Drug delivery systems, methods, and devices

Abstract

The present invention relates to drug administration sets and other components for assisting in the administration of medications to patients. [Solution] An analyte detection system comprising an analyte sensor assembly including a shallow analyte sensor and a deep analyte sensor, and a controller capable of 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 if the data from the analyte sensor deviates from an expected relationship by more than a threshold value.

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] According to one embodiment of the present disclosure, an exemplary medication delivery device may include a body including a central region and a peripheral region. The peripheral region may include a plurality of petals extending outward from the central region. The device may further include at least one coupling portion on a first surface of the central region. The device may also include at least one sharps holder on an opposing surface of the central region. Each sharps holder may be fluidly connected to a corresponding coupling portion. In some embodiments, the central region may be raised 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 rocker member. In some embodiments, the sharps holder may be made of etched silicon. In some embodiments, each sharps holder 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 a stepped protrusion on the opposing surface via an adhesive. In some embodiments, the device may further include a septum that seals a passage 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 retaining member. In some embodiments, the device may further include an adhesive retaining member. 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 position the first microneedle at a shallow destination and the second height may be selected to position the second microneedle at a deeper 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 fluidly connected only to its respective coupling.

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

[0004] In some embodiments, the body may be joined to a ridge included in a portion of the body. In some embodiments, the body may include a plurality of tabs that join to slits in the body. In some embodiments, the central region may be raised relative to the peripheral region. In some embodiments, each joining portion may be a fitting. In some embodiments, each coupling portion may be a tube receptacle that receives a fluid line connected to the 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 structure may be injection molded. In some embodiments, the opposing surfaces of the structure may include at least one rocking member. In some embodiments, the sharps holders may be comprised of etched silicon. In some embodiments, each sharps holder may be attached to at least one stepped protrusion on the opposing surface by an injection molding process. In some embodiments, each sharps holder 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 passage fluidly connected to the sharps holder. In some embodiments, the opposing surfaces of the structure may be at least partially covered with an adhesive retaining member. In some embodiments, the device may further include an adhesive retaining member. 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 sharp holder may include at least one microneedle having a first height, and another sharp holder may include a second microneedle of a different height. In some embodiments, the first height may be selected to position the first microneedle at a shallow destination, and the second height may be selected to position the second microneedle at a deeper 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 holder may be fluidly connected only to its respective coupling.

[0005] According to another embodiment of the present disclosure, an exemplary medication delivery device can include a body including a central region and a peripheral region. The peripheral region can include a plurality of petals extending outward 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 also 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 portion. The at least one sharps holder can be coupled to a stepped protrusion on the opposing surface.

[0006] According to 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 outward from the central region. The device can further include at least one sharps holder on a first surface of the central region. Each 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.

[0007] In some embodiments, the central region may be raised 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 holder and at least one second electrode on another sharps holder. 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 holder may be coupled to a stepped protrusion on the first surface. In some embodiments, each sharps holder may be coupled to a stepped protrusion during an injection molding process. In some embodiments, the first surface may include at least one stepped protrusion. The first and second electrodes may each be coupled to one of the stepped protrusions. In some embodiments, the first and second electrodes may each be coupled to a stepped 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 holder may be comprised of etched silicon. In some embodiments, the first surface of the central region may be at least partially covered with 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 with 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] According to 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 surface of the central region. The device can further include at least one access member on an opposing surface 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 surface of the central region.

[0009] In some embodiments, the coupling portion may be a fitting such as a Luer lock fitting. In some embodiments, the coupling portion may include at least one guide and at least one connector receptacle. Each connector receptacle may have a sloped surface and a stepped surface. In some embodiments, the device may further include a septum sealing a passageway fluidly connected to the access member. In some embodiments, the device may further include at least one transmitter. In some embodiments, opposing surfaces of the central region may include at least one stepped protrusion. The access member and the electrode may each be coupled to the at least one stepped protrusion. In some embodiments, opposing surfaces of the central region may include at least one rocking member. In some embodiments, 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 holder. In some embodiments, the electrode may include a micro-penetrator extending from the sharps holder. In some embodiments, the access member may be composed 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 group of electrodes configured to detect the analyte concentration at a shallow location within the biological barrier and a second group of electrodes configured to detect the analyte concentration at a subcutaneous location. In some embodiments, the shallow location may be an intradermal location.

[0010] According to 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 outward 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 as the body transitions 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 as the body transitions 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] According to 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 fluidly connected to 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 sensor data.

[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 first portion of the infusion device and a second portion removably coupled to the first portion. 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 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 whether a pressure decay rate exceeds a predefined criterion. In some embodiments, the controller may be configured to analyze data from the at least one sensor and determine whether 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 whether 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 falls 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 whether 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 whether the rate of volume change of the variable volume chamber exceeds a predefined threshold, and display an alert on a user interface of the system when the rate of volume change exceeds the threshold. In some embodiments, the controller may be 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 predefined threshold, and display an alert on a user interface of the system when the rate of volume change falls below the threshold. In some embodiments, at least one intradermal access member may include microneedles. In some embodiments, at least one intradermal access member may include an array of microneedles on a sharps holder coupled to a stepped protrusion on a surface of the set. In some embodiments, the surface 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 retracted state to an expanded state. As the body moves from the retracted state to the expanded state, at least two adhesive retaining portions may be configured to expand and displace. When the body transitions from the stowed state to the deployed state, the central region may be configured to move toward the 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 delivery impedance from the at least one access member.

[0014] According to another embodiment, an exemplary drug delivery system can include an infusion device. The infusion device can include a delivery assembly including at least one pump mechanism. The system can further include a set fluidly connected to the delivery device. The set can include at least one shallow access member and at least one subcutaneous access member. The system can further include a controller configured to manage operation of the at least one pump mechanism. The controller can be in data communication with the at least one sensor, can 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 can 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 from the at least one sensor.

[0015] In some embodiments, at least one shallow access member and at least one subcutaneous access member may be microneedles. In some embodiments, at least one shallow access member and at least one subcutaneous access member may include an array of microneedles on a sharps holder coupled to a stepped protrusion on a surface of the set. In some embodiments, the surface 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 retracted state to an expanded state. As the body moves from the retracted state to the expanded state, at least two adhesive retaining portions may be configured to expand and displace. When the body transitions from the stowed state to the deployed state, the central region may be configured to move toward the 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 first portion of the infusion device and a second portion removably coupled thereto. 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 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 alert 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] According to yet another embodiment of the present disclosure, a drug administration system comprises an infusion device including a delivery assembly, where the delivery assembly may include at least one pump mechanism. The system may further comprise a set fluidly connected to 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 comprise 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, at least one shallow analyte sensor and at least one subcutaneous analyte sensor may include a micropenetrator. In some embodiments, the surface of the set may include at least one step, and the shallow analyte sensor and the deep analyte sensor may be coupled to one of the at least one step. In some embodiments, the surface 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 stowed state to an unfolded state. When the body moves from the stowed state to the unfolded state, the at least two adhesive retaining portions may be configured to displace while spreading. When the body moves from the stowed state to the unfolded state, the central region may be configured to move toward the 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 glucose sensors. 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 first portion of the infusion device and a second portion removably coupled thereto. 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, each of 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 by 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 data indicates that either analyte sensor has shifted from a predetermined position.

[0018] According to yet another embodiment of the present disclosure, a drug administration 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 fluidly connected to 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 is configured to generate a signal that varies in relation to 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 its intended position.

[0019] In some embodiments, at least one shallow access member and at least one deep access member may be microneedles. In some embodiments, at least one shallow access member and at least one deep access member may include an array of microneedles in a sharps holder and coupled to a stepped protrusion on a face of the set. In some embodiments, the set of faces may include at least one rocker member. In some embodiments, the set may include a body having a central region and a peripheral region including a plurality of petals. In some embodiments, the body may be configured to be transitionable from a retracted state to a deployed state. The at least two adhesive retaining portions may be displaced and expand as the body transitions from the retracted state to the deployed state. When the body transitions from the retracted state to the deployed state, the central region may be configured to move toward the 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 detachably 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 portion for coupling to 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 wires extending from at least one analyte monitor. The fluid transfer connector may include contacts that are positioned relative to the conductive wires when the fluid transfer connector is engaged with the coupling. In some embodiments, an electrical communication path may extend from the contacts along the length of the fluid line.

[0020] According to 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 micropenetrator. 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 for wired communication with the controller. 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 protrusion. The shallow analyte sensor and the deep analyte sensor may each be disposed on at least one stepped protrusion. 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 stowed state to an deployed state. As the body moves from the stowed state to the deployed state, the at least two adhesive retaining portions may be configured to displace and spread apart. When the body transitions from the stowed state to the deployed state, the central region may be configured to move towards the biological barrier to which the analyte detection assembly is applied. [Brief explanation of the drawings]

[0022] These and other aspects will become more apparent upon reference to the following detailed description of 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] [Figure 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] [Figure 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 an example embodiment of a set.

[0027] [Figure 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] FIG. 10 is a plan view of an exemplary embodiment of multiple access members arranged on a sharps holder.

[0034] [Figure 10A] FIG. 10 is a plan view of an exemplary embodiment of multiple access members arranged 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] FIG. 10 is a plan view of an exemplary embodiment of multiple access members arranged 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] 11B is a cross-sectional view of FIG. 11A at the indicated cutting plane.

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

[0040] [Figure 13] FIG. 1 is a perspective view of an exemplary set.

[0041] [Figure 14]FIG. 1 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. 10 is a bottom view of an exemplary body of an exemplary set.

[0044] [Figure 17] FIG. 10 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 illustrates an exemplary set of delivery conditions at an injection site of a biological barrier.

[0047] [Figure 20] FIG. 1 is a side view of an exemplary set.

[0048] [Figure 21] FIG. 1 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. 1 is a perspective view of an exemplary set with an exemplary body partially disassembled from the set.

[0052] [Figure 25]FIG. 10 is an exploded view of an exemplary set with adhesive liners removed from the adhesive members included in the set.

[0053] [Figure 26] FIG. 1 is a perspective view of an exemplary set.

[0054] [Figure 27] FIG. 1 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. [Figure 30] 1 shows a conceptual diagram of an exemplary set in a delivery state.

[0057] [Figure 31] 10A-10C illustrate an exemplary perspective view of a body having a stepped projection with multiple access members coupled thereto.

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

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

[0060] [Figure 34] 10 illustrates a cutaway cross-sectional view of an exemplary step projection and an exemplary access member disposed on a sharps retainer.

[0061] [Figure 35] 1 is a diagram of an exemplary body including a plurality of step projections, each step projection associated with at least one access member and fluidly isolated from one another. [Figure 36] 1 is a diagram of an exemplary body including a plurality of step projections, each step 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 rocker member. [Figure 38] 1 shows a conceptual diagram of an exemplary set including a rocker member.

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

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

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

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

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

[0068] [Figure 44] FIG. 1 is a perspective view of an exemplary set.

[0069] [Figure 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. 45.

[0071] [Figure 47] FIG. 1 is an exploded view of an exemplary analyte sensor and transmitter.

[0072] [Figure 48] FIG. 1 is a bottom view of an exemplary analyte sensor.

[0073] [Figure 49] FIG. 1B 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] FIG. 1 is a plan view of an exemplary access assembly and an exemplary connector.

[0076] [Figure 52] FIG. 10 is a bottom view of another exemplary access assembly.

