Oral drug delivery device with expansion arms

Abstract

The present disclosure provides a drug delivery device. The drug delivery device is orally ingested by a patient and then activated within the patient's gastrointestinal (GI) tract. Upon activation, a resilient arm within the drug delivery device expands and engages the GI tract wall. A driver then drives a plunger within the drug delivery device, pushing a drug through a channel in the resilient arm 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

[0001] This application is a divisional application of the invention patent application filed on September 15, 2021, with application number 202180063363.8 and invention title "Oral Drug Delivery Device with Expanding Arm". Technical Field

[0002] This invention relates to an oral drug delivery device. More specifically, this disclosure relates to an oral drug delivery device having an extension arm / expansion arm that is activated in the small intestine to deliver a drug through the gastrointestinal wall. Background Technology

[0003] For patients receiving treatment with drugs or certain other bioactive compounds, oral administration is often the most convenient method. However, some compounds are characterized by their inability to retain their activity once consumed. For example, some compounds denature, are digested, or become inactive once placed in the gastrointestinal (GI) system. Furthermore, some compounds diffuse from the gastrointestinal system into the bloodstream at a very low rate, which may hinder the delivery of an adequate dose to the patient. For compounds with these characteristics, patients typically receive them by injection, which is painful and inconvenient. Therefore, there is a need to develop an oral drug delivery device capable of successfully delivering drugs that are ineffective when taken orally. Summary of the Invention

[0004] This invention provides a drug delivery device. The drug delivery device is orally administered by a patient and then activated within the patient's digestive tract / gastrointestinal (GI) tract. Upon activation, an arm within the drug delivery device expands / extends, and a penetrating tip penetrates the gastrointestinal tract. A actuator then drives a plunger within the drug delivery device, propelling the drug through the penetrating tip and the patient's gastrointestinal wall. After a period of time, at least a portion of the drug delivery device dissolves, and the drug delivery device has passed through the gastrointestinal tract.

[0005] In one exemplary embodiment, a drug delivery device is disclosed, comprising: a capsule configured to degrade within a patient's gastrointestinal (GI) tract; a drug delivery mechanism within the capsule, configured to interact with the patient's gastrointestinal wall, the drug delivery mechanism including a plurality of resilient arms, a plurality of gastrointestinal wall abutments / connections / contacts, and a plurality of drug delivery channels, wherein the plurality of gastrointestinal wall abutments are fluidly connected to the plurality of drug delivery channels; a drug housing fluidly connected to the drug delivery mechanism and configured to contain a volume of drug / amount of drug; and a drive mechanism coupled to the drug housing, the drive mechanism including a stop / block, a trigger, and a driver, wherein the drive mechanism actuates the delivery of the drug via the drug delivery mechanism.

[0006] In another embodiment, a drug delivery device is disclosed, comprising a biodegradable capsule; a drug delivery mechanism located within the biodegradable capsule, including a fluid channel and a plurality of drug delivery components; a drug shell fluidly connected to the fluid channel and configured to contain a volume of drug; and a drive mechanism coupled to and at least partially located within the drug shell, the drive mechanism comprising: a drug shell cap configured to fluidly seal the drug shell; a drive rod slidable within the drug shell; a drive stop coupled to the drive rod and configured to engage with the drug; an actuator located within the drug shell cap and coupled to the drive rod; and a soluble trigger configured to hold the drive rod in a first position, wherein when the soluble trigger degrades, the actuator pushes the drive rod from the first position to a second position, and when the drive rod moves from the first position to the second position, the drug is released through the drug delivery mechanism.

[0007] In yet another embodiment, an oral drug delivery device is disclosed, comprising a shell capsule; a drug delivery mechanism within the shell capsule, comprising: at least one drug delivery member configured to interact with a patient's gastrointestinal wall; a fluid channel within the at least one drug delivery member configured to allow drug flow through the drug delivery member, wherein fluid resistance within the fluid channel is greater than interstitial resistance from the interaction with the gastrointestinal wall; a drug shell coupled to the drug delivery mechanism; and a drive mechanism configured to drive the drug from the drug shell to the drug delivery mechanism.

