Medical device, method and system

Abstract

To provide a medical device system.SOLUTION: The medical system includes: a medical device including a first portion and a second portion; and an accessory configured to attach to the medical device and provide battery power to the medical device. In some embodiments, the accessory attaches to the second portion of the medical device. In some embodiments, the accessory attaches to the first portion of the medical device.SELECTED DRAWING: Figure 6

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is a patent application claiming priority to U.S. Provisional Patent Application No. 62 / 898,336 (Attorney Docket No. Z91), filed September 10, 2019, and entitled "Medical Devices, Methods and Systems," which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to medical devices. More particularly, the present disclosure relates to devices, methods, and systems. [Background technology]

[0003] Many potentially valuable drugs or compounds, including biologics, are not orally active due to poor absorption, liver metabolism, or other pharmacodynamic factors. In addition, some therapeutic compounds can be absorbed orally, but sometimes require very frequent administration, making it difficult for patients to maintain the desired schedule. In these cases, parenteral delivery is often employed or can be employed.

[0004] Effective parenteral routes of drug delivery and other fluids and compounds, such as subcutaneous injection, intramuscular injection, and intravenous (IV) administration, involve puncturing the skin with a needle or stylet. Insulin is an example of a therapeutic fluid that is self-injected by millions of diabetic patients. Users of parenterally delivered drugs could benefit from wearable devices that would automatically deliver the needed drug / compound over a period of time.

[0005] To this end, attempts have been made to design portable and wearable devices for the controlled release of therapeutic agents. Such devices are known to have reservoirs, such as cartridges, syringes, or bags, and to be electronically controlled. These devices suffer from several drawbacks, including a high rate of malfunction. Reducing the size, weight, and cost of these devices is also an ongoing challenge. In addition, these devices are often applied to the skin, presenting the challenge of frequent repositioning for application. Providing power or charging these devices can be cumbersome or problematic in certain scenarios. The small size of such devices also limits the amount of power they can store and imposes constraints on the size of the various components included therein. Additionally, the integration of these devices into networked systems, while beneficial, is not perfect. Summary of the Invention [Means for solving the problem]

[0006] According to one aspect of the present invention, a medical device system is disclosed, the medical system including a medical device including a first portion and a second portion, and an accessory configured to attach to the medical device and provide battery power to the medical device.

[0007] Some embodiments of this aspect of the invention may include one or more of the following: The accessory is attached to a second portion of the medical device. The accessory is attached to a first portion of the medical device.

[0008] According to one aspect of the present invention, a medical system is provided. The medical system may include a medical device accessory. The medical device accessory may have a mechanical coupling. The medical device may also include at least one additional component selected from the list consisting of charging circuitry, a user interface, a wireless signal booster, and an alarm. The system may also include a medical device that engages with the mechanical coupling for removably attaching to the medical device accessory.

[0009] In some embodiments, the charging circuitry may be wireless charging circuitry. In some embodiments, the charging circuitry may be wired charging circuitry. In some embodiments, the user interface may include a touchscreen. In some embodiments, the system may further include an analyte monitor. In some embodiments, a wireless signal booster may boost an analyte monitor signal output from the analyte monitor. In some embodiments, the alarm may be a vibration motor. In some embodiments, the alarm may be at least one light emitter. In some embodiments, the alarm may be an audio speaker. In some embodiments, the medical device may include a second alarm. The alarm of the medical device accessory may be the same type of alarm as the second alarm of the medical device, but may be a more powerful or stronger version of that alarm. In some embodiments, the medical device may be a pump. In some embodiments, the medical device may be a diabetes management device. In some embodiments, the medical device may be an insulin pump.

[0010] The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description, drawings, and claims. The present invention provides, for example, the following. (Item 1) 1. A medical device system comprising: a medical device comprising a first portion and a second portion; an accessory configured to attach to the medical device and provide battery power to the medical device; A medical device system comprising: (Item 2) Item 10. The medical device system of item 1, wherein the accessory is attached to the second portion of the medical device. (Item 3) Item 10. The medical device system of item 1, wherein the accessory is attached to the first portion of the medical device. [Brief explanation of the drawings]

[0011] These and other aspects will become more apparent from the following detailed description of various embodiments of the present disclosure, taken in conjunction with the drawings.