[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. 1 is a block diagram of an exemplary delivery assembly included in a particular exemplary injection device. [Figure 59] FIG. 1 is a block diagram of an exemplary delivery assembly included in a particular exemplary injection device. [Figure 60]FIG. 1 is a block diagram of an exemplary delivery assembly included in a particular exemplary injection device. [Figure 61] FIG. 1 is a block diagram of an exemplary delivery assembly included in a particular exemplary injection device. [Figure 62] FIG. 1 is a block diagram of an exemplary delivery assembly included in a particular exemplary injection device. [Figure 63] FIG. 1 is a block diagram of an exemplary delivery assembly included in a particular exemplary injection device. DETAILED DESCRIPTION OF THE INVENTION

[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 user's skin layer 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, including 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," Attorney Docket 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, entitled "FILLING MECHANISM FOR AN INJECTION 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 can 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. Microneedles described herein include, but are not limited to, the various microneedles described in U.S. Patent Application No. 11,154,698, issued October 26, 2021 (Entitled "Microneedle System and Device"; Attorney Docket No. G34) or U.S. Patent Application No. 5,983,136, issued November 9, 1999 (Entitled "Transport-Based Drug Delivery System"; 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 adhered to a portion of a patient's skin 14 to establish access to a delivery 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 delivery destination. Each access member 16 is an indwelling body that extends at least partially into the skin during use. The delivery destination may be subcutaneous or a shallow delivery destination. In a shallow delivery destination, the at least one access member 16 delivers fluid to a portion of the skin between the stratum corneum and the subcutaneous tissue. A shallow delivery 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 delivery destination may also be an intradermal delivery 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 (e.g., 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 access members 16 individually or may communicate delivery to all access members 16. Any combination of 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. These access members 16 may penetrate to different depths into the patient. For example, the set 12 may include at least one subcutaneous access member 16 and at least one shallow delivery access member 16. Alternatively, the set 12 may include access members 16 that extend to different shallow delivery destinations when attached to a patient.

[0084] For delivery of certain drugs, it may be desirable for the set 12 to include at least one access member 16 suitable for shallow delivery. For example, because the dermal region is highly vascularized, it may be absorbed more quickly than if the same drug were administered subcutaneously. This allows for faster-acting injections of drugs such as insulin. Therefore, such shallow delivery may facilitate tighter control of the concentration of an analyte of interest. Shallow delivery may also reduce variability in absorption rates between patients and between different injection sites within the same patient. Furthermore, drugs such as insulin come in various forms, such as rapid-acting, short-acting, intermediate-acting, and long-acting, which vary in speed and duration of action. Because of rapid absorption in the intradermal region, drugs with slower onset of action may be delivered with a faster onset of action than if administered subcutaneously. Shallow injections may improve patient compliance and quality of life. This may be particularly true in certain patient populations, such as those with juvenile diabetes. Applying the set 12 with the access member 16 to a shallow delivery site may be painless because the access member 16 is short enough to not reach deeper anatomically located nerve endings. Additionally, certain types of access members 16 may be better tolerated by patients. For example, silicone microneedles may not pose the same allergy concerns 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 pump components or provide data regarding 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 certain embodiments, the infusion device 18 includes reusable and disposable components that are detachably coupled. By way of example, the infusion device 18 includes a cassette assembly 25 that can be attached to the reusable portion. The cassette assembly 25 includes a reservoir 22, and the fluid in the reservoir is replaced when depleted. The delivery assembly 24 can be divided between the cassette assembly 25 and a reusable portion. For example, the cassette assembly 25 can include fluid channels and valves that can be actuated via a flexible membrane that covers at least a portion of the cassette 25. The reusable portion can 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 fluid 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 tubing 28; however, 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 tubing 28 may be omitted. Any suitable connector 26 may be used, and the set 12 may include a cooperating interface that fluidically and sealingly engages with the connector 26. The connector 26 may be a luer lock fitting, or 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 herein by reference. In certain examples, the connector 26 may engage a coupling 98 (see, e.g., FIG. 13 ) attached to the set 12 via set tubing 96. If a luer fitting is used, the luer fitting may include a check valve to prevent fluid flow when not connected to the set 12. A cap or cover may be used to cover the connector 26 and / or coupling when not connected.

[0087] The infusion device 18 can deliver a desired fluid to a destination via the set 12. In various examples, the infusion device 18 delivers at least one medication. The medication typically includes a continuous or near-continuously delivered drug, although other medications can be used. This may include small molecules, biopharmaceuticals, recombinantly produced drugs, and their analogs. In various examples, the infusion device 18 can deliver a medication that affects the cardiovascular system or blood vessels. For example, the infusion device 18 can deliver a vasodilator. In certain examples, a medication 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 medication can also be a medication for treating diabetes or for altering blood glucose levels. In certain embodiments, the infusion device 18 can deliver insulin. In certain embodiments, the infusion device 18 can deliver glucagon. Chemotherapy medications can also be delivered via the set 12. In certain embodiments, multiple medications can be delivered by one or more infusion devices 18 of the system 10. For example, any of the medications described above can be delivered. The drug being delivered may include one or more excipients that may or may not facilitate absorption. For example, insulin may be delivered as nicotinamide. References herein to insulin, glucagon, blood glucose, diabetes, etc., are merely exemplary and should be construed as intended for use with other medical conditions, drugs, and analytes.

[0088] In various embodiments, the system 10 may include one or more analyte sensors 30. The analyte sensors 30 may generate data related to the concentration of an analyte of interest in a patient. The analyte sensors 30 may include amperometric sensors that generate a current proportional to the concentration of the analyte of interest in a patient. The analyte sensors 30 may include one or more electrode arrangements, the surface of which may be covered, coated, or otherwise associated 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 EC1.1 in certain examples. The enzyme may be classified as EC1.1.3 in certain embodiments. In certain examples, glucose oxidase is used, but any sensor chemistry appropriate 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. Certain embodiments may also 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, in some examples, monitor bodily fluids in the subcutaneous space.

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

[0090] The analyte sensor 30 may include or be associated with a transmitter 32. The transmitter 32 may be integrated into 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 for storing sensor data. The analyte sensor 30 may transmit sensor data via the transmitter 32 in response to an inquiry by another component of the system 10 or based on a predefined schedule. For example, the transmitter may transmit sensor data after a predetermined time (e.g., 1-5 minutes) has elapsed since the last transmission. If transmission is based on a predefined schedule, data may also be transmitted in response to an inquiry by another component of the system 10. The transmitted data 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 predetermined 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 establish a wired or other physical connection with other components of the system 10 (or when data transfer is required). In embodiments that include a transmitter 32, a wired connection may be available to access data from the sensor 30 as needed.

[0091] In one example, transmitter 32 may transmit alarms when data from analyte sensor 30 determines that a user of system 10 needs to be alerted. These alarms may be transmitted by transmitter 32 independent of a predetermined schedule or without inquiry from other components of system 10. In some embodiments, sensor data may be transmitted over a first type of transmitter included in transmitter 32 (e.g., NFC) and alarms may be transmitted over a second type of transmitter (e.g., Bluetooth).

[0092] The sensor data may be transmitted to the infusion device 18, the first interface 34, the second interface 36 of the system 10 (which may, in some examples, also include a third, fourth, and fifth interface), a database 40 in the cloud 38, or a combination thereof. Additionally, the data may be transmitted to one or more of the above components, which then communicate the data to other components of the system 10. In some examples, the first interface 34 is a reader for the analyte sensor 30, and 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 smartwatch, 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 transmit an alarm to other components of the system 10 when the received data meets 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 its trend exceeds a threshold or is determined to be outside a predetermined 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 predetermined 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 occurs. In one embodiment, the infusion device 18 may deliver fluid to the sets 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 may adjust the basal delivery rate, adjust the bolus delivery (or both). If multiple medications are being delivered (e.g., to different sets 12, see FIG. 2), the type of medication delivered may be changed. For example, if a medication that lowers the analyte concentration is being administered and the analyte concentration is declining at a rate greater than a certain rate, the layer thickness may be switched to a medication that increases the 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 an infusion device 18 (e.g., via tubing 28 or by direct connection). 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 or different from the others. Similarly, each connector 26, 44 may be identical to or different from the others. In some embodiments, the infusion device 18 may provide different medications to each set 12, 42 and include fluidly separated reservoirs 22 containing those 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 a separate reservoir 22 for each medication and 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 sets 12, 42, the drugs may be related in terms of their effects. 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 infusion devices 18 may be included.

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

[0097] Referring to FIG. 3 , in certain examples, the system 10 may not include a separate set 14 or analyte sensor 30. In certain examples, the system 10 includes an access assembly 46, 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 portions 31 of the analyte sensors 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 channel 68 or bore, and such an indwelling portion 31 is referred to as a micropenetrator. The micropenetrator may be constructed of etched silicon and may optionally 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 the insulating material may include one or more conductive electrodes on its surface. Known analyte sensor configurations may also 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. 2.

[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. A 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 leading to the infusion device 18. Specific examples of the access assembly 46 are shown and described in connection with Figures 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 a patient's skin. The exemplary set 12 is designed to be easily applied to various injection sites on a patient's body and sized to be easily concealed under clothing. The exemplary set 12 is also designed for simple manual application. Therefore, an inserter assembly may not be required to position 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 medication 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 communicating with a connector 26 that connects to 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 containing 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 access members 16 are spaced 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 FIGS. 4A-4B, the access members 16 are depicted as delivery sharps. The delivery sharps in FIGS. 4A-4B are microneedles. These microneedles may be included in the set 12 with shallow delivery destinations (e.g., above the subcutaneous tissue). In some instances, the microneedles may extend slightly into the subcutaneous tissue.

[0103] While microneedles are used in Figure 25, the microneedles described herein may, in certain embodiments, be polyhedral (e.g., pyramidal) silicon crystal microneedles fabricated with MEMS. 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 microneedles may be 1200-1500 microns, or even greater in some instances. In some embodiments, the microneedles may have a height sufficient to penetrate subcutaneous tissue to at least a certain depth. At least some edges of the microneedles may be rounded or filleted, although such microneedles may still be referred to as polyhedral herein. In some examples, as shown in Figure 25, the microneedles described herein may generally be in the shape of a heptagonal prism cut at an angle to form a heptagonal ramp or pointed wedge (although pentagonal, nonagonal, and other polygonal prisms may also be used as base shapes). In such embodiments, the heptagonal prism may be divided by a plane extending from the apex 58 on 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 a microneedle may still be referred to as pointed). In such embodiments, the rear side edge 66 may be a rounded surface, or the rear side edge 66 and the adjacent sidewall 64 may be replaced by a rounded surface.

[0104] The tip or end of the microneedle may be solid, or the channel 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 channel 68 extending to the tip of the microneedle. In some embodiments, the microneedle may be a hollow microneedle, such as those 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 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 medication, into a patient's skin. In some examples, features common to insect stingers or biotoxin administration structures may be incorporated. These features may include various recesses or indentations formed on each microneedle, or as part of at least one microneedle, of set 12. These indentations or indentations may be in fluid communication with the flow channel 68 of the respective microneedle. In some embodiments, different microneedles of set 12 may include different indentations, or some microneedles may include multiple indentations that may (but need not) be different.

[0106] For example, as shown in Figures 6A-7B, the microneedle can include a channel or trough 200 on the outer slope 72 extending 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 and through the channel 70, finding the path of least resistance, or weakest link, into 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, a target for intradermal delivery, is a weak link in the skin structure and is difficult to inject consistently and directly due to its relative thinness (typically about 40 nm thick). A microneedle including a channel 70 can, for example, allow the medical agent to flow to the pellucida junction when the pellucida junction passes the outlet of the flow channel 68. The channel 70 can facilitate distribution of the medical agent through a larger penetration or injection area. In some examples, incorporating the channel 70 into the microneedle can 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] Steeper sidewalls of the channel 70 can be created using suitable silicon etching techniques (or molds in embodiments using polymer microneedles). This can help prevent the skin from bending and blocking the channel 70. Non-limiting examples of etching techniques that can be used include 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 or dry etching process. In some non-limiting embodiments, the channel 70 can have a width from side to side in the range of 50 to 60 microns. In some non-limiting embodiments, the channel 68 can have a diameter of 50 to 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 smaller or larger than the width of the channel 68. The channel 70 can be approximately 5 to 10 percent of the height of the microneedle.

[0108] To avoid leakage of fluid from channel 70, it may be desirable to ensure that 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 pellucida junction). In some embodiments, channel 70 extends from flow path 68 to within a maximum of 50 microns (e.g., 50-200 microns) of microneedle base 62. In some embodiments, the end of channel 70 most proximal to microneedle base 62 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 channel 70 closest to base 62 may be located below the epidermis (e.g., in the basement membrane) or within the epidermis.

