Patch pump system and device and method for managing diabetes

Abstract

Embodiments of the present disclosure relate to systems, devices, and methods for diabetes management. In particular, the present disclosure relates to systems, devices, and methods for dispensing insulin to a patient using a miniature portable patch pump.

Description

[0001] This application is a divisional application of application number 201880040067.4, application date June 15, 2018, and invention name “Patch pump system and device and method for managing diabetes”. Technical Field

[0002] Embodiments of the present disclosure relate to systems, devices, and methods for managing diabetes. More specifically, the present disclosure relates to a miniature portable skin-fixable insulin patch pump for dispensing insulin to a patient. Background Art

[0003] People with diabetes need to take varying amounts of insulin throughout the day to control their blood sugar levels. Ambulatory, portable insulin infusion pumps can be used as an alternative to multiple daily insulin injections, but such pumps can be bulky and complex to operate. Summary of the invention

[0004] Embodiments of the present disclosure relate to a diabetes management system comprising a miniature insulin patch pump. In some embodiments, it may be desirable that the tubeless insulin patch pump that the skin can fix is ​​a "pager-style" insulin pump, because they are relatively small and avoid pipeline handling and complications. Although the pump is miniaturized, it may also be desirable that the patch pump meets at least the technical specifications and user interface requirements similar to the pager pump. Although the discussion of several embodiments in the current disclosure is to use insulin as the medicine delivered by the patch pump disclosed herein, it should be understood that the use of the disclosed patch pump for other fluids is also considered to be within the scope of the invention embodiments described herein.

[0005] In some embodiments, the patch pump can be controlled by a handheld controller with a wired or wireless communication device, examples of which include RF communication devices, such as but not limited to Bluetooth or Bluetooth low energy (BLE). The patch pump can be integrated into a diabetes management system, which includes a continuous glucose monitor (CGM) and a blood glucose monitor (BGM). The artificial pancreas algorithm on the patch pump processor can control the delivery of insulin ("closed loop system") according to the continuous or intermittent glucose readings received from the remote CGM (e.g., automatically when prompted, etc.). The patch pump can regularly (e.g., continuously) deliver insulin, receive glucose readings from the CGM and thus administer insulin, and receive push commands from the controller at mealtime. The controller can communicate with a smart phone and / or with one or more servers (e.g., in a one-way or two-way communication line to the cloud), so that data from the diabetes management system can be transmitted online to a remote location. As an example, the controller of the patch pump worn by a pediatric patient can transmit various data collected and / or received by the patch pump to a parent's smartphone and / or one or more computer servers of a child's health care provider.

[0006] In some embodiments, the patch pump may include one or more of the following: 1) a reusable part (RP), which may include a housing ("RP housing"), a connecting magnet / iron plate, one or more power sources (such as batteries), a buzzer, a drive mechanism (including a motor, gears and a lead screw), at least a portion of a pumping mechanism in some instances, and an electronic module (including a PCB, a microprocessor and a sensor); 2) a disposable part (DP), which may include a housing ("DP housing"), a connecting magnet / iron plate, an adhesive substrate, at least a portion of a pumping mechanism in some instances, the pumping mechanism may include a cannula, a first reservoir and a second reservoir (a dosing device), a first plunger and a second plunger, a dosing device actuator, a conductive catheter, a dual-chamber valve mechanism, an inlet and an outlet ("well"); 3) a preloaded disposable inserter assembly (also referred to herein as a patch pump auxiliary system, and these phrases are used interchangeably throughout the text), which may include a housing, a trigger, a safety buckle, a cannula insertion mechanism, a release mechanism, an observation window, and 4) a charger.

[0007] In some embodiments, the RP includes at least two compartments, a ventilated compartment and a sealed compartment that are connected to atmospheric air. The ventilated compartment includes a cavity occupied by the first reservoir after the RP-DP connection. The sealed compartment includes a drive mechanism, an electronic module, and a cavity occupied by the first reservoir (doser) after the RP-DP connection. The drive mechanism includes a motor (e.g., a stepper motor or a DC motor), a gear, and a lead screw. The lead screw pin vertically crosses the opening at the tail of the lead screw and can slide freely in the groove of the RP housing. During the operation (and rotation) of the motor and gear, the lead screw pin prevents the lead screw from rotating and thus causes the lead screw to linearly displace in one direction. Reversing the direction of rotation of the motor and gear causes the lead screw to linearly displace in the opposite direction.

[0008] In some embodiments, DP includes a pumping mechanism and all or substantially all parts in contact with the delivered fluid (e.g., a drug such as, but not limited to, insulin), including a reservoir, a dual-chamber valve mechanism, a conduit, a filling port, and an outlet. The dual-chamber valve mechanism ("valve mechanism") may include an inlet chamber and a discharge chamber. The main conduit is a first conduit communicating between the first reservoir and the inlet chamber and a second conduit communicating between the discharge chamber and the outlet. In some embodiments, DP is provided with a sleeve-a cylinder rigidly connected to the DP housing and accommodating a dosing device so that the dosing device can be freely linearly displaced in the sleeve. The sleeve is connected to a sleeve cover, and the sleeve cover keeps the dosing device in the sleeve cavity. At least one gasket (e.g., RP-DP O-ring) adjacent to the sleeve can provide a seal of the RP sealed compartment after the RP-DP is connected.

[0009] In some embodiments, the DP is provided with an adhesive substrate. The adhesive substrate includes a flexible substrate having an adhesive upper surface and a bottom surface, a filling hole (filling port) covered by a self-sealing rubber diaphragm (filling diaphragm), and a cannula hole. Before operation (for example, before making an RP-DP connection), both adhesive surfaces are covered with a folded removable liner. After the RP-DP connection, the liner is removed, the upper adhesive surface is adhered to the RP housing, and the lower adhesive surface is adhered to the patient's skin. A firm and reversible connection between the RP and the DP can be provided by the combined force of the connecting magnet and the upper adhesive surface of the adhesive substrate. The connecting magnet and the iron plate can be interchangeably located on the RP and / or DP.

[0010] In some embodiments, the DP is provided with a cannula that is inserted into the patient after the patch pump is adhered to the skin. The cannula can be rigid or at least substantially rigid (e.g., a steel cannula) with a sharp tip at the distal end, a cap (cannula cap) at the proximal end, and an opening (cannula opening) in the middle of the cannula. The cannula can be linearly displaced in a groove (DP groove) in a DP housing that traverses the DP housing. The DP groove has an upper end, a lower end, and a middle portion, and the middle portion has a cavity (well). The distal end of the DP groove is communicated with the bonding substrate cannula hole and is sealed by a bottom seal and a bottom spacer. Before insertion, the upper end of the cannula protrudes from the DP housing so that the cannula cap and the cannula opening are located above the DP housing, and the sharp tip is located in the well. During cannula insertion, the cannula cap is aligned with the DP housing, the cannula passes through the bottom seal and the bottom gasket, and the sharp tip of the cannula protrudes below the DP housing through the bonding substrate cannula hole. After insertion, the casing opening is aligned with the well, thereby providing hydraulic communication between the drainage chamber and the casing via the second conduit.

[0011] In some embodiments, when RP and DP are connected, the patch pump is operable. After RP-DP is connected, the first reservoir resides in the RP ventilation compartment, and the dosing device resides in the RP sealed compartment. RP and DP are firmly and / or reversibly connected to the following interfaces: 1) the interface between the magnet (DP) and the iron plate (RP) (or vice versa), and 2) the interface between the adhesive substrate (DP) and the RP housing (RP). After use, the DP adhesive substrate is peeled off from the RP housing and the magnet-iron plate is separated.

[0012] In some embodiments, a preloaded disposable inserter (inserter system, also referred to as a patch pump auxiliary system) is provided. The inserter may include an inserter housing, a RP notch, a safety buckle, an observation window, a trigger, a DP retainer, a preload spring, a rotary nut with a rotary thread and a separator, and a hammer with a linear thread and a sleeve pusher. The rotary thread and the linear thread can engage with each other. When the trigger is pressed, the preload spring rotates the rotary nut, the rotary thread, and the separator, and the hammer moves linearly in the skin direction, and the DP retainer is displaced laterally. The rapid linear displacement of the hammer and the hammer sleeve pusher inserts the sleeve into the body. After insertion, the inserter is removed, and the patch pump is ready for operation.

[0013] In some embodiments, the inserter and DP may be preassembled and provided in a sterile blister. The DP adhesive substrate may be located on the bottom side of the inserter housing. The RP is inserted into the inserter housing through the RP notch, and the RP is connected to the DP within the inserter housing. After the RP-DP connection, the first reservoir is filled through the fill port, and the patch pump is primed according to the controller command.

[0014] In some embodiments, the first reservoir can be filled with a syringe. After extracting fluid (e.g., medicine such as insulin) from a vial, medicine can be injected into the first conduit and the first reservoir from a syringe needle through a filling port. Before the sleeve is inserted, air bubbles can be automatically scavenged when the pumping mechanism is activated by a controller command. Fluid (via a catheter and a dual-chamber valve mechanism) is distributed to a doser from the first reservoir, to a well from the doser, to a cannula tip (before insertion, the cannula tip is located in the well) from the well, and to a cannula opening (before insertion, located above the DP housing) from the cannula tip. When the inserter and the DP housing are in a vertical position, trapped air can be scavenged from the cannula opening before dispensing fluid. During perfusion, the dripping of fluid droplets can be seen through the inserter observation window. Observing the droplets that appear from the cannula opening can notify the user that the patch pump has been perfused. After perfusion is completed, the inserter and the patch pump are adhered to the skin, the sleeve is inserted, and then the inserter is removed from the skin and disposed of.

[0015] In some embodiments, the patch pump provides a reversible engagement mechanism between the RP lead screw and the DP second plunger. The engagement mechanism provides a reversible rigid connection between the lead screw and the second plunger after the RP-DP connection, and allows the lead screw to be disconnected from the second plunger during the RP-DP disconnection. In some embodiments, the engagement mechanism includes a scraper spring. The scraper spring is rigidly or substantially rigidly connected to the second plunger and includes a flexible bracket that is formed to have a recessed portion that can be expanded or reduced in size. In some embodiments, the scraper spring includes a plurality of flat ribs (e.g., three flat ribs); each rib is folded outward into a petal shape. In some specific implementations, the tip of the drive screw has a conical protrusion, and the sleeve cover also has a protrusion ("sleeve cover protrusion"). During the RP-DP connection, the conical protrusion of the drive screw (a part of the RP) is at least substantially rigidly engaged with the scraper spring (a part of the DP). When the second plunger reaches the proximal end of the doser, the scraper spring engages with the sleeve cover protrusion and expands slightly, the lead screw is free to disengage from the scraper spring, and the RP is free to disengage from the DP.

[0016] In some embodiments, the pumping mechanism may include a first reservoir, a first plunger, a second reservoir (doser), a second plunger, a dual chamber valve mechanism (valve mechanism), a first conduit, a second conduit and a well. The dual chamber valve mechanism includes two chambers (inlet chamber and discharge chamber) and a sliding needle, which is at least substantially rigidly connected to the doser. The sliding needle has a proximal end, a closed dead end at the distal end and at least one opening at the midpoint that is hydraulically connected to the doser. The first conduit is communicated between the first reservoir and the inlet chamber ("first conduit"), and the second conduit is communicated between the discharge chamber and the outlet. The first conduit is hydraulically connected to the filling port. During the filling of the first reservoir, the fluid is injected into the first reservoir (e.g., using a needle syringe) through the filling port and the first conduit. The DP outlet (well) includes a sealed cavity that is communicated with the second conduit. The cavity is sealed by a top seal and a bottom seal. During pump operation, the fluid is transported to the well from the discharge chamber through the second conduit, and then transported to the patient through the casing from the well.

[0017] In some embodiments, the first reservoir and the second reservoir both have a proximal end and a distal end. When these reservoirs (the first reservoir and the second reservoir) are empty, the plunger is located at the distal end. When filling the reservoir, the plunger is displaced in the proximal direction, and when the reservoir is filled to maximum capacity, the plunger is located at the most proximal end. In some embodiments, the first reservoir is shaped as a cylinder, so as to have a wall and a cavity. The cross section of the cylinder can be an oval, an elliptical, four arches, a circle or any other symmetrical or nearly symmetrical structure. The dosing device and the sliding needle can be linearly displaced relative to the first reservoir due to the linear displacement of the lead screw and the continuous linear displacement of the second plunger. When the second plunger is displaced in one direction, the dosing device and the sliding needle are linearly displaced along the same first direction (e.g., forward direction), and the sliding needle opening is located in the inlet chamber. In this delivery phase (dosing filling phase), fluid is delivered to the inlet chamber and the dosing device from the first reservoir via the first conduit. When the second plunger is displaced in the opposite direction, the dosing device and the sliding needle are linearly displaced in the same opposite direction (e.g., backward direction), and the sliding needle opening is located in the drainage chamber. In this delivery phase (dosing device emptying phase), the fluid is transported from the dosing device to the well via the drainage chamber and the second conduit, and then transported to the casing from the well. In some embodiments, the first plunger includes a piston and two washers, a first proximal washer and a second distal washer. In some embodiments, the plunger includes a single piece made of a sealing material (e.g., rubber) and having two surfaces in circumferential contact with the first reservoir cavity.

[0018] In some embodiments, the patch pump is provided with a doser sensor. The linear displacement of the second plunger causes two continuous actions: first, the displacement of the doser relative to the first reservoir and the RP housing, and second, the displacement of the second plunger relative to the doser. The patch pump is provided with a sensor (doser sensor) that detects the linear displacement of the doser relative to the first reservoir and the RP housing. The doser sensor can be used to at least substantially accurately define the initiation of fluid delivery (e.g., by calculating the insulin dose) and / or the detection of RP-DP connection / disconnection. When the second plunger is linearly displaced in one direction by the lead screw, the doser is displaced in the same direction due to the friction between the doser and the second plunger. When the doser reaches a rigid stop (e.g., the distal end of the sleeve), the further displacement of the second plunger causes the fluid in the doser to be displaced in the same direction (e.g., insulin delivery). In some embodiments, the sensor includes a photodetector rigidly connected to the RP electronic module. The doser sensor detects the linear motion of the doser label, which can be a sliding identifier rigidly connected to the doser and located within the field of view of the photodetector. A non-limiting example of an identifier may be a barcode, which may include a simple rectangular mark containing black and white colors (e.g., equal amounts). In such examples, black may be interpreted by a photodetector and converted into a relatively low current (or voltage). When the dosing device begins to move forward, the microprocessor of the electronic module activates the photodetector. When the dosing device is further displaced in the forward direction, the black mark gradually occupies the window of the photodetector, and the output voltage decreases. When the dosing device stops displacing, the output voltage remains constant, and the microprocessor interprets the signal as no relative motion between the photodetector and the dosing device label (and no relative motion between the dosing device and the RP housing). In the case where the RP-DP connection is incorrect and / or the RP-DP is accidentally disconnected during pump operation, the dosing device sensor can provide a warning to the user of the patch pump.

