Oral drug delivery device with expanding arms

Abstract

To provide an oral drug delivery device having expanding arms to be activated in the small intestine to deliver a drug through a gastrointestinal wall.SOLUTION: A drug delivery device 100 is taken orally by a patient, and then activates within the gastrointestinal (GI) tract of the patient. Upon activation, resilient arms 215 within the drug delivery device 100 expand and engage the GI tract walls. A driver then drives a plunger 340 within the drug delivery device 100, pushing a drug through a channel 213 in the resilient arms 215 and through the GI tract walls of the patient. After a period of time, at least a portion of the drug delivery device 100 dissolves and the drug delivery device 100 passes through the GI tract.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure relates to an oral drug delivery device. More specifically, the present disclosure relates to an oral drug delivery device having an expandable arm that operates in the small intestine to deliver a drug through the gastrointestinal wall.

Background Art

[0002] For patients being treated with a drug or other biologically active compound, it is often most convenient for the compound to be received orally. However, due to the nature of some compounds, once ingested, their activity is prevented from being maintained. For example, some compounds are denatured, digested, or inactivated when placed in the environment of the gastrointestinal (GI) system. In addition, some compounds have a low diffusion rate from the GI system into the bloodstream, which may prevent a sufficient dose from being delivered to the patient. For compounds having these characteristics, patients often receive the compound through injection, which is painful and inconvenient. Therefore, it is desirable to develop an oral drug delivery device that can successfully deliver drugs that would otherwise be ineffective when taken orally.

Summary of the Invention

[0003] The present disclosure provides a drug delivery device. The drug delivery device is orally ingested by a patient and then operates within the patient's gastrointestinal (GI) tract. When activated, an arm within the drug delivery device expands and a penetrating tip penetrates the GI tract. Then, a driver drives a plunger within the drug delivery device to push the drug through the penetrating tip and through the patient's GI tract wall. After a period of time, at least a portion of the drug delivery device dissolves and the drug delivery device passes through the GI tract.

[0004] In an exemplary embodiment, a drug delivery device is disclosed that includes a capsule configured to degrade within a patient's gastrointestinal (GI) tract, and a drug delivery mechanism within the capsule and configured to engage the patient's GI wall, the drug delivery mechanism including a plurality of elastic arms, a plurality of GI wall engagement ends, and a plurality of drug delivery channels, the plurality of GI wall engagement ends being fluidly coupled to the plurality of drug delivery channels, a drug housing fluidly coupled to the drug delivery mechanism and configured to contain a volume of drug, and a drive mechanism coupled to the drug housing and including a stopper, a trigger, and a driver, the drive mechanism operating to effect delivery of the drug through the drug delivery mechanism.

[0005] In another embodiment, a drug delivery device is disclosed that includes a drug delivery mechanism located within a degradable capsule that includes a degradable capsule, fluid channels, and a plurality of drug delivery members, a drug housing fluidly coupled to a fluid channel configured to hold a volume of drug, and a drive mechanism coupled to the drug housing and at least partially located within the drug housing, the drive mechanism including a drug housing cap configured to fluidly seal the drug housing, a drive rod slidable within the drug housing, a drive stopper coupled to the drive rod and configured to engage the drug, a driver within the drug housing cap and coupled to the drive rod, and a soluble trigger configured to hold the drive rod in a first position, the driver pushing the drive rod from the first position to a second position when the soluble trigger degrades, and the drug being released through the drug delivery mechanism when the drive rod moves from the first position to the second position.

[0006] In yet another embodiment, an oral drug delivery device is disclosed that includes a housing capsule, a drug delivery mechanism within the housing capsule, at least one drug delivery member configured to engage the wall of a patient's gastrointestinal tract, a fluid channel within at least one drug delivery member configured to allow drug to flow through the drug delivery member, the fluid channel having a fluid resistance within the fluid channel that is greater than a gap resistance due to engagement with the wall of the gastrointestinal tract, a drug housing coupled to the drug delivery mechanism, and a drive mechanism configured to drive drug from the drug housing to the drug delivery mechanism.

[0007] In yet another embodiment, an oral drug delivery device includes a biodegradable capsule, a plurality of arms, and a liquid drug, and has a closed configuration in which the plurality of arms are disposed within the capsule, an open configuration in which the plurality of arms extend radially outwardly and contact the patient upon decomposition of the capsule, a delivery configuration in which the liquid drug is injected into the patient via the plurality of arms, and a release configuration in which the plurality of arms are separated from the patient and pass through the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The above and other features and advantages of the present disclosure, and the manner in which they are achieved, will become more apparent and the present invention will be better understood by referring to the following description of embodiments of the present invention in conjunction with the accompanying drawings.

[0009]

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[0010] Throughout the several views, corresponding reference numerals indicate corresponding parts. The examples described herein illustrate exemplary embodiments of the invention and such examples should not be construed as limiting the scope of the invention in any way.

