Oral drug delivery device having extendable arms - Patents.com

Abstract

The present disclosure provides a drug delivery device. The drug delivery device is orally ingested by a patient and then actuated within the patient's gastrointestinal (GI) tract. Upon actuation, resilient arms within the drug delivery device expand and engage the GI tract wall. A driver then drives a plunger within the drug delivery device, pushing the drug through a channel in the resilient arms 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.

Description

[Technical field]

[0001] The present disclosure relates to oral drug delivery devices. More specifically, the present disclosure relates to oral drug delivery devices having expandable arms that operate in the small intestine to deliver drugs through the gastrointestinal wall. [Background technology]

[0002] For patients being treated with drugs or other biologically active compounds, it is often most convenient to receive the compound orally. However, the properties of some compounds prevent them from maintaining their activity once ingested. 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 to the bloodstream, which can prevent a sufficient dosage from being delivered to the patient. For compounds with these properties, 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 actuated in the patient's gastrointestinal (GI) tract. Upon actuation, an arm in the drug delivery device extends and a piercing tip penetrates the GI tract. A driver then drives a plunger in the drug delivery device, pushing the drug through the piercing tip and 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 disintegrate in a patient's gastrointestinal (GI) tract; a drug delivery mechanism within the capsule and configured to interface with a wall of the patient's GI tract, the drug delivery mechanism including a plurality of resilient arms, a plurality of GI wall interface ends, and a plurality of drug delivery channels, the plurality of GI 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 drug; and a drive mechanism coupled to the drug housing, the drive mechanism including a stopper, a trigger, and a driver, actuating delivery of the drug via the drug delivery mechanism.

[0005] In another embodiment, a drug delivery device is disclosed comprising: a drug delivery mechanism located within the degradable capsule, the drug delivery mechanism including a degradable capsule, 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 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 configured to interface with the drug, a driver within the drug housing cap and coupled to the drive rod, and a dissolvable 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 dissolvable trigger degrades, and the drug is 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, the drug delivery mechanism including at least one drug delivery member configured to interface with a wall of the gastrointestinal tract of a patient, a fluid channel within the at least one drug delivery member configured to allow a drug to flow through the drug delivery member, the fluid channel having a fluid resistance greater than a gap resistance due to the interface with the wall of the gastrointestinal tract, a drug housing coupled to the drug delivery mechanism, and a drive mechanism configured to drive the drug from the drug housing to the drug delivery mechanism.

[0007] In yet another embodiment, an oral drug delivery device is disclosed that includes a biodegradable capsule, a plurality of arms, and a liquid drug, the oral drug delivery device having 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 outward to contact a patient upon degradation 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 passed through the patient. [Brief description of the drawings]