[0019] The operation cycle of the patch pump includes at least two stages: 1) doser filling stage, and 2) doser emptying stage. In the doser filling stage, fluid is delivered to the doser from the first reservoir. In the doser emptying stage, fluid is delivered to the outlet from the doser. In the doser filling stage, the displacement of the second plunger in the doser causes negative pressure (relative to atmospheric pressure) in the inlet chamber, the first conduit and the first reservoir. Due to the pressure gradient between the atmosphere and the first reservoir, fluid is delivered to the second reservoir (doser) from the first reservoir and the first plunger is displaced in the direction of fluid displacement. The pressure gradient between the atmosphere and the first reservoir forces air to enter the reservoir through the interface between the first plunger and the first reservoir. The air entering the first reservoir forms bubbles in the delivered fluid (e.g., insulin) and may cause harm to the diabetic pump user due to air injection rather than insulin injection. In addition, during the continuous delivery cycle, the bubble volume increases and the total bubble volume can occupy the main part of the first reservoir volume.

[0020] Embodiments of the present disclosure provide solutions to prevent air from entering the first reservoir, including active solutions and passive solutions. In the active solution, the relative negative pressure in the first reservoir is actively increased to be higher than atmospheric pressure, and in the passive solution, air is at least substantially prevented from entering the first reservoir. In some embodiments of the active solution, when there is fluid communication between the doser and the first reservoir, the negative pressure is eliminated by reversing the direction of fluid delivery at the end of the doser filling phase. The flow delivery from the doser to the first reservoir increases the pressure in the first reservoir to be higher than atmospheric pressure, and therefore air now follows the reverse pressure gradient to move from the first reservoir to the external atmosphere. The reversal of the fluid delivery direction is achieved by the reversal of the second plunger displacement direction (from the filling phase to the emptying phase). At the beginning of the second plunger displacement (emptying phase), the doser lock is activated and the doser rigidity is temporarily fixed in place. At this stage, the displacement of the second plunger causes fluid to be displaced from the doser to the first reservoir. When the doser lock is deactivated, the doser is removed and fixed, and the further displacement of the second plunger displaces the doser and the sliding needle until the opening of the sliding needle is located in the drainage chamber. At this stage, the further displacement of the second plunger displaces the fluid from the doser to the drainage chamber, the second conduit, the well, the sleeve and enters the patient. The doser lock can be operated by, for example, nitinol wire, solenoid, piezoelectric actuator, etc. In the doser lock based on nitinol, the nitinol wire is preformed in the form of a spring; when the spring is transmitted with an electric current, the total length of the spring coil is reduced (for example, due to the nitinol contraction phenomenon), and therefore the doser lock is displaced and engaged with the doser. When the electric current stops, the nitinol wire recovers its length, and the doser lock is disengaged from the doser, and the doser is freely displaceable.

[0021] In some embodiments of the passive solution, air is prevented from entering the first reservoir by a fluid residing between the two washers of the first plunger. The fluid may be, for example, oil or any other high viscosity fluid that can be injected between the two washers. In some embodiments, the fluid is insulin injected between the washers during the filling of the first reservoir. The first reservoir is provided with a circumferential cavity at the distal end, which is slightly larger than the rest of the reservoir cavity. The first plunger is provided with a slot connected to the external atmosphere, which allows air to be scavenged and prevents fluid from being scavenged (fluid restrictor). During the filling of the first reservoir, the plunger is located at the distal end of the first reservoir, the fluid initially occupies the space between the washers, and the air is scavenged into the atmosphere through the fluid restrictor. When the space between the washers is completely occupied by the fluid, the additional fluid injected into the first reservoir displaces the plunger in the proximal direction of the first reservoir. At this stage of the filling of the first reservoir, the first washer of the first plunger is in close contact with the first reservoir wall and maintains the seal between the first reservoir cavity and the wall.

[0022] In some embodiments, the patch pump is provided with a reservoir sensor. The reservoir sensor may include an axial pole magnet that can be attached to the first reservoir plunger, and two Hall sensors residing in the RP sealed compartment adjacent to the first reservoir. The Hall sensor can be a transducer that changes its output voltage in response to a magnetic field. In the case of a known magnetic field, their distance relative to the axial pole magnet (and the first reservoir plunger) can be determined and the relative position of the plunger can be derived. The axial pole magnet and the plunger are displaced within the first reservoir during filling of the first reservoir and during operation of the pump. It should be noted that although the discussion of embodiments related to magnets in this disclosure refers to axial pole magnets, the use of any other magnet type is considered to be within the scope of the inventive embodiments described herein (and is therefore not limited to axial pole magnets).

[0023] In some embodiments, the patch pump is ready for use after the following operations: filling the first reservoir, inserting the RP into the inserter housing, connecting the RP and DP with the magnet / iron plate and adhesive substrate, purging the air (priming), adhering the adhesive substrate to the skin, pressing the inserter trigger, inserting the cannula and disposing of the inserter. At the end of the use of the patch pump (which may be 2-5 days of use in some cases), the pump can be removed from the body by disconnecting the adhesive substrate from the skin. After removing the pump, the adhesive substrate can be folded over the cannula to prevent the user from accidentally stabbing himself. Then, the RP is disconnected from the DP by disconnecting the RP iron plate from the DP magnet (or vice versa). After the RP-DP is disconnected, the RP is placed in a charger to recharge the RP battery for additional operating cycles, and the DP is disposed of.

[0024] Some of the advantages of the embodiments of the present disclosure include the miniature size of the device (thus, convenient portability), its accuracy, and ease of integration. For example, the devices and systems may have the ability to be integrated with closed-loop and open-loop diabetes management systems. In addition, they can be used for longer periods of time compared to conventional systems. In addition, the present embodiments disclose methods for removing bubbles from fluids, a feature that distinguishes these features from conventional methods and systems.

[0025] In some embodiments, a portable device comprising an insulin reservoir communicated with a subcutaneous cannula and a method for continuous (basal) and on-demand (bolus) delivery of insulin are disclosed. Basal and bolus administration rates can contribute to improving the accuracy of insulin delivery. In some embodiments, a mobile skin-adhesive insulin pump (patch pump) that is significantly smaller in size, smaller in volume, thinner and lighter than previously known insulin delivery systems is disclosed. In addition, the skin-adhesive patch pump can be concealable. In some embodiments, the device may not have an operating button and / or may be remotely controlled. In addition, the patch pump can be controlled by various consumer electronic devices that can be used by the patient, such as but not limited to a smartphone, a smart watch, a tablet computer and / or a PC.

[0026] Some embodiments of the present disclosure disclose a patch pump auxiliary system configured to at least be used to insert a cannula into tissue, the system comprising: a housing; a disposable portion (DP) of a patch pump drug delivery system removably attached to the housing; a recess or opening formed in a side of the housing and configured to receive at least a reusable portion (RP) of the patch pump drug delivery device; at least two safety buckles arranged on the housing; and an insertion mechanism configured to insert the cannula when activated.

[0027] The above embodiments (and other embodiments disclosed in the present disclosure) may include at least one or another (or any multiple) of the following features, structures, and functions to provide yet another embodiment of the present disclosure:

[0028] The patch pump assist system includes a trigger for activating the insertion mechanism;

[0029] ●When the notch receives the RP, the RP and DP can be connected;

[0030] The patch pump auxiliary system includes a release mechanism configured to release the connected DP and RP after activation of the insertion mechanism;

[0031] The DP includes a reservoir, and the housing may be configured to receive an external supply of drug that fills the reservoir via the fill port;

[0032] The RP of the patch pump includes a motor configured to automatically achieve priming of the patch pump when connected to the DP;

[0033] The cannula is configured to have at least two openings, a first opening configured for priming the patch pump and a second opening configured for delivering a drug once inserted into tissue;

[0034] The first opening is arranged at or near the proximal end of the cannula, and the second opening is arranged at or near the distal end of the cannula, which is inserted first into the tissue;

[0035] • The first opening is in fluid communication with the reservoir of the DP;

[0036] The cannula is inserted via triggering of the insertion mechanism and simultaneous pressing of at least two safety buckles;

[0037] The cannula is configured to be inserted into the tissue through the DP of the patch pump;

[0038] The patch pump auxiliary system may further include a cannula cap configured to seal the groove in the proximal end of the cannula;

[0039] • When the cannula is inserted into the tissue, the cannula is rigidly connected to and in fluid communication with the patch pump;

[0040] At least one of the insertion mechanism and the release mechanism includes a pivoting lever, a rotating nut, a spring, a trigger, and a hammer;

[0041] ●The trigger includes a trigger stop and a rotation nut stop;

[0042] ●The rotating nut stopper includes a rotating thread and a separator;

[0043] The hammer includes at least one of a hammer linear thread, a hammer guide, and a casing pusher;

[0044] ● The rotary thread is configured to engage with the hammer linear thread;

[0045] ● Movement of the trigger and the swivel nut stop allows the spring and swivel nut to rotate;

[0046] ●The energy stored in the spring causes the rotating nut, rotating threads and separator to rotate;

[0047] ● rotation of the rotating nut causes linear displacement of at least one of the hammer and the casing pusher;

[0048] • Rotation of the separator causes linear displacement of one or more DP retainers configured to release the system after insertion of the cannula;

[0049] The patch pump assist system is configured to perform at least one of: aligning the RP and DP during their connection, maintaining the patch pump during at least one of filling, priming, and skin adhesion of the patch pump; inserting the cannula in a semi-automatic manner upon activation of the trigger;

[0050] The patch pump auxiliary system may include a window configured to provide one or more views for observing drug release during priming of the patch pump;

[0051] ●When the trigger is activated, the rotating nut stop is linearly displaced and the rotating nut is free to rotate about the pivot rod;

[0052] The hammer guide is configured to maintain the linear displacement of the hammer during movement of the hammer in the first direction;

[0053] ● upon activation of the system, the cannula pusher pushes the cannula in a first direction;

[0054] ●Release the trigger stop by depressing or otherwise moving the safety catch;

[0055] The patch pump auxiliary system may further include at least one disposable part (DP) holder, wherein the DP holder is configured to hold an adhesive substrate of a disposable part (DP) of the patch pump substantially in place on a bottom side of the auxiliary system prior to activation of the insertion mechanism and insertion of the cannula;

[0056] ● After activation of the insertion mechanism, the DP holder is displaced laterally and releases the bonded substrate;

[0057] The DP holder is configured to substantially hold the adhesive substrate in place prior to activation of the insertion mechanism;

[0058] ● After activation of the insertion mechanism, the DP holder is displaced laterally to release the adhesive substrate for removal of the auxiliary system;

[0059] The insertion mechanism includes at least a rotational element and a first linear displacement element, and upon activation of the insertion mechanism by a trigger, rotational movement of the rotational element is converted into linear movement of the first linear displacement element to insert the cannula into tissue;

[0060] ● rotational movement of the rotational element occurs in a first plane, and linear movement of the first linear displacement element occurs in a second plane approximately perpendicular to the first plane;

[0061] the insertion mechanism includes a second linear displacement element, and rotational movement of the rotational element causes linear displacement of the first linear displacement element in a first plane orthogonal to the rotational plane and causes linear displacement of the second linear element in a second plane orthogonal to both the rotational element and the first linear displacement element; and

[0062] - The patch pump auxiliary system also includes a liner removably attached to the adhesive substrate.

[0063] Some embodiments of the present disclosure disclose methods of using a patch pump drug delivery system. Such methods may include the following steps: providing a patch pump drug delivery system having a reusable portion (RP) and a disposable portion (DP); providing the patch pump auxiliary system disclosed above; and receiving the reusable portion (RP) of the patch pump via a notch of the auxiliary system so that the RP of the patch pump is connected to the DP of the patch pump.

[0064] The above embodiments (and other embodiments disclosed in the present disclosure) may include at least one or another (or any number of) of the following features, structures, functions, and method steps to provide yet another embodiment of the present disclosure:

[0065] • Fold the liner of the bonding substrate around the upper and bottom sides of the bonding substrate of the DP;

[0066] • Filling the reservoir of the DP of the patch pump with drug via the filling port for delivery by the patch pump;

[0067] ● Prime the patch pump;

[0068] • viewing at least one of the DP, the cannula, and the cannula cap through a window of the auxiliary system;

[0069] Observing droplets emerging from openings in a proximal portion of the cannula via a window in the auxiliary system, wherein in some embodiments the cannula is configured to prevent drug from dripping from one or more first openings disposed at a proximal end thereof during priming;

[0070] ● Automatic activation of the patch pump perfusion via the motor in the RP when the RP is connected to the DP;

[0071] ●Remove the liner and adhere the patch pump to the user's skin;

[0072] • Simultaneously depressing the trigger and at least two safety catches to activate the insertion mechanism to insert the cannula into the tissue; and

[0073] • Activating the insertion mechanism to effect at least one of insertion of the cannula and detachment of the patch pump.

[0074] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in more detail below (assuming such concepts are not mutually inconsistent) are considered part of the inventive subject matter disclosed herein. In particular, all combinations of the claimed subject matter appearing at the end of this disclosure are considered part of the inventive subject matter disclosed herein. It should also be appreciated that terms explicitly adopted herein may also appear in any disclosure incorporated by reference and should be given the meaning most consistent with the specific concepts disclosed herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0075] Those skilled in the art will appreciate that the drawings are primarily for illustrative purposes and are not intended to limit the scope of the inventive subject matter described herein. The drawings are not necessarily drawn to scale; in some cases, various aspects of the inventive subject matter disclosed herein may be shown exaggerated or enlarged in the drawings to facilitate understanding of different features. In the drawings, the same reference numerals generally represent the same features (e.g., functionally similar and / or structurally similar elements).

[0076] Figure 1 A diabetes management system according to some embodiments is shown.

[0077] Figure 2 Shown are top-level components of an insulin delivery system according to some embodiments.

[0078] Figure 3A -C shows the RP-DP connection before ( Figure 3A ), after RP-DP connection ( Figure 3B ) and after the inserter is removed ( Figure 3C ) patch pump.

[0079] Figure 4 The main components of the RP and DP are shown according to some embodiments.

[0080] Figure 5 The assembly of the DP within an inserter is shown according to some embodiments.

