Delivery devices, systems, and methods

Abstract

We provide a delivery device for delivering medical drugs to a barrier. [Solution] A delivery device 10 for delivering medical drugs to a barrier comprises a body 20 having a central area defined as a housing and a peripheral area defined by a plurality of petal-shaped members. The delivery device 10 includes a reservoir 12 having at least one delivery sharp, a main internal volume, and at least one septum that is in fluid communication with the main internal volume, and the reservoir 12 is coupled to the body 20 via retaining tabs 580. The delivery device 10 may also include an adhesive coupled to the body, and at least one biasing member positioned between the reservoir 12 and the wall of the housing.

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 the 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 project]

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

[0006] In some embodiments, puncturing the biological barrier may involve moving at least one delivery sharp in a substantially perpendicular direction until it contacts the biological barrier. In some embodiments, at least one delivery sharp may include at least one microneedle. In some embodiments, the movement path may be arc-shaped. In some embodiments, moving at least one delivery sharp may position the delivery sharp in a direction closer to perpendicular to the biological barrier than the orientation of the needle when the biological barrier was punctured. In some embodiments, stretching the biological barrier may involve adhering a delivery device including at least one delivery sharp to the biological barrier and moving at least two portions of the delivery device in a spread-out direction. In some embodiments, moving at least two portions of the delivery device in a spread-out direction may involve applying force to the delivery device in a direction perpendicular to the biological barrier. In some embodiments, releasing liquid from at least one delivery sharp may involve increasing the delivery pressure of the liquid supplied to the delivery sharp until the liquid begins to be delivered from at least one delivery sharp into the biological barrier. In some embodiments, moving at least one delivery sharp along a nonlinear movement path may include driving the oblique blade of the delivery sharp into the barrier. In some embodiments, moving at least one delivery sharp along a nonlinear movement path may include moving the face of at least one delivery sharp, including the exit of the delivery sharp, away from the portion of the barrier that was in contact during the initial puncture.

[0007] According to exemplary embodiments of the present disclosure, a method for a delivery device for delivering a liquid into a biological barrier includes adhering a delivery device, which includes at least one delivery sharp, to the biological barrier. The method further includes applying force to a portion of the delivery device to move a reservoir assembly with the delivery sharp toward the biological barrier. The method further includes puncturing the barrier with at least one delivery sharp. The method further includes tilting the reservoir assembly and at least one delivery sharp by bringing a member protruding from one side of the reservoir assembly into contact with the barrier, while continuing to move the opposite side of the reservoir assembly toward the barrier. The method further includes releasing the liquid from the internal space of the reservoir assembly through at least one delivery sharp.

[0008] In some embodiments, supplying fluid from the internal volume of the reservoir assembly may involve at least partially collapsing the internal volume of the reservoir assembly. In some embodiments, the internal volume of the reservoir assembly may include a first portion and a second portion more proximal to at least one delivery sharp. Supplying fluid from the internal volume of the reservoir assembly may involve increasing the pressure in the second portion until fluid begins to be delivered from at least the delivery sharp to the biological barrier. In some embodiments, at least one delivery sharp may include at least one microneedle. In some embodiments, tilting the reservoir assembly and the delivery sharp may involve driving the oblique edge of the microneedle into the barrier. In some embodiments, this method may involve shifting the biasing member of the delivery device into a stressed state and applying its restoring force to the reservoir assembly. In some embodiments, this method may involve spreading and displacing at least two portions of the delivery device.

[0009] According to other embodiments of the present disclosure, a method for positioning a delivery sharp within a biological barrier at a shallow depth includes stretching the biological barrier. Furthermore, the method includes moving the holder of the delivery sharp toward the biological barrier. The method further includes moving at least one delivery sharp in a direction substantially perpendicular to the biological barrier to puncture the biological barrier. The method further includes bringing the biological barrier into contact with at least one oscillating member protruding from one side of the holder. The method further includes continuing to move the opposite side of the holder (opposite the oscillating member) toward the barrier. The method further includes moving at least one delivery sharp along a non-linear path within the skin.

[0010] In some embodiments, stretching the biological barrier may involve spreading and displacing at least two parts of the delivery device, which includes a holder and at least one delivery sharp. In some embodiments, at least one delivery sharp may be a microneedle. In some embodiments, moving at least one delivery sharp along a nonlinear path may involve moving the delivery sharp along a curved path as the holder opposite at least one rocking member moves toward the barrier. In some embodiments, the movement of at least one delivery sharp may position the delivery sharp in a direction closer to perpendicular to the barrier than when it punctured the barrier. In some embodiments, moving the delivery sharp along a nonlinear path may involve moving at least one delivery sharp in an arc of 3–5°.

[0011] In other embodiments of the present disclosure, the fluid delivery assembly may include a delivery device, which may include a liquid-holding portion and a coupling. The delivery assembly may further include an adapter, which may include an adapter coupling configured to connect to the coupling of the delivery device to form a liquid-tight coupling. The adapter may further include an adapter body, which may further include a sharp bearing body having slanted sidewalls and at least one delivery sharp protruding from its surface. The adapter body may be molded such that the material of the adapter body covers only a portion of the sidewalls, thereby coupling the sharp bearing body and the adapter body together.

[0012] In some embodiments, the delivery device may be a syringe. In some embodiments, the connector and adapter connector of the delivery device may be a coordinating Luer lock connector. In some embodiments, at least one delivery sharp may be a microneedle. In some embodiments, the sharp holder and at least one delivery sharp may be made of silicon. In some embodiments, at least one delivery sharp may include an array of microneedles. In some embodiments, at least one delivery sharp may include microneedles having a height of 500 microns or more. In some embodiments, at least one delivery sharp may have a flow lumen communicating with a channel engraved on the outer surface of the microneedle. In some embodiments, the delivery sharp and at least one delivery sharp may be formed as a single, integrated structure.

[0013] According to other embodiments of the present disclosure, an adapter for a delivery device may include an adapter coupling configured to connect in a liquid-tight manner to a coordinating coupling of the delivery device. The adapter may further include an adapter body. The adapter may further include a sharpener holder having an angled sidewall from which at least one delivery sharpener protrudes. The adapter body may be molded to cover only a portion of the sidewall in order to secure the sharpener holder to the adapter.

[0014] In some embodiments, the footprint of the sharp holder may increase as the distance from the surface increases. In some embodiments, the sharp holder may be formed of silicon. In some embodiments, the sharp holder and at least one delivery sharp may be formed as a single, integrated component. In some embodiments, at least one delivery sharp may be a microneedle. In some embodiments, at least one delivery sharp may be a microneedle with a height of 500 microns or more. In some embodiments, the adapter connector may be a Luer lock connector. In some embodiments, at least one delivery sharp may include an array of microneedles. In some embodiments, at least one delivery sharp may include a microneedle having a channel communicating with a channel engraved on its outer surface.

[0015] According to other exemplary embodiments of the present disclosure, the delivery device may have a body including a central region and a peripheral region. The peripheral region may have a plurality of petal-like members extending outward from the central region. The delivery device may further include a variable-volume reservoir coupled to the body. The delivery device may further include a sharp retainer having at least one microneedle protruding from a surface, with its sidewalls positioned at an acute angle to the surface. The material of the rigid portion of the reservoir may be molded to cover only a portion of the sidewalls, and the sharp retainer and the reservoir may be coupled. The delivery device may further include an adhesive disposed in at least a portion of the body.

[0016] In some embodiments, the central region defines a housing, and the top region and base may be connected by a wall. Petal-shaped members may extend from the base. In some embodiments, the reservoir may be at least partially located within the housing. In some embodiments, the delivery device may further include a biasing member located within the housing between the upper part and the reservoir. In some embodiments, the Sharp holder and at least one microneedle may be a single, integrated structure. In some embodiments, the Sharp holder and at least one microneedle may be formed of silicon. In some embodiments, the reservoir may include a first and second part separated from each other by a flow limiter. The second part may be located more proximal to at least one microneedle than the first part.

[0017] According to other exemplary embodiments of the present disclosure, a method for forming a microneedle support may include etching a plurality of microneedles onto a silicon wafer. The method may further include dicing a sharp retainer containing at least one microneedle from the wafer. The cutting may form sidewalls of the sharp retainer such that the footprint of the sharp retainer expands as the distance from the plane where at least one microneedle is located increases. The method may further include shaping a body to cover only a portion of the sidewalls of the sharp retainer located distal to the plane.

[0018] In some embodiments, the body may be part of a syringe. In some embodiments, the body may be an adapter for attachment to a delivery device. In some embodiments, the body may form part of a delivery device. In some embodiments, the body may be a stage projection of the reservoir of a delivery device. In some embodiments, multiple microneedles may each have a channel communicating with a channel engraved on its outer surface. In some embodiments, a Sharp holder may contain an array of microneedles. In some embodiments, a Sharp holder may contain a row of microneedles. Dicing a Sharp holder from a wafer may involve using a dicing saw with blades configured to form angled sidewalls. In some embodiments, etching multiple microneedles may involve etching the microneedles to a height of 500 microns or more.

[0019] According to other exemplary embodiments of the present disclosure, a delivery device package has a first portion formed of a rigid material including a plurality of wells, at least two of which may be connected by a passage. The package may further include a second portion detachably bonded to the edge of the first portion. The package may further include a delivery device having a body covered with an adhesive liner. The adhesive liner may be bonded to the surface of the first wells. When the body is removed from the wells, the adhesive liner may be configured to peel off from the adhesive and remain in the wells.

[0020] In some embodiments, a unique identifier may be included in at least one of the first and second parts. In some embodiments, the second part may be configured to allow a disinfectant to pass through. In some embodiments, the delivery device may include a pull tab extending from the body through a passage to a second well. In some embodiments, the delivery device may include at least one delivery sharp and a delivery sharp cap covering the delivery sharp. In some embodiments, the cap may be connected to the surface of the first well and configured to remain in the well when the delivery device is removed from the well.

[0021] According to other exemplary embodiments of the present disclosure, a delivery device for supplying a liquid into a biological barrier may include a body. The delivery device may further include an adhesive bonded to at least part of the body and used to bond the delivery device to the biological barrier. The delivery device may further include a reservoir coupled to the body, and may include at least one delivery sharp and at least one oscillating member. The body may be configured to transition from a first state to a second state. The reservoir is configured to move toward the biological barrier when the body transitions from the first state to the second state, and the oscillating member may be configured to tilt the reservoir after the reservoir has moved toward the biological barrier.

[0022] In some embodiments, the reservoir may be at least partially collapsible. In some embodiments, at least two portions of the body to which adhesive is attached may be configured to expand as the body transitions from a first state to a second state. In some embodiments, the body may include a central region and a peripheral region having a plurality of petal-like members extending outward from the central region. The central region may define a housing for accommodating at least a portion of the reservoir. In some embodiments, the reservoir may include at least one rigid portion and at least one flexible portion. In some embodiments, at least one oscillating member may be positioned along the periphery of the rigid portion of the reservoir. In some embodiments, at least one oscillating member may be a projection extending from the rigid portion of the reservoir. In some embodiments, at least one delivery sharp may be mounted on a stage protruding from the rigid portion of the reservoir. At least one oscillating member may be positioned closer to the periphery of the rigid portion than the stage. In some embodiments, the height of at least one oscillating member may be approximately the same as the height of the stage. In some embodiments, at least one delivery sharp includes at least one microneedle, the portion of the at least one microneedle closest to the oscillating member may be the cutting edge of the microneedle. In some embodiments, at least one oscillating member may be configured to tilt the reservoir so that at least one delivery sharp oscillates in an arc of 3–5°. In some embodiments, at least one oscillating member may be configured to tilt the reservoir only after the biological barrier has been punctured by at least one delivery sharp.

[0023] According to yet another embodiment of the present disclosure, the delivery device may comprise a body comprising a central region and a peripheral region having a plurality of petal-like members extending from the central region. The central region defines a housing and has an upper region and a base, which may be connected by a wall. The delivery device further comprises a variable-volume reservoir comprising at least one delivery sharp and at least one oscillating member, the oscillating member may be closer to the periphery of the reservoir than the delivery sharp. The reservoir may be coupled to the body and at least partially located within the housing. Furthermore, the delivery device may comprise an adhesive disposed at least in part of the body.

[0024] In some embodiments, at least one delivery sharp may be a microneedle. In some embodiments, the oscillating member may be a projection extending from a rigid portion of the reservoir. In some embodiments, at least one delivery sharp may include a microneedle, with the portion of the microneedle closest to the oscillating member being the cutting edge of the microneedle. In some embodiments, the oscillating member may be located on the periphery of the reservoir. In some embodiments, the reservoir may include a planar body with a step protruding from it. At least one delivery sharp may be attached to the step. In some embodiments, the delivery sharp may protrude from the step at an acute angle to a plane perpendicular to the plane of the planar body. In some embodiments, the oscillating member may contain a marking agent. In some embodiments, the body may be configured to transition from a first state to a second state when it is bonded to a surface via an adhesive. The reservoir may be configured to move substantially perpendicular to the surface until the oscillating member contacts the surface as the body transitions from the first state to the second state. The portion of the reservoir opposite the oscillating member may be configured to continue moving toward the surface as the body transitions from a first state to a second state, even after the oscillating member has made contact with the surface. In some embodiments, at least one delivery sharp may be configured to puncture the surface as the reservoir moves in a direction substantially perpendicular to the surface, and the delivery sharp may be tilted as the portion of the reservoir opposite the oscillating member moves further toward the surface after the oscillating member has made contact with the surface.

[0025] According to other exemplary embodiments of the present disclosure, a delivery device for supplying a liquid into a biological barrier may include a body. The delivery device may further include an adhesive disposed on at least a portion of the body and used to bond the delivery device to the biological barrier. The delivery device may further include a reservoir coupled to the body, which includes at least one delivery sharp. The reservoir may include a main internal volume for holding a fluid and a septum that is in fluid communication with the main internal volume. The body may be configured to transition between a first state and a second state. The reservoir may be configured to displace toward the biological barrier when the body transitions from the first state to the second state.

[0026] In some embodiments, the reservoir may further include a projection positioned closer to the periphery of the reservoir than at least one distribution sharp. In some embodiments, the projection may be configured to tilt the reservoir as the body transitions from a first state to a second state. In some embodiments, the main internal volume may be at least partially collapsible. In some embodiments, at least two portions of the body where the adhesive is placed may be configured to displace in an expanding manner as the body transitions from a first state to a second state. In some embodiments, the body includes a central region and a peripheral region, the peripheral region may have a plurality of petal-like members extending outward from the central region. The central region may define a dwelling for housing at least a portion of the reservoir. In some embodiments, the reservoir may include at least one rigid portion and at least one flexible portion. In some embodiments, the reservoir may include a guard to prevent a distribution sharp penetrating the septum from contacting a portion of the reservoir. In some embodiments, the guard may be at least partially formed by the septum, allowing a sharp-receiving space to be established within the reservoir. In some embodiments, the reservoir may include a channel from the main internal volume to the septum. In some embodiments, the septum may include a plug portion positioned at the opening of the rigid portion of the reservoir. In some embodiments, the septum may include the plug portion and a standoff extending from the plug portion. The standoff may include two raised portions flanking a recessed channel. In some embodiments, at least one delivery sharp may be mounted on a step protruding from the rigid portion of the reservoir. In some embodiments, at least one delivery sharp may include at least one microneedle. In some embodiments, the reservoir may further include at least one marking agent disposed on a raised portion of the reservoir. In some embodiments, the reservoir may further include a marking member.

[0027] According to another exemplary embodiment of the present disclosure, the delivery device may include a body having a central region and a peripheral region including a plurality of petal-like members extending from the central region. The central region defines a receiving portion, and the upper part (top region) and the base may be connected by a wall. The delivery device may further include a variable volume reservoir including at least one septum in communication with the main internal volume of at least one delivery sharp and a reservoir. The delivery device may further include a variable volume reservoir including a main volume in communication with at least one delivery sharp and a septum, the reservoir being coupled to the body and at least partially disposed within the receiving portion. The delivery device may further include an adhesive disposed on at least a portion of the body.

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

[0029] According to other exemplary embodiments of the present disclosure, a delivery device for delivering a medical agent to a biological barrier may include a body defining a central region defining a receiving portion, a peripheral region defined by a plurality of flap-like members, and a series of retaining tabs extending into the receiving portion. The delivery device may further include a reservoir including at least one delivery sharp, a main internal volume, and at least one septum communicating with the main internal volume, the reservoir being coupled to the body via the retaining tabs. The delivery device may further include an adhesive coupled to the body. The delivery device may further include at least one biasing member disposed in the receiving portion between the reservoir and the wall of the receiving portion.

