Delivery device apparatuses, systems, and methods

CA3320072A1Pending Publication Date: 2025-09-18DEKA PRODUCTS LP
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Patent Information

Application Number
CA3320072
Authority / Receiving Office
CA · CA
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-12-04
Filing Date
2024-12-06
Publication Date
2025-09-18

AI Technical Summary

Technical Problem

Existing medical systems are ill-equipped to handle novel pathogens, leading to challenges in vaccine production, PPE shortages, and psychological barriers that hinder effective contact tracing and medical facility visits, exacerbating public health crises.

Method used

A delivery device with a rigid guide body, petal members, and a reservoir containing microneedles, featuring a sloped guide track and trigger mechanism for controlled agent delivery, allowing for precise application of medical agents through microneedles.

Benefits of technology

Facilitates efficient and controlled delivery of medical agents, overcoming logistical and psychological barriers, enhancing public health responses to novel pathogens by ensuring widespread and safe administration.

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Abstract

A device for delivery of agent to a biological barrier may comprise a petal bearing main body having a set of guides each having an upstream and downstream portion, lire device may further comprise a reservoir including at least one delivery sharp. The device may further comprise a plunger having a. set of plunger protrusions each disposed in a respective guide. The device may further comprise a first bias member urging the plunger toward a position in which the protrusions are at an end of the downstream portions. The device may further comprise a trigger body with a first and second set of barriers. The trigger body may be displaceable between a position in which the second barriers are stowed and the first barriers obstruct displacement of the protrusions and another position in which the first barriers are stowed and the second barriers obstruct travel of the protrusions.
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Description

Attorney Docket: 00101.00467.AB674WO Delivery Device Apparatuses, Systems, and Methods STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0001] This invention was made with Government support under Agreement W911NF- 17-3-0003-CLIN 0008, awarded by ACC-APG-RTP. The Government has certain rights in the invention.

[0002] This invention was made with Government support under Agreement W911NF- 17-3-0003-CLIN 0010, awarded by ACC-APG-RTP. The Government has certain rights in the invention. BACKGROUND Field of Disclosure:

[0003] This disclosure relates to medical agent delivery. More specifically, this disclosure relates to dispensers for therapeutic and other medical agents. Description of Related Art

[0004] 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 atAttorney Docket: 00101.00467.AB674WO 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.

[0005] 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. SUMMARY

[0006] In accordance with an embodiment of the present disclosure an example delivery device for delivery of medical agent to a biological barrier may comprise a rigid guide body. The rigid guide body may comprise a plurality of petal members extending outwardly from a first end thereof. The rigid guide body may further comprise a sloped guide track partitioned into an upstream portion and downstream portion by an interrupt channel. The delivery device may further comprise a reservoir including at least one delivery sharp, the reservoir may be coupled to the rigid guide body. The delivery device may further comprise a plunger partially disposed in the guide track. The delivery device may further comprise a bias member intermediate the plunger and a wall at a second end of the rigid guide body. The bias member may exert a force compelling the plunger along the guide track when in a distorted state. The delivery device may further comprise a trigger body with a first barrier projection. The first barrier projection may present an interference to displacement of the plunger along the guide track when the trigger body is in a blocking position. The first barrier projection may be disposed within the channel with a track completing surface aligned with the upstream and downstream portion when the trigger body is in a trigger position. The delivery device may further comprise a deformable spacer having a first state in which the trigger body is held in the blocking position. The deformable spacer may transition to a deformed state upon displacement of the trigger body to the trigger position.

[0007] In some embodiments, the sloped guide track may be a ledge on the interior sidewall of the rigid guide body. In some embodiments, the sloped guide track may include a terminal channel at a downstream end of the guide track. In some embodiments, the triggerAttorney Docket: 00101.00467.AB674WO body may include a second barrier projection. The second barrier projection may be disposed within the terminal channel when the trigger body is in the trigger position. The second barrier may be in an unobstructing position relative to the terminal channel when the trigger body is in the blocking position. In some embodiments, the deformable spacer may be a spring. In some embodiments, the deformable spacer may be a flexure of the trigger body which extends from a portion of the trigger body to the second end of the rigid guide body. In some embodiments, each of the at least one delivery sharp may be a microneedle. In some embodiments, the delivery device may further comprise an adhesive coupled to the petal members. In some embodiments, the reservoir may include a displaceable wall defining a portion of a main interior volume of the reservoir. The plunger may be out of contact with the displaceable wall when the portion of the plunger disposed in the guide track is in the upstream portion of the guide track. In some embodiments, the reservoir may include a septum.

[0008] In accordance with another embodiment of the present disclosure an example delivery device for delivery of medical agent to a biological barrier may comprise a petal bearing main body. The main body may comprise a set of cam tracks each partitioned into an upstream portion and downstream portion by an interrupt channel. The delivery device may further comprise a reservoir including at least one delivery sharp. The delivery device may further comprise a plunger having a set of plunger protrusions each disposed in a respective cam track. The plunger may be biased by a first bias member from a first position in which the protrusions are disposed at the upstream portions toward a second position in which the protrusions are disposed at the downstream portions. The delivery device may further comprise a button with a first set of barriers. The button may be displaceable between a blocking position in which the first set of barriers obstruct travel of the protrusions along the respective cam tracks and a trigger position in which the first set of barriers fill the interrupt channel and complete the cam track.

[0009] In some embodiments, the delivery device may further comprise a deformable spacer between the main body and the button. In some embodiments, the deformable spacer may be a flexure extending from one of the main body and button. In some embodiments, the deformable spacer may be a second bias member. In some embodiments, the delivery device may further comprise a deformable spacer which transitions from a home state to a deformed state upon displacement of the button to the trigger position. In some embodiments, the deformable spacer may transition to the deformed state upon application of more than a threshold force urging the button toward the trigger position. In some embodiments, the petal bearing main body may comprise a plurality of petal members. The petal members mayAttorney Docket: 00101.00467.AB674WO displace from a relaxed position to a spreadingly displaced position when a threshold petal spreading force is applied. In some embodiments, the delivery device may further comprise a deformable spacer intermediate the button and main body. The button may displace from the blocking position to the trigger position and deform the spacer upon application of a threshold deforming force which is greater than the threshold petal spreading force. In some embodiments, each of the at least one delivery sharp may be a microneedle. In some embodiments, the button may be biased to the blocking position by a second bias member. In some embodiments, the button may include a second set of barriers which obstruct travel of the protrusions to a terminal region of the downstream portions when the button is in the trigger position. In some embodiments, the reservoir may include a displaceable wall defining a portion of a main interior volume of the reservoir. The plunger may be out of contact with the displaceable wall when the protrusions are disposed at the upstream portion of the respective cam tracks. In some embodiments, the reservoir may include a septum.

[0010] In accordance with another embodiment of the present disclosure and example delivery device for delivery of medical agent to a biological barrier may comprise a petal bearing main body. The main body may comprise a set of guides each having an upstream portion and downstream portion. The delivery device may further comprise a reservoir including at least one delivery sharp. The delivery device may further comprise a plunger having a set of plunger protrusions each disposed in a respective guide. The plunger may be biased by a first bias member from a first position in which the protrusions are disposed at the upstream portions toward a second position in which the protrusions are disposed at the downstream portions. The delivery device may further comprise a trigger body with a first set of barriers. The trigger body may be displaceable between a blocking position in which the first set of barriers obstruct displacement of the protrusions between the upstream and downstream sections of the respective guides and a trigger position in which the first set of barriers are in a stowed state.

[0011] In some embodiments, each of the at least one delivery sharp may be a microneedle. In some embodiments, the delivery device may further comprise a deformable spacer between the main body and the trigger body. In some embodiments, the deformable spacer may be a flexure extending from one of the main body and trigger body. In some embodiments, the deformable spacer may be a second bias member. In some embodiments, the delivery device may further comprise a deformable spacer which transitions from a home state to a deformed state upon displacement of the trigger body to the trigger position. In some embodiments, the deformable spacer may transition to the deformed state upon application ofAttorney Docket: 00101.00467.AB674WO more than a threshold force urging the trigger body toward the trigger position. In some embodiments, the petal bearing main body may comprise a plurality of petal members. The petal members may displace from a relaxed position to a spreadingly displaced position when a threshold petal spreading force is applied. In some embodiments, the delivery device may further comprise a spacer intermediate the trigger body and main body. The trigger body may displace from the blocking position to the trigger position and deform the spacer upon application of a threshold deforming force which is greater than the threshold petal spreading force. In some embodiments, the trigger body may be biased to the blocking position by a second bias member. In some embodiments, the trigger body may include a second set of barriers which obstruct travel of the protrusions to a terminal region of the downstream portions when the trigger body is in the trigger position. In some embodiments, the reservoir may include a displaceable wall defining a portion of a main interior volume of the reservoir. The plunger may be out of contact with the displaceable wall when the protrusions are disposed at the upstream portion of the respective guides.

[0012] In accordance with another embodiment of the present disclosure an example delivery device for delivery of medical agent to a biological may comprise a petal bearing main body having a set of guides. Each guide may comprise an upstream portion and downstream portion. The delivery device may further comprise a reservoir including at least one delivery sharp. The delivery device may further comprise a plunger having a set of plunger protrusions each disposed in a respective guide. The delivery device may further comprise a first bias member urging the plunger toward a position in which the protrusions are at an end of the downstream portions. The delivery device may further comprise a trigger body with a first and second set of barriers. The trigger body may be displaceable between a blocking position in which the second set of barriers may be stowed and the first set of barriers may obstruct displacement of the protrusions between the upstream and downstream portions of the respective guides and a trigger position in which the first set of barriers may be stowed and the second set of barriers may obstruct travel of the protrusions to the end of the downstream portions.

[0013] In some embodiments, each of the at least one delivery sharp may be a microneedle. In some embodiments, each of the guides may be a sloped track. In some embodiments, each of the first set of barriers may be within an interrupt channel defined in each guide when the trigger body is in blocking position. In some embodiments, each of the guides may be a cam track. In some embodiments, the reservoir may include a displaceable wall defining a portion of a main interior volume of the reservoir. The plunger may be out ofAttorney Docket: 00101.00467.AB674WO contact with the displaceable wall when the protrusions are disposed at the upstream portion of the respective guides. In some embodiments, the petal bearing main body may comprise a plurality of petal members. The petal members may displace from a relaxed position to a spreadingly displaced position when a threshold petal spreading force is applied. In some embodiment, the delivery device may further comprise a spacer intermediate the trigger body and main body. The trigger body may displace from the blocking position to the trigger position and deform the spacer upon application of a threshold deforming force which is greater than the threshold petal spreading force. In some embodiments the trigger body may be biased to the blocking position by a second bias member. In some embodiments, the delivery device may further comprise a deformable spacer between the main body and the trigger body. In some embodiments, the deformable spacer may be a flexure extending from one of the main body and trigger body.

[0014] In accordance with another embodiments of the present disclosure an example method of expelling an agent from a delivery device may comprise applying the delivery device to a barrier. The method may further comprise generating a spreading displacement of petal members of a main body of the delivery device by exerting a first threshold force on a trigger body of the delivery device. The method may further comprise displacing the trigger body toward the main body to a trigger position by exerting a second threshold force greater than the first on the trigger body. The method may further comprise displacing at least one first barrier of the trigger body from an obstructing position to a stowed position. In some embodiments, expelling the agent from a reservoir of the delivery device by collapsing the reservoir with a spring biased plunger when each of the at least one first barrier is in the stowed position. The method may further comprise guiding displacement of the spring biased plunger with at least one guide track.

[0015] In some embodiments, applying the delivery device to the barrier may comprise adhering at least the petal members of the delivery device to the barrier. In some embodiments, the method may further comprise preventing displacement of the trigger body to the trigger position with a deformable spacer when the first threshold force is exerted on the trigger body. In some embodiments, the method may further comprise biasing the trigger body in a direction away from the main body with at least one bias member. In some embodiments, displacing the at least one first barrier from the obstructing position to the stowed position may comprise driving each of the at least one first barrier into an interrupt channel of a respective guide track. In some embodiments, displacing the at least one first barrier from the obstructing position to the stowed position may comprise displacing a surface of each of the at least one first barrierAttorney Docket: 00101.00467.AB674WO into a guide track completing position. The surface of each of the at least one first barrier may define a span of a respective guide track of the at least one guide track in the guide track completing position. In some embodiments, each of the at least one guide track may be a cam track and guiding the displacement of the spring bias plunger may comprise engendering rotation of the plunger as the advances along the at least one guide track. In some embodiments, the method may further comprise displacing at least one second barrier from a retracted position to a guide track terminus obstructing position as the trigger body is displaced to the trigger position. Each of the at least one second barrier may block a terminal end of a respective one of the at least one guide track in the guide track terminus obstructing position. In some embodiments, the method may further comprise displacing the plunger into contact with the at least one second barrier. In some embodiments, the method may further comprise ceasing exertion of force on the trigger body after the trigger body is in the trigger position and driving the trigger body away from the main body via a bias member until the at least one second barrier is returned to the retracted position and the method further comprises displacing the plunger to an end of a displacement range of the plunger.

[0016] In accordance with an embodiment of the present disclosure a method of expelling an agent from a delivery device may comprise adhering petal members of a main body of the delivery device to a barrier. The method may further comprise generating a spreading displacement of the petal members and puncturing the barrier with at least one delivery sharp of a reservoir of the delivery device by exerting a first threshold force on a trigger body of the delivery device. The method may further comprise displacing the trigger body to a trigger position by exerting a second threshold force greater than the first on the trigger body. The method may further comprise freeing a spring biased plunger to collapse the reservoir by displacing at least one first barrier of the trigger body from an obstructing position to a stowed position. The method may further comprise guiding displacement of the spring biased plunger with at least one guide track.

[0017] In some embodiments, the method may further comprise preventing displacement of the trigger body to the trigger position with a deformable spacer when the first threshold force is exerted on the trigger body. In some embodiments, the method may further comprise biasing the trigger body in a direction away from the main body with at least one bias member. In some embodiments, displacing the at least one first barrier from the obstructing position to the stowed position may comprise driving each of the at least one first barrier into an interrupt channel of a respective guide track. In some embodiments, displacing the at least one first barrier from the obstructing position to the stowed position may comprise displacingAttorney Docket: 00101.00467.AB674WO a surface of each of the at least one first barrier into a guide track completing position. The surface of each of the at least one first barrier may define a span of a respective guide track of the at least one guide track in the guide track completing position. In some embodiments, each of the at least one guide track may be a cam track and guiding the displacement of the spring bias plunger may comprise engendering rotation of the plunger as the advances along the at least one guide track. In some embodiments, the method may further comprise displacing at least one second barrier from a retracted position to a guide track terminus obstructing position as the trigger body is displaced to the trigger position. Each of the at least one second barrier may block a terminal end of a respective one of the at least one guide track in the guide track terminus obstructing position. In some embodiments, the method may further comprise displacing the plunger into contact with the at least one second barrier. In some embodiments, the method may further comprise ceasing exertion of force on the trigger body after the trigger body is in the trigger position and driving the trigger body away from the main body via a bias member until the at least one second barrier is returned to the retracted position and the method may further comprise displacing the plunger to an end of a displacement range of the plunger.

[0018] In accordance with another example embodiment of the present disclosure an example rigid reservoir portion of a medical agent administration device may comprise a proximal face. The reservoir portion may further comprise a distal face opposite the proximal face. The reservoir portion may further comprise a sharp bearing body. The sharp bearing body may comprise a sharp bearing face with at least one delivery sharp projecting therefrom. The sharp bearing face may further comprise a sharp free face opposite the sharp bearing face. The sharp bearing body may further comprise at least one lumen. Each of the at least one lumen may extend through a respective one of the at least one delivery sharp to the sharp free face. The reservoir portion may further comprise a receptacle located on one of the proximal and distal face of the rigid reservoir portion. The sharp bearing body may seated in the receptacle with a portion of the at least one delivery sharp protruding beyond the proximal face of the rigid reservoir portion. The reservoir portion may further comprise a bead of a swaged material circumscribing and at least partially overlaying a peripheral portion of the sharp bearing body.

[0019] In some embodiments, the swaged material may be a material selected to absorb an output wavelength from a swaging laser. In some embodiments, the swaged material may be laser swaged. In some embodiments, the swaged material is a heat swaged. In some embodiments, the swaged material may be a material which is different than a second material which forms at least a majority of the remainder of the rigid reservoir portion. In some embodiments, the swaged material may be a material which is the same as a material formingAttorney Docket: 00101.00467.AB674WO at least a majority of a remainder of the rigid reservoir portion. In some embodiments, the swaged material may be an elastomer. In some embodiments, the sharp bearing body may further comprise a set of sidewalls between the sharp bearing face and the sharp free face. In some embodiments, each of sidewalls may comprise a step disposed intermediate the sharp bearing face and the sharp free face. A first cross-sectional area of the sharp bearing body proximate the sharp free face may be larger than the area of the sharp bearing face. In some embodiments, the sidewalls may each include at least one tapered span and the area of the sharp free face may be larger than the area of the sharp bearing face.

[0020] In accordance with another example embodiment of the present disclosure, a method for securing a sharp bearing body to a rigid reservoir portion of a medical agent administration device may comprise locating a receptacle on a face of the rigid reservoir portion. The method may further comprise seating the sharp bearing body in a position in the receptacle so that at least one sharp of the sharp bearing body is protruding from the rigid reservoir portion. The method may further comprise forming a bead of a material in a position circumscribing the receptacle. The method may further comprise temporarily applying a bead displacing condition that changes the position of at least a portion of the bead into a sharp bearing body retaining position. The method may further comprise setting the at least a portion of the bead in the sharp bearing body retaining position.

[0021] In some embodiments, temporarily applying the displacing condition may comprise applying a heat swage tool. In some embodiments, temporarily applying the displacing condition may comprise illuminating the bead with a swaging laser. In some embodiments, the sharp bearing body retaining position may be a position in which the at least of portion of the bead is on a sharp bearing face of the sharp bearing body. In some embodiments, the sharp bearing body retaining position may be a position in which the at least of portion of the bead is on at least a portion of a sidewall of the sharp bearing body. In some embodiments, the sharp bearing body retaining position may be a position in which the at least a portion of the bead is on the sharp free face of the sharp bearing body. In some embodiments, forming the bead of material may comprise depositing the bead around the receptacle. In some embodiments, forming the bead of material may comprise overmolding the bead of material in position around the receptacle.

[0022] In accordance with an embodiment of the present disclosure an example delivery device for delivery of medical agent to a biological barrier may comprise a main body having a housing with a plurality of petal members extending outwardly from a first end thereof. The delivery device may further comprise a guide insert coupled into the housing withAttorney Docket: 00101.00467.AB674WO a sloped guide track which is partitioned into an upstream portion and downstream portion by an interrupt channel. The delivery device may further comprise a reservoir including at least one delivery sharp coupled to the housing and enclosing the guide insert within the housing. The delivery device may further comprise a plunger partially disposed in the guide track. The delivery device may further comprise a bias member intermediate the plunger and a wall at a second end of the housing. The bias member may exert a force compelling the plunger to displace along the guide track. The delivery device may further comprise a trigger body with a first barrier projection. The first barrier projection may present an interference to displacement of the plunger along the guide track when the trigger body is in a blocking position and may be disposed within the channel with a track completing surface aligned with the upstream and downstream portion in when the trigger body is in a trigger position. The delivery device may further comprise a deformable spacer having a first state in which the trigger body is held in the blocking position. The deformable spacer may transition to a deformed state upon displacement of the trigger body to the trigger position.

[0023] In some embodiments, the sloped guide track may be a ledge on the interior sidewall of the guide insert. In some embodiments, the sloped guide track includes a terminal channel at a downstream end of the guide track. In some embodiments, the trigger body may include a second barrier projection. The second barrier projection may be disposed within the terminal channel when the trigger body is in the trigger position and may be in an unobstructing position relative to the terminal channel when the trigger body is in the blocking position. In some embodiments, the deformable spacer may be a spring. In some embodiments, the deformable spacer may be a flexure of the trigger body which extends from a portion of the trigger body to the second end of the rigid guide body. In some embodiments, each of the at least one delivery sharp may be a microneedle. In some embodiments, the delivery device may further comprise an adhesive coupled to the petal members. In some embodiments, the reservoir may include a displaceable wall defining a portion of a main interior volume of the reservoir. The plunger may be out of contact with the displaceable wall when the portion of the plunger disposed in the guide track is in the upstream portion of the guide track. In some embodiments, the reservoir may include a septum.

[0024] In accordance with another embodiment of the present disclosure an example delivery device for delivery of medical agent to a biological barrier may comprise a petal bearing main body. The delivery device may further comprise an insert within the main body having a set of cam tracks each partitioned into an upstream portion and downstream portion by an interrupt channel. The delivery device may further comprise a reservoir including at leastAttorney Docket: 00101.00467.AB674WO one delivery sharp. The delivery device may further comprise a plunger having a set of plunger protrusions each disposed in a respective cam track. The plunger biased by a first bias member from a first position in which the protrusions are disposed at the upstream portions toward a second position in which the protrusions are disposed at the downstream portions. The delivery device may further comprise a button with a first set of barriers. The button may be displaceable between a blocking position in which the first set of barriers obstruct travel of the protrusions along the respective cam tracks and a trigger position in which the first set of barriers fill the interrupt channel and complete the cam track.

[0025] In some embodiments, the delivery device may further comprise a deformable spacer between the main body and the button. In some embodiments, the deformable spacer may be a flexure extending from one of the main body and button. In some embodiments, the deformable spacer may be a second bias member. In some embodiments, the delivery device may further comprise a deformable spacer which transitions from a home state to a deformed state upon displacement of the button to the trigger position. In some embodiments, the button may include at least one latch projection and the main body may include a respective catch for each of the at least one latch projection. Each of the at least one latch projection may engage its respective catch when the button is displaced to from the blocking position toward the trigger position. In some embodiments, the petal bearing main body may comprise a plurality of petal members. The petal members may displace from a relaxed position to a spreadingly displaced position when a threshold petal spreading force is applied. In some embodiments, the delivery device may further comprise a deformable spacer intermediate the button and main body. The button may displace from the blocking position to the trigger position and may deform the spacer upon application of a threshold deforming force which is greater than the threshold petal spreading force. In some embodiments, each of the at least one delivery sharp may be a microneedle. In some embodiments, the button may be biased to the blocking position by a second bias member. In some embodiments, the button may include a second set of barriers which obstruct travel of the protrusions to a terminal region of the downstream portions when the button is in the trigger position. In some embodiments, the reservoir may include a displaceable wall defining a portion of a main interior volume of the reservoir. The plunger may be out of contact with the displaceable wall when the protrusions are disposed at the upstream portion of the respective cam tracks.

[0026] In accordance with another embodiment of the present disclosure, an example delivery device for delivery of medical agent to a biological barrier may comprise a petal bearing main body. The delivery device may further comprise an insert coupled within theAttorney Docket: 00101.00467.AB674WO main body with a set of guides each having an upstream portion and downstream portion. The delivery device may further comprise a reservoir including at least one delivery sharp. The delivery device may further comprise a plunger having a set of plunger protrusions each disposed in a respective guide. The plunger biased by a first bias member from a first position in which the protrusions are disposed at the upstream portions toward a second position in which the protrusions are disposed at the downstream portions. The delivery device may further comprise a trigger body with a first set of barriers. The trigger body may be displaceable between a blocking position in which the first set of barriers obstruct displacement of the protrusions between the upstream and downstream sections of the respective guides and a trigger position in which the first set of barriers are in a stowed state.

[0027] In some embodiments, each of the at least one delivery sharp may be a microneedle. In some embodiments, the delivery device may further comprise a deformable spacer between the main body and the trigger body. In some embodiments, the deformable spacer may be selected from a group consisting of a flexure extending from one of the main body and trigger body and a second bias member. In some embodiments, the deformable spacer may be a latch projection. The latch projection may extend from the trigger body. The main body may include a catch. The latch projection may enter into engagement with the catch as the trigger body is transitioned to the trigger position. In some embodiments, the delivery device may further comprise a deformable spacer which transitions from a home state to a deformed state upon displacement of the trigger body to the trigger position. In some embodiments, the petal bearing main body may comprise a plurality of petal members. The petal members may displace from a relaxed position to a spreadingly displaced position when a threshold petal spreading force is applied. In some embodiments, the delivery device may further comprise a spacer intermediate the trigger body and main body. The trigger body may displace from the blocking position to the trigger position and may deform the spacer upon application of a threshold deforming force which is greater than the threshold petal spreading force. In some embodiments, the main body may include a window. The plunger may include a region of contrasting appearance. The region of contrasting appearance may be aligned with the window when the protrusions are disposed at the downstream portions. In some embodiments, the trigger body may include a second set of barriers which obstruct travel of the protrusions to a terminal region of the downstream portions when the trigger body is in the trigger position. In some embodiments, the reservoir may include a displaceable wall defining a portion of a main interior volume of the reservoir. The plunger may be out of contact with the displaceable wall when the protrusions are disposed at the upstream portion of theAttorney Docket: 00101.00467.AB674WO respective guides. In some embodiments, the reservoir may include a displaceable wall defining a portion of a main interior volume of the reservoir. The displaceable wall may have a first state when the reservoir is filled with agent and a second state when the reservoir is depleted. The main body may include a fill verification aperture through which at least a portion of the displaceable wall is visible when the displaceable wall is in the first state.

[0028] In accordance with still another embodiment of the present disclosure an example delivery device for delivery of medical agent to a biological barrier may comprise a petal bearing main body. The delivery device may further comprise a guide bearing body defining a set of guides each having an upstream portion and downstream portion. The delivery device may further comprise a reservoir including at least one delivery sharp. The delivery device may further comprise a plunger having a set of plunger protrusions each disposed in a respective guide. The delivery device may further comprise a first bias member urging the plunger toward a position in which the protrusions are at an end of the downstream portions. The delivery device may further comprise a trigger body with a first and second set of barriers. The trigger body may be displaceable between a blocking position in which the second set of barriers are stowed and the first set of barriers obstruct displacement of the protrusions between the upstream and downstream portions of the respective guides and a trigger position in which the first set of barriers are stowed and the second set of barriers obstruct travel of the protrusions to the end of the downstream portions.

[0029] In some embodiments, each of the at least one delivery sharp may be a microneedle. In some embodiments, each of the guides may be a sloped track. In some embodiments, each of the first set of barriers may be within an interrupt channel defined in each guide when the trigger body is in blocking position. In some embodiments, each of the guides is a cam track. In some embodiments, the reservoir may include a displaceable wall defining a portion of a main interior volume of the reservoir. The plunger may be out of contact with the displaceable wall when the protrusions are disposed at the upstream portion of the respective guides. In some embodiments, the petal bearing main body may comprise a plurality of petal members. The petal members may displace from a relaxed position to a spreadingly displaced position when a threshold petal spreading force is applied. In some embodiments, the delivery device may further comprise a spacer intermediate the trigger body and main body. The trigger body may displace from the blocking position to the trigger position and may deform the spacer upon application of a threshold deforming force which is greater than the threshold petal spreading force. In some embodiments, the reservoir may include a displaceable wall defining a portion of a main interior volume of the reservoir. The displaceable wall mayAttorney Docket: 00101.00467.AB674WO have a first state when the reservoir is filled with agent and a second state when the reservoir is depleted. The main body may include a fill verification aperture through which at least a portion of the displaceable wall is visible when the displaceable wall is in the first state.

[0030] In some embodiments, the delivery device may further comprise a deformable spacer between the main body and the trigger body. The deformable spacer may be selected from a list consisting of a bias member, a compression spring, a flexure, and a latching projection extending from the trigger body. In some embodiments, the main body may include a window and the plunger may include a region of contrasting appearance. The region of contrasting appearance being aligned with the window when the protrusions are disposed at the downstream portions.

[0031] In accordance with a further embodiment of the present disclosure an example method of expelling an agent from a delivery device may comprise applying the delivery device to a barrier. The method may further comprise generating a spreading displacement of petal members of a main body of the delivery device by exerting a first threshold force on a trigger body of the delivery device. The method may further comprise displacing the trigger body toward the main body to a trigger position by exerting a second threshold force greater than the first on the trigger body. The method may further comprise displacing at least one first barrier of the trigger body from an obstructing position to a stowed position. The method may further comprise expelling the agent from a reservoir of the delivery device by collapsing the reservoir with a spring biased plunger when each of the at least one first barrier is in the stowed position. The method may further comprise guiding displacement of the spring biased plunger with a guide insert coupled to the main body.

[0032] In some embodiments, applying the delivery device to the barrier may comprise adhering at least the petal members of the delivery device to the barrier. In some embodiments, the method may further comprise resisting displacement of the trigger body to the trigger position with a deformable spacer when the first threshold force is exerted on the trigger body. In some embodiments, the method may further comprise biasing the trigger body in a direction away from the main body with at least one bias member. In some embodiments, displacing the at least one first barrier from the obstructing position to the stowed position may comprise driving each of the at least one first barrier into an interrupt channel of a respective guide track defined in the guide insert. In some embodiments, displacing the at least one first barrier from the obstructing position to the stowed position may comprise displacing a surface of each of the at least one first barrier into a guide track completing position. The surface of each of theAttorney Docket: 00101.00467.AB674WO at least one first barrier may define a span of a respective guide track of the guide insert in the guide track completing position.

