Automated insulin delivery device and methods associated thereof

Abstract

The present disclosure is directed to embodiments for an automated insulin delivery (AID) device which includes, inter alia, a housing including an adhesive tape configured, to adhere the housing to the skin of a user via. an adhesive tape. The housing houses at least an insulin pump including a single lumen cannula, a glucose sensor including a sensor probe, a processor, an insertion assembly for inserting the single lumen cannula, and the sensor probe within subcutaneous tissue, and an automated-insulin-delivery algorithm (AIDA). The sensor 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 automatically control insulin delivery by the insulin pump according to glucose levels from subcutaneous tissue based on signals received from the glucose sensor.

Description

AUTOMATED INSULIN DELIVERY DEVICEAND METHODS ASSOCIATED THEREOFRELATED APPLICATIONS

[0001] The present disclosure claims benefit of and priority to U.S. provisional patent application no. 63 / 746,881, filed January 17, 2025, and U.S. provisional patent application no.63 / 903,659, filed October 22, 2025, each disclosure of which is herein incorporated by reference it its entirety.FIELD OF DISCLOSURE

[0002] The present disclosure is directed to inventions and corresponding embodiments for an automated insulin delivery (AID) device, and more specifically, to a skin adhered AID patch (which may also be referred to interchangeably throughout the disclosure as AID device) that includes a continuous insulin delivery mechanism (pump), a continuous glucose monitoring (CGM) mechanism, and an algorithm that automatically control insulin delivery according to glucose monitoring. In some embodiments, an AID patch is disclosed 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 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 the CGM device and an insulin pump can be done directly or through a controller (usually a smartphone), with the AID algorithm residing 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 thesubcutaneous tissue. In most cases, both the insulin pump cannula and the sensor probe are inserted into the subcutaneous tissue with a designated insertion device ("inserter"). The inserter includes a sharp needle and insertion mechanism for needle insertion and retraction.

[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 and 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, including, for example, adhesive tape for both the pump and the CGM occupy a large skin "real estate" with high risk of irritation. Both the pump and the GGM include respective pricking points ("ports" for cannula and sensor probe). Such points increase the risk of local and systemic infection, CGM-pump communication interferences, high production cost (pump device and CGM device), and replacement cycle mismatch. In addition, they may require two inserters.

[0006] Thus, there is a need for an AID system that comprises one-piece, one-port, skin adhered device (" AID patch") that includes an insulin pump, a CGM device, and an AID algorithm. There is also a need for a fully disposable AID patch that includes a fully automated insertion mechanism for the insulin pump cannula and the sensor probe.SUMMARY

[0007] Accordingly, embodiments of the present disclosure include a one-piece, one-port, skin adhered device (hereinafter " AID patch") that includes an insulin pump device, a CGM device, and an AID algorithm. That AID patch includes a single housing and a single adhesive tape for adhering the AID patch to the skin of a patient, a single pricking point, thus, no wireless communication between CGM and pump, and one replacement cycle.

[0008] In some embodiments, the AID system includes a skin adhered AID patch and an AID patch mobile application for adjusting AID patch settings, presenting received data, and communicating with the cloud (e.g., remote servers / device / storage in communication with the cloud). In some embodiments, the AID patch includes an inductive coupling for near field communication (NFC), which can be used to wake the AID patch via proximity of a smartphone with the AID patch, and pairing between the two devices can be automatically performed via BLE (Bluetooth low energy) after wake-up. The AID patch, according to someembodiments, includes an insulin pump for continuous delivery of insulin and a glucose sensor for continuous glucose monitoring (CGM, hereinafter "sensor" or "glucose sensor" or " CGM")). An AID algorithm (which in some embodiments is configured as computer instructions operating on a processor on the AID patch) present on the AID patch, receives glucose readings from the glucose sensor and automatically adjusts insulin delivery rate from the insulin pump. The insulin pump delivers insulin into the subcutaneous tissue via the cannula, and the glucose sensor monitors glucose level in the subcutaneous tissue by a sensor probe. In some embodiments, the cannula and the sensor probe are automatically inserted into the subcutaneous tissue with a needle that is automatically retracted after insertion. In some embodiments, within the AID patch, the sensor probe resides within the needle, and the needle resides within the cannula before insertion. Accordingly, within the subcutaneous tissue, after insertion, the sensor probe resides within the cannula, and the sensor probe tip is located apart from cannula tip.

[0009] In some embodiments, an AID patch is provided and includes a housing, an adhesive tape, a glucose sensor and an insulin pump. The glucose sensor can be comprised of a sensing assembly and a sensor probe. The insulin pump can be comprised of a driving assembly, a delivery assembly, an insulin line, and a cannula. In some embodiments, the AID patch includes an electronic assembly that includes a main PCBA, one or more batteries (battery and batteries are used interchangeably throughout), and one or more (in some embodiments, all) accessories: an interface PCBA, a control switch, a volume sensor, and a priming sensor. In some embodiments, the AID patch includes an insertion assembly (which can also be referred to as an insertion mechanism) for insertion of a needle, a cannula, and a sensor probe into the subcutaneous tissue and retraction of needle after insertion. In some embodiments, during AID patch operation, an AID algorithm continuously receives glucose readings from the sensing assembly and automatically adjusts operation of the driving assembly which controls the delivery assembly and delivery of insulin via the insulin line and the cannula into the subcutaneous tissue.

[0010] In some embodiments, an AID patch is provided that includes a top cover, a bottom cover, a battery / batteries cover, and an adhesive tape that is protected with a liner before use. The bottom cover can include a filling port and an opening for a septum ("cannula opening septum") that is pierced by an insertion needle during insertion and maintains the sealing of the cannula during AID patch operation. Prior to use (e.g., shelf life), the cannula opening septum is covered with a sheet (e.g., tinfoil, paper, or alike) to maintain sterility. Before adherence ofthe AID patch to skin, the adhesive tape liner and cannula septum cover are removed thereby exposing the adhesive tape and cannula opening septum to skin contact.

[0011] In some embodiments, an AID patch is provided which includes two compartments, a sterile compartment that includes all subassemblies and electronic accessories, and an electronic compartment that includes (in some embodiments one or more, in some embodiments all) a main PCBA, one or more batteries, and a zebra connector. The sterile compartment is confined between the top cover and the bottom cover and includes the cannula opening septum. The electronic compartment is confined between the bottom cover and the batteries cover. The Zebra connector (within a gasket) provides an electrical connection between the main PCBA (electronic compartment) and the interface PCBA (sterile compartment). Assembly of the AID patch and sterilization processes can include the following 4 consecutive steps: 1) assembly of all subassemblies and electronic assembly accessories within the top cover and the bottom cover (sterile compartment), 2) sterilization (e.g., e-beam radiation), 3) assembly of the PCBA, the batteries, and the zebra connector within the electronic compartment, and 4) assembly of the batteries cover and closing the electronic compartment.

[0012] In some embodiments, the electronic assembly is reusable. In such a configuration, the electronic assembly is packed within a shell (which in some embodiments is rigid), the batteries are rechargeable, and two electronic assemblies are provided. During AID patch operation, one electronic assembly is operated, and the other is charged by, e.g., a wall charger and / or a docker. After a use cycle (e.g., 3-4 days), the charged electronic assembly is then used / operated, and the recently used electronic assembly is charged. The Zebra connector provides electrical connection between the electronic assembly and the interface PCBA. The reusable electronic assembly can be repetitively connected and disconnected from the AID patch. In some embodiments, the electronic assembly is disposable, and after a use cycle, the batteries cover is removed, the electronic assembly is disconnected from AID patch and then disposed of into a batteries can for recycling.

[0013] In some embodiments, an AID patch includes hardware and software for operation. In some embodiments, hardware components include (in some embodiments one or more of, and in some embodiments, all of) a / the main PCBA, an / the interface PCBA, a / the sensor probe, a / the volume sensor, a / the priming sensor, a / the buzzer, a / the gear-motor or motor (both terms used interchangeably throughout the disclosure), and a / the control switch. The main PCBA can include an MCU, or master-control-unit (e.g., a processor) that can include a / the AID algorithm and wireless (e.g., Bluetooth / BLE) communication circuitry. Hardware can also includeelectrical traces on the interface PCBA to connect various components including, via a / the zebra connector, between the main PCBA and the sensor probe, the control switch, the volume sensor, the priming sensor, and the gear-motor. Continuous signals, generated by electrodes of sensor probe (e.g., the working electrode, the reference electrode, and the counter electrode), are received by the MCU and used by the AID algorithm to adjust insulin delivery rate by controlling operation of the gear-motor. In some embodiments, control of an insulin delivery rate is achieved by controlling a number of gear-motor rotations. In some embodiments, the control switch provides feedback to the MCU on operation of the gear-motor (i.e., yes / no movement). Batteries provide power to the hardware (components of which operate the software) and gear-motor operation. In some cases, a user may provide inputs via a smartphone such as meal and exercise announcements, and the AID algorithm may adjust insulin delivery accordingly.

[0014] In some embodiments, an AID patch is provided which includes a driving assembly (mechanism) that can be controlled by a control switch. The driving assembly includes one or more of (and in some embodiments, all of) a / the gear-motor, a one-way bearing that includes an excentre, a tilting arm that includes a sliding window, a tilting arm lever, a tilting arm cylinder, a control switch arm, a ratchet drive spring arm, a ratchet drive spring, a ratchet stopper spring, a ratchet wheel, a ratchet gear, a drive controller, and a drive screw. In some embodiments, two (2) operation phases of the driving mechanism are provided: 1) a "delivery phase" - with rotation of the ratchet wheel, and 2) a "no delivery phase" - with no rotation of ratchet wheel. During the delivery phase, rotation of excentre within sliding window causes movement of the tilting arm lever, displacement of the control switch arm and the ratchet drive spring arm, and rotation of the ratchet wheel. The ratchet stopper spring prevents rotation of ratchet wheel in the opposite direction. Rotation of the ratchet wheel rotates the ratchet gear and drive connector which displaces the drive screw and plunger within reservoir. Displacement of control switch arm disconnects control switch (control switch "off'). During the "no delivery phase", rotation of excentre at the opposite direction causes movement of sliding window and tilting arm lever in the opposite direction, displacement of control switch arm and ratchet drive spring arm in the opposite direction and no rotation of ratchet wheel. Ratchet stopper spring prevents rotation of ratchet wheel. Displacement of control switch arm in the opposite direction connects control switch (electric connection resumes, control switch "on"). During normal operation, each revolution of excentre cause one up and down movement of tilting arm, displacement of one tooth of ratchet wheel, and one "on" / "off' cycle of controlswitch. Displacement of one tooth is translated to predefined movement of drive screw and predefined amount of delivered insulin (e.g., 0.05 units). In cases of driving mechanism failure (e.g., a motor stuck) or occlusion in insulin path, there is a mismatch between an MCU command, and the gear-motor operation and alarm will be generated by control switch (stuck in "on" or "off position).

[0015] In some embodiments, the AID patch includes a one-way bearing that includes a / the motor shaft, a / the excentre, one or more (preferably a plurality) triangle grooves, one or more rollers (preferably a plurality) and actuator cylinder. In some embodiments, the motor shaft is rotated by a / the gear-motor. In in a first / one direction of rotation, the rollers are arranged in the broad base of respective triangle grooves; there is little to no friction between rollers, and there is no rotation of the actuator cylinder. In the opposite direction of the first direction of rotation, the rollers are arranged in a narrow corner of triangle grooves; there is little to no friction between the rollers, and the actuator cylinder is rotating. Operation of the AID patch according to some embodiments includes the following two consecutive steps: Step 1 - activation of the gear-motor, the motor shaft, and the excentre in one direction, a / the actuator cylinder is rotating, a / the trigger is displaced, and an / the insertion mechanism is activated (cannula and sensor probe are inserted into subcutaneous tissue). Step 2 - activation of the gear-motor, the motor shaft, and the excentre in an opposite direction (to the one direction), the actuator cylinder is not rotating, and there is no movement of the trigger, the tilting arm is activated (bidirection movement corresponding to up and down movement), a / the driving and a / the delivery assemblies are activated, and insulin is delivered.

[0016] In some embodiments, the AID patch includes an insulin line that is flexible and can be made of metal (e.g., stainless steel) or plastic (e.g., silicone, polypropylene, etc.). During insertion with respect to such embodiments, the insulin line is bent and follows displacement of the cannula. In some embodiments, the AID patch includes a flexible printed circuit (which can be a / the sensor FPC) connected to a sensor contacts plate ("contacts plate") of a / the sensor probe. During insertion, the sensor FPC is bent and follows displacement of the contacts plate and the sensor probe.

[0017] In some embodiments, the AID patch includes an insertion assembly (which can also be referred to as an insertion mechanism) and a probe / cannula assembly. The insertion mechanism includes one or more of (and in some embodiments, all of) a middle frame, a middle frame latch, a cannula stopper, an upper frame, a torsion spring, a crank, a crank bulge, a sled, a sled bulge, a rod, a lever, a first lever arm, a second lever arm, and a lever arm window. Theprobe / cannula assembly can include one or more (and in some embodiments all of) a needle hub, a needle, a carrier, a cannula, a cannula septum, a cannula connector, and a sensor probe. Activation of the insertion mechanism causes insertion of the needle, the cannula, and the sensor probe into the subcutaneous tissue, bending of the insulin line and the sensor FPC, and immediate retraction of the needle. The insertion mechanism, according to some embodiments, is activated in 3 consecutive steps: Step 1 - rotation of the gear-motor, a / the one-way bearing, and the excentre causes rotation of the actuator cylinder and a spiral groove, Step 2 - rotation of the spiral groove causes displacement of a / the trigger and release of the middle frame latch, and Step 3 - the middle frame latch is released, allowing the sled and the rod to be displaced by the lever. The insertion process, in some embodiments, includes at least one of (and in some embodiments, a plurality of, and in some embodiments, all of) insertion of the needle, the cannula, and the sensor probe into the subcutaneous tissue, displacement of the contacts plate, bending of insulin line, bending of the sensor FPC, and retraction of the needle. The insertion process, according to some embodiments, includes 3 phases: phase 1) before activation - the needle, the cannula, and the sensor probe are concealed within the AID patch, the sensor probe resides within the needle and the needle resides within the cannula, and the needle transverses the cannula septum, phase 2) after activation - the needle, the cannula, and the sensor probe are inserted into the subcutaneous tissue, the sensor probe resides within the cannula, the cannula resides within the needle, and the insulin line and the sensor FPC are bent, phase 3) -the needle is retracted and concealed within the AID patch, the needle tip is located apart from the cannula septum, the cannula and the sensor probe remain within the subcutaneous tissue, the sensor probe resides within cannula, and the cannula tip is located apart from sensor probe tip. The cannula septum can be made of an elastomer (e.g., silicone rubber) and is configured to be self-sealable following needle retraction. The cannula can be locked in place by the cannula stopper. Operation of the insertion mechanism can include the following process (one or more of the following, a plurality of, or all of - depending upon the embodiment) - the middle frame latch is released by the trigger (phase 2), the sled is released, the torsion spring causes rotation of the crank and the crank bulge (locked between first and second lever arms), displacement of the lever arm window and the sled bulge, and displacement of the sled, the rod, and the needle. Further rotation of the crank and the crank bulge (phase 3) causes displacement of the sled bulge, the sled, and the rod in an opposite direction, and retraction of the needle.

[0018] In some embodiments, the AID patch includes a sensor probe and a contacts plate. Thesensor probe and the contacts plate are planar, cut from the same or similar planar sheet, preferably includes a rectangular cross section, and can be made from any material known in the art used for an electrode substrate (e.g., polyimide / Kapton). In some embodiments, the sensor probe includes (on one side), one or more working electrodes, one or more reference electrodes, and one or more priming electrodes, and on the opposite side, one or more counter electrodes (in some embodiments, the first side can include a single one of each of the preceding referred to electrodes). The e

[0019] Electrodes can be electrically connected via sensor probe traces to electrical contacts on the contacts plate. The working electrode, reference electrode, and counter electrode can be used for continuous measurements of glucose (glucose sensor) within the subcutaneous tissue, the priming electrode being used for detection of insulin in the cannula during priming. In other embodiments, location of electrodes on the sensor probe could be changed and / or replaced (e.g., the counter electrode on same side as the working electrode), in some embodiments more or less electrodes could be used, for example, two (2) working electrodes, no reference electrode, etc.

[0020] In some embodiments, the AID patch includes a probe / cannula assembly that includes a / the sensor probe, a / the contacts plate, a / the sensor FPC, a / the sensor FPC contacts, a / the sensor FPC connector, a / the cannula, a / the cannula septum, a / the cannula connector, a / the needle, a / the needle hub, and a / the carrier. The sensor probe, in some embodiments, includes a rectangular cross section, the cannula can be cylindrical, and the needle can be a cylinder with a sharp tip and a needle slot. The needle slot allows the needle crossing of the contacts plate during needle retraction. The carrier provides a connection between the contacts plate and the sensor FPC contacts. The cannula septum is preferably self-sealed (elastomer) and maintains sealing of an / the insulin path after needle retraction. The insulin line can be connected to the cannula via cannula connector and insulin is delivered from insulin line into the cannula.

[0021] In some embodiments, the AID patch includes a pumping assembly (mechanism) that includes a / the ratchet wheel, a / the ratchet gear, a / the drive connector, a / the drive screw, a / the drive thread, a plunger, a plunger O-ring, and a reservoir. The reservoir can be filled with insulin at user discretion from a minimal threshold (e.g., 80 insulin units) and up to a full reservoir (e.g., 200 insulin units). Following reservoir filling, the pumping mechanism, in some embodiments, is operated at the following three (3) consecutive phases: Phase 1 - the reservoir is partially or fully filled with insulin, the plunger and the drive screw are displaced backward. Phase 2 - the ratchet wheel is rotated and causes rotation of the ratchet gear which is rigidlyconnected with the ratchet wheel. The ratchet wheel and the ratchet gear are fixed in place and are not displaced forward or backward during all three (3) operational phases. The ratchet gear causes rotation of the drive connector, and the drive connector causes rotation of the drive thread, which is rigidly connected with the drive connector, the drive connector is displaced backward. In some embodiments, the drive connector is made of plastic and the drive thread, and the drive screw are made of metal. Phase 3 - the ratchet wheel rotates and causes rotation of the ratchet gear. The ratchet gear causes rotation of the drive connector, and the drive connector causes rotation of the drive thread. The ratchet gear is engaged with the drive connector, and the drive connector displacement is stopped (no further backward movement), and the drive screw is displaced forward. Displacement of the drive screw causes displacement of the plunger within the reservoir and insulin is delivered from the reservoir via insulin line and cannula into the body.

