Drug delivery systems, methods and devices

Abstract

The drug delivery device may comprise a body including a central region and a peripheral region, the peripheral region may have a plurality of petals extending outwardly from the central region. The device may further comprise at least one coupling portion on a first side of the central region and at least one sharps retainer on an opposite side of the central region. Each of the at least one sharps retainer may be in fluid communication with a respective one of the at least one coupling portions.

Description

[Technical field]

[0001] The present disclosure relates to the administration of medications. More particularly, the present disclosure relates to medication administration sets and other components for assisting in the administration of medications to patients. Summary of the Invention

[0002] In accordance with one embodiment of the present disclosure, an exemplary drug delivery device may include a body including a central region and a peripheral region. The peripheral region may include a plurality of petals extending outwardly from the central region. The device may further include at least one coupling portion on a first surface of the central region. Also, the device may include at least one sharps retainer on an opposing surface of the central region. Each sharps retainer may be fluidly connected to a corresponding coupling portion. In some embodiments, the central region may be elevated relative to the peripheral region. In some embodiments, each coupling portion may be a fitting. In some embodiments, the coupling portion may include a connector receptacle having an inclined surface and a stepped surface. In some embodiments, the coupling portion may include at least one guide. In some embodiments, each coupling portion may include a luer fitting. In some embodiments, the body and the coupling portion may be configured for injection molding without side action. In some embodiments, the opposing surface of the central region may include at least one rocking member. In some embodiments, the sharps retainer may be comprised of etched silicon. In some embodiments, each sharps retainer may be attached to a stepped protrusion on the opposing surface during an injection molding process. In some embodiments, each sharps holder may be attached to the step projection of the opposing surface via an adhesive. In some embodiments, the device may further include a septum that seals a passageway fluidly connected to the sharps holder. In some embodiments, the opposing surface of the central region may be at least partially covered with an adhesive holder. In some embodiments, the device may further include an adhesive holder. In some embodiments, each sharps holder may include at least one microneedle. In some embodiments, each sharps holder may include an array of microneedles. In some embodiments, one sharps holder may include at least one microneedle having a first height and another sharps holder may include a second microneedle of a different height.In some embodiments, the first height may be selected to place the first microneedle at a shallow destination and the second height may be selected to place the second microneedle at a deep destination when the device is in use. In some embodiments, the shallow destination may be an intradermal destination. In some embodiments, the deep destination may be a subcutaneous destination. In some embodiments, each sharp retainer may be in fluid communication only with its respective coupling.

[0003] In accordance with another embodiment of the present disclosure, an exemplary drug delivery device can include a body including a central region and a peripheral region. The peripheral region can include a plurality of petals extending outwardly from the central region. The device can further include at least one coupling portion on a first side of the central region and at least one sharps retainer on an opposing side of the central region. Each sharps retainer can be fluidly connected to a corresponding coupling portion.

[0004] In some embodiments, the body may be coupled to a ridge included in a portion of said body. In some embodiments, the body may include a plurality of tabs that couple to slits in the body. In some embodiments, the central region may be raised relative to the peripheral region. In some embodiments, each coupling may be a fitting. In some embodiments, each coupling may be a tube receptacle that receives a fluid line that is connected to the fitting. In some embodiments, the coupling may include a connector receptacle having an inclined surface and a stepped surface. In some embodiments, the coupling may include at least one guide. In some embodiments, each coupling may include a luer fitting. In some embodiments, the body and the structure may be injection molded. In some embodiments, the opposing surface of the structure may include at least one rocker member. In some embodiments, the sharps retainer may be comprised of etched silicon. In some embodiments, each sharps retainer may be attached to at least one stepped protrusion on the opposing surface in an injection molding process. In some embodiments, each sharps retainer may be attached to the stepped protrusion on the opposing surface via an adhesive. In some embodiments, the device may further include a septum that seals a passageway fluidly connected to the sharps retainer. In some embodiments, the opposing surface of the structure may be at least partially covered with an adhesive retainer. In some embodiments, the device may further comprise an adhesive retainer. In some embodiments, each sharp retainer may include at least one microneedle. In some embodiments, each sharp retainer may include an array of microneedles. In some embodiments, one sharp retainer may include at least one microneedle having a first height and another sharp retainer may include a second microneedle of a different height. In some embodiments, the first height may be selected to place the first microneedle at a shallow destination and the second height may be selected to place the second microneedle at a deep destination when the device is in use. In some embodiments, the shallow destination may be an intradermal destination.In some embodiments, the deep destination may be a subcutaneous destination. In some embodiments, each sharp retainer may be in fluid communication only with its respective coupling.

[0005] In accordance with another embodiment of the present disclosure, an exemplary drug delivery device can include a body including a central region and a peripheral region. The peripheral region can include a plurality of petals extending outwardly from the central region. The device can further include at least one coupling portion on a first surface of the central region. Also, the device can include at least one sharps holder on an opposing surface of the central region. Each of the at least one sharps holder can be in fluid communication with a respective one of the at least one coupling portions. The at least one sharps holder can be coupled to a step protrusion on an opposing surface.

[0006] In accordance with another embodiment of the present disclosure, an analyte sensor device can include a body including a central region and a peripheral region. The peripheral region can include a plurality of petals extending outwardly from the central region. The device can further include at least one sharps retainer on a first surface of the central region. Each sharps retainer can include at least one electrode. The device can include at least one first electrode and at least one second electrode associated with an analyte detection chemistry.

[0007] In some embodiments, the central region may be elevated relative to the peripheral region. In some embodiments, each electrode may be connected to a conductive trace extending to an opposing surface of the central region. In some embodiments, the device may include at least one first electrode on a first sharps retainer and at least one second electrode on another sharps retainer. In some embodiments, an opposing surface opposite the first surface of the central region may include at least one coupling member for coupling the device to a transmitter. In some embodiments, each sharps retainer may be coupled to a step protrusion on the first surface. In some embodiments, each sharps retainer may be coupled to a step protrusion in an injection molding process. In some embodiments, the first surface may include at least one step protrusion. The first and second electrodes may each be coupled to one of the step protrusions. In some embodiments, the first and second electrodes may each be coupled to a step protrusion during an injection molding process. In some embodiments, the body may be injection molded. In some embodiments, the first surface of the central region may include at least one rocker member. In some embodiments, the sharps retainer may be comprised of etched silicon. In some embodiments, the first surface of the central region may be at least partially covered by an adhesive retaining member. In some embodiments, the device may further comprise an adhesive retaining member. In some embodiments, each of the first and second electrodes may be a micro-penetrator. In some embodiments, each of the first and second electrodes may be included in a micro-penetrator that is at least partially covered by an insulating material. In some embodiments, one of the at least one second electrode may be configured to penetrate a first depth within the biological barrier and another of the at least one second electrode may be configured to penetrate a second depth within the biological barrier. In some embodiments, the first depth may be a shallow depth and the second depth may be a subcutaneous depth. In some embodiments, the shallow depth may be an intradermal depth. In some embodiments, the device may further comprise at least one transmitter. In some embodiments, the transmitter may be disposed on a second surface opposite the first surface of the central region.In some embodiments, the analyte sensor device may be a glucose sensor.

[0008] In accordance with another embodiment of the present disclosure, an access assembly device for a biological barrier can include a body including a central region and a peripheral region. The peripheral region can include a plurality of petals. The device can further include a bond on a first side of the central region. The device can further include at least one access member on an opposing side of the central region. The access member can have a delivery lumen. The device can further include at least one analyte sensor having an electrode on an opposing side of the central region.

[0009] In some embodiments, the coupling may be a fitting such as a Luer lock fitting. In some embodiments, the coupling may include at least one guide and at least one connector receptacle. Each connector receptacle may have an inclined surface and a stepped surface. In some embodiments, the device may further include a septum sealing a passageway fluidly connected with the access member. In some embodiments, the device may further include at least one transmitter. In some embodiments, the opposing surfaces of the central region may include at least one stepped protrusion. The access member and the electrode may each be coupled to at least one stepped protrusion. In some embodiments, the opposing surfaces of the central region may include at least one rocking member. In some embodiments, the opposing surfaces of the central region may include at least one stepped protrusion, one of which may form the rocking member. In some embodiments, the analyte sensor may be a glucose sensor. In some embodiments, the access member may include an array of microneedles extending from a sharps retainer. In some embodiments, the electrodes may include micro-penetrators extending from a sharps retainer. In some embodiments, the access member may be comprised of etched silicon. In some embodiments, the access member may include a first access member for shallow delivery and a second access member for subcutaneous delivery. In some embodiments, the first access member may be configured for intradermal delivery. In some embodiments, the electrodes may include a first population of electrodes configured to detect an analyte concentration at a shallow location within the biological barrier and a second population of electrodes configured to detect an analyte concentration at a subcutaneous location. In some embodiments, the shallow location may be an intradermal location.

[0010] In accordance with yet another embodiment of the present disclosure, an exemplary access assembly device for a biological barrier can include a body including a central region and a peripheral region. The peripheral region can include a plurality of petals extending outwardly from the central region. The device can further include at least one coupling portion on a first surface of the central region. The device can further include at least one first sharps holder on an opposing surface of the central region. Each first sharps holder can be fluidly connected to a corresponding coupling portion. The device can further include at least one second sharps holder on an opposing surface of the central region. Each second sharps holder can include at least one electrode. The device can include at least one first electrode and at least one second electrode associated with an analyte detection chemistry.

[0011] In certain embodiments of any of the above devices, the body may be configured to transition from a stored state to a deployed state. At least two portions of the body may undergo a spreading displacement upon transition from the stored state to the deployed state. In certain embodiments of any of the above devices, at least two adhesive retaining portions of the body may undergo a spreading displacement upon transition from the stored state to the deployed state. In certain embodiments of any of the above devices, a central region of the body may be configured to move toward a biological barrier to which the device is applied as the device transitions from the stored state to the deployed state.

[0012] In accordance with another embodiment of the present disclosure, a drug delivery system may include an infusion device. The infusion device may include a delivery assembly including at least one sensor and at least one pump mechanism. The system may further include a set in fluid communication with the delivery device. The set may include at least one intradermal access member. The system may further include a controller configured to manage operation of the at least one pump mechanism. The controller may be in data communication with the at least one sensor and configured to analyze data from the sensor. The controller may be configured to determine whether a change in depth of the at least one access member has occurred based on data from the sensor.

[0013] In some embodiments, the system may further include at least one analyte monitor. In some embodiments, the system may further include a glucose monitor. In some embodiments, the controller may be capable of communicating with the at least one smart device and the infusion device. In some embodiments, the delivery assembly may be divided into a second part removably coupled to a first part of the infusion device. In some embodiments, the second part may be a cassette assembly. The cassette assembly may include at least one fluid path and at least one valve component, which may be covered by at least one membrane. In some embodiments, the at least one sensor may include a pressure sensor configured to monitor a volume of fluid delivered from the infusion device to the set. In some embodiments, the controller may be configured to analyze data from the at least one sensor and determine if a pressure decay rate exceeds a predefined criteria. In some embodiments, the controller may be configured to analyze data from the at least one sensor and determine if a pressure decay rate exceeds a predefined threshold and display an alert on a user interface of the system if the pressure decay rate exceeds the threshold. In some embodiments, the controller may be configured to analyze data from the at least one sensor and determine if a pressure decay rate is below a predefined threshold and display an alert on a user interface of the system if the pressure decay rate is below the threshold. In some embodiments, the at least one sensor may include an acoustic volume sensor including a variable volume chamber, and data from the at least one sensor may be indicative of a volume of fluid in the variable volume chamber. In some embodiments, the controller may be configured to analyze the data from the at least one sensor and determine if a change in volume of the variable volume chamber exceeds a predefined criterion.In some embodiments, the controller may be configured to analyze data from the at least one sensor to determine if the volume change rate of the variable volume chamber exceeds a predefined threshold and display an alert on a user interface of the system if the volume change rate exceeds the threshold. In some embodiments, the controller may be configured to analyze data from the at least one sensor to determine if the volume change rate of the variable volume chamber is below a predefined threshold and display an alert on a user interface of the system if the volume change rate falls below the threshold. In some embodiments, the at least one intradermal access member may include a microneedle. In some embodiments, the at least one intradermal access member may include an array of microneedles on a sharp retainer coupled to a stepped projection on a face of the set. In some embodiments, the face of the set may include at least one rocking member. In some embodiments, the set may include a body having a central region and a peripheral region including a plurality of petal members. In some embodiments, the body may be configured to be transitionable from a stored state to a deployed state. As the body transitions from the stored state to the deployed state, the at least two adhesive retaining portions may be configured to displace while spreading. When the body transitions from the stowed state to the deployed state, the central region may be configured to move toward a biological barrier to which the set is applied. In some embodiments, the at least one sensor may be configured to generate a data signal that varies in relation to a delivery impedance from the at least one access member.

[0014] In accordance with another embodiment, an exemplary drug delivery system may include an infusion device. The infusion device may include a delivery assembly including at least one pump mechanism. The system may further include a set in fluid communication with the delivery device. The set may include at least one shallow access member and at least one subcutaneous access member. The system may further include a controller configured to manage operation of the at least one pump mechanism. The controller may be in data communication with the at least one sensor, and configured to compare data from the at least one sensor associated with fluid delivery to the one or more shallow access members and the at least one subcutaneous access member, and determine a change in depth of the one or more shallow access members and the at least one subcutaneous access member based on the data of the at least one sensor.

[0015] In some embodiments, the at least one shallow access member and the at least one subcutaneous access member may be microneedles. In some embodiments, the at least one shallow access member and the at least one subcutaneous access member may include an array of microneedles on a sharp retainer coupled to a stepped projection on a face of the set. In some embodiments, the face of the set may include at least one rocking member. In some embodiments, the set may include a body having a central region and a peripheral region including a plurality of petal members. In some embodiments, the body may be configured to be movable from a stored state to a deployed state. As the body moves from the stored state to the deployed state, the at least two adhesive retaining portions may be configured to displace while spreading. As the body moves from the stored state to the deployed state, the central region may be configured to move toward a biological barrier to which the set is applied. In some embodiments, the system may further include at least one analyte monitor. In some embodiments, the system may further include a glucose monitor. In some embodiments, the controller may be capable of communicating with at least one smart device and the infusion device. In some embodiments, the delivery assembly may be divided into a second portion removably coupled to a first portion of the infusion device. In some embodiments, the second portion may be a cassette assembly. The cassette assembly may include at least one fluid path and at least one valve component, which may be covered by at least one membrane. In some embodiments, the at least one sensor may be configured to generate a data signal that varies in relation to a delivery impedance from the at least one access member. In some embodiments, the controller may be configured to determine that the at least one subcutaneous access member has been displaced to an intradermal depth due to an increase in delivery impedance. In some embodiments, the controller may be configured to determine that the at least one subcutaneous access member has displaced to an intradermal depth when a delivery impedance of the at least one subcutaneous access member indicated by the at least one sensor increases within a range of historical data associated with the at least one intradermal access member. In some embodiments, the controller may be configured to generate an alarm when a delivery impedance of the at least one subcutaneous access member indicated by the at least one sensor increases within a range of historical data associated with the at least one intradermal access member and a delivery impedance associated with the at least one intradermal access member indicated by the at least one sensor decreases.

[0016] In accordance with yet another embodiment of the present disclosure, a drug delivery system includes an infusion device including a delivery assembly, where the delivery assembly may include at least one pump mechanism. The system may further include a set in fluid communication with the delivery device. The set may include at least one access member, a shallow analyte sensor, and a deep analyte sensor. The system may further include a controller configured to manage operation of the at least one pump mechanism to selectively deliver fluid from the infusion device to the at least one access member. The controller may be in data communication with the shallow analyte sensor and the deep analyte sensor, and may be configured to compare data from both sensors and generate a notification when a relationship between the data exceeds a predetermined criterion.

[0017] In some embodiments, the at least one shallow analyte sensor and the at least one subcutaneous analyte sensor may include a micro-penetrator. In some embodiments, the face of the set may include at least one step, and the shallow analyte sensor and the deep analyte sensor may be coupled to any of the at least one step. In some embodiments, the face of the set may include at least one rocking member. In some embodiments, the set may include a body having a central region and a peripheral region including a plurality of petal members. In some embodiments, the body may be configured to be movable from a stored state to a deployed state. When the body moves from the stored state to the deployed state, the at least two adhesive retaining portions may be configured to displace while spreading. When the body moves from the stored state to the deployed state, the central region may be configured to move toward a biological barrier to which the set is applied. In some embodiments, the shallow analyte sensor may be an intradermal analyte sensor and the deep analyte sensor may be a subcutaneous analyte sensor. In some embodiments, the shallow analyte sensor and the deep analyte sensor may be a glucose sensor. In some embodiments, the controller may be capable of communicating with at least one smart device and an infusion device. In some embodiments, the delivery assembly may be divided into a second part removably coupled to the first part of the infusion device. In some embodiments, the second part may be a cassette assembly. The cassette assembly may include at least one flow path and at least one valve component, which may be covered by at least one membrane. In some embodiments, the predetermined criterion may be a time lag between a change in analyte concentration measured at the shallow analyte sensor and the deep analyte sensor. In some embodiments, the predetermined criterion may be determined from historical data collected from the shallow analyte sensor and the deep analyte sensor. In some embodiments, the controller may be configured to further analyze data from the shallow analyte sensor and the deep analyte sensor and generate a notification if there is data indicating that either analyte sensor has shifted from a predetermined position.

[0018] In accordance with yet another embodiment of the present disclosure, a drug delivery system includes an infusion device including a delivery assembly, where the delivery assembly may include at least one pump mechanism. The system may further include a set in fluid communication with the delivery device. The set may include at least one shallow access member, at least one deep access member, and at least one analyte monitor. The system may further include a controller configured to manage operation of the at least one pump mechanism to selectively deliver fluid from the infusion device to each access member. The system may further include at least one sensor, where the sensor may be configured to generate a signal that varies in relation to a delivery impedance from the access member. The controller may be configured to analyze data from the sensor and the analyte monitor, and generate a notification if either the analyte monitor or the access member is displaced from an intended position.

[0019] In some embodiments, the at least one shallow access member and the at least one deep access member may be microneedles. In some embodiments, the at least one shallow access member and the at least one deep access member may include an array of microneedles on a sharps retainer and may be coupled to a stepped protrusion on the face of the set. In some embodiments, the face of the set may include at least one rocking member. In some embodiments, the set may include a body having a central region and a peripheral region including a plurality of petal members. In some embodiments, the body may be configured to be movable from a stored state to a deployed state. The at least two adhesive retaining portions may be displaced as they spread as the body moves from the stored state to the deployed state. When the body moves from the stored state to the deployed state, the central region may be configured to move toward a biological barrier to which the set is applied. In some embodiments, the at least one shallow access member may be an intradermal access member and the at least one deep access member may be a subcutaneous access member. In some embodiments, the at least one analyte monitor may include a micropenetrator. In some embodiments, the controller may be capable of communicating with at least one smart device and an infusion device. In some embodiments, the delivery assembly may be divided into a second portion removably coupled to the first portion of the infusion device. In some embodiments, the second portion may be a cassette assembly. The cassette assembly may include at least one fluid path and at least one valve component, which may be covered by at least one membrane. In some embodiments, the set may include a coupling for coupling with a fluid transfer connector disposed at the end of a fluid line extending from the infusion device. In some embodiments, the set may include conductive traces extending from at least one analyte monitor. The fluid transfer connector may include contacts that are positioned against the conductive traces when the fluid transfer connector engages the coupling. In some embodiments, an electrical communication path may extend from the contacts along the length of the fluid line.

[0020] In accordance with yet another embodiment of the present disclosure, an analyte detection system can include an analyte sensor assembly including a shallow analyte sensor and a deep analyte sensor. The system may further include a controller in data communication with the shallow analyte sensor and the deep analyte sensor. The controller may be configured to compare data received from the shallow analyte sensor and the deep analyte sensor and generate a notification when data from the analyte sensors deviates from an expected relationship by more than a threshold value.

[0021] In some embodiments, the controller may be configured to initialize the expected relationship to a predefined expected relationship. In some embodiments, the controller may be configured to adjust the expected relationship based on data received from the shallow analyte sensor and the deep analyte sensor. In some embodiments, the controller may be configured to set the expected relationship based at least in part on historical data received from the shallow analyte sensor and the deep analyte sensor. In some embodiments, the shallow analyte sensor may be an intradermal analyte sensor and the deep analyte sensor may be a subcutaneous analyte sensor. In some embodiments, the shallow analyte sensor and the deep analyte sensor may each include at least one micro-penetrator. In some embodiments, the expected relationship may define a delay between a change in analyte concentration (level) sensed by the shallow analyte sensor and a change in analyte concentration (level) sensed by the deep analyte sensor. In some embodiments, the analyte detection assembly may include a connection for a connector that communicates with the controller in a wired manner. In some embodiments, the analyte detection assembly may be configured to couple to a transmitter for wirelessly communicating data to the controller. In some embodiments, the analyte detection assembly may include a surface having at least one stepped projection. The shallow analyte sensor and the deep analyte sensor may each be disposed on at least one stepped projection. In some embodiments, the surface may include a rocking member. In some embodiments, the analyte detection assembly may include a body having a central region and a peripheral region including a plurality of petal members. In some embodiments, the body may be configured to be movable from a stored state to a deployed state. As the body moves from the stored state to the deployed state, the at least two adhesive retaining portions may be configured to displace while spreading. As the body moves from the stored state to the deployed state, the central region may be configured to move toward a biological barrier to which the analyte detection assembly is applied. [Brief description of the drawings]

[0022] These and other aspects will become more apparent upon reference to the following detailed description of the various embodiments and drawings.

[0023] [Figure 1] FIG. 1 is a block diagram of an exemplary system including components such as a set, an analyte sensor, and a transmitter.

[0024] [Diagram 2] FIG. 1 is a block diagram of an exemplary system including components such as a plurality of sets, an analyte sensor, and a transmitter.

[0025] [Diagram 3] 1 shows a block diagram of an exemplary system including an access assembly (including an analyte sensor, a transmitter, and at least one access member).

[0026] [Figure 4] 4A-4B show one example embodiment of a set.

[0027] [Diagram 5] 1 is a perspective view of an exemplary embodiment of an access member;

[0028] [Figure 6] 6A-6B are views of an exemplary embodiment of an access member.

[0029] [Figure 7] 7A-7B are views of an exemplary embodiment of an access member.

[0030] [Figure 8A] 1 is a perspective view of an exemplary embodiment of a plurality of access members disposed on a sharps holder;

[0031] [Figure 8B] 1 is a perspective view of an exemplary embodiment of a plurality of access members disposed on a sharps holder;

[0032] [Figure 9A] 1 is a perspective view of an exemplary embodiment of a plurality of access members disposed on a sharps holder;

[0033] [Figure 9B] 1 is a top view of an exemplary embodiment of multiple access members disposed on a sharps holder;

[0034] [Figure 10A] 1 is a top view of an exemplary embodiment of multiple access members disposed on a sharps holder;

[0035] [Figure 10B] 1 is a perspective view of an exemplary embodiment of a plurality of access members disposed on a sharps holder;

[0036] [Figure 11A] 1 is a top view of an exemplary embodiment of multiple access members disposed on a sharps holder;

[0037] [Figure 11B] 1 is a perspective view of an exemplary embodiment of a plurality of access members disposed on a sharps holder;

[0038] [Figure 11C] FIG. 11B is a cross-sectional view taken along the indicated cutting plane of FIG. 11A.

