Remote activation of cannula insertion

Abstract

Infusion devices are disclosed herein. The technology of the invention includes, for example, infusion devices for delivering a medicament to a user's body. The device can include an insertion assembly including a cannula, a reservoir assembly including a reservoir configured to hold a medicament, and a trigger assembly configured to trigger insertion of the cannula into the user in response to a command from a remote computing device communicatively coupled to the infusion device.

Description

[0001] Cross-references to related applications

[0002] This application claims the priority of U.S. Provisional Application No. 63 / 112,578, filed November 11, 2020, and U.S. Application No. 17 / 454,600, filed November 11, 2021, both of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present invention relates generally to medical devices, and more specifically to remotely activated cannula insertion. Background Technology

[0004] Portable infusion pumps are relatively small, or at least substantially stand-alone, devices used to deliver medications and other infusionable substances (collectively, “medications”) into a user’s body. Some infusion pumps are configured to be attached to a belt, placed in a clothing pocket, or similarly. Others are configured to adhere to the skin in a patch-like manner. The advantage of infusion pumps is that they can be used, for example, to deliver (or “infuse”) medications subcutaneously, or even continuously, outside of a clinical setting. Another advantage is that they significantly reduce the frequency of subcutaneous access events, such as needle-based injections. An example of a medication that can be delivered by an infusion pump is a liquid formulation of insulin. Other exemplary medications that can be delivered by an infusion pump include, but are not limited to, medications for treating cancer and medications for suppressing pain perception.

[0005] Many conventional infusion pumps improve users' health and quality of life. However, the inventors have determined that conventional infusion pumps are susceptible to extensive modifications. By way of example and not limitation, the inventors have determined that it is desirable to provide an infusion pump that is smaller, simpler, more reliable, and less expensive than conventional infusion pumps, while also being more accurate and user-friendly. Summary of the Invention

[0006] Several aspects of the present invention include an infusion device for delivering a drug to a user's body. The infusion device may include, for example, an insertion assembly including a cannula; a reservoir assembly including a reservoir configured to receive a drug; and a motor configured to, in response to a command from a remote computing device communicatively connected to the infusion device,: (a) rotate in a first direction to cause the drug to flow from the reservoir into the cannula, and (b) rotate in the opposite second direction to trigger insertion of the cannula into the user.

[0007] In some embodiments, the insertion assembly includes a cannula carrier, and the cannula is secured to the cannula carrier. The cannula carrier can be configured to rotate from a first position in which the cannula carrier is locked in a pre-insertion state to a second position in which the cannula carrier is free to move for insertion of the cannula. In several of such embodiments, the cannula carrier is rotationally biased toward the second position.

[0008] According to several embodiments, the infusion device includes a trigger assembly movable between a first configuration in which the trigger assembly prevents movement of the cannula carrier toward the second position and a second configuration in which the trigger assembly allows movement of the cannula carrier toward the second position. In several of such embodiments, movement of the motor in the opposite second direction moves the trigger assembly from the first configuration to the second configuration, allowing movement of the cannula carrier for cannula insertion. The trigger assembly can include a ratchet that allows movement of the cannula carrier when the motor is rotated in the opposite second direction. In some embodiments, the trigger assembly includes a hydraulic cylinder.

[0009] Some aspects of the technology of the present invention include a trigger assembly configured to move out of engagement with the cannula carrier when the motor is rotated in the opposite second direction.

[0010] The infusion device of claim 2, further comprising a trigger assembly configured to push the cannula carrier into the second position when the motor is rotated in the opposite second direction.

[0011] The infusion device of claim 2, further comprising a trigger assembly configured to pull the cannula carrier into the second position when the motor is rotated in the opposite second direction.

[0012] The technology of the present invention includes methods for operating an infusion device. One method can include, for example, rotating a motor of the infusion device in a first direction to determine a volume of a medicament in a reservoir of the infusion device; receiving a command from a remote controller to rotate the motor in a second direction opposite the first direction; and

[0013] rotating the motor in the second direction, thereby triggering insertion of a cannula of the infusion device. In some embodiments, the method further includes rotating the motor in the first direction to deliver the medicament through the cannula after rotating the motor in the second direction.

[0014] According to several methods, the infusion device includes a cannula carrier, and the cannula is secured to the cannula carrier. The cannula carrier can be configured to rotate from a first position in which the cannula carrier is locked in a pre-insertion state to a second position in which the cannula carrier is free to move to insert the cannula. Rotation of the motor in the second direction can move the cannula carrier from the first position to the second position. In some embodiments, rotation of the motor in the second direction causes a trigger assembly to push the cannula carrier from the first position into the second position. In other embodiments, rotation of the motor in the second direction causes a trigger assembly to pull the cannula carrier from the first position into the second position.

[0015] In some aspects of the technology of the present disclosure, the cannula carrier is biased to rotate toward the second position. For example, rotation of the motor in the second direction can disengage a trigger assembly from the cannula carrier, allowing the cannula carrier to rotate into the second position. In some embodiments, rotating the motor in the second direction causes a ratchet to simultaneously rotate in the second direction. In several embodiments, rotating the motor in the second direction activates a linear clutch coupled to a reservoir assembly of the infusion device.

[0016] According to some embodiments, an infusion device includes an insertion assembly including a cannula, a reservoir assembly including a reservoir configured to house a medication, and a trigger assembly coupled to the insertion assembly and in fluid communication with the reservoir. In response to a command from a remote computing device communicatively coupled to the infusion device, the reservoir assembly can deliver medication to the trigger assembly to trigger insertion of the cannula by the insertion assembly. The infusion device can include a motor actuated by the command from the remote computing device and, when actuated, causes the medication to be delivered from the reservoir to the trigger assembly. In some embodiments, the reservoir includes a pusher, and the infusion device further includes a motor actuated by the command from the remote computing device. When actuated, the motor causes the pusher to advance within the reservoir to cause the medication to be delivered from the reservoir to the trigger assembly. In several embodiments, delivering the medication to the trigger assembly to trigger insertion of the cannula does not cause the medication to be infused into a patient. The trigger assembly can be configured to engage the insertion assembly to prevent cannula insertion, and wherein the medication delivered into the trigger assembly causes the trigger assembly to disengage the insertion assembly, allowing the insertion assembly to insert the cannula.

[0017] According to several embodiments, the infusion device includes an insertion assembly including a cannula carrier, and the cannula is secured to the cannula carrier. The cannula carrier can be configured to rotate from a first position in which the cannula carrier is locked in a pre-insertion state to a second position in which the cannula carrier is free to move to insert the cannula. In some embodiments, the trigger assembly is mechanically coupled to the cannula carrier and prevents rotation of the cannula carrier toward the second position.

[0018] In some embodiments, the trigger assembly includes a tubular housing defining an internal cavity therein and a piston positioned within the internal cavity, and wherein the internal cavity is in fluid communication with the reservoir. Delivery of a medicament to the trigger assembly to trigger insertion of the cannula can cause the piston to move, and movement of the piston a predetermined amount causes a portion of the piston to align with a portion of the insertion assembly to trigger cannula insertion. In some embodiments, the trigger assembly includes a hydraulic actuator.

[0019] Some methods for operating an infusion device include receiving a command from a remote computing device to actuate a motor of the infusion device, wherein the infusion device has a reservoir containing a medicament, an insertion assembly including a cannula, and a trigger assembly coupled to the insertion assembly and in fluid communication with the reservoir. In response to the command, the motor is actuated to push at least some of the medicament stored within the reservoir into the trigger assembly, thereby causing the insertion assembly to drive the cannula outside of the infusion device.

[0020] Some methods for operating an infusion device include receiving a command from a remote computing device to rotate a motor of the infusion device in a first direction, thereby causing an insertion assembly of the infusion device to drive a cannula outside of the infusion device. After rotating the motor in the first direction, the motor is rotated in a second direction opposite the first direction to push a medicament stored in a reservoir of the infusion device through the cannula. BRIEF DESCRIPTION OF DRAWINGS

[0021] Many aspects of the disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure.

[0022] FIG. 1A is a perspective view of an infusion device according to several embodiments of the technology of the present invention.

