Systems, devices and methods for automated insulin delivery device including voice-coil actuation

Abstract

The present disclosure is directed to automated-insulin-delivery (AID) systems, devices and methods. Specifically, in some aspects, an AID device / patch includes a housing having an adhesive tape, an insulin pump including a single lumen cannula, a glucose sensor including a flat probe, a processor, and an automated-insulin-delivery algorithm (AIDA). In some embodiments, the housing is configured to be adhered the skin of a user via the adhesive tape and house the insulin pump, glucose sensor, and AIDA, the probe at least partially resides within the cannula, and the AIDA is configured as computer instructions operating on the processor causing the processor to control insulin delivery by the insulin pump according to glucose levels determined in subcutaneous tissue based on signals received from the glucose sensor.

Description

Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO SYSTEMS, DEVICES AND METHODS FOR AUTOMATED INSULIN DELIVERY DEVICE INCLUDING VOICE-COIL ACTUATION RELATED APPLICATIONS

[0001] The present disclosure claims benefit of and priority to U.S. provisional patent application no.63 / 645,723, filed May 10, 2024, titled “AUTOMATED INSULIN DELIVERY DEVICE WITH VOICE-COIL ACTUATION,” the entire disclosure of which is herein incorporated by reference in its entirety. FIELD OF INVENTION

[0002] The present disclosure relates to various systems, devices, patches, and methods for automated insulin delivery (AID), and in particular, a skin adhered AID patch that includes a continuous insulin delivery-mechanism (pump), continuous glucose monitoring (CGM) mechanism, and an algorithm that automatically control insulin delivery according to glucose monitoring. More particularly, an AID patch that includes a cannula for continuous insulin delivery and a sensor probe that resides within the cannula for continuous glucose monitoring. BACKGROUND

[0003] Automated insulin delivery (AID) systems eliminate disease burden in people with diabetes (PwD) treated with insulin. Existing AID systems include two separate devices: a first device for continuous delivery of insulin (insulin pump), and a second device for continuous glucose monitoring (CGM device). An AID algorithm (AIDA) automatically controls insulin delivery from the insulin pump according to glucose readings received from the CGM device. Wireless communication (usually Bluetooth Low Energy, BLE) between CGM device and insulin pump can be done directly or through a controller (usually smartphone), the AIDA may reside in the pump or in the controller. The insulin pump includes a cannula (catheter) that crosses the skin and delivers insulin into the subcutaneous tissue. The CGM device includes a sensor probe that crosses the skin and measures glucose levels within the subcutaneous tissue.Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO

[0004] There are two types of insulin pumps, with and without tubing, also known as "pager pump" and "patch pump", respectively. A pager pump is stored in a pocket or connected to clothing; insulin is delivered through a long tube to the cannula insertion site (tube, cannula, and cannula adhesive are called "infusion set"). A patch pump is adhered to the skin with adhesive tape and the cannula protrudes from the bottom surface of the device.

[0005] Two-piece AID systems have limitations. For example, adhesive tape for both the pump and the CGM occupy large skin "real estate" with high risk of irritation, and both the pump and the GGM include respective pricking points ("ports" for cannula and sensor probe) which increase the risk of local and systemic infection, CGM-pump communication interferences, high production cost (pump device and CGM device), and replacement cycle mismatch.

[0006] Thus, there is a need for an AID system that comprises a one (1)-piece, one (1)-port, skin adhered device that includes at least an insulin pump, a CGM device, and an AIDA. SUMMARY

[0007] Accordingly, embodiments of the present disclosure include one (1)-piece, one (1)-port, skin adhered device (hereinafter "AID patch" or “AID device”, such phrases used interchangeably throughout the disclosure) that includes insulin pump, CGM device, and AIDA. This AID patch includes a single adhesive for adhering the device to the skin of a patient, a single pricking point, no wireless communication between CGM and pump, and one replacement cycle.

[0008] The AID system includes an AID patch and a smartphone application for settings, data presentation, and cloud communication. The AID patch includes a housing, a continuous insulin delivery mechanism (hereinafter "pump"), a continuous glucose monitoring (CGM) mechanism (hereinafter "sensor" or "glucose sensor"), and an AIDA for controlling insulin delivery according to glucose readings. An electronic assembly (which may also be referred to as an “electronics assembly”) within the AID patch housing includes, for example, batteries, PCBA, buzzer, and micro controller unit (MCU, which can also be referred to as a processor, such terms / phrases used interchangeably throughout the disclosure) that includes the AIDA. The pump includes voice coil actuator, drive mechanism, reservoir, free-floating reservoir piston, insulin line, and cannula that has a single lumen. Back and forth linear movement of voice coil shaft rotates a drive cogwheel that forwardly displaces lead screw and reservoirAtty. Docket No.: 43654-02028 / WO TING-007 / 00WO piston. During filling, free floating reservoir piston is displaced backward and during operation reservoir piston is displaced forward after engagement with lead screw. Insulin is displaced from reservoir through insulin line and cannula into the subcutaneous tissue. The sensor includes subcutaneous sensor probe, electrical contacts, and traces. Electrical current generated by sensor probe electrodes in correlation with glucose levels is conducted to an MCU and AIDA via a printed circuit board assembly (PCBA). Sensor probe can be a flat structure, and may include a rectangular shape, and can partially reside within the insertion needle before insertion; the cannula can encircle the insertion needle. After insertion, the sensor probe at least partially resides within the single lumen cannula and sensor probe tip and cannula tip reside within the subcutaneous tissue where the sensor probe tip is located apart from cannula tip. Concomitant insertion of cannula and sensor probe is done with removable inserter. The inserter includes trigger, insertion needle, and retraction spring. Upon trigger activation, cannula and sensor probe are inserted into the subcutaneous tissue followed by automatic insertion needle retraction. Following cannula and sensor probe insertion, the inserter is removed, and AID patch remains adhered to skin.

[0009] In some embodiments, an AID patch is provided and includes a housing having an adhesive tape, an insulin pump including a single lumen cannula, a glucose sensor including a flat sensor probe, a processor, and an automated-insulin-delivery algorithm (AIDA). In some embodiments, the housing is configured to be adhered the skin of a user via the adhesive tape and house the insulin pump, glucose sensor, and AIDA, the sensor probe at least partially resides within the cannula, and the AIDA is configured as computer instructions operating on the processor causing the processor to control insulin delivery by the insulin pump according to glucose levels determined in subcutaneous tissue based on signals received from the glucose sensor.

[0010] In some embodiments, an AID patch is provided and includes a housing including a plurality of housing openings comprising a first housing opening, a second housing opening, and a plurality of housing septa including a first housing septum and a second housing septum, a housing slider including a plurality of housing slider openings comprising a first slider opening, a second slider opening, and a plurality of housing slider septa comprising a first slider septum, and a second slider septum. The AID patch also includes an insulin pump including a single lumen cannula, a glucose sensor including a sensor probe, and a retractable insertion needle extending through the first slider opening, the first housing opening, and second slider opening, along a longitudinal axis. Before retraction of the insertion needle, the cannulaAtty. Docket No.: 43654-02028 / WO TING-007 / 00WO encircles the insertion needle and the sensor probe at least partially resides within the insertion needle, and after retraction of the insertion needle, the sensor probe at least partially resides within the cannula.

[0011] In some embodiments, an automated-insulin-delivery device (AID) is provided and includes at least one housing, a pump, a single lumen cannula, a glucose sensor including a probe, a processor, and an automated-insulin-delivery algorithm (AIDA). The housing is configured to be adhered the skin of a user via the adhesive tape and house the insulin pump, glucose sensor, and AIDA, the probe at least partially resides within the cannula, the AIDA is configured as computer instructions operating on the processor causing the processor to control insulin delivery by the insulin pump according to glucose levels determined in subcutaneous tissue based on signals received from the glucose sensor.

[0012] In some of the embodiments, including those listed above, the at least one housing can include: a plurality of housing openings comprising a first housing opening, a second housing opening, a plurality of housing septa comprising a first housing septum and a second housing septum, a housing slider including a plurality of housing slider openings comprising a first slider opening, a second slider opening, and a plurality of housing slider septa comprising a first slider septum, and a second slider septum. The device can further include a retractable insertion needle extending through the first slider opening, the first housing opening, and second slider opening, along a longitudinal axis. Before retraction of the insertion needle, the cannula encircles the insertion needle and the sensor probe at least partially resides within the insertion needle, and after retraction of the insertion needle, the sensor probe at least partially resides within the cannula.

[0013] The above-noted embodiments can include one and / or another of (and in some embodiments, if not mutually exclusive (or previously recited above), a plurality of, in some embodiments, a majority of, in some embodiments, substantially all of, and in some embodiments, all of) the following elements, structures, steps, features, functions, functionality, and clarifications: - an adhesive for adhering the device to the skin before inserting the cannula and sensor probe; - during insertion, the housing slider, the insertion needle, the cannula, and the sensor probe are displaced along the longitudinal axis;Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO - the insertion needle extends through the housing slider opening, the first housing opening, the second housing slider opening, and the second housing opening along the longitudinal axis; - the insertion needle is retracted and the first housing slider septum, the first housing septum, the second housing slider septum and the second housing septum are sealed; - the device is configured only for one-time use; - the entire device is disposable; - a single port configured for passing the cannula and sensor probe into tissue; - at least two compartments; o the at least two compartments comprise only two compartments; o at least one of the compartments is sealed; o at least two compartments are sealed; o the at least two compartments comprise a first compartment sealed to ensure microorganism and water resistance after sterilization, and / or a second compartment including the electronic assembly is sealed to ensure water resistance of the electronic assembly; and / or o the first compartment is assembled with the second compartment; - the at least one housing comprises two housings including an electronic assembly housing including the electronic assembly, and an AID patch housing; - a / the plurality of housing openings, a / the plurality of housing slider openings, a / the plurality of housing septa and a / the plurality of housing slider septa are associated with a / the plurality of housing openings and a / the plurality of housing slider openings so as to seal respective openings; - the sensor probe is rigidly connected with the cannula, and / or includes a supporting plate configured for enabling such rigid connection; - the sensor probe is rigidly connected with the cannula which is arranged for downward displacement during insertion; - a supporting plate shaped and sized to couple insulin delivery structure with a plurality of electrical contacts;Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO o the electrical contacts can be sized and shaped for connection to a collapsible electrical contact; and / or o a / the collapsible electrical contacts comprise at least one of a wire and a spring; - an insulin delivery line for communicating insulin from a reservoir to the cannula; o the insulin delivery line can be sized and shaped to fold during insertion of the glucose sensor probe and cannula; - a drive mechanism comprising a voice-coil for communicating insulin to the cannula; o the drive mechanism further comprises at least one of one or more gears, at least one lead screw, and at least one drive wheel; o the voice-coil is configured to move in a back-and-forth manner which rotates a / the drive wheel; o a / the drive wheel rotates a / the lead screw, and the lead screw is sized and shaped to convert circular motion to linear motion; - a control switch for detecting movement via at least one contact; - at least one reservoir; - at least one floating piston; - during filling, a / the floating piston is freely displaced within a / the reservoir; - a / the lead screw is coupled to a / the floating piston via one or more leg screw legs; - a / the lead screw is coupled to a floating piston via a latch; - the glucose sensor probe fully resides within the cannula; - a / the insertion needle is at least partially retractable; - a cartridge prefilled with insulin which is configured for plugged connection with the device; - an insulin line and insulin flow into the insulin line is via a syringe; - at least two (2) electrodes arranged on the glucose sensor probe and arranged so detect insulin in the subcutaneous tissue; - a piston and a reservoir, the piston being arranged within the reservoir; - at least one magnet, and a reed switch configured to detect the location of a / the piston within the reservoir via the magnetic field generated by the magnet; and - at least one of a protecting tube and a sponge, sized, shaped, and arranged for collecting drops of insulin during a priming operation;

[0014] In some embodiments, an automated insulin delivery system (AID system) for controlling glucose levels is provided and includes a skin adherable automated-insulin-deliveryAtty. Docket No.: 43654-02028 / WO TING-007 / 00WO patch (AID patch) including at least one housing, an insulin pump, a glucose sensor, a processor, and an automated-insulin-delivery algorithm (AIDA) for controlling insulin delivery according to glucose readings detected by the glucose sensor. The system can also include an application operable on a smartphone for controlling at least one or more of: one or more settings, presentation of data to the user of the smartphone, and cloud communications. The insulin pump comprises a drive mechanism, a lead screw, a reservoir, a floating piston, and (in some embodiments, “or”) a cannula having a single lumen. The glucose sensor includes a subcutaneous sensor probe. During filling of the reservoir, the floating piston is displaced in a first direction and during operation is displaced in a second direction opposite to the first direction after engagement with the lead screw, and after insertion of the sensor probe, the sensor probe at least partially resides within the single lumen cannula.