[0039] [Figure 12] 12A-12D show various views of an exemplary access member.

[0040] [Figure 13] FIG. 2 is a perspective view of an exemplary set.

[0041] [Figure 14] FIG. 2 is a plan view of an exemplary set.

[0042] [Figure 15] 15 is a cross-sectional view taken along the indicated cutting plane of FIG. 14.

[0043] [Figure 16] FIG. 13 is a bottom view of an exemplary body of the exemplary set.

[0044] [Figure 17] FIG. 13 is a conceptual diagram of an exemplary body of an exemplary set in a delivery state.

[0045] [Figure 18] 1 shows an exemplary set positioned at an injection site of a biological barrier.

[0046] [Figure 19] 1 shows an exemplary set of delivery conditions at an injection site of a biological barrier.

[0047] [Figure 20] FIG. 2 is a side view of an exemplary set.

[0048] [Figure 21] FIG. 2 is a perspective view of an exemplary set.

[0049] [Figure 22] 22A-22I show exemplary plan views of multiple bodies.

[0050] [Figure 23] 1 shows a perspective view of an exemplary embodiment of a set;

[0051] [Figure 24] FIG. 2 is a perspective view of an exemplary set with an exemplary body partially disassembled from the set.

[0052] [Diagram 25] FIG. 2 is an exploded view of an exemplary set with adhesive liners removed from the adhesive members included in the set.

[0053] [Figure 26] FIG. 2 is a perspective view of an exemplary set.

[0054] [Figure 27] FIG. 2 is a cross-sectional view along the midplane of an exemplary set.

[0055] [Figure 28] 28A-28B show an exemplary set in a stored and delivered state, respectively.

[0056] [Figure 29] 1 shows a conceptual diagram of an exemplary set in a delivery state. [Diagram 30] 1 shows a conceptual diagram of an exemplary set in a delivery state.

[0057] [Diagram 31] 1 illustrates an exemplary perspective view of a body having a stepped projection with multiple access members coupled thereto;

[0058] [Diagram 32] 1 illustrates a perspective view of an exemplary structure.

[0059] [Diagram 33] 1 illustrates a cross-sectional view of an exemplary structure.

[0060] [Diagram 34] 1 illustrates a cutaway cross-sectional view of an exemplary step projection and an exemplary access member disposed on a sharps retainer.

[0061] [Diagram 35] 1 is a diagram of an exemplary body including a plurality of stepped projections, each stepped projection associated with at least one access member and fluidly isolated from one another. [Diagram 36]1 is a diagram of an exemplary body including a plurality of stepped projections, each stepped projection associated with at least one access member and fluidly isolated from one another.

[0062] [Figure 37] 1 shows a conceptual diagram of an exemplary set including a rocking member. [Figure 38] 1 shows a conceptual diagram of an exemplary set including a rocking member.

[0063] [Figure 39] 39A-39B show exemplary body views.

[0064] [Diagram 40] 1 illustrates a detailed view of a portion of an exemplary body.

[0065] [Diagram 41] 1 shows a plan view of an exemplary set.

[0066] [Diagram 42] FIG. 42 is a detailed view of the indicated area of ​​FIG. 41.

[0067] [Diagram 43] FIG. 1 is a perspective view of an exemplary connector.

[0068] [Diagram 44] FIG. 2 is a perspective view of an exemplary set.

[0069] [Diagram 45] FIG. 2 is a cross-sectional view of an exemplary set.

[0070] [Figure 46] FIG. 46 is a detailed view of the indicated area of ​​FIG.

[0071] [Figure 47] FIG. 2 is an exploded view of an exemplary analyte sensor and transmitter.

[0072] [Figure 48] FIG. 2 is a bottom view of an exemplary analyte sensor.

[0073] [Figure 49] FIG. 13 is a cutaway perspective view of an exemplary electrode set of an analyte sensor on an exemplary stepped projection.

[0074] [Figure 50] FIG. 1 is a bottom view of an exemplary access assembly.

[0075] [Figure 51] 1 is a plan view of an exemplary access assembly and an exemplary connector.

[0076] [Figure 52] 13 is a bottom view of another exemplary access assembly. FIG.

[0077] [Figure 53] FIG. 53 is a detailed view of the indicated area of ​​FIG. 52.

[0078] [Figure 54] FIG. 53 is a detailed view of the indicated area of ​​FIG. 52.

[0079] [Figure 55] 1 illustrates various exemplary adhesive members on an exemplary set. [Figure 56] 1 illustrates various exemplary adhesive members on an exemplary set. [Figure 57] 1 illustrates various exemplary adhesive members on an exemplary set.

[0080] [Figure 58] FIG. 2 is a block diagram of an exemplary delivery assembly included in a particular exemplary injection device. [Figure 59] FIG. 2 is a block diagram of an exemplary delivery assembly included in a particular exemplary injection device. [Figure 60] FIG. 2 is a block diagram of an exemplary delivery assembly included in a particular exemplary injection device. [Figure 61] FIG. 2 is a block diagram of an exemplary delivery assembly included in a particular exemplary injection device. [Figure 62] FIG. 2 is a block diagram of an exemplary delivery assembly included in a particular exemplary injection device. [Figure 63] FIG. 2 is a block diagram of an exemplary delivery assembly included in a particular exemplary injection device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0081] In various embodiments, the set can be used in combination with infusion devices, systems, and related methods. In various embodiments, the exemplary set can be configured to be inserted into a skin layer of a user and fluidly connected to a fluid source. In various embodiments, the exemplary set can be fluidly connected to a length of tubing and / or an infusion device. Infusion devices include any type of infusion pump, including those disclosed in U.S. Patent Application No. 13 / 788,260, filed March 7, 2013, entitled "Infusion Pump Assembly"; now U.S. Publication No. US-2014-0107579, published April 17, 2014, Attorney Docket No. K40; U.S. Patent No. 8,491,570, issued July 23, 2013, entitled "Infusion Pump Assembly"; now U.S. Patent No. G75; U.S. Patent No. No. 8,414,522, issued April 9, 2013; entitled "FLUID DELIVERY SYSTEM AND METHOD; Attorney Docket No. E70," U.S. Pat. No. 8,262,616, issued September 11, 2012; Attorney Docket No. F51, and U.S. Pat. No. 7,306,578, issued December 11, 2007; Charging Mechanism for an Infusion Pump; Attorney Docket No. C54, all of which are incorporated herein by reference in their entirety. Any connector connecting a fluid line from a pump to an infusion set may be used with the set described herein or any connector described in U.S. Patent Application No. 16 / 797,624, filed February 21, 2020 (Infusion Set and Inserter Assembly System and Method; now U.S. Publication No. US-2020-0289748, published September 17, 2020, Attorney Docket No. 00101.00307.AA159), which is also incorporated herein by reference in its entirety. The microneedles described herein include, but are not limited to, the various microneedles described in U.S. Patent No. 11,154,698, issued October 26, 2021 (Entitled Microneedle Systems and Apparatus; Attorney Docket No. G34) or U.S. Patent No. 5,983,136, issued November 9, 1999 (Entitled Drug Delivery System by Convection; Attorney Docket No. B60).

[0082] Various embodiments are described and illustrated herein, and each embodiment of each element of each apparatus may be applied to other device embodiments.

[0083] Referring to FIG. 1, a block diagram of an exemplary system 10 is shown. The exemplary system 10 may include a set 12. The set 12 may be any of the sets 12 described herein. The set 12 is attached to a portion of the patient's skin 14 to establish access to a destination within the patient. The set 12 includes at least one access member 16 through which fluid can be delivered from the set 12 to the destination. Each access member 16 is an indwelling body that extends at least partially into the skin during use. The destination may be subcutaneous or may be a shallow destination. In the case of a shallow destination, the at least one access member 16 delivers fluid to a portion of the skin between the stratum corneum and the subcutaneous tissue. The shallow destination may include a target location in the epidermis or dermis, or the junction of the epidermis and dermis, or the dermis and subcutaneous tissue. The destination may be an intradermal destination. The at least one access member 16 may be any of the access members described herein, and in certain examples, includes at least one delivery sharp (such as a microneedle). In certain examples, the set 12 may include access members 16 with different characteristics. The system 10 may deliver to one or more of the access members 16 individually or may communicate delivery to all of the access members 16. Any combination of the access members 16 described herein may be used. A single set 12 may include one or more first access members, one or more second access members, one or more third access members, etc. The access members 16 may penetrate to different depths in the patient. For example, the set 12 may include at least one subcutaneous access member 16 and at least one shallow destination access member 16. Alternatively, the set 12 may include access members 16 that extend to different shallow destinations when placed on the patient.

[0084] For delivery of certain drugs, it may be desirable to include at least one access member 16 in the set 12 suitable for shallow delivery. For example, the dermal region is highly vascularized and may therefore be absorbed more quickly than if the same drug were administered subcutaneously. This allows for faster-acting injections of drugs such as insulin. Such shallow delivery may therefore facilitate tighter control of the concentration of the analyte of interest. Shallow delivery may also reduce variability in absorption rates between patients and between different injection sites in the same patient. Additionally, drugs such as insulin come in a variety of types, such as rapid, short, intermediate, and long acting, which have different speeds and durations of action. Because of the fast absorption in the intradermal region, delivery of drugs with slower onset of action may still have a faster onset of action than if administered subcutaneously. Shallow injections may improve patient compliance and quality of life. This may be true in certain patient populations, particularly those with juvenile diabetes. Shallow application of the set 12 with the access member 16 may be painless since the access member 16 is short enough not to reach deeper anatomical nerve endings. Additionally, certain types of access members 16 may be better tolerated by patients. For example, microneedles made of silicone may not pose as much allergy concern as access members 16 made from materials containing nickel (e.g., stainless steel).

[0085] The set 12 is fluidly connected to an infusion device 18. The infusion device 18 includes a controller 20 that operates a delivery assembly 24 (e.g., pump components, valves, sensors configured to monitor the pump components or provide data regarding the cartwheel of fluid delivery from the infusion device, etc.) to output a desired amount of fluid from a reservoir 22 associated with the infusion device 18. Multiple controllers 20 may be included, with at least one controller 20 located external to the infusion device 18. An exemplary delivery assembly 24 is shown and described in Figures 58-63. In an embodiment, the infusion device 18 includes reusable and disposable components that are removably coupled. By way of example, the infusion device 18 includes a cassette assembly 25 that can be attached to a reusable portion. The cassette assembly 25 includes a reservoir 22 that is replaced when the fluid in the reservoir is depleted. The delivery assembly 24 can be divided between the cassette assembly 25 and a reusable portion. For example, the cassette assembly 25 may include fluid paths and valves that may be actuated via a flexible membrane that covers at least a portion of the cassette 25. The reusable portion may include the controller 20, a power source (e.g., a battery), a speaker, a user interface, wireless communication hardware, and various sensors and actuators for controlling the dispensing of fluids through the cassette assembly 25.

[0086] The infusion device 18 (e.g., the outlet of the cassette assembly 25) is fluidly connected to the set 12 via a connector 26. In another embodiment, the outlet of the cassette assembly 25 may be directly coupled to the set 12. In the exemplary embodiment, the connector 26 is connected to the infusion device 18 via a tube 28, but in other embodiments, the connector 26 may be provided as part of the infusion device 18 (e.g., the cassette assembly 25) and the intermediate tube 28 may be omitted. Any suitable connector 26 may be used, and the set 12 may include a cooperating interface that fluidly and sealingly engages with the connector 26. The connector 26 may be a luer lock fitting, and a luer fitting may be part of the set 12. In other embodiments, the connector 26 may be any of the connectors described in the documents incorporated by reference herein. In a particular example, the connector 26 may engage a coupling 98 (see, e.g., FIG. 13) attached to the set 12 via a set tube 96. If a luer fitting is used, the luer fitting may be provided with a check valve to prevent fluid flow when not connected to the set 12. When the connector 26 and / or coupling is not connected, a cap or cover may be used to cover it.

[0087] The infusion device 18 can deliver the desired fluid to the destination via the set 12. In various examples, the infusion device 18 delivers at least one drug. The drug delivered typically includes a drug delivered continuously or near continuously, although other drugs can be used. This can include small molecules, biopharmaceuticals, recombinantly produced drugs, and analogs thereof. In various examples, the infusion device 18 can deliver a drug that affects the cardiovascular system or blood vessels. For example, the infusion device 18 can deliver a vasodilator. In certain examples, a drug for treating pulmonary arterial hypertension, such as treprostinil, can be delivered. In some examples, a peptide, such as a regulatory hormone, can be delivered. The drug can also be a drug for treating diabetes or a drug that modulates blood glucose levels. In certain embodiments, the infusion device 18 can deliver insulin. In some embodiments, the infusion device 18 can deliver glucagon. Chemotherapy drugs can also be delivered via the set 12. In certain embodiments, multiple drugs can be delivered by one or more of the infusion devices 18 of the system 10. For example, any of the drugs described above can be delivered. The agent to be delivered may include one or more excipients that may or may not facilitate absorption. For example, insulin may be delivered with nicotinamide. Where insulin, glucagon, blood glucose, diabetes, etc. are mentioned herein, their use is merely exemplary and their use with other medical conditions, agents, and analytes should be considered.

[0088] In various embodiments, the system 10 may include one or more analyte sensors 30. The analyte sensor 30 may generate data related to the concentration of an analyte of interest in the patient. The analyte sensor 30 may include an amperometric sensor that generates a current proportional to the concentration of the analyte of interest in the patient. The analyte sensor 30 may include one or more electrode arrangements, the surface of which may be covered, coated, or otherwise associated as a sensor with an enzyme specific to the analyte of interest to facilitate such sensing. Any known chemical approach to the analyte of interest may be used. The enzyme may be an oxidoreductase from the Enzyme Committee Group EC 1.1 in certain examples. The enzyme may be classified as EC 1.1.3 in certain embodiments. In certain examples, glucose oxidase is used, but any sensor chemistry suitable for the analyte of interest may be used. Some examples include an exclusion membrane that blocks, for example, large molecules, molecules above a certain molecular weight (e.g., when the analyte is glucose), or interferents, to separate the enzyme from other patient tissue. Also, certain embodiments may include a membrane to improve biocompatibility. In certain implementations, the analyte sensor 30 may be a blood glucose monitor. Other analytes may also be monitored. The analyte sensor 30 may monitor bodily fluids in the subcutaneous space in some examples.

[0089] In alternative examples, the analyte sensor 30 monitors the patient's body fluid at at least a shallow location. For example, the analyte sensor 30 can monitor body fluid in a portion of the skin between the stratum corneum and subcutaneous tissue. Shallow measurement locations may include target locations in the epidermis or dermis, or at the junction of the epidermis and dermis, or the dermis and subcutaneous tissue. The measurement location may be an intradermal location in certain examples. The analyte sensor 30 may be any sensor described herein, for example, those associated with FIGS. 47-49.

[0090] The analyte sensor 30 may include or be associated with a transmitter 32. The transmitter 32 may be incorporated within the housing of the analyte sensor 30 or, alternatively, may be a separate component that docks with the sensor 30 and transmits data collected by the analyte sensor 30. The transmitter 32 may be a wireless transmitter (e.g., a radio frequency transmitter), such as a near field communication (NFC) transmitter or a Bluetooth transmitter. In some embodiments, the transmitter 32 may include multiple types of transmitters (e.g., NFC and Bluetooth). The analyte sensor 30 and / or the transmitter 32 may include a power source (e.g., a coin cell battery) and may include memory to store the sensor data. The analyte sensor 30 may transmit the sensor data via the transmitter 32 in response to an inquiry by other components of the system 10 or based on a predefined schedule. For example, the transmitter may transmit the sensor data after a predetermined time (e.g., 1-5 minutes) has elapsed since the last transmission. If the transmission is based on a predefined schedule, the data may also be transmitted in response to an inquiry by other components of the system 10. The data transmitted may be individual sensor readings or processed data from the analyte sensor 30 (e.g., an average of sensor readings over a period of time). Each sensor reading may be taken at a given time or each reading may be calculated from the sensor signal over a period of time. Any of the analyte sensors 30 described herein may omit the transmitter 32 and instead (or when data transfer is required) establish a wired or other physical connection with other components of the system 10. In embodiments that include a transmitter 32, a wired connection may be possible to access data from the sensor 30 as needed.

[0091] In one example, the transmitter 32 may transmit an alarm when data from the analyte sensor 30 is determined to require alerting a user of the system 10. These alarms may be transmitted by the transmitter 32 independent of a predefined schedule or without inquiry from other components of the system 10. In some embodiments, the sensor data may be transmitted over a first type of transmitter included in the transmitter 32 (e.g., NFC) and the alarms may be transmitted over a second type of transmitter (e.g., Bluetooth).

[0092] The sensor data may be transferred to the infusion device 18, the first interface 34, the second interface 36 of the system 10 (which may include a third, fourth, and fifth interface in some examples), a database 40 in the cloud 38, or a combination thereof. Additionally, the data may be transferred to one or more of the above components, which may communicate the data to other system 10 components. In one example, the first interface 34 is a reader for the analyte sensor 30, which may be a dedicated reader or a smart device such as a smartphone. The second interface 36 may also be a smart device. For example, the first interface 34 may be a smartphone and the second interface may be a smart watch, tablet, or another smartphone (e.g., of a parent, guardian, caregiver, etc.). The infusion device 18, the first or second interface 34, 36, or the cloud 38 may generate and send an alarm to other components of the system 10 when the received data meets a predetermined criteria.

[0093] The infusion device 18 receives data (directly or indirectly) from the transmitter 32, and the controller 20 of the infusion device 18 can analyze this data to inform drug administration from the infusion device 18. In this manner, drug delivery may be closed loop. In another example, drug delivery is open loop, but data from the analyte sensor 30, for example, may be used to inform the generation of an alert by the controller 20.

[0094] The controller 20 of the infusion device 18 can start or stop drug delivery if the analyte concentration or trend is determined to exceed a threshold or be outside a predefined range. The controller 20 can also adjust drug delivery if certain criteria are met. For example, if data from the analyte sensor 30 indicates that the analyte concentration is changing according to a predefined trend, the controller can increase or decrease the infusion rate. If a drug that decreases the analyte concentration is being used, the delivery rate can be decreased or stopped if the analyte concentration is decreasing. If the analyte concentration is increasing, the controller 20 can increase the delivery rate. Conversely, if a drug that increases the analyte concentration is being used, the opposite action is taken. In one embodiment, the infusion device 18 may supply fluid to the set 12 at a basal rate and occasionally administer a bolus to the patient. Depending on the rate of change of the analyte concentration, the controller 20 can adjust the basal delivery rate or adjust the administration of a bolus (or both). If multiple agents are being delivered (e.g., to different sets 12, see FIG. 2), the type of agent delivered can be changed. For example, if an agent that decreases analyte concentration is being administered and the analyte concentration is decreasing above a certain rate, the layer thickness can be switched to an agent that increases analyte concentration (and vice versa).

[0095] As shown in FIG. 2, in some embodiments, the system 10 may include a first set 12 and a second set 42. Each set 12, 42 is fluidly connected to the infusion device 18 (e.g., via tubing 28 or directly connected). Alternatively, each set 12, 42 may be connected to a separate infusion device 18 (only one shown in FIG. 2). Illustratively, each set 12, 42 is connected to a first connector 26 and a second connector 44, respectively. Each set 12, 42 may be identical to one another or different. Similarly, each connector 26, 44 may be identical to one another or different. In some embodiments, the infusion device 18 may provide different medications to each set 12, 42 and may include fluidly separated reservoirs 22 containing the medications (although in some cases the same medication may be provided to both). If a single infusion device 18 is used, the infusion device 18 may have separate reservoirs 22 for each medication and may include multiple delivery assemblies 24. In certain examples, each set 12, 42 may have a different delivery destination. For example, one set 12, 42 may deliver to a shallow delivery destination and the other to a subcutaneous delivery destination. In embodiments in which different drugs are delivered to a patient via the sets 12, 42, the drugs may be related in terms of their effect. For example, each drug may alter the same analyte. If one drug is a hormone, the other drug may also be a hormone that counteracts the effect of the hormone. In the example of a system 10 used to treat diabetes, one drug may be insulin and the other drug may be glucagon. In other examples, more sets may be included. Also, any appropriate number of drug reservoirs 22 and / or infusion devices 18 may be included.

[0096] In an alternative embodiment, each set 12, 42 may be integrated into a single assembly and include fluid paths and access members 16 associated with the connector interfaces of the respective connectors 26, 44. Within this single assembly, each set of fluid paths and access members 16 is fluidly isolated from the other sets. Thus, a drug may be delivered to set 12 via the first connector 26 and another drug may be delivered to set 12 via the second connector 44. This prevents mixing of the drugs within the delivery assembly.

[0097] 3, in certain examples, the system 10 may not include a separate set 14 or analyte sensor 30. In certain examples, an access assembly 46 is included, which includes one or more access members 16 (e.g., a microneedle array) for delivering a drug to a destination and at least one analyte sensor 30. The access members 16 and the indwelling portion 31 of the analyte sensor 30 are positioned at least a certain distance from each other. In certain examples, the distance between them may be 5-15 mm (e.g., 7-11 mm or more).

[0098] The indwelling portion 31 of the analyte sensor may be a microneedle in certain instances. In certain embodiments, the indwelling portion 31 may be a microneedle without a flow passage 68 or bore, such a portion 31 being referred to as a micropenetrator. The micropenetrator may be constructed of etched silicon and may in some cases function as an electrode for the analyte sensor 30. The silicon used may be doped to optimize its use as an electrode. In other embodiments, the micropenetrator may be at least partially coated with an insulating material and include one or more conductive electrodes on a surface of the insulating material. Known analyte sensor configurations may be incorporated into the set 14 in alternative embodiments.

[0099] The access assembly 46 is fluidly connected to the infusion device 18 via tubing and connectors 26 (see, e.g., FIG. 43). In some instances, multiple medications may be delivered through the access assembly 46 and multiple connectors 26, 44 may be connected to the access assembly 46. In that case, the fluid delivery portion of the access assembly 46 is configured as described in connection with FIG.

[0100] The transmitter 32 may also be included in the access assembly 46. Alternatively, the transmitter 32 may dock with the access assembly 46 and transmit data received from the analyte sensors 30. The system 10 including the access assembly 46 may also include one or more individual analyte sensors 30 or sets 12, 42 separate from the access assembly 46. In other embodiments, data from the sensors 30 may be transferred via a wired connection. For example, the connector 26 may include contacts that are associated with wires that lead to the infusion set 18. An example of an access assembly 46 is shown and described in connection with FIGS. 50-54.

[0101] 4A and 4B, an embodiment of an exemplary set 12 is shown. The exemplary set 12 may be a low profile set 12 that is applied to the skin of a patient. The exemplary set 12 is designed to be sized to be easily applied to various injection sites on a patient's body and easily concealed under clothing. The exemplary set 12 is also designed for simple manual application. Thus, an inserter assembly may not be required to place the set 12 at the injection site and introduce the access member 16 of the set 12 into the patient.

