Wearable injection device

Abstract

The present disclosure relates to a wearable injection device that includes a flexible element. An exemplary device can include a flexible reservoir, a flexible housing, and a flexible metering mechanism. The flexible element of the present disclosure provides an improved wearable injection device with a low profile, streamlined flexible case that can withstand impacts without adversely affecting performance or being torn off the patient.

Description

[Technical Field]

[0001] The present disclosure relates generally to wearable injection devices, such as patch pumps and pump systems, having flexible elements that enable parenteral administration routes, such as subcutaneous, intradermal, intramuscular, or intravenous delivery. [Background technology]

[0002] Common conditions requiring frequent injections can be burdensome for patients. For example, diabetic patients must monitor and regulate their blood glucose levels multiple times a day by administering insulin injections. Treatments for chronic pain, migraines, rheumatoid arthritis, psoriasis, IBD / Crohn's disease, asthma, dermatitis, cardiovascular disease, or other therapies, such as cancer treatment with immuno-oncology drugs, can require frequent injections and delivery of larger volumes, greater than 2 mL per injection. These measures can disrupt patients' daily routines and negatively impact their lifestyles.

[0003] Currently, there are two types of wearable injection devices used by patients who require frequent parenteral injections. The first is an injection pump that is attached to the body, usually on a belt. The pump is connected by tubing to a needle inserted into the body. The second, relevant to this disclosure, is a patch pump that is attached to the patient's skin with an adhesive. Patch pumps provide partially automated medication injections and can reduce some of the burden on the patient. However, current patch pumps may have drawbacks.

[0004] For example, patch pumps that initially operated for patients for a few hours to a day are now being adapted to last for three days or longer. As the need for longer-lasting patch pumps has arisen, the conventional reservoirs and batteries used in patch pumps have grown in size to meet this need, increasing the weight of the pumps and causing them to extend higher above the patient's skin. Furthermore, current patch pumps have rigid cases that cannot deform with the skin while the patient is moving. Current patch pumps also require relatively powerful pump mechanisms to overcome the break-loose and glide forces of stoppers present in conventional reservoirs, further increasing the size of the pump mechanism and battery. For these reasons, current patch pumps are at risk of becoming dislodged or dislodged if the patient bumps the rigid body. Patch pumps have the potential to help alleviate the burden on patients with diseases that require frequent injections. However, drawbacks of currently available patch pumps have slowed their adoption. Summary of the Invention [Problem to be solved by the invention]

[0005] There is a need for improved patch pumps that overcome the shortcomings of currently available devices. Accordingly, the present disclosure relates to wearable injection devices, such as patch pumps and patch pump systems, having flexible bodies and flexible reservoirs that offer advantages over current devices. [Means for solving the problem]

[0006] The present disclosure generally relates to a wearable injection device with flexible elements that improves user experience and quality of care. The wearable injection device can include multiple flexible elements, such as a flexible housing, a flexible reservoir, and flexible electronics. The flexible elements can lower the profile of the device and allow it to bend and flex with the patient's skin to which it is adhered. This can reduce patient discomfort and minimize the possibility of the device suddenly becoming detached, which can occur, for example, when a diabetic patient is engaging in physical activities recommended to improve their health.

[0007] In one embodiment, the present disclosure provides a wearable injection device including a housing including a flexible body and a reservoir. The reservoir includes a flexible outer wall having an interior volume and at least one port in fluid communication with the interior volume. In various embodiments, the flexible body includes one of silicone, polyurethane rubber, or a synthetic rubber such as neoprene foam, styrene-butadiene rubber (SBR), styrene-chloroprene rubber (SCR), or chloroprene rubber (CR).

[0008] The wearable injection device of the present disclosure further includes a pump mechanism configured to dispense a medication from the wearable injection device. In various embodiments, the wearable injection device further includes an injection mechanism in fluid communication with the interior volume of the reservoir. Additionally, the wearable injection device includes a metering mechanism configured to control the dosage of the medication dispensed from the wearable injection device.

[0009] In another embodiment, the present disclosure provides a wearable injection device including a housing including a plate and a reservoir. The reservoir includes a flexible outer wall having an interior volume and at least one port in fluid communication with the interior volume. The wearable injection device further includes a pump mechanism configured to dispense a medication from the wearable injection device. In various embodiments, the wearable injection device further includes an injection mechanism in fluid communication with the interior volume of the reservoir. Additionally, the wearable injection device includes a metering mechanism configured to control the dosage of the medication dispensed from the wearable injection device.

[0010] In another embodiment, the present disclosure provides a method of delivering medication comprising attaching a wearable injection device to a user and powering on the wearable device. The method of delivering medication further comprises signaling a metering mechanism and dispensing the medication at a programmable dosage and frequency. In some embodiments, the method further comprises bending or compressing the wearable injection device without permanently affecting the performance and functionality of the wearable injection device.

[0011] In various embodiments, the pharmaceutical agent used in the devices and methods of the present disclosure is insulin. In some embodiments, the pharmaceutical agent comprises one of human insulin, a human insulin analog or derivative, a glucagon-like peptide (GLP-1), a GLP-1 analog, a GLP-1 receptor agonist, a GLP-1 analog or derivative, a dipeptidyl peptidase-4 (DPP4) inhibitor, a pharmaceutically acceptable DPP4 salt, a DPP4 solvate, or any mixture thereof.

[0012] In another embodiment, the present disclosure provides a reservoir for use in an injection device. The reservoir includes a flexible outer wall, an internal volume, at least one port, and a channel connecting the at least one port to the internal volume. In some embodiments, the flexible outer wall of the reservoir includes a polymer. In some embodiments, the at least one port includes a resealable membrane or valve.

