Miniature positive displacement pump for wearable drug delivery devices

Abstract

The embodiments of the present disclosure relate to techniques, processes, devices, or systems for pump devices. In one approach, the wearable drug delivery device includes a reservoir configured to store a liquid drug, the reservoir includes a housing including an outer wall defining an internal chamber, a seal member, and a slit through the housing, the seal member configured to seal the slit. The wearable drug delivery device further includes a delivery pump device including a drive mechanism coupled to the reservoir to force the liquid drug from the reservoir, the drive mechanism including a piston head disposed within the internal chamber of the housing and a lead screw coupled to a drive nut, the drive nut including a blade adjacent to the piston head, the blade positionable through the slit in the housing.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 191436, filed May 21, 2021, the contents of which are incorporated herein by reference in their entirety.

[0002] The disclosed embodiments relate generally to drug delivery, and more particularly to techniques, processes, systems, and delivery devices for delivering fluid drugs in a space-efficient manner. [Background technology]

[0003] Many wearable drug delivery devices include a reservoir for storing a liquid medication. A pump device including a drive mechanism is actuated to force the stored liquid medication from the reservoir for delivery to a user. Some conventional positive displacement pump devices use a plunger in the drive mechanism to force the liquid medication from the reservoir. Therefore, the drive mechanism has a length approximately equal to the length of the reservoir. When the reservoir is filled, the drive mechanism requires the length of the drug delivery device to be significantly larger, e.g., approximately twice the length of the reservoir, to allow the plunger to move across the length of the reservoir to force the fluid out. Increasing the size of the drug delivery device to accommodate a filled reservoir or pre-filled cartridge and corresponding drive mechanism components results in a bulky device that is uncomfortable for a user wearing it. Summary of the Invention [Problem to be solved by the invention]

[0004] Therefore, a simplified system is needed for accurately expelling liquid medication from a reservoir while simultaneously reducing the overall size of the drug delivery device. [Means for solving the problem]

[0005] This Summary is intended to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to equate key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter.

[0006] In some approaches, the wearable drug delivery device can include a reservoir configured to store a liquid drug, the reservoir including a housing including an outer wall defining an interior chamber, a seal member, and a slit through the housing, the seal member configured to seal the slit. The wearable drug delivery device can further include a delivery pump device including a drive mechanism coupled to the reservoir to force the liquid drug from the reservoir, the drive mechanism including a piston head disposed within the interior chamber of the housing and a lead screw coupled to a drive nut, the drive nut including a blade adjacent to the piston head, the blade positionable through the slit in the housing.

[0007] In some approaches, a wearable drug delivery device can include a reservoir configured to store a liquid drug, the reservoir including a housing having an outer wall defining an interior chamber, a seal member, and a slit passing through the housing, the seal member configured to seal the slit. The wearable drug delivery device can further include a delivery pump device including a drive mechanism coupled to the reservoir to force the liquid drug from the reservoir. The drive mechanism can include a piston head disposed within the interior chamber of the housing and a lead screw coupled to a drive nut, the drive nut including a blade adjacent to the piston head, the blade positionable through the slit in the housing, the lead screw having a male thread portion that engages with a corresponding female thread portion of the drive nut, and rotation of the lead screw moves the blade axially along the lead screw.

[0008] In some approaches, a method can include providing a reservoir configured to store a liquid chemical, the reservoir including a housing including an outer wall defining an interior chamber, a seal member, and a slit extending through the housing, the seal member configured to seal the slit. The method can further include coupling a drive mechanism of a delivery pump device to the reservoir, the drive mechanism including a piston head disposed within the interior chamber of the housing and a lead screw coupled to a drive nut, the drive nut including a blade adjacent to the piston head, the blade positioned through the slit in the housing. The method can further include rotating the lead screw to move the drive nut axially along the lead screw between a first position and a second position to force the liquid chemical from the reservoir.

[0009] In the drawings, like reference numerals generally refer to the same parts throughout the different views.In the following description, various embodiments of the present disclosure are described with reference to the following drawings, in which: [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a schematic diagram of a drug delivery system according to an embodiment of the present disclosure.

[0011] [Figure 2A] FIG. 2A is a perspective view of a drive mechanism of a delivery pump device according to an embodiment of the present disclosure.

[0012] [Figure 2B] FIG. 2B is a partial cutaway perspective view of the drive mechanism of FIG. 2A according to an embodiment of the present disclosure.

[0013] [Figure 3A] FIG. 3A is a side cross-sectional view illustrating use of a drive mechanism according to an embodiment of the present disclosure.

[0014] [Figure 3B]FIG. 3B is a side cross-sectional view illustrating use of a drive mechanism according to an embodiment of the present disclosure.

[0015] [Figure 3C] FIG. 3C is a side cross-sectional view illustrating use of a drive mechanism according to an embodiment of the present disclosure.

[0016] [Figure 4] FIG. 4 is a perspective view of a drive mechanism of a delivery pump device according to an embodiment of the present disclosure.