[0081] Figure 6 Components of a charger according to some embodiments are shown.

[0082] Figure 7 The main components of a RP according to some embodiments are shown.

[0083] Figure 8 Shown are exploded views of portions of a drive mechanism according to some embodiments.

[0084] Fig. 9 A spatial view of an assembled drive mechanism is shown according to some embodiments.

[0085] Fig. 10A -B shows a longitudinal cross-sectional view of a drive mechanism according to some embodiments.

[0086] Fig.11A -B shows a cross-sectional view and a spatial view of the RP according to some embodiments.

[0087] Fig.12A spatial view (bottom side view) of some of the components of the DP according to some embodiments is shown.

[0088] Fig.13 Shown are exploded spatial views of some of the components of a DP according to some embodiments.

[0089] Fig.14 Shown are exploded spatial views of some of the components of a DP according to some embodiments.

[0090] Fig.15 A cross-sectional longitudinal view of an assembled pump is shown according to some embodiments.

[0091] Fig.16A -B shows a longitudinal cross-sectional view of the DP according to some embodiments.

[0092] Fig.17 A cross-sectional front view of an insulin delivery catheter according to some embodiments is shown.

[0093] Fig.18A -B shows a longitudinal cross-sectional view through the DP sleeve groove and outlet and through the fill port according to some embodiments.

[0094] Fig.19A -D shows an aerial view and a longitudinal cross-sectional view of the DP before and after cannulation, according to some embodiments.

[0095] Fig. 20A -B shows a longitudinal cross-sectional view through the DP cannula groove and filling catheter before and after cannula insertion according to some embodiments.

[0096] Fig.21A -D shows a longitudinal cross-sectional view of a DP groove according to some embodiments.

[0097] Fig.22A -B shows a cross-sectional view of a DP groove during priming and operation according to some embodiments.

[0098] Fig.23 A spatial view of the RP and DP is shown according to some embodiments.

[0099] Fig.24A -B shows a plan cross-sectional view of a patch pump according to some embodiments.

[0100] Fig.25 A scheme of the RP-DP interface and pumping mechanism after RP-DP connection is shown according to some embodiments.

[0101] Fig.26A-C shows a spatial and cross-sectional view of a magnet and an iron plate before and after RP-DP connection according to some embodiments.

[0102] Fig.27A -B shows a magnified version of the magnet and iron plate before and after RP-DP disconnection according to some embodiments.

[0103] Fig.28 Shown is a spatial view of a bonded substrate according to some embodiments.

[0104] Fig.29A -B shows a schematic diagram without a sleeve ( Fig.29A ) and with cannula (before insertion) ( Fig.29A )’s spatial view of DP.

[0105] 30-34 illustrate a sequential process of patch pump handling, including RP-DP connection, liner removal, cannula insertion, patch pump removal, flexible base folding, and RP-DP disconnection, according to some embodiments.

[0106] Figure 35-4 4 illustrates an inserter 300, inserter activation, and inserter operation, including inserter components, mechanisms of action, and user interfaces, according to some embodiments.

[0107] Fig.45A -B shows a partially transparent cross-sectional view (viewing window perspective) of the inserter and patch pump before and after cannula insertion according to some embodiments.

[0108] 46-54 illustrate a reversible engagement mechanism between a RP lead screw and a DP doser plunger according to some embodiments.

[0109] Figure 55-58 A scheme of patch pump operation including a pumping mechanism operation cycle (doser fill phase and doser empty phase), patch pump priming, and patch pump filling according to some embodiments is shown.

[0110] Figure 59-6 4 shows disposable components of a pumping mechanism and an operating cycle of the pumping mechanism according to some embodiments.

[0111] Figures 65-67 Hardware components and hardware operating modes according to some embodiments are shown.

[0112] 68-70 illustrate components and modes of operation of a doser sensor according to some embodiments.

[0113] Figures 71-73Components and modes of operation of a reservoir sensor according to some embodiments are shown.

[0114] Figures 74-83 Components and modes of operation of a bubble guard according to some embodiments are shown. DETAILED DESCRIPTION

[0115] Figure 1 A scheme of a diabetes management system 1000 according to some embodiments is shown. The system includes at least one of the following components: an insulin patch pump 1, a controller 2, a smartphone 8, a continuous glucose monitor (CGM) 3, a blood glucose monitor (BGM) 4, and a server cloud 7. The components of the system 1000 can be configured to communicate with each other in a unidirectional and / or bidirectional communication channel. For example, bidirectional communication may occur between the pump 1 and the controller 2, while unidirectional communication may occur between the pump 1 and the smartphone 8 (e.g., from the pump to the smartphone) or between the pump 1 and the cloud 7 (e.g., from the pump to the cloud). The communication protocol can be Bluetooth, Bluetooth Low Energy (BLE), And any other RF protocol (including proprietary protocols) (such as but not limited to RFID) in one or more. The pump controller 2 can provide the user with an interface for the pump 1 to command the basic dose and the bolus dose and curve and to receive warnings, alarms, log files, etc. The communication between the CGM 3 and the pump 1 can provide an artificial pancreas (closed loop system 5) function, wherein the insulin dose is automatically administered according to the glucose level monitored by the CGM 3 and the algorithm 6. The readings transmitted by the BGM 4 and / or CGM 3 to the pump controller 2 and / or the smart phone 8 provide the user with a glucose reading for calculating the insulin dose. Real-time data and stored data from the pump 1, the pump controller 2, the CGM 3 and the BGM 4 can be transmitted to the smart phone 8 for display or storage. The two-way cellular communication between the smart phone 8 and the cloud 7 can provide the patient with the ability to download personal data stored on a remote server. The data in the cloud 7 can be downloaded, processed and transmitted to or from a PC, a remote smart phone or any other consumer product supporting BLE or wireless communication functions.

[0116] Figure 2The top components of the insulin delivery system 2000 according to some embodiments are shown. The system 2000 may include a patch pump 1, a controller 2, an inserter 300 (interchangeably referred to as a patch pump auxiliary system throughout this disclosure) for inserting an insulin delivery cannula into subcutaneous tissue, and a charger 400 for charging a RP power source (such as a battery). In some embodiments, the length of the patch pump 1 may be in the range of about 30mm to about 50mm, about 32mm to about 45mm, about 35mm to about 40mm, about 37mm (including values ​​and sub-ranges therebetween). In some embodiments, the width of the patch pump 1 may be in the range of about 20mm to about 40mm, about 24mm to about 36mm, about 22mm to about 32mm, about 30mm (including values ​​and sub-ranges therebetween). In some embodiments, the height of the patch pump 1 may be in the range of about 4mm to about 20mm, about 6mm to about 14mm, about 8mm to about 12mm, about 10mm (including values ​​and sub-ranges therebetween). In some embodiments, the weight of the patch pump 1 (including the weight of a liquid medication such as insulin when filled) can be in the range of about 0.2 ounces to about 1 ounce, about 0.3 ounces to about 0.8 ounces, about 0.4 ounces to about 0.6 ounces, about 0.56 ounces, including values ​​and sub-ranges therebetween.

[0117] Figure 3A -C shows the RP-DP connection before ( Figure 3A ), after RP-DP connection ( Figure 3B ) and after the inserter 300 is removed ( Figure 3C ) of the present invention. The patch pump 1 includes a reusable part (RP) 10 and a disposable part (DP) 100.

[0118] Figure 4 The main components of the RP 10 and DP 100 according to some embodiments are shown. The RP 10 may include a housing 20 and at least two compartments, including a vented compartment 22 and a sealed compartment 21. The RP drive mechanism may include a motor 42 and a lead screw 41. The DP 100 may include a housing 110, a front foil 111, a first reservoir 120, a second reservoir (doser) 130, and an adhesive substrate 190. Prior to RP-DP connection, the adhesive substrate 190 may be covered with a removable liner 197.

[0119] Figure 5The assembly of the DP 100 in the inserter 300 is shown according to some embodiments. The DP includes a first reservoir 120, a doser 130, and an adhesive base 190. The inserter 300 includes a trigger 320, a safety catch 330, and a RP notch 312. After the assembly process of the DP 100 in the inserter 300 (dashed arrows), the adhesive base 190 is located on the bottom side of the inserter 300. In some embodiments, a filling syringe 500 is provided. The syringe 500 is used to draw liquid (e.g., insulin) from a vial and fill the first reservoir 120 using a syringe needle 510. In some embodiments, the assembled inserter-DP and syringe 500 are placed in a sterile blister (not shown).

[0120] Figure 6 Components of a charger 400 according to some embodiments are shown, including a charging adapter 410, a USB plug 420, and an electrical plug 430. In some embodiments, the insulin delivery system may include multiple RPs. For example, the insulin delivery system may include two RPs 10, and in such embodiments, when one RP 10 is operating, the second RP 10 is connected to the charger 400 for battery charging. Any other connector (USB, micro-USB, pin connector, etc.) that can be directly plugged into the RP can be used for battery charging.

[0121] Figure 7 Some of the main components of the RP 10 according to some embodiments are shown. The RP housing (20, not shown) includes an RP cover 25 and an RP base 24. The RP cover 25 includes a buzzer 90 embedded in the RP cover 25 and the upper RP groove 23. The RP base 24 includes two embedded charging pads 224 (bottom side), a bottom RP groove 231, a doser sensor socket 631, a reservoir sensor socket one 641 and a reservoir sensor socket two 642. The RP 10 includes a drive mechanism 40, an electronic module 60 and a battery 80. The drive mechanism 40 includes a motor 42, a motor cover 442, a lead screw 44 and a lead screw pin 45. The lead screw pin 45 slides freely in the bottom RP groove 23 and the upper RP groove 231 and prevents rotation of the drive screw 44 during operation of the motor 42. The electronic module 60 may include a PCB 61, a doser sensor 63 and an encoder sensor 66.

[0122] Figure 8An exploded view of some parts of the drive mechanism 40 including the gear 43, the motor 42 and the lead screw 44 according to some embodiments is shown. The drive mechanism base 41 is a frame that aligns three cogwheels - the pinion 431, the idler 433 and the rotating nut 435. The three cogwheels can be spur gears or helical gears, or any other type of gears. The pinion cover 432 holds the pinion 431 in place. In some embodiments, the bearing 436 provides free rotation of the rotating nut 436 within the drive mechanism base 41, and the idler 433 pivots about the idler shaft 434. The lead screw 44 includes a lead screw tip 441, a lead screw tail 445, a lead screw protrusion 443 and a lead screw opening 444. The lead screw 44 engages with the rotating nut 425. In some embodiments, the lead screw pin 45 is transversely perpendicular to the lead screw opening 444 and prevents the lead screw 44 from rotating during operation of the motor 42. Operation of the motor 42 may rotate the pinion 431, the idler gear 433, and the rotating nut 435, and linearly displace the lead screw 44 in one direction. Reversing the rotation direction of the motor 42 may linearly displace the lead screw 44 in the opposite direction.

[0123] Fig. 9 A spatial view of an assembled drive mechanism 40 according to some embodiments is shown. The drive mechanism 40 includes a drive mechanism base 41, which serves as a frame for a motor 42, an assembled gear 43, and a lead screw 44. The gear includes a pinion 431, an idler 433, a rotating nut 435, and a rotating nut bearing 436. A motor sensor (encoder) 46 is attached to the pinion 431. The lead screw 44 engages with the rotating nut 435 and includes a lead screw tip 441 and a lead screw protrusion 443. The lead screw pin 45 prevents the lead screw 44 from rotating during operation of the motor 42 and the gear 43.

[0124] Fig. 10A -B shows a schematic diagram without the lead screw 44 ( Fig. 10A ) and with a lead screw 44 ( Fig. 10B ) is a longitudinal cross-sectional view of a drive mechanism 40. The drive mechanism base 41 supports a motor 42, a pinion 431, a pinion cover 432, an idler gear 433, a rotating nut 435, a bearing 436, and an encoder 46. The lead screw 44 is engaged with the rotating nut 435 ( Fig. 10B ), and includes a lead screw tip 441, a lead screw tail 445 and a lead screw opening 444.

[0125] Fig.11A -B shows a cross-sectional view of RP 10 according to some embodiments ( Fig.11A ) and spatial views ( Fig. 11B). The RP 10 includes a RP housing 20 and is divided (dashed lines) into at least two compartments, including a vented compartment 22 and a sealed compartment 21. The vented compartment 22 includes a cavity 222 for accommodating a DP first reservoir, and the sealed compartment 21 includes a cavity 221 for accommodating a DP second reservoir (after RP-DP connection). The sealed compartment 21 has an opening (sealed compartment opening 26), which can be closed by a DP-RP O-ring ( Fig.12 ) seal. The sealed compartment 21 includes the motor 42, gear 43, battery 80 and lead screws 44a-b. The lead screws (44a-b) are shown in their most forward (distal) position 44a and most rearward (proximal) position 44b. The magnet / iron plate 70 is attached to the motor cover 442, thereby providing a secure interface with the DP magnet / iron plate.

[0126] Fig.12 A spatial view (bottom side view) of some of the components of DP 100 according to some embodiments is shown. DP 100 includes a housing 110, a first reservoir 120, a second reservoir (doser) 130, a sleeve 171, a filling port 180, and a cannula 200. In some embodiments, the cannula is rigid (steel cannula) with a sharp tip 201. The first reservoir 120 has a first plunger 121, a proximal end 1221, and a distal end 1222. The doser 130 (covered by the sleeve 171) can move freely within the sleeve 171. The sleeve 171 has a sleeve cover 173, and it is surrounded by a DP-RP O-ring 170.

[0127] Fig.13An exploded spatial view of some of the components of the DP 100 according to some embodiments is shown. The DP 100 includes a housing 110, a front foil 111, an opening (DP opening 178), and an adhesive substrate 190. A DP groove (upper end 1121 shown) traverses the DP housing 110 and accommodates the cannula 200 before and after insertion. The cannula 200 includes at least one opening 118 (hereinafter referred to as a "cannula opening"). The DP groove includes a cannula spacer 119 (interchangeably referred to as an "upper spacer" or "upper cannula spacer"), a top seal 113, a bottom seal 114, and a bottom spacer 116. The cannula opening 118 is located above the DP groove before insertion and within the DP groove after insertion. The fill port (bottom side, not shown) includes a fill septum 182 and a septum cap 183. The first reservoir 120 includes a plunger 121, which includes a piston 122 and a gasket 124. The first reservoir is shaped as a cylinder, and its cross section can be oval, elliptical, four arches, circular or any other symmetrical or nearly symmetrical configuration. In some embodiments, the plunger 121 may include more than one gasket 124 and / or may include a single piece made of an airtight material (e.g., rubber, EPDM, bromobutyl rubber, etc.), which has at least one circumferential contact point relative to the first reservoir 120. The second reservoir (doser) 130 includes a second plunger (doser plunger) 131, a label 145 (barcode of the doser sensor), a scraper spring 175 (reversible connector with RP lead screw) and a sliding needle 140, and the second plunger (doser plunger) includes a doser piston 132 and a doser gasket 134. The second reservoir 130 can be linearly displaced in a sleeve 171 connected to a sleeve cover 173 and a circumferential gasket (DP-RP O-ring 170). The sleeve 171 is connected to the DP opening 178 by threading, gluing and / or welding.