[0013]

[0006] Embodiments of the present disclosure provide wearable injection devices, such as patch pumps, and methods of delivering medication that improve user experience and quality of care. The embodiments of the present disclosure provide flexible elements that allow for a low profile of the device. The disclosed embodiments also provide a wearable injection device that can bend and flex with the skin to which it is adhered to reduce patient discomfort and prevent device dislodgement.

[0014] Reference will now be made to exemplary embodiments, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. The drawings are not necessarily to scale. [Brief explanation of the drawings]

[0015] [Figure 1] 1 illustrates a wearable injection device according to various embodiments of the present disclosure. [Figure 2] 2 illustrates an exploded view of the wearable injection device shown in FIG. 1 according to various embodiments of the present disclosure. [Figure 3A] 3 illustrates the flexible body of FIG. 2 according to various embodiments of the present disclosure. [Figure 3B] 3A-3C illustrate different embodiments of the flexible body of FIG. 2 according to various embodiments of the present disclosure. [Figure 4A] 3 shows a side view of the reservoir of FIG. 2 according to various embodiments of the present disclosure. [Figure 4B] 3 shows a top view of the reservoir of FIG. 2 according to various embodiments of the present disclosure. [Figure 4C]10A and 10B show a top view and a side view of another embodiment of a reservoir according to various embodiments of the present disclosure. [Figure 5A] 3 illustrates a perspective view of the flexible base shown in FIG. 2 according to various embodiments of the present disclosure. [Figure 5B] 5B illustrates a bottom view of the flexible base shown in FIG. 5A according to various embodiments of the present disclosure. [Figure 6] 10 illustrates another embodiment of a wearable injection device in which the housing includes multiple plates, according to various embodiments of the present disclosure. [Figure 7] 7 illustrates one embodiment of a plate used in the housing of the wearable injection device shown in FIG. 6, according to various embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0016] Reference will now be made in detail to various embodiments of the disclosed devices and methods, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or like parts.

[0017] As used herein, the use of the singular includes the plural unless specifically stated otherwise. As used herein, the use of "or" means "and / or" unless specifically stated otherwise. Furthermore, the use of the term "including," as well as other forms such as "includes" and "included," is not limiting. All ranges set forth herein are understood to include the endpoints and all values ​​between those endpoints.

[0018] The section headings used herein are for general information purposes only and should not be construed as limiting the subject matter described. All documents or portions of documents cited in this application, including but not limited to patents, patent applications, articles, books, and treatises, are hereby expressly incorporated by reference in their entirety for all purposes.

[0019] Current patch pumps that adhere to a patient's skin provide partially automated drug injections, alleviating some of the burden on patients. However, current patch pumps have drawbacks. For example, as the need for longer-lasting patch pumps has arisen, conventional reservoirs and batteries used in patch pumps have grown in size, resulting in taller, heavier pumps that extend further from the patient's skin. Current patch pumps can pull the adhesive from the skin, potentially causing the device to loosen from the patient's skin. These drawbacks have hindered the development of patch pumps for a wider range of therapeutic indications, such as when larger volumes must be administered over multiple days.

[0020] Furthermore, current patch pumps have rigid cases that cannot deform with the skin or limb to which the pump is attached while a person moves. As a result, current patch pumps can be torn off if a patient bumps into the rigid body. For example, current patch pumps can be torn off if a patient bumps into a door frame or similar hard surface. Patch pumps have the potential to help ease the burden of monitoring and regulating blood glucose levels for millions of diabetic patients. However, drawbacks of currently available patch pumps have slowed their adoption.

[0021] Furthermore, current patch pumps use conventional reservoirs that require the pump mechanism to move a rubber stopper to expel the medication. This movement requires the pump mechanism to overcome sliding breakthrough and balancing stresses, which can be relatively high, have some variability, and can increase with storage time. Therefore, the pump mechanism and battery of current patch pumps must be appropriately sized to address the sliding breakthrough and balancing stresses present in conventional reservoirs. In the proposed embodiment with a flexible reservoir, these stresses are not present, allowing for the implementation of smaller pump mechanisms and batteries, resulting in smaller, more lightweight, and / or lower-profile injection devices.

[0022] Embodiments of the present disclosure relate to wearable injection devices, such as insulin patch pumps, that include flexible elements. The flexible elements of the present disclosure allow the wearable injection device to have a lower profile and be lighter weight than current devices. Additionally, the wearable injection device of the present disclosure includes a flexible body that can flex and twist with the patient. The wearable injection device of the present disclosure moves more naturally with the patient, improving patient comfort and reducing the risk of dislodging or loosening.

[0023] One embodiment of an exemplary wearable injection device, injection device 100, is shown in Figure 1. As shown, injection device 100 includes a housing 200. Injection device 100 and its components are described in further detail in Figure 2, which shows an exploded view of injection device 100.

[0024] 2 simplifies the components of the injection device 100 to provide an overview of the main elements of the device. In various embodiments, the housing 200 of the injection device 100 includes a flexible body 210. The flexible body 210 can be provided in a variety of shapes and materials. In various embodiments, the flexible body 210 surrounds many of the components of the injection device 100.

[0025] In various embodiments, the injection device 100 includes a reservoir 300. The reservoir 300 includes a flexible outer wall having an interior volume. In various embodiments, the reservoir 300 contains a medication, fluid, or gel that can be administered subcutaneously by the injection device 100. The reservoir 300 can be provided in a variety of shapes, configurations, materials, and volumes. In various embodiments, the reservoir 300 further includes a port 306 in fluid communication with the interior volume. In various embodiments, the reservoir 300 includes an additional port that can be used to fill or refill the reservoir 300 with a medication, fluid, or gel.