[0017] [Figure 5A] 5A is a perspective view illustrating the operation of the drive mechanism of FIG. 4 according to an embodiment of the present disclosure.

[0018] [Figure 5B] 5B is a perspective view illustrating the operation of the drive mechanism of FIG. 4 according to an embodiment of the present disclosure.

[0019] [Figure 6] FIG. 6 is a flow chart of a method according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0020] The drawings are not necessarily to scale. The drawings are merely representational and are not intended to depict specific parameters of the present disclosure. The drawings are intended to illustrate preferred embodiments of the present disclosure and should not be construed as limiting the scope. Furthermore, in some of the figures, certain elements may be omitted or not drawn to scale for clarity. Furthermore, in some of the figures, some reference numbers may be omitted in certain figures for clarity.

[0021] Systems, devices, and methods according to the present disclosure are described more fully below with reference to the accompanying drawings, in which one or more embodiments are shown. The systems, devices, and methods may be implemented in a variety of ways and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the methods and devices to those skilled in the art. Each of the systems, devices, and methods disclosed herein offers one or more advantages over conventional systems, components, and methods.

[0022] As mentioned above, the goal is to provide a compact pumping solution to minimize impact on the patient. In the present disclosure, a positive displacement pump utilizing a drive mechanism including a lead screw and drive nut is used to incrementally move a piston head forward. Unlike prior art approaches that require the total amount of space for the drive mechanism to be twice the length of the reservoir so that the piston plunger can fully extend behind the reservoir when the reservoir is filled, embodiments of the present disclosure maintain the position of the plunger relative to the reservoir housing to improve the impact of the device's size while maintaining the benefits of a positive displacement pumping method.

[0023] In some embodiments, the wearable drug delivery device includes a reservoir having a central core shaft with one or more slits extending through its sidewall. A membrane seal member can be attached to the outer and / or inner surface of the core shaft, with the membrane covering the slits. The drive mechanism of the wearable drug delivery device can include a piston head with one or more sealing rings (e.g., O-rings), a lead screw extending through the core shaft, and a drive nut coupled to the lead screw. The drive nut can include a blade operable to extend through the slit to break the membrane upon contact. To deliver the liquid drug from the reservoir, the lead screw is rotated, causing the drive nut to move down the lead screw. The blade or an adjacent portion of the drive nut transmits force to the piston head, which pushes the piston head within the reservoir, forcing the liquid drug out of the reservoir. In some embodiments, the piston head includes an internal sealing ring, which presses against the membrane and / or the core shaft.

[0024] In some embodiments, the drive mechanism may include one or more components positioned outside the reservoir housing. For example, a lead screw may be positioned adjacent to the outer surface of the housing's outer wall, with a drive nut extending between the lead screw and a piston head positioned within the housing's internal chamber. The drive nut may include one or more blades extending through slits in the housing's outer wall. To deliver liquid chemical from the reservoir, turning the lead screw moves the drive nut down the lead screw. The blades or portions adjacent thereto of the drive nut transmit force to the piston head, which pushes the piston head within the reservoir, forcing the liquid chemical out of the reservoir. The blades cut open a thin-film seal member, which may be positioned along the inner surface of the housing's outer wall, to allow continued advancement of the piston head. Alternatively, the seal member may be positioned within a slit in the housing's outer wall and / or along the outer surface of the outer wall.

[0025] In various embodiments, the wearable drug delivery devices described herein can include an analyte sensor, such as a blood glucose sensor, and the cannula or microneedle array can be operable to measure analyte levels in a user of the device.

[0026] FIG. 1 is a simplified block diagram of an example system (hereinafter referred to as the “system”) 100. The system 100 may be an on-body drug delivery device and / or analyte sensor that is wearable or attached to the skin of a patient 103. The system 100 may include a controller 102, a pump mechanism 104 (hereinafter referred to as the “pump 104”), and a sensor 108. The sensor 108 may be a glucose or other analyte monitor, such as a continuous glucose monitor, and may be incorporated into a wearable device. The sensor 108 may be operable, for example, to measure a user's blood glucose (BG) value to generate a measured BG level signal 112. The controller 102, pump 104, and sensor 108 may be communicatively coupled to each other via wired or wireless communication paths. For example, the controller 102, pump 104, and sensor 108 may each include a radio frequency transceiver operable to communicate via one or more communication protocols, such as Bluetooth® or the like. The system 100 may also include a delivery pump device (hereinafter "device") 105, which includes a drive mechanism 106 coupled to the reservoir 126 for driving the liquid chemical 125 from the reservoir 126. As described in further detail herein, the drive mechanism 106 may include a piston head 134 disposed within an internal chamber of a housing 139 of the reservoir 126 and a lead screw 135 coupled to a drive nut 136. In some embodiments, the drive nut 136 may include a blade adjacent the piston head 134, where the blade is positionable through a slit in the housing 139 to engage a seal member 141 disposed within the housing. The system 100 may include additional components not shown or described for the sake of brevity.

