Additive device for drug dose tracking

Abstract

A device for monitoring a bolus dose of a medicament administered by a medicament delivery device, such as a wearable infusion device, includes a housing and a sensor disposed in the housing, wherein the sensor detects a signal generated by the wearable infusion device when a dose of medicament is administered. The device may also be provided as a system having the drug delivery device and a user device, wherein the user device collects data regarding the use of the drug delivery device and the dose of the administered drug.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 401,500, filed on August 26, 2022, which is hereby incorporated by reference in its entirety. Technical Field

[0003] The present disclosure relates generally to monitoring dosages of medications, and more particularly to systems and methods for monitoring bolus doses of medications administered by a pump device, such as a wearable patch pump. Background Art

[0004] Insulin pumps can provide users with constant basic delivery and / or bolus administration of drugs (e.g., insulin). Although bolus administration can be activated by the user at any time, bolus insulin administration typically starts during mealtime. Some existing bolus administration systems and methods that rely on user self-administration may not be able to track the number of insulin doses that have been self-administered. For example, in some devices, the dose administered corresponds to the number of times the administration button on the device is pressed, and the user must count and remember the number of times the administration button is pressed. If the patient fails to accurately count or remember the number of times the button is pressed, there is a risk of suffering from hyperglycemia (i.e., insufficient insulin administration) or hypoglycemia (i.e., excessive insulin administration). Therefore, an improved device and system for tracking the administration of insulin (particularly self-administered bolus doses) would be beneficial. Summary of the invention

[0005] Devices and methods are provided for monitoring and tracking a bolus dose of a drug administered by a drug delivery device.

[0006] In one aspect, the device is configured for use with a wearable infusion device. In some cases, the device includes a housing and a sensor disposed within the housing. The sensor may be configured to detect and track a signal generated by the wearable infusion device when a dose of a drug is administered. In some embodiments, the housing includes a first end and a second end, and the sensor may be disposed within the first end of the housing. The first end and / or the second end of the housing may be configured to facilitate releasable attachment of the device to the wearable infusion device. In some embodiments, the first end and the second end are connected by at least one flexible arm. For example, the at least one flexible arm may include two flexible arms. In some cases, a window (or gap) may be formed between the flexible arm and the first end and the second end of the housing. In some embodiments, the sensor is an accelerometer. In this way, pressing at least one actuator button of the wearable infusion device may generate a signal detectable by the accelerometer. In some embodiments, the drug is insulin. In some embodiments, the device is configured to be wirelessly connected to a user device, such as a computer and / or a mobile user device, such as a smartphone, etc. In some embodiments, the device further comprises at least one attachment track configured to facilitate releasable attachment of the device to the wearable infusion device.

[0007] On the other hand, a matching device for use with a wearable insulin pump is provided. The matching device may include a housing and an electronic assembly disposed within the housing. The matching device may be configured to be releasably attached to the wearable insulin pump. In some cases, the electronic assembly includes a sensor, a controller, and / or a battery. The sensor may be configured to detect a signal generated by the wearable insulin pump when a dose of insulin is administered. In some embodiments, the controller and antenna are configured to track the signal detected by the sensor and transmit the signal wirelessly to a user device and / or a wireless network. In some other embodiments, the signal is transmitted to an application installed on the user device, wherein the application displays a plurality of doses administered by the wearable insulin pump. In some embodiments, the housing includes a first end and a second end. In certain embodiments, the first end includes the electronic assembly, and the first end and / or the second end may be configured to facilitate releasable attachment of the matching device to the insulin pump. In some embodiments, the sensor is an accelerometer. The insulin pump may also include at least one dosing button, wherein the accelerometer is configured to detect a sound or vibration caused by pressing the at least one dosing button. In some embodiments, the matching device includes at least one attachment track. In some embodiments, the at least one attachment track extends at least partially along the length of the companion device. In some embodiments, the at least one attachment track is configured to slide between a gap defined between the housing and the base of the insulin pump.

[0008] On the other hand, a system is provided, comprising an infusion device, a supporting device and a user device. The supporting device may include a housing and a sensor assembly disposed in the housing. The supporting device may be configured to be removably connected to the infusion device. The sensor assembly may be configured to collect data related to the use of the infusion device and transmit the data to the user device so that the user of the user device can see the data. In some embodiments, the system also includes an application installed on the user device. The application may be configured to display the data related to the use of the infusion device. In some embodiments, the data corresponds to the number of drug doses administered by the infusion device. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The detailed description is set forth with reference to the accompanying drawings. The use of the same reference numerals may indicate similar or identical items. Various embodiments may utilize elements and / or components other than those shown in the accompanying drawings, and some elements and / or components may not be present in various embodiments. The elements and / or components in the accompanying drawings are not necessarily drawn to scale. Throughout this disclosure, singular or plural terms may be used interchangeably, depending on the context.

[0010] Figure 1 is a front view of an infusion device according to one or more embodiments of the present disclosure.

[0011] Figure 2A is a mechanical connection according to one or more embodiments of the present disclosure Figure 1 Front view of the accessory device of the infusion device.

[0012] Figure 2B According to one or more embodiments of the present disclosure Figure 2A A perspective view of the accessory device and infusion device shown in .

[0013] Figure 3 is separated from the infusion device according to one or more embodiments of the present disclosure Figure 2A-2B Rear view of the supporting device.

[0014] Figure 4 According to one or more embodiments of the present disclosure Figure 2A-2B and a partial cross-sectional view of the supporting device of 3.

[0015] Figures 5A-5C Depicted is a sequence for attaching a companion device to an infusion device according to one or more embodiments of the present disclosure.

[0016] Figure 6 is an illustration of an infusion system according to one or more embodiments of the present disclosure.

[0017] Figure 7 Depicted is a user interface for an application for use with an infusion device and / or companion device in accordance with one or more embodiments of the present disclosure.

[0018] Figure 8 is a mechanical connection according to one or more embodiments of the present disclosure Figure 1 A perspective view of a companion device for an infusion device.

[0019] Fig. 9 is a mechanical connection according to one or more embodiments of the present disclosure Figure 1 Front view of the accessory device of the infusion device.

[0020] Fig.10 According to one or more embodiments of the present disclosure, Figure 1 Front view of the accessory device of the infusion device.

[0021] Fig.11 is a mechanical connection according to one or more embodiments of the present disclosure Figure 1 Front view of the accessory device of the infusion device.

[0022] Fig.12 is a mechanical connection according to one or more embodiments of the present disclosure Figure 1 Front view of the accessory device of the infusion device.