DETAILED DESCRIPTION OF THE INVENTION

[0011] Referring initially to FIGS. 1 - 6, a drug delivery device 100 is shown. The drug delivery device 100 comprises a capsule 110, a delivery mechanism 200, a drive mechanism 300, and a drug housing 400. The drug housing 400 may be referred to as a cartridge. When the drug delivery device 100 is fully assembled, the capsule 110 encloses the delivery mechanism 200, the drive mechanism 300, and the drug housing 400. As will be discussed in more detail herein, the drug delivery device 100 is configured to be orally ingested by a patient. When it enters a portion of the patient's gastrointestinal (GI) tract, the capsule 110 either decomposes or breaks apart, thereby enabling the delivery mechanism 200 to engage with the inner wall of the GI tract and secure the drug delivery device 100 in place. When the delivery mechanism 200 engages with the patient's GI tract, the drive mechanism 300 actuates the delivery of a drug 500 from the drug housing 400 through the GI wall to the patient. When the drug 500 is delivered, the drug delivery device 100 passes through the GI tract.

[0012] As shown in FIG. 2, the capsule 110 consists of two components, a first rear capsule portion 104 and a second front capsule portion 106. As will be discussed in more detail herein, the first capsule portion 104 and the second capsule portion 106 are joined together to form the capsule 110.

[0013] The delivery mechanism 200 is configured to fit within the capsule 110 when the drug delivery device 100 is assembled. In the illustrated embodiment, the delivery mechanism 200 comprises a delivery base 230, a plurality of delivery members 210 extending from the delivery base 230, a membrane 220, and a central bore 250 extending through the delivery base 230. Each delivery member 210 comprises an elastic arm 215, a delivery channel 213, a joining end 217, and a through - assembly 260. In the illustrated embodiment, three delivery members 210 extend from the delivery base 230 and are spaced equidistantly around it, although in other embodiments, any number of delivery members 210 and spacing arrangements may be used.

[0014] The delivery mechanism 200 is configured to allow fluid to flow from the central bore 250 through the delivery channel 213 to the junction end 217. The delivery channel 213 is fluidly coupled to the central bore 250 and extends along the elastic arm 215. In the illustrated embodiment, the delivery channel 213 is formed as a groove exposed within the outer surface of the elastic arm 215. Referring to FIG. 12, the membrane 220 is adhered to the surface of the elastic arm 215 to enclose and seal the delivery channel 213. The membrane 220 may be adhered to the surface of the elastic arm 215 by an adhesive, welding (heat, UV, laser, ultrasonic, solvent, friction, injection, high frequency, etc.), mechanical connection, or any other connection means. The use of the membrane 220 may simplify the formation (e.g., molding, cutting) of the channel 213 on the outer surface of the elastic arm 215. In other embodiments, the delivery channel 213 may be a separate component such as a tube coupled to a portion of the delivery mechanism 200. Further, the delivery channel 213 may be fully located within the elastic arm 215 such that the interior of the delivery channel 213 is completely enclosed (e.g., a bore passing through the elastic arm 215).

[0015] Referring to the exemplary embodiments of FIGS. 14 - 15, the junction end 217 is located near the end of each elastic arm 215 and is configured to join with the interior of the patient's GI tract. The junction end 217 includes a socket 267 configured to receive a penetration assembly 260. The penetration assembly 260 includes a penetration base 264 and a penetration tip 266. As shown in FIG. 14, in one embodiment, the penetration tip 266 is separated from the penetration base 264, and the penetration base 264 includes a receiving bore 265 configured to couple the penetration base 264 to the penetration tip 266. In another embodiment, as shown in FIG. 15, the penetration base 264 and the penetration tip 266 may be formed as a single piece. The socket 267 is configured to fluidly couple each delivery channel 213 to a corresponding penetration tip 266 such that fluid can flow from the delivery channel 213 to the penetration tip 266. At least one of the penetration base 264 and the penetration tip 266 may be biodegradable. In an exemplary embodiment, the junction end 217 joins with the inner wall of the GI tract and is substantially parallel to the longitudinal axis A1, and the penetration tip 266 pierces or penetrates the GI tract wall and is substantially perpendicular to the axis A1. After a predetermined time has elapsed, the penetration base 264 and / or the penetration tip 266 decompose and exit the GI tract. In the illustrated embodiment, the penetration tip 266 has the shape of a hypodermic needle. In other embodiments, the penetration tip 266 may include a piercing tip having a fluid outlet located below the piercing tip (e.g., on the side of the penetration tip 266) to avoid blockage in the delivery of the drug 500. Further, each delivery member 210 may include any number of penetration tips 266, including an array of microneedles.