[0027] The controller 102 may receive a desired BG level signal indicative of a desired BG level or range for the patient 103, which may be the first signal. The desired BG level signal may be stored in memory in the controller 109 of the device 105 and received from a user interface to the controller 102 or other device, or by an algorithm within the controller 109 (or controller 102) that automatically measures the patient's 103 BG level. The sensor 108 may be coupled to the patient 103 and operable to measure an estimate of the user's BG level. In response to the measured BG level or value, the sensor 108 may generate a signal indicative of the measured BG value. As shown, the controller 102 may also receive a measured BG level signal 112 from the sensor 108 via the communication path, which may be the second signal.

[0028] Based on the desired BG level signal and the measured BG level signal 112, the controller 102 or the controller 109 may generate one or more control signals to direct operation of the pump 104. For example, one control signal 119 from the controller 102 or the controller 109 may turn on the pump 104 or activate one or more power elements 123 operatively connected to the device 105. A specified amount of liquid medication 125 may be determined as the appropriate amount of insulin to bring the user's measured BG level to the desired BG level. Based on the operation of the pump 104 determined by the control signal 119, the patient 103 may receive liquid medication from the reservoir 126. The system 100 can operate as a closed-loop system, an open-loop system, or a hybrid system. In a preferred closed-loop system, the controller 109 can direct operation of the device 105 without input from the controller 102 and receive the BG level signal 112 from the sensor 108. The sensor 108 may be housed within the device 105 or may be housed in a separate device and communicate directly with the device 105 wirelessly.

[0029] As further shown, the system 100 can include a needle placement component 128 in communication with the controller 102 or the controller 109. The needle placement component 128 can include a needle / cannula 129 that can be placed within the patient 103 and may have one or more holes at its distal end. The device 105 can be connected to the needle / cannula 129 by a fluid path component 130. The fluid path component 130 can have any size and shape and can be made from any material. The fluid path component 130 enables the transfer of a fluid, such as a liquid drug 125 in a reservoir 126, to the needle / cannula 129.

[0030] The controller 102 / 109 can be implemented in hardware, software, or any combination thereof. The controller 102 / 109 may be, for example, a processor, logic circuit, or microcomputer coupled to a memory. The controller 102 / 109 may store the date and time as well as other functions (e.g., calculations, etc.) performed by the processor. The controller 102 / 109 may be operable to execute an artificial pancreas (AP) algorithm stored in memory (not shown), which enables the controller 102 / 109 to direct operation of the pump 104. For example, the controller 102 / 109 may be operable to receive input from the sensor 108, where the input indicates an automatic insulin delivery (AID) application setting. Based on the AID application setting, the controller 102 / 109 can modify operation of the pump 104 and the resulting amount of liquid medication 125 delivered to the patient 103 via the device 105.

[0031] In some embodiments, the sensor 108 may be, for example, a continuous glucose monitor (CGM). The sensor 108 may be physically separate from the pump 104 or may be an integrated component within the same housing. The sensor 108 may provide the controller 102 with data indicative of the user's measured or detected blood glucose level.

[0032] The power supply element 123 may be a battery, a piezoelectric device, or the like for powering the device 105. In other embodiments, the power supply element 123 or an additional power source (not shown) may provide power to other components of the pump 104, such as the controller 102, memory, sensor 108, and / or needle placement component 128.

[0033] In one embodiment, the sensor 108 may be a device communicatively coupled to the controller 102 and operable to measure blood glucose levels at predetermined time intervals, such as approximately every 5 minutes, every 10 minutes, etc. The sensor 108 may provide multiple blood glucose measurements to the AP application.

[0034] In some embodiments, when operating in a normal operating mode, the pump 104 delivers insulin stored in the reservoir 126 to the patient 103 based on information provided by the sensor 108 or other functional elements of the pump 104 (such as blood glucose measurements, blood glucose target levels, internal insulin, previous insulin deliveries, time of day, day of the week, input from an inertial measurement unit, a global positioning system-enabled device, a Wi-Fi-enabled device, or the like). For example, the pump 104 may include analog and / or digital circuitry that can be implemented as a controller 102 / 109 for controlling the delivery of a drug or therapeutic agent. The circuitry used to implement the controller 102 / 109 may include discrete, dedicated logic and / or components, application specific integrated circuits, microcontrollers or processors, or any combination thereof, that execute software instructions, firmware, programming instructions or programming code stored in memory to enable, for example, an AP application. For example, the controller 102 / 109 can execute control algorithms and other programming code that can enable the controller 102 / 109 to cause the pump to administer a dosage of a drug or therapeutic agent to the user at predetermined intervals or as needed to bring the measured blood glucose level to a target blood glucose level. The quantity and / or timing of the dosage can be pre-programmed into the AP application by the patient 103 or a third party (e.g., a caregiver, parent or guardian, manufacturer of the wearable drug delivery device, or the like) using, for example, a wired or wireless link.

[0035] Although not shown, in some embodiments, the sensor 108 may include a processor, memory, sensing or measuring equipment, and communication equipment. The memory may store AP applications and other programming code, and may be operable to store data related to the AP applications.