[0012] [Figure 1] FIG. 1 depicts a block diagram of a system including a medical device and an associated medical device accessory. [Figure 2] 2-7 depict embodiments of medical device accessories. [Figure 3] 2-7 depict embodiments of medical device accessories. [Figure 4] 2-7 depict embodiments of medical device accessories. [Figure 5] 2-7 depict embodiments of medical device accessories. [Figure 6] 2-7 depict embodiments of medical device accessories. [Figure 7] 2-7 depict embodiments of medical device accessories. [Figure 8] FIG. 8 depicts a block diagram showing charging components contained within a medical device and a medical device accessory. [Figure 9] 9-12 depict another embodiment of a medical device accessory. [Figure 10]9-12 depict another embodiment of a medical device accessory. [Figure 11] 9-12 depict another embodiment of a medical device accessory. [Figure 12] 9-12 depict another embodiment of a medical device accessory. [Figure 13] 13-16 depict another embodiment of a medical device accessory. [Figure 14] 13-16 depict another embodiment of a medical device accessory. [Figure 15] 13-16 depict another embodiment of a medical device accessory. [Figure 16] 13-16 depict another embodiment of a medical device accessory. [Figure 17] 17-20 depict another embodiment of a medical device accessory. [Figure 18] 17-20 depict another embodiment of a medical device accessory. [Figure 19] 17-20 depict another embodiment of a medical device accessory. [Figure 20] 17-20 depict another embodiment of a medical device accessory. [Figure 21] 21-26 depict yet another embodiment of a medical device accessory. [Figure 22] 21-26 depict yet another embodiment of a medical device accessory. [Figure 23] 21-26 depict yet another embodiment of a medical device accessory. [Figure 24] 21-26 depict yet another embodiment of a medical device accessory. [Figure 25] 21-26 depict yet another embodiment of a medical device accessory. [Figure 26] 21-26 depict yet another embodiment of a medical device accessory. [Figure 27] 27-30 depict yet another embodiment of a medical device accessory. [Figure 28] 27-30 depict yet another embodiment of a medical device accessory. [Figure 29] 27-30 depict yet another embodiment of a medical device accessory. [Figure 30] 27-30 depict yet another embodiment of a medical device accessory. [Figure 31] 31-34 depict yet another embodiment of a medical device accessory. [Figure 32] 31-34 depict yet another embodiment of a medical device accessory. [Figure 33] 31-34 depict yet another embodiment of a medical device accessory. [Figure 34] 31-34 depict yet another embodiment of a medical device accessory. [Figure 35] 35-40 depict yet another embodiment of a medical device accessory. [Figure 36] 35-40 depict yet another embodiment of a medical device accessory. [Figure 37] 35-40 depict yet another embodiment of a medical device accessory. [Figure 38] 35-40 depict yet another embodiment of a medical device accessory. [Figure 39] 35-40 depict yet another embodiment of a medical device accessory. [Figure 40] 35-40 depict yet another embodiment of a medical device accessory. [Figure 41] 41-47 depict yet another embodiment of a medical device accessory. [Figure 42] 41-47 depict yet another embodiment of a medical device accessory. [Figure 43] 41-47 depict yet another embodiment of a medical device accessory. [Figure 44] 41-47 depict yet another embodiment of a medical device accessory. [Figure 45] 41-47 depict yet another embodiment of a medical device accessory. [Figure 46] 41-47 depict yet another embodiment of a medical device accessory. [Figure 47] 41-47 depict yet another embodiment of a medical device accessory. [Figure 48] 48-51 depict yet another embodiment of a medical device accessory. [Figure 49] 48-51 depict yet another embodiment of a medical device accessory. [Figure 50] 48-51 depict yet another embodiment of a medical device accessory. [Figure 51] 48-51 depict yet another embodiment of a medical device accessory. [Figure 52] 52-55 depict yet another embodiment of a medical device accessory. [Figure 53] 52-55 depict yet another embodiment of a medical device accessory. [Figure 54] 52-55 depict yet another embodiment of a medical device accessory. [Figure 55] 52-55 depict yet another embodiment of a medical device accessory. [Figure 56] 56-58 depict yet another embodiment of a medical device accessory. [Figure 57] 56-58 depict yet another embodiment of a medical device accessory. [Figure 58] 56-58 depict yet another embodiment of a medical device accessory. [Figure 59] FIG. 59 depicts the medical device accessory in an open state with a medical device disposed therein. [Figure 60] FIG. 60 depicts the medical device accessory in a closed state with a medical device disposed therein. [Figure 61]61-65 depict yet another embodiment of a medical device accessory. [Figure 62] 61-65 depict yet another embodiment of a medical device accessory. [Figure 63] 61-65 depict yet another embodiment of a medical device accessory. [Figure 64] 61-65 depict yet another embodiment of a medical device accessory. [Figure 65] 61-65 depict yet another embodiment of a medical device accessory. [Figure 66] 66-69 depict yet another embodiment of a medical device accessory. [Figure 67] 66-69 depict yet another embodiment of a medical device accessory. [Figure 68] 66-69 depict yet another embodiment of a medical device accessory. [Figure 69] 66-69 depict yet another embodiment of a medical device accessory. [Figure 70] 70-72 depict yet another embodiment of a medical device accessory. [Figure 71] 70-72 depict yet another embodiment of a medical device accessory. [Figure 72] 70-72 depict yet another embodiment of a medical device accessory. [Figure 73] 73-74 depict yet another embodiment of a medical device accessory. [Figure 74] 73-74 depict yet another embodiment of a medical device accessory. [Figure 75] FIG. 75 depicts an embodiment of a medical device accessory having contacts for establishing communication with cooperating contacts on a medical device. [Figure 76] FIG. 76 depicts a medical device accessory having a user interface. [Figure 77]FIG. 77 depicts a medical device accessory having a user interface displaying an exemplary screen.

[0013] Like reference symbols in the various drawings indicate like elements. DETAILED DESCRIPTION OF THE INVENTION

[0014] Detailed Description of the Preferred Embodiments FIG. 1 depicts a block diagram of a medical device 10 and an associated accessory 12. The medical device 10 may be any medical device, including, but not limited to, a portable medical device, a drug delivery device, a physiological monitor, an analyte sensor, a diabetes management device, and a medical device intended for use in the home or other non-clinical / non-hospital setting. A single accessory 12 may also be coupled to multiple medical devices 10 (e.g., an insulin pump and a glucose meter). The block diagram shown in FIG. 1 depicts the medical device 10 as a drug delivery device, which is in fluid communication with a patient access 16, such as a needle, cannula, or subcutaneous infusion set, via tubing 14. The medical device 10 may deliver a drug or drugs, such as insulin, glucagon, treprostinil, an oncology drug, or the like, or some combination thereof, to a patient.

[0015] Medical device 10 is depicted as having a first portion 18 and a second portion 20. Second portion 20 may be a cartridge or other consumable item including a drug reservoir and possibly a valve and / or actuatable pumping components that mates with first portion 18. First portion 18 may include a controller, battery 22, a pump actuation assembly, sensors, communication hardware, and other reusable components. Examples of such drug delivery devices and / or medical devices having a first portion and a second portion are shown and described in U.S. Patent Application No. 13 / 788,260 (Attorney Docket No. K40), now U.S. Patent Publication No. US-2014-0107579, filed March 7, 2013, entitled "Infusion Pump Assembly," published April 17, 2014; U.S. Patent No. 8,491,570 (Attorney Docket No. G75), issued July 23, 2013, entitled "Infusion Pump Assembly," and U.S. Patent No. 8,414,522 (Attorney Docket No. E70), issued April 9, 2013, entitled "Fluid Delivery Systems and Methods," each of which is incorporated herein by reference in its entirety. Although various embodiments of the present disclosure are described in connection with a particular medical device 10, such as a drug delivery device or a diabetes management device, this is done for illustrative purposes and other medical devices 10 may be used in place of the exemplary medical device 10 described.