[0016] In another embodiment, the connection end 217 includes a liquid jet delivery mechanism for delivering fluid through the GI tract. In this embodiment, the penetration assembly 260 (e.g., element 265) is formed as a nozzle or jet for delivering fluid at high speed from the delivery channel 213 to pierce and penetrate the GI tract without using the penetration tip 266 for drug delivery. In this embodiment, the drive mechanism 300 including the driver 360 described herein actuates the delivery of the drug 500 from the drug housing 400 with a high force suitable for driving the liquid jet.

[0017] Referring again to FIGS. 1-6, in the illustrated embodiment, the delivery base 230 and the delivery member 210 of the delivery mechanism 200 are constructed as a single integral part. In the illustrated embodiment, the delivery member 210 and the delivery base 230 are elastic and have the properties of a rigid spring adapted such that the delivery member 210 bends relative to the base 230, as described herein. In an exemplary embodiment, the delivery mechanism 200 is adapted to dissolve or biodegrade in the intestine following delivery of the fluid. In an exemplary embodiment, the delivery mechanism 200 is made of a polymer such as a bioabsorbable / biodegradable polymer. Exemplary polymers may include polyglycolic acid, polylactic acid, polycaprolactone, and polyethylene glycol, their copolymers and blends. In other embodiments, the delivery mechanism 200 may be made of metal or other suitable materials. As shown in FIG. 13, the delivery mechanism 200 may alternatively be constructed from a plurality of components connected through one or more coupling members 270. In the illustrated embodiment of FIG. 13, the coupling member 270 joins a plurality of delivery members 210 together at the delivery base 230. Further, in the illustrated embodiment, the coupling member 270 is an I-shaped connector. In other embodiments, the coupling member 270 may be a fastener, screw, snap, pin, staple, or any other mechanical coupling means. The coupling member 270 may be made of a biodegradable material including the above bioabsorbable / biodegradable polymer such that the delivery mechanism 200 breaks into separate parts upon disassembling of the coupling member 270. Both the delivery member 210 and the coupling member 270 may be made of a biodegradable material, or only one of the delivery member 210 and the coupling member 270 may be made of a biodegradable material. In other embodiments, any component of the delivery mechanism 200 may be manufactured as a separate part and joined together through the coupling member 270. Further, the components of the delivery mechanism 200 may be joined to each other by an adhesive, welding, or other joining means.

[0018] Referring again to FIGS. 1-6, the drug housing 400 is configured to be fluidly coupled to the delivery mechanism 200 through the housing coupling 450. The drug housing 400 is further configured to generally hold a volume of drug 500 in liquid or other flowable form. In an exemplary embodiment, the drug 500 is a compound that is typically of low efficacy when taken by standard oral delivery and digestion, such as a peptide or protein like insulin. In an exemplary embodiment, the drug 500 refers to, but is not limited to, insulin analogs such as insulin, insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, combined GIP / GLP-1 agonists such as tildepagliflozin, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies, and other suitable therapeutic agents. The drug 500 may also include a vaccine or a gene-based drug. In other embodiments, the drug 500 may be any biologically active compound administered to a patient. The drug housing 400 may be made of a polymer, metal, ceramic, crystalline solid, or any other material capable of holding the volume of drug 500.

[0019] Referring to FIGS. 16 - 21, in another embodiment of the drug delivery device 100, a sealing assembly may be used between the drug housing 400 and the delivery mechanism 200 to hold the drug 500 in a sealed manner within the drug housing 400 until the drug 500 is ready to be introduced into the delivery mechanism 200. First referring to FIGS. 16 - 17, in one embodiment, the drug housing 400 may include a septum 420 configured to be pierced by a needle 415, similar to a configuration commonly utilized by automatic injection systems known in the art. The needle 415 may be driven to pierce the septum 420, for example, during the priming step of the drug delivery device 100 when the drug delivery device 100 is assembled as shown in FIGS. 28 - 32. The needle 415 may also be driven through the septum 420 after the drug delivery device 100 has been taken by a patient. For example, the needle 415 may be driven as a result of the decomposition of the capsule 110 or by including additional degradable or force - providing components (not shown) that can drive the needle 415 during decomposition. In the illustrated embodiment, the septum 420 is an elastomer and is coupled to the drug housing 400 by overmolding. In other embodiments, the septum 420 may be made of any material suitable for holding the drug 500 within the drug housing 400 and capable of being pierced by the needle 415. Piercing the septum 420 with the needle 415 fluidly couples the interior of the drug housing 400 to the delivery mechanism 200 through a connection channel 450, enabling the drug 500 to flow into the delivery mechanism 200.

[0020] In the illustrated embodiment, the delivery mechanism 200 includes a housing sleeve 233 that is coupled to the delivery base 230 and configured to couple the delivery mechanism 200 to the housing 400. The housing sleeve 233 may be a sleeve that fits completely around the housing 400 or may include several separate members. The housing sleeve 233 may also include retention features 231. The retention mechanism 231 may be a ridge, bump, groove, or other means for retaining the housing sleeve 233 on the housing 400. The housing 400 may also include complementary features that engage the retention function 231. Additionally, an adhesive or other form of binder may be applied to the housing sleeve 233 and / or the housing 400 to assist in retaining the housing sleeve 233 around the housing 400.

