Remote activated cannula insertion

Abstract

Infusion devices are disclosed herein. Techniques of the present invention include, for example, infusion devices for delivering a drug to a user's body. The device may include: an insertion assembly including a cannula; a reservoir assembly, the reservoir assembly comprising a reservoir configured to receive 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] This application is a divisional application of a divisional patent application entitled "Remotely Activated Cannula Insertion" with national application number 202180075774.9, wherein the parent application is an invention patent application entitled "Remotely Activated Cannula Insertion" with international application date of November 11, 2021 and international application number PCT / US2021 / 072365.

[0002] Cross-reference to related applications

[0003] 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

[0004] The present invention relates generally to medical devices, and more specifically to remotely activated cannula insertion. Background Technology

[0005] 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.

[0006] 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

[0007] 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.

[0008] In some embodiments, the insertion assembly includes a cannula carrier, to which the cannula is secured. The cannula carrier can be configured to rotate from a first position to a second position, in which the cannula carrier is locked in a pre-insertion state, and in the second position, the cannula carrier is free to move for insertion of the cannula. In several embodiments of such embodiments, the cannula carrier is rotatably biased toward the second position.

[0009] According to several embodiments, the infusion device includes a trigger assembly movable between a first configuration and a second configuration, in which the trigger assembly prevents the cannula carrier from moving toward the second position, and in the second configuration, the trigger assembly allows the cannula carrier to move toward the second position. In several embodiments of such embodiments, movement of the motor in the opposite second direction causes the trigger assembly to move from the first configuration to the second configuration, thereby allowing movement of the cannula carrier for cannula insertion. The trigger assembly may include a ratchet that allows movement of the cannula carrier when the motor rotates in the opposite second direction. In some embodiments, the trigger assembly includes a hydraulic cylinder.

[0010] Some aspects of the technology of the present invention include a trigger assembly configured to move out of engagement with the sleeve carrier when the motor rotates in the opposite second direction.

[0011] The infusion apparatus of claim 2 further includes a trigger assembly configured to push the cannula carrier into the second position when the motor rotates in the opposite second direction.

[0012] The infusion apparatus of claim 2 further includes a trigger assembly configured to pull the cannula carrier into the second position when the motor rotates in the opposite second direction.

[0013] The present invention includes a method for operating an infusion device. One method may include, for example, rotating a motor of the infusion device in a first direction to determine the volume of drug in a reservoir of the infusion device; receiving a command from a remote controller to rotate the motor in a second direction opposite to the first direction; and...

[0014] The method involves rotating the motor in the second direction to trigger the insertion of the cannula of the infusion device. In some embodiments, the method further includes rotating the motor in the first direction after rotating it in the second direction to deliver the drug through the cannula.

[0015] According to several methods, the infusion device includes a cannula carrier, to which the cannula is secured. The cannula carrier can be configured to rotate from a first position to a second position, in which the cannula carrier is locked in a pre-insertion state, and in the second position, the cannula carrier is free to move for insertion of 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 to 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 to the second position.

[0016] In some aspects of the invention, the cannula carrier is biased to rotate toward the second position. For example, rotation of the motor in the second direction can disengage the trigger assembly from the cannula carrier, thereby allowing the cannula carrier to rotate into the second position. In some embodiments, rotation of the motor in the second direction causes a ratchet to rotate simultaneously in the second direction. In several embodiments, rotation of the motor in the second direction activates a linear clutch coupled to a reservoir assembly of the infusion device.

[0017] According to some embodiments, the infusion device includes: an insertion assembly including a cannula; a reservoir assembly including a reservoir configured to receive a drug; and a trigger assembly coupled to the insertion assembly and in fluid communication with the reservoir. In response to a command from a telecomputing device communicatively coupled to the infusion device, the reservoir assembly may deliver the drug to the trigger assembly to trigger insertion of the cannula through the insertion assembly. The infusion device may include a motor actuated by the command from the telecomputing device, and when actuated, deliver the drug 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 a command from the telecomputing device. When actuated, the motor advances the pusher within the reservoir to deliver the drug from the reservoir to the trigger assembly. In several embodiments, delivering the drug to the trigger assembly to trigger insertion of the cannula does not result in infusion of the drug into a patient. The trigger assembly can be configured to engage the insert assembly to prevent cannula insertion, and wherein the drug delivered to the trigger assembly disengages the trigger assembly from the insert assembly, thereby allowing the insert assembly to insert the cannula.

[0018] According to several embodiments, the infusion device includes an insertion assembly comprising a cannula carrier to which the cannula is secured. The cannula carrier can be configured to rotate from a first position to a second position, in which the cannula carrier is locked in a pre-insertion state, and in the second position, the cannula carrier is free to move for insertion of the cannula. In some embodiments, a trigger assembly is mechanically coupled to the cannula carrier and prevents the cannula carrier from rotating toward the second position.

[0019] In some embodiments, the trigger assembly includes a tubular housing defining an inner cavity therein and a piston positioned within the inner cavity, wherein the inner cavity is in fluid communication with the reservoir. Delivery of a drug to the trigger assembly to trigger insertion of the cannula causes the piston to move, and the piston moves a predetermined amount to align a portion of the piston with a portion of the insertion assembly to trigger cannula insertion. In some embodiments, the trigger assembly includes a hydraulically driven cylinder.

[0020] 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 drug, 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 drug stored in the reservoir into the trigger assembly, thereby causing the insertion assembly to drive the cannula out of the infusion device.

[0021] 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 driving an insertion assembly of the infusion device out of the infusion device. After rotating the motor in the first direction, rotating the motor in a second direction opposite to the first direction to push a drug stored in a reservoir of the infusion device through the cannula. Attached Figure Description

[0022] Many aspects of this disclosure can be better understood by referring to the following accompanying drawings. The components in the drawings are not necessarily drawn to scale. Rather, the focus is on clearly illustrating the principles of this disclosure.

[0023] Figure 1A This is a perspective view of an infusion device according to several embodiments of the technology of the present invention.

[0024] Figure 1B yes Figure 1A A perspective view of the bottom of the infusion device.

[0025] Figure 2A yes Figure 1A and Figure 1B A perspective view of the durable components of the infusion device.

[0026] Figure 2B and Figure 2C yes Figure 2A A perspective view of some parts of the durable component shown.

[0027] Figure 3A yes Figure 1A and Figure 1B A perspective view of a disposable component of an infusion device.

[0028] Figure 3B yes Figure 3A A perspective view of some parts of the disposable component shown.

[0029] Figure 4A It shows Figure 3A A cross-sectional view of the insert component of the disposable component shown (in state one).

[0030] Figure 4B yes Figure 4A The perspective view of the inserted component shown.

[0031] Figure 5A and Figure 5B This is a perspective view of certain components of a disposable assembly (shown in state two) prior to cannula insertion.

[0032] Figure 5C It shows the use of with Figure 5A and Figure 5BA side view of another component used together with the first component (shown in the position before the sleeve is inserted).

[0033] Figure 5D It shows the use of with Figures 5A to 5C A cross-sectional view of another component used together with the first component (shown in the position before the sleeve is inserted).

[0034] Figure 6A It is after the cannula is inserted but before the cannula is retracted. Figure 5D A cross-sectional view of the component (shown in state three).

[0035] Figure 6B It shows the use of with Figure 6A A perspective view of another component used together with the first component (shown in the position after cannula insertion but before cannula retraction).

