Wearable drug delivery device, wearable pump assembly and inserter system

Abstract

The utility model 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 of manufacturing, assembling, and using wearable drug delivery devices and drug delivery systems including an inserter system for a wearable drug delivery device. BACKGROUND

[0002] Wearable drug delivery devices are widely used. For example, such devices in the form of wearable drug delivery pumps are commonly used to automatically, controllably deliver insulin to patients with Type 1 or Type 2 diabetes.

[0003] Wearable drug delivery pumps can provide greater lifestyle flexibility compared to multiple daily injections with a pen or syringe. They can provide potentially better therapeutic control. For example, in the case of diabetes, they can provide potentially tighter glycemic control without increasing the risk of hypoglycemia, seizures, coma, or even death.

[0004] Current or previously used wearable drug delivery pumps often have one or more drawbacks. For example, some wearable drug delivery pumps have a controller housing that is attached to a patient’s body and one or more external tubes that extend from the housing to a patch at an infusion site. Other wearable drug delivery pumps are bulky even without tubes. Existing designs can be inconvenient to deploy or wear and can be uncomfortable and unattractive.

[0005] Current or previously used wearable drug delivery pumps can also have other drawbacks. For example, such existing devices can 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 wearability, external tubes, inconvenient to use, difficult to use, poor drug delivery accuracy, poor drug delivery consistency, high cost, and / or difficult or expensive to manufacture. SUMMARY

[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 reservoir chamber and a reservoir axis. The reservoir is 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 can have a wide, flat, low profile. For example, the ratio of the diameter or width of the reservoir to the depth of the reservoir can be 2: 1 or more.

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

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

[0010] In some embodiments, the reservoir includes one or more internal ribs. The wearable pump assembly further includes a piston disc that can have one or more notches for accommodating the one or more internal ribs of the reservoir. The wearable pump assembly further includes a sealing gasket around the perimeter of the piston disc, which can have one or more notches for accommodating the one or more internal ribs of the reservoir.

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

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

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

[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 can include a holder adapted to be selectively attached to a patch assembly. The inserter device is adapted to initiate the cannula assembly so that the cannula assembly is connected 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 DRAWINGS

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

[0018] FIG. 2A A top view of a cartridge assembly of an exemplary embodiment of FIG. 1 is shown.

[0019] FIG. 2B A bottom view of a cartridge assembly of an exemplary embodiment of FIG. 1 is shown.

[0020] FIG. 2C A perspective view of a cartridge assembly of an exemplary embodiment of FIG. 1 is shown.

[0021] FIG. 2D Another perspective view of a cartridge assembly of an exemplary embodiment of FIG. 1 is shown.

[0022] FIG. 2E Another perspective view of a cartridge assembly of an exemplary embodiment of FIG. 1 is shown.

[0023] FIG. 3 An exploded view of a cartridge assembly of an exemplary embodiment of FIG. 1 is shown.

[0024] FIG. 4A An exploded view of some of the components of a cartridge assembly of an exemplary embodiment of FIG. 1 is shown, with certain components oriented to show certain features.

[0025] FIG. 4B Another exploded view of some of the components of a cartridge assembly of an exemplary embodiment of FIG. 1 is shown.

[0026] FIG. 4C A perspective view of some of the components of a cartridge assembly of an exemplary embodiment of FIG. 1 is shown.

[0027] FIG. 4D A perspective view of some of the components of a cartridge assembly of an exemplary embodiment of FIG. 1 is also shown.

[0028] FIG. 5A A perspective view of some of the components of a cartridge assembly of an exemplary embodiment of FIG. 1a top view of the reservoir of the cartridge assembly of the example embodiment.

[0029] FIG. 5B a side view of the reservoir of the cartridge assembly of the example embodiment is shown. FIG. 1

[0030] FIG. 5C a perspective view of the reservoir of the cartridge assembly of the example embodiment is shown, generally from the bottom. FIG. 1

[0031] FIG. 5D a side view of the reservoir with the piston disk is shown.

[0032] FIG. 6A a perspective view of the controller module of the example embodiment is shown, with the upper housing separated from the rest of the components. FIG. 1

[0033] a perspective view of the controller module of the example embodiment is shown, generally from the bottom. FIG. 6B FIG. 1

[0034] the interior of the upper housing of the controller module of the example embodiment is shown. FIG. 6C FIG. 1 a perspective view of the components of the example embodiment is shown, showing the positioning of the cartridge assembly within the controller module.

[0035] FIG. 7A FIG. 1 a perspective view of the components of the example embodiment is shown, showing the positioning of the cartridge assembly within the controller module, with certain components of the controller module separated from the rest of the components.

[0036] FIG. 7B a perspective view of the components of the example embodiment is shown, with the lower housing of the controller module removed. FIG. 1

[0037] a perspective view of the components of the example embodiment is shown, with the lower housing of the controller module removed. FIG. 7C FIG. 1 a perspective view of the lower housing of the controller module of the example embodiment is shown, generally from the bottom.

[0038] FIG. 8A FIG. 1 a perspective view of the patch assembly of the example embodiment of the wearable drug delivery device is shown, generally from the top.

[0039] FIG. 8B a perspective view of the patch assembly of the example embodiment of the wearable drug delivery device is shown, generally from the top. FIG. 1

[0040] ​​​​​​​​FIG. 8C A top view of a patch assembly of FIG. 8B is shown.