[0008] In yet another embodiment, an oral drug delivery device is disclosed, comprising a biodegradable capsule, multiple arms, and a liquid drug, wherein the oral drug delivery device has a closed configuration in which the multiple arms are disposed within the capsule, an open configuration in which the multiple arms extend radially outward to contact the patient as the capsule degrades, a delivery configuration in which the liquid drug is injected into the patient through the multiple arms, and a release configuration in which the multiple arms are separated from the patient to pass through the patient. Attached Figure Description

[0009] The above and other features and advantages of this disclosure, as well as the ways in which they are obtained, will become more apparent from the following description, taken in conjunction with the accompanying drawings and reference to embodiments of the invention, and the invention itself will be better understood, wherein:

[0010] Figure 1 This is a perspective view of an exemplary embodiment of a drug delivery device according to the present disclosure; Figure 2 yes Figure 1 An exploded perspective view of the drug delivery device shown. Figure 3 yes Figure 1 Right view of the drug delivery device shown; Figure 4 yes Figure 1 Right sectional view of the drug delivery device shown; Figure 5 yes Figure 1 A front view of the drug delivery device shown; Figure 6 yes Figure 1 Rear view of the drug delivery device shown; Figure 7 It is in the closed position. Figure 1 A perspective view of the drug delivery device shown. Figure 8 It is in the open position. Figure 7 A perspective view of the drug delivery device shown. Figure 9 yes Figure 1 The drug delivery device shown is in the left-hand view of its open configuration within the patient's gastrointestinal tract, with the drive mechanism in the loading position. Figure 10 yes Figure 9 A side view of the drug delivery device shown, with the drive mechanism in the delivery position; Figure 11 yes Figure 1 The image shows a front view of a drug delivery device in the open position, delivering medication into the patient's gastrointestinal tract. Figure 12 yes Figure 1 A partial exploded view of the drug delivery components of the drug delivery device shown; Figure 13 yes Figure 1 A partial exploded view of the drug delivery mechanism of the drug delivery device shown; Figure 14-15 yes Figure 1 A partial exploded view of the gastrointestinal wall penetration system of the drug delivery device shown; Figure 16-21 yes Figure 1 A simplified cross-sectional view of the device shown, with alternative sealing components; Figure 22 yes Figure 1 A perspective view of the trigger of the drug delivery device shown; Figure 23 yes Figure 1 An exemplary timeline of device degradation shown; Figure 24 It is used for Figure 1 A perspective view of the assembly mechanism of the drug delivery device shown; Figure 25-26 They are Figure 12 Cross-sectional view and partial cross-sectional view of the assembly mechanism shown; Figure 27 yes Figure 12Partial exploded view of several internal components of the assembly mechanism shown; and Figure 28-32 Depicting Figure 1 Assembly method of the drug delivery device shown.

[0011] In several views, corresponding reference characters denote corresponding components. The examples set forth herein illustrate exemplary embodiments of the invention, and these examples should not be construed as limiting the scope of the invention in any way. Detailed Implementation

[0012] First refer to Figure 1-6 The image shows a drug delivery device 100. The drug delivery device 100 includes a capsule 110, a delivery mechanism 200, a drive mechanism 300, and a drug casing 400. The drug casing 400 may also be referred to as a cartridge. When the drug delivery device 100 is fully assembled, the capsule 110 encapsulates the delivery mechanism 200, the drive mechanism 300, and the drug casing 400. As discussed in more detail herein, the drug delivery device 100 is configured for oral administration by a patient. Upon entering a portion of the patient's gastrointestinal (GI) tract, the capsule 110 degrades or otherwise ruptures, thereby allowing the delivery mechanism 200 to interact with the inner wall of the gastrointestinal tract and hold the drug delivery device 100 in place. Once the delivery mechanism 200 has interacted with the patient's gastrointestinal tract, the drive mechanism 300 actuates the delivery of drug 500 from the drug casing 400 through the gastrointestinal wall to the patient. Once the drug 500 has been delivered, the drug delivery device 100 traverses the gastrointestinal tract.