[0036] Figure 7A This occurs after the cannula is inserted and after the cannula is retracted. Figure 5D and Figure 6A A cross-sectional view of the component (shown in state four).

[0037] Figure 7B It shows the use of with Figure 7A A perspective view of another component used together with the first component (shown in the position after cannula insertion and after cannula retraction).

[0038] Figure 7C and Figure 7D yes Figure 7A A cross-sectional view of some parts of the component.

[0039] Figure 8 This is a perspective view of a disposable component configured according to several embodiments of the technology of the present invention.

[0040] Figure 9A This is a perspective view of a disposable component configured according to several embodiments of the technology of the present invention.

[0041] Figure 9B yes Figure 9A Cross-sectional view of certain parts of a disposable component.

[0042] Figure 9C yes Figure 9A A perspective view of certain parts of a disposable component.

[0043] Figure 10A This is a perspective view of a disposable component configured according to several embodiments of the technology of the present invention.

[0044] Figure 10B yes Figure 9A Cross-sectional view of certain parts of a disposable component.

[0045] Figure 10C yes Figure 9A A perspective view of certain parts of a disposable component.

[0046] Figure 11A This is a top view of a portion of a disposable component configured according to several embodiments of the technology of the present invention (shown in a first state before cannula insertion).

[0047] Figure 11B schematically depicted Figure 11A A hydraulic trigger assembly for one-time use.

[0048] Figure 12A yes Figure 11A A top view of a portion of a disposable component (shown in the second state after cannula insertion).

[0049] Figure 12B schematically depicted Figure 12A A hydraulic trigger assembly for one-time use. Detailed Implementation

[0050] The technology of this invention includes an infusion device (sometimes referred to as a "patch pump") configured to adhere to a user's skin above a delivery site. The infusion device includes a reservoir configured to receive and contain medication, a motor, and an insertion assembly having a cannula operatively connected to the reservoir. After the device is applied to the skin, the user activates the insertion assembly to subcutaneously insert the cannula. This insertion step typically requires the user to manually press or pull a trigger on the device, which can be burdensome for the patient. This document discloses an infusion device configured for remotely triggering cannula insertion (e.g., triggered by a computing device separate from but communicatively coupled to the infusion device). As described in more detail below, the infusion device of this invention is configured to communicatively coupled to a remote controller that, upon user command, sends instructions to the infusion device causing 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 balances the rotation of the motor to move the insertion assembly or allow the insertion assembly to move to a cannula release position. In any case, the infusion device of the present invention enables cannula insertion via remote control, which is more convenient for the user than conventional manual triggers.

[0051] Figure 1A and Figure 1BThe top and bottom sides of an infusion device 100 according to several embodiments of the invention are shown respectively. As previously described, the bottom side 100b of the device 100 is configured to adhere to the user's skin, with the top side 100a facing away from the user. The device 100 includes a durable component 200 and a disposable component 300, each having a corresponding housing 202 and 302. The durable component 200 and the disposable component 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 may also include a pre-pull plug (PBUP) 108 and a filling port 106.

[0052] Device 100 can be used in conjunction with various remote controllers. For example, the remote controller can be a device-specific controller, a mobile phone, a tablet, etc. Such a remote controller can be used, for example, to allow a user to send instructions to durable component 200 or otherwise facilitate communication between durable component 200 and the user (e.g., alarm status messages or other messages regarding the status of device 100). In some embodiments, the remote controller is configured to send instructions to and / or receive instructions from disposable component 300.

[0053] The remote controller can be configured to facilitate one, some, or all of the following operations:

[0054] ● Turn the remote controller on or off;

[0055] ●Associate (or “assign”) the remote controller to the durable component 200;

[0056] ● Obtain status information, such as medication levels, battery charge levels, and / or alarm status;

[0057] ●Silence alarms on durable components;

[0058] ● Select options that can be associated with alarms on durable components, such as alarm type (audible, tactile, visible, or a combination thereof) and alarm strength / volume;

[0059] ● Connect the remote controller to a computer to, for example, update the firmware of the remote controller or durable component, load and delete the delivery profile stored in the durable component 200 or the remote controller, and otherwise reprogram the durable component 200 and / or the remote controller.

[0060] ● Select medication options, such as drug concentration;

[0061] ● Select the stored drug delivery profile;

[0062] ●Increase and decrease the rate of drug administration;

[0063] ● Trigger sleeve insertion;

[0064] ●Initiate drug delivery;

[0065] ●Suspend allocation operations;

[0066] ● and / or other processes.

[0067] Users can pause delivery in order to remove or replace the structure of the user application (e.g., disposable components), adjust current or anticipated changes in physical condition (e.g., hypoglycemia, strenuous exercise), follow a physician's advice, or disconnect the durable component 200 from the body for any other reason.

[0068] In some implementations, the remote controller is configured to generate indicators based on information from the microprocessor of the durable component 200, such indicators indicating, for example, the amount of time remaining in the current dispensing procedure, the amount of time until the next disposable component replacement, etc. The indicators can be audible, visible, tactile, or a combination thereof. Remaining time indicators can be useful for various reasons. For example, knowing the remaining time before the next disposable component replacement allows a user to determine, at least in part, whether it would be more convenient to replace the disposable component 300 before the end of the dispensing procedure, based on the current time of day and upcoming events (e.g., travel or sleep). Alternatively or additionally, the remote controller may also be configured to generate indicators of the remaining insulin amount and / or battery power.

[0069] Regarding dimensions, device 100 may have a length of approximately 35mm-60mm; a width of approximately 30mm-45mm; and an overall thickness or height of approximately 8mm-18mm. Suitable housing materials include, but are not limited to, plastics or other materials with an elastic modulus of 0.2 million psi to 1.0 million psi.

[0070] To use the infusion device 100, a user (e.g., a patient) connects the disposable component 300 to the durable component 200. Unless the reservoir of the disposable component 300 has been adequately preloaded, the user injects the desired amount of medication into the reservoir via the filling port 106. A plunger-finding procedure (described in detail below) can be initiated by the user or automatically. To attach the device 100 to the user, the adhesive backing 104 can be peeled off 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 gently pressed to adhere the adhesive pad 102 to the skin surface. In some embodiments, the user triggers automatic cannula insertion via a remote controller (e.g., after the plunger-finding operation is complete). In some embodiments, plunger-finding is not required.

[0071] exist Figures 2A to 2CThe durable component 200, shown in more detail, may include: a housing 202, a buzzer or other alarm device 204, one or more batteries or other power supplies 206, a microprocessor (not shown), and a coil assembly 208 (which serves as the stator of the motor) including one or more Hall-effect sensors 210. In some embodiments, the power supply 206 is a rechargeable battery, such as a rechargeable lithium battery, which has sufficient power to continuously drive the motor without capacitors or other additional energy storage devices.