[0030] In some embodiments, at least one biasing member may be a coil spring having an integral member that contacts the reservoir. In some embodiments, the body may be configured to transition between a first state and a second state. The reservoir may be configured to displace toward the biological barrier when the body transitions from the first state to the second state. In some embodiments, the biasing member may be configured to deform when the body transitions from the first state to the second state. The biasing member may exert a restorative force toward the reservoir after being deformed by the body transitioning from the first state to the second state, pushing fluid out from at least one delivery sharp. In some embodiments, the biasing member may be selected from a list consisting of foam, rubber, and elastomer materials. In some embodiments, the main internal volume may be formed by a wall containing at least one collapse-promoting section. In some embodiments, at least one biasing member may be formed of an elastomer material and may include at least one hollow section. In some embodiments, the hollow section may be formed by a passage through the biasing member. In some embodiments, the biasing member is formed of an elastomer material and has first and second stages, which may have footprints of different areas. In some embodiments, the reservoir may include a sharp receiving space. In some embodiments, the reservoir may include a guard formed at least partially by a septum. In some embodiments, a flow path from the main internal volume to the septum may be included within the reservoir. In some embodiments, the device further comprises a septum, which may include a plug portion fluid-tightly positioned within an opening penetrating the rigid portion of the reservoir. In some embodiments, the device further comprises a septum, which may include a portion positioned within the fluid-containing portion of the reservoir, which may have two ridges flanking a recessed channel. In some embodiments, the reservoir may include a rigid portion and a flexible portion coupled to the rigid portion.The delivery device may further include a septum, which may include a first portion positioned within a passage through a rigid portion. The septum may include a second portion having a recessed channel, which may be configured to prevent the flexible portion from displacing within the recessed channel. In some embodiments, the reservoir may be filled with an overdose intervention drug. In some embodiments, the reservoir may be filled with at least one vaccine. In some embodiments, the reservoir may be filled with a COVID-19 vaccine. In some embodiments, the reservoir may further include a projection closer to the periphery of the reservoir than at least one delivery sharp. In some embodiments, the body may be configured to transition between a first state and a second state. The reservoir may be configured to displace toward the biological barrier when the body transitions from the first state to the second state. Its protrusions may be configured to tilt the reservoir when the body transitions from the first state to the second state. In some embodiments, the body may be formed integrally with the retaining tab by a side-action-free injection molding operation. In some embodiments, the body may include a set of stop members associated with the retaining tab.

[0031] According to other exemplary embodiments of the present disclosure, the delivery device may include a body comprising a central region and a peripheral region having a plurality of petal-like members extending from the central region. The central region may define a housing, and the top and base may be connected by a wall. The delivery device may further include a variable-volume reservoir containing at least one delivery sharp, the reservoir being coupled to the body and at least partially located within the housing. The delivery device may further include an elastomer body located within the housing between the top and the reservoir. The delivery device may also include adhesive placed on at least part of the main body.

[0032] In some embodiments, the elastomer may include at least one hollow portion. In some embodiments, each hollow portion may be formed by a passage through which at least a portion of the elastomer passes. In some embodiments, the elastomer may have a stepped structure. In some embodiments, the reservoir may further include a septum. In some embodiments, the body may include a set of retaining tabs extending into the housing. The reservoir may be configured to be coupled to the reservoir by a snap-fit ​​by passing through the retaining tabs and proceeding beyond them. In some embodiments, the reservoir may further include a projection closer to the periphery of the reservoir than at least one delivery sharp. In some embodiments, the marking agent may be held in the projection. In some embodiments, the body may be configured to transition between a first state and a second state. The reservoir may be configured to displace along the path as the body transitions from the first state to the second state. In some embodiments, at least one delivery sharp may include an array of spaced microneedles. In some embodiments, the majority of each petal-like member may be flat and positioned at an acute angle to the central axis of the delivery device. In some embodiments, the peripheral region may include the outermost part that defines the periphery of the main body. Each petal-like member may define a portion of the periphery of the main body. In some embodiments, the outermost part of each petal-like member may be arched along a radius with a center point along the central axis of the delivery device. In some embodiments, each petal-like member may be separated by a slit in the peripheral region. The outermost part of each petal-like member may be located further away from the central region than the end of the slit furthest from the central region. The outermost part may narrow as it moves away from the central region.

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

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

[0035] According to yet another exemplary embodiment of the present disclosure, a method for delivering a drug may include mounting a delivery device to a surface, which includes at least one delivery sharp coupled to a variable-volume reservoir containing the drug, when the delivery device is in a first state. The method may further include applying and releasing pressure to the delivery device to move the delivery device to a second state, which penetrates the surface with at least one delivery sharp, causing the reservoir to collapse and the drug to be pushed out from the delivery sharp.

[0036] In some embodiments, the method may further include stretching the skin as the delivery device transitions from a first state to a second state. In some embodiments, the method may further include tilting at least one delivery sharp after the delivery sharp has penetrated the surface. In some embodiments, the method may further include contacting the surface with a projection from the reservoir after the delivery sharp has penetrated the surface. In some embodiments, the method may further include creating a mark on the surface with the projection. In some embodiments, the method may further include filling the reservoir through the septum. In some embodiments, at least one delivery sharp may be a microneedle. In some embodiments, at least one delivery sharp may be an array of spaced microneedles. In some embodiments, the method may further include compressing a biasing member against the reservoir. In some embodiments, the method may further include compressing an elastomer against the reservoir. In some embodiments, the method may further include displacing at least two portions of the surface-mounted delivery device with spreading from an initial state. In some embodiments, transitioning the delivery device to a second state by applying or releasing pressure may include returning at least two portions of the skin-mounted delivery device from a retracted state through an intermediate state to at least partially a retracted state. In some embodiments, transitioning the delivery device to a second state by applying or releasing pressure may include transitioning at least two portions of the skin-mounted delivery device from a retracted state to a maximally deformed state and then at least partially elastically restoring them from that state. In some embodiments, at least two portions may be petal-shaped members extending periphery from a central region of the delivery device body. In some embodiments, distributing liquid from a reservoir may include substantially inverting a portion of the delivery device and compressing a biasing member between the portion and the reservoir.

[0037] According to yet another exemplary embodiment of the present disclosure, a method for delivering a drug may include mounting a delivery device to a surface, which includes at least one delivery sharp coupled to a variable-volume reservoir containing the drug. The method may further include applying pressure to the delivery device to move first and second portions, respectively, into deformed states, penetrating the surface with at least one delivery sharp, initiating the collapse of the reservoir and pushing the drug out from the delivery sharp. The method may further include releasing the pressure applied to the delivery device to at least partially restore the first portion of the delivery device from its deformed state and lift the surface.

[0038] In some embodiments, transitioning the first portion to a deformed state may include displacing the segments of the first portion so that they spread apart from one another. In some embodiments, the method may further include tilting at least one delivery sharp after it has penetrated the surface. In some embodiments, the method may further include making contact with the surface at a projection from the reservoir after it has penetrated the surface. In some embodiments, the collapse of the reservoir may continue while the first portion of the delivery device recovers at least partially from the deformed state. In some embodiments, at least one delivery sharp may be a microneedle. In some embodiments, at least one delivery sharp may be an array of spaced microneedles. In some embodiments, transitioning the second portion to a deformed state may include compressing the biasing member against the reservoir. In some embodiments, transitioning the second portion to a deformed state may include transitioning the second portion from a protruding state to a recessed state. In some embodiments, the first portion of the delivery device includes a plurality of petal-shaped members extending from a central region outward toward the periphery of the body of the delivery device, and the second portion may be part of the central region. It can be translated as follows:

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

[0040] In some embodiments, the delivery device may have an adhesive on at least part of the body for attaching the delivery device to a biological barrier. In some embodiments, the reservoir may further include at least one oscillating member. In some embodiments, the reservoir may be configured to displace along a displacement path as the body transitions from a first state to a second state. In some embodiments, the reservoir may include a rigid portion having at least one projection, which may be configured to tilt the reservoir as it displaces along the displacement path. In some embodiments, the reservoir may be at least partially collapsible. In some embodiments, the petal-like member may be at least partially covered with adhesive. The petal-like member may be configured to displace with spreading as it deforms from an initial state to an intermediate state. In some embodiments, the body may include a central region. Multiple petal-like members may be arranged in a direction extending outward from a central region. The central region may define a housing that contains at least a portion of the reservoir. In some embodiments, the reservoir may include at least one rigid portion and at least one flexible portion. In some embodiments, the flexible portion may include a reservoir wall having a disintegration-promoting section. In some embodiments, the majority of each petal-like member may be substantially flat. In some embodiments, the majority of each petal-like member extends at a constant angle with respect to the central axis of the delivery device, and each petal-like member may include a segment having a curve toward the central region of the body. In some embodiments, each petal-like member may include an intermediate curved portion between a first substantially flat region and a second substantially flat region. In some embodiments, at least one delivery sharp may be mounted on a step protruding from the rigid portion of the reservoir. In some embodiments, at least one delivery sharp may include at least one microneedle. In some embodiments, the periphery of the delivery device may be defined by the outermost edge of the petal-like member. This outermost edge may curve along a path different from a path defined by a constant radius extending from a point along the central axis of the delivery device. In some embodiments, each petal-like member may have an outermost region that narrows in width as it moves away from the central region. Each outermost region may include an outermost edge along a path different from a path defined by a constant radius extending from a point along the central axis of the delivery device. In some embodiments, the body may include a central region formed integrally with the peripheral region. The central region may include a portion configured to invert from a protruding state to a concave state when the body transitions from a first state to a second state. In some embodiments, the delivery device may further include a biasing member positioned between the reservoir and the portion. The biasing member may be configured to deform when the portion inverts to a concave state. In some embodiments, the biasing member may be an elastomer. In some embodiments, the biasing member may be a stepped elastomer having a passage through which at least a portion passes. In some embodiments, the reservoir may further include a septum. [Brief explanation of the drawing]

[0041] These and other embodiments will become more apparent from the following detailed description of various embodiments of this disclosure with reference to the drawings.

[0042] [Figure 1A] This is a block diagram of an exemplary delivery device in a stored state according to various aspects and embodiments of the present disclosure.

[0043] [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.

[0044] [Figure 2] This is a diagram illustrating an exemplary microneedle according to various aspects and embodiments of the present disclosure.

[0045] [Figure 3A] This is a diagram illustrating an exemplary sharp holder incorporating microneedles, according to various aspects and embodiments of the present disclosure.

[0046] [Figure 3B] This is a diagram illustrating an exemplary microneedle according to various aspects and embodiments of the present disclosure.

[0047] [Figure 4A] This is a diagram illustrating an exemplary sharp holder incorporating microneedles, according to various aspects and embodiments of the present disclosure.

[0048] [Figure 4B] This is a diagram illustrating an exemplary microneedle according to various aspects and embodiments of the present disclosure.

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

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

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

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

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

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

[0055] [Figure 8A] This is an exemplary top view of a sharp holder including a set of microneedles according to various aspects and embodiments of the present disclosure.

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

[0057] [Figure 8C] This is a cross-sectional view of the cross-section shown in Figure 8A according to various aspects and embodiments of the present disclosure.

[0058] [Figures 9A-9D] Various figures of exemplary microneedles with side ports according to various aspects and embodiments of this disclosure are shown.

[0059] [Figure 10A] These are some block diagrams of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0060] [Figure 10B] These are some block diagrams of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0061] [Figure 11] These are some block diagrams of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0062] [Figure 12] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

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

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

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

[0066] [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.

[0067] [Figure 17]This is a diagram of an exemplary delivery device in a stored state according to various aspects and embodiments of the present disclosure.

[0068] [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.

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

[0070] [Figure 20] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0071] [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.

[0072] [Figure 22] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0073] [Figure 23] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0074] [Figure 24] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0075] [Figure 25] This is a perspective view of exemplary delivery device packages according to various aspects and embodiments of the present disclosure.

[0076] [Figure 26] This is an exemplary top view of a delivery device package with the delivery device removed, according to various aspects and embodiments of the present disclosure.

[0077] [Figure 27] This is a diagram of an exemplary delivery device in a stored state according to various aspects and embodiments of the present disclosure.

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

[0079] [Figure 29A] 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.

[0080] [Figure 29B] 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.

[0081] [Figure 30A] 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.

[0082] [Figure 30B] 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.

[0083] [Figure 31] 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.

[0084] [Figure 32] Figure 31 is a side view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0085] [Figure 33] Figure 31 is an exploded view of a delivery device shown in various aspects and embodiments of this disclosure.

[0086] [Figure 34] Figure 31 is a plan view of a delivery device according to various aspects and embodiments of this disclosure.

[0087] [Figure 35] This is a cross-sectional view of the delivery device shown in Figure 33, taken from the cross-section shown in Figure 34, according to various aspects and embodiments of this disclosure.

[0088] [Figure 36] The following are representative diagrams of exemplary delivery devices, including distribution assemblies, according to various aspects and embodiments of this disclosure.

[0089] [Figure 37] The following are representative diagrams of exemplary delivery devices, including distribution assemblies, according to various aspects and embodiments of this disclosure.

[0090] [Figure 38] The following are representative diagrams of exemplary delivery devices, including distribution assemblies, according to various aspects and embodiments of this disclosure.

[0091] [Figure 39] Exemplary perspective views of delivery devices and biasing members according to various aspects and embodiments of this disclosure are shown.

[0092] [Figure 40] The following are perspective views of exemplary biasing members that may be included in delivery devices according to various aspects and embodiments of this disclosure.

[0093] [Figure 41] The following are some cross-sectional views of exemplary delivery devices according to various aspects and embodiments of this disclosure.

[0094] [Figure 42] The following are some cross-sectional views of exemplary delivery devices according to various aspects and embodiments of this disclosure.

[0095] [Figure 43] The following are perspective views of exemplary pressing bodies that may be included in delivery devices according to various aspects and embodiments of this disclosure.

[0096] [Figure 44] Exemplary depressor bodies and biasing members are shown in which the biasing members are under stress according to various aspects and embodiments of the present disclosure.

[0097] [Figure 45] The following are exemplary cross-sectional views of a pressing body and a biasing member in a stressed state, according to various aspects and embodiments of the present disclosure.

[0098] [Figure 46A] The following are perspective views of exemplary delivery devices according to various aspects and embodiments of this disclosure.

[0099] [Figure 46B] The following are perspective views of exemplary stopping members that may be included in delivery devices according to various aspects and embodiments of this disclosure.

[0100] [Figure 46C] The following are perspective views of exemplary delivery assemblies and exemplary stopping members that may be included in delivery devices according to various aspects and embodiments of this disclosure.

[0101] [Figure 46D] The following are perspective views of exemplary biasing members and exemplary pressing bodies that may be included in delivery devices according to various aspects and embodiments of this disclosure.

[0102] [Figure 47] The following are representative diagrams of exemplary delivery devices including biasing members according to various aspects and embodiments of this disclosure.

[0103] [Figure 48A] An exemplary bottom view of a body that may be included in a delivery device according to various aspects and embodiments of this disclosure is shown.

[0104] [Figure 48B] The following are perspective views of exemplary bodies and exemplary biasing members that may be included in delivery devices according to various aspects and embodiments of this disclosure.

[0105] [Figure 48C] The following are perspective views of exemplary bodies and exemplary biasing members that may be included in delivery devices according to various aspects and embodiments of this disclosure.

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

[0107] [Figure 49B] The following are cross-sectional views of exemplary delivery devices according to various aspects and embodiments of this disclosure.

[0108] [Figure 50] This document shows exploded views of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0109] [Figure 51] Figures 51A and 51B show some exemplary delivery devices according to various aspects and embodiments of the present disclosure, in their stored and delivered states, respectively.

[0110] [Figure 52] The following are exemplary bottom views of the main body and some of the pressing elements of a delivery device according to various aspects and embodiments of this disclosure.

[0111] [Figure 53A] This is a perspective view of exemplary holders for Sharp holders according to various aspects and embodiments of the present disclosure.

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

[0113] [Figure 53C] This is a plan view from below of an exemplary holder for a Sharp holder according to various aspects and embodiments of the present disclosure.

[0114] [Figure 53D] This is a perspective view of exemplary holders for Sharp holders according to various aspects and embodiments of the present disclosure.

[0115] [Figure 54A] Exemplary perspective views of holders including stepped protrusions according to various aspects and embodiments of this disclosure are shown.

[0116] [Figure 54B] Exemplary perspective views of holders including stepped protrusions according to various aspects and embodiments of this disclosure are shown.

[0117] [Figure 54C] The following are bottom views of exemplary holders including stepped protrusions according to various aspects and embodiments of this disclosure.

[0118] [Figure 55A] The following is a side view of an exemplary holder including a stepped projection to which an exemplary sharp holder according to various aspects and embodiments of the present disclosure is attached.

[0119] [Figure 55B] Detailed views of the region shown in Figure 55A according to various aspects and embodiments of this disclosure are shown.

[0120] [Figure 55C] The following are cross-sectional views of exemplary holders, including stepped protrusions to which exemplary sharp holders according to various aspects and embodiments of this disclosure are attached.

[0121] [Figure 55D] Detailed views of the area shown in Figure 55C according to various aspects and embodiments of this disclosure are shown.

[0122] [Figure 56A] This is a perspective view of exemplary portions of reservoirs according to various aspects and embodiments of the present disclosure.

[0123] [Figure 56B] This is a side view of an exemplary portion of a reservoir according to various aspects and embodiments of the present disclosure.

[0124] [Figure 56C] This is a perspective view of exemplary portions of reservoirs according to various aspects and embodiments of the present disclosure.

[0125] [Figure 56D] This is a plan view of an exemplary portion of a reservoir according to various aspects and embodiments of the present disclosure.

[0126] [Figure 57] Exemplary perspective views of reservoirs according to various aspects and embodiments of this disclosure are shown.

[0127] [Figure 58] The following are perspective views of other exemplary reservoirs according to various aspects and embodiments of the present disclosure.

[0128] [Figure 59] These are block diagrams of exemplary reservoir assemblies according to various aspects and embodiments of the present disclosure.

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

[0130] [Figure 61A] The following are block diagrams of exemplary reservoir assemblies according to various aspects and embodiments of the present disclosure.

[0131] [Figure 61B]The following are block diagrams of exemplary reservoir assemblies according to various aspects and embodiments of the present disclosure.

[0132] [Figure 62] The following are representative diagrams of exemplary delivery devices including a reservoir divided into multiple parts according to various aspects and embodiments of the present disclosure.

[0133] [Figure 63A] This disclosure shows various aspects and a block diagram of a delivery device with an example of a rocking member according to an embodiment.

[0134] [Figure 63B] This disclosure shows various aspects and a block diagram of a delivery device with an example of a rocking member according to an embodiment.

[0135] [Figure 64A] The following are perspective views of a delivery device equipped with an example of a rocking member according to various aspects and embodiments of this disclosure.