[0128] Fig.14 An exploded spatial view of some of the components of the DP 100 according to some embodiments is shown. The DP housing 110 includes a first reservoir 120, an upper end of a DP groove 1121, and a DP opening 178. The pre-assembled parts of the doser 130, sleeve 171, and dual chamber valve mechanism 160 are shown from left to right as follows: sleeve components—sleeve 171, sleeve cover 173, and DP-RP O-ring 170; doser components—doser 130, spring scraper 175, doser piston 132, doser plunger 134, doser tab 145, and slide needle 140; and dual chamber valve mechanism 160—front spacer 163, seal-4 164, rear spacer 165, and seal-2 166.

[0129] Fig.15A cross-sectional longitudinal view (through doser 130) of an assembled DP 100 according to some embodiments is shown. A cannula 200 is connected to a DP housing 110. The doser 130 includes a doser wall 1334, a doser cavity 1333, and a slide needle 140 in hydraulic communication with the doser cavity 1333. The doser plunger 131 is composed of a doser piston 132, a doser gasket 134, and a scraper spring 175. The doser plunger 131 is linearly displaceable within the doser 130. The doser 130 is linearly displaceable within a sleeve 171 and a sleeve cover 173. The sleeve cover 173 includes a sleeve protrusion 174 that engages with a scraper spring 175 when the plunger 131 is in a proximal position (e.g., a proximal-most position). A DP-RP O-ring 170 surrounding the sleeve 171 provides sealing of the RP sealed compartment after the DP-RP connection.

[0130] Fig.16A -B shows a longitudinal cross-sectional view of DP 100 according to some embodiments (rear view: Fig.16A , front view: Fig. 16B ). The first reservoir 120 includes a reservoir wall 126, a cavity 127, and a first conduit-a first reservoir channel 1551. The DP housing 110 includes a DP sleeve groove 112, a filling port 180, and a DP opening 178. Fig. 16B A first conduit 150, a second conduit 151, and a first conduit-first reservoir channel 1551 are shown.

[0131] Fig.17 A transverse front view of an insulin delivery catheter according to some embodiments is shown. The first conduit 150 communicates between the first reservoir and the inlet chamber of the valve mechanism ( Figure 59-6 2). A second conduit 151 is connected between the drain chamber and the outlet (well) of the valve mechanism. During the dosing device filling phase ( Fig.55 ), insulin is delivered from the first reservoir via the first conduit-first reservoir channel 1501 and via the first conduit-intake chamber channel 1502 to the inlet chamber. During the dosing device emptying phase ( Fig.56 ), insulin is delivered from the drain chamber to the outlet via the drain chamber-second conduit passage 1511, via the second conduit 151, and via the delivery conduit 153. The filling conduit 152 communicates between the filling port and the first conduit 150. During filling of the first reservoir, a fluid such as insulin can be delivered to the first reservoir via the filling conduit 152, via the first conduit 150, and through the first conduit-first reservoir passage 1501.

[0132] Fig.18A -B shows the DP sleeve groove and outlet according to some embodiments ( Fig.18A) and through the fill port ( Fig.18B ) longitudinal cross-section. Fig.18A Shown are cannula 200, cannula cap 50, cannula septum 119, upper seal 113, bottom seal 114, and bottom septum 116. Insulin is delivered into well 115 through delivery catheter 153 and from well 115 through cannula 200 into the patient. Fig.18B A fill port 180 is shown including a fill hole 181, a fill septum 182, and a septum cap 183. During the first reservoir fill, the syringe needle ( Figure 5 ) is introduced through the filling septum 182, and insulin is delivered via the filling conduit 152 into the first reservoir (via the first conduit).

[0133] Fig.19A -D shows the cannula 200 before insertion according to some embodiments ( Fig.19A and Fig.19C ) and after ( Fig.19B and Fig.19D )'s spatial view of DP 100 ( Fig.19A and Fig.19B ) and longitudinal cross-section ( Fig.19C and Fig.19D ). The DP includes a DP housing 110, a first reservoir 120, a doser 130, an adhesive substrate 190 (a cover with a liner 197), and an upper end of a DP cannula groove 1121. Before the cannula 200 is inserted, the cannula cap 50 is located above the DP housing 110. After insertion, the cannula cap 50 is aligned with the top side DP housing 110.

[0134] Fig. 20A -B shows the cannula 200 before insertion according to some embodiments ( Fig. 20A ) and after ( Fig. 20B ) is a longitudinal cross-sectional view through the DP cannula groove 112 and the filling conduit 153. The DP cannula groove 112 (dashed rectangle) includes a cannula spacer 119, a top seal 115, a well 115, a bottom seal 114, and a bottom spacer 116. The cannula 200 includes a cannula cap 50, a cannula opening 118, and a cannula tip 117. Before the cannula 200 is inserted, the cannula cap 50 and the cannula opening 118 are located above the DP groove 112. After the cannula 200 is inserted, the cannula cap 50 resides in the DP groove 112 and the cannula opening 118 resides in the well 115.

[0135] Fig.21A -D shows a longitudinal cross-sectional view of a DP groove according to some embodiments. Fig.21AShown are DP groove upper end 1121, DP groove lower end 1122, upper seal 113 and lower seal 114. Upper seal 113 and lower seal 114 are both coin-shaped and made of a flexible elastomer (e.g., rubber, silicone, etc.). Well 115 is a sealed compartment in fluid communication with delivery conduit 153. Fig. 21B Shown are a cannula spacer 119 and a lower spacer 116. Both spacers are shaped as cylinders made of a flexible elastomer (eg, rubber, silicone, etc.). Fig. 21C and Fig. 21C It shows that before insertion ( Fig. 21C ) and after ( Fig.21D ) in the DP groove of the sleeve 200. The sleeve 200 includes a sleeve cap 50 and a sleeve opening 118.

[0136] Fig.22A -B shows the perfusion ( Fig.22A ) and operations ( Fig. 22B ) during priming. The DP groove includes a casing spacer 119, a top seal 113, a bottom seal 114, a bottom spacer 116, and a well 115. The well 115 is in hydraulic communication with a fill conduit 153. The casing 200 includes a casing cap 50, a casing opening 118, and a casing tip 117. During priming ( Fig.22A ), the cannula tip 117 is located in the well 115, and the cannula opening 118 and cannula cap 50 are located above the DP housing 110. Insulin is delivered to the well 115 through the delivery catheter 153 and from the well 115 to the opening 118 through the cannula 200. The priming is performed when the patch pump is in the vertical position. The priming is continued until insulin drops are seen appearing at the cannula opening 118 and there is no residual air in the system. During pump operation ( Fig. 22B ), the cannula opening 118 is located in the well 115, and the cannula tip 117 is located below the DP housing 110. Insulin is delivered to the well 115 through the delivery catheter 153, and is delivered from the well 115 to the cannula tip 117 and the patient's body through the cannula 200.

[0137] Fig.23 A spatial view of the RP 10 and DP 100 according to some embodiments is shown. The thick double-arrow dashed line shows the direction of RP-DP connection and disconnection. The light double-arrow line shows the proximal and distal directions of the patch pump parts and components.

[0138] Fig.24A -B shows a planar cross-sectional view of the patch pump 1 according to some embodiments. The patch pump 1 may include a first reservoir 120, a second reservoir 130, a drive mechanism 40, a valve mechanism 160, a battery 80, a motor 42, and an adhesive substrate 190. The dashed line ( Fig.24A) shows the boundaries of the RP sealed compartment.

[0139] Fig.25 A scheme of the RP-DP interface and pumping mechanism 600 after RP-DP connection according to some embodiments is shown. In some embodiments, the pumping mechanism 600 includes the RP lead screw 44 and the DP doser 130, the valve mechanism 160, the doser plunger 131 and the scraper spring 175. Such examples may include embodiments in which the pumping mechanism 600 or at least one part thereof is included only in the RP, only in the DP, or in both the RP and the DP. In some embodiments, the doser 130 includes a wall 1334 and a cavity 1333. The doser plunger 131 is rigidly connected to the scraper spring 175. The lead screw 44 is reversibly connected to the scraper spring 175.

[0140] Fig.26A -C shows the RP-DP connection before ( Fig.26A ) and RP-DP connection ( Fig.26B and Fig.26C ) of the magnet 70 and the iron plate 701 ( Fig.26A ) and cross-sectional view ( Fig.26A and Fig.26B ). The magnet 70 provides a removable secure connection between the RP housing 20 and the DP housing 110. The magnet 70 is rigidly connected to the DP housing 110, and the iron plate is rigidly connected to the motor cover 442 covering the motor 42. After the RP-DP connection, the magnet 70 and the iron plate 701 are in contact with each other. The magnet 70 and the iron plate 71 are interchangeable in position.

[0141] Fig.27A -B shows the RP-DP disconnection before ( Fig.27A ) and after ( Fig.27B ) is an enlarged view of the magnet 70 and the iron plate 701 of the DP housing 110. The iron plate 701 is rigidly connected to the motor cover 442, and the magnet 70 is rigidly connected to the DP housing 110. The dotted arrow shows the direction of movement during disconnection.

[0142] Fig.28A spatial view of an adhesive substrate 190 according to some embodiments is shown. The adhesive substrate 190 includes a flexible substrate 191, a bend line 196, a filling hole 181, and a cannula hole 193. The flexible substrate 191 includes two adhesive surfaces (shown by dashed arrows) - an upper adhesive surface 194 and a lower adhesive surface 195. The two adhesive surfaces (194 and 195) are covered with a folded liner 197. The liner 197 can be removed by grasping the liner flange 198 and peeling the liner 197 from the adhesive substrate bottom surface 195 and the adhesive substrate upper surface 194. The flexible substrate 191 can be folded at the pivot bend line 196. The adhesive substrate upper surface 194 provides a removable secure connection between the DP and the RP. The adhesive substrate bottom surface 195 provides a removable secure connection between the patch pump and the skin.

[0143] Fig.29A -B shows a diagram without ( Fig.29A ) and with ( Fig.29B ) A spatial view of the DP 100 with the cannula 200 (before insertion). The DP 100 includes a first reservoir 120, a doser 130, a flexible base 191, a liner 197, a liner flange 198 and a cannula 200.

[0144] 30-34 illustrate a sequential process of patch pump handling according to some embodiments, including RP-DP connection, liner removal, cannula insertion, patch pump removal, flexible base folding, and RP-DP disconnection. For example, in some embodiments, Fig. 30A -D and Fig.31A -C shows a steric view of the patch pump 1 processing including RP-DP assembly, liner peeling, skin adhesion, and cannula insertion. Fig. 30A An assembled inserter 300 is shown with the DP (reservoir 120 shown) attached to the underside of the inserter (see FIG. Figure 35-4 3). Liner 197 covers both sides of adhesive substrate 190 (hidden, shown in phantom). Fig. 30B The RP 10 is shown inserted into the inserter 300 in the direction of the dashed arrow. Fig. 30C The RP 10 is shown within the inserter 300 (RP and DP connected). Peeling of the liner 197 is initiated by grasping the liner flange 198. Fig.30D The liner 197 is shown during the peeling process, with the liner 197 partially removed from the lower surface (hidden) of the adhesive substrate. Fig.31A The next stage of peeling of the liner 197 is shown, where the liner 197 is removed from the adhesive substrate bottom surface 195 (hidden, shown in phantom) but still covers the adhesive substrate top surface 194. Fig.31BThe inserter 300 and patch pump (partially hidden) are shown after the liner 197 has been completely removed from both adhesive substrate surfaces (194 and 195). At this stage, the adhesive substrate upper surface 194 adheres to the RP and provides a removable, secure connection between the RP and the DP. Fig.31C The inserter 300 is shown positioned on the skin (dashed square) with the adhesive base bottom surface adhered to the skin and the trigger 320 depressed (dashed bold arrow) to insert the cannula.

[0145] Fig.32A -F. Fig.33A -E and Fig.34A -C shows an axial view and a cross-sectional view of the pump treatment after removal from the patient's skin according to some embodiments. Fig.32A and Fig.32B The patch pump 1 , cannula 200 , and flexible substrate 191 are shown after the patch pump 1 has been removed from the skin. Fig.32C The beginning of the folding of the flexible substrate 191 is shown—the adhesive substrate bottom surface 195 folds in the direction of the sleeve 200 , thereby pivoting about the bend line 196 . Fig.32D -F shows further folding of the flexible substrate 191 , with the adhesive substrate upper surface 194 moving away from the RP housing 20 . Fig.33A -E shows further folding of the flexible substrate 191 and bundling of the sleeve 200. After the folding of the flexible substrate 191 is completed, the adhesive substrate bottom surface 195 covers the bundled sleeve 200, which is hidden and prevents the user from accidentally stabbing himself. Fig.34A -C shows a longitudinal cross-sectional view of the DP-RP disconnection stage after the folding of the flexible substrate 191 is completed. RP 10 is disconnected from DP 100 (in the direction of the thick dashed arrow) ( Fig.34A -B). After RP-DP disconnection ( Fig.34C ), recharge RP and dispose of DP.