[0072] For details, please refer to the following: Figure 2C The coil assembly 208 can be positioned around a recessed portion 212 of the durable component housing 202, the recessed portion being configured to fit into the disposable housing 302. Figure 3A The protruding portion 303 is mounted on the disposable component 300. Figure 3B The magnetic motor rotor 331 is located above the durable component 200. In this two-piece motor, the motor coil assembly 208 is located within the durable component 200 and positioned around the motor rotor 331, which is part of the disposable component 300. The Hall effect sensor 210 is positioned above the coil assembly 208 within the durable component 200. In this configuration, a gap exists between the motor coil assembly 208 and the motor rotor 331. In the illustrated embodiment, some or all of the gap may be defined (and occupied) by housing portions (e.g., durable housing portion 212 and disposable housing portion 303). In other embodiments, the gap between the motor coil assembly 208 and the motor rotor 331 may be occupied by only a portion of the durable component housing 202, or by only a portion of the disposable component housing 302, or there may be no structure at all and it may be merely 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 from about 0.5 mm to 2.0 mm. Therefore, there is no gear meshing or other mechanical connection between the durable component 200 and the disposable component 300. All electronic components can be housed within the durable component 200, and the energy required by the disposable component 300 is transferred via an electromagnetic torque connection, which is a connection without direct mechanical or electrical contact from the durable component 200. These designs offer the additional advantage of making waterproofing, or at least water resistance, relatively simple.

[0073] An exemplary motor rotor 331 may be a 2-pole, cylindrical, rare-earth (such as neodymium) rotor, magnetized in diameter, having a diameter of 5 mm and a height of 5 mm. Other suitable motor rotors may be larger or smaller, or multi-pole. The cost per piece of this type of motor rotor is typically about 5 cents, thus helping to control the total cost of the disposable component 300. A microprocessor (not shown) directs the rotation of the motor rotor 331 by sequentially exciting the coils of the motor coil assembly 208 to create an electromagnetic torque connection 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 an inverse EMF, a rotary encoder, one or more Hall effect sensors 210, etc. For example, a Hall effect sensor 210 mounted above the coil windings 208 can be used to supply the microprocessor with a count, tachometer signal, or rotor position, thereby allowing for low-cost closed-loop control of the rotor speed. This type of brushless motor is efficient and operates at low temperatures.

[0074] exist Figure 3A and Figure 3B The disposable component 300, shown in more detail, may 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 may include a drive assembly 329, a reservoir 336, a plunger actuator 335a, and a plunger 335b. The plunger actuator 335a is coupled to the drive assembly 329, and both the plunger actuator 335a and the plunger 335b are housed within the reservoir 336. The insertion assembly 400 includes a sleeve 441 (see [link to insert assembly]). Figure 4A The device includes a reservoir assembly 304 and several components for driving the cannula 441 into the user's skin. The trigger assembly 304 may be operably coupled to one or more components of the reservoir 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 may be operably coupled to a gear train 332 such that remote activation of a motor moves the trigger assembly 304 to engage or disengage with the insertion assembly 400, thereby actuating the insertion assembly 400 and releasing the cannula. Reference is made below. Figures 8 to 12B Further details regarding remotely actuated trigger components were discussed.

[0075] Still referencing Figure 3A and Figure 3B The drive assembly may include a magneto motor rotor 331 and a gear train 332. The gear train 332 is attached to a pusher 335a positioned in a reservoir 336. The magneto motor rotor 331 may be mechanically attached via the gear train 332 to influence the translation of the plunger pusher 335a (and plunger 335b, when attached to the plunger pusher 335a) within the reservoir 336.

[0076] As in Figure 3B As best seen in the image, gear train 332 includes a worm gear drive consisting of a worm 333a and a worm wheel 333b, and further includes a lead screw nut 334a and a small-pitch lead screw 351 (surrounded by the lead screw nut 334a). The worm wheel 333b is connected to the lead screw 351 via the lead screw nut 334a. A protrusion 334b ​​on the lead screw nut 334a corresponds to a recess (not shown) inside the worm wheel 333b, and a threaded portion (not shown) inside the lead screw nut 334a mates with the thread on the lead screw 351 surrounded by the lead screw nut 334a. The configuration of gear train 332 prevents rearward drive due to reservoir pressure, thereby eliminating the need for a clutch or other locking mechanism. Suitable materials for the components of gear train 332 include, but are not limited to, stainless steel or high-strength plastics such as nylon, acetal (Delrin.RTM.), or polycarbonate.

[0077] The reservoir 336 is pre-filled with medication. For example, the medication may be U-100 insulin, U-500 insulin, or other concentrations of insulin to suit different user profiles, or it may be available for the user to fill via port 106. Figure 1B Filled. In some embodiments, the reservoir 336 may be mounted on a reservoir support block ( Figure 3B (Not shown in the image). The reservoir outlet fitting 348 is in fluid communication with the reservoir 336. The reservoir outlet fitting 348 may be made of a pharmaceutically compatible material, such as, but not limited to, polypropylene, cyclic olefin polymer (COP), or polyethylene.

[0078] In cases where reservoir 336 is filled by the user, the user may either completely fill the reservoir with medication to reach capacity, or choose to introduce less medication and not completely fill the reservoir. Since an unknown amount of medication may be injected into a user-filled reservoir, the plunger zeroing procedure (or "plunger search") may be user-initiated or may be an automated aspect of pump operation. Prior to any medication dispensing, the plunger search procedure precisely determines and / or sets how far plunger 335a has traveled before engaging plunger 335b, allowing calculations to be performed to determine the amount of medication in the reservoir and thus an estimate of the emptying time and the time for replacement of disposable components.

[0079] Figure 3B The reservoir 336 is shown before any drug is introduced into it. The plunger 335b is disconnected from the plunger actuator 335a (and therefore free-floating), and the plunger actuator 335a is in the fully retracted position. At this point, and until the plunger seeking operation is complete, PBUP 108 ( Figure 1BThe plunger 335b is held in place to prevent premature flow of the medication between the reservoir 336 and the insertion assembly 400 (except in the hydraulic trigger implementation discussed below with reference to 11A-12B, where the PBUP may not be necessary). When the medication is introduced into the reservoir 336 via the filling port 106, the plunger 335b is pushed against the plunger pusher 335a. If the reservoir 336 is filled to capacity, the plunger 335b will be pushed into contact with the plunger pusher 335a. In some embodiments, this causes the hook 337 (or other suitable attachment method) on the plunger 335b to engage with and permanently lock into the pusher 335a. If the reservoir 336 is not filled to capacity, the plunger 335b will be positioned at an unknown point within the reservoir 336 until the plunger seeking operation is complete. Once the user has introduced the medication into the reservoir 336, the plunger seeking operation can be initiated by the user or can be an automated aspect of pump operation. When the plunger seeking operation is initiated, the electric motor advances the plunger actuator 335a until it contacts the plunger 335b. In some embodiments, they are locked together with the plunger hook 337 or some other suitable attachment method. In some embodiments, the plunger actuator 335a and the plunger 335b are not configured to be mechanically locked. The reservoir 336 and the plunger 335b may be made of cyclic olefin polymers (COP), polypropylene, or other pharmaceutically compatible polymers. Suitable materials for the plunger actuator 335a include, but are not limited to, stainless steel, COP, nylon, and polycarbonate.

[0080] As previously described, a plunger seeking operation is performed when the flow from reservoir 336 is blocked by PBUP 108. Considering potential variations in tolerances and drug filling related to cartridge manufacturing, the distance traveled by plunger pusher 335a from its initial position before contacting plunger 335b may vary. Under microprocessor control, an electric motor advances plunger pusher 335a to contact plunger 335b, resulting in increased fluid path pressure. Sampling is performed on Hall effect sensor 210, encoder, or other monitoring / sensing devices to determine when motor stall occurs during the advancement of plunger pusher 335a. A lack of signal from Hall effect sensor 210 indicates that the motor is not rotating. Motor stall is considered to be due to hydraulic locking and therefore indicates that plunger pusher 335a is in contact with plunger 335b of the cartridge device. In some embodiments, the procedure may employ two or more speeds to advance plunger pusher 335a. Furthermore, the plunger actuator 335a can be propelled with controlled torque or limited force, causing the motor to stall with the least possible force to achieve reliable results, thereby reducing the load on the system (e.g., bearings and battery). As mentioned above, the known distance traveled by the plunger actuator 335a before contacting the plunger 335b allows for the calculation of the drug volume and the estimated time until the replacement of the disposable component 300.

