Patent Application
20220273925
This disclosure relates to medical agent delivery. More specifically, this disclosure relates to dispensers for therapeutic and other medical agents.
Novel pathogens present a variety of public health challenges which are not simple to quickly overcome. From the medical perspective, existing preventive medicine infrastructure has not been and is not well suited to novel pathogens such as SARS, MERS, Zika, and COVID-19. Other pathogens for which herd immunity does not exist (e.g. Ebola), or highly dangerous pathogens which mutate quickly may present similar challenges. Vaccines typically take years to create and once a vaccine does exist, the prospect of rapidly generating billions of doses would almost certainly exceed current vaccine production capabilities. Without vaccination, other preventative measures such as, testing, contact tracing, and personal protective equipment (PPE) are of elevated importance. Again, however, these preventative measures can only provide as much benefit as relevant supply chains allow. Shortages of PPE and testing kits have plagued medical systems in the United States and elsewhere across the globe as they struggle to address the COVID-19 pandemic. In turn, this has hampered the potential to perform effective contact tracing which is already a vast undertaking due to the scale of the COVID-19 pandemic. Additionally, novel pathogens may refocus medical systems away from their typical functions. Secondary impacts often result when the medical community's attention is demanded by a widespread pandemic. This can take the form of delayed surgeries, elective procedures, routine doctor's office visits, etc., but secondary impacts can also be much worse. As has been pointed out by the Chief of Immunizations at UNICEF, for example, during efforts to control an Ebola outbreak in the Democratic Republic of the Congo in 2019 the number of deaths due to measles was double the death toll from Ebola. Novel pathogens also present challenges that are more psychological in nature. Put simply, such pathogens scare people. Without readily available PPE and testing, people may elect to avoid visiting medical facilities or clinics for fear of exposure to disease. Even with readily available PPE, certain individuals, such as populations in high risk demographics for a particular pathogen, may still have misgivings about visiting such facilities. Additionally, as has been the case in the United States, some may fiercely object to usage of PPE for various reasons. This presents a further public health challenge to systems attempting to deal with pandemics. Solutions to novel pathogens should seek to address and work around these challenges in order to be effective.
In accordance with an exemplary embodiment of the present disclosure an example delivery device may comprise a main body including a central region and a peripheral region. The central region may be shaped substantially as a thimble and may have a top surface and a base. The peripheral region may be defined by a plurality of petal members and a plurality of first slots therebetween. The plurality of petal members may extend outward from the base. The delivery device may further comprise an adhesive coupled to at least a part of the main body. The delivery device may further comprise a collapsible reservoir coupled to the main body and to at least one delivery sharp.
In some embodiments, the top surface may be convex and may include a plurality of second slots therein. In some embodiments, the central region may include a plurality of fenestrations disposed in a ring along a perimeter of the top surface. In some embodiments, the delivery device may further comprise a sharp bearing body including the at least one delivery sharp. In some embodiments, the at least one delivery sharp is a microneedle including a flow lumen with an elongate cross-section The sharp bearing body may be coupled to the collapsible reservoir. The collapsible reservoir may be coupled to an inside surface of the central region. In some embodiments, when the delivery device is in the storage state, the collapsible reservoir may contain a fluid and the adhesive may be affixed to a penetrable surface of a member external to the delivery device. When the delivery device is in the delivery state, the penetrable surface may be stretched by the adhesive, the at least one delivery sharp may penetrate the penetrable surface, and the collapsible reservoir may be urged to at least partially collapse, enabling the fluid to enter the member through the penetrable surface via the at least one delivery sharp. In some embodiments, the adhesive may be coupled to at least a part of at least two of the plurality of petal members on sides thereof most distal to the top surface. In some embodiments, when the delivery device is in the storage state, the collapsible reservoir may contain a fluid and the adhesive may be affixed to a penetrable surface of a member external to the delivery device. When the delivery device is in the delivery state, the penetrable surface may be stretched by the adhesive, the at least one delivery sharp may penetrate the penetrable surface, and the collapsible reservoir may be urged to at least partially collapse, enabling the fluid to enter the member through the penetrable surface via the at least one delivery sharp. In some embodiments, the adhesive may be coupled to at least a part of at least two of the plurality of petal members on sides thereof most distal to the top surface. In some embodiments, the top surface may be configured to transition the delivery device, in response to pressure applied thereon, from a storage state in which the top surface is convex, to a delivery state in which the top surface is concave. In some embodiments, at least two of the plurality of petal members may be configured to curl in response to pressure applied on the top surface as the delivery device transitions to the delivery state. In some embodiments, the at least two of the plurality of petal members may be configured to curl so as to have a substantially constant radius of curvature in response to pressure applied on the top surface as the delivery device transitions to the delivery state. In some embodiments, at least a part of a first one of the plurality of petal members may be configured to move farther away from at least a corresponding part of a second one of the plurality of petal members during at least a part of the transition between the storage state and the delivery state, the first and second petal members being positioned opposite each other. In some embodiments, at least a part of a first one of the plurality of petal members may be configured to move farther away from at least a corresponding part of a second one of the plurality of petal members during at least a part of the transition between the storage state and the delivery state and thereby stretch a surface to which the delivery device is affixed with the adhesive, the first and second petal members being positioned opposite each other. In some embodiments, the at least one delivery sharp may be a microneedle. In some embodiments the delivery device may be an intradermal delivery device. In some embodiments, wherein the reservoir may be partitioned into a first section and a second section. In some embodiments, the first section and second section may be in fluid communication with one another through a flow restrictor. In some embodiments, the reservoir may include an orifice plate.
In accordance with another example embodiment of the present disclosure, an example method of delivering a medical agent may comprise affixing, to a skin surface, a delivery device that includes at least one delivery sharp coupled to a collapsible reservoir containing the medical agent, the delivery device being in a storage state. The method may further comprise applying pressure to the delivery device directed at the skin surface to transition the delivery device to a delivery state, penetrate the skin surface with the at least one delivery sharp, and to cause collapse the reservoir to force the medical agent into the skin via the at least one delivery sharp.
In some embodiments, the method may further comprise stretching the skin surface as the delivery device transitions from the storage state to the delivery state. In some embodiments, the method may further comprise scratching the skin surface with at least one of the at least one delivery sharp. In some embodiments, the method may further comprise preventing reuse of the delivery device. In some embodiments, transitioning the delivery device to a delivery state may comprise at least partially inverting at least one region of a main body of the delivery device. In some embodiments, transitioning the delivery device to the delivery state may comprise deforming a main body of the delivery device out of a first stable state and into a second stable state. In some embodiments, collapsing the reservoir may comprise displacing a flexible wall of the reservoir against a rigid wall of the reservoir. In some embodiments, forcing the medical agent into the skin via the at least one delivery sharp may comprise transferring the medical agent from the reservoir to the skin via a respective flow lumen and channel in each of the at least one delivery sharp.
In accordance with another exemplary embodiment of the present disclosure an example delivery device may comprise a main body including a central region coupled to a peripheral region. The central region may be shaped substantially as a thimble and may have a top surface and a base. The peripheral region may surround the central region. The peripheral region may have an inner perimeter and an outer perimeter. The inner perimeter may be coupled to the base such that the peripheral region extends outward from the base. The peripheral region may include a plurality of first slots extending inward from the outer perimeter. The delivery device may further comprise an adhesive coupled to at least a part of the main body. The delivery device may further comprise a collapsible reservoir coupled to the main body and to at least one delivery sharp.
In some embodiments, the top surface may be convex and include a plurality of second slots therein. In some embodiments, the plurality of second slots may extend outward with respect to a center point of the top surface. In some embodiments, the central region may include a plurality of fenestrations disposed along the base. In some embodiments, the central region may include a plurality of fenestrations disposed along a perimeter of the top surface. In some embodiments, the delivery device may further comprise a sharp bearing body including the at least one delivery sharp. The sharp bearing body may be coupled to the collapsible reservoir. The collapsible reservoir may be coupled to an inside surface of the central region. In some embodiments, the adhesive may be coupled to at least a part of a side of the peripheral region most distal to the top surface. In some embodiments, the top surface may be configured to transition the delivery device, in response to pressure applied thereon, from a storage state in which the top surface is convex, to a delivery state in which the top surface is concave. In some embodiments, the main body may have a footprint with an area and may be configured such that the area increases during at least a part of the transition between the storage state and the delivery state. In some embodiments, the main body may have a footprint with an area and may be configured such that the area increases during at least a part of the transition between the storage state and the delivery state and thereby stretches a surface to which the delivery device is affixed with the adhesive. In some embodiments, when the delivery device is in the storage state, the collapsible reservoir may contain a fluid and the adhesive may be affixed to a penetrable surface of a member external to the delivery device. When the delivery device is in the delivery state, the penetrable surface may be stretched by the adhesive, the at least one delivery sharp may penetrate the penetrable surface, and the collapsible reservoir may be urged to at least partially collapse, enabling the fluid to enter the member through the penetrable surface via the at least one delivery sharp. In some embodiments, the at least a part of the side may include first and second areas between two pairs of adjacent first slots of the plurality of first slots. In some embodiments, the adhesive may be coupled to at least a part of a side of the peripheral region most distal to the top surface. In some embodiments, the at least a part of the side may include first and second areas between two pairs of adjacent first slots of the plurality of first slots. In some embodiments, when the delivery device is in the storage state, the collapsible reservoir may contain a fluid and the adhesive is affixed to a penetrable surface of a member external to the delivery device. When the delivery device is in the delivery state, the penetrable surface may be stretched by the adhesive, the at least one delivery sharp may penetrate the penetrable surface, and the collapsible reservoir may be urged to at least partially collapse, enabling the fluid to enter the member through the penetrable surface via the at least one delivery sharp. In some embodiments, the top surface may be configured to transition the delivery device, in response to pressure applied thereon, from a storage state in which the top surface is convex, to a delivery state in which the top surface is concave. In some embodiments, the main body may have a footprint with an area and may be configured such that the area of the footprint increases during at least a part of the transition between the storage state and the delivery state. In some embodiments, the main body may a footprint with an area and may be configured such that the area of the footprint increases during at least a part of the transition between the storage state and the delivery state and thereby stretches a surface to which the delivery device is affixed with the adhesive.
In accordance with another example embodiment of the present disclosure an example actuator assembly for inhibiting reuse of a drug delivery device may comprise a flexure including first and second members and a plurality of struts which couple the first and second members together. Each strut may have a resiliency which resists displacement of the first and second member toward one another. The first member may include at least one first engagement member. The second member may include a cooperating engagement member for each of the first engagement member. The struts may be configured to deflect and engender a rotational motion of at least one of the first and second member when the first and second member are urged toward one another with more than a threshold force. The at least one first engagement member and each respective second engagement member may be configured to form a coupling when distance between the first and second member is decreased beyond a threshold distance.
In accordance with another exemplary embodiment of the present disclosure and example delivery device may comprise a first portion at least partially covered with a first adhesive and including a cantilevered arm. The delivery device may further comprise a second portion at least partially covered with a second adhesive and including at least one ramp element. The second portion may be coupled to the first portion via the first adhesive. The second portion may be configured to elongate from a first state to an elongated state. The delivery device may further comprise a collapsible reservoir including at least one delivery sharp. The reservoir may be coupled to an unsupported end of the cantilevered arm.
In some embodiments, the at least one delivery sharp may include one of a one dimensional array of microneedles and a two dimensional array of microneedles. In some embodiments, the second portion may include a delivery aperture. The delivery aperture may be out of alignment with the at least one delivery sharp when the second portion is in the first state and in alignment with the at least one delivery sharp when the second portion is in the elongated state. In some embodiments, the second portion may include a folded region in the first state. The folded region may be configured to unfurl as the second portion is transitioned to the elongated state. In some embodiments, the second portion may include a folded region. A layer of the folded region may be coupled to the first adhesive. In some embodiments, each of the at least one ramp element may be disposed on a first side of the cantilevered arm when the second portion is in the first state and disposed on a second side of the cantilevered arm when the second portion is in the second state. In some embodiments, the second portion may be at least partly elastic. In some embodiments, the second portion may include a pull tab. In some embodiments, the delivery device may further comprise a lock adhesive disposed on a section of the first portion and the delivery device may further comprise a tether having a first end which is coupled to the second portion. In some embodiments, a second end of the tether may be coupled to the lock adhesive and cover the lock adhesive when the second portion is in the first state. The second end of the tether may be configured to at least partially disassociate from the lock adhesive when the second portion is in the elongated state to expose the lock adhesive. In some embodiments, a second end of the tether may be coupled to the lock adhesive and the tether may be doubled over upon itself when the second portion is in the first state. In some embodiments, the first adhesive and second adhesive may be disposed a first distance from one another when the second portion is in the first state and the first and second adhesive may be disposed a second distance from one another when the second portion is in the elongated state. The second distance may be greater than the first distance. In some embodiments, the at least one ramp element may be configured to resiliently deflect the cantilevered arm as the second portion is transitioned from the first state to the second state.