[0021] Referring now to FIGS. 18 - 19, in another embodiment, the housing 400 may include a frangible membrane 430 at the end of the connection channel 450. The frangible membrane 430 is configured to retain the drug 500 within the drug housing 400 until either the frangible membrane 430 ruptures due to an increase in pressure or the frangible membrane 430 permits passage of the drug 500 through the connection channel 450. The increase in pressure may be caused by driving the plunger 340. In the illustrated embodiment, the housing 400 is joined to the delivery base 230 at the housing interface 425. The housing interface 425 is configured to contact the delivery base 230 when the housing sleeve 233 engages the housing 400. The housing interface 425 may be coated with an adhesive or other binder to assist in coupling the housing 400 to the delivery mechanism 200. The housing interface 425 may also include surface features such as ridges, bumps, grooves, or other retention features for engaging the delivery base 230. In such an embodiment, the delivery base 230 may include complementary surface features.

[0022] Referring to FIGS. 20 - 21, in yet another embodiment, the housing 400 may be closed and formed to create an intentional weak point 440. The weak point 440 may rupture in a similar manner to the breakable membrane 430 as described above, enabling the drug 500 to pass through the housing coupling 450. Embodiments with a breakable membrane 430 and / or a weak point 440 may not require the priming or activation steps required by the configuration of the needle 415 and septum 420 shown in FIGS. 16 - 17.

[0023] The drive mechanism 300 is configured to at least partially fit within the drug housing 400 and to activate the flow of the drug 500 from the drug housing 400 to the delivery mechanism 200. The drive mechanism 300 includes a stopper 310, a plunger 340, a cap 330, a driver 360, and a trigger 350, and is disposed substantially coaxially with the longitudinal axis A1. The cap 330 seals the drug 500 within the drug housing 400 and at least partially encloses the driver 360. The plunger 340 includes a stopper end 342 adjacent to the stopper 310 and a trigger end 344 adjacent to the trigger 350, and is movable along substantially the axis A1 from a first loading position to a second delivery position. At the stopper end 342 of the plunger 340, the plunger 340 is coupled to the stopper 310. In another embodiment, the plunger 340 is not coupled to the stopper 310. In an embodiment, the stopper 310 is separated from the drive mechanism 300 and can be inserted into the drug housing 400 before the drive mechanism 300 is coupled to the drug housing 400. This separation allows the drive mechanism 300 without the stopper 310 to be assembled or manufactured separately from the drug housing 400 and the stopper 310, such that the drive mechanism can later be coupled to the drug housing 400.

[0024] Next, referring to FIGS. 9-10, the stopper 310 is configured to seal the drug 500 within the drug housing 400 and is slidable generally along the axis A1. In the first loading position (see FIG. 9), the trigger 350 is disposed between the trigger end 344 and the cap 330, thereby preventing the trigger end 344 from passing through the cap 330 and further preventing movement of the plunger 340. In the first loading position, the driver 360 applies a force to the stopper end 342 generally toward the housing coupling 450. In the illustrated embodiment, the trigger 350 is made of a degradable material and is configured to degrade over time. When the trigger 350 degrades and is removed from the position between the trigger end 344 and the cap 330, the force applied to the plunger 340 by the driver 360 moves the plunger 340 to a second delivery position (see FIG. 10) generally along the axis A1. When moving from the first position to the second position, the plunger 340 and the stopper 310 move generally toward the housing coupling 450, thereby reducing the available volume of the drug housing 400 and pushing the drug 500 from the drug housing 400 into the delivery mechanism 200.

[0025] In the illustrated embodiment, the driver 360 is a spring. In other embodiments, the driver 360 may be any member capable of delivering a force to move the plunger 340 from the first position to the second position, including a balloon, a piston, or a motor. In the illustrated embodiment, due to the presence of the cap 330, after the drug delivery device 100 is actuated and the drug 500 is delivered, the stopper 310, the plunger 340, and the driver 360 all remain within the drug housing 400. In this embodiment, the containment of most of the drive mechanism 300 within the drug housing 400 prevents additional potentially damaging components from being released into the GI tract and instead holds the components within the relatively smooth drug housing 400 that will ultimately pass through the patient.

[0026] Referring now to FIG. 22, the trigger 350 includes an interior 352, an inner edge 353, an upper surface 354, and at least one bevel 355. The bevel 355 may also be located at other points along the inner edge 353 and may even extend completely around the inner edge 353. Further, the upper surface 354 may be angled downwardly toward the interior 352, either in part or in whole, of the trigger 350. The plunger 340 is configured to fit within the interior 352 of the trigger 350. The bevel 355, along with the generally horseshoe-shaped configuration of the trigger 350, is configured to direct the force from the driver 360 through the trigger end 344 of the plunger 340 and toward a smaller area of the trigger 350. Thus, the trigger 350 is configured to break more easily than if the trigger 350 were a solid disk. Further, since many biodegradable materials do not completely dissolve in a short period of time, the shape of the trigger 350 and the bevel 355 cause the trigger 350 to catastrophically fail by snapping or breaking after the decomposition threshold level has occurred. This configuration allows the drive mechanism 300 to operate relatively quickly when the trigger 350 decomposes beyond a threshold amount.

