Large-volume wearable drug delivery device

Abstract

Provided herein is a wearable drug delivery device including a housing having a perimeter and defining an interior, the housing having first and second ports arranged on an external surface thereof, a needle moveable between a first position in which the needle is received entirely within the housing interior and a second position in which at least a portion of the needle extends through the first port, a button arranged on the external surface of the housing, the button configured to cause the needle to move from the first position to the second position, a cannula arranged about an exterior of the needle, a pump received within the housing interior, the pump in fluid communication with the cannula, a reservoir arranged outside of the housing interior and offset from the housing perimeter, the reservoir in fluid communication with the second port and the pump.

Description

LARGE- VOLUME WEARABLE DRUG DELIVERY DEVICECROSS-REFERENCE TO RELATED APPLICATION

[0001] The present invention claims priority to United States Provisional Application No. 63 / 535,096, entitled “Large-Volume Wearable Drug Delivery Device” filed August 29, 2023, the disclosure of which is hereby incorporated by reference in its entirety.BACKGROUND OF THE INVENTIONField of the Invention

[0002] The present disclosure relates generally to wearable drug delivery devices, and in particular, to wearable drug delivery devices with large-volume reservoirs and features that allow for greater comfort and security when being worn by a patient.Description of Related Art

[0003] Various types of automatic injection or drug delivery devices have been developed to allow drug solutions and other liquid therapeutic preparations to be administered by medical personnel or to be self-injected. Generally, these devices include a reservoir that is pre-filled with the liquid therapeutic preparation, and some type of automatic needle-injection mechanism that can be triggered by the user. When the volume of fluid or drug to be administered is generally below a certain volume, such as 1 mL, an auto-injector is typically used, which typically has an injection time of about 10 to 15 seconds. When the volume of fluid or drug to be administered is above 1 mL and / or when the fluid is sufficiently viscous, the injection time generally becomes longer, resulting in difficulties for the patient to maintain compliance and contact between the device and the target area of the patient’s skin. Further, as the volume of drug to be administered becomes larger, increasing the time period for injection becomes desirable. The traditional method for a drug to be injected slowly into a patient is to initiate an IV and inject the drug into the patient’s body slowly. Such a procedure is typically performed in a hospital or an outpatient setting.

[0004] Conventional automatic injectors are limited in the amount of pharmaceutical compositions that can delivered to the patient due to size constraints of the injector itself. Typically, it is desirable for the automatic injector to be discretely worn, providing only limited space for the storage of the pharmaceutical composition. Furthermore, automatic injectors are typically adhered to the patient’s skin by an adhesive pad, which limits the weight of pharmaceutical composition that can be safely carried without risk of detachment. Thus, thereis a need in the art for wearable devices with larger reservoirs and with features that increase patient compliance and allow for more secure adherence of the device to the patient.SUMMARY OF THE INVENTION

[0005] Provided herein is a wearable drug delivery device including a housing having a perimeter and defining an interior, the housing having first and second ports arranged on an external surface thereof, an adhesive pad arranged on the external surface of the housing, the adhesive pad configured to removably secure the housing to a patient’s skin, a needle moveable between a first position in which the needle is received entirely within the housing interior and a second position in which at least a portion of the needle extends through the first port, a button arranged on the external surface of the housing, the button configured to cause the needle to move from the first position to the second position, a cannula arranged about an exterior of the needle, a pump received within the housing interior, the pump in fluid communication with the cannula, and a reservoir arranged outside of the housing interior and offset from the housing perimeter, the reservoir in fluid communication with the second port and the pump.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] FIG. 1 is a perspective view of a drug delivery device according to non-limiting embodiments described herein;

[0007] FIG. 2 is a rear perspective view of a drug delivery device according to non-limiting embodiments described herein;

[0008] FIG. 3 is a perspective view of a drug delivery device according to non-limiting embodiments described herein;

[0009] FIG. 4 is a schematic view of a drug delivery device according to non-limiting embodiments described herein;

[0010] FIG. 5 is a schematic view of a drug delivery device according to non-limiting embodiments described herein;

[0011] FIG. 6 is a top view of a drug delivery device according to non-limiting embodiments described herein;