[0146] Figure 35-4 4 shows an inserter 300, inserter activation, and inserter operation according to some embodiments, including inserter components, mechanisms of action, and user interfaces. In some embodiments, a preloaded inserter 300 is provided. The inserter 300 provides one or more of the following functions: 1- aligns the RP and DP during RP-DP connection, 2- serves as a patch pump holder during filling, priming, and skin adhesion, and 3- inserts the cannula in a semi-automatic manner (when the trigger is pressed). After the cannula is inserted, the inserter 300 is automatically released from the patch pump and disposed of. For example, in some embodiments, Fig.35A spatial view of the main components of the inserter 300 is shown. The inserter includes a housing 310, an RP notch 312, a trigger 320, and two safety buckles 330 on both sides of the inserter housing 310. The RP notch can provide access to the RP during RP-DP connection. The insertion mechanism 341 and the release mechanism 340 include a pivot rod 350, an inserter rotation nut 360, an inserter spring 370, a trigger 320, and an inserter hammer 380. The trigger 320 includes a trigger stop 362 and an inserter rotation nut stop 364. The inserter rotation nut 360 includes a rotation thread 361 (hidden, dashed arrow) and a separator 363. The inserter hammer 380 includes a hammer linear thread 381, a hammer guide 382, ​​and a sleeve pusher 383. In some embodiments, when the inserter components are assembled, the rotation thread 361 engages with the hammer linear thread 381. Pressing the two safety buckles 330 releases the trigger stop 362 and allows the trigger 320 to move downward when the trigger 320 is pressed at the same time. The downward movement of the trigger 320 and the inserter rotation nut stop 364 allows the inserter spring 370 and the inserter rotation nut 360 to rotate freely. The energy stored in the preloaded inserter spring 370 causes the inserter rotation nut 360, the rotation thread 361 and the separator 363 to rotate. The rotation of the inserter rotation nut 361 is converted into a downward linear displacement of the hammer 380 and the cannula pusher 383, and thus the cannula is inserted into the human body. The rotation of the separator 363 is converted into a DP retainer (311, Fig.35 lateral linear displacement of the inserter 300 (not shown) to provide free release of the inserter 300 after the cannula has been inserted.

[0147] Fig.36A -B shows a spatial view of inserter 300 according to some embodiments. Inserter 300 includes housing 310, trigger 320, safety buckle, RP notch 312, and viewing window 390. Viewing window 390 provides a line of sight for observing insulin droplets during priming of the patch pump.

[0148] Fig.37A -C shows a spatial view of the insertion mechanism according to some embodiments. The insertion mechanism includes a trigger 320, an inserter spring 370, an inserter rotation nut 360, a pivot rod 350, and a hammer 380. The trigger 320 includes a trigger stop 362 (on both sides) and an inserter rotation nut stop 364. The inserter rotation nut 360 includes a rotation thread 361 and a separator 363. The hammer includes a hammer guide 382 (on both sides) and a sleeve pusher 383. Fig.37A and Fig.37B The insertion mechanism is shown before the trigger 320 is pressed. Fig.37CThe insertion mechanism is shown after the trigger 320 is pressed in the direction of the bold dashed arrow. The inserter rotation nut stopper 364 is linearly displaced in the direction of the bold dashed arrow, and the inserter rotation nut 360 is free to rotate around the pivot rod 350.

[0149] Fig.38A -B shows a cross-sectional plan bottom view of the inserter 300 according to some embodiments ( Fig.38A ) and top view ( Fig.38B ). Fig.38A An inserter hammer 380 is shown, which includes a hammer guide 382 (on both sides) and a cannula pusher 383. The hammer guide maintains the linear displacement of the hammer 380 during downward movement. Upon inserter activation, the cannula pusher 383 pushes the cannula downward. The trigger 320 includes a trigger stop 362 (on both sides) that is released by pressing the safety catch 320. Prior to inserter activation and cannula insertion, the DP retainer 311 (on both sides) holds the DP adhesive base in place on the bottom side of the inserter. After inserter activation, the DP retainer 311 is displaced laterally and releases the DP adhesive base (Figure 41). Fig.38B Inserter housing 310, trigger 320, and safety catch 330 (on both sides) are shown.

[0150] Fig.39 A spatial view of the bottom side of an inserter 300 and a DP 100 (with adhesive base 190 partially removed) within the inserter 300 is shown according to some embodiments. The inserter 300 includes a housing 310, a hammer 380, a safety buckle 330, and a DP retainer 311 (on both sides). The DP 100 includes a first reservoir 120, a doser 130, a filling hole 181, and a cannula hole 193. Before the inserter 300 is activated, the DP retainer 311 holds the DP adhesive base 190 in place. After the inserter is activated, the DP retainer 311 is laterally displaced (FIG. 41), thereby releasing the DP adhesive base 190 and allowing the inserter to be freely removed.

[0151] Fig.40A cross-sectional view of an inserter 300 and DP 100 according to some embodiments is shown. The inserter includes a trigger 320, an inserter rotation nut 360, a rotation thread 361, an inserter spring 370, a pivot rod 350, an inserter hammer 380, a sleeve pusher 383, and a liner thread 381. The DP includes a first reservoir 200, a DP magnet 70, a sleeve 200, and an adhesive substrate 190. When the trigger 120 is pressed, the inserter spring 370 causes the inserter rotation nut 360 and the inserter thread 361 to rotate around the pivot rod 350. When the rotation thread 361 rotates, the hammer linear thread 381 is linearly displaced downward (in the direction of the thick dashed line), and therefore, the hammer 380 and the hammer pusher 383 are displaced in the same direction. The downward displacement of the sleeve pusher 383 causes the sleeve 200 to displace in the dashed line direction.

[0152] Fig.41A -B shows the first reservoir 120 before filling according to some embodiments ( Fig.41A ) and after ( Fig.41B ) is a cross-sectional view of an inserter 300 and a patch pump 1. The inserter 300 includes a trigger 320, a viewing window 390, an inserter spring 370, and an inserter hammer 380. The patch pump 1 includes a first reservoir 120, a first reservoir plunger 121, a cannula 200, an adhesive substrate 190, and a liner 197. During filling of the first reservoir, insulin displaces the second reservoir plunger 121 in the direction of the thick dashed arrow ( Fig.41A ). When the first liquid reservoir 120 is filled to the maximum capacity ( Fig.41B ), the first reservoir plunger 121 is located at the proximal end.

[0153] Fig.42A -B shows the inserter 300 before activation according to some embodiments ( Fig.42A ) and after ( Fig.42B ) is a planar cross-sectional view of the release mechanism 340. Rotation (counterclockwise) of the separator 363 ( Fig.42A ) displaces the rod 3111 transversely (in the direction of the thick dashed arrow), and the rod displaces the DP holder 311 in the same transverse direction. Fig.42B ), the DP bonding substrate 190 is detached from the interposer.

[0154] Fig.43A -E shows a spatial view of inserter 300 processing according to some embodiments. Fig.43A Insertion of the RP 10 into the interposer notch 312 and connection of the RP 10 to the DP 100 (partially shown) are shown. Fig.43B Patch pump 1 (partially shown) is shown within inserter 300, now with RP 10 connected to DP 100. Liner 197 is folded around the upper and bottom sides of adhesive substrate 190. Fig.43C A first reservoir fill is shown. A patch pump (hidden) is located on the bottom side of inserter 300. Insulin is injected through fill port 181 using a syringe 500 and syringe needle (not shown). Fig.43D Inserter 300 and patch pump 1 are shown after liner 197 is removed from adhesive substrate 190 . Fig.43E Inserter 300 is shown after being disconnected from patch pump 1. Adhesive substrate 190 is now adhered to the patient's skin and inserter 300 is disposed of.

[0155] Fig.44A -D shows a cross-sectional view (viewing window perspective) of the inserter 300 when irrigated and cannulated, according to some embodiments. Fig.44A An inserter 300 including a trigger 320 and a viewing window 390 is shown. The DP is located within the inserter 300, and the cannula 200 and cannula cap 50 are visible through the viewing window 390. After the RP is inserted into the inserter (FIG. 42), the patch pump is ready for priming. Priming is performed automatically when the patch pump receives a command from the controller. Fig.44B An enlarged view of the viewing window 390 during priming is shown (light dashed arrow). The cannula 200, cannula cap 50 and cannula opening 118 can be seen at the inserter viewing window 390. During the priming process, the inserter 300 and viewing window 190 remain in a vertical position (dashed arrow). When insulin (droplets) are seen to continuously emerge (e.g., without bubbles) from the cannula opening 118, priming is complete, the patch pump can be adhered to the skin and the cannula 200 can be inserted. Fig.44C Inserter 300 is shown during activation of a cannula insertion procedure, with trigger 320 depressed downwardly in the direction of the bold dashed arrow and hammer cannula pusher 383 displacing cannula 200 in the same direction. Fig.44D The inserter and patch pump (not shown) are shown at the end of the insertion process of the cannula 200. The trigger 320 is pressed in the direction of the bold dashed arrow; the hammer linear thread 381 after the linear displacement is completed in the same direction can be seen in the viewing window 190, and the cannula protrudes from the bottom side of the adhesive substrate (not shown) after the complete displacement in the same direction.

[0156] Fig.45A -B shows the cannula 200 before insertion according to some embodiments ( Fig.45A ) and after ( Fig.45B ) is a cross-sectional partial perspective view (observation window perspective view) of an inserter 300 and a patch pump 1. The inserter 300 includes a trigger 320, an observation window 390, an inserter spring 370, a hammer linear thread 381, and a hammer sleeve pusher 383. The patch pump 1 includes a first reservoir 120, a dosing device 130, a sleeve 200, and a sleeve cap 50. Fig.45AThe inserter 300 is shown during activation of the cannula insertion process. The trigger 320 is pressed downwardly in the direction of the bold dashed arrow and the hammer cannula pusher 383 displaces the cannula 200 in the same direction. Fig.45B The inserter 300 and the patch pump 1 are shown at the end of the insertion process of the cannula 200. The trigger 320 is pressed in the direction of the thick dashed arrow; the hammer linear thread 381 after the linear displacement is completed in the same direction can be seen in the viewing window 190, and the cannula protrudes from the bottom side of the adhesive substrate (not shown) after the complete displacement in the same direction.

[0157] 46-53 illustrate a reversible engagement mechanism between the RP lead screw and the DP doser plunger according to some embodiments. The engagement mechanism provides a secure connection during patch pump operation and allows disengagement during RP-DP disconnection. For example, Fig.46A -C shows an exemplary embodiment of the engagement mechanism between the lead screw 44 and the doser plunger 131 . Fig.46A A lead screw 44 including a lead screw tip 441 and a lead screw protrusion 443 is shown. The dosing device 130 is rigidly connected to the slide needle 140 and can be linearly displaced in a sleeve (not shown) and a sleeve cover 173. The sleeve cover 173 has a protrusion 174. The dosing device plunger 131 can be linearly displaced in the dosing device 130. The dosing device plunger 130 includes a piston 132 and a gasket 134 and a scraper spring 175. During the RP-DP connection (the direction of the thick dashed arrow), the lead screw tip 441 and the lead screw protrusion 443 are reversibly engaged with the spring scraper 175. Fig.46B The engaged lead screw 44 and spring scraper 175 are shown. The doser plunger 131 is located at the most proximal position within the doser 130, and the scraper flap 177 (enlarged view in Figure 47) contacts the sleeve cover protrusion 174. The linear displacement of the lead screw 44 in the direction of the thick dashed arrow (X) causes the plunger 131 to displace in the same direction. The linear displacement of the lead screw 44 in the direction of the thick dashed arrow (Y) forces the spring scraper flap 177 to rest against the sleeve cover protrusion 174, and thus the spring scraper 175 is expanded, the lead screw protrusion 443 is disengaged, and the lead screw 44 (and the entire RP) can be disengaged from the doser plunger 31 (and the entire DP). Fig.46C The lead screw 44 is shown engaged with the spring scraper 175, the lead screw tip 441 and the lead screw protrusion 443 are located in the spring scraper groove 179 (shown in Figure 47), and the doser plunger 131 is displaced in the direction of the thick dashed arrow to the farthest position in the doser 130 (the doser emptying stage is over, Fig.55 ).

[0158] Fig.47A-C shows an enlarged spatial view of the spring scraper 175 and the lead screw 44 according to some embodiments. Fig.47A (side view) and Fig.47B (Top view) shows a spring scraper 175. The spring scraper comprises a scraper rib 176, a scraper petal 177 and a scraper groove 179. Fig.47C The lead screw 44 is shown to include a lead screw tip 441 and a lead screw protrusion 443. When the lead screw 44 is engaged with the spring scraper 175, the lead screw tip 441 and the lead screw protrusion 443 are located within the spring scraper groove 179.

[0159] Fig.48A -B shows the prior to joining ( Fig.48A ) and after ( Fig.48B ) is a longitudinal cross-sectional view of the lead screw 44 and the dosing device plunger 131. The lead screw 44 includes a lead screw tip 441 and a lead screw protrusion 443. The dosing device plunger 131 includes a washer 134, a scraper spring rib 176 and a scraper spring petal 177. Fig.48A The lead screw 44 and doser plunger 131 are shown prior to engagement. The lead screw 44 is displaced in the direction of the bold dashed arrow and resides within the scraper spring groove 179. Fig.48B The lead screw 44 is shown engaged with a scraper spring 175. The scraper spring 175 includes a scraper spring rib 176 and a scraper spring petal 177. The lead screw tip and lead screw protrusion (hidden) are located within a scraper spring groove 179.

[0160] Fig.49A -C shows a spatial view of a bayonet engagement mechanism according to some embodiments ( Fig.49A -B) and cross-sectional view ( Fig.49C ). The drive screw 644 includes a tip 645 having a T-shaped configuration ( FIG. 50 ). The sleeve cover 600 includes four cogs 601, and the doser plunger 610 includes four cogs 611. When the plunger 610 is in the most proximal position, the doser plunger cogs 611 engage with the sleeve cover cogs 601, the doser plunger 611 rotates, and the drive screw tip 645 disengages from the doser plunger 610.

[0161] Fig.50A -F shows a doser plunger 610 ( Fig.50A -B), sleeve cover 600 ( Fig.50C ) and drive screw tip 645 ( Fig.50D-F) of the space view. The plunger 610 includes four cogs 611, and the sleeve cover 600 includes four cogs 601. In some embodiments, the plunger and / or the sleeve cover may include less than or more than four cogs. The engagement of the cogs 601 with the cogs 611 provides the rotation of the dosing device plunger 610 and the disengagement of the drive screw tip 645 from the dosing device plunger 610.

[0162] Fig.51A -D shows a cross-sectional view of a binding engagement mechanism according to some embodiments ( Fig.51A )、Space cross section( Fig.51B ) and spatial views ( Fig.51C -D). The drive screw 744 includes a tip 745 having a spear shape. The doser plunger 731 includes a circular notch 746. Due to non-collinearity (binding phenomenon), the drive screw tip 744 is firmly engaged with the doser plunger notch 746. When the plunger 731 is in the most proximal position in the doser 730, the doser plunger circular notch 746 is aligned in line with the drive screw tip 745 and can be disengaged.

[0163] Fig.52 A cross-sectional view of an O-ring engagement mechanism according to some embodiments is shown. The drive screw 844 includes a protruding tip 845. The doser plunger 831 includes an O-ring 846. When the plunger 831 is in the most proximal position within the doser (not shown), additional movement of the drive screw in the direction of the bold dashed arrow causes the protruding tip 845 to squeeze the O-ring 846 and disengage the drive screw 844 from the doser plunger 831.