[0026] According to various embodiments of the present disclosure, the injection device 100 includes a pump mechanism 400 configured to dispense a medication from the wearable injection device 100. In various embodiments, the injection device 100 includes an injection mechanism 500 in fluid communication with the interior volume of the reservoir. The injection device 100 further includes a metering mechanism 600 configured to control the dose of medication dispensed from the wearable injection device 100.

[0027] One advantage of the housings of the present disclosure is that they are flexible. When a patient uses the injection device 100, the housing 200 and the flexible body 210 can be temporarily deformed without causing damage to the device and without adversely affecting its function. The flexible body 210 can be provided with various materials to achieve this advantage. For example, the material of the flexible body 210 can have elastic properties to provide a flexible body and acceptable biocompatibility for wearing on the skin for an extended period of time.

[0028] The flexible body 210 can comprise a number of suitable materials. In various embodiments, the flexible body 210 can comprise one of a silicone polymer, a polyurethane rubber, a thermoplastic elastomer, polyvinyl chloride, or a synthetic rubber such as neoprene foam, styrene-butadiene rubber (SBR), styrene-chloroprene rubber (SCR), or chloroprene rubber (CR). In some embodiments, the flexible body 210 can comprise polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polyamide (PA), ethylene vinyl acetate (EVA), cycloolefin copolymer (COC), or cycloolefin polymer (COP). The flexible body 210 can comprise multiple layers of different polymeric materials. In various embodiments, the flexible body 210 can comprise polymers and / or copolymers, including, but not limited to, thermoset elastomers such as ethylene vinyl acetate, low-density polyethylene, polyolefin elastomers, or polypropylene elastomers.

[0029] The exterior of flexible body 210 can be covered with fabric to improve wearing comfort. Flexible body 210 can have a moisture vapor transmission rate that can be beneficial for improving the comfort of wearing the device and improving biocompatibility between the material and the skin. In some embodiments, a semi-permeable membrane material such as Gore-Tex can be used with flexible body 210.

[0030] In some embodiments, the flexible body 210 can be provided as a combination of two or more materials. For example, the flexible body 210 can be formed from a denser or stiffer, more durable material near the metering mechanism to enhance its protection, and a less dense and more flexible material near its periphery (e.g., identified as periphery 211 in FIG. 3A ). In this embodiment, the material at or near periphery 211 can provide a greater range of flexure and deformation, thereby allowing periphery 211 to remain adhered to the patient's skin. In some embodiments, the denser material forms a pattern, such as a lattice, array, spiral, or mosaic, in the less dense material, which can enhance the deformability of the flexible body 210 and reduce the weight of the injection device 100 while still providing sufficient crash protection.

[0031] As discussed above, the flexible body 210 of the injection device 100 can be provided in a variety of configurations and sizes. Figures 3A and 3B show different embodiments of the flexible body 210. Figure 3A shows the flexible body 210 previously shown in Figure 2, according to various embodiments of the present disclosure. The flexible body 210 includes a partial oval shape and has a minimal height, allowing the injection device 100 to have a low profile when adhered to a patient's skin.

[0032] In various embodiments, flexible body 210 includes a periphery 211. While FIG. 3A illustrates flexible body 210 as being concave and partially elliptical, flexible bodies of the present disclosure are not limited to such configurations. For example, flexible body 210 can be polygonal, prismatic, convex, partially convex, concave, partially concave, or a combination thereof. In some embodiments, flexible body 210 mimics a natural shape, such as the shape of a turtle shell, a bivalve shell, a scallop shell, a stingray such as a podworm, or a combination or portion of a combination thereof.

[0033] In some embodiments, the flexible body of the present disclosure can include additional elements to improve adhesion or streamline the profile of the injection device 100. For example, FIG. 3B shows an alternative embodiment of a flexible body according to various embodiments of the present disclosure. The flexible body 210′ ​​includes a dome 212 and a flange 214. In various embodiments, the flange 214 includes a curved, parabolic shape to reduce edges or hard lines on the flexible body 210′. The flange 214 also provides sufficient flat surface area to ensure that the injection device 100 adheres to the patient's skin. The flexible body 210′ ​​has a low-profile, streamlined shape, which results in a minimalistic design that is unobtrusive to the patient.

[0034] In various embodiments, the surfaces of the flexible bodies of the present disclosure are provided in a variety of configurations. For example, the flexible bodies 210, 210' can be provided in a range of colors. In some embodiments, the flexible bodies 210, 210' are provided in a continuous skin tone, so that the wearable injection device 100 blends in with the patient's skin. In some embodiments, the flexible bodies 210, 210' have a variety of surface finishes and configurations to suit the patient's needs. For example, the flexible bodies 210, 210' can have indentations that can improve the patient's grip on the device, for example, when putting on or taking off the device for replacement. In a further example, the flexible bodies 210, 210' can have the same smoothness and / or texture as the skin, so that the wearable injection device 100 blends in with the skin and is less noticeable. In some embodiments, the flexible body 210, 210' can come in colorful colors, patterns, and designs to match the patient's style or to make a child more comfortable with the device, for example.

[0035] In current wearable injectors, the size of the reservoir dictates the final size of the injector itself. This is because current reservoirs are typically cylindrical, rigid cartridges. As the need for longer-lasting patch pumps has arisen, conventional reservoirs and batteries used in patch pumps have grown in size to meet this need, causing the pumps to weigh more and extend higher from the skin. The resulting injectors are more prominent, heavier, bulkier, and protrude further from the skin, increasing the likelihood that the injector will get caught on a surface and become dislodged. To allow for larger reservoir volumes without increasing the height of the wearable injector, the present disclosure provides reservoirs with flexible outer walls that come in a variety of configurations and sizes. The present disclosure further provides reservoirs that can mirror the shape of a housing and be nested within the housing.