[0109] The channel 70 does not need 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 approximately 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. While the depth of the channel 70 may be constant along the length of the channel 70, 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, for example, FIG. 8B). The width of the channel 70 may be approximately 20-30 percent of the width of the distal side 60 of the microneedle at its narrowest point. 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 point 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 embodiments, 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 containing multiple microneedles is shown. In certain embodiments, the channel 70 may not be included. Instead, the microneedle may include a flow path 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 positioned in place within a patient's body. Thus, thin and / or weak layers of skin may be more likely to be targeted when the microneedle is advanced into the patient's body. The elongated lumen 68 may also help reduce the pressure required for injection. Such elongated flow path 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, such as, but not limited to, rectangular, trapezoidal, or triangular, may also be used. In certain instances, the cross-sectional length (in the elongated direction) 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 below at least the stratum corneum (and possibly one or more of the stratum lucidum, stratum granulosum, stratum spinosum, and stratum basale). In some embodiments, it may be located below the epidermis (e.g., within the basement membrane) or within the epidermis.

[0113] 9A-9B, in certain embodiments, the beveled surface 72 of the microneedle may not extend all the way to the base 62 of the microneedle. For example, it may extend from the base 62 to the distal side 60 of the microneedle. If a vertical surface 76 is included, the vertical surface 76 may align 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 may help ensure consistent fluid delivery to the target destination of a particular microneedle. As shown in FIGS. 9A-9B, any of the microneedles shown herein may be configured 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 path 68 of the microneedle. Thus, the recess 78 can form a side port for the microneedle through which fluid can be delivered to the patient. The side port may be the only outlet for 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, fluid delivered through the set 12 can 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 removing material during the manufacturing of the microneedle or may be formed during a molding operation. Removal of material can be achieved by any known suitable process, such as 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 approximately 130% to 110% of the distance from the back edge 66 to the channel 68.

[0115] In a particular example, as now shown in Figures 10A and 10B, the microneedle can include a beveled surface 72 from which extends a lumen 68 extending 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 can be used. The rounded blade edge 84 may arc at a constant radius or may arc 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 can aid in the introduction of the microneedle into the skin when the microneedle is inserted at a specific angle or over a variety of different angles.

[0116] In yet another embodiment, as shown in FIGS. 11A-11C, the lumen 68 can 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 need 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 can be positioned so 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. Furthermore, the outlet of the channel 68 at the lumen exit surface 88 can be positioned so 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 true for all embodiments (see, e.g., FIGS. 10A-10B). When a microneedle of the type shown in FIGS. 11A-11C is inserted, a vertical gap can 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 can be included in an array, such as any of the arrays described herein. When obelisk-shaped microneedles are 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. An exemplary microneedle includes a set of sidewalls 64' extending 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 to 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 obelisk-shaped microneedle embodiments, the microneedle may include at least one side port 94 that can function as an exit port for the microneedle. Such a side port 94 may be difficult to block due to tissue that may be compressed during insertion of the microneedle into a patient. In an exemplary embodiment, the lumen 68 extends through the base 62' of the microneedle and terminates 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 cause the end of the lumen 68 to be 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 the 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 composed of a biocompatible, non-ductile, high Young's modulus material that has sufficient indentation hardness to allow penetration into the skin without fracture.

[0120] If the set 12 includes microneedles, they may be applied to the patient with little or no pain. This may make such sets more appealing to users than other types of infusion sets. This advantage is particularly pronounced for certain patient populations, such as juvenile diabetics. Furthermore, such sets 12 may be easier to apply. A microneedle-containing set 12 is ready to apply immediately or almost immediately (e.g., after removing the adhesive backing sheet) upon removal from the packaging. Therefore, it may not require an inserter to pierce the skin and place the infusion set. A microneedle-containing set 12 can easily be changed without the need to carry additional components, such as a relatively large inserter. Furthermore, eliminating the inserter (usually a disposable, single-use item) can reduce the financial burden on patients associated with frequent site changes. This may make it easier for patients to adhere to a prescribed site change schedule or allow for more frequent site changes (e.g., daily).

[0121] Referring again primarily to FIGS. 4A and 4B , the exemplary set 12 may include a body 52. ​​The body 52 may be a deformable body that can transition from a storage state (see FIG. 4A ) to a delivery state (see FIG. 4B ). In certain examples, this 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 cannot return to the storage state. Removing the set 12 from the patient and rendering it unusable may require the destruction of a portion of the body 52 or a portion of the set 12 engaged with the body 52. ​​If a permanent change occurs upon transition to the delivery state, this permanent change may not only prohibit reuse but 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 storage state to the delivery state can be achieved via bending, pivoting, or deformation of one or more regions of body 52. ​​In certain examples, body 52 can be or include a bistable element having a first stable state corresponding to the storage state and a second stable state corresponding to the delivery state. Body 52 can 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 storage state to the delivery state.

[0123] The transition can be affected by applying a force throughout the entire transition. Alternatively, the transition may only require applying a 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 surface 24 of the body. The adhesive 54 may serve to couple the body 52 to the skin surface at the patient's injection site. Thus, the first surface 24 may be the skin-adjacent or proximal (proximal and distal as defined with respect to the patient) surface of the body 52. ​​When the body 52 is in the storage state and then transitions 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, stretching or widening the surfaces secured to the body 52 via the adhesive 54. When these 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 it may hold the skin taut to facilitate puncture of 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 54-bearing portions or may increase the spacing between the two adhesive 54-bearing portions. In other embodiments, the distance between the two adhesive 54-bearing portions may not increase or may even decrease while causing stretching of the skin surface. This may occur, for example, when the transition pulls a flat portion of skin around the curve or contour of the body 52 (see, for example, Figures 18 and 19). The displacement of the adhesive 54-bearing portions relative to one another (whether a positive or negative change in the distance between the adhesive 54-bearing portions) that results in stretching of the adhered skin may be referred to as spreading displacement. Two adhesive-bearing portions 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 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 an access member 16 is attached. The access member 16 may be included in a sharps holder 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 fluid path communicating with the access member 16. The conduit 96 may be plumbed to connect to the fluid 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) can be connected. The coupling 98 may include a check valve that restricts fluid flow when the conduit is 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. ​​The body 52 may be formed as a thin sheet or disc of material that can 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 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 either the storage state or the delivery state. The body 52 may be more easily transitioned from the reverse state to the molded state. Therefore, 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 into its delivery state shape. During assembly of the set 12, the body 52 may be placed in its storage state configuration and remain in that configuration until use.

[0129] The central region 100 may be dome-shaped, forming a housing 104 proximal to the body 52 within which the structure 50 may be placed. The structure 50 may be bonded within the housing 104 via an adhesive or another suitable method. The central region 100 may also include a series of fenestrations 106, which 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 circular pattern generally 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 multiple 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 throughout at least a portion of the central region 100. The fenestrations 106 in the central region 100 may be located radially inward of the ends 112 of each slot 108. Thus, the body 52 may include the central region 100 surrounded by a plurality of petals 114, which are spaced apart via the slots 108.

[0131] 16, a plan view of the proximal surface 56 of the body 52 is shown. As shown, an 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 to bond the set 12 to the skin surface at the injection site. In an exemplary embodiment, adhesive 54 may be included on the peripheral region 102 of body 52 . While the adhesive 54 is shown covering 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 embodiments, the adhesive 54 may be included on at least one pair of oppositely disposed (e.g., diametrically opposed in the illustrative embodiment) petals 114. 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 vary from petal 114 to petal 114. Some petals 114 may be covered with a stronger adhesive 54, while other petals 114 may be covered with a weaker adhesive 54. Additional adhesive members 22 are described elsewhere herein (e.g., see 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 the delivery state. In the delivery state, at least the central region 100 of the body 52 can substantially invert. 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 displace 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 displace extensively over at least a portion of the transition. The slots 108 in the body 52 help facilitate the expanded displacement of the petals 114 as the transition occurs, thereby facilitating 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] Figure 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. ​​Figure 19 is a conceptual diagram showing the set 12 in a delivery state. As shown, the set 12 can be applied to the skin 14 in the retracted state. The set 12 can then be transitioned to the delivery state. As the transition occurs, a spreading displacement of the opposing petals 114 of the body 52 can 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 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 surface of the skin 14 between the two points 116A, B when the set 12 is in the delivery state may be greater than the length of the surface of the skin 14 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 puncturing the skin 14 with the access member 16.

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

[0137] As mentioned above, in certain examples, 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. The petals 114 themselves may be constructed so 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, 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 because it may help reduce potential discomfort while wearing the set 12 due to excessive tension on the skin 14. Additionally, this may be helpful for certain patient populations because skin characteristics vary with age, hydration status, lifestyle (sun exposure, nutrition), etc. Loose or sagging skin may be more desirable to stretch than more elastic skin. Thus, instead of providing various sets 12 with different adhesives 54 targeted at 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 generally annular in shape and may include an inner periphery and an outer periphery or rim 110 that coincide with the base 122. The set 12 may be formed by injection molding. The upper surface 118 may have, for example, a generally circular, rounded footprint 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, aperture, or void in various embodiments. The slot 126 may aid in the transition of the set 12 from the storage state to the delivery state while relieving pressure from above. The slots 126 may extend radially relative to a center point 128 of the upper surface 118, with respective first endpoints 130 surrounding an area that includes the center point 128 of the upper surface 118, and respective second endpoints 132 terminating at a fixed distance (e.g., all slots 126 are the same distance) from the periphery 124 of the upper 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. While a thermoformable body 52 is shown, the features described with respect to a thermoformed body 52 may be included in a body 52 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, as shown in FIG. 22 , the slots 126 can be arranged so that they do not extend radially relative to a center point 128. For example, the slots 126 can each extend at a common angle relative to the radial direction. In such embodiments, the slots 126 can be equally spaced around the top surface 118 and each can be the same length. In other embodiments, the slots 126 do not all need to extend at a common angle relative to the radial direction. At least one (and perhaps all) of the slots 126 can be arranged at a different angle relative to the radial direction. In some embodiments, the slots 126 can be relatively short, arranged around the periphery 124 of the top surface 118, and located within an outer region of the top surface 118 (see, e.g., FIG. 22A ). In other embodiments, the slots 126 can extend across the outer and middle regions of the top surface 118 (see, e.g., FIG. 22B ). In still other embodiments, the slots 126 can extend from the outer region of the top surface 118 into the central region of the top surface 118 (see, e.g., FIG. 22C ). The curved slot 126 can help reduce the amount of pressure required to transition the set 12 from the storage state to the delivery state. Positioning the slot 126 at a more acute angle relative to the radial direction can generally reduce this pressure. The width of the slot 126 can decrease slightly during at least a portion of the transition from the storage state to the delivery state.

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

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

[0144] 22D and 22F, slots 126 may be included in other regions of body 52. ​​In an exemplary embodiment, the region of body 52 that will become support structure 120 (when body 52 is thermoformed) includes 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 petals 114 of body 52.

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

[0146] As shown in FIG. 23 , the central region 100 can be monolithically formed with the petals 114, including the area between each pair of slots 108 (see also FIGS. 13-19 and the examples and embodiments described above in this regard). The support structures 120 can extend upward from the petals 114 at an angle of 90° or greater, e.g., 100-105°, although the angle need not be limited to a certain range. The vertical distance from the base 122 of the support structure 120 to the periphery 124 of the upper surface 118 can be long enough to provide a housing for the structure 50 in the central region 100. The slots 108 can extend from the periphery 110 of the set 12 to the base 122 of the support structure 120, but they can terminate at the base 122 and not extend through the support structure 120 itself. In such embodiments, rather than substantially inverting the entire central region 100 when pressure is applied from above (e.g., with a finger), only the upper surface 118 may invert and assume a concave shape in the delivery 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 so that the outer end of the petal 114 can be manipulated by a patient or healthcare provider as a pull tab 138. The pull tab 138 can be grasped by a user to remove the set 12 from the skin 14 (see, for example, FIG. 1 ) after use. The pull tab 138 can 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 can be attached to or integrally formed with the petal 114 by injection molding or known techniques. While the pull tab 138 is shown extending upward toward the top surface 118, in other embodiments, the pull tab 138 may be positioned generally perpendicular to the height of the set 12. In this manner, the pull tab 138 lies substantially flat against the skin 14 and is oriented generally parallel to the skin 14 when the user is wearing the set, thereby minimizing the possibility 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, for example, 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, the distance may be approximately 0.15 inches.