[0033] In some embodiments, the guide insert may include at least one plunger guide track. Each of the at least one guide track may be a cam track and guiding the displacement of the spring biased plunger comprises engendering rotation of the plunger as the plunger advances along the at least one guide track. In some embodiments, the method may further comprise displacing at least one second barrier from a retracted position to an obstructing position as the trigger body is displaced to the trigger position. Each of the at least one second barrier may block a terminal end of a respective guide track defined in the guide insert in the obstructing position. In some embodiments, the method may further comprise displacing the plunger into contact with the at least one second barrier. In some embodiments, the method may further comprise ceasing exertion of force on the trigger body after the trigger body is in the trigger position and driving the trigger body away from the main body via a bias member until the at least one second barrier is returned to the retracted position. The method may further comprise displacing the plunger to an end of a displacement range of the plunger.

[0034] In accordance with still another example embodiment of the present disclosure a method of expelling an agent from a delivery device may comprise adhering petal members of a main body of the delivery device to a barrier. The method may further comprise generating a spreading displacement of the petal members and puncturing the barrier with at least one delivery sharp of a reservoir of the delivery device by exerting a first threshold force on a trigger body of the delivery device. The method may further comprise displacing the trigger body to a trigger position by exerting a second threshold force greater than the first on the trigger body. The method may further comprise freeing a spring biased plunger to collapse the reservoir by displacing at least one first barrier of the trigger body from an obstructing position to a stowed position. The method may further comprise guiding displacement of the spring biased plunger with a guide insert coupled to the main body.

[0035] In some embodiments, the method may further comprise inhibiting displacement of the trigger body to the trigger position with a deformable spacer when the first threshold force is exerted on the trigger body. In some embodiments, the method may further comprise biasing the trigger body in a direction away from the main body with at least one resilient spacer. In some embodiments, displacing the at least one first barrier from the obstructing position to the stowed position may comprise driving each of the at least one first barrier into an interrupt channel of a respective guide track of the guide insert. In some embodiments, displacing the at least one first barrier from the obstructing position to the stowedAttorney Docket: 00101.00467.AB674WO position may comprise displacing a surface of each of the at least one first barrier into a guide track completing position. The surface of each of the at least one first barrier defining a span of a respective guide track of the guide insert in the guide track completing position. In some embodiments, the guide insert may include at least one plunger guide track. Each of the at least one guide track may be a cam track and guiding the displacement of the spring biased plunger may comprise engendering rotation of the plunger as the advances along the at least one guide track. In some embodiments, the method may further comprise displacing at least one second barrier from a retracted position to an obstructing position as the trigger body is displaced to the trigger position. Each of the at least one second barrier may block a terminal end of a respective guide track defined in the guide insert in the obstructing position. In some embodiments, the method further may comprise displacing the plunger into contact with the at least one second barrier. In some embodiments, the method may further comprise ceasing exertion of force on the trigger body after the trigger body is in the trigger position and driving the trigger body away from the main body via a bias member until the at least one second barrier is returned to the retracted position. The method may further comprise displacing the plunger to an end of a displacement range of the plunger. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] 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:

[0037] FIG. 1A is a block diagram of an example delivery device in a storage state in accordance with various aspects and embodiments of the present disclosure;

[0038] FIG.1B is a block diagram of an example delivery device in a delivery state in accordance with various aspects and embodiments of the present disclosure;

[0039] FIG. 2 is a diagram of an example microneedle in accordance with various aspects and embodiments of the present disclosure;

[0040] FIG. 3A is a diagram of an example sharp bearing body incorporating microneedles in accordance with various aspects and embodiments of the present disclosure;

[0041] FIG. 3B is a diagram of an example microneedle in accordance with various aspects and embodiments of the present disclosure;

[0042] FIG. 4A is a diagram of an example sharp bearing body incorporating microneedles in accordance with various aspects and embodiments of the present disclosure;Attorney Docket: 00101.00467.AB674WO

[0043] FIG. 4B is a diagram of an example microneedle in accordance with various aspects and embodiments of the present disclosure;

[0044] FIG.5A is a perspective view of an example sharp bearing body including a set of exemplary microneedles in accordance with various aspects and embodiments of the present disclosure;

[0045] FIG.5B is a perspective view of an example sharp bearing body including a set of exemplary microneedles in accordance with various aspects and embodiments of the present disclosure;

[0046] FIG. 6A is a perspective view of an example sharp bearing body include a set of exemplary microneedles in accordance with various aspects and embodiments of the present disclosure;

[0047] FIG. 6B is a top plan view of the example sharp bearing body shown in FIG. 6A in accordance with various aspects and embodiments of the present disclosure;

[0048] FIG. 7A is a top down view of an example sharp bearing body including a set of exemplary microneedles in accordance with various aspects and embodiments of the present disclosure;

[0049] FIG.7B is a perspective view of an example sharp bearing body including a set of exemplary microneedles in accordance with various aspects and embodiments of the present disclosure;

[0050] FIG. 8A is a top down view of an example sharp bearing body including a set of microneedles in accordance with various aspects and embodiments of the present disclosure;

[0051] FIG.8B is a perspective view of an example sharp bearing body including a set of exemplary microneedles in accordance with various aspects and embodiments of the present disclosure;

[0052] FIG.8C is a cross-sectional view taken at the indicated cut plane of FIG.8A in accordance with various aspects and embodiments of the present disclosure;

[0053] FIGS.9A-9D depict various views of an exemplary microneedle with side ports in accordance with various aspects and embodiments of the present disclosure;

[0054] FIG.10A depicts a top plane view of an example sharp bearing body;

[0055] FIG.10B depicts a side view of an example sharp bearing body;

[0056] FIG.10C depicts a detailed view of the indicated region of FIG.10A;

[0057] FIG.10D depicts a perspective view of an example sharp bearing body;

[0058] FIG. 11A is a block diagram of parts of an example delivery device in accordance with various aspects and embodiments of the present disclosure;Attorney Docket: 00101.00467.AB674WO

[0059] FIG. 11B is a block diagram of parts of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0060] FIG.12 is a block diagram of parts of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0061] FIG. 13 is a perspective view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0062] FIG. 14 is a plan view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0063] FIG. 15 is a side view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0064] FIG. 16 is a plan view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0065] FIG. 17 is a conceptual representation of an exemplary delivery device in a delivery state in accordance with various aspects and embodiments of the present disclosure;

[0066] FIG. 18 is a diagram of an example delivery device in a storage state in accordance with various aspects and embodiments of the present disclosure;

[0067] FIG. 19 is a conceptual representation of an example delivery device in a delivery state in accordance with various aspects and embodiments of the present disclosure;

[0068] FIG. 20 is a side view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0069] FIG. 21 is a perspective view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0070] FIGS.22A-22I depicts various example embodiments of main bodies including different slot patterns and top surface apertures in accordance with various aspects and embodiments of the present disclosure;

[0071] FIG. 23 is a perspective view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0072] FIG. 24 is a perspective view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0073] FIG. 25 is a perspective view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0074] FIG. 26 depicts a perspective view of an example delivery device package in accordance with various aspects and embodiments of the present disclosure;Attorney Docket: 00101.00467.AB674WO

[0075] FIG.27 depicts a top plan view of an example delivery device package with the delivery device removed in accordance with various aspects and embodiments of the present disclosure;

[0076] FIG. 28 is a diagram of an example delivery device in a storage state in accordance with various aspects and embodiments of the present disclosure;

[0077] FIG. 29 is a cross-section perspective view of a main body of an example delivery device in a storage state in accordance with various aspects and embodiments of the present disclosure;

[0078] FIG. 30A is a side view conceptual diagram of an example delivery device in transition to a delivery state in accordance with various aspects and embodiments of the present disclosure;

[0079] FIG. 30B is a side view conceptual diagram of an example delivery device in transition to a delivery state in accordance with various aspects and embodiments of the present disclosure;

[0080] FIG. 31A is a plan view diagram of an example delivery device illustrating example dimensions of one delivery device embodiment in accordance with an embodiment of the present disclosure;

[0081] FIG. 31B is a side view diagram of an exemplary delivery device illustrating example dimensions of one delivery device embodiment in accordance with an embodiment of the present disclosure;

[0082] FIG. 32 is a perspective view diagram conceptually illustrating an example delivery device in a delivery state in accordance with various aspects and embodiments of the present disclosure;

[0083] FIG. 33 is a side view diagram of the example delivery device of FIG. 32 in accordance with various aspects and embodiments of the present disclosure;

[0084] FIG. 34 is an exploded view diagram of the delivery device shown in FIG. 32 in accordance with various aspects and embodiments of the present disclosure;

[0085] FIG. 35 is a plan view diagram of the delivery device shown in FIG. 32 in accordance with various aspects and embodiments of the present disclosure;

[0086] FIG.36 is a cross section view diagram of the delivery device shown in FIG.32 taken at the indicated cut plane in FIG.35 in accordance with various aspects and embodiments of the present disclosure;Attorney Docket: 00101.00467.AB674WO

[0087] FIG. 37 depicts a representational illustration of an example delivery device including a dispensing assembly in accordance with various aspects and embodiments of the present disclosure;

[0088] FIG. 38 depicts a representational illustration of an example delivery device including a dispensing assembly in accordance with various aspects and embodiments of the present disclosure;

[0089] FIG. 39 depicts a representational illustration of an example delivery device including a dispensing assembly in accordance with various aspects and embodiments of the present disclosure;

[0090] FIG. 40 depicts a perspective view of an example delivery device and bias member in accordance with various aspects and embodiments of the present disclosure;

[0091] FIG. 41 depicts a perspective view of an example bias member which may be included in a delivery device in accordance with various aspects and embodiments of the present disclosure;

[0092] FIG. 42 depicts a cross-sectional view of a portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0093] FIG. 43 depicts a cross-sectional view of a portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0094] FIG.44 depicts a perspective view of an example depressor body which may be included in a delivery device in accordance with various aspects and embodiments of the present disclosure;

[0095] FIG. 45 depicts an example depressor body and bias member where the bias member is in a stressed state in accordance with various aspects and embodiments of the present disclosure;

[0096] FIG. 46 depicts a cross-sectional view of an example depressor body and bias member where the bias member is in a stressed state in accordance with various aspects and embodiments of the present disclosure;

[0097] FIG. 47A depicts a perspective view of an exemplary delivery device in accordance with various aspects and embodiments of the present disclosure;

[0098] FIG.47B depicts a perspective view of an exemplary stop member which may be included in a delivery device in accordance with various aspects and embodiments of the present disclosure;Attorney Docket: 00101.00467.AB674WO

[0099] FIG. 47C depicts a perspective view of an example delivery assembly and example stop member which may be included in a delivery device in accordance with various aspects and embodiments of the present disclosure;

[0100] FIG. 47D depicts a perspective view of an example bias member and example depressor body which may be included in a delivery device in accordance with various aspects and embodiments of the present disclosure;

[0101] FIG. 48 depicts a representational illustration of an example delivery device including a bias member in accordance with various aspects and embodiments of the present disclosure;

[0102] FIG.49A depicts a bottom plan view of an exemplary main body which may be included in a delivery device in accordance with various aspects and embodiments of the present disclosure;

[0103] FIG.49B depicts a perspective view of an example main body and example bias member which may be included in a delivery device in accordance with various aspects and embodiments of the present disclosure;

[0104] FIG.49C depicts a perspective view of an example main body and example bias member which may be included in a delivery device in accordance with various aspects and embodiments of the present disclosure;

[0105] FIG.50A depicts a side view of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0106] FIG. 50B depicts a cross-section view of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0107] FIG.51 depicts an exploded view of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0108] FIGS. 52A-52B depict views of portions of an example delivery device respectively in a storage state and a delivery state in accordance with various aspects and embodiments of the present disclosure;

[0109] FIG. 53 depicts a bottom view of an example main body of a delivery device and a portion of a depressor body in accordance with various aspects and embodiments of the present disclosure;

[0110] FIG.54A is a perspective view diagram of an example holder for a sharp bearing body in accordance with various aspects and embodiments of the present disclosure;

[0111] FIG.54B is a side view diagram of an example holder for a sharp bearing body in accordance with various aspects and embodiments of the present disclosure;Attorney Docket: 00101.00467.AB674WO

[0112] FIG. 54C is a bottom-up plan view diagram of an example holder for a sharp bearing body in accordance with various aspects and embodiments of the present disclosure;

[0113] FIG. 54D is a perspective view diagram of an exemplary holder for a sharp bearing body in accordance with various aspects and embodiments of the present disclosure;

[0114] FIG. 55A depicts a perspective view of an example holder including a stage projection in accordance with various aspects and embodiments of the present disclosure;

[0115] FIG. 55B depicts a perspective view of an example holder including a stage projection in accordance with various aspects and embodiments of the present disclosure;

[0116] FIG. 55C depicts a bottom plan view of an example holder including a stage projection in accordance with various aspects and embodiments of the present disclosure;

[0117] FIG.56A depicts a side view of an example holder including a stage projection to which an example sharp bearing body is mounted in accordance with various aspects and embodiments of the present disclosure;

[0118] FIG. 56B depicts a detailed view of the indicated region of FIG. 56A in accordance with various aspects and embodiments of the present disclosure;

[0119] FIG.56C depicts a cross-sectional view of an example holder including a stage projection to which an example sharp bearing body is mounted in accordance with various aspects and embodiments of the present disclosure;

[0120] FIG. 56D depicts a detailed view of the indicated region of FIG. 56C in accordance with various aspects and embodiments of the present disclosure;

[0121] FIG.57 depicts a view of a portion of an example sharp bearing body;

[0122] FIG.58 depicts a view of a portion of another example sharp bearing body;

[0123] FIG.59 depicts a view of a portion of another example sharp bearing body;

[0124] FIG.60 depicts a view of a portion of another example sharp bearing body;

[0125] FIG. 61 depicts a perspective view of another example sharp bearing body having a plurality of example microneedles projecting therefrom;

[0126] FIG.62A depicts a view of a backside of a sharp bearing body overmolded into a molded component;

[0127] FIG.62B depicts a cross-sectional view taken at the indicated cut plane of FIG. 62A:

[0128] FIG.62C depicts a detailed view of the indicated region of FIG.62B;

[0129] FIG.63 depicts a cross-sectional view of an example mold which may be used to overmold a component onto a sharp bearing body;Attorney Docket: 00101.00467.AB674WO

[0130] FIG.64 depicts another cross-sectional view of an example mold which may be used to overmold a component onto a sharp bearing body;

[0131] FIG.65A depicts a cross-sectional view of an example sharp bearing body and set of shut-offs;

[0132] FIG.65B depicts a perspective view of an example mold shut-off;

[0133] FIG. 65C depicts cross-sectional view depicting a set of microneedles positioned in pockets of an example shut-off;

[0134] FIG.66 depicts a block diagram depicting various portions of an example mold and a number of ejector pins;

[0135] FIG.67 depicts a block diagram of an example mold;

[0136] FIG.68 depicts a view of a portion of an example ejector pin with a cleat;

[0137] FIG. 69A depicts a perspective view of an example sharp bearing body in an example component surrounded by a bead of material which may be deformed via swaging to couple the sharp bearing body to the component in accordance with various aspects and embodiments of the present disclosure;

[0138] FIG.69B depicts a cross-sectional view of the example sharp bearing body and component of FIG. 69A in accordance with various aspects and embodiments of the present disclosure;

[0139] FIG. 69C depicts a detailed view of the indicated region of FIG. 69B in accordance with various aspects and embodiments of the present disclosure;

[0140] FIG. 70A depicts a perspective view of an example sharp bearing body in an example component surrounded by a bead of material which may be deformed via swaging to couple the sharp bearing body to the component in accordance with various aspects and embodiments of the present disclosure;

[0141] FIG.70B depicts a cross-sectional view of the example sharp bearing body and component of FIG. 70A in accordance with various aspects and embodiments of the present disclosure;

[0142] FIG. 70C depicts a detailed view of the indicated region of FIG. 70B in accordance with various aspects and embodiments of the present disclosure;

[0143] FIG.71A is a perspective view diagram of an exemplary portion of a reservoir in accordance with various aspects and embodiments of the present disclosure

[0144] FIG. 71B is a side view diagram of an exemplary portion of a reservoir in accordance with various aspects and embodiments of the present disclosure;Attorney Docket: 00101.00467.AB674WO

[0145] FIG. 71C is a perspective view diagram of an exemplary portion of a reservoir in accordance with various aspects and embodiments of the present disclosure;

[0146] FIG. 71D is a plan view diagram of an exemplary portion of a reservoir in accordance with various aspects and embodiments of the present disclosure;

[0147] FIG.72 depicts a perspective view of an exemplary reservoir in accordance with various aspects and embodiments of the present disclosure;

[0148] FIG.73 depicts a perspective view of another exemplary reservoir in accordance with various aspects and embodiments of the present disclosure;

[0149] FIG.74 is a block diagram of an example reservoir assembly in accordance with various aspects and embodiments of the present disclosure;

[0150] FIG. 75 is a block diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0151] FIG. 76A depicts a block diagram of an example reservoir assembly in accordance with various aspects and embodiments of the present disclosure;

[0152] FIG. 76B depicts a block diagram of an example reservoir assembly in accordance with various aspects and embodiments of the present disclosure;

[0153] FIG. 77 depicts a representational illustration of an example delivery device including a reservoir partitioned into a plurality of portions in accordance with various aspects and embodiments of the present disclosure;

[0154] FIG.78 depicts a block diagram of an example delivery device having a delivery unit and a trigger unit in accordance with various aspects and embodiments of the present disclosure;

[0155] FIG. 79A depicts an illustrative diagram of an example guide which may be including in a delivery unit of certain example delivery devices in accordance with various aspects and embodiments of the present disclosure;

[0156] FIG.79B depicts and illustrative diagram of an portions of an example delivery device in an initial state in accordance with various aspects and embodiments of the present disclosure;

[0157] FIG. 79C depicts an illustrative diagram of portions of an example delivery device in a state in which pressure has been applied to a trigger body of the example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0158] FIG. 79D depicts an illustrative diagram of an example delivery device transitioned into a trigger state in accordance with various aspects and embodiments of the present disclosure;Attorney Docket: 00101.00467.AB674WO

[0159] FIG. 79E depicts an illustrative diagram of an example delivery device at the end of a first stage of actuation of the delivery device in accordance with various aspects and embodiments of the present disclosure;

[0160] FIG. 79F depicts an illustrative diagram of an example delivery device at the end of a second stage of actuation of the delivery device in accordance with various aspects and embodiments of the present disclosure;

[0161] FIG.80A depicts an exploded perspective view of an exemplary delivery device with a trigger unit and a delivery unit in accordance with various aspects and embodiments of the present disclosure;

[0162] FIG. 80B depicts another exploded perspective view of an exemplary delivery device with a trigger unit and a delivery unit in accordance with various aspects and embodiments of the present disclosure;

[0163] FIG. 80C depicts cross-sectioned view of a main body and trigger body of an example delivery device with a portion of a rigid guide body of the main body removed in accordance with various aspects and embodiments of the present disclosure;

[0164] FIG.81A depicts a perspective view of an example delivery device with a lock installed thereon;

[0165] FIG. 81B depicts a cross-sectional view of a portion of an example delivery device and lock;

[0166] FIG.82 depicts a top plan view of an example lock;

[0167] FIG.83 depicts an exploded view of an example delivery device with a lock;

[0168] FIG.84 depicts a perspective view of an exemplary guide insert;

[0169] FIG. 85 depicts a perspective view of an example main body of a delivery device;

[0170] FIG.86 depicts a diagrammatic view of an example trigger body for a delivery device;

[0171] FIGS.87A-87B depict views of an example reservoir interface member having regions of contrasting appearance.

[0172] FIG. 88A depicts a view of an example delivery device having a window with which a first region of a reservoir interface member is aligned; and

[0173] FIG. 88B depicts a view of an example delivery device having a window with which a second region of a reservoir interface member is aligned;Attorney Docket: 00101.00467.AB674WO

[0174] FIG. 89A depicts a block diagram view of an example delivery device with an example rocker member in accordance with various aspects and embodiments of the present disclosure;

[0175] FIG. 89B depicts a block diagram view of an example delivery device with an example rocker member in accordance with various aspects and embodiments of the present disclosure;

[0176] FIG. 90A depicts a perspective view of an example delivery device including an example rocker member in accordance with various aspects and embodiments of the present disclosure;

[0177] FIG. 90B depicts a perspective view of another example delivery device including a plurality of example rocker members in accordance with various aspects and embodiments of the present disclosure;

[0178] FIG. 91 depicts a flowchart detailing a number of example actions which may be executed to delivery agent with a delivery device in accordance with various aspects and embodiments of the present disclosure;

[0179] FIG.92 depicts an illustration of an example delivery device after being applied to a user in accordance with various aspects and embodiments of the present disclosure;

[0180] FIG. 93 depicts an illustration of an example delivery device in process of transitioning from a storage state to a delivery state in accordance with various aspects and embodiments of the present disclosure;

[0181] FIG. 94 depicts an illustration of an example delivery device in process of transitioning from a storage state to a delivery state in accordance with various aspects and embodiments of the present disclosure;

[0182] FIG. 95 depicts an illustration of a delivery device in a delivery state in accordance with various aspects and embodiments of the present disclosure;

[0183] FIG.96A depicts a view of an example main body which may be included in a delivery device in accordance with various aspects and embodiments of the present disclosure;

[0184] FIG.96B depicts a side view of an example main body which may be included in a delivery device in accordance with various aspects and embodiments of the present disclosure;

[0185] FIG. 97 depicts a detailed view of a portion of an exemplary main body in accordance with various aspects and embodiments of the present disclosure;

[0186] FIG.98A depicts a view of an example main body which may be included in a delivery device in accordance with various aspects and embodiments of the present disclosure;Attorney Docket: 00101.00467.AB674WO

[0187] FIG.98B depicts a side view of an example main body which may be included in a delivery device in accordance with various aspects and embodiments of the present disclosure;

[0188] FIG.99A depicts a top front right perspective view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0189] FIG. 99B depicts a bottom plan view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0190] FIG.99C depicts a top plan view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0191] FIG.99D depicts a front side view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0192] FIG.99E depicts a right side view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0193] FIG.99F depicts a back side view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0194] FIG.99G depicts a left side view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0195] FIG. 100A depicts a top front right perspective view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0196] FIG.100B depicts a top plan view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0197] FIG. 100C depicts a bottom plan view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0198] FIG. 100D depicts a front side view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0199] FIG. 100E depicts a right side view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0200] FIG. 100F depicts a back side view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0201] FIG.100G depicts a left side view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;Attorney Docket: 00101.00467.AB674WO

[0202] FIG. 101A depicts a top front right perspective view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0203] FIG.101B depicts a top plan view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0204] FIG. 101C depicts a bottom plan view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0205] FIG. 101D depicts a front side view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0206] FIG. 101E depicts a right side view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0207] FIG. 101F depicts a back side view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0208] FIG.101G depicts a left side view of an example portion of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0209] FIG. 102A depicts a top plan view of an example reservoir in accordance with various aspects and embodiments of the present disclosure;

[0210] FIG. 102B depicts a bottom plan view of an example reservoir in accordance with various aspects and embodiments of the present disclosure;

[0211] FIG. 103 depicts a perspective view of an example septum in accordance with various aspects and embodiments of the present disclosure;

[0212] FIG. 104 depicts a cross-sectional view of an example reservoir including a septum in accordance with various aspects and embodiments of the present disclosure;

[0213] FIG.105 depicts a perspective view of an example delivery device including a septum in accordance with various aspects and embodiments of the present disclosure;

[0214] FIG.106A depicts a perspective cross-sectional view of an example main body including retention tabs in accordance with various aspects and embodiments of the present disclosure;

[0215] FIG. 106B depicts a detailed view of the indicated region of FIG. 106A in accordance with various aspects and embodiments of the present disclosure;

[0216] FIG. 107A depicts a bottom plan view of an example delivery device with an example adhesive member in accordance with various aspects and embodiments of the present disclosure;Attorney Docket: 00101.00467.AB674WO

[0217] FIG.107B depicts a bottom plan view of another example delivery device with another example adhesive member in accordance with various aspects and embodiments of the present disclosure;

[0218] FIG.107C depicts a bottom plan view of another example delivery device with another example adhesive member in accordance with various aspects and embodiments of the present disclosure;

[0219] FIG. 108A is a perspective view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0220] FIG. 108B is a perspective view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0221] FIG.109A is a side view diagram of an example delivery device in a first state in accordance with various aspects and embodiments of the present disclosure;

[0222] FIG. 109B is a side view diagram of an example delivery device in a second state in accordance with various aspects and embodiments of the present disclosure;

[0223] FIG.109C is a side view diagram of an example delivery device in a third state in accordance with various aspects and embodiments of the present disclosure;

[0224] FIG. 110A is a perspective view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0225] FIG.110B is a cutaway view diagram of an example flexure of a delivery device in accordance with various aspects and embodiments of the present disclosure;

[0226] FIG. 110C is a perspective view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0227] FIG. 111A is a perspective view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0228] FIG. 111B is a perspective view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0229] FIG. 112 is a perspective view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0230] FIG. 113 is a plan view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0231] FIG.114A is a side view diagram of an example delivery device in a first state in accordance with various aspects and embodiments of the present disclosure;

[0232] FIG. 114B is a side view diagram of an example delivery device in a second state in accordance with various aspects and embodiments of the present disclosure;Attorney Docket: 00101.00467.AB674WO

[0233] FIG.114C is a side view diagram of an example delivery device in a third state in accordance with various aspects and embodiments of the present disclosure;

[0234] FIG. 115 is a cross section view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0235] FIG. 116A is a block diagram of an example delivery device in a storage state in accordance with various aspects and embodiments of the present disclosure;

[0236] FIG.116B is a block diagram of an example delivery device in a delivery state in accordance with various aspects and embodiments of the present disclosure;

[0237] FIG. 117 is a perspective view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0238] FIG. 118 is a perspective view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0239] FIG. 119 is an exploded view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0240] FIG. 120 is an exploded view diagram of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0241] FIG.121A is a side view diagram of an example delivery device in a first state in accordance with various aspects and embodiments of the present disclosure;

[0242] FIG.121B is an enlarged view of the indicated region of the delivery device of FIG.121A in accordance with various aspects and embodiments of the present disclosure;

[0243] FIG. 122A is a side view diagram of an example delivery device in a second state in accordance with various aspects and embodiments of the present disclosure;

[0244] FIG.122B is an enlarged view of the indicated region of the delivery device of FIG.122A in accordance with various aspects and embodiments of the present disclosure;

[0245] FIG.123 is a cross section view diagram of an example delivery device in a first state in accordance with various aspects and embodiments of the present disclosure;

[0246] FIG. 124 is a cross section view diagram of an example delivery device in a second state in accordance with various aspects and embodiments of the present disclosure;

[0247] FIG.125 depicts an exploded view of an example delivery device in accordance with various aspects and embodiments of the present disclosure;

[0248] FIG.126 depicts an exploded view of an example delivery device in accordance with various aspects and embodiments of the present disclosure;Attorney Docket: 00101.00467.AB674WO

[0249] FIG. 127 is a perspective view diagram of an example flexure which may be included as or as part of an actuation assembly of an exemplary delivery device in accordance with various aspects and embodiments of the present disclosure;

[0250] FIG. 128 is a side view diagram of an example flexure which may be included as or as part of an actuation assembly of an exemplary delivery device in accordance with various aspects and embodiments of the present disclosure;

[0251] FIG.129 is a plan view diagram of an example flexure which may be included as or as part of an actuation assembly of an exemplary delivery device in accordance with various aspects and embodiments of the present disclosure;

[0252] FIG.130 depicts a perspective view of an example package for a delivery device in accordance with various aspects and embodiments of the present disclosure;

[0253] FIG.131 depicts a view of an example main body of a delivery device separated for an example reservoir assembly which may be included in a delivery device in accordance with various aspects and embodiments of the present disclosure;

[0254] FIG.132 depicts a view of an example delivery device being removed from skin of a patient revealing a mark created on the skin by the delivery device in accordance with various aspects and embodiments of the present disclosure; and

[0255] FIG.133 depicts an example thermal image of an injection site in which a bleb from an injection into the skin is visible in accordance with various aspects and embodiments of the present disclosure. DETAILED DESCRIPTION

[0256] FIG. 1A and FIG. 1B depict an embodiment of an exemplary delivery device 10. The example delivery device 10 may be a low profile delivery device 10 which may be applied over the skin of a patient. The example delivery device 10 may be sized for handheld use and may be easily applied to a wide variety of injection sites over a patient’s body. Additionally, the example delivery device 10 may be designed for use by a patient or relatively untrained or minimally trained individual. Thus a medical caregiver may not be necessary for use of the delivery device 10.

[0257] 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 exampleAttorney Docket: 00101.00467.AB674WO 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 FIG. 1A, the number and arrangement of delivery sharps 72 may differ in alternative embodiments. Any suitable number of rows and / or columns may be included in various examples. In various embodiments there may, for example, be a single row array of delivery sharps 72 including up to five delivery sharps 72. Preferably, the delivery sharps 72 may be arranged so as to prevent a bed of nails type scenario in which penetration of the skin via the delivery sharps 72 may be inhibited or inconsistent across users or delivery devices 10. This may occur when too many delivery sharps 72 are arranged in close proximity to one another. Thus, the array may be referred to as a spaced array of delivery sharps 72.

[0258] 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.