[0016] The accessory 12 may be electrically, communicatively, mechanically, or some combination thereof coupled to the medical device 10. When the accessory 12 is coupled to multiple medical devices 10, the type of coupling between the medical devices 10 and the accessory 12 may vary. For example, a first medical device may be electrically, communicatively, and mechanically coupled to the accessory 12, while a second medical device may only be communicatively coupled.

[0017] The accessory 12 may cooperate with the medical device 10 to provide power to the medical device 10, augment the existing functionality of the medical device 10, and / or help provide additional functionality. For example, the accessory 12 may include a power source such as a battery 24. The battery 24 may be used as an auxiliary battery, which may be drawn from in place of the battery 22 included in the medical device 10. The battery 24 included in the accessory 12 may also be used to recharge the battery 22 included in the medical device 10. In such cases, a contact-based electrical connection between the accessory 12 and the medical device 10 may be used to transfer power. Such an embodiment may include a set of conductive contacts that may cooperate with contacts provided on the medical device 10 when the accessory 12 is disposed thereon. A male / female plug-type interface may also be included on the accessory 12 and the medical device 10 to provide electrical communication. Alternatively, the battery 22 of the medical device 10 may be recharged via wireless coupling. The accessory 12 may be wirelessly (e.g., inductively, acoustically) coupled to the medical device 10 and transfer power to the medical device 10 using, for example, but not limited to, PMA, Airfuel, A4WP, Open dots, Rezence, Qi, acoustic power transfer, or other wireless power transfer standards. This may allow, for example, a user to travel or perform various activities with the medical device 10 without needing to carry a relatively heavy consumable battery supply or various adapters and cables. Furthermore, a user may be able to charge the medical device 10 in scenarios when access to the electrical grid is unavailable or inconvenient (e.g., camping, hiking, the beach, etc.). Additionally, this may facilitate recharging the medical device 10 while the medical device 10 is currently in use and attached to a patient. For example, an insulin pump may be recharged by a user wearing the pump while sleeping via the attached accessory 12.The absence of a cord can be beneficial / desirable for many reasons, including, but not limited to, making the experience more hassle-free, convenient, and user-friendly. Additionally, concerns related to damaging the cord or charging port may be eliminated. Wireless charging may also simplify certain aspects of medical device 10 design, for example, by increasing the ease with which such devices can be waterproofed.

[0018] The accessory 12 may include one or more alarms 26. The alarm 26 may include a speaker, a tactile stimulation array (e.g., a vibration motor), an illuminator, or any combination of one or more thereof. In some embodiments, the alarm 26 may augment an existing alarm system included within the medical device 10. Because the accessory 12 may, in some embodiments, have its own dedicated battery 24, the accessory 12 may be configured to emit a stronger or more aggressive alarm than an alarm system included within the medical device 10. For example, a larger or more powerful vibration motor may be included within the accessory 12 than would be practical for inclusion within the medical device 10. Similarly, a larger or higher-pitched speaker may be included within the accessory 12. An illuminator included as part of the alarm 26 of the accessory 12 may have a brighter output than any light included as part of the medical device 10. Such an alarm may help, for example, to wake a user or caregiver while sleeping. This can be particularly advantageous for insulin pump users, as their arousal response can be impaired during nocturnal hypoglycemia episodes. In some embodiments, accessory 12 can include a heat alarm, which may have one or more heating elements. Accessory 12 can generate heat, for example, using a heating element, which can alert the user that an alarm or condition of interest exists. The heat produced can be 5°F or more above body temperature, so as to be noticeable, but not excessive.

[0019] The accessory 12 may include a radio 28. The radio 28 may include one or more of an antenna for cellular, WiFi, Bluetooth, Zigbee, etc. The radio 28 may enable the accessory 12 to download updates for the medical device 10. The radio 28 may provide wireless communication capabilities for a medical device 10 that does not have such capabilities. Additionally, the radio 28 may serve to complement an existing radio within the medical device 10. For example, the radio within the accessory 12 may have a wider range or greater transmission power output than the radio or radios included within the medical device 10. The accessory 12 may be communicatively coupled to the medical device 10 and may boost any signal output from the medical device 10 or act as a repeater for the signal output from the medical device 10. This may enable the medical device 10 to have an increased communication range or be less susceptible to interference that may limit the robustness of the communication connection to other components of the medical system. For example, the accessory 12 may output a stronger signal, enabling remote monitoring of the status of the medical device 10. In one embodiment, the wireless communicator 28 of the accessory 12 may receive data from a physiological or analyte sensor and wirelessly transmit the data to a receiver at a frequency or signal strength that would be impractical if relying solely on the battery 22 included within the medical device 10. This may be particularly advantageous for certain medical devices 10, such as continuous glucose monitors, that are worn during sleep. Signal dropouts present a problem as a user may shift position and move the monitor into a position where the signal it outputs is disrupted. Alarms associated with dropouts during sleep can be disturbing to the user, reduce quality of life, and may play a significant role in a patient's decision to discontinue use of such monitors despite the benefits they offer. Additionally, such signal issues can lead to missing blood glucose data points on a remote monitoring device (e.g., a smartphone or dedicated monitor). The wireless communicator 28 in the associated accessory 12 can help mitigate these problems.