[0136] [Figure 64B] The following is a perspective view of another delivery device, which includes an example of multiple oscillating members according to various aspects and embodiments of the present disclosure.

[0137] [Figure 65] This flowchart details several exemplary actions that may be performed for drug delivery using a delivery device according to various aspects and embodiments of this disclosure.

[0138] [Figure 66] Diagrams of exemplary delivery devices after application to a user are shown according to various aspects and embodiments of this disclosure.

[0139] [Figure 67] Diagrams illustrating an exemplary delivery device in the process of transitioning from a storage state to a delivery state are shown according to various aspects and embodiments of this disclosure.

[0140] [Figure 68] Diagrams illustrating an exemplary delivery device in the process of transitioning from a storage state to a delivery state are shown according to various aspects and embodiments of this disclosure.

[0141] [Figure 69] This disclosure shows various aspects and diagrams of a delivery device in a delivery state according to embodiments.

[0142] [Figure 70A] This disclosure shows various aspects and exemplary bodies that may be included in delivery devices according to embodiments.

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

[0144] [Figure 71] This disclosure shows various aspects and detailed drawings of exemplary parts of the body according to embodiments.

[0145] [Figure 72A] The following are diagrams illustrating exemplary bodies that may be included in delivery devices according to various aspects and embodiments of this disclosure.

[0146] [Figure 72B] The following are various aspects of the present disclosure and an exemplary side view of a body that may be included in a delivery device according to an embodiment.

[0147] [Figure 73A] The following are front right top perspective views of various aspects and embodiments of the exemplary delivery device according to this disclosure.

[0148] [Figure 73B] The following are bottom plan views of exemplary portions of exemplary delivery devices according to various aspects and embodiments of this disclosure.

[0149] [Figure 73C] The above shows various aspects of the present disclosure and a top view of an exemplary portion of an exemplary delivery device according to an embodiment.

[0150] [Figure 73D] The following are front views of exemplary delivery devices and exemplary portions of various aspects and embodiments of this disclosure.

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

[0152] [Figure 73F] The following are rear views of exemplary portions of exemplary delivery devices according to various aspects and embodiments of this disclosure.

[0153] [Figure 73G] The following are left side views of exemplary portions of exemplary delivery devices according to various aspects and embodiments of this disclosure.

[0154] [Figure 74A] The following are front right perspective views of various aspects and embodiments of the exemplary delivery device according to this disclosure.

[0155] [Figure 74B] The above shows various aspects of the present disclosure and a top plan view of an exemplary portion of an exemplary delivery device according to an exemplary embodiment.

[0156] [Figure 74C] The following are bottom plan views of exemplary portions of exemplary delivery devices according to various aspects and embodiments of this disclosure.

[0157] [Figure 74D] The following are front views of exemplary portions of exemplary delivery devices according to various aspects and embodiments of this disclosure.

[0158] [Figure 74E]The right side view shows an exemplary portion of an exemplary delivery device according to various aspects and embodiments of this disclosure.

[0159] [Figure 74F] The following are rear views of exemplary portions of exemplary delivery devices according to various aspects and embodiments of this disclosure.

[0160] [Figure 74G] The following are left side views of exemplary portions of exemplary delivery devices according to various aspects and embodiments of this disclosure.

[0161] [Figure 75A] The following are front right perspective views of various aspects and embodiments of the exemplary delivery device according to this disclosure.

[0162] [Figure 75B] The above shows various aspects of the present disclosure and a top view of an exemplary portion of an exemplary delivery device according to an embodiment.

[0163] [Figure 75C] The following are various aspects of this disclosure and bottom views of exemplary portions of exemplary delivery devices according to embodiments.

[0164] [Figure 75D] The following are front views of exemplary portions of exemplary delivery devices according to various aspects and embodiments of this disclosure.

[0165] [Figure 75E] The following are right side views of exemplary portions of exemplary delivery devices according to various aspects and embodiments of this disclosure.

[0166] [Figure 75F] The following are rear views of exemplary portions of exemplary delivery devices according to various aspects and embodiments of this disclosure.

[0167] [Figure 75G]The following are left side views of exemplary portions of exemplary delivery devices according to various aspects and embodiments of this disclosure.

[0168] [Figure 76A] The following are exemplary top views of reservoirs according to various aspects and embodiments of this disclosure.

[0169] [Figure 76B] The following are exemplary bottom views of a reservoir according to various aspects and embodiments of this disclosure.

[0170] [Figure 77] This disclosure shows various aspects and exemplary perspective views of septums according to embodiments.

[0171] [Figure 78] The following are cross-sectional views of an exemplary reservoir, including a septum, according to various aspects and embodiments of this disclosure.

[0172] [Figure 79] The following are perspective views of an exemplary delivery device, including a septum, according to various aspects and embodiments of this disclosure.

[0173] [Figure 80A] The following are perspective cross-sectional views of an exemplary body, including a retaining tab, according to various aspects and embodiments of this disclosure.

[0174] [Figure 80B] Detailed views of the areas shown in Figure 80A according to various aspects and embodiments of this disclosure are shown.

[0175] [Figure 81A] The following are various aspects of the present disclosure and a bottom view of an exemplary delivery device with exemplary adhesive members according to embodiments.

[0176] [Figure 81B]The following are various aspects of this disclosure and a bottom view of another exemplary delivery device with another exemplary adhesive member according to an embodiment.

[0177] [Figure 81C] The following are various aspects of this disclosure and a bottom view of another exemplary delivery device with another exemplary adhesive member according to an embodiment.

[0178] [Figure 82A] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0179] [Figure 82B] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

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

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

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

[0183] [Figure 84A] This is a perspective view of various aspects and exemplary delivery devices according to embodiments of the present disclosure.

[0184] [Figure 84B] 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.

[0185] [Figure 84C] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0186] [Figure 85A] Perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0187] [Figure 85B] Perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0188] [Figure 86] Perspective view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0189] [Figure 87] Plan view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0190] [Figure 88A] Side view of an exemplary delivery device in a first state according to various aspects and embodiments of the present disclosure.

[0191] [Figure 88B] Side view of an exemplary delivery device in a second state according to various aspects and embodiments of the present disclosure.

[0192] [Figure 88C] Side view of an exemplary delivery device in a third state according to various aspects and embodiments of the present disclosure.

[0193] [Figure 89] Cross-sectional view of an exemplary delivery device according to various aspects and embodiments of the present disclosure.

[0194] [Figure 90A] Block diagram of an exemplary delivery device in a stored state according to various aspects and embodiments of the present disclosure.

[0195] [Figure 90B]This is a block diagram of an exemplary delivery device in a delivery state according to various aspects and embodiments of the present disclosure.

[0196] [Figure 91] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

[0197] [Figure 92] This is a perspective view of exemplary delivery devices according to various aspects and embodiments of the present disclosure.

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

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

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

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

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

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

[0204] [Figure 97] 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.

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

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

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

[0208] [Figure 101] Perspective view of an exemplary flexure that can be included as an operating assembly of an exemplary delivery device, or as a part thereof, according to various aspects and embodiments of the present disclosure.

[0209] [Figure 102] Side view of an exemplary flexure that can be included as an operating assembly of an exemplary delivery device, or as a part thereof, according to various aspects and embodiments of the present disclosure.

[0210] [Figure 103] Plan view of an exemplary flexure that can be included as an operating assembly of an exemplary delivery device, or as a part thereof, according to various aspects and embodiments of the present disclosure.

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

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

[0213] [Figure 106]This disclosure reveals marks formed on the skin by delivery devices according to various aspects and embodiments of this disclosure, and shows the removal of an exemplary delivery device from the patient's skin.

[0214] [Figure 107] Various aspects and embodiments of this disclosure illustrate examples of thermal images of injection sites showing blisters caused by injections into the skin. [Modes for carrying out the invention]

[0215] 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.

[0216] Such a delivery device 10 may be used to administer a drug to a patient's target delivery site 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 decreases as fluid is distributed from the reservoir 12. When the reservoir 12 is empty, the reservoir 12 may collapse at least partially. 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.

[0217] The Sharp 72 for delivery can be selected based on the patient's desired delivery site. In certain embodiments, the delivery site may be at a transcutaneous location. For example, the delivery site may be a subcutaneous destination or an intramuscular destination. Alternatively, the delivery site may be a shallow destination between the patient's stratum corneum and subcutaneous tissue. Such shallow destinations may be referred to herein as intradermal destinations. Shallow destinations may include target sites 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 be located within a delivery device 10 having a shallow (e.g., above subcutaneous tissue) delivery site. For example, in alternative embodiments where the delivery site is at a subcutaneous or intramuscular location, a conventional delivery sharp (e.g., a 30-gauge needle) may be used.

[0218] 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 a point on 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.

[0219] The tip or tip of the microneedle may be solid, and the channel 126 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, in which the channel 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.

[0220] 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 indentations formed as part of each microneedle or at least one microneedle of the delivery device 10. These recesses or indentations may be in fluid communication with the flow path 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.

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

[0222] 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 channel 126 may have a diameter of 50 to 60 microns. The channel 200 may have a width equal to the diameter of the channel 126 or its widest portion, or the channel 200 may have a width smaller or larger than the width of the channel 126. The channel 200 may be about 5 to 10 percent of the height of the microneedle.

[0223] 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 further reaches the target skin layer (e.g., the lamina junction). In some embodiments, the channel 200 extends from the flow path 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.

[0224] 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.

[0225] 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.

[0226] Referring here to Figures 5A and 5B, in other examples, the channel 200 may extend from the location of the flow path 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 location 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 (or near) the base 17.

[0227] 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 microneedles may include a channel 126 having an elongated cross-section (at least at the outlet; see also Figures 7B and 8B). Microneedles with both the channel 200 and the elongated lumen 126 are also possible. The elongated lumen 126, once positioned in place within the patient's body, may be able to fluidize multiple layers of skin, for example. Therefore, when the microneedle is advanced into the patient's body, thin and / or weak layers of skin may be more easily targeted. The elongated lumen 126 may also help reduce the pressure required for injection. Such an elongated channel 126 may have any suitable cross-section. In some embodiments, the cross-section may be oval or elliptical. Alternatively, a lumen 126 with an elliptical cross-section may be used, as shown in Figures 6A and 6B. Polygonal cross-sectional shapes, such as rectangular, trapezoidal, and triangular, 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). When an elongated lumen 126 is included, the end of the lumen 126 most proximal to the distal end 15 may be spaced at least a certain distance from the distal end 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.

[0228] 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 holder 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 holder 26 and help ensure consistent fluid delivery to the target site of a particular microneedle. As shown in Figures 6A-6B, any of the microneedles shown herein may be configured with a vertical surface 13.

[0229] 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 is in fluid communication with the microneedle's flow path 126. 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 manufacturing 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 within 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 channel 126.

[0230] 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.

[0231] In yet another embodiment, as shown in Figures 8A-8C, the lumen 126 may include a rounded blade edge 31 and a lumen exit surface 35. The lumen 126 may extend through the microneedle to the lumen exit surface 35 and may not be formed in a straight line through the microneedle. The lumen exit surface 35 may be angled 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 path 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 path 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 void. 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.

[0232] 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.

[0233] 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.

[0234] 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.

[0235] Referring again primarily to Figures 1A and 1B, the delivery device 10 described herein can deliver any of a variety of drugs or other medical agents to a patient. In certain embodiments, the reservoir 12 of the delivery device 10 may be filled with a vaccine. 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.

[0236] 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 (and its variants and subspecies). The delivery device 10 described herein is also not limited to human use. Such delivery devices 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 devices 10 described herein may also be useful for research applications.

[0237] When the delivery device 10 is filled with vaccine, it may be desirable that the delivery site be a shallow delivery site. 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.

[0238] 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.

[0239] 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.

[0240] 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.

[0241] 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.

[0242] 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.

[0243] The delivery device 10 described and shown herein may also be suitable for administering overdose prevention medications such as opioid antagonists (e.g., naloxone). The delivery device 10 described herein can be easily used at an overdose scene by an untrained bystander. Alternatively, the delivery device 10 may be used by emergency medical services (EMS) personnel responding to an overdose. Such a delivery device 10 can, for example, provide rapid access to the patient who has overdosed and deliver the drug to a superficial site. This allows for rapid delivery of the drug to the patient who has overdosed and may eliminate the need to establish venous access, which can be particularly difficult for those administering intravenous medications.

[0244] Referring further to Figures 1A-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 distorted and cannot return to its stored state. In other examples, a weak point 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 coupling can be engaged to hold the main body 20 in the delivery state or to prevent the main body 20 from returning to the stored 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.

[0245] In various examples, the transition of the delivery device 10 from a stowed 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 stowed 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 reverse shape (e.g., from convex to concave) or that at least partially reverse when the delivery device 10 transitions from a stowed state to a delivery state. In some embodiments, the body 20 may include one or more reversible regions and may also include one or more regions that deform and at least partially return to their original shape when the delivery device transitions to a delivery state.

[0246] The transition may be affected by applying force throughout the entire transition, or it may only require force to be applied 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 further external force being applied. For instance, 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.

[0247] The body 20 may be at least partially covered with adhesive 22 on a first surface 24 of the body. The body 20 may help to bond to the skin surface of the patient's injection or injection site. Thus, the first surface 24 may be the skin-adjacent or proximal (proximal and distal as defined with respect to the patient) surface of the body 20. When the body 20 is in a retracted state 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.

[0248] 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 site of delivery 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.

[0249] 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.

[0250] In embodiments where the drug in the reservoir 12 of the delivery device 10 must be stored at very low temperatures, packet 208 may contain a liquid, for example, if the drug is a vaccine having such requirements. For example, a vaccine may be stored and / or transported at commercial freezer temperatures in the range of -18°C (or lower, e.g., -70°C or -20°C for certain vaccines). The liquid may have a boiling point higher than the storage temperature of the drug (e.g., vaccine) but lower than room temperature or another suitable temperature setting. Any suitable liquid can be used, but 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.

[0251] The delivery device 10 can be attached to the user's skin surface along with a reservoir 12 containing a cryogenically stored / shipped vaccine and a packet 208 containing liquid butane (or any other suitable substance). If the ambient temperature is room temperature, e.g., about 20°C, the contents will warm up (heat from the patient may help this). In an exemplary embodiment, the liquid butane boils and turns into a gas when it reaches its boiling point -1°C. As the liquid boils and transitions to a gaseous state, the pressure in the packet 208 increases, causing the packet 208 to expand and exert a downward pressure on the reservoir 12, as shown in Figure 10B. For example, butane gas has a vapor pressure of 35.4 psi at 25°C. Therefore, the final pressure in the reservoir 12 may 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 may help direct the pressure towards the reservoir 12.

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

[0253] In some embodiments, a considerable downward pressure on the reservoir 12, for example, a considerable downward pressure exceeding 50 psi, may be desirable to provide a force that collapses the reservoir 12 and pushes the fluid within it into the user's skin via the delivery sharp 72. See Figures 1A and 1B. In such embodiments, the packet 208 can be incorporated into a squeezeable container 350, as shown in Figure 11. The container 350 can be made of a squeezeable plastic or any other suitable material, as will be understood by those skilled in the art. The container 350 can be formed by injection molding, thermoforming, or any other technique known to those skilled in the art. In addition to housing the packet 208, a first substance can be stored in the container 350. The packet 208 can hold a second substance. The first and second substances may be, for example, components of an expanding foam. The first and second substances may be selected so that they expand and create pressure when they come into contact with each other. For example, a chemical reaction that generates gas (such as baking soda or vinegar) can be used. When the delivery device 10 is applied to the skin surface, the user can, for example, pinch, crush, press, or squeeze the container 350. This causes the packets 208 inside to burst, thereby causing the first and second substances to interact and apply downward pressure to the reservoir 12 below.

[0254] 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 packet 208 may cause packet 208 to be destroyed, allowing the biasing member to be restored. When the biasing member is restored, pressure is applied to reservoir 12, generating pressure for delivery.

[0255] 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.

[0256] 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 49-61B and 12-29B.

[0257] Referring to Figures 12-14, an exemplary delivery device 10 is shown. The exemplary delivery device 10 is shown in a stowed 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 holder 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 the 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 disk of material which can be thermoformed to form the raised central region 28 and the flat peripheral region 30.

[0258] 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 35), the main body 20 may be injection-molded to be in a stored state or a delivered 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 stored state to the delivered state, it may be desirable to mold the main body 20 of the delivery device 10 into the shape of its delivered state. During the assembly of the delivery device 10, the main body 20 may be in its stored state configuration and remain in that configuration until use.

[0259] The central region 28 may be dome-shaped, and its dome shape may form a housing 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 housing 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.

[0260] 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-shaped members 42, these petal-shaped members 42 spaced apart via the slots 36.

[0261] 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-shaped member 42 within the peripheral region 30, but other embodiments may differ. For example, only certain petal-shaped members 42 may contain the adhesive 22. In such embodiments, the adhesive 22 may be contained in at least one pair of petal-shaped 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-shaped member 42 contained within the peripheral region 30 (e.g., most of the surface area) may be covered with the adhesive 22. Alternatively or additionally, the adhesive 22 may differ for each petal-shaped member 42. Some petal-shaped members 42 may be covered with a stronger adhesive 22, while others may be covered with a less strong adhesive 22. In certain cases, the entire proximal surface 24 may be covered with adhesive 22. Additional adhesive members 22 are described elsewhere in this specification (see, for example, Figures 81A to 81C) and can be used in the delivery device 10.

[0262] 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-shaped member 42 when the transition occurs, thereby promoting the stretching of the user's skin.

[0263] The body 20 may be a bistable element or may include at least one bistable region that can be stable in both the stored and delivered states. When the body 20 is in the stored 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 delivered state similar to that shown in Figure 16. Therefore, only a trigger force can be applied to initiate the transition. The remaining change between the stored and delivered states may be caused by the snap-through phenomenon.