[0164] Fig.53A -B shows a cross-sectional view of a pot magnet engagement mechanism according to some embodiments ( Fig.53A ) and spatial views ( Fig.53B ). The drive screw 944 includes a pot tip 948 and a magnet / iron plate 945 connected to the pot tip 948. The dosing device plunger 931 includes a magnet / iron plate 946. If the drive screw is linearly displaced in the direction of the plunger 931 and in the opposite direction of the plunger 931, respectively, the pot tip 948 can be engaged (thick dashed arrow X) or disengaged (thick dashed arrow Y) with the dosing device plunger 931.

[0165] Fig.54A -E shows a cross-sectional view of an undercut appearance gasket engagement mechanism according to some embodiments ( Fig.54A ) and spatial views ( Fig.54B-E). The drive screw 954 includes a spear-like shaped tip 955. The doser plunger 951 includes a tapered cavity 957. A tapered bracket 956 having an opening 958 occupies the cavity 957. When the drive screw 954 is engaged with the doser plunger 951, the drive screw tip 955 is located in the opening 958, and the tip 955 is firmly engaged with the bracket 956. When the plunger 951 is in the most proximal position in the doser 960, the bracket 956 is displaced in the cavity 957 in the direction of the bold dashed arrow, and the drive screw tip 955 can be disengaged from the bracket 957.

[0166] Figure 55-58 A pumping mechanism (doser filling phase - Fig.55 and doser emptying phase - Fig.56 ) and patch pump infusion ( Fig.57 ) and reservoir filling ( Fig.58 ) of the patch pump operation scheme. The pumping mechanism of the patch pump includes an operation cycle, which includes two operation phases: a doser filling phase and a doser emptying phase. During the doser filling phase, insulin is delivered from the first reservoir to the doser. During the doser emptying phase, insulin is delivered from the doser to the outlet, and then delivered from the outlet to the patient through the cannula. The patch pump priming cycle includes two operation phases – a doser filling phase and a doser emptying phase. During the doser emptying phase, insulin is delivered from the doser to the outlet, from the outlet to the cannula opening, and then from the cannula opening to the air.

[0167] Fig.55 A pumping mechanism scheme during the dosing device filling stage according to some embodiments is shown. The pumping mechanism includes a first reservoir 120, a second reservoir (dosing device) 130, a dual chamber valve mechanism ("valve mechanism") 160, a first conduit 150, a second conduit 151, an outlet 115 and a sleeve 200. The filling conduit 152 is hydraulically connected to the first conduit 150. The first reservoir 120 has a proximal end 1221, a distal end 1222 and a first conduit-first reservoir channel 1501. The first reservoir plunger 121 can be passively displaced in the direction of the thick arrow (X). The dosing device 130 has a proximal end 1331 and a distal end 1332. The dosing device plunger 131 can be displaced in the direction of the thick arrow (Y) by a lead screw 44. The dosing device proximal stopper 147 (the proximal end of the sleeve 1771) limits the displacement of the dosing device in the direction of the thick arrow (Y). The doser distal stop 146 (distal end of sleeve 1772) limits displacement of the doser 130 in the opposite direction during the doser emptying phase ( Fig.56). The doser 130 is rigidly connected to the slide needle 140, and the doser chamber 1333 is hydraulically connected to the slide needle 140. The slide needle has a proximal end 141, a distal end (sharp tip) 142 and an opening 144 (one or more openings). The valve mechanism 160 includes an inlet chamber 161, a discharge chamber 162, a rear seal 164, a front seal 166, a first conduit-inlet chamber passage 1502 and a discharge chamber-second conduit passage 1511. The outlet 115 includes a top seal 113 and a bottom seal 114. During the doser filling stage, the lead screw 44 and the doser plunger are displaced in the direction of the thick arrow Y. When the doser plunger 131 begins to displace, the doser 130 is displaced in the direction of the thick dashed arrow (Z) until it reaches the proximal stopper 147 (due to the friction between the doser 130 and the doser plunger 131). After the dosing device 130 is displaced, the sliding needle 140 is displaced in the same direction and positions the sliding needle opening 144 in the inlet chamber 161. At this time, the further displacement of the plunger 131 in the direction of the thick arrow (Y) causes the insulin to be displaced in the direction of the light dashed arrow and the first reservoir plunger 121 to be displaced in the direction of the thick arrow (X). Insulin is delivered from the first reservoir 120 to the dosing device 130 through the first conduit 150, the inlet chamber 161, the sliding needle opening 144, and the sliding needle 140.

[0168] Fig.56 A scheme of the pumping mechanism during the doser emptying phase according to some embodiments is shown (see above for reference Fig.55 Component nomenclature is provided in the description of ). During the dosing device emptying stage, the lead screw 44 and the dosing device plunger 131 are displaced in the direction of the thick arrow Y. When the dosing device plunger 131 begins to displace, the dosing device 130 is displaced in the direction of the thick dashed arrow (Z) until it reaches the distal stopper 146. After the dosing device 130 is displaced, the sliding needle 140 is displaced in the same direction, and the sliding needle opening 144 is positioned in the drainage chamber 162. At this time, the further displacement of the plunger 131 in the direction of the thick arrow (Y) causes the insulin to be displaced in the direction of the shallow dashed arrow. Insulin is delivered to the patient's subcutaneous tissue from the dosing device 130 through the sliding needle 140, the sliding needle opening 144, the second conduit 151, the outlet 115, and the sleeve 200.

[0169] Fig.57 A scheme of the pumping mechanism during patch pump priming according to some embodiments is shown (see above for reference Fig.55 Component nomenclature is provided in the description of ). Cannula 200 is not inserted into the patient, cannula tip 117 is located within well 115, and cannula cap 50 and cannula opening 118 are located above DP housing (110, dashed square). Fig.58), based on commands received from the controller, an automatic priming process (air purge) is performed on the patch pump while the patch pump (and inserter, FIG. 44 ) is held in a vertical position. The priming process includes a priming cycle with two phases, which are parallel to the pump operation phase ( Fig.55 and Fig.56 ) are the same - the doser filling phase and the doser emptying phase. The doser filling phase of the priming process is the same as the doser filling phase of the pump operating cycle ( Fig.55 ) is the same. During the dosing device emptying stage of the perfusion process, the lead screw 44 and the dosing device plunger 131 are displaced in the direction of the thick arrow Y. When the dosing device plunger 131 begins to displace, the dosing device 130 is displaced in the direction of the thick dashed arrow (Z) until it reaches the distal stopper 146. After the dosing device 130 is displaced, the sliding needle 140 is displaced in the same direction and the sliding needle opening 144 is positioned in the drainage chamber 162. At this time, the further displacement of the plunger 131 in the direction of the thick arrow (Y) causes the insulin to be displaced in the direction of the shallow dashed arrow. Insulin is delivered to the air from the dosing device 130 through the sliding needle 140, the sliding needle opening 144, the second conduit 151, the outlet 115, and the cannula opening 118. If after a perfusion cycle (dosing device filling stage and dosing device emptying stage), no insulin is observed (droplets appear in the opening 118, Figure 44), then the patient is allowed to perform continuous perfusion cycles as appropriate until insulin drops are observed.

[0170] Fig.58 A scheme of the pumping mechanism during patch pump filling according to some embodiments is shown (see above for reference Fig.55 Component nomenclature is provided in the description of ). The cannula 200 is not inserted into the patient, the cannula tip 117 is located in the well 115, and the cannula cap 50 and the cannula opening 118 are located above the DP housing (110, dashed square). The doser plunger 131 is located at the distal-most position 1332, and the sliding needle opening 144 is located in the drainage chamber 162. Insulin is injected into the filling conduit 152 through the needle 510 using the filling syringe 500, and injected into the first reservoir 120 through the first conduit 150. During filling, the first reservoir plunger 121 is displaced in the direction of the thick arrow. The first reservoir 120 can be filled to any desired volume ( Figures 71-73 ), up to maximum capacity.

[0171] Figure 59-6 4 shows the disposable components of the pumping mechanism and the operating cycle of the pumping mechanism according to some embodiments. For example, in some embodiments, Fig.59A plan cross-sectional view of some of the DP 100 components and disposable components of the pumping mechanism is shown. The DP 100 components include the first reservoir 120, the doser 130, the valve mechanism 160, the second conduit 151, the delivery conduit 153 and the filling port 180. The doser plunger 131 and the slide needle 140 are in the most distal position (end of the doser emptying phase).

[0172] Fig.60 A planar cross-sectional enlarged view of a disposable component of a pumping mechanism according to some embodiments is shown. The pumping mechanism includes a doser 130, a doser plunger 131, a sleeve 171, a sleeve cover 173 and a valve mechanism 160. The doser 130 includes a doser wall 1334 and a doser chamber 1333. The doser 130 is rigidly connected to a slide needle 140, and the doser chamber 1333 is hydraulically connected to the slide needle 140. The doser plunger 131 includes a doser piston 132, a doser gasket 134 and a scraper spring 175. The sleeve 171 and the sleeve cover 173 form a cylinder with a proximal end 1771 and a distal end 1772. The sleeve cover has a protrusion 174. The valve mechanism 160 includes a liquid inlet chamber 161, a liquid discharge chamber 162, a front spacer 163, a rear seal 164, a rear spacer 165 and a front seal 166. The drain chamber 162 is in hydraulic communication with the second conduit 151. The RP-DP O-ring 170 surrounds the sleeve 171 and provides a seal to the RP sealing compartment after the RP-DP connection (Figures 11 and 24). The doser 130 is linearly displaceable within the sleeve 171, and the doser plunger 131 is linearly displaceable within the doser 130. When the doser plunger 131 is in the most proximal position, the spring scraper 175 engages the sleeve cover protrusion 174 (Figures 46-48).

[0173] Fig.61A -C and Fig.62A -C shows the doser filling phase according to some embodiments ( Fig.61A -C) and doser emptying phase ( Fig.61A -C) is a cross-sectional view of the dosing device 130 and the valve mechanism 160. Fig.61AThe doser 130, doser plunger 131, sleeve 171 and valve mechanism 160 are shown. The doser 130 has a proximal end 1331 and a distal end 1332. The sleeve 171 has a proximal end 1771 and a distal end 1772. At the beginning of the doser filling stage, the doser 130 is located in the most distal position within the sleeve 171 (1332 and 1772 are in contact, 1331 and 1771 are separated - shallow double-headed arrow), the doser plunger 131 is located in the most distal position within the sleeve 171, and the sliding needle opening 144 is located within the drainage chamber 162. At this stage, the doser 130 is displaced in the direction of the dashed arrow. Fig.61B The doser 130 is shown after displacement within the sleeve (positions of 1332 and 1772 separated—light double-headed arrow, 1331 and 1771 in contact), with the slide needle opening 144 positioned within the inlet chamber 161. At this stage, further displacement of the doser plunger 131 in the direction of the bold dashed arrow causes the doser plunger 131 to be linearly displaced within the doser 130. Fig.61C The doser plunger 131 is shown after displacement in the direction of the bold dashed arrow within the doser 130. The position of the doser plunger 131 is separated from the doser distal end 1332 (shallow double-headed arrow). The displacement of the doser plunger 131 within the doser 130 displaces insulin in the direction of the bold dashed arrow and thus fills the doser 130.

[0174] Fig.62A The doser 130 and doser plunger 131 are shown at the beginning of the doser emptying phase. The doser 130 is in the most proximal position within the sleeve 171 (1331 and 1771 are in contact, 1332 and 1772 are separated - shallow double-headed arrow), the doser plunger 131 is in the most proximal position within the doser 130, and the slide needle opening 144 is located within the inlet chamber 161. At this stage, the doser 130 is displaced in the direction of the dashed arrow. Fig.62B The doser 130 is shown after displacement in the direction of the bold dashed arrow within the sleeve 171. The position of the doser proximal end 1331 is separated from the sleeve proximal end 1771 (shallow double-headed arrow), the doser distal end 1332 and the sleeve distal end 1772 are in contact, and the slide needle opening 144 is located within the drainage chamber 162. Fig.62C The doser plunger 131 is shown after displacement in the direction of the bold dashed arrow within the doser 130. The position of the doser plunger 131 is separated from the doser proximal end 1331. The displacement of the doser plunger 131 within the doser 130 displaces insulin in the direction of the bold dashed arrow and thus empties the doser 130.

[0175] Fig.63A-B shows the doser filling phase according to some embodiments ( Fig.63A ) and doser emptying phase ( Fig.63B ) is an enlarged cross-sectional view of the valve mechanism 160 of the dosing device. The valve mechanism 160 includes a liquid inlet chamber 161, a liquid outlet chamber 162, a front spacer 163, a rear seal 164, a rear spacer 165 and a front seal 166. Fig.63A ), the distal end of the dosing device 130 is separated from the distal end of the sleeve 171 (thick dashed double-headed arrow), and the sliding needle opening 144 is located in the liquid inlet chamber 161. During the dosing device emptying phase ( Fig.63B ), the distal end of the dosing device 130 contacts the distal end of the sleeve 171, and the sliding needle opening 144 is located in the drainage chamber 162.

[0176] Fig.64A -B shows a cross-sectional view of a slide needle 140 according to some embodiments ( Fig.64A ) and spatial views ( Fig.64B ). The slide needle includes a proximal end 141, a distal end 142, and an opening 144. The proximal end is in hydraulic communication with the dosing device cavity. The distal end is closed and has a sharp tip. In some embodiments, there are two slide needle openings. In some embodiments, one or more openings are provided.

[0177] Figures 65-67 1 shows hardware components and hardware operating modes according to some embodiments. For example, in some embodiments, Fig.65 A spatial view of the hardware components of the RP is shown (RP cover 25 is removed, Figure 7 ). The hardware includes a (folded) PCB 61 and a battery 80. The PCB 61 includes various electronic components (ie, microprocessor, transceiver, sensors, etc.). Some of the RP components are shown, including the motor 42, lead screw 44, and sockets 641 and 642 for the reservoir sensors.

[0178] Fig.66 A hardware state machine according to some embodiments is shown. The processor commands the drive mechanism to receive input from the sensor (i.e., encoder sensor) and adjusts the operation of the drive mechanism accordingly. The processor accepts input from the timer (i.e., RTC), memory, and RF transceiver, and provides an alarm / alert output. There is two-way communication between the processor, memory, and transceiver, and between the sensor and the drive mechanism.