[0036] In various embodiments, the sensing / measuring device of the sensor 108 may include one or more sensor elements, such as a blood glucose measuring element, a heart rate monitor, a blood oxygen sensor element, or the like. The sensor processor may include discrete, specific logic and / or components that execute software instructions, firmware, programming instructions stored in memory, an application specific integrated circuit, a microcontroller or processor, or a combination thereof.

[0037] 2A-2B, drive mechanism 106 according to an embodiment of the present disclosure will be described in further detail. As shown, drive mechanism 106 can be positioned within an interior chamber 150 of a housing 139 of reservoir 126. Housing 139 can include an exterior wall 151 that defines interior chamber 150, with exterior wall 151 including an interior surface 153 and an opposing exterior surface 152. Without limitation, housing 139 can be an elliptical cylinder including a first end 157 and an opposing second end 158.

[0038] In some embodiments, the housing 139 may include a core shaft 154 within the internal chamber 150. As shown, the core shaft 154 may include one or more slits 161 extending axially along the length of the wall defining the core shaft 154. A seal member 160 (e.g., a thin polyethylene film) may be disposed along the outer surface 159 of the core shaft 154. As shown, the seal member 160 may cover or extend across each slit 161 in the core shaft 154. In various embodiments, the seal member 160 may cover all or only a portion of the outer surface 159 of the core shaft 154. In other embodiments, the seal member 160 may be disposed along the inner surface of the core shaft 154 and / or positioned directly within the slits 160. In such a case, tearing of the seal member 160 may be avoided and a better seal may be obtained between the inner surface 164 of the piston head 134 and the core shaft 154 than if the seal member 160 were positioned on the outer surface 159 of the core shaft 154.

[0039] As further shown, the drive mechanism 106 can include a piston head 134 disposed within the interior chamber 150 of the housing 139. In some embodiments, the piston head 134 can include a first seal ring 162 (e.g., an O-ring) extending circumferentially around the outer surface 163. The first seal ring 162 contacts the inner surface 153 of the outer wall 151 to create a fluid-tight seal therebetween. Although not shown, the piston head 134 can also include a second seal ring extending circumferentially around the inner surface 164. The second seal ring can provide a fluid-tight seal between the inner surface 164 and the core shaft 154 (or a seal member 160 surrounding the core shaft 154).

[0040] The drive mechanism 106 may further include a lead screw 135 extending into the interior 166 of the core shaft 154. The lead screw 135 may include a first end 172 disposed at the bottom of the interior 166 of the core shaft 154 and a second end 173 extending outside the core shaft 154. Although not shown, the second end 173 of the lead screw 135 may be coupled to a clutch mechanism, a ratchet mechanism, or other device operable to rotate the lead screw 135. In some embodiments, the lead screw 135 is coupled to a drive nut 136, which may include one or more blades 168 extending through the slits 161 in the core shaft 154. The blades 168 may be metallic portions of the drive nut 136 oriented perpendicular to the lead screw 135. As shown, the blades 168 may be in direct physical contact with an outer surface 169 of the piston head 134. The blade 168 may include a sharp portion capable of cutting through the seal member 160 and a non-sharp or blunt portion that is in direct physical contact with the outer surface 169 of the piston head 134. Alternatively, the blade 168 may have a substantially uniform shape along its entire leading edge (e.g., the entire leading edge may have substantially the same sharpness or bluntness). In use, as the lead screw 135 rotates, the drive nut 136 moves toward the second end 158 of the housing 139, thereby causing the leading edge 170 of the blade 168 to cut through the seal member 160 and press against the outer surface 169 of the piston head 134, moving the piston head 134 downward (i.e., toward the second end 158) within the internal chamber 150. In some embodiments, a portion of the leading edge 170 of the blade 168 may be sharpened to better cut through the seal member 160.

[0041] 3A-3C, operation of the drive mechanism 106 according to embodiments of the present disclosure will be described in more detail. In FIG. 3A, which shows the reservoir 126 filled with liquid chemical 125, the piston head 134 and drive nut 136 are adjacent to a first end 157 of the housing 139 of the reservoir 126. The internal chamber 150 can be filled with the liquid chemical 125 by pumping the liquid chemical 125 under sufficient hydraulic pressure to open an inlet port (not shown) of the reservoir 126 and retract the piston head toward the first end 157 of the housing 139. In some embodiments, the hydraulic pressure can rotate the piston head 134 about the lead screw 135 until the piston head 134 is positioned adjacent to the second end 173 of the lead screw 135. As shown, the first end 172 of the lead screw 135 can remain in contact with or adjacent to a bottom wall 176 that defines the bottom of the core shaft 154.

[0042] As further shown, the piston head 134 may include a first seal ring 162 extending circumferentially around the outer surface 163 and a second seal ring 177 extending circumferentially around the inner surface 164. The first seal ring 162 may contact the inner surface 153 of the outer wall 151 to create a fluid-tight seal therebetween. The second seal ring 177 may provide a fluid-tight seal between the inner surface 164 and a seal member 160 that surrounds the core shaft 154.