[0015] The above-noted embodiments can include one and / or another of (and in some embodiments, if not mutually exclusive (or previously recited above), a plurality of, in some embodiments, a majority of, in some embodiments, substantially all of, and in some embodiments, all of) the following elements, structures, steps, features, functions, functionality, and clarifications: - the processor includes computer instructions operating thereon for enabling at least one of changing pump or sensor parameters, receiving data and presenting data which can include glucose readings, and communicating with a computer network; - the AID patch includes a first, upper cover and a second bottom cover, wherein the first cover includes at least one vent; - the AID patch can include a / the first cover including at least one and preferably at least two sealing walls aligned with at least one and preferably two sealing walls of the second cover sealing walls, to establish a sealed compartment after the first and second covers are assembled with the AID patch; - the AID patch include a second cover including at least one of: one or more lead screw supporting ribs, a second cover guide, a second cover opening; - the AID patch includes a second cover including at least one of: one or more electrical paths which can include one or more second cover traces, one or more sealing wall contacts, one or more control switch contacts, one or more sensor contacts, and one or more pump mechanism contacts; - the AID patch includes a first sealed compartment and a second sealed compartment;Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO - the AID patch includes first and second sealed compartments that are formed by the first and second covers; - the AID patch includes an electronic assembly including an electronic assembly housing, a housing sealing interface, and an electronic assembly sealing interface; - the AID patch further comprising at least one housing slider cap; - a / the AID patch electronic assembly in electrical communication with at least one electrical path via respective a contact of a printed circuit board assembly (PCBA); - continuous signals are generated by a plurality of electrodes of the sensor probe which are received and analyzed by a sensor glucose determination algorithm which then provides resultant glucose level signals as input to the AIDA; - the AIDA, after receiving and analyzing the glucose level signals, automatically controls the pump to adjust insulin delivery rate in accordance with the analyzed glucose level signals; - a / the drive mechanism comprises a voice coil and the amount of insulin delivered to the user is determined by a number of actuations of the voice coil; o each actuation of the voice coil produces a back-and-forth movement of a shaft of the voice coil; o movement of the shaft is configured to cause rotation of a drive wheel which causes displacement of the lead screw; o a control switch configured to provide feedback to controlling operation of the voice coil; o the processor is configured to receive user input with respect to at least one of meal and exercise information, and the AIDA is operable to adjust insulin delivery to the user based on such information; o at least one housing includes an adhesive for adhering to the skin of the user; o the cannula is part of a cannula assembly which includes a supporting plate, a sensor contacts plate and supporting plate traces; - the AID patch includes a sensor spring configured for providing electrical connection(s) between the sensor probe and the electronic assembly prior to insertion; o the sensor spring is arranged in a stretched position prior to insertion of the cannula and in a compressed position after insertion of the cannula; o the electrical connection(s) is foldable; o a / the drive wheel is configured to rotate in a single direction;Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO - the drive mechanism includes any one or more of: voice coil drive shaft, a drive leg and associated drive arm, lead screw threads arranged on the lead screw and configured for operative connection with a portion of the drive arm, a drive wheel housing, a lead screw tip, a drive wheel housing stopper, a ratchet lock, and drive wheel teeth arranged on a circumference of the drive wheel; o linear movement of the lead screw causes movement of the drive leg and drive arm in a first direction; o the lead screw plate interfaces with the drive wheel housing stopper, resulting in the forcing of linear movement of the lead screw; o during movement of the drive leg in a direction opposite to a first direction, the ratchet lock maintains a position of the drive wheel; o a / the voice coil actuator comprises an electromagnetic actuator which includes at least a plurality of: a housing, a coil, a shaft, a bobbin, a ferro plate, a magnet, and a bushing; o pulsing electrical current in the coil causes linear motion of the magnet and the shaft; - delivery initiation is detected by reaching a pre-defined threshold of frictional force between the piston and the reservoir; o a / the pre-defined threshold of frictional force corresponds to a rise in electric current consumption of a / the voice coil actuator; and / or o following detection of initiation, at least one of a delivery amount and a delivery rate are derived from a controlled displacement of lead screw; - a / the lead screw tip includes one or more lead screw legs configured to retain a / the piston in an aligned position within the reservoir; and - a / the lead screw includes a piston latch which can include a conical shape and a flexible snap, such that, after the reservoir is filled, the drive mechanism is operated causing the lead screw and the lead screw tip are displaced toward an end of the piston until engagement of the lead screw tip with the piston latch; o where the piston snap can be configured to enable rigid connection so as to avoid opposite displacement of the lead screw.Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO

[0016] In some embodiments, an automated-insulin-delivery device (AID) is provided and includes a housing including a plurality of housing openings comprising a first housing opening, a second housing opening, and at least one of, and preferably a plurality of housing septa comprising a first housing septum and a second housing septum. The device can also include a housing slider which can include one or more of a plurality of housing slider openings comprising a first slider opening, a second slider opening, and one or more housing slider septa which can include a first slider septum, and a second slider septum. The device further includes an insertion needle extending through the first slider opening, the first housing opening, and second slider opening, along a longitudinal axis, a cannula that encircles the insertion needle, and a glucose sensor probe. In some embodiments, before insertion, at least a portion of the glucose sensor probe is disposed within the insertion needle, during insertion, the housing slider, the insertion needle, the cannula, and the sensor probe are displaced along the longitudinal axis, and insertion needle extends through the first housing slider opening, the first housing opening, the second housing slider opening, and the second house opening along the longitudinal axis, and after insertion, the insertion needle is retracted and the first slider septum, the first housing septum, the second housing slider septum and the second housing septum are sealed and at least a portion of the glucose sensor probe is disposed within the cannula.

[0017] In some embodiments, an automated-insulin-delivery (AID) system for controlling glucose levels in a diabetic is provided and the system includes a skin adhered device for automated-insulin-delivery (AID patch), and an application operable on a smartphone for controlling at least one or more of: one or more settings, presentation of data to the user of the smartphone, and cloud communications. The AID patch includes a housing, a pump, a glucose sensor, and an automated-insulin-delivery algorithm (AIDA) for controlling insulin delivery according to glucose readings detected by the glucose sensor; and an electronic assembly within the housing and including at least a processor, a battery, a PCBA, a buzzer and / or speaker. The AIDA is operable on the processor, and the pump includes a voice coil actuator, a drive mechanism, a reservoir, a reservoir piston, an insulin conduit, and a cannula having a single lumen and a cannula tip. The drive mechanism includes at least a drive wheel, and reciprocating linear movement of the voice coil rotates a drive wheel which is sized and shaped to displace a lead screw and floating piston. During filling of the reservoir, the floating piston is displaced in a first direction and during operation is displaced in a second direction opposite to the first direction after engagement with the lead screw. Insulin is displaced from reservoir through insulin conduit and cannula into subcutaneous tissue of the user. The glucose sensorAtty. Docket No.: 43654-02028 / WO TING-007 / 00WO includes a subcutaneous sensor probe (“sensor probe”) having a probe tip and at least two electrodes in electrical communication with two respective electrical contacts via associated traces. Electrical signals generated by probe electrodes in correlation with glucose levels is received by the processor and used as input to the AIDA. The sensor probe can, in some embodiments, include a flat and / or rectangular shape, and at least partially resides within the insertion needle prior insertion. The cannula is arranged to at least partially encircle the insertion needle. After insertion of the sensor probe, the sensor probe at least partially resides within the single lumen cannula and the probe tip and cannula tip reside within the subcutaneous tissue, and the sensor tip is spaced apart from cannula tip. Concomitant insertion of cannula and sensor probe is accomplished via a removable inserter, the removable inserter comprises a trigger, an insertion needle, and a retraction spring, wherein upon activating the trigger, the cannula and sensor probe are inserted into the subcutaneous tissue followed by automatic insertion needle retraction, and following cannula and sensor probe insertion, the removable inserter is removed, and the AID patch remains adhered to skin.

[0018] These and other inventions, embodiments, and various aspects thereof will become even more clear by reference to the drawings and detailed description which follows. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] FIG.1 shows the AID system that includes an AID patch and a smartphone controller, according to some embodiments;

[0020] FIGs.2a-c show the AID patch on the arm (2a) and AID patch spatial configurations (2b-c), according to some embodiments;

[0021] FIGs.3a-c show the inserter (3a), insertion process (3b), and AID patch after inserter removal (3c), according to some embodiments;

[0022] FIGs. 4a-d show the housing of the AID patch, upper cover (4a-b) and bottom cover (4c-d), according to some embodiments;

[0023] FIGs.5a-d show the two sealed compartments of the AID patch, adhesion surfaces of upper cover and bottom cover (5a-b), and adhesion surfaces of electronic assembly and AID patch housing (5c-d), according to some embodiments;

[0024] FIGs.6a-d show the electronic assembly, before and after integration with AID patch housing (6a-b) and electronic assembly parts (6c-d), according to some embodiments;Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO

[0025] FIGs. 7a-d show the electrical paths (contacts and traces) of sensor, voice coil, and control switch, top level view (7a) and spatial views (7b-d), according to some embodiments;

[0026] FIG.8 shows a block diagram of AID patch hardware and software, according to some embodiments;

[0027] FIG.9 shows a scheme of the main components of the AID patch, pump, sensor, and AIDA and the subcomponents of the pump and the sensor, according to some embodiments;

[0028] FIGs.10a-b shows a scheme of the AID patch that includes housing and housing slider, openings, and septa, before (10a) and after (10b) insertion of cannula and sensor probe, according to some embodiments;

[0029] FIGs. 11a-c show schemes of electrical and insulin paths before insertion of cannula and sensor probe (11a), after insertion (11b), and after retraction of insertion needle (11c), according to some embodiments;

[0030] FIGs.11d-e show schemes of spring electrical connection before (11d) and after (11e) insertion, according to some embodiments;

[0031] FIG.12 shows an exploded view of AID patch components – probe / cannula assembly, electronic assembly, drive mechanism, insulin path, and the main subcomponents, according to some embodiments;

[0032] FIGs.13a-c show the assembled AID patch main components, spatial view (13a) and top-level view (13b-c), according to some embodiments;

[0033] FIGs. 14a-b show spatial configurations of the AID patch, with housing slider (14a) and housing slider removed (14b), according to some embodiments;

[0034] FIGs.15a-b show the AID patch insulin path, according to some embodiments;

[0035] FIG.16a-c show transverse cross section views of the AID patch openings and septa, before insertion of cannula and sensor probe (16a), after insertion (16b), and after retraction of insertion needle (16c), according to some embodiments;