[0041] FIG. 8D A top view of a patch assembly of FIG. 8B to FIG. 8C is shown.

[0042] FIG. 9A An exemplary embodiment of certain components of an inserter system is shown.

[0043] FIG. 9B Another view of an exemplary embodiment of FIG. 9A is shown.

[0044] FIG. 9C A bottom view of a retainer component of an embodiment of FIG. 9A is shown.

[0045] FIG. 10A An exploded view of certain components of an exemplary embodiment of FIG. 9A is shown.

[0046] FIG. 10B An exemplary embodiment of a cannula assembly of a wearable drug delivery device is shown, which can be used with a patch assembly of FIG. 8B to FIG. 8C and a detachable pump assembly of FIG. 1 .

[0047] FIG. 11A A cross-sectional view of certain components of an exemplary inserter system of FIG. 9A is shown, prior to attachment of the cannula assembly to the patch assembly.

[0048] FIG. 11B A cross-sectional view of the cannula assembly of FIG. 11A attached to a patch assembly is shown.

[0049] FIG. 12A A partial exploded view of an exemplary inserter system is shown, with the inserter device in a first position.

[0050] FIG. 12B A perspective view of an exemplary inserter system of FIG. 12A is shown, with the inserter device in a second position.

[0051] FIG. 12C An exemplary drug delivery system is shown, after deployment of the cannula assembly and separation of the inserter device from the patch cannula assembly.

[0052] FIG. 12D The underside of the patch cannula assembly is shown, after deployment of the cannula assembly.

[0053] FIG. 12EAn assembled wearable drug delivery device is shown, with certain components of the upper housing and controller module removed. DETAILED DESCRIPTION

[0054] The following is a detailed description of the illustrated embodiments and certain variations thereof. As those skilled in the art will appreciate, 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 can be supplied to a user (patient, healthcare professional, etc.) in the form of (i) an inserter system including an inserter device, a cannula assembly loaded in the inserter device, and a patch assembly attached to (or attachable to) the inserter device; and (ii) a detachable pump assembly (assembled or as components suitable for assembly). The inserter device can be used to facilitate placement of the patch assembly on a patient, and to activate the cannula assembly so that a cannula of the cannula assembly is inserted through the patient's skin and into the patient's body, and so that the cannula assembly is connected with the patch assembly. Components of the detachable pump assembly can include a cartridge assembly and a controller module. The cartridge assembly and the controller module can be supplied to the user as separate components, or can be assembled together as the detachable pump assembly. Once the inserter device has been used to place the patch assembly on a patient and to activate the cannula assembly so that the cannula is inserted into the patient's body, the inserter device can 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] FIG. 1 Components of an exemplary embodiment of a detachable pump assembly 120 of an exemplary wearable drug delivery device 110 are shown (see FIG. 12C ). The illustrated detachable pump assembly 120 includes a controller module 130 and a cartridge assembly 160.

[0057] FIG. 2A A top view of the cartridge assembly 160 of an exemplary embodiment of FIG. 1 is shown. FIG. 2B A bottom view of the cartridge assembly 160 is shown. FIG. 2C to FIG. 2E A perspective view of the cartridge assembly 160 is shown.

[0058] FIG. 3 An exploded view of the cartridge assembly 160 is shown. FIG. 4A and FIG. 4B An exploded view of some of the components of the cartridge assembly 160 is shown, with certain components oriented to show certain features. FIG. 4C andFIG. 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 components of the cartridge assembly 160 are located. The cartridge assembly 160 includes a reservoir 164 located within the housing.

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

[0061] The top of the reservoir 164 has an opening that accommodates a movable piston, which, in the illustrated embodiment, is disc-shaped. In the illustrated... FIG. 4D In this embodiment, the piston disc 180 is a thin, flat disc. The piston disc 180 may be located in a plane, or it may be slightly domed or convex to conform to the shape of the bottom wall 164b of the reservoir 164 (described below). The piston disc 180 has a sealing gasket 184 surrounding its outer periphery. When assembled, the sealing gasket 184 forms a seal with the inner wall of the reservoir 164, such that the reservoir 164, the piston disc 180, and the sealing gasket 184 form a closed drug fluid chamber that opens only at the fluid outlet port 167 (described below, the filling port 168 is kept closed by a filling diaphragm 169, but the filling port 168 allows passage into the reservoir 164 for filling).

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

[0063] The piston disk 180 can have one or more notches 181 at its outer edge. The sealing gasket 184 can correspondingly have one or more notches 185 that correspond to the notches 181 of the piston disk 180. As described below, the notches 181, 185 accommodate the interior rib 170 of the reservoir 164.

[0064] The piston disk 180 advances in the reservoir 164 to dispense the drug fluid to the patient by action of the actuator assembly 190. The actuator assembly 190 includes a gear 192, in the illustrated embodiment in the form of a disc gear, also known as a spur gear or a cogwheel, having gear teeth around its outer periphery. The gear 192 is connected to a first threaded actuator 194, in the illustrated embodiment a female threaded tube, i.e., a tube having helical threads 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 helical threads along its outer surface. When assembled, the rod is mounted within the tube with the outer threads of the rod in threaded engagement with the inner threads of the tube. In alternative embodiments, the female and male threaded actuators are reversed, such that the first threaded actuator connected to the gear 192 is a male threaded rod and the second threaded actuator connected to the piston disk 180 is a female threaded tube.