[0264] Figure 17 shows the delivery device 10 in its retracted 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 its retracted state. Subsequently, the delivery device 10 can transition to the delivery state. When the transition occurs, spreading displacement of the opposing petal-shaped members 42 of the main body 20 may occur.

[0265] 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 the retracted state (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 the adhesive 22 and cannot pass through the body 20, the skin 44 may be forced to conform to the curvature of the proximal surface 24. Therefore, the length of the skin surface 44 between the two points 46A and 46B when the delivery device 10 is in the delivery state may be greater than the length of the skin surface 44 between points 46A and 46B when the delivery device 10 is in the retracted state. The skin 44 may be placed under tension and stretched to adapt to this change in length. This stretching may, in turn, help to facilitate puncture of the skin 44 by the delivery sharp 72.

[0266] When attempting to return to its unstretched state, due to the elasticity of the skin 44, the skin 44 can exert a restorative force against 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 site of delivery 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. Stretched skin 44 can help to empty and collapse the reservoir 12.

[0267] As described above, in certain examples, some petal-shaped 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-shaped members 42. If some petal-shaped members 42 do not have adhesive 22, this may help limit the stretching of the skin 44. Similarly, petal-shaped members 42 with a less strong adhesive 22 may release the attached skin 44 patch if the force required to stretch the skin 44 exceeds a threshold. The petal-shaped members 42 themselves may be constructed such that at least one of the petal-shaped 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-shaped members 42 may bend or buckle in the relief region to relieve some of the tension on the skin 44.

[0268] 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.

[0269] 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. The slots 254 can help the delivery device 10 transition from the storage state to the delivery state while reducing pressure from above. The slots 254 extend radially with respect to the center point 256 of the top surface 250, with each first endpoint 258 enclosing a region including the center point 256 of the top surface 250, and each second endpoint 260 terminating at a certain distance (for example, the slots 254 are the same distance) from the periphery 340 of the top surface 250. In embodiments including the slots 254, the slots 254 may be arranged at regular angular intervals, but are not required. In embodiments including the slots 254 described herein, the slots 254 may be the same length, but are not required.

[0270] Referring to Figures 21A to 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 such as that shown in Figure 19. Although thermoformable body 20s are shown, the features described with respect to the thermoformed body 20 may be included in any body 20 manufactured in any desired manner. As shown in Figures 21A to 21I, the slots 254 may be provided in many different formats. Furthermore, in some embodiments, the slots 254 may not be included.

[0271] In some embodiments, as shown in Figure 22, the slots 254 may be positioned 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 embodiments, the slots 254 may be positioned at equal intervals around the top surface 250 and may each 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 positioned at different angles with respect to the radial direction. In some embodiments, the slots 254 may be relatively short and positioned around the periphery 340 of the top surface 250 and within the outer region of the top surface 250 (see, for example, Figure 21A). In other embodiments, the slots 254 may extend across the outer and intermediate regions of the top surface 250 (see, for example, Figure 21B). In yet another embodiment, the slots 254 may extend from the outer region of the top surface 250 into the central region of the top surface 250 (see, for example, Figure 21C). The curved slot 254 may help reduce the amount of pressure required to transition the delivery device 10 from the storage state to the delivery state. Positioning the slot 254 at a sharper angle to the radial direction may generally reduce this pressure. The width of the slot 254 may be slightly reduced during at least part of the transition from the storage state to the delivery state.

[0272] 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.

[0273] In some examples, the top surface may not include one or more slots 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 can enclose almost the entire upper surface 250.

[0274] 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-shaped members 42 of the body 20.

[0275] 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.

[0276] As shown in Figure 22, the central region 28 may be monolithically formed with petal-shaped 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-shaped 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 a housing for the reservoir 12 in the central region 28 (see, e.g., Figure 60), and in some embodiments, any packets 208 and / or containers 350 (see, e.g., Figures 10A–11), springs, or foam adhesive material. The housing may also be sized to accommodate a portion of an operating assembly or distribution assembly 480 (see, e.g., Figure 36). 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.

[0277] In some embodiments, as shown in Figure 23, at least one of the petal-shaped members 42 may be made to an extended length so that the outer end of the petal-shaped 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 and has a first rounded end and a second end opposite the first end, and is attached to the petal-shaped member 42. The second end may be attached to or formed integrally with the petal-shaped 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.

[0278] As shown in Figure 24, the pull tab 266 may also help facilitate the user peeling the release liner 265 from the bottom of the delivery device 10 before the delivery device 10 is applied to the skin surface via the adhesive 22. The release liner 265 can be removed in the same manner as peeling a release liner from a bandage before 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.

[0279] Referring to Figures 25 and 26, an example embodiment of a package 401 for a delivery device 10 is shown. Figure 25 depicts the delivery device 10 as it is housed within the package 401. The package 401 may include a first component 404 and a second component 406 (not shown in Figures 25-26, see, for example, Figure 104). The first component 404 may be a rigid component such as plastic. The second component 406 is a flexible component (e.g., an ethylene oxide (EtOx) permeable sheet) that can be peeled off from the first component 404 to access the delivery device 10. The interior of the package 401 may be a protected environment (e.g., an EtOx or other suitable sterile environment) until the second component 406 is removed from the first component. The second component 406 may be detachably bonded to an edge 403 included in the first component.

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

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

[0282] Referring to Figures 27-28 and 30A-30B, 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.

[0283] 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-shaped 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 to the base 262. In Figure 27, the delivery device 10 is shown in a retracted state. The delivery device 10 may include slots 36 that can be positioned between the petal-shaped members 42, as in other embodiments of the delivery device 10 described herein. Adhesive 22 (see, for example, Figure 24) may be attached to at least portions of at least two of the petal-shaped members 42.

[0284] Referring to Figure 28, 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 a support structure 252. The support structure 252 may be thickened in a region near the base 262 to form the ridge 290. This allows for easy formation of the ridge 290, for example, in an injection molding operation that forms the rest of the body 20. This can also provide the support structure 252 with 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 attached. Such a ridge 290 may be included in any embodiment of the delivery device 10 described herein. The reservoir assembly 12 and the ridge 290 will be described further elsewhere in this specification. Any embodiment including the ridge 290 may instead include a retaining tab 580 and a stop surface 582, as shown in Figures 79-80B.

[0285] 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. When the delivery device 10 is attached to the skin with adhesive 22 and pressure is applied to the delivery device 10 from above, for example by the user's fingertips, the delivery device 10 can transition to a delivery state. When the petal-shaped members 42 are pressed against the surface of the skin, the petal-shaped members 42 are displaced and spread outward, and at least a portion of the petal-shaped members 42 may curl upward due to the skin and / or the patient's body. Next, as the portions of the opposing petal-shaped members 42, each fixed to the skin surface by adhesive 22 (shown only in Figure 30A), separate from each other or are displaced and spread outward, the skin may stretch. When the delivery device 10 transitions to a delivery state, at least a portion of each of the curved petal-shaped members 42 may be curved further or with a narrower radius of curvature. Upon reaching the delivery state, the curvature of the petal-shaped 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-shaped 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-shaped 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-shaped 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 enhance the ability of the petal-shaped member 42 to curl upward. This causes the points 360 on the opposing petal-shaped members 42 (each fixed to the skin by adhesive 22) to spread and displace, which can facilitate 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.

[0286] In some non-limiting examples, the delivery device 10 may have dimensions and radii of curvature as shown in Figures 29A-29B when in its stowed state. 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.

[0287] Referring to Figures 27-28 and 30A-30B, 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.

[0288] Furthermore, as shown in Figures 27-28 and 30A-30B, 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).

[0289] Furthermore, referring to Figures 27-28 and Figures 30A and 30B, 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 can 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.

[0290] Referring primarily to Figures 33-35, 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 stored 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-shaped 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 can also take on an inverted shape due to the curling of the petal-shaped member 42.

[0291] 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 / project in substantially the same direction in both the stowed and delivered 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 27) 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.

[0292] Furthermore, as shown in Figures 33-35, the reservoir 12 may be formed as an assembly and may include a reservoir portion 271 and a holder 270 (see Figures 49-61B 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 holder 26 (see additional description with reference to embodiments in Figures 12-20 and 49-61B). 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-shaped members 42 may be constructed to incorporate a pull tab (not shown in Figures 33–35), such as the pull tab 266 described above with reference to Figure 23.

[0293] Referring now to Figure 36, 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. In some examples, the reservoir interface member 474 may be omitted, and the biasing members 470 may be in direct contact with the reservoir 12.

[0294] In some embodiments, the biasing member 470 may be unstressed when the associated delivery device 10 is in a retracted state. 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 of the delivery device 10 (e.g., defined on the body 20) 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.

[0295] In other embodiments, the biasing member 470 may be in a stressed state when the associated delivery device 10 is in a stowed state, 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 main body 20) and 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 can engage with the main body 20, for example, when the delivery device 10 is in the stowed state. User interaction with the delivery device 10 to transition it to the delivery state can disengage the press 472, allowing it to move freely. Once the press 472 is free to move, the biasing member 470 returns to a stress-free or at least low-stress state, allowing the reservoir interface member 474 of the distribution assembly 480 to be driven toward the reservoir 12. This causes the reservoir 12 to collapse, and the fluid is discharged from the reservoir 12 into the patient's body.

[0296] Referring next to Figures 39-38, a typical example of a delivery device 10 is shown, which includes a biasing member 470 that is not subjected to stress in the stored state. 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 in 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 in 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, rubber bodies, elastomers, etc.) may be used.

[0297] 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.

[0298] 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 33). This is not shown in Figures 39-38 for ease of explanation.

[0299] Referring to Figures 39 and 40, in certain embodiments, the delivery device 10 may include a biasing member 470 that is under stress while the delivery device 10 is in a retracted state. Referring to Figure 40, 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 can be made of any suitable material, and in some examples it may be made of elastic plastic or spring steel.

[0300] 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 27).

[0301] Referring here to Figures 41-43, 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 41. The press 472 may be rotated from a position or range of position that limits translational displacement (see, for example, Figure 41) to a position or range of position that allows translational displacement (see, for example, Figure 40). 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.

[0302] As best shown in Figure 45, 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 of which functions 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 39) 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.

[0303] The press 472 is shown in Figure 41 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 48, 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.

[0304] Referring to Figures 48 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 41). Thus, the biasing member 470 can be held under stress.

[0305] During the operation of the associated delivery device 10 from its stowed state to the delivery state, 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.

[0306] Referring here to Figures 48A-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 43). This may engage with the stopping member 473 instead of the body 20. As shown in Figure 48B, 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'.

[0307] 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.

[0308] As mainly shown in Figures 48C and 46D, the biasing member 470 may be a conical spring. When the delivery device 10 is in the stowed position 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 44-45. 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.

[0309] Referring now to Figure 47, 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 36) 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.

[0310] Furthermore, as shown in Figure 47, when the associated delivery device 10 is in the retracted state, the biasing member 470 may be in a stress-free state. Pressure does not need to be applied to the reservoir 12 in the retracted state. 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 the retracted state (e.g., 0.05 to 2 mm). Alternatively, the biasing member 470 may be in contact with the reservoir 12 but not pressing against it. When the delivery device 10 is used, it can transition to the delivery state as described elsewhere in this specification. As with the various embodiments described herein, when transitioning to the 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 retracted state. This causes 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 stowed 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 is restored, 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 sending fluid into the patient. Therefore, for example, pressure can be continuously 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, even without continuous manual pressure on the delivery device 10.

[0311] Referring here to Figures 48A-48B, exemplary embodiments of the body 20 and the body 20 with the biasing member 470 are shown, respectively. Figure 48A shows a bottom view of the body 20. Figure 48B 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 shown, the body 20 may include a number of positioning protrusions 471. In another embodiment, the positioning protrusions 471 may be replaced by circular or annular positioning walls. There may be a set of positioning protrusions 471 located in the central region of the top surface 250. A second set of positioning protrusions 471 may be spaced outward from the central region. In an exemplary embodiment, the second set 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 assembly of the delivery device 10. In certain examples, 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 48C). 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. The positioning projections 471 can also help ensure that the biasing member 470 transitions to a 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.

[0312] As shown here in Figure 48C, 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 48C, 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 477 may be spaced irregularly. 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.

[0313] Furthermore, in Figures 48A-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 48B, 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 48C).

[0314] Referring to Figures 49A and 49B, in other examples the biasing member 470 may be a block of compressible material (e.g., rubber or elastomer). The surface of the biasing member 470 adjacent to the reservoir 12 functions as a reservoir interface member 474, which in some embodiments may be substantially flat or planar. Thus, various delivery devices 10 may include a flexible reservoir interface member 474. The delivery device 10 depicted in Figures 49A and 49B is shown in its stowed state. As shown in the figures, the delivery device 10 may include a press 472 coupled to the upper surface 250 of the body 20. The upper surface 250 of the body 20 may have a funnel-shaped or trumpet-shaped form in some examples in the stowed state. Such an upper surface 250 may also be included in various other embodiments described herein. As shown in the figures, the press 472 includes a post 469. The post 469 penetrates the upper surface 250 of the body 20 and may be coupled to the upper surface 250 (e.g., via heat riveting, adhesive, or a dogged central opening 459). The press body 472 may further include a dish-shaped body 467 coupled to the post 469. The dish-shaped body 467 may be positioned on the upper surface 250 of the body 20. The dish-shaped body 467 provides an ergonomic position for the user to press when transitioning the delivery device 10 into the delivery state. When the delivery device 10 is in the delivery state, the upper surface 250 inverts sharply, and the biasing member 470 may be compressed against the reservoir 12. This encourages fluid to be discharged from the reservoir 12. In some embodiments, the biasing member 470 may be coupled to the end of the post 469 opposite to the dish-shaped body 467. For example, the biasing member 470 may include a receiving recess 465 (see, e.g., Figure 50) into which the end of the post 469 fits. Although the dish-shaped body 467 is depicted as a concave dish, it is not necessary for a dish-shaped body to be included in all embodiments. For example, in some embodiments, the dish-shaped body 467 may be replaced with a relatively flat body or plate.

[0315] Referring to Figure 50, an exploded view of a delivery device 10 similar to that shown in Figure 49B is shown. As shown in the figure, some delivery devices 10 may include a biasing member 470 made of an elastomer material such as silicone, whose width changes along the height direction. For example, the biasing member 470 may have a stepped shape. In the example shown in the figure, the biasing member 470 may include two steps. Furthermore, the biasing member 470 may include one or more hollow regions. In the example embodiment, the biasing member 470 includes a plurality of passages 463 that penetrate the biasing member 470 and form hollow regions. The passages 463 penetrate at least one step, both of which in this embodiment are located in the first step or base step of the biasing member 470. The passages 463 are evenly distributed around the biasing member 470, and in the example shown, the biasing member 470 is arranged to have a symmetrical plane. As previously stated, when the upper surface 250 of the main body 20 transitions from the storage state to the delivery state, the biasing member 470 can be compressed. When the biasing member 470 recovers from its compressed state, fluid may be discharged from the reservoir 12. The passage 463 can make the initial application of force more gradual and abrupt when the biasing member 470 applies force to the reservoir 12. This can ensure that the reservoir 12 is more robust in use and at the same time substantially empties during delivery.

[0316] Referring to Figures 51A-52, various views of the main body 20 and the press 472 are shown. The press 472 of the delivery device 10 may include a dish-shaped region 467' from which a skirt 461 extends. The skirt 461 may have a pair of ears 457 extending outward, as shown in Figure 50. The ears 457 may be spaced evenly apart. The dish-shaped region 467 may have a shape similar to the other dish-shaped regions 467 described herein. The skirt 461 may be sized to fit into the support structure 252 of the main body 20 when the delivery device 10 transitions from a stowed state (Figure 51A) to a delivery state (Figure 51B). Thus, the support structure 252 may act as a guide to suppress tilting of the press 472 and ensure that the press 472 is displaced along its axis when pressure is applied. When fully transitioned to the delivery state, the end of the skirt 461 opposite the dish-shaped region 467' is close to the petal-shaped member 42, but with sufficient space so as not to restrict the movement of the petal-shaped member 42. The presser may include a post 469, as best shown in Figure 52. The post 469 may extend through a dog-shaped opening 459 in the center of the upper surface 250 of the body 20. When the presser 472 is pulled away from the body 20, the dogs of the dog-shaped opening 459 rotate and bite into the post 469, preventing the presser 472 from separating from the rest of the delivery device 10. When the delivery device 10 is assembled, the post 469 may enter the receiving recess 465 of the biasing member 470.

[0317] In some embodiments, as shown in Figures 53A-D (perspective views from the top, side, bottom, and underside, respectively, of the application surface of the delivery device 10, such as the skin surface), an exemplary holder 270 for a sharp holder 26 (see, for example, Figure 33) containing a delivery sharp 72 (see, for example, Figure 33) 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 53B). Thus, the rounded recess 274 may form a projection protruding from the proximal surface of the holder 270.

[0318] The rounded recess 274 may include a pocket 276 formed therein. The pocket 276 may be formed on the proximal surface of the holder 270 (e.g., within a projection). The pocket 276 may be located at the center of the rounded recess 274 and at the lowest point (with respect to the skin surface when the delivery device 10 is fixed to the skin surface). The pocket 276 may be sized to fit into and receive a sharpener holder 26 having a delivery sharpener 72 on it, such as the sharpener holder 26 containing the delivery sharpener 72 in Figure 33. The sharpener holder 26 containing the delivery sharpener 72 may be fitted into the pocket 276 by, for example, injection molding or adhesive. The holder 270 may be overmolded around the sharpener holder 26 to bond its components together. 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 across 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.

[0319] 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.

[0320] Another exemplary holder 270 is shown in 54A–54C. 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 54A–54C. 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 46A) 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.