[0036] FIGs. 17a-d show cross section views of the housing slider and probe / cannula assembly before insertion of cannula and sensor probe (17a) and after insertion (17c), and spatial views of the supporting plate (housing slider removed) before (17b) and after insertion (17d), according to some embodiments; be consistent with "probe / cannula assembly" along the entire document, it should be "probe / cannula assembly"Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO

[0037] FIGs. 18a-e show the probe / cannula assembly, spatial views (18a, 18c, 18e), cross section view (18b), and exploded view (18d), according to some embodiments;

[0038] FIG. 19 shows exploded view of the drive mechanism, according to some embodiments;

[0039] FIGs. 20a1-a2, 20b show the driving mechanism principle of operation, operation of drive wheel (20a1-a2) and drive mechanism (20b), according to some embodiments;

[0040] FIGs.21a-b show the voice coil, spatial view (21a) and exploded view (21b), according to some embodiments;

[0041] FIGs. 22a-b show the control switch, spatial view (22a) and magnified view (22b), according to some embodiments;

[0042] FIGs.23a-e show the drive mechanism and insulin path before insulin filling, during operation, and at the end of reservoir, according to some embodiments. FIG.23a shows spatial view of the operating AID patch. FIG.23b shows the filling process by the user. FIGs.23c1- 4 shows cross section views of lead screw and reservoir piston during filling and operation. FIG.23d shows cross section view of one embodiment of lead screw and piston engagement. FIGs.23e1-2 shows preferred embodiment of engagement mechanism between lead screw and piston;

[0043] FIG. 24a-b shows schemes of the 2 sides (side a and side b) of the sensor probe, according to some embodiments;

[0044] FIGs. 25a-e show schemes of cannula and sensor probe, according to some embodiments: - before insertion (25a), - after insertion (25b), - after insertion needle retraction (25c), - a cross-section view of the insertion needle, cannula encircled the insertion needle and sensor probe within the insertion needle (25d), and - insertion needle is partially retracted after insertion (25e);

[0045] FIGs.26a-d show cross section views of the inserter and AID patch, according to some embodiments:Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO - before insertion of sensor probe and cannula (26a), - after insertion (26b), - after insertion needle retraction (26c), after inserter removal (26d), and - magnified views (26b1) and (26d1);

[0046] FIGs.27a1-3, -27c show schemes of the inserter, according to some embodiments: - before insertion of sensor probe and cannula (27a1), - after insertion (27a2), - after retraction of insertion needle (27a3); - exploded view of the inserter (27b); and - the insertion needle, releaser, and fixer (27c);

[0047] FIGs. 28a-f show spatial views of the AID patch with a pre-filled insulin cartridge, according to some embodiments: - before cartridge insertion (28a); - during insertion (28b); - insertion completed, door open (28c); - door is closing (28d); and - door closed (28e-f);

[0048] FIG.29a-b show schemes of subcutaneous insulin depot during basal (29a) and large bolus (29b) insulin delivery from cannula, according to some embodiments;

[0049] FIGs.30a-c show schemes of reservoir filling process through an insulin line septum, before filling (30a), during filling (30b), and after filling syringe removal and device operation (30c), according to some embodiments;

[0050] FIG. 31a-c show schemes of a mechanism for detection of insulin in cannula during priming, according to some embodiments: - FIGs. 31a-b show the electrical connections (traces) between sensor probe and electronic assembly, before (31a), and during (31b) priming; and - FIG.31c shows a magnified scheme of sensor probe with priming electrodes for insulin detection;Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO

[0051] FIG.32a-b show schemes of a mechanism for turning on the AID patch, according to some embodiments: FIG.32a – off state, and FIG.32b – on state; and

[0052] FIG. 33a-b show schemes of preferred embodiment of AID patch that includes a cannula / probe protecting tube for insulin collection during priming, according to some embodiments. DETAILED DESCRIPTION

[0053] FIG.1 shows the AID system 100 that includes AID patch 1 and controller 200 which can be a smartphone or a dedicated controller. Controller 200 is used for AID patch 1 settings (i.e., personal parameters), changing pump or sensor parameters, receiving data, and presenting data from AID patch 1 (i.e., glucose readings), and communicating with the cloud. The AID patch 1 comprises a housing 10 and includes a pump 5 (dashed dot line) for continuous delivery of insulin and a sensor 6 (square dot line) for continuous monitoring of glucose levels. An AIDA 2 (which in some embodiments is configured as computer instructions operating on a processor on the AID patch 1) receives glucose readings from sensor 6 and automatically adjusts pump 5 insulin delivery rate. The AID patch housing 10 is adhered to skin 25 by adhesive tape 30 that is connected to bottom cover 13 (FIG.4). Pump 5 delivers insulin into subcutaneous tissue 255 by cannula 3. Sensor 6 monitors glucose level in the subcutaneous tissue 255 by sensor probe 4. Sensor probe 4 partially resides within cannula 3, and sensor probe tip 411 is located within the subcutaneous tissue 255 apart from the cannula tip 31.

[0054] FIG.2a shows the AID patch 1 on the arm of a subject. The AID patch 1 is adhered to any preferred skin location such as abdomen, buttocks, thighs, etc. FIGs. 2b and 2c show spatial configurations of AID patch 1 and adhesive tape 30. Adhesive tape 30 has a sticky surface to be adhered to skin 25, sticky surface is protected with liner 311 that is removed before use.

[0055] FIG. 3a shows inserter 20 that includes inserter trigger ("trigger") 21 and inserter housing 22. FIG. 3b shows the insertion process, upon pressing (inserter activation), trigger 21 is displaced downward relatively to inserter housing 22; at a predetermined trigger 21 displacement, cannula 3 and sensor probe 4 (not shown) are inserted into the subcutaneous tissue 255. Following insertion, inserter 20 is removed and the AID patch 1 remains on the user skin 25, firmly adhered by adhesive tape 30.Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO

[0056] FIG.4 shows the upper cover 12 (FIGs.4a-b) and bottom cover 13 (FIGs.4c-d). FIG. 4a shows the upper cover 12 that includes venting holes 145 and upper cover opening (2ndopening) 32. FIG.4b shows the upper cover 12 at invert position including upper cover guide 142, upper cover sealing walls 1 and 2 (143 and 144, respectively), and 2ndopening 32. Upper cover guide 142 is engaged with bottom cover guide 133 and guides the housing slider 11 (FIG. 14) during insertion. Upper cover sealing walls 1 and 2 (143, 144, respectively) are aligned with bottom cover sealing walls 1 and 2 (134, 135, respectively), providing a sealed compartment after upper cover 12 and bottom cover 13 assembly (FIG.5). FIG.4c shows the bottom cover 13 that includes led screw supporting ribs 132, bottom cover guide 133, bottom cover opening (3rdopening) 33, and bottom cover sealing walls 1 and 2 (134 and 135, respectively). FIG.4c shows the bottom cover electrical paths including bottom cover traces 136, sealing wall contacts 69, control switch contacts 66, sensor contacts 67, and voice coil contacts 68 (FIG.7).

[0057] FIG.5 shows the two sealed compartments of the AID patch 1, sealed compartment 1 57 and sealed compartment 258. FIG.5a shows the upper cover 12 and the upper cover sealing interface 123. FIG.5b shows the bottom cover 13 and the bottom cover sealing interface 124. During assembly of upper cover 12 and bottom cover 13, the upper cover and bottom cover sealing interfaces (123 and 124, respectively) are connected forming the sealed compartment 1 57. Sealed compartment 1 57 provides a tight waterproof sealing and maintains sterility (avoids microorganism penetration) after radiation (gamma or e-beam). FIGs.5c and 5d show electronic assembly 70, electronic assembly housing 71, housing sealing interface 121, and electronic assembly sealing interface 122. Following assembly of upper cover 12 and lower cover 13 (forming sealed compartment 157), the electronic assembly 70 is assembled with AID patch housing 10 by connection of housing sealing interface 121 and electronic assembly sealing interface 122, forming sealed compartment 258. Sealed compartment 258 is assembled after sterilization and provides waterproof protection. Connection of all sealing interfaces can be done by laser, ultrasound, or glue.

[0058] FIG.6a shows the electronic assembly 70 within the AID patch 1. AID patch 1 includes housing slider cap 111 and 1stseptum 35. Electronic assembly 70 is electrically connected to all electrical paths (FIG. 7) via PCBA contacts 750. PCBA contacts 750 can be pogo pins, metal springs, or any other electrical connectors. FIG. 6b shows the electronic assembly 70 before assembly with AID patch 1. FIG.6c and 6d show the electronic assembly housing 71, electronic assembly lid 72, and electronic assembly 70 components – batteries 73, PCBA 74,Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO micro controller unit (MCU) 745, and buzzer 75. After assembly of electronic assembly housing 71 with electronic assembly lid 72, the electronic assembly 70 is sealed.

[0059] FIG.7 shows the electrical paths of the AID patch 1. Electronic assembly 70 includes batteries 73, PCBA 74, and PCBA contacts 750. PCBA contacts 750 are connected to sealing wall contacts 69 (FIG. 4d) and bottom cover traces 136. Electrical paths conduct current to power consumers – 1) voice coil 40 (FIG.20) - voice coil traces 49 and voice coil contacts 68, 2) sensor probe 4 (FIG. 18) - sensor traces 47 and sensor contacts 67, and 3) control switch (FIG.22) - control switch traces 48, and control switch contacts 66.

[0060] FIG. 8 shows a block diagram of AID patch 1 hardware and software. Hardware components include PCBA 74, sensor probe 4, led 76, buzzer 75, voice coil 40, and control switch 80. PCBA 74 includes MCU 745, analog front end (AFE) 753, watchdog controller 752, power management 744, Bluetooth Low Energy or BLE 746, BLE antenna 747, voice coil driver 748, and buzzer driver 751. The MCU 745 includes sensor algorithm 7, AIDA 2, and pump control 8. The dashed lines show the main component of the automated insulin delivery (AID) path. Continuous signals, generated by the 3 sensor probe electrodes (FIGs.24 and 25), are received by AFE 753 and analyzed by sensor algorithm 7 that provides glucose readings to the AIDA 2. AIDA 2 receives glucose readings and automatically commands pump control 8 to adjust insulin delivery rate. Control of insulin delivery rate is achieved by controlling the number of voice coil 40 actuations, each actuation produces a back-and-forth movement of voice coil shaft 43, rotation of drive wheel 53, and forward displacement of lead screw 56 (FIG. 20). The control switch 80 provides feedback to pump control 8 on voice coil 40 operation (yes / no movement). In some cases, the user may provide inputs by the controller 200, such as meal and exercise announcements, and the AIDA 2 may adjust insulin delivery accordingly (long dash dot line).

[0061] FIG.9 shows a scheme of the AID patch 1. The AID patch 1 includes a housing 10 that is adhered to skin 25 with adhesive tape 30. The AID patch 1 includes a pump 5 (dash dot line) and a sensor 6 (square dot line). Pump 5 includes electronic assembly 70, insulin path 9 - reservoir 90, insulin line 14, insulin line bend 141, cannula 3, and drive mechanism 50 (FIG. 20) – voice coil 40 and drive wheel 53. Actuation of voice coil 40 (dash line) rotates drive wheel 53 and linearly displaced lead screw 56, piston 92, and insulin from reservoir 90 through insulin line 14, insulin line bend 141 and cannula 3. Control switch 80 provides feedback to electronic assembly 70 via control switch traces 48 (dash line). Sensor 6 includes an electronic assembly 70, sensor probe 4, sensor contacts plate 19, and sensor traces 47 (dash line) thatAtty. Docket No.: 43654-02028 / WO TING-007 / 00WO conduct signals (glucose level data) from sensor probe 4 to electronic assembly 70. AIDA 2 receives glucose level signals from sensor 6 and accordingly, automatically controls pump 5 and regulates insulin delivery rate.

