opening. The central opening may include an increased opening width portion aligned with the discharge direction.

[0044] In some embodiments, the reservoir may include a flexible portion and a rigid portion. An adhesive member may be attached to the body and the rigid portion. In some embodiments, the reservoir may include a flexible portion and a rigid portion. The rigid portion may have a footprint comprising a first area. The central opening may surround a second area which is 60-100% of the first area. In some embodiments, the center of the central opening may be coaxial with the center of the reservoir. In some embodiments, the adhesive member may include at least one spoke projecting 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 microneedles. In some embodiments, the body may have a first state and a second state. The body may include at least one partially reversible region which is a first shape in the first state and substantially reverses relative to the first shape over at least a portion of the reversible region in the second state. In some embodiments, the body may be configured such that at least two of the petal members spread out and displace when the body transitions from a first state to a second state. In some embodiments, at least one delivery sharp may be displaced to communicate with the delivery destination when the body is displaced from the first state to the second state. In some embodiments, the central opening may include at least one notch in the increased opening width portion that extends outward from around the central opening through the adhesive member.

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

[0046] In some embodiments, the reservoir may include a flexible portion and a rigid portion. In some embodiments, adhesive members may be attached to the body and the rigid portion. In some embodiments, the reservoir may include a flexible portion and a rigid portion. The rigid portion may have a mounting area comprising a first region. The central opening may surround a second region which is 60-100% 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 may include at least one spoke projecting 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 microneedles. In some embodiments, the body may have a first state and a second state. The body may include at least one partially reversible region that is a first shape in the first state and substantially reverses relative to the first shape over at least a portion of the reversible region in the second state. In some embodiments, the body may be configured such that at least two of the petal members spread out and displace when the body transitions from the first state to the second state. In some embodiments, at least one delivery sharp may be displaced to communicate with the delivery destination when the body is displaced from the first state to the second state. In some embodiments, the central opening may include at least one notch in the increased opening width portion that extends outward from around the central opening through the adhesive member.

[0047] According to yet another exemplary embodiment of the present disclosure, the delivery device may comprise a body. The body may include a peripheral region. The peripheral region may include a number of petal members. The body may further include a central region. The central region may extend outward from the peripheral region. The central region may have a top surface and a base. The delivery device may further comprise an adhesive bonded to at least a portion of the body. The delivery device may further comprise a reservoir including at least one flexible portion. The at least one flexible portion may include a cavity defined by a first wall including a disintegration-promoting portion. The delivery device may further comprise at least one delivery sharp having fluid communication with the reservoir.

[0048] In some embodiments, the disintegration accelerator may include a bellows. In some embodiments, the disintegration accelerator may include pleats extending spirally around a wall. In some embodiments, the disintegration accelerator may include at least one stepped region formed in the wall. In some embodiments, the first wall may extend from a flange coupled to a rigid portion of the reservoir. In some embodiments, the first wall may 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 the end of the cavity, the second wall forming a substantially flat surface. In some embodiments, the second surface may include a central recess. In some embodiments, the wall may extend from the flange or be formed integrally with the flange. In some embodiments, the cavity may be defined by a first wall and a second wall at the end of the cavity, the second wall being substantially parallel to the flange. In some embodiments, at least one delivery sharp may include a microneedle. [Brief explanation of the drawing]

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

[0050] [Figure 1] This is a block diagram of an exemplary delivery device in storage, according to various aspects and embodiments of the present disclosure.

[0051] [Figure 1B] This is a block diagram of an exemplary delivery device in a delivery state according to various aspects and embodiments of the present disclosure.

[0052] [Figure 2] This is a diagram illustrating an exemplary microneedle according to various aspects and embodiments of the present disclosure.

[0053] [Figure 3A] This is a diagram illustrating an exemplary Sharp support incorporating microneedles, according to various aspects and embodiments of the present disclosure.

[0054] [Figure 3B] This is a diagram illustrating an exemplary microneedle according to various aspects and embodiments of the present disclosure.

[0055] [Figure 4A] This is a diagram illustrating an exemplary Sharp support incorporating microneedles, according to various aspects and embodiments of the present disclosure.

[0056] [Figure 4B] This is a diagram illustrating an exemplary microneedle according to various aspects and embodiments of the present disclosure.

[0057] [Figure 5A] A perspective view of an exemplary Sharp bearing including a set of exemplary microneedles.

[0058] [Figure 5B] A perspective view of an exemplary Sharp bearing including a set of exemplary microneedles.

[0059] [Figure 6A] A perspective view of an exemplary Sharp bearing including a set of exemplary microneedles.

[0060] [Figure 6B] Figure 6A is a top view of an exemplary Sharp support.

[0061] [Figure 7A] This is a top view of an exemplary Sharp support including a set of exemplary microneedles.

[0062] [Figure 7B] A perspective view of an exemplary Sharp bearing including a set of exemplary microneedles.

[0063] [Figure 8A] This is a top view of an exemplary Sharp support containing a set of microneedles.

[0064] [Figure 8B] A perspective view of an exemplary Sharp bearing including a set of exemplary microneedles.

[0065] [Figure 8C] This is a cross-sectional view of the cross-section shown in Figure 8A.

[0066] [Figures 9A-9D] Various diagrams of exemplary microneedles with side ports are shown.

[0067] [Figure 10A] These are some block diagrams of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0068] [Figure 10B] These are some block diagrams of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0069] [Figure 11] These are some block diagrams of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0070] [Figure 12] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

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

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

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

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

[0075] [Figure 17] This is a diagram of an exemplary delivery device in storage, according to various aspects and embodiments of the present disclosure.

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

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

[0078] [Figure 20] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0079] [Figure 21A-21I] This figure shows various exemplary embodiments of the body, including different slot patterns and top openings, according to various aspects and embodiments of the present disclosure.

[0080] [Figure 22] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0081] [Figure 23] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0082] [Figure 24] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0083] [Figure 25] This is a diagram of an exemplary delivery device in storage, according to various aspects and embodiments of the present disclosure.

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

[0085] [Figure 27A] This is a plan view of an exemplary delivery device showing an example of dimensions of one embodiment of the delivery device according to one embodiment of the present disclosure.

[0086] [Figure 27B] An exemplary side view of a delivery device showing an example of dimensions of one embodiment of a delivery device according to one embodiment of the present disclosure.

[0087] [Figure 28A] This is a side conceptual diagram of an exemplary delivery device transitioning to a delivery state according to various aspects and embodiments of the present disclosure.

[0088] [Figure 28B] This is a side conceptual diagram of an exemplary delivery device transitioning to a delivery state according to various aspects and embodiments of the present disclosure.

[0089] [Figure 29] This is a conceptual perspective view showing an exemplary delivery device in a delivery state according to various aspects and embodiments of the present disclosure.

[0090] [Figure 30] Figure 29 is a side view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0091] [Figure 31] Figure 29 is an exploded view of a delivery device shown in various aspects and embodiments of this disclosure.

[0092] [Figure 32] Figure 29 is a plan view of a delivery device according to various aspects and embodiments of this disclosure.

[0093] [Figure 33] This is a cross-sectional view of the delivery device shown in Figure 29, taken from the cross-section shown in Figure 32, according to various aspects and embodiments of the present disclosure.

[0094] [Figure 34] A typical diagram of an exemplary delivery device, including a distribution assembly, is shown.

[0095] [Figure 35] A typical diagram of an exemplary delivery device, including a distribution assembly, is shown.

[0096] [Figure 36] A typical diagram of an exemplary delivery device, including a distribution assembly, is shown.

[0097] [Figure 37] An exemplary perspective view of a delivery device and biasing member is shown.

[0098] [Figure 38] An exemplary biasing member that may be included in a delivery device is shown in a perspective view.

[0099] [Figure 39] A cross-sectional view of a portion of an exemplary delivery device is shown.

[0100] [Figure 40] A cross-sectional view of a portion of an exemplary delivery device is shown.

[0101] [Figure 41]An exemplary perspective view of a pressing element that may be included in a delivery device is shown.

[0102] [Figure 42] An exemplary depressor body and biasing member are shown, with the biasing member under stress.

[0103] [Figure 43] An exemplary cross-sectional view of a pressing body and biasing member is shown, where the biasing member is under stress.

[0104] [Figure 44A] An illustrative perspective view of a delivery device is shown.

[0105] [Figure 44B] An exemplary perspective view of a stopper that may be included in a delivery device is shown.

[0106] [Figure 44C] Exemplary delivery assemblies and exemplary stopping members that may be included in a delivery device are shown in perspective views.

[0107] [Figure 44D] Exemplary biasing members and exemplary pressing bodies that may be included in a delivery device are shown in perspective views.

[0108] [Figure 45] A typical diagram of an exemplary delivery device including a biasing member is shown.

[0109] [Figure 46A] An exemplary bottom view of a main body that may be included in a delivery device is shown.

[0110] [Figure 46B] The diagram shows an exemplary body and exemplary biasing member that may be included in the delivery device.

[0111] [Figure 46C] The diagram shows an exemplary body and exemplary biasing member that may be included in the delivery device.

[0112] [Figure 47] This is a perspective view of exemplary holders for Sharp bearings according to various aspects and embodiments of the present disclosure.

[0113] [Figure 48] This is a side view of an exemplary holder for a Sharp support according to various aspects and embodiments of the present disclosure.

[0114] [Figure 49] This is a bottom view plan of an exemplary holder for a Sharp support according to various aspects and embodiments of the present disclosure.

[0115] [Figure 50] This is a perspective view of exemplary holders for Sharp bearings according to various aspects and embodiments of the present disclosure.

[0116] [Figure 51A] An exemplary perspective view of a holder, including a stage projection, is shown.

[0117] [Figure 51B] An exemplary perspective view of a holder, including a stage projection, is shown.

[0118] [Figure 51C] An exemplary bottom view of a holder, including the stage projection, is shown.

[0119] [Figure 52A] An exemplary side view of a holder including a stage projection to which an exemplary Sharp support is attached is shown.

[0120] [Figure 52B] A detailed view of the region shown in Figure 52A is provided.

[0121] [Figure 52C] A cross-sectional view of an exemplary holder, including a stage projection to which an exemplary Sharp support is attached, is shown.

[0122] [Figure 52D] A detailed view of the region shown in Figure 52C is provided.

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

[0124] [Figure 54] This is a plan view of an exemplary portion of a reservoir according to various aspects and embodiments of the present disclosure.

[0125] [Figure 55] This is a perspective view of exemplary portions of reservoirs according to various aspects and embodiments of the present disclosure.

[0126] [Figure 56] This is a perspective view of exemplary portions of reservoirs according to various aspects and embodiments of the present disclosure.

[0127] [Figure 57] An exemplary perspective view of a reservoir is shown.

[0128] [Figure 58] Another exemplary reservoir is shown in a perspective view.

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

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

[0131] [Figure 61A] A block diagram of an exemplary reservoir assembly is shown.

[0132] [Figure 61B] A block diagram of an exemplary reservoir assembly is shown.

[0133] [Figure 62] A typical diagram of an exemplary delivery device, including a reservoir divided into multiple parts, is shown.

[0134] [Figure 63A] A bottom view of an exemplary delivery device with exemplary adhesive members is shown.

[0135] [Figure 63B] A bottom view of another exemplary delivery device with another exemplary adhesive member is shown.

[0136] [Figure 63C] A bottom view of another exemplary delivery device with another exemplary adhesive member is shown.

[0137] [Figure 64A] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0138] [Figure 64B] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0139] [Figure 65A] This is a side view of an exemplary delivery device in a first state according to various aspects and embodiments of the present disclosure.

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

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

[0142] [Figure 66A] This is an exemplary cross-sectional view of a bent portion of a delivery device according to various aspects and embodiments of the present disclosure.

[0143] [Figure 66B] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0144] [Figure 66C] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0145] [Figure 67A] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0146] [Figure 67B] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0147] [Figure 68] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

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

[0149] [Figure 70A] This is a side view of an exemplary delivery device in a first state according to various aspects and embodiments of the present disclosure.

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

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

[0152] [Figure 71] This is a cross-sectional view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0153] [Figure 72A] This is a block diagram of an exemplary delivery device in storage, according to various aspects and embodiments of the present disclosure.

[0154] [Figure 72B] This is a block diagram of an exemplary delivery device in a delivery state according to various aspects and embodiments of the present disclosure.

[0155] [Figure 73] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0156] [Figure 74] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

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

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

[0159] [Figure 77A] This is a side view of an exemplary delivery device in a first state according to various aspects and embodiments of the present disclosure.

[0160] [Figure 77B] This is an enlarged view of the area shown in Figure 77A, which contains the delivery device.

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

[0162] [Figure 78B] This is an enlarged view of the area shown in Figure 78A, which contains the delivery device.

[0163] [Figure 79] This is a cross-sectional view of an exemplary delivery device in a first state according to various aspects and embodiments of the present disclosure.

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

[0165] [Figure 81] This document shows exploded views of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0166] [Figure 82] This document shows exploded views of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0167] [Figure 83] This is a perspective view of an exemplary deflection portion that may be included as or as part of an operational assembly of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0168] [Figure 84] This is an exemplary side view of a deflection portion that may be included as or as part of an operational assembly of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0169] [Figure 85] This is a plan view of an exemplary deflection portion that may be included as or as part of an operational assembly of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0170] [Figure 86] An exemplary perspective view of a package for a delivery device is shown.

[0171] [Figure 87] A diagram shows an exemplary body of a delivery device separated from an exemplary reservoir assembly that may be included in the delivery device.

[0172] [Figure 88] The image reveals a mark formed on the skin by the delivery device, and shows the patient having the exemplary delivery device removed from their skin.

[0173] [Figure 89] This shows an example of a thermal image of an injection site where blisters from an injection into the skin are visible. [Modes for carrying out the invention]

[0174] Figures 1A and 1B show an exemplary embodiment of the delivery device 10. The exemplary delivery device 10 may be a low-profile delivery device 10 that can be applied to the patient's skin. The exemplary delivery device 10 can be made into a size suitable for handheld use and can be easily applied to a wide variety of injection sites on the patient's body. Furthermore, the exemplary delivery device 10 may be designed to be used by the patient or an individual who is relatively untrained or has minimal training. Therefore, healthcare workers may not be required to use the delivery device 10.

[0175] Such a delivery device 10 may be used to administer a drug to a patient's target delivery destination via one or more delivery sharps 72 from a reservoir 12 included as part of the delivery device 10. The reservoir 12 may be at least partially flexible and may have a variable volume that can decrease as fluid is distributed from the reservoir 12. When the reservoir 12 is empty, the reservoir 12 may be at least partially collapsed. In exemplary embodiments, multiple delivery sharps 72 are included in the delivery device 10, but other embodiments may include only a single delivery sharp 72. The exemplary multiple delivery sharps 72 may be arranged in a one-dimensional or two-dimensional array and may extend from the reservoir 12. When multiple delivery sharps 72 are included, the delivery sharps 72 may be arranged in one or more rows and / or columns. Figure 1A shows three delivery sharps 72 arranged in a row, but multiple delivery sharps 72 may be arranged. The number and arrangement of the delivery sharps 72 may differ in alternative embodiments. Various examples may include any appropriate number of rows and / or columns. In various embodiments, for example, there may be a single-column array of delivery sharps 72 containing up to five delivery sharps 72. Preferably, the delivery sharps 72 can be arranged to prevent penetration into the skin between the user and the delivery device 10, or to prevent inconsistent bed of nails type situations. They can be arranged to prevent scenarios in which a bed of nails penetrates. This can occur if too many delivery sharps 72 are placed too close to each other. Thus, this array is sometimes called a spaced array of delivery sharps 72.

[0176] The delivery sharp 72 can be selected based on the patient's desired target delivery location. In certain embodiments, the target delivery destination may be a transcutaneous location. For example, the target delivery destination may be a subcutaneous or intramuscular location. Alternatively, the target delivery destination may be a shallow location between the patient's stratum corneum and subcutaneous tissue. Such shallow destinations may be referred to herein as intradermal delivery destinations. Shallow delivery destinations may include target locations in the epidermis or dermis, or they may target, for example, the junction between the epidermis and dermis, or between the dermis and subcutaneous tissue. In exemplary embodiments, the delivery sharp 72 is shown as a microneedle. Such a delivery sharp 72 may reside within a delivery device 10 having a shallow (e.g., above subcutaneous tissue) target delivery destination. For example, in alternative embodiments where the target delivery destination is a subcutaneous or intramuscular location, a conventional delivery sharp (e.g., a 30-gauge needle) may be used.

[0177] In Figure 2, a microneedle is used, but the microneedles described herein may, in certain embodiments, be polyhedral (e.g., pyramidal) silicon crystal microneedles manufactured by MEMS. These microneedles may have a height of 1 mm or less, for example, 0.6 mm or 0.8 mm (however, longer or shorter microneedles may also be used). At least some of the edges of the microneedle may be rounded or filleted, but such microneedles may still be referred to herein as polyhedra. In some examples, as shown in Figure 2, the microneedles described herein may generally be in the shape of a heptagonal prism cut obliquely to form a heptagonal ramp or a pointed wedge (however, pentagonal, nonagonal, and other polygonal prisms may also be used as basic shapes). In such embodiments, the heptagonal prism may be divided by a plane extending from the vertex 14 of the top surface of the prism through the most distal side 15 of the base 17. At least two sides of the base of the microneedle may be parallel. The side wall 19 may extend substantially perpendicularly from the base 17. The microneedle 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 microneedle may be conical. Any other suitable shape may also be used. In this example, the apex 14 is shown as the point that forms the tip of the microneedle. In other embodiments, this part of the microneedle may be rounded (although it may still be referred to as the apex 14 in this specification, and such a microneedle may still be referred to as pointed). In such embodiments, the rear side edge 23 may be a rounded surface, or the rear side edge 23 and the adjacent side wall 19 may be replaced by a rounded surface.

[0178] The tip or tip of the microneedle may be solid, and the flow lumen 126 passing through the microneedle may be offset from the tip or tip of the microneedle (in Figure 2, the vertex 14 forms the tip). Microneedles with a hollow tip may also be used, where the flow lumen 126 extends to the tip of the microneedle. In some embodiments, the microneedle may be a hollow microneedle, available from NanoPass Technologies Ltd., Ness Giona, Golda Meir3, Israel. It should be noted that the microneedle (or the substrate on which the microneedle is placed) described herein as being composed of silicon may have a silicon dioxide surface layer (which may be formed, for example, by exposure to air), while still being considered to be composed of silicon.

[0179] Referring to Figures 3A–4B, in some embodiments, the microneedles may be constructed to include specific features that help reduce the pressure required to inject fluids, such as drugs, into the patient's skin. In some examples, features common to insect needles or biotoxin delivery structures may be incorporated. These features may include various recesses or depressions formed as part of each microneedle or at least one microneedle of the delivery device 10. These recesses or depressions may be in fluid communication with the flow lumen 126 of each microneedle. In some embodiments, different microneedles of the delivery device 10 may include different recesses, or some microneedles may include multiple recesses that (but do not have to) be different.

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

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

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

[0183] The channel 200 does not need to be straight or have the shape shown and described in Figures 4A-4B. In some embodiments, the channel 200 may be a more meandering channel 200. For example, a curved channel 200 can be used if the dimensions of the microneedle are suitable. Furthermore, there does not need to be only one channel 200. Two or more channels can be used if the structural integrity of the microneedle is taken into consideration.

[0184] The depth of channel 200 may be approximately 25 microns or more (e.g., 25–50 microns) in certain examples. The depth of channel 200 may be less than 5 percent of the height of the microneedle. The depth of channel 200 may be constant along the length of channel 200, but it does not have to be constant along the length of channel 200. Similarly, the width of channel 200 does not have to be constant along the length of channel 200 (see, for example, Figure 5B). The width of channel 200 may be approximately 20–30 percent of the width of the distal end 15 of the microneedle at the narrowest point of channel 200. In some embodiments, the width of channel 200 may increase as the distance to the distal end 15 decreases. In some embodiments, channel 200 may have a width of 50% or more of the width of the distal end 15 at its widest point.

[0185] Referring here to Figures 5A and 5B, in other examples, the channel 200 may extend from the position of the lumen 126 toward the tip or apex 14 of the microneedle (see, for example, Figure 5B). Furthermore, in some examples, the channel 200 may extend from the position of the lumen 126 toward the apex 14 and toward the base 17. That is, the channel 200 may include portions on both sides of the lumen 126 (see, for example, Figure 5A). As shown, the lumen 126 can be located substantially in the center of the inclined surface 21 of the microneedle. In such embodiments, the channel 200 may extend toward the distal side 15 of the base 17, and the channel 200 may extend toward the tip or apex 14. In other embodiments, the lumen 126 may be located at the end of the channel 200 closest to the base 17 (or near it).

[0186] Referring here to Figures 6A-6B, a sharp bearing body 26 containing numerous microneedles is shown. In certain embodiments, the channel 200 may not be included. Instead, the microneedle may include a flow lumen 126 having an elongated cross-section (at least at the exit; see also Figures 7B and 8B). A microneedle with both the channel 200 and the elongated lumen 126 is also possible. The elongated lumen 126, once positioned in place within the patient's body, may be in fluid communication with, for example, multiple skin layers. Thus, as the microneedle is advanced into the patient's body, thin and / or weak layers of 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, a lumen 126 having an elliptical cross-section can be used, as shown in Figures 6A and 6B. Polygonal cross-sectional shapes such as rectangles, trapezoids, and triangles may also be used, though not limited to these. In certain examples, the length (extension direction) of the cross-section of the lumen 126 may be 100–200 μm or greater (however, it may be smaller in certain examples). If an elongated lumen 126 is included, the end of the lumen 126 most proximal to the distal side 15 can be spaced at least a certain distance from the distal side 15. This spacing may be such that, when the microneedle is inserted into the skin, its most proximal end is located at the distal end 15 of the lumen 126, below at least the stratum corneum (and possibly one or more of the stratum lucidum, stratum granulosum, stratum spinosum, and stratum basale). In some embodiments, it may be located below the epidermis (e.g., within the basement membrane) or within the epidermis.