[0012] FIG. 7 is a perspective, partially exploded view of a drug delivery device according to non-limiting embodiments described herein;

[0013] FIG. 8 is a perspective view of a drug delivery device according to non-limiting embodiments described herein;

[0014] FIG. 9 is a top view of a drug delivery device according to non-limiting embodiments described herein;

[0015] FIG. 10 is a top view of a drug delivery device according to non-limiting embodiments described herein;

[0016] FIG. 11 is a top view of a drug delivery device according to non-limiting embodiments described herein;

[0017] FIG. 12 is a top view of a drug delivery device according to non-limiting embodiments described herein;

[0018] FIG. 13 is a top view of a drug delivery device according to non-limiting embodiments described herein;

[0019] FIGS. 14A and 14B is a top view of a drug delivery device according to non-limiting embodiments described herein;

[0020] FIG. 15 is a front view of an adhesive pad according to non-limiting embodiments described herein;

[0021] FIG. 16 is a front view of an adhesive pad according to non-limiting embodiments described herein;

[0022] FIG. 17 is a front view of an adhesive pad according to non-limiting embodiments described herein;

[0023] FIG. 18 is a front view of an adhesive pad according to non-limiting embodiments described herein;

[0024] FIG. 19 is a front view of an adhesive pad according to non-limiting embodiments described herein;

[0025] FIG. 20 is a schematic view of a drug delivery device according to non-limiting embodiments described herein; and

[0026] FIG. 21 is a diagram of a non-limiting embodiment or aspect of components of a drug delivery device as described herein.DESCRIPTION OF THE INVENTION

[0027] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0028] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.

[0029] It should be understood that any numerical range recited herein is intended to include all values and sub-ranges subsumed therein. For example, a range of “1 to 10” is intended to include all sub-ranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, that is, having a minimum value equal to or greater than 1 and a maximum value of equal to or less than 10.

[0030] Provided herein are wearable drug delivery devices with larger reservoirs to allow for delivery of a wider variety of therapeutic compositions, including features that increase patient compliance and adherence of the device to the patient, ensuring full delivery of the therapeutic compositions. Various components that may be useful in a drug delivery device as described herein, and functioning of those components, are presented in U.S. Patent Application Publication Nos. 2022 / 0211952, 2022 / 0211935, 2022 / 0211939, 2022 / 0211936, and 2022 / 0211940, the contents of which are incorporated herein by reference in their entirety.

[0031] Turning to FIGS. 1 and 2, shown is a non-limiting embodiment of a wearable drug delivery device 100. Drug delivery device 100 includes a housing 110 that defines a perimeter. Housing 110 may have a top surface, a bottom surface, a front surface, a rear surface, and side surfaces. Housing 110 may be formed of any suitable material, and as will be discussed below, may include a plurality of sections, which may, in non-limiting embodiments, be separable from one another. Drug delivery device 100 further includes a container 120 that is connectable to housing 110, but which falls outside of the perimeter of the housing 110. Container 120 may extend from any surface of housing 110. As shown in FIG 1, container 120 extends from a side of housing 110. As also shown in FIG. 1, drug delivery device 100 may include an adhesive pad 130, which may be configured to secure drug delivery device 100 to a patient. Suitable adhesives, including those with anti-microbial and / or biocompatible features, are known to those of skill in the art and may be useful with drug delivery device 100. In nonlimiting embodiments (as will be discussed below), adhesive pad 130 may include an adhesive layer and a backing layer. As shown in FIG. 1, drug delivery device 100 may further includea button 150, which may be a mechanical or an electronic button, which can be configured to cause a needle (not shown) to prick the skin of the patient, to allow for a cannula (not shown) to be placed through the patient’s skin, for example subcutaneously, for delivery of a therapeutic composition. Button 150 and insertion mechanism 246 (shown in FIG. 4, for example) may be linked mechanically and / or electrically, such that the injection mechanism may be mechanical / manual, responsive to depressing button 150, and / or may be electric al / automatic, for example based on instructions received from a processor in response to depressing button 150. In non-limiting embodiments, drug delivery device 100 may be activated remotely, through one or more computer components as described herein. As shown in FIG. 1, drug delivery device 100 may further include a display 140. Display 140 may be configured to display any useful information. In non-limiting embodiments, display 140 is configured to display status of delivery of a therapeutic composition.