[0023] FIG. 1B is a perspective view of a bottom of the infusion device of FIG. 1A

[0024] FIG. 2A is a perspective view of a bottom of the infusion device of FIG. 1A and FIG. 1B ​Perspective view of certain components of the durable assembly shown in

[0025] FIG. 2B and FIG. 2C is FIG. 2A Perspective view of certain components of the durable assembly shown in

[0026] FIG. 3A is FIG. 1A and FIG. 1B Perspective view of the disposable assembly of the infusion device shown in

[0027] FIG. 3B is FIG. 3A Perspective view of certain components of the disposable assembly shown in

[0028] FIG. 4A is a cross-sectional view showing the insertion assembly (shown in state one) of the disposable assembly shown in FIG. 3A

[0029] is a perspective view of the insertion assembly shown in FIG. 4B FIG. 4A and

[0030] is a perspective view of certain components of the disposable assembly (shown in state two) prior to cannula insertion FIG. 5A FIG. 5B is a side view showing additional components (shown in a position prior to cannula insertion) for use with components of

[0031] and FIG. 5C FIG. 5A FIG. 5B

[0032] FIG. 5D is a cross-sectional view showing additional components (shown in a position prior to cannula insertion) for use with components of FIGS. 5A-5C

[0033] is a cross-sectional view of components (shown in state three) of FIG. 6A FIG. 5D

[0034] FIG. 6B is a perspective view showing additional components (shown in a position after cannula insertion but prior to trocar retraction) for use with components of FIG. 6A

[0035] is a cross-sectional view of components (shown in state four) of FIG. 7A and FIG. 5D FIG. 6A

[0036] ​​​​​​​FIG. 7B is a perspective view showing a further component for use with the components of FIG. 7A is a perspective view of certain components of the disposable assembly of

[0037] FIG. 7C and FIG. 7D is a perspective view of certain components of the disposable assembly of FIG. 7A

[0038] FIG. 8 is a perspective view of a disposable assembly configured in accordance with several embodiments of the technology of the present application.

[0039] FIG. 9A is a perspective view of a disposable assembly configured in accordance with several embodiments of the technology of the present application.

[0040] FIG. 9B is a perspective view of certain components of the disposable assembly of FIG. 9A

[0041] FIG. 9C is a perspective view of certain components of the disposable assembly of FIG. 9A

[0042] is a perspective view of a disposable assembly configured in accordance with several embodiments of the technology of the present application. FIG. 10A

[0043] is a perspective view of certain components of the disposable assembly of FIG. 10B FIG. 9A

[0044] FIG. 10C is a perspective view of certain components of the disposable assembly of FIG. 9A

[0045] is a top view of a portion of a disposable assembly configured in accordance with several embodiments of the technology of the present application (shown in a first state prior to cannula insertion). FIG. 11A

[0046] schematically depicts a hydraulic trigger assembly of the disposable assembly of FIG. 11B FIG. 11A is a top view of a portion of a disposable assembly of

[0047] FIG. 12A FIG. 11A is a top view of a portion of a disposable assembly of

[0048] FIG. 12B schematically depicts a hydraulic trigger assembly of the disposable assembly of FIG. 12A DETAILED DESCRIPTION

[0049] ​​​​​​​The technology of the present invention includes infusion devices (sometimes referred to as “patch pumps”) that are configured to adhere to a user’s skin over a delivery site. The infusion devices include a reservoir configured to house and contain a medicament, a motor, and an insertion assembly having a cannula operably connected to the reservoir. After the device is applied to the skin, the user activates the insertion assembly to insert the cannula subcutaneously. This insertion step often requires the user to manually press or pull a trigger on the device, which can be burdensome for the patient. Disclosed herein are infusion devices configured for remote triggering of cannula insertion (e.g., triggered by a computing device that is separate from but communicatively coupled to the infusion device). As described in greater detail below, the infusion devices herein are configured to be communicatively coupled to a remote controller that, at the user’s command, sends instructions to the infusion device that cause the insertion assembly to deploy the cannula. In some embodiments, the instructions cause a predetermined rotation of the motor, and the infusion device includes a trigger assembly that counterbalances the rotation of the motor to move or allow movement of the insertion assembly to a cannula release position. In any case, the infusion devices of the technology of the present invention enable cannula insertion via remote control, which can be more convenient for the user than a conventional manual trigger.

[0050] FIG. 1A and FIG. 1B The top and bottom sides of an infusion device 100 according to several embodiments of the technology of the present invention are shown, respectively. As previously described, the bottom side 100b of the device 100 is configured to adhere to a user’s skin, with the top side 100a facing away from the user. The device 100 includes a durable assembly 200 and a disposable assembly 300, each having respective housings 202 and 302. The durable assembly 200 and the disposable assembly 300 are disposed on an adhesive pad 102 having an adhesive backing 104 for securing to the user’s skin. The bottom side 100b of the device 100 can also include a pre-use pull tab (PBUP) 108 and a fill port 106.

[0051] The device 100 can be used in conjunction with a variety of remote controllers. For example, the remote controller can be a controller specific to the device, a mobile phone, a tablet, etc. Such remote controllers can be used, for example, to allow the user to send instructions to the durable assembly 200 or otherwise facilitate communication between the durable assembly 200 and the user (e.g., an alert condition message or other message regarding the condition of the device 100). In some embodiments, the remote controller is configured to send instructions to and / or receive instructions from the disposable assembly 300.

[0052] The remote controller can be configured to facilitate one, some, or all of the following operations:

[0053] • turning the remote controller on or off;

[0054] • associating (or "assigning") a remote controller to the durable assembly 200;

[0055] • obtaining status information, such as medication levels, battery charge levels, and / or alarm conditions;

[0056] • silencing alarms of the durable assembly;

[0057] • selecting options that can be associated with alarms of the durable assembly, such as alarm type (audible, tactile, visual, or a combination thereof) and alarm intensity / volume;

[0058] • connecting the remote controller to a computer to, for example, update the remote controller or durable assembly firmware, load and delete delivery profiles stored in the durable assembly 200 or remote controller, and otherwise reprogram the durable assembly 200 and / or remote controller;

[0059] • selecting medication options, such as medication concentration;

[0060] • selecting a stored medication delivery profile;

[0061] • increasing and decreasing medication administration rates;

[0062] • triggering cannula insertion;

[0063] • initiating medication delivery;

[0064] • pausing dispensing operations;

[0065] • and / or other processes.

[0066] The user can pause delivery in order to remove or replace a structure (e.g., a disposable assembly) applied by the user, adjust for a current or anticipated change in a physical condition (e.g., low blood sugar, strenuous exercise), follow a physician's recommendation, or disconnect the durable assembly 200 from the body for any other reason.

[0067] In some embodiments, the remote controller is configured to generate an indicator based on information from the microprocessor of the durable assembly 200, the indicator indicating, for example, an amount of time remaining in a current dispensing program, an amount of time until a next disposable assembly replacement, and the like. The indicator can be audible, visual, tactile, or a combination thereof. A remaining time indicator can be useful for a variety of reasons. For example, knowing the time remaining until a next disposable assembly replacement allows the user to determine whether it is more convenient to replace the disposable assembly 300 before the dispensing program ends based at least in part on a current time of day and upcoming events (e.g., travel or sleep). Additionally or alternatively, the remote controller can also be configured to generate an indicator of an amount of insulin remaining and / or an indicator of battery power.

[0068] As to dimensions, the device 100 can have a length of about 35 mm - 60 mm; a width of about 30 mm - 45 mm; and an overall thickness or height of about 8 mm - 18 mm. Suitable housing materials include, but are not limited to, plastics or other materials having an elastic modulus of 0.2 million psi - 1.0 million psi.

[0069] To use the infusion device 100, a user (e.g., a patient) connects the disposable assembly 300 to the durable assembly 200. Unless the reservoir of the disposable assembly 300 has been sufficiently pre-loaded, the user injects a desired amount of medicament into the reservoir via the fill port 106. A plunger finding procedure (described in detail below) can be initiated by the user or automatically. To adhere the device 100 to the user, the adhesive backing 104 can be peeled away to expose the adhesive pad 102; the PBUP 108 can be removed; and / or the device 100 can be positioned over a selected body location and pressed lightly to adhere the adhesive pad 102 to the skin surface. In some embodiments, the user triggers an automatic cannula insertion via a remote control (e.g., after the plunger finding operation is complete). In some embodiments, plunger finding is not required.

[0070] In FIGS. 2A-2C greater detail, the durable assembly 200 can include a housing 202, a buzzer or other alert device 204, one or more batteries or other energy supply 206, a microprocessor (not shown), and a coil assembly 208 including one or more Hall-effect sensors 210 (which function as a motor stator). In some embodiments, the energy supply 206 is a rechargeable battery, such as a rechargeable lithium battery, having sufficient power to drive the motor continuously without the need for capacitors or other additional energy storage devices.

[0071] With particular reference to FIG. 2C , the coil assembly 208 can be positioned around a recessed portion 212 of the durable assembly housing 202 that is configured to fit over a protruding portion 303 of the disposable housing 302( FIG. 3A ) that, in turn, fits over the protruding portion 303 of the disposable assembly 300( FIG. 3Babove the magnetic motor rotor 331 of the two-piece motor. In this two-piece motor, the motor coil assembly 208 is in the durable assembly 200 and is positioned around the motor rotor 331 that is part of the disposable assembly 300. The Hall effect sensors 210 are positioned above the coil assembly 208 in the durable assembly 200. In this configuration, there is a gap between the motor coil assembly 208 and the motor rotor 331. In the illustrated embodiment, some or all of the gap can be defined (and occupied) by housing portions (e.g., the durable housing portion 212 and the disposable housing portion 303). In other embodiments, the gap between the motor coil assembly 208 and the motor rotor 331 can be occupied by only a portion of the durable assembly housing 202, or by only a portion of the disposable assembly housing 302, or no structure at all and can simply be an air gap. The size of the gap defined by the distance between the motor coil assembly 208 and the motor rotor 331 is typically about 0.5 mm to 2.0 mm. Thus, there is no gear meshing or other mechanical connection between the durable assembly 200 and the disposable assembly 300. All electronics can be positioned within the durable assembly 200, the energy required by the disposable assembly 300 is delivered through an electromagnetic torque coupling, which is a coupling without direct mechanical coupling or electrical contact from the durable assembly 200. These designs provide the additional advantage of making it relatively simple to make waterproof or at least water resistant.