[0013] like Figure 2 As shown, capsule 110 consists of two parts: a first rear capsule portion 104 and a second front capsule portion 106. As discussed in more detail herein, the first capsule portion 104 and the second capsule portion 106 are joined together to form capsule 110.

[0014] When the drug delivery device 100 is assembled, the delivery mechanism 200 is configured to be installed within the capsule 110. In the illustrated embodiment, the delivery mechanism 200 includes a delivery base 230, a plurality of delivery members 210 extending from the delivery base 230, a membrane 220, and a central aperture 250 extending through the delivery base 230. Each delivery member 210 includes a resilient arm 215, a delivery channel 213, a docking end 217, and a penetration assembly 260. In the illustrated embodiment, three delivery members 210 extend from the delivery base 230 and are circumferentially equidistant from the delivery base 230; however, in other embodiments, any number of delivery members 210 and their spacing may be used.

[0015] The conveying mechanism 200 is configured to allow fluid to flow from the central aperture 250 through the conveying channel 213 to the mating end 217. The conveying channel 213 is fluidly connected to the central aperture 250 and extends along the resilient arm 215. In the illustrated embodiment, the conveying channel 213 is formed as an exposed groove within the outer surface of the resilient arm 215. (Refer to...) Figure 12 The membrane 220 adheres to the surface of the elastic arm 215 to close and seal the delivery channel 213. The membrane 220 can be attached to the surface of the elastic arm 215 by adhesives, welding (heat, UV, laser, ultrasonic, solvent, friction, injection, high frequency, etc.), mechanical connection, or any other connection method. The use of the membrane 220 simplifies the formation (e.g., molding, cutting) of the channel 213 in the outer surface of the elastic arm 215. In other embodiments, the delivery channel 213 may be a separate component (e.g., a tube) coupled to a portion of the delivery mechanism 200. Furthermore, the delivery channel 213 may be entirely located within the elastic arm 215, such that the interior of the delivery channel 213 is completely closed (e.g., through a hole in the elastic arm 215).

[0016] Reference Figure 14-15 In an illustrative embodiment, a docking end 217 is located near the end of each resilient arm 215 and configured to dock with the interior of a patient's gastrointestinal tract. The docking end 217 includes a port 267 configured to receive a penetrating assembly 260. The penetrating assembly 260 includes a penetrating base 264 and a penetrating tip 266. Figure 14 As shown, in one embodiment, the penetrating tip 266 is separated from the penetrating base 264, and the penetrating base 264 includes a receiving aperture 265 configured to connect the penetrating base 264 to the penetrating tip 266. In another embodiment, as... Figure 15 As shown, the penetrating base 264 and penetrating tip 266 can be formed as a single piece. The port 267 is configured to fluidly connect each delivery channel 213 to the corresponding penetrating tip 266, allowing fluid to flow from the delivery channel 213 to the penetrating tip 266. At least one of the penetrating base 264 and penetrating tip 266 can be biodegradable. In an exemplary embodiment, the docking end 217 interacts with the inner wall of the gastrointestinal tract and is generally parallel to the longitudinal axis A1, while the penetrating tip 266 pierces or penetrates the gastrointestinal wall and is generally perpendicular to axis A1. After a predetermined time has elapsed, the penetrating base 264 and / or the penetrating tip 266 can degrade and detach from the gastrointestinal tract. In the illustrated embodiment, the penetrating tip 266 has the shape of a hypodermic needle. In other embodiments, the penetrating tip 266 may include a puncture tip having a fluid outlet located below the penetrating tip (e.g., in the side surface of the penetrating tip 266) to avoid obstruction during drug delivery 500. In addition, each delivery member 210 may include any number of penetrating tips 266, including microneedle arrays.

[0017] In an alternative embodiment, docking end 217 includes a liquid jet delivery mechanism for delivering fluid through the gastrointestinal tract. In this embodiment, the penetration component 260 (e.g., element 265) is formed as a nozzle or jet that delivers fluid at high speed from delivery channel 213 to puncture and penetrate the gastrointestinal tract, without using penetration tip 266 to deliver the drug. In this embodiment, drive mechanism 300, including the actuator 360 described herein, is adapted to actuate the delivery of drug 500 from drug casing 400 with high force to drive the liquid jet.

