Wearable drug delivery device, wearable pump assembly and inserter system

Abstract

The invention relates to a wearable drug delivery device, a wearable pump assembly and an inserter system. The wearable drug delivery device includes a detachable pump assembly including a cartridge assembly and a controller module, a patch assembly, and a cannula assembly. The cartridge assembly may include a reservoir oriented such that the reservoir axis is parallel to the cannula axis. The reservoir may have a wide, flat, low profile. The apparatus may include an encoder and / or a pressure sensor. For example, the reservoir may be made of a deep drawn metal sheet. The reservoir may have one or more internal ribs for holding the piston in alignment. The actuator assembly may include a large diameter threaded actuator having a high thread density. The drive system may include a worm gear.

Description

Technical Field

[0001] The present disclosure relates to wearable drug delivery devices and drug delivery systems including an inserter system for a wearable drug delivery device. The present disclosure also relates to related methods for manufacturing, assembling, and using wearable drug delivery devices and drug delivery systems including an inserter system for a wearable drug delivery device. Background Art

[0002] Wearable drug delivery devices are widely used. For example, such devices in the form of wearable drug delivery pumps are commonly used for the automatic, controlled delivery of insulin to patients with type 1 or type 2 diabetes.

[0003] Compared to multiple daily injections with an injection pen or syringe, wearable drug delivery pumps can provide greater lifestyle flexibility. They can provide potentially better therapeutic control. For example, in the case of diabetes, they can provide potentially more stringent blood glucose control without increasing the risk of hypoglycemia, seizures, coma, or even death.

[0004] Currently or previously used wearable drug delivery pumps often have one or more drawbacks. For example, some wearable drug delivery pumps have a controller housing attached to the patient's body and one or more external tubes extending from the housing to a patch at the infusion site. Other wearable drug delivery pumps are bulky even without tubes. Existing designs may not be convenient to deploy or wear and may be uncomfortable and unaesthetic.

[0005] Currently or previously used wearable drug delivery pumps may also have other drawbacks. For example, such existing devices may have one or more of the following drawbacks: large size, large footprint, high profile, excessive weight, too small internal reservoir volume, poor aesthetics, discomfort, poor abrasion resistance, external tubes, inconvenient use, difficult use, poor drug delivery accuracy, poor drug delivery consistency, high cost, and / or difficult or expensive to manufacture. Summary of the Invention

[0006] In some embodiments, a wearable drug delivery device includes a detachable pump assembly including a cartridge assembly and a controller module, a patch assembly, and a cannula assembly including a cannula having a cannula axis. The cartridge assembly includes a reservoir having a storage chamber and a reservoir axis. The reservoir can be oriented in the cartridge assembly such that when the detachable pump assembly is attached to the patch assembly, the reservoir axis is aligned parallel to the cannula axis.

[0007] In some embodiments, the reservoir may have a wide, flat, low profile. For example, the ratio of the diameter or width of the reservoir chamber to the depth of the reservoir chamber may be 2:1 or greater.

[0008] In some embodiments, the controller module housing may be translucent or transparent. The wearable drug delivery device may include an encoder and / or a pressure sensor.

[0009] In some embodiments, the wearable pump assembly includes a cartridge assembly and a controller module. The cartridge assembly may have a reservoir made of a metal sheet. The cartridge assembly may have a reservoir manufactured using a deep drawing process.

[0010] In some embodiments, the reservoir includes one or more internal ribs. The piston disk may have one or more notches for receiving one or more ribs of the reservoir. A sealing gasket located around the periphery of the piston disk may have one or more notches for receiving one or more ribs of the reservoir.

[0011] In some embodiments, the wearable pump assembly includes a cartridge assembly and a controller module, wherein the cartridge assembly includes a reservoir having a reservoir chamber, a piston disk, and an actuator assembly having a threaded actuator attached to the piston disk. The diameter of the threaded actuator attached to the piston disk may be one-fourth or more of the diameter or width of the reservoir chamber. The diameter of the threaded actuator attached to the piston disk may be one-half or more of the diameter or width of the reservoir chamber.

[0012] The cartridge assembly may further include an actuator retainer for maintaining the alignment of the actuator assembly. The detachable pump assembly may further include a drive system having a worm gear for driving the actuator assembly.

[0013] The threaded actuator may have a high thread density. For example, the threaded actuator may have a thread density of 80 threads per inch or higher.

[0014] In some embodiments, an inserter system for a drug delivery system includes an inserter device and a cannula assembly loaded in the inserter device. The inserter device may include a retainer adapted to selectively attach to a patch assembly. The inserter device may be adapted to activate the cannula assembly such that the cannula assembly connects to the patch assembly.

[0015] In some embodiments, a method of manufacturing a drug delivery system or a component for a drug delivery system is disclosed.

[0016] In some embodiments, a method of using a drug delivery system or a component for a drug delivery system is disclosed. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 A perspective view of components of an exemplary embodiment of a detachable pump assembly of a wearable drug delivery device is shown.

[0018] Figure 2A Shows Figure 1 A top view of a cartridge assembly of an exemplary embodiment of

[0019] Figure 2B Shows Figure 1 A bottom view of a cartridge assembly of an exemplary embodiment of

[0020] Figure 2C Shows Figure 1 A perspective view of a cartridge assembly of an exemplary embodiment of

[0021] Figure 2D Shows Figure 1 Another perspective view of a cartridge assembly of an exemplary embodiment of

[0022] Figure 2E Shows Figure 1 Another perspective view of a cartridge assembly of an exemplary embodiment of

[0023] Figure 3 Shows Figure 1 An exploded view of a cartridge assembly of an exemplary embodiment of

[0024] Figure 4A Shows Figure 1 An exploded view of some of the components of a cartridge assembly of an exemplary embodiment of, wherein certain components are oriented to show certain features.

[0025] Figure 4B Shows Figure 1 Another exploded view of some of the components of a cartridge assembly of an exemplary embodiment of

[0026] Figure 4C Shows Figure 1 A perspective view of some of the components of a cartridge assembly of an exemplary embodiment of

[0027] Figure 4D Also shows Figure 1 A perspective view of some of the components of a cartridge assembly of an exemplary embodiment of

[0028] Figure 5A Shows Figure 1 A top view of a reservoir of a cartridge assembly of an exemplary embodiment of

[0029] Figure 5B shows a Figure 1 side view of a reservoir of a cartridge assembly of an exemplary embodiment of

[0030] Figure 5C shows a Figure 1 perspective view of a reservoir of an exemplary embodiment of

[0031] Figure 5D side view of a reservoir having a piston disk.

[0032] Figure 6A shows a Figure 1 perspective view of a controller module of an example embodiment of

[0033] Figure 6B shows a Figure 1 perspective view of a controller module of an example embodiment of

[0034] Figure 6C shows a Figure 1 interior of an upper housing of a controller module of an exemplary embodiment of

[0035] Figure 7A shows a Figure 1 exploded view of components of an example embodiment of

[0036] Figure 7B shows a Figure 1 perspective view of components of an exemplary embodiment of

[0037] Figure 7C shows a Figure 1 perspective view of components of an exemplary embodiment of

[0038] Figure 8A shows a Figure 1 perspective view of a lower housing of a controller module of an exemplary embodiment of

[0039] Figure 8B exploded perspective view, generally viewed from the top, of a patch assembly of an exemplary embodiment of a wearable drug delivery device, the patch assembly being usable with Figure 1 a detachable pump assembly.

[0040] Figure 8C shows a Figure 8BTop view of the patch assembly.

[0041] Figure 8D Shows Figures 8B to 8C Side view of the locking stud of the patch assembly.

[0042] Figure 9A Shows an exemplary embodiment of certain components of the inserter system.

[0043] Figure 9B Shows Figure 9A Another view of the exemplary embodiment.

[0044] Figure 9C Shows Figure 9A Bottom view of the holder component of the embodiment.

[0045] Figure 10A Shows Figure 9A Exploded view of certain components of the exemplary embodiment.

[0046] Figure 10B Shows an exemplary embodiment of a cannula assembly of a wearable drug delivery device, which cannula assembly can be used with Figures 8B to 8C the patch assembly and Figure 1 the detachable pump assembly.

[0047] Figure 11A Shows, before attaching the cannula assembly to the patch assembly, Figure 9A Cross-sectional view of certain components of the exemplary inserter system.

[0048] Figure 11B Shows Figure 11A Cross-sectional view of the cannula assembly attached to the patch assembly.

[0049] Figure 12A Shows an exploded partial view of the exemplary inserter system, where the inserter device is in the first position.