[0062] FIG.10 shows schemes of AID patch 1 housing 10 and housing slider 11 before (FIG. 10a) and after (FIG.10b) insertion of cannula 3 and sensor probe 4. During insertion, housing slider 11 and probe / cannula assembly 60 (FIG.12) are displaced downward in the direction of bold arrow along the longitudinal axis (long dash dot line). Slider housing 11 includes 1stopening 31 and 3rdopening 33, 1stseptum 35 and 3rdseptum 37. AID patch housing 10 includes 2ndopening 32 and 4thopening 34, 2ndseptum 36, and 4thseptum 38. Supporting plate 62 is rigidly connected to housing slider 11 and provides support to sensor probe contacts plate 19, probe connector 61 (FIG.18), and cannula 3. Before insertion (FIG.10a), insertion needle 24 transverse 1stseptum 35 and 3rdseptum 37. During insertion, insertion needle sharp tip 243 pierces 4thseptum and after insertion, insertion needle 24 transverse 1stseptum 35, 3rdseptum 37, and 4thseptum 38. Before insertion, sensor probe 4 resides within insertion needle 24 (dash line) and cannula 3 encircles insertion needle 24 (insertion needle 24 goes through entire length of cannula 3). After insertion of cannula 3 and sensor probe 4 in subcutaneous tissue 255, along the longitudinal axis (long dash dot line), insertion needle 24 is retracted (not shown). Insertion needle 24 has a slot 246 (FIGs.25d and 27c) allowing insertion needle 24 retraction through sensor contacts plate 19. During insertion, housing slider 11 is displaced relative to AID patch housing 10 and at the end of insertion, 1stseptum 35 and housing slider cap 111 are aligned with upper cover 12 (FIGs.6a-b).

[0063] FIG. 11 shows schemes of electrical path and insulin path of AID patch 1 before insertion of cannula 3 and sensor probe 4 (FIG. 11a), after insertion (FIG. 11b), and after retraction of insertion needle 24 (FIG.11c). AID patch 1 includes a housing 10 that is adhered to skin 25, housing slider 11, electronic assembly 70, AIDA 2, sensor contacts 67 and sensor trace (dash line) 47 (FIG. 7). Insulin path 9 (FIG. 12) includes reservoir 90, insulin line 14, insulin line bend 141, and cannula 3. Probe / cannula assembly 60 (FIG.12) includes supporting plate 62, sensor contacts plate 19, supporting plate traces (dash line) 64, and conductive elastomer (x3) 65. Before insertion (FIG.11a), sensor probe 4 resides within insertion needle 24, cannula 3 encircled insertion needle 24, insertion needle sharp tip 243 resides within housing 10, and conductive elastomer 65 and sensor contacts 67 are separated. During insertion, housing slider 11, supporting plate 62, and insulin line bend 141 are displaced in the direction of bold arrow (FIG.11b). After insertion (FIG.10b), insertion needle sharp tip 243,Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO cannula tip 31, and sensor probe tip 411 (FIG.29) resides within subcutaneous tissue 255, and conductive elastomer 65 and sensor contacts 67 are electrically coupled.

[0064] After insertion needle 24 removal (FIG.11c), insulin is delivered from reservoir 70 via insulin line 14, and cannula 3 into the subcutaneous tissue 255, and signals (glucose readings) are conducted from sensor probe 4 to contacts plate 19 and via sensor traces 47 to electronic assembly 70. Insulin delivery rate is controlled by the AIDA 2 according to glucose readings received from sensor probe 4. FIGs. 11d-e show another preferred embodiment of electrical connection between supporting plate traces 64 and sensor contacts 67, before (11d) and after (11e) insertion. A metal sensor spring 26 provides electrical connection between sensor probe 4 and electronic assembly 70 before insertion, thus, allowing sensor operation before insertion and avoiding the risk of contacts failure after insertion. The sensor spring 26 is in stretch position before insertion (11d) and squeezed after insertion (11e). The invention also includes any known in the art foldable connections such as electrical wire, flex PCB, etc.

[0065] FIG. 12 shows an exploded view of main assemblies and subassemblies of the AID patch 1. Main assemblies are – electronic assembly 70, probe / cannula assembly 60, drive mechanism 50, and insulin path 9. AID patch 1 includes a housing 10 (outer shell) that is comprised of an upper cover 12, bottom cover 13, and electronic assembly lid 72. Following insertion, the slider housing cap 111, and 1stseptum 35 are aligned with upper cover 12. Adhesive tape 30 is connected to bottom cover 13 for adhering AID patch housing 10 to skin 25. Electronic assembly 70 includes batteries 73, PCBA 74, MCU 745, and buzzer 75. Probe / cannula assembly 60 includes cannula 3, supporting plate 62, conductive elastomer (x3) 65, sensor probe 4, sensor contacts plate 19, supporting plate PCB 63, and probe connector 61. Drive mechanism 50 includes voice coil 40, drive wheel 53, drive wheel housing 54, ratchet lock 55, and lead screw 56 (FIG.20). Insulin path 9 includes reservoir 70, reservoir piston 92, insulin line 14, and insulin line bend 141.

[0066] FIGs.13a-c show spatial (FIG.13a) and top level (FIGs.13b-c) views of AID patch 1 main components. AID patch housing (outer shell) 10 is comprised of upper cover 12, bottom cover 13, and electronic assembly lid 72. FIG. 13a shows the voice coil 40, reservoir 90, electronic assembly 70, insulin line bend 141, housing slider 11, and housing slider cap 111. During insertion, housing slider 11 and housing slider cap 111 are displaced downward through 1stopening 31 of upper cover 12. FIG. 13b (upper cover 12 removed) shows the AID patch housing 10, electronic assembly 70, reservoir 90, voice coil 40, insulin line bend 141, drive wheel 53, drive wheel housing 54, drive wheel housing stopper 541, and lead screw 56. FIG.Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO 13c (electronic assembly housing 71 and lead screw 56 removed) shows the AID patch housing 10, electronic assembly lid 72, voice coil 40, control switch 80, reservoir 90, bottom cover traces 136, lead screw supporting ribs 132, insulin line bend 141, and batteries 73.

[0067] FIG. 14a shows spatial view of AID patch 1 main components (upper cover 12 removed) before insertion – bottom cover 13, voice coil 40, reservoir 90, supporting plate 62, housing slider 11, housing slider cap 111, and electronic assembly 70. Electronic assembly 70 components include batteries 73, PCBA 74, and MCU 745. FIG.14b (housing slider removed) shows the reservoir 90, voice coil 40, insulin line bend 141, drive wheel housing stopper 541, lead screw 56, and supporting plate 62.

[0068] FIGs.15a-b show the AID patch 1 insulin path 9 (FIG.12). After reservoir 90 filling (FIG. 23) and voice coil 40 actuation, insulin within reservoir 90 is displaced by forward movement of lead screw 56 and piston 92 within reservoir cylinder 91. Displaced insulin is transported via exit port 95 into insulin line 14 and insulin line bend 141 and through cannula 3 into subcutaneous tissue 255.

[0069] FIG. 16 shows transverse cross section views of the AID patch 1 before insertion of cannula 3 and sensor probe 4 (FIG. 16a), after insertion (FIG. 16b), and after retraction of insertion needle 24 (FIG.16c). During insertion, housing slider 11 and probe / cannula assembly 60 (FIG.12 and FIG.18) are displaced downward in the direction of bold arrow 1. AID patch housing 10 is adhered to skin 25 and includes 2ndseptum 36 and 4thseptum 38. Slider housing 11 includes 1stseptum 35 and 3rdseptum 37. Probe / cannula assembly 60 includes cannula 3, supporting plate 62, conductive elastomer (x3) 75 (FIG.18), sensor probe 4, sensor contacts plate 19, supporting plate PCB 63, and probe connector 61. Supporting plate 62 is rigidly connected to housing slider 11 and provides support to sensor probe contacts plate 19, probe connector 61 (FIG.18), supporting plate PCB 63, and cannula 3. Before insertion (FIG.16a), insertion needle 24 transverse 1stseptum 35 and 3rdseptum 37. During insertion, insertion needle sharp tip 243 pierces 4thseptum 38 and after insertion (FIG.16b), insertion needle 24 transverse 1stseptum 35, 3rdseptum 37, and 4thseptum 38. A portion of sensor probe 4 resides within insertion needle 24 and another portion resides within cannula 3. Cannula 3 encircled insertion needle 24. After insertion of cannula 3 and sensor probe 4 in subcutaneous tissue 255, insertion needle 24 is retracted (FIG. 16c). During insertion, housing slider 11 is displaced relative to AID patch housing 10 and, at the end of insertion, 1stseptum 35 and housing slider cap 111 are aligned with upper cover 12 (FIGs.6a-b). Insertion needle 24 includes fixer 245 (FIG.27c), insertion needle trailing edge 242, insertion needle leading edge 241, and insertionAtty. Docket No.: 43654-02028 / WO TING-007 / 00WO needle sharp tip 243 for penetration of 4thseptum 38 and skin 25. Insertion needle leading edge 242 has a slot (FIG. 25d and 27c) allowing insertion needle 24 retraction through sensor contacts plate 19. Retraction spring 23 is released after insertion and retracts insertion needle 24 in the direction of bold arrow 2. After insertion, a portion of sensor probe 4 remains within cannula 3 and sensor probe tip 411 and cannula tip 31 (FIG.29) are separated.

[0070] FIG. 17 shows cross section and spatial views of the housing slider 11 and probe / cannula assembly 60 before insertion of cannula 3 and sensor probe 4 (FIGs.17a-b) and after insertion (FIGs.17c-d). FIGs.17b and 17d show spatial views (housing slider removed) of probe / cannula assembly 60 before (FIG. 17b) and after insertion (FIG. 17d). During insertion (FIGs.17a and 17b), housing slider 11 and probe / cannula assembly 60 are displaced downward in the direction of bold arrows. AID patch housing 10 includes upper cover 12, bottom cover 13, reservoir 90, voice coil 40, lead screw 56, 2ndseptum 36, and 4thseptum 38. Bottom cover 13 is shown in FIGs. 17b and 17d (upper cover 12 and housing slider 11 removed), bottom cover 13 includes a bottom cover guide 133 for guiding supporting plate 62 during insertion. Slider housing 11 includes 1stseptum 35 and 3rdseptum 37. Probe / cannula assembly 60 includes cannula 3, supporting plate 62, sensor probe 4, sensor contacts plate 19, supporting plate PCB 63, and probe connector 61. Supporting plate 62 is rigidly connected to housing slider 11 and provides support to sensor probe contacts plate 19, probe connector 61, supporting plate PCB 63, and cannula 3. During insertion (FIGs.17a and 17b), housing slider 11 is displaced relative to AID patch housing 10 and at the end of insertion, 1stseptum 35 and housing slider cap 111 are aligned with upper cover 12. FIGs. 17c and 17d (upper cover 12 and housing slider 11 removed) show position of probe / cannula assembly 60 after insertion, supporting plate 62 resides within bottom cover guide 133, cannula 3 and sensor probe 4 reside within the subcutaneous tissue 255.