[0022] In some embodiments, the AID patch includes an engagement mechanism of a / the ratchet gear and a / the drive connector. The engagement mechanism allows filling of reservoir at any desired volume between minimal and maximum (capacity) and provides minimal time between beginning of a / the gear-motor operation and displacement of a / the plunger within the reservoir (insulin delivery). The engagement mechanism can also include a / the ratchet wheel, a / the ratchet gear, a / the ratchet gear protrusion, a / the drive connector, a / the drive connector groove, and a / the drive connector lock. The engagement mechanism can include four (4) operational phases: Phase 1 - before reservoir filling, the ratchet gear protrusion is located within the drive connector groove, Phase 2 - partial reservoir filling, the plunger and the drive connector are displaced backward, Phase 3 - rotation of the ratchet wheel, the ratchet gear, and the drive connector, the drive connector is displaced backward, the ratchet gear protrusion is freely displaced backward within the drive connector groove. Phase 4 - further rotation of the ratchet wheel, the ratchet gear, and the drive connector, the ratchet wheel protrusion is locked within the drive connector lock, displacement of the drive connector is stopped, the drive screw and the plunger are displaced forward.

[0023] In some embodiments, the AID patch includes a filling assembly which directs insulin flow from a filling syringe to a / the reservoir during reservoir filling and directs insulin flow from the reservoir to a / the insulin line during delivery. The filling assembly prevents delivery of insulin into the insulin line during reservoir filling. In some embodiments, the filling assembly includes a / the filling port, a / the filling septum, and a / the filling O-ring. The filling port is located at the bottom side of the AID patch, and it is not covered with adhesive tape (insome embodiments). During filling, the filling needle transverses the filling septum, crosses the filling O-ring, blocks the insulin line, and insulin is delivered into the reservoir. Following reservoir filling to a desired amount, a / the filling needle is retracted, the filling septum is selfsealed, and insulin is delivered into the insulin line. In some embodiments, a / the filling needle tip is slightly curved avoiding scratching of the filling O-ring during penetration by the filling needle. In some embodiments, the filling assembly also includes a / the valve body, a / the valve O-ring (OR), a / the valve sphere, a / the valve spring, and a / the valve septum. During filling, the filling needle traverses the valve septum, displaces the valve sphere and the sealed insulin line, and insulin is delivered into the reservoir. Following reservoir filling to the desired amount, the filling needle is retracted, the valve sphere is displaced by the valve spring, the insulin line is "open,” and insulin is delivered into the insulin line.

[0024] In some embodiments, the AID patch includes a volume sensor that includes one or more volume sensor connectors, a volume sensor rod, and a volume sensor traces. The volume sensor rod is preferably rigidly connected with a / the plunger. The volume sensor connectors are made of any conductive element, and the volume sensor is used for detection of a minimal insulin filling threshold during filling and detection of a minimal predetermined insulin volume in the reservoir for alerting the user during insulin delivery. During filling, the volume sensor rod is electrically engaged with the volume sensor connectors. During insulin delivery, the plunger and the volume sensor rod are displaced forward until reaching a disconnection point (electrical circuit is closed) and alarming the user of a minimal volume in reservoir.

[0025] In some embodiments, the AID patch includes a priming sensor that includes a / the priming electrode, a / the priming sensor trace, and a / the priming electrode contact. The priming electrode is located on the proximal end of sensor probe. Priming is initiated after insulin filling for purging air from insulin line. The priming sensor is used for detection of insulin within a / the cannula and alerts the user that the AID patch is ready for operation (insulin delivery). In some embodiments, the priming electrode is made of any conducive metal sheet. An electrical circuit between the priming electrode and any other electrode is closed when insulin (i.e., a conductive solution) causes a short-circuit between the two electrodes. After filling the reservoir at a desired or required amount of insulin, there is no insulin in the insulin line. At the end of priming, the insulin line and a proximal end of the cannula are filled with insulin, the priming electrode detects insulin in the cannula, and the patient is alerted at the end of priming.

[0026] In some embodiments, an automated-insulin-delivery (AID) device is provided andincludes a housing including an adhesive tape configured to adhere the housing to the skin of a user via an adhesive tape. The housing houses at least an insulin pump including a single lumen cannula, a glucose sensor including a sensor probe, a processor, an insertion assembly for inserting the single lumen cannula and the sensor probe within subcutaneous tissue, and an autoraated-insulin-delivery algorithm (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 automatically control insulin delivery by the insulin pump according to glucose levels from subcutaneous tissue based on signals received from the glucose sensor.

[0027] Such embodiments (as well as other embodiments disclosed herein) may additionally including one and / or another of the following functions, functionality, structure, step, and / or clarifications (and if not mutually exclusive, in some embodiments a plurality of, and in some embodiments, a majority of, and in some embodiments, substantially all of, and in some embodiments, all of):one or more settings for the operation of the AIDA are set via a controller;a / the controller comprising a mobile smart device (e.g., a smartphone);one or more batteries, which may be configured with or as a platform or electronic assembly (together “electronic assembly”) for removal from the housing for recharging; the electronic assembly includes additional circuitry aiding in control of the device, in some embodiments, the circuitry includes the processor;one or more settings selected from a group consisting of: at least one personal parameter, glucose sensor, and / or AID algorithm parameters, receiving data and / or presenting data from the device, and communicating with a remote or cloud-based apparatus;a sensor probe tip is located within subcutaneous tissue of a user and is spaced away from a cannula tip of the cannula;the device is configured for pairing with the controller or another device, where pairing can be via an NFC chip or circuitry provided with the device - the NFC chip or circuitry comprises an inductive coupling;a wake up of the device is accomplished via a volume sensor during filling, and / or via near-field communication (NFC);- the housing includes a first (top) cover, a second (bottom) cover, and cannula frame; a needle residing within the lumen of the cannula during insertion of the cannula within tissue,o die glucose sensor comprises a probe which resides within the cannula during insertion of the cannula within tissue, and (if not mutually exclusive) / or o after the cannula and sensor probe are inserted into tissue, the cannula and the sensor probe remain with the tissue;any, one or more of, a plurality of, or all of a filling port, a cannula frame, a cannula opening, and a cannula opening septum;- the adhesive includes a liner which is removed to adhere the device to the skin of a / the user;a / the cannula opening septum includes a septum cover which protects the cannula opening septum and is removed concomitantly with liner removal, in some embodiments, the cannula opening septum is arranged for piercing by the needle during needle insertion, with the cannula and the sensor probe, and retraction while maintaining sealing of the cannula with the septum during device operation;- the sensor probe is part of a sensing assembly;a sensing assembly comprises the sensor probe;an insulin pump, in some embodiments, the pump includes any one or more of or all of a driving assembly, a delivery assembly, an insulin line, and a / the cannula;a / the electronic assembly includes any one or more of or all of a main PCBA, a control switch, a / the volume sensor, a priming sensor, and interface PCBA;a / the interface PCBA comprises any one or more of or all of conductive traces;- the insertion assembly includes an insertion mechanism for insertion of cannula and the sensor probe into tissue and retraction of a / the needle after insertion;during operation of the device, the AIDA receives glucose readings from the glucose sensor having the sensor probe, and automatically adjusts operation of a / the driving assembly resulting in control of a / the delivery assembly and delivery of insulin via insulin line and the cannula into tissue;a / the driving assembly includes any and all of a motor, one or more gears;a / the delivery assembly includes any one or more or all of an / the insulin line and a reservoir;- the housing further comprises at least one battery / batteries cover;a / the electronic assembly is reusable;a / the electronic assembly is at least one of: removable, reusable, and rechargeable; a / the electronic assembly includes a rigid shell or housing;at least one of a zebra connector for connecting a / the electronic assembly to at least one of a / the interface PCBA and other circuitry within the housing;- the housing includes an electronic compartment for receiving a / the electronic assembly;a / the electronic compartment is closed by a / the battery / batteries cover;a ratchet wheel;any one or more of or all of a MCU, an analog front end (AFE), a direct-current regulator (DC2DC), a memory, an antenna for wireless communications, a motor driver, a motor power switch, and a buzzer-driver;a / the MCU comprises the processor;an internal watchdog;a / the conductive traces include at least one or more of or all of: a sensor trace, one or more control switch traces, a volume sensor trace, a priming sensor trace, and one or more motor traces;- the sensor probe comprises a working electrode, a reference electrode, and a counter electrode,signals generated by one or more electrodes of the glucose sensor are received by a / the analog front end (AFE) and analyzed by the AIDA;- the AIDA automatically adjusts a delivery rate of insulin via control of the number of rotations of a / the motor;rotation of a / the motor causes a / the ratchet wheel to rotating and forward displacement of a drive screw within a / the reservoir;a / the control switch provides feedback to the processor / MCU on the operation of a / the motor;- the processor receives one or more signals from at least one of, a plurality of, or all of:a / the volume sensor, a / the priming sensor, meal data, and exercise data, and based on such inputs, the AIDA can adjust insulin delivery, as necessary;- the housing is divided into at least a sterile compartment and an electronic compartment;- the sterile compartment arranged between a / the first cover and a / the second cover; - the cannula opening septum is arranged in the cannula opening which is located in the sterile compartment;a gasket to isolate the electronic compartment from the sterile compartment;at least one torsion spring;a / the liner includes a cannula opening septum-cover, such that, the cannula opening septum is uncovered upon use after the liner is removed;- the insertion assembly further includes any of, a plurality of, or all of a / the torsion spring, a crank, a lever, an upper frame, a middle frame, a latch, a cannula stopper, a trigger, a sled, a rod, a needle, a / the needle, a carrier;a delivery assembly and / or the delivery assembly comprises an insulin line, a cannula, and a cannula septum;a sensing assembly and / or the sensing assembly comprises any one or more of (or all of) the sensor probe, a contacts plate, a sensor flexible printed circuit (FPC), and a / the sensor FPC contact;a / the probe / cannula assembly includes at least one or more components of a / the delivery assembly and / or one or more components of a / the sensor assembly;a driving assembly and / or the driving assembly comprises any one or more of, or all of: a motor / gear-motor, a one-way bearing, a tilting arm, a ratchet wheel, a ratchet gear, a ratchet stopper spring, a ratchet drive spring, a reservoir cap, a locker, a drive connector, and a drive screw;a delivery assembly and / or the delivery assembly includes any one or more of, or all of: a plunger, a plunger O-ring, a reservoir, and a filling port;a / the electronic assembly includes any one or more of, or all of: a control switch, and a / the volume sensor;a pumping assembly;a pumping assembly including one or more of, or all of: a ratchet wheel, a ratchet gear, a drive connector, a drive screw, a plunger, a plunger O-ring, and a reservoir;a filling assembly;a filling assembly including one or more of, or all of: a filling port and directing means / mechanism for directing insulin flow during filling and during delivery;a tilting arm;a tilting arm including one or more of or all of: a sliding window, a tilting arm lever, a tilting arm cylinder, a ratchet drive spring arm, and a control switch arm;o the tilting arm cylinder rotates around a virtual axis of rotation; and (if not mutually exclusive) / oro bi -direct! onal di splacement of the sliding window and / or the tilting arm lever in a first direction causes rotation of the ratchet drive spring arm and (in some embodiments) the control switch arm;movement of the sliding window and / or the tilting arm lever in a second direction causes rotation of the ratchet drive spring arm and / or the control switch arm; a / the drive assembly comprising / further comprises an excentre;an actuator cylinder;an actuator cylinder including a spiral groove;a motor shaft;a motor shaft including one or more triangular grooves, one or more rollers, and / or a supporting ring;a gear-motor;a gear-motor engaged with a / the motor shaft such that rotation of the gear-motor causes rotation of motor shaft;rotation of a / the actuator cylinder in a specific direction causes displacement of a / the trigger;a / the one-way bearing includes any one or more of or all of: a / the motor shaft, a / the excentre, a / the plurality of triangular grooves, a / the plurality of rollers, and a / the actuator cylinder;one or more rollers;one or more rollers where each is arranged in a respective triangular groove of the plurality of triangle grooves, such that, each roller is rotated during rotation of the motor shaft;a / the insertion mechanism includes a / the torsion spring, a crank, a crank bulge, a lever, a / the first lever arm, a / the second lever arm, a / the sled, a sled bulge, a first and a second lever arm window;a / the insertion mechanism comprises / further comprises a latch, and / or an upper frame; a delivery assembly;a delivery assembly which includes a / the cannula, a cannula connector, and / or an / the insulin line;during insertion of the cannula, a / the insulin line is bent and follows displacement of the cannula and / or a cannula connector;during insertion, a / the contacts plate is displaced with the sensor probe and a / the sensor FPC is bent and follows displacement of a / the contacts plate;a needle hub;- the sensor probe and / or a / the contacts plate is planar and include a rectangular cross section;- the sensor probe includes at least two sides;- the sensor probe includes a plurality of electrodes;- the plurality of electrodes of the sensor probe are selected from the group consisting a working electrode, a reference electrode, and a one priming electrode;- the sensor probe includes at least two sides, where the at least two sides comprise a first side and a second side;o the first side includes no electrodes, one electrode, or a plurality of electrodes; o the second side includes no electrodes, one electrode, or a plurality ofelectrodes;o the first side includes at least one working electrode, at least one reference electrode, at least one counter electrode and at least one priming electrode; and (if not mutually exclusive) / oro the second side including a working electrode, a reference electrode, and a counter electrode.each electrode of the sensor probe is electrically connected via respective sensor probe traces to a corresponding electrical contact on a / the contacts plate;a / the working electrode, a / the reference electrode, and a / the counter electrode provides continuous measurements of glucose within the subcutaneous tissue;a / the priming electrode detects insulin during priming of the device;the sensor probe comprises a working electrode, a reference electrode, a priming electrode, a working electrode, a reference electrode, and a counter electrode;a first plurality of a / the plurality of electrodes of the sensor probe is provided on a first side of the sensor probe, and a second plurality of the plurality of electrodes of the sensor probe are provided on a second side of the sensor probe;a / the second side of the probe sensor is opposite a / the first side;a / the pumping assembly includes one or more of, or all of a / the ratchet wheel, a / the ratchet gear, a / the drive connector, a / the drive screw, a drive thread, a / the plunger, a / the plunger O-ring, and a / the reservoir;a / the driving assembly includes one or more of, or all of a / the ratchet drive spring, a / the tilting arm, and a / the reservoir cap;following filling of a / the reservoir, a / the pumping assembly is operated according to a plurality of phases;o the plurality of phases can include one or more, or all of the following:o a first phase of a plurality of the phases of the pumping assembly operation, the reservoir is partially filled with insulin and a / the plunger and a / the drive screw is displaced;o a second phase of the plurality of phases of the pumping assembly operation,the ratchet wheel is rotated so as to cause rotation of the ratchet gear; and (if not mutually exclusive) / oro a third phase of the plurality of phases, where a / the ratchet wheel is rotated so as to cause rotation of a / the ratchet gear;following filling of a / the reservoir:o a / the pumping assembly is operated according to a plurality of phases, where a / the ratchet gear is rigidly connected with a / the ratchet wheel;o a / the pumping assembly is operated according to a plurality of phases, where a / the ratchet wheel and a / the ratchet drive is fixed in place;o a / the pumping assembly is operated according to a plurality of phases, where during each of the plurality of phases, the ratchet wheel and the ratchet drive are not displaced;o a / the pumping assembly is operated according to a plurality of phases, where a / the ratchet gear is engaged with and optionally causes rotation of a / the drive connector;o a / the pumping assembly is operated according to a plurality of phases, a / the drive connector causes rotation of a / the drive thread;o a / the pumping assembly is operated according to a plurality of phases, a / the drive thread is rigidly connected with a / the drive connector;o displacement of a / the drive connector is halted and a / the drive screw is displaced; and (if not mutually exclusive) / oro displacement of the drive screw causes displacement of a / the plunger within a / the reservoir such that insulin is delivered from the reservoir via a / the insulin line and the cannula into tissue;engagement between a / the ratchet gear and a / the drive connector at any desired filling volume allows minimal time between the initiation of a / the gear-motor operation and displacement of a / the plunger within a / the reservoir;o engagement can be via an engagement mechanism that can include one or more of, or all of: a / the ratchet wheel, a / the ratchet gear, a / the ratchet gear protrusion, a / the drive connector, a / the drive connector groove, a / the drive connector lock;o prior to filling of the reservoir, a / the ratchet gear protrusion is located within a / the drive connector groove;o after partial reservoir filling, a / the plunger and a / the drive connector is displaced;o after beginning of rotation of a / the ratchet wheel, a / the ratchet gear, and a / the drive connector, the ratchet gear protrusion is freely displaced within a / the drive connector groove in a same direction; and (if not mutually exclusive) / or o a / the ratchet gear causes rotation of a / the drive connector by a force applied by a / the ratchet gear protrusion on a / the drive connector groove, further rotation of the ratchet wheel, the ratchet gear, and the drive connector can cause the ratchet wheel protrusion to be locked within a / the drive connector lock;a / the filling assembly directs insulin flow from a filling syringe to a / the reservoir during filling of the reservoir as well as directing insulin flow from the reservoir to a / the insulin line during delivery;a / the filling assembly prevents delivery of insulin into the insulin line during filling of the reservoir;a / the filling assembly includes or further includes any one or more of, or all of a filling septum, and a filling O-ring, a filling needle, the reservoir, a / the plunger, and an / the insulin line;a / the filling port is located on a side of the device which is adhered to the skin of a user; a / the filling needle transverses a / the filling septum, crosses a / the filling O-ring, and blocks an / the insulin line;following filling of the reservoir to a desired amount, a / the filling needle is retracted and a / the filling septum is self-sealed, the filling needle may include a curved tip; a / the filling assembly further includes any one or more of, or all of a valve body, a valve O-ring, a valve membrane, a valve sphere, a valve spring, a valve bushing, and a valve septum;during filling, a / the filling needle traverses a / the valve septum and displaces a / the valve sphere and a / the (sealed) insulin line;a / the volume sensor includes any one or more of, or all of one or more volume sensorconnectors, a volume sensor rod, and one or more volume sensor traces; o the volume sensor rod is rigidly connected with a / the plunger;o the volume sensor connectors are comprised of a conductive element; o the volume sensor is used for detection of a minimal insulin filling threshold during filling and detection of minimal predetermined insulin volume in the reservoir;o during insulin delivery, the plunger and the volume sensor rod are displaced and an electrical circuit is closed; and (if not mutually exclusive) / or o after displacement of the plunger to a minimal predetermined point, no further movement of the plunger occurs, and the volume sensor rod is disconnected from the volume sensor connectors, and the electrical circuit is open;anda / the priming sensor includes any one or more of, or all of: a priming electrode, a priming sensor trace, and a priming electrode contact;o the priming electrode is located on a proximal end of a / the sensor probe; and (if not mutually exclusive) / oro the priming sensor detects insulin within the cannula and for alerting the user that the device is ready for operation (insulin delivery);

[0028] In some embodiments, an automated-insulin-delivery (AID) method for an AID device (which may also be configured in the same or substantially same manner as a testing method fortesting operation of the AID device) according to any of the embodiments disclosed herein, configured to operate in at least one of two operational phases, the operational phases comprising at least a delivery phase and a non-delivery phase.