[0321] Referring further to Figures 54A-54C, the holder 270 may include at least one stepped projection 279. The stepped projection 279 may be included in addition to, or instead of, the rounded recess 272 and spherical segment of the embodiments described above in relation to Figures 53A-53D. The stepped projection 279 can provide a well 281 on the distal side of the tab projection 277. The stepped projection 279 may extend proximally beyond the tab projection 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 stepped projection 279 may typically extend at an angle perpendicular to the disk. The sidewall 283 of the stepped projection 279 may be chamfered so as to extend non-perpendicular to the proximal surface of the tab projection 277. The stepped projection 279 may include a pocket 276. The size of the pocket 276 may be such that it can be fitted and receive the sharp holder 26 with the delivery sharp 72, as described elsewhere in this specification.

[0322] Referring here to Figures 55A-55D, in some embodiments, the pocket 276 of the stepped projection 279 may be oriented non-parallel to the plane of the disk body 275. In Figure 55D, when the sharp holder 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 such that the delivery sharp 72 extends at an angle of 10-20° (e.g., 15°) with respect to a plane perpendicular to the disk body 275. In other embodiments, the pocket 276 is oriented such 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 stepped projection 279 can protrude from the disk body 275 at a desired angle. Thus, the delivery sharp 72 can extend at that angle when coupled to the pocket 276.

[0323] The sharp holder 26 can be attached to any of the holders 270 described herein during the molding process or by using an adhesive. When the sharp holder 26 is attached to any of the holders 270 described individually during molding, a portion of the material is molded to cover the sidewall 27 of the sharp holder 26 and extends to the surface where the delivery sharp 72 protrudes from the sharp holder 26, thereby capturing the sharp holder 26. It may have chamfers or angles that are not perpendicular to the surface. The footprint or cross-sectional area of ​​the sharp holder 26 may increase as the distance from the surface containing the sharp increases. If the delivery sharp 72 is made of silicon, typically multiple sets of delivery sharps 72 are formed on a large wafer, and sharp holders 26 containing a predetermined number of delivery sharps 72 are diced from the wafer. To form the chamfered sidewall 27, the dicing saw has an angled cutting edge, and as a result, the dicing process may create the desired chamfer or angle on the sidewall 27. In certain embodiments, sidewalls 27 with an angle of 30–60° (e.g., 45°) may be used. If chamfered sidewalls 27 are present, the material is molded only on a portion of the sidewalls 27, allowing the sharp retainer 26 to be coupled to the holder 270. This ensures that the sharp retainer 26 is captured by the holder 270 (or other molded parts, such as part of a delivery device or a syringe adapter connected to that delivery device via a Luer lock, etc.), while no material is molded onto the sharp-containing surface of the sharp retainer 26 (although this can be done if necessary). Thus, any molded material can act as a standoff on the sharp-retaining surface, preventing the entire length of the delivery sharp 72 from penetrating the skin.

[0324] In some embodiments, the reservoir portion 271 is shown as in Figures 56A–56D (a perspective view looking down from above, a side view, a perspective view looking up from below, and a top view, respectively, with respect 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 side 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. In some examples, the tunnel 282 may be formed as a semipipe or semicylinder that can be formed from the annular portion 284. In alternative embodiments, any suitable cross-sectional shape may be used. The side channel or tunnel 282 may communicate with the dome-shaped portion 280 via the arch 286 such that the combination of the dome-shaped portion 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 portion 280 may flare outward or taper to facilitate filling. The annular portion 284 may have an inner edge that coincides with the base outer circumference 288 of the dome-shaped portion 280. The reservoir portion 271 may be manufactured, for example, by thermoforming a flat sheet of material (e.g., plastic or layers of various plastics or other materials). If a multilayer sheet is used, the sheet may include drug or pharmacokinetic layers, barrier layers, binding layers, etc. In some embodiments, vacuum forming may be used to manufacture the reservoir portion 271. Other known techniques such as injection molding are also possible. The reservoir portion 271 can be formed from polycarbonate material or other suitable material and can be coated with cyclic olefin polymer (COP) or other suitable coating material. The dome-shaped section 280 can be folded when pressure is applied.

[0325] 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.

[0326] 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 36) or a portion of the biasing members 470, 481 (see, for example, Figures 37 and 48B, 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.

[0327] 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.

[0328] Referring to Figure 58, the wall 261 is stepped and may include at least one stepped region 259. The cross-sectional area of ​​the cavity varies in each stepped region 259. In this example, the cross-sectional area of ​​the cavity is largest adjacent to the flange 284 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, but in other embodiments, any number may be included. As in the example above, this stepped wall 261 may help reduce the force required to collapse the cavity and induce collapse in a predetermined manner. An example of a delivery device 10 including a reservoir 12 having such a stepped wall 261 is shown in Figure 49B. An example of a reservoir 12 with a stepped wall 261 is shown in Figure 78.

[0329] 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.

[0330] For example, a drug such as a vaccine can be inserted into the reservoir 12 through the side channel 282, and the side channel 282 can then be sealed by any known technique such as ultrasonic welding, thermal scribing, or any other suitable technique described herein. In another embodiment, the reservoir 12 may include a septum 550 (see, for example, Figures 76A-78) into which the drug is transferred. In such an example, the channel 282 may again be omitted, and the periphery of the flange 284 of the reservoir portion 217 may be completely sealed to the top surface 273.

[0331] The sharp holder 26 (see, for example, Figure 33), which includes the delivery sharp 72 (see, for example, Figure 33), 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, the holder 270 can be formed around the sharp holder 26. As described elsewhere in this specification, the delivery sharp 72 may be one or more microneedles in various examples.

[0332] In one exemplary embodiment, the reservoir 12 can hold approximately 2 microliters of vaccine or other 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 36) or at least one biasing member 470 (see, for example, Figure 47) may be positioned between the underside of the upper surface 250 and the reservoir 12.

[0333] 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.

[0334] Referring to Figure 60, in one embodiment, the raised portion 290 may be formed on the inner surface of the central region 28 of the delivery device 10, and as a result, the raised portion 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 raised portion 290 using an adhesive. Those skilled in the art will understand that any suitable bonding technique may be used. In other embodiments, the distal surface of the reservoir portion 271 may be attached to the proximal surface of the protrusion 290. The distal surface of the reservoir portion 271 may be coupled to the protrusion 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 54A) coupled to a receiving slit 278 (see, for example, Figure 48A) defined in the body 20 may be used as an alternative or additional feature. Instead of the protrusion 290, the body 20 may include a retaining tab 580 and a stop surface 582 (see, for example, Figures 79-80B) which can couple the reservoir 12 in place within the delivery device 10.

[0335] In certain embodiments, referring to Figures 61A-61B, the shape of the reservoir portion 271 can be adjusted to change the maximum cross-sectional area of ​​the reservoir portion 271. This can help achieve a desired discharge 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 crushes it when delivery is taking place.

[0336] 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 31), 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.

[0337] 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.

[0338] Referring to Figure 62, in such an embodiment, the reservoir 12 may be divided into a first portion 520 and a second portion 522. The first portion 520 and the second portion 522 may be in fluid communication with each other via a flow limiter 524 (see, for example, Figure 49B). 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, a flow limiter 524 with an orifice measuring 15–25 microns may be included. In other embodiments, the orifice may have a diameter of up to 100 microns (e.g., 70–80 microns or 75 microns). In some embodiments, the orifice may have a diameter greater than 100 microns. The size of the orifice may be selected based on considerations such as the viscosity and / or surface tension of the agent to be filled into 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 may also be formed by other suitable methods.

[0339] 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 upstream of at least the pocket 276 (see, for example, Figures 53A–54C) to which the sharp holder 26 can be coupled. In exemplary embodiments, the flow limiter 524 can separate the round recess 274 (see, for example, Figures 53A–53D) 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 54A–54C) 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 54A–54C).

[0340] In certain examples, the first portion 520 and the second portion 522 of the divided reservoir 12 may be filled with different fluids. For example, the first portion 520 may be filled with 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).

[0341] 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, foam, rubber, or elastomer). 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 36) or other components of the delivery assembly 280 (see, for example, Figure 36). A flow limiter 524 can slowly increase the pressure of the fluid in the second portion 522 of the reservoir 512 to the pressure at which injection to the patient begins. The flow limiter 524 can then limit the increase in pressure in the second portion 522 as the infusion progresses. Thus, injections tend to be performed at or near the minimum pressure at which the patient will accept the delivery. This may facilitate the use of stronger springs and reduce discomfort associated with delivery. 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. Additionally, this can influence blister formation due to delivery. Because delivery tends to be performed relatively slowly and at relatively low pressure, more diffuse, shallow (e.g., intradermal) injections tend to result. Adjusting the size of any orifice within the flow limiter 524 can alter the duration of delivery and the characteristics of the blister.

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

[0343] In some embodiments, parts of the delivery device 10 may be deformed or adjusted to adjust for the oscillation of the reservoir 12. The tilt of the reservoir 12 may cause the delivery sharp 72 to move along a non-linear trajectory. For example, the delivery sharp 72 may rotate or swing along an arc-shaped trajectory, at least in part, when the delivery device 10 transitions to the delivery state. In some embodiments, the tilt may occur automatically when the delivery device 10 transitions to the delivery state. Interlocking with guide elements or linkage mechanisms may not be required to achieve the tilt. For example, the presence of one or more oscillating members 526 may cause the entire reservoir 12 to tilt as a whole. Such tilt of the reservoir 12 may reduce the pressure at which injection is initiated and / or increase the delivery flow rate in certain embodiments of the delivery device 10. The presence of the oscillating members 526 may also affect the characteristics of bleb formation during delivery. Furthermore, the tilt may help to facilitate delivery if the delivery sharp 72 initially enters the skin nearly perpendicular to the skin.

[0344] Referring again to Figures 63A and 63B, the oscillating member 526 may be a projection protruding from the proximal surface of the holder 270. In some examples, the oscillating member 526 is located on or inside the periphery of the holder 270. The height of the oscillating member 526 may be approximately the same as the height of the stepped projection 279 (see, for example, Figures 54A–55D). The height of the oscillating member 526 can also be shorter or longer. Alternatively, if the holder 270 includes a rounded recess 274 (see, for example, Figure 53A), the oscillating member 526 may be set to the same height as the ridge corresponding to the rounded recess. In such embodiments as well, shorter or taller oscillating members 526 may be provided.

[0345] When the delivery device 10, which includes at least one oscillating member 526, transitions to the delivery state, the oscillating member 526 may come into contact with the user and prevent further movement of the portion of the reservoir 12 that includes the oscillating member 526. On the opposite side, where there is no oscillating member 526, the reservoir 12 may tilt or swing to continue moving toward the user. In certain examples, the delivery sharp 72 (e.g., a microneedle) may be tilted 3-5° (e.g., 4°) relative to its initial position. In other examples, the delivery sharp 72 may be tilted more or less. The height of the oscillating member 526 may affect when the delivery sharp 72 begins to rotate or swing as it transitions to the delivery state. An oscillating member 526 at the same height as the step 279 tends to begin tilting, for example, after the delivery sharp 72 has penetrated the skin.

[0346] In certain cases, the delivery sharp 72 may be a microneedle, as described herein. If the delivery sharp 72 is a microneedle, the oscillating member 526 may be positioned on the side of the reservoir 12 closest to the dorsal edge 23 of the microneedle. The oscillating member 526 may be positioned such that the dorsal edge 23 of the microneedle is the part (of the microneedle) closest to the oscillating member 526. As the reservoir 12 oscillates, the dorsal edge 23 of the microneedle may follow a path that penetrates the skin. As the slanted surface moves toward the dorsal edge 23, it can facilitate skin cutting when the microneedle is positioned. In this way, the dorsal edge 23 can become a cutting edge. Furthermore, the surface on which the exit of the flow path 126 of each microneedle is positioned may move away from the skin it contacts during initial insertion. For example, when using a microneedle as shown in Figure 2, the lumen 126 may move away from the skin that the slanted surface 21 contacts during initial insertion. Such movement of the microneedle can help ensure that fluid flows easily from the lumen 126 into the skin once delivery is made. Such movement can create a small receptive volume for fluid delivery from the lumen 126 into the skin. When the pressure applied to bring the delivery device 10 into the delivery state is released, the delivery sharp 72 may move slightly away from the patient. This can create a small receptive volume in the skin, causing the lumen 126 to move away from the skin it made contact with during initial insertion. The oscillating member 526 may help facilitate this movement.

[0347] As shown in Figures 55A-D and 63B, in some examples, the delivery sharp 72 may be mounted on a step 279 having a mounting surface (e.g., pocket 256) that is not parallel to the disc body 275 of the holder 270. In such examples, the delivery sharp 72 may extend from the step 279 at a predetermined angle (e.g., 15°) with respect to a plane perpendicular to the disc body 275. When the delivery device 10 is first applied to a user, the disc body 275 and the skin are usually parallel, so the delivery sharp 72 may be angled with respect to a plane perpendicular to the skin. As the reservoir 12 tilts, the delivery sharp 72 may move to a position close to perpendicular to the skin (e.g., 3-5°). Depending on the mounting angle of the delivery sharp 72, tilting the reservoir 12 may move the delivery sharp 72 to a position perpendicular or nearly perpendicular to the skin. In other embodiments, the delivery sharp 72 may be located at a position 10° or more (e.g., 11-12°) away from the vertical direction.

[0348] Referring again to Figures 63A-63B, in some examples the reservoir 12 may include at least one marking member. At least one marking member may come into contact with or be pressed against the skin when the delivery device 10 delivers the drug to the user. In some embodiments the oscillating member 526 may also function as a marking member, although a dedicated marking member may also exist. The marking member can also be used in embodiments that do not include the oscillating member 526. When the delivery device 10 is used, one or more marking members may leave a recognizable mark on the skin. This mark may be a temporary impression or indentation caused by the marking member pressing against the skin during delivery. Alternatively, or further, the marking member (e.g., the oscillating member 526) may have a marking agent (e.g., ink) which is transferred to the skin when the delivery device 10 is used. If the size of the contact surface of this marking member is known, the recognizable mark may function as a reference point. After the delivery device 10 is removed, the delivery site is imaged, and the image of the delivery site can be analyzed by the controller to identify (identify) a perceptible mark. In some cases, the image may need to be taken within a set time after the delivery device 10 is removed. The perceptible marking can help confirm that the delivery device 10 was used when identified in the image. Furthermore, the perceptible marking may help determine attributes related to delivery (e.g., the presence, size, area, and relative position of the bleb to the mark). For example, the controller may analyze an image area at a certain distance from the marking to confirm one or more attributes related to delivery, or to confirm that an attribute of interest conforms to an expected relationship with the mark (e.g., being within a distance range from the mark). The marks left by the marking member, and the placement of the marking member on the delivery device 10, can be selected to leave a perceptible mark with a specific pattern. Any suitable pattern can be used. This pattern may be selected to assist in image analysis or to provide a patient-friendly delivery confirmation mark (e.g., a smiley face).

[0349] Referring next to Figures 64A and 64B, an oblique view of the bottom surface of the delivery device 10 including the oscillating member 526 is shown (the adhesive member 22 is hidden). As shown, the oscillating member 526 may be a projection extending along the periphery of the disk body 275. The oscillating member 526 shown in the example in Figure 64A is arc-shaped, but the oscillating member 526 may also be linear, zigzag, wavy, winding, or extend along a different path. In other examples, as shown in Figure 64B, there may be multiple (two shown here, but more) oscillating members 526. The oscillating member 526 may be included as a set of bumps or projections protruding from the proximal surface of the disk body 275. The size and arrangement of the oscillating member 526 may be determined so that the oscillation and tilting of the reservoir 12 generally occur along a predetermined plane (for example, a plane containing or parallel to a predetermined displacement path taken by one or more delivery sharps 72 of the delivery device 10 when tilting occurs). The position and size of the oscillating member 526 may affect the characteristics of the breb formed during delivery by some delivery devices 10. For example, the oscillating member 526 in Figure 64A may promote a tendency for the breb to spread out in the left-right direction from the center of the oscillating member 526.

[0350] Referring to Figure 65, a flowchart 600 is drawn showing several exemplary actions performed to deliver the drug from the delivery device 10 to the injection site. As shown, in block 602, the adhesive backing paper 265 (see, for example, Figures 24 and 26) may be removed from the delivery device 10. Furthermore, in block 602, the cover protecting the delivery sharp 72 (for example, cover 409 in Figure 26) may be removed from the delivery device 10. In block 604, the delivery device 10 may be positioned at the desired injection site.

[0351] Referring to Figure 66, in block 606, pressure may be applied to the delivery device 10. In some examples, pressure may be applied to the upper surface 250 of the body 20 of the delivery device 10. Alternatively, as shown in the illustration in Figure 66, pressure may be applied to the pressing body 472 (e.g., the disc-shaped body 467) of the delivery device 10. The pressure may be applied manually, for example, with a single finger of the user.

[0352] Referring primarily to Figures 65 and 67, in block 608, the skin may be stretched when the delivery device 10 is attached to the skin via the adhesive 22. The skin may be pulled and stretched as at least two parts of the delivery device 10 deform and spread out from their initial state. For example, this may occur when the petal-shaped member 42 of the main body 20 deforms as pressure is applied to the delivery device 10. As the petal-shaped member 42 deforms as described here, the reservoir 12 and delivery sharp 72 coupled to it move toward the skin. In block 610, the delivery sharp 72 may penetrate the skin and tilt arbitrarily (for example, due to the presence of the oscillating member 526, see Figures 63A-64B and related descriptions). As shown in Figure 67, the upper surface 250 of the delivery device 10 may resist deformation, at least in the initial stages when the petal-shaped member 42 begins to spread out.