[0023] Fig.13 is a mechanical connection according to one or more embodiments of the present disclosure Figure 1 A perspective view of a companion device for an infusion device. DETAILED DESCRIPTION

[0024] The present disclosure will be described more fully hereinafter with reference to the accompanying drawings, in which example embodiments of the present disclosure are shown. However, the present disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

[0025] Devices, systems and methods for monitoring the administration of bolus doses of drug delivery devices such as insulin pumps have been developed. In some embodiments, the monitoring device (referred to herein as an accessory device) is an external device that is configured to fit over or otherwise mechanically couple with a wearable drug delivery device, which may include an insulin pump or patch and / or an infusion device.

[0026] Figure 1 A wearable infusion device 10, such as an insulin pump or the like, is depicted. In some embodiments, the infusion device 10 includes a housing 12, a base 14, a first actuator control button 16, and a second actuator control button 18. In some cases, the wearable infusion device 10 may correspond to a CEQUR sold by CeQur Corporation. Device. In some embodiments, housing 12 is formed of multiple device layers gathered together, as described in U.S. Pat. No. 8,128,596, the relevant portions of which are incorporated herein by reference. For example, each layer defines various components of the device, such as a reservoir, a fluid conduit, a pump chamber, and a valve chamber. The device may include various other components and functions.

[0027] In some embodiments, base 14 includes an adhesive coating, such as a pressure sensitive adhesive tape as known in the art, to allow the device to be adhered to the patient's skin. In some embodiments, the adhesive coating is initially covered with a releasable cover that can be peeled off base 14 before the patient adheres device 10 to the patient's skin. In some embodiments, device 10 is adhered to the patient's skin prior to deployment of the cannula.

[0028] In some embodiments, the first actuator control button 16 and the second actuator control button 18 are placed on opposite sides of the infusion device 10 and directly opposite each other. This makes it more convenient to manually press the buttons simultaneously (or nearly simultaneously) when the patient wishes to self-administer a bolus dose of a liquid drug contained within the infusion device 10. The arrangement also applies substantially equal and opposite forces on the device during dose delivery to prevent the device from lateral displacement and possible peeling off the patient. As will be seen further below, the substantially simultaneous pressing of the buttons is particularly advantageously used.

[0029] Substantially simultaneously pressing the first actuator control button 16 and the second actuator control button 18 can be particularly advantageous in preventing unintended drug delivery. For example, given the wearable nature of the infusion device 10, a user may inadvertently interfere with the infusion device 10, or more specifically, the first actuator control button 16 or the second actuator control button 18. Requiring simultaneous pressing of the first actuator control button 16 and the second actuator control button 18 for intended drug administration advantageously prevents accidental or unintentional contact with the infusion device 10 from producing unintentional drug administration.

[0030] In some embodiments, the actuator button 16 functions as a valve controller that, when in a first position, establishes a first fluid path between the device reservoir and the device pump to support pump filling, and, when in a second or depressed position, establishes a second fluid path between the device pump and the device outlet or cannula to allow dose delivery to a patient. The linkage between the first control actuator button 16 and the second control actuator button 18 enables the device pump to be actuated with the second actuator control button 18 only when the second fluid path has been established by the first actuator control button 16.

[0031] Additional embodiments and additional features of infusion devices operable with the companion devices disclosed herein are described in U.S. Patents Nos. 8,226,607, 8,128,597, and 7,976,500, each of which is incorporated herein by reference.

[0032] Figure 2A-4 Described is a method for use with a wearable drug delivery device (such as with respect to Figure 1In some embodiments, the infusion device 10 may be disposable, while the accessory device 100 may be reusable. That is, the accessory device 100 may be releasably attached to and detached from multiple infusion devices. For example, after each use, the accessory device 100 may be removed from the infusion device before the infusion device is discarded, and then the accessory device 100 may be reattached to a new infusion device for continued use. When the accessory device 100 is attached to the new infusion device 10, the connection between the devices 100 and 10 may be reestablished manually or automatically.

[0033] In some embodiments, Figure 2A-2B As shown in , the accessory device 100 has a first end 102, a second end 104, a first arm 106 and a second arm 108. In some cases, a window 103 (or gap) is set between the first end 102, the second end 104, the first arm 106 and the second arm 108. The window 103 can make it possible to approach the outer surface of the accessory device 100 when the accessory device 100 is attached to the outer surface of the infusion device 10. The first end 102 can contain an operable component of the accessory device 100, such as a battery, a printed circuit board (PCB), a microprocessor, a wireless communication system and / or one or more sensors. The operable component can be placed at any position around or within the accessory device. The first end 102 and / or the second end 104 can be configured to fix the accessory device 100 to the infusion device 10. The first arm 106 and the second arm 108 can extend between the first end 102 and the second end 104 and connect the first end and the second end, and are used to maintain a firm connection between the accessory device 100 and the infusion device 10, while also maintaining a relatively low profile, so as not to become an obstacle to the user's daily activities. In a preferred embodiment, the first arm 106 and the second arm 108 are disposed along the edge of the housing 12 adjacent to the first actuator control button 16 and the second actuator control button 18, respectively. Positioning the first arm 106 and the second arm 108 along the middle portion of the infusion device 10 can prevent the accessory device 100 from obstructing or interfering with the first actuator control button 16 and the second actuator control button 18. In this manner, the first arm 106 and the second arm 108 can be shaped and / or include cutouts to prevent the accessory device 100 from obstructing or interfering with the first actuator control button 16 and / or the second actuator control button 18. The first arm 106 and the second arm 108 can be any suitable shape or configuration. In some embodiments, the first end 102 and / or the second end 104 of the accessory device 100 follows the contour of the infusion device 10 to achieve a better fit.

[0034] In some embodiments, the first arm 106 and the second arm 108 can be flexible. In this way, the first arm 106 and the second arm 108 can bend when the accessory device 100 is slid onto the infusion device 10. For example, when the accessory device 100 is slid onto the infusion device 10, the first arm 106 and the second arm 108 can bend outwardly away from the infusion device 10 (elastic deformation) so that the second end 104 can slide over the infusion device 10 and be positioned around the second end 24 of the infusion device 10. That is, the first arm 106 and the second arm 108 can bend outwardly away from the infusion device 10 to keep the second end 104 of the accessory device 100 in an outward position to facilitate attaching the accessory device 100 to the infusion device 10.