[0065] As described in more detail below, each of the threaded elements of the actuator assembly 190, i.e., the first threaded actuator 194 and the second threaded actuator 196, has very precise, fine helical threads. 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 example cartridge assembly 160 also has an actuator holder 172 that is used to maintain the positioning and alignment of the components of the actuator assembly 190. In this example, the actuator assembly components are aligned vertically with respect to the piston disk 180. The first threaded actuator 194 and the second threaded actuator 196 are aligned along a central longitudinal axis, i.e., axis 191, that passes 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 holder 172 helps maintain the components of the actuator assembly 190 aligned so 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 holder 172 is a bracket having a center plate 173, an extension 174, and an opening 175 in the center plate 173. When the cartridge assembly 160 is assembled, the extension 174 is supported relative to the housing 162 such that the actuator holder 172 remains stable. The actuator assembly 190 is positioned within the opening 175 in the center plate 173 such that it is supported by the edge of the center plate 173 around the opening 175. In this manner, the actuator holder 172 helps to keep the components of the actuator assembly 190 aligned such that the axis 191 is aligned with the axis 165 of the reservoir 164. Thus, the actuator holder 172 precisely supports the axial (vertical) directional alignment and movement of the first and second 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 holder 172 can also help to hold the actuator assembly 190 together. In some embodiments, the center plate 173 of the actuator holder 172 can act as a support underneath the gear 192. Thus, the actuator holder 172 can help to resist downward external pressure acting on the actuator assembly 190 as well as unwanted dispensing of the medicament fluid from the reservoir 164. For example, the actuator holder 172 can resist external pressure, such as during an aircraft flight, which can cause unwanted movement of the actuator assembly 190.

[0069] In the illustrated embodiment, the example cartridge assembly 160 also includes an encoder 176 that moves with the gear 192. The encoder 176 can be a disk that is connected to the gear 192. The encoder 176 has markings in the form of flags, electromagnetic elements, optical elements, or the like that can be detected by the encoder reader 156 to provide feedback regarding the movement and / or position of the actuator and the corresponding piston disk 180. While the encoder 176 can be a disk that is connected to the gear 192, in alternative embodiments, the encoder 176 can be markings directly on the gear 192 or on the first threaded actuator 194 or another rotating portion 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, 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 position of the piston disk 180 and / or allowing for correction of the position of the piston disk 180).

[0070] In the illustrated embodiment, the example cartridge assembly 160 can also include a pressure sensor 178. The pressure sensor 178 can 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 fluid outlet port 167 or other occlusion or problem with the fluid exiting the reservoir 164, or if the piston disk 180 reaches the bottom of the reservoir 164, further actuation of the actuator assembly 190 and movement restriction of the piston disk 180 will create an upward force on the actuator assembly 190. The pressure sensor 178 can detect this force to detect the occlusion (or other problem). In some embodiments, the pressure sensor 178 contacts the disk gear, i.e., one side of the gear 192. In other embodiments, one or more components can be located between the pressure sensor 178 and the gear 192 or other components of the actuator assembly 190.

[0071] The example cartridge assembly 160 can also include a battery 198. The battery 198 can be a component of the cartridge assembly 160 and / or the controller module 130. The battery 198 provides power as needed, e.g., to drive the actuator assembly and / or for one or more sensors / readers (e.g., an encoder, a pressure sensor, etc. and / or associated readers).

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

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

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

[0075] As illustrated in the figures, the example 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 that are assembled together to form the housing 132. The lower housing 132b has an opening 134 for placing the controller module 130 over the cartridge assembly 160 to connect the controller module 30 and the cartridge assembly 160 together.

[0076] The example 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 gear 144. In this example, the gear 144 is a worm gear that 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 can be used to drive the actuator assembly 190.

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

[0078] In the illustrated implementation, the example controller module 130 can also include a pressure sensor 158, which can be used in addition to or instead of the pressure sensor 178. Like the pressure sensor 178, the pressure sensor 158 can be positioned to sense the upward force on the actuator assembly 190. As described above, the pressure sensor 158 can be positioned similarly to the pressure sensor 178. One or more wires or connections 159 can connect the pressure sensors 158, 178 to the PCBA 146.

[0079] The microcontroller or other electronics on the PCBA 146 can be programmed to correlate detected electrical signals (voltage) from the pressure sensors 158, 178 to corresponding relevant pressures, and to send one or more signals when the detected pressure is outside of a certain range. For example, pressure exceeding a programmed maximum pressure can indicate that an occlusion is blocking or restricting the outflow of drug fluid, or that the piston disk has reached the bottom of the reservoir, or that some malfunction has occurred. When a pressure exceeding the programmed maximum pressure is detected, the microcontroller or other electronics can activate one or more signals, such as sounding a buzzer or other alarm in the device, illuminating or flashing one or more lights (LEDs) on the device, and / or activating a vibration mechanism in the device to vibrate the device. The maximum pressure threshold can be programmed to 10 grams, 12 grams, 15 grams, or other amount of force, for example, depending on the embodiment and application.

[0080] The example controller module 130 can also include an encoder reader 156 or detector. 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 so that it can read the encoder 176 when the cartridge assembly 160 is assembled within the controller module 130. One or more wires or connections 157 can electrically connect the encoder reader 156 to the PCBA 146.