[0043] 3B , to dispense the liquid chemical 125 from the reservoir 126, the lead screw 135 is rotated within the interior 166 of the core shaft 154, thereby moving the drive nut 136 axially from the second end 173 of the lead screw 135 toward the first end 172 of the lead screw 135. In some embodiments, the lead screw 135 can include male threads 178 that engage corresponding female threads 179 of the drive nut 136 to press the drive nut 136 against the outer surface 169 of the piston head 134. As the drive nut 136 and piston head 134 move toward the second end 158 of the housing 139, the blade 168 of the drive nut 136 moves along the slit 161 and cuts through the seal member 160, allowing the drive nut 136 and piston head 134 to continue advancing. The blade 168 creates an opening in the seal member 160, but positions the first and second seal rings 162, 177 forward of the blade 168 along the direction of travel of the drive nut 136, thereby preventing the fluid-tight seal of the reservoir 126 from being breached. As shown, the first end 172 of the lead screw 135 can remain in place adjacent the bottom wall 176 of the core shaft 154 as the piston head 134 moves.

[0044] Rotation of the lead screw 135 is allowed to continue until the piston head 134 moves to the end of the interior chamber 150 of the housing 139, as shown in Figure 3C. At this position, the drive mechanism 106 has completely expelled the liquid chemical 125 from the reservoir 126.

[0045] 4, another drive mechanism 206 according to an embodiment of the present disclosure will be described in further detail. The drive mechanism 206 may be part of an on-body drug delivery device and / or analyte sensor that is wearable or attached to the patient's skin, such as the system 100 described above. As shown, the drive mechanism 206 may be coupled to a housing 239 of the reservoir 226. The housing 239 may include an outer wall 251 that defines an interior chamber 250, the outer wall 251 including an inner surface 253 and an opposing outer surface 252. Without limitation, the housing 239 may be an elliptical cylinder including a first end 257 opposite a second end 258.

[0046] In some embodiments, a sealing member 260 (e.g., a polyethylene film) can be disposed along the inner surface 253 of the outer wall 251 of the housing 239. In other embodiments, the sealing member 260 can be disposed along the outer surface 252 of the outer wall 251 of the housing 239 or directly within the slit 261, and the sealing member can be a wax material, a paint coating, or a flexible polycarbonate material. The sealing member 260 can cover all or only a portion of the inner surface 253, the outer surface 252, or the slit 261. As shown, the sealing member 260 can extend across the slit 261 formed through the outer wall 251 of the housing 239.

[0047] As further shown, drive mechanism 206 may include a piston head 234 disposed within an interior chamber 250 of housing 239. In some embodiments, piston head 234 may include one or more seal rings (not shown) extending circumferentially around its outer surface. The seal rings may be in direct contact with the interior of seal member 260 to create a fluid-tight seal therebetween.

[0048] The drive mechanism 206 may further include a lead screw 235 extending adjacent / external to the outer wall 251 of the housing 239. The lead screw 235 may include a first end 272 adjacent the second end 258 of the housing 239 and a second end 273 adjacent the first end 257 of the housing 239. Although not shown, the second end 273 of the lead screw 235 may be coupled to a clutch mechanism or other device operable to rotate the lead screw 235. In some embodiments, the lead screw 235 is coupled to a drive nut 267, which may include one or more blades 268 extending through slits 261 in the outer wall 251 of the housing 239. As shown, the blades 268 may extend perpendicular to the lead screw 235. In some embodiments, the blades 268 may be directly adjacent to the outer surface 269 of the piston head 234. In use, as the lead screw 235 rotates, the drive nut 267 moves axially along the lead screw 235 toward the second end 258 of the housing 239, causing the leading edge 270 of the blade 268 to cut through the seal member 260. The blade 268 presses against the outer surface 269 of the piston head 234, moving the piston head 234 downward (i.e., toward the second end 258) within the internal chamber 250. In some embodiments, a portion of the leading edge 270 of the blade 268 may be sharpened to better cut through the seal member 260.

[0049] 5A-5B, operation of drive mechanism 206 according to an embodiment of the present disclosure will be described in more detail. Rotating lead screw 235 to dispense liquid chemical from reservoir 226 causes drive nut 236 to move axially from second end 273 of lead screw 235 toward first end 272 of lead screw 235. In some embodiments, lead screw 235 can include male threads that engage corresponding female threads on drive nut 236 to press drive nut 236 against outer surface 269 of piston head 234 (not shown in FIG. 5B for clarity). As drive nut 236 and piston head 234 move toward second end 258 of housing 239, blade 268 of drive nut 236 moves along slit 261 and cuts through seal member 260, thereby allowing continued advancement of drive nut 236 and piston head 234. Rotation of the lead screw 235 is allowed to continue until the piston head 234 moves to the end of the internal chamber 250 and the liquid drug is completely expelled from the reservoir 226 .

