Systems and devices for delivering medical agents

Abstract

A medical agent delivery device may include a body including a central region and a peripheral region. The peripheral region may have a plurality of petal members extending outwardly from the central region. The device may also include at least one coupling on a first face of the central region. The device may also include at least one pointed carrier on an opposite side of the central region. Each of the at least one pointed carrier may be in fluid communication with a respective one of the at least one coupling.

Description

Technical Field

[0001] FIELD OF THE DISCLOSURE: The present disclosure relates to medical agent administration. More specifically, the present disclosure relates to medical agent administration kits and other components that can help support the administration of a medical agent to a patient. Summary of the invention

[0002] According to an example embodiment of the present disclosure, an example medical agent delivery device may include a body including a central region and a peripheral region. The peripheral region may have a plurality of petal-shaped members extending outward from the central region. The device may also include at least one coupling member on a first face of the central region. The device may also include at least one prong carrier on an opposite face of the central region. Each of the at least one prong carrier may be in fluid communication with a corresponding one of the at least one coupling member.

[0003] In some embodiments, the central region may be raised relative to the peripheral region. In some embodiments, each of the at least one coupling may be a fitting. In some embodiments, the at least one coupling may include a connector receiver, each of the connector receivers having a ramp face and a flange face. In some embodiments, the at least one coupling may include at least one guide. In some embodiments, each of the at least one coupling may include a Luer fitting. In some embodiments, the body and coupling may be configured for injection molding without side action. In some embodiments, the opposite face of the central region may include at least one rocking member. In some embodiments, the at least one prong carrier may be composed of etched silicon. In some embodiments, in an injection molding operation, each of the at least one prong carrier may be coupled to a corresponding one of at least one boss on the opposite face. In some embodiments, each of the at least one prong carrier may be coupled to a corresponding one of at least one boss on the opposite face via an adhesive. In some embodiments, the device may further include a diaphragm that seals a passageway in fluid communication with the at least one prong carrier. In some embodiments, the opposite face of the central region may be at least partially covered by an adhesive carrier member. In some embodiments, the device may further include an adhesive carrier member. In some embodiments, each of the at least one prong carrier may include at least one microneedle. In some embodiments, each of the at least one pointed carrier may include an array of microneedles. In some embodiments, the first of the at least one pointed carrier may include at least one first microneedle having a first height. The second of the at least one pointed carrier may include at least one second microneedle having a second height different from the first height. In some embodiments, when using the device, the first height may be selected to place the at least one first microneedle in a shallow delivery destination, and the second height may be selected to place the at least one second microneedle in a deeper delivery destination. In some embodiments, the shallow delivery destination may be an intradermal delivery destination. In some embodiments, the deeper delivery destination may be a subcutaneous delivery destination. In some embodiments, each of the at least one pointed carrier may be in fluid communication with a corresponding one of the at least one connectors.

[0004] According to another example embodiment of the present disclosure, an example medical agent delivery device may include a body including a central region and a peripheral region. The peripheral region may have a plurality of petal-shaped members extending outward from the central region. The device may also include a body coupled to the body, the body including at least one coupling on a first face of the central region and at least one prong carrier on an opposite face of the central region. Each of the at least one prong carrier may be in fluid communication with a corresponding one of the at least one coupling.

[0005] In some embodiments, the body can be coupled to a ridge included in a portion of the body. In some embodiments, the body can include a plurality of tabs that are coupled to a slit in the body. In some embodiments, the central region can be raised relative to the peripheral region. In some embodiments, each of the at least one coupling can be a fitting. In some embodiments, each of the at least one coupling can be a pipe receiver to which a fluid line leading to the fitting is coupled. In some embodiments, the at least one coupling can include a connector receiver, each of which has a ramp face and a flange face. In some embodiments, the at least one coupling can include at least one guide. In some embodiments, each of the at least one coupling can include a Luer fitting. In some embodiments, the body and the body can be injection molded. In some embodiments, the opposite face of the body can include at least one rocking member. In some embodiments, the at least one prong carrier can be composed of etched silicon. In some embodiments, in an injection molding operation, each of the at least one prong carrier can be coupled to a corresponding one of at least one boss on the opposite face. In some embodiments, each of the at least one prong carrier can be coupled to a corresponding one of at least one boss on the opposite face via an adhesive. In some embodiments, the device can also include a diaphragm that seals a passageway in fluid communication with the at least one prong carrier. In some embodiments, the opposite side of the body may be at least partially covered by an adhesive carrier member. In some embodiments, the device may further include an adhesive carrier member. In some embodiments, each of the at least one pointed carrier may include at least one microneedle. In some embodiments, each of the at least one pointed carrier may include an array of microneedles. In some embodiments, the first of the at least one pointed carrier may include at least one first microneedle having a first height. The second of the at least one pointed carrier may include at least one second microneedle having a second height different from the first height. In some embodiments, when using the device, the first height may be selected to place the at least one first microneedle in a shallow delivery destination, and the second height may be selected to place the at least one second microneedle in a deeper delivery destination. In some embodiments, the shallow delivery destination may be an intradermal delivery destination. In some embodiments, the deeper delivery destination may be a subcutaneous delivery destination. In some embodiments, each of the at least one pointed carrier may be in fluid communication with a corresponding one of the at least one connector.

[0006] According to another exemplary embodiment of the present disclosure, an exemplary medical agent delivery device may include a body including a central region and a peripheral region. The peripheral region may have a plurality of petal-shaped members extending outward from the central region. The device may also include at least one coupling member on a first face of the central region. The device may also include at least one prong carrier on an opposite face of the central region. Each of the at least one prong carrier may be in fluid communication with a corresponding one of the at least one coupling member. The at least one prong carrier may be coupled to a boss on an opposite face.

[0007] According to another exemplary embodiment of the present disclosure, an analyte sensor device may include a body including a central region and a peripheral region. The peripheral region may include a plurality of petal-shaped members extending outward from the central region. The device may also include at least one prong carrier on a first face of the central region. Each of the at least one prong carrier may include at least one electrode. The device may include at least one first electrode and at least one second electrode associated with an analyte sensing chemical substance.

[0008] In some embodiments, the central region may be raised relative to the peripheral region. In some embodiments, each of the at least one electrode may communicate with a conductive trace extending to an opposite side of the central region. In some embodiments, the device may include a first pointed carrier and a second pointed carrier, wherein the first pointed carrier includes the at least one first electrode, and the second pointed carrier is separate from the first pointed carrier and includes the at least one second electrode. In some embodiments, the opposite face of the central region opposite to the first face may include at least one coupling member for coupling the device to a transmitter. In some embodiments, each of the at least one pointed carrier may be coupled to a boss on the first face of the central region. In some embodiments, each of the at least one pointed carrier may be coupled to the boss during an injection molding operation. In some embodiments, the first face of the central region may include at least one boss. The at least one first electrode and the at least one second electrode may each be coupled to one of the at least one boss. In some embodiments, the at least one first electrode and the at least one second electrode may each be coupled to one of the at least one boss during an injection molding operation. In some embodiments, the body may be injection molded. In some embodiments, the first face of the central region may include at least one rocking member. In some embodiments, the at least one pointed carrier may be composed of etched silicon. In some embodiments, the first face of the central region may be at least partially covered by an adhesive bearing member. In some embodiments, the device may further include an adhesive bearing member. In some embodiments, each of the at least one first electrode and each of the at least one second electrode may be a micro-penetrator. In some embodiments, each of the at least one first electrode and each of the at least one second electrode may be included in a micro-penetrator at least partially covered in an insulating material. In some embodiments, the first electrode of the at least one second electrode may be configured to penetrate into a first depth in a biological barrier, and the second electrode of the at least one second electrode may be configured to penetrate into a second depth in a biological barrier. In some embodiments, the first depth may be selected as a shallow depth, and the second depth may be selected as a subcutaneous depth. In some embodiments, the shallow depth may be an intradermal depth. In some embodiments, the device may further include at least one transmitter. In some embodiments, the at least one transmitter may be disposed on a second face opposite to the first face in the central region. In some embodiments, the analyte sensor device may be a glucose sensor.

[0009] According to another exemplary embodiment of the present disclosure, an entry assembly device for a biological barrier may include a body including a central region and a peripheral region. The peripheral region may have a plurality of petal-shaped members. The device may also include a coupling on a first face of the central region. The device may also include at least one entry member on an opposite face of the central region. The at least one entry member may have a delivery lumen. The device may also include at least one analyte sensor having an electrode on an opposite face of the central region.

[0010] In some embodiments, the coupling may be a fitting, such as a Luer lock fitting. In some embodiments, the coupling may include at least one guide and at least one connector receiver. Each of the at least one connector receiver may have a ramp face and a flange face. In some embodiments, the device may further include a diaphragm that seals a passage in fluid communication with the at least one entry member. In some embodiments, the device may further include at least one transmitter. In some embodiments, the opposite side of the central region may include at least one boss. The entry member and the electrode may each be coupled to one of the at least one boss. In some embodiments, the opposite side of the central region may include at least one rocking member. In some embodiments, the opposite side of the central region may include at least one boss. The at least one entry member and the electrode may each be coupled to one of the at least one boss, and one of the at least one boss may form one of the at least one rocking member. In some embodiments, the analyte sensor may be a glucose sensor. In some embodiments, the at least one entry member may include an array of microneedles extending from a pointed carrier. In some embodiments, the electrode may include a micropenetrator extending from a pointed carrier. In some embodiments, the at least one entry member may be composed of etched silicon. In some embodiments, the at least one access member may include at least one first access member and at least one second access member, wherein the at least one first access member is configured for shallow delivery and the at least one second access member is configured for subcutaneous delivery. In some embodiments, the at least one first access member may be configured for intradermal delivery. In some embodiments, the electrodes include a first set of electrodes and a second set of electrodes, wherein the first set of electrodes is configured to sense analyte levels at a shallow location in the biological barrier and the second set of electrodes is configured to sense analyte levels at a subcutaneous location in the biological barrier. In some embodiments, the shallow location may be an intradermal location.

[0011] According to another example embodiment of the present disclosure, an example entry assembly device for a biobarrier may include a body including a central region and a peripheral region. The peripheral region may have a plurality of petal-shaped members extending outward from the central region. The device may also include at least one coupling member on a first face of the central region. The device may also include at least one first prong carrier located on an opposite face of the central region. Each of the at least one first prong carrier may be in fluid communication with a corresponding one of the at least one coupling member. The device may also include at least one second prong carrier located on an opposite face of the central region. Each of the at least one second prong carrier may include at least one electrode. The device may include at least one first electrode and at least one second electrode associated with an analyte sensing chemical substance.

[0012] In certain embodiments of any of the above-described devices, the body can be configured to transition from a storage state to an expanded state. At least two portions of the body can be displaced expansively as the body transitions from a storage state to an expanded state. In certain embodiments of any of the above-described devices, the body can be configured to transition from a storage state to an expanded state. At least two adhesive-bearing portions of the body can be displaced expansively as the body transitions from a storage state to an expanded state. In certain embodiments of any of the above-described devices, the body can be configured to transition from a storage state to an expanded state. The central area can be configured to translate toward a biological barrier to which the device has been applied as the body transitions from a storage state to an expanded state.

[0013] According to another example embodiment of the present disclosure, a medical agent administration system may include an infusion device. The infusion device may include a delivery assembly including at least one sensor and at least one pumping arrangement. The system may also include a kit in fluid communication with the delivery device. The kit may include at least one intradermal access member. The system may also include a controller configured to manage the operation of the at least one pumping arrangement. The controller may be in data communication with the at least one sensor and configured to analyze data from the at least one sensor. The controller may be configured to determine that a change in the depth of the at least one access member has occurred based on data from the at least one sensor.

[0014] In some embodiments, the system may further include at least one analyte monitor. In some embodiments, the system may also include a glucose monitor. In some embodiments, the controller may communicate with at least one smart device and an infusion device. In some embodiments, the delivery assembly may be separated between a first portion of the infusion device and a second portion of the infusion device that is removably coupled to the first portion. In some embodiments, the second portion may be a box assembly. In some embodiments, the box assembly may include at least one flow path and at least one valve component overlapped by at least one film. In some embodiments, the at least one sensor may include a pressure sensor configured to monitor the volume of the fluid delivered to the kit from the infusion device. In some embodiments, the controller may be configured to analyze data from the at least one sensor to determine whether the pressure decay rate violates a predefined standard. In some embodiments, the controller may be configured to analyze data from the at least one sensor to determine whether the pressure decay rate exceeds a predefined threshold, and is configured to generate a warning for display on the user interface of the system when the pressure decay rate exceeds the threshold. In some embodiments, the controller may be configured to analyze data from the at least one sensor to determine whether the pressure decay rate is below a predefined threshold, and is configured to generate a warning for display on the user interface of the system when the pressure decay rate exceeds the threshold. In some embodiments, the at least one sensor may include an acoustic volume sensor having a variable volume chamber, and the data from the at least one sensor may indicate the 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 to determine whether the change in the volume of the variable volume chamber over time violates a predefined standard. In some embodiments, the controller may be configured to analyze the data from the at least one sensor to determine whether the rate of change of the volume of the variable volume chamber exceeds a predefined threshold, and is configured to generate a warning for display on the user interface of the system when the rate of change exceeds the threshold. In some embodiments, the controller may be configured to analyze the data from the at least one sensor to determine whether the rate of change of the volume of the variable volume chamber is below a predefined threshold, and is configured to generate a warning for display on the user interface of the system when the rate of change is below the threshold. In some embodiments, the at least one intradermal access member may include a microneedle. In some embodiments, the at least one intradermal access member may include an array of microneedles on a pointed carrier, the pointed carrier being coupled to a boss on the face of the kit. In some embodiments, the face of the kit may include at least one shaking member. In some embodiments, the kit may include a body having a central region and a peripheral region including a plurality of petal-shaped members. In some embodiments, the body may be configured to transition from a stored state to a deployed state.As the main body is transformed from the storage state to the expanded state, at least two adhesive bearing portions of the main body can be displaced in an extended manner. The central area can be configured to translate toward the bio-barrier of the application kit as the main body is transformed from the storage state to the expanded state. In some embodiments, the at least one sensor can be configured to generate a data signal that varies with respect to the delivery impedance from the at least one entry member.

[0015] According to another example embodiment of the present disclosure, an example medical agent delivery system may include an infusion device. The infusion device may include a delivery component including at least one sensor and at least one pumping arrangement device. The system may also include a kit in fluid communication with the delivery device. The kit may include at least one shallow entry member and at least one subcutaneous entry member. The system may also include a controller configured to manage the operation of the at least one pumping arrangement device. The controller may communicate data with the at least one sensor and is configured to compare data from the at least one sensor related to fluid delivery with the shallow entry member and the at least one subcutaneous entry member, and determine a change in the depth of one or more of the shallow entry member and the at least one subcutaneous entry member based on the data from the at least one sensor.

[0016] In some embodiments, the at least one shallow entry member and the at least one subcutaneous entry member may be microneedles. In some embodiments, the at least one shallow entry member and the at least one subcutaneous entry member may each include an array of microneedles on a pointed carrier, which is connected to a boss on the face of the kit. In some embodiments, the face of the kit may include at least one shaking member. In some embodiments, the kit may include a main body having a central area and a peripheral area including a plurality of petal-shaped members. In some embodiments, the main body may be configured to transition from a storage state to an expanded state. As the main body transitions from a storage state to an expanded state, at least two adhesive bearing portions of the main body may be displaced in an extended manner. The central area may be configured to translate toward the biobarrier of the application kit as the main body transitions from a storage state to an expanded state. In some embodiments, the system may further include at least one analyte monitor. In some embodiments, the system may also include a glucose monitor. In some embodiments, the controller may communicate with at least one smart device and an infusion device. In some embodiments, the delivery assembly may be separated between a first portion of the infusion device and a second portion of the infusion device that is removably connected to the first portion. In some embodiments, the second portion may be a box assembly. In some embodiments, the box assembly may include at least one flow path and at least one valve component overlapped by at least one membrane. In some embodiments, the at least one sensor can be configured to generate a data signal that varies relative to a delivery impedance from the at least one access member. In some embodiments, the controller can be configured to determine that the at least one subcutaneous access member has shifted to an intradermal depth when the delivery impedance associated with the at least one subcutaneous access member indicated by the at least one data increases. In some embodiments, the controller can be configured to determine that the at least one subcutaneous access member has shifted to an intradermal depth when the delivery impedance associated with the at least one subcutaneous access member indicated by the at least one sensor increases to within the range of historical data associated with the at least one intradermal access member. In some embodiments, the controller can be configured to generate an alarm when the delivery impedance associated with the at least one subcutaneous access member indicated by the at least one sensor increases to within the range of historical data associated with the at least one intradermal access member and the delivery impedance associated with the at least one intradermal access member indicated by the at least one sensor decreases.

[0017] According to another exemplary embodiment of the present disclosure, a medical agent administration system may include an infusion device having a delivery assembly. The delivery assembly may include at least one pumping arrangement device. The system may also include a kit in fluid communication with the delivery device. The kit may include at least one entry member, a shallow analyte sensor, and a deep analyte sensor. The system may also include a controller configured to manage the operation of the at least one pumping arrangement device to selectively deliver fluid from the infusion device to the at least one entry member. The controller may communicate with the shallow analyte sensor and the deep analyte sensor data. The controller may be configured to compare data from the shallow analyte sensor and data from the deep analyte sensor, and generate a notification when the relationship between the data from the shallow analyte sensor and the data from the deep analyte sensor violates a predefined standard.

[0018] In some embodiments, the at least one shallow analyte sensor and the at least one subcutaneous analyte sensor may include a micro-penetrator. In some embodiments, the face of the kit may include at least one boss, and the shallow analyte sensor and the deep analyte sensor may each be coupled to one of the at least one boss. In some embodiments, the face of the kit may include at least one shaking member. In some embodiments, the kit may include a main body having a central area and a peripheral area including a plurality of petal-shaped members. In some embodiments, the main body may be configured to transition from a storage state to an expanded state. As the main body transitions from a storage state to an expanded state, at least two adhesive bearing portions of the main body may be displaced expansively. The central area may be configured to translate toward the bio-barrier of the application kit as the main body transitions from a storage state to an expanded state. 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 communicate with at least one smart device and an infusion device. In some embodiments, the delivery assembly may be separated between a first portion of an infusion device and a second portion of an infusion device that may be removably coupled to the first portion. In some embodiments, the second portion may be a box assembly. In some embodiments, the box assembly may include at least one flow path and at least one valve component stacked by at least one film. In some embodiments, the predefined standard may be a time lag between changes in analyte levels measured by a shallow analyte sensor and a deep analyte sensor. In some embodiments, the predefined standard may be determined based on historical data collected from a shallow analyte sensor and a deep analyte sensor. In some embodiments, the controller may also be configured to analyze data from a shallow analyte sensor and a deep analyte sensor, and generate a notification when data from any one of the analyte sensors indicates that the corresponding analyte sensor has been displaced from its expected position.

[0019] According to another exemplary embodiment of the present disclosure, a medical agent administration system may include an infusion device having a delivery component. The delivery component may include at least one pumping arrangement device. The system may also include a kit in fluid communication with the delivery device. The kit may include at least one shallow entry member, at least one deep entry member, and at least one analyte monitor. The system may also include a controller configured to manage the operation of the at least one pumping arrangement device to selectively deliver fluid from the infusion device to each of the entry members. The system may also include at least one sensor configured to generate a signal that varies with respect to the delivery impedance from the entry member. The controller may be configured to analyze data from the sensor and the at least one analyte monitor, and generate a notification when the data from the at least one analyte monitor and the data from the sensor respectively indicate that at least one of the at least one analyte sensor and at least one of the entry members have been displaced from their expected positions.

[0020] In some embodiments, the at least one shallow entry member and the at least one deep entry member may be microneedles. In some embodiments, the at least one shallow entry member and the at least one deep entry member may each include an array of microneedles located on a pointed carrier, which is connected to a boss on the face of the kit. In some embodiments, the face of the kit may include at least one shaking member. In some embodiments, the kit may include a body having a central area and a peripheral area including a plurality of petal-shaped members. In some embodiments, the body may be configured to transition from a storage state to an expanded state. As the body transitions from a storage state to an expanded state, at least two adhesive bearing portions of the body may be displaced expansively. The central area may be configured to translate toward the biobarrier of the application kit as the body transitions from a storage state to an expanded state. In some embodiments, the at least one shallow entry member may be an intradermal entry member, and the at least one deep entry member may be a subcutaneous entry member. In some embodiments, the at least one analyte monitor may include a micropenetrator. In some embodiments, the controller may communicate with at least one smart device and an infusion device. In some embodiments, the delivery assembly may be separated between a first portion of the infusion device and a second portion of the infusion device that is removably connected to the first portion. In some embodiments, the second portion may be a box assembly. In some embodiments, the box assembly may include at least one flow path and at least one valve component overlapped by at least one film. In some embodiments, the kit may include a coupling configured to couple with a fluid transfer connector at a terminal end of a fluid line extending from an infusion device. In some embodiments, the kit may include a conductive trace extending from the at least one analyte monitor. The fluid transfer connector may include a contact configured to abut against the conductive trace when the fluid transfer connector engages with the coupling. In some embodiments, the electrical communication path may extend from the contact and extend along the length of the fluid line.

[0021] According to another example embodiment of the present disclosure, an analyte sensing system may include an analyte sensor assembly including a shallow analyte sensor and a deep analyte sensor. The system may also 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 if the data from the analyte sensor deviates from an expected relationship by more than a threshold.