[0050] Figure 12B Shows Figure 12A Perspective view of the exemplary inserter system, where the inserter device is in the second position.

[0051] Figure 12C Shows an exemplary drug delivery system after deploying the cannula assembly and separating the inserter device from the patch cannula assembly.

[0052] Figure 12D Shows the underside of the patch cannula assembly after deploying the cannula assembly.

[0053] Figure 12EShows an assembled wearable drug delivery device, where certain components of the upper housing and the controller module are removed. DETAILED DESCRIPTION

[0054] The following is a detailed description of the illustrated embodiments and certain variations thereof. As will be understood by those of ordinary skill in the art, many other variations are possible within the scope of the present disclosure.

[0055] Various embodiments of a drug delivery system are described herein. In one exemplary embodiment, the drug delivery system may be supplied to a user (patient, healthcare provider, etc.) in the form of: (i) an inserter system that includes an inserter device, a cannula assembly loaded in the inserter device, and a patch assembly attached (or attachable) to the inserter device; and (ii) a detachable pump assembly (assembled or as components suitable for assembly). The inserter device may be used to facilitate placement of the patch assembly on the patient and to activate the cannula assembly such that the cannula of the cannula assembly is inserted through the patient's skin into the patient's body and such that the cannula assembly is connected to the patch assembly. The components of the detachable pump assembly may include a cartridge assembly and a controller module. The cartridge assembly and the controller module may be supplied to the user as separate components or may be assembled together as a detachable pump assembly. Once the inserter device has been used to place the patch assembly on the patient and activate the cannula assembly such that the cannula is inserted into the patient's body, the inserter device may be removed and optionally discarded. The remaining components - the patch assembly with the connected cannula assembly and the detachable pump assembly (cartridge assembly and controller module) - together form a wearable drug delivery device for delivering a selected drug to the patient in a controlled manner.

[0056] Figure 1 Shows the components of an exemplary embodiment of the detachable pump assembly 120 of an exemplary wearable drug delivery device 110 (see Figure 12C ). The illustrated detachable pump assembly 120 includes a controller module 130 and a cartridge assembly 160.

[0057] Figure 2A Shows Figure 1 A top view of an exemplary embodiment of the cartridge assembly 160. Figure 2B Shows a bottom view of the cartridge assembly 160. Figures 2C to 2E Shows a perspective view of the cartridge assembly 160.

[0058] Figure 3 Shows an exploded view of the cartridge assembly 160. Figure 4A And Figure 4B Shows an exploded view of some of the components of the cartridge assembly 160, where certain components are oriented to show certain features. Figure 4C AndFigure 4D A perspective view of some of the components of the cartridge assembly 160 is shown.

[0059] As illustrated, the exemplary cartridge assembly 160 has a housing 162, in which the components of the cartridge assembly 160 are located. The cartridge assembly 160 includes a reservoir 164 located in the housing.

[0060] The reservoir 164 has an internal storage chamber that houses a drug fluid to be delivered to a patient. In this embodiment, the reservoir 164 is generally shaped in a cylindrical form, but many other shapes are possible. The bottom of the reservoir 164 has a microtube 166 that has a fluid outlet port 167 at its distal end. The bottom of the reservoir also has a fill port 168, which is an opening in the bottom wall of the reservoir. The fill port 168 is covered by a fill diaphragm 169, which can be an elastomer such as silicone or rubber.

[0061] The top of the reservoir 164 has an opening that houses a movable piston 180, which is in the form of a disk in the illustrated embodiment. In the Figure 4D illustrated embodiment, the piston disk 180 is a thin and flat disk. The piston disk 180 can be located in a plane or can be slightly dome-shaped or convex to conform to the shape of the bottom wall 164b of the reservoir 164 (as described below). The piston disk 180 has a gasket 184 that surrounds its outer periphery around its outer edge. When assembled, the gasket 184 forms a seal with the inner wall of the reservoir 164, such that the reservoir 164 and the piston disk 180 and the gasket 184 form a closed drug fluid chamber that is open only at the outlet port 167 (as described below, the fill port 168 is kept closed by the diaphragm 169, but the fill port 168 allows access to the reservoir 164 for filling).

[0062] To facilitate the connection between the piston disk 180 and the sealing gasket 184, the disk 180 can have one or more holes 182 passing through it. In the illustrated example, the disk 180 has a plurality of holes 182 that are circularly aligned near the outer edge of the disk 180 or aligned along one or more arcs. Figure 4D The holes 182 are shown; Figure 4B has a portion of the gasket 184 removed to show the location of some of the holes 182. The gasket 184 can be formed by overmolding on the outer edge of the disk 180 such that the material of the gasket 184 passes through the holes 182. In this way, the cured gasket 184 is firmly bonded to the disk 180. This helps to prevent the gasket 184 from detaching from the disk 180 when it slides against the inner wall of the reservoir 164. This also facilitates achieving a proper and uniform seal and helps to prevent leakage.

[0063] The disk 180 can have one or more notches 181 at its outer edge. The seal washer 184 can correspondingly have one or more notches 185 that correspond to the notches 181 of the disk 180. As described below, the notches 181, 185 receive the ribs 170 inside the reservoir 164.

[0064] The piston disk 180 advances in the reservoir 164 to dispense a medicament fluid to a patient by the action of the actuator assembly 190. The actuator assembly 190 includes a gear 192 which, in the illustrated embodiment, is in the form of a disk gear, also known as a spur gear or gear wheel, having gear teeth around its outer periphery. The gear 192 is connected to a first threaded actuator 194 which, in the illustrated embodiment, is a female threaded tube, i.e., a tube having a helical thread along its inner surface. A second threaded actuator 196 is connected to the piston disk 180. In the illustrated embodiment, the second threaded actuator 196 is a male threaded rod, i.e., a rod having a helical thread along its outer surface. When assembled, the rod is mounted inside the tube, where the outer thread of the rod threadably engages the inner thread of the tube. In an alternative embodiment, the female threaded actuator and the male threaded actuator are inverted such that the first threaded actuator connected to the gear 192 is a male threaded rod and the second threaded actuator connected to the disk 180 is a female threaded tube.

[0065] As described in more detail below, each of the threaded elements of the actuator assembly 190, namely the first threaded actuator 194 and the second threaded actuator 196, has a very precise, fine helical thread. The result is a precision threaded actuator that causes the piston disk 180 to make very precise small movements to achieve precise drug delivery.

[0066] In the illustrated embodiment, the exemplary cartridge assembly 160 also has an actuator retainer 172 for holding the components of the actuator assembly 190 in position and alignment. In this example, the actuator assembly components are vertically aligned relative to the piston disk 180. The first threaded actuator 194 and the second threaded actuator 196 are aligned along a central longitudinal axis 191 passing through the rod and the tube. The axis 191 is the axis of rotation for the gear 192 and the first threaded actuator 194. The axis 191 is perpendicular to the general plane of the piston disk 180. The actuator retainer 172 helps to keep the components of the actuator assembly 190 aligned such that the axis 191 is aligned (parallel and / or collinear) with the axis 165 of the reservoir 164.

[0067] In the illustrated embodiment, the actuator retainer 172 is a bracket having a central plate 173, extensions 174, and an opening 175 in the plate 173. When the cartridge assembly 160 is assembled, the extensions 174 are supported relative to the housing 162 such that the actuator retainer 172 remains stable. The actuator assembly 190 is positioned within the opening 175 in the plate 173 such that it is supported by the edge of the plate 173 around the opening 175. In this way, the actuator retainer 172 helps to maintain alignment of the components of the actuator assembly 190 such that the axis 191 is aligned with the axis 165 of the reservoir 164. Thus, the actuator retainer 172 precisely supports the axial (vertical) alignment and movement of the threaded actuators 194, 196 and helps to prevent the piston disk 180 from tilting relative to the reservoir 164 during fluid dispensing.

[0068] The actuator retainer 172 can also help to hold the actuator assembly 190 together. In some embodiments, the plate 173 of the actuator retainer 172 can serve as a support beneath the gear 192. Thus, the actuator retainer 172 can help to resist downward external pressure acting on the actuator assembly 190 and unwanted dispensing of the pharmaceutical fluid from the reservoir 164. For example, the actuator retainer 172 can resist external pressure such as during flight of an aircraft, which could cause unwanted movement of the actuator assembly 190.