[0036] 4A-4C illustrate various reservoir embodiments of the present disclosure. The reservoir 300 of FIG. 2 is shown in FIGS. 4A-4B. FIG. 4A illustrates a side view of the reservoir 300 according to various embodiments of the present disclosure, and FIG. 4B illustrates a top view of the reservoir 300. The reservoir 300 includes a flexible outer wall 302 and an interior volume 304. The flexible outer wall can be provided with a variety of materials. For example, in some embodiments, the flexible outer wall 302 includes polymers such as polyethylene (PE), polypropylene (PP), cycloolefin polymer (COP), polyvinyl chloride (PVC), polyamide (PA), and similar; copolymers such as cycloolefin copolymer (COC), thermoplastics such as various types of thermoplastic elastomers (TPE), silicone, or various combinations thereof.

[0037] The material of flexible reservoir 300 must comply with the requirements for pharmaceutical use as the primary container material and must not affect the physicochemical stability, purity, and sterility of the filled drug product. In some embodiments, reservoir 300 is protected by a separate, attached or laminated flexible shield. The shield is made of a puncture-resistant material, such as carbon fiber or Kevlar. In some embodiments, housing 200 is made of a material with sufficient stiffness or rigidity to provide mechanical protection for the underlying reservoir 300.

[0038] 4A-4B, in various embodiments, reservoir 300 includes at least one port 306. Additionally, reservoir 300 includes a channel 308 connecting port 306 to interior volume 304. In some embodiments, port 306 includes a resealable membrane or valve (not shown). In some embodiments, a user can refill interior volume 304 of reservoir 300 by injecting a medication through port 306. In various embodiments, reservoir 300 includes a separate port and channel dedicated to filling, such that port 306 and channel 308 are dedicated to dispensing the medication.

[0039] Reservoirs of the present disclosure can be provided in a variety of configurations. FIG. 4C shows a top view of another embodiment of a reservoir according to various embodiments of the present disclosure. Reservoir 300′ is provided in an oval torus configuration and includes the same elements as reservoir 300. The interior volume 304 of reservoir 300′ is in the shape of an oval torus. Reservoirs of the present disclosure can be provided in a variety of configurations, including, but not limited to, rectangular, circular, oval, or polygonal. In some embodiments, reservoirs of the present disclosure can be provided in various symmetrical configurations, such as an infinity symbol, or various asymmetrical configurations.

[0040] In various embodiments, the interior volume 304 of the reservoir 300, 300' is provided in a variety of volumes. In some embodiments, the interior volume 304 is 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0, 10.5, 11.0, 11.5, 12.0, 12.5, 13.0, 13.5, 14.0, 14.5, 15.0, 20.0, 25.0, 30.0, 35.0, 40.0, 45.0, 50.0 milliliters (mL) or greater. These values ​​can be used to define discrete volumes, such as 5.0 mL, or ranges of volumes, such as 2.0 to 3.0 mL. In some embodiments, a suitable maximum volume may be up to 50 ml, or even larger if larger injections are required.

[0041] In various embodiments, the flexibility of reservoir 300 allows for the use of a partially filled volume without jeopardizing the functional performance of the injection device. For example, a flexible reservoir that can nominally hold 3 mL may be filled with only 2 mL to provide a flat reservoir. Furthermore, the size of internal volume 304 can be adjusted depending on the concentration or viscosity of the drug, the desired device operation time, or the available space within injection device 100.

[0042] In current devices, rigid reservoir cartridges present several challenges. For example, the plunger used to force the medication toward the outlet of the rigid reservoir forms a tight seal with the inner wall of the reservoir. The maximum force required to overcome the static friction between the plunger and the reservoir wall is called the sliding initiation stress. The energy required to advance the plunger in current devices with rigid reservoirs consumes significant battery energy and space for the plunger to extend.

[0043] In the disclosed device, the flexible reservoir 300 does not include a plunger; deformation of the reservoir's flexible wall alone is sufficient to dispense the drug from the device. Because the disclosed device does not need to overcome sliding initiation stress, a smaller, lighter pump can be used, which consumes less energy and allows for the use of smaller batteries. In particular, a microelectromechanical system pump (MEMS micropump) may be preferred for use with such a compact, precise-dosing, low-energy-consuming device. Furthermore, the disclosed device does not need to accommodate space for the retraction and advancement of a plunger. This allows the disclosed device to be smaller, lighter, and more flexible than current devices.

[0044] In some embodiments, the injection device 100 includes multiple reservoirs. Multiple reservoirs can be implemented to optimize free space within the injection device 100. In some embodiments, using two smaller reservoirs instead of one larger reservoir can optimize space within the injection device, allowing for a lower height and profile of the device. In some embodiments, multiple reservoirs can increase the total volume of medication within the injection device 100 and extend its duration of use, which can also reduce the frequency with which a patient needs to replace or refill reservoirs. In some embodiments, the multiple reservoirs can hold different medications for different patient needs. For example, for a diabetic patient, one reservoir can be responsible for administering insulin at a basal rate, while the other can be used for periodic booster injections.

[0045] It should be noted that the term "flexible reservoir" does not necessarily indicate that all components of the reservoir are flexible. For example, the outer wall 302 may be flexible, but the port 306 may be rigid or semi-rigid to ensure reliable interlocking with other elements of the injection device 100. However, in some embodiments, the reservoir 300, 300' may be entirely flexible.

[0046] Another element of the housing 200 is the flexible base 250, which can be provided in a variety of configurations. FIG. 5A shows an isometric view of the flexible base 250 shown in FIG. 2 according to various embodiments of the present disclosure. In various embodiments, the flexible base 250 includes a flexible sheet 252 and a peripheral edge 251. The flexible sheet 252 can include various materials, including, but not limited to, polymers, copolymers, silicones, elastomers, rubbers, or combinations of these materials. The flexible sheet 252 can be capable of stretching and twisting along multiple axes. With such stretching and twisting, the flexible sheet 252 can remain more reliably adhered to the skin during movement than current rigid, flat surfaces that do not conform to the body during movement.