[0187] Referring to Figures 6A-6B, in certain embodiments, the inclined surface 21 of the microneedle does not have to extend to the base 17 of the microneedle. For example, there may be a vertical surface 13 extending from the base 17 to the distal side 15 of the microneedle. If a vertical surface 13 is included, it can be aligned with a side of the Sharp support 26 (e.g., the distal side 15) and form an extension thereof. Including such a vertical surface 13 can help reduce the size of the Sharp support 26 and help ensure consistent fluid delivery to the target destination of a particular microneedle. As shown in Figures 6A-6B, any of the microneedles shown herein may be configured with a vertical surface 13.

[0188] Furthermore, 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 recess (though not necessarily so), as shown in Figures 3A-3B. The recess 202 may have a maximum depth through which it fluidly communicates with the flow lumen 126 of the microneedle. Thus, the recess 202 can form a side port for the microneedle from which fluid can be delivered to the patient. The side port may be the sole exit of the microneedle, or it may be an additional exit for the lumen on the surface 21 of the microneedle. Once the microneedle is inserted into the skin surface, the fluid contained in the delivery device 10 can be delivered to the patient, at least partially, by being pumped into the recess 202. The recess 202 may be formed, for example, by excising material during the manufacture of the microneedle, or it may be formed during the molding process. Excision of material can be achieved by any known suitable process, such as etching (e.g., wet etching). In some embodiments, the recess 202 may be recessed into at least one side wall 19 or edge of the microneedle (e.g., where two side walls 19 meet). As shown in Figures 3A–3B, the recess 202 is formed in a substantially vertical dorsal side edge 23 of the microneedle extending from the base 17 to the apex 14. This can establish or increase the vertical void volume generated by the microneedle when it penetrates the skin. That is, such a recess 202 can establish an open space in the patient from which fluid can be easily delivered from the microneedle. By positioning the recess 202 in the dorsal side edge 23, a low-resistance path can be provided for fluid to enter the skin through which the microneedle has penetrated. In embodiments in which the microneedle includes at least one substantially vertical wall, the recess 202 may be recessed into the substantially vertical wall. In exemplary embodiments, the maximum depth of the recess 202 may be about 130% to 110% of the distance from the dorsal side edge 23 to the fluid lumen 126.

[0189] In certain examples, the microneedle may include a beveled surface 21 on 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 end 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, but other types of bevels may also be used. The rounded blade edge 31 may arc with a constant radius or with a variable radius. The rounded blade edge 31 may have an arc dimension of less than 90°, or in certain examples, an arc dimension of greater than 90° (see, for example, Figures 8A-8C). The rounded blade edge 31 can help introduce the microneedle into the skin when the microneedle is inserted at a specific angle or across a variety of different angles.

[0190] In yet another embodiment, as shown in Figures 8A-8C, the lumen 126 may include a rounded blade edge 31 and a lumen exit surface 35. The lumen 126 may extend through the microneedle to the lumen exit surface 35, or it may not be formed in a straight line through the microneedle. The lumen exit surface 35 may be angled distally from the apex 14 to the distal side 15 to form an undercut. The distal edge 15 may be positioned so that a plane perpendicular to the base 17 passing through the distal edge 15 also passes through the rounded or arcuate blade edge 31. Furthermore, the exit of the flow lumen 126 at the lumen exit surface 35 is positioned so that one or all planes perpendicular to the base 17 and passing through the exit of the flow lumen 126 also pass through the blade edge 31. This is not required in all embodiments (see, for example, Figures 7A-7B). When the type of microneedle shown in Figures 8A-8C is inserted, the undercut may create a vertical gap. This may provide a low-resistance pathway for fluid injection. Furthermore, the undercut may help reduce the possibility of lumen 126 being blocked by the skin when the microneedle is inserted into the patient or when delivery is made.

[0191] In yet another embodiment, as shown in Figures 9A to 9D, the delivery sharp 72 may be a microneedle having a high aspect ratio shape, or may include one. In some embodiments, the microneedle may be obelisk-shaped. Such microneedles can be included in arrays, such as any array described herein. When an obelisk-shaped microneedle is used, the microneedle may include a base 17'. The base 17' may be any desired circular or polygonal shape. As an example, Figures 9A–9D show a base 17' that is quadrangular or rhomboid. An exemplary microneedle includes a pair of side walls 19' extending from the base 17' to the end region 25 of the microneedle. The side wall 19' may be positioned at an angle 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 at the base 17' may include a chamfered tip 27. Such a tip 27 can facilitate skin puncture and may help increase the robustness of the end region 25. Any suitable bevel, such as a single bevel or a double bevel, may also be used.

[0192] In an embodiment of an 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 in 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 have a termination closer to the end region 15 than the base 17'. The lumen 126 may have a relatively constant cross-section. The taper of the side wall 19' may cause the termination of the lumen 126 to be wider than the portion of the cross-section of the corresponding region of the microneedle. Thus, the lumen 126 can form an opening in the side wall 19' that functions as a side port 29. In various examples, the lumen 126 may be centrally located, resulting in a symmetrical side port 29. In an alternative embodiment, the lumen 126 does not need to be centrally located, and the side port 29 does not need to be symmetrical.

[0193] In various embodiments in which silicon is not used to form the microneedles, the microneedles described herein may be constructed from glass (e.g., silica glass, borosilicate glass), ceramics (e.g., organically modified ceramics such as alumina, calcium sulfate dihydrate, calcium phosphate dihydrate, ormoser), polymers (e.g., polymethyl methacrylate or PMMA, polylactic acid or PLA, polylactic acid-coglycolic acid or PLGA, polyglycolic acid or PGA, polycarbonate, cyclic olefin copolymer or COC, polyvinylpyrrolidone or PVP, polyvinyl alcohol PVA, polystyrene, polymethyl vinyl ether-co-maleic anhydride), carbohydrates, or metals (e.g., stainless steel, titanium, palladium, nickel, palladium-cobalt alloy, and other alloys). Any suitable microneedle structure, including soluble microneedles, may be used. Microneedles and their features may be manufactured by one or more of the following processes: molding, etching, ablation (e.g., laser ablation), or material addition (e.g., 3D printing). In various embodiments, it may be desirable that the microneedles be made of a biocompatible, non-ductile, high Young's modulus material having sufficient indentation hardness to allow penetration into the skin without breakage.

[0194] Referring again primarily to Figures 1A and 1B, the delivery device 10 described herein can deliver any of a variety of drugs or other medical agents to a patient. In certain embodiments, the reservoir 12 of the delivery device 10 may be filled with a vaccine. While such a delivery device 10 can deliver any suitable vaccine, it may be particularly well suited for vaccines against novel pathogens (e.g., SARS-CoV-2) or pathogens for which herd immunity does not exist (e.g., Ebola hemorrhagic fever). Furthermore, such a delivery device 10 may be particularly useful in outbreaks of pathogens (e.g., measles) in communities that have chosen to refrain from typical vaccination. For example, such a delivery device 10 can be distributed without requiring patients to gather in hospitals or other shared spaces. This may reduce concerns about pathogen transmission associated with vaccination programs and mitigate potential concerns that people may refrain from reporting for vaccination. Instead, the delivery device 10 can be picked up and used by patients without violating recommendations regarding social distancing, gathering size, or other safety guidelines. Alternatively, such a delivery device 10 can be delivered directly to the patient without the patient having to leave their home or the distributor having to interact with individuals who refuse to use the recommended PPE. The delivery device 10 can be filled with vaccines against novel pathogens, or it can be filled with vaccines typical of a normal vaccination schedule. In the latter case, such a delivery device 10 can help prevent interruptions in vaccination against known pathogens during a pandemic of a novel pathogen.

[0195] Any suitable vaccine can be delivered through such a delivery device 10. For example, the vaccine may be, but is not limited to, a reduced-toxicity vaccine, an inactivated virus vaccine, a cell-free vaccine, a cell vaccine, a toxoid vaccine, atypical vaccine or Jenner vaccine, a monovalent vaccine, a polyvalent vaccine, a nucleic acid vaccine (e.g., DNA, plasmid vaccine, mRNA), a virus-like particle vaccine, a recombinant vector vaccine (e.g., replicated, non-replicated), 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 complex vaccine. Note that these are not necessarily mutually exclusive. For example, the vaccine may be a recombinant protein nanoparticle vaccine or any other combination of the above. Vaccines can also refer to combination vaccines (e.g., DTaP, MMR, MMRV, etc.) or vaccines that target a single pathogen or multiple strains of a single pathogen. Examples of vaccines include, but are not limited to, vaccines for various coronaviruses such as SARS-CoV, SARS-CoV-2, MERS-CoV, HCoV-NL63, HCoV-229E, HCoV-OC43, and HKU1. The delivery 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 may be filled with a vaccine against at least one non-human pathogen. The delivery device 10 described herein may also be useful for research applications.

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

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

[0198] In particular, in the case of new vaccines developed to combat ongoing pandemics (e.g., vaccines for SARS-CoV-2), the prospect of rapidly producing billions of doses of vaccine would almost certainly exceed current vaccine production capacity. The potential for injection and dose savings of the delivery device 10 described herein would allow such a delivery device 10 to facilitate the vaccination of large numbers of people, even when much-needed vaccines are in short supply. Furthermore, as a result of potential dose and injection savings, a delivery device 10 as shown and described herein could potentially be more cost-effective for injections. Additionally, because the required amount of vaccine is small, the delivery device 10 can be made relatively small. This could simplify transportation and facilitate the rapid distribution of vaccines to the population. This could be particularly attractive for vaccines requiring cold chain distribution, as packaging volume may become more critical.

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

[0200] A 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 the high demand for vaccines against novel pathogens, for example, by taking advantage of the dose / injection savings that can be made possible with intradermal vaccination. Furthermore, since the intradermal delivery device 10 described herein is painless or nearly painless, it may be more preferable to users than other types of injections. That being said, and also as mentioned above, the delivery device 10 described herein is not limited to delivery via an intradermal route. The delivery device 10 may 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 a vaccine delivery device. Such a delivery device 10 can fill many niches in the medical field. Other drugs, such as diagnostic or test agents, may be delivered via certain exemplary delivery devices 10. For example, allergens or potential allergens may be administered via the delivery device 10. Tuberculosis test agents may be delivered via the delivery device 10. Such devices 10 may also be used to deliver drugs for endocrine diseases. For example, insulin may be delivered using some exemplary delivery devices 10.

[0202] Referring further to Figures 1A and 1B, the delivery device 10 may include a body 20. The body 20 may be a deformable body that can transition from a storage state (see Figure 1A) to a delivery state (see Figure 1B). In certain examples, this transition may be reversible, but in other embodiments, the transition may result in a permanent change to the body 20 and / or another part of the delivery device 10. The main body 20 may be plastically deformed to the point where it becomes permanently warped and cannot return to its storage state. In other examples, a fragile part included in the delivery device 10 may break when the main body 20 transitions to the delivery state. Alternatively or additionally, a latch, lock, or other connector may be engaged to hold the main body 20 in the delivery state or prevent it from returning to the storage state. To disengage such a connection, it may be necessary to destroy part of the main body 20 or part of the delivery device 10 engaged with the main body 20, which 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 prevent reuse but also provide the user with a perceptible (e.g., visual) indication that the delivery device 10 has been used. The indication that a transition has occurred can also be generated by the delivery device 10. For example, an audible or tactile indication can be generated when a latch engages or a vulnerable part is destroyed.

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

[0204] The body 20 may be at least partially covered with adhesive 22 on a first surface 24 of the body. The body 20 may help to bond the body 20 to the skin surface of the patient's injection or injection site. Thus, the first surface 24 may be the skin-adjacent surface of the body 20 or the proximal (proximal and distal as defined with respect to the patient) surface. When the body 20 is in storage and then transitions to a delivery state, the body 20 may adhere to the skin. When the transition occurs, at least two adhesive-carrying portions of the body 20 can displace relative to each other, stretching or spreading the surface fixed to the body 20 via the adhesive 22. Once these portions adhere to the skin surface, the skin may be stretched as the adhesive-carrying portions displace relative to each other. This may be desirable because it may keep the skin taut to facilitate skin puncture by the delivery sharp 72 when the body 20 transitions to a delivery state. In certain examples, the adhesive-carrying portions may be arranged, for example, facing each other. Displacement of two adhesive-bearing portions may increase the distance between them or widen the gap between them. In other embodiments, the distance between 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 a curve or contour of the body 20 by the transition (see, for example, Figures 17 and 18). Displacement of adhesive-bearing portions relative to each other that results in stretching of the bonded skin (regardless of whether the distance between the adhesive-bearing portions is positive or negative) may be referred to as spreading displacement. Two adhesive-bearing portions that are displaced in this manner may be referred to as being spread-displaced.

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

[0206] In some embodiments, a foldable pouch or packet 208 can be placed on top of the reservoir 12 in the delivery device 10, as shown in Figure 10A. The packet 208 may contain a substance that is in a resting state in a first state and transitions to a powered state in a second state. In one embodiment, the substance is in a resting state at a first temperature and can be powered, for example, to the reservoir 12 at a second temperature. In exemplary embodiments, the first temperature may be lower than the second temperature. The first temperature may be the cold chain storage temperature of the vaccine. The second temperature may be room temperature or at least lower than the average body temperature of a patient (e.g., 98.6°F in the case of a human). In some embodiments, the volume of the substance may change when it transitions from a resting state to a powered state. Alternatively or additionally, the substance may change from one state of matter to another when it transitions from a resting state to a powered state. In exemplary embodiments, the substance may change from a liquid to a gas during the transition from a resting state to a 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 lower, 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 warm up (heat from the patient may help this). In an exemplary embodiment, the liquid butane boils and changes to a gas when it reaches its boiling point of -1 °C. As the liquid boils and transitions to the gaseous state, the pressure inside the packet 208 increases, causing the packet 208 to expand and apply a downward pressure from above to the reservoir 12 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 exceeds 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 that exceeds 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 a 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 will be understood by those skilled 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 wring 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 another embodiment, the packet 208 may be a vacuum-packed biasing member (e.g., a foam spring). In the vacuum-packed state, the biasing member may be compressed. User interaction with the packet 208 may cause the packet 208 to break, allowing the biasing member to be restored. When the biasing member is restored, pressure is applied to the reservoir 12, generating pressure for delivery.

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

[0213] In other embodiments, packet 208 in Figure 10A or Figure 10B may be a biasing member or include a biasing member. In some embodiments, packet 208 may be a foam adhesive material located on top of reservoir 12. In such examples, when the user presses down on the delivery device 10 (after the delivery device 10 is attached to the skin surface), the foam adhesive can also facilitate a uniform distribution of pressure across the entire top of reservoir 12. The assembly of the components described in relation to the above embodiments will be described below with reference to Figures 47-61B and 12-27B.

[0214] Referring to Figures 12-14, an exemplary delivery device 10 is shown. The exemplary delivery device 10 is shown in a stored state in Figures 12-14. As shown, the delivery device 10 may include a body 20 and a reservoir 12. The reservoir 12 may include at least one delivery sharp 72. The delivery sharp 72 may be contained on a sharp support 26 which may be coupled to the wall of the reservoir 12. The body 20 of the exemplary delivery device 10 may have a circular (e.g., circular) footprint and may include a central region 28 and a peripheral region 30. The central region 28 may be a raised region of the body. The body 20 and peripheral region 30 may be substantially flat regions of the body 20 surrounding the central region 28. The thickness of the body 20 may be substantially uniform throughout the body 20. It may be formed as a thin sheet or disc of material which can be thermoformed to form the raised central region 28 and the flat peripheral region 30.

[0215] Alternatively, the main body 20 may be injection-molded, forming the raised central region 28 and the flat peripheral region 30 during the molding process. In various embodiments in which the delivery device 10 is injection-molded or can be injection-molded (for example, embodiments described in relation to Figures 12 to 33), the main body 20 may be injection-molded to be in a storage state or a delivery state. The main body 20 can be more easily transitioned from the reverse state to the molded state. Therefore, to reduce the effort required to transition the delivery device 10 from the storage state to the delivery state, it may be desirable to mold the main body 20 of the delivery device 10 into the shape of its delivery state. During the assembly of the delivery device 10, the main body 20 may be in its storage state configuration and remain in that configuration until use.

[0216] The central region 28 may be dome-shaped, and its dome shape may form a receptacle 32 on the proximal side of the body 20, in which a reservoir 12 may be placed. The reservoir 12 may be bonded to the receptacle 32 via adhesive or by another suitable method. The central region 28 may also include a series of openings 34 that can form a windowed ring in the central region 28. In this example, the openings 34 are spaced equally apart and arranged in a circular pattern substantially coaxial with the center. In alternative embodiments, the openings 34 may be spaced irregularly or omitted. Furthermore, in some embodiments, the openings 34 may be replaced by thin-walled regions or rings of material in the body 20.

[0217] The body 20 may include a number of slots 36. The slots 36 may extend from the periphery 38 of the body 20 toward the center or midpoint of the body 20. In exemplary embodiments, 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 of the central region 28 may be located radially inward from the ends 40 of each slot 36. Thus, the body 20 may include a central region 28 surrounded by a number of petal members 42, these petal members 42 spaced apart via the slots 36.

[0218] Referring to Figure 15, a plan view of the proximal surface 24 of the main 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 may help to bond the delivery device 10 to the skin surface of the injection site. In exemplary embodiments, the adhesive 22 may be included on the peripheral region 30 of the main body 20. The adhesive 22 is shown to cover the entire surface of each petal member 42 within the peripheral region 30, but other embodiments may differ. For example, only certain petal members 42 may contain the adhesive 22. In such embodiments, the adhesive 22 may be contained in at least one pair of petal members 42 that are positioned opposite each other (for example, opposite each other in the exemplary embodiment). In some examples, only a portion of each petal member 42 contained within the peripheral region 30 (e.g., the majority of the surface area) may be covered with the adhesive 22. Alternatively or additionally, the adhesive 22 may differ for each petal member 42. Some petal members 42 may be covered with a stronger adhesive 22, while others may be covered with a less strong adhesive 22. In certain examples, additional adhesive members 22 are described elsewhere in this specification (see, for example, Figures 63A–63C) and can be used in the delivery device 10.

[0219] Referring to Figure 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 opening 34 can facilitate this inversion by allowing increased deflection of the body 20 in the opening 24. Thus, the central region 28 of the body 20 can take on a concave shape instead of a convex dome 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 an exemplary embodiment, the entire body 20 takes on a bowl shape when transitioned to the delivery state. The peripheral region 30 can also be displaced over a wide area, at least a portion of the transition. The slots 36 in the main body 20 help to facilitate the expanding displacement of the petal member 42 when the transition occurs, thereby promoting 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 and delivery states. When the body 20 is in the storage state, an axial load acting on the central region 28 may cause the body 20 to deform and become unstable. The body 20 then exhibits a snap-through buckling action, which can rapidly transition the body 20 to a stable delivery state similar to that shown in Figure 16. Therefore, only a trigger force can be applied to initiate the transition. The remaining changes between the storage and delivery states may be caused by the snap-through phenomenon.

[0221] Figure 17 shows the delivery device 10 in storage state, bonded to the skin 44 via adhesive 22 on the proximal surface 24 of the main body 20. Figure 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 storage state. Subsequently, the delivery device 10 can transition to the delivery state. When the transition occurs, spreading displacement of the opposing petal members 42 of the main body 20 may occur.

[0222] Two opposing points 46A and 46B, located on the periphery of the proximal surface 24, are shown in Figures 17 and 18. When the delivery device 10 is in storage (Figure 17), the shortest distance between the opposing points 46A and 46B is a straight line that does not pass through the proximal surface 24. This line is approximately parallel. However, in the delivery state, the shortest distance between the opposing points 46A and 46B is a straight line that passes through the proximal surface 24. If the skin 44 is fixed to the body 20 via adhesive 2 and cannot pass through the body 20, the skin 44 may be forced to conform to the curvature of the proximal surface 24. Therefore, the length of the skin 44 surface between the two points 46A and 46B when the delivery device 10 is in delivery state may be greater than the length of the skin 44 surface between points 46A and 46B when the delivery device 10 is in storage state. The skin 44 may be placed under tension and stretched to adapt to this change in length. This stretching can, in turn, help facilitate the puncture of the skin 44 by the delivery Sharp 72.

[0223] When attempting to return to its unstretched state, due to the elasticity of the skin 44, the skin 44 can exert a restorative force on the proximal surface 24 of the body 20. The body 20 can resist this restorative 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 punctures the skin 44 and establishes fluid communication with the target delivery destination in the patient's body. Furthermore, because the reservoir 12 is foldable, the restorative force exerted by the skin 44 can pressurize the reservoir 12, causing the fluid to be discharged from the reservoir 12 via the delivery sharp 72. The stretched skin 44 may help to empty and burst the reservoir 12.

[0224] As described above, in certain examples, some petal members 42 may not include an adhesive 22 area, 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 some petal members 42 do not have adhesive 22, this may help limit the stretching of the skin 44. Similarly, petal members 42 with a less strong adhesive 22 may release the patch of skin 44 that they are attached to 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 area). For example, if the force required to stretch the skin 44 exceeds a threshold, one or more of the petal members 42 may bend or buckle in the relief region to relieve some of the tension on the skin 44.