[0018] Refer again Figure 1-6 In the illustrated embodiment, the delivery base 230 and delivery member 210 of the delivery mechanism 200 are a single integral piece. In the illustrated embodiment, the delivery member 210 and delivery base 230 are elastic, having rigid, spring-like properties, wherein the delivery member 210 is adapted 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 after delivery of the fluid. In an exemplary embodiment, the delivery mechanism 200 is constructed of a polymer, such as a bioabsorbable / biodegradable polymer. Exemplary polymers include polyglycolic acid, polylactic acid, polycaprolactone, and copolymers and mixtures thereof, which may include polyethylene glycol. In other embodiments, the delivery mechanism 200 may be constructed of metal or other suitable materials. Figure 13 As shown, the conveying mechanism 200 may alternatively consist of multiple parts connected by one or more connecting members 270. Figure 13 In the illustrated embodiment, the connecting member 270 connects multiple conveying members 210 together at the conveying base 230. Furthermore, in the illustrated embodiment, the connecting member 270 is an I-beam connector. In other embodiments, the connecting member 270 may be a fastener, screw, snap, pin, nail, or any other mechanical connection. The connecting member 270 may be made of a biodegradable material, including the aforementioned bioabsorbable / biodegradable polymers, such that the conveying mechanism 200 decomposes into separate parts upon degradation of the connecting member 270. Both the conveying members 210 and the connecting member 270 may be made of biodegradable materials, or only one of them may be made of a biodegradable material. In other embodiments, any component of the conveying mechanism 200 may be manufactured as a single piece and connected together by the connecting member 270. Furthermore, the components of the conveying mechanism 200 may be connected together by adhesives, welding, or other connection methods.

[0019] Refer again Figure 1-6The drug casing 400 is configured to be fluidly coupled to the delivery mechanism 200 via a casing coupling 450. The drug casing 400 is further configured to contain a volume of drug 500, typically in a liquid or other flowable form. In an exemplary embodiment, drug 500 is a compound that typically has less efficacy when taken orally and digestively, such as a peptide or protein, like insulin. In one illustrative embodiment, drug 500 includes one or more therapeutic agents, including but not limited to insulin, insulin analogs such as lispro or glargine insulin, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory peptides (GIPs), GIP analogs, GIP derivatives, combined GIP / GLP-1 agonists such as tezepamide, gastrin analogs, gastrin derivatives, therapeutic antibodies, and other suitable therapeutic agents. Drug 500 may also include vaccines or gene-based drugs. In other embodiments, drug 500 may be any bioactive compound to be administered to a patient. The drug casing 400 may be made of polymer, metal, ceramic, crystalline solid or any other material capable of containing a volume of drug 500.

[0020] Reference Figure 16-21 In an alternative embodiment of the drug delivery device 100, a sealing assembly may be used between the drug housing 400 and the delivery mechanism 200 to retain the drug 500 within the drug housing 400 in a sealed manner until the drug 500 is ready to be introduced into the delivery mechanism 200. First refer to... Figure 16-17 In one embodiment, the drug casing 400 may include a diaphragm 420 configured to be punctured by a needle 415, similar to a configuration commonly used in automated injection systems known in the art. During the priming / starting step of the drug delivery device 100, for example when the drug delivery device 100... Figure 28-32 In the illustrated assembly, needle 415 can be driven to pierce diaphragm 420. Needle 415 can also be driven through diaphragm 420 after the drug delivery device 100 has been ingested by the patient. For example, needle 415 can be driven due to degradation of capsule 110, or by incorporating additional degradable or force-providing components (not shown) that can drive needle 415 upon degradation. In the illustrated embodiment, diaphragm 420 is elastic and overmolded to drug housing 400. In other embodiments, diaphragm 420 can be made of any material suitable for retaining drug 500 within drug housing 400 and capable of being pierced by needle 415. When diaphragm 420 is pierced with needle 415, the interior of drug housing 400 is fluidly connected to delivery mechanism 200 via connection channel 450, allowing drug 500 to flow into delivery mechanism 200.