[0102] Such a set 12 is used to deliver a drug to a target destination in a patient via one or more access members 16. In the illustrated embodiment, multiple access members 16 are included in the set 12, although other embodiments may include only a single access member 16. The illustrated multiple access members 16 are arranged in a one or two dimensional array and extend from a structure 50 with a connector 26 that interfaces with an infusion device 18. When multiple access members 16 are included, they may be arranged in one or more rows and / or columns. As shown in FIG. 4A, three access members 16 are arranged in a row, but in other embodiments, the number and arrangement of the access members 16 may vary. In various examples, any suitable number of rows and / or columns may be included. In some embodiments, there may be a single row array including up to five access members 16. It may be desirable to space the access members 16 apart to avoid a "bed of nails" situation where the access members 16 are placed too closely together, which may hinder or inconsistently penetrate the skin between users and sets 12. The height of each access member 16 may be the same, or at least one access member 16 may have a different height than at least one of the other access members 16 in the set 12. In the exemplary embodiment shown in Figures 4A-4B, the access members 16 are depicted as delivery sharps. The delivery sharps in Figures 4A-4B are microneedles. These microneedles may be included in the set 12 with shallow (e.g., above the subcutaneous tissue) delivery destinations. In some instances, the microneedles may extend slightly into the subcutaneous tissue.

[0103] In FIG. 25, microneedles are used, but the microneedles described herein may be polyhedral (e.g., pyramidal) silicon crystal microneedles fabricated with MEMS in certain embodiments. These microneedles may be 1 mm or less in height, e.g., 0.6 mm or 0.8 mm (although longer or shorter microneedles may also be used). In some embodiments, the height of the microneedle may be 1200-1500 microns, or more in some examples. In some embodiments, the microneedle may have a sufficient height to penetrate the subcutaneous tissue at least to a certain depth. At least some edges of the microneedle may be rounded or filleted, but such microneedles may still be referred to as polyhedral herein. In some examples, as shown in FIG. 25, the microneedles described herein may be generally in the shape of a heptagonal prism cut at an angle to form a heptagonal ramp or a pointed wedge (although pentagons, nonagons, and other polygonal prisms may also be used as base shapes). In such an embodiment, the heptagonal prism may be divided by a plane extending from the apex 58 of the top surface of the prism through the distal-most side 60 of the base 62. At least two sides of the base of the microneedle may be parallel. The sidewalls 64 may extend substantially perpendicularly from the base 62. The microneedle may be substantially symmetrical about a line of symmetry extending from the apex 58 to a point on the center of the distal-most side 60. In other embodiments, the microneedle may be conical. Any other suitable shape may also be used. In this example, the apex 58 is shown as a point that forms the tip of the microneedle. In other embodiments, this portion of the microneedle may be rounded (although it may still be referred to herein as the apex 58 and such microneedles may still be referred to as pointed). In such an embodiment, the rear side edge 66 may be a rounded surface, or the rear side edge 66 and the adjacent sidewalls 64 may be replaced by rounded surfaces.

[0104] The tip or end of the microneedle may be solid, and the flow path 68 through the microneedle may be offset from the tip or end of the microneedle (in FIG. 25 , apex 58 forms the tip). Hollow-tipped microneedles may also be utilized, with the flow path 68 extending to the tip of the microneedle. In some embodiments, the microneedle may be a hollow microneedle, available from NanoPass Technologies Ltd., Golda Meir 3, Ness Ziona, Israel. It should be noted that microneedles described herein as being composed of silicon (or the substrate on which the microneedle is disposed), while still being considered to be composed of silicon, may have a surface layer of silicon dioxide (which may form, for example, due to exposure to air).

[0105] 6A-7B, in some embodiments, the microneedles may be constructed to include certain features that help reduce the pressure required to inject a fluid, such as a drug, into a patient's skin. In some instances, features common to insect stingers or biotoxin administration structures may be incorporated. These features may include various recesses or depressions formed in each microneedle or as part of at least one microneedle of set 12. These recesses or depressions may be in fluid communication with the flow channels 68 of the respective microneedles. In some embodiments, different microneedles of set 12 may include different recesses, or some microneedles may include multiple recesses that may (but need not) be different.

[0106] For example, as shown in Figures 6A-7B, the microneedle may include a channel or trough 200 on the outer inclined surface 72 from the flow channel 68 toward the distal side 60. The channel 70 allows the medical agent to flow along the outside of the microneedle through the channel 70 to find the path of least resistance, or weakest link, to the skin. In the illustrated embodiment, if the outlet of the flow channel 68 is inserted deeper than the depth of the weak area of ​​the skin, the channel 70 allows the agent to flow along the outside of the microneedle to the weak area of ​​the skin. The pellucida junction, the destination of intradermal delivery, is a weak link in the skin structure and is difficult to inject directly thereto consistently due to its relative thinness (typically about 40 nm thick). A microneedle including a channel 70 may allow the medical agent to flow to the pellucida junction, for example, when the pellucida junction passes the outlet of the flow channel 68. The channel 70 may facilitate distribution of the medical agent through a larger penetration or injection area. In some instances, the incorporation of the channel 70 into the microneedle may significantly reduce the pressure required to inject the agent into the skin. In certain instances, the pressure may be reduced by over 600% (eg, from 120 pounds per square inch (psi) to 18-20 psi in certain instances).

[0107] A suitable silicon etching technique (or mold in embodiments using polymer microneedles) can be used to create steeper side walls of the channel 70. This can help inhibit the skin from bending and blocking the channel 70. Etching techniques that can be used include, by way of non-limiting example, chemical etching techniques (e.g., acid). Suitable etching techniques include ion-based etching techniques (e.g., reactive ion etching). The etching process can be a wet etching process or a dry etching process. In some non-limiting embodiments, the channel 70 can have a side-to-side width in the range of 50-60 microns. In some non-limiting embodiments, the channel 68 can have a diameter of 50-60 microns. The channel 70 can have a width equal to the diameter or widest portion of the channel 68, or the channel 70 can have a width less than or greater than the width of the channel 68. The channel 70 can be about 5-10 percent of the height of the microneedle.

[0108] To avoid leakage of fluid from the channel 70, it may be desirable to ensure that the channel 70 terminates at least a certain distance below the surface of the skin when the microneedle is inserted into the skin, and also reaches the target skin layer (e.g., the pellucid plate junction). In some embodiments, the channel 70 extends from the flow path 68 to within up to 50 microns (e.g., 50-200 microns) of the base 62 of the microneedle. In some embodiments, the end of the channel 70 most proximal to the base 62 of the microneedle may be below at least the stratum corneum (and possibly one or more of the stratum lucidum, stratum granulosum, stratum spinosum, and stratum basale) when the microneedle is inserted into the skin. In some embodiments, the end of the channel 70 closest to the base 62 may be located below the epidermis (e.g., in the basement membrane) or within the epidermis.

[0109] The channel 70 does not have to be straight or shaped as shown and described in Figures 7A-7B. In some embodiments, the channel 70 may be a more tortuous flow path 200. For example, a curved flow path 200 may be used if the dimensions of the microneedle allow for it. Furthermore, there need not be only one channel 70. Two or more channels may be used if the structural integrity of the microneedle is taken into consideration.

[0110] The depth of the channel 70 may be about 25 microns or more (e.g., 25-50 microns) in certain examples. The depth of the channel 70 may be 5 percent or less of the height of the microneedle. The depth of the channel 70 may be constant along the length of the channel 70, but the depth of the channel 70 need not be constant along the length of the channel 70. Similarly, the width of the channel 70 need not be constant along the length of the channel 70 (see, e.g., FIG. 8B). The width of the channel 70 may be about 20-30 percent of the width of the distal side 60 of the microneedle at the narrowest point of the channel 70. In some embodiments, the width of the channel 70 may increase as the distance to the distal end 15 decreases. In some embodiments, the channel 70 may have a width at its widest that is 50% or more of the width of the distal side 60.

[0111] 8A and 8B, in other examples, the channel 70 may extend from the location of the flow passage 68 toward the tip or apex 58 of the microneedle (see, e.g., FIG. 8B). Additionally, in some examples, the channel 70 may extend from the location of the lumen 68 toward the apex 58 and toward the base 62. That is, the channel 70 may include a portion of both sides of the lumen 68 (see, e.g., FIG. 8A). As shown, the lumen 68 may be located substantially in the center of the beveled surface 72 of the microneedle. In such an embodiment, the channel 70 extends toward the distal side 60 of the base 62, and the channel 70 may extend toward the tip or apex 58. In other embodiments, the lumen 68 may be positioned at (or near) the end of the channel 70 closest to the base 62.

[0112] 9A-9B, a sharp bearing body 74 is shown containing a number of microneedles. In certain embodiments, the channel 70 may not be included. Instead, the microneedle may include a flow passage 68 having an elongated cross section (at least at the outlet, see also FIGS. 10B and 11B). Microneedles with a channel 70 and an elongated lumen 68 are also possible. The elongated lumen 68 may be in fluid communication with, for example, multiple skin layers when placed in a predetermined position within the patient's body. Thus, thin and / or weak layers of skin may be easier to target when the microneedle is advanced into the patient's body. The elongated lumen 68 may also help to reduce the pressure required for injection. Such elongated flow passage 68 may have any suitable cross section. In some embodiments, the cross section may be oval or elliptical. Alternatively, a lumen 68 having an elliptical cross section may be used, as shown in FIGS. 9A and 9B. Polygonal cross-sectional shapes may also be used, such as, but not limited to, rectangular, trapezoidal, triangular, etc. In certain instances, the cross-sectional length (in the direction of elongation) of the lumen 68 may be up to 100-200 μm or more (although in certain instances it may be less). When an elongated lumen 68 is included, the end of the lumen 68 most proximal to the distal side 60 may be spaced at least a certain distance from the distal side 60. This spacing may be such that when the microneedle is inserted into the skin, the end of the lumen 68 most proximal to the distal side 60 may be at least below the stratum corneum (and possibly one or more of the stratum lucidum, stratum granulosum, stratum spinosum, and stratum basale). In some embodiments, it may be located below the epidermis (e.g., in the basement membrane) or within the epidermis.

[0113] 9A-9B, in certain embodiments, the inclined surface 72 of the microneedle may not extend to the base 62 of the microneedle. For example, it may extend from the base 62 of the microneedle to the distal side 60. If a vertical surface 76 is included, the vertical surface 76 may be aligned with and form an extension of a side (e.g., distal side 60) of the sharps retainer 74. The inclusion of such a vertical surface 76 may help reduce the size of the sharps retainer 74 and help ensure consistent fluid delivery to a target destination of a particular microneedle. As shown in FIGS. 9A-9B, any of the microneedles shown herein may be arranged with a vertical surface 76.

[0114] Additionally or alternatively, the microneedle may include a recess 78. The recess 78 may include first and second opposing apexes 80, 82. In some embodiments, the recess 78 may be (but is not necessarily) a rounded depression or a concave depression, as shown in Figures 6A-6B. The recess 78 may have a maximum depth at which the recess 78 is in fluid communication with the flow passage 68 of the microneedle. The recess 78 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 the outlet of the lumen at the inclined surface 72 of the microneedle. When the microneedle is inserted into the skin surface, the fluid delivered through the set 12 may be delivered to the patient, at least in part, by being pumped into the recess 78. The recess 78 may be formed, for example, by cutting out material during the manufacture of the microneedle or may be formed during a molding operation. The cutting out of material may be accomplished by any known suitable process, such as, for example, etching (e.g., wet etching). In some embodiments, the recess 78 may be recessed into at least one sidewall 64 or edge of the microneedle (e.g., where two sidewalls 64 join). As shown in FIGS. 6A-6B, the recess 78 is formed in the substantially vertical back edge 66 of the microneedle, which extends from the base 62 to the apex 58. This may establish or increase the vertical void volume created by the microneedle as it penetrates the skin. That is, such a recess 78 may establish an open space in the patient through which fluid may be easily delivered from the microneedle. Locating the recess 78 in the back edge 66 may provide a low resistance path for fluid to enter the skin penetrated by the microneedle. In embodiments where the microneedle includes at least one substantially vertical wall, the recess 78 may be recessed into the substantially vertical wall. In an exemplary embodiment, the maximum depth of the recess 78 may be about 130% to 110% of the distance from the back edge 66 to the flow channel 68.

[0115] In certain examples, as shown next in Figures 10A and 10B, the microneedle may include a beveled surface 72 from which a lumen 68 extends through the microneedle. The microneedle may also include a rounded blade edge 84. In this example, the rounded blade edge 84 extends from a point 86 opposite the distal side 60 and extends in an arcuate path to the apex or tip 58 of the microneedle. In this example, the rounded blade edge 84 includes a double bevel, although other types of bevels may be used. The rounded blade edge 84 may be arced at a constant radius or may be arced at a variable radius. The rounded blade edge 31 may have an arc dimension less than 90°, or in certain examples, may have an arc dimension greater than 90° (see, e.g., Figures 11A-11C). The rounded blade edge 84 may aid in the introduction of the microneedle into the skin when the microneedle is inserted at a particular angle or over a variety of different angles.

[0116] In yet another embodiment, as shown in Figures 11A-11C, the lumen 68 may include a rounded blade edge 84 and a lumen exit surface 88. The lumen 68 may extend through the microneedle to the lumen exit surface 88, and may not be formed in a straight line through the microneedle. The lumen exit surface 88 may be angled from the apex 58 toward the distal side 60 to form an undercut. The distal edge 60 may be positioned such that a plane perpendicular to the base 62 passing through the distal edge 60 can also pass through the rounded or arcuate blade edge 84. Additionally, the outlet of the channel 68 at the lumen exit surface 88 may be positioned such that one or all planes perpendicular to the base 62 and passing through the outlet of the channel 68 can also pass through the blade edge 84. This need not be the case in all embodiments (see, for example, Figures 10A-10B). When a microneedle of the type shown in Figures 11A-11C is inserted, a vertical gap may result from the undercut. This may provide a low resistance path for fluid injection. Additionally, the undercut may help reduce the likelihood of lumen 68 becoming blocked by the skin when the microneedle is inserted into the patient or when delivery occurs.

[0117] In yet other embodiments, as shown in Figures 12A-12D, the access member 16 may be or include a microneedle having a high aspect ratio shape. In some embodiments, the microneedle may be obelisk shaped. Such microneedles may be included in an array, such as any of the arrays described herein. When an obelisk shaped microneedle is used, the microneedle may include a base 62'. The base 62' may be any desired circular or polygonal shape. By way of example, Figures 12A-12D show a base 62' that is square or diamond shaped. The exemplary microneedle includes a set of sidewalls 64' that extend from the base 62' to an end region 90 of the microneedle. The sidewalls 64' may be disposed at an angle that is not perpendicular to the base 62'. Thus, the microneedle may taper to have a smaller cross-sectional area as the distance from the base 62' increases. The portion of the microneedle most distal to the base 62' may include a beveled tip 92. Such a tip 92 may facilitate piercing the skin and may help increase the robustness of the end region 90. Any suitable bevel may be used, such as a single bevel or a double bevel.

[0118] In an embodiment of an obelisk-shaped microneedle, the microneedle may include at least one side port 94 that may function as an outlet for the microneedle. Such a side port 94 may be difficult to block with tissue that may be compressed during insertion of the microneedle into a patient. In an exemplary embodiment, the lumen 68 may extend through the base 62' of the microneedle and terminate closer to the end region 15 than the base 62'. The lumen 68 may have a relatively constant cross-section. The taper of the side wall 64' may be such that the end of the lumen 68 is wider than the cross-section of the corresponding region of the microneedle. Thus, the lumen 68 may form an opening in the side wall 64' that functions as a side port 94. In various examples, the lumen 68 may be centrally located, resulting in a symmetrical side port 94. In alternative embodiments, the lumen 68 need not be centrally located, and the side port 94 may not be symmetrical.

[0119] The microneedles and their features may be manufactured by one or more of, but not limited to, molding, etching, ablation (e.g., laser ablation), or material additive processes (e.g., 3D printing). In various embodiments, it may be desirable for the microneedles to be constructed of a biocompatible, non-ductile, high Young's modulus material that has sufficient indentation hardness to allow penetration into the skin without breaking.

[0120] If the set 12 includes microneedles, they may be painless or almost painless when applied to the patient. For this reason, such sets may be preferred by users over other types of infusion sets. This advantage is particularly noticeable for certain patient populations, such as juvenile diabetes patients. Furthermore, such sets 12 may be easier to apply. The set 12 including microneedles is ready to be applied immediately or almost immediately (e.g., when the adhesive backsheet needs to be removed) when removed from the package. As such, it may not require an inserter to pierce the skin and place the infusion set. The set 12 including microneedles can easily be changed at the site without the need to carry additional parts such as a relatively large inserter. Furthermore, the elimination of the inserter (usually a disposable single-use item) can reduce the financial burden on the patient associated with frequent site changes. This may make it easier for the patient to follow the prescribed site change schedule or to change the site more frequently (e.g., daily).

[0121] Referring again primarily to Figures 4A and 4B, the exemplary set 12 may include a body 52. ​​The body 52 may be a deformable body that may transition from a storage state (see Figure 4A) to a delivery state (see Figure 4B). In certain instances, the transition may be reversible, but in other embodiments, the transition may result in a permanent change to the body 52 and / or another portion of the set 12. At least a portion of the body 52 may be plastically deformed such that it is permanently distorted and does not return to the storage state. Destruction of a portion of the body 52, or a portion of the set 12 engaged to the body 52, may be required to remove the set 12 from the patient and render the set 12 unusable. If a permanent change occurs upon transition to the delivery state, this permanent change may not only prohibit reuse, but may also provide a perceptible (e.g., visual) indication to the user that the set 12 has been used. An indication that a transition has occurred may also be generated by the set 10. For example, an audible or tactile indication may be generated after transitioning from the storage state to the delivery state.

[0122] In various examples, the transition of set 12 from the stored state to the delivery state may be accomplished via bending, pivoting, or deformation of one or more regions of body 52. ​​In certain examples, body 52 may be or include a bistable element having a first stable state corresponding to the stored state and a second stable state corresponding to the delivery state. Body 52 may have, for example, one or more reversible regions that substantially or partially reverse shape (e.g., from convex to concave) or at least partially reverse when set 12 transitions from the stored state to the delivery state.

[0123] The transition can be affected by the application of force throughout the entire transition. Alternatively, the transition may only require the application of force throughout a portion of the transition. For example, in some embodiments, a trigger force may be applied to initiate the transition, after which the transition may be completed without the application of an external force. For example, after application of the trigger force, the transition may be characterized by a snap-through buckling in which the body 52 rapidly transitions to the delivery state.

[0124] The body 52 may be at least partially covered with adhesive 54 on the first side 24 of the body. The body 52 may serve to couple the body 52 to a skin surface at a patient's injection site. Thus, the first side 24 may be the skin-adjacent or proximal (proximal and distal defined with respect to the patient) side of the body 52. ​​When the body 52 is in the storage state and is then transitioned to the delivery state, the body 52 may be adhered to the skin. When the transition occurs, at least two adhesive-bearing portions of the body 52 may be displaced relative to one another to stretch or widen the surfaces secured to the body 52 via the adhesive 54. When the portions are adhered to the skin surface, the skin may be stretched as the adhesive-bearing portions are displaced relative to one another. This may be desirable because the skin may be held taut to facilitate puncturing the skin by the access member 16 when the body 52 transitions to the delivery state. In certain examples, the adhesive 54-bearing portions may be positioned, for example, opposite one another. The displacement of the two adhesive-bearing portions may increase the distance between the two adhesive-bearing portions or may cause the two adhesive-bearing portions to spread apart. In other embodiments, the distance between the two adhesive-bearing portions may not increase or may even decrease while causing a stretching of the skin surface. This may occur, for example, when the transition pulls a flat portion of the skin around a curve or contour of the body 52 (see, for example, Figures 18 and 19). The displacement of the adhesive-bearing portions relative to each other (whether a positive or negative change in the distance between the adhesive-bearing portions) that results in a stretching of the adhered skin may be referred to as a spreading displacement. The two adhesive-bearing portions that are so displaced may be referred to as being spreading displaced.

[0125] When body 52 transitions to the delivery state, access member 16 may be displaced or lowered proximally toward and into the skin. In the embodiments described herein, access member 16 may be covered prior to use.

[0126] 13-15, an exemplary set 12 is shown. In FIGS. 13-15, the set 12 is depicted in a retracted state. The set 12 may include a body 52 and a structure 50 to which the access member 16 is attached. The access member 16 may be included in a sharps retainer 74, which may be attached to the structure 50. A conduit 96 (e.g., microbore tubing) may be connected to the structure 50, and the structure 50 may include a flow path in communication with the access member 16. The conduit 96 may be plumbed to connect with the flow path through a portion of the body 52. ​​The conduit 96 may include a coupling 98 to which a connector 26 (e.g., a luer connector, see FIG. 1, or the connector 26 shown in FIG. 43) may be connected. The coupling 98 may include a check valve to inhibit the flow of fluid when not connected to a fluid source (e.g., the connector 26 from the infusion device 18).

[0127] The body 52 of the set 12 may have a rounded (e.g., circular) footprint and may include a central region 100 and a peripheral region 102. The central region 100 may be a raised region of the body. The body 52 and the peripheral region 102 may be substantially flat regions of the body 52 surrounding the central region 100. The thickness of the body 52 may be substantially uniform throughout the body 52. ​​It may be formed as a thin sheet or disc of material that may be thermoformed to form the raised central region 100 and the flat peripheral region 102.

[0128] Alternatively, the body 52 may be injection molded, with the raised central region 100 and the flat peripheral region 102 formed during the molding operation. In various embodiments in which the set 12 is or can be injection molded, the body 52 may be injection molded to be in a stored or delivery state. The body 52 may be more easily transitioned from the reverse state to the molded state. Thus, to reduce the effort required to transition the set 12 from the storage state to the delivery state, it may be desirable to mold the body 52 of the set 12 to the shape of its delivery state. During assembly of the set 12, the body 52 may be placed in its stored state configuration and remain in that configuration until use.

[0129] The central region 100 may be dome-shaped, which defines a receptacle 104 proximal to the body 52 within which the structure 50 may be placed. The structure 50 may be bonded within the receptacle 104 via an adhesive or in another suitable manner. The central region 100 may also include a series of fenestrations 106 that may form a fenestrated ring in the central region 100. In this example, the fenestrations 106 are equally spaced from one another and arranged in a circle approximately coaxial with the center. In alternative embodiments, the fenestrations 106 may be irregularly spaced or omitted. Additionally, in some embodiments, the fenestrations 106 may be replaced with a thinned region or ring of material in the body 52.

[0130] The body 52 may include a number of slots 108. The slots 108 may extend from a periphery 110 of the body 52 toward a center or midpoint of the body 52. ​​In an exemplary embodiment, the slots 108 extend radially. The slots 108 may extend throughout the peripheral region 102. In some embodiments, as shown, the slots 108 may also extend through at least a portion of the central region 100. The fenestrations 106 in the central region 100 may be disposed radially inward of the ends 112 of each slot 108. Thus, the body 52 may include a central region 100 surrounded by a number of petals 114, which are spaced apart via the slots 108.