[0225] This may be desirable as it can help reduce potential discomfort during injection due to excessive tension in the skin 44. Furthermore, since skin characteristics vary with age, hydration status, and lifestyle (sun exposure, nutrition), it may be beneficial for specific patient populations. Sagging or loose skin may be more desirable to stretch than highly elastic skin. Therefore, instead of providing various delivery devices 10 with different adhesives 22 for specific patient populations, the delivery device 10 can be manufactured in a more general way.

[0226] Referring to Figures 19 and 20, in another embodiment, the delivery device 10 may include a central region 28 having a top surface 250 and a support structure 252 integral with the top surface 250. The support structure 252 may have a circular, for example, substantially circular base. The peripheral region 30 may be substantially annular in shape and may include an inner circumference and outer circumference or periphery 38 that coincide with the base 262. The delivery device 10 may be constructed of Nycoa 2012 nylon or other similar nylon material and may be formed by injection molding. Any other suitable plastic may be used. The top surface 250 may have, for example, a substantially circular rounded mounting area or a convex surface forming a dome shape. The top surface 250 may have a periphery 340. The top surface 250 may include slots 254. In various embodiments, the slots 254 may be notches, holes, holes, openings, or voids. Slots 254 can help the delivery device 10 transition from a storage state to a delivery state under reduced pressure from above. Slots 254 are arranged such that each first endpoint 258 encloses a region including the center point 256 of the upper surface 250, and each second endpoint 260 is at a certain distance (in embodiments including slots 254, the slots 254 may be arranged in regular angular increments (but are not required). In embodiments described herein that include slots 254, the slots 254 may (but do not necessarily) be of the same length.

[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 manner. As shown in FIGS. 21A - 21I, the slots 254 can be provided in many different formats. Further, in some embodiments, the slots 254 may not be included.

[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 and intermediate regions of the upper surface 250 (see, for example, FIG. 21B). In yet 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 slightly decrease 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 curvature, as primarily shown in Figure 21E. Curvature can be defined by a constant or variable radius. Curvature may only be present on segments of the slot 254. In alternative embodiments, the slot 254 may comprise two or more sections angled to each other. In the exemplary embodiment shown in Figure 1, Figure 21E shows four curved slots 254, which are spaced apart by equal angular increments. The slots 254 are arc-shaped and comprise a first end 258 and a second end 260. Each exemplary slot 254 is oriented to curve, initially extending in a first direction from the first end 258 and extending in a second direction like a slot. The second direction may be closer to (or even perpendicular to) the radial direction than the first direction.

[0230] In some examples, the top surface may not include the slot 254, but instead may include at least one opening 255, as is then mainly shown in Figures 21D and 21F. In the illustrated example, the opening 255 is located in the center of the top surface 250. In some embodiments, the opening 255 may enclose substantially the entire top surface 250.

[0231] As shown in Figures 21D and 21F, the slots 254 may be included in other areas of the body 20. In exemplary embodiments, the areas of the body 20 that become the support structure 252 (when the body 20 is thermoformed) include the slots 254. These slots 254 may be straight, curved, angled (with respect to the radial dimension), or a combination thereof, as are the patterns of slots 254 on the various top surfaces 250 described herein. As shown, the slots 254 are spaced apart at a constant angular interval and are spaced apart between the petal members 42 of the body 20.

[0232] In further embodiments, the width of one or more slots 254 may vary along the length of the slot 254. Several embodiments including variable-width slots 254 are shown in Figures 21G-21I. The slots 254 may have a continuously changing width and may terminate at a pointed first or second end 258, 260. The variable-width slots 254 may extend radially, but are not required in all embodiments. In an exemplary embodiment, each slot 254 is widest near the center point 256 of the top surface 250, and its width continuously decreases as the slot 254 extends distally toward the periphery 340 of the top surface 250. The top surface 250 shown in Figures 21G-21I may have slots 254 in a sunburst pattern, which radiates outwards like rays of sunlight. In other embodiments, the slots 254 do not necessarily have to continuously increase or decrease in width from one end to the other.

[0233] As shown in Figure 22, the central region 28 may be formed monolithically with the petal members 42, including the regions between each pair of slots 36 (see also Figures 12–18 and the examples and embodiments described above). The support structure 252 may extend upward from the petal members 42 at an angle of 90° or greater than 90°, e.g., 100–105°, but the scale of the angle does not need to be limited to a certain range. The (vertical) distance from the base 262 of the support structure 252 to the periphery 340 of the upper surface 250 may be long enough to provide the central region 28 with a receptacle for the reservoir 12 (see, e.g., Figure 60), and in some embodiments, any packet 208 and / or container 350 (see, e.g., Figures 10A–11), spring, or foam adhesive material. The receptacle may also be sized to accommodate part of the actuation assembly or distribution assembly 480 (see, e.g., Figure 34). As will be described in more detail elsewhere in this specification, the packet 208 may include a gas bag, a butane packet, or a delivery force supply packet, and any associated container 350 as described above with respect to Figure 10A-11. In some embodiments, the aforementioned distance may be about 0.3 inches (e.g., 0.315 inches). The slot 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), only the top surface 250 may invert, rather than the entire central region 28 substantially inverting, allowing it to take on a concave shape in the delivery state. In some embodiments, the support structure 252 may include openings 264 spaced at equal intervals around the base 262. The openings 264 can facilitate the manufacture of the delivery device 10 in embodiments in which the body 20 is thermoformed.

[0234] In some embodiments, as shown in Figure 23, at least one of the petal members 42 may be made of an extended length so that the outer end of the petal member 42 can be operated by the patient or healthcare provider as a pull tab 266. The pull tab 266 can be grasped by the user to remove the delivery device 10 from the skin after use. The pull tab 266 can be any suitable shape. In one example, the pull tab 266 is substantially semicircular, having a first rounded end and a second end opposite the first end, and is attached to the petal member 42. The second end may be attached to or formed integrally with the petal member 42 by injection molding or by other known techniques that allow the pull tab 266 to be lifted sufficiently away from the skin surface so that it can be held by the user.

[0235] As shown in Figure 24, the pull tab 266 may also help the user to peel off 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 way as peeling a release liner from a bandage before it is applied to the skin. An exemplary delivery device 10 having a pull tab 266 and including the release liner 265 and adhesive 22 is shown in Figure 24. For illustrative purposes, the release liner 265 has been peeled from the adhesive 22.

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

[0237] Furthermore, or alternatively, the peripheral region 30 does not have to be substantially flat and annular in shape. The peripheral region 30 may be defined by downwardly extending curved petal members 42 such that the periphery 38 is positioned away from the plane of the base 262 of the support structure 252 (for example, at approximately the same distance as or less than the distance from the base 262 to the periphery 340 of the upper surface 250). The periphery 38 may be positioned along a plane more distal to the periphery 340 of the upper surface 250 than the base 262. In Figure 25, the delivery device 10 is shown in storage. The delivery device 10 may include slots 36 that can be positioned between the petal members 42, as in other embodiments of the delivery device 10 described herein. The adhesive 22 (see, for example, Figure 24) may be attached to at least portions of at least two of the petal members 42.

[0238] Referring to Figure 26, a perspective cross-sectional view of the body 20 of the delivery device 10, the body 20 may include an internal ridge 290. The ridge 290 may be located on the base 262 of the support structure 252. The support structure 252 may be thickened in a region near the base 262 to form the ridge 290. This allows the ridge 290 to be easily formed, for example, in an injection molding operation that forms the rest of the body 20. This can also give the support structure 252 additional rigidity. The ridge 290 can provide a step, protrusion, or other mounting surface on which a portion of the reservoir assembly 12 of the delivery device 10 can be mounted. Such a ridge 290 may be included in any embodiment of the delivery device described herein. The reservoir assembly 12 and the ridge 290 will be described further elsewhere in this specification.

[0239] Referring primarily to Figures 28A-28B, two conceptual representations of the delivery device 10 transitioning from a storage state to a delivery state are shown. The delivery device 10 can transition to a delivery state when it is attached to the skin with adhesive 22 and pressure is applied to it from above, for example, by the user's fingertips. When the petal members 42 are pressed against the surface of the skin, the petal members 42 are displaced and spread outward, and at least a portion of the petal members 42 may curl upward due to the skin and / or the patient's body. Next, the skin may stretch as the portions of the opposing petal members 42, each fixed to the skin surface by adhesive 22 (shown only in Figure 28A), separate from each other or are displaced and spread outward. When the delivery device 10 transitions to a delivery state, at least a portion of each of the curved petal members 42 may be curved further or with a narrower radius of curvature. Upon reaching the delivery state, the curvature of the petal members 42 can be extended from the base 262 to the inflection point 360. The inflection point 360 lies in a plane spaced apart from the plane of the base 262 and, in such embodiments, may also be called the lowest point. In such embodiments, the lowest point 360 may be in a plane distal to the periphery 340 of the upper surface 250 than to the base 262. From the inflection point 360, the petal member 42 may curve upward and return so as to move closer and closer to the plane in which the periphery 340 of the upper surface 250 is located. The periphery 38 of the petal member 42 may be located, for example, in the plane of the base 262 or at a point on it (closer to the plane of the periphery 340 of the upper surface 250). Each petal member 42 has a constant radius of curvature from the inflection point 360 to its periphery 38, although this is not necessarily required. A constant radius of curvature returning upward can increase the ability of the petal member 42 to curl upward. This causes the points 360 on the opposing petal members 42 (each fixed to the skin by adhesive 22) to spread and displace, which may promote stretching of the user's skin. As described elsewhere in this specification, the upper surface 250 of the main body 20 can also be inverted when the delivery device 10 transitions to the delivery state 10.

[0240] In some non-limiting examples, the delivery device 10 may have dimensions and radii of curvature as shown in Figures 27A-27B when in storage. It should be understood that the dimensions shown are illustrative only. Other delivery devices 10 with the same proportions but different sizes are possible and intended. Furthermore, delivery devices 10 with different dimensions and proportions are possible and intended.

[0241] Referring to Figures 25-26 and 28A-28B, in some embodiments, the support structure 252 may not include the equally spaced openings 264 (see, for example, Figure 19) around the base 262. The body 20 may be manufactured by injection molding. Those skilled in the art will readily understand that other manufacturing techniques may be used. The body 20 may be constructed from a single monolithic piece of material such that the central region 28 and the peripheral region 30 are integrated with each other. The body 20 may be made of a polymer material. In some embodiments, the body 20 may be made of a nylon material such as Nycoa2012 nylon or other similar nylon material. In other embodiments, the body 20 may be made of a polypropylene material. The body 20 may be manufactured of a material that helps minimize water absorption or a material that helps maximize its ability to adhere to the adhesive 22. A material may be selected that achieves both of these objectives to the desired extent. These materials may be used for any of the body 20 described herein.

[0242] Furthermore, as shown in Figures 25-26 and 28A-28B, the top surface 250 may have a rounded surface area, such as a substantially circular shape, or it may be a convex surface forming a dome shape (including the periphery 340). The top surface 250 may include slots 254. In various embodiments, the slots 254 may be notches, openings, holes, openings, or voids. Each slot 254 may have a first endpoint 258 surrounding a region including the center point 256 of the top surface 250, and each second endpoint 260 may terminate at a certain distance from the periphery 340 of the top surface 250 (for example, each slot 254 may terminate at the same distance). In certain embodiments, the slots 254 may be arranged in regular angular increments and each may be of equal length (however, this is not required in all embodiments).

[0243] Furthermore, referring to Figures 25-26 and Figures 28A and 28B, as described above with reference to Figure 22, in an alternative embodiment, 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 may be arranged at equal intervals around the top surface 250 and each may be of the same length. In other embodiments, not all of the slots 254 may extend at a common angle with respect to the radial direction. At least one (perhaps all) of the slots 254 may be arranged at different angles with respect to the radial direction.

[0244] Referring primarily to Figures 29-33, several diagrams illustrating a conceptual representation of the delivery device 10 in the delivery state are shown. As described above (and also referring to embodiments in Figures 12-20), the delivery device 10 can transition from the storage state to the delivery state when downward pressure is applied to the upper surface 250. In this delivery state, the body 20 of the delivery device 10 is substantially, or at least partially, inverted. The user can remove the adhesive liner 265 (see, for example, Figure 24) from the delivery device 10 and apply the delivery device 10 to the skin. The user can then push the upper surface 250 downward (i.e., toward the skin). This causes the petal member 42 to spread outward and displace, curl upward (at least over a portion of it), and stretch the skin. The upper surface 250 inverts, pushing the delivery sharp 72 into the skin, and may remain inverted when the delivery device 10 reaches the delivery state. The peripheral region 20 may also take on an inverted shape due to the curling of the petal member 42.

[0245] In various embodiments, certain regions of the body 20 of the delivery device 10 may remain stationary or not invert. Therefore, the body 20 may include invertible and elastic regions. While described as elastic regions, it should be understood that some degree of bending or deformation may still occur when pressure is applied. However, these regions may appear substantially the same or extend / protrude in substantially the same direction in both the storage and delivery states. As illustrated, the peripheral region 30 and the top surface 250 may invert, but a portion of the central region 28 may resist this degree of deformation. Support structures 252 shown in other embodiments described herein (see, for example, Figure 19 or Figure 25) may also be elastic regions. Thus, a particular delivery device 10 may include a body 20 with invertible regions separated from each other by elastic regions.

[0246] Furthermore, as shown in Figures 29-33, the reservoir 12 may be formed as an assembly and include a reservoir portion 271 and a holder 270 (see Figures 47-61B for further details below). 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. A slot 254 can help the delivery device 10 transition from the storage state to the delivery state under reduced pressure from above. An opening 34 can also facilitate the transition. As described above with reference to embodiments in Figures 12-20, the central region 28 may have space for the reservoir 12 and the Sharp support 26 (see additional description with reference to embodiments in Figures 12-20 and 47-61B). In some embodiments, a packet 208 and / or container 350 (see, for example, Figures 10A-11) and / or foam adhesive material may also be housed within the central region 28. As will be 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 Figures 10A–11. In some examples, one or more petal members 42 may be constructed to incorporate a pull tab (not shown in Figures 29–33), such as the pull tab 266 described above with reference to Figure 23.

[0247] Referring now to Figure 34, a block diagram of an exemplary delivery device 10 is shown. As shown, the delivery device 10 may include a body 20 and a reservoir 12. The delivery device 10 may also include one or more biasing members 470. One or more biasing members 470 may be included as part of a distribution assembly 480 included in the delivery device 10. The distribution assembly 480 can help pressurize the reservoir 12 and help drain fluid from the reservoir 12 during injection. In some embodiments, the distribution assembly 480 may include a press 472 which can be coupled to or associated with at least one biasing member 470. A reservoir interface member 474 may also form part of the distribution assembly 480 of the delivery device 10.

[0248] In some such embodiments, the biasing member 470 may be unstressed when the associated delivery device 10 is in storage. User interaction with the delivery device 10 to transition it to a delivery state may include the step of applying pressure to the press 472 of the distribution assembly 480. This allows the press 472 to be displaced toward the reservoir 12. The press 472 may include an engagement mechanism (e.g., a catch or retainer) that engages with a holding mechanism (e.g., defined on the body 20) of the delivery device 10 to hold the press 472 in the displaced position. The displacement of the press 472 causes bias to build up in the biasing member 470. When the delivery device 10 transitions to a delivery state, the biasing member 470 returns to an unstressed state. When the biasing member 470 is restored, the reservoir interface member 474 of the distribution assembly 480 is biased toward the reservoir 12, allowing the reservoir 12 to collapse and deliver fluid into the patient. Therefore, for example, pressure can be applied to the reservoir 12 for a sufficient amount of time (e.g., 5 minutes in a particular embodiment) to completely deliver the contents of the reservoir 12 without continuous manual pressure on the delivery device 10.

[0249] In other embodiments, the biasing member 470 may be in a stressed state when the associated delivery device 10 is in storage, and may be coupled to or associated with a press 472 of the distribution assembly 480. The press 472 can contact a part of the delivery device 10 (e.g., the body 20) to act to resist displacement under the restoring force generated by the biasing member 470. This prevents the biasing member 470 from restoring from its stressed state. A catch or stopper within the press 472 may engage with the body 20, for example, when the delivery device 10 is in storage. User interaction with the delivery device 10 to transition it to a delivery state can disengage the press 472 so that it can move freely. Once the press 472 can move freely, the biasing member 470 returns to a stress-free state, or at least a low-stress state, and can drive the reservoir interface member 474 of the distribution assembly 480 toward the reservoir 12. As a result, reservoir 12 collapses, and the fluid is discharged from reservoir 12 into the patient's body.

[0250] Referring next to Figures 35-36, a typical example of a delivery device 10 including a biasing member 470 that is not subjected to stress in storage is shown. The delivery device 10, like the various other delivery devices 10 described above, may include a body 20 and a reservoir 12. As shown, the pressing body 472 of the distribution assembly 480 may include an elongated member 476, such as a pin, extending through the upper surface 250 of the body 20. In some embodiments, the elongated member 476 may include a head 478 or other surface at its distal end. The head 478 may include a rounded or tapered portion to help the head 478 pass through the opening of the body 20 during assembly. On the opposite side of the tapered or rounded portion, the head 478 may 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 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 positioned between the elongated member 476 and the reservoir interface member 474. In exemplary embodiments, one or more biasing members 470 are shown as a pair of arched springs, but any suitable number of arched springs can be used. In alternative embodiments, other biasing members 470 (e.g., elastic foam, coil springs, air bladders, etc.) may be used.

[0251] When pressure is applied to bring the delivery device 10 into a delivery state, the elongated member 476 may be displaced toward the reservoir 12. This may cause stress on the biasing member 470. As shown in the figure, the elongated member 476 includes a detent or notch 482. The notch 482 engages with the body 20 to hold the elongated member 476 in a depressed position. The engagement of the notch 482 with the body 20 may also serve to indicate that the delivery device 10 has been used.

[0252] When the biasing member 470 is returned to a less stressed state while the elongated member 476 is held in place, the reservoir interface member 474 may be displaced 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 parts of the main body 20 may be displaced and / or inverted over a wide area (see, for example, Figure 29). This is not shown in Figures 35 and 36 for ease of explanation.

[0253] Referring to Figures 37 and 38, in certain embodiments, the delivery device 10 may include a biasing member 470 that is under stress while the delivery device 10 is in storage. Referring to Figure 38, the biasing member 470 (shown in an unstressed state) may include an enclosure 490. The enclosure 490 may be, for example, annular in shape, but any suitable shape can be used. A number of biasing protrusions 492 may extend from the enclosure 490 toward the center of the biasing member 470. The biasing protrusions 492 may extend radially inward from the enclosure 490 toward the center of the biasing member 470. In exemplary embodiments, the biasing protrusions 492 may be spaced at equal angular increments, but this is not required in all embodiments. The enclosure 490 may be made of any suitable material, and in some examples it may be made of elastic plastic or spring steel.

[0254] The main body 20 of the delivery device 10 may include a number of passages 494 extending through the main body 20. The passages 494 may be located within the support structure 252 of the main body 20. The spacing of the passages 494 may correspond to the spacing of the biasing projections 492 on the biasing member 470. When the delivery device 10 is assembled, the biasing projections 492 may be introduced into and partially passed through each of the passages 494 within the main body 20. The enclosure 490 may be placed on the distal surface of the peripheral region 30 of the main body 20 (see, for example, Figure 25).

[0255] Referring here to Figures 39-41, the delivery device 10 may include a press 472. In the illustrated example, the press 472 includes a reservoir interface member 474 at its proximal end. The press 472 may be rotatably displaceable within an opening 496 of the body 20. The opening 496 may be located on the upper surface 250 of the body 20, for example, as shown in Figure 39. The press 472 may be rotated from a position or range of position that limits translational displacement (see, for example, Figure 39) to a position or range of position that allows translational displacement (see, for example, Figure 38). In the translational displacement limiting position, the retaining elements of the press 472 can engage with a cooperating lock defined on the body 20. In the translational displacement allowing position, the retaining elements of the press 472 can disengage from the lock on the body 20.

[0256] As best illustrated in Figure 41, the exemplary press 472 includes a stem 500 extending through an opening 496 in the body 20 of the delivery device 10. The stem 500 may include a pair of notches 498 or other recesses, each serving as a retaining element. The cross-sectional shape of the stem 500 does not have to be circular or a regular polygon. Thus, one of the width and length dimensions of the cross-sectional shape of the stem 500 may be shorter than the other. In the exemplary embodiment, the cross-sectional shape of the stem is oval. In another example, other cross-sectional shapes may be used. The notches 498 may be positioned to recess into the widest part of the stem 500. The opening 496 (see, for example, Figure 37) may have a shape corresponding to the cross-sectional shape of the stem 500, but may be slightly larger than the cross-sectional shape of the stem 500. The notches 498 may be recessed to a depth such that the press 472 can rotate within the opening 496 when it is at the same height as the wall of the body 20 in which the opening 496 is formed.

[0257] The press 472 is shown in Figure 39 in a position where translational displacement is restricted. In this position, the rotational direction of the press 472 may be such that the notch 498 protrudes into the portion of the body 20 where the opening 496 is defined. As a result, the body 20 may mechanically interfere with the translational displacement of the press 472. Therefore, the region of the body 20 adjacent to the opening 496 can function as a lock for the press 472. As shown in Figure 40, once the press 472 has rotated to a position that allows translational displacement, the rotational direction of the press 472 can be such that it can be translated within the correspondingly shaped opening 496 of the body.