[0027] Referring to FIGS. 7-8, the drug delivery device 100 is movable from a first or closed state (see FIG. 7) to a second or open state (see FIG. 8). The delivery member 210 of the delivery mechanism 200 is made of an elastic material such as a polymer having flexible stiffness and spring-like properties. In the illustrated embodiment, when no force is acting on the delivery member 210, the natural state of the delivery member 210 is the open state. However, the delivery member 210 may move to the closed state and then, due to the elasticity of the delivery member 210, return to the second state and bounce back or expand. In the closed state, the delivery member 210 is housed within the capsule 110 and lies substantially parallel to the axis A1 (see FIG. 7). In the closed state, the delivery member 210 applies a radially outward force on the interior of the capsule 110. When the capsule 110 decomposes, dissolves, or otherwise disintegrates beyond a predetermined point, the delivery member 210 may break through the remaining capsule 110 and move radially outward from the axis A1 to enter the open state (see FIG. 8).

[0028] When the drug delivery device 100 is used to treat a patient, the patient orally receives the drug delivery device 100, and the drug delivery device 100 moves through the patient's GI tract. In an exemplary embodiment, the capsule 110 degrades as the environment surrounding the drug delivery device 100 changes pH, for example, when exiting the acidic stomach and entering the relatively alkaline small intestine. When the capsule 110 degrades by a threshold amount beyond the predetermined point described above, the drug delivery mechanism 200 breaks through the capsule 110 and the delivery member 210 extends outward. When the delivery member 210 extends outward within the patient's GI tract, the engagement end 217 engages with the interior of the patient's GI tract, also referred to as the GI wall 700. The penetration tip 266 penetrates the GI wall 700, thereby fixing the drug delivery device 100 to the wall 700 at the penetration point (see FIG. 9). The engagement end 217 is configured to engage with the wall surface 710 when the penetration tip 266 penetrates the wall 700. In embodiments using liquid jet delivery, the spring force of the delivery member 210 against the wall 700 may be configured to provide sufficient fixing force to deliver the drug. Additionally or alternatively, the end 217 may include engagement features such as a penetration tip or a ridge for gripping the device 100 and fixing it to the wall 700 during liquid jet delivery.

[0029] After the drug delivery device 100 penetrates the GI wall 700, the trigger 350 decomposes beyond a threshold value, enabling the driver 360 to drive the plunger 340 and the stopper 310 into the drug housing 400, and push the drug 500 through the delivery mechanism 200 (see FIG. 10) and into the wall 700 through the penetration tip 266 (see FIG. 11). After the drug 500 is delivered to the patient through the penetration tip 266, the penetration assembly 260 decomposes. After the penetration assembly 260 decomposes beyond a threshold value, the delivery mechanism 200 either breaks or is released from the penetration assembly 260 and passes through the GI tract. As described above, the other components of the delivery mechanism 200 may also come apart upon decomposition of the coupling member 270. In some embodiments, the components of the delivery mechanism 200 made of biodegradable / biocompatible polymers (described herein) are also adapted to decompose and dissolve following drug delivery.

[0030] Referring to FIG. 23, a depiction of the relative decomposition times of the different components of the drug delivery device 100 is shown according to one exemplary embodiment. In the illustrated embodiment, the first component to decompose is the capsule 110, which enables exposure of the internal components of the device 100, spring release of the device 100, and positioning of the device itself within the GI tract. The next component to decompose is the trigger 350, which thereby activates the delivery mechanism 300 and delivers the drug 500 to the patient. The next components to decompose are the delivery member 210 and / or the coupling member 270, which thereby enable the drug delivery device 100 to pass through the remainder of the GI tract and be passed by the patient. Finally, the penetration assembly 260, or a particular component within the penetration assembly 260, decomposes. Both the capsule 110 and the trigger 350 decompose on a scale of approximately minutes or seconds. The delivery member 210 and / or the coupling member 270 decompose on a scale of approximately hours. The penetration assembly 260 or its components decompose on a scale of approximately hours or days. The components of the drug delivery device 100 may be designed to decompose at other suitable time scales in other embodiments.