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

[0009] [Figure 1] FIG. 1 is a perspective view of a drug delivery device according to the present disclosure. [Diagram 2] FIG. 2 is an exploded perspective view of the drug delivery device of FIG. 1. [Diagram 3] FIG. 2 is a right side view of the drug delivery device of FIG. 1. [Figure 4] FIG. 2 is a right cross-sectional view of the drug delivery device of FIG. 1. [Diagram 5] FIG. 2 is a front view of the drug delivery device of FIG. 1. [Figure 6] FIG. 2 is a rear view of the drug delivery device of FIG. 1. [Figure 7] FIG. 2 is a perspective view of the drug delivery device of FIG. 1 in a closed position. [Figure 8] FIG. 8 is a perspective view of the drug delivery device of FIG. 7 in an open position. [Figure 9] FIG. 2 is a left side view of the drug delivery device of FIG. 1 in an open configuration within the GI tract of a patient, with the drive mechanism in a loaded position. [Figure 10] FIG. 10 is a side view of the drug delivery device of FIG. 9 with the drive mechanism in a delivery position. [Figure 11] FIG. 2 is a front view of the drug delivery device of FIG. 1 in an open configuration delivering drug to the GI tract of a patient. [Figure 12] FIG. 2 is a partially exploded view of the drug delivery member of the drug delivery device of FIG. 1. [Figure 13] FIG. 2 is a partially exploded view of the drug delivery mechanism of the drug delivery device of FIG. 1. [Figure 14] FIG. 2 is a partial exploded view of the GI tract wall penetration system of the drug delivery device of FIG. 1. [Figure 15] FIG. 2 is a partial exploded view of the GI tract wall penetration system of the drug delivery device of FIG. 1. [Figure 16] FIG. 2 is a simplified cross-sectional view of the device of FIG. 1 with alternating sealing assemblies. [Figure 17] FIG. 2 is a simplified cross-sectional view of the device of FIG. 1 with alternating sealing assemblies. [Figure 18] FIG. 2 is a simplified cross-sectional view of the device of FIG. 1 with alternating sealing assemblies. [Figure 19] FIG. 2 is a simplified cross-sectional view of the device of FIG. 1 with alternating sealing assemblies. [Figure 20] FIG. 2 is a simplified cross-sectional view of the device of FIG. 1 with alternating sealing assemblies. [Figure 21] FIG. 2 is a simplified cross-sectional view of the device of FIG. 1 with alternating sealing assemblies. [Figure 22] FIG. 2 is a perspective view of the drug delivery device of FIG. 1. [Figure 23] 2 is an exemplary timeline for disassembly of the device of FIG. 1. [Figure 24] FIG. 2 is a perspective view of an assembly mechanism for use with the drug delivery device of FIG. 1. [Diagram 25] 13A and 13B are cross-sectional and partial cross-sectional views of the assembly mechanism of FIG. 12. [Figure 26] 13A and 13B are cross-sectional and partial cross-sectional views of the assembly mechanism of FIG. 12. [Figure 27] FIG. 13 is a partial exploded view of some internal components of the assembly mechanism of FIG. [Figure 28] 2 is a depiction of a method of assembling the drug delivery device of FIG. 1. [Figure 29] 2 is a depiction of a method of assembling the drug delivery device of FIG. 1. [Diagram 30] 2 is a depiction of a method of assembling the drug delivery device of FIG. 1. [Diagram 31] 2 is a depiction of a method of assembling the drug delivery device of FIG. 1. [Diagram 32] 2 is a depiction of a method of assembling the drug delivery device of FIG. 1.

[0010] Corresponding reference characters indicate corresponding parts throughout the several views. The illustrations set forth herein illustrate exemplary embodiments of the present invention, and such illustrations should not be construed as limiting the scope of the present invention in any manner. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] 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. Upon entering a portion of the patient's gastrointestinal (GI) tract, the capsule 110 disintegrates or otherwise breaks apart, thereby allowing the delivery mechanism 200 to interface with the inner wall of the GI tract and secure the drug delivery device 100 in place. Once the delivery mechanism 200 interfaces with the patient's GI tract, the drive mechanism 300 actuates the delivery of the drug 500 from the drug housing 400 through the GI tract wall to the patient. As the drug 500 is delivered, the drug delivery device 100 passes through the GI tract.

[0012] 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 a resilient arm 215, a delivery channel 213, a mating end 217, and a piercing assembly 260. In the illustrated embodiment, three delivery members 210 extend from and are equally spaced around the delivery base 230, 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 mating end 217. The delivery channel 213 is fluidly coupled to the central bore 250 and extends along the resilient arm 215. In the illustrated embodiment, the delivery channel 213 is formed as an exposed groove in the outer surface of the resilient arm 215. With reference to FIG. 12, the membrane 220 is bonded to the surface of the resilient arm 215 to encapsulate and seal the delivery channel 213. The membrane 220 may be bonded to the surface of the resilient arm 215 by adhesive, welding (heat, UV, laser, ultrasonic, solvent, friction, injection, radio frequency, etc.), mechanical connection, or any other connecting means. The use of the membrane 220 may simplify the formation (e.g., molding, cutting) of the channel 213 into the outer surface of the resilient 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. Additionally, the delivery channel 213 may be located completely within the resilient arm 215 such that the interior of the delivery channel 213 is completely enclosed (eg, a bore through the resilient arm 215).

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

[0016] In another embodiment, the connecting end 217 includes a liquid jet delivery mechanism for delivering fluid through the GI tract. In this embodiment, the piercing assembly 260 (e.g., element 265) is formed as a nozzle or jet that delivers fluid from the delivery channel 213 at high velocity to puncture and penetrate the GI tract without the use of a piercing 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 high force suitable for driving a liquid jet.