[0131] Referring to FIG. 16, a plan view of the proximal surface 56 of the body 52 is shown. As shown, adhesive 54 may be included on at least a portion of the proximal surface 56. The adhesive 54 may be a skin-compatible adhesive and may help bond the set 12 to the skin surface at the injection site. In an exemplary embodiment, the adhesive 54 may be included on the peripheral region 102 of the body 52. ​​Although the adhesive 54 is shown to cover the entire surface of each petal 114 in the peripheral region 102, other embodiments may differ. For example, only certain petals 114 may include adhesive 54. In such an embodiment, the adhesive 54 may be included on at least one pair of petals 114 that are arranged oppositely (e.g., diametrically opposed in the exemplary embodiment). In some examples, only a portion (e.g., a majority of the surface area) of each petal 114 included in the peripheral region 102 may be covered with adhesive 54. Alternatively or additionally, the adhesive 54 may be different for each petal 114. Some petals 114 may be covered with a stronger adhesive 54 and other petals 114 may be covered with a less strong adhesive 54. Additional adhesive members 22 are described elsewhere herein (see, e.g., Figures 55-57) and may be used in the set 12.

[0132] Referring to FIG. 17, a conceptual representation of the body 52 of the set 12 is shown in a delivery state. In the delivery state, at least the central region 100 of the body 52 can be substantially inverted. The fenestrations 106 can facilitate this inversion by allowing increased flexure of the body 52 at the fenestrations 106. Thus, the central region 100 of the body 52 can assume a concave shape instead of a convex dome-like shape. When the peripheral region 102 is coupled to the central region 100, the peripheral region 102 can be displaced as a result of the inversion of the central region 100. In an exemplary embodiment, the entire body 52 assumes a bowl shape when transitioned to the delivery state. The peripheral region 102 can also be displaced extensively over at least a portion of the transition. The slots 108 of the body 52 can help facilitate the expansion displacement of the petals 114 as the transition occurs, thereby facilitating the stretching of the user's skin.

[0133] Body 52 may be a bistable element or may include at least one bistable region that may be stable in both the storage and delivery states. When body 52 is in the storage state, an axial load acting on central region 100 may cause body 52 to deform into an unstable state. Body 52 may then exhibit a snap-through buckling action, rapidly transitioning body 52 to a stable delivery state similar to that shown in FIG. 17. Thus, only a trigger force may be applied to initiate the transition. The remaining changes between the storage and delivery states may be caused by the snap-through phenomenon.

[0134] FIG 18 shows the set 12 in a retracted state and adhered to the skin 14 via adhesive 54 on the proximal surface 56 of the body 52. ​​FIG 19 is a conceptual diagram showing the set 12 in a delivery state. As shown, the set 12 may be applied to the skin 14 in the retracted state. The set 12 may then transition to the delivery state. As the transition occurs, a spreading displacement of the opposing petals 114 of the body 52 may occur.

[0135] Two opposing points 116A, B located on the periphery of the proximal surface 56 are shown in Figs. 18 and 19. When the set 12 is in the retracted state (Fig. 18), the shortest distance between the opposing points 116A, B is a straight line that does not pass through the proximal surface 56. This straight line is approximately parallel. However, in the delivery state, the shortest distance between the opposing points 116A, B is a straight line that passes through the proximal surface 56. If the skin 14 is secured to the body 52 via the adhesive 54 and cannot pass through the body 52, the skin 14 may be forced to conform to the curvature of the proximal surface 56. Thus, the length of the skin 14 surface between the two points 116A, B when the set 12 is in the delivery state may be greater than the length of the skin 14 surface between the points 116A, B when the set 12 is in the retracted state. The outer skin 44 may be placed under tension and stretched to accommodate this change in length. This stretching, in turn, may help facilitate piercing the skin 14 by the access member 16.

[0136] Due to the elasticity of the skin 14, when attempting to return to an unstretched state, the skin 14 may exert a restoring force against the proximal surface 56 of the body 52. ​​The body 52 may resist this restoring force and maintain its bowl shape. However, the structure 50 may be compressed between the skin 14 and the body 52. ​​This may help ensure that the access member 16 pierces the skin 14 and is in fluid communication with the target delivery destination within the patient's body.

[0137] As mentioned above, in certain instances, some petals 114 may not include adhesive 54 regions or may have proximal surfaces 56 at least partially covered with adhesive 54 that is less strong than the adhesive 54 on other petals 114. If some petals 114 are free of adhesive 54, this may help limit stretching of the skin 14. Similarly, petals 114 with less strong adhesive 54 may release the attached skin 14 patch if the force required to stretch the skin 14 exceeds a threshold value. The petals 114 themselves may be constructed such that at least one of the petals 114 includes a relief region (e.g., a thin or narrow region). For example, if the force required to stretch the skin 14 exceeds a threshold value, one or more of the petals 114 may bend or buckle at the relief region to relieve some of the tension on the skin 14.

[0138] This may be desirable as it may help reduce potential discomfort during wear of the set 12 due to excessive tension on the skin 14. Additionally, it may be useful for certain patient populations as skin characteristics vary with age, hydration status, lifestyle (exposure to sun, nutrition), etc. It may be desirable for loose or saggy skin to stretch more than skin that is more elastic. Thus, instead of providing a variety of sets 12 with different adhesives 54 targeted to specific patient populations, the set 12 may be made in a more generic manner.

[0139] 20 and 21, in another embodiment, the exemplary set 12 may include a central region 100 having an upper surface 118 and a support structure 120 integral with the upper surface 118. The support structure 120 may have a circular, e.g., substantially circular, base. The peripheral region 102 may be approximately annular in shape and may include an inner periphery and an outer periphery or rim 110 that coincides with the base 122. The set 12 may be formed by injection molding. The upper surface 118 may have a rounded footprint, e.g., approximately circular, or may be convex forming a dome shape. The upper surface 118 may have a rim 124. The upper surface 118 may include a slot 126. The slot 126 may be a notch, hole, hole, opening, or void in various embodiments. The slot 126 may aid the set 12 in transitioning from a storage state to a delivery state while relieving pressure from above. The slots 126 may extend radially relative to a center point 128 of the top surface 118, with respective first endpoints 130 circumscribing an area that includes the center point 128 of the top surface 118, and respective second endpoints 132 terminating at a fixed distance (e.g., all of the slots 126 are the same distance) from the periphery 124 of the top surface 118. In embodiments that include slots 126, the slots 126 may be, but are not required to be, spaced at regular angular intervals. In embodiments that include slots 126 described herein, the slots 126 do not necessarily have to be of the same length, but may be of the same length.

[0140] 22A-22I, various different body 52 embodiments are shown. The exemplary body 52 is shown in a flat state and can be thermoformed into a shape, such as that shown in FIG. 19. Although a thermoformable body 52 is shown, the features described with respect to a thermoformed body 52 may be included in a body 52 that is manufactured in any desired manner. As shown in FIGS. 22A-22I, the slot 126 can be provided in many different formats. Additionally, in some embodiments, the slot 126 may not be included.

[0141] In some embodiments, the slots 126 may be arranged so that they do not extend radially relative to the center point 128, as shown in FIG. 22. For example, the slots 126 may each extend at a common angle relative to the radial direction. In such embodiments, the slots 126 may be equally spaced about the top surface 118 and each may be of the same length. In other embodiments, the slots 126 may not all extend at a common angle relative to the radial direction. At least one (and possibly all) of the slots 126 may be arranged at a different angle relative to the radial direction. In some embodiments, the slots 126 may be relatively short and arranged around the periphery 124 of the top surface 118 and within an outer region of the top surface 118 (see, e.g., FIG. 22A). In other embodiments, the slots 126 may extend across the outer and middle regions of the top surface 118 (see, e.g., FIG. 22B). In yet other embodiments, the slots 126 may extend from the outer region of the top surface 118 into the middle region of the top surface 118 (see, e.g., FIG. 22C). The curved slot 126 may help to reduce the amount of pressure required to transition the set 12 from the stored state to the delivery state. Positioning the slot 126 at a more acute angle relative to the radial direction may generally reduce this pressure. The width of the slot 126 may decrease slightly during at least a portion of the transition from the stored state to the delivery state.

[0142] In other embodiments, as shown primarily in FIG. 22E, at least one of the slots 126 may have a curvature. The curvature may be defined by a constant or variable radius. The curvature may only be present on a segment of the slot 126. In alternative embodiments, the slot 126 may include two or more sections that are angled from one another. In the exemplary embodiment shown in FIG. 1, FIG. 22E shows four curved slots 126, which are spaced apart at equal angular increments. The slots 126 are arcuate and include a first end 130 and a first end 132. Each exemplary slot 126 is oriented to initially begin extending from the first end 130 in a first direction and curve to extend in a second direction like a slot. The second direction may be closer to (or may be perpendicular to) the radial direction than the first direction.

[0143] 22D and 22F, the top surface may not include one or more slots 126, but may instead include at least one aperture 118. In the illustrated example, the aperture 136 is centrally located within the top surface 118. In some embodiments, the aperture 136 may surround substantially the entire top surface 118.

[0144] 22D and 22F, the slots 126 may be included in other regions of the body 52. ​​In the exemplary embodiment, the regions of the body 52 that will become the support structures 120 (when the body 52 is thermoformed) include the slots 126. These slots 126 may be straight, curved, angled (in terms of the radial dimension), or a combination thereof, similar to the patterns of slots 126 in the various top surfaces 118 described herein. As shown, the slots 126 are spaced at regular angular intervals and are spaced between the petals 114 of the body 52.

[0145] In yet other embodiments, the width of one or more slots 126 may vary over the length of the slot 126. Several embodiments including variable width slots 126 are shown in FIGS. 22G-22I. The slots 126 may vary in width continuously and may terminate at a pointed first or second end 258, 260. The variable width slots 126 may extend along a radial direction, but not necessarily in all embodiments. In an exemplary embodiment, each of the slots 126 is widest proximate the center point 128 of the top surface 118 and decreases in width continuously as the slots 126 extend distally toward the periphery 124 of the top surface 118. The top surface 118 shown in FIGS. 22G-22I may have slots 126 in a sunburst pattern. In other embodiments, the slots 126 do not necessarily increase or decrease in width continuously from one end to the other.

[0146] As shown in FIG. 23, the central region 100 may be monolithically formed with the petals 114, including the region between each pair of slots 108 (see also FIGS. 13-19 and the examples and embodiments described above with respect thereto). The support structures 120 may extend upward from the petals 114 at an angle of 90° or at an angle greater than 90°, e.g., 100-105°, although the scale of the angle need not be limited to a range. The (vertical) distance from the base 122 of the support structures 120 to the periphery 124 of the top surface 118 may be long enough to provide a housing for the structures 50 in the central region 100. The slots 108 may extend from the periphery 110 of the set 12 to the base 122 of the support structures 120, but may terminate at the base 122 and not extend into the support structures 120 themselves. In such embodiments, rather than substantially the entire central region 100 everting when pressure is applied from above (e.g., with a finger), only the top surface 118 may evertate and assume a concave shape in the delivered state. In some embodiments, the support structure 120 may include fenestrations 134 evenly spaced about the base 122. The fenestrations 134 may facilitate manufacturing of the set 12 in embodiments in which the body 52 is thermoformed.

[0147] In some embodiments, as shown in FIG. 24, at least one of the petals 114 may be made with an extended length such that an outer end of the petal 114 may be manipulated by a patient or health care provider as a pull tab 138. The pull tab 138 may be grasped by a user to remove the set 12 from the skin 14 (see, e.g., FIG. 1) after use. The pull tab 138 may be any suitable shape. In one example, the pull tab 138 is approximately semicircular, has a first rounded end and a second end opposite the first end, and is attached to the petal 114. The second end may be attached to or integrally formed with the petal 114 by injection molding or known techniques. Although the pull tab 138 is shown extending upward toward the top surface 118, in other embodiments, the pull tab 138 may be disposed generally perpendicular to the height of the set 12. In this manner, the pull tab 138 lies generally flat against the skin 14 and is oriented generally parallel to the skin 14 when the set is worn by a user, thereby minimizing the chance that the pull tab 138 will catch on clothing or other objects.

[0148] As shown in Figure 25, a release liner 140 covering the adhesive 53 on the set 12 can be peeled off from the bottom of the set 12 before the set 12 is applied to the surface of the skin 14 (see, e.g., Figure 1). The release liner 140 can be removed in the same manner as a release liner is peeled off a bandage before application to the skin. An exemplary set 12 having a pull tab 138 and including a release liner 140 and adhesive 54 is shown in Figure 25. For purposes of illustration, the release liner 140 has been peeled off the adhesive 54.

[0149] 26-27 and 28A-28B, in some embodiments, the set 12 may include a central region 100 that is generally thimble or dome shaped, but has a relatively low height compared to certain other embodiments described herein. The (vertical) distance from the base 122 to the periphery 124 of the top surface 118 may be relatively short. In some embodiments, said distance may be approximately 0.15 inches.

[0150] Additionally or alternatively, the peripheral region 102 may not be a substantially flat annular shape. The peripheral region 102 may be defined by downwardly continuing curved petals 114 such that the periphery 110 is disposed away from the plane of the base 122 of the support structure 120 (e.g., approximately equal to or less than the distance from the base 122 to the periphery 124 of the top surface 118). The periphery 110 may be disposed along a plane more distal to the periphery 124 of the top surface 118 than to the base 122. In FIG. 26, the set 12 is shown in a stored state. The set 12 may include slots 108 that may be disposed between the petals 114, similar to other set 12 embodiments described herein. An adhesive 54 (see, e.g., FIG. 25) may be affixed to at least a portion of at least two petals 114.

[0151] 27, which is a perspective cross-sectional view of the body 52 of the set 12, the body 52 can include an inner ridge 142. The ridge 142 can be located at the base 122 of the support structure 120. The support structure 120 can be thickened in an area near the base 122 to form the ridge 142. This can facilitate forming the ridge 142, for example, in an injection molding operation that forms the remainder of the body 52. ​​This can also provide additional rigidity to the support structure 120. The ridge 142 can provide a step, ledge, or other mounting surface to which a portion of the reservoir assembly 12 of the set 12 can be attached. Such a ridge 142 can be included in any of the embodiments of the set 12 described herein. The reservoir assembly 12 and the ridge 142 are further described elsewhere herein.

[0152] 28A-28B, two conceptual representations of the set 12 transitioning from a storage state to a delivery state are shown. The set 12 may transition to the delivery state when the set 12 is affixed to the skin with adhesive 54 and pressure is applied to the set 12 from above, for example by a user's fingertip. When the petals 114 are pressed against the surface of the skin, the petals 114 may be displaced outward and at least some of the petals 114 may curl upwards due to the skin and / or the patient's body. The skin may then stretch as portions of the opposing petals 114, each secured to the skin surface by adhesive 54 (shown only in FIG. 28A ), move away from each other or displaced. As the set 12 transitions to the delivery state, at least a portion of each of the curved petals 114 may curve with a further or narrower radius of curvature. Upon reaching the delivery state, the curvature of the petals 114 may extend from the base 122 to the inflection point 144. The inflection point 144 is located in a plane away from the plane of the base 122 and may also be referred to as the lowest point in such embodiments. In such embodiments, the lowest point 144 may be in a plane more distal to the periphery 124 of the top surface 118 than the base 122. From the inflection point 144, the petals 114 may curve back upward to increasingly approach the plane in which the periphery 124 of the top surface 118 is located. The periphery 110 of the petals 114 may be located, for example, in the plane of the base 122 or at a point thereon (closer to the plane of the periphery 124 of the top surface 118). The petals 114 each have a constant radius of curvature from the inflection point 144 to the periphery 110, although this is not required. A constant radius of curvature returning upward may enhance the ability of the petals 114 to curl upward. This may promote stretching of the user's skin due to the spreading and displacement of points 360 on opposing petals 114 (each secured to the skin by adhesive 54). As noted elsewhere herein, the top surface 118 of the body 52 may also be inverted as the set 12 transitions to the delivery state 10.

[0153] 26-28B, in some embodiments, the support structure 120 may not include fenestrations 134 (see, e.g., FIG. 20) evenly spaced about the base 122. The body 52 may be manufactured by injection molding. Those skilled in the art will readily appreciate that other manufacturing techniques may be used. The body 52 may be constructed from one monolithic piece of material such that the central region 100 and the peripheral region 102 are integral with one another. The body 52 may be constructed from a polymeric material.

[0154] As shown in FIGS. 26-28B, the top surface 118 may have a rounded footprint, e.g., generally circular, or may be convex forming a dome shape (including the periphery 124). The top surface 118 may include slots 126. The slots 126 may be notches, openings, holes, apertures, or voids in various embodiments. The slots 126 may each have a first end 130 that encircles an area that includes a center point 128 of the top surface 118, and each have a second end 132 that each terminate at a distance from the periphery 124 of the top surface 118 (e.g., the slots 126 may each terminate at the same distance). In certain embodiments, the slots 126 may be disposed at regular angular increments and each be of equal length (although this need not be the case in all embodiments).

[0155] 26-28B, as described above with reference to FIG. 23, in alternative embodiments, the slots 126 may be positioned such that they do not extend radially relative to a center point 128. For example, the slots 126 may each extend at a common angle relative to the radial direction. In such embodiments, the slots 126 may be equally spaced about the top surface 118 and each may be the same length. In other embodiments, the slots 126 may not all extend at a common angle relative to the radial direction. At least one (and perhaps all) of the slots 126 may be positioned at a different angle relative to the radial direction.

[0156] Referring now primarily to Figures 29-30, several diagrams of conceptual representations of set 12 in a delivery state are shown. As explained above (and with reference to the embodiment of Figures 13-21), set 12 may transition from a storage state to a delivery state when downward pressure is applied to top surface 118. In this delivery state, body 52 of set 12 is substantially or at least partially inverted. A user may remove adhesive liner 140 (see, e.g., Figure 25) from set 12 and apply set 12 to skin 14. A user may then press top surface 118 downward (i.e., toward skin 14). This may cause petals 114 to splay outward and displace and curl upward (at least over a portion thereof), stretching skin 14. Top surface 118 may invert to press access members 16 into skin 14 and remain inverted when set 12 reaches the delivery state. The peripheral region 20 may also assume an inverted shape due to curling of the petals 114 .

[0157] In various embodiments, certain regions of the body 52 of the set 12 may remain stationary or may not invert. Thus, the body 52 may include inverting regions and elastic regions. Although described as elastic regions, it should be understood that some degree of bending or deformation may still occur when pressure is applied. However, these regions may look generally similar or extend / protrude in generally the same direction in both the stored and delivery states. As shown, the peripheral region 102 and the top surface 118 may invert, while a portion of the central region 100 may resist this degree of deformation. The support structure 120 shown in other embodiments described herein (see, for example, FIG. 20 or FIG. 26) may also be an elastic region. Thus, a particular set 12 may include a body 52 with invertible regions separated from each other by elastic regions. The slot 126 may relieve pressure from above and help the set 12 transition from the stored state to the delivery state. The opening 106 may also facilitate that transition.

[0158] As shown in FIGS. 31-33 (lower perspective view, lower perspective view, and cross-sectional view, respectively), an exemplary structure 50 for mounting a sharps retainer 74 including an access member 16 is shown. In some examples, the structure 50 may be formed as a round (generally circular) body 148, which may be substantially disk-like or planar in various examples. The distal side of the structure 50 may include a conduit receiver 150 for connecting an end of the conduit 96 extending from the coupling portion 98 (see FIG. 13). The conduit receiver 150 may include a passageway 152 that communicates with the flow passage of any access member 16 attached to the structure 50. The conduit 96 may be connected to the passageway 152 in a suitable manner (e.g., adhesive). The structure 50 may be manufactured by any technique known to one skilled in the art, such as injection molding. A distal surface of the structure 50 may be connected to a portion of the body 52 of the set 12. For example, the periphery 154 of the distal face may be connected to the inner ridge 142 (see FIG. 27) of the body 52. ​​In some instances, one or more tabs 164 (see FIGS. 35-36) extending from the periphery of the structure 50 may fit (e.g., snap-connect) into slits in the body 52 to aid in connecting the structure 50 to the body 52.

[0159] 31-33, the exemplary structure 50 may include at least one step projection 156. The step projection 156 extends from the proximal side of the circular body 148. The exemplary step projection 156 may have a height from the proximal side that is equal to or greater than the height of the microneedles (e.g., 600 microns) of the set 12. The step projection 156 extends at a near perpendicular angle from the circular body 148. The sidewall 158 of the step projection 156 may be chamfered to extend in a direction that is not perpendicular to the proximal surface of the circular body 148. The step projection 156 includes a pocket 160 for receiving the sharps retainer 74 and the access member 16 thereon. The pocket 160 is sized to fit the sharps retainer 74, which in the example shown in FIGS. 31-33 is adhesively bonded to the pocket 160. The stepped projections 156 function as protruding portions that serve to concentrate the force applied to the set 12 on the access member 16, aiding in the insertion of the access member 16 into the skin 14 (see, for example, FIG. 1).

[0160] The sharp retainer 74 may be bonded to the structure 50 during the molding process in certain instances. When the sharp retainer 74 is bonded to the structure 50 during molding, the molding material may be molded along the sidewall 162 of the sharp retainer 74, up to the surface of the sharp retainer 74 from which the access members 16 protrude. In another embodiment, the sidewall 162 of the sharp retainer 74 may be chamfered at an angle that is not perpendicular to the surface. The footprint or cross-sectional area of ​​the sharp retainer 74 may increase as the distance from the sharp retainer surface of the sharp retainer 74 increases. When the access members 16 are silicon microneedles, it is common for multiple sets of access members 16 to be formed on a large wafer, and the sharp retainer 74 containing the required number of access members 16 is cut from the wafer. To form the chamfered sidewall 162, a dicing saw may have an angled surface to create the required chamfer or angle in the sidewall 162 during the dicing process. In certain embodiments, the angle of the sidewall 162 may be 30-60° (e.g., 45°). If a chamfered sidewall 162 is present, material may be molded onto only a portion of the sidewall 162 to bond the sharps retainer 74 to the structure 50 and secured without the molded material overhanging the sharps retaining surface of the sharps retainer 74 (although this can be done if desired). Thus, the molded material acts as a standoff for the sharps retainer and does not prevent the full height of the access member 16 from fully penetrating the skin 14 (see, e.g., FIG. 1).

[0161] Referring to FIG. 34, a cross-sectional view of a portion of the step projection 156 is shown. In some embodiments, the pocket 160 of the step projection 156 may be oriented non-parallel to the plane of the circular body 148 (and the skin 14 when the set 12 is applied to a user). When the sharps holder 74 is attached to the pocket 160, the orientation of the pocket 160 causes the access member 16 (e.g., microneedle) to extend at a predetermined angle relative to the circular body 148. As an example, the pocket 160 may be positioned such that the access member 16 extends at an angle of 10-20° (e.g., 15°) relative to a plane perpendicular to the circular body 148. In other embodiments, the pocket 160 may be positioned at 45°, 60°, or any angle between 10-60°. The appropriate angle may be selected at will. In another embodiment, the entire step projection 156 may protrude from the circular body 148 at a desired angle. In this manner, when the access member 16 is attached to the pocket 160 it can extend at a desired angle relative to a plane perpendicular to the circular body 148 .

[0162] 35-36, top and bottom views of an exemplary structure 50 are shown, respectively. As previously mentioned, in some examples, the structure 50 includes tabs 164 that attach or aid in the attachment of the structure 50 to the body 52 of the set 12. In the example shown, the circular body 148 includes a plurality of circumferentially disposed tab projections 164. The tab projections 164 are symmetrically disposed about the circular body 148 and may be spaced at regular angular intervals. In another embodiment, the tab projections 164 may be asymmetrically disposed about the base or at irregular angular intervals. The tab projections 164 may engage with receiving slits disposed in the body 52 of the set 12. Thus, the tab projections 164 may be used to secure the structure 50 to the set 12. Asymmetric or irregularly disposed tab projections 164 may attach the structure 50 to the body 52 in a particular orientation, which may be desirable.