[0071] FIG. 18 shows the probe / cannula assembly 60, spatial views (FIGs. 18a, 18c, and 18e), cross section views (FIG. 18b), and exploded view (FIG. 18d) (insertion needle 24 removed). Probe / cannula assembly 60 integrates the insulin delivery path (from insulin line bend 141 to cannula 3) with electrical path (from sensor probe 4 to conductive elastomers 75). Probe / cannula assembly 60 is configured to be displaced during insertion of cannula 3 and probe 4, and after insertion is configured to maintain hydraulic connection between reservoir 90 and cannula 3 and electrical connection between sensor probe 4 and electronic assembly 70 (FIG.11). Probe / cannula assembly 60 includes supporting plate 62, supporting plate PCB 63, sensor probe 4, contacts plate 19, probe connector 61, supporting plate traces 64, conductiveAtty. Docket No.: 43654-02028 / WO TING-007 / 00WO elastomers (x3) 65, and 3rdseptum 37. Insulin is delivered from insulin line bend 141, through supporting plate 62, to cannula 3. Electrical current generated by electrodes of sensor probe 4 (FIG.24) is conducted to contacts plate 19 and via probe connector 61 and supporting traces 64 to conductive elastomers 65. 3rdseptum 37 provides waterproofing and microorganisms protection. In other preferred embodiments, number of traces 64 and conductive elastomers 65 could be 2 – 5, according to number of electrode, and conductive elastomers 65 could be replaced by any other know-in-the-art conductive element (i.e., metal springs, wires, etc.).

[0072] FIG. 19 shows an exploded view of drive mechanism 50 that includes voice coil 40, shaft 43, drive leg 51, drive arm 52, lead screw 56, lead screw tip 654, drive wheel housing 54, drive wheel housing stopper 541, ratchet lock 55, and drive wheel 53. Operation of drive mechanism 50 causes displacement of piston 92 within reservoir cylinder 91.

[0073] FIGs.20a-b show the drive mechanism 50. FIG.20a shows the principle of operation - unidirectional rotation of drive wheel 53 (having drive wheel teeth 532) and unidirectional (forward) linear movement of lead screw 56. Forward movement of drive leg 51 and drive arm 52 in the direction of bold arrow 1 (FIG.20a2) engages drive arm 52 with drive wheel 53 and rotates drive wheel 53 in the direction of bold arrow 2. Rotation of drive wheel 53 and drive wheel thread 531 which is coupled with lead screw thread 561, causes linear displacement of lead screw 56. Lead screw plate 562 interfaces with drive wheel housing stopper 541 (FIG. 20b) which forces linear movement of lead screw 56. During backward movement of drive leg 51 and drive arm 52 in the direction of bold arrow 3 (FIG. 20a1), ratchet lock 55 maintains drive wheel 53 position and avoids rotation at the opposite direction. FIG.20b shows the drive mechanism 50 that includes voice coil 40, shaft 43, drive leg 51, drive arm 52, lead screw 56, drive wheel housing 54, drive wheel housing stopper 541, ratchet lock 55, and drive wheel 53. Lead screw 56 comprises lead screw thread 561, lead screw plate 562, and lead screw tip 564. Actuation of voice coil 40 causes back and forth movements (bold double arrow line 4) of shaft 43, drive leg 51, and drive arm 52. Forward movement causes rotation of drive wheel 53 in the direction of bold arrow 5 and forward displacement of lead screw 56 in the direction of bold arrow 6. Drive wheel housing stoper 541 interfaces with lead screw plate 562 and forces linear displacement of lead screw 56; engagement of lead screw tip 564 with piston 92 (FIG.23) and linear displacement of reservoir piston 92 relative to reservoir cylinder 91 in the direction of bold arrow 7.

[0074] FIG.21 shows spatial view (FIG.21a) and exploded view (FIG.21b) of the voice coil 40 actuator. Voice coil 40 is an electromagnetic actuator that includes housing 41, coil 42, shaftAtty. Docket No.: 43654-02028 / WO TING-007 / 00WO 43, bobbin 44, ferro plate 45, magnet 46, and bushing 83. On / off electrical current in coil 42 causes linear motion of magnet 46 and shaft 43. In other preferred embodiments, other actuators may be used such as stepper motor, DC motor, piezo- electric actuator, and alike.

[0075] FIG. 22 shows the control switch 80, spatial view (FIG. 22a) and magnified view (FIG.22b). Control switch 80 provides feedback to pump control 8 (FIG.8) on voice coil 40 actuation and consequently drive mechanism 50 operation. Control switch 80 includes metal springs (x2) 82, drive leg 51, drive arm 52, control switch traces 48, and control switch contacts 81. Forward movement of voice coil shaft 43 displaces drive leg 51 and drive arm 52 in the direction of bold arrow and causes electrical contact between drive arm 52 and metal springs 82 (switch "on"). Control switch contacts 81 and control switch traces 48 conduct the electrical current to electronic assembly 70. Backward movement of voice coil shaft 43 displaces drive leg 51 and drive arm 52 at the opposite direction of bold arrow and causes disconnection of electrical contact between drive arm 52 and metal springs 82 (switch "off"). If control switch 80 is not turned-on during voice coil 40 actuation (partial or no forward movement), an alarm is triggered (buzzer 74 and led 76, FIG.8). Forward movement failure of voice coil 40 could be related to insulin path 9 occlusion (usually cannula occlusion) and consequently no insulin delivery. In cases of occlusion detection, AID patch 1 should be removed and replaced.

[0076] FIG. 23a shows spatial view of the operating AID patch 1 that includes drive mechanism 50 components – voice coil 40, lead screw 56, lead screw tip 564, and drive wheel housing 54, and insulin path 9 components – reservoir 90, filling port 94, exit port 95, insulin line 14, insulin line bend 141, and cannula 3. FIG.23b shows the filling process, insulin from filling syringe 96 is injected into reservoir 90 (not shown) through filling port 94 at the bottom of AID patch 1. FIGs. 23c1-4 show cross section views of reservoir 90 filling and insulin delivery. FIG.23c1 shows the basic positions of piston 92 and lead screw 56 before reservoir filling, piston 92 is at "reservoir end" position (piston 92 touches reservoir end). FIG. 23c2 shows reservoir 90 filling through filling port 94. Reservoir piston is "free floating” and not connected to lead screw 56. During filling, "free floating" piston 92 is displaced in the direction of bold arrow 1. The amount of insulin filled in reservoir 90 is at user discretion (not necessarily full), so at the end of filling, piston 92 can be positioned at any place along reservoir cylinder 91. FIG.23c3 shows the engagement of lead screw tip 564 with reservoir piston 92, at filling completion, drive mechanism 50 operation displaces lead screw 56 in the direction of bold arrow 2. Insulin delivery begins after engagement of lead screw 56 with reservoir piston 92, further lead screw displacement causes insulin displacement and insulin delivery. DeliveryAtty. Docket No.: 43654-02028 / WO TING-007 / 00WO initiation point is detected by reaching a pre-defined threshold of friction force (between piston 92 and cylinder 91) and momentary rise in electric current consumption.

[0077] Following detection of initiation point, delivery amount and delivery rate are derived from controlled displacement of lead screw 56. FIG. 13c4 shows the end of insulin delivery (empty reservoir 90). Piston 92 is continuously displaced by lead screw 56 in the direction of bold arrow 3 until reservoir 90 is empty, or, at user discretion (any piston 92 position). FIG. 23d shows cross section view of one preferred embodiment of lead screw tip 564 having lead screw legs 563. The lead screw legs 563 avoid piston 92 wobbling during displacement of lead screw 56 and piston 92 within reservoir cylinder 91. FIGs.23 e1-2 show prefer embodiment of rigid connection between lead screw tip 564 and reservoir piston 92. Drive mechanism 50 includes drive wheel 53, lead screw 56, and lead screw tip 564. Lead screw tip 564 has a conical shape. Insulin path 9 includes reservoir cylinder 91, filling port 94, exit port 95, piston 92, and piston latch 922. Piston latch 922 has a conical shape and includes a flexible, piston snap 923. After reservoir 90 filling and upon drive mechanism 50 operation (FIG.23c3), lead screw 56 and lead screw tip 564 are displaced in the direction of bold arrow until engagement with piston latch 922 (FIG. 23e1). The flexible piston snap 923 provides rigid connection and avoids backward lead screw 56 displacement (FIG.23e2). The invention includes any other known in the art mechanism for engagement and rigid connection of lead screw 56 and piston 92.

[0078] FIG.24 shows sensor probe 4. Sensor probe 4 can be planar (flat) and can include two sides – side a (FIG.24a) and side b (FIG.24b). Sensor probe is made of any plastic material, preferably polyimide (Kapton). Senor probe 4 has a sensor probe tip 411 and a widened extension at the same plane – sensor probe contacts plate 19 (also "sensor contacts plate" or "contacts plate") which includes sensor probe contacts 75. In some embodiments, side a includes 2 electrodes – working electrode 16 and reference electrode 17, two sensor probe traces 78, and two sensor probe contacts 75, and side b includes one electrode – counter electrode 18, one trace 78, and one sensor contact 75. Sensor probe 4 may include additional or less electrodes, traces, and sensor probe contacts. Sensor contact plate 19 is engaged with probe connector 61 (FIG. 18) which interfaces with sensor probe contacts 75 that are positioned on side a and side b of sensor probe 4.

[0079] FIGs. 25a-d show schemes of cannula 3 and sensor probe 4 before insertion (FIG. 25a), after insertion (FIG.25b), and after removal of insertion needle 24 (FIG.25c). FIG.25d shows a cross-section view of the insertion needle 24 before insertion. Cannula 3 is in hydraulic connection with insulin line 14. Sensor probe (side a, FIG.24) includes electrodes – workingAtty. Docket No.: 43654-02028 / WO TING-007 / 00WO electrode 16 and reference electrode 17, sensor probe traces 78, contacts plate 19, and sensor contacts 75 (side b, FIG. 25 not shown). Insertion needle 24 includes a sharp tip (insertion needle tip) 243. Before insertion (FIG.25a), sensor probe 4 resides within insertion needle 24, and cannula 3 encircled insertion needle 24. Insertion needle sharp tip 243 resides within housing 10 (not shown) above skin 25. After insertion in the direction of bold arrow 1 (FIG. 25b), sensor probe 4 resides within insertion needle 24, and cannula 3 encircled insertion needle 24. Insertion needle sharp tip 243 resides within subcutaneous tissue 255 below skin 25. After insertion completion, insertion needle 24 is retracted in the direction of bold arrow 2 into inserter 20 (FIG.26). FIG.25c shows cannula 3 and sensor probe 4 after insertion needle 24 retraction and during operation of AID patch 1; insulin is delivered from insulin line 14 through cannula 3 into subcutaneous tissue 255; sensor probe 4 is partially resides within the single lumen cannula 3, electrical current generated by electrodes 16, 17, and 18, is conducted via sensor probe traces 78 to sensor contacts 75 that are located on contacts plate 19. FIG. 25d shows a cross-section view of cannula 3, sensor probe 4, and insertion needle 24 before insertion needle 24 retraction (FIGs.25a and 25b). Insertion needle 24 includes a slot 246 at the leading edge 241 (FIG.27) that allows insertion needle 24 retraction through contacts plate 19. The planar sensor probe 4 (rectangular cross section) resides within insertion needle 24, cannula 3 encircled insertion needle 24. FIG. 25e shows preferred embodiment of insertion needle 24 position after retraction and during operation of AID patch 1. Following insertion, insertion needle 24 is partially retracted such that at the end of insertion, insertion needle 24 remains within AID patch housing 10, sensor probe 4 remain partially within insertion needle 24, and cannula 3 encircled at least a portion of insertion needle 24.