[0031] In an exemplary embodiment, the delivery mechanism 200 comprises a pressure regulator (not shown). When the penetration tip 266 penetrates the GI wall 700, an interstitial pressure is generated on the wall surface 710. In order for the drug 500 to move across the GI wall surface 710, the driver 360 must generate a pressure within the drug 500 that is greater than the interstitial pressure so that the drug 500 flows through the wall 700. The pressure regulator sets a pressure threshold that is greater than the interstitial pressure of each delivery member 210 such that the driver 360 must generate a pressure within the drug 500 that is greater than the pressure threshold for the drug 500 to flow through the delivery member 210. Thus, if one or more of the penetration tips 266 do not penetrate the wall 700, the disengaged penetration tips 266 that did not penetrate the wall 700 will still receive the pressure threshold set by the pressure regulator, and a portion of the drug 500 will still be delivered through the engaged penetration tips 266 that penetrated the wall 700. In the absence of a pressure regulator, most of the drug 500 will escape through the penetration tips 266 that did not penetrate the wall 700 because they provide a path of less resistance.

[0032] In another embodiment, only one of the delivery members 210 may house the delivery channel 213, and thus only that one delivery member 210 can deliver the drug 500 to the patient. The other delivery members 210 may be configured to function as "dummy" or structural delivery members 210 and may be present to assist in fixing the drug delivery device 100 within the GI tract without functioning as a means for delivering the drug 500. Since the drug 500 does not flow through the delivery member 210 and then through the penetration assembly 260, the structural delivery member 210 may not include the penetration assembly 260. The structural delivery member 210 may comprise a joining feature (not shown) on the joining end 217 for gripping the GI wall 700. Such joining features may include ridges, protrusions, adhesives, or other gripping / attachment means. The structural delivery member 210 may also comprise a microneedle, a patch, a solid drug deposit, or other drug delivery means that allow for the diffusion of drugs or other active agents through the wall 700 without penetration.

[0033] Referring to FIGS. 24 - 27, a device assembly mechanism 800 is provided to reduce the potential for viscoelastic creep within the delivery mechanism 200. In an exemplary embodiment, a user or patient may receive the device assembly mechanism 800 and assemble the drug delivery device 100 immediately prior to oral ingestion of the drug delivery device 100. The device assembly mechanism 800 includes an assembly housing 820, an assembly actuator 810, an access window 825, a rotating member 850, a first drive rod 840, a second closure rod 845, and a device retrieval area 830. The assembly actuator 810 is configured to be pushed by a user or otherwise actuated to initiate the assembly of a single drug delivery device 100 at a time. In the illustrated embodiment, several drug delivery devices 100 are loaded into the device assembly mechanism 800. The first capsule portion 104 and the internal components of the drug delivery device 100 (specifically, the delivery mechanism 200, the drive mechanism 300, the drug housing 400, and the drug 500) are held by the rotating member 850, and the second capsule portion 106 is held by the actuator 810. In the illustrated embodiment, the access window 825 may be removed to allow for additional loading of the device assembly mechanism 800. When the assembly actuator 810 is actuated, the first drive rod 840 drives the internal components of the drug delivery device 100 into the first capsule portion 104. The first drive rod 840 also brings the second capsule portion 106 into contact with the first capsule portion 104. The second capsule portion 106 and the first capsule portion 104 may be joined by friction, welding, adhesives, mechanical fasteners, or other joining means. When the capsule 110 is fully formed around the internal components of the drug delivery device 100, the second closure rod 845 releases the drug delivery device 100 from the rotating member 850 and allows the drug delivery device to enter the device retrieval area 830. This process may be repeated before the patient orally ingests each drug delivery device 100.

[0034] Referring to FIGS. 28 - 32, an exemplary embodiment of the device assembly process is depicted. The drug housing 400 and the drive mechanism 300 are combined and simplified in the drug drive unit 900. The delivery mechanism 200 is pushed into the first capsule portion 104, and the delivery member 210 enters a closed state that partially seals the drug drive unit 900. The drug drive unit 900 is further pushed into the delivery mechanism 200 such that the drug drive unit 900 and the delivery mechanism are fluidly coupled. Next, the second capsule portion 106 is pushed over the drug drive unit 900 and the delivery mechanism 200 and then sealed to the first capsule portion 104.

[0035] In another embodiment, the drug delivery device 100 may comprise a wireless communication device configured to transmit and / or receive signals to / from a wireless receiver (not shown). The wireless communication device may be configured to measure or sense biological information within a patient after the drug delivery device 100 has been ingested. For example, the wireless receiver may transmit a signal when the delivery mechanism 200 is expanded or when a portion of the drug delivery device 100 has disassembled. Further, the wireless communication device may measure / sense other biological information within the GI tract, such as chemical substance concentration, pH, temperature, or other biological information. The wireless receiver may be used by the patient undergoing treatment or by another user such as a physician or caregiver. The wireless communication device and the wireless receiver may communicate through RFID, magneto - acoustic, near - field communication, ultrasonic, Bluetooth technology, or other wireless communication means.

[0036] Although the invention has been described as having an exemplary design, the invention can be further modified within the spirit and scope of the present disclosure. Accordingly, this application is intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and fall within the limits of the appended claims.