[0050] 6 illustrates an example process 300 according to an embodiment of the present disclosure. In block 301, process 300 can include providing a reservoir configured to store a liquid drug, the reservoir including a housing having an outer wall defining an interior chamber, a sealing member within the interior chamber, and a slit through the housing, the sealing member configured to extend across the slit. In some embodiments, the reservoir is part of a wearable drug delivery device. In some embodiments, the sealing member is a thin film (e.g., polyethylene, low-density polyethylene, highly chlorinated polyethylene) or wax or other material suitable for filling a slit in a housing.

[0051] In some embodiments, the reservoir housing includes a core shaft within the interior chamber, the seal member is formed along an outer surface of the core shaft, the lead screw of the drive mechanism can extend within the interior of the core shaft, and the slit is formed through the core shaft.

[0052] In some embodiments, a slit can be formed through an outer wall of the housing, and the seal member can be disposed along an inner surface of the outer wall, such that the seal member extends across the slit to surround the interior chamber.

[0053] At block 302, the process 300 may further include coupling a drive mechanism of the delivery pump device to the reservoir, the drive mechanism including a piston head disposed within the interior chamber of the housing and a lead screw coupled to a drive nut, the drive nut including a blade adjacent to the piston head. The blade may be positionable through a slot in the housing to engage the piston head and the seal member. In some embodiments, the lead screw is positioned within a core shaft of the housing. In other embodiments, the lead screw is positioned adjacent / external to an outer wall of the housing. The blade of the drive nut may extend perpendicular to the lead screw. In some embodiments, the blade of the drive nut is directly adjacent to and / or in direct physical contact with the outer surface of the piston head. In some embodiments, the lead screw may include male threads that engage corresponding female threads of the drive nut to compress the drive nut against the outer surface of the piston head.

[0054] In some embodiments, the method includes installing a first seal ring around an outer surface of the piston head and installing a second seal ring around an inner surface of the piston head, wherein the first seal ring is in direct physical contact with an inner surface of the outer wall of the housing and the second seal ring is in direct physical contact with the seal member.

[0055] At block 303, the process 300 may include rotating the lead screw to move the drive nut axially along the lead screw between a first position and a second position to force the liquid chemical from the reservoir. In the first position, the drive nut may be adjacent to a first end of the reservoir housing. In the second position, the drive nut may be adjacent to a second end of the reservoir housing. In some embodiments, blades of the drive nut cut through the seal member as the drive nut moves between the first and second positions.

[0056] As used herein, an algorithm or computer application that manages blood glucose levels and insulin therapy may be referred to as an "artificial pancreas" algorithmic system or more generally as an artificial pancreas (AP) application. An AP application may be programming code stored in a memory device and executable by a processor, controller, or computer device.

[0057] The techniques described herein for a drug delivery system (e.g., system 100 or any component thereof) can be implemented in hardware, software, or any combination thereof. Any component described herein can be implemented in hardware, software, or any combination thereof. For example, system 100 or any component thereof can be implemented in hardware, software, or any combination thereof. Software-related implementations of the techniques described herein can include, but are not limited to, firmware, application-specific software, or any other type of computer-readable instructions executable by one or more processors. Hardware-related implementations of the techniques described herein include, but are not limited to, integrated circuits (ICs), application-specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), and / or programmable logic devices (PLDs). In some embodiments, the techniques described herein and / or the system or configuration components described herein can be implemented by a processor executing computer-readable instructions stored in one or more memory components.

[0058] Some embodiments of the disclosed apparatus can be implemented using, for example, a storage medium, computer-readable medium, or article of manufacture capable of storing instructions or sets of instructions that, when executed by a machine (i.e., a processor or controller), cause the machine to perform methods and / or operations according to embodiments of the present disclosure. Such a machine can include, for example, any suitable processing platform, computing platform, computing device, processing equipment, computing system, processing system, computer, processor, or the like, and can be implemented using any suitable combination of hardware and / or software. A computer-readable medium or article may include, for example, any suitable type of memory unit, memory, memory product, memory medium, storage device, storage product, storage medium, and / or storage unit, such as memory (including non-transitory memory), removable or non-removable media, erasable or non-erasable media, writable or rewritable media, digital or analog media, hard disk, floppy disk, compact disk read-only memory (CD-ROM), compact disk recordable (CD-R), rewritable compact disk (CD-RW), optical disk, magnetic media, magneto-optical media, removable memory card or disk, various types of digital versatile disks (DVD), tape, cassette, or the like. Instructions may include any suitable type of code, such as source code, compiled code, interpreted code, executable code, static code, dynamic code, encrypted code, programming code, and the like, implemented using any suitable high-level, low-level, object-oriented, visual, compiled, and / or interpreted programming language. The non-transitory computer readable medium embodied programming code that, when executed, causes a processor to perform the functions as described herein.