[0072] An exemplary motor rotor 331 can be a 2-pole, cylindrical, rare earth (such as neodymium) rotor that is magnetized on the diameter, with a 5 mm diameter and a 5 mm height. Other suitable motor rotors can be larger or smaller, or multi-pole. The cost of each piece of this type of motor rotor is typically about 5 cents, helping to control the overall cost of the disposable assembly 300. A microprocessor (not shown) directs the rotation of the motor rotor 331 by sequentially energizing the coils of the motor coil assembly 208 to create an electromagnetic torque coupling between the motor coil assembly 208 and the motor rotor 331. The position / orientation of the rotor poles relative to the rotating magnetic field generator (coil assembly 208) is measured by back EMF, a rotary encoder, one or more Hall effect sensors 210, etc. For example, Hall effect sensors 210 mounted above the coil windings 208 can be used to supply a count, tachometer signal, or rotor position to the microprocessor, allowing for low cost closed loop control of the rotor speed. This type of brushless motor is efficient and runs at a relatively low temperature.

[0073] In FIG. 3A and FIG. 3BThe disposable assembly 300, shown in greater detail, can include a reservoir assembly, a trigger assembly 304 (shown schematically), and an insertion assembly 400, all mounted on a base plate 350. The reservoir assembly can include a drive assembly 329, a reservoir 336, a plunger pusher 335a, and a plunger 335b. The plunger pusher 335a is coupled to the drive assembly 329, and both the plunger pusher 335a and the plunger 335b are housed within the reservoir 336. The insertion assembly 400 includes a cannula 441 (see FIG. 4A ) and several components for driving the cannula 441 into a user's skin. The trigger assembly 304 can operably couple one or more components of the reservoir assembly to the insertion assembly 400 to control the insertion timing of the cannula 441. In some embodiments, for example, one or more components of the trigger assembly 304 are operably coupled to the gear train 332 such that remote activation of the motor moves the trigger assembly 304 into or out of engagement with the insertion assembly 400, thereby actuating the insertion assembly 400 and releasing the cannula. Additional details regarding the remotely-actuatable trigger assembly are discussed below with respect to FIGS. 8-12B .

[0074] Still referring to FIG. 3A and FIG. 3B , the drive assembly can include a magnetic motor rotor 331 and a gear train 332. The gear train 332 is attached to the pusher 335a positioned in the reservoir 336. The magnetic motor rotor 331 can be mechanically attached through the gear train 332 to effect translation of the plunger pusher 335a (and the plunger 335b, when attached to the plunger pusher 335a) within the reservoir 336.

[0075] As best seen in FIG. 3B , the gear train 332 includes a worm drive consisting of a worm 333a and a worm gear 333b, and also includes a leadscrew nut 334a and a small-pitch leadscrew 351 (encircled by the leadscrew nut 334a). The worm gear 333b is coupled to the leadscrew 351 via the leadscrew nut 334a. A protrusion 334b on the leadscrew nut 334a corresponds to a recess (not shown) inside the worm gear 333b, and a threaded portion (not shown) inside the leadscrew nut 334a mates with threads on the leadscrew 351 encircled by the leadscrew nut 334a. The configuration of the gear train 332 prevents back-driving due to reservoir pressure, eliminating the need for a clutch or other locking mechanism. Suitable materials for the components of the gear train 332 include, but are not limited to, stainless steel or high-strength plastics such as nylon, Delrin.RTM., or polycarbonate.

[0076] Reservoir 336 is pre-filled with medicament. For example, the medicament can be U-100 insulin or U-500 insulin or other concentrations of insulin to suit different user usage profiles, or can be user fillable through fill port 106 FIG. 1B ) in some embodiments, reservoir 336 can be mounted on a reservoir support block FIG. 3B (not shown). Reservoir outlet fitting 348 is in fluid communication with reservoir 336. Reservoir outlet fitting 348 can be made of a drug product compatible material such as, but not limited to, polypropylene, cyclic olefin polymer (COP), or polyethylene.

[0077] In those cases where reservoir 336 is user filled, the user can fill the reservoir completely with medicament to capacity, or the user can choose to introduce less medicament and not completely fill the reservoir. Since an unknown amount of medicament can be injected into a user filled reservoir, the plunger pusher zeroing procedure (or “plunger find”) can be user initiated, or can be an automatic aspect of pump operation. The pusher find procedure precisely determines and / or sets how far the plunger pusher 335a travels before it engages with the plunger 335b, allowing calculations to be made to determine the amount of medicament in the reservoir and thus an estimate of the time to empty as well as the time for replacement of the disposable assembly, prior to any medicament dispensing.

[0078] FIG. 3B Reservoir 336 is shown prior to any medicament being introduced into it. Plunger 335b is disconnected from plunger pusher 335a (and thus free floating), and plunger pusher 335a is in the fully retracted position. At this point, and until the plunger find operation is complete, PBUP 108 FIG. 1B) to prevent premature flow of drug between the reservoir 336 and the insertion assembly 400 (except in the hydraulic trigger embodiments discussed below with reference to 11A-12B, where a PBUP can not be necessary). When drug is introduced into the reservoir 336 via the fill port 106, the plunger 335b is pushed towards the plunger pusher 335a. If the reservoir 336 is filled to capacity, the plunger 336b will be pushed into contact with the plunger pusher 335a. In some embodiments, this causes the hooks 337 (or other suitable attachment method) on the plunger 335b to engage with the pusher 335a and permanently lock. If the reservoir 336 is not filled to capacity, the plunger 335b will be positioned at some unknown point within the reservoir 336 until the plunger finding operation is complete. Once the user has introduced drug into the reservoir 336, the plunger finding operation can be initiated by the user or can be an automatic aspect of the pump operation. When the plunger finding operation is initiated, the motor advances the plunger pusher 335a until it contacts the plunger 335b. In some embodiments, they lock together with the plunger hooks 337 or some other suitable attachment method. In some embodiments, the plunger pusher 335a and plunger 335b are not configured to mechanically lock. The reservoir 336 and plunger 335b can be made of cyclic olefin polymer (COP), polypropylene, or other drug product compatible polymeric materials. Suitable materials for the plunger pusher 335a include, but are not limited to, stainless steel, COP, nylon, and polycarbonate.

[0079] As previously described, the plunger finding operation is performed when flow from the reservoir 336 is blocked by the PBUP 108. Given that there can be tolerances associated with the manufacture of the cartridge and variations in drug fill, the distance that the plunger pusher 335a travels from its initial home position before it contacts the plunger 335b can vary. Under microprocessor control, the motor advances the plunger pusher 335a into contact with the plunger 335b, causing an increased fluid path pressure. The Hall effect sensor 210, encoder, or other monitoring / sensing means is sampled to determine when motor stall occurs as the plunger pusher 335a is advanced. The absence of a signal from the Hall effect sensor 210 indicates that the motor is not turning. Motor stall is taken to be due to hydraulic locking and thus indicates that the plunger pusher 335a is in contact with the plunger 335b of the installed device. In some embodiments, the procedure can employ two or more speeds to advance the plunger pusher 335a. Also, the plunger pusher 335a can be advanced with a controlled torque or limited force, such that the motor will stall with a possibly minimal amount of force for a reliable result, in order to reduce the load on the system (e.g., bearings and battery). As described above, knowing the distance that the plunger pusher 335a travels before contacting the plunger 335b allows the calculation of the volume of drug and the estimated time until replacement of the disposable assembly 300.

[0080] In some implementations, instead of sensing motor stall, or in addition to sensing motor stall (as described above), device 100 can be configured to sense increased load on the motor. For example, device 100 can be configured to sense a decrease in motor speed of less than 100% (which would be equivalent to motor stall), which can be sensed much faster than motor stall. Device 100 can be configured to sense speed decreases of, for example, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90%. For example, suppose device 100 operates the motor in a speed-controlled manner by changing the motor current to control the speed. When the reservoir pressure increases, the motor current increases to maintain the desired speed. Therefore, device 100 is configured to sense blockage and piston seeking by sensing an increase in motor load. This increased load can be sensed in various ways, such as an increase in power, a decrease in speed, etc.