[0163] With continued reference to Figures 35-36, the exemplary structure 50 includes a plurality of conduit receptacles 150, each capable of receiving a conduit 96 in fluid communication with a coupling 98. In another embodiment, the conduit receptacles 150 may be omitted and the coupling 98 may be provided directly on the structure 50. For example, a luer fitting may be attached to the structure 50 or may be molded as part of the structure 50. In certain embodiments, the coupling on the structure 50 may be the coupling 98 described in connection with Figures 41-46.

[0164] The structure 50 may include a plurality of step projections 156. The step projections 156 are associated with where the sharps retainer 74 is attached and are associated with each conduit receiver 150 (or joint 98 of the structure 50) included in the structure 50. Although two step projections 156 and conduit receivers 150 are shown, more may be included in other examples.

[0165] The step projections 156 may be as shown, for example, in FIGS. 31-34. The conduits 96 attached to each conduit receiver 150 may be in fluid communication with the flow passages 68 (see FIG. 34) of the access members 16 attached to the corresponding step projections 156. Alternatively, if the couplings 98 are included in the structure 50 instead of the conduit receivers, the couplings 98 may be in fluid communication with the flow passages 68. The flow passages from a first conduit receiver 150 (or first couplings 98) to the access members 16 attached to the corresponding first step projections 156 may be fluidly separated from the flow passages from the other conduit receivers 150 (or couplings 98) to the access members 16 attached to the corresponding step projections 156. Each coupling 98 may connect to a connector 26, 44 from an infusion device 18 (see, for example, FIG. 2) of the system 10 (see FIG. 2).

[0166] A first drug may be administered through an access member 16 connected to one of the stepped projections 156, and a different drug may be administered through an access member 16 connected to the other stepped projection 156. For example, drugs with opposing effects may be administered. A first regulatory hormone may be administered and a second regulatory hormone that counteracts it. An example would be administering insulin and glucagon. Alternatively, the same drug may be administered through an access member 16 connected to each stepped projection 156. Or, different types of the same drug may be administered through an access member 16 connected to each stepped projection 156.

[0167] Each access member 16 connected to the stepped projection 156 may be identical or nearly identical. In certain instances, one stepped projection 156 may have more or fewer access members 16 connected to it than the other stepped projections 156. Alternatively, the access members 16 connected to one stepped projection 156 may be longer or shorter than the other stepped projections 156. The stepped projections 156 may be included with any number of heights of access members 16, and for example, insulin may be delivered through shorter access members 16 (e.g., intradermal destinations) when a rapid response is required or desired, and through longer access members 16 (e.g., subcutaneous destinations) in other situations. The distribution of the drug to the long or short access members 16 (or simultaneously to access members 16 of different heights) may be controlled by the controller 20 of the infusion device 18. The selection of which access member 16 to use may be determined by the controller 20 based on how quickly the delivered drug is desired to act.

[0168] When multiple step projections 156 are provided, they may be arranged in a row on the structure 50. As shown in FIG. 36, each step projection 156 may be arranged in the same orientation. The step projections 156 may be arranged generally along the central plane of the structure 50 in some cases. The access members 16 connected to the step projections 156 may each have the same orientation. In an example in which microneedles are used, the rear side edge 66 (see FIG. 5) of each microneedle may be arranged in a substantially coplanar manner. The step projections 156 may be arranged on both sides of the proximal surface of the structure 50 or may be arranged in the center. In certain embodiments, only a single step projection 156 may be included and multiple sharps holders 74 may be connected thereto. The flow paths from the conduit receiver 150 to each sharps holder 74 may be isolated from each other by walls or partitions inside the step projections 156.

[0169] As shown in Figs. 63A and 63B, various sets 12 described herein may include a structure 50 with at least one rocking member 166. When such a set 12 is applied to a user and transitions to a delivery state, a portion of the set 12 spreads and moves, stretching the skin so that at least one access member 16 of the set 12 penetrates the stretched skin. The movement of the access member 16 typically proceeds in a first direction that is approximately perpendicular to the surface of the skin, and the access member 16 penetrates downward into the skin. The rocking member 166 may cause the structure 50 to tilt or rock as the set 12 transitions to the delivery state. The rocking member 16 may cause the access member 16 to move slightly in a second direction substantially opposite to the first direction when pressure is released from the set 12. The movement in the second direction may occur simultaneously with the tilt.

[0170] In some embodiments, portions of the set 12 may also be deformed or adjusted to accommodate the sway of the structure 50. The tilt of the structure 50 may cause the access member 16 to move in a non-linear trajectory. For example, the access member 16 may rotate or swing along an arc-shaped trajectory at least in part as the set 12 transitions to the delivery state. In some embodiments, the tilt may occur automatically as the set 12 transitions to the delivery state. In some cases, no interlocking or linkage with a guide element is required to achieve the tilt. As an example, the presence of one or more rocking members 166 may cause the entire structure 50 to tilt as a unit. Such tilting of the structure 50 may reduce the pressure at which injection begins and / or increase the delivery flow rate in certain set 12 embodiments. The presence of the rocking members 166 may also affect the bleb formation characteristics of the delivery. Additionally, the tilt may help facilitate delivery when the access member 16 initially enters the skin 14 approximately perpendicular to the skin 14.

[0171] 37 and 38, the rocking member 166 can be a protrusion that protrudes from a proximal surface of the structure 50. In some examples, the rocking member 166 is disposed on or within the periphery of the holder 270. The height of the rocking member 166 can be approximately the same as the height of the stage protrusion 156 (see, e.g., FIGS. 31-36). The height of the rocking member 166 can also be shorter or longer.

[0172] When the set 12 including at least one rocking member 166 transitions to the delivery state, the rocking member 166 may contact the user and prevent further movement of the portion of the structure 50 including the rocking member 166. The opposite side may not have a rocking member 166 and may tilt or swing to continue moving toward the user. In certain examples, the access member 16 (e.g., microneedle) may tilt 3-5° (e.g., 4°) relative to the initial position. In other examples, the access member 16 may tilt more or less. The height of the rocking member 166 may change the point at which the access member 16 starts to rotate or swing as it transitions to the delivery state. A rocking member 166 with the same height as the step protrusion 156, for example, tends to start tilting after the access member 16 penetrates the skin 14 (see, e.g., FIG. 1).

[0173] In a particular example, the access member 16 may be a microneedle, as described herein. When the access member 16 is a microneedle, the rocking member 166 may be positioned on the side of the structure 50 closest to the back edge 66 of the microneedle. The rocking member 166 may be positioned such that the back edge 66 of the microneedle is the portion of the microneedle closest to the rocking member 166. As the structure 50 rocks, the back edge 66 of the microneedle may trace a path that penetrates the skin. The beveled surface may advance toward the back edge 66, which may facilitate cutting of the skin 14 (see, e.g., FIG. 1) when the microneedle is deployed. In this manner, the back edge 66 may be a cutting edge. Additionally, the surface on which the outlet of the flow channel 68 of each microneedle is located may move away from the skin that it contacts during initial penetration. For example, when using a microneedle as shown in FIG. 2, the lumen 68 may move away from the skin 14 that the beveled surface 21 contacts during initial penetration. Such movement of the microneedle may help ensure that fluid easily flows from the lumen 68 to the skin 14 once delivery has occurred. Such movement may create a small receiving volume for fluid to be delivered from the lumen 68 to the skin 14. When the pressure applied to transition the set 12 to the delivery state is released, the access member 16 may move slightly away from the patient. This creates a small receiving volume at the skin 14 and may move the lumen 68 away from the skin 14 where it was contacted during initial penetration. The rocking member 166 may help facilitate this movement.

[0174] As shown in FIGS. 34 and 38, in some examples, the access member 16 may be attached to a stepped projection 156 having a mounting surface (e.g., pocket 160) that is non-parallel to the circular body 148 of the holder 270. In such examples, the access member 16 may extend from the stepped projection 156 at an angle (e.g., 15°) relative to a plane perpendicular to the circular body 148. When the set 12 is first applied to a user, the circular body 148 and the skin 14 are typically parallel, so the access member 16 may be angled relative to a plane perpendicular to the skin 14 (see, e.g., FIG. 1). When the structure 50 is tilted, the access member 16 may move to a position close to perpendicular to the skin (e.g., 3-5°). Depending on the mounting angle of the access member 16, tilting the structure 50 may move the access member 16 to a position perpendicular or nearly perpendicular to the skin. In other embodiments, the access member 16 may be at a position 10° or more (e.g., 11-12°) away from perpendicular.

[0175] In certain instances, the step projection 156 may be located at the position of the rocking member 166 shown in FIGS. 37 and 38. In such an embodiment, the rocking member 166 may be omitted or may be present as a lateral extension on either side of the step projection 156. In certain instances, the step projection 156 may not be located in the center of the structure 50 (although in certain instances the step projection 156 may be located in the center of the structure 50). When the set 12 transitions to the delivery state, the access member 16 pierces the skin 14 and the step projection 156 prevents further displacement of that side of the structure 50 towards the skin 14. The opposing side of the structure 50 may continue to displace towards the skin 14. As the opposing side continues to displace towards the skin 14, a rocking or tilting motion with the movement of the access member 16 may occur as described above.

[0176] When pressure is removed from the set 12, a portion of the set 12 may at least partially return from the deformed state to its original shape. This may result in at least one region of the set 12 that is elastically deformed as the set 12 transitions to the delivery state. The at least one region that is elastically deformed may deform from an initial state to an intermediate state and then at least partially return from the intermediate state to its original shape during the transition to the delivery state. The intermediate state may be a state in which the region is maximally deformed. The region may return from this state to its initial state. For example, the petals 114 may at least partially return from their maximally deformed state to their original shape. Because the petals 114 of the set 12 are adhered to the skin 14 via the adhesive 54 of the set 12, the skin 14 may be pulled away from the underlying anatomical structure as the petals 114 return to their original shape. This may partially relieve pressure at the injection site. This reduction in pressure at the injection site may allow fluid to move more easily from the access member 16 to the delivery destination. Additionally, depending on the orientation of the access member 16, the access member 16 may pull up on the skin that it penetrates, which may result in the skin being pulled away from the underlying anatomical structure. Again, this may reduce compression of the anatomical structure at the delivery destination, facilitating delivery. The shape of the petals 114 and the materials used in the construction of the set 12 may be selected to encourage the petals 114 to at least partially return to their original shape when pressure is removed. The petals 114 may be shaped in the storage state to have a tendency to return to the stowed state when pressure is released from the set 12 during use. Petals 114 that return to their original state as the set 12 transitions to the delivery state may be included in any of the set 12 embodiments shown or described herein.

[0177] The petals 114 may be relatively free of curvature. For example, the petals 114 may be generally flat and / or extend at an angle from other portions of the body 52. ​​This may result in a relatively low force being required to deflect the petals 114 when pressure is applied to the set 12, which may facilitate the spreading displacement of the petals 114 and help ensure that the access member 16 penetrates the skin before the top surface 118 of the exemplary body 52 deforms.

[0178] As shown in FIGS. 39A-39B, the petals 114 of the exemplary body 52 each include a first region 620 adjacent the support structure 120 and a second region 622 forming a more peripheral portion of the petals 114. As shown in the figures, the first region 620 may be arcuate like the adjacent portion of the support structure 120. The second region 622 may be disposed at an angle relative to the central axis A1 of the body 52. ​​The second region 622 may form a majority of the petals 114. In some instances, the petals 114 may be primarily flat, while having curved regions or surfaces. In various embodiments, a small curved transition 621 may be included between the first and second regions 620, 622 of the petals 114 (see, for example, FIG. 40).

[0179] A living hinge may be formed at the transition between the first and second regions 620, 622. When pressure is applied to the set 12, the living hinge allows the second region 622 of the petals 114 to move relative to the first region 620. The first region 620 may deform less than the second region 622 during the transition of the set 12 to the delivery state. In some instances, the first region 620 may resist significant deformation and remain substantially undeformed during the transition. Thus, the first region 620 may act as a stop and help limit the spreading displacement of the petals 114 after a desired amount of spreading displacement has been achieved. The curved transition 621 may be included to encourage the petals 114 to at least partially return to their original position after pressure applied to the set 12 is released. In examples including petals 114 such as those in FIGS. 39A-39B, it may be desirable for the base of the step projection 156 to be approximately flush with the edge of the second region 622 of the petals 114 closest to the support structure 120 in the stored state.

[0180] In the example embodiment shown in FIG. 41 and FIG. 42, a set 12 is depicted. The set 12 includes a central region 100 and a peripheral region 102. The peripheral region 102 includes a number of slots 108 that divide the peripheral region 102 into a number of petals 114. One of the petals 114 includes a pull tab 138. The example pull tab 138 extends generally within a plane that includes the peripheral edge 110 of the peripheral region 102. When the user wears the set 12, the pull tab 138 lies flat against the skin 14, thereby minimizing the possibility that the pull tab 138 will get caught on clothing or other objects. The pull tab 138 may include one or more ridges 168 or gripping patterns to facilitate a user's grip of the pull tab 138. In the example, the included ridges 168 are ridges.

[0181] The central region 100 in the example embodiment includes a base surface 170 onto which several features extend. In the example, the base surface 170 is a flat surface, such as a plateau, and is generally flat. The base surface 170 is disposed above the peripheral region 102 or is flush with the highest portion of the peripheral region 102. The central region 100 may include a coupling 98 to which the connector 26 may be coupled. In various embodiments, a fitting (e.g., a luer lock) that serves as the coupling 98 may be attached to the central region 100, or in some cases the fitting may be integrally molded with the central region 100.

[0182] Also, as shown in FIG. 43, the central region 100 may include, by way of example, a connector receptacle 172. The connector receptacle 172 is a connector connecting protrusion extending from the base surface 170. The connector receptacle 172 includes a ramp surface 174 and a stepped surface 176. When a latch body 178 of the example connector 26 is pushed toward the connector receptacle 172, the latch body 178 may abut against the ramp surface 174 of the connector receptacle 172. In various embodiments, the latch body 178 is cantilevered from the remainder of the connector 26. Further displacement of the connector 26 may cause the latch body 178 to deflect as it is forced along the ramp surface 174. The ends of the latch body 178 may include cooperative ramp surfaces to facilitate the deflection. The latch body 178 includes a catch 180, and when the catch 180 clears the respective ramp surface 174, the latch body 178 may return to its original state. When the latch body 178 returns to its original state, the catch 180 engages the stepped surface 176 of the connector receptacle 172, securing the connector 26 to the set 12. Thus, the connector receptacle 172 can form the coupling 98 in the set 12. In some embodiments, the catch 180 can include a surface that is approximately parallel to the stepped surface 176 of the connector receptacle 172 when the catch 180 engages the stepped surface 176 of the connector receptacle 172. In other embodiments, when the connector 26 is attached to the set 12, the surface of the catch 180 can be non-parallel to the stepped surface 176, which can facilitate the connector 26 being dislodged from the set 12 if the tube 28 from the connector 26 to the infusion device 18 gets caught during user movement. In such a situation, the angle of the surface of the catch 180 can be altered to adjust the ease with which the connector 26 is dislodged from the set 12.

[0183] The connector 26 can be manually removed from the set 12 when necessary, for example when a user is showering or swimming and the infusion device 18 is not suitable for exposure to water. As shown in the example, the latch body 178 extends from outer arms 182 of the connector 26, which themselves cantilever from a central region of the connector 26. Pressing the outer arms 182 together disengages the latch body 178 from the connector receptacle 170, allowing the connector 26 to be removed. In the example embodiment, when the outer arms 182 flex towards each other, the catch 180 disengages from contact with the stepped surface 176, allowing the latch body 178 to be pulled out of the connector receptacle 172.

[0184] Connector 26 may also include sharp flanking projections 184. These side projections 184 extend generally parallel to sharps 186 included on connector 26 and act as obstacles to prevent a user from accidentally touching sharps 186. A shielding wall 188 may be provided in central region 100 to help prevent fingers or objects from accidentally disengaging latch body 178 from connector receptacle 172.

[0185] 44, the central region 100 of the set 12 includes a guide for attaching the connector 26 to the set 12. As shown in the example, a guide wall 192 protrudes from the base surface 170 of the central region 100. The guide wall 192 is generally perpendicular to the base surface 170 in various embodiments. When attaching the connector 26 to the set 12, at least either the latch body 178 or the side projection moves along the guide wall 192 to assist in aligning the connector 26 along a desired displacement path as the connector 26 is attached to the set 12. This ensures that the sharp 186 of the connector 26 penetrates the septum 196 of the set 12 along a desired puncture axis. The guide may facilitate attachment of the connector 26 to the set 12 for individuals with reduced dexterity or impaired vision. In some examples, the guide may guide the connector 26 to a proper coupling path and assist the user in coupling the connector 26 to the set 12 without looking at the set 12. "

[0186] The set 12 may also include restraining walls 194 to limit movement of the connector 26 in a particular direction. For example, a bridge of material may extend from the shielding wall 188 to the guide wall 192 to prevent vertical displacement of the latch body 178 relative to the base surface 170 when the connector 26 is attached to the set 12. This may prevent the latch body 178 from lifting past the connector receptacle 172 and causing the connector 26 to become dislodged from the set 12. In an example embodiment, the guide and restraining walls 194 are positioned approximately flush with the top surface of the connector 26 when the connector 26 is attached to the set 12, which may limit the possibility of the set 12 and / or connector 26 getting caught on clothing or other items during use.

[0187] As also shown, the set 12 may include a septum housing 198 (most clearly shown in FIG. 42). The septum housing 198 may be approximately centered within the central region 100 of the set 12. The septum housing 198 is bounded by a wall 200 that is raised from the base surface 170. The wall 200 encloses an interior space in which a septum 196 (shown in FIG. 44) is disposed upon assembly. An interior surface 202 of the wall 200 includes a plurality of ribs 204 that extend radially inward toward the axial direction of the septum housing 198 to aid in positioning and compressing the septum 196.

[0188] When the septum 196 is installed in the septum housing 198, the top of the septum 196 may be at least partially covered. In some examples, the wall 200 includes an extended region 208 furthest from the base surface 170, which may be crimped after the septum 196 is installed to help retain the septum 196 within the septum housing 198. In alternative embodiments, a plug, cap, or cover may be attached to the top of the wall 200 to cover the exposed surface of the septum 196. These plugs, caps, or covers may be attached in any suitable manner (e.g., snap fit, threaded connection, sonic welding, etc.).

[0189] 45 and 41-44, the septum housing 198 may include a post 210. The post 210 is located approximately at the center of the septum housing 198 and includes a passageway 212 therethrough that is fluidly connected to the access member 16. The cross section of the passageway 212 is shaped like the Latin letter "I," which minimizes the dead volume of the passageway 212 while maintaining a substantially uniform wall thickness of the post 210. As best seen in FIG. 45, the septum 196 includes a septum recess 208 that at least partially seats on and fluidly seals against the post 210. The post 210 helps center the septum 196 within the septum housing 198 during assembly. A portion of the septum recess 208 is disposed adjacent the post 210 when the septum 196 is installed in the bay 198, providing a fluid introduction space through which fluid is delivered from the connector 26.

[0190] The wall 200 of the septum receiving portion 198 may include a port 206, such as a notch or opening (not shown). When the connector 26 is connected to the set 12, the sharp 186 of the connector 26 moves along a displacement path that passes through the port 206 and a portion of the septum 196. When the connector 26 is connected to the set 12, the outlet 214 of the sharp 186 is disposed within the fluid introduction space formed by the recess 208 of the septum 196. When fluid pumped by the infusion device 18 (e.g., see FIG. 1 ) is discharged through the outlet 214 of the sharp 186, the fluid flows through the passage 212 and the flow path 68 of the access member 16 of the set 12 to reach the delivery destination in the patient. The septum 196 is preferably formed of a material that automatically seals after puncture and removal of the sharp 186. In some examples, the septum 196 is a silicone material.

[0191] In order to mold the set 12 without side motion, it may be desirable to include a notch extending from the top of the wall 200 toward the base surface 170. Example sets 12 may be molded without side motion using, for example, a bypass shutoff. The central region 100 may include various gaps or openings 205 to facilitate molding.

[0192] 45 and 46, the proximal side 222 of the central region 100 (the side facing the skin 14 when the set 12 is worn) includes at least one step projection 156. A sharps retainer 74 including at least one access member 16 is attached to each step projection 156 (e.g., bonded to the step projection 156 using an adhesive or during injection molding). The sharps retainer 74 is positioned such that the access member 16 extends at a desired angle relative to a plane perpendicular to the proximal side 222 of the central region 100. In some examples, the angle may be in the range of 5-45° (e.g., 30° or 15°). In alternative embodiments, the access member 16 may protrude approximately perpendicular to the proximal side 222 of the central region 100. In example embodiments, the access members 16 are depicted as microneedles.

[0193] A rocking member 166 is also disposed about the periphery of the proximal side 222 of the central region 100. As the set 12 transitions to the delivery state (the retracted state is shown in FIGS. 45 and 46), the access member 16 penetrates the skin 14 (see, e.g., FIG. 1) and the central region 100 begins to tilt as the rocking member 166 contacts the skin 14. As described herein, the tilting motion allows the access member 16 to travel along a curvilinear path within the skin 14, which helps facilitate delivery and reduce the pressure at which delivery is initiated into the skin 14.

[0194] As shown in FIGS. 41-46, the example set 12 does not include the structure 50. Instead, a step projection 156 is formed on the proximal side 222 of the central region 100. The sets 12 described herein that include the structure 50 can instead be configured such that the features of the structure 50 are included in the central region 100 of the body 52. ​​For example, the structure 50 shown in connection with FIGS. 31-38 may be included in at least a portion of the central region 100 of the set 12 and may be integrally molded with the peripheral region 102 of the body 52. ​​This can limit the number of parts and simplify assembly of the set 12. Nevertheless, the various sets 12 described herein can be modified such that the features described in FIGS. 41-46 as part of the central region 100 are included in a separate structure 50 that can be coupled to the body 52 of the set 12.

[0195] As shown in FIGS. 47-49, exploded views of an example analyte sensor 30 and transmitter 32 are shown. The transmitter 32 includes a housing 290 that contains a power source 294 (e.g., a coin cell), sensor circuitry 296, at least one transmitter / receiver 298, and memory 300. The transmitter 32 can be removably attached to the analyte sensor 30. The attachment can be by screwing, clipping, snapping, gluing, or any suitable method. When the transmitter 32 is connected to the analyte sensor 30, it is electrically connected to the sensor electrodes 302A, 302B via the conductive traces 292. In other embodiments, the transmitter 32 can be provided attached to the analyte sensor 30 and cannot be removed.

[0196] The analyte sensor 30 includes a body 352. The body 352 of the analyte sensor 30 has a circular footprint and includes a central region 400 and a peripheral region 402. The central region 400 is a raised portion of the body 352, and the peripheral region 402 surrounds the central region 400. The body 352 is injection molded, with the raised central region 400 and peripheral region 402 formed during the molding process. The central region 400 is generally planar and may include a base surface 470. The conductive traces 292 extend to the base surface 470, connecting to the electrodes 302A,B in various embodiments. The central region 400 includes one or more interfaces for connecting the transmitter 32 and the analyte sensor 30 during use. The body 352 includes a plurality of slots 408 that extend from a periphery 410 of the body 352 toward a center or midpoint of the body 352. In the example embodiment, the slots 408 extend radially and penetrate the entire peripheral region 402 such that the body 352 includes a central region 400 surrounded by a plurality of petals 414 spaced apart by the slots 408.