Claims

1. 1. A drug delivery device comprising: a capsule configured to disintegrate in a gastrointestinal (GI) tract of a patient; a drug delivery mechanism within the capsule and configured to interface with a GI tract wall of the patient, the drug delivery mechanism comprising a plurality of resilient arms, a plurality of wall interface ends, and a plurality of drug delivery channels, the plurality of wall interface ends being fluidly coupled to the plurality of drug delivery channels; a drug housing fluidly coupled to the drug delivery mechanism and configured to contain a volume of a drug; a drive mechanism coupled to the drug housing, the drive mechanism comprising a stopper, a trigger, and a driver positioned within the drug housing to actuate delivery of the drug via the drug delivery mechanism; A drug delivery device comprising:

2. The capsule is configured to disintegrate after entering the small intestine of the patient. The drug delivery device of claim 1 .

3. the drug delivery mechanism is configured to transition from a closed position to an open position after the capsule disintegrates, the drug delivery mechanism expanding radially outward to interface with a wall of the GI tract of the patient in the open position. The drug delivery device of claim 1 .

4. the plurality of wall-jointing ends include a piercing tip, the piercing tip configured to pierce the GI tract wall when the drug delivery mechanism is in the open position; The drug delivery device of claim 3.

5. the plurality of wall joint ends including at least one liquid jet configured to deliver the drug as a jet through the GI tract wall; The drug delivery device of claim 3.

6. the trigger is dissolvable in the gastrointestinal tract of the patient and degrades after the drug delivery mechanism is in the open position, and upon degradation of the trigger, the drive mechanism is actuated. The drug delivery device of claim 3.

7. the wall-jointed end includes a piercing tip that is a dissolvable needle structure, the dissolvable needle structure configured to pierce the GI tract wall of the patient and to disintegrate within the gastrointestinal tract of the patient. The drug delivery device of claim 1 .

8. the resilient arms are coupled together through a plurality of dissolvable coupling members, the dissolvable coupling members being configured to degrade in the gastrointestinal tract of the patient. The drug delivery device of claim 1 .

9. and a channel membrane, each of the plurality of drug delivery channels formed within a corresponding resilient arm, the channel membrane separating an interior of the plurality of drug delivery channels from the gastrointestinal tract of the patient. The drug delivery device of claim 1 .

10. and a membrane within the drug housing, the membrane including a closed configuration in which the membrane retains the drug within the drug housing, and an open configuration in which the membrane is at least partially open to permit flow of the drug out of the drug housing. The drug delivery device of claim 1 .

11. and a cap coupled to the drug housing, the cap preventing the drive mechanism from exiting the drug housing and entering the GI tract. The drug delivery device of claim 1 .

12. After the drive mechanism actuates the delivery of the drug, at least one component of the drug delivery mechanism degrades. The drug delivery device of claim 1 .

13. the drug delivery mechanism further comprising a plurality of binding members, the binding members configured to degrade in the GI tract; 13. The drug delivery device of claim 12.

14. the stopper is coupled to the medication housing separately from the driver and the trigger; The drug delivery device of claim 1 .

15. The drug delivery mechanism is comprised of a biodegradable polymer comprising at least one of polyglycolic acid, polylactic acid, and polycaprolactone; The drug delivery device of claim 1 .

16. and a drug contained within the drug housing, the drug comprising at least one of a peptide and a protein. The drug delivery device of claim 1 .

17. 13. An assembly system for assembling the drug delivery device of claim 1, comprising: a housing for the assembly system; an assembly actuator coupled to the housing and configured to be actuated by a user; a rotatable member within the housing configured to hold a first portion of the capsule; a drive rod configured to at least partially drive the drug delivery mechanism, the drug housing, and the drive mechanism within the first portion of the capsule when the assembly actuator is actuated; a closure rod configured to couple a second portion of the capsule to the first portion of the capsule, thereby enclosing the drug delivery mechanism, the drug housing, and the drive mechanism entirely within the capsule; An assembly system comprising:

18. 1. A drug delivery device comprising: A degradable capsule; a drug delivery mechanism located within the degradable capsule, the drug delivery mechanism comprising a fluid channel and a plurality of drug delivery members; a drug housing fluidly coupled to the fluid channel configured to hold a volume of a drug; a drive mechanism coupled to the drug housing and located at least partially within the drug housing, the drive mechanism comprising: a medication housing cap configured to fluidly seal the medication housing; a drive rod slidable within the drug housing; a drive stopper coupled to the drive rod configured to interface with the drug; a driver within the medication housing cap and coupled to the drive rod; a dissolvable trigger configured to hold the drive rod in a first position; the driver urges the drive rod from the first position to the second position when the dissolvable trigger disintegrates, and the drug is released through the drug delivery mechanism as the drive rod moves from the first position to the second position. Drug delivery devices.

19. The degradable capsule is configured to degrade after a pH change occurs in an environment surrounding the degradable capsule.