[0081] FIG. 4A and FIG. 4B The insertion component 400 is shown in more detail below. FIG. 4A and FIG. 4B The insertion assembly 400 is shown in a ready-to-fire and locked position (e.g., before the user removes PBUP 108 and remotely activates trigger assembly 304). Insertion assembly 400 may include a cylindrical guide housing 420, a main insertion spring 410, a sleeve carrier 412, and a sleeve 441 secured to the sleeve carrier 412. The sleeve carrier 412 also includes a trigger boss 411 configured to engage with trigger assembly 304 to move (or allow movement) the sleeve carrier 412. The main insertion spring 410 extends between a top flange of the guide housing 420 and a portion of the sleeve carrier 412. When insertion assembly 400 is in the pre-insertion position (e.g., before the user removes PBUP 108 and remotely activates trigger assembly 304), the insertion assembly 400 is engaged. FIG. 4A When (as shown), the main insertion spring 410 is in a compressed state and applies a downward force to the sleeve carrier 412. The sleeve carrier 412 and the support flange 422 of the guide housing 420 (as shown) FIG. 4B The engagement between the main insertion spring 410 and the sleeve carrier 412 keeps the main insertion spring 410 in a compressed state and prevents the sleeve carrier 412 from moving downward.

[0082] Insertion assembly 400 also includes a trocar 447, a trocar carrier 474, a trocar seal 480, a trocar retraction spring 482, a cannula seal 430, a seal ring 431, and a cannula seal retainer 434. Trocar 447, which includes an elongated rod with a sharp distal tip, can be made of metal, such as stainless steel, or other relatively rigid biocompatible material, such as rigid plastic, ceramic, or other rigid biocompatible material, and is used to penetrate the skin and penetrate a short distance into the flesh in order to create a passageway for cannula 441. Cannula 441 can be made of polytetrafluoroethylene (PTFE), such as TEFLON.RTM. PTFE or other biocompatible polymeric material. As described further below, these components provide highly effective cannula sealing and highly reliable drug sealing with low cannula insertion force. The components involved and details of how insertion assembly 400 performs these actions are described in greater detail below.

[0083] Insertion assembly 400 can be a 4-state system. FIGS. 4A-4B Insertion assembly 400 is shown in its first state: ready-to-fire position (e.g., before the user removes PBUP 108 and remotely activates trigger assembly 304 to insert cannula 441). In this state, PBUP 108 is positioned to block the fluid path from reservoir 336, and cannula carrier 412 is held above and spaced apart from cannula seal 430, as described further below. In this state, and as best seen in FIG. 3B , the plunger-seeking procedure described above can advance plunger pusher 335a into contact with plunger 335b, slightly pressurizing reservoir 336 without injecting drug into the user. As best seen in FIG. 4A , a seal is formed between seal ring 431 and the outer surface of PBUP 108, allowing the pressure sought by the plunger.

[0084] FIGS. 5A-5D Insertion assembly 400 is shown in its second state. In this state, PBUP 108 has been removed and insertion assembly 400 is ready to fire. The fluid path from reservoir 336 FIG. 3A is open to atmosphere, and any residual pressure is vented prior to cannula insertion.

[0085] As will be described in greater detail below, removal of PBUP 108 allows for cannula insertion, which can be triggered based on activation of trigger assembly 304 via a remote controller. Triggering cannula insertion can cause trocar 447 and cannula 441 (best seen in FIG. 5D ) to extend from disposable assembly 300 (i.e., FIG. 6A and FIG. 6BState Three) shown in FIG. 4B, and then causes the trocar needle 447 to retract into the insertion assembly 400, leaving the cannula 441 in place (which is FIG. 7A and FIG. 7D State Four) shown in FIG. 4C.

[0086] FIG. 5B The insertion assembly 400 is shown with the primary insertion spring 410 and the guide housing 420 removed. In FIG. 5C , the primary insertion spring 410 is removed and the guide housing 420 is translucent. FIG. 5D is a cross-sectional view of the components of FIG. 5C . The primary insertion spring 410 can provide a stroke of about 7 mm with a starting force of about 15 Newtons (N) and a terminal force of about 7 N, and can be made of, for example, a music wire with a diameter of 0.75 mm with 6 turns and an outer dimension of 13.25 mm. The trocar needle retraction spring 482 can provide a stroke of about 7 mm with a starting force of about 4 N and a terminal force of about 1 N, and can be made of, for example, a music wire with a diameter of 0.5 mm with 6 turns and an outer dimension of 3 mm. The guide housing 420 and the cannula seal retainer 434 can be made of a high-strength plastic such as nylon, Delrin.RTM., or polycarbonate. The cannula carrier 412 and the trocar needle carrier 474 can be made of COP, polypropylene, or other similar drug- compatible materials. The trocar needle seal 480 and the cannula seal 430 can be made of an elastomer, a rubber such as silicone rubber or bromobutyl rubber, or other relatively suitable sealing materials that are also drug-compatible.

[0087] As described above, FIGS. 5A-5D The insertion assembly 400 is shown in State Two, the ready-to-fire position (e.g., before the user activates the trigger assembly 304 remotely to cause the cannula carrier 412 to drive the cannula 441 into the insertion position). Prior to insertion, the cannula carrier 412 is supported on the support flange 422 of the guide housing 420 (best seen in FIG. 5D , which in turn holds the primary insertion spring 410 in a compressed state. It should be noted that the guide housing 420 does not move during cannula insertion.

[0088] Activation of the trigger assembly 304 causes the cannula carrier 412 to rotate so that the carrier tab 413 moves away from the support flange 422 and into alignment with the slot 424 in the guide housing 420 (shown in FIG. 4B , FIG. 5A and FIG. 5C). While the cannula carrier 412 is shown as being rotated counterclockwise to release, in other embodiments the cannula carrier can be rotated clockwise to release (in such embodiments, the slot 424 can be disposed immediately to the left of the tab 413). Once the cannula carrier 412 is no longer supported by the guide housing flange 422, the cannula carrier 412 is no longer able to resist the force of the main insertion spring 410, and the elastic energy contained in the main insertion spring 410 is converted to motion. The main insertion spring 410 drives the cannula carrier 412 with attached cannula 441, the cannula needle carrier 474 with attached cannula needle 447, the cannula needle seal 480, and the cannula needle retraction spring 482 downward. As these components move downward, the sharp distal tip of the cannula needle 447, which extends slightly beyond the distal end of the cannula 441, penetrates the user’s skin, and the cannula 441, which surrounds the cannula needle 447, is inserted, so the end of the cannula 441 is located about 6 mm below the surface of the user’s skin. At this point, as FIG. 6A and FIG. 6B can be seen, the insertion assembly 400 is in state three.

[0089] As best seen in FIG. 5B , FIG. 6B and FIG. 7B , the cannula carrier 412 and the cannula needle carrier 474 include features for locking them together before and during cannula insertion. The cannula needle carrier 474 includes a locking flange 475 (labeled only in FIG. 7B ) that fits under a locking boss 415 (labeled only in FIG. 6B and FIG. 7B ) on the cannula carrier 412. When the cannula carrier 412 and the cannula needle carrier 474 are locked together, the cannula needle retraction spring 482 is held in a compressed state. Additionally, the cannula needle carrier 474 includes a locking flange wall 477 that contacts a locking boss wall 417 on the cannula carrier 412. These walls ensure that the cannula needle carrier 474 moves with the cannula carrier 412 (e.g., only counterclockwise or any rotational direction in which the cannula carrier 412 moves), so the locking flange 475 of the cannula needle carrier does not accidentally slide out from under the locking boss 415 of the cannula carrier and inadvertently trigger penetration of the cannula needle 447.

[0090] Once the cannula carrier 412 and the cannula needle carrier 474 are rotated to begin cannula insertion and move downward toward the user, the angled edge 479 of the tab 478 on the cannula needle carrier 474 contacts the corner 435 on the seal holder 434. As the cannula needle carrier 474 moves downward, the contact between the corner 435 and the angled edge 479 causes the cannula needle carrier 474 to rotate more and more (e.g., counterclockwise) during cannula insertion. As the cannula carrier 412 moves downward, the carrier tab 413 contacts the slot 424 in the guide housing 420 (as FIG. 4B ,FIG. 5A and FIG. 5C The locking flange 475 of the trocar carrier 474 is aligned with the locking ledge 415 of the cannula carrier 412 (as shown) allowing the cannula carrier 412 to slide downward while preventing further rotation of the cannula carrier 412. As the trocar carrier 474 is further rotated counterclockwise, the locking flange 475 of the trocar carrier slides out from under the locking ledge 415 of the cannula carrier.

[0091] FIG. 6A and FIG. 6B The insertion assembly 400 is shown in state three: FIG. 6A The fully fired main insertion spring 410, fully down cannula carrier 412, and fully inserted cannula 441 are shown at the instant the trocar carrier 474 is released and before the trocar retraction spring 482 drives the trocar carrier 474 and trocar 447 upward. (As shown, the skin is pierced at about 90 degrees and the cannula end is positioned about 6 mm below the skin surface.) FIG. 6B The same instant is shown with the main insertion spring 410 and guide housing 420 removed. This view shows the moment the locking flange 475 of the trocar carrier is released from under the locking ledge 415 of the cannula carrier.