[0258] Referring to Figures 42 and 43, the press 472 may include an enlarged portion 502. The reservoir interface member 474 may 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 press against the enlarged portion 502, thereby capturing or coupling the enlarged portion within the biasing projection 492. Furthermore, the biasing member 470 can be substantially prevented from being displaced as a whole, since the biasing projection can be supplied through a passage 494 within the body 20. When the biasing member 470 is constrained in place, the biasing projection 492 may bend and stressed when the depressor body 472 is lifted. When the press 472 is lifted so that the notch 498 is identical to the portion of the body 20 in which the opening 496 is defined, the press 472 can be rotated to a translational displacement limiting position (see, for example, Figure 39). Thus, the biasing member 470 can be held under stress.

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

[0260] Referring here to Figures 44A-44D, in some examples, the biasing member 470 for the delivery device 10 may be entirely inside the delivery device 10. Furthermore, the pressing body 472 does not have to latch or engage with a portion of the body 20 to prevent translation of the body 20. In some examples of such embodiments, a stopping member 473 may be included in the delivery device 10. The pressing body 472 may include a recess 475 (or instead a set of notches 498, see, for example, Figure 41). This may engage with the stopping member 473 instead of the body 20. As shown in Figure 44B, the stopping member 473 may include an opening 496' which has 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 it is at the same height as the opening 496'.

[0261] The stop member 473 can rotate from a translational displacement limiting position to a translational displacement allowable position where it can be freely translated. In the translational displacement limiting position, the opening 496' may be positioned such that the stem 500 protrudes from a portion of the 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 a position that allows translational displacement, the stem 500 no longer protrudes from the body 479 of the stop member 473. In this position, the press 472 can translate within the correspondingly shaped opening 496' of the stop member 473. The stop member 473 may include raised sections, knurling, bumps, grips, spokes, or other features to facilitate rotational displacement of the stop member 473 due to interaction with the user's fingers.

[0262] As mainly shown in Figures 44C and 44D, the biasing member 470 may be a conical spring. When the delivery device 10 is in storage and the stop member 473 is in the translational displacement limiting 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 presser 472 relative to the reservoir 12, as described above with respect to Figures 42-43. When the presser 472 is displaced by the relaxation of the biasing member 470, the stem 500 of the presser 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. The presser 472 can also move to a position where the recess 475 is inside the delivery device 10. Thus, the stop member 473 can be prevented from being reconnected to the presser 472. 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. Therefore, the stop member 473 can also function as an indicator that a particular delivery device 10 is available.

[0263] Referring now to Figure 45, a block diagram of another exemplary delivery device 10 is shown. As shown in the figure, the delivery device 10 may include a main body 20 and a reservoir 12. The delivery device 10 may also include one or more biasing members 470. One or more biasing members 470 may form the entire distribution assembly 480. Furthermore, the biasing members 470 may be in direct contact with the reservoir 12 and may help to apply pressure to the reservoir 12 in order to deliver fluid from the reservoir 12. In certain examples, a reservoir interface member 474 (see, for example, Figure 34) may be included. If included, the reservoir interface member 474 may be formed as part of (but not necessarily) at least one biasing member 470 and integrated with it. The reservoir interface member 474 may be in direct contact with the reservoir 12. At least one biasing member 470 may be a spring, a compression spring, a conical spring, elastic foam, an air bladder, any other suitable biasing member, or any combination thereof, or may include them.

[0264] Furthermore, as shown in Figure 45, when the associated delivery device 10 is in storage, the biasing member 470 may be in a stress-free state. Pressure does not need to be applied to the reservoir 12 in storage. In certain examples, at least one biasing member 470 (and any reservoir interface member 474) does not need to be in full contact with the reservoir 12 in storage (e.g., 0.05–2 mm). When the delivery device 10 is used, it can transition to a delivery state as described elsewhere in this specification. As with the various embodiments described herein, when transitioning to a delivery state, at least a portion of the delivery device 10 can be inverted at least partially. For example, at least the domed upper surface 250 of the central region 28 can be inverted or partially inverted. The distance between the reservoir 12 and the inverted upper surface 250 in the delivery state may be shorter than the distance between the reservoir 12 and the upper surface 250 in the storage state. This allows bias to accumulate within the biasing member 470. At least one biasing member 470 may be compressed when the top surface 250 is inverted, in one example. Furthermore, if at least one biasing member 470 is separated from the reservoir 12 in the storage state, at least one biasing member 470 or the reservoir interface member 474 (which may be part of the biasing member 470) can move and make contact. The inverted top surface 250 may 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 position, at least one biasing member (and / or the reservoir interface member 474 (if included)) can press against the reservoir 12, crushing the reservoir 12 and delivering the fluid into the patient. Thus, for example, pressure can be maintained on the reservoir 12 for a sufficient amount of time (e.g., 5 minutes in a particular embodiment) to completely deliver the contents of the reservoir 12, even without sustained manual pressure on the delivery device 10.

[0265] Referring here to Figures 46A-46B, exemplary embodiments of the body 20 and the body 20 with the biasing member 470 are shown, respectively. Figure 46A shows a bottom view of the body 20. Figure 46B shows a perspective view of the body 20 and the biasing member 470. The body 20 is shown inverted with its top surface for illustrative purposes. As illustrated, the body 20 may include a number of positioning protrusions 471. There may be a pair of positioning protrusions 471 located in the central region of the top surface 250. A second pair of positioning protrusions 471 may be spaced outward from the central region. In the exemplary embodiment, the second pair of positioning protrusions 471 extend from the top surface 250. In other examples, the positioning protrusions 471 may extend radially inward from the support structure 252 in the central region 28. The ends of the biasing member 470 are centered by the positioning projections 471 when the biasing member 470 is placed within the delivery device 10 assembly. In certain cases, the ends of the biasing member 470 can be joined in place. For example, once the biasing member 470 is properly positioned, the ends of the biasing member 470 adjacent to the upper surface 250 may be heat-crimped (see, for example, Figure 46C). Once the delivery device 10 is fully assembled, the heat stake can hold the biasing member 470 in place relative to the body 20. As a result, the biasing member 470 can be held away from contact with the reservoir 12 until the delivery device 10 transitions to the delivery state. Positioning projections 471 can also help ensure that the biasing member 470 transitions to the stressed state in the desired manner. For example, if a compression spring is used, a second set of positioning projections 471 can restrain the biasing member 470 so that it is substantially compressed along the axis of the biasing member 470.

[0266] As shown here in Figure 46C, in some examples, the biasing member 470 may be restricted in displacement by one or more guide bodies 477. One or more guide bodies 477 may extend from the support structure 252 in the central region 28 of the body 20 toward the 0 axis of the biasing member 47. In the example shown in Figure 46C, four guide bodies 477 are included and spaced apart in equal angular increments. In other embodiments, the number of guide bodies 477 may vary, and / or the guide bodies may be irregularly spaced. The guide bodies 477 may help ensure that the biasing member 470 is substantially compressed along its axis and may help suppress tilting of the biasing member 470 during use of the delivery device 10.

[0267] Furthermore, in Figures 46A-C, if the biasing member 470 is a compression spring, the end 481 of the biasing member 470 can form a reservoir interface member 474. The biasing member 470 of the end 481 can be routed in a manner that helps to distribute the pressure more evenly. The end 481 of the biasing member 470 can be routed in a certain direction or in a desired pattern. The end 481 may also be substantially located in a plane that is identical to or adjacent to the end of the biasing member 470. As shown in Figure 46B, the end 481 of the coil is bent to extend between opposing points on the biasing member 470. In this example, the end 481 extends substantially diametrically across the end of the biasing member 470 on the proximal side of the reservoir 12. In some embodiments, the end 481 of the biasing member 470 may be routed in a spiral or other pattern (see, for example, Figure 46C).

[0268] In some embodiments, as shown in Figures 47-50 (a top perspective view, a side view, a bottom view, and a bottom perspective view, respectively, of the application surface of the delivery device 10, such as the skin surface), an exemplary holder 270 for a sharp support body 26 (see, for example, Figure 31) including a delivery sharp 72 (see, for example, Figure 31) may be formed as an annular portion 272 integrated with a rounded recess 274. The recess 274 may be centrally located. In one example, the rounded recess 274 may have the shape of a spherical segment. The annular portion 272 may have an inner edge, and the rounded recess 274 may have a perimeter. The inner edge of the annular portion 272 may coincide with the perimeter of the rounded recess 274. When the delivery device 10 incorporating the holder 270 is attached to the user's skin surface, the rounded recess 274 extends below the plane of the annular portion 272 (see Figure 48).

[0269] The round recess 274 may include a pocket 276 formed therein. The pocket 276 may be formed on the proximal surface of the holder 270. The pocket 276 may be located at the center of the round recess 274 and at the lowest point (relative to the skin surface when the delivery device 10 is fixed to the skin surface). The pocket 276 may be sized to fit into and receive a sharp support 26 having a delivery sharp 72 on it, such as the sharp support 26 containing the delivery sharp 72 in Figure 31. The sharp support 26 containing the delivery sharp 72 may be fitted into the pocket 276 by, for example, injection molding or adhesive. The holder 270 may be overmolded around the sharp support 26 to connect its components to each other. In various embodiments, the delivery device 10 may be positioned so that pressure from above (e.g., from a finger) on the delivery device 10 can be uniformly distributed over the entire area of ​​the holder 270. In some embodiments, the recess 274 can function as a force-concentrating projection from the holder 270, which ensures that the force applied to the delivery device 10 is concentrated on the delivery sharp 72, thereby assisting in the insertion of the delivery sharp 72 into the skin.

[0270] In exemplary embodiments, the width (e.g., diameter) of the holder 270 may be about 0.7 inches (e.g., 0.744 inches). The footprint of the exemplary holder 270 may be about 0.45 square inches (e.g., 0.44 square inches). The holder 270 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 in Figures 51A–51C. As illustrated, the holder 270 may include a disk body 275. The disk body 275 is substantially flat and may include a number of circumferentially arranged tab protrusions 277. The tab protrusions 277 may be arranged symmetrically around the disk body 275 and may be spaced at regular angular intervals, as shown in Figures 51A–51C. In alternative embodiments, the tab protrusions 277 may be arranged asymmetrically around the base or at irregular angular intervals. The tab protrusions 277 can engage with receiving slits 278 (see, for example, Figure 44A) located 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. Asymmetrical or irregularly spaced tab protrusions 277 allow the holder 270 to be coupled to the body 20 in a desired predetermined direction in some examples.

[0272] Referring further to Figures 51A-51C, the holder 270 may include at least one stage projection 279. The stage projection 279 may be included in addition to, or instead of, the round recess 272 and spherical segment of the embodiments described above in relation to Figures 47-50. The stage projection 279 can provide a well 281 on the distal side of the disk body 277. The stage projection 279 may extend protruding from the proximal side of the disk body 277 by a height that in certain examples may be at least the same as the height of the microneedle 277 of the delivery device 10. The stage projection 279 may typically extend at an angle perpendicular to the disk. The sidewall 283 of the stage projection 279 may be chamfered so as to extend non-perpendicular to the proximal surface of the disk body 279. The stage projection 279 may include a pocket 276. The size of the pocket 276 may be such that it fits and receives a sharp support 26 with a delivery sharp 72, as described elsewhere in this specification.

[0273] Referring here to Figures 52A to 52D, in some embodiments, the pocket 276 of the stage projection 279 may be oriented non-parallel to the plane of the disk body 275. In Figure 52D, when the sharp support 26 is attached to the pocket 276, the orientation of the pocket 276 may ensure that the delivery sharp 72 (e.g., a microneedle) extends at a predetermined angle relative to the disk body 275. In an exemplary embodiment, the pocket 276 may be oriented so that the delivery sharp 72 extends at an angle of 10 to 20° (e.g., 15°) relative to the plane of the disk body 275. In other embodiments, the pocket 276 is oriented so that the delivery sharp 72 protrudes at an angle of 45° or 60°, or an angle in between. Any suitable angle can be used. In an alternative embodiment, the entire stage projection 279 may 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, the reservoir portion 271 is shown as in Figures 53–56 (a side view, top view, top-down perspective view, and bottom-down perspective view, respectively, relative to the application surface of the delivery device 10, such as the skin surface). The reservoir portion 271 can be shaped to incorporate a dome-shaped portion 280, a tunnel or channel 282, and a flange or annular portion 284 as a single structure. That is, these features can be contained in a single monolithic material piece. In some embodiments, the dome-shaped portion 280 may be shaped as a substantially hemisphere or other spherical segment, but any other suitable shape is possible. In examples where the reservoir portion 271 includes a rounded shape that forms a cavity (e.g., the dome-shaped portion 280), the most distal rounded portion of the flange 284 may include a plateau or flat surface. The flat surface may generally be parallel to the flange 284. In some examples, a central recess 267 (see, for example, Figure 57) may also be included in the flat surface. The tunnel 282 may be formed as a semipipe or semi-cylindrical section, which in some examples may be formed from the annular section 284. In alternative embodiments, any suitable cross-sectional shape may be used. The side channel or tunnel 282 may communicate with the dome-shaped section 280 via the arch 286 such that the combination of the dome-shaped section 280 and the tunnel 282 forms a structure that is substantially igloo-like in shape. In some embodiments, the end of the tunnel 282 opposite the dome-shaped section 280 may flare outward or taper to enhance ease of filling. The annular section 284 may have an inner edge that coincides with the base outer circumference 288 of the dome-shaped section 280. The reservoir section 271 may be manufactured, for example, by thermoforming a flat sheet of material (e.g., plastic or layers of various plastics or other materials). If a multilayer sheet is used, the sheet may include drug or pharmacocompatible layers, barrier layers, binding layers, etc. In some embodiments, vacuum forming may be used to manufacture the reservoir section 271. Other known techniques, such as injection molding, are also possible.The reservoir portion 271 can be formed from polycarbonate material or other suitable material and can be coated with cyclic olefin polymer (COP) or other suitable coating material. The dome-shaped portion 280 can be folded when pressure is applied.

[0275] Referring here to Figure 57, an exemplary perspective view of reservoir portion 271 is shown. In a particular example, reservoir portion 271 may include at least one cavity incorporating one or more collapse-facilitating sections. Collapse-facilitating sections can facilitate the collapse of the cavity in a predetermined manner and reduce the force required to collapse the cavity. Collapse-facilitating sections can also help ensure that the cavity collapses in such a way that dead volume is minimized. Similarly, including collapse-facilitating sections may help reduce the possibility of fluid contained in reservoir 12 becoming trapped or pocketed in areas of reservoir 12 where communication with the outlet is cut off during cavity collapse. Other reservoirs 12 described herein may include at least one collapse-facilitating section.

[0276] The collapse-promoting section may be a pleated, bellows-like, accordion-like, wrinkled, ribbed, stepped, or bellows-like wall 261 extending upward from the flange 284. The wall 261 may extend beyond the flange 284 and may taper (e.g., continuously or stepwise) as the distance from the flange 284 increases. The upper wall 263 may span the most distal portion of the wall 261 of 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, may extend parallel to the flange 284. The upper wall 263 may, in certain examples, include a central recess 267. The central recess 267 may function to assist in the positioning of the reservoir interface member 474 (see, for example, Figure 34) or a portion of the biasing members 470, 481 (see, for example, Figures 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 pleat, bellows, accordion, fold, or frill pattern may be used, but in certain embodiments, the wall 261 may include at least one pleat 269 of a helical pattern. At least one helical pleat 269 may extend from a point adjacent to the flange 284 and end at a point adjacent to the upper wall 263. Any helical pleat 269 may have a conical shape corresponding to its taper if the wall 261 tapers as the distance from the flange 284 increases. Any helical pleat 269 may have a pitch such that each pleat 269 wraps around the wall 261 multiple times. In the exemplary embodiment shown in Figure 57, the helical pleat 269 wraps around the wall 261 about three times. Such pleats 269 may help collapse the cavity while the fluid is being pushed out of the reservoir 12 during the operation of the delivery device 10. Therefore, the force required to deform and deplete such a reservoir 12 during use can be minimal. Furthermore, such pleats 269 can help ensure that a small amount of dead volume remains in the reservoir 12 after delivery is complete. The use of a flat top wall 263 can also help in the collapse of the cavity.

[0278] As shown in Figure 58, the wall 261 is stepped and may include at least one stepped region 259. The cross-sectional area of ​​the cavity may vary in each stepped region 259. In this example, the cross-sectional area of ​​the cavity is largest adjacent to the flange and decreases gradually as the distance from the flange 284 increases. In the example shown in Figure 58, the wall 261 includes two stepped regions 259; however, in alternative embodiments, any suitable number may be included. As in the example above, the stepped wall 261 helps reduce the force required to collapse the cavity and helps guide the collapse in a predetermined manner.

[0279] In one embodiment, the reservoir 12 may be formed by attaching a reservoir portion 271 to a holder 270, as shown in Figure 59. In the illustrated example, the reservoir portion 271 may be positioned on top of the holder 270, and the lower surface region 285 of the annular portion 284 may be fixed to the disk body 275 or the upper surface region 273 of the annular portion 272. For example, the reservoir portion 271 may be attached to the holder 270 by ultrasonic welding, but any form of welding or any other bonding technique known to those skilled in the art may be used. For example, the reservoir portion 271 and the holder 270 may be sealed with double-sided adhesive. Other suitable techniques for sealing the reservoir portion 271 and the holder 270 together include, but are not limited to, the use of UV-curable adhesive, heat scribing, and laser welding.

[0280] For example, a drug such as a vaccine can be inserted into the reservoir 12 via the side channel 282, and the side channel 282 can then be sealed by any known technique, such as any well-known technique, such as ultrasonic welding, or any other suitable technique described herein. The sharp support 26 (see, for example, Figure 31), which includes the delivery sharp 72 (see, for example, Figure 31), can be inserted into the pocket 276 and secured therein by any suitable technique, such as welding, before the drug (e.g., vaccine) is inserted into the reservoir 12. Alternatively, as described above, a holder 270 can be formed around the sharp support 26. As described elsewhere in this specification, the delivery sharp 72 may be one or more microneedles in various examples.

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

[0282] Referring to Figure 60, the reservoir 12 (for example, the reservoir 12 described above with reference to Figure 59) can be fixed inside the delivery device 10. A typical example of the delivery device 10 is shown, but the reservoir 12 can similarly be attached to the body 20 of any embodiment of the delivery device 10 described herein. The reservoir 12 may contain a drug (e.g., a vaccine) before being assembled into the delivery device 10. The reservoir 12 may be removed from a refrigerated storage facility before being installed inside the body 20 of the delivery device 10.

[0283] Referring to Figure 60, in one embodiment, the ridge 290 may be formed on the inner surface of the central region 28 of the delivery device 10, and as a result, the ridge 290 may function as a seating structure on which a section or region of the reservoir 12 is positioned or coupled. In one example, the annular portion 272 or holder 270 may be bonded to the ridge 290 using an adhesive. Those skilled in the art will understand that any suitable bonding technique may be used. In another embodiment, the distal surface of the reservoir portion 271 may be attached to the proximal surface of the ridge 290. The distal surface of the reservoir portion 271 may be coupled to the ridge 290 of the body 20 of the delivery device 10, for example, as shown in Figure 26. A tab projection 277 (see, for example, Figure 51A) that couples to a receiving slit 278 (see, for example, Figure 44A) defined in the body 20 may be used alternatively or additionally.

[0284] In certain embodiments, referring to Figures 61A-61B, the shape of the reservoir portion 271 can be adjusted to change its maximum cross-sectional area. This can help achieve a desired delivery pressure. For example, in some embodiments, the reservoir portion 271 may be formed to have a balloon shape (shown in Figures 61A-61B), a cylindrical shape, a polygonal prism shape, etc. The height of the reservoir portion 271 may be adjusted as follows. Given a pre-selected maximum cross-sectional area, a desired internal volume can be obtained. As shown, the holder 270 may include at least one buttress 289. At least one buttress 289 may at least partially surround the reservoir portion 271. At least one buttress 289 may help hold the reservoir portion 271 in a desired position within the body. At least one buttress 289 may also help guide the reservoir portion 271 in a direction that compresses it when delivery is made.

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

[0286] Referring to Figure 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, it may be desirable to start fluid injection at a relatively low pressure, or at or near the minimum pressure at which injection is possible for a particular patient. The delivery pressure can be increased until this delivery initiation pressure is reached for a particular patient. By slowly increasing the pressure, it may be possible to reach the delivery initiation pressure for a wide variety of patients using the same design of delivery device 10. Furthermore, once injection has started, it may be desirable for the delivery pressure to be maintained at or near the delivery initiation pressure. Furthermore, referring to Figure 62, in such embodiments, it may be desirable to use at least one biasing member 470 to facilitate delivery. For example, a compression spring made of hook-and-a-wan material may be used.

[0287] Referring to Figure 62, in such embodiments, the reservoir 12 may be divided into a first portion 520 and a second portion 522. The first portion 520 and the second portion 522 may be in fluid communication with each other via a flow limiter 524. The flow limiter 524 may be positioned between the portion of the reservoir 12 closer to the microneedle and the portion of the reservoir 12 distal to the microneedle. In certain embodiments, the flow limiter 524 may be an orifice plate having one or more orifices extending through it. In some embodiments, the flow limiter 524 may include orifices with orifices of 15 to 25 microns. In other embodiments, the orifices may have a diameter of up to 100 microns (e.g., 70 to 80 microns or 75 microns). In some embodiments, the orifices may have a diameter greater than 100 microns. The size of the orifices may be selected based on considerations such as the viscosity and / or surface tension of the drug filling the reservoir, the desired injection rate, and how quickly the injection pressure should be increased. The orifice plate may be an injection-molded part, but it can also be formed by other suitable methods.