[0029] Such embodiments (as well as other embodiments disclosed herein) may additionally including one and / or another of the following functions, functionality, structure, step, and / or clarifications (and if not mutually exclusive, in some embodiments a plurality of, and in some embodiments, a majority of, and in some embodiments, substantially all of, and in some embodiments, all of):during the delivery phase, a / the ratchet wheel rotates, and during the non-delivery phase, the ratchet does not rotate,during the delivery phase, rotation of a / the excentre in a first rotational direction within a / the sliding window results in at least one of:o movement of at least one of the sliding window and a / the tilting arm lever in a first linear direction, ando displacement of at least one of a / the control switch arm and ratchet drive spring arm in respective linear directions;displacement of a / the ratchet drive spring results in rotation of the ratchet wheel in a first rotational direction;o the first rotational direction is a counterclockwise direction; ando an opposite rotational direction to the first rotational direction is a clockwise direction;a / the ratchet stopper spring is arranged to avoid rotation of the ratchet wheel in an opposition rotational direction to a / the ratchet drive spring;rotation of a / the ratchet wheel results in rotation of a / the ratchet gear and a / the drive connector causing displacement of a / the drive screw;displacement of a / the control switch arm in one direction results in disconnection of a / the control switch and in a second opposite direction, results in connection of the control switch;o disconnection of the control switch corresponds to an “OFF” position in which there is no electrical communication therethrough, and connection of the control switch corresponds to an “ON” position in which there is electrical communication therethrough;during the delivery phase, each revolution of a / the excentre causes at least one of (and preferably a plurality or all of):o at least one up and down movement of a / the tilting arm;o displacement of at least one tooth of a / the ratchet wheel (a displacement of one tooth can correspond to movement of a / the drive screw and a predefined amount of delivered insulin); ando at least one on / off cycle of a / the control switch;- upon failure of a / the driving assembly or an occlusion in the insulin delivery path, generating at least one of a visual, haptic, and audible alarm, via a / the control switch being kept in either an “ON” or “OFF” position;during a delivery phase:o first rotation of a / the gear-motor, a / the motor shaft, and a / the excentre in a first, clockwise direction such that a / the actuator cylinder is correspondingly rotating in a same direction, a / the trigger is displaced causing activation of a / the insertion mechanism so as to insert the cannula and the sensor probe into subcutaneous tissue; ando second rotation of the gear-motor, the motor shaft, and the excentre in the first clockwise rotation such that actuator cylinder does not rotate, the trigger is not displaced, the excentre rotates, a / the tilting arm moves in a linear, back and forth manner, a / the delivery assembly is activated, and insulin is delivered into subcutaneous tissue;the cannula and the sensor probe are inserted with a / the needle, and immediately after insertion, the needle is immediately retracted;andduring the above-noted delivery phase:o the first rotation also causes rotation of a / the one-way bearing and the excentre causing the rotation of the actuator cylinder and a / the spiral groove;o rotation of the spiral groove causes the displacement of the trigger and release of a / the latch; andc upon a / the latch being released, a / the sled and a / the rod is displaced by a lever in predetermined direction.(0030 In some embodiments, a cannula and sensor probe insertion method (or method for testing insertion of a cannula and sensor probe, according to some embodiments) for an automated-insulin-delivery (AID) device of any of the disclosed embodiments, features, functionality, or structure thereof includes, prior to insertion, concealing a / the needle, a / the cannula, and a / the sensor probe within the AID device as part of an insertion mechanism, activating insertion of the cannula and sensor probe, upon which a / the needle, cannula and sensor probe are inserted into subcutaneous tissue; and after activation, retracting andconcealing within the AID device the needle while the cannula and sensor probe remain within the subcutaneous tissue.

[0031] Such embodiments (as well as other embodiments disclosed herein) may additionally including one and / or another of the following functions, functionality, structure, step, and / or clarifications (and if not mutually exclusive, in some embodiments a plurality of, and in some embodiments, a majority of, and in some embodiments, substantially all of, and in some embodiments, all of):following release of a / the latch, a / the sled is released and a / the torsion spring causes rotation of a / the crank and a / the crank bulge;rotation of a / the sled bulge, which is locked between a / the first lever arm and the second lever arm, causes displacement of a / the lever arm window;o the sled bulge located within a / the lever arm window is displaced so as to cause displacement of the sled, the rod, and the needle; and / oro further rotation of the crank and the crank bulge causes further displacement of the sled bulge and the sled in a predetermined direction and displacement of the rod in the same direction, and retraction of the needle.

[0032] These and other inventions, embodiments, objects, features and advantages are become even more evident in the detailed description which follows and the provided for drawings, a brief description of which is provided below.BRIEF DESCRIPTION OF THE DRAWINGS

[0033] FIGs. 1A-D show schematics of an AID system and modes of operation according to some embodiments of the disclosure.

[0034] FIGs. 2A-E show longitudinal cross section views (FIGs. 2A-B), bottom view (FIG.2D) and spatial views (FIG.2E) of an AID patch during modes of operation according to some embodiments of the disclosure.

[0035] FIG. 3 shows a schematic of an AID patch after insertion of cannula and sensor probe according to some embodiments of the disclosure.

[0036] FIGs. 4A-B show right (FIG. 4A) and left (FIG. 4B) exploded views of main components of an AID patch according to some embodiments of the disclosure.

[0037] FIGs. 5A-E show exploded views of an assembled AID patch (FIGs. 5A-B) and a preferred embodiment of a reusable electronic assembly (FIGs. 5C-E) according to some embodiments of the disclosure.

[0038] FIGs. 6A-B show right (FIG. 6A) and left (FIG. 6B) spatial views of an assembled AID patch (upper cover removed) according to some embodiments of the disclosure.

[0039] FIG. 7 shows a block diagram of AID patch hardware and software according to some embodiments of the disclosure.

[0040] FIGs. 8A-B show spatial bottom views of an AID patch (bottom cover removed) according to some embodiments of the disclosure.

[0041] FIGs. 9A-C show spatial top-level views of an AID patch, and an assembly process and a sterilization process of AID patch according to some embodiments of the disclosure.

[0042] FIGs. 10A-B show spatial bottom views of an AID patch before (FIG. 10A) and after (FIG. 10B) removal of an adhesive tape liner and a cannula opening septum cover according to some embodiments of the disclosure.

[0043] FIG. 11 shows exploded view of primary components of subassemblies for an AID patch according to some embodiments of the disclosure.

[0044] FIG. 12 shows spatial view of subassemblies of an AID patch according to some embodiments of the disclosure.

[0045] FIGs. 13A-B show exploded view (FIG. 13A) and spatial view (FIG. 13B) of the main components of a driving assembly, a delivery assembly, and an electronic assembly according to some embodiments of the disclosure.

[0046] FIGs. 14A-D show left (FIGs. 14A-B) and right (FIGs. 14C-D) spatial views of primary components of an AID patch according to some embodiments of the disclosure.

[0047] FIGs. 15A-C show spatial views (FIGs. 15A-B) and exploded view (FIG. 15C) of components of an AID patch according to some embodiments of the disclosure.

[0048] FIGs. 16A-C show longitudinal cross section view (FIG. 16A) and spatial views (FIG.16B-C) of an AID patch according to some embodiments of the disclosure. Fig. 16D shows a tilting arm subassembly of an AID patch according to some embodiments of the present disclosure.

[0049] FIGs. 17A-B show a longitudinal cross section view (FIG. 17A) and a top-level view(FIG. 17B, upper cover removed,) of an AID patch according to some embodiments of the disclosure.

[0050] FIGs. 18A-B show spatial view (FIG. 18A) and transverse cross section view (FIG.18B) of a tilting arm and modes of operation according to some embodiments of the disclosure.

[0051] FIGs. 19A-B show a transverse cross section view (FIG.19A) and a spatial view (FIG.19B) of a primary component of a driving assembly and a control switch according to some embodiments of the disclosure.

[0052] FIGs. 20A-C show transverse cross section views (FIGs. 20A-B) and a spatial view (FIG. 20C) of a driving assembly and a control switch, and modes of operation and control according to some embodiments of the disclosure.

[0053] FIGs.21A-D show spatial views (FIG.21A and FIG.21C) and exploded views (FIGs.21B and FIG.21D) of a one-way bearing according to some embodiments of the disclosure.

[0054] FIGs. 22A-B show transverse cross-section views of a one-way bearing and modes of operation according to some embodiments of the disclosure.

[0055] FIGs.23A-B show an exploded view (FIG.23A) and a spatial view (FIG.23B) of an insertion assembly (mechanism) and a probe / cannula assembly according to some embodiments of the disclosure.

[0056] FIGs. 24A-C show a spatial view (FIG. 24A), an exploded view (FIG. 24B) and a cross-section view (FIG. 24C) of an insertion mechanism components according to some embodiments of the disclosure.

[0057] FIGs. 25A-C show longitudinal cross section views of an insertion mechanism and modes of operation according to some embodiments of the disclosure.

[0058] FIGs. 26A-C, Al-Cl shows top level views (FIGs. 26A-C) and longitudinal cross section views (FIGs.26A1-C1) of an insertion mechanism and modes of operation according to some embodiments of the disclosure.

[0059] FIGs. 27A-C show longitudinal cross section views of an insertion mechanism before (FIG. 27A) and after (FIGs. 27B-C) activation according to some embodiments of the disclosure.

[0060] FIGs.28A-B show detailed spatial views of an insertion mechanism and an insulin line before (FIG. 28A) and after (FIG. 28B) activation according to some embodiments of thedisclosure.

[0061] FIGs. 29A-B show a needle, a cannula, and a sensor probe before (FIG. 29A) and after (FIG. 29B) needle retraction according to some embodiments of the disclosure.

[0062] FIG. 30A and FIGs. 30A1-2 (magnified views) show spatial view of a sensor probe and corresponding electrical contacts according to some embodiments of the disclosure.

[0063] FIGs. 31A1-2, B-C show a top-level view (FIG. 31A1), a spatial view (FIG. 31A2), an exploded view (FIG. 31B), and a transverse cross section view (FIG. 31C) of a probe / cannula assembly according to some embodiments of the disclosure.

[0064] FIGs. 32A-A1 show a spatial view (FIG. 32A) and a magnified view (FIG. 32A1) of an assembled probe / cannula assembly (before insertion) and a priming sensor according to some embodiments of the disclosure.

[0065] FIG. 33 shows an exploded view of a probe / cannula assembly according to some embodiments of the disclosure.

[0066] FIGs. 34A-C show side views (FIG. 34A and FIG. 34C), and a top-level view (FIG.34B) of a sensor probe and a contacts plate according to some embodiments of the disclosure.

[0067] FIGs. 35A-C show a spatial view (FIG. 35A), longitudinal cross section views (FIGs.35B1 and FIG. 35B2) of a probe / cannula assembly and a schematic(FIG. 35C) of an insulin line, a cannula, and hydraulic communication of the insulin line and the cannula according to some embodiments of the disclosure.

[0068] FIGs. 36A-B show a longitudinal transverse view (FIG. 36A) and a spatial view (FIG.36B) of a pumping assembly according to some embodiments of the disclosure.

[0069] FIGs. 37A-C show schematics of a pumping mechanism and modes of operation according to some embodiments of the disclosure.

[0070] FIGs. 38A-D, Al-Dl show longitudinal cross section views (FIGs. 38A-D) and magnified views (FIGs. 38A1-D1) of an engagement mechanism between ratchet gear and a drive connector according to some embodiments of the disclosure.

[0071] FIGs. 39A-D show spatial views of an engagement mechanism between a ratchet gear and a drive connector according to some embodiments of the disclosure.

[0072] FIGs. 40A-B show spatial views of an engagement mechanism and mode of operation during engagement of a ratchet gear and a drive connector according to some embodiments ofthe disclosure.

[0073] FIGs. 41A-B show schematics of an engagement mechanism between a ratchet gear and a drive connector according to some embodiments of the disclosure.

[0074] FIGs. 42A-C show longitudinal cross section views of a filling assembly according to some embodiments of the disclosure.

[0075] FIGs. 43A-D show schematics of a filling assembly according to some embodiments of the disclosure.

[0076] FIG.44 shows an exploded view of a filling assembly according to some embodiments of the disclosure.

[0077] FIGs. 45A-C show longitudinal cross section views of a filling assembly according to some embodiments of the disclosure.

[0078] FIGs. 46A-B show schematics of a volume sensor and modes of operation according to some embodiments of the disclosure.

[0079] FIGs. 47A-B show schematics of a priming sensor and modes of operation according to some embodiments of the disclosure.

[0080] FIGs. 48A-C shows spatial views (FIG. 48A, C) and exploded view (FIG. 48B) of another preferred embodiment of a priming sensor (detector) according to some embodiments of the disclosure.

[0081] FIGs. 49A-C shows spatial views (FIGs. 49A-C) and exploded view (FIGs. 49D) of one preferred embodiment for detection of occlusion according to some embodiments of the disclosure.DETAILED DESCRIPTION

[0001] FIGs. 1A-D show schematics of AID system 100 and modes of operation. FIG. 1A shows AID system 100 that includes AID patch 1 and controller 101 (which can be a smartphone as shown or a dedicated controller). AID patch mobile application (" App") 102 is used for AID patch 1 settings (i.e., personal parameters), changing insulin pump 200 (can also be referred to as pump 200), glucose sensor 300, or AID algorithm parameters, receiving data and presenting data from AID patch 1 (i.e., glucose readings), and communicating with a network (e.g., the cloud 103). AID patch 1 has a housing 120 and it is adhered to the body withan adhesive tape 6. FIG. 1B shows AID patch 1 that includes an insulin pump 200 for continuous delivery of insulin and a glucose sensor 300 for continuous monitoring of glucose levels. An AID algorithm 2 (which in some embodiments is configured as computer instructions operating on a processor on AID patch 1) receives glucose readings from glucose sensor 300 and automatically adjusts insulin delivery rate from insulin pump 200. AID patch 1 is adhered to skin 67 by adhesive tape 6. Insulin pump 200 delivers insulin into the subcutaneous tissue 400 by cannula 80. Glucose sensor 300 monitors glucose level in the subcutaneous tissue 400 by sensor probe 51. Sensor probe 51 partially resides within cannula 80, and sensor probe tip 56 is located within the subcutaneous tissue 400 apart from cannula tip 84 FIG. 1C-D show preferred embodiments of AID patch 1 and modes of wake-up and paring between the BLE devices - AID patch 1 and controller 101. Pairing is the process required to mutually register the information on AID patch 1 and controller 101 to be connected wirelessly with BLE. FIG. 1C shows AID patch 1 that includes an inductive coupling for near field communication (NFC) 105 device. Wake up is done by proximity of controller 101 with AID patch 1 and pairing is automatically done after wake-up. FIG. 1D shows a QR code 104 that is embedded on AID patch 1 or AID patch box 128. Pairing is done by controller 101 screening (via screen 102) of QR code 104. In this configuration AID patch 1 wake-up is done by the volume sensor during filling (e.g., see structure of FIGs. 46A-B).

[0002] FIGs. 2A-E show longitudinal cross section views (FIGs. 2A-C), bottom view (FIG.2D) and spatial views (FIG. 2E) of AID patch 1 during its modes of operation. AID patch 1 includes top cover 3, bottom cover 4, adhesive tape 6, and cannula frame 7. FIG.2A shows AID patch 1 before insertion of cannula 80 and sensor probe 51. FIG. 2B shows AID patch 1 after needle 77 insertion and before needle 77 retraction - needle 77 and cannula 80 reside within the subcutaneous tissue 400 and sensor probe 51 resides within needle 77. FIG. 2C shows AID patch 1 after needle 77 retraction - cannula 80 and sensor probe 51 reside within the subcutaneous tissue 400. FIG. 2D (bottom view) and FIG. 2E (spatial view) show AID patch 1 that includes adhesive tape 6, filling port 32, cannula frame 7, cannula opening 8, and cannula opening septum 9. Adhesive tape 6 is covered by a protective tape liner 66 (FIGs.10A-B), a thin paper that protects the adhesive tape 6 during shelf life and should be removed before AID patch 1 use. Cannula opening septum 9 preserves sterility of sterile compartment (FIGs. 8A and FIG. 9C) before needle 77 insertion. Cannula opening septum 9 is pierced by needle 77 during needle 77 insertion and retraction and maintains cannula 80 sealing during AID patch 1 operation.