[0092] Once the locking flange 475 of the trocar carrier is released from under the locking ledge 415 of the cannula carrier (which is also the moment the cannula 441 is fully inserted and the insertion assembly 400 is in state three, as shown in FIG. 6A and FIG. 6B can be seen), the trocar carrier 474 is no longer able to resist the force of the trocar retraction spring 482. The elastic energy contained in the trocar retraction spring 482 is converted into motion and the trocar retraction spring 482 drives the trocar carrier 474 with attached trocar 447 upward. As the trocar carrier 474 moves upward, the trocar 447 is removed from the user and retracted into the insertion assembly 400 leaving the cannula 441 inserted. This is state four, as FIGS. 7A-7D can be seen.

[0093] FIG. 7A is a cross-sectional view showing the fully fired insertion assembly 400 and the fully retracted trocar 447. FIG. 7B More details of the fully fired insertion assembly 400 are shown with the main insertion spring 410 and guide housing 420 removed. This is the position of the components of the insertion assembly 400 when the device 100 is being used by the user (e.g., during fluid delivery). The drug path is best seen in FIG. 7A and FIG. 7C Generally, the drug flows from the reservoir (not shown) to the outlet fitting 348, into the channel of the cannula seal 430, through the channel 414 in the cannula carrier 412, through the trocar seal 480, and into the cannula 441 for delivery to the user.

[0094] FIG. 7C and FIG. 7D An optimally visible high effective radial compression hydraulic seal is formed between the sleeve carrier 412 and the upper and lower sealing rings 431 of the sleeve seal 430. The upper and lower sealing rings 431 can be separated by about 2.5 mm. The tapering of the sleeve seal 430 to the small contact area of the sealing rings 431 concentrates the surface stress where the sealing rings 431 contact the sleeve carrier 412 to provide a good seal. Additional upper and lower sealing rings are possible but can increase the space requirements. To enhance the seal at the sealing rings 431, the main insertion spring 410 exerts a force on the sleeve carrier 412, keeping it down against the base plate 350 and causing the inner surface 416 of the sleeve carrier 412 to push on the top surface of the sleeve seal 430, as described in more detail below.

[0095] During the transition from state two to state three of the insertion, the inner surface 416 of the sleeve carrier 412 starts to contact the top of the sleeve seal 430 before the bottom surface of the sleeve carrier 412 contacts the base plate 350. When state three is reached, the bottom surface of the sleeve carrier 412 is kept against the base plate 350 and the sleeve seal 430 is compressed from above. The high energy of the main insertion spring 410 improves the seal reliability and the sleeve seal 430 acts as a damper when it is compressed, thus helping to dissipate the energy of the insertion. The residual energy from the firing of the main insertion spring 410 is not wasted or converted into noise and feel that the user can perceive, but is converted from kinetic energy to an enhanced radial compression of the sleeve seal 430.

[0096] Additionally, the contact between the inner surface 416 of the sleeve carrier 412 and the top surface of the sleeve seal 430 forms an auxiliary face seal. In state three, the main insertion spring 410 continues to push down on the sleeve carrier 412 with a force of about 7-10 N. In addition to maintaining the seal at the upper sealing ring 431, this force spread over the top surface of the sleeve seal 430 causes a fluid seal that can seal about 3 bar.

[0097] To further enhance this seal, the seal retainer 434 provides radial support, acting as a stationary backing ring / clamp, increasing the radial compression around the sleeve seal 430. Even further enhancing the seal, the sleeve carrier 412 provides additional radial compression by clamping force on the sleeve seal 430, acting as an additional backing ring / clamp. The 7N-10N residual force from the primary insertion spring 410 causes downward (axial) compression on the sleeve seal 430, causing radial deformation of the sleeve seal 430, further improving the seal formed between the sleeve carrier 412 and the seal ring 431. In state three, the axial compression of the sleeve seal 430 causes radial deformation of the seal 430, increasing the sealing force on the seal ring 431, as the sleeve seal 430 is radially constrained by the seal retainer 434 and the sleeve carrier 412. All of this results in a highly effective and reliable hydraulic sleeve seal.

[0098] Turning now to FIG. 7C , the drug path also includes a compression type fitting 490 formed by the clamping portion 436 of the seal retainer 434 that clamps the ferrule 432 of the sleeve seal 430 down onto the barb 349 of the outlet fitting 348. As an alternative, a separate component could be utilized to deliver the clamping force provided by the clamping portion 436 of the seal retainer 434. Additionally, the ferrule 432 of the sleeve seal 430 and the barb 349 of the outlet fitting 348 could be separate ferrule and barb components, but would introduce additional component interfaces along the drug path, each requiring additional sealing features. In the configuration shown, the sleeve seal 430 seals the sleeve 441, absorbs energy during firing by compressing when struck by the sleeve carrier 412, and helps seal the reservoir 336 with the sleeve 432.

[0099] As best seen in FIG. 7D , the drug next flows through the ferrule 432, through the sleeve seal 430, through the passage 414 in the sleeve carrier 412, through the sleeve needle seal inlet 481, through the sleeve needle seal passage 483, and through the sleeve 441 for delivery to the user. From the comparison FIG. 5D 、 FIG. 6A and FIG. 7AAs can be seen, the trocar seal 480 remains in a position within the trocar carrier 412 before, during, and after the insertion process, and remains in that position during user use of the device 100. The trocar seal 480 includes a sidewall seal ring 484 and a base seal ring 486. The sidewall seal ring 484 prevents drug leakage into the trocar carrier 412, and ultimately into the device 100. The base seal ring 486 prevents leakage from around the trocar 441, and ensures that drug flowing from the trocar seal inlet 481 and through the trocar seal passage 483 is directed into the trocar 441. FIG. 7D A pair of sidewall seal rings 484 and a pair of base seal rings 486 are shown, but additional seals can be used for additional leak protection.

[0100] The insertion assembly 400 provides highly effective, highly reliable drug sealing (all in a compact space) with low insertion force. The energy supplied to insert the trocar 441 is provided by the primary insertion spring 410, and is sufficient to:

[0101] • allow the trocar 447 to quickly and cleanly pierce the skin of a user for trocar insertion;

[0102] • overcome frictional forces during movement of the trocar carrier 412 surface against the trocar seal 430 surface and the seal retainer 434 surface; and

[0103] • result in compression and radial forces that produce reliable drug sealing.

[0104] Excess energy is absorbed by compression of the trocar seal 430, which causes the trocar seal 430 to expand radially, increasing the radial force exerted by the seal ring 431 against the surface of the trocar carrier 412 and the radial force exerted by the trocar seal 430 against the seal retainer 434, as explained in more detail below. Energy requirements and expenditures are also described in more detail presently.

[0105] During operation, as the insertion assembly 400 transitions from state two to state three, the radial compression force applied on the sleeve seal 430 increases. As the sleeve carrier 412 moves downward, it contacts the upper sleeve seal ring 431 and generally causes the sleeve seal 430 to be captured and enclosed between the sleeve carrier 412 and the surface of the seal retainer 434. The seal retainer 434 acts as a stationary backing ring, providing radial support for the sleeve seal 430, contributing to the radial clamping force applied to the sleeve seal 430. However, in some alternatives, as momentarily illustrated, there can be a small gap between the seal retainer 434 and the sleeve seal 430 until the sleeve seal 430 is compressed downward and radially expanded. As the sleeve carrier 412 continues to move downward, the radial force applied to the sleeve seal 430 increases as the amount of contact, and thus the radial force, continues to increase between (i) the sleeve carrier 412 and the surface of the sleeve seal ring 431, (ii) the seal retainer 434 and the sleeve seal 430, and (iii) in some alternatives, the surface of the sleeve carrier 412 and the seal retainer 434. Regarding the next embodiment, the contact between the sleeve carrier 412 and the seal ring 431 during the transition from state two to state three is also described in more detail below.