[0081] 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 reduction 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 reductions 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.

[0082] Figure 4A and Figure 4B The insertion component 400 is shown in more detail below. Figure 4A and Figure 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. Figure 4A When the main insertion spring 410 is compressed and applies a downward force to the sleeve carrier 412, as shown, the sleeve carrier 412 and the support flange 422 of the guide housing 420 (as shown) are in the compressed state. Figure 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.

[0083] The insertion assembly 400 also includes a cannula 447, a cannula carrier 474, a cannula seal 480, a cannula retraction spring 482, a cannula seal 430, a sealing ring 431, and a cannula seal retainer 434. The cannula 447, including an elongated rod with a sharp distal tip, can be made of a metal (such as stainless steel) or other relatively rigid biocompatible materials (such as rigid plastics, ceramics, or other rigid biocompatible materials) and is used to penetrate the skin and a short distance into the flesh to form a channel for the cannula 441. The cannula 441 can be made of polytetrafluoroethylene (PTFE), such as TEFLON.RTM.PTFE or other biocompatible polymer materials. As further described below, these components provide a highly effective cannula seal and a highly reliable drug seal with low cannula insertion force. The components involved and details of how the insertion assembly 400 performs these actions are described in more detail below.

[0084] Insert component 400 can be a 4-state system. Figures 4A to 4B The insertion assembly 400 is shown in its first state: a ready-to-fire position (e.g., before the user removes PBUP 108 and remotely activates trigger assembly 304 to insert sleeve 441). In this state, PBUP 108 is positioned to block the fluid path from reservoir 336, and sleeve carrier 412 is held above and spaced apart from sleeve seal 430, as further described below. In this state, and as in Figure 3B As can be seen in the above-described plunger seeking procedure, the plunger pusher 335a can be advanced to contact the plunger 335b, thereby slightly pressurizing the reservoir 336 without injecting the drug into the user. (As in...) Figure 4A As best seen, a seal is formed between the sealing ring 431 and the outer surface of PBUP 108, thereby allowing the plunger to seek pressure.

[0085] Figures 5A to 5D The insertion component 400 is shown in its second state. In this state, PBUP 108 has been removed and the insertion component 400 is ready to fire. (From memory 336) Figure 3A The fluid path is open to the atmosphere, and any residual pressure is released before the sleeve is inserted.

[0086] As will be described in more detail below, the 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 may cause the cannula needle 447 and cannula 441 (in) Figure 5D (best visible in the middle) extends from the disposable component 300 (i.e., Figure 6A and Figure 6B(As shown in state three), which then causes the cannula 447 to retract into the insertion assembly 400, thereby leaving the cannula 441 in place (which is...) Figure 7A and Figure 7D (State 4 shown in the image).

[0087] Figure 5B The insertion assembly 400 is shown, with the main insertion spring 410 and guide housing 420 removed. Figure 5C In this case, the main insertion spring 410 is removed and the guide housing 420 is semi-transparent. Figure 5D yes Figure 5C The components are shown in cross-sectional view. The main insertion spring 410 provides a stroke of approximately 7 mm, with an initial force of approximately 15 N and a termination force of approximately 7 N, and can be made of, for example, musical instrument wire with a diameter of 0.75 mm, having 6 turns and an external dimension of 13.25 mm. The cannula needle retraction spring 482 provides a stroke of approximately 7 mm, with an initial force of approximately 4 N and a termination force of approximately 1 N, and can be made of, for example, musical instrument wire with a diameter of 0.5 mm, having 6 turns and an external dimension of 3 mm. The guide housing 420 and the cannula seal retainer 434 can be made of high-strength plastics such as nylon, acetal (Delrin.RTM.), or polycarbonate. The cannula carrier 412 and the cannula needle carrier 474 can be made of COP, polypropylene, or other similar pharmaceutically compatible materials. The cannula seal 480 and cannula seal 430 may be made of elastomer, rubber (such as silicone rubber or brominated butyl rubber) or other relatively suitable sealing materials that are also compatible with pharmaceuticals.

[0088] As mentioned above, Figures 5A to 5D The insertion assembly 400 is shown in state two, i.e., the ready-to-fire position (e.g., before the user remotely activates the trigger assembly 304 to drive the cannula carrier 412 to the insertion position). Prior to insertion, the cannula carrier 412 is supported on the support flange 422 of the guide housing 420 (in... Figure 5D (Best visible in the center), the support flange then holds the main insertion spring 410 in a compressed state. It should be noted that the guide housing 420 does not move during sleeve insertion.

[0089] Activation of the trigger assembly 304 causes the sleeve carrier 412 to rotate, causing the carrier tab 413 to move away from the support flange 422 and align with the slot 424 in the guide housing 420 (shown in...). Figure 4B , Figure 5A and Figure 5CAlthough the cannula carrier 412 is shown rotating counterclockwise for release, in other embodiments, the cannula carrier can rotate clockwise for release (in such embodiments, the slot 424 can be positioned adjacent to the left side 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 into motion. The main insertion spring 410 drives downward the cannula carrier 412 with the attached cannula 441, the cannula needle carrier 474 with the attached cannula needle 447, the cannula needle seal 480, and the cannula needle retraction spring 482. As these components move downward, the sharp distal tip of the cannula needle 447, extending slightly beyond the distal end of the cannula 441, penetrates the user's skin and inserts into the cannula 441 surrounding the cannula needle 447, so that the end of the cannula 441 is located approximately 6 mm below the user's skin surface. At this time, as Figure 6A and Figure 6B As can be seen, the inserted component 400 is in state three.

[0090] As in Figure 5B , Figure 6B and Figure 7B As best seen, 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 (only on...). Figure 7B (marked in the middle), its locking boss 415 (only) is mounted on the sleeve carrier 412. Figure 6B and Figure 7B Below. When the cannula carrier 412 and the needle carrier 474 are locked together, the needle retraction spring 482 is held in a compressed state. Additionally, the 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 needle carrier 474 moves with the cannula carrier 412 (e.g., only counterclockwise or in any direction of rotation of the cannula carrier 412), so that the locking flange 475 of the needle carrier will not accidentally slip out from under the locking boss 415 of the cannula carrier and unintentionally trigger the penetration of the needle 447.

[0091] Once the cannula carrier 412 and the cannula needle carrier 474 are rotated to initiate 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 retainer 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 increasingly (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 (e.g., ...). Figure 4B , Figure 5A and Figure 5C (As shown) Alignment is achieved, thereby allowing the cannula carrier 412 to slide downwards while preventing further rotation of the cannula carrier 412. As the cannula needle carrier 474 rotates further counterclockwise, the locking flange 475 of the cannula needle carrier slides out from under the locking boss 415 of the cannula carrier.