[0022] 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 is configured to set the expected relationship based at least in part on historical data received from the shallow analyte sensor and the deep analyte sensor. In some embodiments, the shallow analyte sensor may be an intradermal analyte sensor, and the deep analyte sensor may be a subcutaneous analyte sensor. In some embodiments, the shallow analyte sensor and the deep analyte sensor may each include at least one micro-penetrator. In some embodiments, the expected relationship may define a delay between a change in the analyte level sensed by the shallow analyte sensor and a change in the analyte level sensed by the deep analyte sensor. In some embodiments, the analyte sensing assembly may include a coupling for a connector for hard-wired communication with the controller. In some embodiments, the analyte sensing assembly may be configured to be coupled to a transmitter for wirelessly sending data to the controller. In some embodiments, the analyte sensing assembly may include a face having at least one boss. The shallow analyte sensor and the deep analyte sensor may each be disposed on the at least one boss. In some embodiments, the face may include a shaking member. In some embodiments, the analyte sensing assembly may include a body having a central region and a peripheral region including a plurality of petal-shaped members. In some embodiments, the body may be configured to transition from a storage state to an expanded state. As the body transitions from the storage state to the expanded state, at least two adhesive bearing portions of the body may be displaced expansively. The central region may be configured to translate toward a bio-barrier to which the analyte sensing assembly is applied as the body transitions from the storage state to the expanded state. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] These and other aspects will become more apparent from the following detailed description of various embodiments of the present disclosure with reference to the accompanying drawings, in which:

[0024] Figure 1 depicts a block diagram of an example system including a kit, an analyte sensor and transmitter, and other components;

[0025] Figure 2 depicts a block diagram of an example system including a plurality of kits, analyte sensors and transmitters, and other components;

[0026] Figure 3 depicts a block diagram of an example system including, among other components, an access assembly including an analyte sensor, a transmitter, and at least one access member;

[0027] FIG. 4A to FIG. 4B An exemplary embodiment of a kit is depicted;

[0028] Figure 5 depicts a perspective view of an example embodiment of an access member;

[0029] FIG. 6A to FIG. 6B depicting views of example embodiments of entry members;

[0030] FIG. 7A to FIG. 7B depicting views of example embodiments of entry members;

[0031] Fig. 8A depicts a perspective view of an example embodiment of a plurality of entry members on an example tip carrier;

[0032] Figure 8B depicts a perspective view of an example embodiment of a plurality of entry members on an example tip carrier;

[0033] Fig.9A depicts a perspective view of an example embodiment of a plurality of entry members on an example tip carrier;

[0034] Fig. 9B depicts a top plan view of an example embodiment of a plurality of entry members on an example tip carrier;

[0035] Fig. 10A depicts a top plan view of an example embodiment of a plurality of entry members on an example tip carrier;

[0036] Fig. 10B depicts a perspective view of an example embodiment of a plurality of entry members on an example tip carrier;

[0037] Fig.11A depicts a top plan view of an example embodiment of a plurality of entry members on an example tip carrier;

[0038] Fig. 11B depicts a perspective view of an example embodiment of a plurality of entry members on an example tip carrier;

[0039] Fig. 11C Depicted in Fig.11A A cross-sectional view taken at the indicated cutting plane;

[0040] FIG. 12A to FIG. 12D Various views of exemplary access members are depicted;

[0041] Fig.13 depicts a perspective view of the example kit;

[0042] Fig.14 A top plan view of an example kit is depicted;

[0043] Fig.15 Depicted in Fig.14A cross-sectional view taken at the indicated cutting plane;

[0044] Fig.16 depicting a bottom plan view of an example body of an example kit;

[0045] Fig.17 A conceptual illustration depicting an example body of an example kit in a delivery state;

[0046] Fig.18 depicts a view of an example kit in place at an infusion site on a biological barrier;

[0047] Fig.19 depicts an illustration of an example kit in a delivery state at an infusion site on a biological barrier;

[0048] Fig. 20 A side view of an example kit is depicted;

[0049] Fig.21 depicts a perspective view of the example kit;

[0050] FIG. 22A to FIG. 22I Example top plan views depicting a plurality of subjects;

[0051] Fig.23 depicts a perspective view of an exemplary kit;

[0052] Fig.24 depicts a perspective view of an example kit with the example body partially exploded from the kit;

[0053] Fig.25 depicts an exploded view of an example kit wherein the adhesive liner has been exploded from an adhesive member included on the kit;

[0054] Fig.26 depicts a perspective view of the example kit;

[0055] Fig. 27 depicts a cross-sectional view taken along a mid-plane of a sample kit;

[0056] FIG. 28A to FIG. 28B Depicted are representative views of an example kit in a storage state and a delivery state, respectively;

[0057] Figure 29 to Figure 30 Conceptual image depicting a sample kit in its delivery state;

[0058] Fig.31 depicts a perspective view of an example body having an example boss to which a plurality of example entry members are coupled;

[0059] Fig.32 depicts a perspective view of an example ontology;

[0060] Fig.33 depicts a cross-sectional view of an example body;

[0061] Fig.34 depicts a cutaway cross-sectional view of an example boss and an example entry member on an example tip carrier;

[0062] Figure 35 to Figure 36 depicts a view of an example body including a plurality of example bosses, each boss being associated with at least one entry member and each being fluidly isolated from one another;

[0063] Figure 37 to Figure 38 depicts a representative view of an example kit including a rocking member;

[0064] FIG. 39A to FIG. 39B depicts views of exemplary subjects;

[0065] Fig.40 depicts a detailed view of a portion of the example body;

[0066] Fig.41 A top plan view of an example kit is depicted;

[0067] Fig.42 Depicted Fig.41 Detailed view of the indicated area;

[0068] Fig.43 depicts a perspective view of an exemplary connector;

[0069] Fig.44 depicts a perspective view of the example kit;

[0070] Fig.45 A cross-section of an example kit is depicted;

[0071] Fig.46 Depicted Fig.45 Detailed view of the indicated area;

[0072] Fig.47 depicts an exploded view of an example analyte sensor and transmitter;

[0073] Fig.48 depicts a bottom plan view of an example analyte sensor;

[0074] Fig.49 depicts a cutaway perspective view of an example electrode set of an analyte sensor on an example boss;

[0075] Fig.50 depicts a bottom plan view of an example entry assembly;

[0076] Fig.51depicts a top plan view of an example entry assembly and an example connector;

[0077] Fig.52 depicts a bottom plan view of another example entry assembly;

[0078] Fig.53 Depicted Fig.52 Detailed view of the indicated area;

[0079] Fig.54 Depicted Fig.52 Detailed view of the indicated area;

[0080] Figure 54 to Figure 57 depicts various exemplary adhesive members on an example kit; and

[0081] Figure 58 to Figure 63 Depicted are block diagram views of example delivery components that may be included in certain example infusion devices. DETAILED DESCRIPTION

[0082] In various embodiments, the kit can be used in conjunction with an infusion device, system, and related methods. In various embodiments, the example kit can be configured to be inserted into a user's skin layer and fluidly connected to a fluid source. In various embodiments, the example kit can be fluidly connected to a section of tubing and / or an infusion device. An infusion device includes any infusion pump and may include, but is not limited to, the various infusion devices described in U.S. Patent Application Serial No. 13 / 788,260, filed on March 7, 2013, entitled “Infusion Pump Assembly,” which is currently U.S. Publication No. US-2014-0107579, published on April 17, 2014 (Attorney Docket No. K40); U.S. Patent No. 8,491,570, issued on July 23, 2013, entitled “Infusion Pump Assembly” (Attorney Docket No. G75); U.S. Patent No. 8,414,522, issued on April 9, 2013, entitled “Fluid Delivery Systems and Methods” (Attorney Docket No. E70); U.S. Patent No. 8,414,522, issued on September 11, 2012, entitled “Infusion Pump Assembly” (Attorney Docket No. E70); No. 8,262,616, entitled “Loading Mechanism for Infusion Pump” (Agent Docket No. F51), issued on December 11, 2007; and No. 7,306,578, entitled “Loading Mechanism for Infusion Pump” (Agent Docket No. C54), all of which are incorporated herein by reference in their entirety. Any connector that connects the fluid line from the pump to the infusion set described in the above-referenced application may be used with the kit described herein or with any connector described in U.S. patent application serial number 16 / 797,624, entitled “Infusion Set and Inserter Assembly Systems and Methods,” filed on February 21, 2020, currently a U.S. publication with publication number US-2020-0289748, published on September 17, 2020 (Agent Docket No. 00101.00307.AA159), which is also incorporated herein by reference in its entirety.The microneedles described herein may include, but are not limited to, the various microneedles described in U.S. Patent No. 11,154,698, issued on October 26, 2021, entitled “Microtneedle Systems and Apparatus” (Agent Docket No. G34), or U.S. Patent No. 5,983,136, issued on November 9, 1999, entitled “System for Delivery of Drugs by Transport” (Agent Docket No. B60).

[0083] Various embodiments are described and illustrated herein. Each embodiment of each element of each device can be used in any other device embodiment.

[0084] Reference now Figure 1, depicting a block diagram of an exemplary system 10. The exemplary system 10 may include a kit 12. The kit 12 may be any of the kits 12 described herein. The kit 12 may be adhered to a skin patch of a patient's skin 14 and establish access to a delivery destination within the patient's body. The kit 12 may include at least one access member 16 that may allow fluid to flow out of each access member 16 from the kit 12 and into the delivery destination. Each access member 16 may be a retention body that extends at least partially into the skin during use of the kit 12. The delivery destination may be a subcutaneous destination, but may be a shallow delivery destination in other embodiments. In the case where the delivery destination is a shallow delivery destination, the at least one access member 16 may deliver the fluid to a portion of the skin between the stratum corneum and the subcutaneous tissue. The shallow delivery destination may include an epidermal or dermal target location, or may be, for example, targeted toward an interface between the epidermis and the dermis or between the dermis and the subcutaneous tissue. The delivery destination may be an intradermal delivery destination. The at least one access member 16 may be any of the access members 16 described herein, and may include at least one delivery tip, such as a microneedle, in some examples. In some examples, the kit 12 may include access members 16 with different characteristics. The system 10 can be delivered to one or more access members 16 independently, or any delivery can be transmitted to all access members 16. Any combination of access members 16 described herein can be used. One or more first access members 16, one or more second access members 16, one or more third access members 16, etc. can be included in a single kit 12. Such access members 16 can, for example, penetrate the patient at different depths. In some examples, the kit 12 may include at least one subcutaneous access member 16 and at least one shallow destination access member 16. Alternatively, the kit 12 may include an access member 16 that extends to different shallow delivery destinations when the kit is in place on the patient.

[0085] In order to deliver certain medical agents, it may be desirable that the kit 12 includes at least one entry member 16 suitable for shallow delivery. Due to the high degree of vascularization in the dermal region, for example, the absorption of the medical agent in the dermal region can occur faster than administering the same medical agent to a subcutaneous destination. This can, for example, allow the injection of a medical agent such as insulin to act faster. Therefore, this shallow delivery can promote stricter control of the analyte level of interest. Shallow delivery can also lead to smaller changes in absorption rates between patients or between different infusion sites on the same patient. In addition, certain medical agents such as insulin can be of different types. For example, insulin types can include rapid, short, intermediate and long-acting insulins, which are different in how quickly they will be used to reduce blood sugar levels and the time they will be used to reduce blood sugar levels. Due to the faster absorption in the intradermal region, it is possible to deliver a type of medical agent with a slower effect, and observe an onset time comparable to the onset time of the faster-acting medical agent administered subcutaneously. Shallow injection can also increase patient compliance and quality of life. For certain patient populations, such as those with juvenile diabetes, this may be particularly true. Administration of a kit 12 having an access member 16 for delivery into a shallow delivery destination may be painless because the access member 16 may be too short to reach nerve endings located deeper in the anatomy. Additionally, patients may better tolerate certain types of access members 16. For example, silicon microneedles may not have the same allergy issues as access members 16 formed from materials including nickel (e.g., stainless steel).

[0086] The kit 12 can be in fluid communication with an infusion set 18. The infusion set 18 can include a controller 20 that can control the operation of a delivery component 24 (e.g., a pumping component, a valve, a sensor that monitors the pumping component or is configured to provide data related to aspects of fluid delivery from the infusion set, etc.) to output a desired volume of fluid from a reservoir 22 associated with the infusion set 18. In some embodiments, multiple controllers 20 can be included, and at least one of the controllers 20 can be disposed external to the infusion set 18. Figure 58 to Figure 63 An example delivery assembly 24 is depicted and described. In certain embodiments, the infusion set 18 may include a reusable component and a disposable component that may be removably coupled to one another. Figure 1In the example shown, the infusion set 18 includes a box assembly 25 that can be attached to the reusable portion of the infusion set 18. The box assembly 25 can include a reservoir 22 and can be replaced when the fluid in the reservoir 22 has been exhausted. The delivery assembly 24 can be separated between the box assembly 25 and the reusable portion. The box assembly 25 can, for example, include a fluid path and a valve that can be activated by a flexible film that overlaps at least a portion of the box 25. The reusable portion can include any of the controller 20, a power source (e.g., a battery), a speaker, a user interface, wireless communication hardware, and various sensors and actuators that manage the distribution of fluid through the box assembly 25.

[0087] The infusion set 18 (e.g., the outlet of the cassette assembly 25) can be fluidly coupled to the kit 12 (e.g., see Fig.43 ). In alternative embodiments, the outlet of the box assembly 25 can be hard plumbed to the kit 12. In an example embodiment, the connector 26 is tethered to the infusion set 18 via the travel of tubing 28, however, in alternative embodiments, the connector 26 described herein can be provided as part of the infusion set 18 (e.g., the box assembly 25), and the intermediate tubing 28 can be omitted. Any suitable connector 26 can be used, and the kit 12 can include a cooperative interface that can engage with the connector 26 in a fluid-tight manner. In certain embodiments, the connector 26 can be a Luer lock fitting that can engage with a Luer fitting included as part of the kit 12. In other embodiments, the connector 26 can be any connector described in any of the references cited herein. In some examples, the connector 26 can be coupled to a coupling 98 (see, e.g., Fig.13 ) is engaged, the connector being attached to the set 12 via the travel of the set tube 96 (see e.g. Fig.13 ). Where a Luer fitting is used, the Luer fitting may be associated with a check valve to prevent fluid flow when disconnected from the kit 12. A cap or cover may be included to cover the connector 26 and / or the coupling when in the disconnected state.

[0088] The infusion device 18 can deliver any desired fluid to the delivery destination via the kit 12. In various examples, the infusion device 18 can deliver at least one medical agent. The supplied medical agent can include drugs that are usually provided as a continuous or substantially continuous infusion, but other drugs can also be used. This can include small molecules, biological, recombinantly produced drugs and their analogs. In various examples, the infusion device 18 can deliver medical agents that affect the cardiovascular system or blood vessels. For example, the infusion device 18 can deliver vasodilators. In some examples, drugs for treating pulmonary hypertension (such as treprostinil) can be delivered. In some examples, the infusion device 18 can deliver peptides, such as regulating hormones. In some examples, the medical agent can be a drug for treating diabetes or a drug for changing blood sugar levels. In some examples, the infusion device 18 can deliver insulin. In some embodiments, the infusion device 18 can deliver glucagon. Chemotherapy drugs can also be delivered via the kit 12. In some embodiments, a variety of medical agents can be delivered by one or more infusion devices 18 of the system 10. For example, any of the above-mentioned medical agents can be delivered. Any medical agent delivered may be delivered with one or more excipients, which may or may not help to increase absorption. Using insulin as an example, nicotinamide may be delivered, for example. Where references to insulin, glucagon, blood sugar, diabetes, etc. are described herein, their use is merely exemplary, and it should be understood that use is contemplated for other medical conditions or with other drugs or other analytes.

[0089] In various embodiments, the system 10 may also include one or more analyte sensors 30. The analyte sensor 30 may generate data related to the level of an analyte of interest in the patient. The analyte sensor 30 may include an amperometric sensor that generates a current proportional to the level of an analyte of interest in the patient. The analyte sensor 30 may include one or more electrode arrangements and may be covered, coated or otherwise associated with an enzyme specific to the analyte of interest to facilitate such sensing. Any chemical known to the desired analyte may be used. In some examples, the enzyme may be an oxidoreductase from the enzyme committee group EC1.1. The enzyme may be classified in the enzyme group EC1.1.3. In some embodiments. In some examples, glucose oxidase may be used, but any suitable sensor chemical for the analyte of interest may be used. Some examples may include an exclusion membrane that blocks, for example, macromolecules, molecules above a specific molecular weight (e.g., if glucose is an analyte of interest), or interfering substances that may separate the enzyme from the rest of the patient's anatomical structure. In addition, certain embodiments may include a membrane that may increase biocompatibility. In some embodiments, the analyte sensor 30 may be a blood glucose monitor. Other analytes may also be monitored. In some examples, analyte sensor 30 may monitor fluid in the subcutaneous space.

[0090] In alternative examples, the analyte sensor 30 can monitor patient fluid at least at a shallow location. The analyte sensor 30 can, for example, monitor fluid in a portion of the skin between the stratum corneum and the subcutaneous tissue. The shallow sensing location can include an epidermal or dermal target location, or can, for example, target toward the interface between the epidermis and dermis or between the dermis and subcutaneous tissue. In some examples, the sensing location can be an intradermal location. The analyte sensor 30 can be, for example, a device described herein with respect to Figure 47 to Figure 49 Any of those described.

[0091] The analyte sensor 30 may include a transmitter 32 or be associated with a transmitter 32. The transmitter 32 may be included in a housing for the analyte sensor 30, or may alternatively be a separate component that may, for example, dock with the sensor 30 and transmit data collected by the analyte sensor 30. The transmitter 32 may be a wireless transmitter, such as a radio frequency based transmitter 32. For example, the transmitter 32 may be a near field communication transmitter 32 or may be a Bluetooth transmitter 32. In some embodiments, multiple types of transmitters (e.g., NFC and Bluetooth) may be included in the transmitter 32. The analyte sensor 30 and / or the transmitter 32 may include a power source (e.g., a button battery), and may include a memory for storing sensor data. The analyte sensor 30 may transmit sensor data via the transmitter 32 when interrogated by another component of the system 10, or may transmit sensor data based on a predefined schedule. For example, the transmitter may transmit sensor data after a preset number of minutes (e.g., 1-5 minutes) has passed since the last transmission. In the case where the transmission is based on a predefined schedule, data may also be transmitted when interrogated by another component of the system 10. The data transmitted may be data from individual sensor readings, or may be data from numerical processing of the analyte sensor 30 (e.g., an average of sensor readings over a period of time). Individual sensor readings may be acquired at a given time, or the readings of each individual sensor over a period of time may be presented from the integrated sensor signal. Any of the analyte sensors 30 described herein may forgo the transmitter 32 and instead have (or establish when data transmission is desired) a wired or other physical connection to another component of the system 10. In embodiments including the transmitter 32, the wired connection may still access data from the sensor 30 if desired.

[0092] In some examples, the transmitter 32 may also transmit an alarm if the data from the analyte sensor 30 warrants alerting a user of the system 10. These alarms may be transmitted by the transmitter 32 independent of any predefined schedule and / or without requiring any interrogation by another component of the system 10. In some embodiments, the sensor data may be transmitted by a first type of transmitter (e.g., NFC) included in the transmitter 32, and the alarm may be transmitted by a second type of transmitter (e.g., Bluetooth) in the transmitter 32.

[0093] The sensor data may be transmitted to the infusion device 18, the first interface 34 of the system 10, the second interface 36 of the system 10 (which may also include the third, fourth, fifth, etc. interfaces in some examples), the database 40 in the cloud 38, or some combination thereof. In addition, the data may be transmitted to one or more of the above components, and the component may then pass the data to other components of the system 10. In some examples, the first interface 34 may be a reader for the analyte sensor 30. In some embodiments, the reader may be a dedicated reader or may be a smart device, such as a smart phone. The second interface 36 may be a smart device. In some examples, the first interface 34 may be a smart phone, and the second interface may be a smart watch, a tablet computer, or a second smart phone (e.g., a smart phone of a parent, guardian, caregiver, etc.). If the received data meets certain predefined criteria, any one of the infusion device 18, the first interface 34, the second interface 36, or the cloud 38 may generate an alarm and transmit the alarm to other components of the system 10.

[0094] The infusion set 18 may receive data (directly or indirectly) from the transmitter 32, and the controller 20 of the infusion set 18 may analyze the data to inform the administration of the medical agent from the infusion set 18. Thus, in some examples, the delivery of the medical agent may be closed-loop. In other examples, the delivery of the medical agent may be open-loop, but the data from the analyte sensor 30 may be used, for example, to inform the controller 20 to generate an alert.

[0095] In the event that the analyte level or analyte level trend is determined to violate a threshold or is outside a predefined range, the controller 20 of the infusion device 18 can start or stop delivering the medical agent. The controller 20 can also adjust the delivery of the medical agent when certain criteria are met. For example, the controller can increase or decrease the infusion rate when data from the analyte sensor 30 indicates that the analyte level changes corresponding to a predefined trend. In some embodiments where the medical agent is used to reduce the analyte level, if the analyte level is decreasing, the delivery rate can be reduced or the delivery can be stopped. If the analyte level is increasing, the delivery rate can be increased by the controller 20. In the case where the medical agent is used to increase the analyte level, the opposite may be true. In certain embodiments, the infusion device 18 can pump fluid to the kit 12 at a basal rate and can occasionally provide a push injection to the patient. Depending on the rate of change of the analyte level, the basal infusion rate can be adjusted by the controller 20, or the controller 20 can coordinate the administration of the push injection (or the basal rate can be adjusted in addition to the administration of the push injection). In the case where multiple medical agents are delivered by one or more infusion devices 18 (e.g., delivered to different kits 12, see, e.g. Figure 2), the type of medical agent delivered can be changed. For example, if a medical agent that reduces analyte levels is being delivered, and the analyte levels are decreasing at greater than a certain rate, delivery can be switched to a medical agent for increasing analyte levels (or vice versa).

[0096] Reference now Figure 2 In some embodiments, the system 10 may include a first set 12 and a second set 42 of sets. Each of the sets 12, 42 may be in fluid communication with the infusion set 18 (e.g., via tubing 28 or direct connection). Alternatively, each set 12, 42 may be connected to a separate infusion set 18 ( Figure 2 Only one is shown in the figure). In the example shown, each of the kits 12, 42 can be docked with the first connector 26 and the second connector 44, respectively. Each of the kits 12, 42 can be identical to each other, but can be different in some examples. Similarly, each of the connectors 26, 44 can be identical, but they can be different in alternative embodiments. In some embodiments, the infusion device 18 can supply different medical agents to each kit 12, 42, and can include a reservoir 22 containing a fluid isolation of the medical agent (but in some cases, the same medical agent can be supplied to both). In the case of using a single infusion device 18, the infusion device 18 can have a separate reservoir 22 for each medical agent, and can include multiple delivery components 24. In some examples, the kits 12, 42 can have different delivery destinations. For example, one kit 12, 42 can be delivered to a shallow destination, while another can be delivered to a subcutaneous destination. In embodiments where different medical agents are delivered to a patient via the kits 12, 42, the medical agents may affect each other in a relevant manner. For example, each medical agent can change the same analyte. One of the medical agents may be a hormone and the other medical agent may also be a hormone that counteracts the effects of the first hormone. Using the non-limiting example of a system 10 for treating diabetes, one medical agent may be insulin and the other medical agent may be glucagon. Other kits may be included in other examples. Additionally, any suitable number of medical agent reservoirs 22 may be included in any suitable number of infusion devices 18.

[0097] In an alternative embodiment, each of the kits 12, 42 can be combined into a single assembly having flow paths and access members 16 associated with each respective connector interface for connectors 26, 44. Each set of flow paths and access members 16 can be fluidly isolated from other sets of flow paths and access members 16 within the single assembly. Thus, one medical agent can be delivered to the kit 12 via the coupling of the first connector 26, and a second connector 44 can be delivered to the kit 12 via the coupling of the second connector 44. The medical agents will remain out of fluid communication with each other in the delivery assembly.

[0098] Reference now Figure 3 In some examples, the system 10 may not include a separate kit 14 and analyte sensor 30. Some examples may include an entry assembly 46, which may include one or more entry members 16 (e.g., an array of microneedles) for delivering the medical agent to a delivery destination and at least one analyte sensor 30. The entry member 16 and the retention portion 31 of the analyte sensor 30 may be spaced at least a certain distance from each other. In some examples, they may be 5-15 mm apart (e.g., 7-11 or more millimeters apart).

[0099] In some examples, the retention portion 31 of the analyte sensor can be a microneedle. In certain embodiments, the retention portion 31 can be a microneedle without a flow lumen 68 or a hole. This retention portion 31 can be called a micropenetrator. The micropenetrator can be made of etched silicon, and can serve as an electrode of the analyte sensor 30 in some embodiments. The silicon used can be doped to optimize the conductivity of the micropenetrator used as an electrode. In other embodiments, the micropenetrator can be at least partially coated with an insulating material, and one or more conductive electrodes can be included on the surface of the insulating material. In alternative embodiments, known analyte sensor arrangement devices can also be incorporated into the kit 14.

[0100] The access assembly 46 can be connected to the connector 26 (see, e.g., Fig.43 ) is in fluid communication with the infusion set 18. In some examples, multiple medical agents can be delivered via the access assembly 46, and multiple connectors 26, 44 can be coupled to the access assembly 46. In such examples, the fluid delivery portion of the access assembly 46 can be as described above with respect to Figure 2 Arranged as described.

[0101] The transmitter 32 may also be included in the access assembly 46. Alternatively, the transmitter 32 may interface with the access assembly 46 and transmit data received from any analyte sensor 30. The system 10 including the access assembly 46 may also include one or more separate analyte sensors 30 or kits 12, 42 that are distinct from the access assembly 46. In other embodiments, the data from the sensor 30 may be transmitted via a wired connection. For example, the connector 26 may include contacts and be associated with wires leading to the infusion set 18. Example embodiments of the access assembly 46 with respect to Figure 50 to Figure 54 Show and describe.

[0102] Reference now Figure 4A and Figure 4B, depicting an embodiment of an exemplary kit 12. The exemplary kit 12 can be a low profile kit 12 that can be applied to the patient's skin. The exemplary kit 12 can be sized to be easily applied to a variety of injection sites on the patient's body and can be easily concealed under clothing. In addition, the exemplary kit 12 can be designed for simple manual application. Therefore, an inserter assembly for placing the kit 12 at the infusion site and facilitating the introduction of any access member 16 of the kit 12 into the patient's body may not be required.