[0197] As shown in FIG. 48, a plan view of the proximal surface 356 of the body 352 is depicted. An adhesive may be included on at least a portion of the proximal surface 356 of the body 352. An adhesive-containing member 54 may be connected to the proximal surface 356 of the body 352 of the analyte sensor 30, as shown in FIGS. 55-57. The adhesive is skin compatible and serves to connect the analyte sensor 30 to the skin surface 14 at the measurement site. The adhesive may be disposed on a portion of the proximal surface 422 of the peripheral region 402 and central region 400 of the body 352.

[0198] An example analyte sensor 30 is depicted in a stored state in FIGS. 47-49. When the analyte sensor 30 is applied to a patient, the analyte sensor 30 is placed on the skin 14 in the stored state. The adhesive on the proximal surface 356 of the body 352 serves to secure the sensor 30 to the skin 14. The body 352 is deformable and can transition from the stored state to the deployed state. In some embodiments, this transition is reversible, while in other embodiments, it can result in permanent deformation of a portion of the body 352 and / or the sensor 30. For example, transitioning to the delivery state can cause at least a portion of the body 352 to plastically deform and cannot be returned to its original stored state. It may be necessary to destroy a portion of the body 352 or a portion of the analyte sensor in order to remove the analyte sensor 30 from the patient, rendering the analyte sensor 30 unusable. Upon transitioning to the deployed state, at least two adhesive-containing portions of the body 352 spread toward each other, stretching or widening the skin surface that is applied to the body 352 via the adhesive. This tensions the skin 14 as the body 352 transitions to the deployed state, facilitating penetration of the electrodes 302A,B into the skin 14. An adhesive in the adhesive member 54 (see, e.g., FIGS. 55-57) helps hold the sensor 30 in the deployed state during use. An inserter assembly is not required to apply the analyte sensor 30.

[0199] The analyte sensor 30 is applied to the skin 14, and the user can transition the analyte sensor 30 to the deployed state by depressing the body 352. This eliminates the need for a needle prick each time the analyte sensor 30 is applied. This feature may make the analyte sensor 30 more attractive to certain patient populations (e.g., juvenile diabetics). Additionally, omitting the inserter may reduce the financial burden and encourage adoption by patients who may be hesitant to use the analyte sensor 30 due to this.

[0200] Referring primarily to FIG. 49, there is shown an enlarged view of a portion of the proximal surface 422 of the central region 400 of the example analyte sensor 30 shown in FIGS. 47-48. As shown, the electrodes 302A, 302B are a pair of micro-penetrators, which may be any of the microneedles described herein, but are shown to have a structure that does not have a lumen therethrough. These micro-penetrators may have the structure described in FIG. 5, but may not have a lumen. Each micro-penetrator is constructed of etched silicon, each attached to its own sharps retainer 374, and arranged with no direct electrical connection to each other. One of the electrodes 302A, 302B functions as a counter / reference electrode and the other as a sensing electrode. The electrodes 302A, 302B are attached to a stepped protrusion 358 protruding from the proximal surface 422 of the central region 400, which may be any of the stepped protrusions 156 described herein.

[0201] In other embodiments, the micro-penetrators themselves may not be used as electrodes 302A, 302B. In such embodiments, the micro-penetrators may be at least partially covered with an insulating material. A conductive trace 292 is disposed on top of the insulating material of each micro-penetrator and extends along the sharps holder 374 to the side of the sharps holder 374 opposite the micro-penetrator. When the transmitter 32 is connected to the analyte sensor 30, it is electrically connected to the conductive trace 292. In such embodiments, the counter / reference electrode and the sensing electrode are present on the same sharps holder 374, but each conductive trace 292 is insulated from each other.

[0202] Analyte sensor 30 may be a shallow analyte concentration sensor, for example an intradermal analyte concentration sensor. Analyte sensor 30 may be a sensor that continuously measures analyte concentration (e.g., a continuous blood glucose monitor) and may output analyte concentration data on a pre-set schedule (e.g., every 1-5 minutes). Such analyte sensors 30 have advantages such as minimal invasiveness, minimal pain in use, rapid response, and low risk of irritation or patient reaction.

[0203] The electrodes 302A, 302B have a height suitable for shallow insertion (e.g., intradermal). In one embodiment, the height of the electrodes 302A, 302B is in the range of 500-1000 micrometers, although shorter or longer electrodes may be used in other embodiments. Because the analyte sensor 30 measures the analyte concentration at a shallow site (e.g., intradermal), measurements can be collected that quickly reflect changes in the analyte concentration in the blood. Because the intradermal layer is highly vascularized, the analyte concentration in the skin reflects changes in the analyte concentration in the blood more quickly. Once the analyte sensor 30 measurements are received by the controller 20, the controller 20 can initiate, stop, or adjust drug administration based on the measurements. The detection of rapid analyte concentration changes allows the controller 20 of the infusion device 18 to quickly respond to changes in the analyte concentration in the blood. Additionally, drug administration decisions can be made that are more precisely tailored to the current needs of the patient. In this manner, the analyte sensor 30, together with the infusion device 18, allows for tight control of the analyte concentration in the blood.

[0204] Any suitable analyte detection chemistry or configuration from any manufacturer may be incorporated into the sensing electrode. Configurations for glucose detection may also be used. For example, glucose oxidase chemistry may be used to detect glucose concentrations in bodily fluids. It should be noted that the analyte sensors 30 described herein are not limited to any particular detection chemistry or configuration.

[0205] In an exemplary embodiment, the analyte sensor 30 may include multiple step projections 358 with corresponding electrode groups 302A, B. Alternatively, multiple insulated electrodes 302A, B may be attached to a single step projection 358. Thus, multiple analyte sensors 30 may be associated with a single body 352. In various examples, any number of step projections 358 may be disposed on the proximal surface 422 of the central region of the body 352. In some examples, the step projections 358 may be disposed in an arrangement similar to the step projections 156 shown in connection with FIGS. 35-36. The set of electrodes 302A, B included in the analyte sensor 30 may detect the same analyte in a bodily fluid using the same analyte detection chemistry and configuration. In another example, at least one group of electrodes 302A, B may use different analyte detection chemistry and configuration. When different chemistries are used, at least one group of electrodes 302A, B may detect the same analyte as the other groups of electrodes 302A, B, or may detect a different analyte. In some examples, the micro-penetrators may be provided at different heights. Thus, when the analyte sensor 30 is in a deployed state, the analyte sensor 30 may collect data regarding analyte concentrations at various sites on a user. In some examples, one set of micro-penetrators aids in detection of analyte concentrations at shallower delivery destinations (e.g., intradermal) and other micro-penetrators aid in detection at deeper delivery destinations (e.g., subcutaneous). The heights of the micro-penetrators are appropriately selected to reach the desired detection site on the patient.

[0206] 50-54, example access assemblies 46 are shown. Each access assembly 46 can be used to administer one or more drugs to a patient and collect sensor data related to the concentration of at least one analyte of interest. Thus, instead of separate assemblies for drug administration and analyte detection, a single assembly 46 can be applied.

[0207] The access assembly 46 includes a body 552. The body 552 of the access assembly 46 has a rounded (circular) footprint and includes a central region 500 and a peripheral region 502 surrounding the central region 500. The central region 500 may be a raised region of the body 552, with the peripheral region 502 surrounding the central region 500. The body 552 may be manufactured by injection molding. The central region 500 may be substantially flat in some instances and may include a base surface 570. The body 552 includes a plurality of slots 508. The slots 508 extend from a peripheral edge 510 of the body 552 toward a center or central point. In an example embodiment, the slots 508 extend radially. The slots 508 extend entirely through the peripheral region 502, and the body 552 may include a central region 500 surrounded by a plurality of petals 514 spaced apart by the slots 508.

[0208] The central region 500 may include a coupling 98 defined on a base surface 570. The coupling 98 may be as described in connection with FIGS. 41-46. In another example, the coupling 98 may be a fitting (e.g., a luer fitting). For example, the connector 26 connected to the tubing 28 leading to the infusion set 18 may be removably coupled to the access assembly 46. The connector 26 may be connected to the access assembly 46 as described in connection with FIGS. 41-46. In an example embodiment, the base surface 570 of the central region 500 is provided with conductive contacts 540 that are electrically connected to the electrodes 302A,B of the analyte sensor 30 of the access assembly 46. The connector 26 may include conductive contacts on a surface of the connector 26 that abuts the base surface 570 when the connector 26 is coupled to the access assembly 46. Thus, when the connector 26 is connected to the access assembly 46, the connector 26 is electrically connected to the analyte sensor 30 portion of the access assembly 46. Electrical conductors 542 extend from the conductive contacts of connector 26 through connector 26 and along tubing 28. Infusion pump 18 is electrically connected to the conductive contacts of connector 26 via electrical conductors 542. In such examples, transmitter 32 may not be used, but rather infusion device 18 may communicate directly with analyte sensor 30. In other examples, transmitter 32 may be included in connector 26. In still other embodiments, a separate transmitter 32 may be removably connected to access assembly 46 by threading, clipping, snapping, gluing, or the like. In some embodiments, transmitter 32 may be provided as part of access assembly 46 and may not be removable from access assembly 46.

[0209] 50 and 52-54, a plan view of a proximal surface 556 of an exemplary body 552 is shown. The proximal surface 522 of the central region 500 of the body 552 includes at least one step projection 156 to which at least one access member 16 may be coupled. The access member 16 may include at least one microneedle disposed on a sharps retainer 74 in certain embodiments. If a microneedle is used, the microneedle may be any of those described herein. The step projection 156 may be any of the step projections 156 described herein. The proximal surface 522 of the central region 500 of the body 552 includes at least one step projection 358 to which at least one group of electrodes 302A, B are disposed. The electrodes 302A, B may be silicon micro-penetrators as described herein. Each electrode 302A, B may be included in a separate sharps retainer 374 in such embodiments. Alternatively, the electrodes 302A, B may be conductive traces disposed on an insulating layer included in each micro-penetrator. In such a case, the micro-penetrators in which the electrodes 302A, B are included may be formed on the same sharps holder 374.

[0210] The example access assembly 46 shown in Figs. 50 and 52 includes the same step projection 156 access member 16 arrangement and the same step projection 358 electrode 302A,B arrangement. The arrangement of the step projections 156, 358 varies between the embodiments. In the embodiment shown in Fig. 52, a rocker member 166 is included on the proximal surface 522 of the central region 500. The step projections 156, 358 are located on opposite sides of the central portion of the proximal surface 522 of the central region 500. The rocker member 166 may cause tilting of the central region 500 and the access member 16 as described in connection with Figs. 35-36. The micro-penetrator or electrodes 302A,B may also tilt in the same manner as the access member 16. In the embodiment shown in Fig. 50, the step projection 358 has been moved to the position of the rocker member 166, and the rocker member 166 is absent. The step projection 156 is centrally located on the proximal surface 522 of the central region 500 (as described in connection with FIGS. 35-36). The positions of the step projection 156 and the step projection 358 may be interchanged in alternative embodiments. Each step projection 156, 358 may be approximately the same height in various embodiments. The peripherally located step projections 358 may function as the swinging member 166. When the access assembly 46 transitions to the deployed state, the micro-penetrator and the access member 16 may penetrate the skin 14. When the peripherally located step projections 358 contact the skin 14, they may prevent further displacement of one side of the central region 500 into the skin 14. The opposite side of the central region 500 is not prevented from further displacement into the skin 14, and the central region 500 may swing or tilt as the transition is completed. This may cause the access member 16 to tilt as described in connection with FIGS. 35-36. The micro-penetrator may similarly tilt within the skin 14.

[0211] Similar to the various example sets 12 and example analyte sensors 30 described herein, the example access assembly 46 may include multiple sets of access members 16 and / or multiple electrode groups 302A,B. Each set may be disposed on its own stepped projection 156, 358. When multiple sets of access members 16 and / or multiple electrode groups 302A,B are included, the different sets of access members 16 and / or electrodes 302A,B may all be substantially the same or may include various differences as described herein. For example, the different sets of access members 16 may each include access members 16 of different heights. Similarly, the different electrode groups may also vary in height. In some implementations, the access assembly 46 may include access members 16 for intradermal and subcutaneous administration (each of which may be a microneedle of appropriate length). The example access assembly 46 may also include electrodes 302A,B for an analyte sensor 30 that monitors intradermal analyte concentrations, and electrodes 302A,B for an analyte sensor 30 that monitors subcutaneous analyte concentrations.

[0212] Continuing to refer to FIGS. 50-54, an adhesive may be included on at least a portion of the proximal surface 556. Various adhesive-containing members 54 coupled to the proximal surface 556 of the body 552 of the access assembly 46 are shown and described in connection with FIGS. 55-57. The adhesive may be skin compatible and serve to bond the access assembly 46 to the skin 14 surface at a desired site. An adhesive may be included on a portion of the proximal surface 522 of the peripheral region 502 and central region 500 of the body 552.

[0213] The access assembly 46 illustrated in FIGS. 50-54 is shown in a retracted state. When the access assembly 46 is applied to a patient, the access assembly 46 may be placed on the skin 14 in the retracted state. The adhesive on the proximal surface 556 of the body 552 serves to secure the access assembly 46 to the skin 14. The body 552 is a deformable body that can be transitioned (reversibly or irreversibly) from a retracted state to a deployed state, where at least two adhesive-containing portions of the body 552 are displaced to spread apart relative to one another, thereby pulling the adhesive-secured skin surfaces and tensioning the skin 14. This is desirable to facilitate piercing of the skin 14 by the access member 16 and the electrodes 302A,B as the body 552 transitions to the deployed state. The adhesive-containing adhesive member 54 (see, e.g., FIGS. 55-57) helps to hold the access assembly 46 in the deployed state during use. An inserter assembly is not required to apply the access assembly 46.

[0214] The example access assembly 46 is applied to the skin 14 and can be transitioned to the deployed state by a user depressing the body 552. This can avoid the need for multiple needle sticks each time the access assembly 46 is applied. This can make the access assembly 46 more attractive to certain patient populations, particularly those with juvenile diabetes. The example access assembly 46 does not require a first inserter for an infusion set and a second inserter for an analyte sensor. Removing the inserter from the application process can reduce the financial burden for patients who are hesitant to use the analyte sensor 30. Omitting the inserter can reduce the financial burden associated with frequent site changes, which can help patients adhere to a prescribed site change schedule or allow for more frequent site changes (e.g., daily).

[0215] 55-57, several adhesive members 54 of an exemplary set 12 are shown. The adhesive members 54 shown in FIGS. 55-57 may also be included in the analyte sensor 30 or access assembly 46 described herein. As shown, each exemplary set 12 may include one adhesive member 54. In an alternative embodiment, the adhesive member 54 may be divided into multiple individual adhesive members 54. This may facilitate the use of different adhesives or leaving certain petals 114 adhesive-free. As shown, each adhesive member 54 includes multiple slits 216 extending radially inward from the periphery of the adhesive member 54 to form petals corresponding to the petals 114 of the body 52. ​​The adhesive member 54 may also include a central opening 218 for the access members 16 of the set 12 to access the patient.

[0216] The shape and size of the central opening 218 may help facilitate a particular shallow delivery. In various exemplary sets 12, it may be desirable for the central opening 218 to have a cross-sectional area that is 60-100% of the footprint of the central region 100. It may be preferable for the central opening 218 to have a shape such that at least a portion of the adhesive member 54 is attached to the proximal side 222 of the central region 100 or a portion of the structure 50. In certain examples, the cross-sectional area of ​​the central opening 218 may be greater than 0.13 square inches. In certain examples, the cross-sectional area of ​​the central opening 218 may range from 0.13 square inches to 0.5 square inches (e.g., about 0.3 square inches).

[0217] Additionally, it may be desirable for the central opening 218 to be wider in certain directions than in other directions. For example, each access member 16 (e.g., one or more microneedles) may tend to distribute fluid in an ejection direction (e.g., along the axis of the lumen 68 of the access member 16) extending from the outlet of the respective access member. It may be desirable for the central opening 218 to have a greater or increased width in a direction that coincides with or substantially coincides with the ejection direction. For example, the maximum width (or at least the relatively wider width portion) of the central opening 218 may be along a direction parallel to a plane that includes the ejection direction. By using a set 12 including one or more microneedles similar to that shown in FIG. 5, the increased width portion of the central opening 218 may be aligned with the front-to-rear (from the distal side 60 to the rear end 23, also referred to herein as the length) direction of the microneedle or with a line of symmetry of the microneedle. For example, the central opening 218 may be oval or stadium shaped (see, e.g., FIG. 57) and widest in a direction parallel to the front-to-rear direction (or length dimension) of the microneedle. This can help create a more diffuse, shallow (e.g., intradermal) injection as opposed to a concentrated blister, which may be desirable because it can expose the agent to more blood vessels at the delivery site, which can help facilitate absorption.

[0218] Referring now primarily to FIG. 55, the central opening 218 may be a generally round (e.g., circular) opening, except for a number of inwardly extending teeth or spokes 220 of the adhesive member 54 material. In this exemplary embodiment, the adhesive member 54 includes a central opening 218 with four spokes 220 spaced at regular angular increments from one another. In certain examples, the number of spokes 220 may vary, and the spacing of the spokes 51 may be irregular. The spokes 51 may be arranged such that the central opening 49 has a relatively large width in a direction along the ejection direction. The central opening 49 may have a relatively large width in this direction, but this does not exclude other wide regions of equal, narrower, or possibly wider widths. In the illustrated example, the central opening 218 is approximately equal in width as measured in a direction perpendicular to the anterior-posterior direction of the microneedle. In certain examples, the spokes 220 may be the only portion of the adhesive member 54 that is bonded to the proximal surface 222 of the central region 100 or to the structure 50.

[0219] 56, in certain examples, the central opening 218 may include a notch 224 that extends outwardly from the periphery of the remaining portion of the central opening 218. The notch 218 may be included to widen the central opening 218 if desired. While this example includes a rectangular notch 218, in alternative embodiments the notch may be shaped differently. The notch 218 may be any suitable polygonal shape, for example, circular.

[0220] 45, a user can press the central region 100 of the set 12 to transition the set 12 to the delivery state. As the exemplary set 12 transitions to the delivery state, the access members 16 and step protrusions 156 are displaced toward the skin 14. A spreading displacement of the petals 114 of the set 12 also occurs simultaneously. This spreading displacement stretches the skin 14 (e.g., see FIG. 1 ) to which the set 12 is attached, facilitating the penetration of the access members 16 into the skin 14. The slits 216 in the adhesive member 216 can allow the adhesive to accommodate the spreading displacement of the petals 114 upon transition to the delivery state.

[0221] When the set 12 is applied to the skin 14, initially the adhesive of the peripheral region 102 of the set 12 contacts the skin 14. As the set 12 transitions to the delivery state, it decreases in height. During this time, the adhesive of the adhesive member 54 inside the peripheral region 102 contacts and adheres to the skin 14. If a portion of the adhesive member 54 extends partially to the proximal side 222 of the central region 100 (or alternatively has a structure 50 attached to the body 52), that adhesive will adhere to the skin 14 when the transition is complete. The adhesive adheres to the skin 14, maintaining the set 12 in the delivery state and helping the skin 14 move in unison with the set 12. In this way, the access member 16 is ensured to remain securely in a desired position within the skin 14 while the set 12 is in use.

[0222] Additionally, when the set 12 is in the delivery state, the step projection 156 may be pressed into the skin 14 when the set 12 is in the delivery state, creating an indentation in the skin 14. The indented skin 14 will tend to recover to a non-indented position relative to the step projection 156 while the set 12 is being worn. The adhesive of the adhesive member 54 in the vicinity of the step projection 156 helps to promote this recovery. Thus, the skin pierced by the access member 16 will tend to move with the access member 16, even if the access member 16 or step projection 156 moves away from the skin 14. This helps the access member 16 to remain securely within the skin 14 while the set 12 is being worn, helping to prevent leakage during delivery.

[0223] 58-63, a delivery assembly 24 or arrangement is shown that may be included in a delivery device 18 (see, e.g., FIG. 1). The delivery assembly 24 shown in the figures is exemplary, and the delivery device 18 may include a variety of delivery arrangements 24. A particular delivery device 18 may be a syringe pump. A particular delivery device 18 may include a peristaltic pump mechanism (e.g., a linear or finger type pump mechanism or a rotary peristaltic pump mechanism). If the delivery device 18 delivers multiple medications to one or more sets 12, the infusion device 24 may include multiple delivery assemblies 24 shown in FIGS. 58-63, each coupled to a different medication reservoir 22.

[0224] In the exemplary delivery assembly 24, a closure assembly 232 separates the filled reservoir 22 from the delivery assembly 24. Opening the closure assembly 232 allows fluid to flow into other portions of the delivery assembly 24. To deliver the fluid in the reservoir 22 to the user, a controller 20 (e.g., see FIG. 1 ) included in the delivery device 18 commands the excitation of a shape memory actuator 234. The shape memory actuator 234 is anchored at one end by a shape memory actuator anchor 236 and coupled at the opposite end to a common connector 238 connected to a pump plunger 240A and a reservoir valve assembly 242. The excitation of the shape memory actuator 234 causes the actuation of the pump 240 and the reservoir valve assembly 242. The reservoir valve assembly 242 may include a reservoir valve actuator 242A and a reservoir valve 242B. Actuation of the reservoir valve assembly 242 results in downward displacement of the reservoir valve actuator 242A and closing of the reservoir valve 242B, effectively isolating the reservoir 22 from the delivery assembly 24. A membrane 244 is provided between the pump plunger 240A and the pump chamber 240B of the pump 105, and the reservoir valve actuator 242A presses the membrane 244 against the valve seat of the reservoir valve 242B to close the reservoir valve assembly 242. The pump 240 and the reservoir valve assembly 242 are connected such that the reservoir valve assembly 242 is closed prior to pumping fluid from the pump 240. Actuation of the pump 240 displaces the pump plunger 240A downward towards the pump chamber 240B, forcing fluid out (in the direction of arrow 246). Pump chamber 240B is formed with approximately the same shape as the end of pump plunger 240A, such that each stroke of pump 240 substantially empties pump chamber 240B.

[0225] The volume sensor valve assembly 248 may include a volume sensor valve actuator 248A and a volume sensor valve 248B. Referring also to FIG. 60, the volume sensor valve actuator 248A is held in a closed position by a volume valve spring assembly 248C (e.g., acting against a spring anchor 250) that provides a mechanical force to move the volume sensor valve actuator 248A against the volume sensor valve 248B to close the volume sensor valve 248B. The volume sensor valve actuator 248A presses a membrane 244 included in the cassette assembly 25 against a valve seat of the volume sensor valve 248B to close the volume sensor valve 248. However, when the pump 240 is actuated, if the pressure of the expelled fluid exceeds the mechanical sealing force of the volume sensor valve assembly 248, the fluid may move in the direction of the arrow 252. This may fill a volume sensor chamber 256 in the volume sensor assembly 258 shown in FIG. 62. Using a speaker assembly 260, a port assembly 262, a reference microphone 264, a spring diaphragm 266, and a variable volume microphone 268, the volume sensor assembly 258 can measure the volume of fluid in the volume sensor chamber 256. The operation of such a volume sensor assembly 258 is described, for example, in U.S. Patent No. 8,491,570, entitled Infusion Pump Assembly, issued on July 23, 2013; Attorney Docket No. G75, which is incorporated herein by reference in its entirety. Other suitable delivery volume sensors may be used in other embodiments.