In accordance with an example embodiment of the present disclosure, an example delivery device may comprise a main body including first and second end blocks spaced apart by first and second side panels and a bridge. The side panels and bridge may each include first and second opposing ends. The first ends may each be connected to the first end block via respective first end living hinges. The second ends may each be connected to the second end block via respective second end living hinges. The side panels and bridge also may each include respective intermediate living hinges between their first and second ends. The delivery device may further comprise an adhesive at least partially covering a first side of the end blocks. The delivery device may further comprise a collapsible reservoir including at least one delivery sharp. The reservoir may be coupled to an end of an arm member extending from the bridge toward the first side.
In some embodiments, the side panels may each include at least one guard projection. In some embodiments, the first side panel may include a first guard projection which extends from toward the second side panel and the second side panel may include a second guard projection which extends toward the first side panel. In some embodiments, the first guard projection may include a latch projection and the second side panel may include a latch catch. In some embodiments, the first side panel may include a third guard projection which extends toward the second side panel and the second guide panel may include a fourth guard projection which extends toward the first side panel. In some embodiments, the bridge may include a first panel and a set of struts. The first panel may be connected to the struts via the intermediate living hinge of the bridge. In some embodiments, the arm member may be disposed between the struts and extend from an end of the panel adjacent the intermediate living hinge of the bridge. In some embodiments, the side panels may have a displacement range from an outwardly bowed state to a substantially straight state and the end blocks may be configured to displace away from one another when the side panels are displaced from the outwardly bowed state to the substantially straight state. In some embodiments, the side panels may be configured to displace from the outwardly bowed state to the substantially straight state upon application of a pinching force to the side panels. In some embodiments, at least the intermediate living hinge of the bridge member may be configured to displace toward the first surface of the end blocks when the side panels are displaced from the outwardly bowed state to the substantially straight state. In some embodiments, the side panels may have a displacement range from an outwardly bowed state to a substantially straight state and the bridge may be configured such that the arm member may be displaced from a first position to a second position in which the at least one delivery sharp is disposed below the first surface of the end blocks when the side panels are displaced from the outwardly bowed state to the substantially straight state. In some embodiments, the side panels may have a displacement range from an outwardly bowed state to a substantially straight state and the main body may include a latch projection and a latch catch. The latch projection may be configured to engage the latch catch when the side panels are displaced from the outwardly bowed state to the substantially straight state. In some embodiments, the main body may include a plurality of iris panels which extend from the side panels to create a variable aperture. In some embodiments, the aperture may be configured to vary in size as the side panels are bent about the intermediate living hinge of each side panel.
In accordance with another example embodiment of the present disclosure and example delivery device may comprise a main body including a set of opposed end panels and at least two intermediate panels. The panels may be separated from one another by a plurality of living hinges which each extend across the main body. The delivery device may further comprise an adhesive covering at least a portion of a proximal side of each of the end panels. The delivery device may further comprise a collapsible reservoir including at least one delivery sharp. The reservoir may be coupled to the proximal side of one of the intermediate panels. The two intermediate panels may form a linkage displaceable between a raised position and an over center position when the two end panels are constrained to a plane. A first of the intermediate panels may extend along the plane when the linkage is in the over center position.
In some embodiments, a first of the end panels may be substantially planar and a second of the end panels may include a planar portion and an angled projection extending from the planar portion toward one of the intermediate linkages. In some embodiments, the second of the end panels may include a buttress which extends from the planar portion to the angled projection. In some embodiments, the at least one delivery sharp may include an array of microneedles. In some embodiments, the delivery device may be configured to transition from a storage state to a delivery state. In some embodiments, a second of the intermediate panels may be at least partially covered with adhesive on a proximal side thereof. In some embodiments, the end panels may be displaced apart a first distance along the plane as the linkage displaces from the raised position to a center position and may be displaced toward one another a second distance shorter than the first distance as the linkages displaces from the center position to the over center position. In some embodiments, the reservoir may be disposed on a second of the intermediate panels adjacent a living hinge of the plurality of living hinges which is between the first and second intermediate panels. In some embodiments, one of the panels may include a strain relief flexure. In some embodiments, at least a portion of the main body may be configured to plastically deform when the linkage is displaced to the over center position. In some embodiments, at least one of the living hinges may be configured to break when the linkage is displaced from the raised position to the over center position and back. In some embodiments, the linkage may be at least partially inverted in the over center position with respect to the raised position. In some embodiments, an angle between the intermediate panels when the linkage is in the raised position may be an obtuse angle and an angle between the intermediate panels when the linkage is in the over center may be a reflex angle. In some embodiments, one of the intermediate panels may be parallel to the skin when the linkage is in the over center position.
In accordance with yet another example embodiment of the present disclosure, an example delivery device may comprise an actuator. The delivery device may further comprise a base including a threaded post. The actuator may be in threaded engagement with the post and may be displaceable along the threaded post from a raised state in which the actuator is most distal to the base to a delivery state in which the actuator is more proximal the base. The delivery device may further comprise a carriage disposed within a bore of the post. The carriage may include at least one first frangible supported on a respective ledge defined in the bore and at least one second frangible. The delivery device may further comprise a delivery aid disposed within the bore. The delivery device may further comprise a collapsible reservoir positioned within the bore and including at least one delivery sharp. As the actuator is displaced from the raised state to the delivery state, a portion of the actuator may be configured to apply pressure against the carriage. The pressure may break the at least one of the first frangible and free the carriage to displace within the bore as well as break the at least one of the second frangible such that pressure is exerted through the carriage and delivery aid against the reservoir. Displacement of the actuator to the delivery state may be further configured to displace the reservoir toward the base.
In some embodiments, the actuator may include a projection which may be in alignment with the axis of the post. Pressure against the carriage may be applied via the projection. In some embodiments, the delivery aid may be coupled to an end of the projection most proximal to the base. In some embodiments, the projection may extend through at least a portion of the carriage when the actuator is in at least one of the raised position and the delivery position. In some embodiments, the delivery aid may include a force concentrating protuberance. In some embodiments, the base may include a delivery aperture aligned with the bore of the post. In some embodiments, the at least one first frangible may include a set of frangibles spaced at even angular increments about the carriage. In some embodiments, the at least one second frangible may include a set of frangibles spaced at even angular increments about the carriage. In some embodiments, with the at least one first frangible in a broken state, the carriage may have a displacement range within the bore which is limited by a stop surface disposed at an end of the bore adjacent the base. In some embodiments, the carriage may extend through a delivery aperture in the base when the carriage is against the stop surface such that a skin depressor member of the carriage is external to the bore. In some embodiments, the reservoir may be disposed within a bay of the carriage and frictionally retained therein when pressure applied to the reservoir is below a threshold. In some embodiments, the carriage, delivery aid, and reservoir may be configured to displace together within the bore as a unit after the at least one first frangible is broken. In some embodiments, the carriage delivery aid, and reservoir may be configured to cease displacement together as a unit when the at least one second frangible is broken.
In accordance with another example embodiment of the present disclosure an exemplary microneedle may comprise a base including a first edge and a plurality of second edges. The microneedle may further comprise a plurality of sidewalls extending from the base in a direction substantially perpendicular thereto. The microneedle may further comprise a face extending from the first edge to a vertex at an acute angle to the base. Two adjacent sidewalls of the plurality of sidewalls may define a side edge extending from the base to the vertex in a direction substantially vertical to the base. The microneedle may further comprise a flow lumen extending through the microneedle from the base to an outlet in the face. The microneedle may further comprise a channel defined in the face and connected to the flow lumen.
In some embodiments, the flow lumen may have an elongate cross-sectional shape. In some embodiments, the outlet in the face may be disposed more proximal the vertex than the first edge. In some embodiments, the outlet in the face may be disposed more proximal the first edge than the vertex. In some embodiments, the outlet in the face may be disposed in a mid-region of the face intermediate a region proximal the vertex and a region proximal the first edge. In some embodiments, the channel may extend in a direction toward the first edge from the outlet in the face. In some embodiments, the channel may extend in a direction toward the vertex from the outlet in the face. In some embodiments, the channel may include a first portion and a second portion. The first portion may extend in a direction toward the vertex from the outlet in the face and the second portion may extend in a direction toward the first edge from the outlet in the face. In some embodiments, the channel may have a width which is variable. In some embodiments, the channel may have a substantially constant width. In some embodiments, an end of the channel most proximate the first end may be a distance of at least 50-200 microns from the base. In some embodiments, the microneedle may be constructed of silicon. In some embodiments, a height of the microneedle may be at least 600 microns.
In accordance with another example embodiment of the present disclosure, an example microneedle may comprise a base including a first edge and a plurality of second edges. The microneedle may further comprise a plurality of sidewalls projecting from the second edges to an arcuate blade edge which extends from a base vertex formed by two of the second edges to a second vertex spaced from the base. The microneedle may further comprise a face extending from the first edge to the second vertex. The microneedle may further comprise a flow lumen extending through the microneedle from the base to an outlet in the face.
In some embodiments, the blade edge may be a double beveled blade. In some embodiments, the outlet in the face may have an elongate shape. In some embodiments, the first edge may be disposed such that a plane perpendicular to the base and including the first edge extends through a portion of the blade edge. In some embodiments, the first edge may be disposed such that a plane perpendicular to the base and including the first edge does not pass through the blade edge. In some embodiments, the outlet may be disposed such that at least one plane perpendicular to the base and passing through the outlet also passes through the blade edge. In some embodiments, the outlet may be disposed such that any plane perpendicular to the base and passing through the outlet also passes through the blade edge. In some embodiments, the measure of the arc of the blade edge may be greater than 90°. In some embodiments, the measure of the arc of the blade edge may be less than 90°.
In accordance with yet another example embodiment of the present disclosure, an example delivery device may comprise a main body including a peripheral region and a central region extending proud of the peripheral region. The peripheral region may have a top surface and a base. The peripheral region may include a number of bodies spaced apart by slits which extend from the periphery of the peripheral region toward the central region. The delivery device may further comprise an adhesive coupled to at least a part of the main body. The delivery device may further comprise a collapsible reservoir coupled to the main body and to at least one delivery sharp.
In some embodiments, the main body may have a first state and a second state. The main body may include at least one partially invertible region which is in a first shape in the first state and in the second state is substantially inverted with respect to the first shape over at least a portion of the of the invertible region. In some embodiments, the at least one partially invertible region may include the top surface. In some embodiments, the main body may further comprise a static region which is substantially the same shape when the main body is in the first state and the second state. In some embodiments, the static region may be included in the central region and may extend from a periphery of the top surface to the base. In some embodiments, the main body may be configured such that at least two of the bodies of the peripheral region spreadingly displace as the main body transitions from the first state to the second state. In some embodiments, the top surface may be convex in the first state. In some embodiments, the top surface may be concave in the second state. In some embodiments, the reservoir may be formed as an assembly including a holder to which the microneedle is coupled and a flexible body coupled to the holder. There may be a sealed reservoir volume defined between a portion of the holder and a portion of the flexible body.
In accordance with still another example embodiment of the present disclosure, an example delivery device may comprise a main body including a central region and a peripheral region having a plurality of petal members extending outwardly from the central region. The central region may define a receptacle and having a top region and a base which are connected by a wall. The delivery device may comprise a collapsible reservoir including at least one delivery sharp. The reservoir may be coupled to the main body and at least partially disposed within the receptacle. The delivery device may further comprise an adhesive disposed on at least a portion of the main body.
In some embodiments, the reservoir may comprise a rigid portion and a flexible portion coupled to the rigid portion. A sealed interior volume of the reservoir may be defined between the rigid portion and the flexible portion. The at least one delivery sharp may be coupled to the rigid portion. In some embodiments, the rigid portion may include a stage projection. In some embodiments, the at least one delivery sharp may be coupled to the stage projection and may project from the stage projection at an acute angle with respect to the rigid portion. In some embodiments, the main body may include a ridge adjacent the receptacle. The ridge may form a mounting surface for the reservoir. In some embodiments, the delivery device may further comprise a packet disposed in the receptacle between the top region and the reservoir. In some embodiments, the packet is a gas bladder. In some embodiments, the packet may contain a means for applying pressure to the reservoir. In some embodiments, the packet may be configured to rupture when subjected to more than a threshold pressure. The packet may be disposed within a container and include a first substance. The container may contain a second substance. The first and second substances may be configured to react when combined to expand the volume of the container. In some embodiments, the packet may be configured to rupture when subjected to more than a threshold pressure. The packet may be disposed within a container and filled with a first substance. The container may contain a second substance. The first and second substances may be configured to partake in a chemiluminescent reaction when combined. In some embodiments, the delivery device may further comprise a bias member disposed within the receptacle between the top region and the reservoir. In some embodiments, the bias member may be a conical spring. In some embodiments, the main body may include a plurality of locating projections which may constrain the bias member and the bias member may be coupled to the main body. In some embodiments, the bias member may be heat staked to the main body. In some embodiments, the delivery device may further comprise a dispensing assembly including a depressor body, a reservoir interface member, and a bias member each of which being at least partially disposed within the receptacle between the reservoir and the top region. In some embodiments, the reservoir may be partitioned into a first portion and a second portion. In some embodiments, the first portion may be in fluid communication with the second portion via a flow restrictor.