[0103] Such a kit 12 can be used to distribute a medical agent to a target delivery destination of a patient via one or more access members 16. In an exemplary embodiment, a plurality of access members 16 are included in the kit 12, but other embodiments may include only a single access member 16. The exemplary plurality of access members 16 can be arranged in a one-dimensional or two-dimensional array and can extend from a body 50 to which a connector 26 in communication with an infusion set 18 can be coupled. Where a plurality of access members 16 are included, the access members 16 can be arranged in one or more rows and / or columns. Although in the exemplary embodiment, the plurality of access members 16 can be arranged in a one-dimensional or two-dimensional array, the plurality of access members 16 can be arranged in a one-dimensional or two-dimensional array and can extend from a body 50 to which a connector 26 in communication with an infusion set 18 can be coupled. Figure 4A , three access members 16 are depicted arranged in a single row, but in alternative embodiments, the number and arrangement of access members 16 may differ. Any suitable number of rows and / or columns may be included in various examples. In various embodiments, there may be, for example, a single row array of access members 16 including up to five access members 16. Preferably, the access members 16 may be arranged to prevent a nail bed type situation where penetration of the skin via the access members 16 may be inhibited or inconsistent across a user or the kit 12. This may occur when too many access members 16 are arranged in close proximity to one another. Thus, the array may be referred to as an array of spaced-apart access members 16. Each access member 16 may have the same height, or at least one access member 16 may have a different height than at least one other access member 16 of the kit 12. In FIG. 4A to FIG. 4B In the exemplary embodiment shown, access member 16 is depicted as a delivery tip. FIG. 4A to FIG. 4B The delivery tips shown in are microneedles. Such microneedles may be present in a delivery device 10 having a shallow (e.g., subcutaneous tissue) target delivery destination. In some examples, there may be microneedles that extend slightly into the subcutaneous tissue.

[0104] Now also refer to Figure 5In the case of using microneedles, in some embodiments, the microneedles described herein can be MEMS-produced, polyhedral (e.g., pyramidal), silicon crystal microneedles. The height of these microneedles can be no greater than 1 mm, such as 0.6 mm or 0.8 mm (although longer or shorter microneedles can also be used). In some embodiments, the height of the microneedles can be 1200-1500 microns or may be longer in some examples. In some embodiments, the height of the microneedles can be sufficient to puncture at least some distance into the subcutaneous tissue. At least some edges of the microneedles can be rounded or filleted, but such microneedles can still be referred to as polyhedral herein. In some examples and as Figure 5 As shown, the microneedles described herein may generally be in the shape of a heptagonal prism (but pentagonal, pentagonal and other polygonal prisms may also be used as the base shape), which has been diagonally divided to form a heptagonal slope or a pointed wedge. In such an embodiment, the heptagonal prism may be divided by a plane extending from the vertex 58 of the top surface of the prism through the farthest side 60 of the base 62. At least two sides of the base of the microneedle may be parallel. The sidewall 64 may extend substantially vertically from the base 62. The microneedle may be substantially symmetrical about a line of symmetry extending from the vertex 58 to a point above the center of the farthest side 60. In other embodiments, the microneedle may be conical. Any other suitable shape may be used. In this example, the vertex 58 is shown as a point forming the tip of the microneedle. In other embodiments, this portion of the microneedle may be rounded (but may still be referred to as the vertex 58 herein, and such microneedles may still be referred to as pointed). In such an embodiment, the back edge 66 may be a rounded face, or the back edge 66 and the adjacent sidewall 64 may be replaced by a rounded face.

[0105] The sharp point or tip of the microneedle described herein can be solid, and the flow lumen 68 through the microneedle can be offset from the sharp point or tip of the microneedle (at Figure 5 , apex 58 forms a pointed end). Hollow tip microneedles in which the flow lumen 68 extends to the tip of the microneedle may also be utilized. In some embodiments, the microneedle may be a NanoPass hollow microneedle available from NanoPass Technologies Ltd. of 3 Golda Mir, Nes Ziona, Israel. It should be noted that a microneedle described herein as being comprised of silicon (or a substrate on which it is disposed) may have a silicon dioxide surface layer (which may, for example, be formed to be exposed to air) while still being considered to be comprised of silicon.

[0106] refer to 6A to 7BIn some embodiments, the microneedles may be configured to include certain features that may help reduce the pressure required to inject a fluid, such as a medical agent, into the patient's skin. In some instances, features specific to insect stingers or biological venom administration structures may be incorporated. These features may include various recesses or depressions formed as part of each microneedle or at least one microneedle of the kit 12. These recesses or depressions may be in fluid communication with the flow lumen 68 of the corresponding microneedle. In some embodiments, different microneedles of the kit 12 may include different recesses, or some microneedles may include multiple recesses that may be of different types (but this is not required).

[0107] For example, 6A to 7B As shown in , the microneedle may include a channel or groove 70 on an outer inclined surface 72 leading from the flow lumen 68 to the distal side 60. The channel 70 may allow the medical agent to flow through it along the outside of the microneedle to find the path of least resistance or the weakest link to enter the skin. In the illustrated embodiment, the medical agent may be guided by the channel 70 to flow along the outside of the microneedle to the weak area in the skin when the outlet of the flow lumen 68 has been inserted to a depth greater than the depth of the weak area. The lamina lucida junction - as an intradermal delivery destination, it is a weak link in the skin structure and is difficult to be directly injected consistently due to its relatively thinness (usually about 40nm thick). A microneedle including a channel 70 may allow the medical agent to flow to the lamina lucida junction, for example, when the lamina lucida junction has been passed through the outlet of the flow lumen 68. The channel 70 may promote the distribution of the medical agent through a larger entry or injection area. In some examples, incorporating the channel 70 into the microneedle may greatly reduce the pressure required to inject the medical agent into the skin. In some examples, the pressure may be reduced by more than 600% (eg, from 120 pounds per square inch (psi) to from 18 to 20 psi in some examples).

[0108] Appropriate silicon etching techniques (or molds in embodiments using polymeric microneedles) can be used to create steeper sidewalls of channel 70. This can help inhibit skin bending from entering and occluding channel 70. As a non-limiting example, etching techniques that can be used include chemical etching techniques (e.g., acid). Suitable etching techniques may include ion-based etching techniques (e.g., reactive ion etching). The etching process may be a wet etching process or a dry etching process. In some non-limiting embodiments, channel 70 may be in the range of 50-60 microns wide from side to side. In some non-limiting embodiments, flow lumen 68 may have a diameter of 50-60 microns. Channel 70 may have a width equal to the diameter or widest part of flow lumen 68, or channel 70 may have a width less than or greater than the width of flow lumen 68. In some examples, the width of channel 70 may be about 5-10% of the height of the microneedle.

[0109] To avoid leakage of fluid from the channel 70, it may be desirable to ensure that the channel 70 terminates at least a certain distance below the skin surface but also reaches the target skin layer (e.g., the stratum lucidum junction) when the microneedle is inserted into the skin. In some embodiments, the channel 70 extends from the flow lumen 68 to within at most 50 microns (e.g., 50-70 microns) of the base 62 of the microneedle. In some embodiments, the end of the channel 70 closest to the base 62 of the microneedle can be at least below the stratum corneum (and perhaps one or more of the stratum lucidum, stratum granulosum, stratum spinosum, and stratum basale) when the microneedle is inserted into the skin. In some embodiments, the end of the channel 70 closest to the base 62 can be disposed below the epidermis (e.g., in the basement membrane zone) or within the epidermis.

[0110] The passage 70 need not be straight or FIG. 4A to FIG. 4B In some embodiments, the channel 70 can be a more serpentine channel 70. For example, a curved channel 70 can be used as long as the size of the microneedle is accommodated. Moreover, there need not be only one channel 70. More than one channel can be used as long as the structural integrity of the microneedle is accommodated.

[0111] In some examples, the depth of channel 70 may be about 25 microns or more (e.g., 25-50 microns). The depth of channel 70 may be less than 5% of the height of the microneedle. Although the depth of channel 70 may be constant along the length of channel 70, the depth of channel 70 need not be constant along the length of channel 70. Likewise, the width of channel 70 need not be constant along the length of channel 70 (see, e.g., Figure 5 B). The width of the channel 70, at the narrowest point in the channel 70, can be about 20-30% of the width of the distal side 60 of the microneedle. In some embodiments, the width of the channel 70 can increase as the distance to the distal side 60 decreases. In some embodiments, at its widest point, the width of the channel 70 can be more than 50% of the width of the distal side 60.

[0112] Now also refer to Fig. 8A and Figure 8B In other examples, the channel 70 can extend from the location of the lumen 68 toward the tip or apex 58 of the microneedle (see, e.g., Figure 8B ). Moreover, in some examples, channel 70 can extend from the location of lumen 68 both toward apex 58 and toward base 62. That is, channel 70 can include a portion on both sides of lumen 68 (see, e.g., Fig. 8A). As shown, the lumen 68 can be substantially centered on the beveled face 72 of the microneedle. In such an embodiment, the channel 70 can extend toward the distal side 60 of the base 62 and the channel 70 can extend toward the tip or apex 58. In other embodiments, the lumen 68 can be positioned at (or near) the end of the channel 70 closest to the base 62.

[0113] Reference now FIG. 9A to FIG. 9B , which shows a view of a tip carrier 74 including a plurality of microneedles. In some embodiments, the channel 70 may not be included. Instead, the microneedle may include a flow lumen 68 having an elongated cross-section (at least at the outlet, see also Fig. 10B and Fig. 11B ). Microneedles having a channel 70 and an elongated lumen 68 are also possible. When in place in a patient, the elongated lumen 68 can be in fluid communication with multiple layers of, for example, the skin. Thus, thin and / or weak layers of skin may be more easily targeted as the microneedle is advanced into the patient. The elongated lumen 68 can also help reduce the pressure required for injection. Such an elongated flow lumen 68 can have any suitable cross-section. In some embodiments, the cross-section can be oval or elliptical. Alternatively, a lumen 68 having an oblong cross-section, such as FIG. 9A to FIG. 9B . Polygonal cross-sectional shapes may also be used, such as, but not limited to, rectangles, trapezoids, triangles, and the like. In some examples, the length of the cross section of the lumen 68 (in the direction of elongation) may be up to 100-70 microns or more (but may be smaller in some examples). In the case of including an elongated lumen 68, the end of the lumen 68 closest to the distal side 60 may be spaced apart from the distal side 60 by at least a certain distance. The spacing may be such that the end of the lumen 68 closest to the distal side 60 may be at least below the stratum corneum (and perhaps one or more of the stratum lucidum, stratum granulosum, stratum spinosum, and stratum basale) when the microneedle is inserted into the skin. In some embodiments, it may be disposed below the epidermis (e.g., in the basement membrane zone) or within the epidermis.

[0114] Still refer to FIG. 9A to FIG. 9B In some embodiments, the inclined surface 72 of the microneedle may not extend to the base 62 of the microneedle. There may be, for example, a vertical end surface 76 extending from the base 62 to the distal side 60 of the microneedle. Where a vertical end surface 76 is included, the vertical end surface 76 may be aligned with a side of the tip carrier 74 (e.g., the distal side 60) and may form an extension thereof. Including such a vertical end surface 76 may help reduce the size of the tip carrier 74 and may help ensure consistent fluid delivery into certain target destinations of the microneedles. Although with respect to FIG. 9A to FIG. 9B Not shown, but any of the microneedles shown herein may be arranged with a vertical end face 76 .

[0115] Additionally or alternatively, the microneedle may include a depression 78. The microneedle 202 may include a first opposing vertex 80 and a second opposing vertex 82. In some embodiments, the depression 78 may be (but not necessarily be) a rounded depression or a concave depression, such as FIG. 6A to FIG. 6B As shown in . The recess 78 may have a maximum depth that places the recess 78 in fluid communication with the flow lumen 68 of the microneedle. The recess 78 may thus form a side port for the microneedle, through which the fluid may be delivered to the patient. The side port may be the only outlet of the microneedle, or an outlet in addition to the outlet of the lumen in the inclined surface 72 of the microneedle. When the microneedle is inserted into the skin surface, the fluid transmitted through the kit 12 may be delivered to the patient at least in part by being pumped into the recess 78. The recess 78 may be formed, for example, by cutting away material during manufacture of the microneedle, or the recess 78 may be formed during a molding operation. The cutting away of material may be accomplished by any known suitable process such as, for example, etching (e.g., wet etching). In some embodiments, the recess 78 may be recessed in at least one side wall 64 or edge (e.g., where two side walls 64 join) of the microneedle. In FIG. 6A to FIG. 6B In the example shown in , a depression 78 is formed in the substantially vertical back edge 66 of the microneedle 23, which extends from the base 62 to the apex 58. This can establish or increase the vertical void volume created by the microneedle when the skin is penetrated by the microneedle. That is, such a depression 78 can establish an open space in the patient's body into which fluid can be easily delivered from the microneedle. Positioning the depression 78 in the back edge 66 can provide a low-resistance path for fluid to enter the skin that the microneedle has penetrated. In embodiments in which the microneedle includes at least one substantially vertical wall, the depression 78 can be recessed into a substantially vertical wall. In an example embodiment, the maximum depth of the depression 78 can be approximately 130% to 110% of the distance from the back edge 66 to the flow lumen 68.

[0116] In certain embodiments, and now with reference to Fig. 10A and Fig. 10B , the microneedle can include an inclined surface 72 extending through the lumen 68 of the microneedle and into which it extends. The microneedle can also include a rounded blade edge 84. In this example, the rounded blade edge 84 extends from a point 86 opposite the distal end 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, but other bevel types can be used. The rounded blade edge 84 can be arcuate with a constant radius or a variable radius. The rounded blade edge 84 can have an arc measurement less than 90° or, in some examples, greater than 90° (see, for example, FIG. 11A to FIG. 11C ). The rounded blade edge 84 can help introduce the microneedles into the skin when the microneedles are inserted at certain angles or at a variety of different angles.

[0117] In yet another embodiment, and referring now to FIG. 11A to FIG. 11C , the microneedle may include a rounded blade edge 84 and a lumen outlet end face 88. The lumen 68 may extend through the microneedle to the lumen outlet end face 88 and may not be formed in a straight line through the microneedle. The lumen outlet end face 88 may be angled from the apex 58 toward the distal side 60 to form an undercut. The distal edge 60 may be arranged so that a plane perpendicular to the base 62 passing through the distal edge 60 may also pass through the rounded or curved blade edge 84. In addition, the outlet of the flow lumen 68 in the lumen outlet end face 88 may be arranged so that a plane or all planes perpendicular to the base 62 and passing through the outlet of the flow lumen 68 may also pass through the blade edge 84. This need not be the case in all embodiments (see, for example, FIG. 10A to FIG. 10B ).along with FIG. 11A to FIG. 11C The microneedles of the variety shown in are inserted, possibly creating vertical void spaces due to undercutting. This can provide a low resistance path for fluid injection. Additionally, undercutting can help mitigate the possibility that lumen 68 becomes blocked by the skin as the microneedles are inserted into the patient or as delivery occurs.

[0118] In yet other embodiments and now referring to FIG. 12A to FIG. 12D , the access member 16 can be or include a microneedle having a high aspect ratio shape. In some embodiments, the microneedle can be obelisk-shaped. Such microneedles can be included in an array such as any array described herein. In the case of using obelisk-shaped microneedles, the microneedle can include a base 62'. The base 62' can be any desired circular or polygonal shape. For example, FIG. 12A to FIG. 12D A base 62' is depicted, which is a quadrilateral or diamond shape. The example microneedle includes a set of sidewalls 64' extending from the base 62' to an end region 90 of the microneedle. The sidewalls 64' can be set at an angle that is not perpendicular to the base 62'. Therefore, the microneedle can taper as the distance from the base 62' increases so as to have a smaller cross-sectional area. The portion of the microneedle farthest from the base 62' can include a beveled tip 92. Such a tip 92 can facilitate puncture of the skin and can help increase the robustness of the end region 90. Any suitable bevel can be used, such as a single bevel or a double bevel.

[0119] In the microneedle embodiment in which the microneedle is obelisk-shaped, the microneedle may include at least one side port 94, which may be used as the outlet of the microneedle. Such a side port 94 may be difficult to be blocked by tissue that may become compressed during the insertion of the microneedle into the patient's body. In an exemplary embodiment, the inner cavity 68 may extend through the base 62' of the microneedle and have a terminal end that is closer to the end region 90 than the base 62'. The cross-section of the inner cavity 68 may be relatively constant. The taper of the side wall 64' may make the terminal end of the inner cavity 68 wider than the portion of the cross-section of the corresponding area of ​​the microneedle. Therefore, the inner cavity 68 may form an opening in the side wall 64', which may be used as a side port 94. In various examples, the inner cavity 68 may be centrally disposed, thereby producing a symmetrical side port 94. In an alternative embodiment, the inner cavity 68 does not have to be centrally disposed and the side port 94 may be asymmetric.

[0120] The microneedles and their features may be manufactured by one or more of a molding process, an etching process, an ablation process (e.g., laser ablation), or an additive process (e.g., 3D printing), but are not limited thereto. In various embodiments, it may be desirable for the microneedles to be constructed of a biocompatible, non-ductile, high Young's modulus material with an indentation hardness sufficient to allow penetration into the skin without rupture.

[0121] The kit 12 including microneedles (such as any of those described herein) can be painless or almost painless, and it is applied to the patient. This can make users prefer such kits rather than other types of infusion kits. This is especially true for certain patient populations (e.g., patients with juvenile diabetes). In addition, such a kit 12 may be less complicated to apply. When removed from the package, the kit 12 including microneedles can be ready or substantially ready (e.g., the adhesive backing may need to be removed) for application. Therefore, an inserter for assisting in puncturing the skin and placing the infusion kit may not be required. The kit 12 including microneedles can promote easy site changes without requiring the user to carry additional, relatively bulky components, such as inserters. In addition, since the inserter (which can generally be a disposable item for single use) can be omitted, the patient's financial burden associated with frequent site changes can be reduced. This can help increase the patient's compliance with a prescribed site change schedule, or can allow site changes to be performed more frequently (e.g., every day).

[0122] Reference again FIG. 4A to FIG. 4B , the example kit 12 may include a body 52. ​​The body 52 may be a deformable body that may be deformed from a storage state (see Figure 4A ) to the delivery state (see Figure 4B). In some examples, this conversion can be reversible, although in other embodiments, the conversion may result in permanent changes to the body 52 and / or another portion of the kit 12. For example, once converted to the delivery state, at least a portion of the body 52 may be plastically deformed so that it is permanently deformed and may not return to the storage state. It may be necessary to destroy a portion of the body 52 or a portion of the kit 12 that is attached to the body 52 to remove the kit 12 from the patient, thereby rendering the kit 12 inoperative. In the event that a permanent change is produced when converting to the delivery state, such a permanent change can inhibit reuse and provide a user-perceivable (e.g., visual) indication that the kit 12 has been used. An indication that the conversion has occurred can also be generated by the kit 12. For example, an audible or tactile indication can be generated when transitioning from the storage state to the delivery state.

[0123] In various examples, the conversion of the kit 12 from the storage state to the delivery state can be completed via bending, pivoting or deformation of one or more regions of the body 52. ​​In some embodiments, the body 20 can be or include a bistable element, which can have a first stable state corresponding to the storage state and a second stable state corresponding to the delivery state. The body 52 can, for example, be substantially or partially reversed in shape (e.g., convex to concave), or have one or more reversible regions that at least partially reverse when the kit 12 is converted from the storage state to the delivery state. The conversion may be achieved via a force applied during the entire conversion. Alternatively, the conversion may only require the application of force on a portion of the entire conversion. For example, in some embodiments, a trigger force may be applied to initiate the conversion, and the conversion may be completed subsequently without any external application of force. For example, after the application of the trigger force, the conversion may be characterized by a sudden spring-like flexion, via which the body 52 is quickly converted to the delivery state.

[0124] The body 52 can be at least partially covered with an adhesive 54 on a first face 56 of the body 52. ​​The adhesive 54 can be used to connect the body 52 to the skin surface at the infusion site on the patient. Therefore, the first face 56 can be a skin adjacent end face or a proximal (proximal or distal) face of the body 52. ​​The body 52 can be attached to the skin when the body 52 is in a storage state, and then can be converted to a delivery state. As the conversion occurs, at least two adhesive bearing portions of the body 52 can be displaced relative to each other so as to stretch or expand the surface anchored to the body 52 via the adhesive 54. Since these parts can be attached to the skin surface, the skin can be stretched as the adhesive bearing portions are displaced relative to each other. This may be desirable because as the body 52 is converted to the delivery state, the skin can be tightened to facilitate piercing the skin through the entry member 16. In some examples, the adhesive 54 bearing portions can be, for example, arranged relative to each other. The displacement of the two adhesive 54 bearing portions can increase the distance between the two adhesive 54 bearing portions or expand them. In other embodiments, the distance between the two adhesive 54 bearing portions may not increase or may even decrease while still causing stretching of the skin surface. For example, if the transition causes a flat piece of skin to be pulled around a curve or contour of the body 52 (see, e.g., Figure 18 to Figure 19 ), this occurs. Displacement of adhesive 54 bearing portions relative to one another that causes the attached skin to stretch (regardless of any positive or negative change in the distance between adhesive 54 bearing portions) can be referred to as extended displacement. Two adhesive 54 bearing portions that have been so displaced can be referred to as being extendedly displaced.

[0125] The transition of the body 52 to the delivery state may also result in the proximal displacement or lowering of any access member 16 toward and into the skin. In the embodiments described herein, the access member 16 may be covered prior to use.

[0126] Reference now Figures 13 to 15 , depicting an exemplary kit 12. The exemplary kit 12 is Figures 13 to 15 1 and 1 . As shown, the kit 12 can include a body 52 and a body 50 to which the access member 16 can be coupled. The access member 16 can be included on a tip carrier 74 that can be coupled to the body 50. A conduit 96 (e.g., a microbore tube) can also be coupled to the body 50, and a flow path in communication with the access member 16 can be included in the body 50. The conduit 96 can be connected to the flow path through a portion of the body 52. ​​The conduit 96 can include a coupling 98, a connector 26 (e.g., a Luer connector, see e.g., Figure 1 ,or Fig.43The connector 26 shown may be coupled to the coupling 98. The coupling 98 may be associated with a check valve to inhibit the flow of fluid from the infusion set 18 when not connected to a fluid supply (eg, the connector 26).

[0127] The body 52 of the kit 12 can have a circular (e.g., a circle) footprint and can include a central region 100 and a peripheral region 102. The central region 100 can be a raised area of ​​the body 52 and the peripheral region 102 can be a substantially flat area of ​​the body 52 surrounding the central region 100. The thickness of the body 52 can be substantially uniform throughout the body 52. ​​The body 52 can be formed as a thin sheet or disk of material that can be thermoformed to produce the raised central region 100 and the flat peripheral region 102.

[0128] Alternatively, the body 52 may be injection molded and the raised central region 100 and the flat peripheral region 102 may be formed in a molding operation. In various embodiments in which the kit 12 is or may be injection molded, the body 52 may be injection molded so as to be in a storage state or in a delivery state. The body 52 may be more easily converted from the opposite state to its molded state. Therefore, in order to reduce the effort required to convert the kit 12 from the storage state to the delivery state, it may be desirable to mold the body 52 of the kit 12 in its delivery state configuration. During assembly of the kit 12, the body 52 may be brought into its storage state configuration and maintained in that configuration until use.

[0129] The central region 100 can be domed and the dome shape can establish a receptacle 104 on the proximal side of the body 52, and the body 50 can be disposed in the receptacle 104. The body 50 can be coupled to the receptacle 104 via an adhesive or in another suitable manner. The central region 100 can also include a series of fenestrations 106 that can form a fenestration ring in the central region 100. In this example, the fenestrations 106 are evenly spaced from each other and arranged in a circle that is generally coaxial with the center of the central region 100. In alternative embodiments, the fenestrations 106 can be irregularly spaced or omitted. Additionally, in some embodiments, the fenestrations 106 can be replaced with a thinned region or a ring of thinned material of the body 100 instead.

[0130] The body 52 may include a plurality of slots 108. The slots 108 may extend from a peripheral edge 110 of the body 52 toward a center or midpoint of the body 52. ​​In an exemplary embodiment, the slots 108 extend in a radial direction. The slots 108 may extend through the entire peripheral region 102. In some embodiments, and as shown, the slots 108 may also extend through at least a portion of the central region 100. The fenestrations 106 in the central region 100 may be disposed radially inwardly relative to the endpoints 112 of each of the slots 108. The body 52 may thus include a central region 100 surrounded by a plurality of petal-shaped members 114 that are spaced apart via the slots 108.