[0032] Turning to FIG. 2, shown is a rear view of a non-limiting embodiment of drug delivery device 100. Drug delivery device 100 may include one or more ports 160 to allow for drug delivery and / or filling of container 120. A port through which needle and cannula pass may align with an opening in adhesive pad 130 (such as port 160, shown in FIG. 2), or may pass through adhesive pad 130. Shown is a non-limiting embodiment including a port 160 for filling of container 120, for example through use of a syringe, such as a pre-filled syringe.

[0033] Turning to FIGS. 3-5, shown is a non-limiting embodiment of drug delivery device 100, in which housing 110 is divided into a plurality of discrete sections, and these sections may optionally be separable from one another. While not shown in FIG. 4, one of skill will appreciate that various components in housing interior 112 may be interconnected electrically, mechanically, and / or fluidically (as will be shown later, for example, with reference to FIG. 20). For example, drug delivery device 100 may be divided into a power pack module 210, and a fluidic module 220, which may include a container portion 230 and an injection portion 240. Power pack module 210 may include electronic components, such as a power source 212, motor 214, and one or more computer components 180, such as a processor and / or storage. In non-limiting embodiments, power pack module 210 includes pump 242 and / or motor 214. In non-limiting embodiments, fluidic module 220 includes pump 242. As used herein, the term “computer components” includes one or more components shown in FIG. 21 and described herein with reference to that figure. In non-limiting embodiments, power pack module 210 may be reusable (e.g., power pack module 210 may be separable from container portion 230 and injection portion 240). In non-limiting embodiments, fluidic module 220 is disposable. Innon-limiting embodiments, power source 212 is a rechargeable power source or may be replaced.

[0034] In non-limiting embodiments, power pack module 210 and / or fluidic module 220 may include one or more sensors for detecting one or more parameters of the drug delivery device 100 and / or environment. Exemplary sensors can include those for detecting volume, flow rate, pressure, and / or occlusions within container 120, flexible reservoir 232, one or more fluid conduits included in drug delivery device 100 (for example, those exemplified in FIG. 20) and / or cannula 107. Such sensors may be in communication with, and provide data to, a processor, which may make use of such data to control motor 214 and / or pump 242. FIG. 5 shows an embodiment with a sensor 133 in a certain location within housing interior 112, though it will be appreciated by those of skill in the art that different types of sensors will necessarily be arranged at certain locations within housing interior 112.

[0035] With continuing reference to FIGS. 3-5, fluidic module 220 may include container portion 230, which may include container 120 and, optionally, a flexible reservoir 232 received within container 120. In non-limiting embodiments, container 120 and / or flexible reservoir 232 may be formed of a substantially or completely transparent material, to aid in visualizing any therapeutic composition included therein or added thereto. Those of skill in the art will appreciate that any therapeutic composition can be delivered with the devices described herein; however, those therapeutic compositions which are delivered on a time delay and / or across a long time frame may be particularly suitable for use with the drug delivery devices described herein.

[0036] Fluidic module 220 may also include injection portion 240, which may include pump 242, filling interface 244, and insertion mechanism 246. In non-limiting embodiments, for example where there is only one port 160 in housing 110, filing interface 244 and insertion mechanism 246 may be the same structure. Pump 242 may be in electrical and / or mechanical communication with motor 214, and in fluidic communication with container 120 and insertion mechanism 246. Filling interface 244 may be associated with one or more ports 160 arranged on a surface of housing 110, and may be in fluidic communication with container 120. Insertion mechanism 246 may be in fluidic communication with pump 242, and, with reference to FIG. 5, may include a needle 157 for piercing skin of a user, and a cannula 107 for delivering a therapeutic composition from container 120 to the patient. Needles and cannulae useful in wearable drug delivery devices are known to those of skill in the art and can be formed of any suitable material.