[0080] FIGs.26a-d show cross section views of inserter 20 and AID patch 1 before insertion of sensor probe 4 and cannula 3 (FIG. 26a), after insertion (FIG. 26b), after retraction of insertion needle 24 (FIG.26c), and after inserter 20 removal (FIG.26d). FIGs.26b1 and 26d1 show magnified views. Inserter 20 includes inserter trigger 21, inserter housing 22, insertion needle 24, releaser 244, and retraction spring 23. AID patch 1 includes AID patch housing 10, housing slider 11, supporting plate 62, insulin line 14, insulin line bend 141, cannula 3, and sensor probe 4. FIG. 26a shows the AID patch 1 and inserter 20 before insertion; retraction spring 23 is squeezed, insulin line 14 is minimally curved. FIG. 26b shows the AID patch 1 and inserter 20 at the end of insertion. Upon applying downward pressure on trigger 21 (FIG. 3), trigger 21, housing slider 11, releaser 244, and probe / cannula assembly 60 (FIG. 18) are displaced in the direction of bold arrow 1; cannula 3 and sensor probe 4 are inserted within theAtty. Docket No.: 43654-02028 / WO TING-007 / 00WO subcutaneous tissue 255 by insertion needle 24 (26b1, magnified view), and insulin line 14 is bend. FIG. 26c shows the retraction of inserter needle 24 after completion of insertion. Releaser 244 is activated and retraction spring 23 retracts insertion needle 24 in the direction of bold arrow 2 into inserter housing 22 such that sharp tip 243 is concealed. FIG.26d shows the AID patch 1 following insertion needle 24 retraction and inserter 20 removal; cannula 3 and sensor probe 4 remains in the subcutaneous tissue (26d1magnified view).

[0081] FIGs.27a1-3 show schemes of AID patch 1 and inserter 20 before insertion of sensor probe 4 and cannula 3 (FIG.27a1), after insertion (FIG.27a2), and after retraction of insertion needle 24 (FIG.27a3). Inserter 20 includes inserter trigger 21, inserter housing 22, insertion needle 24, retraction spring 23, and releaser 244. AID patch 1 includes housing slider 11 and housing slider cap 111. FIG. 27a1 shows AID patch 1 and inserter 20 before activation; housing slider cap 111 is located above the upper cover 12 (FIG.4) of AID patch 1, retraction 23 spring is squeezed. FIG. 27a2 shows inserter 20 activation, downward displacement of trigger 21 in the direction of bold arrow 1; housing slider cap 111 is aligned with upper cover 12 of AID patch 1 and releaser 244 is activated. FIG. shows retraction of insertion needle 24; upon activation of releaser 244, retraction spring 27a323 is released and retracts the insertion needle 24 in the direction of bold arrow 2. Following insertion, inserter 20 is removed (not shown) and AID patch 1 remains on skin 25 (not shown). FIG.27b shows an exploded view of inserter 20. Inserter 20 includes inserter trigger 21, inserter housing 22, retraction spring 23, insertion needle 24, and releaser 244. FIG. 27c shows the insertion needle 24, that includes insertion needle tip (also "sharp tip" or "sharp") 243, leading edge 241, trailing edge 242, releaser 244 and fixer 245. Leading edge has a slot 246 (FIG. FIG.).

[0082] FIGs.28a-f shows spatial views of another preferred embodiment of AID patch 1 that includes a pre-filled insulin cartridge 83 ("cartridge"). Cartridge 83 includes septum 86 and piston 92. AID patch 1 includes housing 10, insulin line 14, lead screw 56, housing door 84, and housing door sharp 85. FIG.28a shows AID patch 1, housing door 84 is open, cartridge 83 is outside housing 10. FIG.28b shows cartridge 83 insertion. FIG.28c shows AID patch 1 (upper cover 12 removed) and cartridge 83 in place, cartridge 83 insertion completed, housing door 84 is open. FIG. 28d shows AID patch 1, housing door 84 is partially closed, housing door sharp 85 punctures cartridge septum 86. FIG. 28e (upper cover 12 removed) and FIG. 28f show the AID patch, cartridge 83 in place, and housing door 84 is closed; during AID patch 1 operation, lead screw 56 is engaged with piston 92 and insulin is delivered through insulin line 14 to cannula 3 (not shown).Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO

[0083] FIGs. 29a-b show schemes of subcutaneous insulin depot 29 during basal delivery (FIG.29a) and large bolus delivery (FIG.29b) of insulin from cannula 3. Insulin delivery path 9 (FIGs. 12 and 15) includes insulin line 14, cannula 3, and cannula tip 31. Sensor probe 4 includes sensor probe tip 411, electrodes – working 16 and reference 17 (side a, side b not shown, FIG. 24), sensor probe traces 78, contacts plate 19, and sensor contacts 75. After insertion, cannula 3 and sensor probe 4 transverse skin 25 and reside within the subcutaneous tissue 255. Sensor probe 4 partially resides within cannula 3 and the distance (D) between cannula tip 31 and sensor probe tip 411 is > 4mm. FIG.29a and FIG.29b show insulin depots 29 formed around cannula tip 31 during basal and bolus delivery, respectively. In both basal and insulin delivery, the maximal boundary of insulin depot 29 is a part of sensor electrodes 16 and 17 such that glucose is accurately measured with no interferences of insulin solution.

[0084] FIGs. 30a-c show schemes of preferred embodiment of a mechanism for controlling reservoir 90 filling. AID patch 1 includes reservoir 90, piston 92, lead screw 56, drive wheel 53, insulin line 14, and insulin line septum 146. Insulin line septum 146 is self-sealed and located on insulin line 14. FIG.30a shows the filling syringe 96 (filled after drawing insulin from a vial) before reservoir 90 filling, filling syringe needle 97 crosses insulin line septum 146 such that needle 97 occludes insulin line 14. FIG.30b shows the filling process, insulin from filling syringe 96 is delivered to reservoir 90 in the direction of bold arrow, insulin delivery to insulin line 14 is prevented by filling syringe needle 97. After filling completion (FIG.30c), filling syringe 96 is removed, the self-sealed septum 146 is sealed, drive wheel 53 rotated, lead screw 56, and insulin is delivered in the direction of bold arrow from reservoir 90 to insulin line 14.

[0085] FIGs.31a-c show schemes of a mechanism for detection of insulin in cannula 3. During priming, air in insulin line 14 is purged and insulin line 14 is filled with insulin. Detection of insulin in cannula 3 means that priming is complete and there is no air in insulin line 14. AID patch 1 includes housing 10, reservoir 90, insulin line 14, cannula 3, sensor probe 4, sensor contacts plate 19, electronic assembly 70, voice coil 40, sensor traces 47 (square dot line), and priming traces 27 (long dash dot line). FIG. 31a shows the AID patch 1 before priming, reservoir 90 is filled with insulin and insulin line 14 is filled with air. There is no electrical connection between sensor probe 4 and electronic assembly 70. FIG.31b shows the AID patch 1 during priming, insulin is delivered from reservoir 90 to cannula 3. When insulin reaches cannula 3, sensor probe 4 that resides within cannula 3 detects insulin (FIG.31c) by closing electrical circuit and current is conducted from sensor probe 4, via contacts plate 19 andAtty. Docket No.: 43654-02028 / WO TING-007 / 00WO priming traces 27 to electronic assembly 70. FIG. 31c shows a magnified scheme of insulin path that includes insulin line 14, and cannula 3, electrical paths of glucose sensor (shown also in FIGs.7, 9, and 24) and electrical paths of insulin detection. Electrical paths of glucose sensor include electrodes (working 16, reference 17), sensor probe traces 78, sensor probe contacts 75, and sensor traces 47. Glucose oxidation that occurs on working electrode 16 generates current that is conducted through the electrical path of glucose sensor to the electronic assembly 70. The electrical path of insulin detection includes priming electrodes 187, priming electrode 288, sensor probe priming traces 79, sensor probe priming contacts 77, and priming traces 27. During priming, insulin is delivered from insulin line 14 to cannula 3 and conductivity between priming electrodes 187 and priming electrode 288 (that reside within cannula 3) is increased. Closing the electrical circuit is detected by electronic assembly 70 and priming is stopped. The invention includes other optional combinations of detection conductivity change between any two electrodes on sensor probe 4, i.e., counter electrode 18 (side b, not shown, FIG.24) and one priming electrode (87 or 88).

[0086] FIG.32a-b show schemes of a mechanism for turning on the AID patch 1. AID patch 1 includes housing 10, electronic assembly 70, PCBA 74, reed switch 98, reservoir 90, piston 92, piston magnet 924, drive wheel 53, and lead screw 56. FIG.32a shows the AID patch "off state" before filling. Reed switch 98 is in "off mode". FIG.32b shows reservoir 90 filling with filling syringe 96. During filling, piston 92 and piston magnet 924 are displaced in the direction of bold arrow. At a predetermined piston 92 movement (i.e., 80 units of insulin in reservoir) reed switch 98 is exposed to the magnetic field of piston magnet 98 and changed to "on state". Electrical circuit (dashed line) is closed and AID patch 1 is turned on.