[0259] Referring now also to FIG. 2, where microneedles are used, the microneedles described herein may, in certain embodiments, be MEMS produced, polyhedral (e.g. pyramidal), silicon crystal microneedles. These microneedles may be no greater than 1 mm in height, e.g. 0.6 mm or 0.8mm (though longer or shorter microneedles may also be used). At least some edges of the microneedles may be rounded or filleted, though such microneedles may still be referred to herein as polyhedral. In some examples and as shown in FIG. 2, the microneedles described herein may be generally in the shape of a heptagonal prism (though pentagonal, nonagonal, and other polygonal prisms may also be used as the base shape) whichAttorney Docket: 00101.00467.AB674WO has been diagonally sected to form a heptagonal ramp or pointed wedge. In such embodiments, the heptagonal prism may be sected by a plane extending from a vertex 14 of the top face of the prism through the most distal side 15 of the base 17. At least two sides of the base of the microneedle may be parallel. The side walls 19 may extend substantially perpendicularly from the base 17. The microneedle may be substantially symmetric about a line of symmetry extending from the vertex 14 to a point above the center of the most distal side 15. In other embodiments, the microneedles may be conically shaped. Any other suitable shape may be used. In the example, the vertex 14 is shown as a point which forms a tip of the microneedle. In other embodiments, this portion of a microneedle may be rounded (though may still be referred to herein as a vertex 14 and such microneedles may still be referred to as pointed). In such embodiments, the back facing edge 23 may be a round face or the back facing edge 23 and the adjacent side walls 19 may be replaced by a rounded face.

[0260] 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 FIG.2 the vertex 14 forms the tip) of the microneedles. Hollow tipped microneedles in which the flow lumen 126 extends to the tip of the microneedle may also be utilized. In some embodiments, the microneedles may be NanoPass hollow microneedles available from NanoPass Technologies Ltd. of 3 Golda Meir, Nes Ziona, Israel. It should be noted that microneedles (or the substrate on which they are disposed) described herein as constructed of silicon may have a surface layer of silicon dioxide (which may, for example, form with exposure to air) while still being considered constructed of silicon.

[0261] With reference to FIGS. 3A-4B, in some embodiments microneedles may be constructed to include certain features that may help to reduce the pressure required to inject fluid, such as a medical agent, into the skin of a patient. In some examples, features common certain to insect stingers or biological venom administration structures may be incorporated. These features may include various recesses or depressions which are formed as part of each microneedle or at least one microneedle of a delivery device 10. These recesses or depressions may fluidly communicate with the flow lumen 126 of the respective microneedle. In some embodiments, different microneedles of a delivery device 10 may include different recesses or some microneedles may include a plurality of recesses which could be of different varieties (though need not be).

[0262] For example, as shown in FIGS.4A-4B, a microneedle may include a channel or trough 200 on an exterior sloped face 21 leading from the flow lumen 126 toward the distal side 15. The channel 200 may allow medical agent to flow through it along the outer side ofAttorney Docket: 00101.00467.AB674WO the microneedle to find a path of least resistance, or weakest link, into the skin. In the embodiments shown, medical agent may be routed by the channel 200 to flow along the outer side of the microneedle to a weak region in the skin in the event the outlet of the flow lumen 126 has been inserted to a greater depth than the depth of the weak region. The lamina lucida junction, an intradermal delivery destination, is a weak link in the skin structure, and is difficult to consistently inject directly into due to its relative thinness (it is typically on the order of 40 nm thick). A microneedle including a channel 200 may, for example, allow flow of medical agent to the lamina lucida junction when the lamina lucida junction has been passed by the outlet of the flow lumen 126. The channel 200 may facilitate distribution of the medical agent through a larger area of entry or injection. In some examples, incorporating a channel 200 into a microneedle may reduce the pressure required to inject a medical agent into the skin considerably. In certain examples pressure may be reduced by 600% or more (e.g. from 120 pounds per square inch (psi) to from 18 to 20 psi in certain examples).

[0263] 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.

[0264] 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 theAttorney Docket: 00101.00467.AB674WO 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.

[0265] The channel 200 need not be straight or shaped in the manner shown in and described with reference to FIGS. 4A-4B. In some embodiments, the channel 200 may be a more meandering channel 200. A curved channel 200 could, for example, be used provided the dimensions of the microneedle are accommodated. Moreover, there need not be only one channel 200. More than one channel could be used provided structural integrity of the microneedle is accommodated.

[0266] 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., FIG.5B). The width of the channel 200 may be about 20- 30 percent of the width of the distal side 15 of the microneedle at the narrowest point in the channel 200. In some embodiments, the width of the channel 200 may increase as distance to the distal side 15 decreases. In some embodiments, at its widest, the channel 200 may have a width which is 50% or more the width of the distal side 15.

[0267] Referring now also to FIG.5A and FIG.5B, in other examples, the channel 200 may extend from the location of the lumen 126 toward the tip or vertex 14 of the microneedle (see, e.g., FIG.5B). Moreover, in some examples, the channel 200 may extend both toward the vertex 14 and toward the base 17 from the location of the lumen 126. That is, the channel 200 may include a portion on both sides of the lumen 126 (see, e.g., FIG.5A). As shown, the lumen 126 may be located substantially centrally in the sloped face 21 of the microneedle. In such embodiments, a channel 200 may extend toward the distal side 15 of the base 17 and a channel 200 may extend toward the tip or vertex 14. In other embodiments, the lumen 126 may be positioned at (or near) an end of the channel 200 most proximal the base 17.

[0268] Referring now to FIGS. 6A-6B, views of a sharp bearing body 26 including a number of microneedles are shown. In certain embodiments, a channel 200 may not be included. Instead, a microneedle may include a flow lumen 126 with an elongate cross-section (at least at the outlet, see also FIG. 7B and FIG. 8B). Microneedles with channels 200 and elongate lumens 126 are also possible. When in place within the patient, an elongate lumen 126 may be in fluid communication with, for example, multiple layers of skin. Thus, a thin and / or weak layer of skin may be easier to target when the microneedle is advanced into aAttorney Docket: 00101.00467.AB674WO patient. Elongate lumens 126 may also help to lower pressure required to inject. Such elongate flow lumens 126 may have any suitable cross-section. In some embodiments, the cross-section may be oval or elliptical. Alternatively, a lumen 126 with an obround cross-section may be used as is shown in FIGS.6A-6B. Polygonal cross-sectional shapes may also be used, such as though not limited to rectangular, trapezoidal, triangular, etc. In certain examples, the length (in the direction of elongation) of the cross-section of the lumen 126 may be up to 100-200 microns or greater (though could be less in certain examples). Where elongate lumens 126 are included, the end of the lumen 126 most proximal the distal side 15 may be spaced from the distal side 15 by at least a certain distance. The spacing may be such that, the end of the lumen 126 most proximal the distal side 15 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, it may be disposed below the epidermis (e.g. in the basement membrane) or within the epidermis.

[0269] Still referring to FIGS. 6A-6B in certain embodiments, the sloped face 21 of a microneedle may not extend to the base 17 of a microneedle. There may, for example, be a vertical face 13 extending from the base 17 to the distal side 15 of a microneedle. Where a vertical face 13 is included, the vertical face 13 may be aligned with a side (e.g. distal side 15) of a sharp bearing body 26 and may form an extension thereof. Including such vertical faces 13 may aid in reducing the size of a sharp bearing body 26 and may aid in ensuring consistent fluid delivery into a target destination for certain microneedles. Though shown in relation to FIGS.6A-6B, any of the microneedles shown herein may be arranged with vertical faces 13.

[0270] 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 FIGS. 3A-3B. The depression 202 may have a maximum depth which places the depression 202 into fluid communication with the flow lumen 126 of the microneedle. The depression 202 may thus form a side port for the microneedle through which fluid may be delivered to the patient. The side port may be the only outlet of the microneedle or may be in addition to an outlet of the lumen in the face 21 of the microneedle. When the microneedle is inserted into the skin surface, fluid contained in a delivery device 10 may be delivered to the patient, at least in part, by being pumped into the depression 202. The depression 202 may be formed, for example by cutting away material during manufacture of the microneedle or the depression 202 may be formed during a molding operation. Cutting away material may be accomplished by any known suitable process such as,Attorney Docket: 00101.00467.AB674WO for instance, etching (e.g. wet etching). In some embodiments, the depression 202 may be recessed in at least one side wall 19 or edge (e.g. where two side walls 19 join) of the microneedle. In the example shown in FIGS. 3A-3B, the depression 202 is formed in a substantially vertical back facing edge 23 of the microneedles which extends from the base 17 to the vertex 14. This may establish or increase a vertical void volume created by the microneedle as the skin is penetrated by the microneedle. That is, such a depression 202 may establish an open space in a patient into which fluid may be easily delivered from the microneedle. Positioning the depression 202 in the back facing edge 23 may provide a path of low resistance for a fluid to enter skin that the microneedle has penetrated. In embodiments wherein the microneedle includes at least one substantially vertical wall, the depression 202 may be recessed into a substantially vertical wall. In the example embodiment, the maximum depth of the depression 202 may be about 130% to 110% of the distance from the back facing edge 23 to the flow lumen 126.

[0271] In certain examples, and referring now to FIG.7A and FIG. 7B, a microneedle may include a sloped face 21 to which a lumen 126 extending through the microneedle extends. A microneedle may also include a rounded blade edge 31. In the example, the rounded blade edge 31 extends from a point 33 opposite the distal side 15 and extends in an arcuate path to the vertex or tip 14 of the microneedle. In the example, the rounded blade edge 31 includes a double bevel, though other bevel types may be used. The rounded blade edge 31 may arc at a constant radius or a variable radius. The rounded blade edge 31 may have an arc measure of less than 90° or, in certain examples, greater than 90° (see, e.g., FIG. 8A-8C). The rounded blade edge 31 may aid in introduction of a microneedle into skin when the microneedle is inserted at certain angles or over a variety of different angles.

[0272] In yet another embodiment, and referring now to FIGS. 8A-8C, a microneedle may include a rounded blade edge 31 and a lumen outlet face 35. The lumen 126 may extend through the microneedle to the lumen outlet face 35 and may not be formed in a straight line through the microneedle. The lumen outlet face 35 may be angled from the vertex 14 to the distal side 15 so as to form an undercut. The distal edge 15 may be disposed such that a plane perpendicular to the base 17 passing through the distal edge 15 may also pass through the rounded or arcuate blade edge 31. Additionally, the outlet of the flow lumen 126 in the lumen outlet face 35 may be disposed such that a plane or all planes perpendicular to the base 17 and passing through the outlet of the flow lumen 126 may also pass through the blade edge 31. This need not be true in all embodiments (see, e.g., FIGS.7A-7B). As a microneedle of the variety shown in FIGS. 8A-8C is inserted, a vertical void space may be created due to the undercut.Attorney Docket: 00101.00467.AB674WO This may provide a low resistance pathway for fluid injection. Additionally, the undercut may help to mitigate potential for the lumen 126 to become obstructed by skin as the microneedle is inserted into a patient or as the delivery occurs.

[0273] In still other embodiments and referring now to FIGS. 9A-9D, the delivery sharp(s) 72 may be or include a microneedle which has a shape with a high aspect ratio. In some embodiments, microneedles may be obelisk shaped. Such microneedles may be included in an array such as any array described herein. Where obelisk type microneedles are used, the microneedles may include a base 17’. The base 17’ may be any desired round or polygonal shape. For purposes of example, FIGS. 9A-9D depict a base 17’ which is a quadrilateral or rhombus. The example microneedle includes a set of sidewalls 19’ which extend from the base 17’ to an end region 25 of the microneedle. The sidewalls 19’ may be disposed at an angle which is not perpendicular to the base 17’. Thus the microneedle may taper so as to have a smaller cross-sectional area as distance from the base 17’ increases. A portion of the microneedle most distal to the base 17’ may include a beveled tip 27. Such a tip 27 may facilitate puncture of the skin and may aid in increasing the robustness of the end region 25. Any suitable bevel such as a single or double bevel may be used.

[0274] 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.

[0275] 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, polyvinylAttorney Docket: 00101.00467.AB674WO 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.

[0276] Referring now to FIGS.10A-10D, views of a sharp bearing body 26 including a pair of microneedles are depicted. Such sharp bearing bodies 26 may be preferable for certain fluid delivery applications such as those in which relatively slow delivery of fluid is acceptable or in scenarios where fluid is not delivered via a sustained, manually applied force. Such sharp bearing bodies 26 may also be particularly well suited where a user does not manually maintain the orientation of a delivery implement (e.g. syringe). By including only a pair of microneedles on a sharp bearing body 26, more sharp bearing bodies 26 may be created out the same wafer of silicon material even while increasing the height of the microneedles. This may also make such sharp bearing bodies 26 more cost efficient without adversely impacting delivery in devices where the orientation of the device is not manually maintained and relatively slow delivery is acceptable.

[0277] As shown, the sharp bearing body 26 is arranged such that the cross-sectional area of the sharp bearing body 26 increases as distance from the sharp bearing face of the sharp bearing body 26 increases. In the example, the sharp bearing body 26 has a stepped appearance, though any arrangement described in relation to FIGS.57-61 may be used. Though not shown, the example microneedles depicted in FIGS. 10A-10B could include a vertical face 460 as described in relation to FIGS. 6A-B and FIG. 61. Other features such as any channels 200 described herein may also be included.

[0278] As shown, each of the microneedles includes a tip region 845 and a trailing region 847. The tip region 845 includes a rounded vertex 31 and back facing edge 23. The vertex 31 and back facing edge may in certain examples have a radius of 25-40 microns (e.g. 34 microns). At least one additional radiused region 861 may connect the back facing edge 23 to the trailing region 847 on each side of the microneedle. In the example the at least one additional radiused region is a single constant radiused region on each side of the microneedle. In certain examples, the radius of this region may be 310-335 microns (e.g.324 microns). Thus, the entire tip region 845 may be rounded with the sidewalls 19 in this region being devoid ofAttorney Docket: 00101.00467.AB674WO straight spans or corners. This may generate a microneedle with a particularly robust tip region 845. The sidewalls 19 on each side of the microneedle in the trailing region 847 may be planar. In certain examples, the sidewall segments on each side of the microneedle may be oriented parallel to one another. In alternative examples, the sidewall segments in the trailing region 847 may be at a slight angle to one another (e.g. less than 25° to one another). Greater angles are also possible.

[0279] The lumen 126 for the microneedle may be disposed in the tip region 845 in a central position with respect to the sidewalls 19 on each side of the microneedle. The lumen 126 may be defined by a first radiused wall 867 most proximal the vertex 31 and back facing edge 23. The distance between the back facing edge 23 and the closest portion of the first radiused wall 867 may be 65-80 microns. The lumen 126 may also be defined by a second radiused wall 873 forming the portion of the lumen 126 most distal to the vertex 31 and back facing edge 23. The first radiused wall 867 may have a tighter radius than the second radiused wall 873. In some examples, the first radiused wall 867 may have a radius of 23.5-33.5 microns and the second radiused wall 873 may have a radius of 35-42.5 microns. Straight spans 871 may be present on each side of the lumen 126 to connect the ends of the first radiused wall 867 to respective ends of the radiused wall 873. The minimum distance between the sidewall of the microneedle and the closest wall of the lumen 126 may be 25-30 microns.

[0280] Referring again primarily to FIG. 1A and FIG. 1B, delivery devices 10 described herein may deliver any of a variety of medications or other medical agents to a patient. In certain embodiments, the reservoir 12 of the delivery device 10 may be filled with a vaccine. Such a delivery device 10 may deliver any suitable vaccine, though may be particularly well suited to vaccines for novel pathogens (e.g. SARS-CoV-2) or for pathogens where herd immunity does not exist (e.g. Ebola). Additionally, such delivery devices 10 may be of particular usefulness in outbreaks of pathogens (such as measles for example) in communities which choose to forego typical vaccinations. For example, such delivery devices 10 could be distributed without requiring patients to congregate in hospitals or other shared spaces. This would mitigate concern for pathogen transmission related to vaccination programs and alleviate potential worries that could dissuade people from reporting to receive a vaccination. Instead, delivery devices 10 could be picked up and used by patients without breach of social distancing, gathering size recommendations, or other safety guidelines. Alternatively, such delivery devices 10 could be distributed directly to patients without requiring a patient to leave their domicile or requiring distribution personnel to interact with individuals who decline to utilize recommended PPE. Delivery devices 10 could be filled withAttorney Docket: 00101.00467.AB674WO a vaccine for a novel pathogen or could perhaps be filled with vaccines typical of a normal vaccination schedule. In the latter case, such a delivery device 10 could help to ensure that disruption of vaccination for known pathogens does not occur during a novel pathogen pandemic.

[0281] 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 (and any variants or sub-variants thereof). 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.

[0282] 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.

[0283] 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 overAttorney Docket: 00101.00467.AB674WO 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.

[0284] 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.

[0285] 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.

[0286] 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.

[0287] 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 certainAttorney Docket: 00101.00467.AB674WO 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.

[0288] Delivery devices 10 described and shown herein may also be well suited to deliver drugs for overdose intervention such as opioid antagonists (e.g. Naloxone). Delivery devices 10 described herein may be easily used at the site of an overdose by a non-medically trained bystander. Alternatively, delivery devices 10 may be used by emergency medical services (EMS) personnel responding to an overdose. Such delivery devices 10 may provide rapid access and delivery to, for instance, a shallow destination in the overdose victim. This may allow agent to be supplied to an overdose victim in a rapid manner. Additionally, it may obviate the need to establish an intravenous access which can be particularly difficult for users of intravenous drugs.

[0289] Still referring to FIGS.1A-1B, the delivery device 10 may include a main body 20. The main body 20 may be a deformable body which may transition from a storage state (see FIG. 1A) to a delivery state (see FIG. 1B). In certain examples, this transition may be reversible, though in other embodiments the transition may result in a permanent change in the main body 20 and / or another part of the delivery device 10. For example, once transitioned to the delivery state, the main body 20 may plastically deform such that it is permanently distorted and may not be returned to the storage state. In other examples, a frangible included in the delivery device 10 may be broken upon transition of the main body 20 to the delivery state. Alternatively or additionally, a latch, lock, or other coupling may be engaged to hold the main body 20 in the delivery state or prevent the main body 20 from returning to the storage state. Destruction of a portion of the main body 20 or a portion of the delivery device 10 engaged to the main body 20 may be required to disengage such a coupling and this destruction may render the delivery device 10 inoperative. Where a permanent change is engendered upon transition to the delivery state, this permanent change may inhibit reuse as well as provide a user perceptible (e.g. visual) indication that the delivery device 10 has been used. An indication that the transition has occurred may also be generated by the delivery device 10. For instance, an audible or tactile indication may be generated upon engagement of a latch or breaking of a frangible.

[0290] 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 moreAttorney Docket: 00101.00467.AB674WO 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. In some embodiments, the main body 20 may include one or more regions which may invert while also including one or more regions which distort and at least partially restore as a result of the delivery device being transitioned to a delivery state.

[0291] 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.

[0292] 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., FIGS. 18-19). A displacement of adhesive bearingAttorney Docket: 00101.00467.AB674WO portions with respect to one another that results stretching of the adhered skin (regardless of any positive or negative change in distance between the adhesive bearing portions) may be referred to as a spreading displacement. Two adhesive bearing portions which have been so displaced may be referred to as being spreadingly displaced.

[0293] 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.

[0294] In some embodiments a collapsible pouch, or packet 208, may be positioned in the delivery device 10 above the reservoir 12 as shown in FIG. 11A. The packet 208 may contain a substance that, in a first condition is in a dormant state, and in a second condition transitions to a motive force applying state. In an embodiment the substance may be dormant at a first temperature and apply a motive force, e.g. upon the reservoir 12, at a second temperature. In an example embodiment, the first temperature may be colder than the second temperature. The first temperature may be a cold chain storage temperature for a vaccine. The second temperature may be room temperature or at least below average patient body temperature (e.g. 98.6°F for humans). In some embodiments, the substance may change in volume when it transitions from a dormant state to a motive force applying state. Alternatively or additionally, the substance may change from one state of matter to another state of matter when it transitions from a dormant state to a motive force applying state. In an example embodiment, the substance may change from a liquid to a gas during the transition from a dormant state to a motive force applying state.

[0295] 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 thatAttorney Docket: 00101.00467.AB674WO 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.

[0296] 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 FIG. 11B. Butane gas, for instance, has a vapor pressure of 35.4 psi at 25°C. Accordingly, a final pressure on the reservoir 12 may be higher (e.g. around 38 psi) due to heat transfer from the patient to the packet 208. The main body 20 of the delivery device 10 may be sufficiently resilient to not deform under the pressure applied from the packet 208. This may aid in directing pressure against the reservoir 12.

[0297] 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.

[0298] 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 FIG. 1A and FIG.1B. In such embodiments the packet 208 may be incorporated within a squeezable container 350 as shown in FIG.12. The container 350 may be made of a squeezable plastic or any other suitable material as would be understood by those of skill. The container 350 may be formed by injection molding, thermoforming, or any other technique known to those of skill.Attorney Docket: 00101.00467.AB674WO In addition to housing the packet 208, a first substance may be stored within the container 350. The packet 208 may hold a second substance. The first and second substances may be components of, for example, and an expanding foam. The first and second substances may be selected such that they expand to create pressure when they come into contact with each other. A chemical reaction (e.g. baking soda and vinegar) which generates gas could for example be used. Upon applying the delivery device 10 to the skin surface, a user may, e.g., pinch, crush, smoosh, or squeeze the container 350. This may cause the packet 208 therein to rupture and thereby allow the first and second substances to interact and cause downward pressure on the reservoir 12 below.

[0299] 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.

[0300] In alternative embodiments, a packet 208 of FIG.11A or FIG.11B may be filled with contents which do not change phase when removed from cold storage. For example, the packet 208 may be a gas bladder that may serve to prevent pressure from a user’s finger applied to the top of the delivery device 10 from being applied directly to the reservoir 12. Such a gas bladder may also help to make applied pressure more uniform across the reservoir 12. An example of a suitable gas which may be used to fill such a packet 208 may be nitrogen. Any other suitable gas may be used.

[0301] 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 FIGS.50A-76B and FIGS.13-30B

[0302] Referring now to FIGS.13-15, an exemplary delivery device 10 is depicted. The example delivery device 10 is shown in a storage state in FIGS.13-15. As shown, the delivery device 10 may include a main body 20 and a reservoir 12. The reservoir 12 may include at least one delivery sharp 72. The delivery sharp 72 may be included on a sharp bearing body 26 which may be coupled to a wall of the reservoir 12. The main body 20 of the example deliveryAttorney Docket: 00101.00467.AB674WO device 10 may have a round (e.g. circular) foot print and may include a central region 28 and a peripheral region 30. The central region 28 may be a raised region of the main body 20 and the peripheral region 30 may be a substantially flat region of the main body 20 which surrounds the central region 28. The thickness of the main body 20 may be substantially uniform over the entirety of the main body 20. The main body 20 may be formed as a thin sheet or disc of material which may be thermoformed to create the raised central region 28 and flat peripheral region 30.

[0303] 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 FIGS.13-36) the main body 20 may be injection molded so as to be in the storage state or in the delivery state. The main body 20 may transition more easily into the state in which it was molded from the opposite state. Thus, to lower the effort needed to transition a delivery device 10 from a storage state to a delivery state, it may be desirable to mold the main body 20 of the delivery device 10 in its delivery state configuration. During assembly of a delivery device 10, the main body 20 may be brought into its storage state configuration and remain in that configuration until use.

[0304] 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.

[0305] 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 through 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.Attorney Docket: 00101.00467.AB674WO

[0306] Referring now to FIG.16, a plan view of the proximal face 24 of the main body 20 is depicted. As shown, adhesive 22 may be included on at least a portion of the proximal face 24. The adhesive 22 may be a skin compatible adhesive and may serve to couple a delivery device 10 to a skin surface at an infusion site. In the example embodiments, adhesive 22 may be included on the peripheral region 30 of the main body 20. Though adhesive 22 is shown covering the entire surface of each of the petal members 42 in the peripheral region 30, other embodiments may differ. For example, only certain petal members 42 may include the adhesive 22. In such embodiments, adhesive 22 may be included on at least one pair of oppositely disposed (e.g. diametrically opposed in the example embodiment) petal members 42. Only a portion (e.g. a majority of the surface area) of each petal member 42 included in the peripheral region 30 may be covered with adhesive 22 in some examples. Alternatively or additionally, the adhesive 22 may differ from petal member 42 to petal member 42. Certain petal members 42 may be covered with a more aggressive adhesive 22 while other petal members 42 may be covered with a less aggressive adhesive 22. In certain examples, the entirety of the proximal surface 24 may be covered in adhesive 22. Additional adhesive members 22 are described elsewhere herein (see, e.g., FIGS.107A-C) and may be used on a delivery device 10.

[0307] Referring now to FIG. 17, a conceptual representation of a main body 20 of a delivery device 10 is depicted in a delivery state. In the delivery state, at least the central region 28 of the main body 20 may substantially invert. The fenestrations 34 may facilitate this inversion by helping to allow for increased deflection of the main body 20 at the fenestrations 24. Thus, in place of a convex dome-like shape, the center region 28 of the main body 20 may take on a concave shape. As the peripheral region 30 is coupled to the center region 28, the peripheral region 30 may displace as a result of the inverting of the center region 28. In the example embodiment, the entire main body 20 takes on a bowl shape when transitioned to the delivery state. The peripheral region 30 may also spreadingly displace for at least a portion of the transition. The slots 36 in the main body 20 may help to facilitate spreading displacement of the petal members 42 as the transition takes place, thereby enhancing stretching of the skin of the user.

[0308] 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 FIG. 17. Thus, only a triggering force may be applied to initiate the transition.Attorney Docket: 00101.00467.AB674WO The rest of the shift between the storage and delivery state may be caused by the snap through phenomenon.

[0309] FIG. 18 depicts a delivery device 10 in a storage state and adhered to skin 44 via adhesive 22 on a proximal face 24 of the main body 20. FIG. 19 is a conceptual representation depicting a delivery device 10 in the delivery state. As shown, the delivery device 10 may be applied to the skin 44 in the storage state. The delivery device 10 may then be transitioned to the delivery state. A spreading displacement of opposed petal members 42 of the main body 20 may occur as the transition transpires.

[0310] Two opposing points 46A, B disposed at the peripheral edge of the proximal surface 24 are shown in FIG. 18 and FIG. 19. When the delivery device 10 is in the storage state (FIG. 18), the shortest distance between the opposing points 46A, B is a straight line which does not pass through the proximal surface 24. This straight line is roughly parallel to the surface of the skin 44. In the delivery state, however, the shortest distance between the opposing points 46A, B is a straight line which passes through the proximal surface 24. As the skin 44 is fixed to the main body 20 via the adhesive 22 and cannot pass through the main body 20, the skin 44 may be forced to conform to the curvature of the proximal surface 24. Thus, the length of the skin 44 surface between the two points 46A, B when the delivery device 10 is in the delivery state may be greater than the length of the skin 44 surface between the points 46A, B when the delivery device 10 is in the storage state. The skin 44 may be placed under tension and stretched to accommodate this change in length. This stretching may, in turn, aid in facilitating puncture of the skin 44 by the delivery sharp(s) 72.

[0311] 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.

[0312] 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 toAttorney Docket: 00101.00467.AB674WO 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.

[0313] 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.

[0314] With reference to FIG. 20 and FIG. 21, in another embodiment, a delivery device 10 may include a central region 28 having a top surface 250 and a supporting structure 252 integral with the top surface 250. The supporting structure 252 may have a round, e.g., substantially circular, base 262. The peripheral region 30 may be roughly annular shaped and may include an inner perimeter coincident with the base 262 and an outer perimeter, or peripheral edge 38. The delivery device 10 may be constructed of a nylon material such as Nycoa 2012 nylon or other, similar nylon materials, and may be formed by injection molding. Any other suitable plastic may be used. The top surface 250 may have a round footprint, e.g., of roughly circular shape, and may be convex, forming a dome shape. The top surface 250 may have a periphery 340. The top surface 250 may include slots 254. The slots 254 may be cutouts, apertures, holes, openings, or voids in various embodiments. The slots 254 may help the delivery device 10 to transition from the storage state to the delivery state with reduced pressure from above. The slots 254 may extend radially with respect to a center point 256 of the top surface 250 such that their respective first endpoints 258 surround a region including the center point 256 of the top surface 250 and their respective second endpoints 260 may each terminate a distance (e.g., the slots 254 may each terminate the same distance) from the periphery 340 of the top surface 250. In embodiments including slots 254, the slots 254 may be disposed at regular angular increments (though need not be). In embodiments described herein including slots 254, the slots 254 may (though need not necessarily be) each be of the same length.Attorney Docket: 00101.00467.AB674WO

[0315] Referring now to FIGS. 22A-22I, a variety of different main body 20 embodiments are depicted. The exemplary main bodies 20 are shown in a flat state and may be thermoformed into a configuration such as that shown in, for example FIG. 20. Though thermoformable main bodies 20 are depicted, the features described in relation to thermoformed main bodies 20 may be included in main bodies 20 which are manufactured in any desired manner. As shown in FIGS. 22A-22I, the slots 254 may be provided in a number of different formats. Additionally, in some embodiments, slots 254 may not be included.