In accordance with another example embodiment of the present disclosure, an example delivery device may comprise a main body including a central region and a peripheral region. The peripheral region may include a plurality of peripheral members extending outwardly from the central region. The central region may have a top region and a base which are connected by a wall. The delivery device may further comprise a reservoir portion including a reservoir with at least one delivery sharp. The reservoir portion may be detachably coupled to the main body and a least partially covered by the main body. The delivery device may further comprise an indicator disposed on a section of the reservoir portion covered by the main body. The delivery device may further comprise a first adhesive disposed on at least a portion of the main body. The delivery device may further comprise a second adhesive disposed on at least a part of the reservoir portion. The main body may obstruct line of sight to the indicator when the reservoir portion and main body are coupled together.
In some embodiments, when the delivery device is applied to a surface, the second adhesive may be configured to maintain the reservoir portion against the surface such that a removal force exerted on the main body results in separation of the main body and reservoir portion. In some embodiments, the indicator is selected from a group consisting of a barcode, data matrix, and QR code. In some embodiments, the indicator may encode information related to the contents of the reservoir. In some embodiments, the main body may be opaque. In some embodiments, the main body may be translucent. In some embodiments, the reservoir portion may be coupled to the main body via adhesive. In some embodiments, the peripheral region may include a pull tab. In some embodiments, at least one of the peripheral members may define a pull tab. In some embodiments, the main body may include a set of slots and the reservoir portion may include a number of tabs, each of the tabs extending at least partially though a respective slot to detachably couple the reservoir portion and main body.
In accordance with another example embodiment of the present disclosure and example delivery device may comprise a main body including a central region and a peripheral region. The peripheral region may have a plurality of petal members extending outwardly from the central region. The central region may define a receptacle and may have a top region and a base which are connected by a wall. The delivery device may further comprise a collapsible reservoir including at least one delivery sharp. The reservoir may be coupled to the main body and at least partially disposed within the receptacle. The delivery device may further comprise a dispensing assembly at least partially disposed within the receptacle between the reservoir and the top region. The delivery device may further comprise an adhesive disposed on at least a portion of the main body.
In some embodiments, the dispensing assembly may include a depressor body, at least one bias member, and a reservoir interface member. In some embodiments, the depressor body may include a portion which projects through an aperture in the top region. In some embodiments, the depressor body may include a detent. In some embodiments, the portion of the depressor body may include at least one notch and may have a cross-sectional shape which is not circular and not a regular polygon. In some embodiments, the bias member may include at least one bow spring. In some embodiments, the bias member may include a peripheral region and a number of bias projection which extend inwardly from the peripheral region. The main body may include a number of slots. The bias projections may extend through the slots and into the receptacle. In some embodiments, the reservoir interface member may be integral with the depressor body. In some embodiments, the dispensing assembly may include a coil spring and may include a reservoir interface member. In some embodiments, the reservoir interface member may be formed by a terminal portion of the spring which is routed in a pattern in a plane which is adjacent an end of the coils of the spring. In some embodiments, the dispensing assembly may include a spring and may be out of contact with the reservoir when the delivery device is in a storage state. In some embodiments, the spring may be in an unstressed state when the delivery device is in the storage state.
In accordance with another example embodiment of the present disclosure a delivery device system may comprise a package including an indicium. The system may further comprise a delivery device contained within the package. The system may further comprise a database. The system may further comprise a reader including a user interface and a controller. The reader may be in data communication with the database and may be configured to capture delivery device information from the indicium. The controller may be configured check the delivery device information against associated data in the database. The controller may be configured to generate use instructions on the user interface when the associated data in the database indicates the device is acceptable for use. The controller may prevent use of at least one functionality of the reader until first information has been collected by the reader and a first service is enabled on the reader.
In some embodiments, the indicium may be selected from a group consisting of a barcode, data matrix, and QR code. In some embodiments, the reader may be a smart device and may include an imager. In some embodiments, the at least one functionality may include use of the imager. In some embodiments, the first service may be a notification service. In some embodiments, the first service may be a location service. In some embodiments, the first information may be location information.
In accordance with an example embodiment of the present disclosure an example method of using of a medical delivery device may comprise capturing, with a reader, device information from an indicium on a package containing the medical delivery device. The method may further comprise applying the delivery device to skin of a patient. The method may further comprise establishing data communication between the reader and a database. The method may further comprise comparing the device information against associated device information stored on the database. The method may further comprise generating, with a controller of the reader, a set of use instructions on a user interface of the reader when an acceptability for use criteria is met by the comparison. The method may further comprise capturing, with the reader, data from a post usage indicium after the medical delivery device is used. The method may further comprise updating the database to indicate that the post usage indicium of the delivery device has been captured by the reader.
In some embodiments, the method further may comprise removing a first portion of the medical delivery device to reveal the post usage indicium on a second portion of the delivery device. In some embodiments, the method may further comprise marking the skin with the post usage indicium. In some embodiments, the method may further comprise generating a respective prompt on the user interface for each use instruction of the set of use instructions and preventing display of a next use instruction until a user interaction with the prompt is registered by the controller. In some embodiments, the method may further comprise preventing use of at least one functionality of the reader until a notification service of the reader is enabled. In some embodiments, the at least one functionality may be use of an imager of the reader. In some embodiments, the method may further comprise generating a confirmation of delivery for display on the user interface of the reader. In some embodiments, the reader may be a smart phone.
In accordance with yet another example embodiment of the present disclosure a method of using of a medical delivery device may comprise applying a delivery device to an injection site. The method may further comprise generating, with a controller of a reader, a set of use instructions on a user interface of the reader. The method may further comprise delivering an agent into the injection site from the delivery device. The method may further comprise capturing, with the reader, image data of the injection site, the image data including image data in a spectrum outside of the visible spectrum. The method may further comprise analyzing the image data to determine if the image data conforms to at least one criterion indicative of a proper injection.
In some embodiments, the method may further comprise establishing data communication between the reader and a database. In some embodiments, the method may further comprise updating the database to indicate an outcome of the analysis. In some embodiments, the image data may include image data in the near infrared spectrum. In some embodiments, the image data may include image data in the infrared spectrum. In some embodiments, the image data may include thermal image data. In some embodiments, analyzing the image data may comprise analyzing thermal image data for the presence of a cool region at the injection site. In some embodiments, analyzing the image data may comprise analyzing the image data to determine the presence of at least one characteristic of interest. In some embodiments, the at least one characteristic of interest may include a characteristic indicative of an intradermal bleb and a characteristic indicative of leak. In some embodiments, the reader may be a smart phone.
In accordance with another example embodiment of the present disclosure a microneedle may comprise a base including a first edge and a plurality of second edges. The microneedle may further comprise a plurality of sidewalls extending from the base in a direction substantially perpendicular thereto. The microneedle may further comprise a face extending from the first edge to a vertex at an acute angle to the base. Two adjacent sidewalls of the plurality of sidewalls may define a side edge extending from the base to the vertex in a direction substantially vertical to the base. The microneedle may further comprise a flow lumen extending through the microneedle from the base to an outlet in the face. The flow lumen may have a cross-section with an elongate shape.
In some embodiments, the cross-sectional shape may be obround. In some embodiments, the cross-sectional shape may have a length in a direction of elongation of up to 100 microns. In some embodiments, the cross-sectional shape may have a length in a direction of elongation of up to 200 microns. In some embodiments, the cross-sectional shape may be polygonal. In some embodiments, the microneedle may be constructed of silicon. In some embodiments, a majority of the cross-sectional shape may have a constant width. In some embodiments, the microneedle may have a height of at least 600 microns. In some embodiments, the microneedle may have a height of up to 800 microns.
In accordance with another example embodiment of the present disclosure and example microneedle may comprise a base. The microneedle may further comprise a plurality of sidewalls extending from the base. The sidewalls may be angled such that the microneedle tapers so as to have a smaller cross-sectional area as distance from the base increases. The microneedle may further comprise a flow lumen. The microneedle may further comprise a plurality of side ports in the sidewalls. The side ports may be in fluid communication with the flow lumen. The microneedle may further comprise a tip at an end of the sidewalls opposite the base.
In some embodiments, the microneedle may have a high aspect ratio. In some embodiments, the microneedle may be substantially in the shape of an obelisk. In some embodiments, the base may be polygonal in shape and a sidewall of the plurality of sidewalls may extend from each side of the polygonal shape of the base. In some embodiments, the base may have the shape of a quadrilateral and a sidewall of the plurality of sidewalls may extend from each of the four sides of the base. In some embodiments, the flow lumen may have a substantially constant cross-section. In some embodiments, the flow lumen may extend from the base to a plane in the microneedle where the cross-section of the flow lumen is wider than the portions of the cross-section of the microneedle. In some embodiments, the microneedle may be constructed of silicon and the lumen may be etched into the microneedle. The side ports may be formed as a consequence of the etching of the lumen. In some embodiments, the flow lumen may extend substantially along the long axis of the microneedle. In some embodiments, the tip may be beveled.
In accordance with yet another example embodiment of the present disclosure, a method of delivering a medical agent may comprise affixing to a surface a delivery device that includes at least one delivery sharp which may be in fluid communication with an at least partially collapsible reservoir containing the medical agent while the delivery device is in a storage state. The method may further comprise pressing a portion of the delivery device toward the surface to transition the delivery device to a delivery state. The method may further comprise spreadingly displacing at least two portions of the delivery device to tension the surface to which the delivery device is affixed. The method may further comprise penetrating the surface with the at least one delivery sharp. The method may further comprise transferring fluid out of the at least partially collapsible reservoir and through the at least one delivery sharp until the reservoir is in a depleted state.
In accordance with another example embodiment of the present disclosure, a delivery device may comprise a main body. The main body may comprise a peripheral region having a number of petal members. The main body may further comprise a central region extending proud of the peripheral region. The central region may have a top surface and a base. The delivery device may further comprise a collapsible reservoir in fluid communication with at least one delivery sharp. The at least one delivery sharp may be configured to expel fluid from the reservoir in an ejection direction. The delivery device may further comprise an adhesive member including a central aperture. The central aperture may include an increased aperture width portion aligned with the ejection direction.
In some embodiments, the reservoir may include a flexible portion and a rigid portion. The adhesive member may be affixed to the main body and the rigid portion. In some embodiments, the reservoir may include a flexible portion and a rigid portion. The rigid portion may have a foot print with a first area. The central aperture may encompass a second area which is between 60-100% of the first area. In some embodiments, a center of the central aperture may be coaxial with a center of the reservoir. In some embodiments, the adhesive member may include at least one spoke which projects into the central aperture from the periphery of the central aperture. In some embodiments, the adhesive member may cover at least a portion of each of the petal members. In some embodiments, the at least one delivery sharp may include a spaced array of microneedles. In some embodiments, the main body may have a first state and a second state. The main body may include at least one partially invertible region which is in a first shape in the first state and in the second state is substantially inverted with respect to the first shape over at least a portion of the of the invertible region. In some embodiments, the main body may be configured such that at least two of the petal members spreadingly displace as the main body transitions from the first state to the second state. In some embodiments, the at least one delivery sharp may be displaced into communication with a delivery destination when the main body is displaced from the first state to the second state. In some embodiments, the central aperture may include, at the increased aperture width portion, at least one notch extending outward from the periphery of the central aperture and through the adhesive member.
In accordance with another example embodiment of the present disclosure a delivery device may comprise a main body. The main body may include a peripheral region having a number of petal members. The main body may further include a central region extending proud of the peripheral region and having a top surface and a base. The delivery device may further comprise a collapsible reservoir coupled to the main body. The reservoir may be in fluid communication with at least one microneedle having a width, height, and length. The delivery device may further comprise an adhesive member. The adhesive member may include a central aperture having an increased aperture width portion aligned with the length dimension of the microneedle.
In some embodiments, the reservoir may include a flexible portion and a rigid portion. In some embodiments, the adhesive member may be affixed to the main body and the rigid portion. In some embodiments, the reservoir may include a flexible portion and a rigid portion. The rigid portion may have a foot print with a first area. The central aperture may encompass a second area which is between 60-100% of the first area. In some embodiments, a center of the central aperture is coaxial with a center of the reservoir. In some embodiments, the adhesive member may include at least one spoke which projects into the central aperture from the periphery of the central aperture. In some embodiments, the adhesive member may cover at least a portion of each of the petal members. In some embodiments, the at least one delivery sharp may include a spaced array of microneedles. In some embodiments, the main body may have a first state and a second state. The main body may include at least one partially invertible region which is in a first shape in the first state and in the second state is substantially inverted with respect to the first shape over at least a portion of the of the invertible region. In some embodiments, the main body may be configured such that at least two of the petal members spreadingly displace as the main body transitions from the first state to the second state. In some embodiments, the at least one delivery sharp may be displaced into communication with a delivery destination when the main body is displaced from the first state to the second state. In some embodiments, the central aperture may include at the increased aperture width portion at least one notch extending outward from the periphery of the central aperture and through the adhesive member.
In accordance with still another exemplary embodiment of the present disclosure a delivery device may comprise a main body. The main body may include a peripheral region. The peripheral region may include a number of petal members. The main body may further include a central region. The central region may extend proud of the peripheral region. The central region may have a top surface and a base. The delivery device may further comprise an adhesive coupled to at least a part of the main body. The delivery device may further comprise a reservoir including at least one flexible portion. The at least one flexible portion may include a cavity defined by a first wall including a collapse facilitator. The delivery device may further comprise at least one delivery sharp in fluid communication with the reservoir.