20. The drug delivery device of claim 18.

20. each of the plurality of drug delivery members comprises a resilient arm and a wall-attached end, the wall-attached end including at least one liquid jet configured to deliver the drug as a jet through the GI tract wall; 20. The drug delivery device of claim 18.

21. each of the plurality of drug delivery members comprises a resilient arm and a piercing tip, the piercing tip configured to pierce a wall of the GI tract of the small intestine of the patient; 20. The drug delivery device of claim 18.

22. the piercing tip comprises a needle and a degradable base, the degradable base is coupled to the resilient arm, and the needle is coupled to the degradable base; 22. The drug delivery device of claim 21.

23. the penetrating tip comprises a degradable needle, the degradable needle configured to degrade after penetrating the GI tract wall of the small intestine of the patient.

22. The drug delivery device of claim 21.

24. the dissolvable trigger comprises a bevel, the bevel being configured to weaken the structure of the dissolvable trigger as the dissolvable trigger degrades; 20. The drug delivery device of claim 18.

25. the fluid channel is located within one of the drug delivery members and the remainder of the drug delivery members are structural drug delivery members, the structural drug delivery members being configured to position the drug delivery device within the gastrointestinal tract of a patient; 20. The drug delivery device of claim 18.

26. A housing capsule; a drug delivery mechanism within the housing capsule, at least one drug delivery member configured to interface with a wall of the gastrointestinal (GI) tract of the patient; a drug delivery mechanism comprising: a fluid channel in the at least one drug delivery member configured to allow a drug to flow through the drug delivery member, the fluid resistance within the fluid channel being greater than a gap resistance due to an interface with the wall of the gastrointestinal tract; a drug housing coupled to the drug delivery mechanism; a drive mechanism configured to drive the drug from the drug housing to the drug delivery mechanism; An oral drug delivery device comprising:

27. the drug delivery mechanism is comprised at least in part of an elastomeric polymer configured to transition from a first position to a second position, and the at least one drug delivery member is configured to interface with the wall when the drug delivery mechanism is in the second position.

27. The drug delivery device of claim 26.

28. 27. A method for treatment using the oral drug delivery device of claim 26, comprising: Loading an unassembled oral drug delivery device into an assembly mechanism; actuating the assembly mechanism, the assembly mechanism being configured to insert the drug delivery mechanism into a first portion of the housing capsule and couple a second portion of the housing capsule to the first portion of the housing capsule; receiving the oral drug delivery device from the assembly mechanism; orally ingesting the drug delivery device; A method comprising:

29. the drive mechanism comprises a dissolvable trigger, the dissolvable trigger configured to degrade after the drug delivery mechanism is at least partially removed from the housing capsule.

27. The oral drug delivery device of claim 26.

30. the drug delivery mechanism is configured to expand and anchor within the wall of the gastrointestinal tract; 27. The oral drug delivery device of claim 26.

31. a coupling channel positioned between the drug housing and the delivery mechanism, and a weak point within the coupling channel, the weak point configured to rupture after a threshold pressure is applied to the weak point.

27. The oral drug delivery device of claim 26.

32. 1. An oral drug delivery device comprising: A biodegradable capsule; A plurality of arms; A liquid drug, The oral drug delivery device comprises: a closed configuration, wherein the plurality of arms are disposed within the capsule; an open configuration, wherein the arms extend radially outward to contact a patient upon disassembly of the capsule; a delivery arrangement in which the liquid medication is infused into the patient via the plurality of arms; and a release configuration in which the plurality of arms are separated from the patient and pass through the patient; Oral drug delivery devices.

33. and a needle and a septum, the oral drug delivery device having (1) an unprimed configuration in which the needle does not contact the septum, and (2) a primed configuration in which the needle pierces the septum.

33. The oral drug delivery device of claim 32.

34. a trigger positioned within the capsule, a plunger, and a bevel on the trigger, wherein the oral drug delivery device transitions to the delivery configuration after the trigger at least partially disintegrates and the plunger moves across the bevel.

33. The oral drug delivery device of claim 32.

35. 1. A method for delivering a drug to a patient through a drug delivery device, comprising: orally administering the drug delivery device to the patient; disintegrating the capsule in the small intestine of the patient; expanding a delivery mechanism having multiple ends to interface with the small intestine of the patient after the disintegrating step; engaging a wall of the small intestine of the patient with a penetration assembly disposed on an end of the delivery mechanism; decomposing a trigger of the drug delivery device; delivering the drug to the patient through the delivery mechanism; Degrading the delivery mechanism; and A method comprising:

36. the piercing assembly includes a liquid jet configured to deliver the drug as a jet that penetrates the wall of the small intestine.

36. The method of claim 35.

37. the engaging step includes penetrating the small intestine of the patient with a plurality of penetrating tips disposed on the end of the delivery mechanism.

36. The method of claim 35.

38. the step of degrading further comprises degrading the delivery mechanism.

36. The method of claim 35.

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