[0316] In some embodiments, and as also shown in FIG. 23, the slots 254 could be disposed such that they do not extend radially with respect to the center point 256. For example, the slots 254 may each extend at a common angle with respect to a radial direction. In such embodiments, slots 254 may be evenly spaced about the top surface 250 and may each be of the same length. In other embodiments, the slots 254 may not all extend at a common angle to the radial direction. At least one of the slots 254 (and perhaps all) may be disposed at a different angle to the radial direction. In some embodiments, the slots 254 may be relatively short, positioned about the periphery 340 of the top surface 250, and may be disposed within an outer region of the top surface 250 (see, e.g., FIG.22A). In other embodiments, slots 254 may extend across an outer region and intermediate region of the top surface 250 (see, e.g., FIG. 22B). In still other embodiments, slots 254 may extend from the outer region of the top surface and into a center region of the top surface 250 (see, e.g., FIG. 22C). The angled slots 254 may aid in lowering the amount of pressure needed to transition the delivery device 10 from a storage state to a delivery state. Positioning the slots 254 at a sharper angle with respect to the radial direction may generally lower this pressure. The width of the slots 254 may slightly decrease during at least a portion of the transition from the storage state to the delivery state.

[0317] In other embodiments, and referring primarily to FIG. 22E, at least one of the slots 254 may have a curvature. The curvature may be defined by a constant or variable radius. The curvature may only be present over a segment of the slot 254. In alternative embodiments, a slot 254 may include two or more sections which are angled with respect to one another. In the example embodiment shown in FIG.22E, four curved slots 254 are shown and are spaced apart at even angular increments. The slots 254 are arcuate and include a first end 258 and second end 260. Each example slot 254 is oriented so as to initially begin extending in a first direction from the first end 258 and curve so as to extend in a second direction as the slot 254 reaches the second end 260. The second direction may be closer to perpendicular (or may be perpendicular) to the radial direction than the first direction.Attorney Docket: 00101.00467.AB674WO

[0318] In some examples, and referring now primarily to FIG. 22D and FIG. 22F, the top surface may not include a slot 254 or slots 254 but may instead include at least one aperture 255. In the examples shown, the aperture 255 is disposed centrally within the top surface 250. The aperture 255 may extend over a minority or a majority of the top surface 250. In some embodiments, the aperture 255 may encompass nearly the entirety of the top surface 250.

[0319] As shown exemplarily in FIG. 22D and FIG. 22F, slots 254 may also be included in other regions of a main body 20. In the example embodiment, the region of the main body 20 which would become the supporting structure 252 (when the main body 20 is thermoformed) includes slots 254. These slots 254 may be straight, curved, angled (with respect to the radial dimension) or some mix thereof as with various top surface 250 slot 254 patterns described herein. As shown, the slots 254 are spaced at regular angular intervals and are spaced between petal members 42 of the main bodies 20.

[0320] 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 FIGS.22G-22I. The slots 254 may change in width in a continuous manner and may terminate with a pointed first or second end 258, 260. Variable width slots 254 may extend along a radial direction, though need not necessarily do so in all embodiments. In the example embodiments, each of the slots 254 are widest proximal to the center point 256 of the top surface 250 and continuously decrease in width as the slot 254 extend distally toward the periphery 340 of the top surface 250. Thus, each of the top surfaces 250 depicted in FIGS.22G- 22I have a sunburst type pattern of slots 254. In other embodiments, the slots 254 need not necessarily continuously increase or decrease in width from one end to the other.

[0321] Still referring to FIG. 23, the central region 28 may be monolithically formed with the petal members 42 comprising the regions between respective pairs of slots 36 (see also FIGS. 13-19 and the examples and embodiments described above with respect thereto). The supporting structure 252 may extend upward from the petal members 42 at a 90° angle or an angle greater than 90 degrees, e.g., 100-105 degrees, although the angle measure need not be limited to a range. The distance (vertically) from the base 262 of the supporting structure 252 to the periphery 340 of the top surface 250 may be long enough to provide a receptacle in the central region 28 for a reservoir 12 (see, e.g., FIG.75) and, in some embodiments, any packets 208 and / or containers 350 (see, e.g., FIGS. 11A-12), springs, or foam adhesive material. The receptacle may also be sized to house portions of an actuation assembly or dispensing assembly 480 (see, e.g., FIG. 37). As described in greater detail elsewhere herein, packets 208 may include gas bladders, butane packets, or delivery force supplying packets and any associatedAttorney Docket: 00101.00467.AB674WO containers 350 such those described above with respect to FIGS. 11A-12. In some embodiments the aforementioned distance may be approximately 0.3 inches (e.g.0.315in). The slots 36 may extend from the peripheral edge 38 of the delivery device 10 to the base 262 of the supporting structure 252, but may terminate at the base 262 and not extend into the supporting structure 252 itself. In such embodiments, rather than the entire central region 28 substantially inverting when pressure is applied from the top (e.g., by a finger), only the top surface 250 may invert, taking on a concave shape in the delivery state. The supporting structure 252 may in some embodiments include fenestrations 264 evenly spaced about the base 262. The fenestrations 264 may facilitate manufacturing of the delivery device 10 in embodiments in which the main body 20 is thermoformed.

[0322] In some embodiments and as shown in one example in FIG. 24, at least one of the petal members 42 may be made of an extended length such that an outward end of the petal member 42 may be operated by a patient or health care provider as a pull tab 266. The pull tab 266 may be grasped by a user to remove the delivery device 10 from the skin after use. The pull tab 266 may be of any suitable shape. In an example, the pull tab 266 is approximately semicircular in shape, with a first, rounded end and a second end opposite the first end, attached to a petal member 42. The second end may be attached or formed integral with the petal member 42 by injection molding or any other known technique that permits the pull tab 266 to be lifted sufficiently from the skin surface to be held by a user.

[0323] Referring now to FIG. 25, the pull tab 266 may also serve to facilitate a user peeling off a release liner 265 from the bottom of the delivery device 10 before the delivery device 10 is applied to the skin surface via an adhesive 22. A release liner 265 may be removed in a manner similar to how a release liner is peeled from a bandage before application to skin. An example delivery device 10 having a pull tab 266 and including release liner 265 and adhesive 22 is depicted in FIG. 25. The release liner 265 is exploded away from the adhesive 22 for illustrative purposes.

[0324] Referring now to FIGS.26-27, an example embodiment of a package 401 for a delivery device 10 is depicted. The delivery device 10 is depicted in place within the package 401 in FIG.26. The package 401 may include a first component 404 and a second component 406 (not shown in FIGS. 26-27, see, e.g., FIG. 130). The first component 404 may be a rigid component such as a plastic. The second component 406 may be a flexible component (e.g. EtOx permeable sheet) which may be peeled from the first component 404 to access the delivery device 10. The interior of the package 401 may be a protected environment (e.g. sterilized via EtOx or any other suitable manner) until the second component 406 is removedAttorney Docket: 00101.00467.AB674WO from the first component. The second component 406 may releasably couple to a rim 403 included on the first component.

[0325] The first component 404 may include one or more wells 405. The delivery device 10 may be disposed in one of the wells 405. The pull tab 266 of the delivery device 10 may project along a passage 407 connecting the two wells 405. To remove the delivery device 10 a user may reach into the well 405 unoccupied by the delivery device 10 to grasp a portion of the pull tab 266 extending into that well 405. The delivery device 10 may then easily be lifted out of the package 401 by pulling on the pull tab 266.

[0326] As shown in FIG.27, the liner 265 for the adhesive 22 (see, e.g., FIG.25) may be coupled to the surface of one of the wells 405. This may aid in limiting any movement of a delivery device 10 within a package 401 during transport and handling. As the delivery device 10 is removed, the liner 265 may remain behind in the package 401. Thus the delivery device 10 may be rendered ready for use when removed from a package 401. A cap or cover 409 (e.g. receptacle that surrounds the delivery sharp(s) 72) for the delivery sharp(s) 72 of the delivery device 10 may be included in some examples. The cover 409 may also be coupled to the package 401 and stay behind when the delivery device 10 is removed from the package 401. Again, this may aid in rendering a delivery device 10 ready for use when taken out of the package 401.

[0327] With reference to FIGS. 28-29 and FIGS. 31A-31B, in some embodiments, delivery devices 10 may include a central region 28 which is roughly thimble, or dome, shaped but has a relatively shorter height compared to certain other embodiments described herein. The distance (vertically) from the base 262 to the periphery 340 of the top surface 250 may be relatively shorter. In some embodiments, the aforementioned distance may be approximately 0.15 inches.

[0328] 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 FIG. 28, the delivery device 10 is shown in the storage state. The delivery device 10 may include slots 36 which may be disposed between the petal members 42 like other delivery device 10 embodiments described herein. An adhesive 22 (see, e.g., FIG.25) may be affixed to at least a part of at least two of the petal members 42.Attorney Docket: 00101.00467.AB674WO

[0329] As best shown in FIG.29, a perspective cross-sectional view of a main body 20 of a delivery device 10, the main body 20 may include an interior ridge 290. The ridge 290 may be disposed at the base 262 of the supporting structure 252. The supporting structure 252 may be thickened in a region near the base 262 so as to create the ridge 290. This may allow for the ridge 290 to be formed easily in, for example, an injection molding operation which forms the rest of a main body 20. This may also provide extra rigidity to the supporting structure 252. The ridge 290 may provide a step, ledge, or other mounting surface upon which a portion of a reservoir assembly 12 of a delivery device 10 may be mounted. Such a ridge 290 may be included in any of the delivery device 10 embodiments described herein. Reservoir assemblies 12 and ridges 290 are further described elsewhere in the specification. Any embodiments including ridges 290 may alternatively include retention tabs 580 and stop surfaces 582 such as those shown in FIGS.105-106B.

[0330] Referring now primarily to FIGS.30A-30B, two conceptual representations of a delivery device 10 transitioning from a storage state to a delivery state are shown. When the delivery device 10 is affixed to the skin with an adhesive 22 and pressure is applied to the delivery device 10 from above, e.g., by a user’s fingertip, the delivery device 10 may transition to a delivery state. When the petal members 42 are pushed against the surface of the skin, the petal members 42 may spreadingly displace outward and the skin and / or patient’s body may force at least a portion of the petal members 42 to curl upward. In turn, this may cause the skin to stretch as parts of opposing petal members 42, each affixed to the skin surface by adhesive 22 (only shown in FIG. 30A), move apart from one another or spreadingly displace. As the delivery device 10 transitions to a delivery state, at least a portion of each of the curved petal members 42 may curve further or with a tighter radius of curvature. When a delivery state is reached, the curvature of the petal members 42 may be such that they may extend from the base 262 to an inflection point 360. The inflection point 360 may fall in a plane spaced from that of the base 262 and in such embodiments may also be referred to as a lowest point. In such embodiments, the lowest point 360 may be in a plane more distal to the periphery 340 of the top surface 250 than the base 262. From the inflection point 360, the petal members 42 may curve back upward so as to become increasingly more proximal to the plane in which the periphery 340 of the top surface 250 is disposed. The peripheral edge 38 of the petal members 42 may, for example, be disposed at a point at or above (more proximal the plane of the periphery 340 of the top surface 250) the plane of the base 262. The petal members 42 may, though need not necessarily, each have a constant radius of curvature from the inflection point 360 to the peripheral edge 38. The constant radii curvature back upward may enhanceAttorney Docket: 00101.00467.AB674WO capability of the petal members 42 to curl upward. This may in turn enhance stretching of the skin of the user as points 360 on opposing petal members 42 (each affixed to the skin by adhesive 22) spreadingly displace. As mentioned elsewhere herein, the top surface 250 of the main body 20 may also invert as the delivery device 10 is transitioned to the delivery state 10.

[0331] In some non-limiting examples, a delivery device 10 may have dimensions and radii of curvature as shown in FIGS. 31A-31B when in a storage state. It is to be understood that the dimensions shown are merely exemplary. Other delivery devices 10 of different size and having the same proportions are possible and contemplated. Additionally, delivery devices 10 with different dimensions and proportions are possible and contemplated.

[0332] Referring to FIGS. 28-29 and FIGS. 31A-31B, in some embodiments, the supporting structure 252 may not include fenestrations 264 (see, e.g. FIG. 20) evenly spaced around the base 262. The main body 20 may be manufactured by injection molding. Those of skill would readily appreciate that other manufacturing techniques could be used. The main body 20 may be constructed of one monolithic piece of material such that the central region 28 and peripheral region 30 are integral with respect to each other. The main body 20 may be constructed of a polymer material. In some embodiments, the main body 20 may be a nylon material such as Nycoa 2012 nylon or other, similar nylon materials. In other embodiments the main body 20 may be made of a polypropylene material. The main body 20 may be manufactured of a material that serves to minimize water absorption, or a material that serves to maximize capacity to stick to an adhesive 22. A material that achieves both of these objectives to any desired degree for each may be selected. These materials may be used for any of the main bodies 20 described herein.

[0333] Still referring to FIGS.28-29 and FIGS.31A-31B, the top surface 250 may have a round footprint, e.g., be of roughly circular shape, and may be convex, forming a dome shape (including the periphery 340). The top surface 250 may include slots 254. The slots 254 may be cutouts, apertures, holes, openings, or voids in various embodiments. The slots 254 may extend radially with respect to a center point 256 of the top surface 250 such that their respective first endpoints 258 surround a region including the center point 256 of the top surface 250 and their respective second endpoints 260 may each terminate a distance (e.g., the slots 254 may each terminate the same distance) from the periphery 340 of the top surface 250. In certain embodiments, the slots 254 may be disposed at regular angular increments and each be of equal length (though this need not be true to all embodiments).

[0334] Still referring to FIGS.28-29 and FIGS.31A-31B and as described above with reference to FIG.23, the slots 254 could, in an alternative embodiment, be disposed such thatAttorney Docket: 00101.00467.AB674WO they do not extend radially with respect to the center point 256. For example, the slots 254 may each extend at a common angle with respect to the radial direction. In such embodiments, slots 254 may be evenly spaced about the top surface 250 and may each be of the same length. In other embodiments, the slots 254 may not all extend at a common angle to the radial direction. At least one of the slots 254 (and perhaps all) may be disposed at a different angle to the radial direction.

[0335] Referring now primarily to FIGS. 32-36, a number of views of a conceptual representation of a delivery device 10 in a delivery state are shown. As described above (and also with reference to the embodiments of FIGS. 13-21), the delivery device 10 may, upon downward pressure being applied to the top surface 250, transition from a storage state to a delivery state in which the main body 20 of the delivery device 10 is substantially, or at least partially, inverted. A user may remove an adhesive liner 265 (see, e.g., FIG. 25) from the delivery device 10 and apply the delivery device 10 to the skin. The user may then press downward (i.e., toward the skin) on the top surface 250. This may cause the petal members 42 to spreadingly displace outward and curl upward (over at least a portion thereof), stretching the skin. The top surface 250 may invert, driving delivery sharp(s) 72 into the skin, and remain inverted when the delivery device 10 attains the delivery state. The peripheral region 20 may also take on an inverted shape due to the curling of the petal members 42.

[0336] 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., FIG. 20 or FIG. 28) may also be a resilient region. Thus, certain delivery devices 10 may include a main body 20 with invertible regions which are separated from one another by a resilient region.

[0337] Still referring to FIGS. 32-36, the reservoir 12 may be formed as an assembly and may include a reservoir portion 271 and a holder 270 (described in greater detail below with reference to FIGS.50A-76B). A reservoir 12 may be compressed and / or at least partially collapsed so as to deliver a medical agent contained therein when the delivery device 10 is transitioned to the delivery state. The user may then remove the delivery device 10 from the skin. The slots 254 may aid the delivery device 10 to transition from the storage state to theAttorney Docket: 00101.00467.AB674WO delivery state with reduced pressure from above. The fenestrations 34 may also facilitate the transition. As described above with reference to the embodiments of FIGS. 13-21, there may be room in the central region 28 for a reservoir 12 and sharp bearing body 26 (see additional description with reference to the embodiments of FIGS.13-21 and FIGS. 50A-76B). In some embodiments, packets 208 and / or containers 350 (see, e.g., FIGS. 11A-12) and / or foam adhesive material may also be housed within the central region 28. As described in greater detail elsewhere herein, packets 208 may include gas bladders, butane packets, or delivery force supplying packets and any associated containers 350 such as those described above with respect to FIGS.11A-12. In some examples, one or more petal members 42 may be constructed to incorporate a pull tab (not shown in FIGS.32-36) such as the pull tab 266 described above with reference to FIG.24.

[0338] Referring now to FIG.37, a block diagram of an exemplary delivery device 10 is depicted. As shown, the delivery device 10 may include a main body 20 and a reservoir 12. The delivery device 10 may also include one or more bias member 470. The one or more bias member 470 may be included as part of a dispensing assembly 480 included in a delivery device 10. The dispensing assembly 480 may aid in applying pressure to the reservoir 12 and aid in expelling fluid from the reservoir 12 over the course of the injection. In some embodiments, the dispensing assembly 480 may include a depressor body 472 which may be coupled to or associated with the at least one bias member 470. The depressor body 472 may include or be coupled to (perhaps indirectly via the bias member 470) a reservoir interface member 474 which may also form part of a dispensing assembly 480 of a delivery device 10. In certain examples, a reservoir interface member 474 may be omitted and the bias member 470 may directly contact the reservoir 12.

[0339] In some 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 collapseAttorney Docket: 00101.00467.AB674WO 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).

[0340] 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.

[0341] Referring now to FIGS.38-39, a representational example of a delivery device 10 which includes a bias member 470 that is unstressed in the storage state is depicted. The delivery device 10 may include a main body 20 and a reservoir 12 as with various other delivery devices 10 described above. As shown, the depressor body 472 of the dispensing assembly 480 may include an elongate member 476 such as a pin which may extend through the top surface 250 of the main body 20. In some embodiments, the elongate member 476 may include a head 478 or other surface at a distal end of the elongate member 476. The head 478 may include a rounded or tapered portion to aid in passing the head 478 though an aperture in the main body 20 during assembly. Opposite the tapered or rounded portion, the head 478 may define a step or ledge. The ledge of the head 478 may limit displacement of the elongate body 476 as the ledge may be unable to easily pass back through the aperture in the main body 20. An end of the elongate member 476 opposite the head 478 may couple to one or more bias member 470. The reservoir interface member 474 may be coupled to the one or more bias member 470 such that the one or more bias member 470 is disposed intermediate the elongate member 476 and the reservoir interface member 474. In the example embodiment, the one or more bias member 470 is depicted as a set of bow springs though any suitable number of bow springs may beAttorney Docket: 00101.00467.AB674WO used. In alternative embodiments, other bias members 470 may be used (e.g. resilient foam, coil spring, air bladder, rubber body, elastomeric body, etc.).

[0342] 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.

[0343] 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., FIG. 32). This is not depicted in FIGS. 38-39 for ease of illustration.

[0344] Referring now to FIGS. 40-41, in certain embodiments, a delivery device 10 may include a bias member 470 which is in a stressed state while the delivery device 10 is in a storage state. As shown in FIG. 41, a bias member 470 (depicted in an unstressed state) may include a peripheral body 490. The peripheral body 490 may for example, be annular in shape though any suitable shape may be used. A number of bias projections 492 may extend from the peripheral body 490 toward the center of the bias member 470. The bias projections 492 may extend radially inward toward the center of the bias member 470 from the peripheral body 490. In the example embodiment, the bias projections 492 may be spaced at even angular increments though need not be in all embodiments. The peripheral body 490 may be constructed of any suitable material and in some examples, may be a resilient plastic or a spring steel.

[0345] 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. FIG.28) of the main body 20.

[0346] Referring now also to FIGS. 42-44, the delivery device 10 may include a depressor body 472. In the example shown, the depressor body 472 includes a reservoirAttorney Docket: 00101.00467.AB674WO interface member 474 at a proximal end thereof. The depressor body 472 may be rotationally displaceable within an aperture 496 in the main body 20. The aperture 496 may be disposed in the top surface 250 of the main body 20 as shown in FIG.42 for instance. The depressor body 472 may be rotated from a translational displacement constraining position or range of positions (see, e.g., FIG. 42) to a translational displacement permitting position or range of positions (see, e.g., FIG 41). In a translational displacement constraining position, a retention element of the depressor body 472 may be in engagement with a cooperating lock defined in the main body 20. In a translational displacement permitting position the retention element of the depressor body 472 may be disengaged with the lock of the main body 20.

[0347] As best shown in FIG. 44, the exemplary depressor body 472 includes a stem 500 which extends through the aperture 496 in the main body 20 of a delivery device 10. The stem 500 may include a set of notches 498 or other recess(es) which each may serve as a retention element. The cross-sectional shape of the stem 500 may not be circular or a regular polygon. Thus, one of the width and length dimension of the cross-sectional shape of the stem 500 may be shorter than the other. In the example embodiment, the cross-sectional shape of the stem is an obround shape. Other cross-sectional shapes may be used in alternative examples. The notches 498 may be disposed so as to be recessed into the widest portion of the stem 500. The aperture 496 (see, e.g., FIG. 40) may have a shape which corresponds, though may be slightly larger than, the shape of the stem 500 cross-section. The notches 498 may be recessed to a depth such that when level with the wall of the main body 20 in which the aperture 496 is formed, the depressor body 472 may be rotated within the aperture 496.

[0348] The depressor body 472 is shown in a translational displacement constraining position in FIG.42. In such a position, the rotational orientation of the depressor body 472 may be such that the notches 498 may overhang a portion of the main body 20 in which the aperture 496 is defined. As a result, the main body 20 may present a mechanical interference to translational displacement of the depressor body 472. Thus, the region of the main body 20 adjacent the aperture 496 may act as a lock for the depressor body 472. As shown in FIG.43, when the depressor body 472 is rotated to a translational displacement permitting position, the rotational orientation of the depressor body 472 may be such that it may translationally displace within the correspondingly shaped aperture 496 of the main body.

[0349] Referring now also to FIG.45 and FIG.46, the depressor body 472 may include an enlarged portion 502. The reservoir interface member 474 may form a proximal region of the enlarged portion 502. When a delivery device 10 is assembled, the bias projections 492 of the bias member 470 may press upon the enlarged portion 502 capturing or coupling theAttorney Docket: 00101.00467.AB674WO enlarged portion within the bias projections 492. Additionally, the bias member 470 may be substantially constrained from displacing as a whole since the bias projections may be fed through passages 494 in the main body 20. With the bias member 470 constrained in place, lifting of the depressor body 472 may cause the bias projections 492 to deflect and become stressed. Once the depressor body 472 has been lifted such that the notches 498 are even with the portion of the main body 20 in which the aperture 496 is defined, the depressor body 472 may be rotated to a translational displacement constraining position (see, e.g., FIG.42). Thus, the bias member 470 may be held in a stressed state.

[0350] 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.

[0351] Referring now to FIGS.47A-47D, in some examples, a bias member 470 for a delivery device 10 may be entirely internal to the delivery device 10. Additionally, the depressor body 472 may not latch or engage with a portion of the main body 20 to inhibit translation of the depressor body 472. In some examples of such embodiments, a stop member 473 may be included with the delivery device 10. The depressor body 472 may include a recess 475 (or alternatively set of notches 498, see, e.g., FIG. 44) which may engage with the stop member 473 instead of the main body 20. As best shown in FIG. 47B, the stop member 473 may include an aperture 496’ which may have a shape which corresponds, though may be slightly larger than, cross-sectional shape of the stem 500 of the depressor body 472. The recess(es) 475 may be recessed to a depth such that when level with the aperture 496’, the depressor body 472 may be rotated within the aperture 496’.

[0352] 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 mechanicalAttorney Docket: 00101.00467.AB674WO 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.

[0353] Referring primarily to FIG. 47C and FIG. 47D, the bias member 470 may be a conical spring. The conical spring may be in a stressed (e.g. compressed state) when a delivery device 10 is in a storage state and the stop member 473 is in a translational displacement constraining position. When the stop member 473 is moved to the translational displacement permitting position, the bias member 470 may be free to drive displacement of the depressor body 472 against the reservoir 12 as described above with respect to FIGS. 45-46. As the depressor body 472 is displaced via relaxation of the bias member 470, the stem 500 of the depressor body 472 may fully pass through the aperture 496’ of the stop member 473. The stop member 473 may thus be disassociated from the rest of the delivery device 10. The depressor body 472 may also translate to a position in which the recess(es) 475 are internal to the delivery device 10. Thus, the stop member 473 may be inhibited from being recoupled to the depressor body 472. When a delivery device 10 is observed absent a stop member 473, it may provide a visual cue that the particular delivery device 10 has already been used. Thus, the stop member 473 may also serve as an indicator which conveys that a particular delivery device 10 is available for use.

[0354] Referring now to FIG.48, a block diagram of another exemplary delivery device 10 is depicted. As shown, the delivery device 10 may include a main body 20 and a reservoir 12. The delivery device 10 may also include one or more bias member 470. The one or more bias member 470 may form the entire dispensing assembly 480. The one or more bias member 470 may directly contact the reservoir 12 and may aid in applying pressure to the reservoir 12 in order to deliver fluid out of the reservoir 12. In certain examples, a reservoir interface member 474 (see, e.g., FIG. 37) may be included. Where included, the reservoir interface member 474 may (though need not necessarily be) be formed as a part of the at least one bias member 470 and may be integral therewith. The reservoir interface member 474 may directly contact the reservoir 12. The at least one bias member 470 may be or include a spring, compression spring, conical spring, resilient foam, air bladder, rubber body, elastomeric body, any other suitable bias member, or some combination thereof.Attorney Docket: 00101.00467.AB674WO

[0355] Still referring to FIG. 48, the bias member 470 may be in an unstressed state when the associated delivery device 10 is in a storage state. No pressure may be applied to the reservoir 12 in the storage state. In certain examples, the at least one bias member 470 (and optionally any reservoir interface member 474) may be entirely out of contact with the reservoir 12 in the storage state (e.g. by .05-2mm). Alternatively, the bias member 470 may contact, but not press against the reservoir 12. When the delivery device 10 is used, the delivery device 10 may be transitioned to the delivery state as described elsewhere herein. As with various embodiments discussed herein, when transitioned to a delivery state, at least a portion of the delivery device 10 may at least partially invert. For example, at least the domed top surface 250 of the central region 28 may invert or partially invert. The distance between the reservoir 12 and the inverted top surface 250 in the delivery state may be less than the distance between the reservoir 12 and the top surface 250 in the storage state. This may in turn cause a bias to be stored in the bias member 470. The at least one bias member 470 may, in the example, be compressed when the top surface 250 is inverted. Additionally, where the at least one bias member 470 is spaced from the reservoir 12 in the storage state, the at least one bias member 470 or reservoir interface member 474 (which may be a part of the bias member 470) may be displaced into contact with the reservoir 12. The inverted top surface 250 may be sufficiently strong in the inverted state to withstand any force exerted by the at least one bias member 470. As the at least one bias member 470 restores, the at least one bias member (and / or reservoir interface member 474 if included) may press 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 still applied to the reservoir 12 over a period of time sufficient to fully deliver contents of the reservoir 12 (e.g. five minutes in certain embodiments).

[0356] Referring now to FIGS.49A-49B, an example embodiment of a main body 20 and a main body 20 with a bias member 470 are respectively shown. FIG.49A depicts a bottom plan view of the main body 20. FIG. 49B depicts a perspective view of the main body 20 and bias member 470. The main body 20 is shown with the top surface inverted for illustrative purposes. As shown, the main body 20 may include a number of locating projections 471. In alternative embodiments, the locating projections 471 may be replaced with a round or annular locating wall. There may be a set of locating projections 471 which are disposed in a center region of the top surface 250. A second set of locating projections 471 may be spaced outwardly from the center region may optionally be included. In the example embodiment, the second set of locating projections 471 extend from the top surface 250. In other examples, locationAttorney Docket: 00101.00467.AB674WO projections 471 may extend radially inward from the supporting structure 252 of the central region 28. An end of the bias member 470 may be centered by the locating projections 471 as the bias member 470 is placed into the delivery device 10 assembly. In certain examples, the end of the bias member 470 may be coupled into place. For example, the end of the bias member 470 adjacent the top surface 250 may be heat staked once the bias member 470 is properly positioned (see, e.g., FIG. 49C). When the delivery device 10 is fully assembled, the heat stake may retain the bias member 470 in place against the main body 20. As a result, the bias member 470 may be held out of contact with the reservoir 12 until the delivery device 10 is transitioned to the delivery state. The locating projections 471 may also aid in ensuring that the bias member 470 transitions to the stressed state in a desired manner. For example, where a compression spring is used, the second set of locating projections 471 may constrain the bias member 470 such that the bias member 470 is compressed substantially along the axis of the bias member 470.

[0357] Referring now also to FIG. 49C, in some examples, the bias member 470 may be constrained from displacement by one or more guide body 477. The one or more guide body 477 may extend from the supporting structure 252 of the central region 28 of the main body 20 toward the axis of the bias member 470. In the example shown in FIG.49C, four guide bodies 477 are included and are spaced at even angular increments. In other embodiments, the number of guide bodies 477 may differ and / or the guide bodies 477 could be irregularly spaced. The guide bodies 477 may aid in ensuring that the bias member 470 compresses substantially along its axis and may help inhibit tilting of the bias member 470 during use of a delivery device 10.

[0358] Still referring to FIGS. 49A-C, where the bias member 470 is a compression spring, a terminal end 481 of the bias member 470 may form a reservoir interface member 474. The terminal end 481 bias member 470 may be routed in a manner which helps spread pressure more uniformly over the reservoir 12. The terminal end 481 of the bias member 470 may be routed in a direction or desired pattern. The terminal end 481 may also be disposed substantially within a plane disposed even with or adjacent an end of the bias member 470. In the example embodiment in FIG. 49B, the terminal end 481 of the coil is bent so that it extends between opposing points on the bias member 470. In the example, the terminal end 481 extends substantially diametrically across the end of the bias member 470 proximal the reservoir 12. In other embodiments, the terminal end 481 of the bias member 470 may be routed in a spiral or other pattern (see, e.g., FIG.49C).