[0069] In the illustrated embodiment, the exemplary cartridge assembly 160 further includes an encoder 176 that moves with the gear 192. The encoder 176 can be a disk connected to the gear 192. The encoder 176 has markings in the form of flags, electromagnetic elements, optical elements, etc., that can be detected by a reader 156 to provide feedback regarding the movement and / or position of the actuator and the corresponding piston disk 180. Although the encoder 176 can be a disk connected to the gear 192, in alternative embodiments, the encoder 176 can be markings located directly on the gear 192 or on the first threaded actuator 194 or on another rotating part of the actuator assembly 190. As described below, the encoder 176 cooperates with the encoder reader 156 to provide real-time feedback of the position of the gear 192 and, correspondingly, real-time feedback of the position of the piston disk 180, thereby providing confirmation of the position of the piston disk 180 (and / or indicating any errors in the piston disk 180 position and / or allowing correction of the position of the piston disk 180).

[0070] In the illustrated embodiment, the exemplary cartridge assembly 160 may further include a pressure sensor 178. The pressure sensor 178 may be a component of the cartridge assembly 160 and / or the controller module 130. The pressure sensor 178 is positioned to sense an upward force on the actuator assembly 190. For example, if there is a blockage in the outlet port 167 or other occlusion or problem occurs when the fluid exits the reservoir 164, or if the piston disk 180 reaches the bottom of the reservoir 164, further actuation of the actuator assembly 190 and the movement restriction of the piston disk 180 will generate an upward force on the actuator assembly 190. The pressure sensor 178 may detect this force to detect the occlusion (or other problems). In some embodiments, the pressure sensor 178 contacts one side of the disk gear 192. In other embodiments, one or more components may be located between the pressure sensor 178 and the disk gear 192 or other components of the actuator assembly 190.

[0071] The exemplary cartridge assembly 160 may further include a battery 198. The battery 198 may be a component of the cartridge assembly 160 and / or the controller module 130. The battery 198 provides power as needed, for example, for driving the actuator assembly and / or for one or more sensors / readers (e.g., encoders, pressure sensors, etc. and / or associated readers).

[0072] Figure 5A , Figure 5B and Figure 5C Top, side, and perspective views of an exemplary reservoir 164 are shown. The reservoir 164 has a side wall 164a and a bottom wall 164b. The side wall 164a may define any suitable cross-sectional shape for the storage chamber, such as generally circular (as illustrated), oval, rectangular, square, hexagonal, octagonal, etc. The bottom wall 164b may have any suitable shape, such as flat, conical, domed, convex, etc. In some embodiments, the piston disk 180 may be shaped to correspond to the shape of the bottom wall 164b such that when the actuator is fully deployed, the piston disk 80 abuts flush against the bottom wall 164 to expel all or substantially all of the fluid drug from the reservoir 164. Figure 5D A side view of the reservoir is shown, having a domed bottom wall 164b and a similarly domed piston disk 180 to correspond to the shape of the bottom wall 164a.

[0073] In the illustrated exemplary embodiment, the inner side of the sidewall 164a of the reservoir 164 has inwardly extending ribs 170. The illustrated embodiment shows four ribs equally spaced at 90-degree increments around the inner perimeter of the sidewall 164a; however, any suitable number and location of ribs may be used. For example, the reservoir may have one rib, two ribs spaced 180 degrees apart, three ribs spaced 120 degrees apart, five ribs spaced 72 degrees apart, etc. Uneven spacing may also be used. In an alternative example, eight ribs are arranged in pairs, where each pair of ribs is spaced at 90-degree increments. When the cartridge assembly 160 is assembled, the ribs 170 are received in the notches 181, 185 of the piston disk 180 and the gasket 184, respectively. In this manner, the ribs 170 serve as guides for the piston disk 180, thereby helping to prevent the piston disk 180 from tilting during dispensing.

[0074] Figure 6A and Figure 6B A perspective view of the controller module 130 of the exemplary detachable pump assembly 120 is shown. Figure 6A The controller module with the upper housing 132a separated from the rest of the components is shown. Figure 6C The interior of the upper housing 132a is shown.

[0075] As illustrated, the exemplary controller module 130 has a housing 132, in which the components of the controller module 130 are located. The housing 132 includes an upper housing 132a and a lower housing 132b, which are assembled together to form the housing 132. The lower housing 132b has an opening 134 for placing the controller module 130 above the cartridge assembly 160 to connect the controller module 30 and the cartridge assembly 160 together.

[0076] The exemplary controller module 130 includes an electromechanical drive system 140 inside the housing 132. The electromechanical drive system 140 is used to drive the actuator assembly 190 of the cartridge assembly 160. The electromechanical drive system 140 includes a motor 142 that drives a drive gear 144. In this example, the gear 144 is a worm gear 144, which meshes with the teeth of the gear 192 when the cartridge assembly 160 is assembled within the controller module 130. In alternative embodiments, other arrangements may be used to drive the actuator assembly 190.

[0077] The exemplary controller module 130 further includes a printed circuit board assembly (PCBA) 146. The PCBA 146 may include electronics (hardware, which includes one or more microcontrollers and / or other microchips and runs firmware and / or software) for various functions such as receiving input data from an external source (e.g., from a device (e.g., a smartphone, a tablet, a computer, etc.) or other source that sends signals to control the functions of the wearable drug delivery device as described below); receiving input data from sources inside the wearable drug delivery device (e.g., a pressure sensor, an encoder, and / or one or more other sensors); receiving input data from a battery, such as detecting the battery charge; processing the input data; activating / controlling an electromechanical drive system for dispensing the drug; and / or activating one or more signaling devices, such as an alarm, a light, and / or a vibration mechanism. A connection may be provided such that when the cartridge assembly 160 is assembled within the controller module 130, the PCBA 146 is connected to the battery 198 to receive power from the battery 198. One or more wires or connectors (not numbered) may electrically connect the drive motor 142 to the PCBA 146. The PCBA 146 is illustrated as extending around the inner perimeter of the housing 132 and surrounding other components. The PCBA 146 may extend completely or only partially around the inside of the housing 132. Other arrangements and placements for the PCBA 146 are possible in alternative variations.

[0078] In the illustrated embodiment, the exemplary controller module 130 may further include a pressure sensor 158, which may be used as a supplement or alternative to the pressure sensor 178. Like the pressure sensor 178, the pressure sensor 158 may be positioned to sense an upward force on the actuator assembly 190. As described above, the pressure sensor 158 may be positioned similarly to the pressure sensor 178. One or more wires or connectors 159 may connect the pressure sensors 158, 178 to the PCBA 146.

[0079] The microcontroller or other electronics on the PCBA 146 may be programmed to associate the detected electrical signals (voltages) from the pressure sensors 158, 178 with the corresponding associated pressures and to send one or more signals when the detected pressure exceeds a specific range. For example, a pressure exceeding the programmed maximum pressure may indicate an occlusion clogging or restricting the outflow of the drug fluid, or may indicate that the piston disk has reached the bottom of the reservoir, or that some malfunction has occurred. When the detected pressure exceeds the programmed maximum pressure, the microcontroller or other electronics may activate one or more signals, such as beeping or other alarms in the device, lighting or flashing one or more lights (LEDs) on the device, and / or activating the vibration mechanism in the device to cause the device to vibrate. For example, depending on the embodiment and application, the maximum pressure threshold may be programmed to 10 grams, 12 grams, 15 grams, or some other amount of force.

[0080] The exemplary controller module 130 may also include an encoder reader or detector 156. In one example, the encoder reader 156 is an optical encoder reader. The encoder reader 156 is positioned inside the upper housing 132a. The encoder reader 156 is positioned such that when the cartridge assembly 160 is assembled within the controller module 130, the encoder reader 156 can read the encoder 176. One or more wires or connectors 157 may electrically connect the encoder reader 156 to the PCBA 146.

[0081] The encoder reader 156 detects the movement of the encoder 176 and sends a signal to the electronics on the PCBA 146. These signals indicate how far the encoder 176 has rotated, which indicates how far the rotating member of the actuator assembly 190 has rotated, and thus how far the piston disk 180 has advanced into the reservoir 164. In this way, the electronics receive information about how much medicament fluid has been dispensed from the reservoir.

[0082] During operation of the wearable medicament delivery device, the dispensing of the medicament fluid may be open-loop or closed-loop. In an open-loop embodiment, the electronics receive information about the amount of medicament fluid dispensed at a particular dose and then send a signal to the motor 142 to cause the motor to move by an amount corresponding to the amount of medicament fluid to be dispensed. In a closed-loop embodiment, the electronics receive information about the amount of medicament fluid dispensed at a particular dose and then send a signal to the motor 142 to cause the motor to move to dispense the medicament fluid, and feedback signals from the encoder reader 156 provide information about how far the actuator assembly 190 has moved. When these feedback signals indicate that the expected amount of medicament fluid has been dispensed, the electronics stop driving the motor 142. In some embodiments, the encoder reader 156 and the encoder 176 may also be used to determine the total amount of medicament fluid dispensed from the reservoir 164, and when the medicament fluid in the reservoir 164 has been depleted (or is about to be depleted), the electronics may use this information to activate one or more signals as described above (e.g., beeping or other alerts in the device, lighting or flashing one or more lights (LEDs) on the device, and / or activating a vibration mechanism in the device that causes the device to vibrate).