[0037] Turning to FIGS. 6 and 7, shown are non-limiting embodiments of drug delivery device 100, with emphasis on the removable, pivoting connection between container 120 and housing 110. Without wishing to be bound by the theory, it is believed that a pivoting connection between housing 110 and container 120 allows for drug delivery device 100 to conform to a patient’s waist / stomach, where wearable drug delivery devices are typically placed. As noted above, container 120 may be removable from housing 110, to allow for reuse of one or more components, for example of container 120, power pack module 210 and / or injection portion 240. While FIG. 6, as well as FIGS. 9-11, show pivoting of container 120 across a 40 degree span, those of skill in the art will appreciate that any amount of pivoting, across any angle variation, may be made possible to allow for drug delivery device 100 to securely adhere to a patient.

[0038] Turning to FIG. 8, shown is a non-limiting embodiment of drug delivery device 100, in which container 120 is arranged extending from a bottom surface of housing 110. Drug delivery device 100 in the illustrated embodiment of FIG. 8 may include any feature described herein, including distinct, separable modules / portions, button 150, port 160, display 140, and / or adhesive pad 130.

[0039] Turning to FIGS. 9-14B, shown are non-limiting embodiments of various arrangements of housing 110, container 120, and adhesive 130 of drug delivery device 100. As described briefly above, adhesive pad 130 may include an adhesive layer 132 and a backing layer 134, which overlays adhesive layer 132 prior to application to a patient’s body. Adhesive layer 132 may be formed of any suitable material, and may include any suitable adhesive(s), including, optionally, adhesives with biocompatibility, skin breathability, and / or an antimicrobial property or additive, such as a chlorhexidine gluconate (CHG). In various nonlimiting embodiments, adhesive layer 132 may be a continuous layer that extends along substantially the entire length of housing 110 and container 120, and, in non-limiting embodiments, beyond a perimeter of housing 110 and / or container 120. In non-limiting embodiments, for example as shown in FIGS. 10 and 11, adhesive layer 132 may be discontinuous, for example, adhesive layer 132 may be provided only on a rear surface of housing 110 (132a) and / or container 120 (132b), and not, for example, adjacent a pivot point between housing 110 and container 120. In either embodiment, backing layer 134 may be discontinuous (having parts 134a and 134b that substantially correspond to adhesive layers 132a and 132b), or continuous, as shown in FIGS. 10 and 11, respectively.

[0040] Turning to FIG. 13, in non-limiting embodiments, housing 110, which may include power pack module 210 and injection portion 240 of fluidic module 220 as discussedpreviously, may be provided as generally shown in, for example, FIG. 1. Container portion 230 of fluidic module 220, which may include flexible reservoir 232, may have a rear surface that is curved, for example to align with a patient’s waist or stomach, allowing for a more secure attachment of adhesive layer 132. As also noted previously, a pivot point 170 may be included between housing 110 (including power pack module 210 and injection portion 240) and container module 230.

[0041] With regard to FIGS. 14A-14B, non-limiting arrangements of drug delivery device 100 are shown. In FIG. 14 , housing 110, which may include power pack module and injection portion 240 of fluidic module 220 as discussed previously, may be provided as generally shown in, for example, FIG. 1. Container portion 230 of fluidic module 220, which may include flexible reservoir 232, may have a rear surface that is curved, for example to align with a patient’s waist or stomach, allowing for a more secure attachment of adhesive layer 132. In FIG. 14A, container module 230 is split into multiple sections, with a pivot point 170 between each. Container modules 230 may independently contain, or not contain, a flexible reservoir 232, may have curved rear surfaces and may be in fluid communication with a port on housing 110 and a pump received within injection portion 240. The container modules may be fluidly connected by tubing. In FIG. 14B, power pack module 210 and injection portion 240 of fluidic module 220 are separated by a pivot point 170, and injection portion 240, as well as container portion 230 of fluidic module 220, which may include flexible reservoir 232, may have a rear surface that is curved, for example to align with a patient’s waist or stomach, allowing for a more secure attachment of adhesive layer 132. In embodiments, mechanical interfacing between the power pack module 210 and injection portion 240 of fluidic module 220 may be via a universal joint or friction coupling, electrical interfacing may be via a ribbon cable, and fluid interfacing may be via tubing between internal components of the modules.