[0047] 5B shows a bottom view of flexible base 250 shown in FIG. 5A according to various embodiments of the present disclosure. Flexible base 250 further includes adhesive 254. In various embodiments, adhesive 254 is any adhesive known in the art that enables a secure connection between flexible base 250 and the patient's skin. In various embodiments, adhesive 254 covers an entire side of flexible sheet 252. In other embodiments, adhesive 254 covers only a portion of flexible sheet 252. In some embodiments, adhesive 254 is positioned in an array or grid pattern across flexible sheet 252.

[0048] In various embodiments, periphery 251 of flexible base 250 can be aligned with periphery 211 of flexible body 210. In some embodiments, housing 250 is sealed at the junction of periphery 211 and periphery 251. In some embodiments, flexible body 210 partially contacts the patient's skin, for example, in the embodiment shown in FIG. 3B. In such embodiments, flexible base 250 occupies the area below dome 212 and forms a flat surface with flange 214.

[0049] In addition to providing a flexible housing using a flexible material, embodiments of the present disclosure provide a flexible housing using multiple plates. FIG. 6 shows an injection device 100′ in which the housing includes plates 220. In some embodiments, the plates 220 overlap and are made of a rigid or semi-rigid material. In various embodiments, the plates 220 are retractable. Similar to lobster shells, housing flexibility can also be achieved when the plates 220 can overlap to varying degrees and angles to enable bending, twisting, and torsion of the flexible body 210.

[0050] 7 shows a perspective view of one plate 220 used in the housing of a wearable injection device according to various embodiments of the present disclosure. In some embodiments, the plate 220 includes a width 222, a length 224, and a height 226. The length 224 of the plate 220 extends across the width of the flexible body 210. The sum of the widths 222 of each plate 220 is greater than the length of the flexible body 210 to ensure that the plates 220 overlap and protect the inside of the injection device 100′. In some embodiments, the plates 220 have varying degrees of curvature and shape to ensure a secure fit around and adequate coverage of the injection device 100′.

[0051] In some embodiments, the plates 220 form arcs, as shown in FIG. 7 . In some embodiments, the plates 220 form narrow strips with tapered ends. In some embodiments, the plates 220 include multiple flat segments, giving the flexible body 210 a polygonal shape. The construction material for such plates is preferably a plastic material with certain stiffness / rigidity and elastic properties. Suitable materials include polymers such as polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polyamide (PA), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polycarbonate (PC), polyester carbonate (PEC), polystyrene (PS), polyesters such as acrylonitrile-butadiene-styrene copolymer (ABS), polyacetals such as polyoxymethylene (POM), and the like. In some embodiments, each of the plates 220 is connected to at least one additional plate. In some embodiments, each of the plates 220 is connected by a thin, flexible substrate (not shown). The substrate can be constructed from a flexible material such as a silicone polymer, silicone rubber, or a thermoplastic elastomer, and can allow limited stretching and twisting along multiple axes such that the plates 220 always overlap and no gaps form between them.

[0052] Wearable injection devices with more rigid housings may detach from a patient while the patient moves. For example, current devices detach when the skin underneath the device is bent or deformed as a result of physical activity. Current devices may also detach from a patient when the patient bumps into a rigid structure, such as a door frame. In various embodiments, a thin, flexible substrate provides a wearable injection device that conforms to the skin and remains reliably adhered to the skin while the patient moves. In some embodiments, the flexible body 210 includes a rigid or semi-rigid ring around its periphery 211. In such embodiments, points 228 on each plate 220 connect with the ring at the periphery 221.

[0053] In some embodiments, the plates 220 include latches and hooks to prevent the plates 220 from extending too far and creating gaps between the plates 220 or openings in the wearable injection device 100'. In some embodiments, the plates 220 are arranged or positioned in a grid-like, array-like, or fish-scale-like pattern. In such embodiments, the length 224 of the plates 220 is less than the width of the flexible body 210. Similar to chain mail, the multiple smaller plates 220 protect the interior of the injection device 100' while allowing the flexible body 210 to bend, twist, and torsion.

[0054] 2 and 6, the wearable injection device 100, 100′ further includes a pump mechanism 400 configured to dispense medication from the wearable injection device. In various embodiments, the pump mechanism 400 includes any available pump mechanism known in the art. For example, the pump mechanism 400 can include a microelectronic pump system. In various embodiments, the pump mechanism 400 includes a lift pump, a rotary piston pump, a dual piston pump, a membrane pump, or a microelectromechanical system (MEMS) pump, among others. In some embodiments, the pump mechanism 400 includes a MEMS pump and sensor to require less energy, have a small profile, and enable precise dosing. In this embodiment, a smaller battery can be used in the injection device, thereby making the device smaller, lighter, and / or with a lower profile.

[0055] In some embodiments, the wearable injection device 100, 100′ further includes an injection mechanism 500 in fluid communication with the interior volume 304 of the reservoir 300, 300′. In various embodiments, the injection mechanism 500 includes any available injection mechanism known in the art. For example, the injection mechanism 500 can include a cannula and a cannulation system. In some embodiments, the cannulation system includes an introducer needle, a mechanism for injecting the needle, a mechanism for introducing the cannula, and a mechanism for retracting the needle while leaving the cannula in place.