[0035] For example, to attach the accessory device 100 to the infusion set 10, the first end 102 of the accessory device 100 can be substantially aligned with (or slightly offset from) the first end 22 of the infusion set 10, and the second end 104 of the accessory device 100 can be substantially aligned with (or slightly offset from) the second end 24 of the infusion set 10, so that the accessory device 100 can be slid along its length until the first end 102 of the accessory device 100 abuts the first end 22 of the infusion set 10. For example, referring to FIG2, the first accessory device 100 can be offset to the left of the first end 22 of the infusion set 10 and slid to the right to be substantially aligned with and attached to the infusion set 10. Then, any tension in the first arm 106 and the second arm 108 caused by their outward bending can be released to secure the second end 104 of the accessory device 100 to the second end 24 of the infusion set. In some embodiments, the second end 104 of the accessory device 100 includes a lip 105 that also bends outward during attachment, and then the lip "snaps" onto the infusion device 10 to securely attach the accessory device 100 to the infusion device. The lip 105 can help prevent the accessory device 100 from being accidentally or unexpectedly removed from the infusion device 10. For example, the lip 105 can prevent the accessory device 100 from being pushed or slid in the direction of the first end 22 of the infusion device 10. In some embodiments, the bottom edge of the lip 105 has a tab (not shown) to help further secure the accessory device 100 to the infusion device 10. For example, when the second end 104 of the accessory device 100 is "snapped" onto the infusion device 10, the tab can be positioned in the gap 20 defined between the housing 12 and the base 14 of the infusion device 10.

[0036] In some embodiments, the accessory device 100 is constructed of a biocompatible plastic, such as a polycarbonate plastic, similar to the housing 12 of the infusion device. In other embodiments, the accessory device 100 is constructed of a shock-absorbing flexible material (such as silicone or rubber). In some embodiments, the accessory device 100 is manufactured by a process including injection molding with the possibility of overmolding. In some embodiments, a custom logo can be printed on the connected cover 100.

[0037] like Figure 3 As shown in , the back side of the first end 102 of the accessory device 100 may include an attachment track 110, an on-off switch 112, and a charging contact 114. In some embodiments, the attachment track 110 is integrally formed with the first end 102 of the accessory device 100 to facilitate securely attaching the accessory device 100 to the infusion device 10, as described in more detail with reference to FIG. 5. In some cases, the attachment track 110 may be disposed on opposite sides of the first end 102 of the accessory device 100. In this way, each of the attachment tracks 110 may form a channel 111, etc., in which at least a portion of the infusion device 10 can be slid into and fixed in place. In some other cases, the attachment track 110 may include a single attachment track 110 that at least partially surrounds the first end 102 of the accessory device 100 and extends in an inner portion of the first end to form a single channel 111, in which at least a portion of the infusion device 10 can be slid into and fixed in place. For example, the first end 22 of the infusion set 10 can slide into one or more channels 111 formed by the attachment track 110. In some cases, the attachment track 110 can slide within the gap 20 between the housing 12 and the base 14 of the first end 22 of the infusion set 10 to attach the companion device 100 to the infusion set 10.

[0038] For example, when the first end 102 of the accessory device 100 is engaged with the first end 22 of the infusion set 10 by the attachment track 110, the second end 104 of the accessory device 100 can be bent outward away from the infusion set 10 by the bending of the first arm 106 and the second arm 108. Once the first end 102 of the accessory device 100 is fully aligned with the first end 22 of the infusion set 10, the first arm 106 and the second arm 108 can force the second end 104 and the lip 105 downward around the second end of the infusion set 10. Securing the accessory device 100 to the infusion set 10 in this manner can prevent the unintended removal of the accessory device. For example, placing the attachment track 110 under at least a portion of the infusion set 10 can prevent the accessory device 100 from being pulled out and away from the infusion set 10.

[0039] In some embodiments, the on-off switch 112 allows the user to power on the accessory device 100 when ready for use (e.g., for pairing the infusion device 10 with a smart device) and to power off the accessory device after use (e.g., to enable charging). In the on position, the on-off switch 112 can place the accessory device 100 in a pairing mode in which the accessory device 100 can wirelessly connect to a user device and / or a network. The on-off switch 112 can preferably be located on the back of the accessory device 100 to prevent the user from inadvertently switching the on-off switch 112 to the off position, so that the accessory device 100 always remains operable when wearing the infusion device 10. Although the on-off switch 112 is depicted and described herein as a switch, it will be understood that the on-off switch 112 can also be a power button, etc., as will be understood by those skilled in the art.

[0040] In some embodiments, the accessory device 100 includes one or more feedback indicators. In various embodiments, the feedback indicator can provide an auditory signal, a visual signal, and / or a tactile signal to the user / wearer of the accessory device 100. For example, the feedback indicator may include one or more LED lights for providing visual feedback and / or a vibration indicator for providing tactile feedback. The feedback may be related to the state of the on / off switch. For example, the accessory device 100 can be configured to display a flash or vibration when powered on, thereby confirming to the user that the accessory device is operational. The accessory device 100 can also be configured to display a flash or vibration to convey to the user that the battery of the accessory device 100 is low or the connection with the user device has been lost.

[0041] In some embodiments, the accessory device 100 is powered by a rechargeable battery 116 disposed within the first end 102 of the accessory device 100. Figure 4 As shown in . The battery 116 can be in electronic communication with the charging contacts 114 to charge the battery 116 without removing it from the accessory device 100. In some preferred embodiments, the battery 116 powers the accessory device 100 for at least 24 hours, such as up to 36 hours, up to 48 hours, or up to 72 hours. Any suitable battery can be used herein. In some embodiments, the battery 116 enters a power saving mode (e.g., a sleep mode) during non-use periods to extend the life of the battery 116. It will be understood that although the charging contacts 114 are depicted, other charging components known in the art can be utilized. For example, the charging component can be a charging port, a charging base, inductive charging, etc.

[0042] In some embodiments, the battery 116 is an off-the-shelf battery. In other embodiments, the battery 116 is customized to fit the contours of the infusion device 10 and / or the companion device 100. The battery 116 can be rechargeable, or the battery can be a single-use battery. In some other embodiments, in addition to replacing the battery, other power sources known in the art can be used to power the companion device 100. In some cases, the battery can communicate with one or more induction coils for inductive charging of the battery.

[0043] In some embodiments, the internal components of the on / off switch 112 and the battery 116 are contained within the first end 102 of the companion device 100. Figure 4 As shown in , the first end 102 of the supporting device 100 may also contain a PCB 118, a sensor 120, a microcontroller unit 122, and a wireless communication system 124 having an antenna (such as Bluetooth, etc.). Any suitable wireless protocol may be used herein. The supporting device 100 may also have embedded wiring to connect various electrical and / or power systems housed in the first end 102. Such electrical and / or power systems include, but are not limited to, leads for electronic connections, which may be embedded or printed on the first end 102 of the supporting device 100.