[0042] Turning to FIGS. 15-19, shown are non-limiting embodiments of adhesive layer 132 as may be useful in any embodiment of drug delivery device 100 described herein in order to bring flexibility to the adhesive and to bring comfort when the device is worn. The non-limiting embodiments of FIGS. 15-19 may be useful in, for example, the arrangements of housing 110 and container 120 shown in FIGS. 9-14B, where adhesive layer 132 may include a transition portion 136 that may be arranged, for example to contact a patient’s skin adjacent a pivot point between housing 110 and container 120, between power pack module 210 and injection portion 240, between injection portion 240 and container module 230, and / or between container modules 230. Transition portion 136 may include a narrowing, and the narrowing may include one or more openings therethrough, which may serve to increase flexibility of thetransition portion 136. Openings may be circular, as shown in FIGS. 15 and 16, and / or may be elongated as shown in FIGS. 17 and 18. In non-limiting embodiments, transition portion 136 may include a plurality of undulations, for example as shown in the non-limiting embodiment of FIG. 19.

[0043] Turning to FIG. 20, shown is a schematic representation of non-limiting embodiments of drug delivery device 100. FIG. 20 illustrates connections between various modules and components of drug delivery device 100. While fluidic connections are exemplified in FIG. 20, those of skill in the art will appreciate that any component(s) may be connected mechanically and / or electrically, and, in terms of data transmission between components, connections may be physical and / or wireless. As described above, drug delivery device 100 may be separated into a power pack module 210 including a power source 212, such as one or more batteries (rechargeable or otherwise), a motor 214, and one or more computer components 180, such as a processor and / or storage. Further description of the one or more computer components that may be included in non-limiting embodiments of drug delivery device 100 are described in FIG. 21. Drug delivery device 100 may include a fluidic module 220, which may include injection portion 240, including an insertion mechanism 246, including a needle and / or cannula (not shown). Fluidic module 220 may further include a container module, including container 120. As described, container 120 may be in fluid communication with a port 160 in housing 110, for example through fluid conduits 122, 129. Container 120 and / or flexible reservoir 232 may also be in fluid communication with pump 242, optionally through fluid conduits 122, 129, and 124. Pump 242 may be in fluid communication with insertion mechanism 246. For example, through fluid conduit 126. Optionally fluid conduit 126 may include a reservoir adjacent to insertion mechanism 246.

[0044] Referring now to FIG. 21, shown is a diagram of example components of an exemplary computing device 900 that can be used in the drug delivery device 100 described herein. Such a computing device 900 may correspond to a component within a connection module of a drug delivery device as described herein, a user device as described herein, and / or a healthcare system as described herein. As shown in FIG. 21, a computing device 900 may include bus 902, processor 904, memory 906, storage component 908, input component 910, output component 912, and / or communication interface 914.

[0045] Bus 902 may include a component that permits communication among the components of computing device 900. In some non-limiting embodiments, processor 904 may be implemented in hardware, software, or a combination of hardware and software. For example, processor 904 may include a processor (e.g., a central processing unit (CPU), agraphics processing unit (GPU), an accelerated processing unit (APU), and / or the like), a microprocessor, a digital signal processor (DSP), and / or any processing component (e.g., a field-programmable gate array (FPGA), an application-specific integrated circuit (ASIC), and / or the like) that can be programmed to perform a function. Memory 906 may include random access memory (RAM), read-only memory (ROM), and / or another type of dynamic or static storage memory (e.g., flash memory, magnetic memory, optical memory, and / or the like) that stores information and / or instructions for use by processor 904.

[0046] Storage component 908 may store information and / or software related to the operation and use of computing device 900. For example, storage component 908 may include a hard disk (e.g., a magnetic disk, an optical disk, a magneto-optic disk, a solid state disk, and / or the like), a compact disc (CD), a digital versatile disc (DVD), a floppy disk, a cartridge, a magnetic tape, and / or another type of computer-readable medium, along with a corresponding drive.