[0056] The injection mechanism 500 can inject medication in a variety of modalities. In some embodiments, the injection mechanism 500 administers medication subcutaneously. In some embodiments, the injection mechanism 500 administers medication intramuscularly. In some embodiments, the injection mechanism 500 administers medication intradermally. In some embodiments, the injection mechanism 500 administers medication intravenously. In some embodiments, the injection mechanism 500 includes a needle or cannula that can be inserted at various angles relative to the patient's skin, including 90°, 75°, 60°, 45°, 25°, 15°, or 10°. In some embodiments, the fluid pathway from the pump mechanism to the injection site can extend from the device as a tubing line with an attached needle, enabling injection in areas of the skin not covered by an attached wearable injection device, as in the case of intravenous injection.

[0057] In various embodiments, the wearable injection device 100, 100′ further includes a metering mechanism 600 configured to control the dosage of medication dispensed from the wearable injection device 100, 100′. In various embodiments, the metering mechanism 600 includes any available metering mechanism known in the art. For example, in some embodiments, the metering mechanism 600 includes a receiving means, a processor, a sensor, and a communication means coupling the metering mechanism 600 with the pump mechanism 400 and the injection mechanism 500.

[0058] To enhance device flexibility and user comfort, in various embodiments, the metering mechanism 600 further includes a flexible circuit board. In some embodiments, the metering mechanism 600 includes a soft or flexible battery. In various embodiments, the metering mechanism 600 further includes an array of battery cells. An array of battery cells can allow the designer greater flexibility regarding where individual batteries can be placed, which can also help reduce the height or overall size of the wearable injection device 100, 100′.

[0059] It should be understood that the specific plate 220 configurations of the present disclosure are exemplary and can be varied based on specific clinical goals. Accordingly, the material, size, shape, and quantity of plates 220 can be modified.

[0060] In various embodiments, the present disclosure provides a method of delivering a medication. The method includes attaching a wearable injection device to a user. The method can include attaching any of the embodiments of the wearable injection device provided in the present disclosure. For example, the method can include attaching an injection device 100, 100′ to a patient or user.

[0061] The next step in the method of delivering medication involves powering on the wearable device, e.g., injection device 100, 100'. In some embodiments, the wearable injection device can be powered on using a physical button on the device. Alternatively, in some embodiments, the wearable injection device can be powered on using an external source, for example, by an external remote device or an application loaded on an electronic device.

[0062] In embodiments where the device is powered using an external source, the method of delivering the medication includes sending a signal by wireless means, such as radio frequency, near field communication (NFC), or Bluetooth. In various embodiments, wireless signaling makes it easier to deliver the medication while the patient is in a state of motion.

[0063] The method of delivering the medication then includes sending a signal to a metering mechanism. Similar to powering on the device, sending a signal to the metering mechanism can include pressing a button on the device or wirelessly activating the metering system using an external source. In various embodiments, the metering mechanism dispenses the medication from the reservoir. In some embodiments, the metering mechanism activates a pump mechanism to draw the medication from the reservoir. The medication then travels through a connecting fluid pathway from the reservoir to the pump system and then to the injection system. In various embodiments, the pump system dispenses the medication into the cannula.

[0064] A subsequent step in the method of delivering medication involves dispensing the medication at a programmable dosage and frequency. In that step, the medication passes through a cannula or needle to the desired injection site. The wearable injection device can be programmed to dispense medication periodically and continuously or intermittently. The device can provide a continuous basal dose and / or intermittent booster doses. Programming the device in this manner can allow the user to deliver a specific medication administration profile over a period of time.

[0065] Programming the device can also allow the user to automate adjustments to the dose profile. For example, the user can program the device to adjust the dose profile in response to input from an external sensor, such as from a continuous blood glucose measurement (CGM) sensor. This is useful, for example, when administering basal insulin to a diabetic patient. Additionally, in some embodiments, the patient or user can administer booster drug injections at various times during the day.

[0066] The methods of delivering a medication of the present disclosure further include bending or compressing the wearable injection device without permanently affecting its performance and functionality, which is enabled by flexible elements such as the flexible reservoir 300, 300′, flexible body 210, 210′, and flexible elements of the metering mechanism 600 described above in connection with the injection device 100, 100′.

[0067] In various embodiments, the method of delivering a medication further includes replacing the entire device to replenish the medication. In those embodiments, the entire wearable injection device is a disposable device. In some embodiments, the method of delivering a medication further includes replacing the reservoir to replenish the medication. A user, such as a patient, physician, or medical professional, can be authorized to replace the entire device or just the reservoir 300, 300′ when the medication volume is low or depleted, or when the treatment time exceeds the medication's permitted use time. In some embodiments, the user can replace the entire reservoir. In various embodiments, the user can refill the reservoir with medication.

[0068] The terms "drug" or "medicament" are used interchangeably herein to describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medications are used to treat, cure, prevent, or diagnose disease or otherwise improve physical or mental well-being. Drugs or medications can be used for a limited duration or periodically for chronic disorders.

[0069] As described below, drugs or pharmaceutical agents may contain at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0070] The drug or agent can be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber can be designed to store the drug for about one month to about three years. Storage can occur at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about +2°C to about 8°C).

[0071] In some embodiments, the drug container can be flexible and have multiple flexible chambers therein for simultaneously dispensing two or more drugs. For example, in some embodiments, the device can include: In some cases, the drug container can be or include a dual-chamber vessel configured to separately house two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber container can be configured to allow mixing between the two or more components before and / or during administration to the human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to allow a user to mix the two components before administration, if desired. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the human or animal body.

[0072] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary embolism. Further examples of disorders include acute coronary syndrome (ACS), angina, myocardial infarction, cancer, pain, blood pressure disorders, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those listed in handbooks such as Rote Liste 2019 (e.g., but not limited to, Main Group 12 (antidiabetic agents) or 86 (oncology agents)) and the Merck Index, 15th edition.