[0131] Reference now Fig.16 , which depicts a plan view of the proximal side 56 of the example body 54. As shown, the adhesive 54 may be included on at least a portion of the proximal side 56. The adhesive 54 may be a skin-compatible adhesive and may be used to couple the kit 14 to the surface of the skin 14 at the infusion site. In an example embodiment, the adhesive 54 may be included on the peripheral region 102 of the body 52. ​​Although the adhesive 54 is shown to cover the entire surface of each of the petal members 114 in the peripheral region 102, other embodiments may be different. For example, only some of the petal members 114 may include the adhesive 54. In such an embodiment, the adhesive 54 may be included on at least one pair of oppositely disposed (e.g., diagonally opposite in the example embodiment) petal members 114. In some examples, only a portion (e.g., a majority of the surface area) of each petal member 114 included in the peripheral region 102 may be covered with the adhesive 54. Alternatively or in addition, the adhesive 54 may be different from the petal member 114 to the petal member 114. Certain petal members 114 may be covered with a more tackier adhesive 54, while other petal members 114 may be covered with a less tackier adhesive. Additional adhesive members 54 are described elsewhere herein (see, e.g., Figure 55 to Figure 57 ), and can be used on Kit 12.

[0132] Reference now Fig.17, which depicts a conceptual representation of the body 52 of the kit 12 in a delivery state. In the delivery state, at least the central region 100 of the body 52 can be substantially inverted. The fenestration 106 can facilitate such inversion by helping to allow increased deflection of the body 52 at the fenestration 106. Thus, instead of a convex dome-like shape, the central region 100 of the body 52 can be concave in shape. Because the peripheral region 102 is coupled to the central region 100, the peripheral region 102 can be displaced as a result of the inversion of the central region 100. In an example embodiment, the entire body 52 is bowl-shaped when converted to the delivery state. The peripheral region 102 can also be displaced expansively for at least a portion of the conversion. The narrow grooves 108 in the body 52 can help promote the expansive displacement of the petal-shaped members 114 as the conversion occurs, thereby enhancing the stretching of the user's skin.

[0133] The body 52 may be a bistable element or include at least one bistable region that may be stable in both the storage state and the delivery state. When an axial load is applied to the central region 100 and the body 52 is in the storage state, the body 52 may deform into an unstable state. The body 52 may then exhibit a snap-action flexion action that quickly converts the body 52 into a stable delivery state, similar to the delivery state of the embodiment of the present invention. Fig.17 Thus, only a trigger force may be applied to initiate the transition. The remainder of the displacement between the storage state and the delivery state may be caused by the phenomenon of snap-action.

[0134] Fig.18 The exemplary kit 12 is depicted in a stored state and attached to the skin 14 via the adhesive 54 on the proximal side 56 of the body 52 . Fig.19 is a conceptual representation depicting an example kit 12 in a delivery state. As shown, the kit 12 can be applied to the skin 14 in the storage state. The delivery device can then be transformed into the delivery state. The expansion displacement of the opposed petal members 44 of the body 52 can occur as the transformation occurs.

[0135] exist Fig.18 and Fig.19 1 and 116B are shown disposed at the peripheral edge 110 of the proximal surface 56. Fig.18), the shortest distance between opposing points 116A, 116B is a straight line that does not pass through proximal surface 56. This straight line is roughly parallel to the surface of skin 14. However, in the delivery state, the shortest distance between opposing points 116A, 116B is a straight line that passes through proximal surface 56. Since skin 14 is fixed to body 52 via adhesive 54 and cannot pass through body 52, skin 14 can be forced to conform to the curvature of proximal surface 56. Therefore, the length of the surface of skin 14 between two points 116A, 116B when kit 12 is in the delivery state can be greater than the length of the surface of skin 14 between points 116A, 116B when kit 12 is in the storage state. Skin 14 can be placed under tension and stretched to accommodate this change in length. This stretching can in turn help promote puncture of skin 14 by access member 16.

[0136] Due to the elasticity of skin 14, skin 14 can exert a restoring force on proximal surface 56 of body 52 as it attempts to return to an unstretched state. Body 52 can resist this restoring force and maintain its bowl shape. However, body 50 can be compressed between skin 14 and body 52. ​​This can help ensure that access member 16 pierces skin 14 and establishes fluid communication with the intended delivery destination in the patient's body.

[0137] As described above, in some examples, some petal members 114 may not include an adhesive 54 area or may have a proximal surface 56 that is at least partially covered with an adhesive 54 having a lower tack than the adhesive 54 on other petal members 114. In some embodiments where the petal members 114 do not have an adhesive 54, this may help limit the stretching of the skin 14. Similarly, petal members 114 with adhesive 52 having a lower tack may release the skin piece of skin 14 to which they are attached when the force required to stretch the skin 14 exceeds a threshold. The petal members 114 themselves may also be constructed so that at least one of the petal members 114 includes a pressure relief area (e.g., a thin or narrow area). For example, if the force required to stretch the skin 14 is above a threshold, one of the petal members 114 may bend or flex at the pressure relief area to relieve some of the tension on the skin 14.

[0138] This may be desirable because it may help alleviate potential discomfort caused by over-tensioning of the skin 14 during wear of the kit 12. Additionally, this may be helpful for certain patient populations because skin characteristics vary significantly with age, hydration status, lifestyle (sun exposure, nutrition), etc. It may be desirable that relaxed or loose skin be stretched to a greater degree than highly elastic skin. Thus, instead of providing multiple kits 12 with different adhesives 54 targeted to specific patient populations, the kit 12 may be made in a more universal manner.

[0139] refer to Fig. 20 and Fig.21 In another embodiment, the example kit 12 may include a central region 100 having a top surface 118 and a support structure 252 integral with the top surface 118. The support structure 120 may have a circular, for example, substantially circular base 262. The peripheral region 102 may be generally annular in shape and may include an inner perimeter coinciding with the base 262 and an outer perimeter or peripheral edge 110. The kit 12 may be formed by injection molding. The top surface 118 may have a circular footprint, for example, a generally circular shape, and may be convex, thereby forming a dome shape. The top surface 118 may have a periphery 124. The top surface 118 may include a slot 126. The slot 126 may be a cutout, an orifice, a hole, an opening, or a void in various embodiments. The slot 126 may assist the kit 12 in transitioning from a storage state to a delivery state with reduced pressure from above. The slots 126 may extend radially about the center point 128 of the top surface 118 such that their respective first endpoints 130 surround an area including the center point 128 of the top surface 118, and their respective second endpoints 132 may each terminate a distance from the periphery 124 of the top surface 118 (e.g., the slots 126 may each terminate at the same distance). In embodiments including the slots 126, the slots 126 may be arranged at regular angular increments (but need not be). In embodiments described herein including the slots 126, the slots 126 may (but need not be) each be the same length.

[0140] Reference now FIG. 22A to FIG. 22I , which depicts a variety of different body 52 embodiments. The exemplary body 52 is shown in a flat state and can be thermoformed into a shape such as, for example Fig. 20 Although a thermoformable body 52 is depicted, the features described with respect to a thermoformable body 52 may be included in a body 52 manufactured in any desired manner. FIG. 22A to FIG. 22I As shown in , the slot 126 can be provided in several different styles. In addition, in some embodiments, the slot 126 may not be included.

[0141] In some embodiments, and also as Fig.23, the slots 126 may be arranged so that they do not extend radially about the center point 128. For example, the slots 126 may each extend at a common angle about the radial direction. In such an embodiment, the slots 126 may be evenly spaced around 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 with the radial direction. At least one (and possibly all) of the slots 126 may be arranged at an angle different from the radial direction. In some embodiments, the slots 126 may be relatively short, positioned around the periphery 124 of the top surface 118, and may be arranged in an outer region of the top surface 118 (see, for example, Fig.22A In other embodiments, the slot 126 may extend across the outer region and the middle region of the top surface 118 (see, e.g., Fig. 22B In yet other embodiments, the slot 126 may extend from an outer region of the top surface and into a central region of the top surface 118 (see, e.g., Fig. 22C ). The angled slots 126 can help reduce the amount of pressure required to convert the kit 12 from the storage state to the delivery state. Positioning the slots 126 at a more acute angle with respect to the radial direction can generally reduce such pressure. The width of the slots 126 can be slightly reduced during at least a portion of the conversion from the storage state to the delivery state.

[0142] In other embodiments, and mainly with reference to Fig.22E , at least one of the slots 126 may have a curvature. The curvature may be defined by a constant or variable radius. The curvature may only exist on a segment of the slot 126. In an alternative embodiment, the slot 126 may include two or more segments that are angled with respect to each other. Fig.22E In the example embodiment shown in FIG. 1 , four curved slots 126 are shown and are spaced apart at uniform angular increments. The slots 126 are arcuate and include a first end 130 and a second end 132. Each example slot 126 is oriented to initially extend in a first direction starting from the first end 130 and bends to extend in a second direction as the slot 126 reaches the second end 132. The second direction may be closer to perpendicular to (or may be perpendicular to) the radial direction than the first direction.

[0143] In some examples, and now mainly referring to Fig.22D and Fig.22F , the top surface may not include the slot 126 or the plurality of slots 126, but may instead include at least one aperture 136. In the example shown, the aperture 136 is centrally disposed within the top surface 118. The aperture 136 may extend over a small portion or a large portion of the top surface 118. In some embodiments, the aperture 136 may surround substantially all of the top surface 118.

[0144] like Fig.22D and Fig.22F As exemplarily shown in FIG. 5 , the slots 126 may also be included in other areas of the body 52. ​​In an exemplary embodiment, the area of ​​the body 52 that will become the support structure 120 (when the body 52 is thermoformed) includes the slots 126. These slots 126 can be straight, curved, angled (about the radial dimension), or some mixture thereof, such as the various top surface 118 slot 126 patterns described herein. As shown, the slots 126 are spaced apart at regular angular intervals and are spaced apart between the petal-shaped members 114 of the body 52.

[0145] In yet other embodiments, the width of one or more of the slots 126 may vary over the length of the slot 126. FIG. 22G to FIG. 22I 10 and 11. Several embodiments including variable width slots 126 are depicted in FIG. The slots 126 can vary in width in a continuous manner and can terminate at a pointed first end 130 or second end 132. The variable width slots 126 can extend in a radial direction, but need not necessarily do so in all embodiments. In an example embodiment, each of the slots 126 is widest at a center point 126 near the top surface 118 and continuously decreases in width as the slots 126 extend distally toward the periphery 124 of the top surface 118. Thus, in FIG. FIG. 22G to FIG. 22I Each top surface 118 depicted in FIG. 1 has a radial pattern of slots 126. In other embodiments, the slots 126 need not continuously increase or decrease in width from one end to the other.

[0146] Still refer to Fig.23 , the central region 100 may be integrally formed with the petal-shaped members 114 including the regions between the respective pairs of slots 108 (see also Figures 13 to 19, and the examples and embodiments described above with respect thereto). The support structure 120 may extend upward from the petal-shaped member 114 at an angle of 90° or greater, such as 100-105 degrees, but the angle measurement need not be limited to a range. The distance (vertical) from the base 122 of the support structure 120 to the periphery 124 of the top surface 118 may be long enough to provide a receptacle in the central region 100 for the body 50. The slot 108 may extend from the peripheral edge 110 of the kit 12 to the base 122 of the support structure 120, but may terminate at the base 122 and not extend into the support structure 120 itself. In such an embodiment, rather than the entire central region 100 substantially inverting when pressure is applied from the top (e.g., by a finger), only the top surface 118 may invert, assuming a concave shape in the delivery state. The support structure 120 may include, in some embodiments, windows 134 evenly spaced around the base 122. The fenestrations 134 may facilitate manufacturing of the kit 12 in embodiments in which the body 52 is thermoformed.

[0147] In some embodiments and Fig.24 As shown in one example in FIG. 1 , at least one of the petal members 114 can be made to an extended length so that the outward end of the petal member 114 can be operated by the patient or health care provider as a pull tab 138. The pull tab 138 can be grasped by the user to remove the skin 14 (see FIG. 1 ) after use. Figure 1 ) to remove the kit 12. The pull tab 138 can be any suitable shape. In an example, the pull tab 138 is approximately semicircular in shape, having a first rounded end and a second end opposite the first end, attached to the petal member 114. The second end can be attached to the petal member 114 or formed integrally therewith by injection molding or any other known technique. Although the pull tab 138 is shown as extending upward toward the top surface 118, in other embodiments, in other examples, the pull tab 138 can be approximately perpendicular to the height dimension of the kit 12. Therefore, when the user wears the kit, the pull tab 138 can be substantially flat on the skin 14 and oriented approximately parallel to the skin 14. This can help minimize the chance of the pull tab 138 catching or hooking on clothing or other items.

[0148] Reference now Fig.25 , after applying the kit 12 to the skin 14 (see e.g. Figure 1 ) surface, the release liner 140 covering the adhesive 54 on the kit 12 can be removed from the bottom of the kit 12. The release liner 140 can be removed in a manner similar to peeling off the release liner from a bandage before applying the bandage to the skin. Fig.25 An example kit 12 having a pull tab 138 and including a release liner 140 and an adhesive 54 is depicted in FIG. For purposes of illustration, the release liner 140 is disassembled away from the adhesive 54.

[0149] refer to Figure 26 to Figure 27 as well as FIG. 28A to FIG. 28B In some embodiments, the kit 12 may include a central region 100 that is generally pin-shaped or dome-shaped, but has a relatively shorter height than some other embodiments described herein. The distance (vertical) 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 may not be a substantially flat annular shape. The peripheral region 102 may be defined by curved petal-shaped members 114 that continue in a downward direction such that their peripheral edges 110 are spaced apart from the plane of the base 122 of the support structure 120 (e.g., approximately the same or less than the distance from the base 122 to the periphery 124 of the top surface 118). The peripheral edges 110 may be disposed along a plane that is further away from the periphery 124 of the top surface 118 than the base 122. Fig.26 , the exemplary kit is shown in a stored state. The kit 12 may include slots 108 that may be disposed between petal members 114, as with other kit 12 embodiments described herein. The adhesive 54 (see, e.g., Fig.25 ) can be attached to at least a portion of at least two of the petal-shaped members 114.

[0151] like Fig. 27 , which shows a perspective cross-sectional view of the body 52 of the example kit 12, the body 52 may include an internal ridge 142. The ridge 142 may be disposed at the base 122 of the support structure 120. The support structure 120 may be thickened in an area near the base 122 to create the ridge 142. This may allow the ridge 142 to be easily formed in, for example, an injection molding operation that forms the remainder of the body 52. ​​This may also provide additional rigidity to the support structure 120. The ridge 142 may provide a step, ledge, or other mounting surface to which a portion of the body 50 of the kit 12 may be mounted. Such a ridge 142 may be included in any of the delivery device embodiments described herein. The body 50 and the ridge 142 are further described elsewhere in the specification.

[0152] Now the main reference FIG. 28A to FIG. 28B, which shows two conceptual representations of the transition of the kit 12 from a storage state to a delivery state. When the kit 12 is attached to the skin with adhesive 54 and pressure is applied to the kit 12 from above (e.g., by the user's fingertips), the kit 12 can be transitioned to the delivery state. When the petal-shaped members 114 are pushed against the surface of the skin, the petal-shaped members 114 can be displaced outwardly, and the skin 14 and / or the patient's body can force at least a portion of the petal-shaped members 114 to curl upward. In turn, this can cause the skin to move with the opposing petal-shaped members 114 (each attached to the skin surface by adhesive 54 (only one of the petal-shaped members 114 is attached to the skin surface by adhesive 54)). Fig.28A 14 and 15. The petal-shaped members 114 may be configured to extend from the base 122 to the delivery state as shown in the figure) and as the multiple parts of the petal-shaped members 114 move away from each other or are displaced and stretched in an extended manner. As the kit 12 is converted to the delivery state, at least a portion of each of the curved petal-shaped members 114 may be further curved or bent with a tighter radius of curvature. When the delivery state is reached, the curvature of the petal-shaped members 114 may be such that they can extend from the base 122 to the inflection point 144. The inflection point 144 may fall in a plane spaced apart from the plane of the base 122, and may also be referred to as a lowest point in such an embodiment. In such an embodiment, the lowest point 144 may be in a plane that is farther from the periphery 124 of the top surface 118 than the base 122. Starting from the inflection point 144, the petal-shaped members 114 may bend upward and backward so as to become closer and closer to the plane in which the periphery 124 of the top surface 118 is provided. The peripheral edge 110 of the petal-shaped member 114 may, for example, be disposed at a point at or above the plane of the base 122 (closer to the plane of the periphery 124 of the top surface 118). The petal members 114 may, but need not, each have a constant radius of curvature from the inflection point 144 to the peripheral edge 110. The constant radius of curvature upward and rearward may enhance the ability of the petal members 114 to curl upward. This may in turn enhance the stretching of the user's skin as the points 144 on the opposing petal members 114 (each attached to the skin by the adhesive 54) are extendedly displaced. As described elsewhere herein, the top surface 118 of the body 54 may also be inverted as the kit 12 is converted to the delivery state.

[0153] Still reference Figures 26 to 28B In some embodiments, the support structure 122 may not include fenestrations 134 evenly spaced about the base 122 (see, e.g., Fig. 20 ). The body 52 can be manufactured by injection molding. Those skilled in the art will readily appreciate that other manufacturing techniques can be used. The body 52 can be constructed from a single piece of material such that the central region 100 and the peripheral region 102 are integral with each other. The body 52 can be constructed from a polymer material.

[0154] Still refer to Figures 26 to 28B, the top surface 118 can have a circular footprint, such as being generally circular in shape, and can be convex, forming a dome shape (including the periphery 124). The top surface 118 can include slots 126. The slots 126 can be cutouts, orifices, holes, openings, or voids in various embodiments. The slots 126 can extend radially about a center point 128 of the top surface 118 such that their respective first endpoints 130 surround an area including the center point 128 of the top surface 118, and their respective second endpoints 132 can each terminate at a distance from the periphery 124 of the top surface 118 (e.g., the slots 126 can each terminate at the same distance). In some embodiments, the slots 126 can be arranged in regular angular increments and each be of equal length (but this need not be the case for all embodiments).

[0155] Still refer to Figures 26 to 28B And as mentioned above Fig.23 As mentioned above, in alternative embodiments, the slots 126 may be arranged so that they do not extend radially about the center point 128. For example, the slots 126 may each extend at a common angle about the radial direction. In such an embodiment, the slots 126 may be evenly spaced around 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 with the radial direction. At least one of the slots 126 (and possibly all) may be arranged at an angle different from the radial direction.

[0156] Now the main reference Figure 29 to Figure 30 , which shows several conceptual representations of the kit 12 in a delivery state. As described above (and also with reference to Figures 13 to 21 ), the kit 12 can be converted from the storage state to the delivery state when downward pressure is applied to the top surface 118, wherein the body 52 of the kit 12 is substantially or at least partially inverted. The user can remove the adhesive liner 140 from the kit 12 (see, e.g., Fig.25 ), and apply the kit 12 to the skin 14. The user can then press downward on the top surface 118 (i.e., toward the skin 14). This can cause the petal-shaped members 114 to displace outwardly and curl upward (on at least a portion thereof), thereby stretching the skin 14. The top surface 118 can invert, thereby pushing the entry member 16 into the skin 14, and remain inverted when the kit 12 reaches the delivery state. Due to the curling of the petal-shaped members 114, the peripheral area 102 can also take an inverted shape.

[0157] In various embodiments, certain areas of the body 52 of the kit 12 may remain stationary or may not invert. Thus, the body 52 may include inverted areas and elastic areas. Although described as elastic areas, it should be understood that some bending or deformation may still occur when pressure is applied. However, these areas may appear generally similar or extend / protrude in generally the same direction in both the storage and delivery states. As shown, the peripheral area 102 and the top surface 118 may invert, but a portion of the central area 100 may resist such a degree of deformation. The support structure 120 shown in other embodiments described herein (see, for example, Fig. 20 or Fig.26 ) may also be an elastic region. Thus, some kits 12 may include a body 52 with reversible regions separated from each other by elastic regions. Slots 126 may help convert the kit 12 from a storage state to a delivery state with reduced pressure from above. Window 106 may also facilitate conversion.

[0158] In some embodiments, Figure 31 to Figure 33 1 and 2 (a perspective view from the bottom, a perspective view from the bottom, and a cross-sectional view, respectively), illustrate an example body 50 for mounting a tip carrier 74 including an access member 16. Some example bodies 50 can be formed as a circular (e.g., substantially circular) body 148. In various examples, the circular body 148 can be substantially disc-shaped or planar. The distal end of the body 50 can include a catheter receiver 150, and the catheter 96 (see, e.g., Fig.13 ) from the terminal end of the connector 98 (see, for example Fig.13 ) is connected to the catheter receiver 150. The catheter receiver 150 may include a passage 152 that can communicate with the flow lumen 68 of any access member 16 mounted to the body 50. The catheter 96 can be coupled to the passage 152 in any suitable manner (e.g., via an adhesive). The body 50 can be manufactured by any technique known to those skilled in the art, including, for example, injection molding. The distal surface of the body 50 can be coupled to a portion of the body 52 of the kit 12. For example, the periphery 154 of the distal surface can be coupled to the internal ridge 142 of the body 52 (see, e.g., Fig. 27 In some examples, one or more tabs 164 (see, e.g., Figure 35 to Figure 36 ) can be coupled (e.g., snapped) into a slit in the body 52 to couple or assist in coupling the body 50 to the body 52.

[0159] Still reference Figure 31 to Figure 33, the example body 50 may include at least one boss 156. The boss 156 may extend from the proximal side of the circular body 148. The example boss 156 may protrude from the proximal side to a certain height, and in some examples, the height may be at least equal to the height of the microneedles of the kit 12 (e.g., 600 microns). The boss 156 may generally extend from the circular body 148 at a vertical angle. The sidewalls 158 of the boss 156 may be chamfered so as to extend in a non-vertical direction relative to the proximal side of the circular body 148. The boss 156 may include a recess 160. The size of the recess 160 may be set to fit and accept the pointed carrier 74 having the entry member 16 thereon. In Figure 31 to Figure 33 In the example shown, the prong carrier 74 may be fitted into the recess 160 by an adhesive. The boss 156 may act as a force concentrating protrusion extending from the remainder of the body 50, which is used to ensure that the force applied to the kit 12 is concentrated on the access member 16, thereby facilitating the insertion of the access member 16 into the skin 14 (see, e.g., Figure 1 ).

[0160] In some examples, the tip carrier 74 can be coupled to any of the bodies 50 during the molding operation. In the case where the tip carrier 74 is joined to the body 50 during molding, some material can be molded on the sidewalls 162 of the tip carrier 74 and on the face of the tip carrier 74 from which the entry member 16 protrudes to capture the tip carrier 74. In alternative embodiments, the sidewalls 162 of the tip carrier 74 can be chamfered or angled to be non-perpendicular to the face of the tip carrier 74 from which the entry member 16 extends. The footprint or cross-sectional area of ​​the tip carrier 74 can increase as the distance from the tip bearing face of the tip carrier 74 increases. In the case where the entry member 16 is a silicon microneedle, multiple groups of entry members 16 can be formed, typically on a large wafer, and the tip carrier 74 including the desired number of entry members 16 can be cut out of the wafer. To form the chamfered sidewall 162, the cutting saw can have an angled face so that the cutting process produces the desired chamfer or angle on the sidewall 162. In some embodiments, a sidewall 162 between 30°-60° (e.g., 45°) can be used. In the presence of a chamfered sidewall 162, material can be molded over only a portion of the sidewall 162 to connect the prong carrier 74 to the body 50. This can allow the prong carrier 74 to be captured in the body 50 without material being molded onto the prong bearing surface of the prong carrier 74 (although this can be done optionally). Thus, the molded material does not act as a standoff on the prong bearing surface that prevents any entry member 16 from penetrating the entire height into the skin 14 (see, e.g., Figure 1 ).

[0161] Now also refer to Fig.34, depicting a cross-sectional view of a portion of the boss 156. In some embodiments, the recess 160 of the boss 156 can be in a non-parallel orientation relative to the plane of the circular body 148 (and the skin 14 when the kit 12 is applied to the user). When the tip carrier 74 is mounted to the recess 160, the orientation of the recess 160 can ensure that the entry member 16 (e.g., microneedle) extends at a specified angle relative to the circular body 148. In an example embodiment, the recess 160 can be oriented so that the entry 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 recess 160 can be oriented so that the entry member 16 protrudes at an angle of 45° or 60° or at an angle between 10°-60°. Any suitable angle can be used. In an alternative embodiment, the entire boss 156 can protrude from the circular body 148 at a desired angle. Therefore, when connected to the recess 160, the entry member 16 can extend at a desired angle relative to a plane perpendicular to the circular body 148.