In some embodiments, the collapse facilitator may include a bellows. In some embodiments, the collapse facilitator may include a pleat which extends around the wall in a spiral manner. In some embodiments, the collapse facilitator may include at least one stepped region formed in the wall. In some embodiments, the first wall may extend from a flange coupled to a rigid portion of the reservoir. In some embodiments, the first wall may taper as distance from the flange increases such that the cross-sectional area of the cavity decreases with distance from the flange. In some embodiments, the cavity may also be defined by a second wall at an end of the cavity, the second wall forming a substantially flat surface. In some embodiments, the second surface may include a central depression. In some embodiments, the wall may extend from a flange and may be formed integrally therewith. In some embodiments, the cavity may be defined by the first wall and a second wall at an end of the cavity, the second wall being substantially parallel to the flange. In some embodiments, the at least one delivery sharp may include a microneedle.
These and other aspects will become more apparent from the following detailed description of the various embodiments of the present disclosure with reference to the drawings wherein:
Such delivery devices 10 may be used to dispense a medical agent from a reservoir 12 included as part of the delivery device 10 into a target delivery destination of a patient via one or more delivery sharp 72. The reservoir 12 may be at least partly flexible and may have a variable volume which may deplete as fluid is dispensed from the reservoir 12. As the reservoir 12 depletes, the reservoir 12 may at least partially collapse. In the example embodiment, a plurality of delivery sharps 72 are included in the delivery device 10, though other embodiments may only include a single delivery sharp 72. The exemplary plurality of delivery sharps 72 may be arranged in a one or two dimensional array and may extend from the reservoir 12. Where multiple delivery sharps 72 are included, the delivery sharps 72 may be arranged in one or more rows and/or columns. Though three delivery sharps 72 arranged in a single row are depicted in
The delivery sharps 72 may be selected based on the desired target delivery destination in a patient. In certain embodiments, the target delivery destination may be a transcutaneous location. For example, the target delivery destination may be a subcutaneous delivery destination or an intramuscular delivery destination. Alternatively, the target delivery destination may be a shallow delivery destination between the stratum corneum of a patient and the subcutaneous tissue of the patient. Such shallow destinations may be referred to herein as intradermal delivery destinations. Shallow delivery destinations may include an epidermal or dermal target location or may, for example, target a junctional area between the epidermis and dermis or dermis and subcutis. In the example embodiment, the delivery sharps 72 are depicted as microneedles. Such delivery sharps 72 may be present in delivery devices 10 with shallow (e.g. above subcutaneous tissue) target delivery destinations. In alternative embodiments where, for instance, the target delivery destination is a subcutaneous or intramuscular location, conventional delivery sharps (e.g. 30-gauge needle) may be utilized.
Referring now also to
The points or tips of microneedles described herein may be solid and the flow lumens 126 through the microneedles may be offset from the points or tips (in
With reference to
For example, as shown in
An appropriate silicon etching technique (or mold in embodiments using polymeric microneedles) may be used to create steeper side walls of the channel 200. This may help inhibit the skin from bending into and occluding the channel 200. Etching techniques that could be used include, by way of non-limiting example, chemical etching techniques (e.g., acid). Suitable etching techniques may include ion based etching techniques (e.g. reactive ion etching). The etching process could be a wet etching process or a dry etching process. In some non-limiting embodiments, the channel 200 may be within a range of 50-60 microns wide from side to side. In some non-limiting embodiments, the flow lumen 126 may have a diameter of 50-60 microns. The channel 200 may have a width equal to the diameter or widest portion of the flow lumen 126 or the channel 200 may have a width which is less than or greater than the width of the flow lumen 126. In certain examples, the width of the channel 200 may be about 5-10 percent of the height of the microneedle.
To avoid leakage of the fluid from the channel 200, it may be desirable to ensure that the channel 200 terminates at least a certain distance beneath the surface of the skin yet also reaches the targeted skin layer (e.g., the lamina lucida junction) when the microneedle is inserted into the skin. In some embodiments the channel 200 extends from the flow lumen 126 to within at most 50 microns (e.g. 50-200 microns) of the base 17 of the microneedle. In some embodiments, the end of the channel 200 most proximal the base 17 of the microneedle may be at least below the stratum corneum (and perhaps 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 most proximal the base 17 may be disposed below the epidermis (e.g. in the basement membrane) or within the epidermis.
The channel 200 need not be straight or shaped in the manner shown in and described with reference to
The depth of the channel 200 may be about 25 microns or more (e.g. 25-50 microns) in certain examples. The depth of the channel 200 may be or be less than 5 percent the height of the microneedle. While the depth of the channel 200 may be constant along the length of the channel 200, the depth of the channel 200 need not be constant along the length of the channel 200. Likewise, the width of the channel 200 need not be constant along the length of the channel 200 (see, e.g.,
Referring now also to
Referring now to
Still referring to
Additionally or in the alternative, a microneedle may include a depression 202. The depression 202 may include first and second opposing vertices 204, 206. In some embodiments the depression 202 may be (though need not necessarily be) a rounded depression or a concave depression, as shown in
In certain examples, and referring now to
In yet another embodiment, and referring now to
In still other embodiments and referring now to
In embodiments of microneedles which are obelisk shaped, the microneedles may include at least one side port 29 which may serve as an outlet for that microneedle. Such side port(s) 29 may be difficult to block off with tissue which that may become compressed during insertion of the microneedle into a patient. In the example embodiment, a lumen 126 may extend through the base 17′ of the microneedle and have a terminal end which is more proximal the end region 15 than the base 17′. The lumen 126 may be of relatively constant cross-section. The taper of the sidewalls 19′ may be such that the terminal end of the lumen 126 is wider than portions of the cross-section of the corresponding region of the microneedle. Thus, the lumen 126 may form openings in the sidewalls 19′ which may serve as the side ports 29. In various examples, the lumen 126 may be centrally disposed yielding symmetrical side ports 29. In alternative embodiments, the lumen 126 need not be centrally disposed and the side ports 29 may not be symmetrical.
In various embodiments where silicon is not used to form the microneedles, microneedles described herein may be constructed of glass (e.g. silica glass, borosilicate glass), ceramic (e.g. alumina, calcium sulfate dehydrate, calcium phosphate dehydrate, organically modified ceramics such as Ormocer), polymer (e.g. polymethyl methacrylate or PMMA, polylactic acid or PLA, polylactic-co-glycolic acid or PLGA, polyglycolic acid or PGA, polycarbonate, cyclic-olefin copolymer or COC, polyvinylpyrrolidone or PVP, polyvinyl alcohol PVA, polystyrene, polymethyl vinyl ether-co-maleic anhydride), carbohydrate, or metal (e.g. stainless steel, titanium, palladium, nickel, alloys such as palladium cobalt alloys, etc.). Any suitable microneedle constructions including dissolvable microneedles may be used. Microneedles and features thereof may be manufactured in one or more of, though are not limited to, a molding process, etching process, ablative process (e.g. laser ablation), or a material additive process (e.g. 3D printed). In various embodiments, it may be desirable that microneedles be constructed of a biocompatible, non-ductile, high Young's modulus material with an indentation hardness sufficient to allow penetration into skin without breakage.
Referring again primarily to
Any suitable vaccine may be delivered via such a delivery device 10. For example, the vaccine may be but is not limited to, attenuated live vaccines, inactivated virus vaccines, acellular vaccines, cellular vaccines, toxoid vaccines, heterotypic or Jennerian vaccines, monovalent vaccines, polyvalent vaccines, nucleic acid vaccines (e.g. DNA, plasmid vaccine, mRNA), virus like particle vaccines, recombinant vector vaccines (e.g. replicating, non-replicating), dendritic cell vaccines, T-cell receptor peptide vaccines, chimeric vaccines, subunit vaccines, nanoparticle vaccines, recombinant protein vaccines, polysaccharide vaccines, and conjugate vaccines. It should be noted that these are not necessarily mutually exclusive. For instance, a vaccine could be a recombinant protein nanoparticle vaccine or some other combination of the above. Vaccine may also refer to a combination vaccine (e.g. DTaP, MMR, MMRV, etc.) or a vaccination agent which targets a single pathogen or multiple strains of a single pathogen. Example vaccines may 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. Delivery devices 10 described herein are also not limited for use with humans. Such delivery devices 10 may be used for livestock, pets, services animals, or in other veterinary applications. In such cases, these delivery devices 10 may be filled with a vaccine for at least one non-human pathogen. Delivery devices 10 described herein may also be useful for research applications.
Where a delivery device 10 is filled with a vaccine, it may be desirable that the target delivery destination be a shallow delivery destination. This may be particularly desirable where the amount of available vaccine is limited. For example, such a delivery device 10 may be well suited for use with new vaccines having high demand. Vaccines for novel pathogens (e.g. SARS-CoV-2 or other coronaviruses) may, for instance, be well suited for use with delivery devices 10 described herein.
Evidence suggests that shallow delivery of vaccines may provoke protective immune response with smaller amounts of vaccine antigen. As a result, dose sparing may be practiced allowing the same quantity of vaccine to be effective for immunizing a greater number of people. Alternatively or additionally, injection sparing may be possible. Shallow administration with a delivery device 10 such as those shown herein may allow for a single injection protocol where other routes of administration may require multiple injections over some period of time. One or more adjuvants may be included in some vaccine formulations to further aid in facilitating dose or injection sparing, though less reliance on adjuvants could also be possible with when a vaccine is administered intradermally.
Particularly for new vaccines generated to combat an ongoing pandemic (e.g. a vaccine for SARS-CoV-2), the prospect of rapidly generating billions of doses would almost certainly exceed current vaccine production capabilities. Due to the injection and dose sparing potential of delivery devices 10 described herein, such delivery devices 10 may facilitate vaccination of large numbers of people even when a critically needed vaccine is in short supply. Additionally, as a consequence of potential dose and injection sparing, delivery devices 10 such as those shown and described herein may allow injections to be more cost effective. Moreover, due to the small volume of vaccine needed, delivery devices 10 may be made relatively small. This may simplify shipping and help to facilitate rapid distribution of vaccine to a population. This may be particularly attractive for vaccines which require cold chain distribution as packing volume may be of heightened importance.
Additionally, some studies have suggested that shallow administration may be particularly helpful in certain patient populations. For example, elderly populations may receive superior protection from vaccinations received intradermally than via other routes. That said, the Mantoux technique, which is typically used for intradermal administration, can pose reliability concerns and can be difficult to perform, especially without training. Per the World Health Organization, a large factor which has limited the use of intradermal vaccination has been the lack of a delivery platform.
Delivery devices 10, such as those shown and described herein, may provide an attractive delivery platform for intradermal vaccination. Consequentially, delivery devices 10 described and shown herein may help to give better protection to vulnerable populations and may help in meeting the large demand for vaccines against, for example, novel pathogens by leveraging dose/injection sparing which may be possible with intradermal vaccination. Moreover, intradermal delivery devices 10 described herein may be painless or nearly pain free which may make the delivery devices 10 described herein user preferable over other types of injections. That said, and as mentioned above, delivery devices 10 described herein are not limited to delivery via the intradermal route. Delivery devices 10 may, for instance, be configured as transdermal (e.g. subcutaneous or intramuscular) delivery devices 10.
The example delivery devices 10 shown herein additionally are not limited to vaccine delivery devices. Such a delivery device 10 may fill a number of niches in the medical field. Other agents, for example, diagnostic or testing agents may be supplied via certain example delivery devices 10. For instance, allergens or potential allergens may be administered via the delivery device 10. Tuberculosis testing agents may be delivered via the delivery device 10. Such delivery devices 10 may also be used to deliver medication for endocrine disorders. For instance, insulin may be delivered with some exemplary delivery devices 10.
Still referring to
In various examples, transition of the delivery device 10 from the storage state to the delivery state may be accomplished via bending, pivoting, or deformation of one or more regions of the main body 20. In certain examples, the main body 20 may include one or more hinges (e.g. living hinge to aid in lowering part count) at which the main body 20 may bend. In other embodiments, the main body 20 may be or include a bi-stable element which may have a first stable state which corresponds to the storage state and a second stable state which corresponds to the delivery state. The main body 20 may for example substantially or partially invert (e.g. convex to concave) in shape or have one or more invertible regions which at least partially invert when the delivery device 10 is transitioned from the storage state to the delivery state. The transition may be affected via application of force throughout the entire transition. Alternatively, the transition may only require application of force throughout a portion of the transition. For example, in some embodiments a triggering force may be applied to initiate the transition and the transition may subsequently complete in the absence of any external application of force. For example, after application of the triggering force, the transition may be characterized by a snap-through buckling via which the main body 20 rapidly shifts into the delivery state.