[0092] Figure 6A and Figure 6B The insertion component 400 in state three is shown: Figure 6A The diagram shows the fully fired main insertion spring 410, the fully downward-facing cannula 412, and the fully inserted cannula 441 at the instant the cannula carrier 474 is released and before the cannula retraction spring 482 drives the cannula carrier 474 and cannula 447 upward. (As shown, the skin is pierced at approximately 90 degrees, and the cannula tip is positioned approximately 6 mm below the skin surface.) Figure 6B The same instant is shown, in which the main insertion spring 410 and guide housing 420 are removed. This view shows the moment when the locking flange 475 of the cannula carrier is released from beneath the locking boss 415 of the cannula carrier.

[0093] Once the locking flange 475 of the cannula carrier is released from below the locking boss 415 of the cannula carrier (this is also the moment when the cannula 441 is fully inserted and the insertion assembly 400 is in state three, such as...), Figure 6A and Figure 6B As can be seen, the cannula carrier 474 can no longer resist the force of the cannula retraction spring 482. The elastic energy contained in the cannula retraction spring 482 is converted into motion, and the cannula retraction spring 482 drives the cannula carrier 474 with the attached cannula 447 upward. As the cannula carrier 474 moves upward, the cannula 447 is removed from the user and retracts into the insertion assembly 400, allowing the cannula 441 to be inserted. This is state four, as... Figures 7A to 7D visible.

[0094] Figure 7A This is a cross-sectional view showing the fully fired insertion assembly 400 and the fully retracted cannula 447. Figure 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 used by the user (e.g., during fluid delivery). Drug pathway in Figure 7A and Figure 7C The best view is in the middle. In summary, the drug flows from the reservoir (not shown) to the outlet fitting 348, into the channel of the sleeve seal 430, through the channel 414 in the sleeve carrier 412, through the sleeve needle seal 480, and into the sleeve 441 for delivery to the user.

[0095] Figure 7C and Figure 7D The optimal visible high-efficiency radial compression hydraulic seal is formed between the upper and lower sealing rings 431 of the sleeve carrier 412 and the sleeve seal 430. The upper and lower sealing rings 431 can be separated by approximately 2.5 mm. The tapering of the small contact area between the sleeve seal 430 and the sealing rings 431 concentrates surface stress, with the sealing rings 431 contacting the sleeve carrier 412 to provide a good seal. Additional upper and lower sealing rings are possible, but this would increase space requirements. To enhance the seal at the sealing rings 431, the main insertion spring 410 applies force to the sleeve carrier 412, thereby holding it downward against the substrate 350 and causing the inner surface 416 of the sleeve carrier 412 to push against the top surface of the sleeve seal 430, as described in more detail below.

[0096] During the transition from insertion state two to state three, the inner surface 416 of the sleeve carrier 412 begins to contact the top of the sleeve seal 430 before the bottom surface of the sleeve carrier 412 contacts the substrate 350. Upon reaching state three, the bottom surface of the sleeve carrier 412 remains against the substrate 350, and the sleeve seal 430 is compressed from above. The high-energy main insertion spring 410 improves seal reliability, and the sleeve seal 430 acts as a damper during compression, thus helping to dissipate the energy of insertion. The residual energy from the firing of the main insertion spring 410 is not wasted or converted into user-perceptible noise and sensation, but is instead converted from kinetic energy into enhanced radial compression of the sleeve seal 430.

[0097] 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 surface seal. In state three, the main insertion spring 410 continues to push downwards onto the sleeve carrier 412 with a force of approximately 7N-10N. In addition to maintaining the seal at the upper sealing ring 431, this force distributed on the top surface of the sleeve seal 430 causes a fluid seal capable of sealing approximately 3 bar.

[0098] To further enhance this seal, the seal retainer 434 provides radial support, thus acting as a retaining backing ring / clamp, increasing radial compression around the sleeve seal 430. Even further enhancing the seal, the sleeve carrier 412 provides additional radial compression through clamping force on the sleeve seal 430, thus acting as an additional backing ring / clamp. A residual force of 7N-10N from the main insertion spring 410 causes downward (axial) compression on the sleeve seal 430, resulting in radial deformation of the sleeve seal 430, further improving the seal formed between the sleeve carrier 412 and the sealing ring 431. In state three, because the sleeve seal 430 is radially constrained by the seal retainer 434 and the sleeve carrier 412, the axial compression of the sleeve seal 430 causes radial deformation of the seal 430, thereby increasing the sealing force on the sealing ring 431. All of this results in a highly effective and reliable hydraulic sleeve seal.

[0099] Now go to Figure 7C The drug pathway also includes a compression-type fitting 490, which is formed by a clamping portion 436 of a seal retainer 434 that clamps the collar 432 of the sleeve seal 430 downward onto a barb 349 of the outlet fitting 348. Alternatively, separate components can be used to deliver the clamping force provided by the clamping portion 436 of the seal retainer 434. Furthermore, the collar 432 of the sleeve seal 430 and the barb 349 of the outlet fitting 348 can be separate collar and barb components, but this introduces additional component interfaces along the drug pathway, each requiring additional sealing features. In the illustrated configuration, the sleeve seal 430 seals the sleeve 441, absorbs energy during firing by compression upon impact with the sleeve carrier 412, and facilitates sealing the reservoir 336 with the sleeve 432.

[0100] As in Figure 7D In the best visible direction, the drug then flows through the collar 432, through the cannula seal 430, through the channel 414 in the cannula carrier 412, through the cannula needle seal inlet 481, through the cannula needle seal channel 483, and through the cannula 441 to be delivered to the user. From comparison... Figure 5D , Figure 6A and Figure 7AAs can be seen, the cannula seal 480 remains in one position within the cannula carrier 412 before, during, and after insertion, and remains in that position during user use of the device 100. The cannula seal 480 includes a sidewall sealing ring 484 and a base sealing ring 486. The sidewall sealing ring 484 prevents medication leakage into the cannula carrier 412 and ultimately into the device 100. The base sealing ring 486 prevents leakage from around the cannula 441 and ensures that medication flowing from the cannula seal inlet 481 and through the cannula seal channel 483 is guided into the cannula 441. Figure 7D A pair of sidewall sealing rings 484 and a pair of base sealing rings 486 are shown, but additional seals can be used for additional leakage protection.

[0101] The insertion assembly 400 provides a highly effective and reliable drug seal (all within a compact space) with low insertion force. Energy is supplied to the insertion sleeve 441 by the main insertion spring 410, and is sufficient to:

[0102] ● Allows the cannula 447 to quickly and cleanly pierce the user's skin for cannula insertion;

[0103] ● It overcomes the frictional force during the movement of the casing carrier 412 surface against the casing seal 430 surface and the seal retainer 434 surface; and

[0104] ●The compressive and radial forces that result in a reliable drug seal.

[0105] Excess energy is absorbed by the compression of the sleeve seal 430, which causes the sleeve seal 430 to expand radially. This increases the radial force exerted by the sealing ring 431 against the surface of the sleeve carrier 412 and by the radial force exerted by the sleeve seal 430 against the seal retainer 434, as explained in more detail below. Energy requirements and expenditures are also described in more detail hereafter.

[0106] During operation, as the insertion assembly 400 transitions from state two to state three, the radial compressive force applied to the sleeve seal 430 increases. As the sleeve carrier 412 moves downward, it contacts the upper sleeve sealing ring 431, typically causing the sleeve seal 430 to be captured and surrounded between the surfaces of the sleeve carrier 412 and the seal retainer 434. The seal retainer 434 acts as a retaining backing ring, thereby providing radial support to the sleeve seal 430 and contributing to the radial clamping force applied to the sleeve seal 430. However, in some alternatives, as briefly illustrated, a small gap may exist 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 because the amount of contact, and therefore the radial force, continues to increase between: (i) the surfaces of the sleeve carrier 412 and the sleeve sealing ring 431, (ii) the seal retainer 434 and the sleeve seal 430, and (iii) in some alternatives, the surfaces of the sleeve carrier 412 and the seal retainer 434. Regarding the next embodiment, the contact between the sleeve carrier 412 and the sealing ring 431 during the transition from state two to state three is also described in more detail below.