[0162] Reference now Figure 35 to Figure 36 , respectively showing a top view and a bottom plan view of an example embodiment of the body 50. As described above, in some examples, the body 50 may include a tab 164 that may couple or assist in coupling the body 50 to the main body 52 of the kit 12. In the example shown, the circular body 148 may include a plurality of circumferentially disposed tabs 164. The tabs 164 may be symmetrically disposed around the circular body 148 and may be spaced apart at regular angular intervals. In alternative embodiments, the tabs 164 may be asymmetrically disposed around the base or at irregular angular intervals. The tabs 164 may engage with receiving slits disposed in the main body 52 of the kit 12. Thus, the tabs 164 may be used to couple the body 50 to an appropriate position in the kit 12. Asymmetrical or irregularly spaced tabs 164 may allow the body 50 to be coupled to the main body 52 in a specified orientation, which may be desirable in some examples.

[0163] Still refer to Figure 35 to Figure 36 , the exemplary body 50 includes a plurality of conduit receivers 150, each of which can receive a conduit 96 in fluid communication with a corresponding coupling 98. In alternative embodiments, the conduit receivers 150 can be omitted, and the coupling 98 can be disposed directly on the body 50. For example, a Luer fitting can be coupled to or molded as part of the body 50. In some embodiments, the coupling on the body 50 can be about Figure 41 to Figure 46 The coupling 98 is described.

[0164] The body 50 may include a plurality of bosses 156. A boss 156 to which the tip carrier 74 may be coupled may be associated with each of the catheter receivers 150 included on the body 50 (or alternatively, the coupling 98 on the body 50). Although two bosses 156 and catheter receivers 150 are shown, a greater number may be included in alternative examples.

[0165] Boss 156 may be, for example, any of those described herein, such as Figure 31 to Figure 34 The conduit 96 coupled to each conduit receiver 150 can be coupled to the flow lumen 68 of the access member 16 coupled to the corresponding boss 156 (see, e.g. Fig.34 ) fluidly connected. Alternatively, where a coupling 98 is included on the body 50 in place of a catheter receiver, the coupling 98 can be in fluid communication with the flow lumen 68. The flow path from a first catheter receiver (or first coupling 98) in the catheter receivers 150 to an access member 16 coupled to a corresponding first boss 156 can be fluidly isolated from the flow path from any other catheter receiver 150 (or coupling 98) to an access member 16 coupled to a corresponding boss 156. Each of the couplings 98 can be connected from an infusion set 18 (see, e.g., Figure 2 ) is connected to the connector 26, 44 (see for example Figure 2 ).

[0166] A first medical agent can be administered through the access member 16 connected to the first of the first bosses 156, and a different medical agent can be administered through the access member 16 connected to the other bosses 156. For example, a medical agent with a counteracting effect can be administered. A first regulating hormone and a second regulating hormone that counteracts the first regulating hormone can be administered. In some examples, insulin and glucagon can be delivered. Alternatively, the same medical agent can be administered through the access member 16 connected to each boss 156. Alternatively, different types of the same medical agent can be administered through the access member 16 connected to each boss 156.

[0167] The access members 16 coupled to each boss 156 may be identical or substantially identical. In some examples, one boss 156 may have a greater or lesser number of access members 16 coupled thereto than another of the access members 16. In some examples, the access member 16 coupled to one of the bosses 156 may be longer or shorter than the access member 16 coupled to another of the bosses 156. Bosses 156 having access members 16 of any number of heights may be included. Using insulin as an example, if a rapid response is required or desired, insulin may be delivered by a shorter access member 16 (e.g., to an intradermal destination), while in other cases, insulin may be delivered by a longer access member 16 (e.g., to a subcutaneous destination). The routing of the medical agent to a longer or shorter access member 16 (or to access members 16 of different heights at the same time) may be managed by the controller 20 of the infusion device 18. The access member 16 selected for delivery may be determined by the controller 20 at least in part based on the desired onset speed of the delivered medical agent.

[0168] Where a plurality of bosses 156 are provided, the bosses 156 may be arranged in a row on the body 50. The bosses 156 may each have a Fig.36 In some examples, the boss 156 can be arranged substantially along the mid-plane of the body 50. The entry members 16 coupled to the boss 156 can each have the same orientation. In some examples using microneedles, the back edge 66 of each microneedle (see, e.g. Figure 5 ) may all be disposed in substantially the same plane. The bosses 156 may be disposed on the opposite side of the proximal side of the body 50. Alternatively, the bosses 156 may each be disposed centrally on the body 50. In certain embodiments, only a single boss 156 may be included, and a plurality of tip carriers 74 may be coupled thereto. The flow paths from the catheter receiver 150 to each respective tip carrier 74 may be isolated from one another by walls or partitions within the interior of the bosses 156.

[0169] Reference now Figure 37 to Figure 38 , various kits 12 described herein may include a body 50 having at least one rocking member 166. When such a kit 12 is applied to a user and transitioned to a delivery state, the skin 14 (see, e.g., Figure 1) can be tightened due to the extended displacement of the portion of the kit 12, and the access member 16 of the kit 12 can be displaced into the stretched skin 14. The movement of the access member 16 can generally be in a first direction substantially perpendicular to the surface of the skin 14, and the access member 16 can penetrate generally downward into the skin 14. The at least one rocking member 166 can cause the body 50 to tilt or rock due to the conversion of the kit 12 to the delivery state. When the pressure is released from the kit 12, the at least one rocking member 166 can slightly displace the access member 16 in a second direction substantially opposite to the first direction. Tilt and displacement along the second direction may occur.

[0170] In some embodiments, portions of the kit 12 may also deform or adjust in response to the shaking of the body 50 so as to accommodate the shaking of the body 50. The tilting of the body 50 may displace the entry member 16 in a non-straight path. For example, the entry member 16 may rotate or swing along an arc path during at least a portion of the transition of the kit 12 to the delivery state. In an example embodiment, the tilt may occur automatically due to the transition of the kit 12 to the delivery state. In order to achieve the tilt, a link or interaction with a guide element may not be required. Due to the presence of one or more rocking members 166, the example body 50 may tilt together as a single unit. In some kit 12 embodiments, this tilting of the body 50 may reduce the pressure at which the injection may begin to occur and / or increase the delivery flow rate. In addition, including one or more rocking members 166 may affect the characteristics of the bubble formation during delivery. Tilt may also help facilitate delivery, wherein the entry member 16 is initially advanced into the skin 14 at an angle substantially perpendicular to the skin 14.

[0171] Still reference Figure 37 to Figure 38 , the rocking member 166 may be a protrusion extending from the proximal side of the body 50. In various examples, the rocking member 166 may be disposed at or within the peripheral edge of the body 50. The height of the rocking member 166 may be approximately the height of the boss 156 (e.g., see Figure 31 to Figure 36 ). Shorter and longer rocking members 166 are also possible.

[0172] When the kit 12 including at least one rocking member 166 is transitioned to the delivery state, the rocking member 166 may contact the user and prevent further displacement of the portion of the body 50 including the rocking member 166. The opposite side may not have any rocking members 166, and the body 50 may tilt or rock to accommodate continued displacement of the opposite side toward the user. In some examples, the entry member 16 (e.g., a microneedle) may be tilted 3-5° (e.g., 4°) relative to its initial orientation. In other examples, the entry member 16 may be tilted by a smaller or larger amount. The height of the rocking member 166 may change the point at which the entry member 16 begins to rotate or swing during the transition of the kit 12 to the delivery state. Even a rocking member 166 having the height of the boss 156 may begin to tilt, for example, after the entry member 16 has pierced the skin 14 (see, e.g., Figure 1 ).

[0173] In some examples, the access member 16 can be a microneedle, such as any of those described herein. In the case where the access member 16 is a microneedle, the rocking member 166 can be disposed on the back edge 66 of the body closest to the microneedle (see, e.g., Figure 5 ). The rocking member 166 can be positioned so that the back edge 66 of the microneedle is the portion of the microneedle closest to the rocking member 166. When the body 50 is rocked, the displacement path followed by the microneedle can be such that the back edge 66 can be driven through the skin. The sloped surface leading to the back edge 66 can facilitate cutting the skin 14 when the microneedle is displaced (see, e.g. Figure 1 ). Thus, the back edge 66 may be a cutting edge. In addition, this may cause the face of each microneedle (where the exit of the lumen 68 of the microneedle is located) to be displaced away from the skin that was contacted during the initial puncture. For example, when using a microneedle such as Figure 5 During the initial penetration of the microneedles shown, the lumen 68 of any microneedle can be displaced away from the skin 14 contacted by the inclined surface 72. This displacement of the microneedles can help ensure that the fluid can easily flow out of the lumen 68 and into the skin 14 when delivery occurs. The above displacement can also create a small receiving volume in the skin 14, into which the fluid can be delivered from the lumen 68. When the pressure applied to the kit 12 to convert the kit 12 to the delivery state is released, the entry member 16 can be slightly displaced in a direction away from the patient. This can create a small receiving volume in the skin 14 and displace the lumen 68 away from the skin 14 contacted during the initial penetration. The shaking member 166 can help promote this.

[0174] In some examples (see e.g. Fig.34 and Fig.38), the access member 16 can be mounted to a boss 156 having a non-parallel mounting area (e.g., recess 160) relative to the circular body 148 of the body 50. In such an example, the access member 16 can extend from the boss 156 at a specified angle (e.g., 15°) relative to a plane perpendicular to the circular body 148. When the various example kits 12 are first applied to a user, the circular body 148 and the skin 14 (see, e.g., Figure 1 ) can be substantially parallel. Thus, access members 16 can be angled relative to a plane perpendicular to skin 14. As body 50 tilts, access members 16 can shift to a position where they are closer (e.g., 3-5°) to a vertical orientation relative to skin 14. Depending on the mounting angle of access members 16, access members 16 can be at or near a vertical orientation relative to skin 14 when body 50 is tilted. In other embodiments, access members 16 can be 10° or more (e.g., 11-12°) away from a vertical orientation.

[0175] In some examples, the boss 156 may be disposed on Figure 37 to Figure 38 14. The rocking member 166 is shown in the figure. In such embodiments, the rocking member 166 may be omitted or may be present as a lateral extension on either side of the boss 156. The boss 156 may not be present in the center of the body 50 (although in certain examples, the boss 156 may also be centrally located on the body 50). When the kit 12 is transformed into the delivery state, the access member 16 may pierce the skin 14, and the boss 156 may prevent further displacement of that side of the body 50 toward the skin 14. The opposite side of the body 50 will be free to continue to displace toward the skin 14. As the opposite side continues to displace toward the skin 14, a rocking or tilting may occur that causes the access member 16 to move in the manner described above.

[0176] When the pressure is removed from the kit 12, one or more parts of the kit 12 may at least partially recover from its deformed state. Thus, the kit 12 may have at least one region that is elastically deformed as the kit 12 transitions to the delivery state. The elastically deformed at least one region may be deformed from an initial state to an intermediate state, and then at least partially elastically recover from the intermediate state during the transition to the delivery state. The intermediate state may be a state of maximum deformation of the region during the transition. The region may recover from this state to the initial state. The petal-shaped member 114 may, for example, at least partially recover from its maximum deformation state. When the petal-shaped member 114 of the kit 12 is adhered to the skin 14 via the adhesive 54 of the kit 12, the skin 14 may be pulled away from the underlying anatomical structure as the petal-shaped member 114 recovers. This may relieve some of the pressure on the injection site. This reduced compression at the injection site may allow fluid to be more easily transferred from the entry member 16 to the delivery destination. In addition, depending on the orientation of the entry member 16, the entry member 16 may pull the skin 14 that they have pierced upward from the underlying anatomical structure as the petal-shaped member 114 recovers. Again, this can help facilitate delivery because the compactness of the anatomical structure at the delivery destination can be reduced. The shape of the petal members 114 and the materials used to construct the kit 12 can be selected to help promote this at least partial recovery or retraction of the petal members 114 when pressure is removed. Molding the petal members 114 in the storage state can also give the petal members 114 a tendency to recover toward the storage state when pressure is released from the kit 12 during use. The petal members 114 that recover toward their initial state during the conversion of the kit 12 to the delivery state can be included in any kit 12 embodiment shown or described herein.

[0177] Petal members 114 can be relatively free of curvature. For example, petal members 114 can be substantially flat and / or extend from the rest of body 52 at an angle to the rest of body 52. ​​This can help to make the force required to deflect petal members 114 relatively low when pressure is applied to kit 12. In turn, this can help to help generate an expanded displacement of petal members 114 before top surface 118 of example body 52 is deformed and help ensure that the skin is punctured with access member 16.

[0178] like FIG. 39A to FIG. 39BAs shown, the petal members 114 of the example body 20 may each include a first region 620 adjacent to the support structure 120 and a second region 622 forming a more peripheral portion of the petal member 114. As shown, the first region 620 may be roughly arc-shaped similar to the adjacent portion of the support structure 120. The second region 622 may be oriented at a constant angle to the central axis A1 of the body 20. The second region 622 may form a majority of the petal member 114. In some examples, the petal member 114 may have a curved region or surface while being primarily flat. In various embodiments, a small curved transition portion 621 between the first region 620 and the second region 622 of the petal member 114 may be included (see, e.g. Fig.40 ).

[0179] A living hinge may be formed at the transition between the first region 620 and the second region 622. When pressure is applied to the kit 12, the living hinge may allow the second region 622 of the petal member 114 to shift relative to the first region 620. Throughout the transition of the kit 12 to the delivery state, the first region 620 may be less deformed than the second region 622. In some examples, the first region 620 may resist significant deformation and remain substantially undeformed throughout the transition. Therefore, the first region 620 may behave as a stopper that may help limit the expansion displacement of the petal member 14 after the desired amount of expansion displacement has been achieved. A curved transition 621 may be included to help facilitate at least partial recovery of the petal member 114 once the pressure on the kit 12 has been released. In examples including petal members 114 such as those in Figures 70A to 70B, it may be preferred that, in the storage state, the base of any boss 156 is substantially flush with the end of the second region 622 of the petal member 114 closest to the support structure 120.

[0180] Reference now Figure 41 to Figure 42 , depicts an example embodiment of a kit 12. The example kit 12 includes a central region 100 and a peripheral region 102. The peripheral region 102 includes a plurality of slots 108 that divide the peripheral region 102 into a plurality of petal-like members 114. One of the petal-like members 114 includes a pull tab 138. The example pull tab 138 extends in a direction substantially within a plane that includes a peripheral edge 110 of the peripheral region 102. When the user wears the kit 12, the pull tab 138 can generally lie flat against the skin 14 to minimize the possibility of the pull tab 138 catching on clothing or other items. The pull tab 138 can include one or more raised bodies 168 or gripping patterns to facilitate the user's gripping of the pull tab 138. In this example, the included raised bodies 168 are ridges.

[0181] The central region 100 in the example embodiment is shown to include a base surface 170 from which a plurality of features extend. In this example, the base surface 170 is depicted as a platform-like surface and is substantially planar. The base surface 170 can be disposed above the peripheral region 102 or flush with the highest portion of the peripheral region 102. The central region 100 can include a coupling 98 to which the connector 26 from the infusion set 18 can be coupled. In various embodiments, a fitting (e.g., a Luer lock) can be coupled to the central region 100 and used as the coupling 98. In some embodiments, the fitting can be integrally molded with the central region 100.

[0182] Now also refer to Fig.43 , the central region 100 may, for example, include a connector receiver 172. The connector receiver 172 may be a connector engagement protrusion extending from the base surface 170. The connector receiver 172 may include a ramp surface 174 and a flange surface 176. When the latch body 178 of the example connector 26 is driven toward the connector receiver 172, they may abut the ramp surface 174 of the connector receiver 172. In various embodiments, the latch body 178 may be suspended from the remainder of the connector 26. When the latch body 178 is driven along the ramp surface 174, further displacement of the connector 26 may cause deflection of the latch body 178. The terminal end of the latch body 178 may include a face that is tilted in a cooperative manner to help facilitate deflection. The latch body 178 may include a catch 180. When the catch 180 passes over the corresponding ramp surface 174, the latch body 178 can be free to recover from its deflected state. When the latch body 178 is restored from the deflected state, the clip 180 can be displaced to engage the flange surface 176 of the connector receiver 170 to hold the connector 26 in place on the kit 12. Thus, the connector receiving portion 172 can form a coupling 98 on the kit 12. In some embodiments, the clip 180 can include a face that is substantially parallel to the flange surface 176 of the connector receiver 172 when engaged with the flange surface 176. In an alternative embodiment, the clip 180 can include a face that is not parallel to the flange surface 176 when the connector 26 is coupled to the kit 12. This can facilitate the separation of the connector 26 from the kit 12 in the event that the tubing 28 leading from the connector 26 to the infusion set 18 is hooked when the user moves. In this case, the angle of the face of the clip 180 can be adjusted to change the ease with which the connector 26 can be separated from the kit 12.

[0183] The connector 26 can be manually separated from the kit 12 as needed. For example, this can be done if the user desires to shower or swim and the infusion set 18 is not suitable for exposure to water. As shown, the latch body 178 extends from the outer arm 182 of the connector 26. The outer arm 182 itself can be cantilevered from the central area of ​​the connector 26. The outer arm 182 can be squeezed together to displace the latch body 178 out of engagement with the connector receiver 170 to allow the connector 26 to be removed. In an example embodiment, when the outer arms 182 are deflected toward each other, the catch 180 can be displaced out of contact with the flange surface 176, and the latch body 178 can then be freely withdrawn from the connector receiver 172.

[0184] Prong wing projections 184 may also be present on the connector 26. These wing projections 184 may extend substantially parallel to the prongs 186 included on the connector 26, and may be present to help prevent accidental contact between the prongs 186 and a user. A shield wall 188 may be provided on the central region 100, and may help prevent a finger or object from inadvertently moving the latch body 178 out of engagement with the connector receiver 172.

[0185] Now also refer to Fig.44 , the central region 100 of the kit 12 may include a plurality of guides. These guides may facilitate the coupling of the connector 26 to the kit 12. As shown, a set of guide walls 192 protrude from the base surface 170 of the central region 100. In various embodiments, the guide walls 192 may be substantially perpendicular to the base surface 170. When the connector 26 is coupled to the kit 12, at least one of the latch body 178 or the wing protrusions may be guided along one of the guide walls 192 to help align the connector 26 along the desired displacement path when the connector 26 is coupled to the kit 12. This may ensure that the tip 186 of the connector 26 pierces the septum 196 of the kit 12 along the desired puncture axis. The guides may also help make it easier for individuals with low dexterity or impaired vision to couple the connector 26 to the kit 12. In some examples, the guides may help guide the connector 26 into the appropriate coupling path so that the user may couple the connector 26 to the kit 12 without looking at the kit 12.

[0186] The kit 12 may also include a restraining wall 194 that may, for example, prevent movement of portions of the connector 26 in certain directions. For example, a material bridge extends from the shielding wall 188 to the guide wall 192. This may prevent the latch body 178 from shifting in a direction perpendicular to the base surface 170 when the connector 26 is coupled to the kit 12. This may inhibit the latch body 178 from being lifted above the connector receiver 172, causing the connector 26 to disengage from the kit 12. In an example embodiment, the guide and restraining wall 194 are arranged to be substantially flush with the top surface of the connector 26 when the connector 26 is coupled to the kit 12. This may help limit the likelihood that the kit 12 or the connector 26 will snag on clothing or other items when in use.

[0187] As also shown, the kit 12 may include a diaphragm compartment 198 (in Fig.42 100 ). The diaphragm compartment 198 can be generally centrally located in the central region 100 of the kit 12. The diaphragm compartment 198 can be defined by a wall 200 that protrudes from the base surface 170. The wall 200 can surround an interior void in which the diaphragm 196 (at Fig.44 200) can be deposited into the internal void during assembly. The inner surface 202 of the wall 200 may include a plurality of ribs 204 that extend radially inward toward the axis of the diaphragm compartment 198. The ribs 204 can help position and compress the diaphragm 196 within the diaphragm compartment 198.

[0188] Once the diaphragm 196 has been installed in the diaphragm compartment 198, the top of the diaphragm 196 can be at least partially covered. In some examples, the wall 200 can include an extended area 208 farthest from the base surface 170. The extended area 208 can be swaged after the diaphragm 196 is installed to help hold the diaphragm 196 in place within the diaphragm compartment 198. In alternative embodiments, a plug, cap, or cover can be coupled to the top of the wall 200 to cover the exposed face of the diaphragm 196. Such a plug, cap, or cover can be coupled in any suitable manner (e.g., a snap fit, a threaded connection, a weld such as a sonic weld, etc.).

[0189] Reference now Fig.45 as well as Figure 41 to Figure 44 , the diaphragm compartment 198 may include a column 210. The column 210 may be substantially centrally located within the diaphragm compartment 198. The column 210 may include a passage 212 extending therethrough that is in fluid communication with the entry member 16. The passage 212 may have a cross-section that is generally in the shape of the Latin letter "I". This may help minimize the dead volume of the passage 212 while maintaining a substantially uniform wall thickness of the column 210. Fig.45As best shown, the septum 196 can include a septum recess 208 that can be at least partially seated on the post 210 and form a fluid-tight seal against the post 210. The post 210 can help center the septum 196 in the septum compartment 198 during assembly. When the septum 196 is installed in the compartment 198, a portion of the septum recess 208 can be disposed adjacent to the post 210. This portion can provide a fluid introduction volume into which fluid from the connector 26 can be delivered.

[0190] The wall 200 of the septum compartment 198 may include a port 206, such as a notch or window (not shown). When the connector 26 is coupled to the kit 12, the prong 186 of the connector 26 may be displaced along a displacement path extending through the port 206 and through a portion of the septum 196. When the connector 26 is coupled to the kit 12, the outlet 214 of the prong 186 may be disposed within a fluid introduction volume formed by the recess 208 of the septum 196. When the infusion set 18 (see, e.g., Figure 1 ) When the pumped fluid is discharged through the outlet 214 of the tip 186, the fluid can travel through the passage 212 and flow lumen 68 of any access member 16 of the kit 12 to reach the delivery destination in the patient. The septum 196 can be formed of a material that can self-seal when the tip 186 is punctured and removed. In some examples, the septum 196 can be a silicone material.

[0191] In various examples, it may be preferable to include a notch extending from the top of the wall 200 toward the base surface 170 because it can facilitate molding of the kit 12 without side action. For example, the example kit 12 can be molded using a bypass cutout and without side action. Various gaps or apertures 205 in the center region 100 may be included to facilitate molding.

[0192] Now mainly see Figure 45 to Figure 46 , the proximal side 222 of the central region 100 (the side facing the skin 14 when the kit 12 is worn) may include at least one boss 156. A pointed carrier 74 including at least one entry member 16 may be coupled to each boss 156 (e.g., via an adhesive, or may be joined to the boss 156 during injection molding). The pointed carrier 74 may be configured so that the entry 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 between 45 degrees and 5 degrees (e.g., 30° or 15°). In alternative embodiments, the entry member 16 may protrude substantially perpendicular to the proximal side 222 of the central region 100. In an example embodiment, the entry member 16 is depicted as a microneedle.

[0193] Also included near the periphery of the proximal side 222 of the central region 100 is a rocking member 166. When the kit 12 is converted to the delivery state (in Figure 45 to Figure 46 12 is shown in a stored state), the access member 16 can be penetrated into the skin 14 (see, e.g. Figure 1 ), and once the rocking member 166 contacts the skin 14, the central region 100 can begin to tilt. As described elsewhere herein, the tilting motion can displace the access member 16 along a tortuous path within the skin 14. This can help facilitate delivery and help reduce pressure into the skin 14 where delivery can begin to occur.

[0194] like Figure 41 to Figure 46 As shown, the example kit 12 does not include the body 50. Instead, the boss 156 is formed on the proximal side 222 of the central region 100. Any kit 12 described herein as including the body 50 may alternatively be configured such that the features of the body 50 are instead included in the central region 100 of the body 52. ​​For example, with respect to Figures 31 to 38 The body 50 shown and described can be included as at least a portion of the central region 100 of the kit 12 and can be integrally formed with the peripheral region 102 of the body 52. ​​This can help limit the parts count and simplify assembly of the kit 12. That is, the various kits 12 described herein can be modified so that the kits described as part of the central region 100 are not necessarily formed integrally with the peripheral region 102 of the body 52. Figure 41 to Figure 46 The features in may alternatively be included on a separate body 50 that may be coupled to the main body 52 of the kit 12 .