[0017] Referring again to FIGS. 1-6, in the illustrated embodiment, the delivery base 230 and delivery member 210 of the delivery mechanism 200 are constructed as a single, integral piece. In the illustrated embodiment, the delivery member 210 and delivery base 230 are resilient and have a stiff, spring-like characteristic adapted to allow the delivery member 210 to flex 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 comprised of a polymer, such as a bioabsorbable / biodegradable polymer. Exemplary polymers include polyglycolic acid, polylactic acid, polycaprolactone, and copolymers and blends thereof, which may include polyethylene glycol. In other embodiments, the delivery mechanism 200 may be comprised of a metal or other suitable material. As shown in FIG. 13, the delivery mechanism 200 may alternatively be constructed of multiple pieces connected through one or more coupling members 270. In the illustrated embodiment of FIG. 13, the coupling member 270 couples the multiple delivery members 210 together at the delivery base 230. Moreover, 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 bioabsorbable / biodegradable polymers listed above, such that upon degradation of the coupling member 270, the delivery mechanism 200 breaks into separate pieces. Both the delivery members 210 and the coupling member 270 may be made of a biodegradable material, or only one of the delivery members 210 and the coupling member 270 may be made of a biodegradable material. In other embodiments, any components of the delivery mechanism 200 may be manufactured as separate pieces and coupled together through the coupling member 270. Furthermore, the components of the delivery mechanism 200 may be coupled to each other by adhesives, welding, or other coupling means.

[0018] Referring again to FIGS. 1-6, the drug housing 400 is configured to fluidly couple with the delivery mechanism 200 through the housing coupling 450. The drug housing 400 is further configured to hold a volume of the drug 500, generally in a liquid or other flowable form. In an exemplary embodiment, the drug 500 is a compound that is typically less effective when ingested by standard oral delivery and digestion, such as a peptide or protein, such as insulin. In an exemplary embodiment, the drug 500 refers to, but is not limited to, insulin, insulin analogs, such as 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 tirzepatide, 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, drug 500 may be any biologically active compound administered to a patient. Drug housing 400 may be made of a polymer, metal, ceramic, crystalline solid, or any other material capable of retaining a volume of drug 500.

[0019] 16-21, in another embodiment of the drug delivery device 100, a seal assembly may be used between the drug housing 400 and the delivery mechanism 200 to retain 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. Referring initially 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 configurations commonly utilized by automatic injection systems known in the art. The needle 415 may be driven to pierce the septum 420, for example, in a step of priming 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 is ingested by the patient. For example, the needle 415 may be actuated as a result of the degradation of the capsule 110 or by including an additional degradable or force providing component (not shown) that can actuate the needle 415 upon degradation. In the illustrated embodiment, the septum 420 is elastomeric and is coupled to the drug housing 400 by overmolding. In other embodiments, the septum 420 may be made of any material suitable for retaining the drug 500 within the drug housing 400 and that can be pierced by the needle 415. Upon piercing the septum 420 with the needle 415, the interior of the drug housing 400 is fluidly coupled to the delivery mechanism 200 through the connecting channel 450, allowing the drug 500 to flow into the delivery mechanism 200.

[0020] In the illustrated embodiment, the delivery mechanism 200 comprises a housing sleeve 233 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 comprise several separate members. The housing sleeve 233 may also comprise a retention feature 231. The retention feature 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 comprise a complementary feature that interfaces with the retention feature 231. Additionally, an adhesive or other form of bonding agent may be applied to the housing sleeve 233 and / or the housing 400 to help retain the housing sleeve 233 around the housing 400.

[0021] 18-19, in another embodiment, the housing 400 may comprise a rupturable membrane 430 at the end of the connecting channel 450. The rupturable membrane 430 is configured to retain the drug 500 within the drug housing 400 until an increase in pressure causes the rupturable membrane 430 to rupture or otherwise allow passage of the drug 500 through the connecting channel 450. The increase in pressure may be caused by actuation of the plunger 340. In the illustrated embodiment, the housing 400 mates with 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 bonding agent to aid in bonding the housing 400 to the delivery mechanism 200. The housing interface 425 may also comprise surface features such as ridges, bumps, grooves, or other retention features for mating with the delivery base 230. In such embodiments, the delivery base 230 may be provided with complementary surface features.