[0288] Furthermore, as shown in Figure 62, the first portion 520 of the reservoir 12 may comprise the majority of the reservoir 12. The second portion 522 of the reservoir 12 may be located proximal to the delivery sharp 72 relative to the first portion 520. The flow limiter 524 can separate the larger first portion 520 from the smaller second portion 522 located proximal to the delivery sharp 72. In certain examples, the first portion 520 may have a volume substantially equal to the filling volume of the reservoir 12. The flow limiter 524 may be located at least upstream of the pocket 276 (see, for example, Figures 47–51C) to which the sharp support 26 can be coupled. In exemplary embodiments, the flow limiter 524 can separate the round recess 274 (see, for example, Figures 47–50) from the rest of the reservoir 12. In such embodiments, the flow limiter 524 may be coupled to the distal surface of the reservoir 12 on the round recess 274. In other examples, the flow limiter 524 can isolate the well 281 (see, for example, Figures 51A-51C) from the rest of the reservoir 12. In such embodiments, the flow limiter 524 can be coupled to the distal surface of the disk body 275 on the well 281 (see, for example, Figures 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 the drug to be delivered (e.g., medicine, vaccine, medical drug). The portion closer to the delivery sharp 72 may be filled with a gas (e.g., sterile air or cleanroom air from the manufacturing environment, inert gas, etc.). The orifice may be sized such that, depending on the properties of the drug (e.g., surface tension, viscosity), the drug does not pass through the second portion 522 without pressurizing the reservoir 12. Despite the fluid communication between the first and second portions 520 and 522, the second portion 522 may remain unwetted by any drug filled in the reservoir 12 until it is used during manufacturing. When the delivery device 10 is used, there may be an incubation period during which the fluid is pushed from the first portion 520 to the second portion 522. Subsequently, the pressure in the second portion 522 may rise to a pressure at which the patient's anatomical structures begin to receive the delivery. Once delivery begins, 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 the 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). Depending on the embodiment, at least one biasing member 470 may be in direct contact with the reservoir 12 or may apply pressure via a reservoir interface member 474 (see, for example, Figure 34) or other components of the delivery assembly 280 (see, for example, Figure 34). The flow limiter 524 can slowly raise the pressure of the fluid in the second portion 522 of the reservoir 512 to the pressure at which injection to the patient begins. Subsequently, the flow limiter 524 can limit the pressure increase in the second section 522 as the infusion progresses. Thus, the injection tends to be performed at or near the minimum pressure the patient accepts. This facilitates the use of stronger springs and can reduce discomfort associated with the delivery. Furthermore, the design of a single delivery device 10 allows for use in a wide range of patient populations (e.g., any patient) or with a wide variety of different drugs. In addition, this can influence blister formation due to the delivery. Because the delivery tends to be performed relatively slowly and at relatively low pressure, a more diffused, shallow (e.g., intradermal) injection tends to result. Adjusting the size of any orifice in the flow limiter 524 can change the duration of delivery and the characteristics of the blister.

[0291] Referring here to Figures 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 in each exemplary delivery device 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 prevents adhesive from being left incomplete on certain petal members 42. As shown, each adhesive member 22 may include a plurality of slits 43 extending radially inward from the periphery of the adhesive member 22 to form a petal portion that aligns with the petal members 42 of the main 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 may affect blister formation resulting from delivery when the delivery device 10 is used. Furthermore, the shape and size of the central opening 49 may help facilitate certain shallow delivery or shallow delivery 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 of ​​60–100% of the mounting area of ​​the holder 270. It may be preferable for the central opening 49 to have a shape such that at least a portion of the adhesive member 22 can be attached to a portion of the holder 270 or other rigid portion of the reservoir 12. In certain examples, the cross-sectional area of ​​the central opening 49 may be greater than 0.13 square inches. In certain examples, the cross-sectional area of ​​the central opening 49 may be in the range of 0.13 square inches to 0.5 square inches (e.g., about 0.3 square inches).

[0293] Furthermore, it may be desirable for the central opening 49 to be wider in certain directions compared to other directions. For example, each delivery sharp 72 (e.g., one or more microneedles) may tend to distribute fluid in the discharge 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 larger or increased width in a direction that coincides with, or substantially coincides with, the discharge direction. For example, the maximum width (or at least a relatively wide portion) of the central opening 49 may be along a direction parallel to the plane containing the discharge direction. By using a delivery device 10 including one or more microneedles similar to those shown in Figure 2, the increased width portion of the central opening 49 can be aligned with the anterior-posterior direction (from the distal end 15 to the posterior end 23, also referred to herein as the length) or line of symmetry of the microneedle. For example, the central opening 49 may be elliptical and widest in a direction parallel to the anterior-posterior direction of the microneedle. This may help to create a more diffused, shallow (e.g., intradermal) injection as opposed to a concentrated blister. This may be desirable because it could help enhance the effectiveness of the injection. For example, injecting a vaccine more broadly into the skin may expose more immune-related cells in the intradermal area to the vaccine, potentially enhancing the immune response.

[0294] Referring primarily to Figure 63A, the central opening 49 may be a generally round (e.g., circular) opening, except for a number of inwardly extending teeth or spokes 51 in the adhesive member 22 material. In this exemplary embodiment, the adhesive member 22 includes a central opening 49 with four spokes 51 spaced apart from each other by regular angular increments. In specific examples, the number of spokes 51 may vary, and the spacing between the spokes 51 may be irregular. The spokes 51 may be arranged such that the central opening 49 has a relatively large width in the direction along the discharge direction. While the central opening 49 may have a relatively large width in this direction, this does not preclude other wide areas of equal, narrower, or possibly wider width. In the illustrated example, the central opening 49 has approximately equal width when measured in a direction perpendicular to the front-rear direction of the microneedle. In specific examples, the spokes 51 can assist in attachment to the holder 270 or other rigid reservoir 12 portion. This allows, for example, the adhesive member 22 to be firmly attached to both the body and the holder 270. In certain examples, the spoke 51 may be the sole part of the adhesive member 22 that is bonded to the holder 270.

[0295] Referring primarily to Figures 63B-C, in certain examples, the central opening 49 may include a notch 53 extending outward from the periphery of the rest of the central opening 49. The notch 53 may be included to widen the central opening 49 if desired. While this example includes a rectangular notch 53, the shape of the notch may differ in alternative embodiments. The notch 53 may be any suitable polygon, or, for example, a circle.

[0296] Referring here to Figures 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 containing 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 exemplary embodiments, the body 20 includes a number of living hinges 50 formed integrally with the rest of the body 20. Each living hinge 50 extends over a portion of the body 20, and the body 20 may be divided into a number of panels 52A-D. The body 20 may be injection molded.

[0297] Panels 52A to D may include a pair of opposing end panels 52A, D. Each of the end panels 52A, D may include a planar portion 54. The planar portions 54 may be parallel or coplanar. In this example, the planar portions 54 are coplanar. One of the ends 52A may include an angled projection 56 extending from the planar portion 54. The angled projection 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 projection 56. The angled projection 56 is elastic and resistant to deflection or bending, extending at a constant angle to the planar portion 54. In some examples, a buttress 58 may be included, extending from the planar portion 54 to the angled projection. Each planar portion may have a proximal surface that is at least partially covered with adhesive 22.

[0298] Panels 52A to D may also include at least two intermediate panels 52B, C that extend between the end panels 52A, D and can connect them. One of the panels 52B may be connected to the end of the protruding projection 56 via one of the living hinges 50. The other intermediate panel 52C may be connected to the planar end panel 52D via another of the living hinges 50. Each of the intermediate panels 52B, C may be connected to each other via the living hinges 50 to form a connecting portion 60 between the end panels 52A, D.

[0299] As shown in Figures 65A to 65C, the connecting portion 60 may be displaceable from a raised position (see Figure 65A) to a central position (see Figure 65B) and then to an upper central position (see Figure 65C). When the delivery device 10 is in storage, the connecting portion 60 may be in the raised position. In the raised position, the intermediate panel 52B connected to the raised projection 56 may extend from the raised projection 56 at an angle 62 (angles 62, 64, 66) measured between the proximal faces of the enumerated components. The angle 62 can be selected such that the intermediate panel 52B gradually moves away from the plane of the planar portion 54 as the distance from the raised projection 56 increases. In the illustrated example, when the connecting portion 60 is in the raised position, the angle 62 is obtuse. The intermediate panels 52B and 52C may be positioned at an angle 64 to each other. This angle 64 is also obtuse in the exemplary embodiment when the connecting portion 60 is in the raised position. The intermediate panel 52C and the end panel 52D can form an angle 66 with respect to each other that becomes the reflection angle when the connecting portion 60 is in the raised position. Furthermore, in the raised position, the end panels 52A and 52D may be at the closest possible distance from each other.

[0300] The delivery device 10 can be applied to the skin 44 on the injection site in a stored state with the connector 60 in the raised position. This allows the end panels 52A, D to be fixed so that they are substantially constrained to the plane of the skin patch to which they are adhered. Applying downward pressure to the connector 60 can displace the connector 60 from the raised position toward the center position. When this happens, the angle 64 between the two intermediate panels 52B, C may increase. The angle 62 between the protruding projection 56 and the intermediate panel 52B, and the angle 66 between the end panel 52D and the intermediate panel 52C may decrease. To adapt to the change in the angle 64 between the two intermediate panels 52B, C, the end panels 52A, D may spread apart. When the connector 60 reaches the center position (see Figure 65B), the angle 64 becomes 180°, and the end panels 52, D may be at their maximum distance from each other. The skin 44 may become stretched and taut as the end panels 52A, D are displaced apart.

[0301] As the connecting portion 60 is further displaced, it may become overcentered. The elasticity of the stretched skin 44 can exert a restoring force that tends to drive the end panels 52A and D toward each other. Thus, as the connecting portion 60 is displaced through the center position, it can automatically displace to an overcentered position at the end of the connecting portion 60's displacement range. When the connecting portion 60 is displaced to this overcentered position, the delivery device 10 can transition to the delivery state. As the connecting portion moves to the overcentered position shown in Figure 65C, the distance between the end panels 52A and D may 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 overcentered position at the end of the displacement range, the angle 62 between the raised projection 56 and the intermediate panel 52B may be approximately 90° (e.g., 80° to 110°). The angle 64 between the intermediate panels 52B and C may be the reflection angle. Therefore, the connecting portion 60 can be partially inverted relative 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 in the figure, when the connecting portion 60 reaches the overcenter position at the end of its displacement range, the proximal surface of the intermediate panel 52C may come into contact with the skin 44.

[0302] When the delivery device 10 is in the delivery state (see Figure 65C), the delivery sharp 72 can be pressed into the skin 44 to puncture the skin 44 and establish fluid communication with the delivery destination inside the patient's body. The angle 64 between the intermediate panels 52B, C at the overcenter delivery position (see Figure 65C) can be selected so that the delivery sharp 72 penetrates the skin 44 at a predetermined angle (e.g., 45° to 45° with respect to the surface of the skin 44). The angle 64 can be selected to be in 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 and the surface of the skin 44 at the overcenter delivery position (see Figure 65C) to the length of the intermediate panel 52B within a desired range. When the delivery device 10 is in the delivery state, the reservoir 12 may be pressed against the skin 44. This pressurizes the reservoir 12, allowing fluid to be pushed out of the reservoir 12 through the delivery shank 72 into the patient. The restorative force generated by the stretched skin 44 can provide continuous pressure to the reservoir 12, helping to ensure that the reservoir 12 is completely empty when delivery is made.

[0303] In some embodiments, the proximal surface of the intermediate panel 52C may be at least partially covered with adhesive 22 (see, for example, Figure 65C). When the connecting portion 60 reaches the overcenter position at the end of the displacement range, the adhesive 22 can hold the connecting portion 60 in place. Furthermore, in some embodiments, the body 20 may include at least one force limiter. For example, at least one of the panels 52A, D may include a tension-relieving deflection portion. In an exemplary embodiment, this deflection portion may bend when the force required to stretch the skin 44 exceeds a threshold. When the deflection portion bends, the connecting portion 60 may snap through the center position into the overcenter position, stopping the stretching of the skin 44. This may be desirable as it may help reduce potential discomfort during injection due to excessive tension in the skin 44. Similarly, this may be useful in certain patient populations as skin characteristics vary considerably among potential patients.

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

[0305] The intermediate panel 52C (whereas any intermediate panels 52B, 52C may include such features) may be implemented as, or to include, a deflection portion 290 of at least one lattice structure, as shown in Figures 66A-66B. The deflection portion 290 may be formed by injection molding. The intermediate panel 52C may 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 extending from the first member 296 toward a second member 298 of the intermediate panel 52C at substantially 90° angles. The second member 298 may be adjacent to the connection of the living hinge 50 to an end panel 52D. The second member 298 may be positioned parallel to and opposite the first member 296 and may have at least one arm 302. In the illustrated example, there are two arms 302A-B extending from the second member 298 toward the first member 296 at a substantially 90° angle. Each of the two arms 302A-B may be positioned substantially parallel to each pair of the four support arms 300A-D and extend between them. Each of the two arms 302A-B may be coupled by at least one buttress 304 (e.g., three buttresses 304) to at least one of the associated two support arms 300A-B, 300C-D, positioned on either side of each arm 302A-B. In this example, each of the two arms 302A,B is connected to each of the associated support arms 302A-B. In Figure 66A, only six of the twelve buttresses 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, support arms 300A-D, arms 302A-B, and buttresses 304A-F close at least partially. The number of buttresses 304A-F can be changed to adjust the threshold at which the deflection section 290 gives away. In addition, or alternatively, the amount or thickness of the material of the buttresses 340A-F can be adjusted for this purpose.The buttresses 304A-F are arranged substantially parallel to each other and may extend from their respective arms 302A-B at acute angles to the first member 296. The buttresses 304A-F may be connected to their respective support arms 300A-D at obtuse angles. The deflection section 290 is shown as a non-limiting example and can be incorporated using any suitable shape, angle, and / or structure and / or number of parts.

[0306] In other embodiments, the intermediate panel 52C may incorporate at least one flexure 292, which may be in the form of a crushable body that can deform when a threshold force applied to the body is exceeded. In one embodiment, the flexure 292 may be round and hollow. Referring to Figures 67A-67B, the exemplary flexure 292 may be substantially cylindrical in shape. The illustrated flexure 292 is just one of many possible examples and is not limited to the illustrated structure or shape. The flexure 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 portion of the body 20 may be plastically deformed. 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 a storage state, one or more of the living hinges 50 may break. Thus, the transition from the storage state to the delivery state can be made irreversible, preventing the reuse of the delivery device 10. In some examples, the adhesive 22 may be selected to bond more aggressively to the skin 44 than to 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. In embodiments described herein in which the adhesive 22 is peeled off from the delivery device 10, the adhesive 22 may include a pull tab or similar mechanism to facilitate subsequent removal from the skin 44.

[0308] Referring now to Figures 68-69, another exemplary embodiment of the delivery device 10 is shown. As shown, the delivery device 10 includes a body 20 and a reservoir 12. The reservoir 12 includes a sharp support 26 containing a one-dimensional array of delivery sharps 72. Other embodiments may include any suitable number of delivery sharps 72 arranged in any pattern. The body 20 of the delivery device 10 may have a polygonal footprint that can change from a first polygonal shape (e.g., hexagon) to a second polygonal shape (e.g., rectangle) when the delivery device 10 transitions from a storage state to a delivery state.

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

[0310] Similar to the side panels 71A and B, the bridge 76 may have a first end connected to a first end block 70A by a hinge 74D, and a second end opposite to the first end connected to a second end block 70B by another hinge 75E. The bridge 76 may further include an intermediate hinge 74F positioned between the first and second ends of the bridge 76. The bridge 76 may also include a panel body 78 and a pair of support members 80A and B. The support members 80A and B may be connected to the panel body 78 via the intermediate hinge 74F of the bridge 76. The bridge 76 may also include an arm member 82. The arm member 82 is positioned between the two support members 80A and B and may extend toward the proximal faces of the end blocks 70A and B. In an exemplary embodiment, the arm member 82 extends from the end of the panel body 78 adjacent to the intermediate hinge 74F of the bridge 76. The reservoir 12 can be connected to the proximal surface of the arm member 82 at the end of the arm member 82 opposite to the panel member 78.

[0311] In the exemplary embodiments shown in Figures 68-69, hinges 74A-F are shown as living hinges. In alternative embodiments, at least one of hinges 74A-F may be a conventional hinge, and the body 20 may be constructed as an assembly of multiple components joined to one another via hinges 74A-F. In yet another example, the body 20 may consist of at least two components. Instead of using hinges to join 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 may be displaceable over a displacement range to transition the delivery device 10 between a storage state (shown in Figures 68-69) and a delivery state. In the storage state, the side panels 71A and 71B of the delivery device 10 may be in an outward-bent position. The side panels 71A and 71B can be bent at the intermediate hinges 74C of each side panel 71A and 71B so that the side panels 71A and 71B can assume this outward-bent position. Some pivoting of the side panels 71A and 71B also occurs at the hinges 74A and B that connect the side panels 71A and 71B to the end blocks 70A and B, making it possible for the side panels 71A and 71B to be positioned in an outward-bent position.

[0313] By applying a clamping force that pushes side panels 71A and 71B toward each other, the side panels 71A and 71B can be displaced from their outwardly curved positions to straightened positions. Note that the straightened position does not necessarily have to be a position where side panels 71A and 71B extend along a straight line. In some examples, the straightened position may be a position where the outward curve of side panels 71A and 71B is less than the outwardly curved position.

[0314] The bridge 76 may also be displaceable over a displacement range to transition the delivery device 10 between a storage state (shown in Figures 68-69) and a delivery state. In the storage state, the bridge 76 may be in a raised state, with at least the delivery sharp portion 72 of the reservoir 12 coupled to the arm member 82 positioned above the proximal faces of the end blocks 70A and B. The bridge 76 may be bent at intermediate hinges 74F such that the panel body 78 and the support columns 80A and B extend upward from the end blocks 70A and B and move away from the proximal faces of the end blocks 70A and B. Some pivoting of the hinges 74D and E connecting the bridge 76 to the end blocks 70A and B, as shown in Figure 78 and of the support columns 80A and B, also occurs, allowing the bridge to take the raised position. By applying a force perpendicular to the proximal faces of the end blocks 70A and B to the bridge 76, the bridge can be displaced from the raised position to the lowered position of the opposite end of the bridge 76's displacement range.

[0315] In various embodiments, when the bridge 76 is actuated over its displacement range, the delivery device 10 can transition from a storage state to a delivery state. Furthermore, when the side panels 71A and B are actuated from an outwardly bent state to a straight state, the delivery device 10 can transition from a storage state to a delivery state. Since the bridge 76 and the side panels 71A and B are connected to each other via end blocks 70A and B, when the bridge 76 is actuated over its displacement range, the side panels 71A and B are displaced over their respective displacement ranges. The displacement of the side panels 71A and B over their displacement ranges can result in the displacement of the bridge 76 over that same displacement range.

[0316] Whether to use the side panels 71A, B, or bridge 76 to transition the delivery device 10 may be left to the user. Alternatively, whether the bridge 76 or the side panels 71A, B are activated may depend on the patient population to which the user belongs. For example, activating the bridge 76 applies greater pressure to the arm member 82. This can help ensure the delivery sharp 72 penetrates the skin. Therefore, for patient populations with certain skin characteristics, it may be desirable to instruct them to activate the delivery device 10 via the bridge rather than the side panels 71A, B.

[0317] Here, as shown in Figures 70A-70C, when the side panels 71A and B are in an outwardly curved position and the bridge 76 is in an elevated position (see Figure 70A), the end blocks 70A and B may be at a first distance from each other. When the side panels 71A and B are displaced toward a straight position and the bridge 76 is displaced toward a lowered position (see Figures 70B-70C), the end blocks 70A and B can be displaced toward each other. Since the delivery device 10 is attached to the skin 44 via the adhesive 22 contained in the end blocks 70A and B, the spreading of the end blocks 70A and B can stretch and tighten the skin 44. This can help facilitate the puncture of the skin 44 by the delivery sharp 72 contained in the reservoir 12. As shown in Figure 70C, when the side panels 71A and B reach a straight position and the bridge 76 reaches a lowered position, the delivery sharp 72 punctures the skin 44 and the delivery device 10 can become a delivery device. The reservoir 12 can be compressed between the skin 44 and the arm member 82 to push fluid out of the reservoir 12 into the patient. The reservoir 12 may collapse when delivery is made.

[0318] Referring here to Figure 71, a cross-sectional view of the delivery device 10 in Figures 68-69, in a particular example, the delivery device 10 may include an iris assembly 84. The iris assembly 84 may include a set of iris panels 86A-D that can define an opening 88 whose size is variable from a closed state to a fully open state. The iris panels 86A-D may extend from each of the side panels 71A, B toward the opposite side panel 71A, B. In an exemplary embodiment, two iris panels 86A-D extend from each side panel 71A, B and are positioned on either side of the intermediate hinges 74C, D of each side panel 71A, 71B. When the side panels 71A, 71B are displaced from an outwardly curved position to a straightened position, the iris panels 86A-D adjust the opening 88 so that the opening 88 provides an opening for the delivery sharps 72 of the reservoir 12 to pass through. As shown in Figure 71, when the delivery device 10 is in storage, the opening 88 can be substantially closed. Therefore, such an iris assembly 84 can function as a guard to help prevent accidental contact with the delivery sharp 72 during handling of the delivery device 10.