[0020] The accessory 12 may include a user interface 29. The user interface 29 may include user-actuated hard buttons. When actuated, such buttons may, for example, cause buttons on the medical device 10 to provide input. This may allow a user to maintain full functionality of the medical device 10 if installation of the accessory 12 on the medical device 10 covers one or more buttons of the medical device 10. The hard buttons may also have their own functionality unrelated to buttons included on the medical device 10. Such buttons may, for example, aid in navigation through various screen flows displayed on the user interface 29, including the display (see, e.g., FIG. 77). Such a display may be a liquid crystal display, an LED display, an OLED display, a plasma display, a touchscreen display, or any other suitable display. In such an embodiment, the accessory 12 may enable the medical device 10 to be equipped with a large and / or bright display that has significant power demands because the accessory 12 may have its own battery 24. Thus, accessory 12 may provide the user with an aesthetically appealing and easy-to-use graphical user interface that may convey information about medical device 10, current therapy, or patient-related data. Accessory 12 may also allow for programming or modification of therapy to be provided by medical device 10. Accessory 12 may thus replace or provide redundancy to a user interface on a smartphone or similar device used to review and set therapy parameters and / or check analyte levels or trends.

[0021] In some embodiments, the accessory 12 may also allow user customization of the appearance of the medical device 10. For example, the accessory 12 may have a removable skin that forms part of the housing 50 of the accessory 12 (see, e.g., FIGS. 2-5 ). Several different skins may be attached to the accessory 12 depending on user preferences. Thus, a user may modify the appearance of the medical device 10 to suit their particular tastes. Alternatively, the appearance may be modified to make the accessory 12 easily distinguishable from other accessories 12. The removable skin may be coupled to the accessory 12 in any suitable manner. For example, a magnetic coupling or a snap fit may be used, or an adhesive may be used to adhere the skin to the accessory 12. The skin may also be coupled to the accessory 12 via a clip-on engagement.

[0022] 2-5, several views of an exemplary accessory 12 are shown. The accessory 12 includes a housing 50. The housing 50 includes a medical device receptacle, shown as a bay 52, that is sized and shaped to receive and retain a medical device 10, or a portion thereof. In the exemplary embodiment, the bay 52 includes a coupling member, depicted as an arm 54, located on opposite sides of a docking opening in the housing 50. The arm 54 may be cantilevered so as to resiliently deflect outward as the medical device 10 is docked into the bay 52. A portion of the medical device 10 that is wider than the distance between the inner surfaces of the arm 54 in the resting state can be passed through the arm 54 and into the bay 52 while the arm 54 is deflected outward. The arm 54 can then return to its resting state once the medical device 10 is in position within the bay 52. Thus, the arm 54 can be clipped onto the medical device 10, mechanically retaining the accessory 12 in place on the medical device 10. Preferably, the resilience of the arms 54 is selected to allow retention of the medical device 10 under some compression, but also to allow deployment and removal of the medical device without excessive force or effort. The housing 50 may include one or more fenestrations 56, which may allow a user to view or access portions of the medical device 10. The fenestrations 56 may be included, for example, to allow line-of-sight for user interface components of the medical device 10, such as indicators (e.g., lights) and / or user input components of the medical device (e.g., a touchscreen or buttons, such as a bolus button on a diabetes management pump). The fenestrations 56 may also allow a user to access and press on portions of the medical device 10 to remove it from the attachment 12.

[0023] The housing 50 may also include a second portion 58. The second portion 58 may contain, for example, one or more of the battery 24, charging circuitry, a controller (e.g., a microprocessor, PLC, FPGA, etc.), memory, an alarm 26, a radio 28, and a user interface 29. As shown, the accessory 12 also includes a button 60. The button 60 may turn the accessory 12 on and off. The button 60 may also be used to communicate user input to the accessory 12. For example, the button 60 may be used to acknowledge and silence (e.g., stop generating one or more audible, tactile, or visual outputs) or temporarily snooze an alarm being generated by the accessory 12. The accessory 12 may further include a port 62. The port 62 may be used for data (e.g., log transfer or medical device updates) or power communication. For example, the port 62 may be used to charge the battery 24 included within the accessory 12. Any suitable port 62 may be used, such as a USB, mini USB, micro USB, barrel jack, or any proprietary connector port. In alternative embodiments, the port 62 may not be included. Instead, the battery 24 of the accessory 12 may be charged wirelessly by a charging mat, platform, stand, or similar item. When an embodiment of the accessory 12 is shown herein without a port 62 or as having a particular port 62 type, it should be understood that this is merely exemplary. Any type of port may be used on any of the embodiments depicted herein, and any of the embodiments herein may be charged wirelessly. Similarly, any embodiment herein may include a charging port but also be capable of wireless charging.

[0024] Referring again to FIGS. 6 and 7 , the accessory 12 is depicted with the medical device 10 retained therein and the medical device 10 about to be docked thereto, respectively. As best shown in FIG. 6 , the medical device 10 may be a drug delivery device such as an ambulatory infusion pump. The medical device 10 may be attached to an infusion set 16 via tubing 14 (as shown) or may comprise a patch-type drug delivery device. The medical device 10 may be retained on the body using a skin-compatible adhesive. The accessory 12 may be attached to the medical device 10 while the medical device 10 remains in situ on the user. Preferably, any edges of the accessory 12 that may abut the patient's skin when clipped onto the medical device 10 in situ are rounded or blunt for comfort to the patient wearing the medical device 10. As shown in FIGS. 6 and 7 , the footprint of at least one medical device-receiving portion of the housing 50 for the accessory 12 may mimic the footprint of the medical device 10. In the exemplary embodiment, the medical device 10 is depicted as a disk-shaped device, and the accessory bay 52 has a complementary footprint. Other footprints for the medical device 10 and bay 52 are also possible, such as various polygonal shapes (e.g., rectangular), round shapes, oval shapes, or other shapes with both rounded and rectilinear features. When retained on the medical device 10, the arms of the accessory 12 can clip around the edge 64 of the medical device 10.