[0179] Fig.67A block diagram of hardware according to some embodiments is shown. The processor receives input from sensors (encoder sensors, dosing device sensors, and reservoir sensors) and controls the motor driver, power management, monitor, buzzer driver, and BLE antenna. The motor driver operates the motor (i.e., stepper motor) and encoder. The processor receives input from the encoder and adjusts the operation of the motor accordingly. The battery (e.g., a lithium-ion battery) is charged by an external power source through a charging contact.

[0180] 68-70 illustrate the components and modes of operation of the doser sensor 63 according to some embodiments. The doser sensor 63 detects the relative motion between the doser 130 and the sleeve 171, the position of the doser 130 at the end of the doser filling phase and the doser emptying phase, and the connection and disconnection of the RP-DP. Fig.56 ) during operation of the motor, the doser sensor 63 can provide blockage detection if there is relative movement between the doser 130 and the sleeve 171 rather than between the doser plunger 131 and the doser 130.

[0181] Fig.68A -C shows a scheme of the dosing device sensor 63 operating mode according to some embodiments. The dosing device sensor 63 includes a reflective photoelectric micro-detector 632 ("detector") and a dosing device label 145 adhered to the dosing device 130. The input (voltage) from the detector 632 is processed by a microprocessor, which controls the motor operation (i.e., the direction of rotation) or provides warnings and alarms. The dosing device label 145 includes a bar code. In some embodiments, the bar code includes two areas-a black area and a white area. The bar code may include bars with various widths, any protruding structures, or any other structures that can be detected by the detector 632. Fig.68A and Fig.68A The doser sensor operation during the pump operation cycle (doser filling phase and doser emptying phase) is shown. When the doser 130 is displaced forward and backward in the direction of the thick dashed arrow, the doser label 145 is displaced in the same direction and the photoelectric micro-detector 632 is correspondingly aligned with the white bar code ( Fig.68A ) or black barcode ( Fig.68B) are aligned. The detector 632 converts the change in light reflectivity (light dashed arrow) into a change in current and a change in voltage. During the displacement of the doser 130 (black to white), the current gradually increases (light reflectivity gradually increases). During the displacement of the doser 130 (white to black), the current gradually decreases (light reflectivity gradually decreases). When the doser 130 stops displacing (in both directions), the current (and voltage) remains constant, which is interpreted by the processor 62 as no movement of the doser 130. When the doser 130 stops displacing (in both directions), further displacement of the doser plunger ( Figure 55-56 ) displaces insulin into the doser (doser filling phase) or out of the doser (doser emptying phase). During the doser emptying phase, the precise amount of insulin displaced (insulin delivered—insulin units) is determined by stopping displacement of the doser and starting displacement of the doser plunger within the doser ( Figure 55-56 ) and immediately starts counting the gear revolutions (encoder sensor, Figure 9-1 0) is concluded. Fig.68C Operation of the doser sensor 63 during RP-DP disconnection is shown. The RP 10 includes a photoelectric micro-detector 632 and a processor 62. The DP 100 includes a doser 130 and a doser label 145. When the RP 10 and DP 100 are disconnected (displaced in the direction of the thick dashed arrow), the photoelectric micro-detector 632 does not receive any light reflection (light dashed arrow), and this input is received by the processor and interpreted as RP-DP disconnection. During RP-DP connection (not shown), the alignment of the detector 632 with the label 145 bar code is detected and interpreted as RP-DP connection.

[0182] Fig.69 A cross-sectional view of a doser sensor 63 (dashed rectangle) and the main components of the RP and DP are shown according to some embodiments. The RP 10 includes a lead screw 44, a rotating nut 435, and a photoelectric micro-detector 632. The DP 100 includes a doser 130, a doser tag 145, a sleeve 171, a valve mechanism 160, and a sliding needle 140. The doser sensor 63 (dashed rectangle) includes a photoelectric micro-detector 632 and a doser tag 145.

[0183] Fig.70A -E shows a cross-sectional view of the doser sensor 63 during pump operation and during RP-DP disconnection according to some embodiments. For example, in some embodiments, Fig.70A (doser emptying phase) and Fig.70B(Doser Filling Stage) The doser sensor 63 (dashed rectangle), doser 130, sleeve 171 and lead screw 44 are shown. The doser sensor 63 includes a photoelectric micro-detector 632 and a doser tag 145. The photoelectric micro-detector 632 detects the displacement of the doser 130 and the doser tag 145 in the forward and backward directions (thick dashed arrows), and accordingly the detector 632 accurately defines the relative position of the doser 130 (relative to the sleeve 171 and RP 10) and is interpreted accordingly by the processor. Fig.70C -E shows the successive stages of RP-DP disconnection, with RP displacing in the direction of the thick dashed arrow. Fig.70C The first stage of accidental disconnection of the RP-DP is shown with the doser plunger 131 in an intermediate position within the doser 130 and the detector 632 aligned with the doser label 145 . Fig.70D The next sequential stage of RP-DP disconnection is shown with the doser plunger 131 displaced further in the direction of RP displacement (thick dashed arrow) and the detector 632 no longer aligned with the doser label 145 . Fig.70E Completion of the RP-DP disconnect is shown, with the doser plunger 131 in contact with the sleeve cover 173, the lead screw 44 disengaged from the doser plunger 131, and the detector 632 no longer aligned with the doser label 145. During RP-DP connection (RP displacement in the opposite direction), the lead screw 44 engages the doser plunger 131, the detector 632 is aligned with the doser label 145, the detector 632 detects reflected light, and the processor interprets the detector output as a connection between the RP and DP.

[0184] Fig.71 Schemes of the components of the reservoir sensor 64, locations of the components of the reservoir sensor 64, and modes of operation of the reservoir sensor 64 are shown according to some embodiments. Fig.71 The RP 10 compartment is shown (FIG. 11) including a ventilated compartment 22 and a sealed compartment 21. The sealed compartment 21 includes a PCB 61, which includes a processor 62, a Hall sensor 1 651, and a Hall sensor 2 652. The Hall sensor 1 651 is located in a reservoir sensor socket 1 641, and the Hall sensor 2 652 is located in a reservoir sensor socket 2 642 ( Fig.65). The first reservoir 120 and the first reservoir plunger 121 are part of the DP 100. When the RP 10 and the DP 100 are connected, the first reservoir 120 (part of the DP 100) is located in the ventilation compartment 22 of the RP 10 (Figure 11). In some embodiments, the reservoir sensor 64 includes an axial pole magnet 65 and two Hall sensors, Hall sensor one 651 and Hall sensor two 652. In some embodiments, the magnets can be radial, rectangular, or circular. The axial pole magnet 65 is rigidly attached to the first reservoir plunger 121 located in the first reservoir 120. Hall sensor one 651 and Hall sensor two 652 are located in close proximity to the first reservoir 120. Hall sensors are transducers that change their output voltage in response to a magnetic field. Hall sensor one 651 and Hall sensor two 652 operate as analog transducers, returning voltage directly. In the case of a known magnetic field, their distance relative to the axial pole magnet 65 can be determined. Using two or more sensors, the relative position of the axial pole magnet 65 can be derived. The outputs of both the Hall sensors 651 and 652 are received and processed by the processor 62 and transmitted to the controller. The axial pole magnet 65 is displaced (forward and backward in the directions of the bold dashed arrows X and Y, respectively) within the first reservoir 120 (along with the first reservoir plunger 121) during filling of the first reservoir 120 and during pump operation. The reservoir sensor 64 may provide one or more of the following data points: 1-the precise or substantially precise amount of insulin in the first reservoir 120; 2-the insulin volume exceeding a minimum threshold (e.g., about 50 units, about 40 units, about 30 units, including values ​​therebetween)—the first reservoir plunger 121 is displaced in the direction of the bold dashed arrow X beyond a predetermined point; 3-the pumping mechanism is functioning properly—the first reservoir plunger 121 is displaced in the direction of the bold dashed arrow Y during the doser filling phase; 4—the remaining amount of insulin remaining in the first reservoir 120; 5-the insulin volume is below the minimum threshold—providing a low insulin level warning. In some embodiments, more than two, three, four, five, etc. Hall sensors are provided.

[0185] Fig.72 A spatial view showing some components of the patch pump 1 and the locations of the reservoir sensor sockets 641 and 642 according to some embodiments. The patch pump 1 includes an RP, which includes an RP base 24, a bottom RP groove 231, a reservoir sensor socket one 641, and a reservoir sensor socket two 642. The DP includes a DP housing 110, a first reservoir 120, a dosing device 130, and an adhesive substrate 190. After the RP-DP connection, the reservoir 120 is adjacent to the reservoir sensor sockets 641 and 642.

[0186] Fig.73A graphical diagram of exemplary outputs of reservoir Hall sensors 651 and 652 according to some embodiments is shown. The output of the reservoir Hall sensors is measured during displacement of the first reservoir plunger 121 and the axial pole magnet 65 in the first reservoir 120 in the direction of the thick dashed double arrow. In some embodiments, curves 6511 and 6522 show the output of the reservoir Hall sensors 651 and 652 relative to a reference value line (X). The precise position (relative to zero, in millimeters) of the first reservoir plunger 121 in the first reservoir 120 can be determined by extrapolating the measured values ​​(i.e., current or voltage) of the two reservoir Hall sensors 651 and 652.

[0187] Figures 74-83 Components and modes of operation of a bubble guard according to some embodiments are shown. During filling (if air is not properly purged from the filling syringe) or during pump operation, air bubbles may enter the first reservoir. During the doser filling phase, the doser plunger displacement ( Fig.55 ) and forms a negative pressure in the entire fluid manifold (doser, catheter and first reservoir), and fluid (e.g., insulin) is displaced from the first reservoir to the doser under the action of the negative pressure gradient. The pressure gradient between the atmosphere and the relative negative pressure (compared to the atmosphere) in the first reservoir forces air to move through the first reservoir plunger gasket into the first reservoir cavity and may form bubbles in the first reservoir. The bubble guard includes a passive guard ( Figure 74-75 )—a barrier to prevent air from entering the first reservoir through the first reservoir plunger gasket, and an active bubble guard (Figures 76-83)—avoiding a pressure gradient between the atmosphere and the first reservoir chamber. Pressure equalization or a reverse pressure gradient (pressure in the first reservoir is above atmospheric pressure) can be achieved by actively increasing the pressure in the first reservoir to atmospheric pressure or above atmospheric pressure.

[0188] Fig.74A cross-sectional view of the components and operating principles of a passive bubble guard (oil 128 between the first reservoir plunger gaskets 124 and 125) according to some embodiments is shown. The oil 128 between the gaskets forms a barrier to prevent air ingress by sealingly blocking all potential creases in the first reservoir wall 126 and potential deformations and protrusions (i.e., parting lines) in the gaskets 124 and 125. The oil 128 can be introduced between the gaskets 124 and 125 by the following options: 1-Assembly the gaskets 124 and 125 on the first reservoir plunger 131 in a container filled with oil; 2-Inject oil through the oil filling diaphragm 1281 and through the oil filling channel 1282, 3-Provide negative pressure before oil filling. The injected oil 128 is transported in the direction of the light dashed arrow and introduced into the space between the gaskets 124 and 125. The oil 128 between the gaskets is held in place during filling of the first reservoir (in the direction of the thick dashed arrow X) and during pump operation (in the direction of the thick dashed arrow Y). In addition to the sealing effect, the oil 128 also facilitates the smooth displacement of the first reservoir plunger 121 and the gaskets 124 and 125.

[0189] Fig.75 A cross-sectional view of the components and operating principles of another passive bubble guard according to some embodiments is shown, drug (e.g., insulin) 129 between first reservoir plunger gaskets 124 and 125. The bubble guard barrier is the drug 129 delivered by the patch pump—insulin or any other therapeutic fluid. Fig.75 The first reservoir 120, the first reservoir wall 126, the first reservoir plunger 121, the first reservoir gaskets 124 and 125, the first reservoir filling chamber 1295, the first conduit 150, the top membrane 1291, the air cavity 1292, the liquid barrier 1293, the one-way door 1294 and the insulin 129 are shown. The first reservoir filling chamber 1295 has the shape of a semi-conical cone or any other cavity that allows the drug to flow from 150 to 1293, and it is formed by scraping the first reservoir wall 126 at the distal end 1222. The first reservoir filling chamber 1295 is in hydraulic communication with the first conduit 150. During the filling of the first reservoir 120, the insulin 129 is delivered into the first reservoir filling chamber 1295 through the first conduit 150 and occupies the space between the gaskets 124 and 125. The air trapped between the gaskets prior to filling is forced through the fluid barrier 1293 and the one-way door 1294 into the air cavity 1292 and from the cavity 1292 through the top membrane 1291 into the atmosphere. The fluid restrictor 1293 is a microchannel that provides an air passage and blocks or limits the passage of fluid. The one-way door 1294 can be made of any semi-permeable material (e.g., material) or any other elastomer, the one-way door presses against the hole (i.e., duck valve) and provides further protection against the passage of fluid. If the one-way door 1294 fails, the top membrane 1291 serves as a second line of defense. When the first reservoir filling chamber 1295 and the space between the gaskets 124 and 125 are completely occupied by insulin 129, further injection of insulin 129 into the first reservoir forces the first reservoir plunger 121 to displace in the direction of the thick dashed arrow. When the first reservoir plunger 121 displaces in the direction of the thick dashed arrow X (reservoir filling), the first gasket 124 adheres to the reservoir wall 126 and provides a double seal (by two gaskets). The double seal is provided over the entire length of the displacement of the first reservoir plunger 121 in the direction of the dashed arrow X (reservoir filling) and the dashed arrow Y (pump operation) within the first reservoir 120.

[0190] Figures 76-83 illustrate components and modes of operation of an active bubble guard according to some embodiments. By returning a determined amount of fluid to the manifold, the negative pressure in the manifold (reservoir, conduit and chamber) is raised to above atmospheric pressure (P+) at the end of the doser filling phase. This can be achieved by locking the doser 130 at the beginning of the doser emptying phase and preventing relative displacement of the doser (relative to the sleeve) and displacement of the sliding needle opening from the inlet chamber to the outlet chamber ( Figure 55-56 ). When the doser 130 is locked, further displacement of the doser plunger 131 displaces insulin in the direction of the first reservoir 120 (the reverse direction of flow). The amount of insulin entering the first reservoir 120 increases the pressure in the first reservoir 120 to above atmospheric pressure (P+). The amount of pressure increase in the first reservoir 120 depends on the predetermined amount delivered back into the first reservoir and the amount of air bubbles trapped in the reservoir.