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

[0082] During operation of the wearable drug delivery device, dispensing of the drug fluid can be open loop or closed loop. In an open loop implementation, the electronics receive information about the amount of drug fluid to be dispensed at a particular dose, and then send a signal to the motor 142 for the motor to move by an amount corresponding to the amount of drug fluid to be dispensed. In a closed loop implementation, the electronics receive information about the amount of drug fluid to be dispensed at a particular dose, and then send a signal to the motor 142 for the motor to move to dispense the drug fluid, with feedback signals from the encoder reader 156 providing information about how far the actuator assembly 190 has moved. When these feedback signals indicate that the expected amount of drug fluid has been dispensed, the electronics stop the drive to the motor 142. In some implementations, the encoder reader 156 and the encoder 176 can also be used to determine the total amount of drug fluid dispensed from the reservoir 164, and when the drug fluid in the reservoir 164 has been (or is about to be) depleted, the electronics can use this information to activate one or more signals, as described above (e.g., sounding a buzzer or other alarm in the device, illuminating 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 can also receive input data from the battery, such as detecting the battery charge. The electronics can send a signal (e.g., sound, light, vibration) to indicate that the battery charge is low. The electronics can also send a signal when they detect a fault (e.g., the motor does not move, or the actuator motion detected from the encoder does not match the expected amount of motor motion based on the drive signals 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, tablet, computer, or 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 that is connected to the PCBA 146. In one example, a trace on the PCBA 146 constitutes 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 drug fluid to the patient (e.g., determine a dose, determine a dose time, dispense an additional dose, withhold a dose, etc.).

[0086] FIG. 7A An exploded view of the components of the example detachable pump assembly 120 is shown, illustrating the positioning of the cartridge assembly 160 within the controller module 130. FIG. 7B A perspective view of the detachable pump assembly 120 is shown, including the cartridge assembly 160 within the controller module 130, with certain components of the controller module 130 separated from the remaining components. FIG. 7C A perspective view is shown with the lower housing 132b of the controller module 130 removed.

[0087] In the illustrated embodiment, the opening 134 in the housing 132 of the controller module 130 is shaped and sized 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, with a circular portion (where the reservoir 164 is located) and a narrower width projection extending from the circular portion. Many other shapes are possible in alternative variations.

[0088] The cartridge assembly 160 and / or the controller module 130 can include a locking element (not shown) that holds the cartridge assembly 160 with 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 a locking element can include, but is not limited to, a resilient tab, a slot, an opening, a snap, etc.

[0089] When the cartridge assembly 160 is assembled within the controller module 130, the actuator assembly 190 is aligned with the electromechanical drive system 140 so that the electromechanical 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 is engaged with the gear 144 of the electromechanical drive system 140. That is, the helical threads of the worm gear are engaged with the teeth of the gear 192, thereby driving the worm gear to rotate the gear 192.

[0090] Similarly, other components can be aligned when the cartridge assembly 160 is assembled within the controller module 130, 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 adjacent to or above the encoder 176 so that the encoder reader 156 can read the encoder 176. Further, as described above, when the cartridge assembly 160 is assembled within the controller module 130, the pressure sensor 158 and / or the pressure sensor 178 are positioned to sense the upward force on the actuator assembly 190.

[0091] FIG. 8A A view of the bottom of the lower housing 132b of the controller module 130 is shown. Certain details visible in certain other figures have been omitted for clarity FIG. 8A from certain other figures. As FIG. 8AAs can be seen, the lower housing 132b has a raised ridge 136 in the form of a wall or lip located near or around the opening 134. The ridge 136 includes a locking element 137 that cooperates with a locking element 237 of the ridge 236 of the patch assembly 230 (described below) 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. Such locking elements can include, but are not limited to, resilient tabs, slots, openings, snaps, and the like. In the illustrated embodiment, the locking element 137 is a tab (which can be resilient and / or configured to be a press or interference fit, for example) and the locking element 237 is an opening configured to receive the tab. When the detachable pump assembly 120 is pressed into place on the patch assembly 230 with sufficient force, the tab snaps into the opening and holds the detachable pump assembly 120 secured to the patch assembly 230. The detachable pump assembly 120 can be removed from the patch assembly 230 by applying sufficient upward force on the detachable pump assembly 120 while holding the patch assembly 230, thereby pulling the tab out of the opening 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., twist, etc.) between the detachable pump assembly 120 and the patch assembly 230 can be used.

[0092] As FIG. 8A As can be seen, the lower housing 132b also has a raised ridge 138 in the form of a wall or lip located near or around the lower perimeter of the lower housing 132b. The ridge 138 cooperates with a ridge 238 on the patch assembly 230 to facilitate proper placement of the detachable 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 detachable pump assembly 120. Using a rounded profile with rounded ridges (e.g., the 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 side, outer side, and / or top of the ridges) to facilitate sealing.

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

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

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

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

[0097] As described below, the patch assembly 230 can also include a locking element 242 to facilitate securing the patch assembly 230 to the inserter device. The locking element 242 can be located on the floor 240 of the patch mount 234. In the illustrated embodiment, the locking element 242 is in the form of a stud, wherein it has a shaft 242a that protrudes upwardly from the floor 240 of the patch mount 234 and a head 242b. Other variations of the locking element 242 are possible.

[0098] In the illustrated embodiment, the floor 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, although other shapes are possible. A locking element in the form of a protrusion, i.e., a bump 245, facing inwardly from the inner surface of the wall or hub 244 facilitates retaining the cannula assembly 260.

[0099] FIG. 9A and FIG. 9B An example embodiment of certain components of the inserter system 210 is shown (see, e.g., FIG. 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. FIG. 9C A bottom view of the retainer component 320 of the inserter device 300 is shown.