[0044] The PCB 118 and the microcontroller unit 122, which can be a rigid or flexible PCB, can mechanically and electronically support the components of the supporting device 100. Any suitable controller and / or processor and memory can be used herein. In some embodiments, the microcontroller unit 122 has software installed on its memory. The software can, for example, receive data from a sensor and process the data using a signal processing algorithm to convert the raw data into a useful format. In some embodiments, the PCB 118 and / or the microcontroller unit 122 are configured to be connected to a wireless module (such as a Bluetooth or NFC module) or have an integrated Bluetooth or NFC module. The software installed on the microcontroller unit 122 can also push the raw data and / or the converted data to such a connected or integrated Bluetooth or NFC module.

[0045] In some other embodiments, the PCB 118 and / or the microcontroller unit can be connected to other electronic components contained within the companion device 100 (such as resistors, LEDs, feedback indicators and / or additional circuit systems).

[0046] The sensor 120 may be configured to detect when the first actuator button 16 and the second actuator button 18 of the infusion device 10 are engaged. When the user (i.e., the patient) wishes to receive a dose of the drug, the first actuator button 16 and the second actuator button 18 are pressed simultaneously (or nearly simultaneously) to administer the drug through the infusion device 10. Pressing the first actuator button 16 and the second actuator button 18 substantially simultaneously may generate a signal that may be detected by the sensor 120. In certain embodiments, the sensor 120 is configured to detect a unique profile (or signature) associated with pressing the first actuator button 16 and the second actuator button 18 simultaneously. The signal may indicate that the first actuator button 16 and the second actuator button 18 are pressed substantially simultaneously, indicating that a dose is administered by the infusion device 10. In a preferred embodiment, the sensor 120 is an accelerometer. In another embodiment, the sensor 120 may be a microphone or a switch. In another embodiment, the sensor may be a camera, etc. In this manner, depending on the sensor type, the unique profile (or signature) associated with simultaneously pressing the first actuator button 16 and the second actuator button 18 may include a movement profile, a vibration profile, a sound profile, etc. indicating that the buttons were pressed and the dose was dispensed substantially simultaneously. Other types of sensors may be used to sense any suitable unique profile (or signature).

[0047] In some embodiments, the accessory device 100 has two or more sensors 120. The first sensor can be positioned near the first actuator button 16 and the second actuator button 18, and the second (or subsequent) sensor can be positioned at a certain distance from the first actuator button 16 and the second actuator button 18. When the first actuator button 16 and the second actuator button 18 are not pressed at the same time, the use of two or more sensors can prevent the accessory device 100 from transmitting a signal indicating that a certain dose of the drug has been administered. The second (or subsequent) sensor can be positioned at a predetermined distance from the first actuator button 16 and the second actuator button 18 to achieve this purpose. For example, when a certain dose of the drug is administered (i.e., when the first actuator button 16 and the second actuator button 18 are pressed at the same time), the first sensor can detect a signal, while the second sensor does not detect a signal, which indicates that a certain dose of the drug has been administered. However, in the event of an unexpected signal (e.g., a signal generated due to sound, movement, etc. that is unrelated to the simultaneous pressing of the first actuator button 16 and the second actuator button 18), the first sensor and the second (or subsequent) sensor may receive a signal indicating that a dose of the drug has not been administered.

[0048] In some embodiments, the first sensor is located in the accessory device near the first actuator button 16 and the second actuator button 18, and the second sensor is located in the accessory device 100 at a second position at a certain distance from the first actuator button 16 and the second actuator button 18. In some embodiments, the first sensor is located on or near the first actuator button 16 and the second actuator button 18 in the infusion device 10, and the second sensor is located in the accessory device 100. In some embodiments, the first sensor is located in the accessory device 100 near the first actuator button 16 and the second actuator button 18, and the second sensor is located in the user device (such as a mobile phone). In some embodiments, the first sensor is located in the accessory device 100 near the first actuator button 16 and the second actuator button 18, and the second sensor is directly attached to the user's body (for example, the second sensor is attached to the base 14 of the infusion device 10). In some embodiments, the first sensor is located in an auxiliary device configured to be attached to the first actuator button 16 and the second actuator button 18, and the second sensor is located in the accessory device 100.

[0049] In some embodiments, sensor 120 transmits a signal to a controller system, such as PCB 118 and / or microprocessor 122. In some cases, PCB 118 and / or microprocessor 122 may process the signal from sensor 120 and transmit the processed signal to a user device via Bluetooth antenna 124. The signal may indicate the number of drug doses administered.

[0050] Wires may connect the aforementioned components, or the aforementioned components may all communicate wirelessly, and those skilled in the art will recognize any additional components comparable to those disclosed herein.

[0051] Figures 5A-5C Depicted is a sequence for attaching a companion device to an infusion device according to one or more embodiments of the present disclosure. Figure 5A As shown in , the accessory device 100 can be aligned with the infusion device 10 in preparation for attachment to the infusion device. More specifically, the second end 104 of the accessory device 100 can be aligned with the first end 22 of the infusion device 10, so that the user can then slide the accessory device 100 toward the second end 24 of the infusion device 10. For example, the attachment track 110 of the accessory device 100 can be aligned with and slid into the gap 20 defined between the housing 12 and the base 14 of the infusion device 10, as shown in FIG. Figure 5B, which can help ensure a proper and secure attachment between the accessory device 100 and the infusion device 10. In some embodiments, the first arm 106 and the second arm 108 bend upward away from the infusion device 10 as the accessory device 100 slides from the first end 22 to the second end 24 of the infusion device 10. The bending of the first arm 106 and the second arm 108 can space the second end 104 of the accessory device 100 from the infusion device 10 to facilitate attachment. Once the first end 102 and the second end 104 of the accessory device 10 are aligned with the first end 22 and the second end 24 of the infusion device 10, respectively, the second end 104 of the accessory device 100 can be returned toward the second end 24 of the infusion device 10 and attached to the second end, as shown in FIG. Figure 5C In some embodiments, the lip 105 on the second end 104 of the companion device 100 can be "snapped" onto the infusion device 10 to more securely attach the companion device 100. In some embodiments, the construction materials and geometry of the first end 102 and the second end 104 are optimized to provide tactile feedback when snapping.

[0052] In some embodiments, the accessory device 100 is attached to the infusion device 10 after it has been attached to the user's body. For example, the user may apply the infusion device 10 to the desired part of their body according to normal procedures, and then align, slide, and snap the accessory device 100 onto the already applied infusion device. In other embodiments, the accessory device 100 is attached to the infusion device 10 before the infusion device 10 is attached to the user's body. The process of applying the infusion device 10 to the body while attaching the accessory device 100 is essentially unchanged.