[0003] FIG.3 shows a schematic of AID patch 1 after insertion of cannula 80 and sensor probe 51 into the subcutaneous tissue 400 and retraction of needle 77. AID patch 1 has a housing 120 and includes glucose sensor 300 and insulin pump 200. The glucose sensor 300 is comprised of sensor probe 51 and sensing assembly 50. The insulin pump 200 is comprised of driving assembly 10 and delivery assembly 30 (round dots box), insulin line 31 (bold solid line 5), and cannula 80. Electronic assembly 90 includes AID algorithm 2, batteries (power supply) 93, and main PCBA 91. Electronic assembly 90 includes accessories - control switch 97, volume sensor 96, priming sensor 700, and interface PCBA 94 (hereinafter, the term "electronic assembly 90" is used for both the standalone electronic assembly 90 and for the electronic assembly 90 with accessories). Interface PCBA 94 includes all conductive traces (FIG. 7 and FIGs. 15A-C). Insertion assembly (mechanism) 70 includes a mechanism for insertion of cannula 80 and sensor probe 51 into the subcutaneous tissue 400 and retraction of needle 77 after insertion (FIGs. 23A - FIG. 29B) Hereinafter "insertion assembly 70" is used interchangeably with "insertion mechanism 70". During AID 1 operation, AID algorithm 2 continuously receives glucose readings from sensor probe 51 and sensing assembly 50 (bold dashed lines 1 and 2, respectively) and automatically adjust operation of driving assembly 10 (bold dashed line 3) which controls delivery assembly 30 (bold dashed line 4) and delivery of insulin via insulin line 31 (bold solid line 5) and cannula 80 into the subcutaneous tissue 400 (drops).

[0004] FIGs. 4A-B show right (FIG. 4A) and left (FIG. 4B) exploded views the main components of AID patch 1. AID patch 1 includes top cover 3, interface PCBA 94, bottom cover 4, adhesive tape 6, electronic assembly 90 that includes batteries cover 5, main PCBA 91, and zebra connector 92, insertion assembly 70, sensing assembly 50, driving assembly 10 that includes gear-motor 11, and delivery assembly 30 that includes insulin line 31 and reservoir 40. AID patch 1 housing 120 is comprised of the top cover 3, bottom cover 4, and batteries cover 5.

[0005] FIGs. 5A-E show exploded views of the assembled AID patch 1 (FIGs. 5A-B) and preferred embodiment of a reusable electronic assembly (FIGs.5C-E). FIG. 5A shows the top cover 3, bottom cover 4, and adhesive tape 6 and the components of the electronic assembly 90 - batteries cover 5, batteries 93, batteries connector 95, and zebra connector 92. FIG. 5B shows AID patch 1 that includes the top cover 3, bottom cover 4, interface PCBA 94, and adhesive tape 6. AID patch 1 includes the electronic assembly 90, driving assembly 10, delivery assembly 30, sensing assembly 50, and insertion assembly 70. Top cover 3, bottom cover 4,and batteries cover 5 form the housing of AID patch 1. In one preferred embodiment, the electronic assembly 90 is reusable. In this configuration, electronic assembly is packed within a rigid shell 98, batteries 93 (not shown) are rechargeable, and two electronic assemblies 90 are provided. During AID patch 1 operation, one electronic assembly 90 is operating and the other is charging by wall charger 106 and docker 107. After a use cycle (e.g., 3-7 days) the charged electronic assembly 90 is operating, and the other one is charging. Zebra connector 92 provides electrical connection between electronic assembly 90 and interface PCBA (FIG. 4A). FIGs.5C-D show a preferred configuration of AID patch 1 which includes a reusable electronic assembly 90. AID patch 1 has a housing 120 which is comprised of top cover 3 (FIGs. 5A-B), bottom cover 4 (FIGs.5A-B), and batteries cover 5. FIG.5C shows AID patch 1 and electronic compartment 600 (FIGs. 9A-C) before connection with electronic assembly 90. FIG. 5D shows electronic assembly 90 inserted within electronic compartment 600 of AID patch 1 and before closing the electronic compartment 600 with batteries cover 5. The reusable electronic assembly 90 can be connected and disconnected from AID patch 1 (bold arrows). FIG. 5E shows the electronic assembly 90 within AID patch 1 and after closing of electronic compartment 600 with batteries cover 5. In another preferred embodiment, the electronic assembly 90 is disposable, after a use cycle, batteries cover is removed, electronic assembly 90 is disconnected from AID patch 1 and disposed into a batteries can for recycling.

[0006] FIGs. 6A-B show right (FIG. 6A) and left (FIG. 6B) spatial views of the assembled AID patch 1 (upper cover 3 removed). AID patch 1 includes bottom cover 4, adhesive tape 6, volume sensor 96, insertion assembly 70, batteries 93, and main PCBA 91 (electronic assembly 90), ratchet wheel 13 and gear-motor 11 (driving assembly 10), reservoir 40, insulin line 31, and filling port 32 (delivery assembly 30).

[0007] FIG. 7 shows block diagram of AID patch 1 hardware and software. Hardware components include main PCBA 91, sensor probe 51, volume sensor 96, priming sensor 700, buzzer 85, gear-motor 11, and control switch 97. Main PCBA 91 components include MCU 98, analog front end (AFE) 994, DC2DC 995, external flash 993, BLE antenna 992, gear-motor driver 114, gear-motor power switch 113, and buzzer driver 855. The MCU 78 includes AID algorithm 2, internal watchdog 99, and BLE 991. Electrical traces connecting between components include sensor trace 949, control switch traces 946, volume sensor traces 945, priming electrode trace / sensor trace 5144 and gear-motor traces 947 (location of traces on interface PCBA 94 is shown in FIGs. 15A-C). The dashed lines show the main component of the automated insulin delivery (AID) path. Continuous signals, generated by the 3 electrodesof sensor probe 51 (working electrode 512, reference electrode 515, and counter electrode 513), are received by AFE 994 and analyzed by AID algorithm 2. AID algorithm 2 automatically adjusts insulin delivery rate by controlling operation of gear-motor 11 via gear-motor driver 114. Control of insulin delivery rate is achieved by controlling the number of gear-motor 11 rotations. Gear-motor 11 rotations cause ratchet wheel 13 rotation and forward displacement of drive screw 20 within reservoir 40 (FIGs. 36 - 39). Control switch 97 provides feedback to MCU 98 on operation of gear-motor 11 (yes / no movement). MCU 98 receives inputs from volume sensor 96 (e.g., minimal volume in reservoir, FIG. 46A-B), and inputs from priming sensor / electrode 514 (i.e., end of priming, FIG. 47B). Batteries 93 provide power to hardware, software, and gear-motor 11 operation. In some cases, the user may provide inputs by controller 101 (square dot line), such as meal and exercise announcements, and the AID algorithm 2 may adjust insulin delivery accordingly.

[0008] FIGs.8A-B show spatial bottom views of AID patch 1 (bottom cover 4 removed). FIG.8A - assemblies removed, FIG. 8B - assemblies in place within top cover 3. AID patch 1 includes two compartments, sterile compartment 500, and electronic compartment 600. Sterile compartment 500 is confined between top cover 3 and bottom cover 4 (removed). Cannula opening septum 9, which is secured in the cannula opening 8 (FIGs. 2D-E) is included in the sterile compartment 500 and maintains sterility until removal of adhesive tape liner 66 (FIGs.10A-B) Electronic compartment gasket 301 provides sealing of the sterile compartment 500 by isolation of electronic compartment 600. Sterile compartment 500 includes torsion spring 83 and needle 77 (portion of insertion assembly 70), gear-motor 11, and ratchet wheel 13 (portion of driving assembly 10), reservoir 40, and insulin line 31 (portion of delivery assembly 30), and sensing assembly 50 (not shown).

[0009] FIGs. 9A-C show spatial top-level views of AID patch 1, and assembly process and sterilization process of AID patch 1. Assembly and sterilization processes comprise the following consecutive steps: step 1) assembly of driving assembly 10, delivery assembly 30, sensing assembly 50, and insertion assembly 70 (not shown) within top cover 3 and bottom cover 4 (forming the sterile compartment 500), step 2) sterilization (FIG.9A). Sterilization can be done with E-beam radiation, gamma radiation, or with gas (e.g., ethylene oxide ETO), step 3) assembly of electronic assembly 90 within electronic compartment 600 (FIG. 9B), step 4) assembly of batteries cover 5 and closing the electronic compartment 600 (FIG. 9C).

[0010] FIGs. 10A-B show spatial bottom views of AID patch 1 before (FIG. 10A) and after (FIG. 10B) removal of adhesive tape liner 66 and cannula opening septum cover 9. Bottomside of AID patch 1 includes cannula frame 7, cannula opening 8, cannula opening septum 9, and filling port 32. Cannula opening septum 9 is rigidly connected to cannula opening 8. During needle 77 insertion, cannula opening septum 9 is pierced by needle 77 and maintains cannula 80 sealing after insertion. The cannula opening septum 9 should remain sterile during shelf life because it comes in close contact with the skin 67 (FIG. 1B) Cannula opening septum cover 99 protects cannula opening septum 9 and maintains its sterility during shelf life. Before adherence of AID patch 1 to skin 67, adhesive tape liner 66 and cannula opening septum cover 99 are removed from adhesive tape 6, exposing adhesive tape 6 and cannula opening septum 9. Cannula opening septum cover 99 can be made of tinfoil, plastic material, paper material, etc., and can be attached to adhesive tape liner 66 directly or indirectly with a tab.

[0011] FIG. 11 -FIG. 17B show various components of AID patch 1 subassemblies.

[0012] FIG. 11 shows exploded view of the main parts of AID patch 1 subassemblies. The main parts include parts of the insertion assembly 70: torsion spring 83, crank 82, lever 81, upper frame 73, middle frame 72, latch 722, cannula stopper 733, trigger 71, sled 74, rod 75, needle hub 76, needle 77, carrier 78, delivery assembly 30 - insulin line 31, cannula 80, cannula septum 79, sensing assembly - sensor probe 51, contacts plate 52, sensor FPC (flexible circuit board) 54, and sensor FPC contacts 53. The light dashed line box includes parts of pump 200 and glucose sensor 300, hereinafter "probe / cannula assembly 22".

[0013] FIG. 12 shows spatial view of AID patch 1 subassemblies. Insertion assembly 70 includes torsion spring 83, crank 82, lever 81, upper frame 73, middle frame 72, cannula stopper 733, trigger 71, sled 74, rod 75, needle hub 76, and needle 77. Delivery assembly 30 includes insulin line 31 and cannula 80. Sensing assembly 50 includes sensor probe 51, contacts plate 52, sensor FPC 54, sensor FPC contacts 53, and sensor FPC connector 55.

[0014] FIGs. 13A-B show exploded view (FIG. 13A) and spatial view (FIG. 13B) of the main components of the driving assembly 10 and electronic assembly 90. Driving assembly 10 includes gear-motor 11, one-way bearing 12, tilting arm 17, ratchet wheel 13, ratchet gear 16, ratchet stopper spring 14, ratchet drive spring 15, reservoir cap 18, locker 21, drive connector 19, and drive screw 20. The delivery assembly 30 (some components of which are shown in, e.g., Fig.28B) includes plunger 41, plunger O-ring 411, reservoir 40 (not shown in Fig.28B), and filling port 32 (not shown in Fig. 28B). Some components of electronic assembly 90 include control switch 97, volume sensor 96, and volume sensor rod 966. Hereinafter "pumping assembly 23" (or interchangeable "pumping mechanism 23") includes the ratchet wheel 13,ratchet gear 16, drive connector 19, drive screw 20, plunger 41, plunger O-ring 411, reservoir 40. Hereinafter, "filling assembly 24" includes the filling port 32 and mechanism for directing insulin flow during filling and during delivery (FIGs. 42A - FIG. 45C).

[0015] FIGs. 14A-D show left (14A-B) and right (14C-D) spatial views of AID patch 1 main components. The main components of AID patch 1 include interface PCBA 94, interface PCBA traces 944, upper frame 73, gear-motor 11, volume sensor 96, and control switch 97. FIG. 14A and FIG. 14C show exploded views of electronic assembly 90 and sensor probe 51 before assembly. FIG. 14B and FIG. 14D show the assembled electronic assembly 90 and sensor probe 51.

[0016] FIGs. 15A-C show spatial views (FIGs. 15A-B) and exploded view (FIG. 15C) of AID patch 1 components. AID patch 1 components include electronic assembly 90, volume sensor 96, control switch 97, sensor probe 51, sensor FPC 54, sensor FPC connector 55, interface PCBA 94, sensor traces 949, control switch traces 946, volume sensor traces 945, gear-motor traces 947, zebra connector 92, and gear-motor 11.

[0017] FIGs. 16A-D show longitudinal cross section view (FIG. 16A) and spatial views (FIG.16B-C) of AID patch 1. FIG. 16D shows spatial view of driving mechanism 10. FIG. 16A shows the bottom cover 4, cannula frame 7, upper frame 73, tilting arm 17, one-way bearing 12, gear-motor 11, sled 74, and rod 75. FIG. 16B and FIG. 16C show the bottom cover 4, interface PCBA 94, gear-motor 11, one-way bearing 12, ratchet wheel 13, upper frame 73, reservoir 40, torsion spring 83, lever 81, crank 82, and tilting arm 17. FIG. 16D shows the driving mechanism 10 that includes gear-motor 11, one-way bearing 12, trigger 71, and tilting arm 17. The tilting arm 17 comprises sliding window 177, tilting arm cylinder 180, ratchet drive spring arm 179, and control switch arm 178.

[0018] FIGs. 17A-B show longitudinal cross section view (FIG. 17A) and top-level view (FIG. 17B, upper cover removed,) of AID patch 1. FIG. 17A shows the bottom cover 4, cannula frame 7, volume sensor 96, ratchet wheel 13, sensor FPC 54, drive connector 19, and filling port 32. FIG. 17B shows the ratchet wheel 13, ratchet drive spring 15, volume sensor 96, volume sensor rod 966, ratchet gear 16, drive connector 19, reservoir 40, filling port 32, gear-motor 11, one-way bearing 12, tilting arm 17, sensor FPC 54, sensor probe 51, cannula opening 8, and cannula opening septum 9.

[0019] FIGs. 18A-B show spatial view (FIG. 18A) and transverse cross section view (FIG.18A) of the tilting arm 17 and modes of operation. Tilting arm 17 includes sliding window 177,tilting arm lever 182, tilting arm cylinder 180, ratchet drive spring arm 179, and control switch arm 178. Tilting arm cylinder 180 can be rotated around a virtual axis of rotation 181. Movement (up and down displacement) of sliding window 177 and tilting arm lever 182 in the direction of curved arrow 1 causes rotation of ratchet drive spring arm 179 and control switch arm 178 in the direction of curved arrow 2. Movement of sliding window 177 and tilting arm lever 182 in the direction of curved arrow 3 causes rotation of ratchet drive spring arm 179 and control switch arm 178 in the direction of curved arrow 4. Hereinafter the terms "tilting arm 17" is interchangeably used with tilting arm lever 182.

[0020] FIGs. 19A-B show transverse cross section view (FIG. 19A) and spatial view (FIG.19B) of the main component of the driving assembly 10 and control switch 97. FIG. 19A shows the one-way bearing 12, excentre 112, tilting arm lever 182, ratchet stopper spring 14, control switch arm 178, ratchet drive spring arm 179, ratchet drive spring 15, ratchet wheel 13, ratchet gear 17, drive connector 19, reservoir cap 18, and control switch 97 (electronic assembly 90). In preferred embodiment, ratchet drive spring 15 is made of stainless-steel sheet and is rigidly connected (e.g., glued) to ratchet drive spring arm 179. In one preferred embodiment ratchet stopper spring 14 is made of stainless-steel foil. FIG. 19B shows the gear-motor 11, one-way bearing 12, excentre 112, sliding window 177, tilting arm cylinder 180, ratchet stopper spring 14, ratchet wheel 13, control switch arm 178, ratchet drive spring 15, reservoir cap 18, reservoir 40 (delivery assembly 30). Electronic assembly 90 components include the control switch 97 and volume sensor rod 966.

[0021] FIGs. 20A-C show transverse cross section views (FIGs. 20A-B) and spatial view (FIG. 20C) of driving assembly 10 and control switch 97, and modes of operation and control. Driving assembly 10 includes the gear-motor 11 (FIG. 19B), one-way bearing 12, excentre 112, sliding window 177, tilting arm lever 182, ratchet stopper spring 14, control switch arm 178, ratchet drive spring arm 179, ratchet drive spring 15, ratchet wheel 13, ratchet gear 16, drive controller 19, and control switch 97. There are 2 operation phases: 1) "delivery phase" -rotation of ratchet wheel 13, and 2) "no delivery phase" - no rotation of ratchet wheel 13. FIG.20A shows the driving assembly 10 operation at delivery phase. Rotation of excentre 12 in the direction of bold arrow 1 within sliding window 177 causes movement of sliding window 177 and tilting arm lever 182 in the direction of bold arrows 2, and displacement of control switch arm 178 and ratchet drive spring arm 179 in the direction of bold arrows 3 and 4, respectively. Displacement of ratchet drive spring 15 causes rotation of ratchet wheel 13 in the direction of bold arrow 5 (counterclockwise). Ratchet stopper spring 14 prevents rotation of ratchet wheel13 in the opposite direction (clockwise). Rotation of ratchet wheel 13 rotates ratchet gear 16 and drive connector 19 which displaces drive screw 20 (FIGs.36A-B). Displacement of control switch arm 178 in the direction of bold arrow 3 disconnects control switch 97 (no electric connection, control switch "off). FIG. 20B shows the driving assembly 10 operation at no delivery phase. Rotation of excentre 12 in the direction of bold arrow 1 within sliding window 177 causes movement of sliding window 177 and tilting arm lever 182 in the direction of bold arrows 6, and displacement of control switch arm 178 and ratchet drive spring arm 179 in the direction of bold arrows 7 and 8, respectively. During displacement of ratchet drive spring 15 in the direction of bold arrow 8 there is no rotation of ratchet wheel 13. Ratchet stopper spring 14 prevents rotation of ratchet wheel 13 in the opposite direction (clockwise). Displacement of control switch arm 178 in the direction of bold arrow 7 connects control switch 97 (electric connection resumes, control switch "on"). During normal operation, each revolution of excentre causes movement of tilting arm 17 (see e.g., FIGs. 16A-D), displacement of one tooth of ratchet wheel 13, and one on / off cycle of control switch 97. Displacement of one tooth is translated to predefined movement of drive screw 20 (not shown) and predefined amount of delivered insulin (e.g., 0.05 units). In cases of driving assembly 10 failure (e.g., motor stuck) or occlusion in insulin path, there is a mismatch between MCU 98 command and gear-motor 11 operation and alarm will be generated by control switch 97 (stuck in "on" or "off position).FIG. 20C shows the ratchet wheel 13 and the ratchet gear 16 (FIGs. 36A - 39D). Ratchet wheel 13 and ratchet gear 16 are rigidly connected, rotate together, and cannot be displaced forward or backward.