[0226] 62, a shape memory actuator 270 is fixed (at a first end) to a shape memory actuator anchor 272. The other end of the shape memory actuator 270 is used to provide mechanical energy to a valve actuator 274 to actuate a measurement valve assembly 276. After the volume of fluid in the volume sensor chamber 256 is calculated, the shape memory actuator 270 is excited and the measurement valve assembly 276 is actuated. The measurement valve assembly 276 includes a measurement valve actuator 276A and a measurement valve 276B. When the measurement valve actuator 276A is lifted from the measurement valve 276B and actuated, the mechanical energy applied to the fluid in the volume sensor chamber 256 by the spring diaphragm 266 causes the fluid in the volume sensor chamber 256 to be delivered (in the direction of arrow 278) through the set 12 to the patient. Returning the shape memory actuator to a de-excited state causes the measurement valve actuator 276A to press a membrane included in the cassette assembly 25 against the valve seat 276B via the measurement valve spring assembly 276C (e.g., acting against the spring anchor 280) to close the measurement valve 276B. In some embodiments, the reservoir valve 242B, the pump chamber 240B, the volume sensor valve 248B, and the membrane interface 244 disposed on the measurement valve 276B may be formed from a single material with areas covering each of the components.

[0227] As fluid is delivered to the set 12 or access assembly 46, at least one characteristic associated with the delivery may be monitored by at least one sensor in the delivery mechanism 24. The controller 20 of the delivery device 18 may analyze data obtained from these sensors to determine if the delivery is occurring in a desired manner. For example, the controller 20 may monitor data from the at least one sensor to determine information related to impedance to fluid delivery from the access member 16. Above the skin, there is little impedance to fluid delivery because the access member 16 is in air. The intradermal space has a relatively high impedance and is relatively difficult to deliver fluid to. Delivery to subcutaneous tissue has a lower impedance compared to intradermal tissue.

[0228] When fluid is delivered to the set 12, a pressure drop may occur as the fluid exits the set 12 and into a shallow delivery destination. Typically, fluid flows relatively slowly from the set 12 to a shallow delivery destination. When this occurs, the associated pressure drop is also relatively slow. However, when the access member 16 becomes dislodged and is no longer lodged in the skin 14, the fluid will exit the access member 16 more easily and at a higher rate than expected. In these circumstances, the pressure drop may progress relatively quickly. The pressure drop may also progress rapidly if the access member 16 passes beyond the shallow destination and reaches the subcutaneous space.

[0229] In some embodiments, data from at least one pressure sensor monitoring fluid delivered to set 12 may be analyzed by controller 20 to determine how quickly a pressure drop occurs after fluid is delivered to set 12. If the pressure drop progresses faster than a pre-set threshold (e.g., the derivative of the pressure data exceeds a pre-defined value), it may be determined that access member 16 has shifted from a pre-defined position. In some embodiments, this threshold may be pre-set or calculated based on past data as medication is delivered from infusion device 18. Controller 20 may monitor changes in the rate of pressure drop as fluid is delivered through set 12 and may determine that access member 16 has changed position if the rate of pressure decay changes beyond a pre-defined threshold.

[0230] For decisions made by the controller 20 based on data associated with the access member 16 and / or the analyte sensor 30, the controller 20 can generate an alert based on the decision. The alert may be displayed on a user interface of the delivery device 18. The alert may also include an audible alert (tone, beep, etc.) or a tactile alert (activation of a vibration motor) generated by the delivery device 18 or other components of the system 10. Additionally, the controller 20 can notify various components of the system 10 of the alert. For example, the controller 20 can communicate the alert to at least one smart device (e.g., a smartphone, a smartwatch, a tablet, etc.), which can display the alert and / or generate its own audible or tactile alert. The controller 20 can also communicate the alert to the cloud 38. The controller 20 can determine appropriate user intervention (e.g., need for a new set 12, analyte sensor 30, access assembly 46) and solicit the user's intervention through a user interface of the system 10.

[0231] Additionally, if an occlusion occurs, the pressure may decay slower than expected. The controller 20 may analyze data from at least one pressure sensor and monitor characteristics of the pressure decay indicative of an occlusion (e.g., rate of decay, change in rate of decay from previous data). If the pressure decays slower than a predefined threshold, the controller 20 may determine that an occlusion exists. Similarly, if a change to a rate of pressure decay that is noticeably slower than previous data is observed, the controller 20 may determine that an occlusion is occurring.

[0232] In one embodiment, as shown in FIGS. 58-63, data from at least one volume sensor assembly 258 may be checked multiple times as fluid is delivered from the infusion set 18 to the set 12. The controller 20 may determine whether a change in depth of the access member 16 or an occlusion has occurred based on the data from the at least one volume sensor assembly 258. If the change in volume measured by the volume sensor assembly 258 in a given time period is greater than a predetermined amount or the rate of change is too fast, the controller 20 may determine that the access member 16 has changed position. Similarly, if the change in volume is less than a predetermined amount or the rate of change is too slow, the controller 20 may determine that an occlusion exists. The change in volume or the rate of change may also be compared to previous data to determine whether the delivery impedance is different from previous deliveries.

[0233] The injection device 18 of the system 10 may, for example, individually deliver to at least one long access member 16 or at least one short access member 16 in the set 12. When selecting two or more of the access members 16 of different lengths to deliver the medicament, the controller 20 may compare delivery data for the access members 16 of different lengths. In one example, the set 12 or access assembly 46 may include at least one long access member 16 that interfaces with a subcutaneous delivery destination and at least one short access member 16 that interfaces with a shallow delivery destination. These may be microneedles of different lengths, as described elsewhere.

[0234] Typically, the displacement of the at least one short access member 16 is associated with a similar displacement of the at least one long access member 16. It is desirable to place the at least one short access member 16 and the at least one long access member 16 as close as possible so that the correlation of these displacements is high. If the at least one short access member 16 is displaced from the skin 14, the at least one long access member 16 will often be displaced in a similar direction and by the same amount. In this case, the long access member 16 may be displaced enough to be located at the intradermal delivery destination. The height of the at least one long access member 16 and / or the location of the flow passage 68 or channel 70 in the at least one long access member 16 may be selected to ensure that this occurs. If the at least one short access member 16 has reached the subcutaneous space, the at least one long access member 16 may still remain in the subcutaneous space.

[0235] If data relating to delivery impedance (e.g., pressure drop, dispensed volume sensed by volume sensor assembly 258) from the at least one short access member 16 indicates a change in depth of the at least one short access member 16, the controller 20 can analyze the delivery data for the at least one long access member 16. In some embodiments, the controller 20 can direct delivery to the at least one long access member 16 to collect data. In some embodiments, the at least one long access member 16 may not be used for normal delivery. In such cases, the long access member 16 can be used as a test access member 16 to collect data.

[0236] If an analysis of the delivery data associated with the long access members 16 indicates impedance characteristics expected for intradermal delivery, the controller 20 may determine that the short access members 16 have become dislodged from the skin 14. The controller 20 may stop delivery to the short access members 16 and switch to delivery to the long access members 16 to continue treatment. In some embodiments, if the controller 20 determines (by any method described herein) that one or more access members 16 have become dislodged from the skin 14, the controller 20 may stop delivery to the access members 16. If the controller 20 determines that at least one access member 16 is still capable of delivery to the patient, the controller 20 may adjust the delivery to deliver fluid only to the access members 16 that are still within the patient. The controller 20 may generate an alert to notify the user that this has been done. In some embodiments, the controller 20 may stop all delivery or prompt the user to confirm that delivery to the particular access member 16 is to be redirected.

[0237] If the delivery data associated with the at least one long access member 16 indicates that the delivery impedance increased and then decreased, the controller 20 may determine that the at least one long access member 16 and the at least one short access member 16 have likely become detached from the skin 14. The controller 20 may generate an alert to display this determination on a user interface of the infusion device 18 and / or to notify other components of the system 10 (e.g., a smartphone or smartwatch). Additionally, the controller 20 may generate an indication that delivery should be stopped and the set 12 replaced with a new set 12.

[0238] If analysis of the delivery data associated with the at least one short access member 16 indicates impedance characteristics consistent with past delivery from the at least one long access member 16, the controller 20 can determine that the at least one short access member 16 has moved deeper.

[0239] In other embodiments, access members 16 for independent delivery of fluids may be included on the set 12 at at least three different heights. The shortest access members 16 generally have a height that inhibits access to the subcutaneous space. In these embodiments, at least one long access member 16 and at least one medium height access member 16 may be included. The medium height access members 16 have a height sufficient to deliver to intradermal delivery destinations, and the long access members 16 have a height sufficient to deliver to subcutaneous delivery destinations.

[0240] If the sensor data associated with fluid delivery to the shortest access member 16 indicates a high delivery impedance, then the intermediate and long access members 16 should be within the skin 14. Given the high delivery impedance of the shortest access member 16, if there is data indicating a drop in impedance to flow from the intermediate access member 16, the controller 20 may determine that the intermediate access member 16 has reached the subcutaneous space. If the data associated with fluid delivery to the shortest and intermediate access members 16 indicates a low impedance, the controller 20 may determine that these access members 16 have dislodged from the skin 14. The controller 20 may generate an alert to display such a determination on a user interface of the infusion device 18 and / or to notify other components of the system 10.

[0241] The controller 20 may make delivery calculations based at least in part on the analyte sensor 30 data and the expected drug absorption profile. Because the drug absorption profile may depend on the depth of the delivery destination, the controller 20 may determine the depth of the access member 16 based on the impedance related data and adjust the delivery calculations accordingly. For example, if the controller 20 determines that the drug is absorbed faster or slower, the timing of delivery may be adjusted. Other calculations may also be adjusted based on the depth of the access member 16. Using the insulin example, calculations of insulin amount (IOB) and / or duration of insulin action (DIA) may be adjusted.

[0242] For analyte sensors 30 and access assemblies 46 with multiple electrodes 302A,B that sense analyte concentrations at different depths, the data from each electrode group 302A,B can be compared. If an analyte sensor 30 has an electrode pair 302A,B in air, it should indicate that the analyte sensor 30 is not monitoring a proper location. Furthermore, to measure blood analyte concentrations, analyte sensors 30 monitoring highly vascularized areas (e.g., shallow and intradermal sites) and less vascularized areas (e.g., subcutaneous sites) should collect different data in a predictable and related manner.

[0243] Using diabetes as a non-limiting example, interstitial glucose concentrations in the subcutaneous space may be more delayed than those in blood, whereas interstitial glucose concentrations in the intradermal space tend to respond more quickly. Thus, for example, an analyte sensor 30 monitoring the subcutaneous space may determine that its response to fluctuations in blood glucose levels is delayed or shifted in time from the response detected by an analyte sensor 30 monitoring the intradermal space.

[0244] Insulin or glucagon delivery from the infusion device 18 (or carbohydrate ingestion) causes a change in blood glucose level that should first be most clearly observed by the analyte sensor 30 monitoring the intradermal space. The timing and amount of drug delivery from the infusion device 18 may be known. In some embodiments, the timing and amount of carbohydrate ingestion may also be input by the user into the system 10. Additionally, drug delivery (or carbohydrate ingestion) should cause an expected adjustment in blood glucose level. For example, the response to blood glucose level changes associated with drug delivery should be delayed from that observed in the subcutaneous tissue compared to that observed in the intradermal tissue. The data from the shallow analyte sensor 30 and the deeper analyte sensor 30 should track each other in a predictable manner throughout the life of the analyte sensor 30. An expected relationship between the data from the shallow analyte sensor 30 and the deep analyte sensor 30 may be determined (e.g., by the controller 20) based on the collected data. For example, an expected time shift (or window or range thereof) between the data from each analyte sensor is determined. The relationship may be updated periodically during the life of the analyte sensor 30, or may be initially determined during or immediately after a warm-up period for the analyte sensor 30. In some examples, when a new analyte sensor 30 is attached, the expected relationship may be initialized to a predefined predicted relationship for the patient (e.g., data collected from a previous use of the analyte sensor 30).

[0245] The controller 20 may analyze the data from the analyte sensors 30 to determine analyte concentration trend information for display on the user interface. For example, the analyte concentration trend may be determined by comparing current data to past data. The controller 20 may generate a message or other indication that the blood glucose level is trending downward (or dropping sharply), trending upward (or rising sharply), or approximately constant. In some examples, the controller 20 may determine trend information based on data from a single analyte 30 sensor or may give higher weight to data from a particular analyte sensor 30. For example, if a deeper analyte sensor 30 exhibits a different trend than an intradermal analyte sensor 30, the data from the intradermal analyte sensor 30 may be used or given higher weight to determine the current trend. In some examples, the difference of the data from each analyte sensor 30, a derivative of the data, or a derivative of the difference of the data, may be used to determine blood analyte concentration trend information.

[0246] If the shallow analyte sensor 30 begins to output data indicating it is in air, the controller 20 can check the data from the deeper sensor. If the deeper analyte sensor also indicates it is in air, it may be determined that the analyte sensor has become detached from the skin. If the deeper analyte sensor 30 records a response to a blood glucose change (e.g., due to a drug administration) that matches a response previously typical of the shallow analyte sensor 30, the controller 20 can determine that the shallow sensor has become detached from the skin 14.

[0247] Additionally, by comparing the data from the shallow analyte sensor 30 with the deeper sensor, it can be determined whether a particular analyte sensor 30 is behaving abnormally (e.g., is indicative of a dropout). Historical data can aid in this determination. For example, if one analyte sensor 30 deviates from a typical or expected response relationship to a change in blood glucose level (due to an action such as medication or eating) while the other analyte sensor 30 is within an acceptable range, then that analyte sensor 30 may be indicative of a dropout. Alternatively, or additionally, if the normal relationship between the data from the first and second analyte sensors 30 (e.g., as determined from past analyte sensor 30 data) begins to break down, this may be indicative of a dropout issue or a developing dropout in one of the analyte sensors 30. Based on the above analyte sensor 30 data comparison, the controller 20 can determine that the appropriate analyte sensor 30 is experiencing a dropout. The controller 20 can communicate an alert to a user interface of the infusion device 18 or send an alert for display to other components of the system 10. This helps prevent a user from acting on data from an analyte sensor 30 that is beginning to drop out.

[0248] If the expected relationship of the data between the analyte sensors 30 deteriorates beyond a certain threshold, the controller 20 can analyze the analyte sensor 30 data to troubleshoot. For example, if the expected relationship is lost, the controller 20 can check to see if the analyte sensor 30 is in air. If both the shallow analyte sensor 30 and the deeper analyte sensor 30 are reporting similar analyte concentration changes with no time lag, the controller 20 can determine that the shallow analyte sensor 30 has moved to a deeper location (e.g., subcutaneous). That is, if both sensors are measuring approximately the same analyte concentration at the same time, the controller 20 can determine that both sensors are monitoring the same location on the patient.

[0249] In some embodiments, data collected in association with any penetrator for any purpose may be utilized by the controller 20 to make various determinations regarding their location or status. For example, data from the analyte sensor 30 and data related to delivery impedance from the access member 16 may be used by the controller 20 to determine the status or location of a particular penetrator. When the controller 20 makes a determination regarding the access member 16 or sensor as described elsewhere, additional data related to the other penetrators may be reviewed. This additional data may help to confirm or verify the determination. In some embodiments, an alert may not be generated until the additional data is analyzed. Data from the other access members 16 and other analyte sensors 30 may be used to help determine or verify whether a particular penetrator has changed depth, become occluded, or is experiencing dropout issues with the analyte sensor.

[0250] For example, using the example of the access assembly 46 (see FIG. 3), all of the piercers may be positioned relatively close together on the access assembly 46. If the data associated with all of the access members 16 of the access assembly 46 indicates low impedance and the data of the analyte sensors 30 suggests air, it may be determined that the access assembly 46 has become dislodged or removed. On the other hand, if the data associated with all of the access members 16 indicates that they are in the expected location and only one of the multiple analyte sensors 30 is outputting data outside of the expected value, it is considered unlikely that the non-compliant analyte sensor 30 has changed depth. Thus, the controller 20 may infer that the non-compliant analyte sensor 30 is dropping out.

[0251] If the data indicating the delivery impedance from the access member 16 differs from expected, the controller 20 may analyze the data from the analyte sensor 30. If the analyte sensor 30 data indicates that the analyte concentration change due to drug delivery through the access member 16 is not as expected, the controller 20 may determine that the access member 16 has changed depth (e.g., intradermal instead of subcutaneous, or vice versa). If there are analyte sensors 30 monitoring multiple different depths, the data from each analyte sensor 30 may be confirmed. If the change in analyte concentration due to drug administration is observed by all analyte sensors 30 with a delay greater than expected, it may be determined that the access member 16 has moved to a deeper delivery destination. If the data from the deeper analyte sensors 30 indicates a change in analyte concentration with a shorter delay than expected, and the delivery impedance data associated with at least one long access member 16 is higher than expected, the controller 20 may determine that the deeper analyte sensor 30 and the long access member 16 have changed depth (e.g., from a subcutaneous to an intradermal location). If such an event is observed, the controller 20 may review the data of the shallow analyte sensor 30 and the at least one short access member 16 to verify that they have not become dislodged from the skin 14. Additionally, if the shallow analyte sensor 30 outputs data indicating it is in air and the delivery impedance data associated with the at least one short access member 16 indicates it is in air, the controller 20 may review the data of the deeper analyte sensor 30 and / or the long access member 16. The controller 20 may generate an alert upon verifying that the associated data reflects a change in depth of the deeper analyte sensor 30 and / or the long access member 16.

[0252] Those skilled in the art may devise various alternatives and modifications without departing from the present disclosure. Therefore, the present disclosure is intended to embrace all such alternatives, modifications, and variations. Moreover, although several embodiments of the present disclosure have been shown in the drawings and / or discussed herein, the present disclosure is not intended to be limited thereto, and the present disclosure is intended to be as broad as permitted in the art, and the same goes for the specification. Thus, the detailed description of the invention above should not be construed as limiting, but merely as illustrative of certain embodiments. And, those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto. Other elements, steps, methods, and techniques that are substantially different from those described in the detailed description of the invention and / or the appended claims are also intended to be within the scope of the present disclosure.

[0253] The embodiments are presented only to illustrate certain examples of the present disclosure. Also, the drawings described are for illustration purposes only and not for limitation. In the drawings, the size of some elements may be exaggerated and not drawn to a particular scale for illustrative purposes. Moreover, elements shown in the drawings having the same number may be the same elements or similar elements, depending on the context.

[0254] When the term "comprises" is used in the present specification and claims, it does not exclude other elements or steps. When an indefinite or definite article is used to refer to a singular noun, such as "a," "an," or "the," this also includes the plural of that noun, unless otherwise stated. Thus, the term "comprises" should not be interpreted as being limited to the items listed thereafter. Since it does not exclude other elements or steps, the scope of the expression "a device comprising items A and B" should not be limited to a device consisting of only parts A and B.

[0255] Moreover, terms such as "first," "second," "third," etc., whether used in the specification or in the claims, are provided to distinguish between like elements and not necessarily to describe a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances (unless expressly disclosed otherwise) and that the embodiments of the disclosures described herein can operate in other sequences and / or arrangements than those described or illustrated herein.

Claims

1. a body including a central region and a peripheral region having a plurality of petals extending outwardly from the central region; at least one bond disposed on a first surface of the central region; at least one sharps holder disposed on a second surface of the central region opposite the first surface and in fluid communication with each of the at least one coupling portion; A drug administration device comprising:

2. 2. The medical delivery device of claim 1, wherein the central region is raised relative to the peripheral region.

3. The medication delivery device of claim 1 , wherein each of the at least one coupling is a fitting.

4. The medication delivery device of claim 1 , wherein the at least one coupling portion includes a connector receptacle having an angled surface and a stepped surface.

5. 2. The drug delivery device of claim 1, wherein the at least one coupling portion includes at least one guide for a fluid transfer connector.

6. The medication delivery device of claim 1 , wherein each of the at least one coupling portion comprises a luer fitting.

7. The medication delivery device of claim 1 , wherein the body and the coupling portion are configured to be injection molded without side actions.

8. The medical delivery device of claim 1 , wherein the second surface of the central region includes at least one rocking member.

9. 10. The medication delivery device of claim 1, wherein the at least one sharps retainer is constructed from etched silicon.

10. 2. The medication delivery device of claim 1, wherein the at least one sharps retainer is coupled to each stepped protrusion on the second surface in an injection molding process.

11. 2. The medical delivery device of claim 1, wherein the at least one sharps retainer is bonded to each stepped projection on the second surface by an adhesive.

12. 10. The medication delivery device of claim 1, wherein the device includes a septum sealing a passageway in fluid communication with at least one sharps retainer.

13. The medical delivery device of claim 1 , wherein the second surface of the central region is at least partially covered with an adhesive retaining member.

14. The medical delivery device of claim 1 , wherein the device further comprises an adhesive retaining member.

15. The drug delivery device of claim 1 , wherein each of the at least one sharp holder comprises at least one microneedle.

16. The drug delivery device of claim 1 , wherein each of the at least one sharps holder comprises an array of microneedles.

17. 2. The drug administration device of claim 1, wherein a first sharp holder of the at least one sharp holder includes at least one first microneedle having a first height, and a second sharp holder of the at least one sharp holder includes at least one second microneedle having a second height different from the first height.

18. 18. The drug delivery device of claim 17, wherein the first height is selected to position the at least one first microneedle at a shallow destination and the second height is selected to position the at least one second microneedle at a deeper destination.

19. 20. The drug delivery device of claim 18, wherein the shallow delivery destination is an intradermal delivery destination.

20. 20. The drug delivery device of claim 18, wherein the deeper delivery destination is a subcutaneous delivery destination.

21. The medication delivery device of claim 1 , wherein each of the at least one sharps retainer is in fluid communication with only a corresponding one of the at least one coupling portions.

22. a body including a central region and a peripheral region having a plurality of petals extending outwardly from the central region; a structure coupled to the body, the structure having at least one coupling portion disposed on a first surface of the central region and at least one sharps retainer disposed on an opposite surface of the central region; a structure, each of the at least one sharps retainer being in fluid communication with a corresponding one of the at least one coupling; A drug administration device comprising:

23. 23. The drug delivery device of claim 22, wherein the structure is coupled to a raised portion included in the body.

24. 23. The drug delivery device of claim 22, wherein the structure includes a plurality of tabs that engage slits in the body.

25. 23. A medication delivery device as claimed in claim 22, wherein the central region is raised relative to the peripheral region.

26. 23. The medication delivery device of claim 22, wherein each of the at least one coupling is a fitting.

27. 23. The medication delivery device of claim 22, wherein each of the at least one coupling is a tube receptacle that receives a fluid line that is connected to a fitting.

28. 23. The medication delivery device of claim 22, wherein the at least one coupling portion includes a connector receptacle having an angled surface and a stepped surface.

29. 23. The medication delivery device of claim 22, wherein the at least one coupling portion includes at least one guide.

30. 23. The medication delivery device of claim 22, wherein each of the at least one coupling comprises a luer fitting.

31. 23. The medication delivery device of claim 22, wherein the body and the structure are injection molded.

32. 23. A medical delivery device as claimed in claim 22, wherein the opposing surface of the structure includes at least one rocking member.