[0022] 20-21, in yet another embodiment, the housing 400 may be molded closed to form an intentional weak point 440. The weak point 440 may rupture in a manner similar to the breakable membrane 430, as described above, to allow the drug 500 to pass through the housing coupling 450. Embodiments including a breakable membrane 430 and / or weak point 440 may not require a priming or actuation step as required by the needle 415 and septum 420 configuration shown in FIGS.

[0023] The drive mechanism 300 is configured to at least partially fit within the drug housing 400 and is configured to actuate 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 approximately coaxially with the longitudinal axis A1. The cap 330 seals the drug 500 within the drug housing 400 and at least partially encapsulates the driver 360. The plunger 340 includes a stopper end 342 adjacent the stopper 310 and a trigger end 344 adjacent the trigger 350, and is movable from a first loading position to a second delivery position approximately along the axis A1. 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 embodiments, the stopper 310 can be separated from the drive mechanism 300 and 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 so that the drive mechanism can be coupled to the drug housing 400 at a later time.

[0024] 9-10, the stopper 310 is configured to seal the drug 500 within the drug housing 400 and is slidable generally along axis A1. In a 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. Once the trigger 350 degrades and is removed from the arrangement between the trigger end 344 and the cap 330, the force applied to the plunger 340 by the driver 360 moves the plunger 340 generally along axis A1 to a second delivery position (see FIG. 10). 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 a first position to a second position, including a balloon, a piston, or a motor. In the illustrated embodiment, due to the presence of the cap 330, the stopper 310, the plunger 340, and the driver 360 all remain within the drug housing 400 after the drug delivery device 100 is actuated and the drug 500 is delivered. 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 retains the components within the relatively smooth drug housing 400 that is ultimately passed by the patient.

[0026] 22, trigger 350 includes an interior 352, an inner edge 353, a top surface 354, and at least one bevel 355. Bevel 355 may also be located at other points along inner edge 353 or may even extend completely around inner edge 353. Additionally, top surface 354 may be angled downward toward interior 352 over a portion or all of trigger 350. Plunger 340 is configured to fit within interior 352 of trigger 350. Bevel 355, in conjunction with the generally horseshoe shape of trigger 350, is configured to direct force from driver 360 through trigger end 344 of plunger 340 to a smaller area of ​​trigger 350. Thus, trigger 350 is configured to break more easily than if trigger 350 were a solid disk. Additionally, because many biodegradable materials do not completely dissolve in a short amount of time, the shape and bevel 355 of trigger 350 ensures that trigger 350 will not catastrophically fail by snapping or breaking after a threshold level of degradation occurs. This configuration allows for relatively quick actuation of drive mechanism 300 once trigger 350 has degraded beyond a threshold amount.

[0027] 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 be moved to the closed state, after which it may bounce or expand back to the second state due to the elasticity of the delivery member 210. In the closed state, the delivery member 210 is contained within the capsule 110 and lies approximately parallel to the axis A1 (see FIG. 7). In the closed state, the delivery member 210 exerts a radially outward force on the interior of the capsule 110. Once the capsule 110 has degraded, dissolved, or otherwise disintegrated beyond a predetermined point, the delivery member 210 may break through the remaining capsule 110 and move radially outward from the axis A1 into an 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, which travels 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, e.g., when it leaves the acidic stomach and enters the relatively alkaline small intestine. When the capsule 110 degrades a threshold amount beyond the predetermined point, 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 mating end 217 interfaces with the interior of the patient's GI tract, also referred to as the GI tract wall 700. The piercing tip 266 pierces the GI tract wall 700, thereby securing the drug delivery device 100 to the wall 700 at the piercing point (see FIG. 9 ). The mating end 217 is configured to interface with the wall surface 710 when the piercing tip 266 pierces 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 anchoring force to deliver the drug. Additionally or alternatively, the end 217 may include an interface feature, such as a piercing tip or ridge, for gripping and anchoring the device 100 to the wall 700 during liquid jet delivery.