[0359] Referring now to FIGS.50A-50B, in other examples, the bias member 470 may be block of compressible material such as rubber or elastomer. The surface of the bias memberAttorney Docket: 00101.00467.AB674WO 470 adjacent the reservoir 12 may serve as the reservoir interface member 474 and may be substantially flat or planar in certain embodiments. Thus, various delivery devices 10 may include a reservoir interface member 474 which is compliant. The delivery device 10 depicted in FIGS.50A-50B is shown in a storage state. As shown, the delivery device 10 may include a depressor body 472 which may be coupled to the top surface 250 of the main body 20. The top surface 250 of the main body 20 may have an infundibuliform or trumpet shape when in the storage state in certain examples. Such top surfaces 250 may be included in various other embodiments described herein. As shown, the depressor body 472 includes a post 469. The post 469 may extend through and be coupled to the top surface 250 (e.g. via a heat stake, adhesive, a dogged central aperture 459, etc.). The depressor body 472 may further include a dish body 467 coupled to the post 469. The dish body 467 may be disposed above the top surface 250 of the main body 20. The dish body 467 may provide an ergonomic location for a user to press against when transitioning the delivery device 10 to the delivery state. When the delivery device 10 is transitioned to the delivery state, top surface 250 may substantially invert and the bias member 470 may be compressed against the reservoir 12. This may urge fluid to be dispensed from the reservoir 12. In some embodiments, the bias member 470 may be coupled to an end of the post 469 opposite the dish body 467. For example, the bias member 470 may include a receiving recess 465 (see, e.g., FIG.51) into which the end of the post 469 may be mated. Though a dish body 467 in the form of a concave dish is depicted, a dish like body need not be included in all embodiments. For example, the dish body 467 may be replaced by a relatively planar body or plate in certain embodiments.

[0360] Referring now to FIG. 51, an exploded view of a delivery device 10 similar to that illustrated in FIG.50B is depicted. As shown, some delivery devices 10 may include a bias member 470 which changes in width along its height dimension and is constructed of an elastomeric material such as a silicone material. For example, the bias member 470 may be tiered. In the example shown, the bias member 470 includes two tiers. Additionally, the bias member 470 may include one or more hollow region. In the example embodiment, the bias member 470 includes a plurality of passages 463 which extend through the bias member 470 to form hollow regions. The passages 463 may extend through at least one of the tiers and in the example embodiment, both are disposed in the first or base tier of the bias member 470. The passages 463 may be evenly spaced about the bias member 470 and are disposed such that the bias member 470 has a plane of symmetry in the example shown. As noted above, when the top surface 250 of the main body 20 is transitioned from its storage state position to the delivery state position, the bias member 470 may become compressed. Fluid may be driven outAttorney Docket: 00101.00467.AB674WO of the reservoir 12 as the bias member 470 restores to a less compressed state. The passages 463 may make the initial application of force by the bias member 470 against the reservoir 12 more gentle and less abrupt. This may make reservoirs 12 more robust during use while still ensuring reservoirs 12 are substantially emptied during delivery.

[0361] Referring now also to FIGS. 52A-53, various views of a main body 20 and a depressor body 472 are shown. The depressor body 472 of the delivery device 10 may include a dish region 467’ from which a skirt 461 extends. The skirt 461 may include a set of ears 457 extending outwardly therefrom such as those shown in FIG. 51. Any ears 457 may be spaced at regular angular intervals. The dish region 467 may be shaped similar to dish bodies 467 described elsewhere herein. The skirt 461 may be sized to nest over the supporting structure 252 of the main body 20 when the delivery device 10 is transitioned from the storage state (FIG. 52A) to the delivery state (FIG. 52B). Thus, the supporting structure 252 may act as a guide which helps inhibit tilting of the depressor body 472 and assists in ensuring that the depressor body 472 displaces substantially along an axis as pressure is applied. When transitioned fully to the delivery state, the end of the skirt 461 opposite the dish region 467’ may be near the petal members 42, but sufficiently spaced from the petals members 42 so as not to restrict movement of petal members 42. As shown best in FIG. 53, the depressor body may include a post 469. The post 469 may extend through a dogged aperture 459 in the central portion of the top surface 250 of the main body 20. As the depressor body 472 is pulled in a direction away from the main body 20, the dogs of the dogged aperture 459 may pivot and bite into the post 469 inhibiting the depressor body 472 from being disassociated from the rest of the delivery device 10. When the delivery device 10 is assembled, the post 469 may project into the receiving recess 465 in the bias member 470.

[0362] In some embodiments, as shown in FIGS. 54A-D (respectively a perspective view from the top, view from the side, perspective view from the bottom, and view from below, relative to an application surface for a delivery device 10 such as the skin surface), an example holder 270 for a sharp bearing body 26 (see, e.g., FIG.34) including delivery sharp(s) 72 (see, e.g., FIG. 34), may be formed as an annulus or annular body 272 integral with a rounded depression 274. The rounded depression 274 may be centrally disposed. In one example, the rounded depression 274 may have the shape of a spherical segment. The annulus 272 may have an inner edge, and the rounded depression 274 may have a perimeter. The inner edge of the annulus 272 may be coincident to the perimeter of the rounded depression 274. When a delivery device 10 incorporating a holder 270 is affixed to the skin surface of a user, the roundedAttorney Docket: 00101.00467.AB674WO depression 274 extends below the plane of the annulus 272 (see FIG. 54B). Thus the rounded depression 274 may also form a bump extending proud of the proximal face of the holder 270.

[0363] 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 (e.g. in the bump). 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 FIG. 34. The sharp bearing body 26 including delivery sharp(s) 72 may be mated into the pocket 276 by, e.g., injection molding or adhesive. The holder 270 may be over molded around the sharp bearing body 26 so as to couple the components together. In various embodiments, the delivery device 10 may be arranged such that pressure from above (e.g., from a finger) on the delivery device 10 may be distributed evenly over the area of the holder 270. In some embodiments, the depression 274 may act as a force concentrating protuberance from the holder 270 which serves to ensure force applied to a delivery device 10 is concentrated upon the delivery sharp(s) 72 aiding in insertion of the delivery sharp(s) 72 into the skin.

[0364] 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.

[0365] Another exemplary holder 270 is depicted in FIGS. 55A-55C. As shown, a holder 270 may include a disk body 275. The disk body 275 may be substantially flat and may include a number of peripherally disposed tab projections 277. The tab projections 277 may be symmetrically disposed about the disk body 275 and may be spaced at regular angular intervals as shown in FIGS. 55A-55C. In alternative embodiments, the tab projections 277 may be asymmetrically disposed about the base or disposed at irregular angular intervals. The tab projections 277 may engage with receiving slits 278 (see, e.g., FIG. 47A) disposed in a main body 20 of a delivery device 10. Thus, the tab projections 277 may be used to couple the holder 270 into place in a delivery device 10. Asymmetric or irregularly spaced tab projections 277 may allow for the holder 270 to be coupled to a main body 20 in a prescribed orientation which may be desirable in some examples.

[0366] Still referring primarily to FIGS. 55A-55C, a holder 270 may include at least one stage projection 279. The stage projection 279 may be included in addition or instead ofAttorney Docket: 00101.00467.AB674WO the rounded depression 272 and spherical segment of the embodiment described above in relation to FIGS.54A-54D. The stage projection 279 may provide a well 281 on the distal side of the disk body 277. The stage projection 279 may extend proud of the proximal side of the disk body 277 by a height which may, in certain examples, be at least equal to the height of a microneedle (e.g. 600 microns) of the delivery device 10. The stage projection 279 may generally extend from the disk at a perpendicular angle. The side walls 283 of the stage projection 279 may be chamfered so as to extend in a non-perpendicular direction with respect to the proximal face of the disk body 279. The stage projection 279 may include a pocket 276. The pocket 276 may be sized to fit and accept a sharp bearing body 26 with delivery sharp(s) 72 thereon as described elsewhere herein.

[0367] Referring now to FIGS.56A-56D, in some embodiments, the pocket 276 of the stage projection 279 may be in a non-parallel orientation with respect to the plane of the disk body 275. As best shown in FIG.56D, when a sharp bearing body 26 is mounted to the pocket 276, the orientation of the pocket 276 may ensure that the delivery sharp(s) 72 (e.g. microneedles) extend at a prescribed angle with respect to the disk body 275. In the example embodiment, the pocket 276 may be oriented such that the delivery sharp(s) 72 extend at a 10- 20° angle (e.g. 15°) with respect to a plane perpendicular to the disk body 275. In other embodiments, the pocket 276 may be oriented such that the delivery sharp(s) 72 project at a 45° or 60° angle or some angle therebetween. Any suitable angle may be used. In alternative embodiments, the entire stage projection 279 may project at the desired angle from the disk body 275. Thus, the delivery sharp(s) 72 may extend at that angle when coupled to the pocket 276.

[0368] The sharp bearing body 26 may be coupled to any of the holders 270 described herein during a molding operation or via an adhesive. Sharp bearing bodies 26 may be coupled to any of the holders 270 described herein during a molding operation or via an adhesive. Where the sharp bearing body 26 is joined to any of the holders 270 described herein during molding, some material may be molded up the sidewalls 27 of the sharp bearing body 26 and over onto the face of the sharp bearing body 26 from which the delivery sharp(s) 72 project to capture the sharp bearing body 26. In alternative embodiments, the sidewalls 27 of the sharp bearing body 26 may be chamfered or at an angle which is not perpendicular to the face of the sharp bearing body 26 from which the delivery sharp(s) 72 extend. The footprint or cross- section of the sharp bearing body 26 may increase in area as distance from the sharp bearing face of the sharp bearing body 26 increases. Where the delivery sharp(s) 72 are silicon, a number of sets of delivery sharp(s) 72 may typically be formed on a large wafer and sharpAttorney Docket: 00101.00467.AB674WO bearing bodies 26 including the desired number of delivery sharp(s) 72 may be diced out of the wafer. To form the chamfered sidewalls 27, the dicing saw may have angled faces such that dicing process creates the desired chamfer or angle on the sidewalls 27. In certain embodiments, sidewalls 27 which are between 30-60° (e.g. 45°) may be used. Where chamfered sidewalls 27 are present, material may be molded up only a portion of the sidewall 27 to couple the sharp bearing body 26 to a holder 270. This may allow for a sharp bearing body 26 to be captured in a holder 270 (or any other molded component, e.g., a part of a delivery implement or an adapter for a syringe or other delivery implement which couples to that delivery implement via a luer lock or the like) without material being molded over onto the sharp bearing face of the sharp bearing body 26 (though this could optionally be done). Thus no molded material may act as a stand-off on the sharp bearing face blocking the full height of any delivery sharp(s) 72 from penetrating into the skin. Description in relation to a holder 270 may be generalized to other components and discussion of the holder 270 is merely exemplary.

[0369] In certain examples, and referring now to FIGS.57-61, the peripheral region of a sharp bearing body 26 may be formed in a series of material removal operations. Where the sharp bearing body 26 is constructed of silicon, the sidewall 27 may be formed by dicing, etching, or some combination thereof. The sidewall 27 of the sharp bearing body 26 may include a number of regions which may be some combination of straight regions where the cross-sectional area of the sharp bearing body 26 is constant and chamfered or angled regions over which the cross-sectional area varies. In some embodiments, the sidewall 27 may be tiered and have a stepped appearance with one or more plateau regions. Such sidewalls 27 may make a sharp bearing body 26 amenable to being coupled into a component via molding without material being molded over onto the sharp bearing face. Such sidewalls 27 may also allow for more versatility in molding. For example, materials with a larger variety of shrinkage values after molding may be used to construct a holder 270 or other component (e.g. syringe adapter) to which a sharp bearing body 26 is to be coupled. Sharp bearing bodies 26 with such sidewalls 27 may be particularly robust against stress due to shrinkage loading during molding. Additionally, such sharp bearing bodies 26 may accommodate greater ejection loading when the molded component is ejected from the mold cavity. Sharp bearing bodies 26 with such sidewalls 27 may also facilitate creation of high quality, fluid tight interfaces between overmolded material and sharp bearing body 26 material. Such sidewalls 27 may increase the pressure at which an overmolded component such as a holder 270 or other component remains leak proof. Stepped sidewalls 27 may also help facilitate flow of injection molding materialAttorney Docket: 00101.00467.AB674WO into cracks which may be formed in sharp bearing bodies 26 during handling by automation equipment and thus assisting in limiting rejection percentage.

[0370] In some examples, at least two sets of dicing cuts may be made to form the sidewalls 27 of the sharp bearing body 26. The sidewalls 27 may include a chamfered section extending from the sharp bearing face of the sharp bearing body 26 (see, e.g., FIG. 58). The chamfered section may be formed by a first set of cuts and may be oriented such that the cross- sectional area of the sharp bearing body 26 decreases as proximity to the sharp bearing face increases. The sidewalls 27 may also include a straight region where the cross-sectional area of the sharp bearing body 26 is substantially constant. The straight region of the sidewall 27 may be formed in a second set of dicing cuts and may define the remainder of the sidewall 27. In some embodiments, the sidewall 27 may include two straight regions and an intermediate chamfered region (see, e.g., FIG.59). The straight regions of the sidewalls 27 may respectively be adjacent the sharp baring face and the opposing face of the sharp bearing body 26. A set of angled dicing cuts may be made to form the intermediate section and a second set of dicing cuts may be made to cut back a segment of the resulting chamfered face to form a straight region. The second straight region may be created with another set of dicing cuts. In alternative examples, at least one of the straight regions of the sidewall 27 may be a precision sidewall segment as described below.

[0371] In still other embodiments, and referring now to FIG. 61, the chamfer may be replaced by a stepwise change in cross-sectional area of the sharp bearing body 26. The stepwise change may be provided such that the footprint or cross-sectional area of the sharp bearing body 26 increases as distance from the sharp bearing face of increases. In some examples, the stepwise change in height may be created with a series of dicing cuts. One set of cuts may form a partial cut through the wafer material while another set of cuts may singulate each sharp bearing body 72 from the rest of the wafer. When forming the holder 270, material may be molded over the larger cross section portion of the sharp bearing body 26 and onto the step intermediate the large and small cross-sectional area portions of the sharp bearing body 26. Thus, the larger cross-sectional area region of the sharp bearing body 26 may be encased in the holder 270 (or other component) material and a portion of the peripheral side wall most proximal the sharp bearing face of the sharp bearing body 26 may be only partially covered. Alternatively, the peripheral sidewall may be covered to a height even with the sharp bearing face. As shown in FIG.60, in some examples there may be a small chamfer or radiused region where the step transitions to the sidewall 27 for the smaller cross-sectional area portion of the sharp bearing body 26. Such a step may be created by a dicing saw. Though described as aAttorney Docket: 00101.00467.AB674WO chamfer or radiused region any shape created by the dicing saw kerf may be present. The chamfer or radiused region may only be present for a fraction of the height of the smaller cross- sectional area region of the sharp bearing body 26 (e.g. less than 50% or less than 25%).

[0372] Referring primarily to FIG.61, in various examples, the height of the large and small cross-sectional area portions of the sharp bearing body 26 may be substantially equal. The small cross-sectional area portion of the sharp bearing body 26 may be at least 50% of the height of the sharp bearing body 26. The width of the step between the large cross-sectional area portion of the sharp bearing body 26 and the small cross-sectional area portion of the sharp bearing body 26 may be less than the height of the small or large cross-sectional area portion of the sharp bearing body 26. In some embodiments, the width of the step may be no more than 50% of the height of the small cross-sectional area portion of the sharp bearing body 26. The width of the step may be greater than 50% of the height of the small cross-sectional area of the sharp bearing body 26 in other embodiments. In other examples, the width of the step may be at least 100% of the height of the small or large cross-sectional area portion of the sharp bearing body 26. The width of the step may be the same on each side of the sharp bearing body 26, though may differ in alternative examples. In some embodiments, the width of the step may be the same for each opposing side of the sharp bearing body 26.

[0373] Though sharp bearing bodies 26 described above may be particularly amenable to being attached to a holder 270 (or other component) via overmolding, sharp bearing bodies 26 may also be attached to a holder 270 (or other component) in other suitable manners. For example, sharp bearing bodies 26 described herein may be coupled to a holder 270 (or other component) via swaging (e.g. heat swaging or laser swaging operation).

[0374] Referring now to FIG. 62A-62C, a view of a backside and two cross-sectional views of a sharp bearing body 26 coupled to a holder 270 via injection molding are respectively depicted. While material may be molded over a chamfered or stepped portion (or both) of the sidewall 27 of a sharp bearing body 26, it may also be desirable that material is also molded over a portion of the rear face of sharp bearing body 26. As shown, in some examples, material may be permitted to flow at least over the peripheral edges of the rear face of the sharp bearing body 26 to create a frame 161 over the rear face. In some embodiments, material for the frame 161 may be allowed to flow over other regions of the rear face (and perhaps a majority of the rear face), but be blocked from reaching the lumens 126 of the sharp bearing body 26. This may be accomplished by including a shutoff in the mold for the holder 270 (or other component) which obstructs flow of material over portions of the rear face which are desired to be bare. Including some compliance (see, e.g., compliant member 865 of FIG. 64) in theAttorney Docket: 00101.00467.AB674WO portion of the mold 860 including the shutoff may be desirable as it may aid in maintaining the integrity of the sharp bearing body 26 during the molding operation. By embedding a section of the sidewall 27 and portion of the rear face of the sharp bearing body 26 in the molded material, a sharp bearing body 26 may be robustly retained in a holder 270 or other component. Additionally, the interface between the sharp bearing body 26 and the holder 270 or other component may be leak resistant up to relatively high pressures.

[0375] Where sharp bearing bodies 26 are singulated from a wafer in a series of material removal operations, the manner in which the material is removed may be leveraged to assist in placement of the sharp bearing body 26 into a mold cavity. It may be desirable to have features on the sidewalls 27 which are positionally defined with a high degree of precision (+ / - 1-3 microns). These features may be referred to as precision sidewall segments. Such segments may allow for automation equipment to place a sharp bearing body 26 substantially blindly into a target destination in a mold cavity. This may be particularly important where the vision system’s field of view is obstructed by the sharp bearing body 26 and / or end effector holding the sharp bearing body 26 when the sharp bearing body 26 is placed. The precision sidewall 27 segments may allow the sharp bearing body 26 to be in a highly know position relative to the automation equipment. Inclusion of precision sidewall segments may decrease time required to place the sharp bearing body 26 in a mold cavity. In such examples a portion of the sidewall 27 of a sharp bearing body 26 defining a substantially constant cross-section portion of the sharp bearing body 26 may be formed via an etching process. For example, a highly anisotropic etch such as a deep reactive ion etch may be utilized to form a portion of the sidewall 27 for the sharp bearing body 26. A second portion or portion(s) of the sidewall 27 may be formed in a set of dicing cuts which may be used to singulate the sharp bearing body 26 from the wafer. In some examples precision sidewall 27 segments may form the bounds of a constant cross- sectional area portion of the sharp bearing body 26 on two opposing sides of the sharp bearing body 26. The remainder of the sidewalls 27 may be formed via dicing. Additionally, etched side wall 27 portions may allow for sidewalls 27 which are defined (at least in part) by non- straight line segments. In some examples, only a small portion of the sidewall 27 may be etched. For example, for each sharp bearing body 26 which is to be individualized from a larger wafer, at least one passage may be etched through (or at least partially through) the wafer material in a precise position. The position chosen for the hole may ensure that a portion of the hole forms a section of the sidewall 27 of the sharp bearing body 26 when the sharp bearing body 26 is diced from the wafer. There may for example be sidewall 27 portions defined by remnants of holes on at least two opposing sides of a sharp bearing body 26. Two such precisionAttorney Docket: 00101.00467.AB674WO sidewall 27 segments defined by hole remnants may be included on each of the opposing sides in certain non-limiting examples. Thus, the small divot or notch (e.g. a semi-circle or half- moon shape) in the sidewall 27 may act as a precision sidewall 27 segment which may assist in automated placement of the sharp bearing body 26 into other equipment (e.g. molds).

[0376] As mentioned above in relation to FIGS.6A-6B, certain delivery sharps 72 may be formed with vertical faces 860. In some embodiments, and still referring primarily to FIG. 61, vertical faces 860 of any delivery sharp(s) 72 included on a sharp bearing body 26 may be disposed inboard of the periphery of the sharp bearing body 26. Thus, the footprint of each delivery sharp 72 may be surrounded on all sides by a portion of the sharp bearing face of the sharp bearing body 26. By positioning the delivery sharps(s) 72 inboard of the periphery of a sharp bearing body 26, coupling of the sharp bearing body 26 to a holder 270 during an injection molding operation may be facilitated. This may allow for an edge surface (e.g. chamfered or stepped) to be included such that the sharp bearing body 26 may be robustly coupled to a holder 270 without molding material onto the sharp bearing face of the sharp bearing body 26. Additionally, it avoids having vertical faces 860 of the delivery sharp(s) 72 which are continuous with the outermost portion of the sidewall 27 that may present sealing issues when a sharp bearing body 26 is coupled to a holder 270 via injection molding. Additionally, it may allow for a shut-off 864B to contact the sharp bearing face of the sharp bearing body 26 around all sides of the delivery sharps 72. Where the delivery sharp(s) 72 are one or more microneedles formed of silicon, sharp bearing bodies 26 with arrays of microneedles may generally be diced out of a wafer including a relatively large number of microneedle arrays. When the microneedles are formed, the microneedles may be formed such that their sloped faces 21 extend all the way to sharp bearing face of the sharp bearing body 26. The angle of the sloped face 21 may be defined by a crystallographic plane (e.g. 111) of the wafer. A dicing saw may be used to both separate individual sharp bearing bodies 26 from the larger wafer and to remove a portion of the microneedle to form the vertical face 860 at the desired position. The dicing saw may be moved at high speed over the sharp bearing face and across the portion of the microneedles to be removed. A portion of the sharp bearing face may be removed as this occurs such that the sharp bearing face in this region may be recessed after the vertical faces 860 for the microneedles are formed. This may allow a sharp bearing body 26 with silicon microneedles to maintain a small footprint even with tall microneedles despite the sloped face 21 having an angle defined by the crystallographic plane of the wafer. Additionally, this may facilitate use of sidewalls 27 described above which may make a sharpAttorney Docket: 00101.00467.AB674WO bearing body 26 highly amenable to being coupled to a holder 270 (or other component such an adapter which is part of or couples to a delivery implement) via injection molding.

[0377] Still referring to FIG.61 the sidewalls 456 of the delivery sharp(s) 72 on a sharp bearing body 26 may be angled or rounded such that the width of the delivery sharp(s) 72 decreases adjacent the vertical face 860. The etch used to define the outline of the delivery sharp(s) 72 may be made such that the width of the delivery sharp(s) 72 decreases as proximity to the sacrificial portion of the delivery sharp(s) 72. In some embodiments, the decrease in width may continue into sacrificial portion or the portion of the delivery sharp(s) 72 to be removed. When the vertical face 860 is formed, this may allow the transition from the sidewalls 27 to the vertical face 860 to be less sharp and thus more robust.

[0378] Though sharp bearing bodies 26 may be coupled to other components via adhesives, this can be a time consuming process which is poorly suited to high volume manufacturing. Molding arrays of microneedles into other components allows for efficient high volume mass manufacture of microneedle based fluid delivery platforms. Overmolding of material onto arrays of microneedles to form larger components is a particular challenge in the implementation of microneedles in fluid delivery devices. A fluid tight seal between the sharp bearing body 26 and overmolded material needs to be reliably formed without compromising the integrity of the sharp bearing body 26. Silicon wafer material, from which certain delivery sharps 72 and sharp bearing bodies 26 may be formed is brittle and can break fairly easily. This material is subjected to a number of stresses (ejection loading, thermal expansion and contraction of materials, etc.) during an overmolding process. Moreover, slight misalignment can result in chips, cracks, or other undesired marring of sharp bearing bodies 26 or delivery sharps 72. Additionally, the distance from the sharp bearing face to the opposing face of various sharp bearing bodies 26 may typically be about 200 µm. Thus, the available space for formation of an interface between the overmolded component and the sharp bearing body 26 which is fluid tight up to high pressures (e.g. at least 90 p.s.i.) is relatively small. Additionally, depending on the design of the overmolded component, such pressures may elastically distort the overmolded material in the vicinity of the sharp bearing body 26 presenting further sealing challenges. Moreover, a strong bond between an initial part and the second material used in the overmolding procedure is typically considered critical. Sharp bearing bodies 26 may typically be formed of a material that is dissimilar to material used to form the overmold. Silicon wafer material, for example, will not melt during the overmolding procedure and will not chemically bond with the overmolded material.Attorney Docket: 00101.00467.AB674WO

[0379] Components may be overmolded to sharp bearing bodies 26 as described below in relation to FIGS.63-68. Though the below description is provided in the context of a holder 270 for a delivery device 10, it should be appreciated that the description is generalizable for use with components other than holders 270. For example, adapters for delivery implements such as syringes may be formed similarly to as described herein. Additionally, infusion sets for prolonged delivery of agent to a shallow delivery destination (similar to subcutaneous insulin infusion sets for instance) or subcomponents thereof may be formed as described across FIGS. 63-68. Such components may, for example, include any of those shown and described in U.S. Publication No. US20230277759A1, filed March 3rd, 2023, and entitled “Systems, Methods, and Apparatuses for Medical Agent Administration”, (Attorney Docket No. 00101.00359.AB108) which is hereby incorporated by reference in its entirety. Any other drug delivery hardware which interfaces with patient anatomy via one or more microneedle may be formed similarly to as described herein.

[0380] As mentioned in relation to FIGS. 55A-55D, it may be desirable that the delivery sharps 72 of a component be coupled into that component in a tilted orientation. The sharp bearing body 26 and delivery sharps 72 may be tilted about a tilt axis that extends perpendicular to an axis of the component into which they are molded. For example the delivery sharps 72 may be tilted 15-25° from the orientation in which they would extend parallel to an axial dimension of the component. Though it adds complexity to the mold 860 (multiple shut off planes, part ejection systems not perpendicular to part geometry, etc.), it may be desirable to overmold the material with a mold 660 incorporating a stepped parting line.

[0381] Referring now to FIGS. 63-64, the parting plane 862 for the mold 860 may be oriented such that the sharp bearing body 26 may be deposited into the mold 860 in an orientation in which the force of gravity is normal to the sharp bearing face of the sharp bearing body 26. This may assist in retaining the sharp bearing body 26 in a stable resting orientation within the mold 860 prior to clamping.

[0382] Still referring to FIGS. 63-64, preferably, the shut-offs 864A, B may clamp against two parallel surfaces of the sharp bearing body 26. In the example, the shut-offs 864A, B clamp against the sharp bearing and opposing face of the sharp bearing body 26. Thus, the shut-offs 864A, B may block material from being molded over the sharp bearing face or into openings to the lumens 126 on the opposing face. The clamping force (indicated by arrows 866A, B) applied to the shut-offs 864A, B may be kept normal to the sharp bearing face and opposing face of the sharp bearing body 26 by incorporating a stepped parting line. This will help to ensure that the shut-offs 864 A, B do not deflect or have a tendency to misalign on theAttorney Docket: 00101.00467.AB674WO sharp bearing body 26 once pressure is applied to clamp the sharp bearing body 26 between the shut-offs 864A, B. This may facilitate repeatable and reliable seal creation around the periphery of the sharp bearing body 26 when material is injected into the mold cavity 868. Additionally, it may assist in maintaining the integrity of the sharp bearing body 26 and delivery sharps 72. For example, the shut-off 864B which clamps against the sharp bearing face of the sharp bearing body 26 will include at least one pocket 870 for the delivery sharps 72 on the sharp bearing body 26. The sharp pocket(s) 870 entirely surround the delivery sharps 72. With deflection or misalignment, the walls sharp pocket 870 on the shut-off 864B may contact and damage the delivery sharps 72. The stepped parting line may also help to constrain the nature of any misalignment of the sharp bearing body 26 within the mold 860 such that any misalignment from the ideal position may be kept substantially within a plane. That is, any misalignment may tend to be in a fore / aft, left / right, or rotational yaw type manner. As a result, despite any potential misalignment, the surfaces of the sharp bearing body 26 against which the shut-offs 864A, B press may still be substantially within the plane in which they are anticipated to be. Thus, any misalignment may be kept substantially in directions where the greatest degree of forgiveness is present. This may help inhibit damage to the sharp bearing body 26 and delivery sharps 72 which could be incurred in the event that pitch or roll type misalignment was present during clamping.