[0195] Reference now Figure 47 to Figure 49 , an exploded view of an example embodiment of an analyte sensor 30 and a transmitter 32 is shown. The transmitter 32 may include a housing 290. A power source 294 (e.g., a button cell), a sensor circuit 296, at least one transmitter / transceiver 298, and a memory 300 may be included within the housing 290. The transmitter 32 may be removably coupled to the analyte sensor 30 in any suitable manner. The transmitter 32 may be coupled to the analyte sensor 30 in a threaded, clipped, snapped, adhered, or the like manner, but any suitable coupling means may be used. When the transmitter 32 is coupled to the analyte sensor 30, the transmitter 32 may establish electrical communication with the conductive traces 292 leading to the sensor electrodes 302A, 302B. In other embodiments, the transmitter 32 may be provided coupled to the analyte sensor 30 and may be non-removable.

[0196] As shown, the analyte sensor 30 may include a body 352. The body 352 of the analyte sensor 30 may have a circular (e.g., circular) footprint, and may include a central region 400 and a peripheral region 402. The central region 400 may be a raised region of the body 352, and the peripheral region 402 may surround the central region 400. The body 352 may be injection molded, and the raised central region 400 and the peripheral region 402 may be formed in a molding operation. In some examples, the central region 400 may be substantially planar and may include a base surface 470. In various embodiments, the conductive traces 292 communicating with the electrodes 302A, 302B may extend to the base surface 470. The central region 400 may include one or more coupling interfaces that cooperate with the transmitter 32 to couple the transmitter 32 and the analyte sensor 30 to each other during use. The body 352 may include a plurality of slots 408. The slots 408 may extend from the peripheral edge 410 of the body 352 toward the center or midpoint of the body 352. In an exemplary embodiment, the slots 408 extend in a radial direction. The slots 408 may extend through the entire peripheral region 402. Thus, the body 352 may include a central region 400 bounded by a plurality of petal-shaped members 414 separated by the slots 408.

[0197] Now mainly see Fig.48 , depicts a plan view of a proximal side 356 of an example body 352. An adhesive may be included on at least a portion of the proximal side 356. The various adhesive bearing members 54 that may be coupled to the proximal side 356 of the body 352 of the analyte sensor 30 may include adhesive. Figure 55 to Figure 57 The adhesive may be a skin-compatible adhesive and may be used to couple the analyte sensor 30 to the surface of the skin 14 at the sensing site. The adhesive may be included on the peripheral region 402 of the body 352 and on a portion of the proximal side 422 of the central region 400.

[0198] Example analyte sensor 30 in Figure 47 to Figure 49352 is depicted as being in a storage state. When the analyte sensor 30 is applied to the patient, the analyte sensor 30 can be placed on the skin 14 in the storage state. The adhesive on the proximal side 356 of the body 352 can anchor the analyte sensor 30 to the skin 14. The body 352 can be a deformable body that can be transformed from the storage state to the expanded state. In some examples, the transformation can be reversible, but in other embodiments, the transformation can cause a permanent change in another part of the body 352 and / or the analyte sensor 30. For example, once transformed to the delivery state, at least a portion of the body 352 can be plastically deformed so that it is permanently deformed and can not return to the storage state. It may be necessary to destroy a portion of the body 352 or a portion of the analyte sensor to remove the analyte sensor 30 from the patient, so that the analyte sensor 30 does not work. When transformed to the expanded state, at least two adhesive bearing portions of the body 352 can be displaced relative to each other so as to stretch or expand the skin surface anchored to the body 352 via the adhesive. This may be desirable because when the body 352 is transformed into the deployed state, the skin 14 may be tightened, thereby facilitating penetration of the skin 14 by the electrodes 302A, 302B. The adhesive present on the adhesive member 54 (see, e.g., Figure 55 to Figure 57 ) can help maintain the analyte sensor 30 in the deployed state during use. No inserter assembly is required to administer the analyte sensor 30.

[0199] The analyte sensor 30 can be applied to the skin 14, and the user can press on the body 352 to transform the analyte sensor 30 into the deployed state. This can avoid the need for a needle stick each time the analyte sensor 30 is applied. This can make the use of the analyte sensor 30 more attractive, especially for certain patient populations (e.g., those with juvenile diabetes). In addition, omitting the inserter can help resolve financial considerations for patients, which may otherwise dissuade some patients from choosing to use the analyte sensor 30.

[0200] Now mainly see Fig.49 , showing Figure 47 to Figure 48 4 is a perspective close-up view of a portion of the proximal side 422 of the central region 400 of the example analyte sensor 30 shown. As shown, the electrodes 302A, 302B can be a pair of micro-penetrators. The micro-penetrator is any micro-needle described herein, but as shown, may not extend through any lumen therein. The micro-penetrator can be, for example, Figure 5302B can be constructed as described in, but without an inner cavity. Each micro-penetrator can be composed of etched silicon. Each micro-penetrator can be arranged on its own pointed carrier 374 so that they are not directly electrically connected to each other. One of the electrodes 302A, 302B can serve as a counter electrode / reference electrode, while the other electrode 302A, 302B can serve as a sensing electrode. The electrodes 302A, 302B can be mounted to a boss 358 protruding from the proximal side 422 of the central area 400. The boss 358 can be any boss 156 described herein.

[0201] In alternative embodiments, the micro-penetrators themselves may not be used as electrodes 302A, 302B. In such embodiments, the micro-penetrators may be at least covered with insulating material. Conductive traces 292 may be disposed on the insulating material on each micro-penetrator and may extend along the tip carrier 374 to the side of the tip carrier 374 opposite to the micro-penetrator. When coupled to the analyte sensor 30, the transmitter 32 may establish electrical communication with the conductive traces 292. In such embodiments, the counter electrode / reference electrode and the sensing electrode may be present on the same tip carrier 374 as long as the corresponding conductive traces 292 remain isolated from each other.

[0202] The analyte sensor 30 may be a shallow analyte level sensor. For example, the analyte sensor 30 may be an intradermal analyte level sensor. The analyte sensor 30 may be a continuous analyte sensor 30 (e.g., a continuous glucose monitor) that may output analyte level data on a predefined schedule (e.g., every 1-5 minutes). Such an analyte sensor 30 may be less invasive to use, less painful, more responsive, less likely to cause irritation or patient reaction, among other potential benefits.

[0203] Electrode 302A, 302B can have a height suitable for communicating with a shallow destination. In some embodiments, electrode 302A, 302B can have a height between 500 microns and -1000 microns, but shorter or higher electrodes 302A, 302B can be used in alternative embodiments. When analyte sensor 30 can sense the analyte level at a shallow destination (e.g., intradermal), sensor 30 can collect readings of blood analyte levels, and the time delay of the blood analyte level is less than the time delay of the subcutaneous analyte level sensor. For example, the intradermal layer is highly vascularized, so the analyte level in the intradermal space should more quickly reflect the change in the level of the blood analyte level. When controller 20 receives sensor 30 readings, controller 20 can start, pause or adjust the medical agent administration command for coordinating the delivery from infusion device 18 based at least in part on the readings. Faster sensing of analyte level changes can allow controller 20 of infusion device 18 to react faster to changes in blood analyte levels. Additionally, it may allow the controller 20 of the infusion set 18 to make medical agent dosing determinations that more accurately reflect the patient's current needs. Thus, such an analyte sensor 30 may allow for tighter control of blood analyte levels using the infusion set 18.

[0204] Any suitable analyte sensing chemistry or arrangement from any manufacturer may be incorporated into the sensing electrode. A glucose sensing arrangement may be used. For example, glucose oxidase chemistry may be used to sense glucose levels in body fluids. It should be noted that the analyte sensor 30 is not limited to use with any particular sensing chemistry or arrangement.

[0205] In certain example embodiments, the analyte sensor 30 may include a plurality of bosses 358, each boss being associated with a respective set of electrodes 302A, 302B. Alternatively, multiple sets of isolated electrodes 302A, 302B may be coupled to a single boss 358. Thus, multiple analyte sensors 30 may be associated with a single body 352. In various examples, any number of bosses 358 may be disposed about the proximal side 422 of the central region of the body 352. In some examples, such bosses 358 on the analyte sensor 30 may be associated with a plurality of bosses 358 on the proximal side 422 of the central region of the body 352. Figure 35 to Figure 36Depicted boss 156 is similarly arranged.Electrode groups 302A, 302B included in analyte sensor 30 can use the same analyte sensing chemical substance or arrangement device and sense the same analyte in body fluid.In other embodiments, at least one group of electrodes 302A, 302B can use different analyte sensing chemical substances or arrangement devices.When using different chemical substances, electrodes 302A, 302B can sense the same analyte or different analytes with electrodes 302A, 302B of other groups.In some examples, micro penetrators can be arranged in groups with different heights.Therefore, when analyte sensor 30 is in an expanded state, analyte sensor 30 can collect data about analyte levels at various positions in the user's body.In some examples, one group of micro penetrators can facilitate sensing analyte levels at shallow destinations (e.g., intradermal), and another group of micro penetrators can facilitate sensing at deeper positions (e.g., subcutaneous).The height of the micro penetrator can be selected so that the micro penetrator will puncture the patient with appropriate depth to reach the desired sensing position.

[0206] Reference now Figure 50 to Figure 54 , depicting an example embodiment of an access assembly 46. Each access assembly 46 can be used to deliver one or more medical agents into a patient and to collect sensor data related to the level of at least one analyte of interest. Thus, a single assembly 46 can be used to replace a first assembly for fluid delivery and a separate assembly for analyte sensing.

[0207] The access assembly 46 may include a body 552. The body 552 of the access assembly 46 may have a round (e.g., circular) footprint and may include a central region 500 and a peripheral region 502. The central region 500 may be a raised area of ​​the body 552, and the peripheral region 502 may surround the central region 500. The body 552 may be injection molded. In some examples, the central region 500 may be substantially planar and may include a base surface 570. The body 552 may include a plurality of slots 508. The slots 508 may extend from the peripheral edge 510 of the body 552 toward the center or midpoint of the body 552. In an example embodiment, the slots 508 extend in a radial direction. The slots 508 may extend through the entire peripheral region 502. Thus, the body 552 may include a central region 500 surrounded by a plurality of petal members 514 spaced apart by the slots 508.

[0208] The central region 500 may include a coupling 98 that may be defined on a base surface 570 of the central region 500. The coupling 98 may be as described with respect to Figure 41 to Figure 46In an alternative embodiment, the coupling 98 may be a fitting (e.g., a Luer fitting). The connector 26, which may be attached, for example, to the tubing 28 leading to the infusion set 18, may be releasably coupled to the access assembly 46. The connector 26 may be coupled to the access assembly 46, as described with respect to Figure 41 to Figure 46 In an exemplary embodiment, the base surface 570 of the central region 500 may include a set of conductive contacts 540. The contacts 540 may be electrically connected to the corresponding electrodes 302A, 302B of the analyte sensor 30 of the entry assembly 46. The connector 26 may include conductive contacts on the surface of the connector 26, which abut the base surface 570 when the connector 26 is connected to the entry assembly 46. Therefore, when the connector 26 is connected to the entry assembly 46, the connector 26 can establish electrical communication with the analyte sensor 30 portion of the entry assembly 46. The electrical conduit 542 may extend from each of the connectors 26 through the connector 26 and along the conduit 28. The infusion pump 18 may be electrically connected to the conductive contacts of the connector 26 via the electrical conduit 542. In such embodiments, the transmitter 32 may not be used because the infusion device 18 may be directly connected to the analyte sensor 30. In other embodiments, the connector 26 may include the transmitter 32. In other embodiments, a separate transmitter 32 may be removably coupled (e.g., threaded, clipped, snapped, adhered, etc.) to the access assembly 46. In some embodiments, the transmitter 32 may be provided as part of the access assembly 46 and may not be removed from the access assembly 46.

[0209] Now the main reference Fig.50 and Figure 52 to Figure 54 , depicting a plan view of the proximal side 556 of the example body 552. The proximal side 522 of the central region 500 of the body 552 may include at least one boss 156, to which at least one entry member 16 is coupled. In certain embodiments, the entry member 16 may include at least one microneedle on the tip carrier 74. In the case of using a microneedle, the microneedle may be any microneedle described herein. The boss 156 may be any of the bosses 156 described herein. The proximal side 522 of the central region 500 of the body 552 may include at least one boss 358, on which at least one set of electrodes 302A, 302B are disposed. The electrodes 302A, 302B may be silicon micropenetrators, such as any silicon micropenetrators described herein. In such an embodiment, each electrode 302A, 302B may be included on a separate tip carrier 374. Alternatively, the electrodes 302A, 302B may be conductive traces present on an insulating layer included on the respective micropenetrators. In such an embodiment, the micropenetrator including electrodes 302A, 302B may be formed on the same tip carrier 374 .

[0210] Fig.50 and Fig.52 Each of the example entry assemblies 46 shown in FIG. 4 includes the same arrangement of bosses 156 entry member 16 and the same arrangement of bosses 358 electrodes 302A, 302B. The placement of bosses 156, 358 varies between embodiments. Fig.52 In the illustrated embodiment, the rocking member 166 is included on the proximal side 522 of the central region 500. The bosses 156, 358 are disposed on opposite sides of the middle region of the proximal side 522 of the central region 500. The rocking member 166 can cause the central region 500 and the access member 16 to tilt, as described with respect to FIG. Figure 35 to Figure 26 The micro-penetrators or electrodes 302A, 302B may also be tilted in the same manner as the access member 16. Fig.50 In the illustrated embodiment, the boss 358 has been moved to the position of the rocking member 166, and the rocking member 166 is not present. The boss 156 is centrally disposed on the proximal side 522 of the central region 500 (as shown in FIG. Figure 35 to Figure 36 14). In alternative embodiments, the positions of bosses 156 and bosses 358 may be interchanged. In various embodiments, each boss 156, 358 may have substantially the same height. The peripherally positioned bosses 358 may serve as rocking members 166. When entry assembly 46 is transformed to the deployed state, the micropenetrator and entry member 16 may pierce skin 14. Once central region 500 contacts skin 14, the peripherally positioned bosses 358 may inhibit further displacement of one side of central region 500 toward skin 14. The opposite side of central region 500 may not be prevented from further displacement toward skin 14, and central region 500 may rock or tilt as the transformation is completed. This may be in the form of a rotation of the central region 500 relative to the skin 14. Figure 35 to Figure 36 The described approach results in a tilting of the access member 16. The micropenetrator may be similarly tilted within the skin 14.

[0211] As with the various exemplary kits 12 and exemplary analyte sensors 30 described herein, the example entry assembly 46 may include multiple groups of entry members 16 and / or multiple groups of electrodes 302A, 302B, each group of which may be, for example, disposed on its own corresponding bosses 156, 358. In the case of including multiple entry member 16 groups and / or multiple electrode 302A, 302B groups, different entry members 16 and / or electrode 302A, 302B groups may all be substantially the same. Alternatively, they may include various differences as described elsewhere herein. For example, different groups of entry members 16 may each include one or more entry members 16, and the height of the entry member 16 may be different between groups. Similarly, the height of the electrodes of different groups may be different. In some embodiments, the entry assembly 46 may include entry members 16 (each of which may be a microneedle of suitable length) for intradermal delivery and subcutaneous delivery. The example access assembly 46 may also include electrodes 302A, 302B for an analyte sensor 30 that monitors intradermal analyte levels and include electrodes 302A, 302B for an analyte sensor 30 that monitors subcutaneous analyte levels.

[0212] Still reference Figure 50 to Figure 54 , adhesive may be included on at least a portion of the proximal side 556. Figure 55 to Figure 57 Various adhesive carrying members 54 are shown and described that can be coupled to the proximal side 556 of the body 552 of the access assembly 46. The adhesive can be a skin-compatible adhesive and can be used to couple the access assembly 46 to the surface of the skin 14 at a desired location. The adhesive can be included on the peripheral region 502 of the body 552 and on a portion of the proximal side 522 of the central region 500.

[0213] exist Figure 50 to Figure 54 , example access component 46 is depicted as being in a storage state. When access component 46 is applied to a patient, access component 46 can be placed on skin 14 in the storage state. The adhesive on the proximal side 556 of body 552 can anchor access component 46 to skin 14. Body 552 can be a deformable body that can transition from a storage state to a deployed state (reversibly or irreversibly). When the transition to the deployed state occurs, at least two adhesive-bearing portions of body 552 can be displaced expansionally relative to each other so as to be anchored to the skin surface of body 552 via adhesive stretching or expansion. This may be desirable because when body 552 transitions to the deployed state, skin 14 can be stretched taut to facilitate penetration of skin 14 by access member 16 and electrodes 302A, 302B. The adhesive present on adhesive member 54 (see, e.g. Figure 55 to Figure 57 ) can help maintain access assembly 46 in the expanded state during use. Access assembly 46 can be administered without an inserter assembly.

[0214] The example entry assembly 46 can be applied to the skin 14, and the user can press down on the body 552 to convert the entry assembly 46 to the expanded state. This can avoid the need for multiple needle sticks each time the entry assembly 46 is applied. This can make the use of the entry assembly 46 more attractive, especially for certain patient populations (e.g., patient populations with juvenile diabetes). The example entry assembly 46 can eliminate the need for a first inserter for an infusion kit and a second inserter for an analyte sensor. Removing any inserter from the application process can help break down the patient's financial considerations, which may make some patients not want to use the analyte sensor 30. By omitting the inserter, the financial burden associated with frequent site changes can be alleviated. This can help increase the patient's compliance with a prescribed site change schedule, or can allow site changes to be performed more frequently (e.g., every day).

[0215] Reference now Figure 55 to Figure 57 , a plurality of example adhesive members 54 are depicted on the example kit 12 . Figure 55 to Figure 57 The adhesive member 54 shown in the figure can also be included on the analyte sensor 30 or the access assembly 46 described elsewhere in this article. As shown, each example kit 12 includes a single adhesive member 54. In an alternative embodiment, the adhesive member 54 can be divided into a plurality of separate adhesive members 54. This can facilitate the use of different adhesives or may make some petal members 114 without adhesive. As shown, each adhesive member 54 can include a plurality of slits 216 extending radially inward from the periphery of the adhesive member 54 to produce a petal portion aligned with the petal member 114 of the body 52. ​​The adhesive member 54 can also include a central orifice 218 through which the access member 16 of the kit 12 can enter the patient's body.

[0216] The shape and size of the central orifice 218 can serve to help facilitate certain shallow deliveries. In various exemplary kits 12, it may be desirable that the central orifice 218 has a cross-sectional area of ​​60-100% of the area of ​​the footprint of the central region 100. It may also be desirable that the central orifice 218 is shaped so that at least a portion of the adhesive member 54 is attached to a portion of the body 50 or proximal side 222 of the central region 100. In some examples, the cross-sectional area of ​​the central orifice 218 may be greater than 0.13 in2 (square inches). In some examples, in various embodiments, the cross-sectional area of ​​the central orifice 218 may be in the range of 0.13 in2 to 0.5 in2 (e.g., about 0.3 in2).

[0217] In addition, it may be desirable for the central orifice 218 to be wider in certain directions than in other directions. For example, each access member 16 (e.g., one or more microneedles) may tend to dispense fluid in a spray direction extending from the outlet of the corresponding access member (e.g., along the axis of the lumen 68 of the access member 16). It may be desirable for the central orifice 218 to have a greater or increased width in a direction aligned or substantially aligned with the spray direction. For example, the maximum width (or at least a relatively large portion of the width) of the central orifice 218 can be along a direction parallel to a plane including the spray direction. Using a method including a method similar to Figure 5 In the illustrated kit 12 of one or more microneedles, the increased width portion of the central orifice 218 can be aligned with the front-to-back (distal 60 to back edge 66, also referred to herein as length) direction or symmetry line of the microneedle. For example, the central orifice 218 can be circular or stadium-shaped (see, e.g., Fig.57 ) and is widest in a direction parallel to the front-to-back direction (or length dimension) of the microneedle. This can help produce a more diffuse shallow (e.g., intradermal) injection as opposed to a concentrated bubble for at least some injections. This, in turn, can be desirable because it can help expose the medical agent to more of the vasculature at the delivery destination and can help promote absorption.

[0218] Now mainly see Fig.55 , except for the number of teeth or spokes 220 extending inwardly of the adhesive member 54 material, the central orifice 218 can be generally a circular (e.g., round) hole. In an example embodiment, the adhesive member 54 includes a central orifice 218 having four spokes 220 spaced apart from each other at regular angle increments. The number of spokes 220 can be different, and the spacing of the spokes 220 can be irregular in some examples. The spokes 220 can be arranged so that the central orifice 218 has a relatively large width in the direction aligned with the injection direction. Although the central orifice 218 can have a relatively large width in this direction, this does not exclude other wide areas of equal, smaller or even larger widths. In the example shown, the width of the central orifice 218 is approximately equal when measured in a direction perpendicular to the front-to-back direction of the microneedle. In some examples, the spokes 220 can be a portion of the adhesive member 54 that is only adhered to the body 50 or the proximal side 222 of the central region 100.

[0219] Now mainly see Fig.56 In some examples, the central aperture 218 may include a notch 224 extending outwardly from the periphery of the remainder of the central aperture 218. The notch 218 may be included to widen the central aperture 218 when desired. Although a rectangular notch 218 is included in the example, the shape of the notch may be different in alternative embodiments. The notch 218 may be any suitable polygonal shape or may be circular.

[0220] Now also refer to Fig.45 , the user can press the central area 100 of the kit 12 to convert the kit 12 to the delivery state. When the example kit 12 is converted to the delivery state, the entry member 16 and the boss 156 can be displaced toward the skin 14. An expansion displacement of the petal member 114 of the kit 12 can also occur. This expansion displacement can stretch the skin 14 (see, e.g., Figure 1 ), the kit 12 is adhered to the skin 14, and when any access member 16 of the kit 12 is displaced into the skin 14, the expanded displacement facilitates penetration of the skin 14. The slits 216 in the adhesive member 216 can allow the adhesive to accommodate the expanded displacement of the petal members 114 during the transition to the delivery state.

[0221] Initially, when the kit 12 is applied to the skin 14, the adhesive at the peripheral area 102 of the kit 12 can contact the skin 14. As the transition to the delivery state occurs, the height of the kit 12 can be reduced. When this occurs, the adhesive on the adhesive member 54 inside the peripheral area 102 can begin to contact and stick to the skin 14. The adhesive on the portion of the adhesive member 54 that partially extends to the proximal side 222 of the central area 100 (or alternatively, the body 50 attached to the body 52) can adhere to the skin 14 when the transition is completed. The adhesion of the adhesive to the skin 14 can keep the kit 12 in the delivery state and move the skin 14 and the kit 12 together as a unit. This can help ensure that when the kit 12 is used, the entry member 16 remains at the desired position in the skin 14.

[0222] In addition, when the kit 12 is in the delivery state, the boss 156 can be pressed into the skin 14 and create a depression in the skin 14. When the kit 12 is worn, the depressed skin 14 may tend to try to return to the unpressed position against the boss 156. The adhesive on the adhesive member 54 near the boss 156 can help promote this. Therefore, even when the entry member 16 and the boss 156 move in a direction away from the skin 14, the skin pierced by the entry member 16 may tend to shift with the entry member 16 and the boss 156. This can help to keep the entry member 16 firmly within the skin 14 when the kit 12 is worn, and help to inhibit leakage during delivery.

[0223] Reference now Figure 58 to Figure 63 , showing an example of a device that may be included in a delivery device 18 (see e.g. Figure 1) in a delivery assembly 24 or deployment device. The delivery assembly 24 depicted is an exemplary delivery assembly 24, and the delivery device 18 may include any of a variety of delivery deployment devices 24. Some delivery devices 18 may be syringe pumps. Some delivery devices 18 may include a peripheral pumping mechanism (e.g., a linear or finger-type pumping mechanism or a rotary peristaltic mechanism). In the case where the delivery device 18 delivers multiple medical agents to one or more kits 12, the infusion device 24 may include Figure 58 to Figure 63 Multiple delivery assemblies are shown in the delivery assembly 24 , each of which is in communication with a separate medicinal agent reservoir 22 .