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

[0030] Referring to FIG. 23, a depiction of the relative degradation times of different components of the drug delivery device 100 is shown according to one exemplary embodiment. In the illustrated embodiment, the first component to degrade is the capsule 110, exposing the internal components of the device 100, allowing the device 100 to spring open and position itself within the GI tract. The next component to degrade is the trigger 350, thereby actuating the delivery mechanism 300 and delivering the drug 500 to the patient. The next components to degrade are the delivery member 210 and / or the coupling member 270, thereby allowing the drug delivery device 100 to pass through the remainder of the GI tract and be passed by the patient. Finally, the piercing assembly 260, or certain components within the piercing assembly 260, degrade. Both the capsule 110 and the trigger 350 degrade on the scale of approximately minutes or seconds. The delivery member 210 and / or the coupling member 270 degrade on the scale of approximately hours. The piercing assembly 260 or components thereof degrade on the order of hours or days. Components of the drug delivery device 100 may be designed to degrade on other suitable time scales in other embodiments.

[0031] In an exemplary embodiment, the delivery mechanism 200 includes a pressure regulator (not shown). When the piercing tips 266 penetrate the GI tract wall 700, a gap pressure is created at the wall surface 710. In order for the drug 500 to move across the GI tract wall surface 710, the driver 360 must create a pressure in the drug 500 that is greater than the gap pressure so that the drug 500 will flow through the wall 700. The pressure regulator sets a pressure threshold greater than the gap pressure of each delivery member 210 such that the driver 360 must create a pressure in the drug 500 that is greater than the pressure threshold so that the drug 500 will flow through the delivery member 210. Thus, if one or more of the piercing tips 266 do not penetrate the wall 700, the disengaged piercing tips 266 that did not penetrate the wall 700 will still be subjected to the pressure threshold set by the pressure regulator and a portion of the drug 500 will still be delivered through the engaged piercing tips 266 that penetrated the wall 700. In the absence of a pressure regulator, the majority of the drug 500 would escape through the piercing tip 266 which did not pierce the wall 700 as it provides a path of less resistance.

[0032] In another embodiment, only one of the delivery members 210 may contain a delivery channel 213, and therefore only that one delivery member 210 may deliver the drug 500 to the patient. The other delivery member 210 may be configured to function as a "dummy" or structural delivery member 210 and may be present to help secure the drug delivery device 100 in the GI tract without functioning as a means for delivering the drug 500. The structural delivery member 210 may not include a piercing assembly 260, since the drug 500 does not flow through the delivery member 210 and then through the piercing assembly 260. The structural delivery member 210 may include a mating feature (not shown) on the mating end 217 to grip the GI tract wall 700. Such mating features may include ridges, protrusions, adhesives, or other gripping / attachment means. The structural delivery member 210 may also include microneedles, patches, solid drug deposits, or other drug delivery means that allow diffusion of a drug or other active agent through the wall 700 without penetration.

[0033] 24-27, a device assembly mechanism 800 is provided to reduce the possibility of viscoelastic creep in 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 comprises 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 pressed or otherwise actuated by a user to initiate assembly of a single drug delivery device 100 at a time. In the illustrated embodiment, the device assembly mechanism 800 is loaded with several drug delivery devices 100. 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 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 coupled by friction, welding, adhesives, mechanical fasteners, or other coupling means. Once the capsule 110 is completely 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 each drug delivery device 100 is orally ingested by the patient.

[0034] 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 enters a closed state in which the delivery member 210 partially seals the drug drive unit 900. The drug drive unit 900 is pushed further 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 include a wireless communication device configured to transmit and / or receive signals to and from a wireless receiver (not shown). The wireless communication device may be configured to measure or sense biological information in the patient after the drug delivery device 100 is ingested. For example, the wireless receiver may transmit a signal when the delivery mechanism 200 expands or when a portion of the drug delivery device 100 degrades. Furthermore, the wireless communication device may measure / sense other biological information in the GI tract, such as chemical concentrations, pH, temperature, or other biological information. The wireless receiver may be used by the patient undergoing treatment or by another user, such as a doctor or caregiver. The wireless communication device and the wireless receiver may communicate through RFID, magnetic acoustic, near-field communication, ultrasound, Bluetooth technology, or other wireless communication means.