The main body 20 may be at least partially covered with adhesive 22 over a first face 24 of the main body 20. The adhesive 22 may serve to couple the main body 20 to a skin surface at an infusion or injection site on a patient. Thus, the first face 24 may be a skin adjacent face or proximal (proximal and distal defined in relation to a patient) face of the main body 20. The main body 20 may be adhered to the skin when the main body 20 is in the storage state and then may be transitioned to the delivery state. As the transition occurs, at least two adhesive bearing portions of the main body 20 may be displaced with respect to one another so as to stretch or spread a surface anchored to the main body 20 via the adhesive 22. As these portions may be adhered to the skin surface, the skin may be stretched as the adhesive bearing portions are displaced with respect to one another. This may be desirable as the skin may be rendered taught facilitating piercing of the skin by the delivery sharp(s) 72 as the main body 20 transitions to the delivery state. In certain examples, the adhesive bearing portions may be disposed, for example, in opposition to one another. The displacement of the two adhesive bearing portions may increase the distance between or spread apart the two adhesive bearing portions. In other embodiments, the distance between the two adhesive bearing portions may not increase or may even decrease while still causing stretching of the skin surface. This may for example occur if the transition causes a flat patch of skin to be pulled around a curve or contour of the main body 20 (see, e.g.,
Transition of the main body 20 to the delivery state may also result in a proximal displacement or lowering of the delivery sharp(s) 72 toward and into the skin. In embodiments where the delivery sharp(s) 72 are coupled to the reservoir 12, the reservoir 12 may also be proximally displaced. In some examples, the reservoir 12 may be compressed between the skin surface and a section of the main body 20 when the main body 20 is transitioned from the storage state to the delivery state. Preferably, the delivery sharp(s) 72 may be inserted into the skin prior to the reservoir 12 being substantially compressed. Compression of the reservoir 12 may serve to drive fluid out of the reservoir 12, through the delivery sharp(s) 72 and into the target delivery destination in the patient. In embodiments described herein, the delivery sharp(s) 72 may be covered prior to use. A fluid communication path from the reservoir 12 out of the delivery sharp(s) 72 may not be available prior to use.
In some embodiments a collapsible pouch, or packet 208, may be positioned in the delivery device 10 above the reservoir 12 as shown in
In an embodiment where the medical agent in a reservoir 12 of a delivery device 10 must be stored at very low temperatures, such as, e.g., when the medical agent is a vaccine with such requirements, the packet 208 can contain a liquid. For example, a vaccine may be stored and/or shipped at commercial freezer temperatures, e.g., in the range of −18 degrees C. (or lower, e.g. −70° C. or −20° C. for certain vaccines). The liquid may have a boiling point that is greater than the medical agent (e.g., vaccine) storage temperature but less than room temperature or another suitable temperature set point. Though any suitable liquid may be used, one example of a suitable liquid is butane. Butane has a boiling point of −1° C. Though the example described herein refers to butane, one skilled in the art would appreciate the description is generalizable to any suitable liquid.
The delivery device 10 may be affixed to the skin surface of a user with the reservoir 12 containing cold stored/shipped vaccine and the packet 208 containing liquid butane (or any other suitable substance). If the ambient temperature is room temperature, e.g., about 20 degrees C., the contents will warm up (heat from the patient may aid this). The liquid butane will boil and transition to gas once it reaches its boiling point of −1° C. in the example embodiment. As the liquid boils and transitions to a gaseous state, the pressure in the packet 208 grows, causing it to expand and apply downward pressure on the reservoir 12 from above as shown in
Such an arrangement may also serve to provide visible evidence of whether the delivery device 10 had reached a temperature during storage or shipping that was too high for the medical agent. For example, if a temperature that was beyond the phase change temperature of the packet 208 contents was reached during storage, the delivery device 10 would be emptied due to the pressure applied from above by the packet 208. This may be visibly perceptible to a user. The delivery device 10 would also self-destruct when subjected to certain temperature abuse scenarios. In the event that the delivery device 10 was subjected to a temperature above the phase change temperature of the packet 208 contents, the delivery device 10 would be emptied. As a result, the delivery device 10 would prevent itself from later administering a temperature abused medical agent.
In some embodiments significant downward pressure on the reservoir 12, e.g., greater than 50 psi, may be desired to provide force to collapse the reservoir 12 and force fluid therein into the skin of a user via delivery sharps 72 as described above with reference to
In still other embodiments, the packet 208 could be a vacuum packed bias member (e.g. foam spring). In the vacuum packed state, the bias member may be in a compressed state. User interaction with the packet 208 may cause the packet 208 to break allowing the bias member to restore. As the bias member restores, pressure may be applied to the reservoir 12 to generate pressure for delivery.
In alternative embodiments, a packet 208 of
In other embodiments, the packet 208 may be or include a bias member. In some embodiments, the packet 208 may be a foam adhesive material sitting atop the reservoir 12. In such examples, when a user pushes down on the delivery device 10 (once the delivery device 10 is affixed to the skin surface), the foam adhesive may function like a spring that helps limit maximum pressure applied to the reservoir 12. The foam adhesive may also facilitate even distribution of pressure across the top of the reservoir 12. Assembly of the components described in connection with the above embodiments is described below with reference to
Referring now to
Alternatively, the main body 20 may be injection molded and the raised central region 28 and flat peripheral region 30 may be formed in the molding operation. In various embodiments where delivery devices 10 are or may be injection molded (e.g. the embodiments described in relation to
The central region 28 may be domed and the domed shape may establish a receptacle 32 on the proximal side of the main body 20 within which the reservoir 12 may be disposed. The reservoir 12 may be coupled within the receptacle 32 via adhesive or in another suitable manner. The central region 28 may also include a series of fenestrations 34 which may form a fenestrated ring in the central region 28. In the example, the fenestrations 34 are evenly spaced from one another and arranged in a circle which is generally coaxial with the center of the central region 28. In alternative embodiments, fenestrations 34 may be irregularly spaced or omitted. Additionally, in some embodiments, the fenestrations 34 may instead be replaced with thinned regions or a ring where the material of the main body 20 is thinned.
The main body 20 may include a number of slots 36. The slots 36 may extend from a peripheral edge 38 of the main body 20 toward a center or midpoint of the main body 20. In the example embodiment, the slots 36 extend in a radial direction. The slots 36 may extend through the entirety of the peripheral region 30. In some embodiments, and as shown, the slots 36 may additionally extend though at least a portion of the central region 28 as well. The fenestrations 34 in the central region 28 may be disposed radially inward of the terminus 40 of each of the slots 36. The main body 20 may thus include a central region 28 which is circumscribed by a number of petal members 42 which are spaced apart via the slots 36.
Referring now to
Referring now to
The main body 20 may be a bi-stable element or include at least one bi-stable region which may be stable in both the storage state and the delivery state. When an axial load is applied on the central region 28 and the main body 20 is in the storage state, the main body 20 may deform into an unstable state. The main body 20 may then exhibit a snap through buckling action which rapidly shifts the main body 20 into the stable delivery state similar to that shown in
Two opposing points 46A, B disposed at the peripheral edge of the proximal surface 24 are shown in
Due to the elasticity of the skin 44, the skin 44 may exert a restoring force against the proximal surface 24 of the main body 20 as it attempts to revert to an unstretched state. The main body 20 may resist this restoring force and retain its bowl shape. The reservoir 12, however, may be compressed between the skin 44 and the main body 20. This may aid in ensuring the delivery sharp(s) 72 puncture the skin 44 and enter fluid communication with a target delivery destination in the patient. Additionally, since the reservoir 12 may be collapsible, the restoring force exerted by the skin 44 may pressurize the reservoir 12 and urge fluid to pass out of the reservoir 12 via the delivery sharp(s) 72. Thus, the restoring force exerted by the stretched skin 44 may serve to empty and collapse the reservoir 12.
As mentioned above, in certain examples, some petal members 42 may not include adhesive 22 regions or may have a proximal surface 24 which is at least partially covered in adhesive 22 that is less aggressive than adhesive 22 of on other petal members 42. In embodiments where some petal members 42 are devoid of adhesive 22, this may help to limit stretching of the skin 44. Likewise, petal members 42 with less aggressive adhesive 22 may release the patches of skin 44 to which they are affixed if force needed to stretch the skin 44 exceeds a threshold. The petal members 42 themselves may also be constructed such that at least one of the petal members 42 includes a relief region (e.g. a thin or narrow region). For example, if force needed to stretch the skin 44 is above a threshold, one of more of the petal members 42 may bend or buckle at the relief region to relieve some of the tension on the skin 44.
This may be desirable as it may help to mitigate potential discomfort during an injection due to excessive tensioning of the skin 44. Additionally, this may be helpful in certain patient populations as skin characteristics vary significantly with age, hydration state, lifestyle (sun exposure, nutrition), etc. It may be desirable that slacker or looser skin be stretched to a greater degree than highly elastic skin. Thus, instead of providing a variety of delivery devices 10 with different adhesives 22 targeted at specified patient populations, a delivery device 10 may be made in a more universal manner.
With reference to
Referring now to
In some embodiments, and as also shown in
In other embodiments, and referring primarily to
In some examples, and referring now primarily to
As shown exemplarily in
In still other embodiments, the width of one or more of the slots 254 may vary over the length of that slot 254. A number of embodiments including variable width slots 254 are depicted in
Still referring to
In some embodiments and as shown in one example in
Referring now to
With reference to
Additionally or in the alternative, the peripheral region 30 may not be a substantially flat annular shape. The peripheral region 30 may be defined by curved petal members 42 that continue in a downward direction such that their peripheral edge 38 is spaced from the plane of the base 262 of the supporting structure 252 (e.g. about the same or less than the distance from the base 262 to the periphery 340 of the top surface 250). The peripheral edge 38 may be disposed along a plane which is more distal to the periphery 340 of the top surface 250 than the base 262. As depicted in
As best shown in
Referring now primarily to
In some non-limiting examples, a delivery device 10 may have dimensions and radii of curvature as shown in
Referring to
Still referring to
Still referring to
Referring now primarily to
In various embodiments, certain regions of the main body 20 of the delivery device 10 may remain static or may not invert. Thus, a main body 20 may include inverting regions and resilient regions. Though described as resilient regions, it is to be understood that some bending or deformation may still occur as pressure is applied. These regions may, however, appear generally similar or extend/project in the general same direction in both the storage and delivery state. As shown, the peripheral region 30 and top surface 250 may invert, but a portion of the central region 28 may resist deformation to this degree. The supporting structures 252 shown in other embodiments described herein (see, e.g.,
Still referring to
Referring now to
In some such embodiments, the bias member 470 may be in an unstressed state when the associated delivery device 10 is in a storage state. User interaction with the delivery device 10 to transition the delivery device 10 to a delivery state may involve applying pressure to the depressor body 472 of the dispensing assembly 480. This may displace the depressor body 472 in the direction of the reservoir 12. The depressor body 472 may include an engagement feature (e.g. catch or detent) which may engage with a retention feature of the delivery device 10 (e.g. one defined in the main body 20) to hold the depressor body 472 in the displaced position. Displacement of the depressor body 472 may in turn cause a bias to be stored in the bias member 470. With the delivery device 10 transitioned to the delivery state, the bias member 470 may restore to an unstressed state. As the bias member 470 restores, the reservoir interface member 474 of the dispensing assembly 480 may be urged against the reservoir 12 to collapse the reservoir 12 and drive fluid into a patient. Thus without, for example, sustained manual pressure against the delivery device 10, pressure may be applied to the reservoir 12 over a period of time sufficient to fully deliver contents of the reservoir 12 (e.g. 5 minutes in certain embodiments).
In other embodiments, the bias member 470 may be in a stressed state when the associated delivery device 10 is in a storage state and may be coupled to or associated with the depressor body 472 of the dispensing assembly 480. The depressor body 472 may interface with a portion of the delivery device 10 (e.g. the main body 20) so as to resist displacement under the restoring force exerted by the bias member 470. This may prevent the bias member 470 from restoring from its stressed state. A catch or detent in the depressor body 472 may, for instance, be in engagement with the main body 20 when the delivery device 10 is in a storage state. User interaction with the delivery device 10 to transition the delivery device 10 to a delivery state may disengage the depressor body 472 such that the depressor body 472 is free to displace. Once the depressor body 472 is free to displace, the bias member 470 may restore to an unstressed or at least less stressed state and drive the reservoir interface member 474 of the dispensing assembly 480 against the reservoir 12. Over a period of time, this may cause the reservoir 12 to collapse such that fluid is driven out of the reservoir 12 and into a patient.
Referring now to
As pressure is applied to transition the delivery device 10 to the delivery state, the elongate body 476 may displace toward the reservoir 12. This may cause the bias members 470 to become stressed. As shown, the elongate body 476 includes a detent or notch 482. The notch 482 may engage with the main body 20 to hold the elongate body 476 in a depressed state. Engagement of the notch 482 with the main body 20 may also serve to indicate a delivery device 10 has been used.