[0106] As the sleeve carrier 412 continues to move downward, contact is made between the top surface of the sleeve seal 430 and the carrier inner surface 416 (see FIG. 5D and FIG. 7D). As described above, this contact occurs while the sleeve carrier 412 is still moving downward. Thus, as the sleeve carrier 412 continues to move downward, the inner surface 416 of the sleeve carrier 412 exerts an increasing downward force on the sleeve seal 430, and as it does so, the sleeve seal 430 is increasingly compressed as the sleeve carrier 412 continues to move. As the carrier inner surface 416 increasingly pushes on the sleeve seal 430 from above, the sleeve seal 430 increasingly expands radially, thereby creating additional radial compression forces between (i) the seal ring 431 and the sleeve carrier 412 and (ii) the sleeve seal 430 and the seal retainer 434. The sleeve seal 430 can ultimately expand radially, for example, by 0.5 mm. (In some alternatives, a small gap between the seal retainer 434 and the sleeve seal 430 can be reduced until it is eliminated as the sleeve seal 430 radially expands due to the downward compression of the sleeve seal 430 by the inner surface 416 of the sleeve carrier 412.) Additionally, as described above, the contact between the inner surface 416 of the carrier 412 and the top surface of the sleeve seal 430 forms an auxiliary face seal. In this way, a highly effective and highly reliable sleeve seal is achieved by (1) this face seal formed at the inner surface 416 of the sleeve carrier 412 and the top surface of the sleeve seal 430, (2) the contact between the seal ring 431 and the sleeve carrier 412, (3) the radial clamping force exerted on the sleeve seal 430 by the seal retainer 434, (4) the increasing radial clamping force exerted by the sleeve carrier 412, which acts as an additional backing ring (in addition to the seal retainer 434) and provides increased radial compression of the sleeve seal 430, and (5) the downward force exerted by the sleeve carrier 412 on the top of the sleeve seal 430 at the inner surface 416 of the sleeve carrier 412, which causes the sleeve seal 430 to expand radially and increases (a) the radial force exerted by the seal ring 431 against the surface of the sleeve carrier 412 and (b) the radial force exerted by the sleeve seal 430 against the seal retainer 434.

[0107] I. Selected embodiments of the trigger assembly

[0108] FIGS. 8-12B Representative examples of disposable assemblies 800, 900, 1000, and 1100 having remotely actuatable trigger assemblies with various configurations in accordance with embodiments of the technology of the present application are shown. The disposable assemblies 800, 900, 1000, and 1100 can generally be similar in features to the disposable assembly 300 of FIGS. 1A-7D . Accordingly, like reference numerals are used in FIGS. 1A-7D to identify like or similar components, and FIGS. 8-12B the discussion of the disposable assemblies 800, 900, 1000, and 1100 will be limited to features that differ from those of the disposable assembly 300 ofFIGS. 1A-7D The 300 different features of the disposable components. Additionally, FIGS. 8-12B Any feature of the disposable components 800, 900, 1000, and 1100 can be combined with each other and / or with... FIGS. 1A-7D The feature combination of the disposable component 300.

[0109] In any of the infusion device embodiments disclosed herein, the trigger assembly 304 may be configured to push or pull a portion of the cannula carrier 412 to rotate the tab 413 of the cannula carrier 412 into contact with the slot 424 in the guide housing 420. FIG. 4B Alignment. For example, FIG. 8 A disposable assembly 800 with a trigger assembly coupled to a drive assembly 329 of a reservoir assembly is shown. The trigger assembly may include a shaft 802, a lever 804, a clutch disc 806, and a lever 808. The lever 804 has a first end portion 804a adjacent to a trigger boss 411 of the sleeve carrier 412 and a second end portion 804b adjacent to the lever 808. The lever 808 may be coupled to a fixed portion of the reservoir assembly via a pin 807 and has a first lever arm 808a and a second lever arm 808b configured to rotate about the pin 807. The lever 808 does not translate forward when the plunger pusher 335a translates forward. The first lever arm 808a is positioned adjacent to the end of the lever 804 and rotates counterclockwise when the trigger assembly is activated, thereby pushing the lever 804 forward toward the trigger boss 411 of the sleeve carrier 412 (as indicated by arrow B). The clutch disc 806 is located at the second lever arm 808b. The shaft 802 has a first end (not visible) fixed to the plunger pusher 335a (or another component that moves with the plunger pusher 335a) and a second free end. When the shaft 802 extends rearward from the plunger pusher 335a, it passes through an opening in the clutch disc 806 located at the second lever arm 808b.

[0110] When the drive assembly 329 of the reservoir assembly is operated in the forward direction (e.g., during a plunger seeking operation), the shaft 802 translates forward with the plunger pusher 335a. The clutch disk 806 allows the shaft 802 to pass therethrough in this forward direction. However, when the motor is reversed (e.g., after the plunger seeking operation is complete) and the plunger pusher 335a moves in the backward direction, the clutch disk 806 clamps down on the shaft 802 and prevents the shaft 802 from translating backward through the clutch disk 806. As a result, the shaft 802 becomes a substantially rigid body with the second lever arm 808b, such that the shaft 802 pulls the second lever arm 808b counterclockwise about the pin 807. This rotation of the second lever arm 808b causes rotation of the first lever arm 808a, which engages the second end portion 804b of the rod 804 to push the rod 804 forward (as indicated by arrow B). The forward translation of the rod 804 forces the first end portion 804a of the rod 804 into contact with the trigger tab 411 of the cannula carrier 412 and pushes the cannula carrier 412 clockwise (as indicated by arrow C) to trigger cannula insertion.

[0111] In use, a user positions the device (including the disposable assembly 800) on the skin with the trigger assembly in the locked state. Once the device is adhered to the user’s skin (e.g., after the plunger seeking operation is complete and the PBUP 108 is removed), the user can trigger cannula insertion by interfacing with the remote controller to indicate a desire to trigger cannula insertion. For example, the user can press a button on the touchscreen of the user’s mobile device. In response to the user’s indication, the remote controller can transmit a command to the device (e.g., via the microprocessor of the durable assembly 200) to reverse the motor. In response to the reversed motor, the plunger pusher 335a moves backward, thus rotating the lever 808, and via the translation of the rod 804, forces the tab 413 of the cannula carrier 412 to rotate into alignment with the slot 424 of the guide housing 420 for cannula insertion. After triggering, the plunger pusher 335a advances back into contact with the plunger 335b to begin delivery of the medication.

[0112] In some embodiments of the disposable assembly 800, the rod 804 is configured to pull the trigger tab 411 rather than push as detailed above. For example, the first end portion 804a of the rod 804 can be positioned to the right of the trigger tab 411 and connected thereto via one or more links.

[0113] According to several embodiments, the cannula carrier 412 of the insertion assembly 400 is rotationally biased toward a direction in which the cannula carrier 412 is to be released from the guide housing 420. In such embodiments, the trigger assembly can include a blocking member that prevents such rotational motion until the user remotely activates the trigger assembly to remove the blocking member and release the cannula carrier 412. For example, the blocking member can engage a portion of the cannula carrier 412, such as the trigger boss 411, to prevent the cannula carrier 412 from rotating in the release direction. Remote activation of the trigger assembly causes the blocking member to disengage from the trigger boss 411, allowing the cannula carrier 412 to rotate such that the tab 413 on the carrier 412 aligns with the slot 424 in the guide housing 420. Alignment of the tab 413 with the slot 424 enables the cannula carrier 412 to move downward and the cannula 441 to be inserted.

[0114] To rotationally bias the cannula carrier 412, the insertion assembly 400 can include a torsion spring. In some embodiments, the flange 422 (see FIG. 4B ) of the guide housing 420 can be tilted downward toward the slot 424 such that, when the blocking member is removed, the cannula carrier 412 can no longer resist the force of the primary insertion spring 410, and the elastic energy contained in the primary insertion spring 410 is converted into motion. Due to the tilted flange 422, the cannula carrier 412 rotates as it moves downward until the tab 413 located on the flange 422 aligns with the slot 424 on the guide housing 420.

[0115] FIGS. 9A-9C is a different view of the disposable assembly 900 with a rotationally biased cannula carrier 412 and a trigger assembly operably coupled to the drive assembly 329. The trigger assembly can include a rod 902, a latch 904, and a ratchet 910 coupled to the worm gear 333b of the reservoir assembly such that rotation of the worm gear 333b causes rotation of the ratchet 910. The rod 902 has a first end 902a that abuts the trigger boss 411 on the cannula carrier 412, and a second end 902b that is received within an opening 920 FIG. 9B ) in the reservoir support block 338. In some embodiments, for example as shown in FIGS. 9A-9C , the rod 902 is oriented parallel to the longitudinal axis of the reservoir 336. The reservoir 336, the reservoir support block 338, and / or another component of the disposable assembly 900 can include a groove 906 FIG. 9B ) configured to receive at least a portion of the rod 902 to guide translation of the rod 902 and prevent lateral movement (e.g., any movement that is not parallel to the longitudinal axis of the reservoir 336).

[0116] When the trigger assembly is in the locked state (pre-insertion, as FIGS. 9A-9CWhen (as shown), the first end 904a of the latch 904 prevents the lever 902 from translating beyond the opening 920 (in a direction away from the insertion assembly 400). For example, the latch 904 may be located in a channel 914 in the support block 338, which positions the first end 904a of the latch 904 at the second end 902b of the lever 902 (as shown). FIG. 9C The sleeve carrier 412 is located between the stop 908 on the support block 338 and the stop 908 on the support block 338. As previously described, the sleeve carrier 412 can be rotated and biased in a particular direction (shown here as counterclockwise, as indicated by arrow D), but this is prevented by the lever 902, which is clamped between the trigger boss 411 on the sleeve carrier 412 and the first end 904a of the latch 904. Due to the continuous force exerted on the lever 902 by the sleeve carrier 412, the lever 902 is biased toward rearward translation (towards the support block 338, as indicated by arrow C), but this is prevented by the presence of the first end 904a of the latch 904 across the opening 920.