[0083] As described above, the electronics may also receive input data from the battery, such as detecting the battery charge. The electronics may send signals (e.g., sound, light, vibration) to indicate a low battery charge. The electronics may also send signals when they detect a fault (e.g., the motor does not move, or the actuator movement detected from the encoder does not match the expected motor movement based on the drive signal sent to the motor, or some other problem).

[0084] The wearable drug delivery device 110 can include an antenna for receiving input signals from an external source such as a smartphone, a tablet computer, a computer, or a remote source. The signals can be received in any suitable manner such as Bluetooth, RF technology, WiFi, cellular signals, or other wireless signaling. The antenna can be located on the PCBA 146, or it can be a separate component connected to the PCBA 146. In one example, the traces on the PCBA 146 form the antenna.

[0085] In some embodiments, the wearable drug delivery device 110 can be used without being connected to any glucose monitoring device. In other embodiments, the wearable drug delivery device 110 can include a glucose sensor. In other embodiments, the wearable drug delivery device 110 can be configured to receive signals from an external glucose sensor, which can be worn elsewhere on the patient's body, or which can be used to detect the patient's glucose level (e.g., by reading a sample). The electronics on the PCBA 146 can receive input signals from the glucose sensor and can use these signals to control the delivery of the drug fluid to the patient (e.g., determining the dose, determining the dosing time, dispensing an additional dose, withholding a dose, etc.).

[0086] Figure 7A An exploded view of the components of an exemplary detachable pump assembly 120 is shown, which shows the positioning of the cartridge assembly 160 within the controller module 130. Figure 7B A perspective view of the detachable pump assembly 120 is shown, which includes the cartridge assembly 160 within the controller module 130, where certain components of the controller module 130 are separated from the remaining components. Figure 7C A perspective view is shown in which the lower housing 132b of the controller module 130 has been removed.

[0087] In the illustrated embodiment, the shape and size of the opening 134 in the housing 132 of the controller module 130 are designed to correspond to the shape and size of the cartridge assembly 160. The opening 134 is slightly larger than the cartridge assembly 160 to facilitate placement of the cartridge assembly 160 within the controller module 130. In the illustrated example, the opening 134 and the cartridge assembly 160 generally have the shape of a keyhole, which has a circular shape (where the reservoir 164 is located) and a raised portion of a narrower width extending from the circle. Many other shapes are possible in alternative variations.

[0088] The cartridge assembly 160 and / or the controller module 130 may include a locking element (not shown) that holds the cartridge assembly 160 and the controller module 130 together as a single detachable pump assembly 120 while allowing the cartridge assembly 160 to be easily removed from the controller module 130. Such locking elements may include, but are not limited to, resilient tabs, slots, openings, latches, etc.

[0089] When the cartridge assembly 160 is assembled within the controller module 130, the actuator assembly 190 is aligned with the drive system 140 such that the drive system 140 can drive the actuator assembly 190. In the illustrated example, when the cartridge assembly 160 is assembled within the controller module 130, the gear 192 of the actuator assembly meshes with the gear 144 of the drive system 140. That is, the helical threads of the worm gear 144 engage the teeth of the spur gear 192, thereby driving the worm gear 144 and causing the spur gear 192 to rotate.

[0090] Similarly, when the cartridge assembly 160 is assembled within the controller module 130, other components may be aligned, such as sensors or readers. For example, when the cartridge assembly 160 is assembled within the controller module 130, the encoder reader 156 is positioned near or above the encoder 176 such that the encoder reader 156 can read the encoder 176. Additionally, as described above, when the cartridge assembly 160 is assembled within the controller module 130, the pressure sensors 158 and / or 178 are positioned to sense the upward force on the actuator assembly 190.

[0091] Figure 8A A view of the bottom of the lower housing 132b of the controller module 130 is shown. For clarity, certain details visible in some of the other figures are omitted Figure 8A from those Figure 8AAs can be seen, the lower housing 132b has a raised ridge 136 in the form of a wall or lip near or around the opening 134. The ridge 136 includes a locking element 137 that mates with a locking element 237 (described below) of a ridge 236 of the patch assembly 230 to hold the detachable pump assembly 120 connected to the patch assembly 230 while allowing the detachable pump module 120 to be easily removed from the patch assembly 230. Such locking elements can include, but are not limited to, resilient tabs, slots, openings, snaps, etc. In the illustrated embodiment, the locking element 137 is a tab (e.g., it can be resilient and / or configured for a press fit or interference fit), and the locking element 237 is an opening configured to receive the tab 137. When the detachable pump assembly 120 is pressed into place on the patch assembly 230 with sufficient force, the tab 137 snaps into the opening 237 and holds the detachable water pump assembly 120 fixed to the patch assembly 230. By applying sufficient upward force on the detachable pump assembly 120 while holding the patch assembly 230, the detachable pump assembly 120 can be removed from the patch assembly 230, pulling the tab 137 out of the opening 237 and releasing the detachable pump assembly 120 from the patch assembly 230. Although the illustrated embodiment includes four sets of locking elements 137, 237 positioned as shown, any suitable number and location of locking elements 137 and 237 can be used. Other releasable attachment mechanisms (e.g., twisting, etc.) between the detachable pump assembly 120 and the patch assembly 230 can be used.

[0092] As Figure 8A shown, the lower housing 132b also has a raised ridge 138 in the form of a wall or lip near or around the lower perimeter of the lower housing 132a. The ridge 138 mates with a ridge 238 on the patch assembly 230 to facilitate proper placement of the pump assembly 120 on the patch assembly 230. The ridges 136, 138, 236, and / or 238 can facilitate waterproofing of the device to help prevent water or other liquids from damaging the internal components of the pump assembly 120. Using a circular profile with circular ridges (e.g., ridges 138 and / or 238) can facilitate waterproofing because the pressure distribution around the ridges is uniform. One or more sealing elements, such as elastomeric seals or gaskets, can be provided along one or more of the ridges 136, 236, 138, 238 (e.g., along the inner, outer, and / or top of the ridges) to facilitate sealing.

[0093] Figure 8B An exploded view of an example embodiment of a patch assembly 230 of a wearable drug delivery device is shown. Figure 8C A top view of the patch assembly 230 is shown. Figure 8D A side view of a locking stud 242 of the patch assembly 230 is shown ( Figure 8B the locking stud is not shown in

[0094] The patch assembly 230 can be used with Figure 1 the detachable pump assembly 120. In the illustrated example, the patch assembly 230 includes a patch 232 and a patch mount 234. The patch 232 is a sheet of material adapted to adhere to a patient's body. Although the patch 232 is relatively flexible, the patch mount 234 is relatively inflexible and is made, for example, of injection molded or 3D printed plastic. The patch mount 234 can be adhered or otherwise fixed to the upper side 232a of the patch 232. The upper side 232a can include an adhesive material or coating for securing the patch 232 to the patch mount 234. The lower side 232b of the patch 232 can also include an adhesive material or coating for securing the patch 232 to the patient's skin. The adhesive can cover all, substantially all, or a part or portions of the lower side 232b. The adhesive on the lower side 232b can be covered by a removable paper to be removed before adhering the patch assembly 230 to the patient.

[0095] The patch mount 234 has a base plate 240 fixed to the patch 232. The base plate 240 has a raised inner ridge in the form of a wall or lip, i.e., ridge 236, which is shaped and sized such that the ridge 136 of the controller module 130 can be received within the ridge 236. In certain embodiments, such as the illustrated embodiment, the ridge 236 firmly receives the ridge 136, with a small or no gap between the ridges 136, 236, such that these ridges help prevent movement of the pump assembly 120 relative to the patch assembly 230. The ridge 236 includes a locking element 237 that mates with the locking element 137 of the controller module 130 to hold the detachable pump assembly 120 connected to the patch assembly 230 while allowing the detachable pump assembly 120 to be easily removed from the patch assembly 230. As described above, such locking elements can include, but are not limited to, resilient tabs, slots, openings, snaps, etc. In the illustrated embodiment, the locking element 237 is an opening configured to receive the tab 137 of the controller module 130.