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

[0151] Referring to FIG. 27 , which is a perspective cross-sectional view of the body 52 of the set 12, the body 52 can include an internal 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 a 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] Referring primarily to FIGS. 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, they may splay outward and displace, causing at least a portion of the petals 114 to curl upward 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 splay outward and displace. 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 tighter 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, in such embodiments, may also be referred to as the lowest point. In such embodiments, the lowest point 144 may be in a plane more distal to the periphery 124 of the upper 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 upper 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 upper surface 118). The petals 114 each have a constant radius of curvature from the inflection point 144 to the periphery 110. A constant radius of curvature returning upward can 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 body 52 may also invert as set 12 transitions to delivery state 10.

[0153] 26-28B, in some embodiments, the support structure 120 may not include fenestrations 134 evenly spaced around the base 122 (see, eg, FIG. 20). 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 composed of 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. In various embodiments, the slots 126 may be notches, openings, holes, apertures, or voids. Each first end point 130 of the slots 126 surrounds an area that includes a center point 128 of the top surface 118, and each second end point 132 may terminate at a distance from the periphery 124 of the top surface 118 (e.g., each slot 126 may terminate at the same distance). In certain embodiments, the slots 126 may be disposed at regular angular increments and each may 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 so that they do not extend radially relative to the 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 may each 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 FIGS. 29-30, several diagrams of conceptual representations of set 12 in a delivery state are shown. As described above (and with reference to the embodiments of FIGS. 13-21), set 12 can transition from the storage state to the delivery state when downward pressure is applied to upper surface 118. In this delivery state, body 52 of set 12 is substantially or at least partially inverted. A user can remove adhesive liner 140 (see, e.g., FIG. 25) from set 12 and apply set 12 to skin 14. The user can then press upper surface 118 downward (i.e., toward skin 14). This causes petals 114 to splay outward and displace, curl upward (at least partially), and stretch skin 14. Upper surface 118 inverts to press access member 16 into skin 14 and may remain inverted when set 12 reaches the delivery state. The peripheral region 20 can also assume an inverted shape due to the 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. While described as elastic regions, it should be understood that some bending or deformation may still occur when pressure is applied. However, these regions may appear generally similar or extend / protrude in generally the same direction in both the storage and delivery states. As shown, the peripheral region 102 and 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, Figures 20 or 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 slots 126 can relieve pressure from above and aid in the transition of the set 12 from the storage state to the delivery state. The openings 106 may also facilitate that transition.

[0158] As shown in Figures 31-33 (bottom perspective view, bottom 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-shaped or planar in various examples. The distal side of the structure 50 may include a conduit receptacle 150 for connecting an end of the conduit 96 extending from the coupling 98 (see Figure 13). The conduit receptacle 150 may include a passageway 152 communicating 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 an appropriate manner (e.g., with an adhesive). The structure 50 may be manufactured by any technique known to those skilled in the art, such as injection molding. The distal surface of the structure 50 may be connected to a portion of the body 52 of the set 12. For example, the peripheral edge 154 of the distal face may be connected to the inner ridge 142 of the body 52 (see FIG. 27). In some examples, one or more tabs 164 (see Figures 35-36) extending from the periphery of the structure 50 may fit into (e.g., snap-connect) slits in the main body 52 to assist in connecting the structure 50 to the main body 52.

[0159] Continuing with FIGS. 31-33, the exemplary structure 50 may include at least one stepped protrusion 156. The stepped protrusion 156 extends from the proximal side of the circular body 148. The exemplary stepped protrusion 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 stepped protrusion 156 extends at a substantially perpendicular angle from the circular body 148. The sidewalls 158 of the stepped protrusion 156 may be chamfered to extend in a direction that is not perpendicular to the proximal surface of the circular body 148. The stepped protrusion 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. Step projection 156 functions as a protruding portion that serves to concentrate the force applied to set 12 on access member 16, assisting access member 16 as it is inserted into skin 14 (see, eg, FIG. 1).

[0160] In certain instances, the sharps retainer 74 may be bonded to the structure 50 during the molding process. When the sharps retainer 74 is bonded to the structure 50 during molding, the molding material may mold along the sidewalls 162 of the sharps retainer 74, extending up to the surface of the sharps retainer 74 from which the access members 16 protrude. In another embodiment, the sidewalls 162 of the sharps retainer 74 may be chamfered at an angle that is not perpendicular to the surface. The footprint or cross-sectional area of ​​the sharps retainer 74 may increase as the distance from the sharps retainer surface of the sharps 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 then sharps retainers 74 containing the required number of access members 16 are cut from the wafer. To form the chamfered sidewalls 162, a dicing saw may have an angled surface to create the required chamfer or angle in the sidewalls 162 during the dicing process. In certain embodiments, the angle of the sidewall 162 can be 30-60° (e.g., 45°). When a chamfered sidewall 162 is present, material can be molded onto only a portion of the sidewall 162 to bond the sharps retainer 74 to the structure 50, and can be secured without the molded material overlaying 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 stepped projection 156 is shown. In some embodiments, the pocket 160 of the stepped 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., microneedles) to extend at a predetermined angle relative to the circular body 148. By way of example, the pocket 160 may be positioned so 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 a 45°, 60°, or any angle between 10-60°. The appropriate angle may be selected arbitrarily. In another embodiment, the entire stepped 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, respectively, are shown of an exemplary structure 50. As mentioned above, in some examples, the structure 50 includes tabs 164 that attach or assist in attaching the structure 50 to the body 52 of the set 12. In the example shown, the circular body 148 includes a plurality of circumferentially spaced tab projections 164. The tab projections 164 are symmetrically positioned around the circular body 148 and may be spaced at regular angular intervals. In another embodiment, the tab projections 164 may be asymmetrically positioned around the base or at irregular angular intervals. The tab projections 164 may engage with receiving slits located 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 positioned tab projections 164 may attach the structure 50 to the body 52 in a particular orientation, which may be desirable.

[0163] 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 FIGS. 41-46.

[0164] The structure 50 may include a plurality of step projections 156. The step projections 156 are associated with the locations where the sharps retainers 74 are attached and are associated with respective conduit receivers 150 (or joints 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 stepped projections 156 may be, for example, as shown in FIGS. 31-34 . The conduit 96 attached to each conduit receptacle 150 may be in fluid communication with the flow path 68 (see FIG. 34 ) of the access member 16 attached to the corresponding stepped projection 156. Alternatively, if a coupling 98 is included in the structure 50 instead of the conduit receptacle, the coupling 98 may be in fluid communication with the flow path 68. The flow path from a first conduit receptacle 150 (or first coupling 98) to the access member 16 attached to the corresponding first stepped projection 156 may be fluidly isolated from the flow paths from other conduit receptacles 150 (or couplings 98) to the access member 16 attached to the corresponding stepped projection 156. Each coupling 98 may connect to a connector 26, 44 from an infusion device 18 (e.g., see 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 protrusions 156, and a different drug may be administered through an access member 16 connected to the other stepped protrusion 156. For example, drugs with opposing effects may be administered. A first regulatory hormone may be administered with 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 protrusion 156. Or, different types of the same drug may be administered through an access member 16 connected to each stepped protrusion 156.

[0167] Each access member 16 connected to a 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. Stepped projections 156 with any number of access member 16 heights may be included, and insulin, for example, may be delivered through shorter access members 16 (e.g., intradermal destinations) when a rapid response is necessary or desired, and through longer access members 16 (e.g., subcutaneous destinations) in other situations. The distribution of medication to 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 medication 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, the step projections 156 may each be arranged in the same orientation. In some cases, the step projections 156 are arranged approximately along the central plane of the structure 50. The access members 16 connected to the step projections 156 may each have the same orientation. In examples in which microneedles are used, the rear side edges 66 (see FIG. 5) of each microneedle may be arranged in approximately the same plane. The step projections 156 may be arranged on both sides of the proximal surface of the structure 50 or in the center. In certain embodiments, only a single step projection 156 may be included, with multiple sharps holders 74 connected thereto. The flow paths from the conduit receiver 150 to each sharps holder 74 may be isolated from each other by internal walls or partitions within the step projection 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, portions of the set 12 unfold and move, tensioning the skin and causing at least one access member 16 of the set 12 to penetrate the stretched skin. The movement of the access member 16 typically proceeds in a first direction generally perpendicular to the surface of the skin, with the access member 16 penetrating 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 166 may cause the access member 16 to move slightly in a second direction substantially opposite the first direction when pressure is released from the set 12. The movement in the second direction may occur simultaneously with the tilting.

[0170] In some embodiments, portions of the set 12 may also be deformed or adjusted to accommodate the rocking of the structure 50. Tilting the structure 50 may cause the access members 16 to move in a non-linear trajectory. For example, the access members 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 tilting may occur automatically as the set 12 transitions to the delivery state. A linkage or interlocking mechanism with a guide element may not be required to achieve the tilting. For example, the presence of one or more rocking members 166 may cause the entire structure 50 to tilt in unison. Tilting the structure 50 in this manner may reduce the pressure at which injection begins and / or increase the delivery 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 tilting may help facilitate delivery when the access members 16 initially enter the skin 14 approximately perpendicular to the skin 14.

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

[0172] When a 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 that includes the rocking member 166. The opposite side may not have a rocking member 166, and the structure 50 may tilt or swing as it continues to move toward the user. In certain examples, the access member 16 (e.g., microneedle) may tilt 3-5° (e.g., 4°) relative to its initial position. In other examples, the access member 16 may tilt more or less. The height of the rocking member 166 may affect the point at which the access member 16 begins 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 begin tilting after the access member 16 penetrates the skin 14 (see, e.g., FIG. 1 ).

[0173] In certain examples, the access member 16 may be a microneedle, such as those 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 so 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 ) upon deployment of the microneedle. In this manner, the back edge 66 may serve as 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 such as that shown in FIG. 2, the lumen 68 may move away from the skin 14 where 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 delivery 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 in the skin 14, and may move the lumen 68 away from the skin 14 where it contacted during initial penetration. The pivoting 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 with 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 a predetermined 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 ). Tilting the structure 50 may move the access member 16 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 positioned 10° or more (e.g., 11-12°) away from perpendicular.

[0175] In certain examples, the step protrusion 156 may be located at the position of the rocking member 166 shown in FIGS. 37 and 38 . In such embodiments, the rocking member 166 may be omitted or may be present as lateral extensions on either side of the step protrusion 156. In certain examples, the step protrusion 156 may not be located in the center of the structure 50 (although in certain examples, the step protrusion 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 protrusion 156 prevents further displacement of that side of the structure 50 toward the skin 14. The opposite side of the structure 50 can continue to displace toward the skin 14. As the opposite side continues to displace toward the skin 14, a rocking or tilting motion accompanied by 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 elastically deforms as the set 12 transitions to the delivery state. The at least one elastically deformable region 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. From this state, the region may return to its initial state. For example, the petals 114 may at least partially return to their original shape from their maximally deformed state. Because the petals 114 of the set 12 are adhered to the skin 14 via the adhesive 54 of the set 12, the return of the petals 114 may pull the skin 14 away from the underlying anatomical structures. This may partially relieve pressure at the injection site. This reduction in pressure at the injection site may facilitate easier movement of fluid 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 through which 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 site and facilitate 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. By shaping the petals 114 in the storage state, the petals 114 may have a tendency to return to their stowed state when pressure is released from the set 12 during use. Petals 114 that return to their original state when 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 have relatively little curvature. For example, the petals 114 may be substantially flat and / or extend at an angle from the rest 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, the first region 620 can be arcuate, resembling the adjacent portion of the support structure 120. The second region 622 can be disposed at an angle relative to the central axis A1 of the body 52. ​​The second region 622 can form the majority of the petals 114. In some instances, the petals 114 can be primarily flat, while still having curved regions or surfaces. In various embodiments, a small curved transition 621 can 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, helping to limit the expansion displacement of the petals 114 after the desired amount of expansion displacement has been achieved. The curved transition 621 may be included to facilitate at least partial recovery of the petals 114 after pressure applied to the set 12 is released. In examples including petals 114 such as those in Figures 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] 41 and 42, a set 12 is depicted. Set 12 includes a central region 100 and a peripheral region 102. Peripheral region 102 has a plurality of slots 108 that divide peripheral region 102 into a plurality 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, minimizing the possibility that the pull tab 138 will catch on clothing or other objects. The pull tab 138 may include one or more ridges 168 or gripping patterns to make it easier for the user to grasp the pull tab 138. In an example, the included ridges 168 are ridges.