[0117] The second end 904b of the latch 904 can engage with the tooth 912 on the ratchet 910. FIG. 9B When the worm gear 333b rotates counterclockwise (e.g., during a plunger search operation, pushing the plunger pusher 335a forward), the ratchet 910 also rotates counterclockwise. During this rotation, the teeth 912 of the ratchet 910 do not engage with the latch 904, thereby moving the first end 904a of the latch 904 away from the opening 920. When the motor reverses and the worm gear 333b rotates clockwise ( FIG. 9B As indicated by arrow A), ratchet 910 also rotates clockwise. During this rotation, one of the teeth 912 of ratchet 910 engages the second end 904b of latch 904 and pulls latch 904 away from the second end 902b of lever 902 and opening 920 (indicated by arrow B). Once latch 904 has left opening 920, lever 902 slides freely through opening 920, allowing sleeve carrier 412 to rotate (indicated by arrow D). Rotation of sleeve carrier 412 aligns tab 413 on carrier 412 with slot 424 in guide housing 420 (see arrow B). FIG. 4B This allows the main spring 410 to push the sleeve carrier 412 downward and insert the sleeve 441.

[0118] In use, the user positions the device (including disposable component 900) on the skin with the trigger component locked. Once the device adheres to the user's skin (e.g., if desired, after the plunger searching operation is complete and PBUP108 has been removed), the user can trigger cannula insertion by interfacing with a remote controller to indicate the desired cannula insertion. For example, the user can press a button on the touchscreen of the user's mobile device. In response to the user's instruction, the remote controller can transmit a command to the device (e.g., via the microprocessor of durable component 200) to reverse the motor. In response to the reversing motor, worm gear 333b and ratchet 910 rotate clockwise, thereby moving latch 904 and allowing cannula carrier 412 to descend for insertion. After triggering, plunger pusher 335a advances back to contact plunger 335b to initiate drug delivery.

[0119] FIGS. 10A-10C This is a different view of a disposable component 1000, which has a trigger component operatively coupled to a drive component 329. (Regarding...) FIGS. 9A-9C Compared to the disposable component 900 shown and described, the cannula carrier 412 of the disposable component 1000 is not rotatably biased and requires forced rotation to trigger cannula insertion. The trigger assembly may include a lever 1002, a latch 1004, and a ratchet 1010 coupled to a worm gear 333b, such that rotation of the worm gear 333b causes rotation of the ratchet 1010. The lever 1002 has a first end portion 1002a abutting a trigger boss 411 on the cannula carrier 412, and a second end portion 1002b received within an opening in a reservoir support block 338. In some embodiments, such as... FIGS. 10A-10C As shown, rod 1002 is oriented parallel to the longitudinal axis of reservoir 336. Reservoir 336, reservoir support block 338, and / or another component of disposable assembly 1000 may include recess 1006. FIG. 10C The groove is configured to receive at least a portion of the rod 1002 to guide the translation of the rod 1002 and prevent lateral movement (e.g., any movement not parallel to the longitudinal axis of the reservoir 336).

[0120] When the trigger component is in a locked state (before insertion, such as...) FIGS. 10A-10C When (as shown), the second end portion 1002b extends beyond the opening 920 in the reservoir support block 338 (in a direction away from the insertion assembly 400) and adjacent to the first end portion 1004a of the latch 1004. For example, the latch 1004 may be located in a channel 1014 in the support block 338. The second end portion 1004b of the latch 1004 may engage with the teeth 1012 on the ratchet 1010 (…). FIG. 10B ) engagement, such that when ratchet 1010 is in the counterclockwise direction ( FIG. 10BWhen the lever 1002 is rotated clockwise (indicated by arrow A) in the direction of the arrow, the teeth 1012 push the latch 1004 toward the second end portion 1002b of the lever 1002 (indicated by arrow B). Counterclockwise can be the opposite direction of the normal direction of rotation of the motor, in this case, the clockwise direction. The latch 1004 can have a beveled end surface 1005 such that when the latch 1004 engages the second end portion 1002b of the lever 1002, the beveled end surface 1005 pushes the lever 1002 forward (indicated by arrow C). The forward motion of the lever 1002 causes the first end portion 1002a to engage the trigger tab 411 and force the hub carrier 412 to rotate (indicated by arrow D). Rotation of the hub carrier 412 aligns the tab 413 on the carrier 412 with the slot 424 in the guide housing 420 (see FIG. 4B ), thereby allowing the primary spring 410 to push the hub carrier 412 downward and insert the hub 441.

[0121] In use, a user positions the device (including the disposable assembly 1000) on the skin with the trigger assembly in the locked state. Once the device is adhered to the user’s skin (e.g., after the plunger seek operation, if needed, is complete and the PBUP 108 is removed), the user can trigger the hub insertion by interfacing with the remote controller to indicate the desire for hub insertion. For example, the user can press a button on the touchscreen of the user’s mobile device. In response to the user’s indication, the remote controller can transmit a command to the device (e.g., via the microprocessor of the durable assembly 200) to reverse the motor. In response to the reversed motor, the worm gear 333b and the ratchet 910 rotate counterclockwise, thereby pushing the latch 1004 into engagement with the lever 1002. As a result, the lever 1002 moves in the forward direction and causes the tab 413 of the hub carrier 412 to rotate into alignment with the slot 424 in the guide housing 420, thereby triggering the hub insertion. After the trigger, the plunger pusher 335a advances back into contact with the plunger 335b to begin delivery of the medication.

[0122] As previously mentioned, in some embodiments, the hub carrier 412 of the insertion assembly 400 is rotationally biased toward a direction that will cause hub insertion. For example, the trigger assembly of the present technology can include a hydraulic trigger configured to allow the hub carrier 412 to move. FIG. 11A A top view of a disposable assembly 1100 having a trigger assembly including a hydraulic slave cylinder 1101 configured to share a fluid connection with the reservoir 336 is shown. The slave cylinder 1101 can include a housing 1104, a piston 1108 positioned at least partially within the housing 1104, a seal 1112 between the piston 1108 and the housing 1104 (see FIG. 11B), and a spring-loaded pin 1106 positioned between an end portion of the piston 1108 and a portion of the cannula carrier 412. The piston 1108 can include a channel 1110 (see FIG. 11B ), which extends through its thickness and is configured to receive at least a portion of the pin 1106.

[0123] Referring to FIG. 11B , the housing 1104 can have a first opening through which the piston 1108 extends, a second opening 1114 through which the housing 1104 is configured to share a fluid connection with the reservoir 336, and a third opening 1119 across which the valve 1118 is positioned. Medication from the reservoir can flow through the second opening 1114 into the housing 1104 and into a space defined by the sidewall of the housing 1104, the piston 1108, and the valve 1118.

[0124] In use, the user positions the device (including the disposable assembly 1100) on the skin with the trigger assembly in the locked state. Once the device is adhered to the user’s skin (e.g., after the plunger seek operation, if needed), the user can trigger the cannula insertion by interfacing with the remote controller to indicate the desire for the cannula insertion. For example, the user can press a button on the touchscreen of the user’s mobile device. In response to the user’s indication, the remote controller can transmit a command to the device causing the motor to push the plunger forward and deliver medication into the housing 1104. This delivery of medication pushes the piston 1108 away from the housing 1104 such that the channel 1110 is aligned with the spring-loaded pin 1106. As shown in FIG. 12A and FIG. 12B When the channel 1110 is aligned with the spring-loaded pin 1106, the pin 1106 falls into the channel 1110, disengaging the cannula carrier 412 and allowing the tab 413 of the carrier 412 to rotate into alignment with the slot 424 in the guide housing 420. Now positioned in the channel 1110, the pin 1106 advantageously locks the piston 1108 in place to prevent over-compliance.

[0125] In addition to insertion of the cannula 441 into the patient, downward movement of the cannula carrier 412 also causes the tubular connector 1120 to pass through the valve 1118 and establish a fluid path between the reservoir 336 and the cannula 441. The valve 1118 can be a check valve, and downward movement of the connector 1120 can break the check valve. Other means for establishing a fluid path between the cannula 441 and the reservoir 336 are possible. For example, the valve 1118 can be a septum, and the tubular connector 1120 can be a needle that punctures the septum as the cannula carrier 412 is dropped. In some embodiments, the valve 1118 is a ball valve, and establishing a fluid path includes rotating the ball valve. In any case, use of the hydraulic trigger can advantageously eliminate the need for a PBUP 108, as outflow from the reservoir 336 has been accommodated by the hydraulic driven cylinder.

[0126] To prevent premature triggering of the cannula release while filling the reservoir 336, the device can be configured such that the pressure required to push the piston 1108 is greater than the pressure to push the plunger 335b without use of the motor. For example, the disposable assembly 1100 can be configured such that the piston friction is greater than the pressure attributable to filling the reservoir 336 with a syringe, but still less than the pushing force that can be applied by the motor and less than the leak pressure of the plug seal.