[0100] As shown in FIG. 9A and FIG. 9B , the inserter device 300 includes a housing 302, which in the illustrated embodiment is in the form of a tube, i.e., a tubular housing. The inserter device 300 includes a retainer component 320 that is attached to the distal end of the housing 302 such that the housing 302 can pivot relative to the retainer component 320. In the illustrated embodiment, the housing 302 has a laterally extending connection element, e.g., a tab or lug 308, that connects with a corresponding connection element, e.g., a recess, slot or opening 324, in the wall of the retainer component 320.

[0101] As shown in FIG. 9CAs shown, the retainer component 320 has a locking element 322, which may be located in or on the bottom surface of the retainer component 320. The locking element 322 cooperates with the locking element 242 of the patch assembly 230 to allow the inserter device 300 to connect to and disconnect from the patch assembly 230. In the illustrated example, the locking element 322 is a keyhole or shaped opening that includes a slot with an enlarged region at one end. The locking element 242 or key of the patch assembly 230 is shaped such that the head 242b of the stud can be fitted through the enlarged region of the keyhole but not through the narrow portion of the slot. By placing the enlarged opening of the locking element 322 on the stud and then rotating the inserter device 300, the inserter device 300 connects to the patch assembly 230 such that the head 242b of the stud is locked in place behind the narrow portion of the slot. By reversing the operation, the inserter device 300 disconnects from the patch assembly 230. Many other variations of the locking element are possible to allow the inserter device 300 to connect to and disconnect from the patch assembly 230. In the illustrated embodiment, the retainer component 320 has three locking elements 322 equidistantly spaced in 120-degree increments; however, any suitable number and position of locking elements 322 can be used.

[0102] FIG. 10A An exploded view of some components of an exemplary inserter system 210 is shown. The inserter device 300 includes a housing 302, a retainer component 320, and... FIG. 10A (Not shown in the diagram), spring 304, trigger 306, and piston needle assembly 310. Piston needle assembly 310 includes piston 312, hard needle 314, platform 316, stop housing 318, and retaining ring 319. For example, hard needle 314 can be stainless steel or other suitable metal. Spring 304 is located inside the tubular housing, i.e., 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 the tubular housing, and a rod 312b with a narrower diameter adapted to be fitted within the coil of spring 304. This configuration of piston 312 can help maintain piston 312 aligned within housing 302. Other configurations are also possible.

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

[0104] When the inserter device 300 is assembled, the spring 304 is compressed, and the remaining components inside the tubular housing are in a loaded position. The trigger 306 holds the spring 304 by directly contacting the spring 304 or another component that can hold the spring 304 compressed. The trigger 306 is adapted to allow a 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 fulcrum 306c. In use, a user (e.g., a patient) presses the first end 306a of the trigger 306, which causes the trigger to pivot about the fulcrum 306c, thereby causing the second end of the trigger 306 to move so as to release the spring 304 from its compressed state.

[0105] As shown in the exploded view in FIG. 10A and assembled in FIG. 10B , FIG. 9A The inserter system 210 also includes a cannula assembly 260. The cannula assembly 260 includes a cannula 270 having a distal end adapted for insertion into a patient 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 can be tubular only or other suitable configurations. The cannula 270 has a cannula axis 271, which is the axis of the distal tubular portion 274. The cannula 270 (or at least the tubular portion to be inserted subcutaneously into the patient) can be a relatively soft material, such as a polymer, relative to the hard needle 314.

[0106] The cannula assembly 260 also includes a housing, which can be 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, funnel 268, and proximal end of the cannula 270 are held within the housing. For example, the inner surface of the lower housing 262 can have a ledge or shelf 262a (as shown in FIG. 11A and FIG. 11BThe flange or ledge holds the lip 272a of the cannula 270 proximally and prevents the cannula from moving distally relative to the housing. The funnel 268 is positioned above the cannula 270, and the septum 266 is positioned above the funnel 268. The cap closes the top of the housing and prevents the septum 266, funnel 268, and cannula 270 from moving proximally relative to the housing. In this manner, the lower housing 262, upper housing 264 hold the septum 266, funnel 268, and cannula 270 in place. The cap can be securely fixed (e.g., by ultrasonic or heat welding, adhesive, etc.) to the lower housing 262.

[0107] The housing of the cannula assembly 260 can also 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 the protrusion 245 on the inner surface of the wall or hub 244 of the patch mount 234, so as 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., as shown in FIG. 3A), FIG. 11A , FIG. 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. The hard needle 314 passes through the platform 316 (which can have a central hole, not shown) and the stop housing 318 (which can have a hollow center). The hard needle 314 also passes through the cap (which can have a central hole, not shown), the septum 266 (which can 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] FIG. 11A A cross-sectional view of certain components of the inserter system 210 is shown, prior to attaching the cannula assembly 260 to the patch assembly 230. FIG. 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 can 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 FIG. 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 example embodiment of a method of using a drug delivery system according to this disclosure. An exemplary drug delivery system 100 is supplied to a user (e.g., a patient) in one or more parts. For example, a removable pump assembly 120 may be provided with a cartridge assembly 160 loaded into a controller module 130, or with a cartridge assembly 60 separate from the controller module 130. An inserter system 210 may be supplied as a component separate from the removable pump assembly 120 (or a component thereof). The inserter system 210 may be supplied with a cannula assembly 260 loaded into an inserter device 300, and may also be supplied with an actuation mechanism (spring 304, trigger 306) for the inserter device 200 in a loaded state. The inserter system 210 may be supplied with an inserter device 300 connected, for example, to a patch assembly 230 via 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 means of locking elements 242, 322.