[0191] Fig.76A -B. Fig.77A -B. Fig.78A -B and Fig.79 A scheme of a doser locking mechanism during various stages of a pumping mechanism operating cycle according to some embodiments is shown. The scheme includes some of the components of the pumping mechanism, including the first reservoir 120, the first reservoir plunger 121, the doser 130, the doser plunger 131, the doser lock 148, the sleeve 171, and the valve mechanism 160. The doser 130 is displaced in the direction of the thick dashed arrow on the left side of the doser 130, the doser plunger 131 is displaced in the direction of the thick dashed arrow within the doser 130, the doser lock 148 is displaced in the direction of the thick solid arrow, and the insulin is displaced in the direction of the light dashed arrow. Fig.76AThe first stage of the doser filling phase is shown, and the pressure in the first reservoir is equal to atmospheric pressure (P). At the beginning of the doser filling phase, the doser 130 is displaced in the direction of the thick dashed arrow, and the sliding needle opening (not shown) is displaced from the drain chamber to the inlet chamber ( Fig.55 ). Fig.76B The end of the displacement of the doser 130 within the sleeve 171 is shown. At this stage, the doser plunger 131 is displaced in the direction of the thick dashed arrow within the doser, and insulin is displaced from the first reservoir 120 into the doser 130 in the direction of the light dashed arrow. The pressure in the first reservoir 120 is reduced to below atmospheric pressure (P-). Fig.77A The end of the doser filling phase is shown with the doser plunger 131 reaching the most proximal position within the doser 130, insulin filling (in the direction of the light dashed arrow) is complete, and the pressure within the first reservoir 120 is negative (P-). Fig.77B The beginning of the doser emptying phase is shown. Before the doser plunger 131 begins to displace in the direction of the thick dashed arrow, the doser lock 148 is displaced in the direction of the thick solid arrow. After the doser lock 148 is displaced, the doser lock 148 engages with the doser 130 and limits the displacement of the doser. Further displacement of the doser plunger 131 in the doser 130 displaces insulin back into the first reservoir 120 in the direction of the shallow dashed arrow. The pressure in the first reservoir 120 increases to above atmospheric pressure (P+). Fig.78A The continuation of the reservoir emptying phase is shown. The doser lock 148 is displaced in the direction of the thick solid arrow, thereby releasing the lock of the doser 130. The doser 130 is displaced within the sleeve 171, and the sliding needle opening is displaced from the inlet chamber to the outlet chamber (not shown, see FIG. Fig.56 ). The pressure in the first reservoir is positive (P+). Fig.78A The next stage of the reservoir emptying phase is shown. The doser plunger 131 is displaced in the direction of the thick dashed arrow and insulin is delivered to the patient (light dashed arrow) through an outlet (not shown). The pressure in the first reservoir 120 is above atmospheric pressure (P+). Fig.79 The end of the operating cycle is shown. The doser 130 and the doser plunger 131 are in the most distal position and a new operating cycle begins ( Fig.76A ).

[0192] Figures 80-83 show some configurations of preferred embodiments of dosing device locks according to some embodiments. The dosing device lock can be displaced in one direction (locking dosing device displacement) or in the opposite direction (unlocking dosing device displacement) by an actuator. The actuator can be any type known in the art, such as nitinol wire, hydraulic actuator, solenoid, piezoelectric actuator, DC motor, etc. Figure 80 shows an example of a hydraulic actuator, and Figures 81-83 show examples of nitinol wire actuators. For example, in some embodiments, Fig.80A -B shows a cross-sectional view of the hydraulic doser locking mechanism. FIG80 shows the first reservoir 120, the motor 42, the doser 130, the doser lock 148 and the doser lock conduit 149. The doser lock conduit 149 is in hydraulic communication with the first conduit (not shown) communicating between the first reservoir and the inlet chamber. During the doser filling phase ( Fig.76B and Fig.77A ), the manifold pressure drops below atmospheric pressure ( Fig.80A ). After the pressure in the manifold is reduced and the pressure in the doser lock conduit 149 is reduced, the doser lock 148 is displaced in the direction of the thick dashed arrow, the doser lock 148 engages with the doser 130, and the displacement of the doser 130 is restricted. At the beginning of the doser emptying phase ( Fig.77B ), the manifold pressure and the pressure within the doser lock conduit 149 increase to above atmospheric pressure ( Fig.80B ), the dosing device lock 148 is displaced in the direction of the thick dotted arrow, the dosing device lock 148 is disengaged from the dosing device 130, and the dosing device 130 can be freely displaced.

[0193] Fig.81A -B shows a cross-sectional view of a spring locking mechanism, a mechanical locking mechanism of a dosing device, according to some embodiments ( Fig.81A ) and spatial views ( Fig.81B 81 shows the doser 130, doser plunger 131, DP-RP O-ring 170, sleeve cover 173, sleeve cover protrusion 174, scraper spring 175, sleeve spring lock 155 and sleeve spring lock recess 1555. The sleeve spring lock 155 is connected to the doser 130. During the doser filling stage, the doser is displaced in the bold dashed line X direction ( Fig.76B and Fig.77A ), when the tip of the sleeve spring lock 155 reaches the sleeve spring lock recess 1555, the dosing device 130 is locked and cannot move. During the start of the dosing device emptying phase ( Fig.77B ), the dosing device plunger 131 moves along the thick dotted line Y direction ( Fig.78A and Fig.78B ). When the doser plunger 131 is further displaced in the same direction, the doser scraper spring 175 engages with the doser locker spring 155, the doser locker spring 155 twists, the tip of the doser locker spring 155 is released from the sleeve spring locker notch 1555, and the doser 130 is free to displace.

[0194] Fig.82A -B shows a cross-sectional view of a dosing device locking mechanism based on a nitinol spring 157 according to some embodiments ( Fig.82A ) and spatial views ( Fig.82B ). Fig.82A -B shows dosing device 130, scraper spring 175, sleeve 171, PCB 61, dosing device lock 148 and nitinol spring 157. Dosing device spring 157 is made of nitinol (nickel-titanium shape memory alloy). In some embodiments, spring can be made of any other shape memory alloy (e.g., flexinol, etc.). Nitinol spring 157 is connected to wire (not shown) on both sides. When electric current is transmitted through nitinol spring 157, its total length is shortened (due to the inherent characteristics of nitinol), dosing device lock 148 is displaced along the thick dashed arrow X direction, dosing device lock 148 is engaged with dosing device 130, and the displacement of dosing device 130 is limited. When the current is cut off, nitinol spring 157 recovers its length, dosing device lock 148 is displaced along the thick dashed arrow Y direction, dosing device lock 148 is disengaged from dosing device 130, and dosing device 130 can be freely displaced.

[0195] Fig.83 A spatial view of a Nitinol wire 156 based doser locking mechanism is shown according to some embodiments. Fig.83 PCB 61, dosing device 130, dosing device lock 148 and nitinol wire 156 are shown. Nitinol wire 156 is connected to electric wires (not shown) on both sides. When current is transmitted through Nitinol wire 156, its total length is shortened (due to the inherent characteristics of Nitinol wire), dosing device lock 148 is displaced along the direction of thick dashed arrow X, dosing device lock 148 is engaged with dosing device 130, and the displacement of dosing device 130 is limited. When the current is cut off, Nitinol wire 155 recovers its length, dosing device lock 148 is displaced along the direction of thick dashed arrow Y, dosing device lock 148 is disengaged from dosing device 130, and dosing device 130 can be freely displaced.

[0196] Although various inventive embodiments have been described and illustrated herein, a person of ordinary skill in the art will readily conceive of various other devices and / or structures for performing functions and / or obtaining results and / or one or more advantages described herein, and each of such changes and / or modifications is considered to be within the scope of the inventive embodiments described herein. More generally, it will be readily understood by those skilled in the art that all parameters, dimensions, materials, and configurations described herein are intended to be examples, and that actual parameters, dimensions, materials, and / or configurations will depend on the specific application or application using the teachings of the present invention. Those skilled in the art will recognize or be able to determine many equivalents of the specific inventive embodiments described herein using experiments that do not exceed routine. Therefore, it should be understood that the foregoing embodiments are given by way of example only, and within the scope of the appended claims and their equivalents, embodiments of the present invention may be practiced in a manner different from that specifically described and claimed. The inventive embodiments of the present disclosure relate to each individual feature, system, article, material, kit, and / or method described herein. In addition, if such features, systems, articles, materials, kits, and / or methods do not contradict each other, any combination of two or more such features, systems, articles, materials, kits, and / or methods is included within the scope of the invention disclosed herein.

[0197] In addition, various inventive concepts may be embodied as one or more methods, examples of which have been provided. The actions performed as part of the methods may be ordered in any suitable manner. Accordingly, embodiments may be constructed in which the actions are performed in an order different from that shown, which may include performing some actions simultaneously, even though shown as sequential actions in the exemplary embodiments.

[0198] At least some of the embodiments disclosed above, in particular at least some of the methods / processes disclosed, can be implemented in circuits, computer hardware, firmware, software, and combinations thereof (e.g., computer systems). Such computing systems may include PCs (which may include one or more peripherals well known in the art), smart phones, specially designed medical devices / equipment, and / or other mobile / portable devices / equipment. In some embodiments, the computer system is configured to include a client and a server. The client and the server are usually far away from each other, and usually interact through a communication network (e.g., VPN, the Internet). The relationship between the client and the server is generated by means of a computer program that runs on each computer and has a client-server relationship with each other.

[0199] Some embodiments of the present disclosure (e.g., the methods and processes disclosed above) may be embodied in computer programs / instructions that may be executed and / or interpreted on a processor, which may be connected to other devices (e.g., input devices and output devices / displays) that communicate, for example, via wireless or wired connections.

[0200] Any and all references to publications or other documents, including but not limited to patents, patent applications, articles, web pages, books, etc., appearing anywhere in this application are hereby incorporated by reference in their entirety. Furthermore, 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.

[0201] As used herein in the specification and claims, the indefinite articles "a" and "an" should be understood to mean "at least one", unless explicitly stated to the contrary.

[0202] As used herein in the specification and claims, the phrase "and / or" should be understood to mean "either or both" of the elements so combined, i.e., elements that are present in combination in some cases and separately in other cases. Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" of the elements so combined. In addition to the elements specifically identified by the "and / or" clause, other elements may optionally be present, whether related or unrelated to those specifically identified. Thus, as a non-limiting example, when used in conjunction with open language such as "comprising," a reference to "A and / or B" may refer to only A (optionally including elements other than B) in one embodiment; to only B (optionally including elements other than A) in another embodiment; to both A and B (optionally including other elements) in yet another embodiment; etc.

[0203] As used herein in the specification and 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" should be interpreted as inclusive, i.e. including at least one of many elements or lists of elements, but also including more than one of many elements or lists of elements, and optional additional unlisted items. Only explicitly pointing out the opposite terms such as "only one" or "exactly one" or "consisting of" when used in the claims, refers to including an exact element in many elements or lists of elements. In general, when the front is an exclusive term such as "any", "one of", "only one" or "exactly one", the term "or" as used herein should only be interpreted as indicating a unique alternative (i.e., "one or the other, but not both"). When used in the claims, "essentially consisting of" should have its ordinary meaning as used in the field of patent law.

[0204] As used herein in the specification and claims, the phrase "at least one" referring to a list of one or more elements should be understood to mean at least one element selected from any one or more elements in the list of elements, but not necessarily including at least one of each and every element specifically listed in the list of elements, and not excluding any combination of elements in the list of elements. This definition also allows for the optional presence of elements in addition to the elements specifically identified in the list of elements to which the term "at least one" refers, whether related or unrelated to the specifically identified elements. 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 to at least one, optionally including more than one A, without B (and optionally including elements other than B) in one embodiment; to at least one, optionally including more than one B, without A (and optionally including elements other than A) in 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) in another embodiment; etc.

[0205] In the claims and the foregoing description, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "containing," "comprising," and the like shall be understood as open ended, i.e., meaning 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 described in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.

Claims

1. A patch pump drug delivery device, comprising: A reusable part, the reusable part comprising: Lead screw; Lead screw tip; Reservoir cap; as well as A disposable part, the disposable part comprising: a fluid reservoir having a proximal end and a distal end; a plunger having a proximal end and a distal end, wherein the distal end contacts a medicament contained in the reservoir; doser reservoir; Doser plunger; a flexible support coupled to a proximal end of the doser plunger and including an opening for receiving and reversibly coupling with the lead screw tip; as well as a sleeve cover connected to the proximal end of the doser and including an opening for receiving the lead screw tip and enabling reversible connection with the doser plunger and having an inner edge arranged to face the flexible support, in Upon coupling the reusable portion with the disposable portion, the sleeve cover and doser plunger are disposed at a proximal end of the doser reservoir such that the flexible bracket interacts with an inner edge of the sleeve cover to allow the flexible bracket to receive the lead screw tip within an opening of the flexible bracket and the lead screw tip is coupled to the doser plunger as the doser plunger travels down the doser reservoir during use; as well as Upon disconnecting the reusable portion from the disposable portion, the cartridge cover and doser plunger are positioned proximal to the doser reservoir such that the flexible support interacts with the inner edge of the cartridge cover to allow the lead screw tip to be removed from the opening of the flexible support.

2. The device of claim 1 further comprising an adhesive substrate.

3. The device according to claim 2, wherein: The adhesive substrate is configured as an integral component of the disposable portion.

4. The device according to claim 1 further comprising an inserter.

5. The device according to claim 4, wherein: The inserter includes an inserter housing having an opening on one side thereof to receive at least the disposable part.

6. The device according to claim 4, wherein: The inserter includes an inserter housing having an opening on one side thereof to receive the connected reusable and disposable parts.

7. The device according to claim 1, wherein: The reusable portion also includes a housing and at least two compartments.

8. The device according to claim 7, wherein: The at least two compartments include a ventilated compartment and a sealed compartment.

9. The device according to claim 1, wherein: The reservoir comprises a doser reservoir.

10. The device of claim 1, further comprising a primary reservoir.

11. The device according to claim 4, wherein: The inserter includes a housing, a trigger, at least one safety catch, and an opening for receiving at least the disposable portion.

12. The device according to claim 1, wherein: The reusable portion also includes a housing including a cover and a base.

13. The device according to claim 12, wherein: The cover includes a buzzer.

14. The device of claim 12, wherein the base comprises at least one charging pad.

15. The device according to claim 1, wherein: The reusable portion also includes a motor, a drive screw, and at least one groove configured to prevent rotation of the drive screw during operation of the motor.

16. The device according to claim 1, wherein The reusable portion also includes at least one gear.

17. The device according to claim 16, wherein: The at least one gear includes a plurality of gears.

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