[0047] Input component 910 may include a component that permits computing device 900 to receive information, such as via user input (e.g., a touch screen display, a keyboard, a keypad, a mouse, a button, a switch, a microphone, and / or the like). Additionally or alternatively, input component 910 may include a sensor for sensing information (e.g., a global positioning system (GPS) component, an accelerometer, a gyroscope, an actuator, a microphone, an environmental sensor (e.g., temperature, humidity, and / or the like). Output component 912 may include a component that provides output information from a computing device (e.g., a display, a speaker, one or more light-emitting diodes (LEDs), a tactile indicator, and / or the like).

[0048] Communication interface 914 may include a transceiver-like component (e.g., a transceiver, a separate receiver, and transmitter, etc.) that enables the device to communicate with other devices, such as via a wired connection, a wireless connection, or a combination of wired and wireless connections. Communication interface 914 may permit computing device 900 to transmit and / or receive information from another device. For example, communication interface 914 may include an Ethernet interface, an optical interface, a coaxial interface, an infrared interface, a radio frequency (RF) interface, a universal serial bus (USB) interface, a Wi-Fi® interface, a cellular network interface, a BLUETOOTH interface, near-field communication (NFC) interface, and / or the like. Suitable communication protocols and methods for securing communications between communication interface 914 and a communication interface of another device, such as a computing device (e.g., desktop computer, laptop computer, smartphone, smart watch, PDA, tablet, etc.,) can includeencryption, e.g., using a secure socket layer (SSL) (e.g., by using public / private key pairs as are known in the art). Additional security protocols are disclosed in, for example, U.S. Patent Nos. 9,445,264 and 9,463,325, the contents of which are hereby incorporated by reference in their entirety. In non-limiting embodiments described herein, a communication interface 914 is provided on the plunger rod. In non-limiting embodiments, communication interface 914 is configured to transmit data, but is not configured to receive data transmitted by a computing device, for example by a user’s smartphone.

[0049] A computing device may perform one or more processes described herein. A computing device may perform these processes based on processor 904 executing software instructions stored by a computer-readable medium, such as memory 906 and / or storage component 908, and / or being instructed by a separate computing device. A computer-readable medium (e.g., a non-transitory computer-readable medium) is defined herein as a non- transitory memory device. A non-transitory memory device includes memory space located inside of a single physical storage device or memory space spread across multiple physical storage devices.

[0050] Software instructions may be read into memory 906 and / or storage component 908 from another computer-readable medium or from another device via communication interface 914. When executed, software instructions stored in memory 906 and / or storage component 908 may cause processor 904 to perform one or more processes described herein. Additionally or alternatively, hardwired circuitry may be used in place of or in combination with software instructions to perform one or more processes described herein. Thus, embodiments described herein are not limited to any specific combination of hardware circuitry and software.

[0051] With reference to the accompanying figures, drug delivery device 100 may be operated as follows. A physician or patient may, for example with a syringe, fill container 120 and / or flexible reservoir 232. Drug delivery device 100 may then be applied to the patient, for example with adhesive pad 130. Physician or patient may then press button 150 to begin drug delivery process. Drug delivery process may begin, in non-limiting embodiments, by needle 157 piercing the patient’s skin. By piercing the patient’s skin, cannula 107, which may be received about needle 157, similarly traverses the patient’s skin, and is placed, for example, in a position in which the therapeutic composition may be delivered subcutaneously. Button 150 may be mechanically connected to insertion mechanism 246, such that depressing button 150 causes a corresponding translation of insertion mechanism 246 and needle 157. In embodiments, button 150 is in communication with computer components 180, such as a processor, and pressing button 150 causes the processor to instruct the insertion mechanism246 (for example, based on programming instructions stored in memory 906 that is included with computer components 180), to move the needle 157 to pierce the patient’s skin and place the cannula 107. In non-limiting embodiments, drug delivery may be initiated by actuation of button 150, or another button included on housing 110 (or through a wireless interface, for example via a mobile application for example). In non-limiting embodiments, drug delivery may be delayed based on a mechanical and / or electromechanical delay component, and / or may be delayed based on programming instructions executed by a processor. Following the delay, which may be predetermined based on the therapeutic composition to be delivered, motor 214, optionally under the control of a processor, may cause pump 242 to begin withdrawing therapeutic composition from container 120 and / or flexible reservoir 232, and to cause therapeutic composition to be dispensed through cannula 107. In embodiments, a processor may cause display 140 to provide an indication of the status of drug delivery. In embodiments, a processor may control one or more indicators to provide a visual, audible, and / or tactile indication of completion of the drug delivery process. After drug delivery has been completed, insertion mechanism 246, optionally under the control of a processor, withdrawn cannula 107 and drug delivery device 100 may be disposed of, or, in embodiments, one or more modules and / or portions of drug delivery device 100 may be disposed of or reused.