[0107] As the sleeve carrier 412 continues to move downward, contact is made between the top surface of the sleeve seal 430 and the inner surface 416 of the carrier (see...). Figure 5D and Figure 7DAs described above, this contact occurs while the sleeve carrier 412 is still moving downwards. Therefore, as the sleeve carrier 412 continues to move downwards, the inner surface 416 of the sleeve carrier 412 exerts an increased downward force on the sleeve seal 430, and in doing so, the sleeve seal 430 is increasingly compressed as the sleeve carrier 412 continues to move. As the inner surface 416 of the carrier increasingly pushes against the sleeve seal 430 from above, the sleeve seal 430 increasingly expands radially, thereby generating additional radial compressive forces between (i) the sealing ring 431 and the sleeve carrier 412 and (ii) the sleeve seal 430 and the seal retainer 434. The sleeve seal 430 may ultimately expand radially, for example, by 0.5 mm. (In some alternatives, the small gap between the seal retainer 434 and the sleeve seal 430 can be reduced until the small gap 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.) In addition, 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 surface seal. Thus, a highly effective and highly reliable sleeve seal is achieved by: (1) a face seal formed at the inner surface 416 of the sleeve carrier 412 and the top surface of the sleeve seal 430; (2) contact between the sealing ring 431 and the sleeve carrier 412; (3) a radial clamping force applied to the sleeve seal 430 by the seal retainer 434; (4) an increased radial clamping force applied 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) a downward force applied by the sleeve carrier 412 at the inner surface 416 of the sleeve carrier 412 on the top of the sleeve seal 430, which causes the sleeve seal 430 to expand radially and increases (a) the radial force applied by the sealing ring 431 against the surface of the sleeve carrier 412 and (b) the radial force applied by the sleeve seal 430 against the seal retainer 434.

[0108] I. Selected Implementation Scheme for Trigger Components

[0109] Figures 8 to 12B Representative examples of one-time components 800, 900, 1000, and 1100, having various configurations, are shown according to embodiments of the technology of the present invention. The features of one-time components 800, 900, 1000, and 1100 can be substantially similar to... Figures 1A to 7D The characteristics of the disposable component 300. Therefore, in Figures 1A to 7D The same reference numerals are used to identify similar or identical parts, and Figures 8 to 12B The discussion of the disposable components 800, 900, 1000, and 1100 will be limited to those related to... Figures 1A to 7D The 300 different features of the disposable components. Additionally, Figures 8 to 12B Any feature of the disposable components 800, 900, 1000, and 1100 can be combined with each other and / or with... Figures 1A to 7D The feature combination of the disposable component 300.

[0110] 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. Figure 4B Alignment. For example, Figure 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 together 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.

[0111] When the drive assembly 329 of the reservoir assembly operates in the forward direction (e.g., during a plunger search operation), the shaft 802 translates forward together with the plunger pusher 335a. The clutch disc 806 allows the shaft 802 to pass through in this forward direction. However, when the motor reverses (e.g., after the plunger search operation is complete) and the plunger pusher 335a moves in the rearward direction, the clutch disc 806 clamps downward onto the shaft 802 and prevents the shaft 802 from translating rearward through the clutch disc 806. Therefore, the shaft 802, together with the second lever arm 808b, becomes a substantially rigid body, such that the shaft 802 pulls the second lever arm 808b counterclockwise around 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 lever 804 to push the lever 804 forward (as indicated by arrow B). The forward translation of rod 804 forces the first end portion 804a of rod 804 to contact the trigger boss 411 of sleeve carrier 412, and pushes sleeve carrier 412 clockwise (as indicated by arrow C) to trigger sleeve insertion.

[0112] In use, the user positions the device (including disposable component 800) on the skin with the trigger component locked. Once the device adheres to the user's skin (e.g., after the plunger searching operation is complete and PBUP 108 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, plunger pusher 335a moves rearward, thus rotating lever 808 and, via translation of rod 804, forcing tab 413 of cannula carrier 412 to rotate into alignment with slot 424 of guide housing 420 for cannula insertion. After triggering, plunger pusher 335a advances back to contact plunger 335b to initiate drug delivery.

[0113] In some embodiments of the disposable component 800, the lever 804 is configured to pull the trigger boss 411 instead of pushing it as detailed above. For example, a first end portion 804a of the lever 804 may be positioned to the right of the trigger boss 411 and connected to the trigger boss via one or more links.

[0114] According to several embodiments, the cannula carrier 412 of the insertion assembly 400 is rotated-biased in a direction that will release the cannula carrier 412 from the guide housing 420. In such embodiments, the trigger assembly may include a blocking member that prevents such rotational movement until the user remotely activates the trigger assembly to remove the blocking member and release the cannula carrier 412. For example, the blocking member may engage a portion of the cannula carrier 412 (such as a trigger boss 411) to prevent the cannula carrier 412 from rotating in the release direction. Remote activation of the trigger assembly disengages the blocking member from the trigger boss 411, thereby allowing the cannula carrier 412 to rotate such that a tab 413 on the carrier 412 aligns with a slot 424 in the guide housing 420. The alignment of the tab 413 with the slot 424 allows the cannula carrier 412 to move downward and the cannula 441 to be inserted.

[0115] To rotatably bias the sleeve carrier 412, the insertion assembly 400 may include a torsion spring. In some embodiments, the flange 422 of the guide housing 420 (see...) Figure 4B The sleeve carrier 412 can be tilted downward toward the slot 424 so that when the blocking member is removed, the sleeve carrier 412 no longer resists the force of the main insertion spring 410, and the elastic energy contained in the main insertion spring 410 is converted into motion. Due to the tilted flange 422, the sleeve 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.

[0116] Figures 9A to 9C This is a different view of a disposable component 900, which has a rotationally biased sleeve carrier 412 and a trigger assembly operatively coupled to a drive assembly 329. The trigger assembly may include a lever 902, a latch 904, and a ratchet 910 coupled to a worm gear 333b of a reservoir assembly, such that rotation of the worm gear 333b causes rotation of the ratchet 910. The lever 902 has a first end 902a abutting a trigger boss 411 on the sleeve carrier 412, and an opening 920 received in a reservoir support block 338. Figure 9B The second end 902b within the ). In some embodiments, such as... Figures 9A to 9C As shown, rod 902 is oriented parallel to the longitudinal axis of reservoir 336. Another component of reservoir 336, reservoir support block 338, and / or disposable assembly 900 may include recess 906. Figure 9B The groove is configured to receive at least a portion of the rod 902 to guide the translation of the rod 902 and prevent lateral movement (e.g., any movement not parallel to the longitudinal axis of the reservoir 336).

[0117] When the trigger component is in a locked state (before insertion, such as...) Figures 9A to 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). Figure 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.