[0181] The central region 100 in the example embodiment includes a base surface 170, from 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 positioned above the peripheral region 102 or is positioned at the same height as the highest portion of the peripheral region 102. The central region 100 may include a coupling portion 98 to which the connector 26 may be coupled. In various embodiments, a fitting (e.g., a luer lock) that serves as the coupling portion 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] As shown in FIG. 43 , the central region 100 may also include, for 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 sloped 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 sloped 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 sloped surface 174. The ends of the latch body 178 may include cooperative sloped surfaces to facilitate deflection. The latch body 178 includes a catch 180, and when the catch 180 clears the respective sloped surface 174, the latch body 178 can 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. In other embodiments, when the connector 26 is attached to the set 12, the surface of the catch 180 may not be parallel to the stepped surface 176, which can make it easier for the connector 26 to come off the set 12 if the tubing 28 leading from the connector 26 to the infusion device 18 gets caught during user movement. In such situations, the angle of the surface of the catch 180 can be changed to adjust the ease with which the connector 26 comes off the set 12.

[0183] The connector 26 can be manually removed from the set 12 when necessary, such as when a user showers or swims and the infusion device 18 is not suitable for exposure to water. As shown, the latch body 178 extends from outer arms 182 of the connector 26, which themselves cantilever from a central region of the connector 26. Squeezing 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 toward each other, the catch 180 moves out of contact with the stepped surface 176 and the latch body 178 can be withdrawn from the connector receptacle 172 .

[0184] Connector 26 may also include sharp flanking projections 184. These side projections 184 extend generally parallel to the 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] Referring also to FIG. 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. In various embodiments, the guide wall 192 is generally perpendicular to the base surface 170. When attaching the connector 26 to the set 12, at least either the latch body 178 or the side protrusion moves along the guide wall 192, helping to align 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 can facilitate attachment of the connector 26 to the set 12, even for individuals with limited dexterity or impaired vision. In some examples, the guide can guide the connector 26 to the appropriate coupling path, helping the user couple the connector 26 to the set 12 without looking at the set 12.

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

[0187] As shown, the set 12 may also 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 defined by a wall 200 that extends from the base surface 170. The wall 200 encloses an interior space within which the 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, thereby assisting 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] 41-44, the septum housing 198 may include a post 210. The post 210 is located approximately in 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 shown in FIG. 45, the septum 196 includes a septum recess 208 that at least partially seats on the post 210 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 positioned adjacent to the post 210 when the septum 196 is installed in the bay 198, providing a fluid introduction space for fluid 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 positioned within the fluid introduction space formed by the recess 208 of the septum 196. When fluid pumped by the injection 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 its 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] To allow the set 12 to be molded without side action, 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 action using, for example, a bypass shutoff. The central region 100 may include various gaps or openings 205 to facilitate molding.

[0192] Referring primarily to FIGS. 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 stepped protrusion 156. A sharps holder 74 including at least one access member 16 is attached to each stepped protrusion 156 (e.g., bonded to the stepped protrusion 156 using an adhesive or during injection molding). The sharps holder 74 is positioned so 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 to 45 degrees (e.g., 30 degrees or 15 degrees). In alternative embodiments, the access member 16 may protrude approximately perpendicular to the proximal side 222 of the central region 100. In the example embodiment, the access member 16 is depicted as a microneedle.

[0193] A rocking member 166 is also positioned near 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 (e.g., see 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 move along a curved 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 a structure 50. Instead, a stepped projection 156 is formed on the proximal side 222 of the central region 100. Sets 12 described herein that include a structure 50 can instead be configured so that 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 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 so that the features illustrated as part of the central region 100 in FIGS. 41-46 are included in a separate structure 50 that can be coupled to the body 52 of the set 12.

[0195] 47-49, exploded views of an example analyte sensor 30 and transmitter 32 are shown. The transmitter 32 includes a housing 290 containing 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. Attachment methods can include threading, 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. In various embodiments, conductive traces 292 connect to electrodes 302A, B and extend to the base surface 470. 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. Thus, 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 positioned against 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 may result in permanent deformation of portions of the body 352 and / or the sensor 30. For example, upon transition to the delivery state, at least a portion of the body 352 may undergo plastic deformation and may not be able to return to its original stored state. Removal of the analyte sensor 30 from the patient may require destruction of a portion of the body 352 or a portion of the analyte sensor, rendering the analyte sensor 30 unusable. Upon transition to the deployed state, at least two adhesive-containing portions of the body 352 spread toward each other, stretching or widening the skin surface attached to the body 352 via the adhesive. This tensions the skin 14 as the body 352 transitions to the deployed state, facilitating puncture of the electrodes 302A, B into the skin 14. The adhesive in the adhesive member 54 (see, e.g., Figures 55-57) helps to 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 particularly 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, 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 is shown. As shown, 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 lacking a penetrating lumen. These micro-penetrators may have the structure described in FIG. 5 but lack a lumen. Each micro-penetrator is constructed of etched silicon, each attached to its own sharps holder 374, and positioned 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. 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 micropenetrators themselves may not be used as electrodes 302A, 302B. In such embodiments, the micropenetrators may be at least partially covered with an insulating material. A conductive trace 292 is disposed on top of the insulating material of each micropenetrator, extending along the sharps holder 374 and onto the side of the sharps holder 374 opposite the micropenetrator. 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 reside on the same sharps holder 374, but the conductive traces 292 are insulated from each other.

[0202] Analyte sensor 30 may be a shallow analyte concentration sensor, such as 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 offer advantages such as minimal invasiveness, minimal pain during use, rapid response, and low risk of irritation or patient reaction.

[0203] The electrodes 302A, 302B have a height suitable for shallow (e.g., intradermal) insertion. In some embodiments, the height of the electrodes 302A, 302B ranges from 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 (e.g., intradermal) location, measurements can be collected that rapidly reflect changes in blood analyte concentration. Because the intradermal layer is highly vascularized, intradermal analyte concentrations more quickly reflect changes in blood analyte concentration. When the analyte sensor 30 measurement is received by the controller 20, the controller 20 can initiate, stop, or adjust medication administration based on the measurement. Rapid detection of analyte concentration changes allows the controller 20 of the infusion device 18 to respond quickly to changes in blood analyte concentration and make medication administration decisions that are more accurately tailored to the current patient needs. In this way, the analyte sensor 30, together with the infusion device 18, enables precise control of blood analyte concentrations.

[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 one exemplary embodiment, the analyte sensor 30 may include multiple stepped protrusions 358 with corresponding electrode groups 302A, B. Alternatively, multiple insulated electrodes 302A, B may be attached to a single stepped protrusion 358. Thus, multiple analyte sensors 30 may be associated with a single body 352. In various examples, any number of stepped protrusions 358 may be disposed on the proximal surface 422 of the central region of the body 352. In some examples, the stepped protrusions 358 may be disposed in an arrangement similar to the stepped protrusions 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 a different analyte detection chemistry and configuration. If 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 micropenetrators may be provided at different heights. Thus, when the analyte sensor 30 is in a deployed state, the analyte sensor 30 can collect data regarding analyte concentrations at various locations on a user. In some examples, one set of micropenetrators may assist in detecting analyte concentrations at shallower delivery locations (e.g., intradermal), while other micropenetrators may assist in detecting analyte concentrations at deeper delivery locations (e.g., subcutaneous). The heights of the micropenetrators may be 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 medications to a patient and collect sensor data related to the concentration of at least one analyte of interest. Thus, instead of separate assemblies for medication 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 round (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, in some instances, may be substantially flat and include a base surface 570. The body 552 includes a plurality of slots 508. The slots 508 extend from an outer peripheral edge 510 of the body 552 toward a central or center 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 the 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 portion 98 defined on a base surface 570. The coupling portion 98 may be as described in connection with FIGS. 41-46 . In another example, the coupling portion 98 may be a fitting (e.g., a Luer fitting). For example, the connector 26, which is 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 includes conductive contacts 540 that are electrically connected to each electrode 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 the 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 the 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 stepped 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 holder 74, in certain embodiments. If a microneedle is used, the microneedle may be any of those described herein. The stepped projection 156 may be any of the stepped projections 156 described herein. The proximal surface 522 of the central region 500 of the body 552 includes at least one stepped 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 is included in a separate sharps holder 374, in such embodiments. Alternatively, the electrodes 302A, B may be conductive traces disposed on an insulating layer included in each micro-penetrator, in which case the micro-penetrators including the electrodes 302A, B may be formed on the same sharps holder 374.

[0210] The example access assemblies 46 shown in FIGS. 50 and 52 include the same stepped projection 156 access member 16 arrangement and the same stepped projection 358 electrode 302A, B arrangement. The arrangement of the stepped 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 stepped 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 access member 16, as described in connection with FIGS. 35-36 . The micro-penetrators or electrodes 302A, B may also tilt in the same manner as the access member 16. In the embodiment shown in FIG. 50, the stepped projection 358 has been moved into position with the rocker member 166, and the rocker member 166 is absent. The step projections 156 are 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 projections 156 and 358 may be interchanged in other embodiments. The step projections 156, 358 may be approximately the same height in various embodiments. The peripherally located step projections 358 may function as the swing member 166. When the access assembly 46 transitions to the deployed state, the micro-penetrator and 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, an 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 respective 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 identical or may include various differences as described herein. For example, different sets of access members 16 may each include access members 16 of different heights. Similarly, different electrode groups may also have different heights. 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 an appropriate length). An 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 with reference to Figures 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 Figures 55-57. The adhesive may be skin compatible and serve to bond the access assembly 46 to the surface of the skin 14 at a desired location. The adhesive may be included on portions 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 Figures 50-54 is shown in a retracted state. When the access assembly 46 is applied to a patient, it may be placed against 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. During the transition to the deployed state, at least two adhesive-containing portions of the body 552 are displaced apart relative to each other, thereby tensioning the adhesively secured skin surfaces and tensioning the skin 14. This is desirable to facilitate puncture of the skin 14 by the access member 16 and electrodes 302A, B when the body 552 transitions to the deployed state. The adhesive-containing adhesive member 54 (see, e.g., Figures 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 deployed by a user by depressing the body 552. This avoids the need for multiple needle sticks each time the access assembly 46 is applied. This may make the access assembly 46 more attractive, especially for certain patient populations (e.g., juvenile diabetics). The example access assembly 46 does not require a first inserter for an infusion set and a second inserter for an analyte sensor. Eliminating the inserter from the application process may reduce the financial burden for patients who are hesitant to use the analyte sensor 30. Eliminating the inserter may reduce the financial burden associated with frequent site changes, which may 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 sensors 30 or access assemblies 46 described herein. As shown, each exemplary set 12 may include one adhesive member 54. In alternative embodiments, 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 through which the access members 16 of the set 12 access the patient.

[0216] The shape and size of the central opening 218 can 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 be in the range of 0.13 square inches to 0.5 square inches (e.g., approximately 0.3 square inches).

[0217] Additionally, it may be desirable for the central opening 218 to be wider in certain directions relative to 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 a relatively wider portion) of the central opening 218 may be along a direction parallel to a plane containing 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 anterior-posterior direction (from the distal side 60 to the rear end 23, also referred to herein as the length) 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 anterior-posterior 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. This may be desirable as it may expose the drug to more blood vessels at the delivery site, which may help to promote absorption.

[0218] Referring now primarily to FIG. 55 , the central opening 218 may be a generally round (e.g., circular) opening, except for numerous inwardly extending teeth or spokes 220 in 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. While the central opening 49 can have a relatively large width in this direction, this does not preclude other wide regions of equal, narrower, or possibly wider widths. In the illustrated example, the central opening 218 has approximately the same 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 adhered to the proximal surface 222 of the central region 100 or the structure 50.

[0219] Referring now primarily to FIG. 56 , in certain examples, the central opening 218 may include a notch 224 extending outward from the periphery of the remainder 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, or may be circular, for example.

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

[0221] When the set 12 is applied to the skin 14, the adhesive in the peripheral region 102 of the set 12 initially 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, if there is 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 remains securely in the desired position within the skin 14 while the set 12 is in use.