[0383] Still referring to FIGS. 63-64, as mentioned above creation of a good seal between the overmolded component and the sidewalls 27 of the sharp bearing body 26 is challenging. This seal is formed over a very small region and is required to be fluid tight even when exposed to high pressure (e.g. 90 p.s.i. or greater). The mold 860 may be constructed such that vents 872 in the mold cavity 868 are included adjacent the interface to be formed between the sharp bearing body 26 and the material filled into the mold 860. Instead of incorporating the shut-off 864B as a monolithic part of the “B” block 876 of the mold 860, the shut-off 864B shown in the example embodiment is part of an insert which is deposited in the “B” block 876 of the mold 860. By including the shut-off 864B as a separate component, an interface between the shut-off 864B insert and the surrounding “B” block 876 material is created. This interface may be leveraged to create a number of appropriately sized venting pathways directly abreast the interface between the sharp bearing body 26 sidewalls 27 and the component to be overmolded. This ensures that the mold breathes particularly well in this region and that material fills at this interface in a predictable, consistent, and repeatable manner without any dieseling.Attorney Docket: 00101.00467.AB674WO

[0384] Referring now to FIGS.65A-25C a number of view of example shut-offs 864A- B are depicted. The shut-offs 864A-B may clamp against a sharp bearing body 26 during an injection molding operation where a component is overmolded to the sharp bearing body 26. The shut-offs 864A-B may ensure that a robust fluid tight seal (e.g. up to at least 90 psi) is formed by the overmolded material. At the same time, the shut-offs 864A-B may be arranged to help assist in ensuring a highly reliable positioning of the sharp bearing body 26 while mitigating any potential for damage to the delivery sharps 72 or sharp bearing body 26.

[0385] As shown, shut-off 864A clamp may clamp against a central region of the rear face of the sharp bearing body 26. The exterior surface walls of the shut-off 864A in the vicinity of the sharp bearing body 26 may be smooth and devoid of steps. The exterior walls may also extend in a direction substantially perpendicular to the clamped rear face of the sharp bearing body 26. This may help to ensure good flow of material to the regions immediately adjacent the sharp bearing body 26. In turn, this may ensure that a reliable seal is formed by the material overmolded onto the sharp bearing body 26.

[0386] Shut-off 864B may include a pocket 870 for each delivery sharp 72 present on the sharp bearing body 26. In the example embodiment, two pockets 870 are depicted, however, additional pockets 870 of the same type may be included in shut-offs 864B for sharp bearing bodies 26 with a greater number of delivery sharps 72. The pockets 870 may be constructed to encourage a highly repeatable and reliable sharp bearing body 26 position within a mold 860. The pockets 870 may also bestow this reliable positioning while mitigating potential to damage the delivery sharp 72 or sharp bearing body 26 as the sharp bearing body 26 is installed in a mold 860.

[0387] As best shown in FIG. 65B, the pockets 870 each include a ramped sidewall 821. Opposite the ramped sidewall 821 the pockets 670 include a rounded sidewall section 823. Lateral sidewalls 825A, B connecting the rounded sidewall section 823 to the ramped sidewall 821 may also be present. The width of the pocket 870 may generally increase as distance from the rounded sidewall section 823 increases. The rounded sidewall section 823 and lateral sidewalls 825A, B may taper such that the cross-sectional area of the pocket 870 decreases as distance from the clamping face 831 of the shut-off 864B increases. The slope of the taper on the lateral sidewalls 825A, B may be gentlest at the end regions of the lateral sidewalls 825A, B most proximal the ramped sidewall 821. The width of the pocket 870 may be greatest where the distal side 15 of the base 17 of the delivery sharp 72 is positioned. The tapered region of the rounded sidewall 823 and lateral sidewalls 825A, B may be intermediate two straight wallAttorney Docket: 00101.00467.AB674WO segments which extend substantially perpendicular to the clamping face 831 of the shut-off 864A, B.

[0388] As the sharp bearing body 26 is installed in the mold 860, the delivery sharps 72 may be placed into the pockets 870 of the shut-off 864B. The pockets 870 may guide the delivery sharps 72 into position within their respective pockets 870. The taper on the sidewalls 823, 825A, B may serve to gently funnel the delivery sharps 72 such that they self-center within the pockets 870. Additionally, the sloped face 21 of the delivery sharp 72 may slide along the ramped sidewall 821 of the respective pocket 870. This may tend to bring the back facing edge 23 of the delivery sharp 72 into contact with the rounded sidewall section 823 as shown best in FIG.65A. The pockets 870 may also include a pit region 839. The pit region 839 may be sized to accept the tip 31 of the delivery sharp 72 when the delivery sharp 72 is introduced into the pocket 870 over any of a range of positions. Thus, the tip 31 of the delivery sharp 72 may generally be out of contact with the pocket 870 in the event of minor misalignment and may only contact the pocket 870 as the delivery sharp 72 self-aligns with further advancement into the pocket 870. Thus, the deliver sharp 72 may be substantially protected against damage when the sharp bearing body 26 is located on the shut-off 864B.

[0389] Referring primarily to FIG. 65C, a cross-sectional view of a pair of delivery sharps 72 in pockets 870 of an example shut-off 864B is depicted. The cross-section is taken at the plane of the sharp bearing face of a sharp bearing body 26 to illustrate the position of the delivery sharps 72 within the respective pockets 870. As shown, each delivery sharp 72 has associated kerf regions 827 (see also FIGS.10A-10D) which are artefacts of the etching process used to form silicon delivery sharps 72. It is desirable to carefully accommodate the kerf regions 827 in any shut-off 864B. The kerf regions 827 are relatively delicate and prone to chipping. Particulate formation in the mold 860 may be undesired for a number of reasons. For example, silicon is quite hard and silicon particulate may negatively impact mold 860 longevity. Additionally, particulate trapped between the shut-offs 864A, B and the sharp bearing body 26 may damage the sharp bearing body 26 when clamping force is applied. Silicon particulate may also become entrapped in the overmold material. This may further complicate the challenge of repeatably and reliably generating a fluid tight high pressure seal at the interface of the sharp bearing body 26 and the overmolded material.

[0390] Still referring to FIG. 65C, the width of the open ends of the pockets 870 directly lateral to where the distal side 15 of the base 17 of the delivery sharp 72 is received may be selected to be about double (e.g.85-115%) the width of the distal side 17 of the delivery sharp 72. This may help to ensure that the kerf regions 827 are accommodated within the pocketAttorney Docket: 00101.00467.AB674WO 870 for an associated delivery sharp 72. The tapered region of the lateral sidewalls 825A, B may begin at a depth greater than the maximum height of the kerf regions 827. Thus, the cross- sectional area of the pocket 870 may be at its greatest throughout the volume of the pocket 870 where the kerf regions 727 may be positioned. As mentioned above, the pockets 870 may substantially self-center respective delivery sharps 72 as a sharp bearing body 26 is installed in the shut-off 864B. The self-centering of the respective delivery sharp 72 may be substantially complete before the kerf regions 827 are advanced into the volume of the pocket 870 helping to ensure the kerf regions 827 maximum clearance from the walls of the pocket 870. By self- centering the respective delivery sharps 72 prior to the kerf regions 827 advancing into the pocket 870 the cross-sectional area at the open end of the pockets 870 may be kept relatively small. This may help to maximize the amount of the sharp bearing body 26 available for use as a shut-off surface.

[0391] Referring now to FIG. 66, an example block diagram 880 of a mold 860 is depicted. The example mold 860 includes a multi-stage ejection arrangement with a variety of ejector pins 882A-D disposed within guide pockets 884 defined in the mold 860. The hydraulics of the molding machine may be used to drive the ejector pins 882A-D to remove components of the mold 860 and the molded assembly in a controlled and repeatable sequence. The terminal ends of the ejector pins 882A-D are spaced varying travel distances 886A-C from the ends of their respective guide pockets 884.

[0392] The ejector pins 882A for a runner plate 888 of the mold 860 are arranged with the shortest travel distance. The ejector pins 882B for the “A” block 874 of the mold are positioned with a first intermediate travel distance 886A. The ejector pins 882C for the sharp bearing body 26 and overmolded part are positioned with a second intermediate travel distance 886B greater than the first intermediate travel distance 886A. The ejector pins 882D which disassociate the “B” block 876 from the mold base 890 have a longest travel distance 886C.

[0393] As the hydraulics displace the ejector pins 882A-D, all of the ejector pins 882A- D may move in tandem with one another. The runner plate 888 of the mold 860 is initially ejected from the mold 860. The ejector pins 882A for runner plate 888 may have no travel distance (as shown) to cover and may be in contact with the ends of their respective guide pockets 884 when in their initial position. As the runner plate 888 is ejected, the molded component may be automatically de-gated. The ejector pins 882B for the “A” block 874 of the mold 860 may then contact the ends of their respective guide pockets 884. Further displacement of the ejector pins 882B may disassociate the “A” block 874 from the mold 860. Subsequently, the ejector pins 882C for the sharp bearing body 26 and the molded component contact theAttorney Docket: 00101.00467.AB674WO bottoms of their respective guide pockets 884 driving the overmolded assembly out of the mold 860. The ejector pins 882C for the overmolded assembly may act on a knockout subassembly 892 within the mold 860. This subassembly 892 may include a set of part side ejector pins 894 on a sled 898 which are driven by the hydraulic side ejector pins 882C. The subassembly 892 is biased (e.g. via one or more compression spring 896) to a home position. After ejection, the bias drives the subassembly 892 back to the home position within the “B” block 876. A final ejection step drives the “B” block 876 of the mold 860 off of the mold base 890 as the ejector pins 882D contact the ends of their respective guide pockets 884.

[0394] In an alternative ejection arrangement, the travel distances 886A, 886B may be the same. Thus, the ejector pins 882B for the “A” block 874 of the mold 860 and those acting on the knockout subassembly 892 may begin to displace their respective portions of the mold 860 at the same time. The knockout subassembly 892 thus chases the “A” block 874 of the mold 860 in lock step as the “A” block 874 of the mold 860 is separated from the “B” block 876. The overmolded assembly would then stick on the “A” block 876 of the mold 860 when the knockout subassembly 892 is driven back to its home position. A vacuum grabber (or other suitable picking end-effector) could be used to remove the overmolded assembly. The overmolded assembly could be separated from the “A” block 874 in any other suitable manner. The delivery sharps 72 on the sharp bearing body 26 will be displaced out of the sharp pocket(s) 870 of the shut-off 864B insert in the “B” block 876 in a highly controlled manner along a direction parallel to the axes of the ejector pins 882A-D. This limits opportunity for the delivery sharps 72 on the sharp bearing body 26 come into contact with the pocket(s) 870 in the shut- off 864B and may help to inhibit damage to the delivery sharps 72 during the molding process.

[0395] Referring now also to FIG. 67, the molds 860 described herein may include a resting clamping assembly 900 which may provide a resting clamping force that holds the “A” block 874 and “B” block 876 firmly against one another. A resting clamping force may assist in keeping the sharp bearing body 26 and delivery sharps 72 firmly in place when mold 860 is initially closed before the injection molding machine hydraulics are pressing on clamping platens of the machine. In the example shown in FIG. 67, the resting clamping assembly 900 include a set of rare earth magnets 904 disposed in the “A” block 874 of the mold 860 and the “B” block 876 of the mold 860. When the mold 860 is initially closed, the attraction between the magnets 904 may clamp the sharp bearing body 26 in place. Elastomer cushions 902 may be built into the parting line. These elastomer cushions 902 add some compliance which mitigates potential shock on the sharp bearing body 26 when the magnets 904 drive the “A”Attorney Docket: 00101.00467.AB674WO block 874 and “B” block 876 of the mold 860 together. Though magnets 904 are used, this clamping may be accomplished in any other suitable manner.

[0396] The mold 860 may also include a retainer assembly 905 that maintains the “B” block 876 of the mold 860 against the mold base 890 for at least a portion of the ejection sequence. For example the retainer assembly 905 may hold the “B” block 876 of the mold 860 in place as the “A” block 874 of the mold 860 is ejected. Thus the “B” block 876 will be held in a tightly controlled position as relative displacement of the “A” block 874 occurs. This may help to prevent movement of the delivery sharps 72 within the sharp pocket(s) 870 of the shut- off 864B minimizing potential for the delivery sharps 72 to be compromised. In the example embodiment, the retainer assembly 905 is provided by the magnets 904 in the “B” block 876. As shown, a greater number of magnets 904 are installed in the “B” block 876 than the “A” 874. In the example embodiment, the “B” block 876 includes double the number of magnets 904 than the “A” block 874. This ensures that the “B” block 876 is attracted to the mold base 890 strongly enough to be retained against the mold base 890 as the “A” block 874 is ejected.

[0397] Referring now to FIG. 68 a detailed view of a terminal end 906 of a part side ejector pin 894 of a knockout subassembly 892 which may be included in a mold 860 is depicted. Due to the stepped parting line incorporated into the mold 860, the overmolded component needs to be ejected on a wedge. With a flat terminal end 906, some of the linear ejection force will be translated into lateral deflection force. This may lead to an overmolded component not ejecting cleanly or may place side loads on the part side ejection pins 894 which may damage the part side ejection pins 894. As shown, the terminal end of part side ejector pins 894 may be arranged such that the molded component and the part side ejector pins 894 have interlocking features. As shown, a cleat 908 may be placed in the terminal end 906 of each part side ejector pin 894. Thus, as material is injected into the mold 860, the material may be overmolded onto the cleats 908 and the terminal ends of the part side ejector pins 894 may be embedded into the molded component. The overmolded material will buttress the part side ejector pins 894 against any side loading ensuring that the molded assembly ejects cleanly.

[0398] As shown, the cleats 908 may be included as raised ridges which span across the terminal end 906 of each part side ejector pin 894. The ridges may run in a direction perpendicular to the lateral deflection force which would be experienced by each of the part side ejector pins 894. Additionally, the ridges forming the cleats 908 may be rounded. Thus, the cleats 908 may easily (e.g. automatically) release from the molded assembly as the ejection sequence transpires. Though shown as a ridge, other generously drafted raised features may be included in alternative embodiments. The part side ejector pins 894 could alternatively includeAttorney Docket: 00101.00467.AB674WO a recessed feature or features which would interlock with material of the molded component. It may, however, be preferred that raised features be used in order to avoid creating protrusions on the patient contacting side of the overmolded component.

[0399] In other embodiments and referring now to FIGS. 69A-70C, a sharp bearing body 26 may be coupled to a holder 270 via a material swaging operation. Though described in relation to a holder 270, a sharp bearing body 26 may be coupled to other components which form part of or couple to a delivery implement (e.g. an adapter with a luer fitting) in like manner. Description in relation to a holder 270 may be generalized to other such components and discussion of the holder 270 is merely exemplary. Additionally, the holder 270 shown is merely exemplary and sharp bearing bodies 26 may be coupled to any holder 270 depicted or described herein via a material swaging operation.

[0400] As shown, a holder 270 may include a receptacle 291 for a sharp bearing body 26. The receptacle 291 may be defined on a proximal or distal face of a holder 270 depending on the embodiment. As depicted in FIGS. 69A-69C, the receptacle 291 is included on the proximal side of the holder 270. The receptacle 291 may, for instance, be a pocket 276 on a stage projection 279 or bump of a holder 270. The receptacle 291 may include a shelf 293 which surrounds a passage 295 disposed in a central region of the receptacle 291 which extends through the holder 270. The face of a sharp bearing body 26 opposite the sharp bearing face may be placed on the shelf 293. The passage 295 may provide a fluid communication channel through the holder 270 to the lumen(s) 126 of the delivery sharp(s) 72 of the sharp bearing body 26.

[0401] As shown in FIGS. 70A-70C, a receptacle 291 may alternatively be formed as a recess in the distal face of the holder 270. The example receptacle 291 is shown as a recess in a well 281 of an example stage projection 279 in FIGS.70A-70C, however, could be a recess in a rounded depression 274 (see, e.g., FIG.54A). The receptacle 291 may include a shelf 293 surrounding a passage 295 extending through the holder 270. The sharp bearing face of a sharp bearing body 26 may be seated against the shelf 293 and the delivery sharp(s) 72 may project through the passage 295 proud of the holder 270 such that they may puncture into a patient.

[0402] The receptacle 291 may be surrounded by a bead 297 of material. In some embodiments, the bead 297 may be formed integrally with the remainder of the holder 270 in a single molding operation (as shown). In alternative embodiments, the bead 297 may formed of a material which differs from that the majority of the holder 270. For example, the bead 297 may be formed in a piece of material that is over molded to a first portion of the holder 270. InAttorney Docket: 00101.00467.AB674WO such embodiments, the bead 297 may be formed of elastomer while the first portion of the holder 270 may be formed of a comparatively rigid plastic.

[0403] When a sharp bearing body is 26 installed in a receptacle 291, the bead 297 of material may be swaged over a portion of the sharp bearing body 26 to couple the sharp bearing body 26 in place on the holder 270. In some embodiments, the bead 297 may be heat swaged over a portion of the sharp bearing body 26. In some embodiments, the bead 297 may be laser swaged over a portion of the sharp bearing body 26. Where laser swaging is used, the bead 297 may be constructed of a material which absorbs wavelengths of the laser used to perform the swage. A thermoplastic with a high melt index (e.g.10 or higher).

[0404] Though the examples shown in FIGS.69A-70C depict sharp bearing bodies 26 with sidewalls 27 formed as a single straight surface which is substantially perpendicular to the sharp bearing face, other sidewall 27 arrangements may be used. Where the bead 297 of material is disposed nearest the sharp bearing face of the sharp bearing body (FIGS.69A-69C), various sidewall 27 arrangements may be utilized. The sidewalls 27 may, for example, be arranged such that the cross-sectional area of the sharp bearing body 26 increases as distance from the sharp bearing face increases. This may assist in ensuring that the swaged material does not displace over the sharp bearing face of the sharp bearing body 26, but instead covers only a portion of the sidewalls 27 or substantially the entire sidewall 27 depending on the embodiment. In alternative examples, the microneedle height may be increased and some material may be allowed to displace over the sharp bearing face of the sharp bearing body 26.

[0405] Where the bead 297 of material is disposed closest the face of the sharp bearing body 26 opposite the sharp bearing face, similar sidewall 27 arrangements cut in the opposite fashion may be used. That is, any of the sidewall 27 profiles described above may be used, however, material may be removed such that the cross-sectional area of the sharp bearing body 26 decreases as proximity to the sharp bearing face decreases. This may assist in ensuring that the swaged material does not displace over the face of the sharp bearing body 26 where the upstream end of the lumens 126 are disposed, but instead covers a portion or substantially all of the sidewalls 27. This helps to keep the swaged material from impeding access to lumens 126 of the sharp bearing body 26.

[0406] Retaining a sharp bearing body 26 in a holder 270 or other component via a swaging operation may be advantageous for a variety of reasons. For example, where laser swaging is used, the bead 297 of material may be swaged into a retaining position relatively rapidly (less than a second). Additionally, ejection stress loading of the sharp bearing body 26Attorney Docket: 00101.00467.AB674WO may be absent. The sharp bearing body 26 may also be placed in a holder 270 (or other component) with relatively loose tolerances.

[0407] In some embodiments, as shown in FIGS.71A-71D (respectively a perspective view looking down from above, view from the side, perspective view looking up from below, and view from the top relative to an application surface for a delivery device 10 such as e.g., the skin surface), a reservoir portion 271 is depicted. A reservoir portion 271 may be shaped to incorporate, as an integrated structure, a dome shaped portion 280, a tunnel or side channel 282, and a flange or annular portion 284. That is, these features may be included in a single monolithic piece of material. In some embodiments the dome shaped portion 280 may be shaped approximately as a hemisphere or other spherical segment though any other suitable shape is possible. In examples where the reservoir portion 271 includes a rounded shape which forms a cavity (e.g. the dome shaped portion 280), there may be a plateau or flat surface included at the portion of the rounded shape most distal the flange 284. The flat surface may be generally parallel to the flange 284. In some examples, a central depression 267 (see, e.g. FIG. 72) may also be included in the flat surface. The tunnel 282 may be shaped in some examples as a half-pipe or half cylinder that may be formed from the annular portion 284. Any suitable cross-sectional shape may be used in alternative embodiments. The side channel or tunnel 282 may communicate with the dome shaped portion 280 via an arch 286 such that the combination of dome shaped portion 280 and tunnel 282 form a structure shaped approximately as an igloo. In some embodiments, the end of the tunnel 282 opposite the dome shaped portion 280 may flare or taper outwardly to increase ease of filling. The annular portion 284 may have an inner edge that is coincident with a base perimeter 288 of the dome shaped portion 280. The reservoir portion 271 may be manufactured by, e.g., thermoforming a flat sheet of material (e.g., plastic or layers of various plastic or other material). Where a multilayer sheet is used, the sheet may include a drug or agent compatible layer, barrier layer, tie layer, etc. In some embodiments vacuum forming may be used to manufacture the reservoir portion 271. Other known techniques such as injection molding could be used. The reservoir portion 271 may be formed of a polycarbonate material or other suitable materials and may be coated with a Cyclic Olefin Polymer (COP) or any other suitable coating material. The dome shaped portion 280 may be collapsible when pressure is applied thereto.

[0408] Referring now to FIGS. 72, a perspective view of an exemplary reservoir portion 271 is shown. In certain examples, reservoir portions 271 may include at least one cavity with one or more built in collapse facilitator. The collapse facilitator may encourage the cavity to collapse in a prescribed manner and may lower the force needed to collapse the cavity.Attorney Docket: 00101.00467.AB674WO The collapse facilitator may also aid in ensuring that the cavity collapses such that any dead volume is minimized. Likewise, inclusion of a collapse facilitator may help to mitigate potential for fluid contained in a reservoir 12 to become trapped or pocketed in a region of the reservoir 12 that becomes blocked out of communication with an outlet during collapse of the cavity. Other reservoirs 12 described herein may include at least one collapse facilitator.

[0409] 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., FIG. 37) or a portion of a bias member 470, 481 (see, e.g., FIG. 38 and FIG.49B respectively). Flat top walls 263 and / or central depressions 267 may be included in other reservoirs 12 described herein. The cavity formed by the wall 261 and top wall 263 may have a generally round, circular, elliptical, oval, obround, or polygonal cross- section.

[0410] 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, 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 FIG. 72, the spiral pleat 269 wraps around the wall 261 about three times. Such a pleat 269 may aid in assisting collapse of the cavity while fluid is urged out of a reservoir 12 during operation of a delivery device 10. Thus minimal force may be needed to deform and deplete such a reservoir 12 during use. Additionally, such a pleat 269 may assist in ensuring that little dead volume remains in the reservoir 12 after a delivery has completed. Use of a flat top wall 263 may also assist in collapse of the cavity.

[0411] Referring now to FIG.73, the wall 261 may be stepped and include at least one step region 259. The cross-sectional area of the cavity may change at each step region 259. In the example, the cross-sectional area of the cavity is largest adjacent the flange 284 andAttorney Docket: 00101.00467.AB674WO decreases in a stepwise manner as distance from the flange 284 increases. The wall 261 includes two step regions 259 in the example shown in FIG. 73, though any suitable number may be included in alternative embodiments. As in the examples discussed above, the stepped wall 261 may aid in lowering force needed to collapse the cavity and help to direct the collapse in a prescribed manner. One example delivery device 10 embodiment including a reservoir 12 with such a stepped wall 261 is depicted in FIG.50B. An example reservoir 12 including a stepped wall 261 is depicted in FIG.104.

[0412] In an embodiment, the reservoir 12 may be formed by attaching the reservoir portion 271 to the holder 270, as shown in FIG.74. The reservoir portion 271 may be positioned above the holder 270 in the example shown, and the lower surface area 285 of the annular portion 284 may be affixed to the upper surface area 273 of the annulus 272 or disk body 275. In an embodiment, the reservoir portion 271 may be attached to the holder 270 by ultrasonic welding, although any form of welding or any other coupling technique known to those of skill could be used. For example, the reservoir portion 271 and the holder 270 may be sealed together with a double sided adhesive. Other suitable techniques for sealing the reservoir portion 271 and the holder 270 together include, by way of non-limiting examples, using an ultraviolet curable adhesive, heat staking, and laser welding.

[0413] 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, heat staking, or any other suitable technique described herein. In alternative embodiments, the reservoir 12 may include a septum 550 (see, e.g., FIGS. 102A-104) through which agent may be transferred into the reservoir 12. In such examples, the side channel 282 may be omitted and the periphery of the flange 284 of the reservoir portion 217 may be completely sealed to the upper surface 273.

[0414] The sharp bearing body 26 (see, e.g., FIG. 34) including the delivery sharp(s) 72 (see, e.g., FIG. 34) may be inserted into the pocket 276 and fixed therein by any suitable technique such as, e.g., welding, prior to insertion of the medical agent (e.g., vaccine) into the reservoir 12. Alternatively, and as mentioned above, the holder 270 may be formed around the sharp bearing body 26. As mentioned elsewhere herein, the delivery sharp(s) 72 may be one or more microneedle in various examples.

[0415] 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 theAttorney Docket: 00101.00467.AB674WO 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 FIGS. 11A-12). The packet 208 and / or container 350 or foam adhesive may be disposed between the reservoir 12 and the underside of the top surface 250 of the delivery device 10 when the delivery device 10 is fully assembled. Alternatively and as discussed above, a dispensing assembly 480 (see, e.g., FIG. 37) or at least one bias member 470 (see, e.g., FIG. 48) may be disposed between the underside of the top surface 250 and the reservoir 12 once the reservoir 12 is installed.

[0416] With reference to FIG. 75, a reservoir 12 (e.g., a reservoir 12 such as that described above with reference to FIG. 74) may be affixed to the inside of a delivery device 10. Though a representational example delivery device 10 is depicted, a reservoir 12 may be similarly installed in a main body 20 of any delivery device 10 embodiments described herein. The reservoir 12 may contain a medical agent (e.g., a vaccine) prior to being assembled into the delivery device 10. The reservoir 12 may be removed from cold storage prior to being attached to the inside of the main body 20 of a delivery device 10.

[0417] Still referring to FIG.75, in one embodiment, a ridge 290 may be formed in an inside surface of the central region 28 of the delivery device 10 such that the ridge 290 may serve as a seating structure upon or against which a section or region of the reservoir 12 may be positioned or coupled. In one example, the annulus 272 or the holder 270 may be adhered to the ridge 290 with an adhesive. It would be understood by one of skill that any suitable coupling technique could be used. In other embodiments, the distal face of the reservoir portion 271 may attach to the proximal face of the ridge 290. A distal face of a reservoir portion 271 may for example be coupled to the ridge 290 of the main body 20 of the delivery device 10 shown in FIG. 29. Tab projections 277 (see, e.g., FIG. 55A) which couple into receiving slits 278 (see, e.g., FIG.47A) defined in the main body 20 may alternatively or additionally be used. In place of ridges 290, main bodies 20 may include retention tabs 580 and stop surfaces 582 (see, e.g., FIGS. 105-106B) which may couple the reservoir 12 in place within the delivery device 10.

[0418] In certain embodiments and referring now to FIGS. 76A-76B, the shape of the reservoir portion 271 may be adjusted to alter the maximum cross-sectional area of the reservoir portion 271. This may aid in achieving a desired delivery pressure. For example, in some embodiments, the reservoir portion 271 may be formed so as to have a balloon like (shown in FIG.76A-76B), cylindrical, polygonal prism shape, etc. The height of the reservoir portion 271 may be adjusted to achieve the desired interior volume given a preselectedAttorney Docket: 00101.00467.AB674WO maximum cross-sectional area. As shown, the holder 270 may include at least one buttress 289. The at least one buttress 289 may at least partially surround the reservoir portion 271. The at least one buttress 289 may aid in holding the reservoir portion 271 in a desired position within a delivery device 10. The at least one buttress 289 may also aid in directing collapse the reservoir portion 271 as delivery occurs.

[0419] As shown in FIG.76B, the main body 20 may include a nesting projection 287. As the delivery device 10 is transitioned into a delivery state (see, e.g., FIG. 32) the nesting projection 287 may press against the reservoir portion 271. As delivery progresses, the nesting projection 287 may press the reservoir portion 271 against the at least one buttress 289. In the example embodiment, the nesting projection 287 may be disposed between the exemplary buttresses 289 and may aid in ensuring minimal dead space remains in the reservoir 12 after delivery is complete.

[0420] Referring now to FIG. 77, in certain embodiments, it may be desirable that delivery pressure ramp up relatively slowly when the delivery device 10 is transitioned to a delivery state. For example, it may be desirable that fluid injection begin at a relatively low pressure or at or about the lowest pressure at which injection is possible for a particular patient. The delivery pressure may be ramped up until this delivery initiation pressure is reached for a particular patient. Ramping up pressure slowly may allow for the delivery initiation pressure to be reached for a wide variety of patients using the same delivery device 10 design. Additionally, once the injection begins, it may be desirable that the delivery pressure is held at or near the delivery initiation pressure. Additionally, and as shown in FIG. 77, it may be desirable that such embodiments use at least one bias member 470 to facilitate delivery. For example, a compression spring made of a Hookean material may be used.

[0421] As shown in FIG.77, in such embodiments, the reservoir 12 may be partitioned into a first portion 520 and a second portion 522. The first portion 520 and the second portion 522 may be in fluid communication with one another via a flow restrictor 524 (see, also FIG. 50B). The flow restrictor 524 may be disposed between a portion of the reservoir 12 proximal to the microneedles and a portion of the reservoir 12 more distal to the microneedles. The flow restrictor 524 may be an orifice plate with one or more orifice extending therethrough in certain embodiments. In some embodiments a flow restrictor 524 with a 15-25 micron orifice may be included. In other embodiments, an orifice may be up to 100 microns in diameter (e.g. 70-80 microns or 75 microns). In some embodiments, the orifice may have diameter greater than 100 microns. The orifice size may be selected based on considerations such as the viscosity and / or surface tension of the agent(s) filled into the reservoir, the desired speed of injection and howAttorney Docket: 00101.00467.AB674WO quickly it is desired to ramp up injection pressure. An orifice plate may be an injection molded component though could be formed in any other suitable manner.