With the elongate body 476 held in place, restoration of the bias members 470 to a less stressed state may drive displacement of the reservoir interface member 474 into the reservoir 12. As mentioned above, this may drive reservoir 12 contents out of the reservoir 12 and into the patient. It should be noted that, in various examples, at least some portion(s) of the main body 20 may spreadingly displace and/or invert as the delivery device 10 is transitioned to the delivery state (see, e.g.,
Referring now to
A main body 20 of a delivery device 10 may include a number of passages 494 which extend through the main body 20. The passages 494 may be positioned in a support structure 252 of the main body 20. The spacing of the passages 494 may correspond to the spacing of bias projections 492 on the bias member 470. When a delivery device 10 is assembled, the bias projections 492 may be introduced into and partially through respective passages 494 in the main body 20. The peripheral body 490 may rest on a distal face of the peripheral region 30 (see, e.g.
Referring now also to
As best shown in
The depressor body 472 is shown in a translational displacement constraining position in
Referring now also to
During actuation of an associated delivery device 10 from a storage state to a delivery state, the depressor body 472 may be rotated to a translational displacement permitting position. Once this position is reached, the depressor body 472 may be free to translationally displace and the bias member 470 may urge the depressor body 472 to translationally displace. As the bias member 470 restores to a less stressed state, the reservoir interface member 474 may be driven against the reservoir 12 to force fluid out of the reservoir 12 and into a patient. The amount of the depressor body 472 which extends out of the main body 20 may alter as the bias member 470 restores to a less stressed state. Thus, the amount of depressor body 472 extending out of the main body 20 may serve as an indicator that a delivery device 10 has been used.
Referring now to
The stop member 473 may be rotated from a translational displacement constraining position to a translation displacement permitting position in which the depressor body 472 is free to displace translationally. In the translation displacement constraining position, the aperture 496′ may be positioned such that the stem 500 overhangs a portion of the body 479 of the stop member 473. As a result, the stop member 473 may present a mechanical interference to translational displacement of the depressor body 472. When the stop member 473 is rotated to a translational displacement permitting position, stem 500 may no longer overhang the body 479 of the stop member 473. In this position, the depressor body 472 may translationally displace within the correspondingly shaped aperture 496′ of the stop member 473. The stop member 473 may include ridges, knurling, bumps, grips, spokes, or other features to facilitate rotational displacement of the stop member 473 via interaction with a user's fingers.
Referring primarily to
Referring now to
Still referring to
Referring now to
Referring now also to
Still referring to
In some embodiments, as shown in
The rounded depression 274 may include a pocket 276 formed therein. The pocket 276 may be formed in a proximal face of the holder 270. The pocket 276 may be situated at a center, and lowest (with respect to the skin surface when the delivery device 10 is affixed thereto) point of the rounded depression 274. The pocket 276 may be sized to fit and accept a sharp bearing body 26 with delivery sharp(s) 72 thereon such as, e.g., the sharp bearing body 26 including delivery sharps 72 of
In an example embodiment, the width (e.g. diameter) of the holder 270 may be approximately 0.7 inches (e.g. 0.744 inches). The footprint area of an exemplary holder 270 may be approximately 0.45 square inches (e.g. 0.44 square inches). The holder 270 may be manufactured by any technique known to those of skill including, e.g., injection molding or thermoforming.
Another exemplary holder 270 is depicted in
Still referring primarily to
Referring now to
In some embodiments, as shown in
Referring now to
A collapse facilitator may be a pleated, bellows shaped, accordioned, creased, ruffled, stepped, or concertina shaped wall 261 which extends upward from the flange 284. The wall 261 may extend proud of the flange 284 and may taper (e.g. continuously or in stepwise manner) as distance from the flange 284 increases. A top wall 263 may span across the portion of the wall 261 most distal the flange 284. Thus, the wall 261 and top wall 263 may together form a cavity in the reservoir portion 271. The top wall 263 may be generally planar and extend parallel to the flange 284 in certain examples. The top wall 263 may in certain examples include a central depression 267. The central depression 267 may serve to aid in locating a reservoir interface member 474 (see, e.g.,
Though any pleating, bellows, accordion, crease, or ruffling pattern may be used, in certain embodiments, the wall 261 may include at least one pleat 269 in a spiral pattern. The at least one spiral pleat 269 may extend from a point adjacent the flange 284 and end at a point adjacent the top wall 263. Where the wall 261 tapers as distance from the flange 284 increases, the any spiral pleats 269 may have a conical type spiral to accommodate the taper. Any spiraling pleat(s) 269 may have a pitch which causes each pleat(s) 269 to wrap around the wall 261 a plurality of times. In the example embodiment shown in
Referring now to
In an embodiment, the reservoir 12 may be formed by attaching the reservoir portion 271 to the holder 270, as shown in
A medical agent, such as, e.g., a vaccine, may be inserted into the reservoir 12 via the side channel 282, after which the side channel 282 may be sealed closed by any known technique such as, e.g., sonic welding or any other suitable technique described here. The sharp bearing body 26 (see, e.g.,
In one example embodiment, the reservoir 12 may hold approximately two microliters of vaccine or other medical agent. After a medical agent (e.g., a vaccine) has been inserted, the reservoir 12 may be placed in cold chain storage separately and subsequently installed in the delivery device 10 shortly before use. This may serve to help maximize the yield of vaccine doses per unit volume in cold chain storage. The reservoir 12 may be inserted into the delivery device 10 with a packet 208 and/or container 350 or foam adhesive (such as the packet or foam adhesive material described above with reference to
With reference to
Still referring to
In certain embodiments and referring now to
As shown in
Referring now to
As shown in
Still referring to
In certain examples, the first and second portion 520, 522 of a partitioned reservoir 12 may be filled with different fluids. For example, the first portion 520 may be filled with an agent desired to be delivered (drug, vaccine, medical agent, etc.). The portion proximal the delivery sharp(s) 72 may be filled with a gas (e.g. sterile or cleanroom air from the manufacturing environment, inert gas, etc.). The orifice may be sized such that the properties of the agent (e.g. surface tension, viscosity) prevent the agent from passing to the second portion 522 without addition of pressure on the reservoir 12. Thus, despite the first and second portions 520, 522 being in fluid communication, the second portion 522 may remain unwetted by any agent filled into the reservoir 12 during manufacture until use. When the delivery device 10 is used, there may be a latency period during which fluid is forced into the second portion 522 from the first portion 520. Pressure in the second portion 522 may then ramp up until a pressure at which the patient's anatomy begins to accept the delivery. The pressure may remain relatively steady (or at least not spike considerably) once delivery begins.
When a delivery device 10 including a partitioned reservoir 12 is transitioned to a delivery state, at least one bias member 470 (e.g. a conical spring) may cause pressure to be exerted against the first portion 520 of the reservoir 12. Depending on the embodiment, the at least one bias member 470 may directly contact the reservoir 12 or pressure may be exerted through a reservoir interface member 474 (see, e.g.,
Referring now to
The shape and size of the central aperture 49 may have an effect on bleb formation resulting from delivery when a delivery device 10 is used. Additionally, the shape and size of the central aperture 49 may play a role in helping to facilitate certain shallow deliveries or shallow deliveries into skin having certain characteristics. In various exemplary delivery devices 10, it may be desirable that the central aperture 49 have a cross sectional area which is 60-100% the area of the footprint of the holder 270. It may also be desired that the central aperture 49 be shaped such that at least a portion of the adhesive member 22 is attached to a portion of a holder 270 or other rigid portion of the reservoir 12. In certain examples, the cross-sectional area of the central aperture 49 may be greater than 0.13 in2. In certain examples, the cross-sectional area of the central aperture 49 may be in a range of 0.13 in2 to 0.5 in2 (e.g. about 0.3 in2).
Additionally, it may be desired that the central aperture 49 be wider in certain directions compared to others. For instance, each delivery sharp 72 (e.g. one or more microneedle) may tend to dispense fluid in an ejection direction which extends from the outlet of the respective delivery sharp 72 (e.g. along the axis of the lumen of the delivery sharp 72). It may be desired that the central aperture 49 have a larger or increased width in a direction which aligns or substantially aligns with the ejection direction. For example, the greatest width (or at least a comparatively large width portion) of the central aperture 49 may be along a direction that is parallel to a plane that includes the ejection direction. Using a delivery device 10 including one or more microneedle similar to that shown in
Referring now primarily to
Referring now primarily to
Referring now to
The panels 52A-D may include a pair of opposed 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 the example, the planar portions 54 are coplanar. One of the end portions 52A may include an angled projection 56 which extends from planar portion 54. The angled projection may extend from the planar portion 54 such that an obtuse angle is formed between the distal faces of the planar portion 54 and angled projection 56. The angled projection 56 may be resilient and resist deflection or bending so as to extend at a fixed angle with respect to the planar portion 54. In some examples, a buttress 58 may be included and may extend from the planar portion 54 to the angled projection 56 to aid in preventing displacement of the angled projection 56 with respect to the planar portion 54. Each of the planar portions may have a proximal face which is at least partially covered in adhesive 22.
The panels 52A-D may also include at least two intermediate panels 52B, C which may extend between and couple together the end panels 52A, D. One of the panels 52B may be coupled to an end of the raised projection 56 via one of the living hinges 50. The other of the intermediate panels 52C may be coupled to the planar end panel 52D via another of the living hinges 50. Each of the intermediate panels 52B, C may be coupled to one another via a living hinge 50 so as to form a linkage 60 between the end panels 52A, D.
Referring now to
The delivery device 10 may be applied to the skin 44 over an infusion site in the storage state with the linkage 60 in the raised position. This may fix the end panels 52A, D such that they are substantially constrained to the plane of the skin patch to which they are adhered. Application of downward pressure against the linkage 60 may displace the linkage 60 from the raised position toward the center position. As this occurs, the angle 64 between the two intermediate panels 52B, C may increase. The angle 62 between the raised projection 56 and intermediate panel 52B and the angle 66 between end panel 52D and intermediate panel 52C may decrease. To accommodate the change in the angle 64 between the two intermediate panels 52B, C the end panels 52A, D may spread apart. When the linkage 60 reaches a center position (see
As the linkage 60 is further displaced the linkage 60 may enter an over center state. The elasticity of the stretched skin 44 may exert a restoring force which tends to drive the end panels 52A, D toward one another. Thus, once the linkage 60 is displaced through the center position the linkage 60 may automatically be displaced to an over center position at an end of the displacement range of the linkage 60. When the linkage 60 is displaced into this over center position, the delivery device 10 may be transitioned into the delivery state. As the linkage shifts to the over center position shown in
When the delivery device 10 is in the delivery state (see
In some embodiments, the proximal face of the intermediate panel 52C may be covered at least partially in adhesive 22 (see, e.g.,
In an embodiment, one of the intermediate panels 52B, 52C, for example the intermediate panel 52C, may be implemented as a flexure or including at least one flexure that incorporates a gap and at least one bias member. The gap may be urged to a widened state by the bias member (which may, in some embodiments, be formed integrally with and of the same material as the panel 52B, C). Applying sufficient pressure to the bias member may overcome the bias member and allow the flexure to give. Thus, an intermediate panel 52B, 52C may be formed so as to have a variable length which decreases as force exceeds some predefined threshold.
The intermediate panel 52C (though any intermediate panels 52B, 52C may include such features) may be implemented as or to include at least one lattice-structured flexure 290, as shown in
In another embodiment the intermediate panel 52C may incorporate at least one flexure 292 which may be in the form a squishable body that may deform when a threshold force applied to the body is exceeded. The flexure 292 may be round and hollow in an embodiment. As shown in
In some embodiments, at least a portion of the main body 20 may plastically deform after the delivery device 10 is transitioned from the storage state to the delivery state. For example, one of the living hinges 50 may be plastically deformed. Alternatively, one or more of the living hinges 50 may break when an attempt to transition the delivery device 10 back to the storage state from the delivery state is made. Thus, the transition from the storage state to the delivery state may be rendered irreversible and reuse of the delivery device 10 may be prevented. In some examples, the adhesive 22 may be selected so as to bond more aggressively to the skin 44 than the material forming the main body 20. Thus, upon removal of the delivery device 10, the adhesive 22 may peel off of the delivery device 10. This may also aid in inhibiting reuse of the delivery device 10. In embodiments described herein where the adhesive 22 peels off the delivery device 10, the adhesive 22 may include a pull tab or similar feature which would facilitate subsequent removal from the skin 44.
Referring now to
The main body 20 may include a first and second end block 70A, B. The end block 70A, B may be disposed in opposition to one another. The end blocks 70A, B may be spaced apart and connected together by a set of side panels 71A, B and a bridge 76. The side panels 71A, B may each have a first end which is connected to the first end block 70A by a hinge 74A. The side panels 71A, B may also each have a second end opposed to the first end which is connected to the second end block 70B by a hinge 74B. Each of the side panels 71A, B may also include an intermediate hinge 74C which may be disposed in an intermediate region of the side panels 71A, B between the first and second end of each side panel 71A, B.
Similarly to the side panels 71A, B, the bridge 76 may have a first end connected to the first end block 70A by a hinge 74D and a second end opposite the first which is connected to the second end block 70B by another hinge 75E. The bridge 76 may additionally include an intermediate hinge 74F disposed between the first and second ends of the bridge 76. The bridge 76 may include a panel body 78 and a set of strut members 80A, B. the strut members 80A, B may be connected to the panel body 78 via the intermediate hinge 74F of the bridge 76. The bridge 76 may also include an arm member 82. The arm member 82 may be disposed between two strut members 80A, B and may extend toward a proximal face of the end blocks 70A, B. In the example embodiment, the arm member 82 extends from an end of the panel body 78 adjacent the intermediate hinge 74F of the bridge 76. The reservoir 12 may be coupled to the proximal face of the arm member 82 at an end of the arm member 82 opposite the panel body 78.