[0222] Additionally, when set 12 is in the delivery state, step protrusion 156 may press into skin 14 and create an indentation in skin 14. The indented skin 14 tends to return to a non-indented position relative to step protrusion 156 while set 12 is being worn. The adhesive of adhesive member 54 near step protrusion 156 helps promote this return. As a result, the skin pierced by access member 16 tends to move with it, even if access member 16 or step protrusion 156 moves away from skin 14. This helps access member 16 remain securely within skin 14 while set 12 is being worn, helping to prevent leakage during delivery.

[0223] Referring to Figures 58-63, delivery assemblies 24 or arrangements included in a delivery device 18 (e.g., see Figure 1) are shown. The delivery assemblies 24 shown in the figures are exemplary, and a delivery device 18 can include a variety of delivery arrangements 24. A particular delivery device 18 can be a syringe pump. A particular delivery device 18 can include a peristaltic pump mechanism (e.g., a linear or finger pump mechanism or a rotary peristaltic pump mechanism). If a delivery device 18 delivers multiple medications to one or more sets 12, the infusion device 24 can include multiple delivery assemblies 24 shown in Figures 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 the rest 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 activation 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 activation of the shape-memory actuator 234 causes 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 reservoir valve assembly 242 results in downward displacement of reservoir valve actuator 242A and closing of reservoir valve 242B, effectively isolating reservoir 22 from delivery assembly 24. A membrane 244 is disposed between pump plunger 240A and pump chamber 240B of pump 105, and reservoir valve actuator 242A presses membrane 244 against the valve seat of reservoir valve 242B to close reservoir valve assembly 242. Pump 240 and reservoir valve assembly 242 are connected such that reservoir valve assembly 242 is closed prior to pump 240 delivering fluid. Actuation of pump 240 displaces pump plunger 240A downward toward 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), which provides a mechanical force to move the volume sensor valve actuator 248A relative to the volume sensor valve 248B, closing the volume sensor valve 248B. The volume sensor valve actuator 248A presses a membrane 244 included in the cassette assembly 25 against the valve seat of the volume sensor valve 248B, closing the volume sensor valve 248B. However, when the pump 240 is actuated, if the pressure of the displaced fluid exceeds the mechanical sealing force of the volume sensor valve assembly 248, fluid may move in the direction of arrow 252. This may fill a volume sensor chamber 256 within the volume sensor assembly 258, shown in FIG. 62 . Using speaker assembly 260, port assembly 262, reference microphone 264, spring diaphragm 266, and variable volume microphone 268, volume sensor assembly 258 is able to measure the volume of fluid within 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 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] Referring also to FIG. 62 , shape memory actuator 270 is anchored (at a first end) to shape memory actuator anchor 272. The other end of shape memory actuator 270 is used to provide mechanical energy to valve actuator 274, which actuates measurement valve assembly 276. After the fluid volume in volume sensor chamber 256 is calculated, shape memory actuator 270 is energized, actuating measurement valve assembly 276. Measurement valve assembly 276 includes measurement valve actuator 276A and measurement valve 276B. When measurement valve actuator 276A is lifted from measurement valve 276B and actuated, the mechanical energy applied by spring diaphragm 266 to the fluid in volume sensor chamber 256 causes the fluid in volume sensor chamber 256 to be delivered (in the direction of arrow 278) through set 12 and into the patient. By returning the shape memory actuator to its de-energized state, the measurement valve actuator 276A presses 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), closing 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 component.

[0227] As fluid is delivered to the set 12 or the access assembly 46, at least one characteristic related to 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 whether the delivery is occurring in a desired manner. For example, the controller 20 may monitor data from at least one sensor to determine information related to the impedance to fluid delivery from the access member 16. Above the skin, the access member 16 is in air, so there is little impedance to fluid delivery. The intradermal space has a relatively high impedance, making it more difficult to deliver fluid there. Delivery to subcutaneous tissue has a lower impedance than intradermal tissue.

[0228] When fluid is delivered to the set 12, a pressure drop may occur as the fluid exits the set 12 and exits the shallow delivery destination. Typically, fluid flows relatively slowly from the set 12 to the shallow delivery destination. When this occurs, the associated pressure drop is also relatively slow. However, if the access member 16 becomes dislodged and no longer rests against 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 extends 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 preset threshold (e.g., the derivative of the pressure data exceeds a predetermined value), it may be determined that access member 16 has shifted from its predetermined position. In some embodiments, this threshold may be preset or calculated based on past data from medication delivery 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 predetermined threshold.

[0230] For determinations 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 determination. The alert may be displayed on a user interface of the delivery device 18. The alert may also include an audible alert (e.g., a tone, a beep, etc.) or a tactile alert (e.g., activation of a vibration motor) emitted by the delivery device 18 or other components of the system 10. The controller 20 may also communicate the alert to various components of the system 10. For example, the controller 20 may communicate the alert to at least one smart device (e.g., a smartphone, a smartwatch, a tablet, etc.), which may display the alert and / or emit its own audible or tactile alert. The controller 20 may also communicate the alert to the cloud 38. The controller 20 may determine appropriate user intervention (e.g., the need for a new set 12, analyte sensor 30, or access assembly 46) and prompt the user for 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 that are indicative of an occlusion (e.g., decay rate, change in decay rate from previous data). If the pressure decays slower than a predetermined threshold, the controller 20 may determine that an occlusion exists. Similarly, if a change to the pressure decay rate that is significantly slower than previous data is observed, the controller 20 may determine that an occlusion is occurring.

[0232] In some embodiments, 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 can 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 over a given time period is greater than a predetermined amount or if the rate of change is too rapid, the controller 20 can determine that the access member 16 has changed position. Similarly, if the change in volume is less than a predetermined amount or if the rate of change is too slow, the controller 20 can determine that an occlusion exists. The change in volume or the rate of change can 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 included in the set 12. When selecting two or more access members 16 of different lengths to deliver a drug, 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, which may be microneedles of different lengths, as described elsewhere.

[0234] Typically, displacement of the at least one short access member 16 is related to a similar displacement of the at least one long access member 16. It is desirable to position the at least one short access member 16 and the at least one long access member 16 as close as possible to ensure a high correlation between their displacements. If the at least one short access member 16 disengages from the skin 14, the at least one long access member 16 will often displace in the same direction and by the same amount. In this case, the long access member 16 may be displaced sufficiently to position itself 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 this occurs. Even if the at least one short access member 16 reaches the subcutaneous space, the at least one long access member 16 may still remain within the subcutaneous space.

[0235] If data related 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, controller 20 can analyze the delivery data for the at least one long access member 16. In some embodiments, controller 20 can direct delivery to the at least one long access member 16 to collect data. In certain embodiments, 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 can determine that the short access members 16 have become detached from the skin 14. The controller 20 can 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 detached from the skin 14, the controller 20 can stop delivery to the access members 16. If the controller 20 determines that at least one access member 16 is still capable of delivering to the patient, the controller 20 can adjust delivery to deliver fluid only to the access members 16 that are still within the patient. The controller 20 can generate an alert notifying the user that this has occurred. In some embodiments, the controller 20 can stop all delivery or prompt the user to confirm that delivery to a 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 stop delivery and generate instructions indicating that the set 12 should be replaced with a new set 12.

[0238] If analysis of delivery data associated with at least one short access member 16 indicates impedance characteristics consistent with past delivery from 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 fluid delivery may be included on the set 12 at at least three different heights. The shortest access member 16 generally has 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 member 16 has a height sufficient to deliver to intradermal delivery destinations, and the long access member 16 has a height sufficient to deliver to subcutaneous delivery destinations.

[0240] If sensor data associated with fluid delivery to the shortest access member 16 indicates a high delivery impedance, 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 decrease in impedance to flow from the intermediate access member 16, the controller 20 can determine that the intermediate access member 16 has reached the subcutaneous space. If data associated with fluid delivery to the shortest and intermediate access members 16 indicates a low impedance, the controller 20 can determine that these access members 16 have detached 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 can 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 can depend on the depth of the delivery destination, the controller 20 can 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, it can adjust the timing of delivery. Other calculations may also be adjusted based on the depth of the access member 16. Using the example of insulin, the calculation of the insulin amount (IOB) and the calculation of the duration of insulin action (DIA) may be adjusted.

[0242] In 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 electrode pair 302A, B of an analyte sensor 30 is in air, this should indicate that the analyte sensor 30 is not monitoring the appropriate location. Furthermore, to measure blood analyte concentrations, analyte sensors 30 monitoring highly vascularized regions (e.g., shallow or intradermal sites) and less vascularized regions (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 the 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 time-shifted relative to 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 levels, which should be most clearly observed first 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 into the system 10 by the user. Furthermore, drug delivery (or carbohydrate ingestion) should cause an expected adjustment in blood glucose levels. For example, the response to blood glucose changes associated with drug delivery should be delayed relative to those observed in the subcutaneous tissue compared to those 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) between the data from each analyte sensor may be determined. The relationship may be updated periodically during the life of the analyte sensor 30, or may be initially determined during or immediately after the warm-up period of 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 can analyze data from the analyte sensors 30 to determine analyte concentration trend information and display it on the user interface. For example, the controller 20 can compare current data with historical data to determine analyte concentration trends. The controller 20 can generate a message or other indication that blood glucose levels are trending downward (or rapidly decreasing), trending upward (or rapidly increasing), or remaining approximately constant. In some examples, the controller 20 can determine trend information based on data from a single analyte 30 sensor or can 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 controller 20 can use or weight the data from the intradermal analyte sensor 30 to determine the current trend. In some examples, the controller 20 can determine blood analyte concentration trend information using the difference of data from each analyte sensor 30, the derivative of that data, or the derivative of the difference of the data.

[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 can 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 medication 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, comparing data from shallow analyte sensors 30 with deeper sensors can determine whether a particular analyte sensor 30 is exhibiting abnormal behavior (e.g., whether there is evidence 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 blood glucose fluctuations (due to actions such as medication or eating) while the other analyte sensor 30 is within an acceptable range, that analyte sensor 30 may be exhibiting a dropout. Alternatively, or additionally, if the normal relationship between 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 an indication of a dropout issue or ongoing dropout in one of the analyte sensors 30. Based on the above analyte sensor 30 data comparison, the controller 20 can determine that a dropout is occurring in the corresponding analyte sensor 30. The controller 20 can communicate an alert to the 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 between the data of 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 whether 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). In other words, 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 connection with any lancing body, for any purpose, may be utilized by the controller 20 to make various determinations regarding their location and 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 and location of a particular lancing body. When the controller 20 makes a determination regarding the access member 16 or sensor, as described elsewhere, additional data related to other lancing bodies may be reviewed. This additional data may help confirm or verify the determination. In some embodiments, an alert may not be generated until the additional data is analyzed. Data from other access members 16 and other analyte sensors 30 may be used to help determine or verify whether a particular lancing body has changed depth, has become blocked, or is experiencing dropout issues with the analyte sensor.

[0250] For example, using the example of an access assembly 46 (see FIG. 3), all of the lancing bodies may be positioned relatively close together on the access assembly 46. If data associated with all of the access members 16 of the access assembly 46 indicates low impedance and data from 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 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 expectations, the controller 20 can analyze the data from the analyte sensors 30. If the analyte sensor 30 data indicates that the change in analyte concentration due to drug delivery through the access member 16 is not as expected, the controller 20 can 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 can 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 can 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 can determine that the deeper analyte sensors 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 from 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 air and delivery impedance data associated with the at least one short access member 16 suggests air, the controller 20 may review the data from 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. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications, and variations. Moreover, while several embodiments of the present disclosure have been shown in the drawings and / or discussed herein, the disclosure is not intended to be limited thereto, but is intended to be as broad as permitted by the art, and the same applies to the specification. Accordingly, the above detailed description of the invention should not be construed as limiting, but merely as exemplification of particular embodiments. And, those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto. Other elements, steps, methods, and techniques that differ substantially 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 particular 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. Furthermore, elements shown in the drawings with the same number may be identical 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 construed as being limited to the items listed thereafter. Because 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] Furthermore, terms such as "first," "second," "third," etc., whether used in the specification or the claims, are provided to distinguish between like elements and not necessarily to describe a sequential or chronological order. Terms so used are interchangeable under appropriate circumstances (unless expressly disclosed otherwise), and it should be understood that the disclosed embodiments described herein can operate in other sequences and / or arrangements than those described or illustrated herein.