[0096] The base plate 240 of the patch mount 234 also has a raised outer ridge in the form of a wall or lip, i.e., ridge 238, which is shaped and sized such that the ridge 138 of the controller module 130 can be received within the ridge 238. In certain embodiments, such as the illustrated embodiment, the ridge 238 firmly receives the ridge 138, with a small or no gap between the ridges 138, 238, such that these ridges help prevent movement of the pump assembly 120 relative to the patch assembly 230. Although not shown, the ridge 138 and / or the ridge 238 can include one or more locking elements to facilitate the detachable connection of the pump assembly 120 to the patch assembly 230.

[0097] As described below, the patch assembly 230 may also include a locking element 242 to facilitate securing the patch assembly 230 to the inserter device. The locking element 242 may be located on the base plate 240 of the patch mount 234. In the illustrated embodiment, the locking element 242 is in the form of a stud, having a stem 242a and a head 242b that project upwardly from the base plate 240 of the patch mount 234. Other variations of the locking element 242 are possible.

[0098] In the illustrated embodiment, the base plate 240 of the patch mount 234 also has a raised hub 244 for receiving and retaining the cannula assembly 260. The raised hub 244 is in the form of a cylindrical wall, but other shapes are possible. A locking element 245 in the form of a projection that faces inwardly from the inner surface of the wall or hub 244 facilitates retaining the cannula assembly 260.

[0099] Figure 9A and Figure 9B An exemplary embodiment of certain components of the inserter system 210 is shown (e.g., see Figure 12A ). The supplied inserter system 210 includes an inserter device 300, a patch assembly 230 secured to the bottom of the inserter device 200, and a cannula assembly 260 located within the inserter device 300. Figure 9C A bottom view of the holder member 320 of the inserter device 300 is shown.

[0100] As Figure 9A and Figure 9B shown in

[0101] As Figure 9CAs shown, retainer 320 has a locking element 322 that can be located in or on the bottom surface of retainer 320. Locking element 322 cooperates with locking element 242 of patch assembly 230 to allow inserter device 300 to be connected to and disconnected from patch assembly 230. In the illustrated example, locking element 322 is a keyhole or shaped opening that includes a slot with an enlarged area at one end. The locking element or key 242 of patch assembly 230 is shaped such that the head 242b of stud 242 can be fitted through the enlarged area of keyhole 322, but cannot pass through the narrow portion of the slot of keyhole 322. The inserter device 300 is connected to the patch assembly 230 by placing the enlarged opening of the locking element 322 over the stud 242 and then rotating the inserter device 300 such that the head 242b of the stud 242 is locked in place behind the narrow portion of the slot 322. The inserter device 300 is disconnected from the patch assembly 230 by reversing the operation. Many other locking element variations are possible for allowing the inserter device 300 to be connected to and disconnected from the patch assembly 230. In the illustrated embodiment, retainer 320 has three locking elements 322 equally spaced at 120-degree increments; however, any suitable number and location of locking elements 322 can be used.

[0102] Figure 10A An exploded view of certain components of an exemplary inserter system 210 is shown. Inserter device 300 includes a housing 302, a retainer 320 ( Figure 10A not shown in ), a spring 304, a trigger 306, and a piston needle assembly 310. Piston needle assembly 310 includes a piston 312, a hard needle 314, a platform 316, a stop housing 318, and a retaining ring 319. For example, hard needle 314 can be stainless steel or other suitable metal. Spring 304 is located inside tubular housing 302, with its proximal end arranged to be biased against housing 302 and its distal end arranged to be biased against piston 312. Piston 312 can be a cylindrical element adapted to be driven distally by spring 304. Piston 312 can have a body 312a with a diameter equal to or close to the inner diameter of tubular housing 302 and a rod 312b with a narrower diameter adapted to fit within the coils of spring 304. This configuration of piston 312 can help keep piston 312 aligned within housing 302. Other configurations are possible.

[0103] The hard needle 314 is attached to the piston 312 or, alternatively, to a component driven by the piston 312. When the inserter device 300 is assembled, the platform 316, the stop housing 318, and the retaining ring 319 are positioned inside the tubular housing 302 at the distal end of the piston. The hard needle 314 passes through the platform 316, the stop housing 318, and the retaining ring 319. The stop housing 318 may have a groove or recess for receiving the retaining ring 319 to hold it in place. The retaining ring 319 may be an elastic ring or washer adapted to provide some sliding resistance against the inner wall of the tubular housing 302.

[0104] When the inserter device 300 is assembled, the spring 304 is compressed and the remaining components inside the tubular housing 302 are in a loaded position. The trigger 306 holds the spring 304 by direct contact with the spring 304 or another component that can keep the spring 304 compressed. The trigger 306 is adapted to allow the user to actuate the inserter device 300 by releasing the spring 304 to drive the piston needle assembly 310 and the cannula assembly 260 distally. The trigger 306 includes a first end 306a, a second end 306b, and a pivot point 306c. In use, the user (e.g., a patient) presses the first end 306a of the trigger 306, which causes the trigger to pivot about the pivot point 306c, thereby moving the second end 306b of the trigger 306 to release the spring 304 from its compressed state.

[0105] As Figure 10A shown in the exploded view in Figure 10B and assembled in Figure 9A The inserter system 210 further includes a cannula assembly 260. The cannula assembly 260 includes a cannula 270 having a distal end adapted to be inserted into a patient's body for drug delivery. In the illustrated embodiment, the cannula 270 has a distal tubular portion 274 and a proximal tapered portion 272. In other embodiments, the cannula 270 may be only tubular or other suitable configurations. The cannula 270 has a cannula axis 271 which is the axis of the tubular portion 274. Relative to the hard needle 314, the cannula 270 (or at least the tubular portion to be subcutaneously inserted into the patient's body) may be a relatively soft material such as a polymer.

[0106] The cannula assembly 260 further includes a housing which may be in one or more parts. In the illustrated example, the cannula assembly housing includes a lower housing 262 and a cap or upper housing 264. When the cannula assembly 260 is assembled, the septum 266, the funnel 268, and the proximal end of the cannula 270 are held within the housing. For example, the inner surface of the lower housing 262 may have a flange or ledge 262a (as Figure 11A and Figure 11BAs shown in [FIGURE REFERENCE], the flange or ledge holds the lip 272a at the proximal end of the cannula 270 and prevents the cannula from moving distally relative to the housing. The funnel 268 is positioned above the cannula 270, and the diaphragm 266 is positioned above the funnel 268. The cap 264 closes the top of the housing and prevents the diaphragm 266, the funnel 268, and the cannula 270 from moving proximally relative to the housing. In this way, the housing components 262, 264 hold the diaphragm 266, the funnel 268, and the cannula 270 in place. The cap 264 can be securely fixed (e.g., by ultrasonic or thermal welding, adhesives, etc.) to the lower housing 262.

[0107] The housing of the cannula assembly 260 may further include a locking element 263 for locking the cannula assembly 260 to the patch assembly 230. In the illustrated example, the locking element 263 is a recess adapted to engage a protrusion 245 on the inner surface of the wall or hub 244 of the patch mount 234 to lock the cannula assembly 260 to the patch assembly 230.

[0108] When the inserter device 300 is assembled and in the loaded state (e.g., Figure 11A , Figure 12A ), the spring 304 is compressed and held by the trigger 306, while the piston needle assembly 310 and the cannula assembly 260 are in a first proximal position within the tubular housing 302. The hard needle 314 passes through the platform 316 (the platform 316 may have a central hole, not shown) and the stop housing 318 (which may have a hollow center). The hard needle 314 also passes through the cap 264 (the cap may have a central hole, not shown), the diaphragm 266 (which may be pierced by the hard needle 314), the funnel 268, and the cannula 270. The sharp distal tip 314a of the hard needle 314 extends beyond the distal end of the cannula 270.

[0109] Figure 11A A cross-sectional view of some components of the inserter system 210 is shown before the cannula assembly 260 is attached to the patch assembly 230. Figure 11B A cross-sectional view of the cannula assembly 260 attached to the patch assembly 230 is shown. As described above, the hard needle 314 may be attached to the piston 312 or alternatively to a component driven by the piston 312, such as the platform 316 (in which case the hard needle 314 passes through the stop housing 318 and the retaining ring 319). When the cannula assembly 260 is attached to the patch assembly 230 ( Figure 11B ), the locking element 263 of the lower housing 262 of the cannula assembly 260 is engaged by the protrusion 245 on the inner surface of the wall or hub 244 of the patch mount 234, thereby locking the cannula assembly 260 to the patch assembly 230.