[0422] In some embodiments, the width of the orifice may vary. For example, the orifice may taper from a wider aperture to a smaller aperture as distance to toward the proximal side of the orifice plate increases (the opposite is also possible). Such a tapered arrangement may be preferable depending on the agent to be delivered from the delivery device 10.

[0423] Still referring to FIG.77, the first portion 520 of the reservoir 12 may include a majority of the reservoir 12. The second portion 522 of the reservoir 12 may be disposed proximal to the delivery sharp(s) 72 relative to the first portion 520. Thus, the flow restrictor 524 may separate a large first portion 520 from a smaller second portion 522 which is most proximal the delivery sharp(s) 72. The first portion 520 may have a volume substantially equal to the fill volume of the reservoir 12 in certain examples. The flow restrictor 524 may be disposed upstream of at least the pocket 276 (see, e.g., FIGS. 53A-54C) into which a sharp bearing body 26 may be coupled. In example embodiments, the flow restrictor 524 may separate a rounded depression 274 (see, e.g., FIGS. 54A-54D) from the remainder of the reservoir 12. In such embodiments, the flow restrictor 524 may be coupled to the distal face of the annular body 272 (see, e.g. FIGS. 54A-54D) over the rounded depression 274. In other examples, the flow restrictor 524 may separate the well 281 (see, e.g., FIGS. 55A-55C) from the remainder of the reservoir 12. In such embodiments, the flow restrictor 524 may be coupled to the distal face of the disk body 275 (see, e.g. FIGS.55A-55C) over the well 281.

[0424] 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.Attorney Docket: 00101.00467.AB674WO

[0425] 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, foam body, rubber body, elastomeric body) 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., FIG. 37) or other components of a delivery assembly 280 (see, e.g., FIG. 37). The flow restrictor 524 may cause the pressure of fluid in the second portion 522 of the reservoir 512 to slowly ramp up to a pressure at which injection into a patient begins. Thereafter, the flow restrictor 524 may limit build-up of pressure in the second portion 522 as the injection progresses. Thus the injection will tend to occur at or near the lowest pressure at which the patient will accept the delivery. This may facilitate use of a more aggressive spring and may limit discomfort associated with the delivery. Moreover, it may allow for a single delivery device 10 design to be used on a wide range of patient populations (e.g. any patient) or with a wide variety of different agents. Additionally, this may have an effect on bleb formation resulting from the delivery. As the delivery may tend to occur relatively slowly and at a relatively low pressure, a more diffuse shallow (e.g. intradermal) injection may tend result. Adjustment of the size of any orifice in the flow restrictor 524 may alter the duration of the delivery and characteristics of the bleb.

[0426] Referring now to FIG. 78, in some examples, delivery devices 10 may include a delivery unit 650 and a trigger unit 652. The delivery unit 650 may be formed of a first set of components and the trigger unit 652 may at least include a trigger body 654. The trigger body 654 may displace relative to the delivery unit 650 to transition the delivery device 10 from its storage state to a delivery state. The delivery unit 650 may, for example, include a main body 20, reservoir 12, adhesive 22, bias member 470, and a reservoir interface member 474. The trigger unit 652 may, for example, include the trigger body 654 and a deformable spacer 656 (though the spacer 656 may form part of the delivery unit 650 in certain examples).

[0427] The trigger body 654 may be a button and may include or be coupled to at least one barrier 658A, B which may block displacement of a portion of the delivery unit 650 until the trigger body 654 is displaced by a user. For example, the at least one barrier 658A, B may impede movement of the reservoir interface member 474 in the direction of the reservoir 12. In some embodiments, there may be a set of barriers 658A, B which displace in tandem and block movement of different sections of a reservoir interface member 474 (e.g. sections on opposite sides of the reservoir interface member 474 or sections spaced about the reservoir interface member 474 perhaps at regular angular intervals). The deformable spacer 656 mayAttorney Docket: 00101.00467.AB674WO hold the trigger body 654 in a blocking position and may deform upon application of pressure to make way for the trigger body 654 and barrier(s) 658A, B to displace to a trigger position. The deformable spacer 656 may be a spring, elastomeric body, gas bladder, or any other compliant member in various examples. Alternatively, the deformable spacer 656 may be a flexure formed integral to the trigger body 654 or a portion of the main body 20. The deformable spacer 656 may also be a frangible in certain implementations which may permanently distort or break upon application of pressure. Once the trigger unit 652 has reached the trigger position, the bias member 470 may propel the reservoir interface member 474 in the direction of the reservoir 12 to expel the contents of the reservoir 12.

[0428] In some embodiments, a series of barriers 658A, B may divide displacement of the reservoir interface member 474 into a number of stages. For example, a first barrier 658A (or set of first barriers 658A) may inhibit displacement of the reservoir interface member 474 until the trigger body 654 is displaced to the triggered position. A second barrier 658B (or set of second barriers 658B) may be displaced to a blocking position as the trigger unit 652 is driven to the trigger position. The reservoir interface member 474 may partially displace to an intermediate point in its displacement range due to the presence of the second barrier 658B (or set of second barriers 658B). As pressure upon the trigger unit 652 is released, the deformable spacer 656 may restore to a less distorted state and the second barrier 658B (or set thereof) may be urged to an unobstructing position. This may free the reservoir interface member 474 to displace to a second end of its displacement range allowing the reservoir interface member 474 to bring the reservoir 12 to its depleted state under the urging of the bias member 470.

[0429] Referring now to FIGS. 79A-79F, a number of diagrams of portions of an example delivery device 10 of the variety described in relation to FIG. 78 are depicted. With reference to FIG. 79A, a portion of a delivery unit 650 is depicted alone. As shown, certain exemplary delivery units 650 may include at least one guide track 660. Each of the at least one guide track 660 may be defined as a recess or ledge included in a side wall of a portion of the main body 20. Each guide track 660 may generally slope or ramp from a first end of the main body 20 toward an end of the main body 20 including the peripheral region 30. A barrier channel 666 may be disposed somewhere in the intermediate region of each guide track 660 and may accept the barrier 658A when the barrier 658A is in the trigger position. The reservoir interface member 474 may be propelled by a bias member 470 to displace along the guide track(s) 660 upon triggering of the delivery device 10. As mentioned above, and as shown in FIGS. 79A-79F, the reservoir interface member 474 may be blocked from fully displacing along each guide track 660 by a second barrier 658B when the trigger unit 652 is in a triggerAttorney Docket: 00101.00467.AB674WO position. As pressure on the trigger unit 652 is relieved, the second barrier 658B may retract allowing the reservoir interface member 474 to continue displacement to a terminal point in its displacement range. Thus, such a delivery device 10 may be triggered over two stages. In the first stage, the reservoir interface member 474 may traverse an upstream portion of each guide track 660 and in the second stage the reservoir interface member 474 may proceed to the end of its displacement range along a downstream region of each guide track 660.

[0430] In the embodiment depicted in FIGS. 79A-79F, the guide track 660 shown includes an initial region 662 which is separated from a knoll region 664 of the guide track 660 by the barrier channel 666. The exemplary guide track 660 may also include a terminal region downstream of the knoll region 664. The initial region 662 may be sloped so as to form a ramp. Upstream of the initial region 662 may be a wall or backstop 661 which blocks motion of the reservoir interface member 474 in that direction. The portion of the knoll region 664 most proximal the initial region 662 may be positioned substantially at a point falling on a line at the same angle as the initial region 662 which bridges the barrier channel 666 (line shown in phantom in FIG. 79A). Alternatively, the portion of the knoll region 664 most proximate the initial region 662 may be below this point (that is, closer to the bottom of the barrier channel 666). The terminal region 668 may be a track which extends at a sharp angle or is substantially parallel to the barrier channel 666. The terminal region 668 may also act as a barrier channel for a respective second barrier 658B included in the delivery device 10. The knoll region 664 may be at a constant angle or, as shown, may transition from the angle of the initial portion 662 to the angle of the terminal portion 668. Though the knoll region 664 displays a rounded transition in the example, the transition may be formed of a series of increasingly steeply angled guide track segments 660 in alternative embodiments.

[0431] Referring now primarily to the progression of FIGS. 79B-79F, the portion of the delivery device 10 is shown as the delivery device 10 is transitioning from a storage state to a delivery state. As shown in FIG.79B, in the storage state, the reservoir interface member 474 of the delivery unit 650 may be positioned over the initial region 662 of the example guide track 660. Where multiple guide tracks 660 are included, each may be identical and a portion of the reservoir interface member 474 may be positioned in the initial region 662 of each guide track 600.

[0432] The bias member 470 (represented by an arrow in FIG.79B) may supply a bias against the reservoir interface member 474 which tends to drive the reservoir interface member 474 along the guide track 660 in the direction of the terminal portion 668. A first barrier 658A may be partially within the barrier channel 666 of each guide track 600 and inhibit displacementAttorney Docket: 00101.00467.AB674WO of the reservoir interface member 474 along the guide track 660 under the urging of the bias member 470. As shown in FIG. 79B, the barrier(s) 658A may be held in a blocking position by the deformable spacer 656. In FIG. 79B, an arrow representing force exerted by a spring type deformable spacer 656 is shown within each barrier 658A, B.

[0433] Referring now primarily to FIG. 79C, the reservoir interface member 474 may remain static relative to the guide track(s) 660 as a user begins to apply pressure to the trigger unit 652. The pressure exerted through the trigger body 652 may cause the main body 20 to press against an injection site. As this occurs at least two adhesive bearing portions (e.g. petal member 42) 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 rendering it taut for piercing by the delivery sharp(s) 72 of the delivery device 10. The delivery sharp(s) 72 may also displace toward and pierce the skin (or other surface) as this occurs.

[0434] Referring now to FIG. 79D, the trigger unit 652 may displace at least until the first barrier 658A reaches an unobstructing or stowed position. This may be a guide track completing position in which a ramp surface 670 of each first barrier 658A is advanced to a position in which it is at least even with the respective guide track 660. Thus, in the trigger position, the first barrier(s) 658A may not present an interference to displacement of the reservoir interface member 474 along the guide track under urging of the bias member 470. As shown, a second barrier 658B (where included) may be displaced into the terminal portion 668 of each guide track 660 when the trigger unit 652 is in the trigger position. With the first barrier(s) 658A in their trigger position(s), the bias member 470 may drive the reservoir interface member 474 over the ramp surface(s) 670 of the first barrier(s) 658A and along the guide track 660 toward the terminal region 668. Though in the example embodiment the ramped portion 670 is displaced even with the guide track 660 it could be displaced to a position in which it is recessed with respect to the initial portion 662 in certain examples.

[0435] Referring now primarily to FIG. 79E, in embodiments where second barriers 658B are included, the reservoir interface member 474 may progress to an intermediate point in its displacement range at which it contacts the second barrier(s) 658B. At some point after the reservoir interface member 474 has progressed beyond the initial region 662 of the guide track(s) 660, the reservoir interface member 474 may come into contact with the reservoir 12. Further progress of the reservoir interface member 474 along the guide track(s) 660 may cause a reservoir portion 271 of the reservoir 12 to collapse expelling fluid from the reservoir 12 andAttorney Docket: 00101.00467.AB674WO out of the delivery sharp(s) 72 of the delivery device 10. When the reservoir interface member 474 reaches the terminal region 668 of the guide track 660 (see FIG.79F), the reservoir portion 271 may be fully collapsed and the reservoir 12 may be substantially empty or depleted. In embodiments including second barriers 658B, the intermediate point at which the reservoir interface member 474 encounters the second barriers 658B may be a point at which the reservoir interface member 474 comes into contact with the reservoir portion 271. Pressure may need to be relieved on the trigger unit 652 allowing the second barrier(s) 658B to retract before the reservoir interface member 474 may pass to the terminal region 668 of the guide track 660.

[0436] Use of such a delivery device 10 may provide a number of potential advantages. For example, the guide track 660 may prevent the full force of the bias member 470 from being exerted on the reservoir 12 in a binary manner. Thus, the pressure applied on the reservoir 12 via the bias member 470 may be decreased during an initial portion of the delivery by inclusion of a guide track 660. The steepness or angle of the guide track 660 may be adjusted to increase or decrease the component of force exerted by the bias member 470 which is aligned with the direction of motion of the reservoir interface member 474 toward the reservoir 12. Thus, the pressure exerted by the bias member 470 upon commencement of delivery may be altered. Such a guide track 660 may also be used in conjunction with a flow restrictor 524 (see, e.g., FIG.77) in certain implementations.

[0437] Such a delivery device 10 may also facilitate positioning the reservoir interface member 474 in spaced relation to the reservoir 12 when the delivery device 10 is in a storage state. Upon transition of the trigger unit 652 to the trigger position, the reservoir interface member 474 may be brought into contact with the reservoir portion 271, but prevented from aggressively driving into and impacting the reservoir 12 by the presence of the second barrier(s) 658B. This may assist in initiating the expulsion of fluid from the reservoir 12 in a more gentle manner. Additionally, it may allow for a greater range of reservoir portion 271 materials or material thicknesses to be used in a delivery device 10.

[0438] Referring now to FIGS.80A-80B, exploded views of an example embodiment of a delivery device 10 are depicted. The delivery device 10 may include a delivery unit 650 and a trigger unit 652. The main body 20 of the delivery unit 650 may include a peripheral region 30 and a central region 28. The peripheral region 30 may include a plurality of petal members 42. Any of the petal members 42 shown or described herein may be used. The central region 28 may include a rigid guide body 672. The rigid guide body 672 may include a sidewall 674 extending from a base 262 of the central region 28. As best shown in FIG.80B, the interiorAttorney Docket: 00101.00467.AB674WO face of the sidewall 674 may include a number of guide tracks 660. The guide tracks 660 are depicted as cam type tracks, thus the reservoir interface member 474 will rotate as it progresses through its displacement range along the tracks 660. The face of the rigid guide body 672 most distal the peripheral region 30 may include a central depression or cup 676. The cup 676 may be a locating recess which may assist in locating the deformable spacer 656 of the trigger unit 652 (a compression spring in the example depicted). The trigger body 654 may also include a locating projection 678 for the deformable spacer 656. A number of apertures may be included to allow for passage of the barriers 658A, B of the trigger body 654 into the interior of the rigid guide body 672.

[0439] The delivery unit 650 may include a bias member 470 (e.g. compression spring as shown). The opposing side of the cup 676 may provide a projection which may help locate the bias member 470 within the delivery unit 650. The reservoir interface member 474 may be a plunger having a number of outwardly (e.g. radially) extending protrusions 680. Each of the protrusions 680 may interface with one of the guide tracks 660 defined on the sidewall 674 of the rigid guide body 672. The guide tracks 660 and the protrusions 680 may be spaced at regular angular intervals.

[0440] Referring now also to FIG. 80C, a cross-sectioned view of the main body 20 and trigger body 654 of FIGS.80A-80B are depicted. The portion of the rigid guide body 672 most distal to the base 262 of the central region 28 has also been removed for illustrative purposes. As shown, the barriers 658A, B of the trigger body 654 may be formed monolithically with the trigger body 654. The barriers 658A, B depicted in the example embodiment are formed as peg like projections extending from an end surface of the trigger body 654. In the example, each barrier 658A, B is defined as a region of the same projection though discrete projections for each barrier 658 A, B could be included in alternative embodiments. The barriers 658A, B may be aligned with the barrier channel 666 and terminal region 668 of a respective guide track 660 such that they may displace into these features when the trigger body 654 is brought to a trigger position. Additionally, the trigger body 654 may include at least one guide fin 682. The guide fin 682 may displace along a slot 684 defined in the rigid guide body 672. This may assist in directing displacement of the trigger body 654 during operation and may inhibit rotational displacement of the trigger body 654. The guide fin(s) 682 may also assist in retaining the trigger body 654 in relation with the main body 20 and may thus be referred to as a retention fin or projection herein.

[0441] An alternative embodiment a delivery device 10 including a delivery unit 650 and a trigger unit 652 is shown in FIGS. 81A-83. As shown, the example delivery device 10Attorney Docket: 00101.00467.AB674WO shown in FIG. 81A includes a lock 690 (shown in isolation in FIG. 82). The lock 690 may preferably be formed of a single piece of injection molded material. In the example embodiment, the lock 690 includes a base portion 692 from which a set of arm members 694 extend. The base portion 692 may include a first segment 696 having a protuberance 698. The base portion 692 may also include a second segment 700. The second segment 700 may include a peripheral wall 699 along its edges. The second segment 700 may also include a passage 702 defined therein which extends from an exterior face of the base portion 692, through the lock 690, to an interior face of the base portion 692. The passage 702 may taper from a first cross- section area to a second cross-sectional area smaller than the first as distance from the exterior face increases. In the example, the first and second segments 696, 700 are connected by a living hinge 704.

[0442] As best shown in FIG. 81B, the second segment 700 may include a receptacle 705. The receptacle may accept a protruding body 707 of the reservoir assembly 12 in which a septum 550 is retained. When the lock 690 is engaged with the delivery device 10 and the protruding body 707 is in the receptacle 705, the passage 702 may be aligned with the septum 550. The passage 702 may thus form a sharp guide which may direct a dispensing sharp 570 (e.g. a needle attached to a syringe or automated filling station) into alignment with the septum 550. The receptacle 705 may also help ensure that the delivery device 10 is placed into the lock 690 in a prescribed orientation.

[0443] Still referring to FIGS. 81A-83, as shown the height of the arm members 694 may be selected such that the trigger unit 652 rests on or is in close proximity to a face of the lock 690. The opposite side of lock 690 may rest on the peripheral region 30 of the main body 20 which may support the lock 690. With the lock 690 supported by the peripheral region 30, the trigger unit 652 may be blocked from displacing due to the interference presented by the lock 690. As shown, the base portion 692 may also include a wall which blocks displacement of the trigger unit 652 relative to the delivery unit 650. As the lock 690 may prevent displacement of the trigger unit 652, the lock 690 may inhibit inadvertent actuation of the delivery device 10 during handling or shipping. It may be required that the lock member 690 be removed from the delivery device 10 before use.

[0444] The arm members 694 may be displaceable relative to one another so as to alter the gap between the arm members 694. When the arm members 694 are in a home position, the shape of the arm members 694 may cradle the central region 28 of the main body 20 of the delivery device 10 retaining it in place between the arm members 694. The arm members 694 may be displaced to a spread state in which the delivery device 10 is released from the lockAttorney Docket: 00101.00467.AB674WO 690. When the arm members 694 are in a spread position, the arm members 694 may be biased toward the home position (shown in FIG. 81A and FIG. 82). In the example embodiment, a user may press on the protuberance 698 and displace it toward the most proximal face of the peripheral wall 699 of the second segment 700. This may distort the base member 690 at the living hinge 704 spreading the arm members 694 apart from one another. The material forming the lock 690 may be selected so as to elastically distort as this occurs. When force is relieved, the material may restore to a resting state and the arm members 694 may return to a home position. Alternatively, the lock 690 may be formed of multiple pieces and the living hinge 704 may be replaced by a hinge coupling the first and second segments 696, 700 of the base portion 692.

[0445] The protuberance 698 may include a serif 706 at its unsupported end. The serif 706 may collide with the wall 699 of the second segment 700 when the user pinches the protuberance 698 towards the second segment 700. Thus the serif 706 may provide a stop which inhibits excess deformation of the lock 690 when the arm members 694 are spread. The unsupported ends of the arm members 694 may form a lead in feature which assists in installing the lock 690 on the delivery device 10 during manufacture or packaging. In the example, the interior faces 710 of the end regions 708 of the arm members 694 are angled such that the gap between the arm members 694 increases as proximity to the ends of the arms members 694 increases. Thus, the end regions 708 of the arm members 694 may guide the delivery device 10 into place as it is pressed into the lock 690.

[0446] Referring now primarily to FIG. 83, an exploded view of the example delivery device 10 depicted in FIG. 81A is shown. As mentioned above, the example delivery device 10 includes a delivery unit 650 and a trigger unit 652. The central region 28 of the main body 20 may define a housing 712. Referring now also to FIG. 84, a guide insert 714 may also be included in the delivery unit 650. The interior face of the guide insert 714 may include a number of guide tracks 660. The guide tracks 660 are depicted as cam type tracks, thus the reservoir interface member 474 will rotate as it progresses through its displacement range along the tracks 660. The guide insert 714 may include a number of cantilevered latch projections 716. When the guide insert 714 is advanced into the housing 712 during assembly, the latch projections 716 may deflect toward the longitudinal axis of the guide insert 714. Referring now also to FIG.85, after the guide insert 714 has been advanced beyond a certain distance into the housing 712, the latch projections 716 may reach respective fenestrations 718 in the housing 712 allowing them to restore outward from their deflected states. The latch projections 716 may each include a step 720 which may latch into place against a ledge 722 defined in the wallAttorney Docket: 00101.00467.AB674WO of the fenestration 718. This may retain the guide insert 714 in place within the housing 712. Use of a guide insert 714 in place of a rigid guide body of the type described in relation to FIGS.78-80C may simply manufacture of the delivery device 10.

[0447] Still referring to FIG.85, the main body may include a number of swaged posts 724. The swaged posts 724 may be molded as pegs and the reservoir assembly 12 may be inserted into the main body 20. The molded pegs may be disposed at various positions around the periphery of the reservoir assembly 12. With the reservoir assembly 12 in place, the molded pegs may then be swaged (e.g. heat swaged) over a face of the reservoir assembly 12. Once this is completed, the swaged posts may retain the reservoir assembly 12 in place within the delivery device 12.

[0448] The end of the housing 712 most distal the peripheral region 30 includes a central depression or cup 676. The cup 676 may be a locating recess which may assist in locating the deformable spacer 656 of the trigger unit 652 (a compression spring in the example depicted). As with embodiments described in relation to FIGS. 78-80C, the trigger body 654 may also include a locating projection 678 for the deformable spacer 656. A number of apertures may be included in the housing 712. Barriers 658A, B of the trigger body 654 (described above) may displace into the interior of the housing 712 through the apertures. The trigger body 654 may additionally include at least one guide fin 682 which may displace along a slot 684 defined in the housing 712. This guide fin 682 may assist in directing displacement of the trigger body 654 relative to the delivery unit 650 and prevent rotational displacement of the trigger body 654.

[0449] Still referring to FIG. 85, the opposing side of the cup 676 in the housing 712 may provide a projection 726. The projection 726 may help locate a bias member 470 of the delivery unit 650 in place. The example delivery device 10 includes a plunger as the reservoir interface member 474. The plunger includes a number of outwardly extending protrusions 680 which may interface with one of the guide tracks 660 of the guide insert 714. The example embodiment shown in FIGS. 81A-83 includes a plunger with three outwardly extending protrusions 680 at regular angular intervals. In other examples, and as shown elsewhere herein, four evenly spaced protrusions 680 may be included. The bias member 470 may press the protrusions 680 against respective guide tracks 660. This in turn, may prevent the guide insert 714 from advancing further into the housing 712.

[0450] As the trigger body 654 is displaced toward the delivery unit 650, the barriers 658A, B of the trigger body 654 may move relative to the guide tracks 660. This may allow the plunger to advance toward the reservoir assembly 12 along the guide tracks 660 as furtherAttorney Docket: 00101.00467.AB674WO described in to as further described in relation to FIGS. 78-80C. When the user releases the trigger body 654, the deformable spacer 656 may urge the trigger body 654 and barrier 658A, B to again displace in relation to the guide tracks 660. This may allow the plunger to further advance toward the reservoir assembly 12 and expel fluid from the delivery device 10 as further described in relation to FIGS.78-80C.

[0451] As shown best in FIG. 83, the main body 20 may include at least one reservoir fill verification aperture 728. The aperture(s) 728 may be positioned so as to provide a line of sight to the reservoir portion 100 of the reservoir assembly 12. When the reservoir assembly 12 is in a filled state, the reservoir portion 100 may be in a raised state. After the reservoir assembly 12 is loaded with agent, the delivery device 10 may be positioned such that an imager may view the reservoir portion 100 via a fill verification aperture 728. An image may be taken of the delivery device 10 through the fill verification aperture 728. A controller may analyze the image to determine whether the reservoir portion 100 is in a position consistent with the reservoir assembly 10 being in an appropriate filled state. The delivery device 10 may be associated with a unique identifier (e.g. data matrix) on an exterior of the delivery device 10. The image from the imager and a pass / fail determined by the controller may be associated with a record of the unique identifier for that delivery device 10 which is stored in a database (e.g. cloud database). In the event the image analysis performed by the controller indicates that the reservoir assembly 12 is not properly filled, an alert may be generated by the controller and the delivery device 10 may be separated to prevent its use. Other sensing hardware may be used in alternative embodiments. For example, a beam break sensor could utilized to monitor for the raising of the reservoir portion 100 when the reservoir assembly 12 is brought to a filled state.

[0452] Referring now also to FIG. 86, a diagrammatic representation of an example trigger body 652 is depicted. As shown, the trigger body 652 includes only a single first barrier 658A. This is merely illustrative, the trigger body 652 may include a first barrier 658A for each respective guide track 660 within a delivery device 10. The first barriers 658A may gate displacement of the reservoir interface member 474 as described in relation to FIGS.78-80C. The trigger body 652 may be devoid of second barrier members 658B. The trigger body 652 may also include at least one integral deformable spacer 656. In the example embodiment, the deformable spacer 656 is a cantilevered latch projection. The latch projection includes a step 730 at the unsupported end thereof. The latch projection is disposed at a non-parallel angle to the long axis of the trigger body 652.

[0453] When the trigger body 652 is displaced toward a delivery unit 650, the cantilevered projection may collide with a wall of the main body 20 and deflect. For example,Attorney Docket: 00101.00467.AB674WO the cup 676 of the housing 712 may have a chamfered or filleted opening (see, e.g. FIG. 83) which guides the deflection such that the cantilevered latch projection is directed into the cup 676. As the trigger body 652 reaches the end of its displacement range, the step 730 of the cantilevered latch projection may reach a ledge defined on the main body 20 and the latch projection may restore to a less deflected state and into engagement with the ledge. The may be an opening in the wall of the cup 676 and a sidewall of the opening may serve as the ledge 676 for instance. With the latch projection in the engaged position, the first barriers 658A may be in unobstructing states and the reservoir interface member 474 of the delivery device 10 may be driven along the guide tracks 660 and against the reservoir assembly 12 by the bias member 470. The trigger body 652 may be held in a depressed state by the engagement of the step 730 with the ledge. Additionally, the force required to deflect the cantilevered latch projection may ensure that the petal members 42 spreadingly displace before the trigger body 652 is pressed to the end of its displacement range and the first barriers 658A reach an unobstructing position. This may prevent reuse and serve as an indicator that a delivery device 10 has already been consumed.

[0454] Though the cantilevered latch projection is shown extending from the trigger body 652 it could be included as part of the main body 20 in other embodiments. In such examples, the trigger body 652 would define the ledge on which the step 730 engages.

[0455] Referring now to FIGS. 87A-88B, in some embodiments, a delivery device 10 may include an indicator which communicates whether the delivery device 10 has been used. An example delivery device 10 with a trigger unit 652 and delivery unit 650 is depicts in FIGS. 88A-88B. As with the embodiments described in FIGS. 78-85, example delivery devices 10 may include a reservoir interface member 474 such as a plunger. The reservoir interface member 474 may include regions of contrasting appearance 655A, B as shown in FIGS.87A- 87B. For example, a first portion of the reservoir interface member 474 may be a first color and another region may be a second color. In some embodiments, the contrasting appearance may be accomplished through use of an applique, paint, or the like which is applied after the reservoir interface member 474 is manufactured. Alternatively, the reservoir interface member 474 may be given regions of contrasting appearance 655A, B during molding. For example, a different color material may be overmolded onto a precursor reservoir interface member 474 to complete the reservoir interface member 474. Multi-shot molding or any other suitable method may be used.

[0456] As mentioned above and further described in relation to FIGS. 78-80C, when the delivery device 10 is used, the reservoir interface member 474 may translationally displaceAttorney Docket: 00101.00467.AB674WO against the reservoir assembly 12 and may rotationally displace along the guide tracks 660. The main body 20 of the delivery device 10 may include one or more window 659 in the central region 28. When the delivery device 10 is in the storage state, a portion of the reservoir interface member 474 having a first appearance may be in alignment with the window(s) 659. As the reservoir interface member 474 is displaced to its post usage position, a portion of the reservoir interface member 474 having a second appearance may displace into ...

Claims

Attorney Docket: 00101.00467.AB674WO What is claimed is:

1. A delivery device for delivery of medical agent to a biological barrier comprising: a rigid guide body having a plurality of petal members extending outwardly from a first end thereof and a sloped guide track partitioned into an upstream portion and downstream portion by an interrupt channel; a reservoir including at least one delivery sharp coupled to the rigid guide body; a plunger partially disposed in the guide track; a bias member intermediate the plunger and a wall at a second end of the rigid guide body the bias member exerting a force compelling the plunger along the guide track when in a distorted state; a trigger body with a first barrier projection, the first barrier projection presenting an interference to displacement of the plunger along the guide track when the trigger body is in a blocking position and disposed within the channel with a track completing surface aligned with the upstream and downstream portion in when the trigger body is in a trigger position; and a deformable spacer having a first state in which the trigger body is held in the blocking position, the deformable spacer transitioning to a deformed state upon displacement of the trigger body to the trigger position.