Claims

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

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

3. 10. The method of claim 1, wherein each of the at least one coupling portion is a fitting. Dosing device.

4. 10. The method of claim 9, wherein the at least one coupling portion includes a connector receptacle having a ramp surface and a stepped surface.

2. The drug administration device according to claim 1.

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

6. 10. The method of claim 1, wherein each of the at least one coupling comprises a luer fitting. Drug administration device.

7. The body and the coupling portion are configured to be injection molded without side action. The drug administration device of claim 1 .

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

9. The at least one sharps holder is made of etched silicon.

10. The drug administration device of claim 1.

10. The at least one sharp holder is formed by molding each step of the second surface during an injection molding process.

10. The drug delivery device of claim 1, wherein the drug delivery device is coupled to a protrusion.

11. The at least one sharp holder is attached to each of the steps of the second surface by an adhesive.

10. The drug delivery device of claim 1, wherein the drug delivery device is coupled to a protrusion.

12. The device includes a septum sealing a passageway in fluid communication with at least one sharps holder. The drug delivery device of claim 1 , comprising a tam.

13. the second surface of the central region is at least partially covered with an adhesive retaining member.

2. The drug administration device according to claim 1.

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

15. Each of the at least one sharp holder holds at least one microneedle. The drug delivery device of claim 1 .

16. each of said at least one sharps holder includes an array of microneedles. Item 2. The drug administration device according to item 1.

17. A first sharps holder of the at least one sharps holder has a first height. at least one first microneedle having a sharp holding At least one of the sharps holders has a second height different from the first height.

10. The drug delivery device of claim 1, comprising one second microneedle.

18. The first height positions the at least one first microneedle at a shallow delivery point and The second height positions the at least one second microneedle at a deeper destination.

18. The drug delivery device of claim 17, selected so that

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. Each of the at least one sharp holder is one of the at least one coupling portions.

10. The medication delivery device of claim 1, wherein the medication delivery device is in fluid communication with only the corresponding coupling.

22. The device includes a central region and a peripheral region having a plurality of petals extending outward from the central region. The main body and a structure coupled to the body and disposed on a first surface of the central region, the structure comprising: At least one sharps holder disposed on an opposite surface of the one connecting portion and the central region. a structure having Each of the at least one sharp holder is one of the at least one coupling portions. a structure in fluid communication with a corresponding coupling; A drug administration device comprising:

23. 23. The method of claim 22, wherein the structure is bonded to a ridge included in a portion of the body. Drug administration device.

24. 23. The medication of claim 22, wherein the structure includes a plurality of tabs that couple to slits in the body. Dosing device.

25. 23. The medication delivery device of claim 22, wherein the central region is raised relative to the peripheral region. Place.

26. 23. The method of claim 22, wherein each of the at least one coupling is a fitting. Drug administration device.

27. Each of the at least one coupling receives a fluid line connected to a fitting.

23. The drug administration device of claim 22, which is a tube receiver.

28. The at least one coupling portion includes a connector receptacle having an inclined surface and a stepped surface.

23. The drug administration device of claim 22.

29. 23. The method of claim 22, wherein the at least one coupling includes at least one guide. Drug administration device.

30. 23. The method of claim 22, wherein each of the at least one coupling includes a luer fitting. A drug administration device.

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

32. 23. The medication delivery system of claim 22, wherein the opposing surface of the structure includes at least one rocking member. device.

33. the at least one sharps retainer is comprised of etched silicon; 23. A drug delivery device according to claim 22.

34. Each of the at least one sharps retainer is formed on an opposite surface of the structure during an injection molding process.

23. The method of claim 22, wherein the step projection is coupled to a corresponding one of the at least one step projection. A drug administration device.

35. the at least one sharps holder is attached to at least one of the opposite surfaces of the structure by adhesive; 23. The method of claim 22, wherein each of the step projections is coupled to a corresponding one of the step projections. Drug administration device.

36. The medication delivery device has a passageway in fluid communication with the at least one sharps holder.

23. A medication delivery device as claimed in claim 22, including a sealing septum.

37. 23. The structure of claim 22, wherein the opposite surface is at least partially covered with an adhesive retaining member. The drug administration device according to claim 1.

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

39. Each of the at least one sharp holder holds at least one microneedle.

23. The drug delivery device of claim 22, comprising:

40. each of said at least one sharps holder includes an array of microneedles. Item 23. The drug administration device according to item 22.

41. A first sharps holder of the at least one sharps holder has a first height. at least one first microneedle having a sharp holding At least one of the sharps holders has a second height different from the first height.

23. The drug delivery device of claim 22, comprising one second microneedle.

42. The first height positions the at least one first microneedle at a shallow delivery point and The second height positions the at least one second microneedle at a deeper destination.

42. A medication delivery device according to claim 41, selected so that

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

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

45. Each of the at least one sharp holder is connected to a pair of the at least one connecting portion.

23. A medication delivery device as claimed in claim 22, in fluid communication only with the corresponding coupling.

46. The device includes a central region and a peripheral region having a plurality of petals extending outward from the central region. The main body and 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 sharp holder is connected to a corresponding one of the at least one connecting portion. The at least one sharps holder is in fluid communication with the mating portion, and the at least one sharps holder is in fluid communication with the mating portion. At least one sharps holder coupled to the A drug administration device comprising:

47. 1. An analyte sensor device comprising: The device includes a central region and a peripheral region having a plurality of petals extending outward from the central region. The main body and At least one sharps holder disposed on a first surface of the central region, Each of the at least one sharps holders includes at least one electrode. Sharp holder and the analyte sensor device comprising at least one first sensor associated with an analyte detection chemistry; An analyte sensor device comprising one electrode and at least one second electrode.

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

49. Each of the at least one electrode is connected to a conductive trace that extends on an opposite side of the central region.

48. The analyte sensor apparatus of claim 47,

50. the analyte sensor device comprising a first sharp support containing the at least one first electrode; a second sharp holder separate from the first sharp holder, including the at least one second electrode; 48. The analyte sensor apparatus of claim 47, comprising:

51. On the side opposite the first side of the central region, there is a 48. The analyte sensor apparatus of claim 47, comprising at least one binding moiety for:

52. Each of the at least one sharp holder is connected to a step protrusion on the first surface of the central region.

48. The analyte sensor apparatus of claim 47, wherein

53. Each of the at least one sharp holder is coupled to the step protrusion in an injection molding process.

53. The analyte sensor apparatus of claim 52.

54. The first surface of the central region includes at least one step protrusion, and the at least one first the electrode and the at least one second electrode are respectively located in the sac of the at least one step projection.

48. The analyte sensor apparatus of claim 47, wherein the sensor is coupled to one of:

55. The at least one first electrode and the at least one second electrode are each formed by injection molding.

55. The method of claim 54, wherein the step projection is coupled to one of the at least one step projections in a forming step. Analyte sensor device.

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

57. 48. The analyte of claim 47, comprising at least one rocking member on a first surface of the central region. Sensor device.

58. the at least one sharps retainer is comprised of etched silicon; 48. The analyte sensor device of claim 47.

59. 5. The method of claim 4, wherein the first surface of the central region is at least partially covered with an adhesive retaining member.

8. The analyte sensor device of claim 7.

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

61. Each of the at least one first electrode and each of the at least one second electrode 48. The analyte sensor device of claim 47 which is a micropenetrator.

62. Each of the at least one first electrode and each of the at least one second electrode 5. The method of claim 4, wherein the micro-penetrator is at least partially covered with an insulating material.

8. The analyte sensor device of claim 7.

63. One of the at least one second electrodes penetrates the biological barrier to a first depth. and the other of the at least one second electrode is configured to provide a second electrode to the biological barrier.

48. The analyte sensor apparatus of claim 47, configured to penetrate to a depth.

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

65. 64. The analyte sensor device of claim 63, wherein the shallow depth is intradermal depth.

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

67. The at least one transmitter is disposed on a second surface opposite the first surface of the central region.

48. The analyte sensor apparatus of claim 47.

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

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 portion disposed on an opposite side of the central region and having a delivery lumen. Materials and at least one analyte sensor having electrodes disposed on opposite sides of the central region; 1. An access assembly device for a biological barrier comprising:

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

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

71. The coupling portion includes at least one guide and at least one connector receptacle, 70. The biological barrier access of claim 69, wherein the connector receptacle has an inclined surface and a stepped surface. Assembly equipment.

72. The device includes a septum sealing a passageway in fluid communication with at least one access member.

70. The biological barrier access assembly device of claim 69, further comprising a system.

73. the biological barrier access assembly device further comprising at least one transmitter.

70. The biological barrier access assembly device of claim 69.

74. the opposite surface of the central region includes at least one stepped projection; 70. The method of claim 69, wherein each of the electrodes is coupled to one of the at least one step projection. An access assembly device for a biological barrier as described.

75. 76. The bio-balance of claim 75, wherein the opposite side of the central region includes at least one rocking member. Rear access assembly device.

76. The opposite surface of the central region includes at least one step projection, and the at least one actuator The recess member and the electrode are each coupled to one of the at least one step projections, and One of the at least one step protrusions forms one of the at least one rocking members.

70. The biological barrier access assembly device of claim 69.

77. 70. The biobarrier assembly of claim 69, wherein the analyte sensor is a glucose sensor. Access assembly device.

78. The at least one access member includes an arrangement of microneedles extending from a sharps holder.

70. The apparatus of claim 69, comprising a column.

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

80. 7. The method of claim 6, wherein the at least one access member is comprised of etched silicon.

10. An access assembly device for a biological barrier according to claim 9.

81. the at least one access member is at least one configured for shallow delivery; The device includes a first access member and at least one second access member configured for subcutaneous delivery.

70. The biological barrier access assembly device of claim 69.

82. 7. The method of claim 6, wherein the at least one first access member is configured for intradermal delivery.

10. An access assembly device for a biological barrier according to claim 9.

83. a first electrode configured to detect an analyte concentration at a shallow location within the biological barrier; a second electrode group configured to detect an analyte concentration at a subcutaneous location within the biological barrier; 70. The biological barrier access assembly device of claim 69, comprising an electrode group of:

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

85. The device includes a central region and a peripheral region having a plurality of petals extending outward from the central region. The main body and 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 in fluid communication with a corresponding one of the at least one coupling; A first sharp holder; At least two electrodes, each including at least one electrode, are disposed on opposite sides of the central region. two second sharp holders; at least one first electrode associated with an analyte detection chemistry and at least one a second electrode;

86. The main body is configured to transition from a stored state to an deployed state, and the main body is configured to transition from a stored state to an deployed state. At least two portions of the main body are configured to expand when transitioning from the stored state to the deployed state. The biological burr according to any one of claims 1, 22, 46, 47, 69, and 85, which is displaced in a direction perpendicular to the axis of the burr. Access assembly device for aerial photography.

87. The main body is configured to transition from a stored state to an deployed state, and the main body is configured to transition from a stored state to an deployed state. When the body is moved from the stored state to the deployed state, at least two adhesive holding portions of the body Claims 1, 22, 46, and 4 displace so as to expand when transitioning from the stored state to the deployed state. 7, 69, 85. An access assembly device for a biological barrier according to any one of claims 7, 69, 85.

88. The main body is configured to transition from a stored state to an deployed state, and the main body is configured to transition from a stored state to an deployed state. When the bio-barrier access assembly is transitioned from the stowed state to the deployed state, the central region 1 and 2, wherein the body device is configured to move toward the applied biological barrier. 2, 46, 47, 69, 85. An access assembly device for a biological barrier according to any one of claims 2, 46, 47, 69, 85.

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

90. 90. The drug delivery system according to claim 89, further comprising at least one analyte monitor. The drug delivery system according to claim 1.

91. 90. The drug of claim 89, wherein the drug delivery system further comprises a glucose monitor. Dosing system.

92. The controller is in communication with at least one smart device and the infusion device.

90. The drug delivery system of claim 89,

93. The delivery assembly is detachably connected to the first portion of the injection device.

90. The drug delivery system of claim 89, wherein the second portion is split between the first portion and the second portion. 。

94. 94. The medication delivery system of claim 93, wherein the second part is a cassette assembly.