[0110] The following is a description of an exemplary implementation of a method of using a drug delivery system according to the present disclosure. The exemplary drug delivery system 100 is supplied to a user (e.g., a patient) in one or more parts. For example, the pump assembly 120 may be provided with a cartridge assembly 160 loaded into the controller module 130, or with a cartridge assembly 60 separate from the controller module 130. The inserter system 210 may be supplied as a component separate from the pump assembly 120 (or its components). The inserter system 210 may be supplied with a cannula assembly 260 loaded in the inserter device 300, and with the actuation mechanism (spring 304, trigger 306) of the inserter device 200 in a loaded state. The inserter system 210 may be supplied with an inserter device 300 connected to the patch assembly 230, for example, by locking elements 242, 322. Alternatively, the inserter system 210 may be supplied with an inserter device 300 separate from the patch assembly 230, and the user may connect the inserter device 200 to the patch assembly 230, for example, by locking elements 242, 322.

[0111] Figure 12A A partial exploded view of an exemplary inserter system 210 is shown, where the inserter device 300 is in a first position, where the tubular housing 302 is pivoted relative to the retainer 320 such that the tubular housing 302 is generally horizontal or parallel to the patch 232. The inserter device 300 is in its loaded state, where the cannula assembly 260 is loaded in the inserter device 200, and where the spring 304 is held compressed by the trigger 306. Whether supplied to the user or held by the user, the inserter device 300 is connected to the patch assembly 230, for example, by locking elements 242, 322. In the adhesion step, the patient peels the backing paper from the underside 232b of the patch 232 and adheres the patch 232 to the desired position on the patient's skin (e.g., abdomen, back, arm, shoulder, etc.).

[0112] Next, as Figure 12B shown, the patient moves the inserter device 300 to its second position by pivoting the tubular housing 302 relative to the retainer 320 until the tubular housing 302 is generally vertical or perpendicular to the patch 232. The adhesion step may be performed before or after the tubular housing 302 is positioned generally vertical or perpendicular to the patch 232, in which step the patient peels the backing paper from the underside 232b of the patch 232 and adheres the patch 232 to the desired position on the patient's skin.

[0113] In the case where the tubular housing 302 is positioned generally vertically or perpendicular to the patch 232, the patient presses the first end 306a of the trigger 306, which causes the trigger 306 to pivot about the fulcrum 306c and moves the second end 306b of the trigger to release the spring 304 from its compressed state. When released, the spring 304 drives the piston needle assembly 310 and the cannula assembly 260 distally until the cannula assembly 260 is locked to the patch assembly 230, for example, by the engagement of the locking element 263 with the locking element 245. Thus, by actuating the trigger 306, the patient initiates the cannula assembly 260 for deployment and locking to the patch assembly 230.

[0114] When the spring 304 drives the piston needle assembly 310 and the cannula assembly 260 distally, this force causes the sharp distal end 314a of the hard needle 314 to pierce the patient's skin. The spring 304 drives the hard needle 314 and the tubular distal end of the cannula 270 into the skin to a sufficient depth at which the drug can be effectively delivered from the distal end of the cannula 270 to the patient.

[0115] The forward movement of the piston needle assembly 310 and the cannula assembly 260 is stopped by the engagement of the cannula assembly housing 262 with the patch mount 234. Additionally or alternatively, the forward movement of the piston needle assembly 310 and the cannula assembly 260 can be stopped by the frictional resistance of the retaining ring 319 against the inner surface of the tube 302 and / or by a forced stop feature such as a stop flange on the inner side of the tube 302.

[0116] After the inserter device 300 has been actuated and the cannula 270 is inserted into the patient's skin and the cannula assembly 260 is engaged with the patch assembly 230, the patient can safely remove the inserter device 200. In the illustrated embodiment, the patient removes the inserter device 300 from the patch assembly 230 by rotating the inserter device 300 relative to the patch assembly 230 such that the locking element 322 disengages from the locking element 242. Then, the inserter device 300 can be removed, leaving the patch cannula assembly 220 (i.e., the patch assembly 230 engaged with the cannula assembly 260) adhered to the patient (see Figure 12C the reference numeral 220 in the drawings). The hard needle 314 is withdrawn from the cannula 270 and safely enclosed within the inserter device 300. The cannula 270 remains inserted in the patient's skin. The inserter device 300 can be recycled, discarded, or returned for sterilization and reuse.

[0117] Figure 12C An exemplary drug delivery system 100 is shown after deployment of the cannula assembly 260 and separation of the inserter device 300 from the patch cannula assembly 220. Figure 12D The underside of the patch cannula assembly 220 is shown after deployment of the cannula assembly 260. As Figure 12C andFigure 12D As shown, the cannula assembly 260 is engaged with the patch assembly 230, while the lower side of the patch 232 is adhered to the patient's skin, and the cannula 270 projects beyond the patch 232 and is inserted into the patient's skin.

[0118] With the patch cannula assembly 220 adhered to the patient and the cannula 270 in the drug delivery position, the patient can then mount the pump assembly 120 on the patch cannula assembly 220 to form the complete wearable drug delivery device 110. The cartridge assembly 160 can be supplied to the patient pre-filled with drug fluid, or the patient can fill the cartridge assembly 160 with drug fluid. To fill the cartridge assembly 160, the patient inverts the cartridge assembly 160 so that the fill port 168 is at the top. The patient holds a syringe (not shown) and typically fills the syringe with drug fluid from a vial (not shown) to a predetermined, indicated, or desired level. The patient removes the syringe filled with drug fluid and inserts the needle of the syringe through the fill septum 169 and the fill port 168 and into the chamber of the reservoir 164. The patient then dispenses the drug fluid from the syringe into the reservoir 164. During filling, the fluid outlet port 167 can serve as a vent to allow air to escape. Alternatively, one or more vents can be provided in the wall of the reservoir 164. Once the desired amount of drug fluid has been dispensed into the reservoir 164, the patient removes the needle of the syringe from the fill septum 169 and the fill port 168. The patient then attaches the filled cartridge assembly 160 to the controller module 130 to complete the pump assembly 120. In some embodiments, the connection of the cartridge assembly 130 that houses the battery 198 to the controller module 130 that houses the electronics connects the battery 198 to the electronics and "wakes up" or turns on the pump assembly 120.

[0119] The patient attaches the pump assembly 120 to the patch cannula assembly 220 by placing the pump assembly 120 on the patch cannula assembly 220 such that the ridge 236 of the patch mount 234 receives the ridge 136 of the controller module 130 and such that the ridge 238 of the patch mount 234 receives the ridge 138 of the controller module 30. The locking element 137 of the controller module 130 engages the locking element 237 of the patch mount 234 to secure the detachable pump assembly 120 to the patch cannula assembly 220. Figure 12E The assembled wearable drug delivery device 110 is shown, with certain components of the upper housing and the controller module removed to show the internal features of the pump assembly 120.

[0120] When the detachable pump assembly 120 is connected to the patch cannula assembly 220, the tube 166 from the reservoir 164 is aligned to dispense the medicament fluid from the reservoir 164 into the funnel 268 and the cannula 270. The tube 166 may pierce the septum 266 of the cannula assembly 260 such that the fluid outlet port 167 dispenses the medicament fluid into the funnel 268 and the cannula 270 and thus into the patient's body.

[0121] As described above, the electronics in the detachable pump assembly 120 may receive input data from an external source (e.g., from a smartphone, a tablet computer, a computer, or a remote source). This input data may include signals for controlling the functions of the wearable medicament delivery device and may include information such as the time, frequency, and amount of the dose to be administered.

[0122] The external source (smartphone, tablet computer, computer, etc.) may send this information to the detachable pump assembly 120 based on input from a doctor and / or a patient to an application or a computer program. Such input may be based on various factors such as medical condition, age, weight, lifestyle, expected activity, and / or any other relevant factors. The input may include a dosing regimen. The input may also include a function that allows the user to change the regimen (e.g., deliver an additional dose) under appropriate circumstances (e.g., based on expected activity, glucose level, etc.). The external source may also receive real-time or near real-time information from another source (e.g., from a glucose monitor) and may incorporate this information when determining the signals to send to the detachable pump assembly 120. As described above, the glucose monitor may be incorporated into the detachable pump assembly 120 or may be another device; in either case, the glucose monitor may communicate with the external source that sends signals to control the functions of the wearable medicament delivery device.

[0123] The external source (smartphone, tablet computer, computer, etc.) may also receive input from the wearable medicament delivery device. For example, it may receive information from a pressure sensor, an encoder, and / or one or more other sensors and / or a battery. The external source may use this input in a manner similar to that described above with respect to the electronics of the wearable medicament delivery device. For example, it may activate a signal when an occlusion, reservoir depletion, low battery, etc. is detected.