[0052] Although the present disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the present disclosure is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

THE INVENTION CLAIMED IS1. A wearable drug delivery device comprising: a housing having a perimeter and defining an interior, the housing having first and second ports arranged on an external surface thereof; an adhesive pad arranged on the external surface of the housing, the adhesive pad configured to removably secure the housing to a patient’s skin; a needle moveable between a first position in which the needle is received entirely within the housing interior and a second position in which at least a portion of the needle extends through the first port; a button arranged on the external surface of the housing, the button configured to cause the needle to move from the first position to the second position; a cannula arranged about an exterior of the needle; a pump received within the housing interior, the pump in fluid communication with the cannula; and a reservoir arranged outside of the housing interior and offset from the housing perimeter, the reservoir in fluid communication with the second port and the pump.

2. The wearable drug delivery device of claim 1, wherein the housing comprises a top surface, a bottom surface, a front surface, a back surface, and two side surfaces, wherein the adhesive pad is arranged on the back surface of the housing.

3. The wearable drug delivery device of claim 2, wherein the reservoir extends from the bottom surface of the housing, optionally at a pivot point.

4. The wearable drug delivery device of claim 2, wherein the reservoir extends from a side surface of the housing, optionally at a pivot point.

5. The wearable drug delivery device of claim 4, wherein the reservoir comprises a front surface and a back surface, and wherein the back surface is curved.

6. The wearable drug delivery device of claim 4 or claim 5, wherein the reservoir comprises a plurality of sections, with a pivot between adjacent sections.

7. The wearable drug delivery device of claim 5 or claim 6, wherein the adhesive pad is arranged on the back surface of the reservoir.

8. The wearable drug delivery device of claim 2, wherein the second port is arranged on the front surface of the housing.

9. The wearable drug delivery device of claim 2, wherein the second port is arranged on the back surface of the housing.

10. The wearable drug delivery device of claim 2, wherein the button is arranged on the front surface of the housing.

11. The wearable drug delivery device of claim 2, wherein the housing comprises a plurality of sections that are separable from one another.

12. The wearable drug delivery device of claim 11 wherein a first section of the housing comprises a power source and a motor configured to actuate the pump.

13. The wearable drug delivery device of claim 12, wherein the first section further comprises a processor.

14. The wearable drug delivery device of claim 12 or claim 13, wherein a second section of the housing comprises the pump, the needle, the first port, and the second port.

15. The wearable drug delivery device of any of claims 12-14, wherein the back surface of at least one of the plurality of housing sections is curved.

16. The wearable drug delivery device of any of claims 2-15, further comprising a display on the external surface of the housing.

17. The wearable drug delivery device of claim 16, wherein the display is arranged on the front surface and / or the top surface of the housing.

18. The wearable drug delivery device of claim 17, wherein the display is configured to provide a visual indication of progress of drug delivery.

19. The wearable drug delivery device of any of claims 1-15, wherein the reservoir comprises a flexible container received within a rigid container.

20. The wearable drug delivery device of claim 19, wherein the flexible container is in fluid communication with the pump and the second port.

21. The wearable drug delivery device of claim 19 or claim 20, wherein the rigid container and the flexible container are substantially transparent.

22. The wearable drug delivery device of any of claims 1-21, wherein the adhesive pad is arranged on both the housing and the reservoir.

23. The wearable drug delivery device of claim 22, wherein the adhesive pad comprises first and second sections, connected by a transition section.

24. The wearable drug delivery device of claim 23, wherein the transition section comprises a plurality of openings in the pad.

25. The wearable drug delivery device of claim 24, wherein the openings are circular or elongated.

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