[0053] To remove the accessory device 100, the first arm 106 and the second arm 108 may be bent to lift the second end 104 and / or the lip 105 of the accessory device 100 outwardly away from the infusion device 10. The accessory device 100 may then be slid toward the first end 22 of the infusion device 10 for removal. For example, the accessory device 100 may be slid toward the first end 22 of the infusion device 10 until the attachment track 110 disengages from the infusion device 10, at which point the accessory device 100 may be completely removed.

[0054] In some embodiments, the accessory device 100 is attached to and / or removed from the infusion device 10 when the infusion device 10 is attached to the user's body. In other embodiments, the accessory device 100 is attached to and / or removed from the infusion device when the infusion device 10 is not attached to the user's body.

[0055] In some embodiments, the companion device 100 is configured to connect to a user device and / or a cloud network to facilitate dose monitoring. Figure 6As shown in , the system 300 for monitoring dosage administration includes a companion device 100, a network (or multiple networks) 302, and at least one user device 304, such as a smart phone, tablet, personal computer, server and / or network. In some cases, software installed on the microcontroller unit 122 of the companion device 100 receives, processes, and transmits sensor data about the number of drug doses administered by the user. In some embodiments, the data is transmitted to the user device 304, for example, via Bluetooth, for display on the user interface 700 of the application, such as Figure 7 In other cases, raw unprocessed (or minimally processed) data may be transmitted.

[0056] In some embodiments, the user device 304 displays all information related to the operation of the infusion device 10 and / or the companion device 100 on the user interface 700. For example, the user interface 700 may display information such as the status 702 of the companion device 100, the battery level of the companion device 100, and the number of remaining doses 704. The user interface 700 may also include certain controls, such as controls for disconnecting 706 and / or resetting 708 the companion device 100.

[0057] In some embodiments, the accessory device 100 is directly linked to a hospital information system, a health data management system, a diabetes management software, or a remote patient monitoring system via a network 302. The network 302 may include any one or a combination of networks such as a local area network (LAN), a wide area network (WAN), a telephone network, a cellular network, a cable network, a wireless network, and / or a private / public network (such as the Internet). The network 302 may also support communication technologies such as Bluetooth, cellular, near field communication (NFC), Wi-Fi, Wi-Fi Direct, machine-to-machine communication, human-to-machine communication, and / or visible light communication.

[0058] In use, the system 300 is able to accurately and reliably track the doses of medication delivered by the infusion device 10 and does not require the user or their caregiver to manually track the doses administered. This can aid medication management by mitigating the risk that the user will administer too much or too little medication and / or that the user will waste or prematurely use up the doses of medication in the infusion device 10.

[0059] For example, when the accessory device 100 counts the number of drug doses administered by the infusion device 10, the count can be transmitted to the user device 304 and displayed on the user interface 700 of the application. In some embodiments, the application displays the number of remaining doses available. For example, the application initially displays the total number of available doses (e.g., 180), and as the doses are administered, the number of available doses will decrease in increments of two doses. In other embodiments, the application displays the number of doses administered. In some embodiments, the application is configured to display a warning or provide a push notification to the user, indicating, for example, when the drug supply in the infusion device 10 is low, or when the user has delivered a predetermined maximum amount of drug for a given period of time. The user interface 700 can also display the administration time to ensure patient compliance.

[0060] Reference now Figure 8-13 , an alternative embodiment of a companion device for use with the infusion device 10 is described.

[0061] like Figure 8 As shown in , the accessory device 400 can be a U-shaped device similar to the first end 102 of the accessory device 100. In some embodiments, the accessory device 400 is similar to Figure 1-7 For example, the accessory device 400 may include a base portion 402 and a first arm 404 and a second arm 406 extending from the base portion. The base portion 402 contains operable components of the accessory device 400, such as Figure 1-4 described.

[0062] In some embodiments, the accessory device 400 may include an attachment track (not shown) to facilitate proper and secure attachment of the accessory device 400 to the infusion device. The attachment track may extend along at least a portion of the accessory device 400. That is, the base portion 402, the first arm 404, and / or the second arm 406 may have an attachment track extending along at least a portion thereof. Figure 3 As described, the attachment track may define a channel (not shown) for receiving the infusion set 10. For example, the accessory device 400 may be aligned with and slid onto the first end 22 of the infusion set 10. When the accessory device 400 is attached to the infusion set 10, the first arm 404 and the second arm 406 may abut but not contact the first actuator control button 16 and the second actuator control button 18.

[0063] In some embodiments, the accessory device 500 includes a sleeve 502 configured to fit around at least a portion of the infusion device 10, such as Fig. 9According to a preferred embodiment, the sleeve 502 is disposed around the first end 22 of the infusion set 10, adjacent the first actuator button 16 and the second actuator button 18, so that the first actuator button 16 and the second actuator button 18 remain unobstructed. In some embodiments, the sleeve 502 is formed of an elastically deformable material (e.g., polyethylene, polypropylene, or other thermoplastic polymer) that slides onto the infusion set 10.

[0064] The accessory set 500 may also include an adhesive bag (not shown) that receives the infusion set 10 and the accessory set 500. In some embodiments, the adhesive bag is formed of a flexible material that fits around the infusion set 10 and the accessory set 500 to secure the accessory set 500 to the infusion set 10 and / or to attach the infusion set 10 to the patient. For example, when the infusion set 10 is applied, the adhesive bag can be directly secured to the patient's skin. In some other embodiments, the accessory set 500 has an attachment track (not shown), such as Figure 3 The attachment track. The attachment track can extend along at least a portion of the accessory device 500 to facilitate attachment to the first end 22 of the infusion set 10. The attachment track can define a channel for receiving and securing the infusion set 10 therein when the accessory device 500 is attached.

[0065] In some embodiments, the companion device utilizes an external sensor to detect when a drug is administered by the infusion device 10.

[0066] In some embodiments, the accessory device 600 includes a microphone 602 for detecting when a dose is administered by the infusion device 10, such as Fig.10 . In some embodiments, the infusion device 10 can produce an audible sound when a dose is administered, which sound can be detected by the microphone. The accessory device 600 can also include an adhesive patch 604 molded with a plastic knob (not shown) so that the microphone 602 is slidably attached to the adhesive patch via the molded plastic knob. In some preferred embodiments, the accessory device 600 is placed as close to the infusion device 10 as possible to optimize sound detection and limit interference. For example, as Fig.10 As shown in , the accessory device 600 can be placed next to the second end of the infusion device 10. In other embodiments, the accessory device 600 is integrated with the base 14 of the infusion device 10 to further simplify the user experience. For example, the accessory device 600 may not include a separate adhesive patch and is attached to the patient through the base 14 of the infusion device.

[0067] In some other embodiments, such as Figure 11-12 As shown in , the companion device is configured to cover the first actuator button 16 and the second actuator button 18, and utilizes a force feedback sensor to detect when a dose has been administered.