[0124] When attached to a patient, the wearable medicament delivery device 110 is used to automatically and periodically deliver the required amount of medicament to the patient. During operation, the various inputs described above are received, the dose is controlled, and the various signals described above may be activated based on the input and the programming.

[0125] Once the drug fluid in the cartridge assembly 160 is depleted (fully dispensed or below a certain level after dispensing), the patient can remove the cartridge assembly 160. The patient removes the pump assembly 20 from the patch cannula assembly 220 by unplugging the pump assembly 120 from the patch cannula assembly 220, such that the locking element 137 of the controller module 130 disengages from the locking element 237 of the patch mount 234. Then, the patient disengages the cartridge assembly 160 from the controller module 130. Then, the patient can discard the cartridge assembly 160. In some embodiments, if suitable for a particular drug and application, the patient can reuse the cartridge assembly by refilling the reservoir 164 with drug fluid (using a separate drug-filled vial and syringe) in the same manner as described above. Alternatively, the patient can obtain a new cartridge assembly 160 and fill the reservoir 164 with drug fluid as described above. Then, the patient connects the filled cartridge assembly 160 to the controller module 130 and attaches the pump assembly 120 to the patch cannula assembly 220 in the same manner as described above.

[0126] In certain embodiments, the controller module 130 can be reusable and the cartridge assembly 160 can be discarded after single use, or can be discarded after a certain number of refills or after a certain time. In one example, the controller module can be reused for 24 to 36 months or longer. In one example, a single cartridge assembly can hold enough drug fluid to last 3 - 7 days or longer. Other device lifetimes are possible.

[0127] The wearable drug delivery device disclosed herein can be used to deliver any suitable therapeutic drug for any suitable condition. In one example, the wearable drug delivery device disclosed herein can be used to deliver insulin to treat diabetes. Other drugs and conditions are possible, such as for treating or managing cholesterol, heart disease, high blood pressure, hormone levels, and many other possibilities.

[0128] The wearable drug delivery device disclosed herein can be adhered at any suitable location on the patient's skin. Examples include but are not limited to the patient's abdomen, shoulder, arm, and back.

[0129] In certain embodiments, compared to some existing patch pumps in commercial use, the reservoir of the cartridge assembly can have a wide, flat profile. This gives the reservoir a good fill volume and a low profile, which allows the entire pump device to have a low profile on the patient.

[0130] Thus, in some embodiments, the reservoir may have a larger cross-sectional area (the cross-sectional area is a cross-section taken along a plane perpendicular to the axis 165 of the reservoir) relative to some existing patch pumps. Similarly, the reservoir may have a relatively large diameter, width, or cross-sectional area (measured in a direction perpendicular to the axis 165 of the reservoir) compared to the height of the reservoir (measured in the direction of the axis 165 of the reservoir).

[0131] In the illustrated example, the threaded actuators 194, 196 are aligned along a central longitudinal axis 191 that is perpendicular to the general plane of the piston disk 180. The actuator axis 191 is arranged parallel to the reservoir axis 165. In the illustrated example, the actuator axis 191 is collinear with the reservoir axis 165; in other embodiments, the actuator axis 191 may be offset from the reservoir axis 165. The reservoir 164 has a cross-sectional area perpendicular to its axis 165. Although the reservoir may have any suitable dimensions, in some embodiments, the diameter, width, or cross-sectional area of the reservoir (measured perpendicular to the reservoir axis 165) may be relatively large compared to the height of the reservoir (measured along the reservoir axis 165). For example, in some examples, the inner width or diameter of the storage chamber may be in the range of 0.70 inches to 1.20 inches, and the depth of the storage chamber may be in the range of 0.20 inches to 0.35 inches, such as 0.22 inches to 0.25 inches. Thus, in certain embodiments, the ratio of the diameter or width of the storage chamber to the depth of the storage chamber may be 2:1 or greater, 3:1 or greater, 4:1 or greater, 5:1 or greater, or 6:1 or greater. This results in a wide, flat profile, which has a good fill volume capacity. Although the fill volume capacity of the reservoir may be any suitable fill volume, in some examples, the reservoir volume is in the range of 1 ml to 3 ml. Other volumes are possible.

[0132] In certain embodiments (such as the reservoir 164), the reservoir has a relatively large diameter, width, or cross-sectional area compared to the height of the reservoir, and the reservoir may be oriented in the device such that the reservoir axis 165 is parallel to the cannula axis 271. In certain embodiments, the reservoir axis 165 may be collinear with the cannula axis 271. Thus, when the pump is mounted on a patient, the reservoir axis 165 is vertically aligned (or perpendicular) with the patch adhered to the patient's skin. This is contrary to some existing devices in which the axis of the reservoir is perpendicular to the cannula axis and horizontal (or parallel) to the patient's skin. In the case where the reservoir axis 165 is arranged parallel to the cannula axis 271, or perpendicular to (or vertical to) the patch on the patient's skin, the actuator axis 191 may also be arranged parallel to the cannula axis 271, or perpendicular to (vertical to) the patch on the patient's skin.

[0133] With the above directions and relative dimensions, the reservoir can have a broad, flat profile on the patient's body. This can be analogized to a hockey puck shape, a pancake shape, a disc shape, a flat shape, or a planar shape lying flat on the patient's skin.

[0134] Reservoirs with large cross-sectional areas and broad, flat profiles can pose challenges in maintaining the accuracy, precision, and consistency of drug delivery. In some embodiments, the inventions disclosed herein include the use of certain novel aspects to address these challenges. These novel aspects include those related to materials and manufacturing, which are significantly different from certain existing patch pumps in commercial use.

[0135] Thus, in certain embodiments of the present invention, the reservoir of the cartridge assembly can be made of thin metal sheets using the precision manufacturing techniques disclosed herein. Previously, patch pumps have employed injection-molded plastic reservoirs, and in some embodiments of the present disclosure, the reservoir can be made of injection-molded plastic. However, in some embodiments of the present disclosure, precision manufacturing of metal sheets can be used, and this material and manufacturing are particularly advantageous for drug reservoirs of the size and shape described herein. If desired, the metal sheet can be coated with a coating compatible with the intended drug (e.g., insulin).

[0136] According to some embodiments of the present disclosure, the reservoir can be manufactured using a metal deep drawing process. This process can include using a progressive die that continuously forms the metal in a series of steps from a sheet to the final shape. Such a deep drawing process allows for the precise formation of reservoir features, such as ribs on the inner side of the reservoir wall, to tight tolerances. The ribs serve as guides to help prevent the piston disk from tilting during fluid dispensing. The precision manufacturing of the ribs facilitates precise drug delivery. The deep drawing process also facilitates the formation of a microtube at the bottom of the storage chamber. Other metal manufacturing techniques can be used, such as metal forming, stamping, chemical etching, electrical discharge machining, laser cutting, laser welding, hot isostatic pressing, metal injection molding, 3D printing, or other metal manufacturing processes capable of consistently creating complex features on small metal parts with high accuracy, high precision, and tight tolerances. Metal manufacturing techniques allow for the use of certain automated manufacturing processes, which include, for example, during the preparation of the raw metal material, coating, stamping, deep drawing, and laser welding. Such automated manufacturing processes can reduce manufacturing costs.

[0137] The use and manufacturing of the thin metal sheets disclosed herein can result in the reservoirs disclosed herein, which have a low profile and a good fill volume, enabling accurate, precise, and continuous drug delivery. The materials and manufacturing disclosed herein can achieve tolerances of 0.0005 inches or better, or in some cases 0.0002 inches or better. The tolerances achievable with the materials and manufacturing disclosed herein generally could not be achieved previously with plastic injection-molded reservoirs in certain existing wearable patch pumps.

[0138] Other novel aspects that can be employed to facilitate the use of a reservoir having a large cross-sectional area and a wide, flat profile relate to actuator assemblies. A reservoir with a large cross-sectional area may require a piston disk with a relatively large diameter or width. A large piston disk may require a large contact engagement between the seal at the perimeter of the piston disk and the inner wall of the reservoir. This increases friction and resistance to movement. The large piston disk and associated features can make the piston disk prone to tilting, and drug delivery can be inaccurate, imprecise, or inconsistent.