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

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

[0113] In the case where the tubular housing is positioned substantially upright 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 pivot point 306c and move 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 engagement of the locking element 263 with the locking element. 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, the force causes the distal tip 314a of the hard needle 314 to pierce the patient’s skin. The spring 304 drives the tubular distal end of the hard needle 314 and 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 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 with the inner surface of the tube and / or by a positive stop feature such as a stop flange on the inside of the tube.

[0116] After the inserter device 300 has been actuated, with the cannula 270 inserted into the patient’s skin and the cannula assembly 260 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 it relative to the patch assembly 230 such that the locking element 322 disengages from the locking element 242. The inserter device 300 can then 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 FIG. 12C The hard needle 314 is withdrawn from the cannula 270 and safely housed 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] FIG. 12C An exemplary drug delivery system 100 is shown after the cannula assembly 260 is deployed and the inserter device 300 is separated from the patch cannula assembly 220. FIG. 12D The underside of the patch cannula assembly 220 is shown after the cannula assembly 260 is deployed. As FIG. 12C and FIG. 12DAs shown in FIG. 2, the cannula assembly 260 is engaged with the patch assembly 230, while the underside of the patch 232 is adhered to the skin of the patient, and the cannula 270 protrudes beyond the patch 232 and is inserted into the skin of the patient.

[0118] With the patch and cannula assembly 220 adhered to the patient and the cannula 270 in the drug delivery position, the patient can then mount the detachable pump assembly 120 on the patch and 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 a drug fluid, or the patient can fill the cartridge assembly 160 with a 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 takes a syringe (not shown) and fills the syringe to a predetermined, indicated, or desired level with a drug fluid, typically from a vial (not shown). The patient removes the syringe filled with the 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 the filling process, 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 detachable pump assembly 120. In certain embodiments, the connection of the cartridge assembly 160, which houses the battery 198, to the controller module 130, which houses the electronics, connects the battery 198 to the electronics and "wakes up" or powers on the detachable pump assembly 120.

[0119] The patient attaches the detachable pump assembly 120 to the patch and cannula assembly 220 by placing the detachable pump assembly 120 on the patch and cannula assembly 220 so that the ridge 236 of the patch mount 234 receives the ridge 136 of the controller module 130 and so 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 and cannula assembly 220. FIG. 12E The assembled wearable drug delivery device 110 is shown with certain components of the upper housing and controller module removed to illustrate the internal features of the detachable pump assembly 120.

[0120] When the detachable pump assembly 120 is connected to the patch hub assembly 220, the microtube 166 from the reservoir 164 is aligned to dispense the medication fluid from the reservoir 164 into the funnel 268 and the hub 270. The microtube 166 can pierce the septum 266 of the hub assembly 260 so that the fluid outlet port 167 dispenses the medication fluid into the funnel 268 and the hub 270, and thus into the patient.

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

[0122] The external source (smartphone, tablet, computer, etc.) can send this information to the detachable pump assembly 120 based on input by a physician and / or patient to an application or computer program. This input can be based on various factors, such as medical condition, age, weight, lifestyle, anticipated activity, and / or any other relevant factors. The input can include a dosing regimen. The input can also include functionality that allows the user to alter the regimen (e.g., deliver an additional dose) if appropriate (e.g., based on anticipated activity, glucose level, etc.). The external source can also receive real-time or near real-time information from another source (e.g., from a glucose monitor), and can incorporate this information in determining the signals sent to the detachable pump assembly 120. As noted above, the glucose monitor can be incorporated into the detachable pump assembly 120, or can be another device; in either case, the glucose monitor can be in communication with the external source that sends signals to control the functions of the wearable medication delivery device.

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

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

[0125] Once the drug fluid in the cartridge assembly 160 is depleted (either completely dispensed or below a certain level after dispensing), the patient can remove the cartridge assembly 160. The patient removes the detachable pump assembly 120 from the patch hub assembly 220 by pulling the detachable pump assembly 120 off of the patch hub assembly 220, such that the locking element 137 of the controller module 130 disengages from the locking element 237 of the patch mount 234. The patient then disengages the cartridge assembly 160 from the controller module 130. The patient can then discard the cartridge assembly 160. In some embodiments, 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, if appropriate for the particular drug and application. Alternatively, the patient can obtain a new cartridge assembly 160 and fill the reservoir 164 with drug fluid as described above. The patient then connects the filled cartridge assembly 160 with the controller module 130 and attaches the detachable pump assembly 120 to the patch hub 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 disposable after a single use, or can be disposable 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 more. In one example, a single cartridge assembly can hold enough drug fluid to last for 3-7 days or more. Other device lifetimes are possible.

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

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

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

[0130] Accordingly, in certain embodiments, the reservoir can have a larger cross-sectional area (cross-sectional area being a cross-section taken along an axis 165 perpendicular to the reservoir) relative to certain existing patch pumps. Similarly, the reservoir can have a relatively larger diameter, width, or cross-sectional area (measured in a direction perpendicular to the axis 165 of the reservoir) relative to a height of the reservoir (measured in a direction of the axis 165 of the reservoir).