[0224] In the example delivery assembly 24, the occluder assembly 232 can isolate the filled reservoir 22 from the delivery assembly 24. The opening of the occluder assembly 232 can allow the fluid to flow into the rest of the delivery assembly 24. To enable delivery of the fluid in the reservoir 22 to the user, the controller 20 (see, e.g., Figure 1 ) may command the energization of the shape memory actuator 234, which may be anchored on one end using a shape memory actuator anchor 236. The opposite end of the shape memory actuator 234 may be coupled to a common connector 238 attached to a pump plunger 240A and a reservoir valve assembly 242. Energization of the shape memory actuator 234 may result in activation 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. Activation of the reservoir valve assembly 242 may result in downward displacement of the reservoir valve actuator 242A and closing of the reservoir valve 242B, thereby resulting in effective isolation of the reservoir 22 from the delivery assembly 24. A membrane 244 may be included between the pump plunger 240A and the pump chamber 240B of the pump 105. The reservoir valve actuator 242A can press the membrane 244 against the valve seat of the reservoir valve 242B to close the reservoir valve assembly 242. The pump 240 and the reservoir valve assembly 242 can be arranged and connected by the connector 238, whereby the reservoir valve assembly 242 can be closed before the pump 240 pumps the fluid. Activation of the pump 240 can cause the pump plunger 240A to shift in a downward manner into the pump chamber 240B, resulting in displacement of the fluid (in the direction of arrow 246). The pump chamber 240B can be shaped substantially the same as the end of the pump plunger 240A so that the pump chamber 240B is substantially emptied on each stroke of the pump 240.

[0225] The volume sensor valve assembly 248 may include a volume sensor valve actuator 248A and a volume sensor valve 248B. Fig.60, the volume sensor valve actuator 248A can be maintained in a closed position via a volume valve spring assembly 248C (e.g., acting on a spring anchor 250), which provides a mechanical force to move the volume sensor valve actuator 248A against the volume sensor valve 248B to seal the volume sensor valve 248B. The volume sensor valve actuator 248A can press the membrane 244 included in the cartridge assembly 25 against the valve seat of the volume sensor valve 248B to close the volume sensor valve 248. However, when the pump 240 is activated, if the displacement fluid has sufficient pressure to overcome the mechanical sealing force of the volume sensor valve assembly 248, displacement of the fluid can occur in the direction of arrow 252. This can result in filling the volume sensor valve included in the volume sensor assembly 258 (at Fig.62 2013) is a volume sensor chamber 256 in which a volume sensor is provided. By using a speaker assembly 260, a port assembly 262, a reference microphone 264, a spring diaphragm 266, and a variable volume microphone 268, a volume sensor assembly 258 can determine the volume of fluid within the volume sensor chamber 256. The operation of such a volume sensor assembly 258 can be as discussed in U.S. Pat. No. 8,491,570, entitled “Infusion Pump Assembly” (Attorney Docket No. G75), issued on Jul. 23, 2013, which is incorporated herein by reference in its entirety. Other suitable dispense volume sensors can be used in other embodiments.

[0226] Also refer to Fig.62, shape memory actuator 270 can be anchored (on a first end) to shape memory actuator anchor 272. Additionally, the other end of shape memory actuator 270 can be used to provide mechanical energy to valve actuator 274, which can activate measurement valve assembly 276. Once the volume of fluid contained within volume sensor chamber 256 is calculated, shape memory actuator 270 can be energized, resulting in activation of measurement valve assembly 276. Measurement valve assembly 270 can include measurement valve actuator 276A and measurement valve 276B. Once activated to lift measurement valve actuator 276A from measurement valve 276B, the fluid within volume sensor chamber 256 can be displaced (in the direction of arrow 278) through kit 12 and into the patient due to the mechanical energy exerted by spring diaphragm 266 on the fluid within volume sensor chamber 256. The measuring valve actuator 276A can then press the membrane included in the cartridge assembly 25 against the valve seat 276B by de-energizing the shape memory actuator and by the action of the measuring valve spring assembly 276C (e.g., acting against the spring anchor 280) to close the measuring valve 276B. In some embodiments, the membrane interface 244 included on the reservoir valve 242B, the pump chamber 240B, the volume sensor valve 648B, and the measuring valve 276B can be formed in a single piece of material having an area covering each of these components.

[0227] As fluid is delivered to the kit 12 or access assembly 46, at least one characteristic associated with the delivery can be monitored by at least one sensor of the delivery arrangement 24. The controller 20 of the infusion device 18 can analyze data from one or more sensors to determine whether delivery is occurring in a desired manner. For example, the controller 20 can monitor data from at least one sensor in the delivery arrangement 24 to determine information related to the impedance of fluid delivery from the access member 16. Above the skin, when the access member 16 is in air, very little impedance is delivered from the access member 16. In the intradermal space, the impedance is relatively high, and it is relatively difficult to drive fluid into the intradermal space. The delivery impedance into the subcutaneous tissue can be relatively low compared to the intradermal tissue.

[0228] As fluid is delivered to the kit 12, pressure decay may occur as the fluid exits the kit 12 and enters a shallow delivery destination. Typically, fluid may flow relatively slowly from the kit 12 and into a shallow delivery destination. The associated pressure decay may be relatively slow. If the entry member 16 is disengaged or no longer in the skin 14, the fluid may flow more easily from the entry member 16, and the flow rate out of the entry member 16 may be greater than expected. In this case, the pressure decay may be relatively fast. If the entry member 16 pierces beyond the shallow destination and enters the subcutaneous space, the pressure decay may also occur more quickly.

[0229] In some examples, data from at least one pressure sensor monitoring the fluid being pumped to the kit 12 can be analyzed by the controller 20 to determine the rate at which pressure decay occurs after a certain volume of fluid has been delivered to the kit 12. In the event that the pressure decays faster than a predefined threshold (e.g., the derivative of the pressure data exceeds a predefined value), it can be determined that the entry member 16 may have shifted from a desired position. In some examples, the predefined threshold can be preprogrammed or can be calculated based on historical data of previous deliveries of the medical agent from the infusion device 18. As the volume of fluid is delivered through the kit 12, the controller 20 can monitor the data from the at least one pressure sensor to change the rate of pressure decay. In the event that the pressure decay rate changes by more than a certain threshold, the controller 20 can determine that the entry member 16 has changed position.

[0230] With respect to any determination made by the controller 20 based on data related to the entry member 16 and / or analyte sensor 30 described herein, the controller 20 may generate an associated warning when such a determination is made. The warning may be displayed on the user interface of the infusion device 18. The warning may also include an audible warning (tone, a series of tones, a beep, a plurality of beeps, etc.) or a tactile warning (a vibration motor may be activated) issued by the infusion device 18 or other components of the system 10. The controller 20 may also coordinate the communication of warnings to various components of the system 10. For example, the controller 20 may transmit the warning to at least one smart device (e.g., a smart phone, a smart watch, a tablet computer, etc.), which may display the warning and / or issue an audible or tactile warning by itself. The controller 20 may also transmit the warning to the cloud 38. The controller 20 may also determine appropriate user intervention (e.g., a new kit 12 or an analyte sensor 30 or a required entry component 46), and request the user to perform the intervention via the user interface of the system 10.

[0231] Additionally, in the case of an occlusion, the pressure decay may be slower than expected. The controller 20 may similarly analyze data from at least one pressure sensor to monitor pressure decay characteristics (e.g., decay rate, change in decay rate compared to previous data) that indicate an occlusion. In the event that the pressure decay is slower than a predefined threshold, the controller 20 may determine that an occlusion exists. Similarly, if the pressure decay rate is observed to change to a rate that is slower than previous data by more than a predefined amount, the controller 20 may determine that an occlusion exists.

[0232] In some examples and still refer to Figure 58 to Figure 63, the data from the at least one volume sensor assembly 258 may be checked multiple times as the volume of fluid is delivered from the infusion set 18 to the kit 12. The controller 20 may determine a change in the depth of the access member 16 or that an occlusion has occurred based on the data from the at least one volume sensor assembly 258. In the event that the difference in volume measured by the at least one volume sensor assembly 258 over a predetermined time period is greater than a predefined amount or the rate of change is too rapid, the controller 20 may determine that the access member 16 has changed position. Similarly, if the change in volume is less than a predefined amount or the rate of change is too slow, the controller 20 may determine that an occlusion exists. The volume or rate of change in volume may also be compared to previous data to determine if the delivery impedance is different from a previous delivery.

[0233] The infusion device 18 of the system 10 can be independently delivered to at least one long access member 16 or at least one short access member 16 included in, for example, the kit 12. In a system 10 in which a medical agent can be delivered by two or more selected access members 16 having different lengths, the controller 20 can compare the delivery data from the delivery of at least two different lengths of the access members 16. In some examples, the kit 12 or access assembly 46 can include at least one long access member 16 in communication with a subcutaneous delivery destination and a short access member 16 in communication with a shallow delivery destination. As mentioned elsewhere herein, each access member can be a microneedle of different lengths.

[0234] Typically, the displacement of the at least one short entry member 16 can be associated with a similar displacement of the at least one long entry member 16. The at least one short entry member 16 and the at least one long entry member 16 can be placed as close to each other as possible to help ensure a close association of the displacements of the at least one short entry member 16 and the at least one long entry member 16. In the case where the at least one short entry member 16 is displaced so that it leaves the skin 14, the at least one long entry member 16 can generally be displaced by a similar amount in the same direction. Such displacement of the long entry member 16 may be sufficient to position the long entry member 16 at the intradermal delivery destination. The height of the at least one long entry member 16 and / or the position of any flow lumen 68 or channel 70 in the at least one long entry member 16 can be selected to help ensure that this occurs. In the case where the at least one short entry member 16 has been pierced into the subcutaneous space, the at least one long entry member 16 can still be in the subcutaneous space.

[0235] When data indicating the delivery impedance from the at least one short entry member (e.g., pressure decay, dispensed volume sensed by the volume sensing assembly 258) indicates that the at least one short entry member 16 has changed depth, the controller 20 can analyze the data from the at least one long entry member 16. In some embodiments, the controller 20 can coordinate a delivery to the at least one long entry member 16 to collect data. In some embodiments, the at least one long entry member 16 may not be used for delivery. In such an example, the at least one long entry member 16 may be a test entry member 16 used to collect data when needed.

[0236] Upon analyzing the delivery data associated with the at least one long entry member 16, indicating that the delivery impedance characteristics expected from intradermal delivery will be, the controller 20 can determine that the at least one short entry member 16 has fallen off the skin 14. The controller 20 can stop delivery to the at least one short entry member 16, and only deliver to the at least one long entry member 16, so that treatment can continue. According to an embodiment, if the controller 20 (in any manner described herein) determines that one or more entry members 16 have left the skin 14, the controller 20 can stop delivery to the entry member 16. In the event that the controller 20 determines that at least one entry member 16 is still able to deliver fluid to the patient, the controller 20 can adjust the delivery so that the fluid is only delivered to the entry member 16 that is still in the patient's body. The controller 20 can generate a warning to communicate that this has occurred. In some embodiments, the controller 20 can stop all deliveries or prompt the user to confirm the desire to transfer delivery to certain entry members 16.

[0237] In the event that the delivery data associated with the at least one long access member 16 indicates an increase and subsequent decrease in delivery impedance, it can be determined by the controller 20 that the at least one long access member 16 and the at least one short access member 16 may have moved out of the skin 14. The controller 20 can generate a warning to this effect for display on the user interface of the infusion device 18 and / or for communication with another component of the system 10 (e.g., for display on a smart phone and / or smart watch). The controller 20 can stop delivery and can, for example, generate an indication that the kit 12 should be swapped out with a new kit 12.

[0238] When analysis of delivery data associated with the at least one short access member 16 indicates a delivery impedance characteristic consistent with a previous delivery of the at least one long access member 16, the controller 20 may determine that the at least one short access member 16 has been displaced more deeply.

[0239] In other embodiments, the access members 16 to which fluids can be delivered independently can be included in at least three different heights on the kit 12. The shortest access member 16 can have a height that generally inhibits entry into the subcutaneous space. In such embodiments, there can be at least one long access member 16 and at least one intermediate height access member 16. The intermediate height access member 16 can have a height sufficient to deliver to an intradermal delivery destination. The long access member 16 can have a height sufficient to deliver to a subcutaneous delivery destination.

[0240] In the event that sensor data associated with delivering a volume of fluid to the shortest entry member 16 indicates that there is a high delivery impedance, the intermediate length and long entry members 16 should be in the skin 14. Given the high delivery impedance from the shortest entry member 16, when data associated with the impedance from the intermediate entry member 16 indicates a drop in impedance, the controller 20 can determine that the intermediate entry member 16 is in communication with the subcutaneous space. In the event that data associated with delivering a volume of fluid to the shortest entry member 16 and the intermediate entry member 16 indicates a low impedance, it can be determined by the controller 20 that these entry members 16 have moved out of the skin 14. The controller 20 can generate an alert conveying such a determination for display on a user interface of the infusion device 18 and / or for communication with another component 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 absorption curve of the medical agent. Since the absorption curve for the medical agent can depend on the depth of the delivery destination, the controller 20 can use the impedance-related data to adjust the delivery calculation based on the determined depth of the entry member 16. For example, the controller 20 can adjust the timing of delivery in the case where the controller determines that the medical agent will be absorbed faster or slower. Other calculations can also be adjusted based on the determined depth of the entry member 16. Using the example of insulin, the insulin on board (IOB) calculation or the duration of insulin action (DIA) calculation can be adjusted. In the case where the medical agent is a medical agent other than insulin, the determination of similar medical agents on the board of other medical agents or the duration of the action of the medical agent can be adjusted.

[0242] In an analyte sensor 30 and access assembly 46 having multiple sets of electrodes 302A, 302B that sense analyte levels at different depths, data from each set 302A, 302B of electrodes can be compared. In the case where a pair of electrodes 302A, 302B of the analyte sensor 30 is in air, the readings from the analyte sensor 30 should indicate that the analyte sensor 30 is not monitoring an appropriate location. Additionally, an analyte sensor 30 that monitors a highly vascularized space (e.g., a superficial or intradermal location) and a less vascularized space (e.g., a subcutaneous space) to determine blood analyte levels should collect data that differs in a predictable and relevant manner.

[0243] Using diabetes as a non-limiting example, interstitial glucose levels in the subcutaneous space may lag interstitial glucose levels in the blood by a considerable amount compared to interstitial glucose levels in the intradermal space. Thus, an analyte sensor 30 monitoring, for example, the subcutaneous space will see a response to changes in blood glucose levels that is delayed or time-shifted relative to changes in blood glucose levels sensed by the analyte sensor 30 monitoring the intradermal space.

[0244] The delivery of insulin or glucagon from the infusion device 18 (or carbohydrate intake) should change the blood glucose level, and the change will be most clearly seen by the analyte sensor 30 monitoring the intradermal space. The time of delivering the medical agent from the infusion device 18 and the volume of the delivered medical agent can be known. In some embodiments, the timing of carbohydrate consumption and the amount of carbohydrate consumed can also be input into certain systems 10 by the user. In addition, the expected regulation of blood glucose level should be generated by the delivery of the medical agent (or carbohydrate consumption). The response to the change of blood glucose for the delivery of the medical agent observed in the subcutaneous tissue, for example, should lag behind that observed in the intradermal tissue. The data from the shallow and deeper analyte sensors 30 should generally track each other in a predictable manner during the life of the analyte sensor 30. The expected relationship between the data from the shallow analyte sensor 30 and the data from the deeper analyte sensor 30 can be determined (for example, by the controller 20) based on the data collected from the analyte sensor 30. For example, the expected time shift (or expected time shift window or range) between the data from each analyte sensor 30 can be determined. The relationship may be updated periodically during the life of the analyte sensor 30, and may be initially determined during or after a warm-up period of the analyte sensor 30. In some examples, when a new analyte sensor 30 is placed, the expected relationship may be initialized to a predefined expected relationship for the patient (e.g., from data collected from previous analyte sensor 30 usage).

[0245] In some examples, the controller 20 can analyze the analyte sensor 30 data to determine the analyte level trend information that can be displayed to the user via the user interface. For example, the current data can be compared with the previous data to determine the trend of the analyte level. For example, the controller 20 can generate a message or other indication showing that the blood glucose level is going down (or sharply down), up (or sharply up) or maintaining a roughly level. In some examples, the controller 20 can determine the trend information based on the data from only one analyte sensor in the analyte sensor 30, or by determining the trend information according to the higher weighting of the data from one of the analyte sensors 30. For example, in the case where the deeper analyte sensor 30 indicates a trend different from the trend sensed by the intradermal analyte sensor 30, the data from the intradermal analyte sensor 30 can be used or at least more heavily weighted when determining the current trend for display. In some examples, the difference between the data from each of the analyte sensors 30, the derivative of the data, or the derivative of the difference between the data can also be used or alternatively used to determine the blood analyte level trend information.

[0246] In the event that the shallow analyte sensor 30 begins to output data indicating that the analyte sensor 30 is in air, the data from the deeper analyte sensor 30 may be checked by the controller 20. In the event that the deeper analyte sensor 30 begins to output data indicating that the deeper analyte sensor 30 is also in air, the controller 20 may determine that the analyte sensor 30 has fallen off the skin. In the event that the data from the deeper analyte sensor 30 is recording a response to a change in blood glucose (e.g., due to the administration of a medical agent), the controller 20 may determine that the shallow analyte sensor 30 has moved out of the skin 14.

[0247] In addition, data from the shallow analyte sensor 30 and the deeper analyte sensor 30 may be compared to determine that a particular analyte sensor 30 is beginning to display abnormal behavior (e.g., has or is beginning to fall out). Historical data may be used to assist in such determinations. For example, in the event that a first analyte sensor in the analyte sensors 30 deviates from a typical or expected response relationship to a change in blood analyte levels (e.g., due to medical agent delivery or user action, such as eating), while a second analyte sensor in the analyte sensors 30 does not deviate beyond a certain predefined threshold, the first analyte sensor in the analyte sensors 30 may, for example, begin to fall out. Alternatively or additionally, if the typical relationship between the data from the first analyte sensor 30 and the second analyte sensor 30 (e.g., determined from historical analyte sensor 30 data) begins to deteriorate, this may indicate a fall-out problem or a developing fall-out problem with one of the analyte sensors 30. The controller 20 may determine that a fall-out event is occurring for the relevant analyte sensor 30 based on the comparison of the above analyte sensor 30 data. The controller 20 may communicate a warning to the user interface of the infusion device 18 and / or transmit a warning for display on another component of the system 10. This may help prevent the user from acting on data from the analyte sensor 30 that begins to fall out.

[0248] In some examples, if the expected relationship between the data from the analyte sensors 30 has deteriorated beyond a certain threshold, the controller 20 can analyze the analyte sensor 30 data to perform various troubleshooting. For example, if the expected relationship no longer exists, the controller 20 can check to see if the data from one of the analyte sensors 30 indicates that the analyte sensor is in the air 30. If the shallow analyte sensor 30 and the deeper analyte sensor 30 report data that does not show a time-shifted change in the sensed analyte level, the controller 20 can determine that the shallow analyte sensor 30 may have changed depth to a deeper (e.g., subcutaneous) location. That is, if the analyte sensors 30 simultaneously report approximately the same analyte level and / or the analyte level changes at approximately the same rate over the same time period, the controller 20 can determine that each analyte sensor 30 may be monitoring the same location in the patient's body.

[0249] In some embodiments, data collected about any puncture body, regardless of purpose, can be used in combination by the controller 20 to make various determinations about the position or state of the puncture body. For example, analyte sensor 30 data and data related to the delivery impedance from the entry member 16 can be used by the controller 20 to help determine the state or position of certain puncture bodies. For example, if the controller 20 makes a determination about the entry member 16 or sensor as described elsewhere herein, data related to another puncture body can be checked. Additional data can help confirm or verify the determination. In some embodiments, no warning may be generated before the additional data is analyzed. For example, data related to other entry members 16 or data from other analyte sensors 30 can be used to help determine or verify that a particular puncture body has changed depth, has developed an occlusion, or in the case of an analyte sensor, has a fall-out problem.

[0250] Examples of using the entry assembly 46 (see e.g. Figure 3 ), all puncture bodies on the access assembly 46 can be relatively close to each other. In the case where the data associated with all access members 16 of the access assembly 46 indicates low delivery impedance and the analyte sensor 30 data indicates that the analyte sensor 30 may be in the air, it can be determined that the access assembly 46 has fallen off or been removed. In the case where the data associated with all access members 16 indicates that they are in the expected position and all but one analyte sensor 30 outputs data within predefined expectations, the non-compliant analyte sensor 30 is unlikely to change depth. Therefore, the controller 20 can infer that the non-compliant analyte sensor 30 may have fallen out.

[0251] If the data indicating the delivery impedance from the access member 16 indicates a different impedance than expected, the controller 20 may analyze the analyte sensor 30 data. If the data from the analyte sensor 30 indicates that the analyte level changes in response to the delivery of the medical agent through the access member 16 are not as expected, the controller 20 may determine that the access member 16 has changed depth (e.g., subcutaneous compared to intradermal, if slower than expected, or vice versa, if faster). In the case where there are multiple analyte sensors 30 monitoring different depths, the data from each analyte sensor 30 may be examined. For example, if the response detected by all analyte sensors 30 to the administration of a certain volume of medical agent to change the analyte level is longer than expected, it can be determined that the access member 16 has shifted to a deeper delivery destination. If the data from the deeper analyte sensor 30 indicates a shorter lag time in sensing a change in analyte level (e.g., after delivery of a medical agent) and the delivery impedance-related data from at least one longer entry member 16 indicates a higher than expected impedance, the controller 20 may determine that the deeper analyte sensor 30 and the longer entry member 16 have changed depth (e.g., from a subcutaneous position to an intradermal position). When this is observed, the controller 20 may check the data from the shorter analyte sensor 30 and at least one shorter entry member 16 to verify that they have not moved out of the skin 14. Additionally, if the controller 20 notices that the shallow analyte sensor 30 is providing data indicating that the analyte sensor 30 is in air and the delivery impedance data associated with at least one short entry member 16 indicates that the short entry member 16 may be in air, the controller 20 may check the data from the deeper analyte sensor 30 and / or the longer entry member 16. The controller 20 may verify that the change in depth of the deeper analyte sensor 30 and / or the longer entry member 16 is reflected in the related data before generating an alert.

[0252] Various substitutions and modifications can be designed by those skilled in the art without departing from the present disclosure. Therefore, the present disclosure is intended to include all such substitutions, modifications and variants. In addition, although several embodiments of the present disclosure have been shown in the drawings and / or discussed herein, it is not intended to limit the present disclosure to this, because it is intended that the present disclosure is as wide as the art will allow in scope and this description should be read equally. Therefore, the above description should not be interpreted as limiting, but only as an example of a specific embodiment. And, those skilled in the art will envision other modifications within the scope and spirit of the claims attached hereto. Other elements, steps, methods and techniques that are not substantially different from those described above and / or in the appended claims are also intended to be within the scope of the present disclosure.

[0253] The embodiments shown in the accompanying drawings are presented only to reveal certain examples of the present disclosure. Also, the drawings described are illustrative only and are non-limiting. In the accompanying drawings, for the purpose of illustration, the sizes of some elements may be exaggerated and not drawn to a specific scale. In addition, the elements shown in the drawings with the same number may be the same element or may be similar elements, depending on the context.

[0254] Where the term "comprising" is used in the present description and claims, other elements or steps are not excluded. When an indefinite or definite article is used when referring to a singular noun, for example "a", "an" or "the", this includes the plural of the noun unless specifically stated otherwise. Thus, the term "comprising" should not be interpreted as being limited to the items listed thereafter; other elements or steps are not excluded, and thus the scope of the expression "a device comprising items A and B" should not be limited to a device consisting of only components A and B.

[0255] Furthermore, the terms "first", "second", "third", etc., whether used in the description or in the claims, are provided to distinguish between similar elements and not necessarily to describe a sequential or chronological order. It is to be understood that the terms so used are interchangeable where appropriate (unless expressly disclosed otherwise), and that the embodiments of the disclosure described herein are capable of operation in other sequences and / or arrangements than those described or illustrated herein.

Claims

1. A medical agent delivery device, comprising: a body including a central region and a peripheral region, wherein the peripheral region has a plurality of petal-like members extending outwardly from the central region; at least one coupling member, the at least one coupling member being on a first surface of the central region; as well as At least one prong carrier is disposed on a second side of the central region opposite the first side, each of the at least one prong carrier being in fluid communication with a respective one of the at least one coupling.

2. The medical agent delivery device according to claim 1, wherein: The central region is convex relative to the peripheral region.

3. The medical agent delivery device according to claim 1, wherein: Each of the at least one coupling is a mating piece.

4. The medical agent delivery device according to claim 1, wherein: The at least one coupling includes connector receivers each having a ramp surface and a flange surface.