[0059] Specific embodiments of the present disclosure have been described above. However, it should be clearly understood that the present disclosure is not limited to these embodiments; rather, additions and modifications to those expressly described herein are intended to be within the scope of the present disclosure. Furthermore, it should be understood that the features of the various embodiments described herein are not mutually exclusive and can exist in various combinations and permutations without departing from the spirit and scope of the present disclosure, even if such combinations or permutations are not expressly stated herein. Indeed, variations, modifications, and other implementations of what is described herein will occur to those skilled in the art without departing from the spirit and scope of the present disclosure. Accordingly, the present disclosure is not limited solely by the illustrative description set forth above.

[0060] Program forms of technology can be considered "products" or "articles of manufacture" in the form of executable code and / or associated data typically carried or embodied on machine-readable media. Storage-type media include any or all of the tangible memory of a computer, processor, or the like, or its associated modules, capable of providing non-transitory storage for software programming, such as various semiconductor memories, tape drives, disk drives, and the like. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is provided with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Moreover, in the foregoing Detailed Description, various features are grouped together in a single embodiment for the purpose of conciseness of the disclosure. This method of disclosure should not be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed embodiment. Accordingly, the following claims are hereby incorporated by reference into the Detailed Description, with each claim standing on its own as a separate embodiment. In the claims, the terms "including" and "wherein" are used as the plain English equivalents of "comprising" and "wherein," respectively. Furthermore, the terms "first," "second," "third," etc. are used merely as designators and are not intended to impose numerical requirements on their objects.

[0061] The foregoing description of the embodiments has been presented for purposes of illustration and description. It is not intended to be exhaustive or to be construed as limiting the scope of the invention. It is not intended to limit the disclosure to the precise form disclosed. Many modifications may be made in light of this disclosure. The scope of the present disclosure is limited to the scope of the present invention, not to the detailed description. It is intended to be limited by the claims appended hereto. Future-filed applications extending the present disclosure may claim various aspects of this disclosure, generally as set forth herein. may include any set of one or more limitations as variously disclosed or demonstrated . The present disclosure also includes the following inventions. The first aspect is 1. A wearable drug delivery device comprising: 1. A reservoir configured to store a liquid chemical, the reservoir comprising: a housing including an outer wall defining an interior chamber; A seal member; a slit extending through at least a portion of the housing, the seal member configured to seal the slit; a reservoir comprising: 1. A delivery pump device comprising: a drive mechanism coupled to the reservoir for forcing the liquid drug from the reservoir, the drive mechanism comprising: a piston head disposed within the interior chamber of the housing; a lead screw coupled to a drive nut, the drive nut including a blade adjacent the piston head, the blade positionable through the slit in the housing; and a delivery pump device comprising: A wearable drug delivery device comprising: The second aspect is A wearable drug delivery device in a first aspect, wherein the housing of the reservoir has a core shaft within the internal chamber, the sealing member is formed along the outer surface of the core shaft, and the lead screw of the drive mechanism extends within the interior of the core shaft. The third aspect is The wearable drug delivery device of a second embodiment, wherein the slit is formed through the core shaft. The fourth aspect is A wearable drug delivery device in a second aspect, wherein the piston head includes a first seal ring extending around an outer surface and a second seal ring extending around an inner surface, the second seal ring being in direct physical contact with the seal member formed along the outer surface of the core shaft. The fifth aspect is A wearable drug delivery device in a first aspect, wherein the blades of the drive nut extend perpendicular to or radially outward from the lead screw and the blades of the drive nut are in direct physical contact with the outer surface of the piston head. The sixth aspect is The wearable drug delivery device according to the first aspect, wherein the sealing member is formed along an inner surface of the outer wall of the housing. A seventh aspect is The wearable drug delivery device of the first aspect, wherein the lead screw is positioned externally of the housing of the reservoir. The eighth aspect is The wearable drug delivery device of the first aspect, wherein the slit is formed through the outer wall of the housing. A ninth aspect is 1 is a wearable drug delivery device according to a first embodiment, wherein the sealing member is a polyethylene film. A tenth aspect is A wearable drug delivery device in a first aspect, wherein the lead screw has a male threaded portion that engages with a corresponding female threaded portion of the drive nut, and rotation of the lead screw moves the drive nut axially along the lead screw. An eleventh aspect is 1. A wearable drug delivery device comprising: 1. A reservoir configured to store a liquid chemical, the reservoir comprising: a housing including an outer wall defining an interior chamber; A seal member; a slit extending through at least a portion of the housing, the seal member configured to seal the slit; a reservoir comprising: 1. A delivery pump device comprising: a drive mechanism coupled to the reservoir for forcing the liquid drug from the reservoir, the drive mechanism comprising: a piston head disposed within the interior chamber of the housing; a lead screw coupled to a drive nut, the drive nut including a blade adjacent the piston head, the blade positioned through the slit in the housing, the lead screw having male threads that engage corresponding female threads on the drive nut, such that rotation of the lead screw moves the blade axially along the lead screw; a delivery pump device comprising: A wearable drug delivery device comprising: A twelfth aspect is A wearable drug delivery device in an eleventh aspect, wherein the housing of the reservoir has a core shaft within the internal chamber, the sealing member is formed along the outer surface of the core shaft, the lead screw of the drive mechanism extends within the interior of the core shaft, and the slit is formed through the core shaft. A thirteenth aspect is A wearable drug delivery device in a twelfth aspect, wherein the piston head includes a first seal ring extending around its outer surface and a second seal ring extending around its inner surface, the second seal ring being in direct physical contact with the seal member formed along the outer surface of the core shaft. A fourteenth aspect is The wearable drug delivery device of aspect 11, wherein the blade of the drive nut extends perpendicular to the lead screw and the blade of the drive nut is directly adjacent to an outer surface of the piston head. A fifteenth aspect is A wearable drug delivery device in an eleventh aspect, wherein the sealing member is formed along the inner surface of the outer wall of the housing, the lead screw is positioned outside the housing of the reservoir, and the slit is formed through the outer wall of the housing. A sixteenth aspect is 1. A method comprising: Providing a reservoir configured to store a liquid chemical, said reservoir comprising: a housing including an outer wall defining an interior chamber; A seal member; a slit through the housing, the seal member configured to seal the slit; providing the reservoir, coupling a drive mechanism of a delivery pump device to the reservoir, the drive mechanism comprising: a piston head disposed within the interior chamber of the housing; a lead screw coupled to a drive nut, the drive nut including a blade adjacent the piston head, the blade positionable through the slit in the housing; and coupling the drive mechanism to the reservoir; rotating the lead screw to move the drive nut axially along the lead screw between a first position and a second position to force the liquid chemical from the reservoir; The method includes: A seventeenth aspect is Installing the seal member along an outer surface of a core shaft of the housing, the slit being formed through the core shaft; cutting through the seal member with the blade of the drive nut as the drive nut moves between the first position and the second position; The method of a sixteenth aspect, further comprising: An eighteenth aspect is A method according to a seventeenth aspect, further comprising positioning the lead screw of the drive mechanism within the core shaft. A nineteenth aspect is A method in a seventeenth aspect, further comprising: installing a first seal ring around an outer surface of a piston head; and installing a second seal ring around an inner surface of the piston head, the second seal ring being in direct physical contact with the seal member formed along the outer surface of the core shaft. The twentieth aspect is A method in a sixteenth aspect, further comprising positioning the blade of the drive nut in direct physical contact with an outer surface of the piston head, wherein axial movement of the drive nut moves the piston head within the internal chamber of the housing. A twenty-first aspect is installing the seal member along an inner surface of the outer wall of the housing, the slit being formed through the outer wall of the housing; Mounting the lead screw outside the outer wall of the housing; The method of a sixteenth aspect, further comprising:

Claims

1. A wearable drug delivery device (100), comprising: A reservoir (126) configured to store a liquid chemical (125), said reservoir (126) comprising: a housing (139) including an outer wall (151) defining an interior chamber (150); a seal member (160); a slit (161) through at least a portion of the housing, the seal member being configured to seal the slit; a reservoir (126) comprising: A delivery pump device (105) including a drive mechanism (106) coupled to the reservoir for forcing the liquid drug from the reservoir, the drive mechanism comprising: a piston head (134) disposed within the interior chamber of the housing; a lead screw (135) threadedly engaged with a drive nut, the drive nut having female threads and the lead screw having male threads, the drive nut comprising a blade (168) configured to abut against the piston head and press the piston head into the reservoir to expel medicament from the reservoir, the blade positioned through the slit in the housing and configured to cut through the seal member as the blade moves through the slit; a delivery pump device (105) comprising: A wearable drug delivery device comprising:

2. 2. The wearable drug delivery device of claim 1, wherein the reservoir housing comprises a core shaft (154) within the internal chamber, the seal member is formed along the outer surface of the core shaft, and the lead screw of the drive mechanism extends within the interior of the core shaft.

3. The wearable drug delivery device of claim 2 , wherein the slit is formed through the core shaft.

4. 3. The wearable drug delivery device of claim 2, wherein the piston head includes a first seal ring (162) extending around an outer surface (163) and a second seal ring (177) extending around an inner surface (164), the second seal ring being in direct physical contact with the seal member formed along the outer surface of the core shaft.

5. 2. The wearable drug delivery device of claim 1, wherein the blades of the drive nut extend perpendicular to or radially outward from the lead screw, and the blades of the drive nut are in direct physical contact with the outer surface (169) of the piston head.

6. The wearable drug delivery device of claim 1 , wherein the seal member is formed along an inner surface of the outer wall of the housing.

7. The wearable drug delivery device of claim 1 , wherein the lead screw is positioned external to the housing of the reservoir.

8. The wearable drug delivery device of claim 1 , wherein the slit is formed through the outer wall of the housing.

9. The wearable drug delivery device of claim 1 , wherein the sealing member is a polyethylene film.

10. 2. The wearable drug delivery device of claim 1, wherein the lead screw has a male thread that engages with a corresponding female thread of the drive nut, and rotation of the lead screw moves the drive nut axially along the lead screw.

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