[0025] Referring again now to FIG. 8 , a cross-sectional view of the accessory 12 shown in FIGS. 2-7 is shown mounted on a medical device 10. For illustrative purposes, only the power transfer components of the accessory 12 and medical device 10 are shown and depicted in block diagram form. As shown, the accessory 12 includes a DC power source, shown as a battery 24. The accessory 12 may also include a transmitter circuit 70, which may include an inverter for providing AC to a transmitter coil 72, also included within the accessory 12. The medical device 10 may include a corresponding receiver coil 74. The receiver coil 74 may be in electrical communication with a receiver circuit 76, which may include a rectifier. The receiver circuit 76 may output DC to the rechargeable battery 22 of the medical device 10 to charge the battery 22.

[0026] Another embodiment of the exemplary accessory 12 is depicted in FIGS. 9-12. As shown, the housing 50 includes a first portion, a medical device receiver, which is shaped as a pocket. The pocket is defined by arms 54, which serve as connecting members for retaining the accessory 12 in place on the medical device 10. The pocket is also defined by a second portion 58 of the housing 50 (which may be equipped similarly to that described with respect to FIGS. 2-8) and a base plate 80. The exemplary embodiment also includes a fenestration 56, although additional fenestration 56 may be included in alternative embodiments. The base plate 80 may allow the medical device 10 to be at least partially enclosed on all sides. Thus, the medical device 10 may be attached to the accessory 12 when removed from the body. In some embodiments, the bottom surface of the base plate 80 may include an adhesive region 82, onto which a skin-compatible adhesive may be applied. Thus, the accessory 12 may be adhered to the patient with the medical device 10 retained therein.

[0027] In some embodiments, the charge rate of the medical device 10 may be modified as the medical device 10 is charged. For example, the medical device 10 may be rapidly charged by the accessory 12 until the battery level of the medical device 10 reaches a certain level. For example, the medical device 10 may be rapidly recharged until the battery 22 of the medical device 10 reaches a certain percentage (e.g., 50% or more) at which the medical device 10 will be able to function for a predefined period of time. This may allow a user to quickly dock the accessory 12 to the medical device 10 and reach an acceptable charge state while minimizing any disruption to the activity in which the patient is engaged. The medical device 10 may be charged to a full state when it is more convenient for the user. Thus, convenience may be maximized without unnecessarily degrading the battery 22. In some embodiments, the accessory 12 may rapidly recharge the battery 22 of the medical device 10 only upon receiving communication from the medical device 10 that the battery 22 contained within the medical device 10 is capable of rapid recharging (is of the appropriate type and has no associated errors or faults).

[0028] Another embodiment of the exemplary accessory 12 is depicted in FIGS. 13-15. As shown, the housing 50 includes a bay 52 that is sized and shaped to receive and retain the medical device 10, or a portion thereof. In the exemplary embodiment, the bay 52 includes a connecting member, depicted as an arm 54, located on opposite sides of a docking opening in the housing 50. The bay 52 is also defined by a top plate 84. The accessory 12 may be retained on the medical device 10 in situ. In the exemplary embodiment, the accessory 12 includes a second portion 58. The second portion 58 is disposed laterally relative to the bay 52, giving the accessory 12 a profile that is only slightly taller than the medical device 10 retained therein. The second portion 58 may include components such as those described in connection with FIGS. 2-8. The exemplary accessory 12 also includes a release mechanism 86, which may be activated by a user to remove the accessory 12 from the medical device 10. In the exemplary embodiment, the release mechanism 86 includes a user-displaceable button that, when displaced, can drive an ejection finger 90 (see, e.g., FIG. 15 ) into the medical device 10. As best shown in FIG. 15 , the release mechanism 86 can include a user-contact surface 88. The user-contact surface 88 can include a curved recess, which serves as a depression surface for a user's finger. The release mechanism 86 can also include a hinge 92, which connects the release mechanism 86 to the housing 50 of the accessory 12. In the example, the hinge 92 is depicted as a unitary hinge, but a hinge that includes a pivot pin about which the release mechanism 86 can be displaced can be used in alternative embodiments. When depressed, the release mechanism 86 can pivot about the hinge 92, and the ejection finger 90 can apply a force to the medical device 10. This force may help to displace the medical device 10 out of clip engagement with the arms 54 of the attachment 12 so that the attachment 12 may be removed from the medical device 10 .

[0029] While the exemplary accessory 12 includes a release mechanism 86, other embodiments may include a similar user-actuable component, which may be operated to sense user input to the medical device 10. Accordingly, the accessory 12 may include a user interface 29. For example, in some embodiments, a user input mechanism may be included within the accessory 12. The user input mechanism may be a hinged, displaceable component similar to the release mechanism described above. The user input mechanism may include an input finger instead of an ejection finger. Such an input finger may align with a button or equivalent included within the medical device 10 retained within the accessory 12. When the user input mechanism is actuated (e.g., by a user's finger), the input finger may be advanced relative to an input means included on the medical device 10. This may allow the accessory 12 to be made without the fenestrated portion 56 (see, e.g., FIGS. 2-5 ), while still allowing operation of buttons covered by the accessory 12 when the accessory 12 is disposed on the medical device 10.

[0030] 17-20 , another exemplary embodiment of the accessory 12 is depicted. As shown, the housing 50 includes a bay 52 that is sized and shaped to receive and retain the medical device 10, or a portion thereof. In the exemplary embodiment, the bay 52 includes a connecting member, depicted as an arm 54, located on opposite sides of a docking opening in the housing 50. The bay 52 is also defined by a top plate 84. The accessory 12 may be retained on the medical device 10 in situ. In the exemplary embodiment, the accessory 12 includes a second portion 58. The second portion 58 is positioned laterally relative to the bay 52, giving the accessory a profile that is only slightly taller than the medical device 10 retained therein. The second portion 58 may include components such as those described in connection with FIGS. 2-8 . As shown, the top plate 84 includes a fenestrated portion 56.