[0353] The petal-shaped member 42 may be configured to have a selected stiffness so that this action occurs. For example, the petal-shaped member 42 may be substantially flat and protrude from the rest of the delivery device 10 at a certain angle (see Figures 70A-70B). This allows the petal-shaped member 42 to flex relatively easily when pressure is applied to the delivery device 10. In another embodiment, the petal-shaped member 42 may be curved in at least some areas. The curvature of the petal-shaped member 42 may be selected so that at least a predetermined amount of deformation occurs in the petal-shaped member 42 before the upper surface 250 deforms. In a preferred embodiment, the body 20 is configured so that the petal-shaped member 42 deforms sufficiently to stretch the skin and the delivery sharp 72 can be inserted into the skin before the upper surface 250 is substantially deformed.

[0354] Referring primarily to Figures 65 and 68, in block 612, the upper surface 250 of the main body 20 can change from a protruding state to a recessed state or invert. In block 612, liquid can be discharged from the reservoir 12. As described here, when the upper surface 250 inverts, the biasing member 470 can be compressed. As the biasing member 470 returns to its original shape (less modified shape), liquid is delivered from the reservoir 12 to the injection site through the delivery sharp 72. In embodiments including a press body 472 with a dish-shaped body 467, as shown in Figure 68, the dish-shaped body 467 may come into contact with the end of the support structure 252 when the upper surface 250 inverts. When the upper surface 250 inverts, the dish-shaped body 467 may obstruct its view and provide a visual cue that the delivery device 10 has been used (see also Figure 69).

[0355] Referring mainly to Figures 65 and 69, in block 614, pressure may be released from the delivery device 10 and a predetermined time may be allowed to elapse. This time may be set to be at least equivalent to the expected delivery time, and preferably longer. In some examples, the waiting time is 1 to 5 minutes.

[0356] As shown in Figure 69, when the pressure is removed, a portion of the delivery device 10 may return to its original shape from a state that is at least partially deformed. This means that the main body 20 may have at least one reversible region, at least one elastic region, and at least one region that elastically deforms as the delivery device 10 transitions to the delivery state. The at least one elastically deformable region may deform from an initial state to an intermediate state, and then return at least partially to its original shape from the intermediate state during the transition to the delivery state. The intermediate state may be the state in which the region is maximally deformed. This region may return from this state to the initial state. For example, the petal-shaped member 42 may return at least partially to its original shape. Because the petal-shaped member 42 of the delivery device 10 is adhered to the skin via the adhesive 22 of the delivery device 10, when the petal-shaped member 42 returns to its original shape, the skin may be pulled away from the anatomical structure beneath it. As the petal-shaped member 42 returns to its original shape, the reservoir 12 may also move slightly away from the skin (the rocking member 526 may assist in this, see, for example, the discussion in Figures 63A-64B). If adhesive 22 is present in part of the reservoir 12 (e.g., the holder 270), the skin may also be pulled away from the underlying anatomical structure as the reservoir 12 moves. This may partially relieve the pressure on the injection site and prevent the anatomical structure at the injection site from being compressed. This reduction in pressure at the injection site may make it easier for the fluid to move from the delivery sharp 72 to the destination. Furthermore, depending on the orientation of the delivery sharp 72, it may pull up the skin through which it has penetrated, resulting in the skin being pulled away from the underlying anatomical structure. Again, this may reduce the compression of the anatomical structure at the destination and facilitate delivery. The shape of the petal-shaped member 42 and the materials used for the construction of the main body 20 may be selected to facilitate the petal-shaped member 42 returning to its original shape, at least partially, when the pressure is relieved.

[0357] In block 616, the delivery device 10 may be removed from the injection site. In some embodiments, delivery may be confirmed in block 618. In some embodiments, this confirmation may be performed manually. Staff at the vaccination site or clinic may visually confirm the presence of a bleb (swelling) and no leakage after injection. In other embodiments, images of the injection site may be taken, analyzed, and documented as electronic records (details of which are provided elsewhere). Image analysis may be performed, for example, to determine whether expected markings are present at the injection site or whether the image shows any characteristics of interest (or a desirable relationship with reference markings). In other examples, images may be analyzed to check for the presence of a cold area on the skin (see, for example, Figure 107 and related descriptions).

[0358] Referring to Figures 70A-70B and 72A-72B, two exemplary bodies 20 used in the various delivery devices 10 described herein are shown, respectively. When the delivery device 10 is injection molded, parts of the body 20 may be injection molded in either a retracted or delivered state. Parts of the body 20 may have a tendency to easily transition to or return to a molded state. Such parts may also have a tendency to remain in a molded state. In the example of Figures 70A-70B, the top surface 250 is molded in the delivered state position. The petal-shaped member 42 is molded in the retracted state position. During the assembly of the delivery device 10, various parts of the body 20 may be positioned in a retracted state and remain in that state until use. By molding the top surface 250 in the delivered state, the effort required to transition the delivery device 10 from the retracted state to the delivered state can be reduced. Similarly, by molding the petal-shaped member 42 in the retracted state, the petal-shaped member 42 is more likely to return to the retracted state when pressure is released from the delivery device 10 during use (see Figure 69 and related explanations).

[0359] As mentioned above, in certain embodiments, the petal-shaped member 42 may not be relatively curved. For example, the petal-shaped member 42 may be nearly flat and / or extend at a certain angle from the rest of the body 20. This may result in a relatively low force required for the petal-shaped member 42 to flex when pressure is applied to the delivery device 10, facilitating the spreading displacement of the petal-shaped member 42 and helping to ensure that the delivery sharp 72 penetrates the skin before the upper surface 250 of the body 20 deforms.

[0360] As shown in Figures 70A-70B, the exemplary petal-shaped member 42 of the main body 20 includes a first region 620 adjacent to the support structure 252 and a second region 622 that forms the more peripheral portion of the petal-shaped member 42. As shown in the figures, the first region 620 may be arch-shaped, similar to the adjacent portion of the support structure 252. The second region 622 may be positioned at a certain angle with respect to the central axis A1 of the main body 20. The second region 622 may form the majority of the petal-shaped member 42. In some examples, the petal-shaped member 42 may be mostly flat, although it may have curved regions or surfaces. In various embodiments, a small curved transition 621 may be included between the first and second regions 620, 622 of the petal-shaped member 42 (see, for example, Figure 71).

[0361] A living hinge may be formed in the transition area between the first and second regions 620, 622. When pressure is applied to the upper surface 250 of the main body 20, the living hinge allows the second region 622 of the petal-shaped member 42 to move relative to the first region 620. While the delivery device 10 transitions to the delivery state, the first region 620 may deform less than the second region 622. In some examples, the first region 620 may resist large deformations and remain almost undeformed during the transition. Thus, the first region 620 may act as a stop, helping to limit the spreading displacement of the petal-shaped member 42 after the desired amount of spreading displacement has been achieved. The curved transition section 621 may be included to facilitate the petal-shaped member 42 returning to its original shape, at least partially, after the pressure applied to the delivery device 10 is released. In examples including the petal-shaped member 42 as shown in Figures 70A-70B, it may be desirable that, in the stowed state, the base of the stepped projection 279 be at approximately the same height as the end of the second region 622 of the petal-shaped member 42 closest to the central region 28.

[0362] The main body 20 may have a rounded, nearly circular footprint, as shown in Figures 70A-70B. The portions of each petal-shaped member 42 on the periphery 38 of the main body 20 may be arched along a radius radiating from the n-axis A1 of the main body 20. As shown in Figures 72A-72B, in various examples, the width of the portions of the petal-shaped members 42 forming the periphery 38 may narrow as they move away from the center 28 of the main body 20. For example, the portions of the petal-shaped members 42 forming the periphery 38 of the main body 20 may not be arches along a radius extending from a center point within the central axis A1 of the main body 20. For example, the radius defining the periphery of each petal-shaped member 42 may extend from a center point inside the petal-shaped member 42 or its second region 622. The outermost region of each petal-shaped member 42 is located further from the center 28 than the edge of the slit 36 ​​furthest from the center 28. The outermost region may narrow as it moves away from the center 28. In some cases, the portion forming the periphery 38 of each petal-like member 42 may taper or round, as shown in Figures 72A-72B.

[0363] This may make removal easier when removing the delivery device 10, as it reduces the surface area of ​​adhesive that the user attempts to peel off the skin during the initial removal operation. Although each petal-shaped member 42 is described as having the same shape, there may be at least one petal-shaped member 42 with a slightly different shape to include a pull tab 266 (e.g., see Figure 72B) which may be included to assist in the removal of the delivery device 10.

[0364] Figures 73A–73G show various viewpoints of parts of an exemplary delivery device 10. Figures 74A–75G also show various viewpoints of the exemplary delivery device 10. As shown, compared to a typical syringe or needle-based injection, the type of delivery device 10 shown herein is decorative, which can make it, for example, more approachable. This can be particularly effective for groups prone to needle phobia, such as children. In some examples, parts of the delivery device 10 may be shaped and colored to resemble a flower (e.g., a daisy). The press 472 (and possibly at least part of the central part 28 of the body 20) may have a first appearance (e.g., color, material, pattern), and at least the petal-like members 42 of the body 20 may have a second appearance (e.g., color, material, pattern) that differs from the first appearance. The press 472 may resemble, for example, the central part of a flower. The petal-like members 42 may have a petal-like appearance. As shown by the dotted lines in Figures 73A-75G, the delivery device 10 or its parts may include decorative elements, even if certain features differ or are omitted. Furthermore, the delivery device 10 and its parts shown and described in relation to Figures 73A-75G have decorative elements even when isolated (e.g., the press 472, the main body 20, the periphery 30 of the main body 20, the petal-shaped members 42, the set of petal-shaped members 42). Furthermore, the delivery device 10 and its parts shown and described in relation to Figures 73A-75G may be modified, for example, to increase or decrease the number of petal-shaped members 42. In some implementations, the petal-shaped members 42 are divided by slits in the periphery 30 as shown in Figure 73A-75G, but the size of the petal-shaped members 42 may vary to accommodate a desired number of petal-shaped members 42. In such examples, the petal-shaped members 42 have the same cross-sectional shape as shown in the figure, but their cross-sectional shape may rotate along a larger or smaller arc depending on the number of petal-shaped members 42. The gaps between the petal-shaped members 42 formed by the slits in the peripheral portion 30 may be wider or narrower in another embodiment.

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

[0366] An exemplary reservoir 12 includes a reservoir portion 271 with a wall 261 having a structure that promotes collapse (see, for example, Figures 57-58). In the exemplary embodiment, the wall 261 includes a plurality of stepped regions 259, as described in relation to Figure 58. Thus, the wall 261 has a stepped appearance. The main internal volume of the exemplary reservoir 12 has a stepped pyramidal or ziggurat-shaped volume. The reservoir 12 is shown in a filled state. The holder 270 includes a stepped projection 279 (further described in relation to Figures 55A-D) and a rocking member 526 (further described in relation to Figures 63A-64B).

[0367] In the example shown, the side channels 282 of the reservoir portion 271 are sealed by heat-crimping the material of the reservoir portion 271 to the holder 270. The portion of the side channels 282 at the periphery of the flange 284 is sealed to the holder 270, while the rest of the side channels 282 remains open. In alternative embodiments, the reservoir portion 271 may not include the side channels 282. During manufacturing, the entire periphery of the flange 284 may be bonded to the disk body 275. In certain examples, the walls 261 forming the cavity within the reservoir portion 271 may include branches or nodes that extend away from the main portion of the cavity.

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

[0369] Referring to Figures 77-78, an exemplary reservoir 12 can be filled by establishing a fluid connection between the internal fluid-holding volume of the reservoir 12 and a filling device (not shown). In various examples, a filling device such as a syringe may be used and may include a dispensing sharp 570. The dispensing sharp 570 passes through the septum 550, and the fluid is transferred from the filling device to the internal volume of the reservoir 12 via the dispensing sharp 570. An adhesive member 22 on the delivery device 10 (see, for example, Figures 81A-C) may include an open area to allow access to the septum 550 via the dispensing sharp 570, or may be coupled to the delivery device 10 after filling. After the desired amount of fluid has been transferred to the reservoir 12, the dispensing sharp 570 is withdrawn from the septum 550. The septum 550 is made of a self-sealing material and, after the dispensing sharp 570 is withdrawn, the septum 550 provides a tight seal between the internal volume of the reservoir 12 and the external environment. In some cases, a vacuum may be drawn from reservoir 12 via a filling device before the fluid is transferred to reservoir 12 (for example, by pulling the plunger of a syringe). The dispensing sharp 570 is removed from septum 550, and the gas drawn out of reservoir 12 is discharged from the filling device. This minimizes the amount of gas present in reservoir 12 before filling.

[0370] In some examples, the reservoir 12 may include a guard to prevent the tip 572 of the dispensing sharp 570 from coming into contact with the reservoir portion 271. This guard helps keep the reservoir portion 271 away from the dispensing sharp 570 when filling the reservoir 12. The guard may, for example, prevent a portion of the reservoir portion 271 from moving into the sharp-receiving area where the tip 572 of the dispensing sharp 570 is positioned during filling.

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

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

[0373] When installed within the reservoir 12, the lateral channel 282 (or branch or node from the main cavity of the reservoir 12) formed within the reservoir portion 271 may be prevented from moving into the recessed channel 564 by the rest of the standoff 554. The portion of the standoff 554 adjacent to the recessed channel 564 may hold the reservoir portion 271 above the recessed channel 564. In this way, the recessed channel 564 forms a sharp-receiving space within the reservoir 12. The tip 572 of the distributing sharp 570 may be kept away from the material forming the reservoir portion 271 as it moves into the recessed channel 564.

[0374] In some embodiments, the adapter 566 is used with any suitable filling device to prevent the dispensing sharp 570 from advancing beyond a certain distance within the septum 550. The adapter 566 can be coupled to a hub 568 to which, for example, a filling device or a dispensing sharp 570 is attached. The adapter 566 can extend along a portion of the dispensing sharp 570, shortening the exposed length of the dispensing sharp 570. The adapter 566 can contact or bottom out to the reservoir 12 when the dispensing sharp 570 is inserted into the septum 550, preventing the dispensing sharp 570 from advancing further into the septum 550. The adapter 566 can restrict the tip 572 of the dispensing sharp 570 from moving out of the recessed channel 564. In alternative embodiments, the adapter 566 may be omitted. The dispensing sharp 570 may have an exposed length (e.g., extending from the hub 568) that is shorter than the height of the septum 550 but longer than the distance between the first end 556 of the septum 550 and the nearest point of the recessed channel 564. Therefore, during insertion, the tip 572 of the distribution sharp 570 may be positioned within the recessed channel 564.

[0375] Referring to Figure 79, the exemplary reservoir 12 shown in Figures 76A-78 is shown to be incorporated into the exemplary delivery device 10. Depending on the embodiment, the reservoir 12 may be filled while attached to the delivery device 10, or it may be attached to the delivery device 10 after it has been filled. If the reservoir 12 is filled separately from the delivery device 10, the user can attach the reservoir 12 to the delivery device 10 after filling, and then bond the adhesive member 22 to the delivery device 10. If the delivery device 10 is filled in a pharmacy or the like, a jig may be provided to assist in positioning when bonding the adhesive member 22 to the delivery device 10.

[0376] Referring to Figures 80A-80B, the body 20 of the delivery device 10 may include one or more retaining tabs 580. The retaining tabs 580 may form a ledge extending from the inner side wall of the body 20 and be spaced apart from each stop surface 582 on each retaining tab 580. In various examples, the body 20 may be formed in a single molding operation without using lateral operations of the mold, as a single monolithic body including the retaining tabs 580 and stop surfaces 582. The retaining tabs 580 may be created by incorporating a bypass shutoff into the mold. The retaining tabs 580 may allow the reservoir 12 to be snap-fitted to the body 20. To attach the reservoir 12 to the delivery device 10, the reservoir 12 can be pressed against the underside of the retaining tab 580 (the side closest to the patient when the delivery device 10 is in use) and pushed toward the top surface 250 of the body 20. The retaining tab 580 may bend to allow the disk body 275 of the reservoir 12 to pass over the retaining tab 580 and collide with the stop surface 582. The retaining tab 580 elastically returns to its original shape, securing the reservoir 12 within the delivery device 10. The retaining tab 580 and the stop surface 582 can be incorporated into various delivery devices 10 described herein (e.g., any of those described above). Embodiments including a raised portion 290 (e.g., see Figure 28) may be modified to include the retaining tab 580 and the stop surface 528 instead of the raised portion 290. Referring here to Figures 81A–81C, 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 alternative embodiments, the adhesive member 22 may be disassembled or broken into multiple individual adhesive members 22. This facilitates the use of different adhesives or prevents adhesive from being left missing on certain petal-shaped members 42. As shown in the figure, each adhesive member 22 may include a plurality of slits 43 extending radially inward from the periphery of the adhesive member 22 in order to form a petal portion that aligns with the petal-shaped member 42 of the main body 20. The adhesive member 22 may also include a central opening 49 through which the delivery sharp 72 of the delivery device 10 can access the patient.

[0377] The shape and size of the central opening 49 may affect blister formation resulting from delivery when the delivery device 10 is used. 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).

[0378] 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.

[0379] Referring primarily to Figure 81A, the central opening 49 may be a generally round (e.g., circular) opening, except for a number of inwardly extending teeth or spokes 51 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 certain 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. The central opening 49 may have a relatively large width in this direction, but 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 certain 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.

[0380] Referring primarily to Figures 81B-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.