In the example embodiment shown in
The side panels 71A, B of the delivery device 10 may be displaceable through a displacement range to transition the delivery device 10 between a storage state (shown in
A pinching force which urges the side panels 71A, B toward one another may be exerted against the side panels 71A, B to displace the side panels 71A, B from the outwardly bowed position to a straightened position. It should be understood that the straightened position need not necessarily be a position in which the side panels 71A, B each extend along straight line. In some examples, the straightened position may be a position in which the side panels 71A, B are less outwardly bowed than in the outwardly bowed position.
The bridge 76 may also be displaceable through a displacement range to transition the delivery device 10 between a storage state (shown in
In various embodiments, actuation of the bridge 76 through its displacement range may transition the delivery device 10 from the storage state to the delivery state. Additionally, actuation of the side panels 71A, B from the outwardly bowed state to the straightened state may transition the delivery device 10 from the storage state to the delivery state. Actuation of the bridge 76 through its displacement range may result in displacement of the side panels 71A, B through their displacement range since the bridge 76 and side panels 71A, B are coupled to one another through the end blocks 70A, B Likewise, actuation of the side panels 71A, B through their displacement range may result in displacement of the bridge 76 through its displacement range.
It may be left up to the user whether actuation of the side panels 71A, B or bridge 76 is used to transition the delivery device 10. Alternatively, whether the bridge 76 is actuated or the side panels 71A, B are actuated may depend upon the patient population to which the user belongs. For example, actuation of the bridge 76 may result in a greater amount of pressure being exerted against the arm member 82. This may aid in ensuring puncture of the delivery sharp(s) 72 into the skin. Thus, it may be desirable that patient populations with certain skin characteristics be instructed to actuate the delivery device 10 via the bridge as opposed to the side panels 71A, B.
Referring now also to
Referring now also to
In the example embodiment, one of the iris panels 86A includes a latch projection 90. Another of the iris panels 86B includes a latch catch 92 which may be formed as a notch in that iris panel 86B. The latch projection 90 is ramped. Thus, as the iris panels 86A, B are displaced toward one another, iris panel 86B may deflect and ride up the ramp of the latch projection 90 (see, e.g.,
Referring now to
The proximal face of each of the first and second portion 100, 102 may be at least partially covered with adhesive 22. The adhesive 22 may serve to couple the first and second portion 110, 102 to a skin surface at an infusion site on a patient. The delivery device 10 may be adhered to the skin when delivery device 10 is in the storage state and then may be transitioned to the delivery state. As the transition occurs, an adhesive bearing section of the first portion 100 may be displaced with respect to an adhesive bearing section of the second portion 102. Thus, the distance between these adhesive bearing sections may be increased so as to stretch or spread the underlying skin. This may be desirable as the skin may be rendered taught facilitating piercing of the skin by at least one delivery sharp 72 of a reservoir 12 included in the delivery device 10.
Transition of the delivery device 10 to the delivery state may also result in a proximal displacement or lowering of the delivery sharp(s) 72 toward and into the skin. In embodiments where the delivery sharp(s) 72 are coupled to the reservoir 12, the reservoir 12 may also be proximally displaced. In some examples, the reservoir 12 may be compressed between the skin surface and a section of one of the first and second portions 100, 102 when the delivery device 10 is transitioned from the storage state to the delivery state. Compression of the reservoir 12 may serve to drive fluid out of the reservoir 12, through the delivery sharp(s) 72 and into the target delivery destination in the patient. Additionally, in some embodiments, at least one of an audible or tactile indication may be generated when the delivery sharp(s) 72 are displaced toward the skin.
Referring now to
Referring now also to
The proximal portion 110 may include a pull tab 120 which may be disposed at a first end of the proximal portion 110. The pull tab 120 may be an enlarged or widened section of the proximal portion 110. In some embodiments, the pull tab 120 may include a roughened surface or may include bumps, ridges, or the like to facilitate grasping. In alternative embodiments, the pull tab 120 may include a cut out so as form a pull ring.
The proximal portion 110 may also include at least one ramp element 128 and a folded region 122 at an end of the proximal portion 110 opposite the pull tab 120. In the example embodiment, the proximal portion 110 includes two ramp elements 128 disposed abreast of one another. The folded region 122 may be folded over upon itself a number of times. In the example, the folded region 122 is folded upon itself twice. Thus, when a pulling force is exerted on the pull tab 120, the folded region 122 may unfurl and spool out proximal portion 110 material to allow the proximal portion 110 to elongate. The at least one ramp element 128 may also be displaced as the folded region 122 feeds out material. The number of folds in the folded region 122 may be adjusted to change the amount that the proximal portion 110 elongates as it is transitioned to the elongated state. The folded region 122 may taper from a larger width to a smaller width over at least a section of the folded region 122. In the example embodiment, the layer of the folded region 122 most proximal to the distal portion 112 tapers to a rounded end. The layer of the folded region 112 most proximal to the distal portion 112 may be substantially immobile and anchored in place by the adhesive 22 of the distal portion 112 as the folded region 122 unfurls.
As best shown in
Referring now to
As the folded region 122 unfurls, proximal portion 110 material may be fed out such that the proximal portion 110 elongates and the delivery aperture 124 is displaced into alignment with the delivery sharp(s) 72. The at least one ramp element 128 may be displaced in the direction of the pull tab 120. The at least one ramp element 128 may keep the cantilevered arm 130 slightly deflected toward the distal portion 112 as the proximal portion elongates. This may keep the delivery sharp(s) 72 of the reservoir from dragging against the proximal portion 110 as the proximal portion 110 is transitioned to the elongated state. As the at least one ramp element 128 is further displaced, the cantilevered arm 130 may ride over a sloped region of the at least one ramp element 128 and be further deflected toward the distal portion 112 of the delivery device 10. As the folded region 122 continues to unfurl, the at least one ramp element 128 may advance past the cantilevered arm 130.
Once the at least one ramp element 128 has cleared the cantilevered arm 130, the cantilevered arm 130 may restore to an undeflected state as shown in
As shown, the tether member 118 may be peeled from the lock adhesive 116 as 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 may be at least partially separated from the lock adhesive 116. The exposed lock adhesive 116 may then adhere to the proximal portion 110 to bond the proximal portion 110 in place. The lock adhesive 116 may aggressively adhere to the proximal portion 110. An attempt to separate the proximal portion 110 and lock adhesive 116 may result in damage to one of the components of the delivery device 10. This may help to ensure that the transition of the delivery device 10 to the delivery state is irreversible. The lock adhesive 116 may also inhibit restoring force exerted by the stretched skin from causing the proximal portion 110 to crumple. Thus, the lock adhesive 116 may hold the adhesive 22 on the proximal portion 110 in place such that the skin remains stretched when the proximal portion 110 is in the elongated state and the user releases the pull tab 120.
With reference to
As shown, the exemplary top 306 sits on a base body 309. The top 306 engage with a threaded post or screw 310 included as part of the base body 309. In some non-limiting examples, the threaded 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. One of skill would appreciate that other materials and manufacturing techniques could be used to construct the threaded screw 310.
In an example embodiment, a user may first remove an adhesive liner 265 (see, e.g.,
After affixing the delivery device 10 to the skin, the user may then twist the top 306 of the delivery device 10 and thereby cause the top 306 to advance proximally (e.g., toward the skin) along the threads of the threaded screw 310. Inside the threaded screw 310 a breakable material, or frangible 314 may be housed. The frangible 314 may inhibit displacement of the top 306 and other components of the delivery device 10 until a sufficient force is applied to the top 306. This may aid in preventing transition of the delivery device 10 to a delivery state during storage.
In the example embodiment, the frangible 314 is provided as at least one tab which projects from a carriage 315 that may be disposed within the bore 317 of the threaded post 310. In some embodiments, the carriage 315 may include a set of three frangibles 314 which are disposed at even angular increments about a first end of the carriage 315. The bore 317 may include a ledge 319 to support at least one of the frangibles 315 and preferably a ledge 319 to support each frangible 314. With the frangibles 314 resting on the ledge(s) 319, the carriage 315 may be inhibited from displacing within the bore 317 and twisting motion of the top 306 may be impeded. In certain examples, the ledge(s) 319 may each be an end of a track or rail (best shown in
The top 306 may incorporate a central projection 318 (e.g. column or stepped column as shown) that rests upon a portion of the carriage 315. As the top 306 screws downward or proximally toward the skin surface, the projection 318 may cause the frangible(s) 314 may be pressed against the respective ledges 319. The pressure exerted against the frangible(s) 314 may cause the frangible(s) 314 to break off, allowing the carriage 315 to travel proximally within the bore 317. The carriage 315 may displace proximally and eventually a second end of carriage 315 (opposite the first end from which the frangibles 314 project) may contact the skin surface. It would be understood by one of skill that once the frangible(s) 314 have broken, reuse of the delivery device 10 may be inhibited.
The adhesive pad 312 of the delivery device 10 may have a central aperture 323 though which a portion of the carriage 315 may extend. Skin may not be retained in position against the delivery device 10 in the region of the central aperture 323. Thus, as the carriage 315 continues to displace proximally, the skin in this region may be pressed and stretched as it is displaced by the carriage 315. This may render the skin aligned with the central aperture 323 taut. The base body 309 may include a shelf 321 which extends into the bore 317 at the proximal end of the bore 317 and acts as a stop surface. The carriage 315 may cease proximal displacement upon contacting the shelf 321.
The top 306 may be at an intermediate point in its travel along the post 310 when the carriage 315 contacts the shelf 321. As shown, the carriage 315 may include a second frangible 325 or set of frangibles 325. In some embodiments, there may be three second frangibles 325 spaced at even angular intervals about the carriage 315. The first frangible(s) 314 may be weaker (e.g. thinner) than the second frangible(s) 325. Thus, the second frangible(s) 325 may only break after the first frangible(s) 314. The projection 318 from the top 306 may abut the second frangible(s) 325 when in the carriage 315 is against the stop provided by the shelf 321. The second frangible(s) 325 may impede displacement of the top 306. Further actuation of the top may exert force against the second frangible(s) 325 and result in breaking of the second frangible(s) 325. With the second frangible(s) 325 broken, the top 306 may be free to move proximally while the carriage 315 remains stationary (against the stop provided by the shelf 321). It would be understood by one of skill that once the frangible(s) 325 have broken, reuse of the delivery device 10 may be inhibited.
As shown, 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 of a plastic material formed by injection molding. One of skill would appreciate that other materials and manufacturing techniques could be used to construct the delivery aid 320. The delivery aid 320 may be positioned atop a reservoir 12 that contains a fluid such as, e.g., a medical agent (e.g., a vaccine) and incorporates on an underside a sharp bearing body 26 (see, e.g.,
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 rest upon a shelf within the carriage 315. The reservoir 12 may be retained via friction or via a slip fit within an aperture of the carriage 315 as shown. In some examples, a weak adhesive may hold the reservoir 12 in place within the aperture. In other embodiments, the friction fit may be augmented by a gasket member (e.g. O-ring) disposed between the reservoir 12 sides and the aperture of the carriage 315.
With the second frangible(s) 325 broken, the delivery aid 320 may concentrate force generated as the top 306 is actuated against a reservoir 12 of the delivery device 10. In embodiments where the delivery aid 320 rests upon a shelf in the carriage 315 a portion of the delivery aid 320 may deform or break to allow movement beyond the shelf. The delivery aid 320 and reservoir 12 may move downward as the top 306 continues to advance along the post 310. The force exerted by the top 306 may be sufficient to overcome friction or adhesive holding the reservoir 12 in place. The delivery aid 320 moving downward may cause the reservoir 12 to move downward until the delivery sharp(s) 72 (see, e.g.,
As previously discussed, it may be desirable to prevent reuse of the delivery device 10. It may also be desirable to provide a delivery device 10 in which the delivery sharp(s) 72 scratch across the surface of the skin prior to penetrating the skin surface. In an embodiment, a delivery device 10 may include an actuation assembly which may include first and second displaceable members. The members may be displaceable from a separated state to a proximal state with relation to each other. The members may transition from the separated state to the proximal state when the delivery device 10 is actuated and/or when the delivery device 10 delivers its contents. The members may include cooperating coupling features that may engage with each other upon the members approaching or reaching the proximal state. Once the cooperating coupling features are engaged, the coupling features may inhibit separation of the members and may maintain the members in the proximal state.