[0022] FIGs. 21A-C and FIGs. 22A-B show the one-way bearing 12 and its modes of operation.

[0023] FIGS.21A-D show spatial views (FIG.21A and FIG.21C) and exploded views (FIG.21B and FIG. 21D) of the one-way bearing 12. FIG. 12 shows the actuator cylinder 122, excentre 112, and spiral groove 1221. FIG. 21B shows the actuator cylinder 122 that includes the spiral groove 1221, motor shaft 111 that includes triangle grooves 124, excentre 112, rollers 123, and supporting ring 125. Gear-motor 11 (light dashed line box) is engaged with motor shaft 111 (bold dashed line 1) and rotation of gear-motor 11 causes rotation of motor shaft 111.FIG. 21C shows the one-way bearing 12 that includes actuator cylinder 122, spiral groove 1221 and trigger 71. Rotation of actuator cylinder 122 in the direction of curved arrow 2 causes displacement of trigger 71 in the direction of bold arrow 3. FIG. 21D shows the one-way bearing 12, excentre 112, spiral groove 1221, and trigger 71.

[0024] FIGs. 22A-B show transverse cross-section views of the one-way bearing 12 and modes of operation. The one-way bearing 12 includes motor shaft 111, excentre 112, triangle grooves 124 (x3), rollers 123 (x3), and actuator cylinder 122. Motor shaft 111 can be rotated by gear-motor 11 (not shown) in counterclockwise rotation (no rotation of actuator cylinder 122, FIG. 22A) and clockwise rotation (rotation of actuator cylinder 122, FIG. 22B). FIG.22A shows rotation of motor shaft 111 counterclockwise in the direction of curved arrow 1. Rollers 123 are in the broad base of triangle grooves 124 and could be rotated during rotation of motor shaft 111. Accordingly, there is no friction between rollers 123 and actuator cylinder 122 and there is no rotation of actuator cylinder 122. FIG. 22B shows rotation of motor shaft 111 clockwise in the direction of curved arrow 2. Rollers 123 are in the narrow corner of triangle grooves 124 and could not be rotated during rotation of motor shaft 111. Accordingly, there is friction between rollers 123 and actuator cylinder 122 and rotation of actuator cylinder 122 in the direction of bold arrow 3. Operation of AID patch 1 includes the following two consecutive steps: Step 1) (FIG. 22B) - activation of gear-motor 11 (not shown), motor shaft 111, and excentre 112 in clockwise rotation (curved arrow 2). Actuator cylinder 122 is rotating clockwise (curved arrow 3), trigger 71 is displaced in the direction of bold arrow 3 (FIG.21C) and insertion mechanism 70 is activated (cannula 80 and sensor probe 51 are inserted into subcutaneous tissue). Step 2) (FIG. 22A) - activation of gear-motor 11, motor shaft 111, and excentre 112 in clockwise rotation (curved arrow 1,). Actuator cylinder 122 is not rotating, and there is no movement of trigger 71 (FIG. 21C), excentre 112 is rotating, tilting arm 17 is activated (up and down movements) (FIGs. 20A-B), delivery assembly 30 is activated, and insulin is delivered.

[0025] FIG. 23A - FIG. 28B show the insertion assembly (mechanism) 70 and modes of operation.

[0026] FIGs. 23A-B show exploded view (FIG. 23A) and spatial view (FIG. 23B) of the insertion assembly (mechanism) 70 and probe / cannula assembly 22. FIG.23A shows the main components of the insertion mechanism 70. Insertion mechanism 70 includes the middle frame 72, upper frame 73, lever 81, crank 82, sled 74, rod 75, and parts of probe / cannula assembly 22 - needle hub 76, needle 77, carrier 78, cannula septum 79, sensor probe 51, and cannula 80. Activation of insertion mechanism 70 causes insertion of needle 77, cannula 80, and sensor probe 51 into the subcutaneous tissue 400 followed by immediate retraction of needle 77. FIG.23B shows the assembled insertion mechanism 70.

[0027] FIGs. 24A-C show spatial view (24A), exploded view (24B) and cross section view(14c) of the insertion mechanism 70 components. FIG.24A shows the torsion spring 83, crank 82, crank bulge 822, lever 81, lever arm 1 811, lever arm 2 812, sled 74, and sled bulge 744.FIG. 24B shows the torsion spring 83, crank 82, crank bulge 822, lever 81, lever arm 1 811, lever arm 2 812, lever arm window 813, sled 74, and sled bulge 744. FIG. 24C shows the torsion spring 83, crank 82, crank bulge 822, lever 81, lever arm window 813, sled 74, sled bulge 744, and middle frame 72.

[0028] FIGs. 25A-C show longitudinal cross section views of insertion mechanism 70 and modes of operation. Insertion mechanism 70 includes lever 81, sled 74, sled bulge 744, latch 722, rod 75, and needle 77. Insertion mechanism 70 activation is triggered by components of the driving assembly 10 that include the gear-motor 11, one-way bearing 12, excentre 112, tilting arm 17, and trigger 71. There are 3 steps in the activation process: Step 1) (FIG. 25A) -rotation of gear-motor 11, one-way bearing 12, and excentre 112 (circle arrows 1) (FIG. 21C) causes rotation of actuator cylinder 122 and spiral groove 1221 (see, e.g., FIGS. 21A-D). Step 2) (FIG.25B) - rotation of spiral groove 1221 causes displacement of trigger 71 in the direction of bold arrow 2 and release of latch 722. Step 3) (FIG. 25C) - latch 722 is released, allowing sled 74 and rod 75 to be displaced by lever 81 in the direction of bold arrow 3.

[0029] FIGs. 26A-C, Al-Cl shows top level views (FIGs. 26A-C) and longitudinal cross section views (FIGs. 26A1-C1) of the insertion mechanism and modes of operation. Insertion process includes 3 phases: phase 1) before activation - needle 77, cannula 80, and sensor probe 51 are concealed within AID patch 1, phase 2) after activation - needle 77, cannula 80, and sensor probe 51 are inserted into the subcutaneous tissue 400, phase 3) - needle 77 is retracted and concealed with AID patch, cannula 80 and sensor probe 51 remains within the subcutaneous tissue 400. Components of the insertion mechanism 70 include the middle frame 72, latch 722, upper frame 73, cannula stopper 733, torsion spring 83, lever 81, lever arm 1 811, lever arm 2 812, lever arm window 813, sled 74, sled bulge 744, crank 82, crank bulge 822, rod 75, and needle 77. The insertion process includes insertion of needle 77, cannula 80, and sensor probe 51 into the subcutaneous tissue 400, displacement of contacts plate 52, and retraction of needle 77. FIGs. 26A - Al show the insertion mechanism 70 before activation (phase 1). FIGs. 26B-B1 show the insertion mechanism 70 after activation (phase 2). Following release of latch 722 by trigger 71, sled 74 is released (see e.g., FIGs. 25A-C) and torsion spring 83 causes rotation of crank 82 and crank bulge 822 in the direction of curved arrow 1. Rotation of sled bulge 822 that is locked between lever arm 1 811 and lever arm 2812 causes displacement of lever arm window 813 in the direction of bold arrow 2. Sled bulge 744,located within lever arm window 813, is displaced in the direction of bold arrows 2 and causes displacement of sled 74, rod 75, and needle 77 in the direction of bold arrows 2. At the end of phase 2, needle 77, cannula 80, and sensor probe 51, are inserted within the subcutaneous tissue 400. FIGs. 26C-C1 show the insertion mechanism 70 after retraction of needle 77 (phase 3). Further rotation of crank 82 and crank bulge 822 in the direction of curved arrow 1 causes further displacement of sled bulge 744 and sled 74 in the direction of bold arrows 3, displacement of rod 75 in the same direction, and retraction of needle 77. At the end of phase 3, cannula 80 and sensor probe 51 are located within the subcutaneous tissue 400 and needle 77 is concealed within AID patch 1. Cannula 80 is locked in place by cannula stopper 733 (see e.g., FIGs. 27A-C).

[0030] FIGs. 27A-C show longitudinal cross section views of the insertion mechanism 70 before (FIG. 27A) and after (FIGs. 27B-C) activation. Components of the insertion mechanism 70 includes the middle frame 72, upper frame 73, cannula stopper 733, torsion spring 83, sled bulge 744, crank 82, rod 75, and needle 77. The insertion process includes insertion of needle 77, cannula 80, and sensor probe 51 into the subcutaneous tissue 400, displacement of contacts plate 52, and retraction of needle 77. FIG. 27A shows the insertion mechanism 70 before activation (phase 1). FIG. 27B show the insertion mechanism 70 after activation (phase 2). Torsion spring 83 causes rotation of crank 82, displacement of sled bulge 744 in the direction of bold arrow 1 and displacement of needle 77, cannula 80, sensor probe 51, and contacts plate 52 in the direction of bold arrow 2. FIG. 27C shows the insertion mechanism 70 after needle retraction (phase 3). Further rotation of crank 82 causes displacement of rod 75 in the direction of bold arrows 3 and retraction of needle 77 in the direction of bold arrow 4. At the end of phase 3, cannula 80 and sensor probe 51 are located within the subcutaneous tissue 400 and needle 77 is concealed within AID patch 1. Cannula 80 is locked in place by cannula stopper 733.

[0031] FIGs. 28A-B show detailed spatial views of the insertion mechanism 70 and insulin line 31 before (FIG. 28A) and after (FIG. 28Ab) activation. Components of the insertion mechanism 70 includes the middle frame 72, upper frame 73, sled 74, sled bulge 744, rod 75, needle hub 76, and needle 77. Components of delivery assembly 30 include cannula 80, cannula connector 801, and insulin line 31. Components of the sensing assembly 50 include the sensor probe 51, contacts plate 52, sensor PFC 54, and sensor PFC connector 55. FIG. 28A show the insertion mechanism 70 before activation, needle 77, cannula 80 and sensor probe 51 are concealed within AID patch 1. FIG. 28B shows the insertion mechanism 70 after activation,insertion of needle 77, cannula 80, and sensor probe 51 were displaced in the direction of bold arrow 1 and retraction of needle 77 was displaced in the direction of bold arrow 2. Insulin line 31 is flexible or semi-flexible and can be made of metal (e.g., stainless steel) or plastic e.g., silicone, polypropylene, etc.). During insertion, insulin line 31 is bent and follows the displacement of cannula 80 and cannula connector 801 in the direction of bold arrow 1. During insertion, contacts plate 52 is displaced with sensor probe 51 and sensor FPC 54 is bent and follows the displacement of contacts plate 52 in the direction of bold arrow 1.

[0032] FIGs. 29A-B show the needle 77, cannula 80, and sensor probe 51 before (FIG. 29A) and after (FIG. 29B) needle 77 retraction. FIGs. 29A-B shows the needle 77, needle hub 76, cannula 80, cannula septum 79, cannula connector 801, sensor probe 51, and contacts plate 52.FIG. 29A shows the needle 77 position before insertion, sensor probe 51 resides within needle 77, needle 77 resides within cannula 80, and needle 77 transverse cannula septum 79. FIG.29B shows the needle 77 position after needle 77 insertion and retraction, needle 77 resides within AID patch 1 (not shown), and needle tip is located apart from cannula septum 79. Cannula septum 79 is made of an elastomer (e.g., silicone rubber), following needle 77 retraction cannula septum 79 is self-sealed.

[0033] FIG. 30A - FIG. 34C show details of the sensing assembly 50.

[0034] FIGs. 30A and 30A1-2 (magnified views) show spatial view of the sensor probe 51 and its electrical contacts. FIG. 30A shows one side of the sensor probe 51 and contacts plate 52. The sensor probe 51 and contacts plate 52 are planar, cut from the same planar sheet, have a rectangular cross section, and are made from any material known in the art used for electrode substrate, for example polyimide (Kapton). In preferred embodiment, sensor probe 51 includes on one (e.g., side) working electrode 512, reference electrode 515, and priming electrode 514. Electrodes are electrically connected via sensor probe traces 511 to electrical contacts on contacts plate 52 - working electrode contact 521, reference electrode contact 524, and priming electrode contact 523. Working electrode 512, reference electrode 515, and counter electrode 513 on opposite side (see e.g., FIGs.34A-C) are used for continuous measurements of glucose within the subcutaneous tissue 400, priming electrode 514 is used for detection of insulin during priming of AID patch 1 (principle of operation, see e.g., FIGs. 45A-C). In other preferred embodiments, location of electrodes on sensor probe 51 could be changed and / or replaced (e.g., counter electrode 513 on same side as working electrode 512), in another preferred embodiment more or less electrodes could be used, for example 2 working electrodes 512, no reference electrode 515, etc.

[0035] FIGs. 31A1-2, B-C show top level view (FIG. 31A1) spatial view (FIG. 31A2) exploded view (FIG. 31B), and transverse cross section view (FIG. 31C) of probe / cannula assembly 22. FIG.31 Al shows the sensor probe 51, contacts plate 52, and cannula 80. Needle 77 (before insertion) transverses cannula septum 79, sensor probe 51 partially resides within cannula 80, and needle 77 resides within cannula 80. FIG. 31A2 shows the sensor probe 51, contacts plate 52, sensor FPC 54, sensor FPC contacts 53, sensor FPC connector 55, cannula 80, and cannula connector 801. Sensor probe 51 partially resides within cannula 80, cannula 80 resides within needle 77. FIG. 31B shows the probe / cannula assembly 22 that include the needle hub 76, needle 77, carrier 78, cannula septum 79, cannula 80, cannula connector 801, sensor FPC 54, sensor FPC contacts 53, sensor probe 51, and contacts plate 52. FIG. 31C shows transverse cross section view of needle 77 (before insertion), sensor probe 51, and cannula 80. Sensor probe 51 has a rectangular cross section, cannula 80 is a cylinder, and needle 77 is a cylinder with a sharp tip and a needle slot 777. The needle slot 777 allows needle 71 crossing of contacts plate 52 during needle 77 retraction.

[0036] FIGs. 32A-A1 show spatial view (FIG. 32A) and magnified view (FIG. 32A1) of assembled probe / cannula assembly 22 (before insertion) and priming sensor 700. FIG. 32A shows the assembled probe / cannula assembly 22 that includes sensor probe 51, contacts plate 52, sensor FPC 54, sensor FPC contacts 53, sensor FPC connector 55, cannula 80, cannula connector 801, and needle 77. Sensor probe 51 includes working electrode 512, reference electrode 515, and priming electrode 514. FIG. 32A1 shows priming sensor 700 that includes priming electrode 514, priming electrode trace 5144, and priming electrode contact 523 see e.g., FIGs. 30A-A2).

[0037] FIG. 33 shows exploded view of the probe / cannula assembly 22. Probe / cannula assembly 22 includes the sensor probe 51, contacts plate 52, sensor FPC 54, sensor FPC contacts 53, sensor FPC connector 55, cannula 80, cannula connector 801, and needle 77. Sensor probe 51 includes working electrode 512, reference electrode 515, and priming electrode 514. Carrier 78 provides connection between contacts plate 52 and sensor FPC contacts 53. Needle 77 (before insertion) transverses cannula septum 79 and resides within cannula 80.

[0038] FIGs. 34A-C show side views (FIG. 34A and FIG. 34C), and top-level view (FIG.34B) of sensor probe 51 and contacts plate 52. FIG. 34A shows one side of sensor probe 51 that includes counter electrode 515, counter electrode traces 5133, and counter electrode contact 522. FIG. 34B shows the sensor probe 51. Sensor probe 51 is planar and has arectangular cross section (FIG. 31C). FIG 34C show the opposite side of sensor probe 51 that includes working electrode 512, working electrode trace 5122, working electrode contact 521, reference electrode 515, reference electrode trace 5155, reference electrode contact 5224, priming electrode 514, priming electrode trace 5144, and priming electrode contact 523. In other preferred embodiments, location and number of electrodes, traces, and contacts could be changed (e.g., all electrodes on one side, more electrodes, less electrodes, etc.).

[0039] FIGs. 35A-C show spatial view (FIG. 35A), longitudinal cross section views (FIG.35B1 and FIG. 35B2) of probe / cannula assembly 22 and schematic (FIG. 35C) of insulin line 31, cannula 80, and hydraulic communication of insulin line 31 and cannula 80. FIG. 35A shows the probe / cannula assembly 22 that includes the sensor probe 51 (not shown, hidden in cannula), contacts plate 52, sensor FPC 54, cannula 80, cannula connector 801, and needle 77. Insulin line 31 is connected to cannula 80 via cannula connector 801. FIG. 35B1 and FIG.35B2 show the probe / cannula assembly 22 and insulin line 31, before needle 77 insertion (FIG.35B1) and after needle 77 retraction (FIG. 35B2). Insulin line 31 is hydraulically connected with cannula 80. Probe / cannula assembly includes sensor probe 51, cannula 80, cannula septum 79, cannula connector 801, needle 77, and sensor FPC 54. FIG. 35B1 shows needle 77 that transverse cannula septum 79 and resides within cannula 80. Sensor probe 51 resides within needle 77. FIG. 35B2 (needle 77 retracted) shows the sensor probe 51 and cannula 80, sensor probe 51 resides within cannula 80, insulin is delivered from insulin line 31 into cannula 80.FIG. 35C shows the hydraulic communication between insulin line 31 and cannula 80. Cannula septum 79 is self-sealed (elastomer) and maintain sealing of insulin path after needle 77 retraction.

[0040] FIGs. 36A - FIG. 45C show the pumping assembly (mechanism) 23 and its modes of operation.

[0041] FIGs. 36A-B show longitudinal transverse view (FIG. 36A) and spatial view (FIG.36B) of pumping assembly 23. FIG. 36A shows the pumping assembly 23 that includes the ratchet wheel 13, ratchet gear 16, drive connector 19, drive screw 20, drive thread 21, plunger 41, plunger O-ring 411, and reservoir 40. FIG. 36A also shows parts of driving assembly 10 that includes the ratchet drive spring 15, tilting arm 17, and reservoir cap 18. FIG. 36B shows the ratchet wheel 13, ratchet drive spring 15, ratchet gear 16, drive connector 19, drive screw 20, drive thread 21, plunger 41, plunger O-ring 411, and reservoir 40.