[0381] As described above, various main bodies 20, petal-shaped members 42, central regions 28, upper surfaces 250, raised portions 290, and retaining tabs 580 are described. Please understand that the various delivery devices 10 described herein are illustrative. Any of the main bodies 20 described herein can be used in any of the delivery devices 10 described above. Similarly, any feature of the main body 20 described herein can be incorporated into the main body 20 described herein. The various adhesive members 22 described herein can also be used in any of the delivery devices 10 described herein. Any of the delivery sharps 72 or sharps holders 26 described herein can be used in the delivery devices 10 described herein. In addition, the distribution assemblies 480 described herein and parts thereof (e.g., biasing members 470, pressing members 474) can also be used in any of the delivery devices 10 described herein. Furthermore, the aforementioned reservoir 12 and its features (e.g., holder 270, oscillating member 526, reservoir portion 271, reservoir wall 261, stepped projection 279, flow limiter 524) can also be used in the above-mentioned delivery device 10.

[0382] Referring here to Figures 82A and 82B, 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 holder 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.

[0383] 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.

[0384] 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.

[0385] As shown in Figures 83A to 83C, the connecting portion 60 may be displaceable from a raised position (see Figure 83A) to a center position (see Figure 83B) and then to an upper center position (see Figure 83C). When the delivery device 10 is in the retracted position, 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. Angle 62 can be selected such that as the distance from the raised projection 56 increases, the intermediate panel 52B gradually moves away from the plane of the planar portion 54. In the illustrated example, when the connecting portion 60 is in the raised position, 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.

[0386] The delivery device 10 can be applied to the skin 44 on the injection site in a stowed state with the connecting portion 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 connecting portion 60 can displace it 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 connecting portion 60 reaches the center position (see Figure 83B), 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.

[0387] 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 83C, 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.

[0388] When the delivery device 10 is in the delivery state (see Figure 83C), the delivery sharp 72 can be pressed into the skin 44 to create a hole in 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 83C) 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 83C) 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.

[0389] In some embodiments, the proximal surface of the intermediate panel 52C may be at least partially covered with adhesive 22 (see, for example, Figure 83C). 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.

[0390] 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.

[0391] 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 84A-84B. 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 two associated 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 84B, 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.

[0392] In other embodiments, the intermediate panel 52C may incorporate at least one flexure 292, which may be in the form of a crushable body that 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 85A-85B, 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.

[0393] In some embodiments, after the delivery device 10 transitions from a stored 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 stored state, one or more of the living hinges 50 may break. Thus, the transition from the stored 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.

[0394] Referring now to Figures 86-87, 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 holder 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.

[0395] 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.

[0396] 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.

[0397] In the exemplary embodiments shown in Figures 86-87, hinges 74A-F are shown as living hinges. In alternative embodiments, at least one of hinges 74A-F may be a conventional hinge, and 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.

[0398] 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 stowed state (shown in Figures 86-87) and a delivery state. In the stowed state, the side panels 71A and 71B of the delivery device 10 may be in an outward-curved 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-curved 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-curved position.

[0399] 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.

[0400] The bridge 76 may also be displaceable over a displacement range to transition the delivery device 10 between a stowed state (shown in Figures 86-87) and a delivery state. In the stowed state, the bridge 76 may be in a raised state in which at least the delivery sharp portion 72 of the reservoir 12 coupled to the arm member 82 is 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. There is also 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 the support columns 80A and B, which allows 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.

[0401] In various embodiments, when the bridge 76 is actuated over its displacement range, the delivery device 10 can transition from a stowed state to a delivery state. Furthermore, when the side panels 71A and B are actuated from an outwardly bent state to a straightened state, the delivery device 10 can transition from a stowed 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.

[0402] 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 successful penetration of the delivery sharp 72 into 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.

[0403] Here, as shown in Figures 88A-88C, when the side panels 71A and B are in an outwardly curved position and the bridge 76 is in an elevated position (see Figure 88A), 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 88B-88C), 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 88C, 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 enter a delivery state. 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.

[0404] Referring here to Figure 89, a cross-sectional view of the delivery device 10 in Figures 86-87, 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 89, when the delivery device 10 is in the stowed position, the opening 88 can be substantially closed. Thus, 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.

[0405] In an exemplary embodiment, one of the iris panels 86A includes a latch projection 90. Another panel 86B of the iris panel 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 88B). 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.

[0406] Referring here to Figures 90A-90B, 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 stowed state (see Figure 90A) to a delivery state (see Figure 90B). 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 stretched and / or elongated. In certain examples, the transition to the delivery state may be reversible, but in other embodiments, the transition may be an irreversible unidirectional transition. For example, a latch, lock, or other coupling can be engaged to hold the first and second parts 100, 102 in the delivery state or to prevent them from returning to the stored state. Alternatively, the first part 100 and the second part 102 may be coupled to each other when the delivery device 10 transitions to the stored state. Once the delivery device 10 transitions to the delivery state, coupling or uncoupling between the first part 100 and the second part 102 may require the destruction of a part 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.

[0407] 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 the retracted state 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.

[0408] 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 into the target site for delivery 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.

[0409] Referring here to Figures 91-92, 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.

[0410] Referring here to Figures 93-94, 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 the stowed state, the tether member 118 can be at least partially duplicated.

[0411] 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.

[0412] 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.

[0413] As shown in Figure 93, 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 holder 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 region 122 of the proximal portion 110 may include a delivery opening 124. As shown, when the delivery device 10 is in the retracted position, 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 the retracted position. 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.

[0414] Referring here to Figures 95A-96B, a tensile force can be applied to the pull tab 120 to transition the delivery device 10 from the stored state to the 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 the stored state to the delivery state. As shown, the folded region 122 of the proximal portion 110 can expand 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.

[0415] 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.

[0416] 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 96A and 96B. The delivery device 10 can enter a delivery state once the cantilever arm 130 has separated 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 site for delivery. 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.

[0417] As shown in the figure, the tether member 118 can be detached from the locking adhesive 116 when the delivery device 10 transitions from the storage state to the delivery state. Once the delivery device 10 reaches the delivery state, the tether member 118 can be 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.

[0418] Referring next to Figures 97-100, another exemplary embodiment of the delivery device 10 is shown. Figure 97 shows the exemplary delivery device 10 in a retracted state. Figure 98 shows the exemplary delivery device 10 in a delivery state. Figures 99 and 100 are exploded views of the exemplary delivery device 10. As shown, the exemplary delivery device 10 may include an actuator. In some embodiments, the actuator may form a top 306 or cap having at least one recess or 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 user twisting the top 306 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.

[0419] 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.

[0420] 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 in the illustrated example, the adhesive pad 312 may be annular in shape. In some embodiments, the adhesive pad 312 may be ultrasonically welded to the delivery device 10. Those skilled in the art will understand that other suitable techniques may be used to bond the adhesive pad 312 to the delivery device 10.

[0421] After attaching the delivery device 10 to the skin, the user can advance the top 306 of the delivery device 10 proximal (for example, toward the skin) along the threads of the screw 310 by twisting the top 306. 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.

[0422] 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 99) located within the bore 317, which may help guide the displacement of the carriage 315 within the bore 317.

[0423] The top 306 may incorporate a central 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.

[0424] 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.

[0425] 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.

[0426] 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 on its underside is a sharp holder 26 (e.g., see Figure 33) containing at least one delivery sharp 72 (e.g., see Figure 33).

[0427] 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.

[0428] 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 33) 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 98. 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.

[0429] 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.

[0430] Referring to Figures 101-103, exemplary embodiments of such portions of the working 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 w...

Claims

1. A delivery device for delivering drugs to a barrier, A main body comprising a central region defining a housing portion, a peripheral region defined by a plurality of petal-shaped members, and a set of retaining tabs extending to the housing portion, A reservoir comprising at least one delivery sharp, a main internal volume, and at least one septum in fluid communication with the main internal volume, coupled to the body via the retaining tab, The adhesive bonded to the main body, In the housing section, at least one biasing member is located between the reservoir and the wall of the housing section, Delivery device

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

3. The delivery device according to claim 1, wherein the main body is configured to transition from a first state to a second state, and the reservoir is configured to be displaced toward the barrier when the main body transitions from the first state to the second state.

4. The delivery device according to claim 3, wherein the biasing member is configured to deform when the main body transitions from a first state to a second state, and after the biasing member deforms as the main body transitions from a first state to a second state, it is configured to return to its original state relative to the reservoir and push fluid out from the at least one delivery sharp.

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

6. The delivery device according to claim 1, wherein the main internal volume is formed by a wall containing at least one disintegration accelerator.

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

8. The delivery device according to claim 7, wherein the at least one hollow portion is formed by a passage that penetrates the biasing member.

9. The delivery device according to claim 1, wherein the biasing member is formed of an elastomer material and has a first layer and a second layer having putprints of different areas.

10. The delivery device according to claim 1, wherein the reservoir includes a Sharp receptor space.

11. The delivery device according to claim 1, wherein the reservoir includes a guard defined at least partially by a septum.

12. The delivery device according to claim 1, wherein the fluid path from the main internal volume to the septum is included in the reservoir.

13. The delivery device according to claim 1, further comprising a septum including a plug portion disposed in a liquid-tight manner within an opening that penetrates the rigid portion of the reservoir.

14. The delivery device according to claim 1, comprising a septum including a portion disposed within the fluid-containing portion of the reservoir, wherein the fluid-containing portion is formed such that two raised portions sandwich a recessed channel.

15. The delivery device according to claim 1, wherein the reservoir includes a rigid portion and a flexible portion coupled to the rigid portion, and the delivery device further includes a septum having a first portion disposed in a passage through the rigid portion and a second portion having a recessed channel, the septum being configured to prevent the flexible portion from being displaced into the recessed channel.

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

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

18. The aforementioned reservoir is filled with COVID-19 vaccine. The delivery device according to claim 1.

19. The reservoir further comprises a projection that is closer to the periphery of the reservoir than at least one delivery sharp. The delivery device according to claim 1.

20. The delivery device according to claim 19, wherein the main body is configured to transition between a first state and a second state, the reservoir is configured to be displaced toward the barrier when the main body transitions from the first state to the second state, and the protrusion is configured to tilt the reservoir when the main body transitions from the first state to the second state.

21. The delivery device according to claim 1, wherein the main body is formed integrally with the retaining tab by an injection molding operation that does not involve lateral movement.

22. The delivery device according to claim 1, wherein the main body includes a series of stopping members associated with the retaining tab.

23. A delivery device for delivering fluid into a barrier, The main unit and An adhesive is provided on at least a portion of the main body for attaching the delivery device to the barrier, A reservoir coupled to the main body and including at least one delivery sharp, the reservoir including a main internal volume for holding fluid and a septum that is in fluid communication with the main internal volume, A delivery device comprising a body configured to transition between a first state and a second state, wherein the reservoir is configured to be displaced toward the barrier when the body transitions from the first state to the second state.

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

25. The delivery device according to claim 24, wherein the projection is configured to tilt the reservoir when the main body transitions from the first state to the second state.

26. The delivery device according to claim 23, wherein the main internal volume is at least partially collapsible.

27. The delivery device according to claim 23, wherein at least two portions of the main body on which the adhesive is placed are configured to expand and displace when the main body transitions from the first state to the second state.

28. The delivery device according to claim 23, wherein the main body includes a central region and a peripheral region having a plurality of petal-shaped members extending outward from the central region, and the central region defines a housing portion for housing at least a part of the reservoir.

29. The delivery device according to claim 23, wherein the reservoir includes at least one rigid portion and at least one flexible portion.

30. The delivery device according to claim 23, wherein the reservoir includes a guard for protecting a portion of the reservoir from contact with the dispensing sharp that penetrates the septum.

31. The delivery device according to claim 30, wherein the guard is at least partially defined by the septum, forming a sharp-receiving space within the reservoir.

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

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

34. The delivery device according to claim 23, wherein the septum includes a plug portion and a standoff extending from the plug portion, and the standoff is configured such that two raised portions sandwich a recessed channel.

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

36. The delivery device according to claim 23, wherein the at least one delivery sharp includes at least one microneedle.

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

38. The delivery device according to claim 23, wherein the reservoir further includes a marking member.

39. A delivery device, The main body includes a central region and a peripheral region having a plurality of petal-shaped members extending from the central region, the central region defining a housing section and having an upper region and a base connected by a wall, A variable-volume reservoir comprising at least one delivery sharp and at least one septum communicating with the main internal volume of the reservoir, coupled to the body and at least partially located within the housing, An adhesive placed on at least a part of the main body, A delivery device, including a delivery device.

40. The delivery device according to claim 39, wherein the reservoir further includes at least one protruding member that is closer to the periphery of the reservoir than at least one delivery sharp.

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

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

43. The delivery device according to claim 39, wherein the reservoir includes a planar body from which a step protrudes, and at least one delivery sharp is attached to the step.

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

45. The delivery device according to claim 39, wherein when the main body is attached to a surface via the adhesive, the main body is configured to transition from a first state to a second state, and the reservoir is configured to be displaced mainly in a direction substantially perpendicular to the surface when the main body transitions from the first state to the second state.

46. The delivery device according to claim 39, wherein the reservoir includes a guard.

47. The delivery device according to claim 46, wherein the guard is at least partially defined by a septum.

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

49. The delivery device according to claim 39, wherein the septum includes a plug portion that forms a liquid-tight seal with respect to an opening provided in the rigid portion of the reservoir.

50. The delivery device according to claim 39, wherein the septum includes a first portion and a second portion extending from the first portion, the second portion being configured such that two raised portions sandwich a recessed channel.

51. The delivery device according to claim 39, wherein the reservoir further includes a marking member.

52. The delivery device according to claim 39, wherein a marking agent is supported on a marking member, and the marking member and the at least one delivery sharp extend away from the same side of the reservoir.

53. A delivery device, A main body comprising a central region and a peripheral region having a plurality of petal-shaped members extending from the central region, wherein the central region defines a housing section, and the central region has an upper region and a base connected by a wall, A variable-volume reservoir comprising at least one delivery sharp, wherein the reservoir is coupled to the main body and at least partially located within the housing, and an elastomer body located between the upper region within the housing and the reservoir, An adhesive placed on at least a part of the main body, A delivery device, including a delivery device.

54. The delivery device according to claim 53, wherein the elastomer body includes at least one hollow portion.

55. The delivery device according to claim 54, wherein each of the at least one hollow portion is formed by a passage that at least partially penetrates the elastomer body.

56. The elastomer material is layered. The delivery device according to claim 53.

57. The delivery device according to claim 53, wherein the reservoir further comprises a septum.

58. The delivery device according to claim 53, wherein the main body includes a pair of retaining tabs extending into the receiving portion, and the reservoir is coupled to the reservoir by a snap fit as the reservoir passes through the retaining tabs and proceeds beyond them.

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

60. The delivery device according to claim 59, wherein a marking agent is supported on the projection.

61. The delivery device according to claim 53, wherein the main body is configured to transition between a first state and a second state, and the reservoir is configured to be displaced along a path when the main body transitions from the first state to the second state.

62. The delivery device according to claim 53, wherein the at least one delivery sharp includes an array of spaced microneedles.

63. The delivery device according to claim 53, wherein the majority of each of the petal-shaped members is flat and is arranged at an acute angle with respect to the central axis of the delivery device.

64. The delivery device according to claim 53, wherein the peripheral region includes the outermost portion defining the periphery of the main body, and each of the petal-shaped members defines a part of the periphery.

65. The delivery device according to claim 53, wherein the outermost portion of each petal-shaped member defines a part of the peripheral edge of the main body, and the outermost portion of each petal-shaped member forms an arc along a radius having a center point along the central axis of the delivery device.

66. The delivery device according to claim 53, wherein the outermost portion of each petal-shaped member defines a part of the peripheral edge of the main body, and the outermost portion of each petal-shaped member traces an arc along the radius having a center point within each petal-shaped member.

67. The delivery device according to claim 53, wherein each of the petal-shaped members is separated by a slit in the peripheral region, and each of the petal-shaped members includes an outermost region located further from the central region than the end of the slit furthest from the central region, and the outermost region narrows in width as it moves away from the central region.

68. A method for delivering a drug to an injection site, The delivery device is attached to the skin patch at the injection site, The process involves deforming at least two parts of the delivery device attached to the skin patch from an initial state to a deformed state, such that the skin patch is stretched and at least one of the delivery sharps of the delivery device is displaced in a position to puncture the skin. The fluid is distributed from the reservoir of the delivery device to the injection site via the delivery tool, To return at least two parts of the delivery device attached to the skin patch from the deformed state to the initial state, Removing the delivery device from the skin patch, A method that includes this.

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

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

71. The method according to claim 68, further comprising tilting the at least one delivery sharp while the at least one delivery sharp is in puncture relationship with the skin.

72. The method according to claim 68, further comprising compressing the biasing member of the delivery device with respect to the reservoir.

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

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

75. The method according to claim 68, wherein distributing fluid from the reservoir includes compressing a biasing member between a portion of the delivery device and the reservoir by substantially inverting a portion of the delivery device.

76. The method according to claim 75, wherein distributing fluid from the reservoir includes moving a portion of the delivery device from a protruding direction to a recessed direction so as to compress a biasing member located between the portion of the delivery device and the reservoir.

77. The method according to claim 68, wherein at least two parts of the delivery device are petal-shaped members of the main body coupled to the central region of the main body.

78. The method according to claim 68, wherein the distribution of liquid from the reservoir is performed at least partially while at least two parts of the delivery device return to the initial state.

79. A method of delivering drugs, While the delivery device is in the first state, the delivery device, which includes at least one delivery sharp coupled to a disintegrable reservoir containing a drug, is fixed to the surface. A method comprising: transferring the delivery device to a second state, applying pressure to the delivery device such that the surface is penetrated by the at least one delivery sharp, the reservoir is collapsed, and the drug is pushed out from the at least one delivery sharp, and then releasing the pressure.

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

81. The method according to claim 79, further comprising tilting the at least one delivery sharp after the at least one delivery sharp has penetrated the surface.

82. The method according to claim 79, further comprising bringing a projection from the reservoir into contact with the surface after the at least one delivery sharp has penetrated the surface.