[0319] In an exemplary embodiment, one of the iris panels 86A includes a latch projection 90. Another panel 86B of the iris panels 86B includes a latch catch 92 which may be formed as a notch in that iris panel 86B. The latch projection 90 is inclined. Therefore, when iris panels 86A,B are displaced toward each other, iris panel 86B is deflected and can ride up onto the inclined surface of the latch projection 90 (see, for example, Figure 70B). When the latch catch 92 aligns with the latch projection 90, the iris panel 86B including the latch catch 92 returns to an undefended state, and the latch catch 92 can click into place with the latch projection 90. This allows the delivery device 10 to be fixed in the delivery state. The snapping action of the iris panels 86B can produce a tactile sensation that can be perceived, for example, through the user's fingertips. Alternatively or additionally, the snapping may produce an audible click or slap sound. Therefore, the delivery device 10 can provide an auditory and / or tactile indication that the delivery device 10 has entered a delivery state. The engagement between the latch projection 90 and the latch catch 92 may also help prevent reuse. As described in relation to other embodiments of this specification, the adhesive 22 may be selected to bond more aggressively to the skin 44 than to the material forming the body 20. Therefore, when the delivery device 10 is removed, the adhesive 22 may peel off from the delivery device 10. This may also help prevent the reuse of the delivery device 10.

[0320] Referring here to Figures 72A-72B, another exemplary embodiment of the delivery device 10 is shown. The delivery device 10 may include a first portion 100 and a second portion 102. One of the first portion 100 and the second portion 102 may be displaced translationally relative to the other, thereby transitioning the delivery device 10 from a storage state (see Figure 72A) to a delivery state (see Figure 72B). In some embodiments, only a portion of the first portion 100 or the second portion 102 may be displaced translationally relative to the other. For example, one of the first portion 100 or the second portion 102 may be stretchable and / or elongated. In certain examples, the transition to the delivery state may be reversible, while in other embodiments, the transition may be an irreversible unidirectional transition. For example, a latch, lock, or other coupling may be engaged to hold the first and second portions 100, 102 in the delivery state or to prevent them from returning to the storage state. Alternatively, the first part 100 and the second part 102 may be coupled together when the delivery device 10 transitions to a storage state. When the delivery device 10 transitions to a delivery state, coupling or uncoupling between the first part 100 and the second part 102 may require the destruction of a portion of the delivery device 10. This destruction may render the delivery device 10 inoperable. This not only prevents reuse but can also provide a perceptible (e.g., visual) indication to the user that the delivery device 10 has been used.

[0321] The proximal surfaces of the first and second portions 100, 102 may be at least partially covered with adhesive 22. The adhesive 22 may function to bond the first and second portions 110, 102 to the skin surface of the patient's injection site. The delivery device 10 may be adhered to the skin when the delivery device 10 is in storage and then transition to the 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. Thus, the distance between these adhesive-supporting sections may increase to stretch or spread the underlying skin. This may be desirable to keep the skin taut and facilitate skin puncture by at least one delivery sharp 72 of the reservoir 12 contained in the delivery device 10.

[0322] As the delivery device 10 transitions to the delivery state, the delivery sharp 72 may be displaced or descended proximally into the skin. In embodiments where the delivery sharp 72 is coupled to a 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 parts 100, 102 when the delivery device 10 transitions from the storage state to the delivery state. Compression of the reservoir 12 may help to drain fluid from the reservoir 12 and allow it to flow through the delivery sharp 72 to the target delivery destination in the patient's body. Furthermore, in some embodiments, at least one of audible or tactile indication may be generated when the delivery sharp 72 is displaced toward the skin.

[0323] Referring here to Figures 73-74, an exemplary delivery device 10 is shown. As illustrated, the delivery device 10 may be a substantially planar, thin, and low-profile assembly. The delivery device 10 may include a proximal portion 110 and a distal portion 112. The proximal portion 110 may be formed of a flexible material, and in some embodiments, the proximal portion 110 or at least a portion of the proximal portion may be elastic so that it can stretch. The distal portion 112 may be rigid. The proximal surfaces of both the proximal portion 110 and the distal portion 112 may have at least one area covered with adhesive 22. The proximal portion 110 may be bonded to the distal portion 112 via adhesive 22 on the proximal surface of the distal portion 110. Such embodiments are desirable because the delivery device 10 is suitable for mass production by a reel-to-reel manufacturing process.

[0324] Referring here to Figures 75-76, the proximal portion 110 and the distal portion 112 may be joined together via an adhesive fixing assembly 114. As shown, the adhesive fixing assembly 114 may include a region of lock adhesive 116, which may be located on a portion of the proximal surface of the distal portion 112. The adhesive fixing 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 opposing end. The tether member 118 may be fixedly bonded to the proximal portion 110 by heat riveting, welding, or other means, while being relatively lightly bonded to the lock adhesive 116. In some embodiments, the tether member 118 may consist of an adhesive liner or adhesive support material that can be easily peeled off from the lock adhesive 116. As shown, when the delivery device 10 is in storage, the tether member 118 may be at least partially doubled.

[0325] The proximal portion 110 may include a pull tab 120 which may be located 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 ridges, etc., to facilitate gripping. In alternative embodiments, the pull tab 120 may include a notch to form a pull ring.

[0326] The proximal portion 110 may also include at least one ramp element 128 and a 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 ramp elements 128 aligned to each other. The folding region 122 can be folded over itself multiple times. In this example, the folding region 122 is folded over itself twice. Thus, when a tensile force is applied to the pull tab 120, the folding region 122 can unfold, winding up the material of the proximal portion 110 and allowing the proximal portion 110 to extend. At least one ramp element 128 can also move as the folding region 122 feeds out material. The number of folds of the folding region 122 can be adjusted to vary the amount of extension when the proximal portion 110 transitions to an extended state. The folding region 122 may be tapered from a wider width to a narrower 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 a rounded end. The layer of the most proximal folding region 112 is substantially immobile in the distal portion 112 and can be fixed in place by the adhesive 22 of the distal portion 112 as the folding region 122 unfolds.

[0327] As shown in Figure 75, the delivery device 10 may include a reservoir 12 which may contain at least one delivery sharp 72. Any suitable number of delivery sharps 72 may be arranged in any desired number of rows and / or columns. Any delivery sharp 72 described herein may be used. The delivery sharps 72 may be contained on a sharp support 26 coupled to the reservoir 12. The reservoir 12 may be located on an elastic cantilever arm 130 defined within the distal portion 112 of the delivery device 10. The folding area 122 of the proximal portion 110 may include a delivery opening 124. As shown, when the delivery device 10 is in storage, the delivery opening 124 may not be aligned with the delivery sharp 72. Therefore, the proximal portion 110 can cover the delivery sharp 72 and prevent or protect against accidental contact with the delivery sharp 72 when the delivery device 10 is in storage. However, the delivery opening 124 may allow the delivery sharp 72 of the delivery device 10 to pass through the delivery opening 124 and access the user's skin when the delivery device 10 transitions to the delivery state.

[0328] Referring here to Figures 77A-78B, a tensile force can be applied to the pull tab 120 to transition the delivery device 10 from a storage state to a delivery state. The distal portion 112 of the delivery device 10 can be fixed to the skin 44 via adhesive on the proximal surface of the distal portion 112. Thus, the distal portion 112 of the delivery device 10 may be 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 storage state to a delivery state. As shown, the folded area 122 of the proximal portion 110 can be expanded so that the proximal portion 110 stretches when the pull tab 120 is pulled. Furthermore, in certain embodiments, the proximal portion 110 can be stretched to allow for further extension. The segment of the proximal portion 110 containing 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 adhesive 22 on the proximal portion 110 and the distal portion 112 may be displaced apart when the proximal portion 110 is pulled from a first state to an elongated state. As a result, the skin 44 between the adhesive 22 on the proximal portion 110 and the adhesive 22 on the distal portion 112 may be stretched and taut to facilitate puncture.

[0329] As the folded area 122 expands, material from the proximal portion 110 is fed out, causing the proximal portion 110 to extend and displace so that the delivery opening 124 aligns with the delivery sharp 72. At least one ramp element 128 may be displaced toward the pull tab 120. At least one ramp element 128 may keep the cantilever arm 130 slightly deflected toward the distal portion 112 as the proximal portion extends. This prevents the delivery sharp 72 of the reservoir from being dragged toward the proximal portion 110 as the proximal portion 110 transitions to the extended state. As at least one ramp element 128 is further displaced, the cantilever arm 130 may ride up onto the inclined area of ​​at least one ramp element 128 and be further deflected toward the distal portion 112 of the delivery device 10. As the folded area 122 continues to expand, at least one ramp element 128 may move beyond the cantilever arm 130.

[0330] Once at least one ramp element 128 has passed through the cantilever arm 130, the cantilever arm 130 can return to an unflexed state, as shown in Figures 78A and 78B. The delivery device 10 can enter a delivery state once the cantilever arm 130 has moved away from at least one ramp element 128 and returned to its unflexed state. As the cantilever arm 130 bounces back to an unflexed state, the delivery sharp 72 may be displaced through the delivery opening 124 and puncture the skin 44. This can establish fluid communication between the delivery sharp 72 and the patient's target delivery site. Furthermore, the reservoir 12 may be compressed between the skin 44 and the cantilever arm 130 as the cantilever arm 130 returns to an unflexed state. This compression can serve to drain fluid from the reservoir 12 and deliver it to the patient via the delivery sharp 72. The compression may also help ensure that the reservoir 12 is completely empty during delivery.

[0331] As shown in the figure, the tether member 118 can be detached from the locking adhesive 116 when the delivery device 10 transitions from a storage state to a delivery state. Once the delivery device 10 reaches the delivery state, the tether member 118 can be separated at least partially from the locking adhesive 116. Next, the exposed lock adhesive 116 can adhere to the proximal portion 110, thereby adhering the proximal portion 110 to the appropriate position. The lock adhesive 116 can actively adhere to the proximal portion 110. Attempting to separate the proximal portion 110 from the lock adhesive 116 may damage one of the components of the delivery device 10. This may help ensure the transfer 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 becoming wrinkled due to the restorative force exerted by the stretched skin. Thus, the lock adhesive 116 can hold the adhesive 22 on the proximal portion 110 in place so that the proximal portion 110 is in an elongated state and the skin remains stretched when the user releases the pull tab 120.

[0332] Referring next to Figures 79-82, another exemplary embodiment of the delivery device 10 is shown. Figure 79 shows the exemplary delivery device 10 in storage. Figure 80 shows the exemplary delivery device 10 in delivery. Figures 81 and 82 are exploded views of the exemplary delivery device 10. As shown, the exemplary delivery device 10 may include an actuator. In some embodiments, the actuator may form a top 306 or cap having at least one recess or recess 308 therein (three such recesses 308 are shown, but it will be understood that the number does not have to be three). The recess 308 may help facilitate the 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. Those skilled in the art will understand that the top 306 does not have to be limited to any particular shape as long as it can be twisted by the user.

[0333] As illustrated, the exemplary top 306 rests on the base body 309. The top 306 engages with a threaded post or screw 310 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 formed integrally with the rest of the base body 309. Those skilled in the art will understand that other materials and manufacturing techniques may be used.

[0334] In exemplary embodiments, the user can first remove the adhesive liner 265 (see, for example, Figure 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 peel off the adhesive liner 265 in a manner similar to peeling a liner from a bandage before applying a bandage. Once the liner 265 is removed, the user can apply the delivery device 10 to the skin. As shown in the illustrated examples, the adhesive pad 312 may be annular in shape. In some embodiments, the adhesive pad 312 may be ultrasonically welded to the delivery device 10. Those skilled in the art will understand that other suitable techniques may be used to bond the adhesive pad 312 to the delivery device 10.

[0335] After attaching the delivery device 10 to the skin, the user can twist the top 306 of the delivery device 10 to advance the top 306 proximal (for example, toward the skin) along the threads of the screw 310. The threaded screw 310 may contain a brittle material or a weak point 314. The weak point 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 a delivery state during storage.

[0336] In exemplary embodiments, the weak portion 314 is provided as at least one tab protruding from a carriage 315 which may be located within a bore 317 of a threaded post 310. In some embodiments, the carriage 315 may include a set of three weak portions 314. The bore 317 may include a shelf 319 for supporting at least one of the weak portion objects 314, preferably a shelf 319 for supporting each weak portion 314. When the weak portions 314 rest on the shelves 319, it is possible to prevent the carriage 315 from being displaced within the bore 317 and to prevent torsional motion of the top portion 306. In certain examples, each shelf 319 may also be the end of a track or rail (best shown in Figure 81) located within the bore 317, which may help guide the displacement of the carriage 315 within the bore 317.

[0337] The top 306 may incorporate a central projection 318 (e.g., a column or stepped column as shown) that rests on a portion of the carriage 315. As the top 306 is screwed downward or proximal toward the skin surface, the projection 318 can press the fragile portion 314 against each shelf 319. The pressure applied to the fragile portion 314 causes it to break, allowing the carriage 315 to move proximal within the bore 317. The carriage 315 is displaced proximal, and eventually the second end of the carriage 315 (opposite the first end from which the fragile portion 314 protrudes) can come into contact with the skin surface. Those skilled in the art will understand that if the fragile portion 314 breaks, the delivery device 10 may be rendered unusable.

[0338] The adhesive pad 312 of the delivery device 10 may have a central opening 323 through which a portion of the carriage 315 can extend. The skin may not be held in place relative to the delivery device 10 in the area of ​​the central opening 323. Therefore, as the carriage 315 continues to displace proximal, the skin in this area may be pressed and stretched as it is displaced by the carriage 315. This may cause the skin aligned with the central opening 323 to become taut. The base body 309 may include a shelf 321 that extends into the bore 317 at the proximal end of the bore 317 and functions as a stopping surface. The carriage 315 may stop its proximal displacement when it comes into contact with the shelf 321.

[0339] The top 306 may be at the midpoint of the carriage 315's movement along the post 310 when the carriage 315 contacts the shelf 321. As shown, the carriage 315 may include a second weak point 325 or a set of weak points 325. In some embodiments, there may be three second weak points 325 arranged at equal angular intervals around the carriage 315. The first weak point 314 may be weaker (e.g., thinner) than the second weak points 325. Thus, the second weak points 325 can only break after being fractured. The projection 318 from the top 306 may contact the second weak points 325 when the carriage 315 is in contact with the stop provided by the shelf 321. The second weak points 325 may prevent the displacement of the top 306. Further acting of the top will apply force to the second weak points 325, which may result in the second weak points 325 breaking. When the second weak point 325 is destroyed, the carriage 315 remains stationary (against the restraint provided by the shelf 321), while the top 306 is free to move proximal. Those skilled in the art will understand that if the weak point 325 is destroyed, the delivery device 10 may be rendered unusable.

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

[0341] In some embodiments, the delivery aid 320 may be attached to the proximal end of the projection 318 via adhesive. In some embodiments, the delivery aid 320 may be placed on a shelf within the carriage 315. The reservoir 12 may be held in place within the opening of the carriage 315 by friction fit or slide fit, as shown. In some examples, a weak adhesive can hold the reservoir 12 in place within the opening. In other embodiments, the friction fit may be reinforced by a gasket member (e.g., an O-ring) positioned between the side 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 against the reservoir 12 of the delivery device 10. In embodiments where the delivery aid 320 is placed on a shelf in the carriage 315, a portion of the delivery aid 320 may deform or break, allowing it to move beyond 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 any 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, for example, Figure 31) penetrates the skin surface. At this point, the reservoir 12 may be pinched between the skin and the projection 318 of the top 306, as shown in Figure 80. As the apex 306 continues to displace proximal, pressure from the delivery aid 320 accumulates in the reservoir 12, and the fluid contained in the reservoir 12 is delivered to the patient through the delivery sharp 72. At this point, the apex 306 may have stopped twisting and reached the end of its displacement range. The apex 306 may come into contact with the base 309 at the end of its displacement range, and the base body 309 may provide mechanical interference for further displacement. Once the movement of the apex 306 stops, the user can remove the delivery device 10 from the skin.

[0343] As mentioned above, it may be desirable to prevent the reuse of the delivery device 10. It may also be desirable to provide a delivery device 10 that scratches the surface of the skin before the delivery sharpener 72 penetrates the skin surface. In one embodiment, the delivery device 10 may include an operating assembly that includes first and second displaceable members. These members may be displaceable from a separated state to a close state relative to each other. The members can move from a separated state to a close state when the delivery device 10 is operated and / or when the delivery device 10 delivers its contents. The members may include a cooperating coupling mechanism that can engage with each other when the members approach or reach the close state. When the cooperating coupling mechanism engages, the coupling mechanism can prevent the members from separating and maintain the members in the close state.

[0344] Referring to Figures 83-85, exemplary embodiments of such portions of the operating assembly 327 for the delivery device 10 are shown. The delivery device 10 may have a bend that is integral or integrally formed. The deflection portion may be formed as a pair of vertically spaced first and second bodies 320A, 320B such that the first body 320A is located above or in another plane of the second body 320B. In the exemplary embodiment, the first and second bodies 320A, B are concentric round bodies, specifically shown as circles. The deflection portion may be made of a bendable plastic formed by injection molding or other suitable techniques known to those skilled in the art. The bodies 320A, 320B may be joined by at least two flexible struts 322 integral with the deflection portion. In this example, six such flexible struts 322 are shown, but it will be understood that the number does not have to be six. The support columns 322 may be arranged in equal angular increments, but this is not required in all embodiments. The support columns 322 may extend between the bodies 320A and 320B at an angle that is not perpendicular to the bodies 320A and 320B.

[0345] The body may include at least one hook 324 integrated into one of the bodies 320A, B. The other of the bodies 320A, B may include at least one catch 326. In the exemplary embodiment, the first body 320A includes a number of hooks 324 extending downward from there toward the second body 320B. Six such hooks 324 are shown, but it will be understood that the number does not have to be six. In this example, the hooks 324 are arranged at equal intervals around the first circle 320A, but this is not necessarily the case in all embodiments. This exemplary embodiment also shows at least one catch 326 integrated with the second body 320B. Each of the catches 326 is located at a point on the second body 320B that is not directly below the hooks 324 of the first body 320A. The catches 326 in this example extend upward from the second body 320B toward the first body 320A. Six such catches 326 are shown, but it will be understood that the number does not have to be six. The catches 326 can be arranged around the second body 320B at equal angular increments. The catches 326 can be arranged so that each catch 326 and hook 324 engages with each other when the deflector is activated. The deflector can be activated, for example, by applying pressure to the deflector through a part of the delivery device 10 in which the deflector 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 and B may also rotate. If one of the bodies 320A and B is rotationally constrained, only the other body 320A and B can rotate as the bodies 320A and B are displaced toward each other. With the second body 320B rotationally constrained, the flexible support column 322 may bend if the first body 320A is pushed down from above. The hook 324 may be displaced by rotation (about an axis passing through the center points of the bodies 320A and B). The hook 324 and the first body 320A may also be translated as the first body 320A approaches the second body 320B. The hook may be translated relative to the catch 326 until the hook 324 contacts the catch 326. The hook 324 can deflect around the catch and then elastically return to engage with the catch 326. Thus, when the support column 322 attempts to elastically return to an unbent state, the first body 320A and the second body 320B can be held together by the engagement of the hook 324 and the catch 326. By using a single-piece deflection section (e.g., formed by injection molding), the delivery device 10 can be manufactured at a relatively low cost. The hook 324 engaging with the catch 326 can also help prevent the reuse of the delivery device 10 containing the deflection section. The engaged hook 324 can also help maintain the pressure on the reservoir 12 of the delivery device 10 necessary to ensure the delivery of medical drugs (e.g., vaccines) into the patient via one or more delivery sharps 72 (e.g., see Figure 31).

[0347] The rotational displacement of one of the bodies 320A, B may be a harness that helps drive the delivery sharp (see, for example, Figure 31) across the skin surface to scratch the skin before piercing it. In the exemplary embodiment described above, the delivery sharp 72 (see, for example, Figure 31) may be constrained to move in conjunction with the first body 320A. Thus, the delivery sharp (see, for example, Figure 31) rotates as it moves relative to the skin.

[0348] Referring here to Figure 86, an exemplary package 400 is shown. The package 400 can house the delivery device 10 during distribution and transport. The package 400 may also include other components, such as printed instructions and / or medical wipes, which can be used to prepare the injection site. The package 400 can hold the delivery device 10 and possibly other contents in place during delivery, which can help prevent premature or accidental activation of the delivery device 10. The package 400 may include an internal cavity that may have one or more receivers 402 for the delivery device 10 (part of the package 400 is shown transparently in Figure 86). The receivers 402 can restrain the delivery device 10 within the package 400 so that it does not move excessively or collide violently during handling. The package 400 can also protect the delivery device 10 from exposure to the surrounding environment. In some embodiments, the package 400 and the delivery device 10 may be sterilized (e.g., by EtOx), and the package 400 may keep the delivery device 10 in this state until immediately before use.

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

[0350] As illustrated, package 400 may include at least one unique identifier 408. In other embodiments, the unique identifier 408 may be included in the delivery device 10 or its components instead, or even further. Any suitable unique identifier 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 mark such as a barcode, data matrix, or QR code. The unique identifier 408 may encode various information about the contents of the delivery device 10 or the reservoir 12 of the delivery device 10. For example, the unique identifier 408 may include product identification information, product lot information, product serial number, dosage size information, etc.

[0351] The unique identifier 408 is read by the reader 410. The reader 410 may be a dedicated reader, or in some embodiments, a device such as a smartphone, tablet, smart device, laptop, or other portable device. When a smartphone is used, a dedicated delivery device app may run on the smartphone. When a smartphone is used, the reader 410 may 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 may depend on whether the delivery device 10 is intended for use by individual users at home or in a clinical setting (e.g., a vaccination center, hospital, clinic, or other care facility). A smartphone may be convenient to use as the reader 410 when delivery via the delivery device 10 is self-managed by, for example, a patient (e.g., at home).