[0087] FIG. 33a-b show schemes of preferred embodiment of AID patch 1 that includes a cannula / probe protecting tube 151 for insulin collection during priming. AID patch 1 includes housing 10, housing slider 11, upper cover guide 142, bottom cover guide 133, supporting plate 62, insulin line 14, cannula 3, insertion needle 24, sensor probe 4, contacts plate 19, cannula probe protecting tube 151, cannula probe protecting cap 152, and sponge 153. FIG.33a shows a scheme of AID patch 1 during priming – insulin is delivered from reservoir 90 via insulin line 14 to cannula 3 and purged from canula 3 (scheme drops). Cannula probe protecting tube 151 directs insulin to sponge 153 that is connected to cannula probe protecting cap 152 and insulin is absorbed by sponge 153. FIG. 33b shows the AID patch 1 after priming, cannula probe protecting cap 152 and sponge 153 are removed and AID patch 1 is ready for insertion of insertion needle 24 through 4thopening 34.Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO Examples according to some embodiments: Example 1: An automated-insulin-delivery device (AID) including at least one housing; a pump; a single lumen cannula; a glucose sensor including a probe; a processor; and an automated-insulin-delivery algorithm (AIDA), where the housing is configured to be adhered the skin of a user via the adhesive tape and house the insulin pump, glucose sensor, and AIDA, the probe at least partially resides within the cannula, and the AIDA is configured as computer instructions operating on the processor causing the processor to control insulin delivery by the insulin pump according to glucose levels determined in subcutaneous tissue based on signals received from the glucose sensor. Example 2: The device of example 1, where the at least one housing includes: a plurality of housing openings including a first housing opening, a second housing opening, a plurality of housing septa including a first housing septum and a second housing septum, and a housing slider including a plurality of housing slider openings including a first slider opening, a second slider opening, and a plurality of housing slider septa including a first slider septum, and a second slider septum; and the device further comprises a retractable insertion needle extending through the first slider opening, the first housing opening, and second slider opening, along a longitudinal axis, where before retraction of the insertion needle, the cannula encircles the insertion needle and the sensor probe at least partially resides within the insertion needle, and after retraction of the insertion needle, the sensor probe at least partially resides within the cannula. Example 3: The device of example 2, further including an adhesive for adhering the device to the skin before insertion of the cannula and sensor probe. Example 4: The device of example 2, where during insertion, the housing slider, the insertion needle, the cannula, and the sensor probe are displaced along the longitudinal axis. Example 5: The device of example 2, where the insertion needle extends through the housing slider opening, the first housing opening, the second housing slider opening, and the second housing opening along the longitudinal axis. Example 6: The device of example 2, where after insertion, the insertion needle is retracted and the first housing slider septum, the first housing septum, the second housing slider septum and the second housing septum are sealed. Example 7: The device of any of examples 1-6, where the device is configured only for one- time use. Example 8: The device of any of examples 1-7, where the entire device is disposable.Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO Example 9: The device of examples 7 or 8, where the one-time and / or disposable device includes a single port configured for passing the cannula and sensor probe into tissue. Example 10: The device of any of examples 1-9, further including at least two compartments. Example 11: The device of example 10, where the at least two compartments comprise only two compartments. Example 12: The device of any of examples 10-11, where at least one of the compartments is sealed. Example 13: The device of any of examples 10-11, where the at least two compartments are sealed. Example 14: The device of any of examples 10-13, where the at least two compartments comprise a first compartment sealed to ensure microorganism and water resistance after sterilization, and a second compartment including the electronic assembly is sealed to ensure water resistance of the electronic assembly. Example 15: The device of any of examples 10-14, where the first compartment is assembled with the second compartment. Example 16: The device of any of example 1, where the at least one housing includes two housings including an electronic assembly housing including the electronic assembly, and an AID patch housing. Example 17: The device of examples 2-15, where the plurality of housing openings, the plurality of housing slider openings, the plurality of housing septa and the plurality of housing slider septa are associated with the plurality of housing openings and the plurality of housing slider openings so as to seal respective openings. Example 18: The device of any of examples 1-17, where the sensor probe is rigidly connected with the cannula, and / or includes a supporting plate configured for enabling such rigid connection. Example 19: The device of any of examples 1-17, where the sensor probe is rigidly connected with the cannula which is arranged for downward displacement during insertion. Example 20: The device of any of examples 1-19, further including a supporting plate shaped and sized to couple insulin delivery structure with a plurality of electrical contacts. Example 21: The device of example 20, where the electrical contacts are sized and shaped for connection to a collapsible electrical contact. Example 22: The device of example 21, where the collapsible electrical contacts comprise at least one of a wire and a spring.Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO Example 23: The device of any of examples 1-22, further including an insulin delivery line for communicating insulin from a reservoir to the cannula. Example 24: The device of example 23, where the insulin delivery line is sized and shaped to fold during insertion of the glucose sensor probe and cannula. Example 25: The device of any of examples 1-24, further including a drive mechanism including a voice-coil for communicating insulin to the cannula. Example 26: The device of example 25, where the drive mechanism further includes at least one of one or more gears, at least one lead screw, and at least one drive wheel. Example 27: The device of examples 25 or 26, where the voice-coil is configured to move in a back-and-forth manner which rotates a / the drive wheel. Example 28: The device of any of examples 25-27, where the drive wheel rotates the lead screw, and the lead screw is sized and shaped to convert circular motion to linear motion. Example 29: The device of any of examples 1-28, further including a control switch for detecting movement via at least one contact. Example 30: The device of any of examples 1-29, further including at least one reservoir. Example 31: The device of any of examples 1-30, further including a least one floating piston. Example 32: The device of any of examples 1-31, where during filling, the floating piston is freely displaced within the reservoir. Example 33: The device of any of examples 26-32, where a / the lead screw is coupled to a / the floating piston via one or more leg screw legs. Example 34: The device of example 26, where the lead screw is coupled to a floating piston via a latch. Example 35: The device of any of examples 1-34, where the glucose sensor probe fully resides within the cannula. Example 36: The device of any of examples 1-35, where the insertion needle is at least partially retractable. Example 37: The device of any of examples 1-36, further including a cartridge prefilled with insulin which is configured for plugged connection with the device. Example 38: The device of any of examples 1-37, further including an insulin line and insulin flow into the insulin line is via a syringe. Example 39: The device of any of examples 1-38, further including at least two (2) electrodes arranged on the glucose sensor probe and arranged so detect insulin in the subcutaneous tissue.Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO Example 40: The device of example 1, further including a piston and a reservoir, the piston being arranged within the reservoir and includes at least one magnet, and a reed switch configured to detect the location of the piston via the magnetic field generated by the magnet. Example 41: The device of any of example 1-40, further including at least one of a protecting tube and a sponge, sized, shaped, and arranged for collecting drops of insulin during a priming operation. Example 42: An automated insulin delivery system (AID system) for controlling glucose levels, the system including a skin adherable automated-insulin-delivery patch (AID patch) including at least one housing, an insulin pump, a glucose sensor, a processor, and an automated-insulin-delivery algorithm (AIDA) for controlling insulin delivery according to glucose readings detected by the glucose sensor; and an application operable on a smartphone for controlling at least one or more of: one or more settings, presentation of data to the user of the smartphone, and cloud communications; the insulin pump includes a drive mechanism, a lead screw, a reservoir, a floating piston, and a cannula having a single lumen, the glucose sensor includes a subcutaneous sensor probe, during filling of the reservoir, the floating piston is displaced in a first direction and during operation is displaced in a second direction opposite to the first direction after engagement with the lead screw, and after insertion of the sensor probe, the sensor probe at least partially resides within the single lumen cannula. Example 43: The AID system of example 42, where the processor includes computer instructions operating thereon for enabling at least one of changing pump or sensor parameters, receiving data and presenting data which can include glucose readings, and communicating with a computer network. Example 44: The AID system of examples 42 or 43, where the AID patch includes a first, upper cover and a second bottom cover, where the first cover includes at least one vent. Example 45: The AID system of any of examples 42-44, where the AID patch includes a / the first cover including at least one and preferably at least two sealing walls aligned with at least one and preferably two sealing walls of the second cover sealing walls, to establish a sealed compartment after the first and second covers are assembled with the AID patch. Example 46: The AID system of examples 44 or 45, where the AID patch includes a second cover including at least one of: one or more lead screw supporting ribs, a second cover guide, a second cover opening. Example 47: The AID system of examples 44 or 45, where the AID patch includes a second cover including at least one of: one or more electrical paths which can include one or moreAtty. Docket No.: 43654-02028 / WO TING-007 / 00WO second cover traces, one or more sealing wall contacts, one or more control switch contacts, one or more sensor contacts, and one or more pump mechanism contacts. Example 48: The AID system of any of examples 42-47, where the AID patch including a first sealed compartment and a second sealed compartment. Example 49: The AID system of any of examples 42-47, where the AID patch includes first and second sealed compartments that are formed by the first and second covers. Example 50: The AID system of any of examples 42-49, where the AID patch includes an electronic assembly including an electronic assembly housing, a housing sealing interface, and an electronic assembly sealing interface. Example 51: The AID system of any of examples 42-50, where the AID patch further including at least one housing slider cap. Example 52: The AID system of example 50, where the AID patch electronic assembly is in electrical communication with at least one electrical path via a respective contact of a printed circuit board assembly (PCBA). Example 53: The AID system of any of examples 42-53, where continuous signals are generated by a plurality of electrodes of the sensor probe which are received and analyzed by a sensor glucose determination algorithm which then provides resultant glucose level signals as input to the AIDA. Example 54: The AID system of any of examples 42-53, where the AIDA, after receiving and analyzing the glucose level signals, automatically controls the pump to adjust insulin delivery rate in accordance with the analyzed glucose level signals. Example 55: The AID system of any of examples 42-54, where drive mechanism includes a voice coil and the amount of insulin delivered to the user is determined by a number of actuations of the voice coil. Example 56: The AID system of example 55, where each actuation of the voice coil produces a back-and-forth movement of a shaft of the voice coil. Example 57: The AID system of example 56, where movement of the shaft is configured to cause rotation of a drive wheel which causes displacement of the lead screw. Example 58: The AID system of any of examples 55-57, further including a control switch configured to provide feedback to controlling operation of the voice coil. Example 59: The AID system of any of examples 42-58, where the processor is configured to receive user input with respect to at least one of meal and exercise information, and the AIDA is operable to adjust insulin delivery to the user based on such information.Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO Example 60: The AID system of any of examples 42-59, where at least one housing includes an adhesive for adhering to the skin of the user. Example 61: The AID system of any of examples 42-60, where the cannula is part of a cannula assembly which includes a supporting plate, a sensor contacts plate and supporting plate traces. Example 62: The AID system of any of examples 42-61, where the AID patch includes a sensor spring configured for providing electrical connection(s) between the sensor probe and the electronic assembly prior to insertion. Example 63: The AID system of example 62, where the sensor spring is arranged in a stretched position prior to insertion of the cannula and in a compressed position after insertion of the cannula. Example 64: The AID system of examples 62 or 63, where the electrical connection(s) is foldable. Example 65: The AID system of any of examples 57-64, where the drive wheel is configured to rotate in a single direction. Example 66: The AID system of any of examples 42-65, where the drive mechanism includes any one or more of: voice coil drive shaft, a drive leg and associated drive arm, lead screw threads arranged on the lead screw and configured for operative connection with a portion of the drive arm, a drive wheel housing, a lead screw tip, a drive wheel housing stopper, a ratchet lock, and drive wheel teeth arranged on a circumference of the drive wheel. Example 67: The AID system of example 66, where linear movement of the lead screw causes movement of the drive leg and drive arm in a first direction. Example 68: The AID system of examples 66 or 67, where the lead screw plate interfaces with the drive wheel housing stopper, resulting in the forcing of linear movement of the lead screw. Example 69: The AID system of any of examples 66-68, where during movement of the drive leg in a direction opposite to a first direction, the ratchet lock maintains a position of the drive wheel. Example 70: The AID system of any of examples 55-69, where the voice coil actuator includes an electromagnetic actuator which includes at least a plurality of: a housing, a coil, a shaft, a bobbin, a ferro plate, a magnet, and a bushing. Example 71: The AID system of example 70, pulsing electrical current in the coil causes linear motion of the magnet and the shaft.Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO Example 72: The AID system of any of examples 42-71, where delivery initiation is detected by reaching a pre-defined threshold of frictional force between the piston and the reservoir. Example 73: The AID system of example 72, where the pre-defined threshold of frictional force corresponds to a rise in electric current consumption of a / the voice coil actuator. Example 74: The AID system of example 73, where following detection of initiation, at least one of a delivery amount and a delivery rate are derived from a controlled displacement of lead screw. Example 75: The AID system of any of examples 66-74, where the lead screw tip includes one or more lead screw legs configured to retain a / the piston in an aligned position within the reservoir. Example 76: The AID system of any of examples 66-75, where the lead screw includes a piston latch including a conical shape and a flexible snap, such that, after the reservoir is filled, the drive mechanism is operated causing the lead screw and the lead screw tip are displaced toward an end of the piston until engagement of the lead screw tip with the piston latch. Example 77: The AID system of example 76, where the piston snap enables rigid connection so as to avoid opposite displacement of the lead screw. Example 78: An automated-insulin-delivery device (AID) including a housing including a plurality of housing openings including a first housing opening, a second housing opening, and a plurality of housing septa including a first housing septum and a second housing septum, a housing slider including a plurality of housing slider openings including a first slider opening, a second slider opening, and a plurality of housing slider septa including a first slider septum, and a second slider septum, an insertion needle extending through the first slider opening, the first housing opening, and second slider opening, along a longitudinal axis; a cannula that encircles the insertion needle; and a glucose sensor probe, where before insertion, at least a portion of the glucose sensor probe is disposed within the insertion needle, during insertion, the housing slider, the insertion needle, the cannula, and the sensor probe are displaced along the longitudinal axis, and insertion needle extends through the first housing slider opening, the first housing opening, the second housing slider opening, and the second house opening along the longitudinal axis, and after insertion, the insertion needle is retracted and the first slider septum, the first housing septum, the second housing slider septum and the second housing septum are sealed and at least a portion of the glucose sensor probe is disposed within the cannula. Example 79: An automated-insulin-delivery (AID) system for controlling glucose levels in a diabetic, where the system includes a skin adhered device for automated-insulin-delivery (AIDAtty. Docket No.: 43654-02028 / WO TING-007 / 00WO patch), and an application operable on a smartphone for controlling at least one or more of: one or more settings, presentation of data to the user of the smartphone, and cloud communications, where the AID patch includes a housing, a pump, a glucose sensor, and / or an automated- insulin-delivery algorithm (AIDA) for controlling insulin delivery according to glucose readings detected by the glucose sensor; and an electronic assembly within the housing and including at least a processor, a battery, a PCBA, a buzzer and / or speaker, and where the AIDA is operable on the processor; the pump includes a voice coil actuator, a drive mechanism, a reservoir, a reservoir piston, an insulin conduit, and a cannula having a single lumen and a cannula tip; the drive mechanism includes at least one of (and preferably all of) a drive wheel, and reciprocating linear movement of the voice coil rotates a drive wheel which is sized and shaped to displace a lead screw and floating piston; during filling of the reservoir, the floating piston is displaced in a first direction and during operation is displaced in a second direction opposite to the first direction after engagement with the lead screw; insulin is displaced from reservoir through insulin conduit and cannula into subcutaneous tissue of the user; the glucose sensor includes a subcutaneous sensor probe (“sensor probe”) having a probe tip and at least two electrodes in electrical communication with two respective electrical contacts via associated traces; electrical signals generated by probe electrodes in correlation with glucose levels is received by the processor and used as input to the AIDA; the sensor probe includes a flat and rectangular shape, and at least partially resides within the insertion needle prior insertion; the cannula is arranged to at least partially encircle the insertion needle; after insertion of the sensor probe; the sensor probe at least partially resides within the single lumen cannula and the probe tip and cannula tip reside within the subcutaneous tissue, and the sensor tip is spaced apart from cannula tip; and where concomitant insertion of cannula and sensor probe is accomplished via a removable inserter, the removable inserter includes a trigger, an insertion needle, and a retraction spring, and where upon activating the trigger, the cannula and sensor probe are inserted into the subcutaneous tissue followed by automatic insertion needle retraction; and following cannula and sensor probe insertion, the removable inserter is removed, and the AID patch remains adhered to skin. General Considerations