[0042] FIGs. 37A-C show schematics of pumping mechanism 23 and modes of operation.Pumping mechanism 23 includes the ratchet wheel 13, ratchet gear 16, drive connector 19, drive screw 20, drive thread 21, plunger 41, and reservoir 40. Reservoir 40 can be filled with insulin at user discretion from a minimal threshold (e.g., 20-100 insulin units, see, e.g., FIGs.46A-B) and up to full reservoir 40 (e.g., 200-300 insulin units). Following reservoir 40 filling, the pumping mechanism 23 is operated at the following 3 consecutive phases: Phase 1 (FIG.37A) reservoir 40 is partially filled with insulin (gray dots), plunger 41 and drive screw 20 are displaced in the direction of bold arrow 1. Phase 2 (FIG. 37B), ratchet wheel 13 is rotated (circled arrow 2) and causes rotation of ratchet gear 16 (circled arrow 3) which is rigidly connected with ratchet wheel 13. Ratchet wheel 13 and ratchet gear 16, while rigidly connected, rotate together, and cannot be displaced forward or backward. Ratchet gear 16 causes rotation of drive connector 19 (circled arrow 4) (see e.g., FIGs. 38A - 41B) and drive connector 19 causes rotation of drive thread 21 (circled arrow 5) which is rigidly connected with drive connector 19. Drive connector 19 is displaced in the direction of bold arrow 6. In one preferred embodiment, drive connector 19 is made of plastic and drive thread 21 and drive screw 20 are made of metal. Phase 3 (FIG. 37C) ratchet wheel 13 is rotated (circled arrow 2) and causes rotation of ratchet gear 16 (circled arrow 3). Ratchet gear 16 causes rotation of drive connector 19 (circled arrow 4) and drive connector 19 causes rotation of drive thread 21 (circled arrow 5). Ratchet gear 16 is engaged with drive connector 19 (see e.g., FIGs. 38A - 41B) and drive connector 19 displacement is stopped (no further movement in the direction of bold arrow 6), drive screw 20 is displaced in the direction of bold arrow 7. Displacement of drive screw 20 causes displacement of plunger 41 within reservoir 40 and insulin is delivered from reservoir 40 via insulin line 31 and cannula 80 into the body.

[0043] FIGs. 38A - FIG. 41B show the engagement mechanism of ratchet gear 16 and drive connector 19.

[0044] FIGs. 38A-D, Al-Dl show longitudinal cross section views (FIGs. 38A-D) and magnified views (FIGs. 38A1-D1) of the engagement mechanism between ratchet gear 16 and drive connector 19. The engagement mechanism allows filling of reservoir 40 at any desired volume between minimal (predefined, see e.g., FIGs. 47A-B) and maximum (reservoir 40 capacity) and provides minimal time between beginning of gear-motor 11 operation and displacement of plunger 41 within reservoir 40 (insulin delivery). The engagement mechanism includes the ratchet wheel 13, ratchet gear 16, ratchet gear protrusion 166, drive connector 19, drive connector groove 191, drive connector lock 192, plunger 41, and reservoir 40. FIG. 38A, a1 show the engagement mechanism before reservoir 40 filling. Ratchet gear protrusion 166 islocated within drive connector groove 191. FIGs. 38B, Bl show the engagement mechanism after partial reservoir 40 filling (Phase 1, FIG. 37A). Plunger 41 and drive connector 19 are displaced in the direction of bold arrow 1. FIGs. 38C, Cl show the engagement mechanism after beginning of rotation of ratchet wheel 13, ratchet gear 16, and drive connector 19 (circled arrows 2, 3, and 4) (Phase 2, FIG. 37B). Drive connector 19 is displaced in the direction of bold arrow 5. Ratchet gear protrusion 166 is freely displaced within drive connector groove 191 in the same direction. Ratchet gear 16 causes rotation of drive connector 19 by force applied by ratchet gear protrusion 166 on drive connector groove 191. FIGs. 38D, DI show the engagement mechanism after engagement of ratchet gear 16 and drive connector 19 (Phase 3, FIG. 37C) Further rotation of ratchet wheel 13, ratchet gear 16, and drive connector 19 (circled arrows 2, 3, and 4) causes ratchet gear protrusion 166 to be locked within drive connector lock 192. Displacement of drive connector 19 in the direction of bold arrow 5 is stopped and drive screw 20 (not shown) and plunger 41 are displaced in the direction of bold arrow 6.

[0045] FIGs. 39A-D show spatial views of the engagement mechanism between ratchet gear 16 and drive connector 19. The engagement mechanism includes the ratchet wheel 13, ratchet gear 16, drive connector 19, plunger 41, and reservoir 40. FIG. 39 A shows the engagement mechanism before reservoir 40 filling. FIG. 39B (Phasel, FIG. 37A) shows reservoir 40 filling, plunger 41 and drive connector 19 are displaced in the direction of bold arrow 1. FIG.39C (Phase 2, FIG. 37B) shows the engagement mechanism after operation of gear-motor 11 (not shown), rotation of ratchet wheel 13 (circled arrow 2) and drive connector 19 (circled arrow 3), drive connector 19 is displaced in the direction of bold arrow 4. FIG. 39D (Phase3, FIG. 37C) shows the engagement mechanism after engagement of ratchet gear 16 and drive connector 19, rotation of ratchet wheel (circled arrow 2) and drive connector 19 (circled arrow 3), drive connector 19 is not displacing, drive screw (not shown) and plunger 41 are displaced in the direction of bold arrow 5.

[0046] FIGs. 40A-B show spatial views of engagement mechanism and mode of operation during engagement of ratchet gear 16 and drive connector 19 (Phase 3). The engagement mechanism includes the ratchet wheel 13, ratchet gear 16, ratchet gear protrusion 166, drive connector 19, drive connector groove 191, drive connector lock 192, plunger 41, and reservoir 40. FIG. 40A shows the beginning of engagement process between ratchet gear 16 and drive connector 19, rotation of ratchet wheel 13 and ratchet gear 16 in the direction of curved arrow 2 caused drive connector 19 to move in the direction of curved arrow 3, drive connector isdisplaced in the direction of bold arrow 1 and there is a relative movement between ratchet gear protrusion 166 and drive connector lock 192, ratchet gear protrusion 166 is displaced in the direction of bold arrow 4. FIG. 40B shows the end of engagement process between ratchet gear 16 and drive connector 19. Rotation of ratchet wheel 13 and ratchet gear 16 in the direction of curved arrow 2 causes drive connector 19 to move in the direction of curved arrow 3, ratchet gear protrusion 166 is locked within drive connector lock 192 (see e.g., FIGs. 41A-B), there is no further displacement of drive connector 19, and drive screw 20 (not shown) and plunger 41 are displaced in the direction of bold arrow 5.

[0047] FIGs. 41A-B show schematics of the engagement mechanism between ratchet gear 16 and drive connector. The engagement mechanism includes the drive connector 19, drive connector groove 191, drive connector lock 192, and ratchet gear protrusion 166 which is part of ratchet gear 16 (not shown). FIG. 41 A show the drive connector 19 and the ratchet gear protrusion 166 before engagement, drive connector 19 is rotating (circled arrow 1) and displaced in the direction of bold arrow 2, ratchet gear protrusion 166 cannot be displaced and accordingly, relatively displaced in the direction of dashed line 3 until it gets locked within drive connector lock (bayonet like locking mechanism). FIG. 41B shows the engagement mechanism after engagement, drive connector 19 is rotating (circled arrow 1) but cannot be displaced. Accordingly, further rotation of drive connector cause displacement of drive screw 20 (see e.g., FIGs. 37A-C) in the opposite direction.

[0048] FIG. 42A - FIG. 45C show preferred embodiments of the filling assembly 24.

[0049] FIGs. 42A-C show longitudinal cross section views of one preferred embodiment of the filling assembly 24. Filling assembly 24 directs insulin flow from filling syringe 42 to reservoir 40 during reservoir 40 filling and directs insulin flow from reservoir 40 to insulin line 31 during delivery. Filling assembly 24 prevents delivery of insulin into insulin line 31 during reservoir 40 filling. Filling assembly 24 includes the filling port 32, filling septum 43, and filling O-ring 44. FIGs. 42A-C show other components that include the filling needle 45, reservoir 40, plunger 41, insulin line 31, drive connector 19, and filling syringe 42. The filling port 32 is located at the bottom side of AID patch 1 (FIGs. 2D-E) and it is not covered with adhesive tape 6. FIG. 42A show the filling assembly 24 before filling, reservoir 40 is empty.FIG. 42B shows the filling assembly 24 during filling. Filling needle 45 transverses filling septum 43, crosses filling O-ring 44, and blocks insulin line 31. During filling, insulin is delivered in the direction of bold arrows 1 and 2, insulin fills reservoir 40, and plunger 41 and drive connector 19 are displaced, insulin cannot penetrate the insulin line 31. Followingreservoir 40 filling to the required amount, filling needle 45 is retracted and filling septum 43 is self-sealed. FIG. 42C shows the filling assembly 24 during insulin delivery, insulin is delivered in the direction of bold arrows 3, 4, and 5 into the insulin line 31.

[0050] FIGs. 43A-C show schematics of one preferred embodiment of the filling assembly 24 (FIGs. 43A-C) and preferred embodiment of filling needle 45 (FIG. 43D). The filling assembly 24 includes the filling septum 43 and filling O-ring 44. FIGs. 42A-C show other components that include the filling needle 45, reservoir 40, plunger 41, insulin line 31, and filling syringe 42. FIG. 42A show the filling assembly 24 before filling, reservoir 40 is empty.FIG. 42B shows the filling assembly 24 during reservoir 40 filling. Filling needle 45 transverses filling septum 43, crosses filling O-ring 44, and blocks insulin line 31. During filling, insulin is delivered in the direction of bold arrows 1 and 2, insulin fills reservoir 40, and plunger 41 is displaced, insulin cannot penetrate insulin line 31. Following reservoir 40 filling to the required amount, filling needle 45 is retracted and filling septum 43 is self-sealed. FIG.43C shows the filling assembly 24 during insulin delivery, insulin is delivered in the direction of bold arrows 3, 4, and 5 into the insulin line 31. FIG. 43D shows preferred embodiment of filling needle 45, needle tip 46 is curved. Needle tip 46 curve provides protection from rupture of filling O-ring 44 during penetration of filling needle 45.

[0051] FIG. 44 shows an exploded view of another embodiment of the filling assembly 24. Filling assembly 24 includes the valve body 321, valve O-ring (OR) 322, valve membrane 327, valve sphere 323, valve spring 324, valve bushing 325, valve septum 326, and reservoir 40.

[0052] FIGs. 45A-C show longitudinal cross section views of the filling assembly 24 (FIG.44) The filling assembly includes valve body 321, valve sphere 323, valve spring 324, and valve septum 326, FIGs. 45A-C show the reservoir 40, plunger 41, insulin line 31, and filling needle 45. FIG. 45A shows the filling assembly 24 before filling, reservoir 40 is empty. FIG.45B shows the filling assembly 24 during filling, filling needle 45 traverses valve septum 326, displaces valve sphere 323 and sealed insulin line 31. During filling, insulin is delivered in the direction of bold arrows 1 and 2, insulin fills reservoir 40, and plunger 41 is displaced, insulin cannot penetrate insulin line 31. FIG. 45C shows the filling assembly 24 during insulin delivery, insulin is delivered in the direction of bold arrows 3 and 4 into insulin line 31.

[0053] FIGs. 46A-B show schematics of volume sensor 96 and modes of operation. Volume sensor 96 includes volume sensor connectors 967, volume sensor rod 966, and volume sensor traces 945. Volume sensor rod 966 is rigidly connected with plunger 41 (FIG. 13A, FIG. 17B,and FIG. 19B). Volume sensor connectors 967 are made of any conductive element. Volume sensor is used for detection of minimal insulin filling threshold during filling and detection of minimal predetermined insulin volume in reservoir 40 for user's alert during insulin delivery.FIG. 46 A shows the volume sensor 96 after reservoir 40 filling (not shown). During insulin delivery, plunger 41 and volume sensor rod 966 are displaced in the direction of bold arrow 1, electrical circuit is closed. FIG. 46B shows the reservoir sensor 96 at the minimal predetermined point - further movement of plunger 41 in the direction of bold arrow 1, volume sensor rod 966 is disconnected from volume sensor connectors 967 and electrical circuit is open.

[0054] FIGs. 47A-B show schematics of priming sensor 700 and modes of operation. FIGs.47A-B show the priming sensor 700 that includes the priming electrode 514, priming sensor trace 5144, and priming electrode contact 523 and, in addition, drive screw 20, reservoir 40, plunger 41, insulin line 31, cannula 80, and sensor probe 51. Priming electrode 514 is located on the proximal end of sensor probe 51 (FIG. 30A and FIG. 34C). Priming is initiated after insulin filling for purging air from insulin line 31. Priming sensor 700 is used for detection of insulin within cannula 80 and alerts the user that AID patch 1 is ready for operation (insulin delivery). In a preferred embodiment, priming electrode 514 is made of any conducive metal sheet, electrical circuit between the priming electrode 514 and any other electrode is closed when insulin (conductive solution) causes short-circuit between the two electrodes. FIG. 47A shows the priming sensor 700 after filling the reservoir 40 at the required amount of insulin, there is no insulin in insulin line 31 (FIG. 42A - FIG. 45C). FIG. 47B shows the priming sensor 700 at the end of priming, insulin line 31 and proximal end of cannula 80 are filled with insulin, priming electrode detects insulin in cannula 80 and patient gets alert on end of priming.

[0055] FIGs. 48A-C shows spatial views (FIG. 48A and FIG. 48C) and an exploded view (FIG. 49B) of another preferred embodiment of a priming sensor according to some embodiments of this disclosure. The priming sensor (or priming detector) includes the interface PCBA 94, insulin line 31, flexible insulin line 313, upper frame 73, priming contact 1 (3141), and priming contact 2 (3142). Priming contact 1 (3141) is made of conductive metal and is electrically connected to the interface PCBA 94. Priming contact 2 (3142) is also made of conductive metal and is rigidly connected to the upper frame 73 and to the interface PCBA 94. Insulin line 31 is made of conductive metal and is electrically coupled (in close contact) with the upper frame 73. In this configuration, the insulin path from reservoir 40 (not shown) to cannula 80 (not shown) includes three segments: Segment 1: insulin line 31 (metal tube),Segment 2: flexible insulin line 313 (e.g., silicone, polypropylene, or any other flexible polymer), Segment 3: insulin line (metal). During priming, insulin is purged from reservoir 40 into insulin line 31 (segment 1), then into flexible insulin line 313 (segment 2), and finally into insulin line 31 (segment 3). Before priming, the electrical circuit between priming contact 1 (3141) and priming contact 2 (3142) is open (no electrical current flows between insulin line 31 (segment 1) and insulin line 31 (segment 3)) because the flexible insulin line 313 acts as an electrical insulator. During priming, insulin — being a conductive solution — is delivered through insulin line 31 (segment 1), flexible insulin line 313 (segment 2), and insulin line 31 (segment 3). As the flexible insulin line 313 fills with insulin, it becomes electrically conductive and closes the electrical circuit between priming contact 1 (3141) and priming contact 2 (3142). Closing the electrical circuit triggers the priming alert, notifying the user that priming is complete and the device is ready for on-body operation.

[0056] FIGs.49A-C shows spatial views (FIGs.49A-C) and exploded view (Fig.49D) of one preferred embodiment for detection of occlusion according to some embodiments of the disclosure. Occlusion of cannula 80 (not shown) is usually caused by a blood clot, insulin crystallization, inflammatory reaction, or soft tissue dislodgement. Cannula occlusion blocks insulin delivery from reservoir 40 and plunger 41 (not shown) stall. Rapid occlusion detection is crucial to avoid interruption of insulin delivery and, consequently, severe hyperglycemia and ketoacidosis. Occlusion is usually detected by detection of rapid increase in current consumption, however, in some cases, an increase in power consumption may result from a random rise in plunger 41 friction during displacement within reservoir 40. In one preferred embodiment, the occlusion detector includes (Figs. 49A-C) the interface PCBA 94, tilting arm 17, ratchet wheel 13, encoder 900, encoder cap 901, and encoder switch 902. Fig. 49D shows exploded view of reservoir 40, drive connector 19, volume sensor rod 966, tilting arm 17, ratchet gear 16, ratchet wheel 13, encoder 900, encoder cap 901, encoder switch 902, and interface PCBA 94. Encoder 900 is a cogwheel with multiple teeth, rigidly connected to ratchet wheel 13, and secured in place with encoder cap 901. During operation, tilting arm 17 rotates the ratchet wheel 13, ratchet gear 16, and drive connector 19, and consequently, plunger 41 is displaced within reservoir 40 (FIGs.36a- 40B). Concomitantly with ratchet wheel 13 rotation, encoder 900 rotates in the same direction. Rotation of encoder 900 is detected by the on / off engagement of its teeth with encoder switch 902. In the event of occlusion, rotation of encoder 900 ceases, and an occlusion alarm is triggered due to a mismatch between gear-motor 11 (not shown) operation (on) and encoder switch 902 detection of no rotation (off).