[0031] 21-26 , another exemplary embodiment of the accessory 12 is depicted. As shown, the housing 50 is cap-like and includes a medical device receptacle in the form of a cavity 100 that is sized and shaped to receive and retain the medical device 10, or a portion thereof. The accessory 12 also includes a second portion 58, which may include the components described above in connection with FIGS. 2-8 . In the exemplary embodiment, the housing 50 includes a peripheral wall 102 that, when retained on the medical device 10, substantially surrounds the medical device 10. The peripheral wall 102 may also include a marginal edge 105 at its edge, which may aid in retaining the accessory 12 on the medical device 10. In some embodiments, the marginal edge 105 may be sized to interface with a corresponding groove in the medical device 10. The peripheral wall 102 includes several interruptions 104. These interruptions 104 are, in the exemplary embodiment, spaced at regular angular intervals within the peripheral wall 102. In an example embodiment, a disruption 104 is included approximately every 60°. In alternative embodiments, a disruption 104 may be included, for example, every 45-120°. The disruption 104 may also be irregularly spaced. In embodiments in which the accessory 12 does not have a rounded footprint, for example, there may be at least one disruption per side of the peripheral wall 102 of the accessory 12. In an exemplary embodiment, the disruption 104 follows a linear path generally parallel to the height axis of the accessory 12 and is cut into the peripheral wall 102 in a direction generally perpendicular to the height axis of the accessory 12. As used herein, it should be understood that the term "cut" can, but does not necessarily, mean that a feature is formed via a material removal process. Features described as cut out of, cut into, or the like, a component may be formed during molding, casting, a material-additive process (e.g., 3D printing), or other manufacturing processes that do not involve the removal of material from the component. In other embodiments, the path of the disruption 104 need not follow a straight path and may be cut into the peripheral wall 120 at angles other than those shown.

[0032] The interruption 104 may generate several wall segments that are cantilevered to the upper portion of the accessory 12. Each segment may act as a coupling member, which may help retain the accessory 12 on the medical device 10. Each cantilevered segment may resiliently deflect outward as the medical device 10 is docked into the cavity 100. When the segment is in a resting state, a portion of the medical device 10 that is wider than the opening in the bottom of the accessory 12, provided by the edge 105, may pass into the cavity 100 as the segment is deflected outward. The segment may then return to its resting state once the medical device 10 is in position within the cavity 100. Thus, the accessory 12 may be clipped onto the medical device 10, mechanically retaining the accessory 12 in place on the medical device 10. As shown in FIG. 25, the medical device 10 can remain in situ on the patient while the accessory 12 is attached to the medical device 10 by pressing the accessory 12 onto the top of the medical device 10.

[0033] The peripheral wall 102 of the accessory 12 may also have a gap 106. The gap 106 may be included to accommodate a protrusion, such as a tubing connector or tubing 14, that leads from the medical device 10 to a point beyond the footprint of the accessory 12. In the exemplary embodiment, the gap 106 is a cutout having a Norman window shape; however, any suitable shape may be used. In addition, one of the disruptions 104 in the peripheral wall 102 extends into the gap 106. This need not be the case in all embodiments.

[0034] The gap 106 in the exemplary embodiment is flanked on each side by flanges 108, which in some embodiments are included at the bottom of the peripheral wall 102. The flanges 108 may provide a gripping or contact surface to facilitate removal of the attachment 12 from the medical device 10. The distance that the flanges 108 extend from the peripheral wall 102 may vary, and in some embodiments, increases with proximity to the gap 106.

[0035] 27-30, another exemplary attachment is depicted. In this exemplary embodiment, a flange 108 is present along the entire section of peripheral wall 102 adjacent gap 106. The distance that flange 108 protrudes from peripheral wall 102 is variable along a first section and substantially constant along a second section proximal to gap 106.

[0036] 31-34, in an alternative embodiment, a flange 108 may be included on the top of the attachment 12. Additionally, disruptions 104 in the peripheral wall 102 may be included over only a portion of the peripheral wall 102. In an exemplary embodiment, the disruptions 104 are included at regular angular intervals over the majority of the peripheral wall 102. A gap 106 is flanked on each side by a section of the peripheral wall 102 without the disruptions 104.

[0037] 35-40, another embodiment of the accessory 12 is shown, including a flange 108 extending from the top of the accessory 12. The exemplary embodiment shown in FIGS. 35-38 also includes a peripheral wall 102 having a curvature. This curvature can open an opening in the bottom of the accessory 12, which leads to a cavity 100 smaller than at least a portion of the medical device 10. Thus, as the accessory 12 is coupled onto the medical device 10, the peripheral wall 102 can clip around the medical device 10, holding the accessory 12 in place. As in other embodiments, the accessory 12 can include a second portion 58, which can include the components described in connection with FIGS. 2-8. The accessory 12 also includes a larger gap 106. The larger gap 106 can allow for some rotation of the accessory 12 relative to the medical device 10.

[0038] 41-47, another exemplary embodiment of the accessory 12 is depicted. As shown, the housing 50 of the accessory 12 includes a retaining portion that includes several clips 110. The housing 50 also includes a second portion 58, which may include the components described in connection with FIGS. 2-8. The medical device 10 may include several receiving recesses for the clips 110 of the accessory 12. In certain examples, this may allow the accessory 12 to be mounted to the top of the medical device 10 while the medical device 10 remains operational in situ. In some embodiments, the accessory 12 may be mounted onto the medical device 10 by pressing the accessory 12 against the medical device 10. This may bias each of the clips 110 around a portion of an individual receiving recess in the medical device 10. As the accessory 12 is further advanced relative to the medical device 10, the clips 110 may advance past an obstructing portion of the receiving recess and return to a resting state. Clip 110 may include a hook portion 112, which may latch accessory 12 in place once advanced past an obstructing portion of the receiving recess. As shown, housing 50 of accessory 12 may include a recess 114. Recess 114 may be sized to allow a fingertip to reach under accessory 12 and remove accessory 12 from medical device 10.