[0068] like Fig.11 As shown in , the accessory device 700 is a U-shaped device having a base portion 702 that accommodates the electronic components of the accessory device 700, and a first arm 704 and a second arm 706 that extend from the base portion 702 above the first actuator button 16 and the second actuator button 18, respectively. The first arm 704 and the second arm 706 can generally follow the contour of the first actuator button 16, and the second actuator button 18 includes a sensor for detecting when the buttons 16 and 18 are engaged or pressed. That is, the first arm 704 and the second arm 706 can have a force and / or distance trigger threshold, at which the sensor makes a determination that the dose should be counted. The first arm 704 and the second arm 706 can be tightly coupled to the infusion device 10 to ensure the correct function of the sensor. However, the first arm 704 and the second arm 706 should not be tightly coupled so that the first actuator button 16 and / or the second actuator button 18 are pressed unintentionally.

[0069] In some embodiments, the first arm 704 and the second arm 706 are flexible so that the companion device 700 can be attached to the infusion device without compressing the first actuator button 16 and / or the second actuator button 18. For example, when the base portion 702 of the companion device 700 slides along the first end 22 of the infusion device 10, the first arm 704 and the second arm 706 can bend outward away from the infusion device 10. When the base portion 702 is fixed to the infusion device 10, the first arm 704 and the second arm 706 can return to a resting state adjacent to the first actuator button 16 and the second actuator button 18.

[0070] In some other embodiments, the first arm 704 and the second arm 706 each include an elastic portion that facilitates coupling while also preventing the arms 704, 706 from compressing the actuator buttons 16, 18. Although the elastic portion can bias the first arm 704 and the second arm 706 inward, when the accessory device 700 is coupled to the infusion device 10, the first arm 704 and the second arm 706 can be forced outward to receive the infusion device 10 therein. That is, when the base portion 702 of the accessory device 700 slides along the first end of the infusion device 10, the first arm 704 and the second arm 706 can be forced outward. When the base portion 702 is fixed to the infusion device 10, the first arm 704 and the second arm 706 can return to a resting state.

[0071] In some embodiments, the accessory device 700 has an attachment track (not shown) for securing the accessory device 700 to the infusion device 10, as shown in FIG. Figure 3The attachment track can extend along at least a portion of the base portion 702 and / or along at least a portion of the first arm 704 and / or the second arm 706. The attachment track can also define a channel for receiving an infusion set 10 and securing the accessory set 700 to the infusion set.

[0072] In some embodiments, Fig.12 , the accessory device 800 surrounds the entire perimeter of the infusion device 10. In some embodiments, the accessory device 800 includes a first end 802 containing electronic components of the accessory device 800 and a second end 804 for fixing the accessory device 800 to the infusion device 10. The accessory device 800 may also include a first arm 806 and a second arm 808, which connect the first end 802 and the second end 804 of the accessory device to define a window 803 therebetween. The first arm 806 and the second arm 808 may also cover the first actuator button 16 and the second actuator button 18. In some embodiments, the first arm 806 and the second arm 808 have a first button cover 807 and a second button cover 809 covering the first actuator button 16 and the second actuator button 18, respectively.

[0073] The first button cover 807 and the second button cover 809 follow the contours of the first actuator button 16 and the second actuator button 18 and include sensors (such as switches) to determine when the first actuator button 16 and the second actuator button 18 are pressed. In some embodiments, the first button cover 807 and the second button cover 809 are formed to prevent the first actuator button 16 and the second actuator button 18 from being accidentally pressed. In some embodiments, the first button cover 807 and the second button cover 809 are spring-loaded caps. In other embodiments, the first button cover 807 and the second button cover 809 are co-molded elastomers.

[0074] In some embodiments, the accessory device 800 snaps onto the infusion device 10 via at least one spring-loaded latch at either or both ends of the accessory device. That is, one or both of the first end 802 and the second end 804 are flexible so that the accessory device 800 can fit over the infusion device 10. For the same purpose, the first arm 806 and / or the second arm 808 can also be flexible. In other embodiments, the accessory device 800 can be separated into two parts, each part being configured to slide onto the infusion device 10 at opposite ends and fit together to secure the accessory device 800 to the infusion device. For example, each part of the accessory device can have an attachment track so that the accessory device 800 can slide onto the infusion device 10, as described with respect to Figure 3 described.

[0075] In another embodiment, Fig.13As shown in , the accessory device 900 covers the entire surface of the housing 12 of the infusion device 10, thereby making the first actuator button 16 and the second actuator button 18 accessible. In some embodiments, the accessory device 900 has a first end 902, a second end 904, and a flexible arm portion 906 extending therebetween. Figure 3 As described, the accessory device 900 may have an attachment track (not shown) to facilitate attachment of the accessory device 900 to the infusion device 10. For example, the first end 902 may have an attachment track extending along at least a portion thereof, the attachment track defining a channel in which the first end 22 of the infusion device 10 can be received. In order to attach the accessory device 900 to the infusion device, the second end 904 of the accessory device 900 may be aligned with the infusion device 10 and advanced along the infusion device toward the second end 24. The flexible arm portion 906 and / or the second end 904 may be bent outward away from the infusion device 10 to facilitate the attachment. When the first end 902 of the accessory device 900 is aligned with the first end 22 of the infusion device 10, the second end 904 of the accessory device may be inward toward the device and fixed to the second end 24 of the infusion device. The accessory device 904 may also have a lip 905 attached to the second end 904 to further secure the attachment.

[0076] In some embodiments, the infusion device 10 includes a magnet positioned between the first actuator button 16 and the second actuator button 18, the magnet being configured to move when the first actuator button 16 and the second actuator button 18 are pressed. The accessory device 900 has a corresponding magnet or sensor configured to detect movement of the actuator buttons within the infusion device 10. The accessory device 900 can have the structure of the infusion device 10 as described with respect to any of the previously described embodiments and can be attached to the infusion device, such as Figure 1-12 As described in.

[0077] Some embodiments of the present disclosure may be described in terms of one or more of the following:

[0078] Embodiment 1. A device for use with a wearable infusion device, the device comprising a housing configured to be attached to the wearable infusion device; and a sensor disposed within the housing, wherein the sensor is configured to detect a signal generated by the wearable infusion device when a dose of a drug is administered.

[0079] Embodiment 2. A device according to embodiment 1, wherein the housing comprises a first end and a second end, wherein the sensor is disposed within the first end of the housing, and wherein the second end of the housing is configured to facilitate releasable attachment of the device to the wearable infusion device.

[0080] Embodiment 3. A device according to any one of Embodiments 1 or 2, wherein the first end and the second end are connected by at least one flexible arm.