[0118] The second end 904b of the latch 904 can engage with the tooth 912 on the ratchet 910. Figure 9B ) engagement. 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 ( Figure 9B (See arrow A in the diagram). The ratchet 910 also rotates clockwise. During this rotation, one of the teeth 912 of the ratchet 910 engages the second end 904b of the latch 904 and pulls the latch 904 away from the second end 902b of the lever 902 and the opening 920 (indicated by arrow B). Once the latch 904 has left the opening 920, the lever 902 slides freely through the opening 920, allowing the sleeve carrier 412 to rotate (indicated by arrow D). The rotation of the sleeve carrier 412 aligns the tab 413 on the carrier 412 with the slot 424 in the guide housing 420 (see [reference]). Figure 4B This allows the main spring 410 to push the sleeve carrier 412 downward and insert the sleeve 441.

[0119] 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 needed, 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.

[0120] Figures 10A to 10C This is a different view of a disposable component 1000, which has a trigger component operatively coupled to a drive component 329. (Regarding...) Figures 9A to 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... Figures 10A to 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. Figure 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).

[0121] When the trigger component is in a locked state (before insertion, such as...) Figures 10A to 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 (…). Figure 10B ) engage, such that when ratchet 1010 is in the counterclockwise direction ( Figure 10BWhen rotated on arrow A), tooth 1012 pushes latch 1004 toward the second end portion 1002b of lever 1002 (indicated by arrow B). The counterclockwise direction can be the opposite of the normal rotation direction of the motor, in this case clockwise. Latch 1004 may have a beveled end surface 1005 such that when latch 1004 engages the second end portion 1002b of lever 1002, beveled end surface 1005 pushes lever 1002 forward (indicated by arrow C). The forward movement of lever 1002 causes the first end portion 1002a to engage trigger boss 411 and forces sleeve carrier 412 to rotate (indicated by arrow D). The rotation of sleeve carrier 412 aligns tab 413 on carrier 412 with slot 424 in guide housing 420 (see [link]). Figure 4B This allows the main spring 410 to push the sleeve carrier 412 downward and insert the sleeve 441.

[0122] In use, the user positions the device (including disposable component 1000) on the skin with the trigger assembly locked. Once the device adheres to the user's skin (e.g., if needed, after the plunger searching operation is complete and PBUP 108 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 counterclockwise, thereby actuating latch 1004 into engagement with lever 1002. Lever 1002 thus moves forward and causes tab 413 of cannula carrier 412 to rotate into alignment with slot 424 in guide housing 420, thereby triggering cannula insertion. After triggering, plunger pusher 335a advances back to contact plunger 335b to initiate drug delivery.

[0123] As previously described, in some embodiments, the cannula carrier 412 of the insertion assembly 400 is rotationally biased toward the direction that will cause cannula insertion. For example, the trigger assembly of the present invention may include a hydraulic trigger configured to allow movement of the cannula carrier 412. Figure 11A A top view of a disposable assembly 1100 with a trigger assembly is shown, the trigger assembly including a hydraulically driven cylinder 1101 configured to share a fluid connection with a reservoir 336. The driven cylinder 1101 may include a housing 1104, a piston 1108 at least partially positioned within the housing 1104, and a seal 1112 between the piston 1108 and the housing 1104 (see [link to documentation]). Figure 11B), and a spring-loaded pin 1106 positioned between the end portion of the piston 1108 and a portion of the sleeve carrier 412. The piston 1108 may include a channel 1110 (see...). Figure 11B The channel extends through its thickness and is configured to receive at least a portion of the pin 1106.

[0124] refer to Figure 11B The housing 1104 may 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 through which the valve 1118 is positioned. Drug from the reservoir may flow through the second opening 1114 into the housing 1104 and into the space defined by the sidewalls of the housing 1104, the piston 1108, and the valve 1118.

[0125] In use, the user positions the device (including disposable component 1100) on the skin with the trigger component locked. Once the device adheres to the user's skin (e.g., after the plunger seeking operation is complete, if desired), 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, 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, aligning the channel 1110 with the spring-loaded pin 1106. Figure 12A and Figure 12B As shown, when channel 1110 is aligned with spring-loaded pin 1106, pin 1106 falls into channel 1110, thereby disengaging from sleeve carrier 412 and allowing the tab 413 of carrier 412 to rotate to align with slot 424 in guide housing 420. Now positioned in channel 1110, pin 1106 advantageously locks piston 1108 in place to prevent over-compliance.

[0126] In addition to inserting cannula 441 into the patient, downward movement of cannula carrier 412 causes tubular connector 1120 to pass through valve 1118 and establish a fluid path between reservoir 336 and cannula 441. Valve 1118 may be a check valve, and downward movement of connector 1120 may cause the check valve to rupture. Other means for establishing a fluid path between cannula 441 and reservoir 336 are possible. For example, valve 1118 may be a diaphragm, and tubular connector 1120 may be a needle that punctures the diaphragm when cannula carrier 412 falls. In some embodiments, valve 1118 is a ball valve, and establishing the fluid path involves rotating a ball valve. In any case, the use of a hydraulic trigger can advantageously eliminate the need for PBUP 108, since the outflow from reservoir 336 is already contained by a hydraulically driven cylinder.

[0127] To prevent premature triggering of sleeve release during filling of reservoir 336, the device can be configured such that the pressure required to push piston 1108 is greater than the pressure required to push plunger 335b without the use of an electric motor. For example, disposable component 1100 can be configured such that piston friction is greater than the pressure attributable to filling reservoir 336 with a syringe, but still less than the pushing force that can be applied by an electric motor and less than the leakage pressure of the plug seal.

[0128] In some embodiments, housing 1104 may include additional openings (not shown) in its sidewalls, and a permeable membrane may extend across these openings. In such embodiments, the driven cylinder may also include a diaphragm between the permeable membrane and a flow path to the reservoir (e.g., through a second opening 1114). The trigger assembly may include a needle extending from the end of piston 1108 through the diaphragm. A sterilizing agent (such as ethylene oxide) may enter housing 1104 through the membrane and cross the diaphragm through the inner cavity of the needle. The needle may have an opening in its sidewall, positioned along the needle at a location maintained on the piston side of the diaphragm. Thus, sterilizing agent entering through the membrane may pass through the diaphragm, through the opening in the needle into the inner cavity of the housing, and through the second opening 1114 into the reservoir 336.

[0129] In any of the embodiments disclosed herein, the device may be configured to detect the relative positions of different portions of the trigger assembly and / or the sleeve carrier to determine the insertion state of the device. For example, for Figures 11A to 12BThe trigger assembly shown can measure the relative position of pin 1106 and piston 1108. In some embodiments, pin 1106 includes a magnet (not shown), and the portion of piston 1108 remote from channel 1110 also includes a magnet (not shown). The magnet on pin 1106 can be oriented such that, in the pre-insertion position, the north pole of the pin magnet is closest to piston 1108, and the north pole of the piston magnet is closest to pin 1106. Durable component 200 (or another part of the infusion device) may include a magnetoresistive sensor configured to detect changes in the vicinity of the north poles of the pin magnet and piston magnet. Proximity detection of pin 1106 relative to piston 1108 (or vice versa) is beneficial for detecting insertion and distinguishing between cannula insertion and the pre-insertion state. Furthermore, because the infusion device can detect insertion, the infusion device can automatically resume base delivery (if the base rate was previously set). The relative position of pin 1106 and piston 1108 can also initiate plunger seeking (in addition to or instead of when the force reaches its peak at the motor).