[0073] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, e.g., human insulin, or a human insulin analog or derivative; glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog or derivative thereof; a dipeptidyl peptidase-4 (DPP4) inhibitor; or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or replaced amino acid residue can be either a codable amino acid residue, another naturally occurring residue, or a purely synthetic amino acid residue. Insulin analogs are also referred to as "insulin receptor ligands." In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, for example, the molecular structure of human insulin in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids, including non-codable amino acids, or amino acids, including non-codable ones, are added to the naturally occurring peptide.

[0074] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0075] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0076] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flathead monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rexendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide). , HM-15211, CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP -DI-70, TT-401 (Pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0077] Examples of oligonucleotides are, for example: the cholesterol-lowering antisense therapeutic mipomersen sodium (Kynamro®) for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome.

[0078] Examples of DPP4 inhibitors are linagliptin, vidagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0079] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0080] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low-molecular-weight heparin or ultra-low-molecular-weight heparin or derivatives thereof, or sulfated polysaccharides, such as the polysulfated forms of the aforementioned polysaccharides, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low-molecular-weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives include Hylan G-F20 (Synvisc®) and sodium hyaluronate.

[0081] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain antigen-binding ability. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single-chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, antibody fragment, or mutant that does not support Fc receptor binding, e.g., has a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable region antibody-like binding proteins (CODVs) with a crossover binding region orientation.

[0082] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to antigen. Antibody fragments can include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, e.g., bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, e.g., bivalent, trivalent, tetravalent, and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0083] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences and that are primarily responsible for maintaining the proper orientation of the CDR sequences to enable antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids within the CDRs to interact with the antigen.

[0084] Examples of antibodies are anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0085] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use as drugs or medicaments in drug delivery devices. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0086] Those skilled in the art will appreciate that modifications (additions and / or deletions) to the various components, formulations, devices, methods, systems and embodiments of the API described herein can be made without departing from the full scope and spirit of the invention, which encompasses such modifications and all equivalents thereof.

[0087] Exemplary drug delivery devices may include needle-based injection systems such as those described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems can generally be distinguished into multi-dose container systems and single-dose container systems (with partial or full discharge). The containers may be replaceable or non-replaceable one-piece containers.

[0088] As further described in ISO 11608-1:2014(E), a multi-dose container system may include a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses and may be of fixed or variable size (pre-set by the user). Another multi-dose container system may include a needle-based injection device with a non-replaceable, one-piece container. In such a system, each container holds multiple doses and may be of fixed or variable size (pre-set by the user).

[0089] As further described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with replaceable containers. In one example of such a system, each container holds a single dose and, in doing so, expels the entire deliverable volume (full expulsion). In a further example, each container holds a single dose and, in doing so, expels a portion of the deliverable volume (partial expulsion). Also as described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with a non-replaceable, one-piece container. In one example of such a system, each container holds a single dose and, in doing so, expels the entire deliverable volume (full expulsion). In a further example, each container holds a single dose and, in doing so, expels a portion of the deliverable volume (partial expulsion).

[0090] In one embodiment of the present disclosure, the wearable injection device includes a housing including a flexible body and a reservoir. The reservoir includes a flexible outer wall having an interior volume and at least one port in fluid communication with the interior volume. In some embodiments, the at least one port of the wearable injection device includes a resealable membrane or valve. The wearable injection device further includes a pump mechanism configured to dispense a medication from the wearable injection device. The wearable injection device further includes an injection mechanism in fluid communication with the interior volume of the reservoir and a metering mechanism configured to control the dosage of the medication dispensed from the wearable injection device.

[0091] In some embodiments, the medication of the wearable injection device is insulin, including one of human insulin, a human insulin analog or derivative, a glucagon-like peptide (GLP-1), a GLP-1 analog, a GLP-1 receptor agonist, a GLP-1 analog or derivative, a dipeptidyl peptidase-4 (DPP4) inhibitor, a pharmaceutically acceptable DPP4 salt, a DPP4 solvate, or a mixture of any thereof.

[0092] In some embodiments, the flexible body of the wearable injection device includes a plate. In some embodiments, the plate of the flexible body is made of a rigid or semi-rigid material. In some embodiments, the plate of the flexible body is arranged in a fish scale pattern. In some embodiments, the plate of the flexible body overlaps. In some embodiments, the plate is coupled to at least one additional plate. In some embodiments, the plate is coupled to a flexible substrate.

[0093] In some embodiments, the flexible body of the housing comprises one of silicone, polyurethane rubber, thermoplastic elastomer, or neoprene foam. In some embodiments, the housing further comprises a flexible base. In some embodiments, the flexible base comprises a flexible sheet and an adhesive coating at least a portion of the flexible sheet.

[0094] In some embodiments, the injection mechanism of the wearable injection device includes a cannula and a cannulation system. In some embodiments, the metering mechanism of the wearable injection device includes a receiving means, a processor, a sensor, and a communication means coupling the metering mechanism with the pump mechanism and the injection mechanism. In some embodiments, the metering mechanism of the wearable injection device further includes a flexible circuit board and a soft or flexible battery.

[0095] In one embodiment of the present disclosure, a method of delivering medication includes attaching a wearable injection device to a user, powering on the wearable device, signaling a metering mechanism, and dispensing the medication at a programmable dosage and frequency. In some embodiments, signaling the metering mechanism includes touching the wearable injection device or sending the signal via a separate device by wireless means such as radio frequency, near field communication, or Bluetooth.

[0096] The wearable injection device of the method for delivering a medication includes a housing including a flexible body and a reservoir. The reservoir includes a flexible outer wall having an interior volume and at least one port in fluid communication with the interior volume. The wearable injection device of the method for delivering a medication further includes a pump mechanism configured to dispense the medication from the wearable injection device and an injection mechanism in fluid communication with the interior volume of the reservoir. The wearable injection device of the method for delivering a medication further includes a metering mechanism configured to control the dosage of the medication dispensed from the wearable injection device.