[0081] Embodiment 4. The device of any one of embodiments 1 to 3, wherein the sensor is an accelerometer.

[0082] Embodiment 5. The device of any one of Embodiments 1 to 4, wherein pressing at least one actuator button of the wearable infusion device generates the signal, and wherein the signal is detectable by the accelerometer.

[0083] Embodiment 6. The device of any one of Embodiments 1 to 5, wherein the at least one actuator button comprises at least one medication administration button, and wherein the signal comprises a sound or a vibration caused by actuation of the at least one medication administration button.

[0084] Embodiment 7. The device of any one of embodiments 1 to 6, wherein the wearable infusion device is a wearable patch pump, and wherein the drug is insulin.

[0085] Embodiment 8. The apparatus of any one of Embodiments 1 to 7, wherein the apparatus is configured to wirelessly connect to a user device.

[0086] Embodiment 9. The device of any one of Embodiments 1 to 8, further comprising at least one attachment track configured to facilitate releasable attachment of the device to the wearable infusion device.

[0087] Embodiment 10. A device according to any one of embodiments 1 to 9, wherein the at least one attachment track extends at least partially along the length of the supporting device.

[0088] Embodiment 11. The device of any one of 1 to 10, wherein the at least one attachment track is configured to slide between a gap defined between a housing of the wearable infusion device and a base of the wearable infusion device.

[0089] Embodiment 12. The device of any one of Embodiments 1 to 11, further comprising an electronics assembly disposed within the housing, the electronics assembly comprising the sensor, controller, and battery.

[0090] Embodiment 13. The device of any one of Embodiments 1 to 12, wherein the controller is configured to wirelessly transmit the signal detected by the sensor to a user device and / or a wireless network.

[0091] Embodiment 14. The device of any one of Embodiments 1 to 13, wherein the first end of the housing is configured to receive the electronic assembly therein.

[0092] Embodiment 15. A device according to any one of embodiments 1 to 14, wherein the shell includes a first flexible arm and a second flexible arm, wherein the first flexible arm and the second flexible arm are configured to connect the first end of the shell and the second end of the shell.

[0093] Embodiment 16. A device according to any one of Embodiments 1 to 15, wherein the first flexible arm, the second flexible arm, the first end and the second end define a window in the housing, wherein the wearable infusion device is visible and accessible through the window.

[0094] Embodiment 17. The device of any one of Embodiments 1 to 16, wherein the first flexible arm and the second flexible arm do not cover the first actuator button and the second actuator button, respectively, of the wearable infusion device.

[0095] Embodiment 18. The device of any one of Embodiments 1 to 17, wherein the first flexible arm is positioned inwardly adjacent to the first actuator button, and the second flexible arm is positioned inwardly adjacent to the second actuator button.

[0096] Embodiment 19. A device according to any one of Embodiments 1 to 18, wherein the housing comprises: a base portion, the base portion comprising the sensor; and a first arm and a second arm, the first arm and the second arm extending from the base portion.

[0097] Embodiment 20. The device of any one of Embodiments 1 to 19, wherein the first arm and the second arm do not cover the first actuator button and the second actuator button, respectively, of the wearable infusion device.

[0098] Embodiment 21. The device of any one of Embodiments 1 to 20, wherein the housing comprises a sleeve configured to fit around a base portion of the wearable infusion device, wherein the sleeve comprises the sensor.

[0099] Embodiment 22. The device of any one of Embodiments 1 to 21, wherein the sleeve does not cover at least one actuator button of the wearable infusion device.

[0100] Embodiment 23. A device according to any one of Embodiments 1 to 22, wherein the sleeve comprises an elastically deformable material.

[0101] Embodiment 24. The device of any one of Embodiments 1 to 23, wherein the sensor is located outside the housing of the device.

[0102] Embodiment 25. The device of any one of Embodiments 1 to 24, wherein the sensor is a microphone.

[0103] Embodiment 26. The device of any one of Embodiments 1 to 25, wherein pressing at least one actuator button of the wearable infusion device generates an audible signal, wherein the audible signal is detectable by the microphone.

[0104] Embodiment 27. A device according to any one of Embodiments 1 to 26, wherein the housing comprises: a base portion, the base portion comprising the sensor; and a first arm and a second arm, the first arm and the second arm extending from the base portion.

[0105] Embodiment 28. The device of any one of Embodiments 1 to 27, wherein the first arm and the second arm cover a first actuator button and a second actuator button of the wearable infusion device, respectively.

[0106] Embodiment 29. The device of any one of claims 1 to 28, wherein the first arm and the second arm are biased in an inward direction to facilitate releasable attachment of the device to the wearable infusion device.

[0107] Embodiment 30. The device of any one of Embodiments 1 to 29, wherein the first arm and the second arm each comprise a flexible portion configured to facilitate releasable attachment of the device to the wearable infusion device.

[0108] Embodiment 31. A device according to any one of embodiments 1 to 30, wherein the shell is configured to surround the periphery of the wearable infusion device, and wherein the shell includes a first end, a second end, and a first arm and a second arm connecting the first end and the second end, and the first end includes a sensor.

[0109] Embodiment 32. The device of any one of Embodiments 1 to 31, wherein the first arm and the second arm cover a first actuator button and a second actuator button of the wearable infusion device, respectively.

[0110] Embodiment 33. The device of any one of Embodiments 1 to 32, wherein the first end and the second end are configured to separate to facilitate releasable attachment of the device to the wearable infusion device.

[0111] Embodiment 34. The device of any one of Embodiments 1 to 33, wherein the second end is configured to facilitate releasable attachment of the device to the wearable infusion device.

[0112] Embodiment 35. A device according to any one of embodiments 1 to 34, wherein the housing comprises: a first end, the first end comprising the sensor; a second end, the second end being configured to facilitate releasable attachment of the device to the wearable infusion device; and a flexible arm portion, the flexible arm portion connecting the first end and the second end.

[0113] Embodiment 36. The device of any one of Embodiments 1 to 35, wherein the flexible arm portion is disposed between a first actuator button and a second actuator button of the wearable infusion device.

[0114] Embodiment 37. A matching device for use with a wearable insulin pump, the matching device comprising a shell, the shell being configured to be attached to the wearable insulin pump, the shell comprising a first end, a second end, and a first flexible arm and a second flexible arm, the first flexible arm and the second flexible arm being configured to connect the first end and the second end; and a sensor, the sensor being disposed within the first end of the shell, wherein the sensor is configured to detect a signal generated by the wearable infusion device when a dose of insulin is administered.