[0127] In some embodiments, the housing 1104 can include a further opening (not shown) in its sidewall, and the gas-permeable membrane can extend across the opening. In such embodiments, the driven cylinder can further include a septum between the gas-permeable membrane and the flow path to the reservoir (e.g., through the second opening 1114). The trigger assembly can include a needle that extends from the end of the piston 1108 through the septum. A sterilant, such as ethylene oxide, can enter the housing 1104 through the membrane and across the septum through the needle lumen. The needle can have an opening in its sidewall that is disposed at a location along the needle that remains on the piston side of the septum. In this way, sterilant that enters through the membrane can pass through the septum, into the housing lumen via the opening in the needle, and into the reservoir 336 via the second opening 1114.

[0128] In any of the embodiments disclosed herein, the device can be configured to detect the relative positions of different parts of the trigger assembly and / or the cannula carrier to determine the insertion state of the device. For example, for the embodiment of FIG. 11, the device can be configured to detect the relative positions of the piston 1108, the needle 1116, and the cannula carrier 412. In some embodiments, the device can be configured to detect the relative positions of the piston 1108 and the needle 1116. In some embodiments, the device can be configured to detect the relative positions of the needle 1116 and the cannula carrier 412. FIGS. 11A-12BThe illustrated trigger assembly can measure the relative position of the pin 1106 and the piston 1108. In some embodiments, the pin 1106 includes a magnet (not shown) and the portion of the piston 1108 distal from the channel 1110 also includes a magnet (not shown). The magnet on the pin 1106 can be oriented such that in the pre-insertion position, the north pole of the pin magnet is closest to the piston 1108 and the north pole of the piston magnet is closest to the pin 1106. The durable assembly 200 (or another portion of the infusion device) can include a magnetoresistive sensor configured to detect a change in proximity of the north poles of the pin magnet and the piston magnet. Detection of the proximity of the pin 1106 relative to the piston 1108 (or vice versa) can be beneficial for detecting insertion and distinguishing between cannula insertion and pre-insertion states. Moreover, because the infusion device can detect insertion, the infusion device can automatically resume basal delivery (if the basal rate was previously set). The relative position of the pin 1106 and the piston 1108 can also initiate a plunger seek (in addition to or instead of when the force at the motor peaks).

[0129] For many of the components described above in FIGS. 1A-12B the clockwise or counterclockwise direction. It should be understood that the components and / or devices can also be configured to perform their intended functions by moving in the opposite direction. For example, the worm gear is described below as rotating counterclockwise to push the plunger driver forward and clockwise to reverse the plunger driver. In some embodiments, the worm gear can be configured to rotate clockwise to push the plunger driver forward and counterclockwise to reverse the plunger driver. As another example, the cannula carrier is generally described as rotating counterclockwise to release the carrier tab 413. However, in some embodiments, the cannula carrier can be configured to rotate clockwise to release the carrier tab 413. The motor and / or drive assembly, cannula carrier, ratchet, lever, and / or any components that rotate can similarly have such embodiments where the direction of rotation to achieve the desired result is opposite to that described above.

[0130] CONCLUSION

[0131] While these devices and methods are described in the context of automatic cannula insertion and patch pumps, it should be understood that these techniques are equally applicable to a variety of medical devices (e.g., infusion ports) and a variety of at least partially implantable devices (e.g., sensors). It should also be noted here that the present specification describes structures and methods that are particularly suitable for subcutaneous delivery of high concentration insulins (i.e., U-200 insulin and above) such as U-500 insulin, as well as lower concentration insulins such as U-100 insulin. However, it should be understood that the present application is applicable to a variety of infusion pumps and medications. For example, the present application is also applicable to medications such as, for example, medications for masking pain, chemotherapy and other cancer-related medications, antibiotics, hormones, GLP-1, glucagon, various other medications including macromolecules and proteins that can require high levels of delivery accuracy, and to relatively high concentration insulins (i.e., U-200 insulin and above) such as U-500 insulin, as well as lower concentration insulins such as U-100 insulin.

[0132] The description of embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise form disclosed. The singular terminology used throughout should be understood

[0133] As used herein, the terms "substantially," "essentially," "about," and similar terms are used as terms of approximation and not as terms of degree, and are intended to account for the inherent deviations in measured or calculated values that would be recognized by those of ordinary skill in the art.

[0134] Further, the use of the word "or" in such lists is to be interpreted as encompassing (a) any single item in the list, (b) all of the items in the list, or (c) any combination of items in the list. Additionally, the term "comprising" is used throughout to mean including at least the recited feature such that no other, greater, number of features is to be inferred. It is also to be understood that particular implementations have been described in one form but that other implementations could be employed without departing from the technology. Additionally, although advantages of certain implementations associated with the technology have been described in the context of those implementations, other implementations can also exhibit such advantages, and not all implementations need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other implementations not expressly shown or described herein.

Claims

1. An infusion device for delivering a medicament to a user's body, the infusion device comprising: an insertion assembly comprising a cannula carrier and a cannula secured to the cannula carrier, wherein the cannula carrier is configured to rotate from a first position in which the cannula carrier is locked in a pre-insertion state to a second position in which the cannula carrier is free to move for insertion of the cannula; a reservoir assembly comprising a reservoir configured to hold the medicament; and a motor configured to, in response to a command from a remote computing device communicatively coupled to the infusion device: (a) rotate in a first direction to cause the medicament to flow from the reservoir to the cannula, and (b) rotate in an opposite second direction to cause the cannula carrier to rotate to trigger insertion of the cannula into the user.

2. The infusion device of claim 1, wherein the cannula carrier is rotationally biased toward the second position.

3. The infusion device of claim 1, further comprising a trigger assembly movable between a first configuration in which the trigger assembly prevents movement of the cannula carrier toward the second position and a second configuration in which the trigger assembly allows movement of the cannula carrier toward the second position.

4. The infusion device of claim 3, wherein movement of the motor in the opposite second direction moves the trigger assembly from the first configuration to the second configuration, allowing movement of the cannula carrier for cannula insertion.

5. The infusion device of claim 3 or claim 4, wherein the trigger assembly comprises a ratchet that allows movement of the cannula carrier when the motor is rotated in the opposite second direction.

6. The infusion device of claim 3 or claim 4, wherein the trigger assembly comprises a hydraulic cylinder.

7. The infusion device of claim 1, further comprising a trigger assembly configured to move out of engagement with the cannula carrier when the motor is rotated in the opposite second direction.

8. The infusion device of claim 1, further comprising a trigger assembly configured to push the cannula carrier into the second position when the motor is rotated in the opposite second direction.

9. The infusion device of claim 1, further comprising a trigger assembly configured to pull the cannula carrier into the second position when the motor is rotated in the opposite second direction.

10. An infusion device for delivering a medicament to a user's body, the infusion device comprising: an insertion assembly comprising a cannula carrier and a cannula secured to the cannula carrier, wherein the cannula carrier is configured to rotate from a first position in which the cannula carrier is locked in a pre-insertion state to a second position in which the cannula carrier is free to move to insert the cannula; a reservoir assembly comprising a reservoir configured to house a medicament; and a trigger assembly coupled to the insertion assembly and in fluid communication with the reservoir, and wherein, in response to a command from a remote computing device communicatively coupled to the infusion device, the reservoir assembly delivers medicament to the trigger assembly to cause the cannula carrier to rotate to trigger insertion of the cannula by the insertion assembly.

11. The infusion device of claim 10, further comprising a motor actuated by the command from the remote computing device and, when actuated, causes delivery of medicament from the reservoir to the trigger assembly.

12. The infusion device of claim 10 or claim 11, wherein the reservoir comprises a pusher and the infusion device further comprises a motor actuated by the command from the remote computing device and, when actuated, causes advancement of the pusher within the reservoir to cause delivery of medicament from the reservoir to the trigger assembly.

13. The infusion device of claim 10, wherein the trigger assembly engages the insertion assembly to prevent cannula insertion, and wherein medicament delivered into the trigger assembly causes the trigger assembly to disengage the insertion assembly, thereby allowing the insertion assembly to insert the cannula.

14. The infusion device of claim 10, wherein the delivery of medicament to the trigger assembly to trigger insertion of the cannula does not cause infusion of the medicament into a patient.

15. The infusion device of claim 10, wherein the trigger assembly is mechanically coupled to the cannula carrier and prevents rotation of the cannula carrier toward the second position.

16. The infusion device of claim 10, wherein the trigger assembly comprises a tubular housing defining an internal cavity therein and a piston positioned within the internal cavity, and wherein the internal cavity is in fluid communication with the reservoir.

17. The infusion device of claim 16, wherein the delivery of medicament to the trigger assembly to trigger insertion of the cannula causes the piston to move, and wherein movement of the piston a predetermined amount aligns a portion of the piston with a portion of the insertion assembly to trigger cannula insertion.

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