[0039] In alternative embodiments, the clip 110 of the accessory 12 may interface with a bayonet-type mount included within the medical device 10. In such embodiments, the medical device 10 may include an "L"-shaped slot for each clip 110. The clip 110 of the accessory 12 may be advanced into an opening provided by the legs of the "L"-shaped slot. The accessory 12 may then be rotated so that the clip 110 is displaced along the remainder of the slot into a region of the slot where removal of the clip 110 from the slot is obstructed. Thus, the accessory 12 may be mechanically coupled to the medical device 10. The accessory 12 may be rotated back to a position in which the clip 110 aligns with the opening provided by the legs of the "L"-shaped slot, allowing removal of the accessory 12. In some embodiments, the "L"-shaped slot may include a small protruding portion within which the clip 110 resides when the accessory 12 is mechanically coupled to the medical device 10. The user may be required to depress the attachment 12 and advance the clip 110 out of the ridge portion before the attachment 12 may be rotated to remove it from the medical device 10 .

[0040] 48-51 , another example attachment 12 is depicted. As shown, the housing 50 of the attachment 12 includes a retention portion that includes a pivotable retention member 120. The housing 50 also includes a second portion 58, which may include the components described in connection with FIGS. 2-8 . The illustrated pivotable retention member 120 has an arcuate shape and includes a pin 122 included at its terminal end. The pin 122 may extend into a bearing included on the remainder of the housing 50. During mechanical coupling between the attachment 12 and the medical device 10, the pin 122 may allow the retention member 120 to pivot from a receiving position to a retaining position. In the receiving position, the retention member 120 may be pivoted over the top of the housing 50, allowing the housing 50 to be installed onto the medical device 10 without removing the medical device 10 from the patient. Once in place, the retention member 120 of the accessory 12 may be displaced into the retention position (shown in FIGS. 48-51 ). When in the retention position, the retention member 120 may clip into place around the medical device 10 to hold the accessory 12 in place on the medical device 10. The retention member 120 may also include a flange 124. The flange 124 may be included to facilitate user gripping and actuation of the accessory 12. The housing 50 also includes a notch 126. The notch 126 may allow access to a user interface component of the medical device 10, similar to the fenestration 56 described elsewhere herein.

[0041] 52-55, another example accessory 12 is shown including a pivoting retention member 120. The exemplary embodiment depicted in FIGS. 52-55 is configured to latch around the medical device 10 when disposed thereon. As best shown in the detailed view of FIG. 53, the retention member 120 may include a protrusion 128. When the retention member 120 is in the retaining position, the protrusion 128 may engage with a detent 130 included on another portion of the housing 50. This may help hold the retention member 120 in the retaining position and keep the accessory 12 from being inadvertently removed from the medical device 10 as the user moves around, for example, while sleeping.

[0042] 56-60, another embodiment of the accessory 12 is shown. As shown, the accessory 12 may have a clip 142 that may be disposed on the second portion 58. The second portion 58 may also include the components described in connection with FIGS. 2-8. The second portion 58 may be pivotally coupled to the first portion 140 by a pivot pin 144. The first portion 140 may be pivoted to a loading position in which the medical device 10 may be installed within the accessory 12. From the loading position, the first portion 140 may be pivoted to a retaining position in which the medical device 10 is held in place within the accessory 12. A latching arrangement similar to that shown in FIGS. 52-55 may be included to help hold the first portion 140 in place in the retaining position. The first portion 140 or the second portion 58 of the accessory 12 may include a cradle 146 in which the medical device 10 may be disposed. As shown in FIG. 59 , the medical device 10 is shown in position within the cradle 146 of the first portion 140. The cradle 146 may include one or more wings 148, which may surround at least a portion of the medical device 10 when the medical device 10 is disposed within the cradle 146. Once the medical device 10 is positioned within the cradle 146, the first portion 140 of the accessory 12 may be pivoted toward the second portion 58 of the accessory 12. This may cause the medical device 10 to be pinched within the accessory 12, as shown in FIG. 60 , for example. The clip 142 may be attached to a user's belt or waistband, allowing the medical device 10 to move with the accessory 12 while being carried by the patient.

[0043] An alternative embodiment of the accessory 12 shown in Figures 56-60 is depicted in Figures 61-65. As shown, the first portion 140 and the second portion 58 are attached to one another via a living hinge 150. Thus, the first portion 140 can be displaced relative to the second portion 58 without the need for a pivot pin 144 (see, for example, Figures 56-60). Additionally, a latching arrangement need not be included because the living hinge 150 can be constructed with sufficient resilience to avoid inadvertent deflection once the medical device 10 is disposed within the accessory 12.

[0044] In another alternative embodiment, as shown in FIGS. 66-69 , the accessory 12, together with the housing 50, has a medical device receptacle, shown as a bay 52, that is sized and shaped to receive and retain the medical device 10, or a portion thereof. In the exemplary embodiment, the bay 52 includes a coupling member, depicted as an arm 54, located on an opposite side of the docking opening in the housing 50. The arm 54 may be contoured to embrace the medical device 10 when the medical device 10 is placed within the accessory 12. As shown, the accessory 12 may include a clip 142, which may be disposed on the second portion 58. The second portion 58 may also include the components described in connection with FIGS. 2-8 . The clip 142 may facilitate attachment of the accessory 12 to a user's belt or waistband. Additionally, the clip 142 may ensure that the arm 54 of the bay 52 is positioned such that the medical device 10 can be held in place within the accessory 12 by the force of gravity.