95. The cassette assembly includes at least one fluid path and at least one valve component.

95. The drug delivery system of claim 94, wherein the drug delivery system is comprised of a plurality of drug delivery systems, each of which is covered by at least one membrane. Stem.

96. The at least one sensor monitors the delivery of fluid from the infusion device to the set.

90. The medication delivery system of claim 89, wherein the pressure sensor is configured to monitor the pressure.

97. The controller analyzes data from the at least one sensor to determine whether the pressure reduction 97. The method of claim 96, further configured to determine whether the rate of decay exceeds a predetermined standard. Drug delivery system.

98. The controller analyzes data from the at least one sensor to determine whether the pressure reduction and determining whether the pressure decay rate exceeds a predetermined threshold value, and if the pressure decay rate exceeds the threshold value, and configured to generate an alert for display on a user interface of the medication delivery system.

97. The drug delivery system of claim 96,

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

97. The drug delivery system of claim 96,

100. the at least one sensor is an acoustic volume sensor including a variable volume chamber; Data from the at least one sensor indicates a fluid volume within the variable volume chamber.

90. The drug delivery system of claim 89.

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

102. The controller analyzes data from the at least one sensor to determine the determining whether the rate of volume change of the variable volume chamber exceeds a predetermined threshold; When the conversion rate exceeds the threshold, a display is made on a user interface of the drug administration system.

101. The medication delivery system of claim 100, configured to generate an alert.

103. The controller analyzes data from the at least one sensor to determine the determining whether the rate of change of the volume of the variable volume chamber is below a predetermined threshold; If the rate of change is below the threshold, a display is provided on the user interface of the medication delivery system.

101. The medication delivery system of claim 100, configured to generate an alert.

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

105. the at least one intradermal access member is coupled to a stepped protrusion on a surface of the set; 90. The drug delivery system of claim 89, comprising an array of microneedles on a sharps holder. Hmm.

106. 106. The medication delivery system of claim 105, wherein the set of surfaces includes at least one rocking member. Stem.

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

108. The main body is configured to transition from a stored state to an deployed state, and the main body is configured to transition from a stored state to an deployed state. At least two adhesive holding portions are configured to expand when the device transitions from the stored state to the deployed state. When the main body is shifted from the stored state to the deployed state, the central region is displaced to the living body.

108. The drug delivery system of claim 107, configured to move towards a barrier. Hmm.

109. At least one sensor detects a delivery impedance from the at least one access member.

90. The method of claim 89, further configured to generate a data signal that varies in relation to a dance. Drug delivery system.

110. a delivery assembly including at least one sensor and at least one pump mechanism; an injection device; a set in fluid communication with the injection set, the set including at least one shallow access member; and at least one subcutaneous access member; configured to manage the operation of at least one pump mechanism, a sensor in data communication with the at least one shallow access member and the and detecting a fluid delivery signal from the at least one sensor for at least one subcutaneous access member. The data from the at least one shallow access member is compared to the at least one A change in depth of any of the subcutaneous access members is detected by the at least one sensor. a controller configured to make decisions based on the data; A drug administration system comprising:

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

112. the at least one shallow access member and the at least one subcutaneous access member Each of the micro knees on the sharp holder is connected to a step protrusion on the surface of the set.

111. The medication delivery system of claim 110, comprising an array of dollars.

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

114. the set includes a body having a central region and a peripheral region including a plurality of petals; 111. A drug delivery system as described in claim 110.

115. The main body is configured to transition from a stored state to an deployed state, and the main body is configured to transition from a stored state to an deployed state. At least two adhesive holding portions are configured to expand when the device transitions from the stored state to the deployed state. When the main body is moved from the stored state to the deployed state, the central region is displaced.

115. The drug delivery system of claim 114, configured for rearward movement. 。

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

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

118. The controller is capable of communicating with at least one smart device and the infusion device.

111. The drug delivery system of claim 110, wherein:

119. The delivery assembly is removably coupled to a first portion of the injection device.

111. The drug delivery system of claim 110, wherein the first portion is divided into a first portion and a second portion.

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

121. The set assembly includes at least one flow path and at least one valve component.

121. The drug delivery system of claim 120, wherein they are covered by at least one membrane. Stem.

122. The at least one sensor detects delivery of the at least one access member.

12. The method of claim 11, wherein the data signal is configured to vary in relation to impedance.

10. A drug delivery system as described in claim 0.

123. The controller detects the at least one When a delivery impedance associated with one subcutaneous access member increases, the at least and determining that another subcutaneous access member has moved to intradermal depth. Item 123. A drug administration system according to Item 122.

124. The controller detects the at least one a delivery impedance associated with one subcutaneous access member is greater than or equal to a delivery impedance associated with the at least one intradermal access member; When the range of historical data associated with the subcutaneous access member increases, the subcutaneous access member is 123. The drug delivery system of claim 122, wherein the drug delivery system is configured to determine whether the drug delivery system has moved to a depth within the target area. Tem.

125. The controller detects the at least one a delivery impedance associated with one subcutaneous access member is greater than or equal to a delivery impedance associated with the at least one intradermal access member; and increasing within a range of historical data associated with the at least one intradermal access member. configured to generate an alarm when a delivery impedance associated with the member decreases.

123. The drug delivery system of claim 122.

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 comprising at least one access member, a shallow a set including a thin analyte sensor and a deep analyte sensor; and controlling operation of at least one pump mechanism to provide fluid to said at least one access member. and a shallow analyte sensor and a deep analyte sensor configured to selectively deliver fluids. a controller capable of communicating with the sensor; the controller controls the shallow analyte sensor and the deep analyte sensor and comparing data from the shallow analyte sensor and the deep analyte sensor. and generating a notification when a relationship between the medication administration data exceeds a predetermined criterion. Grant system.

127. At least one shallow analyte sensor and at least one subcutaneous analyte sensor are included.

127. The drug delivery system of claim 126, comprising a micropenetrator.

128. The surface of the set includes at least one step protrusion, and the shallow analyte sensor and the front Each of the analyte sensors is coupled to one of the at least one stepped projection.

127. The drug delivery system of claim 126.

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

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

131. The main body is configured to transition from a stored state to an deployed state, and the main body is configured to transition from a stored state to an deployed state. At least two adhesive holding portions are configured to expand when the device transitions from the stored state to the deployed state. When the main body is moved from the stored state to the deployed state, the central region is displaced.

131. The medication delivery system of claim 130, configured for rearward movement. 。

132. The shallow analyte sensor is an intradermal analyte sensor and the deep analyte sensor is a subcutaneous analyte sensor.

127. The drug administration system of claim 126, which is an analyte sensor.

133. the shallow analyte sensor and the deep analyte sensor are glucose sensors; 127. A drug delivery system as described in claim 126.

134. The controller is capable of communicating with at least one smart device and the infusion device.

127. The pharmaceutical delivery system of claim 126,

135. The delivery assembly is removably coupled to a first portion of the injection device.

127. A drug delivery system as described in claim 126, wherein the first portion is divided into a first portion and a second portion.

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

137. The cassette assembly includes at least one fluid path and at least one valve component.

137. The drug delivery system of claim 136, wherein they are covered by at least one membrane. Stem.

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

139. The predetermined criteria are collected from the shallow analyte sensor and the deep analyte sensor.

127. The drug delivery system of claim 126, wherein the dose is determined based on historical data.

140. The controller analyzes data from the shallow analyte sensor and the deep analyte sensor. The data is analyzed to determine whether the data from any of the analyte sensors is accurate to the intended level. and generating a notification when the device indicates movement from a specified location.

126. A drug delivery system according to claim 126.

141. an infusion device comprising a delivery assembly including at least one pump mechanism; a set in fluid communication with the injection set, the set including at least one shallow access member; , at least one deep access member, and at least one analyte monitor; Set and and controlling operation of the at least one pump mechanism to remove each access member from the infusion device. a controller configured to selectively deliver fluid to the generating a signal that varies in relation to delivery impedance from the access member; With one sensor, wherein the controller controls the sensor and the at least one analyte monitor. analyzing data from said at least one analyte monitor and said sensor; and data from the at least one analyte sensor and the at least one sensor, respectively. If at least one of the access members is displaced from its intended position, and generating a notification when the medication is administered.

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

143. the at least one shallow access member and the at least one deep access member Each microneedle on a sharp holder is connected to a step protrusion on the surface of the set.

142. The drug delivery system of claim 141, comprising an array of:

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

145. the set includes a body having a central region and a peripheral region including a plurality of petals; 142. A drug delivery system as described in claim 141.

146. The main body is configured to transition from a stored state to an deployed state, and the main body is configured to transition from a stored state to an deployed state. At least two adhesive holding portions are configured to expand when the device transitions from the stored state to the deployed state. When the body transitions from the stored state to the deployed state, the central region 145. The set is configured to move toward an applied biological barrier. The drug delivery system according to claim 1.

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

148. 142. The method of claim 141, wherein the at least one analyte monitor comprises a micropenetrator. The drug delivery system according to claim 1.

149. The controller is capable of communicating with at least one smart device and an infusion device.

142. The drug delivery system of claim 141.

150. The delivery assembly is removably coupled to a first portion of the injection device.

142. The drug delivery system of claim 141, wherein the first portion is divided into a first portion and a second portion.

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

152. The cassette assembly includes at least one fluid path and at least one valve component.

152. The pharmaceutical administration of claim 151, wherein said pharmaceutical administration is performed by at least one membrane. system.

153. The set is connected to a fluid transfer connector at the end of a fluid line extending from the infusion device.

142. The drug delivery system of claim 141, comprising a coupling portion configured to couple together.

154. The set includes conductive wires extending from at least one analyte monitor, and the flow When the fluid transfer connector engages the coupling portion, the fluid transfer connector 154. A medication delivery system as described in claim 153, including a contact point configured to seat against the line.

155. 155. The electrical communication path extends from the contact point along the length of the fluid line. The drug delivery system according to claim 1.

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; La and and the controller detects from the shallow analyte sensor and the deep analyte sensor. The received data is compared and the data from the analyte sensor is compared to a threshold value from an expected relationship. An analyte detection system configured to generate a notification when the value deviates beyond the value.

157. The controller initially converts the expected relationship into a predefined expected relationship.

157. The analyte detection system of claim 156, configured to synchronize.

158. the controller receives from the shallow analyte sensor and the deep analyte sensor; 16. The method of claim 15, wherein the method is configured to adjust the predicted relationship based on the acquired data.

8. The analyte detection system of claim 7.

159. The predicted relationship is based on the measured values ​​of the analyte concentrations received from the shallow analyte sensor and the deep analyte sensor.

157. The analysis of claim 156, wherein the analysis is based at least in part on received historical data. Object detection system.

160. The shallow analyte sensor is an intradermal analyte sensor and the deep analyte sensor is a subcutaneous analyte sensor.

157. The analyte detection system of claim 156, which is an analyte sensor.

161. The shallow analyte sensor and the deep analyte sensor each include at least one 157. The analyte detection system of claim 156, comprising a micropenetrator.

162. The predicted relationship may be a function of the change in analyte concentration sensed by the shallow analyte sensor. and a delay between a change in analyte concentration sensed by the deep analyte sensor.

157. The analyte detection system of claim 156.

163. the analyte detection assembly including a connector coupling for wired communication with the controller; 157. The analyte detection system of claim 156.

164. the analyte detection assembly is coupled to a transmitter for wirelessly transmitting data to the controller; 157. The analyte detection system of claim 156, configured to:

165. The analyte detection assembly includes a surface having at least one stepped projection, and the shallow analyte detection assembly the deep analyte sensor and the deep analyte sensor are each disposed on at least one step protrusion.

157. The analyte detection system of claim 156,

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

167. The analyte detection assembly has a central region and a peripheral region including a plurality of petals.

157. The analyte detection system of claim 156, comprising a body.

168. The main body is configured to transition from a stored state to an deployed state, and the main body is configured to transition from a stored state to an deployed state. At least two adhesive holding portions are configured to expand when the device transitions from the stored state to the deployed state. When the body transitions from the stored state to the deployed state, the central region a biological barrier to which the precipitate detection assembly is applied; 168. An analyte detection system according to claim 167.

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

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