[0131] In the illustrated example, the first threaded actuator 194 and the second threaded actuator 196 are aligned along a central longitudinal axis of the generally planar piston disk 180, i.e., an axis 191. The axis 191 of the actuators is arranged in parallel with the axis 165 of the reservoir. In the illustrated example, the axis 191 of the actuators is collinear with the axis 165 of the reservoir; in other embodiments, the axis 191 of the actuators can be offset from the axis 165 of the reservoir. The reservoir 164 has a cross-sectional area perpendicular to its axis 165. While the reservoir can have any suitable dimensions, in some embodiments, the diameter, width, or cross-sectional area of the reservoir (measured perpendicular to the axis 165 of the reservoir) can be relatively larger than the height of the reservoir (measured along the axis 165 of the reservoir). For example, in some examples, the internal width or diameter of the reservoir can be in the range of 0.70 inches to 1.20 inches, and the depth of the reservoir can be in the range of 0.20 inches to 0.35 inches, e.g., 0.22 inches to 0.25 inches. Accordingly, in certain embodiments, the ratio of the diameter or width of the reservoir to the depth of the reservoir can 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 with good fill volume capacity. While the fill volume capacity of the reservoir can be any suitable fill volume, in some examples, the reservoir volume is in the range of 1 ml to 3 ml. Other volumes are also possible.

[0132] In certain embodiments (such as the reservoir 164), the reservoir has a relatively larger diameter, width, or cross-sectional area relative to a height of the reservoir, the reservoir can be oriented in the device such that the axis 165 of the reservoir is parallel to the cannula axis 271. In certain embodiments, the axis 165 of the reservoir can be collinear with the cannula axis 271. Accordingly, when the pump is mounted on a patient, the axis 165 of the reservoir is aligned vertically (or perpendicular) to the patch adhered to the patient's skin. This is in contrast to certain existing devices in which the axis of the reservoir is perpendicular to the cannula axis, and horizontal (or parallel) to the patient's skin. With the axis 165 of the reservoir arranged parallel to the cannula axis 271, or vertically (or perpendicular) to the patch on the patient's skin, the axis 191 of the actuators can also be arranged parallel to the cannula axis 271, or vertically (perpendicular) to the patch on the patient's skin.

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

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

[0135] Accordingly, in certain embodiments of the present disclosure, the reservoir of the cartridge assembly can be made from thin sheet metal using precision manufacturing techniques disclosed herein. Previously, patch pumps have employed injection molded plastic reservoirs, while in some embodiments of the present disclosure, the reservoir can be made from injection molded plastic. However, in some embodiments of the present disclosure, precision manufacturing of sheet metal can be used, and this material and manufacturing is particularly advantageous for drug reservoirs of the size and shape as described herein. If desired, the metal sheet can be coated with a coating that is 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 the use of a progressive die that successively shapes the metal in a series of steps from a sheet of material to the final shape. This deep drawing process allows for the precise formation of reservoir features, such as ribs on the inside of the reservoir wall, to tight tolerances. The ribs act as guides to help prevent the piston disc from tilting during fluid dispensing. The precision manufacturing of the ribs facilitates accurate drug delivery. The deep drawing process also facilitates the formation of microtubes at the bottom of the reservoir chamber. Other metal manufacturing techniques can be used, such as metal forming, stamping, chemical etching, electrical discharge machining, laser cutting, laser welding, hot isostatic forging, metalizing forming, 3D printing, or other metal manufacturing processes that are capable of consistently creating complex features on small metal parts with high precision, high accuracy, and tight tolerances. The metal manufacturing techniques allow for the use of certain automated manufacturing processes, including, for example, in the raw metal material preparation, coating, stamping, deep drawing, and laser welding processes. Such automated manufacturing processes can reduce manufacturing costs.

[0137] The use and manufacture of thin metal sheets disclosed herein can result in reservoirs disclosed herein that have a low profile and good fill volume, enabling accurate, precise, and consistent drug delivery. The materials and manufacturing disclosed herein enable the manufacture of 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 are generally not achievable with prior plastic injection molded reservoirs in some existing wearable patch pumps.

[0138] Other novel aspects that can be employed to facilitate the use of reservoirs with large cross-sectional area and wide flat profile relate to the actuator assembly. Reservoirs with large cross-sectional area can require a piston disk with a large diameter or width. Large piston disks can require a large contact interface between the seal of the piston disk periphery and the inner wall of the reservoir. This can increase friction and movement resistance. Large piston disks and related features can make the piston disk prone to tilting, and inaccurate, imprecise, or inconsistent drug delivery.

[0139] In certain embodiments, a large diameter threaded actuator is used, which helps to prevent the piston disk from tilting. For example, in certain embodiments, the ratio of the diameter of the threaded actuator attached to the piston disk to the width or diameter of the reservoir chamber can be 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 reservoir 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 reservoir 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 reservoir 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 reservoir chamber. One example is a piston disk diameter of 1.0 inch (corresponding to a reservoir chamber diameter or width of about 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. The use of a large threaded actuator diameter facilitates improved accuracy in the axial direction for use with large diameter piston disks. The use of a large threaded actuator diameter helps to prevent the piston disk from tilting during fluid dispensing.