[0097] In some embodiments, the method of delivering a medication comprises bending or compressing the wearable injection device without permanently affecting the performance and functionality of the wearable injection device, hi some embodiments, the method of delivering a medication further comprises replacing or refilling the reservoir to replenish the medication.

[0098] In some embodiments, administering the agent comprises administering a diabetes medication comprising one of human insulin, a human insulin analog or derivative, a glucagon-like peptide (GLP-1), a GLP-1 analog, a GLP-1 receptor agonist, a GLP-1 analog or derivative, a dipeptidyl peptidase-4 (DPP4) inhibitor, a pharmaceutically acceptable DPP4 salt, a DPP4 solvate, or a mixture of any thereof.

[0099] In one embodiment of the present disclosure, a reservoir used in an injection device includes a flexible outer wall, an interior volume, at least one port, and a channel connecting the at least one port with the interior volume. In some embodiments, the flexible outer wall of a reservoir used in an injection device includes one of a polymer or a silicone. In some embodiments, at least one port of a reservoir used in an injection device includes a resealable membrane or valve.

[0100] Generally, the wearable injection device of the present disclosure offers significant advantages over traditional injection devices and older methods, such as self-administered injection of medication. The flexible elements disclosed herein provide a wearable injection device with a lightweight, low profile, streamlined flexible case that conforms to the patient's skin and can withstand impacts without adversely affecting performance or being pulled off the patient. Additional embodiments, configurations, uses, and methods of the present disclosure will be apparent to those skilled in the art.

Claims

1. A wearable injection device (100') comprising: a housing (200) including a flexible body (210); the flexible body (210) including a group of overlapping, retractable plates (220), the overlapping plates allowing at least one of bending, twisting, or torsion of the flexible body; a reservoir (300, 300') including a flexible outer wall (302) having an interior volume (304) and at least one port (306) in fluid communication with the interior volume (304); a pump mechanism (400) configured to dispense a medication from the wearable injection device (100'); an injection mechanism (500) in fluid communication with the interior volume (304) of the reservoir (300, 300'); a metering mechanism (600) configured to control the dosage of a drug dispensed from the wearable injection device (100'); The wearable injection device.

2. 2. The wearable injection device of claim 1, wherein the drug is a diabetes medication comprising one of human insulin, a human insulin analog or derivative, a glucagon-like peptide-1 (GLP-1), a GLP-1 analog, a GLP-1 receptor agonist, a GLP-1 analog or derivative, a dipeptidyl peptidase-4 (DPP4) inhibitor, a pharmaceutically acceptable DPP4 salt, a DPP4 solvate, or a mixture of any thereof.

3. 3. The wearable injection device of claim 1 or 2, wherein each of the plates (220) is flexibly connected to at least one other plate (220), a flexible substrate, or a flexible base (250) of the housing (200).

4. The wearable injection device according to any one of claims 1 to 3, wherein the plate (220) is made from a rigid or semi-rigid material.

5. The wearable injection device according to claim 3 or 4, wherein the plates (220) are arranged in a fish scale pattern.

6. 10. The wearable injection device of claim 1, wherein the flexible body (210) of the housing (200) comprises one of silicone, polyurethane rubber, thermoplastic elastomer, or neoprene foam.

7. The wearable injection device according to any one of claims 1 to 6, wherein the housing (200) further comprises a flexible base (250).

8. 8. The wearable injection device of claim 7, wherein the flexible base (250) comprises a flexible sheet (252) and an adhesive (254) coating at least a portion of the flexible sheet (252).

9. The wearable injection device according to any one of claims 1 to 8, wherein the injection mechanism (500) comprises a cannula and a cannulation system.

10. The metering mechanism (600) further comprises: Acceptance measures and; a processor; a sensor; communication means for connecting the metering mechanism with the pump mechanism and the injection mechanism; The wearable injection device according to any one of claims 1 to 9, comprising:

11. The wearable injection device of any one of claims 1 to 10, wherein the metering mechanism (600) further comprises a flexible circuit board and a soft or flexible battery.

12. A wearable injection device (100') comprising: attaching a wearable injection device (100') to a user; Powering on the wearable injection device (100'); sending a signal to a metering mechanism (600); Dispensing medication at programmable dosages and frequencies; for use in a method comprising: a housing (200) including a flexible body (210); the flexible body (210) including a group of overlapping, retractable plates (220), the overlapping plates allowing at least one of bending, twisting, or torsion of the flexible body; a reservoir (300, 300') including a flexible outer wall (302) having an interior volume (304) and at least one port (306) in fluid communication with the interior volume (304); a pump mechanism (400) configured to dispense a medication from the wearable injection device (100'); an injection mechanism (500) in fluid communication with the interior volume (304) of the reservoir (300, 300'); a metering mechanism (600) configured to control the dosage of medication dispensed from the wearable injection device (100'); The wearable injection device comprising:

13. Permanently affecting the performance and functionality of the wearable injection device (100').

13. The device of claim 12, further comprising bending or compressing the wearable injection device (100') without bending or compressing the wearable injection device (100').

14. 14. The device of claim 12 or 13, wherein sending a signal to the metering mechanism (600) comprises touching the wearable injection device (100') or sending a signal via a separate device by wireless means such as radio frequency, near field communication, or Bluetooth.

15. 15. The device of any one of claims 12 to 14, wherein dispensing a medication comprises dispensing a diabetes medication comprising one of human insulin, a human insulin analog or derivative, a glucagon-like peptide-1 (GLP-1), a GLP-1 analog, a GLP-1 receptor agonist, a GLP-1 analog or derivative, a dipeptidyl peptidase-4 (DPP4) inhibitor, a pharmaceutically acceptable DPP4 salt, a DPP4 solvate, or a mixture of any thereof.

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