With reference to
At least one hook 324, integral to one of the bodies 320A, B may be included. The other of the bodies 320A, B may include at least one catch 326. In the example embodiment, the first body 320A includes a number of hooks 324 which extend downward therefrom toward the second body 320B. Six such hooks 324 are shown but it would be understood that the number need not be six. In the example, the hooks 324 are evenly spaced around the first circle 320A though need not necessarily be in all embodiments. At least one catch 326, integral to the second body 320B is also shown in the example embodiment. Each of the catches 326 is situated at a point on the second body 320B that is not directly beneath a hook 324 of the first body 320A. The example catches 326 extend upward from the second body 320B toward the first body 320A. Six such catches 326 are shown but it would be understood that the number need not be six. The catches 326 may be spaced around the second body 320B at even angular increments. The catches 326 may be positioned such that the respective catches 326 and hooks 324 would engage one another upon actuation of the flexure. The flexure may, for example, be actuated by applying pressure on the flexure via a portion of the delivery device 10 within which it is assembled. The catches 326 may be substantially shaped in the form of an upside down Latin character “U”.
As the first body 320A is displaced toward the second body 320B at least one of the bodies 320A, B may also rotate. If one of the bodies 320A, B is rotationally constrained, only the other of the bodies 320A, B may rotate as the bodies 320A, B are displaced toward one another. With the second body 320B rotationally constrained, pushing down on the first body 320A from above may cause the flexible struts 322 to flex. The hooks 324 may rotationally (about an axis passing through the center points of the bodies 320A, B) displace. The hooks 324 and first body 320A may also translationally displace as the first body 320A approaches the second body 320B. The hooks may also translationally displace with respect to the catches 326 until the hooks 324 contact the catches 326. The hooks 324 may deflect around the catches and then resiliently restore into engagement with the catches 326. Thus, as the struts 322 attempt to resiliently restore to their undeflected state, the first and second bodies 320A, B may be held together by the engagement of the hooks 324 and catches 326. Using a single piece flexure (formed, for example, by injection molding) may allow the delivery device 10 to be manufactured at relatively lower cost. The hooks 324 engagement with the catches 326 may also help to prevent reuse of a delivery device 10 in which the flexure is included. The engaged hooks 324 may also help maintain pressure against a reservoir 12 of a delivery device 10 needed to ensure delivery of a medical agent (e.g., a vaccine) into a patient through one or more delivery sharp 72 (see, e.g.,
The rotational displacement of one of the bodies 320A, B may be harness to help drive the delivery sharp(s) (see, e.g.,
Referring now to
The package 400 itself may be constructed of a first component 404 and a second component 406. The first component 404 may be a rigid base. The rigid base may include a well in which a delivery device 10 (e.g. similar to that shown in
As shown, the package 400 may include at least one unique identifier 408. In other embodiments, a unique identifier 408 may instead or additionally be included on a delivery device 10 or component thereof. Any suitable unique identifier(s) 408 and combinations thereof may be used. In some embodiments, an RFID may be used. In other examples, the unique identifier 408 may be implemented as a printed indicium such as a bar code, data matrix, QR code, etc. The unique identifier 408 may encode various information about the delivery device 10 or contents of the reservoir 12 of the delivery device 10. For example, the unique identifier 408 may include product identity information, product lot information, product serial number, dose size information, etc.
The unique identifier 408 may be read by a reader 410. The reader 410 may be a dedicated reader or a device such as, e.g., a smart phone, tablet, smart device, laptop, or other portable device in some embodiments. Where a smart phone or the like is utilized, a dedicated delivery device app may run on the smart phone. Where a smart phone or the like is used, the reader 410 may include multiple pieces of hardware which may be used to read a unique identifier 408 (e.g. one or more front facing imager and one or more rear facing imager). The reader 410 used may depend on whether the delivery device 10 is intended for use at home by an individual user or in a clinical setting (e.g. vaccination center, hospital, clinic, or other care facility). A smart phone may be convenient for a use as a reader 410 if delivery via the delivery device 10 is to be, for example, self-administered by a patient (e.g. at home).
The reader 410 may communicate with a database 412 (e.g. via internet, other network, cloud platform, etc.). Prior to use of the delivery device 10, a user may read the unique identifier 408 with the reader 410. The identifier 408 for the delivery device 10 may be checked against the database 412 to ensure the unique identifier 408 is not associated with a delivery device 10 which has already been used, subject to recall, expired, etc. The database 412 may also be updated to indicate that the delivery device 10 associated with the unique identifier 408 has been used. Thus, the reader 410 and database 412 may aid in inventory management. Other usage information may also be saved. In some embodiments, geolocation data indicating the location of the package 400 when the unique identifier 408 is read may also be saved to the database 412.
Depending on the infrastructure available, the data may be stored offline in a memory of the reader 410 until a robust connection to the internet or another suitable network is formed. Thereafter, data may be uploaded to the database 412. Alternatively, data may be sent to the database 412 as it is acquired at the reader 410.
In some embodiments, a patient may be required to pre-register in order to receive a delivery device 10. In some embodiments, the reader 410 may be used to register (e.g. where an app on a smart phone is used). Where the reader 410 uses a smart phone app, the smart phone app may inhibit usage of the reader 410 for the delivery in the event that certain services are not enabled. Such an app may generate a unique identifier or code when predefined requisite services (e.g. location tracking, push notifications) have been enabled. This code may be provided to the database 412 and may be referred to as a registration code. A patient may be required to provide the code in order to receive a delivery device 10. The code may be input to a dispenser or provided to distribution personnel and checked against the database 412. A delivery device 10 may be provided to the patient in the event that the code matches a registration code stored on the database 412. In other embodiments, the controller 416 of the reader 410 may generate a manual input screen to collect desired information in the event that the user elects not to enable one or more service or otherwise provide desired user information. For example, when location tracking is not enabled the app may generate a location data input screen. Input of information into any such screens may be required before a code is generated and provided to the database 412.
In some embodiments, when the unique identifier 408 on the package 400 is read, a controller 416 of the reader 410 may generate instructions on a user interface 414 of the reader 410. The instructions may include text, images, animations, videos, etc. detailing how to use the delivery device 10. The instructions may guide a user, step-by-step, from opening of the package 400 to discarding of a delivery device 10 after use. In some embodiments, each step of the instructions set may be followed by generation, via the controller 416, of a prompt on the user interface 414. The user may be required to interact with the prompt to proceed to the next set of instructions. User interactions may be logged and stored in a database 412. This may aid in confirming that a particular delivery device 10 was not only received by a patient, but also applied and used. In some embodiments, the controller 416 may generate a notification (e.g. visual, tactile, audio, or some combination thereof) in the event that not all steps have been completed. In other embodiments, one or more message may be generated in the event that a user is unresponsive to prompts. For example, where a smart phone or the like is used, the messages may be push notifications generated by the app for the delivery device 10.
In other embodiments, at least one message generator 418 in data communication with the database 412 may generate, for instance, a text message, email, phone call (e.g. automated message or connect the user to a human operator) which may be sent to a telephone number or email address provided by the user. In the event that a delay greater than a predefined period of time has occurred since a previous prompt has been interacted with by the user, the message generator 418 may send a communication to the patient. The type of communication triggered may escalate if no response is received after a communication is sent by a message generator 418. The communication may initially be a text message or push notification. In some embodiments, a push message may preferably be sent or may be sent instead of a text message in the event that cellular service is unacceptable or below a threshold. If no user interaction is received after a predefined escalation period, a message generator 418 may generate a more obtrusive communication (e.g. a phone call). Any suitable number of escalation tiers may be used.
In some embodiments, a patient may also provide additional data via the reader 410. This data may be stored in the database 412 and analyzed (e.g. via a cloud analytics tool or tool set). For example, users may indicate via the reader 410 that a problem with their delivery device 10 has occurred. This data may be checked against data associated with other delivery devices 10 from the same lot. If more than a predetermined threshold of problematic delivery devices 10 are deemed to exist within a lot, the lot may be flagged for investigation and prevented from being distributed or used. Alternatively or additionally, a patient may be prompted to provide certain post injection information via the reader 410. For example, the patient may be requested to fill out a side-effect questionnaire or other form which may be generated by the controller 416 of the reader 410 on the user interface 414. Side-effect data may be analyzed to identify patterns common to certain patient types or delivery devices 10 (e.g. delivery devices 10 of the same lot or holding the same contents). Analysis may be conducted via a cloud analytics tool or toolset.
In certain examples and referring now also to
Referring now to
In some examples, the holder 270 (see, e.g.,
In other embodiments, and referring now to
When the delivery device 10 is removed, the mark 510 left on the skin 512 may be imaged by a reader 410 (see, e.g.,
Referring now primarily to
After a delivery device 10 has been used, the reader 410 may be used to capture at least one image of the injection site. At least one image may be captured or generated based on light other than that in the visible spectrum. Image data in the visible spectrum may also be captured in some embodiments. A controller 416 (see, e.g.,
The image data may be analyzed to determine the presence of a bleb 514 formed within the skin during the delivery. Analysis may be automated or may be conducted by a human operator viewing images via a network connection to a database 412 (see, e.g.,
In the event that the image(s) contain characteristics of a bleb 514, it may be concluded that a delivery was actually performed with the delivery device 10 and was successful. In some embodiments, the image(s) may be required to comply with at least one predefined characteristic of interest. For example, in certain implementations, it may be required that a bleb 514 is detected and is of a certain size (e.g. in relation to a marking 510). Additionally, the image(s) may be required to be devoid of characteristics indicative of an improper injection. For example, where a thermal imager is used, a cool region corresponding to a bleb 514 with one or more adjacent cool region or a cool region 514 or a size beyond a certain limit may be flagged as having characteristics of a leak. In such an example, the analysis may indicate an unsuccessful delivery from a delivery device 10.
The analysis may be performed by the controller 416 (see, e.g.,
In examples where the reader 410 is a smart phone, any app used may generate a confirmation that injection with a delivery device 10 was performed upon request by a user. The controller 416 of the reader 410 may generate an option (e.g. displayed button) which may be interacted with by the user to display a conformation notice regarding the injection. Where a delivery device 10 is used to perform a vaccination, the app may provide a proof of vaccination or virtual vaccination record or card which is automatically populated with various information about the user's vaccination. The vaccination record may be stored in a memory of the reader 410 or may be stored in a database 412 (see, e.g.,
In still other embodiments, a container 350 which houses a packet 208 may be included in a delivery device 10 as described elsewhere herein (see, e.g.,
The delivery device 10 may include one or more window (e.g. slots 254 or apertures 255 in a main body 20 like the example shown in
In some alternative embodiments where two (or more) chemicals are combined to produce a visibly perceptible effect, the first chemical or chemicals may be included in the medical wipe. The user may wipe the injection site during preparation and some of the first chemical or chemicals may be deposited on the skin surface. The second chemical or chemicals may be carried by or released by the delivery device 10 during the course of the injection. The first and second chemicals may interact by the time the injection has completed and may, for instance, result in a color change to a delivery indicating color. An image of the injection site may be taken by the reader 410 and analyzed (e.g. locally by the controller 416 or via a cloud analytic tool after the image is uploaded to the database 412) to confirm presence of the delivery indicating color. In the event that the color change is documented in the image, the database 412 may be updated to indicate that the delivery device 10 has been used.
Various alternatives and modifications can be devised by those skilled in the art without departing from the disclosure. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications and variances. Additionally, while several embodiments of the present disclosure have been shown in the drawings and/or discussed herein, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. And, those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto. Other elements, steps, methods and techniques that are insubstantially different from those described above and/or in the appended claims are also intended to be within the scope of the disclosure.
The embodiments shown in drawings are presented only to demonstrate certain examples of the disclosure. And, the drawings described are only illustrative and are non-limiting. In the drawings, for illustrative purposes, the size of some of the elements may be exaggerated and not drawn to a particular scale. Additionally, elements shown within the drawings that have the same numbers may be identical elements or may be similar elements, depending on the context.
Where the term “comprising” is used in the present description and claims, it does not exclude other elements or steps. Where an indefinite or definite article is used when referring to a singular noun, e.g. “a” “an” or “the”, this includes a plural of that noun unless something otherwise is specifically stated. Hence, the term “comprising” should not be interpreted as being restricted to the items listed thereafter; it does not exclude other elements or steps, and so the scope of the expression “a device comprising items A and B” should not be limited to devices consisting only of components A and B.
Furthermore, the terms “first”, “second”, “third” and the like, whether used in the description or in the claims, are provided for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances (unless clearly disclosed otherwise) and that the embodiments of the disclosure described herein are capable of operation in other sequences and/or arrangements than are described or illustrated herein.
The present application claims the benefit of U.S. Provisional Application Ser. No. 63/154,894, entitled Delivery Device Apparatuses and Methods, filed Mar. 1, 2021, Attorney Docket Number 00101.00316.AA484, and claims the benefit of U.S. Provisional Application Ser. No. 63/168,487, entitled Delivery Device Apparatuses and Methods, filed Mar. 31, 2021, Attorney Docket Number 00101.00317.AA537, and also claims the benefit of U.S. Provisional Application Ser. No. 63/256,276, entitled Delivery Device Apparatuses, Systems, and Methods, filed Oct. 15, 2021, Attorney Docket Number 00101.00328.AA742, each of which being incorporated herein in its entirety.
This invention was made with Government support under Agreement W911NF-17-3-0003, awarded by ACC-APG-RTP. The Government has certain rights in the invention.
| Number | Date | Country | |
|---|---|---|---|
| 63154894 | Mar 2021 | US | |
| 63168487 | Mar 2021 | US | |
| 63256276 | Oct 2021 | US |