[0057] ExamplesExample 1: An automated-insulin-delivery (AID) device comprising a housing including an adhesive tape configured to adhere the housing to skin of a user via the adhesive tape and housing at least: an insulin pump including a single lumen cannula, a glucose sensor including a sensor probe, a processor, an insertion assembly for inserting the single lumen cannula and the sensor probe within subcutaneous tissue, and an automated-insulin-delivery algorithm (AIDA), where the sensor 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 automatically control insulin delivery by the insulin pump according to glucose levels from subcutaneous tissue based on signals received from the glucose sensor.Example 2: The device of example 1, where one or more settings for operation of the AIDA are set via a controller.Example 3: The device of example 2, where the controller comprises a mobile smart device.Example 4: The device of example 3, where the mobile smart device is a smartphone.Example 5: The device of any of examples 1-4, further comprising one or more batteries, which may be configured with or as a platform or electronic assembly (together “electronic assembly”) for removal from the housing for recharging.Example 6: The device of example 5, where the electronic assembly includes additional circuitry aiding in control of the device.Example 7: The device of example 6, where the additional circuitry’ includes the processor.Example 8: The device of any of examples 2-7, where the one or more settings are selected from a group consisting of at least one personal parameter, glucose sensor, and / or AID algorithm parameters, receiving data and / or presenting data from the device, and communicating with a remote or cloud-based apparatus.Example 9: The device of examples 1-8, where a sensor probe tip is located within subcutaneous tissue of a user and is spaced away from a cannula tip of the single lumen cannula. Example 10: The device of any of examples 1-9, where the device is configured for pairing with the controller or another device.Example 11: The device of any of examples 1-9, where pairing via an NFC chip or circuitry provided with the device.Example 12: The device of example 11, where the NFC chip or circuitry comprises an inductive coupling.Example 13: The device of any of examples 1-12, where a wake up of the device is accomplished via a volume sensor during filling, and / or via near-field communication (NFC). Example 14: The device of examples 1-13, where the housing includes a first (top) cover, a second (bottom) cover, and cannula frame.Example 15: The device of any of examples 1-14, further comprising a needle residing within the lumen of the single lumen cannula during insertion of the single lumen cannula within tissue.Example 16: The device of example 15, where the glucose sensor comprises a probe which resides within the single lumen cannula during insertion of the single lumen cannula within ti sue.Example 17: The device of example 15, where after the single lumen cannula and sensor probe are inserted into tissue, the single lumen cannula and sensor probe remain with the tissue. Example 18: The device of any of examples 1-17, further comprising any one or more of or all of: a filling port, a cannula frame, a cannula opening, and a cannula opening septum.Example 19: The device of any of examples 1-18, where the adhesive includes a liner which is removed to adhere the device to the skin of a / the user, and a / the single lumen cannula opening septum includes a septum cover which protects the single lumen cannula opening septum and is removed concomitantly with liner removal.Example 20: The device of any of example 18-19, where the single lumen cannula opening septum is arranged for piercing by the needle during needle insertion, with the single lumen cannula and sensor probe, and retraction while maintaining sealing of the single lumen cannula with the septum during device operation.Example 21: The device of any of examples 1-20, where the sensor probe is part of a sensing assembly.Example 22: The device of example 21, where the sensing assembly comprises a sensor probe.Example 23: The device of any of example 1-22, where the insulin pump comprises any one or more of or all of a driving assembly, a delivery assembly, an insulin line, and a / the cannula.Example 24: The device of any of examples 5-23, where the electronic assembly comprises any one or more of or all of a main PCBA, a control switch, a / the volume sensor, a priming sensor, and interface PCBA.Example 25: The device of example 24, where a / the interface PCBA comprises any one or more of or all of conductive traces.Example 26: The device of any of examples 1-25, where the insertion assembly includes an insertion mechanism for insertion of cannula and the / a sensor probe into tissue and retraction of a / the needle after insertion.Example 27: The device of any of examples 1-26, where during operation of the device, the AIDA receives glucose readings from the glucose sensor having a sensor probe and automatically adjusts operation of a / the driving assembly resulting in control of a / the delivery assembly and delivery of insulin via insulin line and cannula into tissue.Example 28: The device of any of examples 1-27, where a / the driving assembly includes any and all of a motor, one or more gears.Example 29: The device of example 28, where the delivery assembly includes any one or more or all of an / the insulin line and a reservoir.Example 30: The device of any of examples 1-29, where the housing further comprises at least one battery cover.Example 31: The device of any of examples 5-30, where the electronic assembly is reusable. Example 32: The device of any of examples 5-31, where the electronic assembly is at least one of: removable, reusable, and rechargeable.Example 33: The device of any of examples 5-32, where the electronic assembly includes a rigid shell or housing.Example 34: The device of any of examples 5-33, further comprising at least one of a zebra connector for connecting the electronic assembly to at least one of a / the interface PCBA and other circuitry within the housing.Example 35: The device of any of examples 5-34, where the housing includes an electronic compartment for receiving the electronic assembly.Example 36: The device of example 35, where the electronic compartment is closed by a / the battery cover.Example 37: The device of any of examples 1-36, further comprising a ratchet wheel.Example 38: The device of any of examples 1-37, further comprising any one or more of or all of a MCU, an analog front end (AFE), a direct-current regulator (DC2DC), memory, an antenna for wireless communications, a motor driver, motor power switch, and a buzzer-driver. Example 39: The device of example 38, where the MCU comprises the processor.Example 40: The device of any of examples 1-39, further comprising an internal watchdog. Example 41: The device of any of examples 25-40, where the conductive traces include at least one or more of or all of: a sensor trace, one or more control switch traces, a volume sensor trace, a priming sensor trace, and one or more motor traces.Example 42: The device of any of examples 1-41, where a / the sensor probe comprises a working electrode, a reference electrode, and a counter electrode.Example 43: The device of any of examples 1-41, where signals generated by one or more electrodes of the glucose sensor are received by a / the analog front end (AFE) and analyzed by the AIDA.Example 44: The device of any of examples 28-43, where the AIDA automatically adjusts a delivery rate of insulin via control of a number of rotations of the motor.Example 45: The device of example 44, where rotation of the motor causes a / the ratchet wheel to rotate and forward displacement of a drive screw within a / the reservoir.Example 46: The device of any of examples 1-45, where a / the control switch provides feedback to a processor / MCU on the operation of a / the motor.Example 47: The device of any of examples 1-46, where the processor receives one or more signals from at least one of, a plurality of, or all of: a / the volume sensor, a / the priming sensor, meal data, and exercise data, and based on such inputs, the AIDA adjusts insulin delivery, as necessary.Example 48: The device of any of examples 1-47, where the housing is divided into at least a sterile compartment and an electronic compartment.Example 49: The device of example 48, where the sterile compartment arranged between a / the first cover and a / the second cover.Example 50: The device of example 48 or 49, where a / the cannula opening septum is arranged in the cannula opening which is located in the sterile compartment.Example 51: The device of any of examples 48-50, further comprising a gasket to isolate the electronic compartment from the sterile compartment.Example 52: The device of any of examples 48-51, further comprising at least one of a torsion spring.Example 53: The device of any of examples 1-52, where a / the adhesive liner includes a cannula opening septum cover, such that, the cannula opening septum is uncovered upon use after the adhesive liner is removed.Example 54: The device of any of example 1-52, where the insertion assembly further comprises any of (if not mutually exclusive: a plurality of in some embodiments, a majority of, in some embodiments substantially all of, and in some embodiments all of): a / the torsion spring, a crank, a lever, an upper frame, a middle frame, a latch, a cannula stopper, a trigger, a sled, a rod, a needle, a / the needle, a carrier.Example 55: The device of any of examples 1-54, where the device further comprises a delivery assembly and / or the delivery assembly comprises an insulin line, a cannula, and a cannula septum.Example 56: The device of any of examples 1-54, where the device further comprises a sensing assembly and / or the sensing assembly comprises a / the sensor probe, a contacts plate, a sensor flexible printed circuit (FPC), and a / the sensor FPC contact.Example 57: The device of any of examples 1-56, where a / the probe / cannula assembly includes at least one or more components of a / the delivery assembly and / or one or more components of a / the sensor assembly.Example 58: The device of any of examples 1-57, where the device further comprises a driving assembly and / or the driving assembly comprises any of (if not mutually exclusive: a plurality of, in some embodiments, a majority of, in some embodiments substantially all of, and in some embodiments all of): a motor / gear-motor, a one-way bearing, a tilting arm, a ratchet wheel, a ratchet gear, a ratchet stopper spring, a ratchet drive spring, a reservoir cap, a locker, a drive connector, and drive screw.Example 59: The device of any of examples 1-58, where the device further comprises a delivery assembly and / or the delivery assembly comprises any of (if not mutually exclusive: a plurality of, in some embodiments, a majority of, in some embodiments substantially all of, and in some embodiments all of): a plunger, a plunger O-ring, a reservoir, and a filling port.Example 60: The device of any of examples 1-59, where the device further comprises an electronic assembly and / or the electronic assembly comprises any of (if not mutually exclusive: a plurality of, in some embodiments, a majority of, in some embodiments substantially all of, and in some embodiments all of): a control switch, and a / the volume sensor.Example 61: The device of any of examples 1-60, where the device further comprises a pumping assembly and / or the pumping assembly comprises any of (if not mutually exclusive: a plurality of, in some embodiments, a majority of, in some embodiments substantially all of, and in some embodiments all of): a / the ratchet wheel, a / the ratchet gear, a drive connector, a drive screw, a plunger, a / the plunger O-ring, a / the reservoir.Example 62: The device of any of examples 1-60, where the device further comprises a filling assembly and / or the filling assembly comprises any of (if not mutually exclusive: a plurality of, in some embodiments, a majority of, in some embodiments substantially all of, and in some embodiments all of): a / the filling port and directing means / mechanism for directing insulin flow during filling and during delivery.Example 63: The device of any of examples 1-62, where a / the tilting arm includes any of (if not mutually exclusive: a plurality of, in some embodiments, a majority of, in some embodiments substantially all of, and in some embodiments all of): a sliding window, a tilting arm lever, a tilting arm cylinder, a ratchet drive spring arm, and a control switch arm.Example 64: The device of example 63, where a tilting arm cylinder is capable of rotation around a virtual axis of rotation.Example 65: The device of examples 63 or 64, where bi-directional displacement of sliding window and / or the tilting arm lever in a first direction causes rotation of the ratchet drive spring arm and (in some embodiments) the control switch arm.Example 66: The device of any of examples 63-65, where movement of the sliding window and / or the tilting arm lever in a second direction causes rotation of the ratchet drive spring arm and / or the control switch arm.Example 67: The device of any of examples 1-66, where a / the drive assembly further comprises an excentre.Example 68: The device of any of examples 1-67, further comprising an actuator cylinder. Example 69: The device of example 68, where the actuator cylinder includes a spiral groove. Example 70: The device of any of examples 1-69, further comprising at least one of a motorshaft including a plurality of triangular grooves, one or more rollers, and a supporting ring. Example 71: The device of any of examples 1-70, where a / the gear-motor is engaged with a / the motor shaft such that rotation of the gear-motor causes rotation of motor shaft.Example 72: The device of any of examples 68-71, where rotation of the actuator cylinder in a specific direction causes displacement of a / the trigger.Example 73: The device of any of examples 58-72, where the one-way bearing includes a / the motor shaft, a / the excentre, a / the plurality of triangular grooves, a / the plurality of rollers, and a / the actuator cylinder.Example 74: The device of any of examples 70-73, where each of the one or more rollers are arranged in a respective triangular groove of a plurality of triangle grooves, such that, each roller is rotated during rotation of motor shaft.Example 75: The device of any of examples 26-74, where the insertion mechanism includes a / the torsion spring, a crank, a crank bulge, a lever, a / the first lever arm, a / the second lever arm, a / the sled, a sled bulge, a first and a second lever arm window.Example 76: The device of any of examples 26-75, where the insertion mechanism further comprises a latch, and an upper frame.Example 77: The device of any of examples 23-76, where the delivery assembly includes a / the single lumen cannula, a cannula connector, and an / the insulin line.Example 78: The device of any of examples 23-77, where during insertion of the single lumen cannula, the insulin line is bent and follows displacement of the single lumen cannula and / or a cannula connector.Example 79: The device of any of examples 56-78, where during insertion, the contacts plate is displaced with the sensor probe and a sensor FPB is bent and follows displacement of the contacts plate.Example 80: The device of any of examples 15-79, further comprising a needle hub.Example 81: The device of any of examples 22-80, where the sensor probe and a / the contacts plate are planar and include a rectangular cross section.Example 82: The device of any of examples 22-81, where the sensor probe comprises at least two sides.Example 83: The device of example 82, where the sensor probe includes a plurality ofelectrodes.Example 84: The device of example 83, where the plurality of electrodes is selected from the group consisting of at least one working electrode, at least one reference electrode, and at least one priming electrode.Example 85: The device of any of examples 82-84, where the at least two sides comprise a first side and a second side.Example 86: The device of example 85, where the first side includes no electrodes, one electrode, or a plurality of electrodes, and where the second side includes no electrodes, one electrode, or a plurality of electrodes.Example 87: The device of example 85, where the first side includes at least one working electrode, at least one reference electrode, at least one counter electrode and at least one priming electrode.Example 88: The device of any of examples 83-87, where each electrode is electrically connected via sensor probe traces to a corresponding electrical contact on a contacts plate. Example 89: The device of any of examples 83-88, where a / the second side including a working electrode, a reference electrode, and a counter electrode.Example 90: The device of any of examples 87-89, where the working electrode, the reference electrode, and the counter electrode provide continuous measurements of glucose within the subcutaneous tissue.Example 91: The device of any of examples 87-90, where the priming electrode detects insulin during priming of the device.Example 92: The device of any of examples 21-91, where the sensor probe comprises a working electrode, a reference electrode, a priming electrode, a working electrode, a reference electrode, and a counter electrode.Example 93: The device of any of examples 83-92, where a first plurality of the plurality of electrodes is provided on a first side of the sensor probe, and a second plurality of the plurality of electrodes are provided on a second side of the sensor probe.Example 94: The device of any of examples 82-93, where a / the second side of the probe sensor is opposite a / the first side.Example 95: The device of any of examples 58-94, where pumping assembly includes a / theratchet wheel, a / the ratchet gear, the drive connector, the drive screw, a drive thread, a / the plunger, a / the plunger O-ring, and a / the reservoir.Example 96: The device of any of examples 23-95, where the driving assembly includes a / the ratchet drive spring, a / the tilting arm, and a / the reservoir cap.Example 97: The device of any of examples 61-95, where following filling of a / the reservoir, the pumping assembly is operated according to a plurality of phases.Example 98: The device of example 97, where during a first phase of a plurality of the phases of the pumping assembly operation, the reservoir is partially filled with insulin and a / the plunger and a / the drive screw are displaced.Example 99: The device of examples 97 or 98, where during a second phase of the plurality of phases of the pumping assembly operation, the ratchet wheel is rotated so as to cause rotation of the ratchet gear.Example 100: The device of any of examples 98-99, where the ratchet gear is rigidly connected with the ratchet wheel.Example 101: The device of any of examples 97-100, where the ratchet wheel and the ratchet drive are fixed in place axially.Example 102: The device of example 101, where during each of the plurality of phases, the ratchet wheel and the ratchet drive are not displaced.Example 103: The device of any of examples 97-102, where the ratchet gear causes rotation of a / the drive connector.Example 104: The device of example 103, where the drive connector causes rotation of the drive thread.Example 105: The device of example 104, where the drive thread is rigidly connected with a / the drive connector.Example 106: The device of any of examples 97-105, where during a third phase of the plurality of phases, the ratchet wheel is rotated so as to cause rotation of the ratchet gear. Example 107: The device of example 106, where rotation of the ratchet gear causes rotation of a / the drive connector.Example 108: The device of example 107, where rotation of the drive connector causes rotation of the drive thread.Example 109: The device of any of examples 106-108, where the ratchet gear is engaged with the drive connector.Example 110: The device of example 109, where displacement of the drive connector is halted, and the drive screw is displaced.Example 111: The device of example 110, where displacement of the drive screw causes displacement of the plunger within the reservoir such that insulin is delivered from the reservoir via a / the insulin line and the single lumen cannula into tissue.Example 112: The device of any of examples 58-111, where engagement between the ratchet gear and the drive connector at any desired filling volume allows minimal time between initiation of a / the gear-motor operation and displacement of a / the plunger within a / the reservoir.Example 113: The device of example 112, where engagement is via an engagement mechanism that includes the ratchet wheel, the ratchet gear, a / the ratchet gear protrusion, a / the drive connector, a / the drive connector groove, a / the drive connector lock.Example 114: The device of example 113, where prior to filling of the reservoir, the ratchet gear protrusion is located within a / the drive connector groove.Example 115: The device of examples 112 or 113, where after partial reservoir filling, the plunger and the drive connector are displaced.Example 116: The device of any of examples 112, 113 and 115, after beginning of rotation of the ratchet wheel, the ratchet gear, and the drive connector, a ratchet gear protrusion is freely displaced within a drive connector groove in a same direction.Example 117: The device of example 116, where the ratchet gear causes rotation of the drive connector by a force applied by the ratchet gear protrusion on the drive connector groove. Example 118: The device of example 117, where further rotation of the ratchet wheel, the ratchet gear, and the drive connector causes the ratchet wheel protrusion to be locked within the drive connector lock.Example 119: The device of any of examples 62-118, where the filling assembly directs insulin flow from a filling syringe to a / the reservoir during filling of the reservoir as well as directing insulin flow from the reservoir to a / the insulin line during delivery.Example 120: The device of any of examples 62-119, where the filling assembly preventsdelivery of insulin into the insulin line during filling of the reservoir.Example 121: The device of any of examples 62-120, where the filling assembly comprises or further comprises a filling septum, and a filling O-ring, a filling needle, the reservoir, a / the plunger, and an / the insulin line.Example 122: The device of example 121, where the filling port is located on a side of the device which is adhered to the skin of a user.Example 123: The device of any of examples 119-122, where a / the filling needle transverses a / the filling septum, crosses a / the filling O-ring, and blocks the insulin line.Example 124: The device of any of examples 119-123, where following filling of the reservoir to a desired amount, the filling needle is retracted, and the filling septum is self-sealed.Example 125: The device of any of examples 119-124, where the filling needle includes a curved tip.Example 126: The device of any of examples 119-125, where the filling assembly further includes a valve body, a valve O-ring, a valve membrane, a valve sphere, a valve spring, a valve bushing, and a valve septum.Example 127: The device of example 126, where during filling, the filling needle traverses the valve septum and displaces the valve sphere and a / the (sealed) insulin line.Example 128: The device of any of examples 13-127, where the volume sensor includes one or more volume sensor connectors, a volume sensor rod, and one or more volume sensor traces. Example 129: The device of example 128, where the volume sensor rod is rigidly connected with a / the plunger.Example 130: The device of any of examples 128-129, where the volume sensor connectors are comprised of a conductive element.Example 131: The device of any of examples 128-130, where the volume sensor is used for detection of a minimal insulin filling threshold during filling and detection of minimal predetermined insulin volume in a / the reservoir.Example 132: The device of any of examples 128-131, where during insulin delivery, the plunger and the volume sensor rod are displaced and an electrical circuit is closed.Example 133: The device of any of examples 128-132, where after displacement of the plunger to a minimal predetermined point, further movement of the plunger is stopped, and thevolume sensor rod is disconnected from the volume sensor connector, and a / the electrical circuit is open.Example 134: The device of any of examples 24-133, where the priming sensor includes a priming electrode, a priming sensor trace, and a priming electrode contact.Example 135: The device of example 134, where the priming electrode is located on a proximal end of a / the sensor probe.Example 136: The device of any of examples 129-135, where a / the priming sensor detects insulin within the single lumen cannula and for alerting the user that the device is ready for operation (insulin delivery).Example 137: The device of any of examples 1-133, where a / the priming sensor includes a / the interface PCBA, a / the insulin line, a / the flexible insulin line, a / the upper frame, a priming contact, and a priming contact.Example 138: The device of example 137, where priming contact 1 is a conductive metal and is electrically connected to the interface PCBA.Example 139: The device of any of examples 137 and 138, where priming contact 2 is a conductive metal and is rigidly connected to the upper frame and to the interface PCBA. Example 140: The device of any of examples 137-139, where a / the insulin line is conductive metal and is electrically coupled with the upper frame.Example 141: The device of any of examples 1-140, including an occlusion sensor for detecting an occlusion of a / the single lumen cannula, and includes a / the interface PCBA, a / the tilting arm, a / the ratchet wheel, an encoder, an encoder cap, and an encoder switch.Example 142: The device of example 141, where the encoder comprises a cogwheel with multiple teeth which is rigidly connected to the ratchet wheel and secured in place with the encoder cap.Example 143: The device of example 142, where during operation, the tilting arm rotates the ratchet wheel, a / the ratchet gear, and a / the drive connector, and consequently, a / the plunger is displaced within a / the reservoir.Example 144: The device of example 143, where concomitantly with rotation of the ratchet wheel, the encoder rotates in the same direction.Example 145: The device of example 144, where Rotation of the encoder is detected by on / offengagement of teeth of the encoder with the encoder switch.Example 146: The device of example 145, where in the event of an occlusion, rotation of the encoder ceases, and an occlusion alarm is triggered due to a mismatch between a / the gearmotor an operation (on) and the encoder switch detection of no rotation (off).Example 147:. An automated-insulin-delivery (A ID) method for an AID device according to any of examples 1-146, configured to operate in at least one of two operational phases, the operational phases comprising at least a delivery phase and a non-delivery phase.Example 148: The method of example 147, where during the delivery phase, a / the ratchet wheel rotates, and during the non-delivery phase, the ratchet does not rotate.Example 149: The method of examples 147 or 148, where during the delivery phase, rotation of a / the excentre in a first rotational direction within a / the sliding window results in at least one of: movement of at least one of the sliding window and a / the tilting arm lever in a first linear direction, and displacement of at least one of a / the control switch arm and ratchet drive spring arm in respective linear directions.Example 150: The method of any of examples 147-149, where displacement of a / the ratchet drive spring results in rotation of a / the ratchet wheel in a first rotational direction.Example 151: The method of example 150, where the first rotational direction is a counterclockwise direction.Example 152: The method of any of examples 147-151, where a / the ratchet stopper spring is arranged to avoid rotation of a / the ratchet wheel in an opposition rotational direction to a / the ratchet drive spring.Example 153: The method of example 152, where the opposite rotational direction is a clockwise direction.Example 154: The method of any of examples 147-153, where rotation of a / the ratchet wheel results in rotation of a / the ratchet gear and a / the drive connector causing displacement of a / the drive screw.Example 155: The method of any of examples 147-150, where displacement of a / the control switch arm in one direction results in disconnection of a / the control switch and in a second opposite direction, results in connection of the control switch.Example 156: The method of example 155, where disconnection of the control switchcorresponds to an “OFF” position in which there is no electrical communication therethrough, and connection of the control switch corresponds to an “ON” position in which there is electrical communication therethrough.Example 157: The method of any of examples 147-156, where during the delivery phase, each revolution of a / the excentre causes at least one of (and preferably a plurality or all of): at least one up and down movement of a / the tilting arm, displacement of at least one tooth of a / the ratchet wheel, and at least one on / off cycle of a / the control switch.Example 158: The method of example 157, where a displacement of one tooth corresponds to movement of a / the drive screw and a predefined amount of delivered insulin.Example 159: The method of any of examples 147-158, upon failure of a / the driving assembly or an occlusion in a / the insulin delivery path, the method further includes generation of at least one of a visual, haptic, and audible alarm, via a / the control switch being kept in either an “ON” or “OFF” position.Example 160: The method of any of examples 147-159, where during a delivery phase, the method further includes: first rotation of a / the gear-motor, a / the motor shaft, and a / the excentre in a first, clockwise direction such that a / the actuator cylinder is correspondingly rotating in a same direction, the trigger is displaced causing activation of a / the insertion mechanism so as to insert a / the single lumen cannula and a / the sensor probe into subcutaneous tissue; and second rotation of the gear-motor, the motor shaft, and the excentre in the first clockwise rotation such that actuator cylinder does not rotate, the trigger is not displaced, the excentre rotates, a / the tilting arm moves in a linear, back and forth manner, a / the delivery assembly is activated, and insulin is delivered into subcutaneous tissue.Example 161: The method of example 160, where the single lumen cannula and the sensor probe are inserted with a / the needle, and immediately after insertion, the needle is immediately retracted.Example 162: The method of any of examples 160-161, where the first rotation also causes rotation of a / the one-way bearing and the excentre causing the rotation of the actuator cylinder and a / the spiral groove, rotation of the spiral groove causes the displacement of the trigger and release of a / the latch; and upon the latch being released, a / the sled and a / the rod are displaced by a / the lever in predetermined direction.Example 163: A cannula and sensor probe insertion method for an automated -insulin-delivery (AID) device of any of examples 1-146 comprising prior to insertion, concealing a / the needle,a / the single lumen cannula, and a / the sensor probe within the AID device as part of an insertion mechanism, activating insertion of the single lumen cannula and sensor probe, upon which the needle, cannula and sensor probe are inserted into subcutaneous tissue, and after activation, retracting and concealing within the AID device while the single lumen cannula and sensor probe remain within the subcutaneous tissue.Example 164: The method of examples 162 or 163, where following release of a / the latch, a / the sled is released and a / the torsion spring causes rotation of a / the crank and a / the crank bulge.Example 165: The method of example 164, where rotation of a / the sled bulge, which is locked between a / the first lever arm and a / the second lever arm, causes displacement of a / the lever arm window.Example 166: The method of example 165, where the sled bulge located within a / the lever arm window is displaced so as to cause displacement of the sled, the rod, and a / the needle.Example 167: The method of any of examples 162-166, where further rotation of a / the crank and a / the crank bulge causes further displacement of a / the sled bulge and the sled in a predetermined direction and displacement of the rod in the same direction, and retraction of a / the needle.Example 168: An automated-insulin-delivery (AID) device comprising a housing including an adhesive tape configured to adhere the housing to skin of a user via the adhesive tape and housing at least: an insulin pump including a single lumen cannula, a glucose sensor including a sensor probe, a processor, an insertion assembly including a needle, the insertion assembly for inserting the single lumen cannula and the sensor probe within subcutaneous tissue, and an automated-insulin-delivery algorithm (AIDA), where the sensor 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 automatically control insulin delivery by the insulin pump according to glucose levels from subcutaneous tissue based on signals received from the glucose sensor.Example 169: The device of example 168, further comprises a driving assembly, where the driving assembly comprises a motor, a one-way bearing, a tilting arm, a ratchet wheel, a ratchet gear, a ratchet stopper spring, a ratchet drive spring arm, a drive screw, and a drive connector, and a ratchet drive spring, a reservoir cap, a locker, a drive connector.Example 170: The device of example 169, where the tilting arm includes a sliding window, atilting arm lever, a tilting arm cylinder, a ratchet drive spring arm, and a control switch arm. Example 171: The device of example 170, where the tilting arm cylinder is configured to rotate around a virtual axis of rotation.Example 172: The device of example 170, where bi-directional displacement of the sliding window and / or the tilting arm lever in a first direction causes rotation of the ratchet drive spring arm and / or the control switch arm.Example 173: The device of example 169, where movement of the sliding window and / or the tilting arm lever in a second direction causes rotation of the ratchet drive spring arm and / or the control switch arm.Example 174: The device of example 170, where the drive assembly further comprises an excentre.Example 175: The device of example 169, further comprising an actuator cylinder.Example 176: The device of example 175, where the actuator cylinder includes a spiral groove.Example 177: The device of example 176, further comprising at least one of a motor shaft including a plurality of triangular grooves, one or more rollers, and a supporting ring.Example 178: The device of example 177, where the motor is engaged with the motor shaft such that rotation of the motor causes rotation of the motor shaft.Example 179: The device of example 175, further comprising a trigger, where rotation of the actuator cylinder in a specific direction causes displacement of the trigger.Example 180: The device of example 169, where the one-way bearing includes a motor shaft, an excentre, a plurality of triangular grooves, a plurality of rollers, and an actuator cylinder. Example 181: The device example 169, after initiation of rotation of the ratchet wheel, the ratchet gear, and the drive connector, a ratchet gear protrusion is freely displaced within a drive connector groove in a same direction.Example 182: The device of example 181, further comprising an encoder, where concomitantly with rotation of the ratchet wheel, the encoder rotates in the same direction. Example 183: The device of example 174 [[7]], where rotation of the excentre in a first rotational direction within the sliding window during a delivery phase results in at least one of: movement of at least one of the sliding window and the tilting arm lever in a first lineardirection, and displacement of at least one of the control switch arm and the ratchet drive spring arm in respective linear directions.Example 184: The device of example 183, where displacement of the ratchet drive spring results in rotation of the ratchet wheel in a first rotational direction.Example 185: The device of example 184, where the first rotational direction is a counterclockwise direction.Example 186: The device of example 169, where the ratchet stopper spring is arranged to avoid rotation of the ratchet wheel in an opposite rotational direction to the ratchet drive spring. Example 187: The device of example 186, where the opposite rotational direction is a clockwise direction.Example 188: The device of example 169, where rotation of the ratchet wheel results in rotation of the ratchet gear and the drive connector causing displacement of the drive screw. Example 189: The device of example 170, where displacement of the control switch arm in one direction results in disconnection of the control switch and in a second opposite direction, results in connection of the control switch.Example 190: The device of example 179, where during a delivery phase: a first rotation of the motor, the motor shaft, and the excentre in a first, clockwise direction such that the actuator cylinder is correspondingly rotated in a same direction, the trigger is displaced causing activation of the insertion mechanism so as to insert the single lumen cannula and the sensor probe into subcutaneous tissue; and second rotation of the motor, the motor shaft, and the excentre in the first clockwise rotation such that actuator cylinder does not rotate, the trigger is not displaced, the excentre rotates, the tilting arm moves in a linear, back and forth manner, the delivery assembly is activated, and insulin can be delivered into subcutaneous tissue.Example 191: The device of example 190, where the device further comprises a latch, a sled, a rod and a lever, the actuator cylinder includes a spiral groove, the first rotation also causes rotation of the one-way bearing and the excentre causing rotation of the actuator cylinder and the spiral groove, rotation of the spiral groove causes the displacement of the trigger and release of the latch; and upon the latch being released, the sled and the rod are displaced by the lever in predetermined direction.Example 192: The device of example 191, where the device further comprises a crank, a crank bulge, a sled budge, and a needle, and further rotation of the crank and the crank bulge causesfurther displacement of the sled bulge and the sled in a predetermined direction and displacement of the rod in the same direction, and retraction of the needle.GENERAL CONSIDERATIONS