[0115] Embodiment 38. A system comprising a wearable insulin pump and a companion device according to any one of embodiments 1 to 37, wherein the companion device is configured to be removably connected to the wearable insulin pump, and wherein the sensor is configured to detect data related to the use of the wearable insulin pump and transmit the data to a user device so that the data is visible to the user on the user device.

[0116] Although the present disclosure has been described with reference to a number of exemplary embodiments, it will be appreciated by those skilled in the art that the present disclosure is not limited to such embodiments. Instead, the disclosed embodiments may be modified to incorporate any number of changes, alterations, substitutions, or equivalent arrangements not described herein but commensurate with the spirit and scope of the present disclosure.

Claims

1. A device for use with a wearable infusion device, the device comprising: a housing configured to be attached to a wearable infusion device; and a sensor, the sensor being disposed in the housing; Wherein the sensor is configured to detect a signal generated by the wearable infusion device when a dose of a drug is administered.

2. The device of claim 1 , wherein the housing comprises a first end and a second end, wherein the sensor is disposed within the first end of the housing, and wherein the second end of the housing is configured to facilitate releasable attachment of the device to the wearable infusion device.

3. The device of claim 2, wherein the first end and the second end are connected by at least one flexible arm.

4. The device according to any one of claims 1 to 3, wherein the sensor is an accelerometer.

5. The device of claim 4, wherein pressing at least one actuator button of the wearable infusion device generates the signal, and wherein the signal is detectable by the accelerometer.

6. The device of claim 5, wherein the at least one actuator button comprises at least one medication administration button, and wherein the signal comprises a sound or a vibration caused by actuation of the at least one medication administration button.

7. The device according to any one of claims 1 to 6, wherein the wearable infusion device is a wearable patch pump, and wherein the drug is insulin.

8. The apparatus according to any one of claims 1 to 7, wherein the apparatus is configured to connect wirelessly to a user device.

9. The device of any one of claims 1 to 8, further comprising at least one attachment track configured to facilitate releasable attachment of the device to the wearable infusion device.

10. A device according to claim 9, wherein the at least one attachment track extends at least partially along the length of the supporting device.

11. The device according to any one of claims 9 or 10, wherein the at least one attachment track is configured to slide between a gap defined between a housing of the wearable infusion device and a base of the wearable infusion device.

12. The device according to any one of claims 1 to 11, further comprising An electronic assembly is disposed in the housing, the electronic assembly including the sensor, a controller and a battery.

13. The device of claim 12, wherein the controller is configured to wirelessly transmit the signal detected by the sensor to a user device and / or a wireless network.

14. The device of any one of claims 12 or 13, wherein the first end of the housing is configured to receive the electronic assembly therein.

15. The device according to any one of claims 1 to 14, wherein the shell comprises a first flexible arm and a second flexible arm, wherein the first flexible arm and the second flexible arm are configured to connect the first end of the shell and the second end of the shell.

16. The device of claim 15, wherein the first flexible arm, the second flexible arm, the first end, and the second end define a window in the housing, wherein the wearable infusion device is visible and accessible through the window.

17. The device according to any one of claims 15 or 16, wherein the first flexible arm and the second flexible arm do not cover the first actuator button and the second actuator button of the wearable infusion device, respectively.

18. The device of claim 17, wherein the first flexible arm is positioned adjacent to the first actuator button and the second flexible arm is positioned adjacent to the second actuator button.

19. The device of any one of claims 1 or 4 to 14, wherein the housing comprises: a base portion, the base portion comprising the sensor; and a first arm and a second arm, the first arm and the second arm extending from the base portion.

20. The device of claim 19, wherein the first arm and the second arm do not cover the first actuator button and the second actuator button, respectively, of the wearable infusion device.

21. The device of any one of claims 1 or 4 to 14, wherein the housing comprises a sleeve configured to fit around a base portion of the wearable infusion device, wherein the sleeve comprises the sensor.

22. The device of claim 21, wherein the sleeve does not cover at least one actuator button of the wearable infusion device.

23. The device of claim 22, wherein the sleeve comprises an elastically deformable material.

24. The device of any one of claims 1, 4 to 11 or 13, wherein the sensor is located outside the housing of the device.

25. The device of claim 24, wherein the sensor is a microphone.

26. The device of claim 25, wherein pressing at least one actuator button of the wearable infusion device generates an audible signal, wherein the audible signal is detectable by the microphone.

27. A device according to any one of claims 1 or 4 to 14, wherein the housing comprises: a base portion, the base portion comprising the sensor; and a first arm and a second arm, the first arm and the second arm extending from the base portion.

28. The device of claim 27, wherein the first arm and the second arm cover a first actuator button and a second actuator button of the wearable infusion device, respectively.

29. The device of any one of claims 27 to 28, wherein the first arm and the second arm are biased in an inward direction to facilitate releasable attachment of the device to the wearable infusion device.

30. The device of any one of claims 27 to 28, wherein the first arm and the second arm each comprise a flexible portion configured to facilitate releasable attachment of the device to the wearable infusion device.

31. The device of any one of claims 1 or 4 to 14, wherein the housing is configured to surround a periphery of the wearable infusion device, and wherein the housing comprises a first end, a second end, and a first arm and a second arm connecting the first end and the second end, the first end comprising a sensor.

32. The device of claim 31 , wherein the first arm and the second arm cover a first actuator button and a second actuator button, respectively, of the wearable infusion device.

33. The device of any one of claims 31 or 32, wherein the first end and the second end are configured to separate to facilitate releasable attachment of the device to the wearable infusion device.

34. The device of any one of claims 31 or 32, wherein the second end is configured to facilitate releasable attachment of the device to the wearable infusion device.

35. The device of any one of claims 1 or 4 to 14, wherein the housing comprises: a first end, the first end comprising the sensor; a second end, the second end configured to facilitate releasable attachment of the device to the wearable infusion device; and a flexible arm portion connecting the first end and the second end.

36. The device of claim 35, wherein the flexible arm portion is disposed between a first actuator button and a second actuator button of the wearable infusion device.

37. A companion device for use with a wearable insulin pump, the companion device comprising: a housing configured to be attached to the wearable insulin pump, the housing comprising a first end, a second end, and a first flexible arm and a second flexible arm, the first flexible arm and the second flexible arm being configured to connect the first end and the second end; as well as a sensor disposed within the first end of the housing; Wherein the sensor is configured to detect a signal generated by the wearable infusion device when a dose of insulin is administered.

38. A system comprising: wearable insulin pumps; and The supporting device according to claim 37; wherein the accessory device is configured to be removably connected to the wearable insulin pump; and wherein the sensor is configured to detect data related to the use of the wearable insulin pump and transmit the data to a user device so that the data is visible to the user on the user device.

Images