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

[0141] While large diameter threaded actuators can have the above advantages, they can also increase the threaded contact area, thereby increasing the friction that the actuator assembly must overcome. This resistance, combined with the resistance from the seal around the large piston disk, can create a large force that the actuator driver must overcome. Accordingly, in accordance with certain embodiments herein, the electromechanical drive system 140 employs a worm gear. This worm gear system provides higher torque in a compact area. The electromechanical drive system 140 with a worm gear can help prevent the threaded actuator assembly from binding with the gear motor during rotation. In accordance with 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 implementation of a low profile device with precise drug delivery.

[0142] Further, in certain embodiments, the threaded actuators are provided with fine precision threads that facilitate the small, 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 fine precision 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 metal (e.g., carbon, stainless steel, cobalt, brass, titanium), plastic, etc.

[0143] Another feature that can be employed with 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. Artwork 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 transparent / clear as a housing alone so that the inner workings of the device and / or the internal artwork can be seen. This can enhance the aesthetics of the device and avoid external decorations or artwork that can be scratched or damaged, thereby improving user compliance with wearing the device. In alternative embodiments, the pump housing is decorated with artwork and has a solid color, multi-color, or any other aesthetically suitable appearance.

[0144] In example embodiments, 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 material 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 septum can be an elastomer such as silicone or rubber. The funnel of the cannula assembly can be metal. The hard needle can be stainless steel or other metal. The cannula or soft needle can be a polymer. Many other variations are possible.

[0146] Embodiments of systems, devices, assemblies, or methods within the scope of the present disclosure can have one or more advantages, such as, but not limited to: small size, small footprint, low profile, flat profile, light weight, large internal reservoir volume, aesthetics, wear resistance, no external tubing outside of the device housing, ease of use, drug delivery accuracy, drug delivery precision, drug delivery consistency, low cost, mass manufacturability, and economical manufacturability. Embodiments of the wearable drug delivery device (wearable infusion cannula patch pump) can be small, unobtrusive, discreet, and unobtrusive, resulting in comfort, aesthetics, use, and compliance advantages. Embodiments can have a low profile while maintaining large capacity reservoirs and accuracy, precision, and consistency of drug delivery.

[0147] Those of ordinary skill in the art will appreciate that the implementations covered by the present disclosure and claims are not limited to the example implementations illustrated and described above. As will be appreciated by those of ordinary skill in the art on the basis of the disclosures contained herein, many other variations, modifications, changes and alternatives are possible and contemplated.

[0148] Cross Reference to Related Applications

[0149] This application claims priority to U.S. Provisional Patent Application No. 63 / 613,229, filed December 21, 2023, entitled “Wearable Drug Delivery Device,” the entire contents of which are incorporated herein by reference.

Claims

1. A wearable drug delivery device, characterized in that, The wearable drug delivery device includes: A detachable pump assembly, the detachable pump assembly including a cartridge assembly and a controller module; Patch panel components; and A sleeve assembly, the sleeve assembly comprising a sleeve having a sleeve axis; The cartridge assembly includes a reservoir having a storage chamber and a reservoir axis; The reservoir is oriented in the cartridge assembly such that when the removable pump assembly is attached to the patch assembly, the reservoir axis is aligned parallel to the sleeve axis.

2. The wearable drug delivery device according to claim 1, characterized in that, 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, characterized in that, The controller module has a semi-transparent or transparent housing.

4. The wearable drug delivery device according to claim 1, characterized in that, The wearable drug delivery device also includes an encoder.

5. The wearable drug delivery device according to claim 1, characterized in that, The wearable drug delivery device also includes a pressure sensor.

6. A wearable pump assembly, characterized in that, The wearable pump assembly includes: cartridge assembly; and Controller module; The cartridge assembly includes a reservoir; The storage device is made of a metal plate.

7. The wearable pump assembly according to claim 6, characterized in that, The storage device is manufactured using a deep-drawing process.

8. The wearable pump assembly according to claim 6, characterized in that, The storage device includes one or more internal ribs.

9. The wearable pump assembly according to claim 8, characterized in that, The wearable pump assembly also includes a piston disc having one or more recesses for receiving the one or more internal ribs of the reservoir.

10. The wearable pump assembly according to claim 9, characterized in that, The wearable pump assembly also includes a sealing gasket surrounding the 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, characterized in that, The wearable pump assembly includes: cartridge assembly; and Controller module; The cartridge assembly includes a reservoir with a storage chamber, a piston disc, and an actuator assembly, the actuator assembly having a threaded actuator attached to the piston disc. The diameter of the threaded actuator attached to the piston disc is one-quarter or more of the diameter or width of the storage chamber.

12. The wearable pump assembly according to claim 11, characterized in that, The wearable pump assembly also includes an actuator retainer for maintaining alignment of the actuator assembly.

13. The wearable pump assembly according to claim 11, characterized in that, The wearable pump assembly also includes a drive system with a worm gear for driving the actuator assembly.

14. The wearable pump assembly according to claim 11, characterized in that, The thread density of the thread actuator is 80 threads per inch or higher.

15. The wearable pump assembly according to claim 11, characterized in that, The diameter of the threaded actuator attached to the piston disc is half or more of the diameter or width of the storage chamber.

16. An inserter system for use in a drug delivery system, characterized in that, The inserter system includes: Insertor device; and A cannula assembly, which is loaded into the inserter device.

17. The inserter system according to claim 16, characterized in that, The inserter device includes a retainer adapted to be selectively attached to the patch assembly.

18. The inserter system according to claim 17, characterized in that, The inserter device is adapted to activate the cannula assembly, thereby connecting the cannula assembly to the patch assembly.

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