[0352] The reader 410 can communicate with the database 412 (for example, via the internet, other networks, cloud platforms, etc.). Before using the delivery device 10, the user can read the unique identifier 408 from 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 is already in use, subject to recall, 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 may also be stored. In some embodiments, geolocation data indicating the location of the package 400 when the unique identifier 408 is read may also be stored in the database 412.

[0353] Depending on the available infrastructure, the data may be stored offline in the reader 410's memory until a robust connection to the internet or another suitable network is established. The data can then be uploaded to the database 412. Alternatively, the data may be sent to the database 412 when retrieved by the reader 410.

[0354] In some embodiments, patients may need to pre-register in order to receive the delivery device 10. In some embodiments, a reader 410 may be used for registration (for example, an app on a smartphone). 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 required services (such as location tracking or push notifications) are enabled. This code may be provided to a database 412 and may be called a registration code. Patients may need to provide a code in order to receive the delivery device 10. The code may be entered into a dispenser or provided to a distributor and matched against the database 412. If the code matches a 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 desired information if the user chooses not to enable one or more services or chooses not to provide desired user information. For example, if location tracking is not enabled, the app may generate a location data input screen. Before the code is generated and provided to database 412, it may be necessary to enter information into such a screen.

[0355] In some embodiments, when a unique identifier 408 on the package 400 is read, the controller 416 of the reader 410 can generate instructions on the user interface 414 of the reader 410. The instructions may include text, images, animations, videos, etc., detailing how to use the delivery device 10. The instructions can guide the user step-by step, from opening the package 400 to disposing of the delivery device 10 after use. In some embodiments, 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 set of instructions. User interactions may be recorded and stored in a database 412. This may help confirm that a particular delivery device 10 has not only been received by a patient but has also been applied and used. In some embodiments, the controller 416 can generate a notification (e.g., visual, tactile, auditory, or a combination thereof) if all steps have not been completed. In other embodiments, one or more messages may be generated if the user does not respond to a prompt. For example, when 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 communicating with the database 412 may generate, for example, text messages, emails, or phone calls (e.g., automated messages or connecting the user to a human operator), which may be sent to a phone number or email address provided by the user. If a delay exceeding a predetermined period occurs after a previous prompt has been interacted with the user, the message generator 418 may send a communication to the user. If no response is received after a communication has been sent by the message generator 418, the type of communication triggered may increase in stages (escalation). The communication may initially be a text message or a push notification. In some embodiments, if cellular service is unavailable or falls below a threshold, a push message may be preferably sent, or may be sent instead of a text message. If no user interaction is received after a predetermined escalation period, the message generator 418 may generate a more intrusive communication (e.g., a phone call). Any appropriate number of escalation layers may be used.

[0357] In some embodiments, patients may also provide additional data via the reader 410. This data is stored in and analyzed in a database 412 (e.g., via a cloud analysis tool or toolset). For example, a user may notify the reader 410 that a problem has occurred with a delivery device 10. This data can be cross-referenced with data related to other delivery devices 10 in the same lot. If it is determined that there are problematic delivery devices 10 in a lot that exceed a predetermined threshold, the lot may be flagged for investigation and prevented from being distributed or used. Alternatively or additionally, patients may be prompted to provide specific post-injection information via the reader 410. For example, a patient may be asked to complete an adverse event questionnaire or other form that may be generated by the controller 416 of the reader 410 on the user interface 414. The adverse event data can be analyzed to identify patterns common to a particular patient type or delivery device 10 (e.g., delivery devices 10 in the same lot or delivery devices 10 holding the same contents). The analysis may be performed via a cloud analysis tool or toolset.

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

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

[0360] In some examples, the holder 270 of the reservoir assembly 12 (see, for example, Figures 47–50 and 51A–51C) may contain adhesive on at least a portion of the proximal surface of the holder 270. If the reservoir assembly 12 of the holder 270 includes a tab 277 (see, for example, Figure 51B) that engages with a slit in the body 20, the tab 277 can disengage from the slit 278 in the body 20 (see, for example, Figure 45) when the user attempts to remove the delivery device 10 from the skin. The bond between the adhesive on the holder 270 and the skin may be sufficient to overcome or disengage the bond between the tab 277 and the body 20 when the patient pulls the body 20 to remove the delivery device 10. In other words, the adhesive can withstand any force applied to separate the body 20 from the rest of the delivery device 10 when the user pulls the body 20. Therefore, the reservoir portion 12 may remain adhered to the skin, while the main body 20 can be removed. The exposure indicator 450 contained on the reservoir 12 becomes visible and can be scanned by the reader 410 (see, for example, Figure 86). The reservoir assembly 12 can then be peeled off the skin by the patient. In the example where the reservoir assembly 12 is adhered to the main body 20, the adhesive connection between the skin and the reservoir assembly 12 may be stronger than the adhesive connection between the reservoir assembly 12 and the main body 20. Therefore, if the patient pulls the main body 20, the main body 20 can separate from the reservoir assembly 12, exposing the exposure indicator 450.

[0361] In other embodiments, as shown in Figure 88, the delivery device 10 may provide a mark 510 on the skin when the delivery device 10 is applied or applied for at least a predetermined period of time. In some embodiments, a marking agent, such as ink, may be included in the portion of the delivery device 10 adjacent to the skin 512. Alternatively, the marking agent may be manufactured as a skin-compatible adhesive for bonding the delivery device 10 to the skin during use. In examples where a pressure-sensitive adhesive is used, the pressure applied when the delivery device 10 is used activates the adhesive and may also release the marking agent. The marking agent may transfer to the skin 512, at least partially, or otherwise mark the skin 512 when the delivery device 10 is applied. Alternatively, the delivery device 10 may create a temporary tattoo during injection. In some embodiments, the mark 510 created may have a pattern that encodes specific information about the delivery device 10. In exemplary embodiments, a series of "X"s are shown, but any suitable mark 510 may 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 has been 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, Figure 86). This mark 510 can help confirm that the injection was administered to the patient by the delivery device 10. In some embodiments, the controller 416 of the reader 410 (see, for example, Figure 86) may analyze the image to determine whether the mark 510 is present. If the controller 416 determines that the appropriate mark 510 is present, the database 412 (see, for example, Figure 86) may be updated to indicate that the delivery device 10 associated with a previously scanned unique identifier 408 was used. It should be understood that this is not necessarily the case in embodiments described herein where the controller 416 is described as performing image analysis or other analysis. For example, the image may be transmitted by the reader 410 to the database 412, and a cloud analysis tool may be used to verify that the image indicates that delivery took place. Regardless of where the analysis is performed, the image may be uploaded to the database 412.

[0363] Referring primarily to Figure 89, in certain embodiments, the reader 410 (see, for example, Figure 86) may include at least one image sensor that is sensitive to one or more wavelengths outside the visible spectrum. Non-visible spectral wavelengths or spectra sensed by the image sensor may be wavelengths that penetrate the skin more deeply than light in the visible spectrum. The reader 410 may include at least one image sensor that is sensitive to various wavelengths in the infrared spectrum (e.g., near-infrared). CCD or CMOS image sensors may be included in various embodiments. Sensors with such capabilities within the reader 410 may not include IR filters (e.g., IR blocking films) commonly applied to typical consumer imaging equipment. The sensors may have filters associated with them that block visible light. In some embodiments, the imaging device may be a thermograph or thermal imaging device. Multiple 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 is used, the reader 410 can be used to capture at least one image of the injection site. At least one image may be acquired or generated based on light outside the visible spectrum. In some embodiments, visible spectrum image data may also be captured. The controller 416 (see, for example, Figure 86) of the reader 410 (see, for example, Figure 86) can generate a prompt (e.g., in an app) for image acquisition. In certain embodiments, the controller 416 may also automatically open an image acquisition program. The controller 416 may enable image acquisition by a suitable imaging device of the reader 410 (e.g., if multiple imaging devices are included in the reader 410).

[0365] Image data can be analyzed to determine the presence of blisters 514 formed within the skin during delivery. The analysis may be automated or performed by a human operator viewing the images via a network connection to a database 412 (see, for example, Figure 86). Because light outside the visible spectrum penetrates the skin more deeply, using such light for imaging purposes allows for the identification, or easier identification, of specific subsurface features of the skin. This can help, for example, facilitate the detection of blisters 514. Furthermore, the temperature of the injected drug may differ from that of the patient. Areas with different temperatures from the surrounding areas of the patient may be identifiable. The injection site may, for example, be colder than the surrounding areas of the patient. For example, Figure 89 shows a thermal image of an arm after injection. As illustrated, cold areas (dark gray) are identifiable in the image and correspond to the locations of blisters 514 on the skin.

[0366] If the image contains features of the blister 514, it can be concluded that the delivery was actually performed using the delivery device 10 and was successful. In some embodiments, the image may be required to conform to at least one predetermined target characteristic. For example, in certain implementations, it may be required that the blister 514 be detected and of a certain size (e.g., with respect to the marking 510). Furthermore, it may be required that the image does not contain features indicating improper injection. For example, if a thermal imaging device is used, a cryogenic region corresponding to a blister 514 having one or more adjacent cryogenic regions, or a size exceeding the cryogenic region 514 or a certain limit, may be flagged as having leak characteristics. In such examples, the analysis may indicate that the delivery from the delivery device 10 failed.

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

[0368] In the example where the reader 410 is a smartphone, any app used may generate confirmation that the injection has been administered by the delivery device 10 at the user's request. The controller 416 of the reader 410 may generate options (e.g., a display button) that the user can interact with to display a confirmation notification regarding the injection. When the delivery device 10 is used to administer the vaccine, the app may provide a certificate of vaccination or a virtual vaccination record or card in which various information about the user's vaccination is automatically entered. The vaccination record may be stored in the memory of the reader 410, or in a database 412 (see, for example, Figure 86) accessible via the reader 410 (or may be stored in multiple locations). Thus, the reader 410 may be used to provide proof of injection as needed. For example, the reader 410 can be used to prove vaccination for access to a specific space (such as a restaurant, stadium, workplace, other venue, airplane or airport, ship, public transport, etc.).

[0369] In yet another embodiment, a container 350 containing the packets 208 may be included in the delivery device 10 as described elsewhere in this specification (see, for example, Figure 11). One of the packets 208 and the container 250 may contain a first chemical, and the other may contain a second chemical. The dye may also be included in one of the container 350 and the packets 208. When pressure is applied to the delivery device 10 to transition it from a storage state to a delivery state, the packets 208 may burst, and the first and second chemicals may mix. These chemicals may react to produce a visually recognizable effect. A chemiluminescence reaction may be initiated, for example, when the first and second chemicals are mixed. In an example of such an embodiment, chemicals commonly used in glow sticks may be filled, for example, in the container 350 and the packets 208.

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

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

[0372] A person skilled in the art will be able to devise various alternatives and modifications without departing from this disclosure. Therefore, this disclosure is intended to encompass all such alternatives, modifications, and variations. Furthermore, while some embodiments of this disclosure have been shown in the drawings and / or discussed herein, this disclosure is not intended to be limited to them, and is intended to be as broad as is permissible in the art, and the same applies to the specification. Therefore, the above detailed description of the invention should not be construed as limiting, but merely as an example of a particular embodiment. A person skilled in the art will then conceive of other modifications within the scope and spirit of the claims appended herein. Any 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 within the scope of this disclosure.

[0373] Embodiments are presented solely to illustrate specific examples of the present disclosure. Furthermore, the drawings described are illustrative and not limiting. In the drawings, the sizes of some elements may be exaggerated for illustrative purposes and may not be drawn to a specific scale. Additionally, elements shown in drawings with the same number may be identical or similar, depending on the context.

[0374] Where the term “including” is used in this specification and in the claims, it does not preclude other elements or steps. Where an indefinite or definite article is used with a singular noun such as “a,” “an,” or “the,” it also includes the plural form of that noun unless otherwise specified. Thus, the term “including” should not be interpreted as being limited to the items listed thereafter. Because it does not preclude other elements or steps, the scope of the expression “device including items A and B” should not be limited to a device consisting only of parts A and B.

[0375] Furthermore, terms such as “first,” “second,” and “third,” whether used in the specification or in the claims, are provided to distinguish similar elements and are not necessarily provided to describe a sequential or chronological order. Terms used in this manner are interchangeable under appropriate circumstances (unless otherwise explicitly disclosed), and it should be understood that embodiments of the disclosures described herein may operate in a different sequence and / or arrangement than those described or illustrated herein.

Claims

1. A delivery device, A body comprising a central region and a peripheral region, wherein the central region is spaced apart from the base and has an upper surface connected to the base, and the peripheral region is defined by a plurality of petal members and a plurality of first slots between them, wherein the plurality of petal members extend outward from the base, and the body, An adhesive bonded to at least a part of the main body, A foldable reservoir coupled to at least one delivery sharp, A delivery device equipped with the following features.

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

3. The delivery device according to claim 1, wherein the central region includes a plurality of openings arranged in a ring along the outer circumference of the upper surface.

4. The delivery device according to claim 1, further comprising a sharp bearing including at least one delivery sharp, wherein the sharp bearing is coupled to the foldable reservoir, and the foldable reservoir is coupled to the inner surface of the central region.

5. The delivery device according to claim 4, wherein when the delivery device is in storage, the collapsible reservoir contains fluid, the adhesive is attached to a penetrable surface of a member outside the delivery device, and when the delivery device is in delivery, the penetrable surface is stretched by the adhesive, the at least one delivery sharp penetrates the penetrable surface, and the collapsible reservoir is prompted to collapse at least partially, allowing fluid to enter the member through the at least one delivery sharp through the penetrable surface.

6. The delivery device according to claim 4, wherein the adhesive is bonded to at least a portion of the side surfaces furthest distal from the upper surface of at least two of the plurality of petal members.

7. The delivery device according to claim 6, wherein when the delivery device is in storage, the collapsible reservoir contains fluid, the adhesive is applied to a penetrable surface of a member outside the delivery device, and when the delivery device is in delivery, the penetrable surface is stretched by the adhesive, the at least one delivery sharp penetrates the penetrable surface, and the collapsible reservoir is prompted to collapse at least partially, allowing fluid to enter the member through the at least one delivery sharp through the penetrable surface.

8. The delivery device according to 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 according to claim 1, wherein the internal volume of the reservoir is divided into a first section and a second section.

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

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

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

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

14. The delivery device according to claim 13, wherein at least two of the plurality of petal members are configured to bend 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.

15. The delivery device according to claim 9, wherein at least a portion of the first petal member among the plurality of petal members is configured to move further away from at least a corresponding portion of the second petal member among the plurality of petal members during at least a portion of the transition between the storage state and the delivery state, and the first petal member and the second petal member are arranged facing each other.

16. The delivery device according to claim 9, wherein at least a portion of the first petal member among the plurality of petal members moves further away from at least a corresponding portion of the second petal member among the plurality of petal members during at least a portion of the transition between the storage state and the delivery state, thereby configuring the delivery device to stretch the surface to which the adhesive is attached, and the first petal member and the second petal member are positioned facing each other.

17. The delivery device according to claim 1, wherein the adhesive is bonded to at least a portion of the side surfaces of at least two of the plurality of petal members, the side surfaces furthest distal from the upper surface.

18. The delivery device according to claim 1, wherein the upper surface is configured to move 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 according to claim 1, wherein the reservoir includes an orifice plate.

20. A method for delivering medical drugs, A step of attaching a delivery device to the skin surface, the delivery device being in storage, the delivery device comprising at least one delivery sharp coupled to a foldable reservoir containing the medical drug; and A step of applying pressure to the delivery device toward the skin surface in order to transition the delivery device to a delivery state, penetrate the skin surface with the at least one delivery sharp, collapse the reservoir, and forcibly deliver the medical drug to the skin through the at least one delivery sharp, Methods that include...

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

22. The method according to claim 21, further comprising scratching the skin surface with at least one of the at least one delivery sharpeners.

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

24. A delivery device, A body comprising a central region coupled to a peripheral region, the central region having a substantially thimble shape with a top surface and a base, the peripheral region surrounding the central region and having an inner circumference and an outer circumference, the inner circumference being coupled to the base such that the peripheral region extends outward from the base, and the peripheral region comprising a plurality of first slots extending inward from the outer circumference, An adhesive bonded to at least a part of the main body, The main body and a foldable reservoir coupled to at least one delivery shank, A delivery device, including a delivery device.

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

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

27. The delivery device according to claim 24, wherein the central region includes a plurality of openings arranged along the base.

28. The delivery device according to claim 24, wherein the central region includes a plurality of openings arranged along the outer periphery of the upper surface.

29. The delivery device according to claim 24, further comprising a sharp bearing body including at least one delivery sharp, wherein the sharp bearing body is coupled to the foldable reservoir, and the foldable reservoir is coupled to the inner surface of the central region.

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

31. The delivery device according to claim 30, wherein the upper surface is configured to move 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. The delivery device according to claim 31, wherein the main body has an installation area having a certain area, and is configured such that the area increases during at least a portion of the transition between the storage state and the delivery state.

33. The delivery device according to claim 31, wherein the main body has an installation area having a certain area, and the area increases during at least a portion of the transition between the storage state and the delivery state so that the delivery device stretches the surface to which the adhesive is attached.

34. The delivery device according to claim 30, wherein when the delivery device is in the storage state, the foldable reservoir contains fluid, the adhesive is applied to a penetrable surface of a member outside the delivery device, and when the delivery device is in the 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 prompted to collapse at least partially, allowing the fluid to enter the member through the at least one delivery sharp through the penetrable surface.

35. The delivery device according to 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 among the plurality of first slots.

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

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

38. The delivery device according to claim 36, wherein when the delivery device is in the storage state, the collapsible reservoir contains fluid, the adhesive is applied to a penetrable surface of a member outside the delivery device, and when the delivery device is in the delivery state, the penetrable surface is stretched by the adhesive, the at least one delivery sharp penetrates the penetrable surface, and the collapsible reservoir is prompted to collapse at least partially, allowing the fluid to enter the member through the at least one delivery sharp through the penetrable surface.

39. The delivery device according to claim 24, wherein the upper surface is configured to move 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. The delivery device according to claim 39, wherein the main body has an installation area having a certain area, and is configured such that the area increases during at least a portion of the transition between the storage state and the delivery state.

41. The delivery device according to claim 40, wherein the main body has an installation area having a certain area, and the area increases during at least a portion of the transition between the storage state and the delivery state so that the delivery device stretches the surface to which the adhesive is attached.

42. An actuator assembly for inhibiting the reuse of a drug delivery device, A deflection portion including the first member and the second member, A plurality of support columns connecting the first member and the second member to each other, each support column having elasticity to resist the relative displacement of the first member and the second member, An actuator assembly comprising, wherein the first member includes at least one first engaging member, the second member includes engaging members cooperating with each of the first engaging members, the plurality of supports are configured to deflect at least one of the first member and the second member to cause rotational motion when the first member and the second member are biased toward each other by a force exceeding a threshold, and the at least one first engaging member and each of the second engaging members are configured to form a coupling when the distance between the first member and the second member decreases beyond a threshold distance.

43. A delivery device The first part, including the cantilever arm, is at least partially covered with the first adhesive. A second part, at least partially covered with a second adhesive, comprising at least one ramp element, wherein the second part is bonded to the first part via the first adhesive, and the second part is configured to extend from a first state to an extended state, A foldable reservoir comprising at least one delivery sharp, the reservoir being coupled to the unsupported end of the cantilever arm, A delivery device equipped with the following features.

44. The delivery apparatus according to claim 43, wherein the at least one delivery sharp includes one of a one-dimensional array of microneedles and a two-dimensional array of microneedles.

45. The delivery device according to claim 43, wherein the second portion includes a delivery opening, the delivery opening 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. The delivery device according to claim 43, wherein the second portion includes a folding region in the first state, and the folding region is configured to expand as the second portion transitions to the extended state.

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

48. The delivery device according to claim 43, wherein each of the at least one lamp element is positioned on the first side of the cantilever arm when the second portion is in the first state, and on the second side of the cantilever arm when the second portion is in the second state.

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

50. The delivery device according to claim 43, wherein the second portion includes a pull tab.

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

52. The delivery device according to claim 51, wherein the second end of the tether is bonded to and covers the lock adhesive when the second portion is in the first state, and the second end of the tether is at least partially detached from the lock adhesive and exposed when the second portion is in the extended state.

53. The delivery device according to claim 51, wherein the second end of the tether is bonded to the locking adhesive, and the tether is doubled over itself when the second portion is in the first state.

54. The delivery device according to claim 43, wherein when the second portion is in the first state, the first adhesive and the second adhesive are arranged at a first distance from each other, and when the second portion is in the extended state, the first adhesive and the second adhesive are arranged at a second distance from each other, the second distance being greater than the first distance.

55. The delivery device according to claim 43, wherein the at least one lamp element is configured to elastically flex the cantilever arm when the second portion transitions from the first state to the second state.

56. A delivery device, A body comprising a first side panel and a second side panel and a bridge, spaced apart by a first end block and a second end block, wherein the side panels and the bridge each include first and second opposing ends, the first ends each connected to the first end block via their respective first end living hinges, the second ends each connected to the second end block via their respective second end living hinges, and the side panels and the bridge each also include their respective intermediate living hinges between their first and second ends; and an adhesive covering at least partially the first side surface of the end block. A foldable reservoir comprising at least one delivery sharp, the reservoir being coupled to the end of an arm member extending from the bridge toward the first side, A delivery device equipped with the following features.

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

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

60. The delivery device according to 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. The delivery device according to claim 56, wherein the bridge includes a first panel and a pair of support columns, the first panel being connected to the support columns via intermediate living hinges of the bridge.