[0130] Regarding the above text Figures 1A to 12B Many of the components described herein are described as rotating in a particular direction (e.g., clockwise or counterclockwise). It should be understood that components and / or devices can also be configured to perform their intended function by moving in the opposite direction. For example, a worm gear is described below as rotating counterclockwise to push a plunger actuator forward and clockwise to reverse the plunger actuator. In some embodiments, the worm gear may be configured to rotate clockwise to push the plunger actuator forward and counterclockwise to reverse the plunger actuator. As another example, a cannula carrier is generally described as rotating counterclockwise to release the carrier tab 413. However, in some embodiments, the cannula carrier may be configured to rotate clockwise to release the carrier tab 413. Electric motors and / or drive assemblies, cannula carriers, ratchet wheels, levers, and / or any rotating components may similarly have embodiments in which the direction of rotation achieving the desired result is opposite to that described above.

[0131] in conclusion

[0132] Although these devices and methods are described in the context of automated 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 this specification describes structures and methods particularly suitable for subcutaneous delivery of high-concentration insulin such as U-500 insulin (i.e., U-200 insulin and above) and lower-concentration insulin such as U-100 insulin. However, it should be understood that the invention is applicable to a wide variety of infusion pumps and pharmaceuticals. For example, the invention is also applicable to pharmaceuticals such as: drugs for masking pain, chemotherapy and other cancer-related drugs, antibiotics, hormones, GLP-1, glucagon, various other pharmaceuticals including macromolecules and proteins that may require high levels of delivery accuracy, and drugs suitable for relatively high-concentration insulin such as U-500 insulin (i.e., U-200 insulin and above) and lower-concentration insulin such as U-100 insulin.

[0133] The description of embodiments of this technology is not intended to be exhaustive or to limit the technology to the exact forms disclosed above. Where context permits, singular or plural terms may also contain plural or singular terms respectively. While specific embodiments and examples of this technology have been described above for illustrative purposes, those skilled in the art will recognize that various equivalent modifications can be made within the scope of this technology. For example, although the steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide other embodiments.

[0134] As used herein, the terms “generally,” “basically,” “about,” and similar terms are used as approximate terms rather than as terms of degree, and are intended to take into account the inherent biases of the measured or calculated values ​​that would be recognized by a person of ordinary skill in the art.

[0135] Furthermore, unless the word “or” is explicitly limited to meaning only a single item exclusive to another item in a list referring to two or more items, its use in such lists can be interpreted as including: (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. Additionally, the term “comprising” throughout the document means to include at least one or more of the described features, such that no larger number of the same features and / or other features of additional types are excluded. It should also be understood that specific embodiments have been described herein for illustrative purposes, but various modifications may be made without departing from the art. Furthermore, while advantages associated with certain embodiments of the art have been described in the context of those embodiments, other embodiments may also present such advantages, and not all embodiments are required to present such advantages to fall within the scope of the art. Therefore, this disclosure and associated art may cover other embodiments not explicitly shown or described herein.

Claims

1. An infusion device for delivering a medicament to a user's body, the device comprising: an insertion assembly comprising a cannula; a reservoir assembly comprising a reservoir configured to hold a medicament; and an electric 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 a second, opposite direction to trigger insertion of the cannula into the user.

2. The infusion device of claim 1, wherein: the insertion assembly comprises a cannula carrier and the cannula is secured to the cannula carrier, and 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.

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

4. The infusion device of claim 2, 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.

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

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

7. The infusion device of claim 4 or claim 5, wherein the trigger assembly comprises a hydraulic cylinder.

8. The infusion device of claim 2, further comprising a trigger assembly configured to move out of engagement with the cannula carrier when the electric motor is rotated in the second, opposite direction.

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

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

11. A method for operating an infusion device, the method comprising: rotating an electric motor of an infusion device in a first direction to determine a volume of medicament in a reservoir of the infusion device; receiving a command from a remote controller to rotate the electric motor in a second direction opposite the first direction; and and rotating the motor in the second direction thereby causing the infusion device to drive a cannula out of the infusion device.

12. The method of claim 11, further comprising, after rotating the motor in the second direction, rotating the motor in the first direction to deliver the medication through the cannula.

13. The method of claim 11 or claim 12, wherein: the infusion device comprises a cannula carrier, and the cannula is secured to the cannula carrier, and 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.

14. The method of claim 13, wherein rotation of the motor in the second direction moves the cannula carrier from the first position to the second position.

15. The method of claim 13 or claim 14, wherein 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.

16. The method of claim 13 or claim 14, wherein 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.

17. The method of claim 13, wherein the cannula carrier is biased to rotate toward the second position.

18. The method of claim 17, wherein rotation of the motor in the second direction causes a trigger assembly to disengage from the cannula carrier, thereby allowing the cannula carrier to rotate into the second position.

19. The method of any one of claims 11 to 18, wherein rotating the motor in the second direction causes a ratchet wheel to simultaneously rotate in the second direction.

20. The method of any one of claims 11 to 18, wherein rotating the motor in the second direction activates a linear clutch of a reservoir assembly coupled to the infusion device.

21. An infusion device for delivering a medication to a user’s body, the device comprising: an insertion assembly comprising a cannula; a reservoir assembly comprising a reservoir configured to house a medication; 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 a medication to the trigger assembly to trigger insertion of the cannula through the insertion assembly.

22. The infusion device of claim 21, further comprising a motor actuated by the command from the remote computing device and, when actuated, causes delivery of a medication from the reservoir to the trigger assembly.

23. The infusion device of claim 21 or claim 22, wherein the reservoir includes a pusher, and the infusion device further includes a motor that is actuated by the command from the remote computing device and, when actuated, advances the pusher within the reservoir to cause delivery of medication from the reservoir to the trigger assembly.

24. The infusion device of any one of claims 21 to 23, wherein the trigger assembly engages the insertion assembly to prevent cannula insertion, and wherein medication delivered into the trigger assembly causes the trigger assembly to disengage the insertion assembly, thereby allowing the insertion assembly to insert the cannula.

25. The infusion device of any one of claims 21 to 24, wherein the delivery of medication to the trigger assembly to trigger insertion of the cannula does not cause infusion of the medication into a patient.

26. The infusion device of any one of claims 21 to 25, wherein: the insertion assembly includes a cannula carrier, and the cannula is secured to the cannula carrier, and 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.

27. The infusion device of claim 26, wherein the trigger assembly is mechanically coupled to the cannula carrier and prevents rotation of the cannula carrier toward the second position.

28. The infusion device of any one of claims 21 to 27, wherein 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.

29. The infusion device of claim 28, wherein the delivery of medication to the trigger assembly to trigger insertion of the cannula causes the piston to move, and wherein movement of the piston by a predetermined amount aligns a portion of the piston with a portion of the insertion assembly to trigger cannula insertion.

30. A method for operating an infusion device, the method comprising: receiving a command from a remote computing device to actuate a motor of the infusion device, the infusion device having a reservoir containing medication, an insertion assembly including a cannula, and a trigger assembly coupled to the insertion assembly and in fluid communication with the reservoir; and in response to the command, actuating the motor to push at least some of the medication stored within the reservoir into the trigger assembly, thereby causing the insertion assembly to drive the cannula out of the infusion device.

31. A method for operating an infusion device, the method comprising: receiving a command from a remote computing device to cause a motor of the infusion device to rotate in a first direction, thereby causing an insertion assembly of the infusion device to drive a cannula out of the infusion device; and after rotating the motor in the first direction, rotating the motor in a second direction opposite the first direction to push the medication stored in a reservoir of the infusion device through the cannula.

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