[0036] While the invention has been described as having an exemplary design, the invention can be further modified within the spirit and scope of the disclosure. This application is therefore 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 disclosure as come within known or customary practice in the art to which this invention pertains and which 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 wall of the patient's GI tract, the drug delivery mechanism comprising a base, a plurality of resilient arms extending from the base and spaced circumferentially about the base, 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 from the drug housing through the drug delivery mechanism; Equipped with the base, the drug housing, and the drive mechanism are disposed along a longitudinal axis; A drug delivery device, wherein the drug delivery mechanism is configured to transition from a closed position to an open position after the capsule disintegrates to interface with the GI tract wall of the patient, and the trigger is dissolvable within the GI tract wall of the patient and configured to disintegrate to activate the driver of the drive mechanism for delivery of the medication after the drug delivery mechanism is in the open position.

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

3. 2. The drug delivery device of claim 1, wherein the multiple resilient arms of the drug delivery mechanism expand radially outward to abut the GI tract wall of the patient in the open position.

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

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

6. 2. The drug delivery device of claim 1, wherein the wall joint 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 degrade within the gastrointestinal tract of the patient.

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

8. 2. The drug delivery device of claim 1, further comprising 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.

9. 2. The drug delivery device of claim 1, further comprising a membrane within the drug housing, the membrane including a sealed 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 allow flow of the drug out of the drug housing.

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

11. The drug delivery device of claim 1 , wherein at least one component of the drug delivery mechanism decomposes after the drive mechanism actuates delivery of the drug.

12. The drug delivery device of claim 11 , wherein the drug delivery mechanism further comprises a plurality of binding members, the binding members configured to degrade in the GI tract.

13. The drug delivery device of claim 1 , wherein the stopper is coupled to the drug housing separately from the driver and the trigger.

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

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

16. 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:

17. 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 drug housing cap coupled to the drug 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; The drug housing cap prevents the drive mechanism from dislodging from the drug housing and entering the GI tract.

18. 20. The drug delivery device of claim 17, wherein the degradable capsule is configured to degrade after a pH change occurs in an environment surrounding the degradable capsule.

19. 20. The drug delivery device of claim 17, wherein 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. 20. The drug delivery device of claim 17, wherein 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 patient's small intestine.

21. 21. The drug delivery device of claim 20, wherein the piercing tip comprises a needle and a degradable base, the degradable base being coupled to the resilient arm and the needle being coupled to the degradable base.

22. 21. The drug delivery device of claim 20, wherein the piercing tip comprises a degradable needle, the degradable needle configured to degrade after penetrating the GI tract wall of the small intestine of the patient.

23. 20. The drug delivery device of claim 17, wherein the dissolvable trigger comprises a bevel, the bevel configured to weaken a structure of the dissolvable trigger as the dissolvable trigger degrades.

24. 18. The drug delivery device of claim 17, wherein 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 configured to position the drug delivery device within the gastrointestinal tract of a patient.

25. a housing capsule configured to disintegrate in a gastrointestinal (GI) tract of a patient; a drug delivery mechanism within the housing capsule, at least one drug delivery member configured to interface with a wall of the GI tract of a 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.

26. 26. The drug delivery device of claim 25, wherein the drug delivery mechanism is at least partially comprised of an elastic 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. 26. The oral drug delivery device of claim 25, wherein the drive mechanism comprises a dissolvable trigger, the dissolvable trigger configured to degrade in the GI tract after the drug delivery mechanism is at least partially removed from the housing capsule.

28. 26. The oral drug delivery device of claim 25, wherein the drug delivery mechanism is configured to expand and anchor within the wall of the gastrointestinal tract.

29. 26. The oral drug delivery device of claim 25, further comprising 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 break after a threshold pressure is applied to the weak point.

30. 1. An oral drug delivery device comprising: A biodegradable capsule; a delivery mechanism including a base and a number of arms extending from the base; a drug housing containing a liquid drug, the base of the delivery mechanism being disposed at an axial end of the drug housing; The oral drug delivery device comprises: a closed configuration, wherein the plurality of arms are disposed within the capsule and adjacent to the medication housing; 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 injected from the medication housing, through the base and the plurality of arms, and into the patient; and An oral drug delivery device having a release configuration in which the multiple arms are separated from the patient and pass through the patient.

31. 31. The oral drug delivery device of claim 30, further comprising 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.

32. 31. The oral drug delivery device of claim 30, further comprising 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 over the bevel.

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