62. The delivery device according to claim 61, wherein the arm member is positioned between the support columns and extends from the end of the panel adjacent to the intermediate living hinge of the bridge.

63. The delivery device according to claim 56, wherein the side panels have a displacement range from a bent outward state to a substantially straight state, and the end blocks are configured to displace away from each other when the side panels are displaced from a bent outward state to a substantially straight state.

64. The delivery device according to claim 63, wherein the side panel is configured to displace from the outwardly bent state to the substantially straight state when a clamping force is applied to the side panel.

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

66. The delivery device according to claim 56, wherein the side panel has a displacement range from an outwardly curved state to a substantially straight state, and the bridge is configured such that when the side panel is displaced from the outwardly curved state to the substantially straight state, the arm member is displaced from a first position to a second position in which the at least one delivery sharp is positioned below the first surface of the end block.

67. The delivery device according to claim 56, wherein the side panel has a displacement range from an outwardly curved state to a substantially straight state, and the body includes a latch projection and a latch catch, wherein the latch projection is configured to engage with the latch catch when the side panel is displaced from the outwardly curved state to the substantially straight state.

68. The delivery device according to claim 56, wherein the main body includes a plurality of iris panels extending from the side panel and forming a variable opening.

69. The delivery device according to claim 68, wherein the opening is configured to change in size as the side panels are bent around the intermediate living hinges of each side panel.

70. A delivery device, A body comprising a pair of opposing end panels and at least two intermediate panels, each panel separated from one another by a plurality of living hinges extending across the body, An adhesive covering at least a portion of the proximal side of each end panel, A foldable reservoir comprising at least one delivery sharp, the reservoir being coupled to one proximal side of the intermediate panel, A delivery device comprising, wherein the two intermediate panels form a displaceable connecting portion between an elevated position and an overcenter position when the two end panels are constrained to a plane, and when the connecting portion is in the overcenter position, the first intermediate panel of the intermediate panels extends along the plane.

71. The delivery device according to claim 70, wherein the first end panel of the end panels is substantially flat, and the second end panel of the end panels includes a flat portion and an angled projection extending from the flat portion toward one of the intermediate connecting portions.

72. The delivery device according to claim 71, wherein the second end panel of the end panel includes a buttress extending from the flat portion to the angled projection.

73. The delivery apparatus according to claim 70, wherein the at least one delivery sharp includes an array of microneedles.

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

75. The delivery device according to claim 70, wherein the second intermediate panel of the intermediate panels is at least partially covered with an adhesive on its proximal side.

76. The delivery device according to claim 70, wherein the end panel is displaced by a first distance along the plane when the connecting portion is displaced from the raised position to the center position, and is displaced toward each other by a second distance shorter than the first distance when the connecting portion is displaced from the center position to the overcenter position.

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

78. The delivery device according to claim 70, wherein one of the panels includes a strain-relieving deflection portion.

79. The delivery device according to claim 70, wherein at least a portion of the main body is configured to undergo plastic deformation when the connecting portion is displaced to an over-center position.

80. The delivery device according to claim 70, wherein at least one of the living hinges is configured to break when the connecting portion is displaced back and forth from the raised position to the over-center position.

81. The delivery device according to claim 70, wherein the connecting portion is at least partially inverted with respect to the raised position at the over-center position.

82. The delivery device according to claim 70, wherein the angle between the intermediate panels is obtuse when the connecting portion is in the raised position, and the angle between the intermediate panels is the reflection angle when the connecting portion is over-center.

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

84. A delivery device, Actuator and A base including a threaded post, wherein the actuator is threaded to the post and is displaceable along the post from a raised position where the actuator is furthest distal to the base to a delivered position where the actuator is closer to the base. A carriage disposed within the bore of the post, the carriage comprising at least one first vulnerable portion and at least one second vulnerable portion supported on each shelf defined within the bore, A delivery aid is placed inside the bore, A foldable reservoir, disposed within the bore and including at least one delivery sharp, A delivery device comprising, wherein when the actuator is displaced from the raised state to the delivery state, a part of the actuator is configured to apply pressure to the carriage, the pressure of which destroys at least one of the first weak points, allowing the carriage to be freed to displace within the bore, and destroys at least one of the second weak points, causing pressure to be applied to the reservoir via the carriage and the delivery aid, and the displacement of the actuator to the delivery state is further configured to displace the reservoir toward the base.

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

86. The delivery device according to claim 85, wherein the delivery assisting device is coupled to the end of the projection closest to the base.

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

88. The delivery device according to claim 84, wherein the delivery assist device includes a projection for concentrating force.

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

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

91. The delivery device according to claim 84, wherein the at least one second vulnerable portion includes a set of vulnerable portions arranged at equal angular increments relative to the carriage.

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

93. The delivery device according to claim 92, wherein when the carriage is facing the stop surface such that the skin pressing member of the carriage is outside the bore, the carriage extends through the delivery opening of the base.

94. The delivery device according to claim 84, wherein the reservoir is located in the bay of the carriage and is frictionally held therein when the pressure applied to the reservoir is below a threshold.

95. The delivery device according to claim 84, wherein the carriage, the delivery aid, and the reservoir are configured to be displaced together as a unit in the bore after at least one first weak point is broken.

96. The delivery device according to claim 95, wherein the carriage, the delivery aid, and the reservoir are configured to stop displacing together as a unit when at least one second vulnerable part is destroyed.

97. It is a microneedle, A base including a first edge and a plurality of second edges, Multiple side walls extending substantially vertically from the base, A surface extending from the first edge to the apex at an acute angle with respect to the base, wherein two adjacent side walls of the plurality of side walls define a side edge extending from the base to the apex in a direction substantially perpendicular to the base, A flow lumen extending from the base to the exit of the surface through the microneedle, A channel defined within the aforementioned plane and connected to the aforementioned flow lumen, A microneedle equipped with this feature.

98. The microneedle according to claim 97, wherein the exit of the surface is located more proximal to the vertex than to the first edge.

99. The microneedle according to claim 97, wherein the exit of the surface is located more proximal to the first edge than the vertex.

100. The microneedle according to claim 97, wherein the exit of the surface is located in an intermediate region of the surface between the region adjacent to the vertex and the region adjacent to the first edge.

101. The microneedle according to claim 97, wherein the channel extends in a direction toward the first edge from the exit of the surface.

102. The microneedle according to claim 97, wherein the channel extends in a direction toward the vertex from the exit of the surface.

103. The microneedle according to claim 97, wherein the channel comprises a first portion and a second portion, the first portion extending in a direction toward the vertex from the exit of the surface, and the second portion extending in a direction toward the first edge from the exit of the surface.

104. The microneedle according to claim 97, wherein the channel has a variable width.

105. The microneedle according to claim 97, wherein the channel has substantially a constant width.

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

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

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

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

110. It is a microneedle, A base including a first edge and multiple second edges, Multiple side walls protruding from the second edge to a curved blade edge extending from the base vertex formed by two of the plurality of second edges to a second vertex spaced apart from the base, A surface extending from the first edge to the second vertex, A flow lumen extending from the base to the exit of the surface through the microneedle, A microneedle equipped with this feature.

111. The microneedle according to claim 110, wherein the blade edge is a double-angled blade.

112. The microneedle according to claim 110, wherein the exit of the aforementioned surface has an elongated shape.

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

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

115. The microneedle according to 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. The microneedle according to claim 110, wherein the outlet is positioned perpendicular to the base and any plane passing through the outlet also passes through the blade edge.

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

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

119. A delivery device, A body comprising a peripheral region and a central region extending outward from the peripheral region and having an upper surface and a base, wherein the peripheral region includes a number of bodies separated by slits extending from the periphery of the peripheral region toward the central region, An adhesive bonded to at least a part of the main body, The main body and a foldable reservoir coupled to at least one delivery shank, A delivery device equipped with the following features.

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

121. The delivery device according to claim 120, wherein the at least one partially reversible region includes the upper surface.

122. The delivery device according to claim 120, wherein the main body further includes a stationary region having substantially the same shape when the main body is in the first state and the second state.

123. The delivery device according to claim 122, wherein the stationary region is included in the central region and extends from the periphery of the upper surface to the base.

124. The delivery device according to claim 120, wherein the main body is configured such that when the main body transitions from the first state to the second state, at least two bodies in the peripheral region expand and are displaced.

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

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

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

128. A delivery device, A body comprising a central region and a peripheral region having a plurality of petal members extending outward from the central region, wherein the central region defines a receptacle and has an upper region and a base connected by a wall, A collapsible reservoir comprising at least one delivery sharp, wherein the reservoir is coupled to the body and at least partially located within the receptacle, An adhesive placed on at least a part of the main body, A delivery device, including a delivery device.

129. The delivery device according to claim 128, wherein the reservoir comprises a rigid portion and a flexible portion coupled to the rigid portion, the 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. The delivery device according to claim 129, wherein the rigid portion includes a stage protrusion.

131. The delivery device according to claim 130, wherein the at least one delivery sharp is coupled to the stage projection and protrudes therefrom at an acute angle with respect to the rigid portion.

132. The delivery device according to claim 128, wherein the main body includes a raised portion adjacent to the receptacle, and the raised portion forms a mounting surface for the reservoir.

133. The delivery device according to claim 128, further comprising packets disposed within the receptacle between the upper region and the reservoir.

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

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

136. The delivery device according to claim 133, wherein the packet is configured to rupture when subjected to a pressure exceeding a threshold pressure, the packet is placed in a container and contains a first substance, the container contains a second substance, and the first substance and the second substance are configured to react when combined to expand the volume of the container.

137. The delivery device according to claim 133, wherein the packet is configured to rupture when subjected to a pressure exceeding a threshold pressure, the packet is placed in a container and filled with a first substance, the container contains a second substance, and the first substance and the second substance are configured to participate in a chemiluminescent reaction when combined.

138. The delivery device according to claim 128, further comprising a biasing member disposed within the receptacle between the upper region and the reservoir.

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

140. The delivery device according to claim 138, wherein the main body includes a plurality of positioning protrusions that restrain the biasing member, and the biasing member is coupled to the main body.

141. The delivery device according to claim 128, further comprising a distribution 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.

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

143. The delivery device according to claim 142, wherein the first part and the second part are in fluid communication via at least one flow limiter.

144. The delivery device according to 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. The delivery device according to claim 142, wherein the first portion has a variable internal volume, the second portion has a substantially fixed internal volume, and the second portion is adjacent to the at least one delivery sharp.

146. The delivery device according to claim 128, wherein the at least one delivery sharp includes an array of spaced microneedles.

147. A delivery device, A main body comprising a central region and a peripheral region including a plurality of peripheral members extending outward from the central region, wherein the central region has an upper region and a base connected by a wall, A reservoir portion comprising a reservoir having at least one delivery sharp, wherein the reservoir portion is detachably coupled to the body and at least partially covered by the body, An indicator is placed in the section of the reservoir portion covered by the main body, A first adhesive is provided on at least a portion of the main body, A second adhesive is provided, which is placed in at least a portion of the reservoir portion. A delivery device comprising the reservoir portion and the main body, wherein when the reservoir portion and the main body are coupled, the main body obstructs the line of sight to the indicator.

148. The delivery device according to claim 147, wherein the second adhesive is configured to maintain the reservoir portion with respect to the surface such that when the delivery device is applied to the surface, the removal force applied to the main body causes separation of the main body and the reservoir portion.

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

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

151. The delivery device according to claim 147, wherein the main body is opaque.

152. The delivery device according to claim 147, wherein the main body is semi-transparent.

153. The delivery device according to claim 147, wherein the reservoir portion is bonded to the main body via an adhesive.

154. The delivery device according to claim 147, wherein the peripheral region includes a pull tab.

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

156. The delivery device according to claim 147, wherein the main body includes a set of slots, the reservoir portion includes a number of tabs, each of the tabs extending at least partially through its respective slot to removably connect the reservoir portion to the main body.

157. A delivery device, The main body comprises a central region and a peripheral region having a plurality of petal members extending outward from the central region, wherein the central region defines a receptacle and has an upper region and a base connected by a wall, A collapsible reservoir comprising at least one delivery sharp, wherein the reservoir is coupled to the body and at least partially located within the receptacle, A distribution assembly, at least partially disposed within the receptacle between the reservoir and the upper region, An adhesive placed on at least a part of the main body, A delivery device, including a delivery device.

158. The delivery device according to claim 157, wherein the distribution assembly includes a pressing body, at least one biasing member, and a reservoir interface member.

159. The delivery device according to claim 157, wherein the pressing body includes a portion that protrudes through the opening in the upper region.

160. The delivery device according to claim 159, wherein the pressing body includes a stopper.

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

162. The delivery device according to claim 157, wherein the biasing member includes a curved spring.

163. The delivery device according to claim 157, wherein the biasing member includes a peripheral region and a number of biasing projections extending inward therefrom, the main body includes a number of slots, and the biasing projections extend into the receptacle through the slots.

164. The delivery device according to claim 157, wherein the reservoir interface member is integrated with the pressing body.

165. The delivery device according to claim 157, wherein the distribution assembly includes a coil spring and a reservoir interface member.

166. The delivery device according to claim 165, wherein the reservoir interface member is formed by the end portion of the spring which is routed in a plane pattern adjacent to the end of the coil of the spring.

167. The delivery device according to claim 157, wherein the distribution assembly includes a spring, and when the delivery device is in storage, the distribution assembly is not in contact with the reservoir.

168. The delivery device according to claim 167, wherein the spring is in a state where no stress is applied in the storage state.

169. A delivery device system, Package including the seal, The delivery device included in the package, database and A delivery device system comprising a reader including a user interface and a controller, wherein the reader is configured to communicate with a database and obtain delivery device information from a seal, the controller is configured to check the delivery device information against relevant data in the database, the controller is configured to generate an instruction manual on the user interface if the relevant data in the database indicates that the device is available, and the controller prevents the use of at least one function of the reader until first information has been collected by the reader and first service has been enabled on the reader.

170. The system according to claim 169, wherein the mark is selected from the group consisting of a barcode, a data matrix, and a QR code.

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

172. The system according to claim 169, wherein the reader includes a plurality of imaging devices.

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

174. The system according to claim 169, wherein the delivery device comprises a reservoir that is in fluid communication with one or more microneedles.

175. The system according to claim 169, wherein the first information is location information.

176. A method for using a medical delivery device, Using a reader, obtain device information from the mark on the package including the delivery device, The delivery device is applied to the patient's skin, To establish data communication between the aforementioned reader and the database, The device information is compared with the related device information stored in the database, If the usage criteria are met by the comparison, the controller of the reader is used to generate a set of user manuals on the user interface of the reader, After the delivery device is used, data is obtained from the post-use stamp using the reader, The database is updated to indicate that the post-use stamp of the delivery device has been captured by the reader, Methods including

177. The method according to claim 176, further comprising removing a first portion of the delivery device to expose the post-use mark on a second portion of the delivery device.

178. The method according to claim 176, further comprising marking the post-use mark on the skin.

179. The method according to claim 176, further comprising: generating a prompt on the user interface for each instruction manual in the set of instruction manuals; and preventing the display of the next instruction manual until the controller registers a user interaction with the prompt.

180. The method according to claim 176, further comprising preventing the use of at least one function of the reader until the notification service of the reader is enabled.

181. The method according to claim 180, wherein the at least one function is the use of the reader's imaging device.

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

183. The method according to claim 176, wherein the reader is a smartphone.

184. It is a microneedle, A base including a first edge and multiple second edges, Multiple side walls extending substantially vertically from the base, A surface extending from the first edge to the apex at an acute angle with respect to the base, wherein two adjacent side walls of the plurality of side walls define a side edge extending from the base to the apex in a direction substantially perpendicular to the base, A flow lumen extending from the base to the exit of the surface through the microneedle and having an elongated cross-section, A microneedle equipped with this feature.

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

186. The microneedle according to claim 184, wherein the length of the cross-sectional shape in the extension direction is 100 microns or less.

187. The microneedle according to claim 184, wherein the length of the cross-sectional shape in the extension direction is 200 microns or less.

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

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

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

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

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

193. It is a microneedle, The base and, Multiple side walls extending from the base and angled so that the chroned needle has a smaller cross-sectional area as the distance from the base increases, Florumen and, A plurality of side ports within the side wall, including side ports that communicate fluidly with the flow lumen, The tip located at the end of the side wall opposite to the base, A microneedle equipped with this feature.

194. A microneedle according to claim 193, having a high aspect ratio.

195. The microneedle according to claim 193, which is in the shape of an obelisk.

196. The microneedle according to claim 193, wherein the base has a polygonal shape, and the side walls among the plurality of side walls extend from each side of the polygon of the base.

197. The microneedle according to claim 193, wherein the base has a rectangular shape, and the side walls of the plurality of side walls extend from each of the four sides of the base.

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

199. The microneedle according to 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 the portion of the cross-section of the microneedle.

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

201. The microneedle according to claim 193, wherein the flow lumen substantially extends along the long axis of the microneedle.

202. The microneedle according to claim 193, wherein the tip is chamfered.

203. A method for using a medical delivery device, Applying a delivery device to the injection site, Using the controller of the reader, a set of user manuals is generated on the user interface of the reader. The drug is delivered from the delivery device to the injection site, The reader is used to capture image data of the injection site, wherein the image data includes image data of the spectrum outside the visible spectrum. The image data is analyzed to determine whether the image data meets at least one criterion indicating an appropriate injection. Methods that include...

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

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

206. The method according to claim 203, wherein the image data includes near-infrared spectral image data.

207. The method according to claim 203, wherein the image data includes infrared spectral image data.

208. The method according to claim 203, wherein the image data includes thermal image data.

209. The method according to claim 203, wherein the analysis of the image data includes analyzing thermal image data for the presence of a low-temperature region at the injection site.

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

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

212. The method according to claim 203, wherein the reader is a smartphone.

213. A method of delivering drugs, While the delivery device is in storage, the delivery device is mounted on its surface, which includes at least one delivery sharp that is in fluid communication with at least a partially foldable reservoir containing a drug. Pushing a part of the delivery device toward the surface to transition the delivery device to a delivery state, To spread and displace at least two parts of the delivery device, thereby applying tension to the surface on which the delivery device is attached, Penetrating the surface with at least one of the aforementioned delivery sharps, Transferring the fluid out of a reservoir that is at least partially foldable, and passing it through at least one delivery sharp until the reservoir is depleted, Methods that include...

214. A delivery device, A peripheral region having multiple petal members, Having an upper surface and a base, a central region extending outward from the peripheral region, A collapsible reservoir having fluid communication with at least one delivery sharp, configured to discharge fluid from the reservoir in a discharge direction, An adhesive member including a central opening having an increased opening width portion aligned with the aforementioned discharge direction, Includes. Delivery device.

215. The delivery device according to claim 214, wherein the reservoir includes a flexible portion and a rigid portion, and the adhesive member is attached to the main body and the rigid portion.

216. The delivery device according to claim 214, wherein the reservoir includes a flexible portion and a rigid portion, the rigid portion having an installation area having a first region, and the central opening surrounds a second region which is 60 to 100% of the first region.

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

218. The delivery device according to claim 214, wherein the adhesive member includes at least one spoke that protrudes from around the central opening into the central opening.

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

220. The delivery device according to claim 214, wherein the at least one delivery sharp includes an array of spaced microneedles.

221. The delivery device according to claim 214, wherein the body has a first state and a second state, and the body includes at least one partially reversible region, which is a first shape in the first state and substantially inverted with respect to the first shape in at least a portion of the reversible region in the second state.

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

223. The delivery device according to claim 223, wherein the at least one delivery sharp is displaced to communicate with the delivery destination when the main body is displaced from the first state to the second state.

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

225. A delivery device, A main body comprising a peripheral region having multiple petal members, and a central region extending outward from the peripheral region and having an upper surface and a base, A foldable reservoir connected to the main body and in fluid communication with at least one microneedle having a certain width, height, and length, An adhesive member including a central opening having an increased width portion aligned with the length dimension of the microneedle, A delivery device, including a delivery device.

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

227. The delivery device according to claim 225, wherein the reservoir includes a flexible portion and a rigid portion, the rigid portion having an installation area having a first region, and the central opening surrounds a second region which is 60 to 100% of the first region.

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

229. The delivery device according to claim 225, wherein the adhesive member includes at least one spoke that protrudes from around the central opening into the central opening.

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

231. The delivery device according to claim 225, wherein the at least one delivery sharp includes an array of spaced microneedles.

232. The delivery device according to claim 225, wherein the body has a first state and a second state, and the body includes at least one partially reversible region, which is a first shape in the first state and substantially inverted with respect to the first shape in at least a portion of the reversible region in the second state.

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

234. The delivery device according to claim 233, wherein the at least one delivery sharp is displaced to communicate with the delivery destination when the main body is displaced from the first state to the second state.

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

236. A delivery device, A main body comprising a peripheral region having multiple petal members, and a central region extending outward from the peripheral region and having an upper surface and a base, An adhesive bonded to at least a part of the main body, A reservoir comprising at least one flexible portion, wherein the at least one flexible portion comprises a cavity defined by a first wall including a collapse-promoting portion, At least one delivery sharp having fluid communication with the reservoir, A delivery device, including a delivery device.

237. The delivery device according to claim 236, wherein the collapse-promoting unit includes a bellows.

238. The delivery device according to claim 236, wherein the collapse-promoting section includes pleats extending spirally around the wall.

239. The delivery device according to claim 236, wherein the collapse-promoting portion includes at least one stepped region formed in the wall.

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

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

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

243. The delivery device according to claim 242, wherein the second surface includes a central recess.

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

245. The delivery device according to claim 236, wherein the at least one delivery sharp includes a microneedle.

246. Any system, method, or apparatus shown or described herein.

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