5. The medical agent delivery device according to claim 1, wherein: The at least one coupling includes at least one guide for the fluid transfer connector.

6. The medical agent delivery device according to claim 1, wherein: Each of the at least one coupling comprises a Luer fitting.

7. The medical agent delivery device according to claim 1, wherein: The body and the coupling are configured for injection molding without side action.

8. The medical agent delivery device according to claim 1, wherein: The second side of the central region includes at least one rocking member.

9. The medical agent delivery device according to claim 1, wherein: The at least one tip carrier consists of etched silicon.

10. The medical agent delivery device according to claim 1, wherein: Each of the at least one tip carrier is coupled to a corresponding one of the at least one boss on the second face during an injection molding operation.

11. The medical agent delivery device according to claim 1, wherein: Each of the at least one tine carrier is coupled to a corresponding one of the at least one boss on the second face by an adhesive.

12. The medical agent delivery device according to claim 1, wherein: The device includes a septum that seals a passageway in fluid communication with the at least one tip carrier.

13. The medical agent delivery device according to claim 1, wherein: The second face of the central region is at least partially covered with an adhesive carrying member.

14. The medical agent delivery device of claim 1, further comprising an adhesive carrying member.

15. The medical agent delivery device according to claim 1, wherein: Each of the at least one pointed carrier includes at least one microneedle.

16. The medical agent delivery device according to claim 1, wherein: Each of the at least one tip carrier includes an array of microneedles.

17. The medical agent delivery device according to claim 1, wherein: A first one of the at least one pointed carrier includes at least one first microneedle having a first height, and a second one of the at least one pointed carrier includes at least one second microneedle having a second height different from the first height.

18. The medical agent delivery device according to claim 17, wherein: When the device is used, the first height is selected to place the at least one first microneedle in a shallow delivery destination, and the second height is selected to place the at least one second microneedle in a deeper delivery destination.

19. The medical agent delivery device according to claim 18, wherein: The shallow delivery destination is an intradermal delivery destination.

20. The medical agent delivery device according to claim 18, wherein: The deeper delivery destination is a subcutaneous delivery destination.

21. The medical agent delivery device according to claim 1, wherein: Each of the at least one tine carrier is in fluid communication with the corresponding one of the at least one coupling.

22. A medical agent delivery device, comprising: a body including a central region and a peripheral region, wherein the peripheral region has a plurality of petal-like members extending outwardly from the central region; as well as A body is coupled to the main body, the body including at least one coupling member on a first face of the central region and at least one prong carrier on an opposite face of the central region, each of the at least one prong carrier being in fluid communication with a respective one of the at least one coupling member.

23. The device according to claim 22, wherein: The body is coupled to a ridge included in a portion of the main body.

24. The device according to claim 22, wherein: The body includes a plurality of tabs that couple to slots in the body.

25. The device according to claim 22, wherein: The central region is convex relative to the peripheral region.

26. The device according to claim 22, wherein: Each of the at least one coupling member is a mating member.

27. The device according to claim 22, wherein: Each of the at least one coupling is a pipe receiver into which a fluid line leading to the fitting is coupled.

28. The device according to claim 22, wherein: The at least one coupling includes connector receivers each having a ramp surface and a flange surface.

29. The device according to claim 22, wherein: The at least one coupling member comprises at least one guide member.

30. The device according to claim 22, wherein: Each of the at least one coupling comprises a Luer fitting.

31. The device according to claim 22, wherein: The main body and the body are injection molded.

32. The device according to claim 22, wherein: The opposite side of the body includes at least one rocking member.

33. The apparatus of claim 22, wherein: The at least one tip carrier consists of etched silicon.

34. The apparatus of claim 22, wherein: Each of the at least one tip carrier is coupled to a corresponding one of the at least one bosses on the opposing faces during an injection molding operation.

35. The apparatus of claim 22, wherein: Each of the at least one prong carrier is coupled to a corresponding one of the at least one boss on the opposing face by an adhesive.

36. The apparatus of claim 22, wherein: The device includes a septum that seals a passageway in fluid communication with the at least one tip carrier.

37. The device according to claim 1, wherein: The opposite face of the body is at least partially covered with an adhesive carrying member.

38. The device of claim 22, further comprising an adhesive carrying member.

39. The apparatus of claim 22, wherein: Each of the at least one pointed carrier includes at least one microneedle.

40. The apparatus of claim 22, wherein: Each of the at least one tip carrier includes an array of microneedles.

41. The apparatus of claim 22, wherein: A first one of the at least one pointed carrier includes at least one first microneedle having a first height, and a second one of the at least one pointed carrier includes at least one second microneedle having a second height different from the first height.

42. The device according to claim 41, wherein When the device is used, the first height is selected to place the at least one first microneedle in a shallow delivery destination, and the second height is selected to place the at least one second microneedle in a deeper delivery destination.

43. The device according to claim 42, wherein: The shallow delivery destination is an intradermal delivery destination.

44. The device according to claim 42, wherein: The deeper delivery destination is a subcutaneous delivery destination.

45. The apparatus of claim 22, wherein: Each of the at least one tine carrier is in fluid communication with the corresponding one of the at least one coupling.

46. ​​A medical agent delivery device, comprising: a body including a central region and a peripheral region, wherein the peripheral region has a plurality of petal-like members extending outwardly from the central region; at least one coupling member, the at least one coupling member being on a first surface of the central region; as well as At least one prong carrier is on the opposite side of the central region, each of the at least one prong carrier being in fluid communication with a corresponding one of the at least one coupling, the at least one prong carrier being coupled to the boss on the opposite side.

47. An analyte sensor device comprising: a body including a central region and a peripheral region, wherein the peripheral region has a plurality of petal-like members extending outwardly from the central region; at least one pointed carrier, the at least one pointed carrier being on the first face of the central region, each of the at least one pointed carrier comprising at least one electrode, the device comprising at least one first electrode and at least one second electrode, wherein the at least one second electrode is associated with an analyte sensing chemical substance.

48. The apparatus of claim 47, wherein: The central region is convex relative to the peripheral region.

49. The apparatus of claim 47, wherein: Each of the at least one electrode is in communication with a conductive trace extending to opposite sides of the central region.

50. The apparatus of claim 47, wherein: The device includes a first tine carrier, wherein the first tine carrier includes the at least one first electrode, and a second tine carrier that is separate from the first tine carrier and includes the at least one second electrode.

51. The apparatus of claim 47, wherein: An opposite face of the central area, opposite to the first face, comprises at least one coupling member for coupling the device to a transmitter.

52. The apparatus of claim 47, wherein: Each of the at least one tine carrier is coupled to a boss on the first face of the central region.

53. The apparatus of claim 52, wherein: Each of the at least one tip carrier is coupled to the boss in an injection molding operation.

54. The apparatus of claim 47, wherein: The first face of the central region includes at least one boss, and the at least one first electrode and the at least one second electrode are each coupled to one of the at least one boss.

55. The apparatus of claim 54, wherein: The at least one first electrode and the at least one second electrode are each coupled to one of the at least one boss during an injection molding operation.

56. The apparatus of claim 47, wherein: The body is injection moulded.

57. The apparatus of claim 47, wherein: The first side of the central region includes at least one rocking member.

58. The apparatus of claim 47, wherein: The at least one tip carrier consists of etched silicon.

59. The apparatus of claim 47, wherein: The first face of the central region is at least partially covered with an adhesive carrying member.

60. The apparatus of claim 47, wherein: The device also includes an adhesive carrying member.

61. The apparatus of claim 47, wherein: Each of the at least one first electrode and each of the at least one second electrode is a micro-penetrator.

62. The apparatus of claim 47, wherein: Each of the at least one first electrode and each of the at least one second electrode are included on a micro-penetrator at least partially covered by an insulating material.

63. The apparatus of claim 47, wherein: A first one of the at least one second electrode is configured to penetrate a first depth into the biological barrier, and a second one of the at least one second electrode is configured to penetrate a second depth into the biological barrier.

64. The apparatus of claim 63, wherein: The first depth is selected to be a shallow depth and the second depth is selected to be a subcutaneous depth.

65. The apparatus of claim 63, wherein: The shallow depth is the intradermal depth.

66. The apparatus of claim 47, wherein: The apparatus comprises at least one transmitter.

67. The apparatus of claim 47, wherein: The at least one transmitter is disposed on a second side of the central area opposite to the first side.

68. The apparatus of claim 47, wherein: The analyte sensor device is a glucose sensor.

69. An access assembly device for a biological barrier, comprising: a body, the body comprising a central region and a peripheral region, wherein the peripheral region has a plurality of petal-like members; A coupling member, the coupling member being disposed on a first surface of the central region; at least one access member having a delivery lumen on opposite sides of the central region; as well as At least one analyte sensor has electrodes on the opposing sides of the central region.

70. The apparatus of claim 69, wherein: The coupling piece is a mating piece.

71. The apparatus of claim 69, wherein: The coupling is a Luer lock.

72. The apparatus of claim 69, wherein: The coupling includes at least one guide and at least one connector receiver, each of the at least one connector receiver having a ramp surface and a flange surface.

73. The apparatus of claim 69, wherein: The device also includes a septum that seals a passageway in fluid communication with the at least one access member.

74. The apparatus of claim 69, wherein: The apparatus further comprises at least one transmitter.

75. The apparatus of claim 69, wherein: The opposite side of the central region includes at least one boss, the entry member and the electrode each being coupled to one of the at least one boss.

76. The apparatus of claim 75, wherein: The opposite side of the central region includes at least one rocking member.

77. The apparatus of claim 69, wherein: The opposite side of the central region includes at least one boss, the at least one entry member and the electrode are each coupled to one of the at least one boss, and one of the at least one boss forms one of the at least one shaking member.

78. The apparatus of claim 69, wherein: The analyte sensor is a glucose sensor.

79. The apparatus of claim 69, wherein: The at least one access member includes an array of microneedles extending from a tip carrier.

80. The apparatus of claim 69, wherein: The electrode includes a micro-penetrator extending from a tip carrier.

81. The apparatus of claim 69, wherein: The at least one entry member is comprised of etched silicon.

82. The apparatus of claim 69, wherein: The at least one access member includes at least one first access member and at least one second access member, wherein the at least one first access member is configured for shallow delivery and the at least one second access member is configured for subcutaneous delivery.

83. The apparatus of claim 69, wherein: The at least one first access member is configured for intradermal delivery.

84. The apparatus of claim 69, wherein: The electrodes include a first set of electrodes configured to sense analyte levels at a superficial location in the biological barrier and a second set of electrodes configured to sense analyte levels at a subcutaneous location in the biological barrier.

85. The apparatus of claim 83, wherein: The superficial location is an intradermal location.

86. An access assembly device for a biological barrier, comprising: a body including a central region and a peripheral region, the peripheral region having a plurality of petal-like members extending outwardly from the central region; at least one coupling member, the at least one coupling member being on a first surface of the central region; at least one first tine carrier on an opposite side of the central region, each of the at least one first tine carrier being in fluid communication with a respective one of the at least one coupling; as well as at least one second prong carrier, said at least one second prong carrier being on said opposite side of said central region, each of said at least one second prong carrier comprising at least one electrode, said device comprising at least one first electrode and at least one second electrode, wherein said at least one second electrode is associated with an analyte sensing chemical substance.

87. The apparatus of claims 1, 22, 46, 47, 69, 85, wherein: The body is configured to transition from a stored state to a deployed state, and at least two portions of the body are expansionally displaced as the body transitions from the stored state to the deployed state.

88. The apparatus of claims 1, 22, 46, 47, 69, 85, wherein: The body is configured to transition from a stored state to a deployed state, and at least two adhesive carrying portions of the body are expansionally displaced as the body transitions from the stored state to the deployed state.

89. The device of claims 1, 22, 46, 47, 69, 85, wherein: The body is configured to transition from a stored state to a deployed state, and the central region is configured to translate toward a biological barrier for administering the device as the body transitions from the stored state to the deployed state.

90. A medical agent delivery system comprising: an infusion set comprising a delivery assembly including at least one sensor and at least one pumping arrangement; a kit in fluid communication with the delivery device, the kit comprising at least one intradermal access member; as well as A controller is configured to manage the operation of the at least one pumping arrangement, the controller is in data communication with the at least one sensor, and the controller is configured to analyze the data from the at least one sensor and determine, based on the data from the at least one sensor, that a change in the depth of the at least one access member has occurred.

91. The system of claim 89, wherein: The system also includes at least one analyte monitor.

92. The system of claim 89, wherein: The system also includes a glucose monitor.

93. The system of claim 89, wherein: The controller is in communication with at least one smart device and the infusion device.

94. The system of claim 89, wherein: The delivery assembly is split between a first portion of the infusion set and a second portion of the infusion set, wherein the second portion is removably coupled to the first portion.

95. The system of claim 93, wherein: The second part is a box assembly.

96. The system of claim 94, wherein: The cartridge assembly includes at least one flow path covered by at least one membrane and at least one valve component.

97. The system of claim 89, wherein: The at least one sensor includes a pressure sensor configured to monitor a volume of fluid delivered from the infusion set to the kit.

98. The system of claim 96, wherein: The controller is configured to analyze data from the at least one sensor to determine whether a pressure decay rate violates a predefined criterion.

99. The system of claim 96, wherein: The controller is configured to analyze data from the at least one sensor to determine whether a pressure decay rate exceeds a predefined threshold, and the controller is configured to generate a warning for display on a user interface of the system when the pressure decay rate exceeds the threshold.

100. The system of claim 96, wherein: The controller is configured to analyze data from the at least one sensor to determine whether a pressure decay rate is below a predefined threshold, and the controller is configured to generate a warning for display on a user interface of the system when the pressure decay rate is below the threshold.

101. The system of claim 89, wherein: The at least one sensor comprises an acoustic volume sensor having a variable volume chamber, and data from the at least one sensor is indicative of a volume of a fluid in the variable volume chamber.

102. The system of claim 100, wherein: The controller is configured to analyze data from the at least one sensor to determine whether a change in volume of the variable volume chamber over time violates a predefined criterion.

103. The system of claim 100, wherein: The controller is configured to analyze data from the at least one sensor to determine whether a rate of change of the volume of the variable volume chamber exceeds a predefined threshold, and the controller is configured to generate a warning for display on a user interface of the system when the rate of change exceeds the threshold.

104. The system of claim 100, wherein: The controller is configured to analyze data from the at least one sensor to determine whether a rate of change of the volume of the variable volume chamber is below a predefined threshold, and the controller is configured to generate a warning for display on a user interface of the system when the rate of change is below the threshold.

105. The system of claim 89, wherein: The at least one intradermal access member comprises a microneedle.

106. The system of claim 89, wherein: The at least one intradermal access member includes an array of microneedles on a pointed carrier coupled to a boss on a face of the kit.

107. The system of claim 105, wherein: The face of the kit includes at least one rocking member.

108. The system of claim 89, wherein: The kit includes a body having a central region and a peripheral region, wherein the peripheral region includes a plurality of petal-like members.

109. The system of claim 107, wherein: The body is configured to transition from a storage state to an expanded state, at least two adhesive-bearing portions of the body are expansively displaced as the body transitions from the storage state to the expanded state, and the central area is configured to translate toward a biological barrier to which the kit is applied as the body transitions from the storage state to the expanded state.

110. The system of claim 89, wherein: The at least one sensor is configured to generate a data signal that varies relative to a delivery impedance from the at least one access member.

111. A medical agent delivery system, comprising: an infusion set comprising a delivery assembly including at least one sensor and at least one pumping arrangement; a kit in fluid communication with the delivery device, the kit comprising at least one superficial access member and at least one subcutaneous access member; as well as and a controller configured to manage the operation of the at least one pumping arrangement, the controller being in data communication with the at least one sensor and being configured to compare data from the at least one sensor relating to fluid delivery to the shallow access member and to the at least one subcutaneous access member, and to determine a change in depth of one or more of the shallow access member and the at least one subcutaneous access member based on the data from the at least one sensor.

112. The system of claim 110, wherein: The at least one superficial access member and the at least one subcutaneous access member are microneedles.

113. The system of claim 110, wherein: The at least one superficial access member and the at least one subcutaneous access member each include an array of microneedles on a pointed carrier coupled to a boss on a face of the kit.

114. The system of claim 112, wherein: The face of the kit includes at least one rocking member.

115. The system of claim 110, wherein: The kit includes a body having a central region and a peripheral region, wherein the peripheral region includes a plurality of petal-like members.

116. The system of claim 114, wherein: The body is configured to transition from a storage state to an expanded state, at least two adhesive-bearing portions of the body are expansively displaced as the body transitions from the storage state to the expanded state, and the central area is configured to translate toward a biological barrier to which the kit is applied as the body transitions from the storage state to the expanded state.

117. The system of claim 110, wherein: The system also includes at least one analyte monitor.

118. The system of claim 110, wherein: The system also includes a glucose monitor.

119. The system of claim 110, wherein: The controller is in communication with at least one smart device and the infusion device.

120. The system of claim 110, wherein: The delivery assembly is split between a first portion of the infusion set and a second portion of the infusion set, wherein the second portion is removably coupled to the first portion.

121. The system of claim 119, wherein: The second part is a box assembly.

122. The system of claim 120, wherein: The cartridge assembly includes at least one flow path covered by at least one membrane and at least one valve component.

123. The system of claim 110, wherein: The at least one sensor is configured to generate a data signal that varies relative to a delivery impedance from the at least one access member.

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

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

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

127. A medical agent delivery system comprising: an infusion set having a delivery assembly including at least one pumping arrangement; a kit in fluid communication with the delivery device, the kit comprising at least one access member, a shallow analyte sensor, and a deep analyte sensor; as well as a controller configured to manage operation of the at least one pumping arrangement to selectively deliver fluid from the infusion set to the at least one access member, the controller being in data communication with the shallow analyte sensor and the deep analyte sensor; and Wherein the controller is configured to compare data from the shallow analyte sensor and data from the deep analyte sensor and to generate a notification when a relationship between the data from the shallow analyte sensor and the data from the deep analyte sensor violates a predefined criterion.

128. The system of claim 126, wherein: The at least one superficial analyte sensor and the at least one subcutaneous analyte sensor include micro-penetrators.

129. The system of claim 126, wherein: The face of the kit includes at least one boss, and the shallow analyte sensor and the deep analyte sensor are each coupled to one of the at least one boss.

130. The system of claim 128, wherein: The face of the kit includes at least one rocking member.

131. The system of claim 126, wherein: The kit includes a body having a central region and a peripheral region including a plurality of petal-like members.

132. The system of claim 130, wherein: The body is configured to transition from a storage state to an expanded state, at least two adhesive-bearing portions of the body are expansively displaced as the body transitions from the storage state to the expanded state, and the central area is configured to translate toward a biological barrier to which the kit is applied as the body transitions from the storage state to the expanded state.

133. The system of claim 126, wherein: The shallow analyte sensor is an intradermal analyte sensor and the deep analyte sensor is a subcutaneous analyte sensor.

134. The system of claim 126, wherein: The shallow analyte sensor and the deep analyte sensor are glucose sensors.

135. The system of claim 126, wherein: The controller is in communication with at least one smart device and the infusion device.

136. The system of claim 126, wherein: The delivery assembly is split between a first portion of the infusion set and a second portion of the infusion set, wherein the second portion is removably coupled to the first portion.

137. The system of claim 135, wherein: The second part is a box assembly.

138. The system of claim 136, wherein: The cartridge assembly includes at least one flow path covered by at least one membrane and at least one valve component.

139. The system of claim 126, wherein: The predefined criterion is a time lag between changes in analyte levels measured by the shallow analyte sensor and the deep analyte sensor.

140. The system of claim 126, wherein: The predefined criteria are determined based on historical data collected from the shallow analyte sensor and the deep analyte sensor.

141. The system of claim 126, wherein: The controller is further configured to analyze data from the shallow analyte sensor and the deep analyte sensor and generate a notification when data from either of the analyte sensors indicates that the corresponding analyte sensor has been displaced from its expected position.

142. A medical agent delivery system, comprising: an infusion set having a delivery assembly including at least one pumping arrangement; a kit in fluid communication with the delivery device, the kit comprising at least one shallow access member, at least one deep access member, and at least one analyte monitor; as well as a controller configured to manage operation of the at least one pumping arrangement to selectively deliver fluid from the infusion set to each of the access members; as well as at least one sensor configured to generate a signal that varies relative to a delivery impedance from the access member; and wherein the controller is configured to analyze data from the sensors and data from the at least one analyte monitor and to generate a notification when the data from the at least one analyte monitor and the data from the sensors respectively indicate that at least one of the at least one analyte sensor and at least one of the entry members have been displaced from their expected positions.

143. The system of claim 141, wherein: The at least one shallow access member and the at least one deep access member are microneedles.

144. The system of claim 141, wherein: The at least one shallow entry member and the at least one deep entry member each include an array of microneedles on a pointed carrier, wherein the pointed carrier is coupled to a boss on a face of the kit.

145. The system of claim 143, wherein: The face of the kit includes at least one rocking member.

146. The system of claim 141, wherein: The kit includes a body having a central region and a peripheral region, wherein the peripheral region includes a plurality of petal-like members.

147. The system of claim 145, wherein: The body is configured to transition from a storage state to an expanded state, at least two adhesive-bearing portions of the body are expansively displaced as the body transitions from the storage state to the expanded state, and the central area is configured to translate toward a biological barrier to which the kit is applied as the body transitions from the storage state to the expanded state.

148. The system of claim 141, wherein: The at least one superficial access member is an intradermal access member, and the at least one deep access member is a subcutaneous access member.

149. The system of claim 141, wherein: The at least one analyte monitor includes a micropenetrator.

150. The system of claim 141, wherein: The controller is in communication with at least one smart device and the infusion device.

151. The system of claim 141, wherein: The delivery assembly is split between a first portion of the infusion set and a second portion of the infusion set, wherein the second portion is removably coupled to the first portion.

152. The system of claim 150, wherein: The second part is a box assembly.

153. The system of claim 151, wherein: The cartridge assembly includes at least one flow path covered by at least one membrane and at least one valve component.

154. The system of claim 141, wherein: The kit includes a coupling configured to couple with a fluid transfer connector at a terminal end of a fluid line extending from the infusion set.

155. The system of claim 153, wherein: The kit includes a conductive trace extending from the at least one analyte monitor, and the fluid transfer connector includes a contact configured to seat against the conductive trace when the fluid transfer connector is engaged with the coupling.

156. The system of claim 154, wherein: An electrical communication path extends from the contact and along the length of the fluid line.

157. An analyte sensing system comprising: an analyte sensor assembly, the analyte sensor assembly comprising a shallow analyte sensor and a deep analyte sensor; A controller is in data communication with the shallow analyte sensor and the deep analyte sensor, the controller being configured to compare data received from the shallow analyte sensor and the deep analyte sensor and to generate a notification if the data from the analyte sensors deviates beyond a threshold from an expected relationship.

158. The system of claim 156, wherein: The controller is configured to initialize the expected relationship to a predefined expected relationship.

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

160. The system of claim 156, wherein: The controller is 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.

161. The system of claim 156, wherein: The shallow analyte sensor is an intradermal analyte sensor and the deep analyte sensor is a subcutaneous analyte sensor.

162. The system of claim 156, wherein: The shallow analyte sensor and the deep analyte sensor each include at least one micro-penetrator.

163. The system of claim 156, wherein: The expected relationship defines a delay between a change in the analyte level sensed by the shallow analyte sensor and a change in the analyte level sensed by the deep analyte sensor.

164. The system of claim 156, wherein: The analyte sensing assembly includes a coupling to a connector for hardwired communication with the controller.

165. The system of claim 156, wherein: The analyte sensing assembly is configured to couple to a transmitter for wirelessly communicating data to the controller.

166. The system of claim 156, wherein: The analyte sensing assembly includes a face having at least one boss, the shallow analyte sensor and the deep analyte sensor each being disposed on the at least one boss.

167. The system of claim 165, wherein: The surface includes a rocking member.

168. The system of claim 156, wherein: The analyte sensing assembly includes a body having a central region and a peripheral region including a plurality of petal-like members.

169. The system of claim 156, wherein: The body is configured to transition from a storage state to an expanded state, at least two adhesive-bearing portions of the body are expansively displaced as the body transitions from the storage state to the expanded state, and the central region is configured to translate toward a biological barrier to which the analyte sensing component is applied as the body transitions from the storage state to the expanded state.

170. Any of the systems, methods, and apparatus shown or described herein.

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