[0045] 70-72 , the accessory 12 may include a belt 160. A strap, sling, or similar component may be included in various embodiments to facilitate ease of donning the accessory 12. As shown, the belt 160 may include a buckle portion 162. The buckle portion 162 may contain, for example, one or more of the battery 24, charging circuitry, a controller (e.g., a microprocessor, PLC, FPGA, etc.), memory, an alarm 26, and a wireless communicator 28. Additionally, the buckle portion 162 may include a slot 164. The slot 164 may be sized to receive the medical device 10. In some embodiments, an arm 54, such as those depicted in FIGS. 9-12 , may be included to assist in retaining the medical device 10 within the slot 164.

[0046] 73-74 , another embodiment of the accessory 12 is depicted. As shown, the accessory 12 may include a pad 170 having a recess 172 sized to receive the medical device 10. The recess 172 may include a number of magnets 174, which may couple to magnets included within the medical device 10. In addition, the pad 170 may contain, for example, one or more of the battery 24, charging circuitry, a controller (e.g., a microprocessor, PLC, FPGA, etc.), memory, an alarm 26, and a wireless communicator 28. The pad 170 may further include a port 62, which may be used for data (e.g., log transfer or medical device updates) or power communication. A USB-type cable 178 is depicted as being coupled into the port 62 in FIG. 74 . An indicator light 176 may be included on the pad 170 and illuminate based on the status of the accessory 12 and / or the medical device 10. For example, the indicator light 176 may illuminate a first color to indicate that the medical device 10 is being wirelessly charged. The indicator light may flash to indicate a low battery 24 in the accessory 12. The indicator light 176 may illuminate a second color in the event of an alarm encountered by the medical device 10 or the accessory 12.

[0047] 75, another exemplary accessory 12 is depicted. The depicted accessory 12 is similar to that shown in FIGS. 2-8, however, the accessory 12 includes a set of conductive contacts 180. When a medical device 10 is placed within the accessory 12, the conductive contacts 180 may interface with conductive zones included on the medical device 10. This may allow the accessory 12 to interface with the medical device 10 for charging purposes.

[0048] 76-77, another exemplary accessory is depicted. As shown, the accessory includes a user interface 29. The user interface 29 may be a touchscreen display, although any other suitable type of display may be included. A home screen of the user interface 29 is depicted in FIG. 77. The home screen may include information such as the patient's current on-board insulin (IOB). The home screen may also include the latest reading from a glucose monitor, such as a CGM. Other information, such as the date, remaining battery life, and remaining medication, may also be included. A user may also be able to access information about the latest bolus or blood glucose trend data from the home screen. A bolus button may be included on the home screen. In addition, the home screen may include a menu button, which may be used to access various settings, program infusion profiles, view historical patient data, access tutorials, etc. The user interface 29 may present any number of other screens that enable a user to program and use the medical device 10.Some exemplary screens that may be generated for presentation on user interface 29 are described in U.S. Patent No. 9,132,227 (Attorney Docket No. G98), issued September 15, 2015, and entitled "Methods and Systems for Controlling an Infusion Pump," U.S. Patent No. 9,656,031 (Attorney Docket No. I06), issued May 23, 2017, and entitled "Infusion Pump Methods and Systems," U.S. Patent No. 9,656,031 (Attorney Docket No. I06), issued May 30, 2017, and entitled "Devices, Methods and Systems for Wireless Control of Medical Devices ... No. 9,662,438 (Attorney Docket No. I98), issued on March 26, 2019, entitled "Devices, Methods and Systems for Wireless Control of Medical Devices," U.S. Patent No. 10,238,794 (Attorney Docket No. K11), issued on February 5, 2019, entitled "Devices, Methods and Systems for Wireless Control of Medical Devices," and U.S. Patent No. 10,195,343 (Attorney Docket No. L72), issued on February 5, 2019, entitled "Devices, Methods and Systems for Wireless Control of Medical Devices," each of which is incorporated herein by reference in its entirety.

[0049] Various alternatives and modifications may be devised by those skilled in the art without departing from the present disclosure. Accordingly, the present disclosure is intended to encompass all such alternatives, modifications, and variations. Additionally, while several embodiments of the present disclosure have been shown in the drawings and / or discussed herein, the present disclosure is not intended to be limited thereto, but rather the disclosure is intended to be read in the broadest scope that the art will permit. Accordingly, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will also envision other modifications within the scope and spirit of the claims appended hereto. Other elements, steps, methods, and techniques that are substantially different from those described above and / or in the appended claims are also intended to be within the scope of the present disclosure.

[0050] The embodiments shown in the drawings are presented only to demonstrate certain examples of the present disclosure. Also, the drawings described are illustrative only and are non-limiting. In the drawings, the size of some of the elements may be exaggerated and not drawn to scale for illustrative purposes. Additionally, elements shown in the drawings with the same number may be the same or similar elements, depending on the context.

[0051] When the term "comprising" is used in the present description and claims, it does not exclude other elements or steps. Where an indefinite or definite article, such as "a," "an," or "the," is used when referring to a singular noun, this also includes the plural of that noun unless something is specifically stated otherwise. Thus, the term "comprising" should not be construed as being limited to the items listed thereafter. That is, it does not exclude other elements or steps, and thus the scope of the expression "a device comprising items A and B" should not be limited to "a device consisting only of components A and B."

[0052] Additionally, the terms "first," "second," "third," and the like, whether used in the description or claims, are provided to distinguish between similar elements and do not necessarily describe a sequential or chronological order. Terms so used are, under appropriate circumstances, interchangeable (unless expressly disclosed otherwise), with the understanding that the herein-described embodiments of the present disclosure may operate in sequences and / or arrangements other than those described or illustrated herein.

[0053] While the principles of the present invention have been described herein, it should be understood by those skilled in the art that this description is made only by way of example and not as a limitation on the scope of the invention. Other embodiments are contemplated within the scope of the present invention in addition to the exemplary embodiments shown and described herein. Modifications and substitutions by those skilled in the art are also deemed to be within the scope of the present invention.

Claims

[Claim 1] The invention as described in the drawings of this application.

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