83. The method according to claim 82, further comprising marking the surface with the projection.

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

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

86. The method according to claim 79, further comprising compressing a biasing member with respect to the reservoir.

87. The method according to claim 79, further comprising compressing the elastomer body with respect to the reservoir.

88. The method according to claim 79, further comprising deforming at least two portions of a delivery device fixed to the surface from an initial state to an expanded and displaced state.

89. The method according to claim 79, wherein applying pressure to move the delivery device to a second state and releasing the pressure includes deforming at least two portions of the delivery device fixed to the skin such that they return at least partially from a retracted state through an intermediate state back to the retracted state.

90. The method according to claim 79, wherein applying pressure to move the delivery device to a second state and releasing the pressure includes deforming at least two portions of the delivery device fixed to the skin from a retracted state to a maximally deformed state and then at least partially elastically restoring them from that state.

91. The method according to claim 90, wherein at least two of the portions are petal-shaped members extending outward from the central region of the main body of the delivery device.

92. The method according to claim 79, wherein distributing fluid from the reservoir includes substantially inverting a portion of the delivery device so as to compress a biasing member located between the portion of the delivery device and the reservoir.

93. The method according to claim 79, further comprising filling the reservoir through the septum.

94. A method of delivering drugs, A delivery device including at least one delivery sharp coupled to a disintegrable reservoir containing a drug is fixed to the surface, Pressure is applied to the delivery device, causing the first and second parts of the delivery device to deform, the surface to be penetrated by the at least one delivery sharp, the reservoir to begin collapsing, and the drug to be pushed out from the at least one delivery sharp. The pressure applied to the delivery device is released, the first part of the delivery device is restored at least partially from its deformed state, and the surface is lifted. Methods that include...

95. The method according to claim 94, wherein transitioning the first portion to the deformed state includes displacing a plurality of segments of the first portion so that they spread apart from one another.

96. The method according to claim 94, further comprising tilting the at least one delivery sharp after the at least one delivery sharp has penetrated the surface.

97. The method according to claim 94, further comprising bringing a projection from the reservoir into contact with the surface after the at least one delivery sharp has penetrated the surface.

98. The method according to claim 97, further comprising marking the surface with the projection.

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

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

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

102. The method according to claim 94, wherein transitioning the second portion to a deformed state includes compressing the biasing member with respect to the reservoir.

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

104. The method according to claim 94, wherein the first portion of the delivery device includes a plurality of petal-shaped members extending from the central region of the main body of the delivery device to the periphery, and the second portion of the delivery device is a part of the central region.

105. A delivery device for delivering fluid to a barrier, A main body including a peripheral region having multiple petal-shaped members, A reservoir coupled to the main body, which includes at least one delivery sharp, A delivery device comprising a body configured to transition between a first state and a second state, wherein when the body transitions from the first state to the second state, the petal-shaped member is configured to deform from an initial state to an intermediate state and to at least partially restore from the intermediate state.

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

107. The delivery device according to claim 105, wherein the reservoir further includes at least one oscillating member.

108. The delivery device according to claim 105, wherein the reservoir is configured to be displaced along a displacement path when the main body transitions from the first state to the second state.

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

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

111. The delivery device according to claim 105, wherein the petal-shaped member is at least partially covered with an adhesive and is configured to expand and displace when the petal-shaped member deforms from the initial state to the intermediate state.

112. The main body includes a central region, the plurality of petal-shaped members extend outward from the central region, and the central region defines a housing for housing at least a portion of the reservoir. The delivery device according to claim 105.

113. The reservoir includes at least one rigid portion and at least one flexible portion. The delivery device according to claim 105.

114. The flexible portion includes a reservoir wall equipped with a disintegration accelerator. The delivery device according to claim 113.

115. Most of the petal-shaped members are substantially flat. The delivery device according to claim 105.

116. The delivery device according to claim 105, wherein the majority of each petal-shaped portion extends at a certain angle with respect to the central axis of the delivery device, and the petal-shaped member includes a portion having curvature that extends to the central region of the main body.

117. The delivery device according to claim 105, wherein each petal-shaped member includes a curved portion midway between a first substantially flat region and a second substantially flat region of each petal-shaped member.

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

119. The delivery device according to claim 105, wherein the at least one delivery sharp includes at least one microneedle.

120. The delivery device according to claim 105, wherein the peripheral edge of the delivery device is defined by the outermost edge of the petal-shaped member, and the outermost edge is curved along a path different from a path defined by a constant radius extending from a point along the central axis of the delivery device.

121. The delivery device according to claim 105, wherein each petal-shaped member has an outermost region whose width decreases as the distance from the central region of the delivery device increases, and each outermost region includes an outermost edge that follows a path different from a path defined by a constant radius extending from a point along the central axis of the delivery device.

122. The delivery device according to claim 105, wherein the main body includes a central region formed integrally with the peripheral region, and the central region includes a portion configured to reverse from a protruding state to a recessed state when the delivery device transitions from a first state to a second state.

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

124. The delivery device according to claim 122, wherein the biasing member is an elastomer.

125. The delivery device according to claim 122, wherein the biasing member is a layered elastomer body through which at least one passage at least partially penetrates.

126. The delivery device according to claim 105, wherein the reservoir further includes a septum.

127. A method for delivering fluid to a barrier, Stretching the aforementioned barrier, The stretched barrier is punctured using at least one delivery sharpener, Displace at least one delivery sharp within the barrier along a non-linear displacement path, Distributing the fluid into the barrier from at least one of the delivery shafts, A method that includes this.

128. The method according to claim 127, wherein puncturing the barrier includes displacing the at least one delivery sharp in a substantially vertical direction until it contacts the barrier.

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

130. The method according to claim 127, wherein the nonlinear displacement path is curved.

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

132. The method according to claim 127, wherein stretching the barrier includes attaching a delivery device including the at least one delivery sharp to the barrier and displacing at least two portions of the delivery device to spread out.

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

134. The method according to claim 127, wherein distributing fluid from the at least one delivery sharp includes increasing the delivery pressure of the fluid supplied to the at least one delivery sharp until delivery from the at least one delivery sharp to the barrier is initiated.

135. The method according to claim 127, wherein displacing the at least one delivery sharp along a nonlinear displacement path includes driving the inclined surface of the at least one delivery sharp through a portion of the barrier.

136. The method according to claim 127, wherein displacing the at least one delivery sharp along a nonlinear displacement path includes displacing the surface of the at least one delivery sharp, including the exit of the at least one delivery sharp, away from the portion of the barrier that made contact with the barrier during the initial puncture.

137. A method for delivering fluid to a barrier, Adhering a delivery device, which includes at least one delivery sharp to the barrier, To displace the reservoir assembly having at least one delivery sharp toward the barrier, a force is applied to a part of the delivery device, The barrier is punctured by the at least one delivery sharpener, By bringing a member protruding from one side of the reservoir assembly into contact with the barrier, and further displacing the opposite side of the reservoir assembly toward the barrier, the reservoir assembly and the at least one delivery sharp are tilted. To deliver fluid from the internal volume of the reservoir assembly through at least one delivery shaft, A method that includes this.

138. The method according to claim 137, wherein discharging fluid from the internal volume of the reservoir assembly includes at least partially collapsing the internal volume of the reservoir assembly.

139. The method according to claim 137, wherein the internal volume of the reservoir assembly includes a first portion and a second portion located more proximal to the first portion than to the at least one delivery sharp, and discharging fluid from the internal volume of the reservoir assembly includes increasing the pressure of the agent in the second portion until delivery from the at least one delivery sharp to the barrier is initiated.

140. The method according to claim 137, wherein the at least one delivery sharp includes a microneedle.

141. The method according to claim 127, wherein tilting the reservoir assembly and the at least one delivery sharp includes causing the bevel of the microneedle to penetrate the barrier.

142. The method according to claim 137, further comprising causing the biasing member of the delivery device to enter a stressed state and exerting a restoring force of the biasing member on the reservoir assembly.

143. The method according to claim 137, further comprising displacing at least two portions of the delivery device to spread out.

144. A positioning method for shallowly delivering at least one delivery sharp within a barrier, Stretching the aforementioned barrier, Displace the holder that holds the at least one delivery sharp toward the barrier, The barrier is penetrated by displacing at least one of the delivery sharps in a direction substantially perpendicular to the barrier, The method involves bringing at least one member protruding from one side of the holder into contact with the barrier, Further displacing the opposite side of the holder toward the barrier, Displace the at least one delivery sharp along a non-linear path within the barrier, A method that includes this.

145. The method according to claim 144, wherein stretching the barrier includes displacing at least two portions of the delivery device, including the holder and the at least one delivery sharp, to spread out.

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

147. The method according to claim 144, wherein displacing at least one delivery sharp along a nonlinear path includes displacing the at least one delivery sharp along a curved displacement path when the opposite side of the holder is further displaced toward the barrier.

148. The method according to claim 144, wherein by displacing the at least one delivery sharp, the at least one delivery sharp is positioned in an orientation closer to an orientation perpendicular to the barrier than the orientation of the at least one delivery sharp when it penetrates the barrier.

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

150. A fluid delivery assembly, A delivery device including a fluid holding part and a coupling part, Adapter and Including, the adapter, An adapter coupling portion configured to engage with the coupling portion of the aforementioned delivery device to form a coupling portion that seals the fluid, The adapter body, and, A fluid delivery assembly comprising a sharp holder having a chamfered side wall and at least one delivery sharp protruding from the surface thereof, wherein the adapter body is molded such that the material of the adapter body covers only a portion of the side wall, thereby connecting the sharp holder and the adapter body to each other.

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

152. The fluid delivery assembly according to claim 150, wherein the coupling portion of the delivery device and the adapter coupling portion are cooperative Luer lock coupling portions.

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

154. The fluid delivery assembly according to claim 150, wherein the sharp holder and the at least one delivery sharp are made of silicon.

155. The fluid delivery assembly according to claim 150, wherein the at least one delivery sharp includes an array of microneedles.

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

157. The fluid delivery assembly according to claim 150, wherein the at least one delivery sharp includes a microneedle having a channel, the channel communicating with a recessed channel on the outer surface of the microneedle.

158. The fluid delivery assembly according to claim 150, wherein the sharp holder and the at least one delivery sharp are formed as an integral structure.

159. Adapter for delivery equipment, An adapter coupling configured to engage with the corresponding coupling of the delivery device in a sealed state for the fluid, The adapter body and A sharps holder having a chamfered side wall and at least one delivery sharps protruding from that face, An adapter for a delivery device, comprising the adapter body being molded to cover only a portion of the side wall in order to fix the Sharp holder to the adapter.

160. The adapter for a delivery device according to claim 159, wherein the footprint of the Sharp holder increases as the distance from its surface increases.

161. The adapter for a delivery device according to claim 159, wherein the Sharp holder is made of silicone.

162. The adapter for a delivery device according to claim 159, wherein the sharp holder and the at least one delivery sharp are formed as a single, integrated structure.

163. The adapter for a delivery device according to claim 159, wherein the at least one delivery sharp is a microneedle.

164. The adapter for a delivery device according to claim 159, wherein the at least one delivery sharp is a microneedle with a height exceeding 500 microns.

165. The adapter for a delivery device according to claim 159, wherein the adapter coupling portion is a Luer lock coupling portion.

166. The adapter for a delivery device according to claim 159, wherein the at least one delivery sharp includes an array of microneedles.

167. The adapter for a delivery device according to claim 159, wherein the at least one delivery sharp has a channel, the channel communicating with a recessed channel on the outer surface of the microneedle.

168. A delivery device, A main body including a central region and a peripheral region having a plurality of petal-shaped members extending outward from the central region, A variable-volume reservoir coupled to the main body, A sharp retainer having at least one microneedle protruding from its surface, the sidewall of which is positioned at an acute angle to the surface, wherein the material of the rigid portion of the reservoir is molded to cover only a portion of the sidewall, and the sharp retainer and the reservoir are joined together. An adhesive placed on at least a part of the main body, A delivery device, including a delivery device.

169. The delivery device according to claim 168, wherein the central region defines a housing and includes an upper region and a base connected by a wall, and the petal-shaped member extends from the base.

170. The delivery device according to claim 169, wherein the reservoir is at least partially located within the housing.

171. The delivery device according to claim 168, further comprising a biasing member disposed within a housing between the upper region and the reservoir.

172. The delivery device according to claim 168, wherein the Sharp holder and the at least one microneedle are integrally constructed.

173. The delivery device according to claim 168, wherein the Sharp holder and the at least one microneedle are made of silicon.

174. The delivery device according to claim 168, wherein the reservoir comprises a first portion and a second portion separated from each other by a flow limiter, the second portion being located more proximal to the at least one microneedle than the first portion.

175. A method for forming a microneedle holder, Etching multiple microneedles onto a silicon wafer, Dicing a sharp holder containing at least one microneedle from the wafer such that the sidewalls of the sharp holder are formed at an angle, and the footprint of the sharp holder increases as the distance from the surface on which the at least one microneedle is located increases, A method comprising molding the main body only on a portion of the side wall of the sharp holder located distal to the aforementioned surface.

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

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

178. The method according to claim 175, wherein the main body forms part of the delivery device.

179. The method according to claim 175, wherein the main body is a stepped projection of the reservoir of the delivery device.

180. The method according to claim 175, wherein the plurality of microneedles include channels that communicate with recessed channels on the outer surface of the microneedles.

181. The method according to claim 175, wherein the Sharp holder includes an array of microneedles.

182. The method according to claim 175, wherein the Sharp holder includes a row of microneedles.

183. The method according to claim 175, wherein dicing the sharp holder from the wafer is performed using a dicing saw having blades configured to form angled sidewalls.

184. The method according to claim 175, wherein etching the plurality of microneedles includes etching a plurality of microneedles having a height exceeding 500 microns.

185. A delivery device package, A first part formed of a rigid material and comprising a plurality of wells, wherein at least two wells are connected by passages, A second part is detachably coupled to the rim of the first part, A delivery device having an adhesive covered with an adhesive liner on its main body, wherein the adhesive liner is bonded to the surface of a first well, A delivery device package comprising, wherein when the main body is removed from the well, the adhesive liner is configured to detach from the adhesive and remain in the well.

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

187. The delivery device package according to claim 185, wherein the second portion is permeable to a sterilizing agent.

188. The delivery device package according to claim 185, wherein the delivery device is equipped with a pull tab, the pull tab extending from the main body and passing through the passage to reach a second well.

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

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

191. A delivery device for delivering fluid to a barrier, The main unit and An adhesive is provided, which is placed on at least a part of the main body for attaching the delivery device to the barrier, A reservoir coupled to the main body, comprising at least one delivery sharp and at least one oscillating member, A delivery device comprising, wherein the main body is configured to transition between a first state and a second state, the reservoir is configured to displace toward the barrier when the main body transitions from the first state to the second state, and the oscillating member is configured to facilitate the tilting of the reservoir after the reservoir has displaced a certain distance toward the barrier.

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

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

194. The delivery device according to claim 191, wherein the main body includes a central region and a peripheral region having a plurality of petal-shaped members extending outward from the central region, and the central region defines a housing portion for housing at least a part of the reservoir.

195. The delivery device according to claim 191, wherein the reservoir includes at least one rigid portion and at least one flexible portion.

196. The delivery device according to claim 191, wherein the at least one oscillating member is arranged along the periphery of the rigid portion of the reservoir.

197. The delivery device according to claim 191, wherein the at least one oscillating member is a projection protruding from the rigid portion of the reservoir.

198. The delivery device according to claim 191, wherein the at least one delivery sharp is attached to a step protruding from the rigid portion of the reservoir, and the at least one oscillating member is positioned closer to the periphery of the rigid portion than the step.

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

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

201. The delivery device according to claim 191, wherein the at least one oscillating member is configured to tilt the reservoir such that the at least one delivery sharp oscillates along an arc of approximately 3–5°.

202. The delivery device according to claim 191, wherein the at least one oscillating member is configured to tilt the reservoir only after the barrier has been perforated by at least one delivery sharp.

203. A delivery device, A main body comprising a central region and a peripheral region having a plurality of petal-shaped members extending outward from the central region, wherein the central region defines a housing and has an upper region and a bottom region connected by a wall, A variable-volume reservoir comprising at least one delivery sharp and at least one oscillating member positioned closer to the periphery of the reservoir than the at least one delivery sharp, wherein the reservoir is coupled to a body and at least partially located within the housing, An adhesive placed on at least a part of the main body, A delivery device, including a delivery device.

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

205. The delivery device according to claim 203, wherein the oscillating member is a projection protruding from the rigid portion of the reservoir.

206. The delivery device according to claim 203, wherein the at least one delivery sharp includes a microneedle, and the portion of the microneedle closest to the oscillating member is the cutting blade of the microneedle.

207. The delivery device according to claim 203, wherein the oscillating member is arranged on the periphery of the reservoir.

208. The reservoir includes a planar body from which a step protrudes, and the at least one delivery sharp is attached to the step. The delivery device according to claim 203.

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

210. The delivery device according to claim 203, wherein a marking agent is supported on the oscillating member.

211. The delivery device according to claim 203, wherein the main body is configured to transition from a first state to a second state when it is attached to a surface via an adhesive, the reservoir is configured to be displaced in a direction substantially perpendicular to the surface until the oscillating member contacts the surface when the main body transitions from the first state to the second state, and a portion of the reservoir located on the opposite side of the oscillating member is configured to continue to be displaced toward the surface even after the oscillating member has contacted the surface when the main body transitions from the first state to the second state.

212. The delivery device according to claim 211, wherein the at least one delivery sharp is configured to puncture the surface when the reservoir is displaced in a direction substantially perpendicular to the surface, and thereafter, after the oscillating member has come into contact with the surface, the portion of the reservoir located on the opposite side of the oscillating member is inclined as it is further displaced toward the surface.

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

Images