33. 23. The medication delivery device of claim 22, wherein the at least one sharps retainer is constructed from etched silicon.

34. 23. The medical delivery device of claim 22, wherein each of the at least one sharps retainer is coupled to a corresponding one of the at least one stepped projections on the opposing surface of the structure in an injection molding process.

35. 23. The medical delivery device of claim 22, wherein the at least one sharps retainer is bonded to a corresponding one of the at least one stepped projections on the opposing surface of the structure by an adhesive.

36. 23. The drug delivery device of claim 22, wherein the drug delivery device includes a septum sealing a passageway in fluid communication with the at least one sharps holder.

37. 23. A medical delivery device as claimed in claim 22, wherein an opposing surface of the structure is at least partially covered with an adhesive retaining member.

38. 23. The drug delivery device of claim 22, further comprising an adhesive retaining member.

39. 23. The drug delivery device of claim 22, wherein each of the at least one sharp holder comprises at least one microneedle.

40. 23. The drug delivery device of claim 22, wherein each of the at least one sharps holder comprises an array of microneedles.

41. 23. The drug administration device of claim 22, wherein a first sharp holder of the at least one sharp holder includes at least one first microneedle having a first height, and a second sharp holder of the at least one sharp holder includes at least one second microneedle having a second height different from the first height.

42. 42. The drug delivery device of claim 41, wherein a first height is selected to position the at least one first microneedle at a shallow destination and wherein the second height is selected to position the at least one second microneedle at a deeper destination.

43. 43. The drug delivery device of claim 42, wherein the shallow delivery destination is an intradermal delivery destination.

44. 43. The drug delivery device of claim 42, wherein the deeper delivery destination is a subcutaneous delivery destination.

45. 23. The medication delivery device of claim 22, wherein each of the at least one sharps retainer is in fluid communication with only a corresponding one of the at least one coupling portions.

46. a body including a central region and a peripheral region having a plurality of petals extending outwardly from the central region; at least one bond disposed on a first surface of the central region; At least one sharps holder disposed on an opposite surface of the central region, each of the at least one sharps holder being in fluid communication with a corresponding one of the at least one coupling portions, and the at least one sharps holder being coupled to a step protrusion on the opposite surface; and A drug administration device comprising:

47. 1. An analyte sensor device comprising: a body including a central region and a peripheral region having a plurality of petals extending outwardly from the central region; at least one sharps holder disposed on a first surface of the central region, each of the at least one sharps holder including at least one electrode; wherein the analyte sensor device includes at least one first electrode and at least one second electrode associated with an analyte detection chemistry.

48. 48. The analyte sensor apparatus of claim 47, wherein the central region is raised relative to the peripheral region.

49. 48. The analyte sensor apparatus of claim 47, wherein each of the at least one electrode is in communication with a conductive trace that extends to an opposite side of the central region.

50. 48. The analyte sensor apparatus of claim 47, wherein the analyte sensor apparatus comprises a first sharps holder comprising the at least one first electrode, and a second sharps holder separate from the first sharps holder comprising the at least one second electrode.

51. 48. The analyte sensor device of claim 47, comprising at least one coupling on a side opposite the first side of the central region for connecting the analyte sensor device to a transmitter.

52. 48. The analyte sensor apparatus of claim 47, wherein each of the at least one sharp retainer is coupled to a stepped protrusion on the first surface of the central region.

53. 53. The analyte sensor apparatus of claim 52, wherein each of said at least one sharp retainer is coupled to said step projection in an injection molding process.

54. 48. The analyte sensor apparatus of claim 47, comprising at least one step protrusion on a first surface of the central region, the at least one first electrode and the at least one second electrode each being coupled to one of the at least one step protrusion.

55. 55. The analyte sensor apparatus of claim 54, wherein the at least one first electrode and the at least one second electrode are each coupled to one of the at least one step projections in an injection molding process.

56. 48. The analyte sensor apparatus of claim 47, wherein the body is injection molded.

57. 48. The analyte sensor apparatus of claim 47, comprising at least one pivot member on a first surface of said central region.

58. 48. The analyte sensor apparatus of claim 47, wherein said at least one sharps retainer is comprised of etched silicon.

59. 48. The analyte sensor apparatus of claim 47, wherein the first surface of the central region is at least partially covered with an adhesive retaining member.

60. 48. The analyte sensor apparatus of claim 47, wherein the analyte sensor apparatus further comprises an adhesive retaining member.

61. 48. The analyte sensor apparatus of claim 47, wherein each of the at least one first electrode and each of the at least one second electrode is a micropenetrator.

62. 48. The analyte sensor apparatus of claim 47, wherein each of the at least one first electrode and each of the at least one second electrode are contained in a micropenetrator that is at least partially covered by an insulating material.

63. 48. The analyte sensor apparatus of claim 47, wherein one of the at least one second electrode is configured to penetrate the biological barrier to a first depth and the other of the at least one second electrode is configured to penetrate the biological barrier to a second depth.

64. 64. The analyte sensor apparatus of claim 63, wherein the first depth is a shallow depth and the second depth is a subcutaneous depth.

65. 64. The analyte sensor apparatus of claim 63, wherein said shallow depth is intradermal depth.

66. 48. The analyte sensor apparatus of claim 47, wherein the analyte sensor apparatus comprises at least one transmitter.

67. 48. The analyte sensor apparatus of claim 47, wherein the at least one transmitter is disposed on a second side of the central region opposite the first side.

68. 48. The analyte sensor apparatus of claim 47, wherein the analyte sensor is a glucose sensor.

69. a body including a central region and a peripheral region having a plurality of petals; a coupling portion disposed on a first surface of the central region; at least one access member disposed on an opposite side of the central region and having a delivery lumen; at least one analyte sensor having electrodes disposed on opposite sides of the central region; 16. An access assembly apparatus for a biological barrier comprising:

70. 70. The biological barrier access assembly apparatus of claim 69, wherein the coupling is a fitting.

70. 70. The biological barrier access assembly apparatus of claim 69, wherein the coupling is a luer lock.

71. 70. The biological barrier access assembly apparatus of claim 69, wherein the coupling portion includes at least one guide and at least one connector receptacle, each connector receptacle having an angled surface and a stepped surface.

72. 70. The biological barrier access assembly apparatus of claim 69, wherein the apparatus further comprises a septum sealing a passageway in fluid communication with at least one access member.

73. 70. The biological barrier access assembly apparatus of claim 69, further comprising at least one transmitter.

74. 70. The biological barrier access assembly apparatus of claim 69, wherein an opposing surface of the central region includes at least one stepped projection, and wherein the access member and the electrode are each coupled to one of the at least one stepped projection.

75. 76. The biological barrier access assembly apparatus of claim 75, wherein an opposing surface of the central region includes at least one pivot member.

76. 70. The access assembly device for a biological barrier of claim 69, wherein the opposite surface of the central region includes at least one step projection, the at least one access member and the electrode are each coupled to one of the at least one step projection, and the at least one step projection forms one of the at least one rocking member.

77. 70. The biological barrier access assembly device of claim 69, wherein the analyte sensor is a glucose sensor.

78. 70. The device of claim 69, wherein the at least one access member comprises an array of microneedles extending from a sharps holder.

79. 70. The biological barrier access assembly device of claim 69, wherein the electrode comprises a micro-penetrator extending from a sharps holder.

80. 70. The biological barrier access assembly apparatus of claim 69, wherein the at least one access member is constructed from etched silicon.

81. 70. The biological barrier access assembly apparatus of claim 69, wherein the at least one access member comprises at least one first access member configured for shallow delivery and at least one second access member configured for subcutaneous delivery.

82. 70. The biological barrier access assembly apparatus of claim 69, wherein the at least one first access member is configured for intradermal delivery.

83. 70. The access assembly device for a biological barrier of claim 69, wherein the electrodes include a first group of electrodes configured for detecting an analyte concentration at a shallow location within the biological barrier and a second group of electrodes configured for detecting an analyte concentration at a subcutaneous location within the biological barrier.

84. 84. The biological barrier access assembly device of claim 83, wherein the shallow location is an intradermal location.

85. a body including a central region and a peripheral region having a plurality of petals extending outwardly from the central region; at least one bond disposed on a first surface of the central region; at least one first sharps holder disposed on an opposite surface of the central region, each first sharps holder being in fluid communication with a corresponding one of the at least one coupling portion; at least one second sharps retainer disposed on an opposite side of the central region, each second sharps retainer including at least one electrode; and including at least one first electrode and at least one second electrode associated with an analyte detection chemistry.

86. An access assembly device for a biological barrier as described in any one of claims 1, 22, 46, 47, 69, or 85, wherein the body is configured to transition from a stored state to an deployed state, and at least two portions of the body displace to spread apart as the body transitions from the stored state to the deployed state.

87. An access assembly device for a biological barrier as described in any one of claims 1, 22, 46, 47, 69, or 85, wherein the body is configured to transition from a stored state to a deployed state, and when the body transitions from the stored state to the deployed state, at least two adhesive retaining portions of the body displace to spread apart when transitioning from the stored state to the deployed state.

88. The biological barrier access assembly device of any one of claims 1, 22, 46, 47, 69, or 85, wherein the body is configured to transition from a stored state to an deployed state, and the central region is configured to move toward the biological barrier to which the biological barrier access assembly device is applied when the body transitions from the stored state to the deployed state.

89. an infusion device having a delivery assembly including at least one sensor and at least one pump mechanism; a set in fluid communication with the infusion device, the set including at least one intradermal access member; a controller configured to manage operation of the at least one pump mechanism, the controller being in data communication with the at least one sensor and configured to analyze data from the at least one sensor to determine that a change in depth of the at least one access member has occurred based on the data from the at least one sensor; A drug administration system comprising:

90. 90. The drug delivery system of claim 89, further comprising at least one analyte monitor.

91. 90. The drug delivery system of claim 89, further comprising a glucose monitor.

92. 90. The medication delivery system of claim 89, wherein the controller is in communication with at least one smart device and the injection device.

93. 90. The medical delivery system of claim 89, wherein the delivery assembly is split between a first portion of the injection device and a second portion that is removably coupled to the first portion of the injection device.

94. 94. A pharmaceutical delivery system as claimed in claim 93, wherein the second part is a cassette assembly.

95. 95. A drug delivery system as described in claim 94, wherein the cassette assembly includes at least one fluid path and at least one valve component, which are covered by at least one membrane.

96. 90. The medication delivery system of claim 89, wherein the at least one sensor is a pressure sensor configured to monitor the rate of delivery of fluid from the infusion device to the set.

97. 97. The medication delivery system of claim 96, wherein the controller is configured to analyze data from the at least one sensor to determine whether a rate of pressure decay has exceeded a predetermined criterion.

98. 97. The drug delivery system of claim 96, wherein the controller is configured to analyze data from the at least one sensor to determine whether a pressure decay rate exceeds a predetermined threshold, and to generate an alert for display on a user interface of the drug delivery system if the pressure decay rate exceeds the threshold.

99. 97. The drug delivery system of claim 96, wherein the controller is configured to analyze data from at least one sensor to determine whether a pressure decay rate is below a predetermined threshold, and to generate an alert for display on a user interface of the drug delivery system if the pressure decay rate is below the threshold.

100. 90. The medication delivery system of claim 89, wherein the at least one sensor is an acoustic volume sensor including a variable volume chamber, and data from the at least one sensor is indicative of a fluid volume within the variable volume chamber.

101. 101. The drug delivery system of claim 100, wherein the controller is configured to analyze data from the at least one sensor to determine whether a change in volume of the variable volume chamber exceeds a predetermined criterion.

102. The drug delivery system of claim 100, wherein the controller is configured to analyze data from the at least one sensor to determine whether the rate of volume change of the variable volume chamber exceeds a predetermined threshold, and to generate an alert for display on a user interface of the drug delivery system if the rate of volume change exceeds the threshold.

103. The drug delivery system of claim 100, wherein the controller is configured to analyze data from the at least one sensor to determine whether the rate of volume change of the variable volume chamber is below a predetermined threshold, and to generate an alert for display on a user interface of the drug delivery system if the rate of volume change is below the threshold.

104. 90. The drug delivery system of claim 89, wherein the at least one intradermal access member comprises a microneedle.

105. 90. The drug delivery system of claim 89, wherein the at least one intradermal access member comprises an array of microneedles on a sharp holder coupled to a stepped protrusion on a face of the set.

106. 106. A drug delivery system as described in claim 105, wherein the set of surfaces includes at least one rocking member.

107. 90. The medical delivery system of claim 89, wherein the set includes a body having a central region and a peripheral region including a plurality of petals.

108. The drug delivery system of claim 107, wherein the body is configured to transition from a stored state to a deployed state, and wherein at least two adhesive holding portions displace to spread apart when the body transitions from the stored state to the deployed state, and wherein the central region moves toward a biological barrier when the body transitions from the stored state to the deployed state.

109. 90. The medication delivery system of claim 89, wherein at least one sensor is configured to generate a data signal that varies in relation to delivery impedance from the at least one access member.

110. an infusion device comprising a delivery assembly including at least one sensor and at least one pump mechanism; a set in fluid communication with the infusion device, the set including at least one shallow access member and at least one subcutaneous access member; a controller configured to manage operation of at least one pump mechanism, the controller being in data communication with the at least one sensor and configured to compare data from the at least one sensor related to fluid delivery to the at least one shallow access member and the at least one subcutaneous access member to determine that a depth of either the at least one shallow access member or the at least one subcutaneous access member has changed based on data from the at least one sensor; A drug administration system comprising:

111. 111. The drug delivery system of claim 110, wherein the at least one shallow access member and the at least one subcutaneous access member are microneedles.

112. The drug delivery system of claim 110, wherein the at least one shallow access member and the at least one subcutaneous access member each include an array of microneedles on a sharp holder coupled to a stepped protrusion on a face of the set.

113. 113. The drug delivery system of claim 112, wherein the set of surfaces includes at least one rocking member.

114. 111. The drug delivery system of claim 110, wherein the set includes a body having a central region and a peripheral region including a plurality of petals.

115. The drug delivery system of claim 114, wherein the body is configured to transition from a stored state to a deployed state, and wherein at least two adhesive holding portions displace to spread apart when the body transitions from the stored state to the deployed state, and wherein the central region moves toward a biological barrier when the body transitions from the stored state to the deployed state.

116. 111. The drug delivery system of claim 110, wherein the drug delivery system includes at least one analyte monitor.

117. 111. The drug delivery system of claim 110, wherein the drug delivery system includes a glucose monitor.

118. The medication delivery system of claim 110, wherein the controller is capable of communicating with at least one smart device and the injection device.

119. 111. The medical delivery system of claim 110, wherein the delivery assembly is split between a first portion of the injection device and a second portion removably coupled to the first portion.

120. 120. The pharmaceutical delivery system of claim 119, wherein the second part is a cassette assembly.

121. 121. The drug delivery system of claim 120, wherein the set assembly includes at least one flow path and at least one valve component, which are covered by at least one membrane.

122. 111. The medication delivery system of claim 110, wherein the at least one sensor is configured to generate a data signal that varies in relation to delivery impedance from the at least one access member.

123. 123. The drug delivery system of claim 122, wherein the controller is configured to determine that the at least one subcutaneous access member has moved to an intradermal depth when a delivery impedance associated with the at least one subcutaneous access member indicated by the at least one sensor increases.

124. The drug delivery system of claim 122, wherein the controller is configured to determine that the subcutaneous access member has moved to an intradermal depth when a delivery impedance associated with the at least one subcutaneous access member indicated by the at least one sensor increases within a range of historical data associated with the at least one intradermal access member.

125. The medication delivery system of claim 122, wherein the controller is configured to generate an alarm when a delivery impedance associated with the at least one subcutaneous access member indicated by the at least one sensor increases within a range of historical data associated with the at least one intradermal access member and a delivery impedance associated with the at least one intradermal access member decreases.

126. an infusion device comprising a delivery assembly including at least one pump mechanism; a set in fluid communication with the injection device, the set including at least one access member, a shallow analyte sensor, and a deep analyte sensor; a controller configured to manage operation of at least one pump mechanism to selectively deliver fluid to the at least one access member and in communication with the shallow analyte sensor and the deep analyte sensor; wherein the controller is configured to compare data from the shallow analyte sensor and the deep analyte sensor and generate a notification if a relationship between the data from the shallow analyte sensor and the deep analyte sensor exceeds a predetermined criteria.

127. 127. The drug delivery system of claim 126, wherein at least one shallow analyte sensor and at least one subcutaneous analyte sensor comprise a micropenetrator.

128. 127. The drug delivery system of claim 126, wherein the set of faces includes at least one step protrusion, and the shallow analyte sensor and the deep analyte sensor are each coupled to one of the at least one step protrusion.

129. 129. The drug delivery system of claim 128, wherein the set of surfaces includes at least one rocking member.

130. 127. The drug delivery system of claim 126, wherein the set includes a body having a central region and a peripheral region including a plurality of petals.

131. The drug delivery system of claim 130, wherein the body is configured to transition from a stored state to a deployed state, and wherein at least two adhesive retaining portions displace to spread apart when the body transitions from the stored state to the deployed state, and wherein the central region moves toward a biological barrier when the body transitions from the stored state to the deployed state.

132. 127. The drug delivery system of claim 126, wherein the shallow analyte sensor is an intradermal analyte sensor and the deep analyte sensor is a subcutaneous analyte sensor.

133. 127. The drug delivery system of claim 126, wherein the shallow analyte sensor and the deep analyte sensor are glucose sensors.

134. The medication delivery system of claim 126, wherein the controller is capable of communicating with at least one smart device and the injection device.

135. 127. The medical delivery system of claim 126, wherein the delivery assembly is split between a first portion of the injection device and a second portion that is removably coupled to the first portion.

136. 136. The pharmaceutical delivery system of claim 135, wherein the second part is a cassette assembly.

137. 137. The drug delivery system of claim 136, wherein the cassette assembly includes at least one flow path and at least one valve component, which are covered by at least one membrane.

138. 127. The drug delivery system of claim 126, wherein the predetermined criterion is a time delay between the change in analyte concentration measured by the shallow analyte sensor and the deep analyte sensor.

139. 127. The medication delivery system of claim 126, wherein the predetermined criteria is determined based on historical data collected from the shallow analyte sensor and the deep analyte sensor.

140. The medication delivery system of claim 126, wherein the controller is configured to analyze data from the shallow analyte sensor and the deep analyte sensor and generate a notification if data from either analyte sensor indicates that the respective analyte sensor has moved from its intended position.

141. an infusion device comprising a delivery assembly including at least one pump mechanism; a set in fluid communication with the infusion device, the set including at least one shallow access member, at least one deep access member, and at least one analyte monitor; a controller configured to manage operation of the at least one pump mechanism to selectively deliver fluid from the infusion set to each access member; at least one sensor that generates a signal that varies in relation to delivery impedance from the access member; wherein the controller is configured to analyze data from the sensor and the at least one analyte monitor and generate a notification if data from the at least one analyte monitor and data from the sensor indicate that at least one of the at least one analyte sensor and the at least one access member, respectively, has been displaced from an intended position.

142. 142. The drug delivery system of claim 141, wherein the at least one shallow access member and the at least one deep access member are microneedles.

143. 142. The drug delivery system of claim 141, wherein the at least one shallow access member and the at least one deep access member each comprise an array of microneedles on a sharp holder coupled to a stepped protrusion on a face of the set.

144. 144. The drug delivery system of claim 143, wherein the set of surfaces includes at least one rocking member.

145. 142. The drug delivery system of claim 141, wherein the set includes a body having a central region and a peripheral region including a plurality of petals.

146. The drug delivery system of claim 145, wherein the body is configured to transition from a stored state to a deployed state, and wherein at least two adhesive holding portions displace to spread apart when the body transitions from the stored state to the deployed state, and wherein the central region is configured to move toward the biological barrier to which the set is applied when the body transitions from the stored state to the deployed state.

147. 142. The drug delivery system of claim 141, wherein the at least one shallow access member is an intradermal access member and the at least one deep access member is a subcutaneous access member.

148. 142. The drug delivery system of claim 141, wherein the at least one analyte monitor comprises a micropenetrator.

149. The medication delivery system of claim 141, wherein the controller is capable of communicating with at least one of a smart device and an injection device.

150. 142. The medical delivery system of claim 141, wherein the delivery assembly is split between a first portion of the injection device and a second portion that is removably coupled to the first portion.

151. 151. The pharmaceutical delivery system of claim 150, wherein the second part is a cassette assembly.

152. 152. A drug delivery system as described in claim 151, wherein the cassette assembly includes at least one flow path and at least one valve component, which are covered by at least one membrane.

153. 142. The drug delivery system of claim 141, wherein the set includes a coupling portion configured to couple with a fluid transfer connector at an end of a fluid line extending from the injection device.

154. The drug delivery system of claim 153, wherein the set includes conductive wiring extending from at least one analyte monitor, and the fluid transfer connector includes contacts configured to seat against the conductive wiring when the fluid transfer connector engages with the coupling portion.

155. 155. The drug delivery system of claim 154, wherein the electrical communication path extends from the contact along the length of the fluid line.

156. an analyte sensor assembly including a shallow analyte sensor and a deep analyte sensor; a controller in data communication with the shallow analyte sensor and the deep analyte sensor; wherein the controller is configured to compare data received from the shallow analyte sensor and the deep analyte sensor and generate a notification when data from the analyte sensor deviates from an expected relationship by more than a threshold.

157. 157. The analyte detection system of claim 156, wherein the controller is configured to initialize the expected relationship to a predefined expected relationship.

158. 158. The analyte detection system of claim 157, wherein the controller is configured to adjust the expected relationship based on data received from the shallow analyte sensor and the deep analyte sensor.

159. 157. The analyte detection system of claim 156, wherein the expected relationship is established based at least in part on historical data received from the shallow analyte sensor and the deep analyte sensor.

160. 157. The analyte detection system of claim 156, wherein the shallow analyte sensor is an intradermal analyte sensor and the deep analyte sensor is a subcutaneous analyte sensor.

161. 157. The analyte detection system of claim 156, wherein the shallow analyte sensor and the deep analyte sensor each comprise at least one micro-penetrator.

162. 157. The analyte detection system of claim 156, wherein the expected relationship defines a delay between a change in analyte concentration detected by the shallow analyte sensor and a change in analyte concentration detected by the deep analyte sensor.

163. 157. The analyte detection system of claim 156, wherein the analyte detection assembly includes a connector coupling capable of wired communication with the controller.

164. 157. The analyte detection system of claim 156, wherein the analyte detection assembly is configured to be coupled to a transmitter for wirelessly communicating data to the controller.

165. 157. The analyte detection system of claim 156, wherein the analyte detection assembly includes a surface having at least one step protrusion, and the shallow analyte sensor and the deep analyte sensor are each disposed on at least one step protrusion.

166. 166. The analyte detection system of claim 165, wherein the surface comprises at least one rocking member.

167. 157. The analyte detection system of claim 156, wherein the analyte detection assembly includes a body having a central region and a peripheral region including a plurality of petals.

168. The analyte detection system of claim 167, wherein the body is configured to transition from a stored state to a deployed state, and wherein at least two adhesive holding portions displace to spread apart when the body transitions from the stored state to the deployed state, and wherein the central region is configured to move toward a biological barrier to which the analyte detection assembly is applied when the body transitions from the stored state to the deployed state.

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

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