[0058] 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 and / or structures for performing the function 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 or illustrated herein. More generally, those skilled in the art will readily appreciate that all structure, parameters, dimensions, materials, functionality, and configurations described herein are meant to be an example and that the actual structure, parameters, dimensions, materials, functionality, 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 the claims supported by the present disclosure, and equivalents thereto, inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are also directed to each individual feature, system, article, structure, material, kit, functionality, step, and method described herein. In addition, any combination of two or more such features, systems, articles, structure, materials, kits, functionalities, steps, and methods, if such are not mutually inconsistent, is included within the inventive scope of the present disclosure. Moreover, some embodiments of this disclosure may be distinguishable from the prior art for specifically lacking one or more features / elements / functionality (i.e., claims directed to such embodiments can include negative limitations distinguishing said claim from the prior art).

[0059] Also, as noted, various inventive concepts may be embodied as one or more methods. The acts performed as part of a method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated and described, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.

[0060] In some embodiments, methods of treatment of a human (e.g., supplying a drug,including, for example, insulin), can also correspond to methods for not treating a human, and can include, for example, testing the devices, systems and components thereof disclosed herein (or testing methods of delivery, for example), which can be the same as or at least substantially similar to such treatment methods. Accordingly, method embodiments for treatment can be drafted as such and not be a method of treatment.

[0061] 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.

[0062] 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). Additionally, “any and all” of certain recited items including a part(s), a structure(s), a function(s) / functionality, a clarification(s) or a step(s) (and the like) corresponds to certain embodiments only including one of such item (and in some embodiments, only such item), certain embodiments including two or more of such items (and in some embodiments, only two or more of such items), certain embodiments including substantially all of the items (and in some embodiments, only substantial number of the items), and certain embodiments including all of such items (and in some embodiment, only all of such embodiments).

[0063] 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.

[0064] 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 withopen ended language such as “comprising” 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.

[0065] 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.”

[0066] “Consisting essentially of,” when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0067] 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.

[0068] 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

1. What is currently claimed:

1. An automated-insulin-delivery (AID) device comprising:a housing including an adhesive tape configured to adhere the housing to skin of a user via the adhesive tape and housing at least:an insulin pump including a single lumen cannula,a glucose sensor including a sensor probe,a processor,an insertion assembly including a needle, the insertion assembly for inserting the single lumen cannula and the sensor probe within subcutaneous tissue, and an automated-insulin-delivery algorithm (AIDA),wherein:the sensor probe at least partially resides within the single lumen cannula,andthe AIDA is configured as computer instructions operating on the processor causing the processor to automatically control insulin delivery by the insulin pump according to glucose levels from subcutaneous tissue based on signals received from the glucose sensor.

2. The device of claim 1, further comprises a driving assembly, wherein the driving assembly comprises a motor, a one-way bearing, a tilting arm, a ratchet wheel, a ratchet gear, a ratchet stopper spring, a ratchet drive spring arm, a drive screw, and a drive connector, and a ratchet drive spring, a reservoir cap, a locker, a drive connector.

3. The device of claim 2, wherein the tilting arm includes a sliding window, a tilting arm lever, a tilting arm cylinder, a ratchet drive spring arm, and a control switch arm.

4. The device of claim 3, wherein the tilting arm cylinder is configured to rotate around a virtual axis of rotation.

5. The device of claim 3, wherein bi-directional displacement of the sliding window and / or the tilting arm lever in a first direction causes rotation of the ratchet drive spring arm and / or the control switch arm.

6. The device of claim 2, wherein movement of the sliding window and / or the tilting arm lever in a second direction causes rotation of the ratchet drive spring arm and / or a control switch arm.

7. The device of claim 3, wherein the driving assembly further comprises an excentre.

8. The device of claim 2, further comprising an actuator cylinder.

9. The device of claim 8, wherein the actuator cylinder includes a spiral groove.

10. The device of claim 9, further comprising at least one of a motor shaft including a plurality of triangular grooves, one or more rollers, and a supporting ring.

11. The device of claim 10, wherein the motor is engaged with the motor shaft such that rotation of the motor causes rotation of the motor shaft.

12. The device of claim 8, further comprising a trigger, wherein rotation of the actuator cylinder in a specific direction causes displacement of the trigger.

13. The device of claim 2, wherein the one-way bearing includes a motor shaft, an excentre, a plurality of triangular grooves, a plurality of rollers, and an actuator cylinder.

14. The device claim 2, wherein after initiation of rotation of the ratchet wheel, the ratchet gear, and the drive connector, a ratchet gear protrusion is freely displaced within a driveconnector groove in a same direction.

15. The device of claim 14, further comprising an encoder, wherein concomitantly with rotation of the ratchet wheel, the encoder rotates in the same direction.

16. The device of claim 7, wherein rotation of the excentre in a first rotational direction within the sliding window during a delivery phase results in at least one of: movement of at least one of the sliding window and the tilting arm lever in a first linear direction,anddisplacement of at least one of the control switch arm and the ratchet drive spring arm in respective linear directions.

17. The device of claim 16, wherein displacement of the ratchet drive spring results in rotation of the ratchet wheel in a first rotational direction.

18. The device of claim 17, wherein the first rotational direction is a counterclockwise direction.

19. The device of claim 2, wherein the ratchet stopper spring is arranged to avoid rotation of the ratchet wheel in an opposite rotational direction to the ratchet drive spring.

20. The device of claim 19, wherein the opposite rotational direction is a clockwise direction.

21. The device of claim 2, wherein rotation of the ratchet wheel results in rotation of the ratchet gear and the drive connector causing displacement of the drive screw.

22. The device of claim 3, wherein displacement of the control switch arm in one direction results in disconnection of a control switch and in a second opposite direction, results in connection of the control switch.

23. The device of claim 12, wherein during a delivery phase:a first rotation of the motor, a motor shaft, and an excentre in a first, clockwise direction such that the actuator cylinder is correspondingly rotated in a same direction, the trigger is displaced causing activation of the insertion assembly so as to insert the single lumen cannula and the sensor probe into subcutaneous tissue; andsecond rotation of the motor, the motor shaft, and the excentre in the first clockwise rotation such that actuator cylinder does not rotate, the trigger is not displaced, the excentre rotates, the tilting arm moves in a linear, back and forth manner, the delivery assembly is activated, and insulin can be delivered into subcutaneous tissue.

24. The device of claim 23, wherein:the device further comprises a latch, a sled, a rod and a lever,the actuator cylinder includes a spiral groove,the first rotation also causes rotation of the one-way bearing and the excentre causing rotation of the actuator cylinder and the spiral groove,rotation of the spiral groove causes the displacement of the trigger and release of the latch;andupon the latch being released, the sled and the rod are displaced by the lever in predetermined direction.

25. The device of claim 24, wherein:the device further comprises a crank, a crank bulge, a sled budge, and a needle,andfurther rotation of the crank and the crank bulge causes further displacement of the sled bulge and the sled in a predetermined direction and displacement of the rod in the same direction, and retraction of the needle.

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