2. The delivery device of claim 1, wherein the sloped guide track is a ledge on the interior sidewall of the rigid guide body.

3. The delivery device of claim 1, wherein the sloped guide track includes a terminal channel at a downstream end of the guide track.

4. The delivery device of claim 3, wherein the trigger body includes a second barrier projection, the second barrier projection being disposed within the terminal channel when the trigger body is in the trigger position and in an unobstructing position relative to the terminal channel when the trigger body is in the blocking position.

5. The delivery device of claim 1, wherein the deformable spacer is a spring.Attorney Docket: 00101.00467.AB674WO 6. The delivery device of claim 1, wherein the deformable spacer is a flexure of the trigger body which extends from a portion of the trigger body to the second end of the rigid guide body.

7. The delivery device of claim 1, wherein each of the at least one delivery sharp is a microneedle.

8. The delivery device of claim 1, wherein the delivery device further comprises an adhesive coupled to the petal members.

9. The delivery device of claim 1, wherein the reservoir includes a displaceable wall defining a portion of a main interior volume of the reservoir, the plunger out of contact with the displaceable wall when the portion of the plunger disposed in the guide track is in the upstream portion of the guide track.

10. The delivery device of claim 1, wherein the reservoir includes a septum.

11. A delivery device for delivery of medical agent to a biological barrier comprising: a petal bearing main body having a set of cam tracks each partitioned into an upstream portion and downstream portion by an interrupt channel; a reservoir including at least one delivery sharp; a plunger having a set of plunger protrusions each disposed in a respective cam track, the plunger biased by a first bias member from a first position in which the protrusions are disposed at the upstream portions toward a second position in which the protrusions are disposed at the downstream portions; and a button with a first set of barriers, the button displaceable between a blocking position in which the first set of barriers obstruct travel of the protrusions along the respective cam tracks and a trigger position in which the first set of barriers fill the interrupt channel and complete the cam track.

12. The delivery device of claim 11, wherein the delivery device further comprises a deformable spacer between the main body and the button.Attorney Docket: 00101.00467.AB674WO 13. The delivery device of claim 12, wherein the deformable spacer is a flexure extending from one of the main body and button.

14. The delivery device of claim 12, wherein the deformable spacer is a second bias member.

15. The delivery device of claim 11, wherein the delivery device further comprises a deformable spacer which transitions from a home state to a deformed state upon displacement of the button to the trigger position.

16. The delivery device of claim 15, wherein the deformable spacer transitions to the deformed state upon application of more than a threshold force urging the button toward the trigger position.

17. The delivery device of claim 11, wherein the petal bearing main body comprises a plurality of petal members, the petal members displacing from a relaxed position to a spreadingly displaced position when a threshold petal spreading force is applied.

18. The delivery device of claim 17, wherein the delivery device further comprises a deformable spacer intermediate the button and main body, the button displacing from the blocking position to the trigger position and deforming the spacer upon application of a threshold deforming force which is greater than the threshold petal spreading force.

19. The delivery device of claim 11, wherein each of the at least one delivery sharp is a microneedle.

20. The delivery device of claim 11, wherein the button is biased to the blocking position by a second bias member.

21. The delivery device of claim 11, wherein the button includes a second set of barriers which obstruct travel of the protrusions to a terminal region of the downstream portions when the button is in the trigger position.

22. The delivery device of claim 11, wherein the reservoir includes a displaceable wall defining a portion of a main interior volume of the reservoir, the plunger out of contact withAttorney Docket: 00101.00467.AB674WO the displaceable wall when the protrusions are disposed at the upstream portion of the respective cam tracks.

23. A delivery device for delivery of medical agent to a biological barrier comprising: a petal bearing main body having a set of guides each having an upstream portion and downstream portion; a reservoir including at least one delivery sharp; a plunger having a set of plunger protrusions each disposed in a respective guide, the plunger biased by a first bias member from a first position in which the protrusions are disposed at the upstream portions toward a second position in which the protrusions are disposed at the downstream portions; and a trigger body with a first set of barriers, the trigger body displaceable between a blocking position in which the first set of barriers obstruct displacement of the protrusions between the upstream and downstream sections of the respective guides and a trigger position in which the first set of barriers are in a stowed state.

24. The delivery device of claim 23, wherein each of the at least one delivery sharp is a microneedle.

25. The delivery device of claim 23, wherein the delivery device further comprises a deformable spacer between the main body and the trigger body.

26. The delivery device of claim 25, wherein the deformable spacer is a flexure extending from one of the main body and trigger body.

27. The delivery device of claim 25, wherein the deformable spacer is a second bias member.

28. The delivery device of claim 23, wherein the delivery device further comprises a deformable spacer which transitions from a home state to a deformed state upon displacement of the trigger body to the trigger position.

29. The delivery device of claim 28, wherein the deformable spacer transitions to the deformed state upon application of more than a threshold force urging the trigger body toward the trigger position.Attorney Docket: 00101.00467.AB674WO 30. The delivery device of claim 23, wherein the petal bearing main body comprises a plurality of petal members, the petal members displacing from a relaxed position to a spreadingly displaced position when a threshold petal spreading force is applied.

31. The delivery device of claim 30, wherein the delivery device further comprises a spacer intermediate the trigger body and main body, the trigger body displacing from the blocking position to the trigger position and deforming the spacer upon application of a threshold deforming force which is greater than the threshold petal spreading force.

32. The delivery device of claim 23, wherein the trigger body is biased to the blocking position by a second bias member.

33. The delivery device of claim 23, wherein the trigger body includes a second set of barriers which obstruct travel of the protrusions to a terminal region of the downstream portions when the trigger body is in the trigger position.

34. The delivery device of claim 23, wherein the reservoir includes a displaceable wall defining a portion of a main interior volume of the reservoir, the plunger out of contact with the displaceable wall when the protrusions are disposed at the upstream portion of the respective guides.

35. A delivery device for delivery of medical agent to a biological barrier comprising: a petal bearing main body having a set of guides each having an upstream portion and downstream portion; a reservoir including at least one delivery sharp; a plunger having a set of plunger protrusions each disposed in a respective guide; a first bias member urging the plunger toward a position in which the protrusions are at an end of the downstream portions; and a trigger body with a first and second set of barriers, the trigger body displaceable between a blocking position in which the second set of barriers are stowed and the first set of barriers obstruct displacement of the protrusions between the upstream and downstream portions of the respective guides and a trigger position in which the first set of barriers areAttorney Docket: 00101.00467.AB674WO stowed and the second set of barriers obstruct travel of the protrusions to the end of the downstream portions.

36. The delivery device of claim 35, wherein each of the at least one delivery sharp is a microneedle.

37. The delivery device of claim 35, wherein each of the guides is a sloped track.

38. The delivery device of claim 35, wherein each of the first set of barriers is within an interrupt channel defined in each guide when the trigger body is in blocking position.

39. The delivery device of claim 35, wherein each of the guides is a cam track.

40. The delivery device of claim 35, wherein the reservoir includes a displaceable wall defining a portion of a main interior volume of the reservoir, the plunger out of contact with the displaceable wall when the protrusions are disposed at the upstream portion of the respective guides.

41. The delivery device of claim 35, wherein the petal bearing main body comprises a plurality of petal members, the petal members displacing from a relaxed position to a spreadingly displaced position when a threshold petal spreading force is applied.

42. The delivery device of claim 41, wherein the delivery device further comprises a spacer intermediate the trigger body and main body, the trigger body displacing from the blocking position to the trigger position and deforming the spacer upon application of a threshold deforming force which is greater than the threshold petal spreading force.

43. The delivery device of claim 35, wherein the trigger body is biased to the blocking position by a second bias member.

44. The delivery device of claim 35, wherein the delivery device further comprises a deformable spacer between the main body and the trigger body.Attorney Docket: 00101.00467.AB674WO 45. The delivery device of claim 35, wherein the deformable spacer is a flexure extending from one of the main body and trigger body.

46. A method of expelling an agent from a delivery device comprising; applying the delivery device to a barrier; generating a spreading displacement of petal members of a main body of the delivery device by exerting a first threshold force on a trigger body of the delivery device; displacing the trigger body toward the main body to a trigger position by exerting a second threshold force greater than the first on the trigger body; displacing at least one first barrier of the trigger body from an obstructing position to a stowed position; expelling the agent from a reservoir of the delivery device by collapsing the reservoir with a spring biased plunger when each of the at least one first barrier is in the stowed position; and guiding displacement of the spring biased plunger with at least one guide track.

47. The method of claim 46, wherein applying the delivery device to the barrier comprises adhering at least the petal members of the delivery device to the barrier.

48. The method of claim 46, wherein the method further comprises preventing displacement of the trigger body to the trigger position with a deformable spacer when the first threshold force is exerted on the trigger body.

49. The method of claim 46, wherein the method further comprises biasing the trigger body in a direction away from the main body with at least one bias member.

50. The method of claim 46, wherein, displacing the at least one first barrier from the obstructing position to the stowed position comprises driving each of the at least one first barrier into an interrupt channel of a respective guide track.

51. The method of claim 46, wherein displacing the at least one first barrier from the obstructing position to the stowed position comprises displacing a surface of each of the at least one first barrier into a guide track completing position, the surface of each of the at leastAttorney Docket: 00101.00467.AB674WO one first barrier defining a span of a respective guide track of the at least one guide track in the guide track completing position.

52. The method of claim 46, wherein each of the at least one guide track is a cam track and guiding the displacement of the spring bias plunger comprises engendering rotation of the plunger as the advances along the at least one guide track.

53. The method of claim 46, wherein the method further comprises displacing at least one second barrier from a retracted position to a guide track terminus obstructing position as the trigger body is displaced to the trigger position, each of the at least one second barrier blocking a terminal end of a respective one of the at least one guide track in the guide track terminus obstructing position.

54. The method of claim 53, wherein the method further comprises displacing the plunger into contact with the at least one second barrier.

55. The method of claim 54, wherein the method further comprises ceasing exertion of force on the trigger body after the trigger body is in the trigger position and driving the trigger body away from the main body via a bias member until the at least one second barrier is returned to the retracted position and the method further comprises displacing the plunger to an end of a displacement range of the plunger.

56. A method of expelling an agent from a delivery device comprising; adhering petal members of a main body of the delivery device to a barrier; generating a spreading displacement of the petal members and puncturing the barrier with at least one delivery sharp of a reservoir of the delivery device by exerting a first threshold force on a trigger body of the delivery device; displacing the trigger body to a trigger position by exerting a second threshold force greater than the first on the trigger body; freeing a spring biased plunger to collapse the reservoir by displacing at least one first barrier of the trigger body from an obstructing position to a stowed position; guiding displacement of the spring biased plunger with at least one guide track.Attorney Docket: 00101.00467.AB674WO 57. The method of claim 56, wherein the method further comprises preventing displacement of the trigger body to the trigger position with a deformable spacer when the first threshold force is exerted on the trigger body.

58. The method of claim 56, wherein the method further comprises biasing the trigger body in a direction away from the main body with at least one bias member.

59. The method of claim 56, wherein, displacing the at least one first barrier from the obstructing position to the stowed position comprises driving each of the at least one first barrier into an interrupt channel of a respective guide track.

60. The method of claim 56, wherein displacing the at least one first barrier from the obstructing position to the stowed position comprises displacing a surface of each of the at least one first barrier into a guide track completing position, the surface of each of the at least one first barrier defining a span of a respective guide track of the at least one guide track in the guide track completing position.

61. The method of claim 56, wherein each of the at least one guide track is a cam track and guiding the displacement of the spring bias plunger comprises engendering rotation of the plunger as the advances along the at least one guide track.

62. The method of claim 56, wherein the method further comprises displacing at least one second barrier from a retracted position to a guide track terminus obstructing position as the trigger body is displaced to the trigger position, each of the at least one second barrier blocking a terminal end of a respective one of the at least one guide track in the guide track terminus obstructing position.

63. The method of claim 62, wherein the method further comprises displacing the plunger into contact with the at least one second barrier.

64. The method of claim 63, wherein the method further comprises ceasing exertion of force on the trigger body after the trigger body is in the trigger position and driving the trigger body away from the main body via a bias member until the at least one second barrier isAttorney Docket: 00101.00467.AB674WO returned to the retracted position and the method further comprises displacing the plunger to an end of a displacement range of the plunger.

65. A rigid reservoir portion of a medical agent administration device comprising: a proximal face; a distal face opposite the proximal face; a sharp bearing body comprising: a sharp bearing face with at least one delivery sharp projecting therefrom; a sharp free face opposite the sharp bearing face; and at least one lumen, each of the at least one lumen extending through a respective one of the at least one delivery sharp to the sharp free face; a receptacle located on one of the proximal and distal face of the rigid reservoir portion, the sharp bearing body seated in the receptacle with a portion of the at least one delivery sharp protruding beyond the proximal face of the rigid reservoir portion; and a bead of a swaged material circumscribing and at least partially overlaying a peripheral portion of the sharp bearing body.

66. The rigid reservoir portion of claim 65, wherein the swaged material is a material selected to absorb an output wavelength from a swaging laser.

67. The rigid reservoir portion of claim 65, wherein the swaged material is heat swaged.

68. The rigid reservoir portion of claim 65, wherein the swaged material is a first material which is different than a second material which forms at least a majority of the remainder of the rigid reservoir portion.

69. The rigid reservoir portion of claim 65, wherein the swaged material is an elastomer.

70. The rigid reservoir portion of claim 65, wherein the sharp bearing body further comprises a set of sidewalls between the sharp bearing face and the sharp free face.

71. The rigid reservoir portion of claim 70, wherein each of sidewalls comprises a step disposed intermediate the sharp bearing face and the sharp free face, a first cross-sectionalAttorney Docket: 00101.00467.AB674WO area of the sharp bearing body proximate the sharp free face being larger than the area of the sharp bearing face.

72. The rigid reservoir portion of claim 70, wherein the sidewalls each include at least one tapered span and the area of the sharp free face is larger than the area of the sharp bearing face.

73. A method for securing a sharp bearing body to a rigid reservoir portion of a medical agent administration device comprising: locating a receptacle on a face of the rigid reservoir portion; seating the sharp bearing body in a position in the receptacle so that at least one sharp of the sharp bearing body is protruding from the rigid reservoir portion; forming a bead of a material in a position circumscribing the receptacle; temporarily applying a bead displacing condition that changes the position of at least a portion of the bead into a sharp bearing body retaining position; and setting the at least a portion of the bead in the sharp bearing body retaining position.

74. The method of claim 73, wherein temporarily applying the displacing condition comprises applying a heat swage tool.

75. The method of claim 73, wherein temporarily applying the displacing condition comprises illuminating the bead with a swaging laser.

76. The method of claim 73, wherein the sharp bearing body retaining position is a position in which the at least of portion of the bead is on a sharp bearing face of the sharp bearing body.

77. The method of claim 73, wherein the sharp bearing body retaining position is a position in which the at least of portion of the bead is on at least a portion of a sidewall of the sharp bearing body.

78. The method of claim 73, wherein, the sharp bearing body retaining position is a position in which the at least a portion of the bead is on the sharp free face of the sharp bearing body.Attorney Docket: 00101.00467.AB674WO 79. The method of claim 73, wherein forming the bead of material comprises depositing the bead around the receptacle.

80. The method of claim 73, wherein forming the bead of material comprises overmolding the bead of material in position around the receptacle.

81. A delivery device for delivery of medical agent to a biological barrier comprising: a main body having a housing with a plurality of petal members extending outwardly from a first end thereof and; a guide insert coupled into the housing with a sloped guide track which is partitioned into an upstream portion and downstream portion by an interrupt channel; a reservoir including at least one delivery sharp coupled to the housing and enclosing the guide insert within the housing; a plunger partially disposed in the guide track; a bias member intermediate the plunger and a wall at a second end of the housing, the bias member exerting a force compelling the plunger along the guide track; a trigger body with a first barrier projection, the first barrier projection presenting an interference to displacement of the plunger along the guide track when the trigger body is in a blocking position and disposed within the channel with a track completing surface aligned with the upstream and downstream portion in when the trigger body is in a trigger position; and a deformable spacer having a first state in which the trigger body is held in the blocking position, the deformable spacer transitioning to a deformed state upon displacement of the trigger body to the trigger position.

82. The delivery device of claim 81, wherein the sloped guide track is a ledge on the interior sidewall of the guide insert.

83. The delivery device of claim 81, wherein the sloped guide track includes a terminal channel at a downstream end of the guide track.

84. The delivery device of claim 83, wherein the trigger body includes a second barrier projection, the second barrier projection being disposed within the terminal channel when theAttorney Docket: 00101.00467.AB674WO trigger body is in the trigger position and in an unobstructing position relative to the terminal channel when the trigger body is in the blocking position.

85. The delivery device of claim 81, wherein the deformable spacer is a spring.

86. The delivery device of claim 81, wherein the deformable spacer is a flexure of the trigger body which extends from a portion of the trigger body to the second end of the rigid guide body.

87. The delivery device of claim 81, wherein each of the at least one delivery sharp is a microneedle.

88. The delivery device of claim 81, wherein the delivery device further comprises an adhesive coupled to the petal members.

89. The delivery device of claim 81, wherein the reservoir includes a displaceable wall defining a portion of a main interior volume of the reservoir, the plunger out of contact with the displaceable wall when the portion of the plunger disposed in the guide track is in the upstream portion of the guide track.

90. The delivery device of claim 81, wherein the reservoir includes a septum.

91. A delivery device for delivery of medical agent to a biological barrier comprising: a petal bearing main body; an insert within the main body having a set of cam tracks each partitioned into an upstream portion and downstream portion by an interrupt channel; a reservoir including at least one delivery sharp; a plunger having a set of plunger protrusions each disposed in a respective cam track, the plunger biased by a first bias member from a first position in which the protrusions are disposed at the upstream portions toward a second position in which the protrusions are disposed at the downstream portions; and a button with a first set of barriers, the button displaceable between a blocking position in which the first set of barriers obstruct travel of the protrusions along the respectiveAttorney Docket: 00101.00467.AB674WO cam tracks and a trigger position in which the first set of barriers fill the interrupt channel and complete the cam track.

92. The delivery device of claim 91, wherein the delivery device further comprises a deformable spacer between the main body and the button.

93. The delivery device of claim 92, wherein the deformable spacer is a flexure extending from one of the main body and button.

94. The delivery device of claim 92, wherein the deformable spacer is a second bias member.

95. The delivery device of claim 91, wherein the delivery device further comprises a deformable spacer which transitions from a home state to a deformed state upon displacement of the button to the trigger position.

96. The delivery device of claim 91, wherein the button includes at least one latch projection and the main body includes a respective catch for each of the at least one latch projection, each of the at least one latch projection engaging the respective catch when the button is displaced to from the blocking position toward the trigger position.

97. The delivery device of claim 91, wherein the petal bearing main body comprises a plurality of petal members, the petal members displacing from a relaxed position to a spreadingly displaced position when a threshold petal spreading force is applied.

98. The delivery device of claim 97, wherein the delivery device further comprises a deformable spacer intermediate the button and main body, the button displacing from the blocking position to the trigger position and deforming the spacer upon application of a threshold deforming force which is greater than the threshold petal spreading force.

99. The delivery device of claim 91, wherein each of the at least one delivery sharp is a microneedle.

100. The delivery device of claim 91, wherein the button is biased to the blocking position by a second bias member.Attorney Docket: 00101.00467.AB674WO 101. The delivery device of claim 91, wherein the button includes a second set of barriers which obstruct travel of the protrusions to a terminal region of the downstream portions when the button is in the trigger position.

102. The delivery device of claim 91, wherein the reservoir includes a displaceable wall defining a portion of a main interior volume of the reservoir, the plunger out of contact with the displaceable wall when the protrusions are disposed at the upstream portion of the respective cam tracks.

103. A delivery device for delivery of medical agent to a biological barrier comprising: a petal bearing main body; an insert coupled within the main body with a set of guides each having an upstream portion and downstream portion; a reservoir including at least one delivery sharp; a plunger having a set of plunger protrusions each disposed in a respective guide, the plunger biased by a first bias member from a first position in which the protrusions are disposed at the upstream portions toward a second position in which the protrusions are disposed at the downstream portions; and a trigger body with a first set of barriers, the trigger body displaceable between a blocking position in which the first set of barriers obstruct displacement of the protrusions between the upstream and downstream sections of the respective guides and a trigger position in which the first set of barriers are in a stowed state.

104. The delivery device of claim 103, wherein each of the at least one delivery sharp is a microneedle.

105. The delivery device of claim 103, wherein the delivery device further comprises a deformable spacer between the main body and the trigger body.

106. The delivery device of claim 105, wherein the deformable spacer is selected from a group consisting of: a flexure extending from one of the main body and trigger body and a second bias member.Attorney Docket: 00101.00467.AB674WO 107. The delivery device of claim 103, wherein the deformable spacer is a latch projection, the latch projection extending from the trigger body, the main body including a catch, the latch projection entering into engagement with the catch as the trigger body is transitioned to the trigger position.

108. The delivery device of claim 103, wherein the delivery device further comprises a deformable spacer which transitions from a home state to a deformed state upon displacement of the trigger body to the trigger position.

109. The delivery device of claim 103, wherein the petal bearing main body comprises a plurality of petal members, the petal members displacing from a relaxed position to a spreadingly displaced position when a threshold petal spreading force is applied.

110. The delivery device of claim 109, wherein the delivery device further comprises a spacer intermediate the trigger body and main body, the trigger body displacing from the blocking position to the trigger position and deforming the spacer upon application of a threshold deforming force which is greater than the threshold petal spreading force.

111. The delivery device of claim 103, wherein the main body includes a window, and the plunger includes a region of contrasting appearance, the region of contrasting appearance being aligned with the window when the protrusions are disposed at the downstream portions.

112. The delivery device of claim 103, wherein the trigger body includes a second set of barriers which obstruct travel of the protrusions to a terminal region of the downstream portions when the trigger body is in the trigger position.

113. The delivery device of claim 103, wherein the reservoir includes a displaceable wall defining a portion of a main interior volume of the reservoir, the plunger out of contact with the displaceable wall when the protrusions are disposed at the upstream portion of the respective guides.

114. The delivery device of claim 103, wherein the reservoir includes a displaceable wall defining a portion of a main interior volume of the reservoir, the displaceable wall having a first state when the reservoir is filled with agent and a second state when the reservoir isAttorney Docket: 00101.00467.AB674WO depleted, the main body including an fill verification aperture through which at least a portion of the displaceable wall is visible when the displaceable wall is in the first state.

115. A delivery device for delivery of medical agent to a biological barrier comprising: a petal bearing main body; a guide bearing body defining a set of guides each having an upstream portion and downstream portion; a reservoir including at least one delivery sharp; a plunger having a set of plunger protrusions each disposed in a respective guide; a first bias member urging the plunger toward a position in which the protrusions are at an end of the downstream portions; and a trigger body with a first and second set of barriers, the trigger body displaceable between a blocking position in which the second set of barriers are stowed and the first set of barriers obstruct displacement of the protrusions between the upstream and downstream portions of the respective guides and a trigger position in which the first set of barriers are stowed and the second set of barriers obstruct travel of the protrusions to the end of the downstream portions.

116. The delivery device of claim 115, wherein each of the at least one delivery sharp is a microneedle.

117. The delivery device of claim 115, wherein each of the guides is a sloped track.

118. The delivery device of claim 115, wherein each of the first set of barriers is within an interrupt channel defined in each guide when the trigger body is in blocking position.

119. The delivery device of claim 115, wherein each of the guides is a cam track.

120. The delivery device of claim 115, wherein the reservoir includes a displaceable wall defining a portion of a main interior volume of the reservoir, the plunger out of contact with the displaceable wall when the protrusions are disposed at the upstream portion of the respective guides.Attorney Docket: 00101.00467.AB674WO 121. The delivery device of claim 115, wherein the petal bearing main body comprises a plurality of petal members, the petal members displacing from a relaxed position to a spreadingly displaced position when a threshold petal spreading force is applied.

122. The delivery device of claim 121, wherein the delivery device further comprises a spacer intermediate the trigger body and main body, the trigger body displacing from the blocking position to the trigger position and deforming the spacer upon application of a threshold deforming force which is greater than the threshold petal spreading force.

123. The delivery device of claim 115, wherein the reservoir includes a displaceable wall defining a portion of a main interior volume of the reservoir, the displaceable wall having a first state when the reservoir is filled with agent and a second state when the reservoir is depleted, the main body including an fill verification aperture through which at least a portion of the displaceable wall is visible when the displaceable wall is in the first state..

124. The delivery device of claim 115, wherein the delivery device further comprises a deformable spacer between the main body and the trigger body, the deformable spacer being selected from a list consisting of a bias member, a compression spring, a flexure, and a latching projection extending from the trigger body.

125. The delivery device of claim 115, wherein the main body includes a window, and the plunger includes a region of contrasting appearance, the region of contrasting appearance being aligned with the window when the protrusions are disposed at the downstream portions.

126. A method of expelling an agent from a delivery device comprising; applying the delivery device to a barrier; generating a spreading displacement of petal members of a main body of the delivery device by exerting a first threshold force on a trigger body of the delivery device; displacing the trigger body toward the main body to a trigger position by exerting a second threshold force greater than the first on the trigger body; displacing at least one first barrier of the trigger body from an obstructing position to a stowed position;Attorney Docket: 00101.00467.AB674WO expelling the agent from a reservoir of the delivery device by collapsing the reservoir with a spring biased plunger when each of the at least one first barrier is in the stowed position; and guiding displacement of the spring biased plunger with a guide insert coupled to the main body.

127. The method of claim 126, wherein applying the delivery device to the barrier comprises adhering at least the petal members of the delivery device to the barrier.

128. The method of claim 126, wherein the method further comprises resisting displacement of the trigger body to the trigger position with a deformable spacer when the first threshold force is exerted on the trigger body.

129. The method of claim 126, wherein the method further comprises biasing the trigger body in a direction away from the main body with at least one bias member.

130. The method of claim 126, wherein displacing the at least one first barrier from the obstructing position to the stowed position comprises driving each of the at least one first barrier into an interrupt channel of a respective guide track defined in the guide insert.

131. The method of claim 126, wherein displacing the at least one first barrier from the obstructing position to the stowed position comprises displacing a surface of each of the at least one first barrier into a guide track completing position, the surface of each of the at least one first barrier defining a span of a respective guide track of the guide insert in the guide track completing position.

132. The method of claim 126, wherein the guide insert includes at least one plunger guide track, each of the at least one guide track being a cam track and guiding the displacement of the spring biased plunger comprises engendering rotation of the plunger as the plunger advances along the at least one guide track.

133. The method of claim 126, wherein the method further comprises displacing at least one second barrier from a retracted position to an obstructing position as the trigger body isAttorney Docket: 00101.00467.AB674WO displaced to the trigger position, each of the at least one second barrier blocking a terminal end of a respective guide track defined in the guide insert in the obstructing position.

134. The method of claim 133, wherein the method further comprises displacing the plunger into contact with the at least one second barrier.

135. The method of claim 124, wherein the method further comprises ceasing exertion of force on the trigger body after the trigger body is in the trigger position and driving the trigger body away from the main body via a bias member until the at least one second barrier is returned to the retracted position and the method further comprises displacing the plunger to an end of a displacement range of the plunger.

136. A method of expelling an agent from a delivery device comprising; adhering petal members of a main body of the delivery device to a barrier; generating a spreading displacement of the petal members and puncturing the barrier with at least one delivery sharp of a reservoir of the delivery device by exerting a first threshold force on a trigger body of the delivery device; displacing the trigger body to a trigger position by exerting a second threshold force greater than the first on the trigger body; freeing a spring biased plunger to collapse the reservoir by displacing at least one first barrier of the trigger body from an obstructing position to a stowed position; guiding displacement of the spring biased plunger with a guide insert coupled to the main body.

137. The method of claim 136, wherein the method further comprises inhibiting displacement of the trigger body to the trigger position with a deformable spacer when the first threshold force is exerted on the trigger body.

138. The method of claim 136, wherein the method further comprises biasing the trigger body in a direction away from the main body with at least one resilient spacer.

139. The method of claim 136, wherein displacing the at least one first barrier from the obstructing position to the stowed position comprises driving each of the at least one first barrier into an interrupt channel of a respective guide track of the guide insert.Attorney Docket: 00101.00467.AB674WO 140. The method of claim 136, wherein displacing the at least one first barrier from the obstructing position to the stowed position comprises displacing a surface of each of the at least one first barrier into a guide track completing position, the surface of each of the at least one first barrier defining a span of a respective guide track of the guide insert in the guide track completing position.

141. The method of claim 136, wherein the guide insert includes at least one plunger guide track, each of the at least one guide track being a cam track and guiding the displacement of the spring biased plunger comprises engendering rotation of the plunger as the advances along the at least one guide track.

142. The method of claim 136, wherein the method further comprises displacing at least one second barrier from a retracted position to an obstructing position as the trigger body is displaced to the trigger position, each of the at least one second barrier blocking a terminal end of a respective guide track defined in the guide insert in the obstructing position.

143. The method of claim 142, wherein the method further comprises displacing the plunger into contact with the at least one second barrier.

144. The method of claim 143, wherein the method further comprises ceasing exertion of force on the trigger body after the trigger body is in the trigger position and driving the trigger body away from the main body via a bias member until the at least one second barrier is returned to the retracted position and the method further comprises displacing the plunger to an end of a displacement range of the plunger.

145. Any of the systems, methods, and apparatuses shown or described herein.