[0088] While various inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means, steps, components, and / or structures for performing the function of the embodiments (and elements thereof)Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO disclosed herein, and / or obtaining the results and / or one or more of the advantages described herein, and each of such variations and / or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, amounts, dimensions, materials, steps, and configurations described herein are meant to be merely an example and that the actual parameters, amounts, dimensions, materials, steps, and configurations will depend upon the specific application or applications for which the inventive teachings is / are used. Those skilled in the art will recognize or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. It is therefore to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of claims supported by the subject disclosure and equivalents thereto, and inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, device, system, article, material, kit, step, function / functionality, and method described herein. In addition, any combination of two or more such features, devices, systems, articles, materials, kits, steps, functions / functionality, and methods, if such features, systems, articles, materials, kits, steps, functions / functionality, and methods are not mutually inconsistent, is included within the inventive scope of the present disclosure and considered embodiments.

[0089] Moreover, in embodiments disclosed for any invention disclosed herein, which include a plurality of elements or a plurality of an element, one of skill in the art will understand that claims to such embodiments including such an element(s) can yield yet one or more additional embodiments / inventions upon the recitation of one or a single of such elements or element. Thus, and for example, if an embodiment is disclosed via at least one of written description and one or more figures, is to a device having a plurality of element “A,” the present disclosure supports claims having one or more or a single embodiment of element A (and / or other elements etc.).

[0090] Embodiments disclosed herein may also be combined with one or more features, components, materials, parameters, as well as complete systems, devices, and / or methods, to yield yet other embodiments and inventions. Moreover, some embodiments, may be distinguishable from the prior art by specifically lacking one and / or another feature disclosed in the particular prior art reference(s); i.e., claims to some embodiments may be distinguishable from the prior art by including one or more negative limitations such that the claim(s) is patentable over the prior art for such embodiments.Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO

[0091] Also, as noted, various inventive concepts may be embodied as one or more methods, of which one or more examples have been provided. The acts performed as part of the method(s) may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments, and, in some embodiments, less than the number of steps can be recited and still results in patentable subject matter distinguishable over the prior art, and supported and enabled via written description and / or one or more figures.

[0092] Any and all references to publications or other documents, including but not limited to, patents, patent applications, articles, webpages, books, etc., presented anywhere in the present application, are herein incorporated by reference in their entirety. Moreover, all definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0093] The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.” The terms “can” and “may” are used interchangeably in the present disclosure, and indicate that the referred to element, component, structure, function, functionality, objective, advantage, operation, step, process, apparatus, system, device, result, or clarification, has the ability to be used, included, or produced, or otherwise stand for the proposition indicated in the statement for which the term is used (or referred to) for a particular embodiment(s).

[0094] The phrase "and / or," as used herein in the specification and in the claims, should be understood to mean "either or both" of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with "and / or" should be construed in the same fashion, i.e., "one or more" of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the "and / or" clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to "A and / or B", when used in conjunction with open-ended language such as "comprising" or “including” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO

[0095] As used herein in the specification and in the claims, "or" should be understood to have the same meaning as "and / or" as defined above. For example, when separating items in a list, "or" or "and / or" shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as "only one of' or "exactly one of," or, when used in the claims, "consisting of," will refer to the inclusion of exactly one element of a number or list of elements. In general, the term "or" as used herein shall only be interpreted as indicating exclusive alternatives (i.e. "one or the other but not both") when preceded by terms of exclusivity, such as "either," "one of," "only one of," or "exactly one of" "Consisting essentially of," when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0096] As used herein in the specification and in the claims, the phrase "at least one," in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase "at least one" refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, "at least one of A and B" (or, equivalently, "at least one of A or B," or, equivalently "at least one of A and / or B") can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.

[0097] In the claims, as well as in the specification above, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," "composed of," and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases "consisting of' and "consisting essentially of’ shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.

Claims

Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO What is currently claimed:

1. An automated-insulin-delivery device (AID or device) comprising: at least one housing; a pump; a single lumen cannula; a glucose sensor including a sensor probe; a processor; and an automated-insulin-delivery algorithm (AIDA); wherein: the at least one housing is configured to be adhered to the skin of a user and house the pump, the glucose sensor, and the AIDA, the probe at least partially resides within the single lumen cannula, and the AIDA is configured as computer instructions operating on the processor causing the processor to control insulin delivery by the pump according to glucose levels determined in subcutaneous tissue based on signals received from the glucose sensor.

2. The device of claim 1, wherein: the at least one housing includes: a plurality of housing openings comprising a first housing opening, a second housing opening, a plurality of housing septa comprising a first housing septum and a second housing septum, a housing slider including a plurality of housing slider openings comprising a first slider opening, a second slider opening, and a plurality of housing slider septa comprising a first slider septum, and a second slider septum; andAtty. Docket No.: 43654-02028 / WO TING-007 / 00WO the device further comprises a retractable insertion needle extending through the first slider opening, the first housing opening, and the second slider opening, along a longitudinal axis, wherein: before retraction of the retractable insertion needle, the single lumen cannula encircles the insertion needle and the sensor probe at least partially resides within the retractable insertion needle, and after retraction of the retractable insertion needle, the sensor probe at least partially resides within the single lumen cannula.

3. The device of claim 2, further comprising an adhesive for adhering the device to the skin of the user before insertion of the single lumen cannula and sensor probe.

4. The device of claim 2, wherein during insertion, the housing slider, the retractable insertion needle, the single lumen cannula, and the sensor probe are displaced along the longitudinal axis.

5. The device of claim 2, wherein the retractable insertion needle extends through the first housing slider opening, the first housing opening, the second housing slider opening, and the second housing opening along the longitudinal axis.

6. The device of claim 2, wherein after insertion, the retractable insertion needle is retracted and the first housing slider septum, the first housing septum, the second housing slider septum and the second housing septum are sealed.

7. The device of claim 1, wherein the device is configured only for one-time use.

8. The device of claim 1, wherein the device is disposable.Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO 9. The device of claims 1, wherein the device includes a single port configured for passing the single lumen cannula and sensor probe into tissue.

10. The device of claim 1, further comprising at least two compartments.

11. The device of claim 10, wherein the at least two compartments comprise only two compartments.

12. The device of claim 10, wherein at least one of the at least two compartments is sealed.

13. The device of claim 10, wherein the at least two compartments are sealed.

14. The device of claim 10, wherein the at least two compartments comprise a first compartment sealed to ensure microorganism and water resistance after sterilization, and a second compartment including an electronic assembly is sealed to ensure water resistance of the electronic assembly.

15. The device of claim 14, wherein the first compartment is assembled with the second compartment.

16. The device of claim 1, wherein the at least one housing comprises two housings including an electronic assembly housing including the electronic assembly, and an AID housing.

17. The device of claim 2, wherein the plurality of housing openings, the plurality of housing slider openings, the plurality of housing septa and the plurality of housing slider septa are associated with the plurality of housing openings and the plurality of housing slider openings so as to seal respective openings.Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO 18. The device of claim 1, wherein the sensor probe is rigidly connected with the single lumen cannula, and / or includes a supporting plate configured for enabling such rigid connection.

19. The device of claim 1, wherein the sensor probe is rigidly connected with the single lumen cannula, is arranged for downward displacement during insertion.

20. The device of claim 1, further comprising a supporting plate shaped and sized to couple insulin delivery structure with a plurality of electrical contacts.

21. The device of claim 20, wherein at least one of the plurality of electrical contacts is sized and shaped for connection to at least one collapsible electrical contact.

22. The device of claim 21, wherein the collapsible electrical contact comprise at least one of a wire and a spring.

23. The device of claim 1, further comprising an insulin delivery line for communicating insulin from a reservoir to the single lumen cannula.

24. The device of claim 23, wherein the insulin delivery line is sized and shaped to fold during insertion of the sensor probe and single lumen cannula.

25. The device of claim 1, further comprising a drive mechanism comprising a voice-coil for communicating insulin to the single lumen cannula.

26. The device of claim 25, wherein the drive mechanism further comprises at least one of one or more gears, at least one lead screw, and at least one drive wheel.

27. The device of claim 25, wherein the voice-coil is configured to move in a back-and- forth manner which rotates a / the drive wheel.Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO 28. The device of claim 26, wherein the at least one drive wheel rotates the at least one lead screw, and the lead screw is sized and shaped to convert circular motion to linear motion.

29. The device of claim 1, further comprising a control switch for detecting movement via at least one contact.

30. The device of claim 1, further comprising at least one reservoir.

31. The device of claim 30, further comprising a least one floating piston.

32. The device of claim 31, wherein during filling of the reservoir, the at least one floating piston is freely displaced within the at least one reservoir.

33. The device of claim 1, wherein the at least one lead screw is coupled to the at least one floating piston via one or more leg screw legs.

34. The device of claim 26, wherein the at least one lead screw is coupled to a floating piston via a latch.

35. The device of claim 1, wherein the sensor probe fully resides within the single lumen cannula.

36. The device of claim 1, further comprising an insertion needle that is at least partially retractable.Atty. Docket No.: 43654-02028 / WO TING-007 / 00WO 37. The device of claim 1, further comprising a cartridge prefilled with insulin which is configured for plugged connection with the device.

38. The device of claim 1, further comprising an insulin line wherein insulin flow into the insulin line is via a syringe.

39. The device of claim 1, further comprising at least two (2) electrodes arranged on the sensor probe and arranged so detect insulin in the subcutaneous tissue.

40. The device of claim 1, further comprising a piston and a reservoir, the piston being arranged within the reservoir and includes at least one magnet, and a reed switch configured to detect a location of the piston via a magnetic field generated by the at least one magnet.

41. The device of claim 1, further comprising at least one of a protecting tube and a sponge, sized, shaped, and arranged for collecting drops of insulin during a priming operation.

42. A system, device, or method according to any of the disclosed embodiments.

Images