[0139] In some embodiments, a large-diameter threaded actuator is used, which helps prevent tilting of the piston disk. For example, in some embodiments, the ratio of the diameter of the threaded actuator attached to the piston disk to the width or diameter of the storage chamber can be from 1:4 to 1:2 or 2:3. That is, the diameter of the threaded actuator attached to the piston disk can be one-quarter to one-half or two-thirds of the diameter or width of the storage chamber. In alternative embodiments, the diameter of the threaded actuator attached to the piston disk can be one-quarter or more of the diameter or width of the storage chamber. In alternative embodiments, the diameter of the threaded actuator attached to the piston disk can be one-half or more of the diameter or width of the storage chamber. In alternative embodiments, the diameter of the threaded actuator attached to the piston disk can be two-thirds or more of the diameter or width of the storage chamber. One example is a piston disk diameter of 1.0 inch (corresponding to a storage chamber diameter or width of approximately 1.0 inch) and a threaded actuator diameter of 0.25 inch to 0.50 inch or 0.60 inch or 0.65 inch. Other sizes and ratios are possible. Using a large threaded actuator diameter facilitates increased precision in the axial direction when used with a large-diameter piston disk. Using a large threaded actuator diameter helps prevent tilting of the piston disk during fluid dispensing.

[0140] Using a large-diameter threaded actuator is also advantageous because the lower threaded actuator can be directly mounted to the piston disk without the need for any additional devices or components to support the threaded actuator in a truly centered position relative to the center of the piston disk. Similarly, the upper threaded actuator can be directly mounted to the gear. The threaded actuator can be directly welded (e.g., tack welded or spot welded) or otherwise bonded or adhered (e.g., with epoxy) to the piston disk and / or gear by any suitable technique (e.g., resistance welding, laser welding, ultrasonic welding, and / or thermal welding). In some alternative embodiments, one or more additional components can be used to attach or support the threaded actuator to or on the piston disk and / or gear, or to attach or support the threaded actuator relative to the piston disk and / or gear.

[0141] While large-diameter threaded actuators can have the above advantages, they also increase the threaded contact area, thereby increasing the friction that the actuator assembly has to overcome. This resistance and the resistance from the seals around the large piston disk create a significant force that the actuator driver has to overcome. Accordingly, in certain embodiments herein, the electromechanical drive system 140 employs a worm gear 144. This worm gear system provides higher torque in a compact area. The electromechanical drive system 140 with the worm gear 144 can help prevent the threaded actuator assembly from engaging with the gear motor during rotation. In certain embodiments herein, a large-capacity, low-profile reservoir can be combined with a small motor with high torque. The features described herein facilitate the realization of a low-profile device with precise drug delivery.

[0142] In addition, in certain embodiments, the threaded actuator is provided with precision fine threads, which facilitate the small and precise movement of the piston disk for precise drug delivery. In some embodiments, the first threaded actuator 194 and the second threaded actuator 196 can have precision fine threads with a density of 80 threads per inch (tpi) or more, 100 tpi or more, 300 tpi or more, 450 tpi or more, or 500 tpi or more. The first threaded actuator 194 and the second threaded actuator 196 can be made of any suitable material such as metals (e.g., carbon, stainless steel, cobalt, brass, titanium), plastics, etc.

[0143] Another feature that can be employed in certain embodiments is that the pump housing (the housing of the controller module) can be wholly or partially translucent or transparent, such as transparent plastic. Works can be laminated, printed, engraved, etched, laser engraved, and / or molded onto the inner surface of the housing. The controller module housing can also be a separate transparent / clear housing so that the internal workings and / or internal works of the device can be seen. This can enhance the aesthetics of the device and avoid external decoration or works that may be scratched or damaged, thereby increasing user compliance in wearing the device. In alternative embodiments, the pump housing is decorated with works and has a solid color, multicolor, or any other aesthetically suitable appearance.

[0144] In an exemplary embodiment, the outer diameter of the controller module can be about 2.0 inches or less, such as 1.7 to 1.8 inches, and the height of the controller module can be about 0.8 inches or less, such as 0.5 to 0.7 inches. The wall thickness of the controller housing can be about 0.040 inches to about 0.060 inches. The inserter device housing can have a diameter of about 0.25 inches. Many other dimensions are possible.

[0145] The components of the drug delivery system as described above can be manufactured from any suitable materials including polymers and metals such as stainless steel and titanium. Any suitable manufacturing process can be used. For example, the controller module housing, the cartridge assembly housing, the reservoir, and / or the patch mount can be injection molded or thermoformed or vacuum formed or 3D printed from a suitable plastic material. Any diaphragm can be an elastomer, such as silicone or rubber. The funnel of the cannula assembly can be metallic. The hard needle can be stainless steel or other metal. The cannula or the soft needle can be polymeric. Many other variations are possible.

[0146] Embodiments of the systems, devices, components, or methods within the scope of this disclosure may have one or more advantages, such as but not limited to: small size, small footprint, low profile, flat profile, light weight, large internal volume of the reservoir, aesthetic appearance, wear resistance, no external tubing outside the device housing, ease of use, easy to use, accurate drug delivery, precise drug delivery, consistent drug delivery, low cost, mass manufacturability, and economic manufacturability. Embodiments of the wearable drug delivery device (wearable infusion cannula patch pump) can be small, unobtrusive, discreet, and inconspicuous, thus bringing advantages in comfort, aesthetics, use, and compliance. Embodiments can have a low profile while maintaining a large-capacity reservoir and the accuracy, precision, and persistence of drug delivery.

[0147] Those of ordinary skill in the art will understand that the embodiments covered by this disclosure and the claims are not limited to the exemplary embodiments shown and described above. As will be understood by those of ordinary skill in the art, many other variations, modifications, changes, and substitutions are possible and contemplated within the scope of this disclosure and the claims.

[0148] Cross - reference to related applications

[0149] This application claims the priority of U.S. Provisional Patent Application No. 63 / 613229, entitled "Wearable Drug Delivery Device", filed on December 21, 2023, the entire content of which is incorporated herein by reference.

Claims

1. A wearable drug delivery device, comprising: a detachable pump assembly, the detachable pump assembly comprising a cartridge assembly and a controller module; SMD components; and a casing assembly, the casing assembly comprising a casing having a casing axis; wherein the cartridge assembly includes a reservoir having a storage chamber and a reservoir axis; wherein the reservoir is oriented in the cartridge assembly such that the reservoir axis is aligned parallel to the cannula axis when the removable pump assembly is attached to the patch assembly.

2. The wearable drug delivery device according to claim 1, wherein: The ratio of the diameter or width of the storage chamber to the depth of the storage chamber is 2:1 or greater.

3. The wearable drug delivery device according to claim 1, wherein: The controller module has a translucent or transparent housing.

4. The wearable drug delivery device of claim 1, further comprising an encoder.

5. The wearable drug delivery device of claim 1, further comprising a pressure sensor.

6. A wearable pump assembly, comprising: Cartridge assembly; and Controller module; Wherein, the cartridge assembly comprises a reservoir; Wherein, the storage is made of metal plate.

7. The wearable pump assembly of claim 6, wherein: The reservoir is manufactured using a deep drawing process.

8. The wearable pump assembly of claim 6, wherein: The reservoir includes one or more internal ribs.

9. The wearable pump assembly of claim 8, further comprising a piston disc, wherein: The piston disc has one or more recesses for receiving the one or more internal ribs of the reservoir.

10. The wearable pump assembly of claim 9, further comprising a sealing gasket around a periphery of the piston disc, wherein: The sealing gasket has one or more recesses for receiving the one or more internal ribs of the reservoir.

11. A wearable pump assembly, comprising: Cartridge assembly; and Controller module; wherein the cartridge assembly includes a reservoir having a storage chamber, a piston disc, and an actuator assembly having a threaded actuator attached to the piston disc; Wherein, the diameter of the threaded actuator attached to the piston disc is one quarter or more of the diameter or width of the reservoir chamber.

12. The wearable pump assembly of claim 11, further comprising an actuator retainer for maintaining alignment of the actuator assembly.

13. The wearable pump assembly of claim 11, further comprising a drive system having a worm gear for driving the actuator assembly.

14. The wearable pump assembly of claim 11, wherein: The threaded actuator has a thread density of 80 threads per inch or more.

15. The wearable pump assembly of claim 11, wherein: The threaded actuator attached to the piston disc has a diameter that is half or more of the diameter or width of the reservoir chamber.

16. An inserter system for a drug delivery system, the inserter system comprising: inserter device; and A cannula assembly is loaded into the inserter device.

17. The inserter system of claim 16, wherein: The interposer device includes a holder adapted to be selectively attached to a patch assembly.

18. The inserter system of claim 17, wherein: The inserter device is adapted to activate the cannula assembly such that the cannula assembly is connected to the patch assembly.

19. A method of manufacturing a drug delivery system or a component for a drug delivery system according to the present disclosure.

20. A method of using a drug delivery system or a component for a drug delivery system according to the present disclosure.

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