[0021] In the illustrated embodiment, the conveying mechanism 200 includes a housing sleeve 233 coupled to the conveying base 230 and configured to connect the conveying mechanism 200 to the housing 400. The housing sleeve 233 may be a sleeve that is completely assembled around the housing 400, or it may include several discrete components. The housing sleeve 233 may also include a retaining feature structure 231. The retaining feature structure 231 may be a ridge, a protrusion, a groove, or other means for retaining the housing sleeve 233 on the housing 400. The housing 400 may also include complementary feature structures that interface with the retaining feature structure 231. Furthermore, adhesives or other forms of bonding agents may be applied to the housing sleeve 233 and / or the housing 400 to help retain the housing sleeve 233 around the housing 400.

[0022] Now refer to Figure 18-19 In another embodiment, housing 400 may include a ruptureable membrane 430 located at one end of connection channel 450. The ruptureable membrane 430 is configured to retain drug 500 within drug housing 400 until an increase in pressure causes the ruptureable membrane 430 to rupture or otherwise allows drug 500 to pass through connection channel 450. The increase in pressure may be caused by actuation of plunger 340. In the illustrated embodiment, housing 400 abuts against delivery base 230 at housing interface / butt 425. Housing interface 425 is configured to contact delivery base 230 when housing sleeve 233 engages housing 400. Housing interface 425 may be coated with adhesive or other bonding agent to aid in attaching housing 400 to delivery mechanism 200. Housing interface 425 may also include surface features such as ridges, bumps, grooves, or other retaining features for interfacing with delivery base 230. In such embodiments, delivery base 230 may include complementary surface features.

[0023] Reference Figure 20-21 In yet another embodiment, the housing 400 may be molded closed to form intentionally created weak points 440. Weak points 440 may rupture in a manner similar to the ruptureable membrane 430 described above to allow the drug 500 to pass through the housing coupling 450. Embodiments including the ruptureable membrane 430 and / or weak points 440 may not require... Figure 16-17 The starting or startup steps required for the needle 415 and diaphragm 420 configuration shown.

[0024] The drive mechanism 300 is configured to be at least partially mounted within the drug housing 400 and to actuate the drug 500 from the drug housing 400 into the delivery mechanism 200. The drive mechanism 300 includes a stop 310, a plunger 340, a cap 330, an actuator 360, and a trigger 350, and is arranged generally coaxially with the longitudinal axis A1. The cap 330 seals the drug 500 within the drug housing 400 and at least partially closes the actuator 360. The plunger 340 includes a stop end 342 adjacent to the stop 310 and a trigger end 344 adjacent to the trigger 350, and is movable generally along the axis A1 from a first loading position to a second delivery position. At the stop end 342, the plunger 340 is coupled to the stop 310. In another embodiment, the plunger 340 is not coupled to the stop 310. In the embodiment described, the stop 310 is separate 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 stop 310 to be assembled or manufactured separately from the drug housing 400 and the stop 310, so that the drive mechanism can be coupled to the drug housing 400 later.

[0025] Next, refer to Figure 9-10 The stop 310 is configured to seal the drug 500 within the drug housing 400 and is generally slidable along axis A1. In the first loading position (see...) Figure 9 The trigger 350 is arranged between the trigger end 344 and the cap 330 to prevent the trigger end 344 from passing through the cap 330 and further to prevent movement of the plunger 340. In the first loading position, the actuator 360 applies a force to the stop end 342 generally toward the housing coupling 450. In the illustrated embodiment, the trigger 350 is made of a biodegradable material and configured to degrade over time. When the trigger 350 degrades and is removed from its arrangement between the trigger end 344 and the cap 330, the force applied to the plunger 340 by the actuator 360 moves the plunger 340 generally along axis A1 to the second delivery position (see [reference]). Figure 10 During the movement from the first position to the second position, the plunger 340 and the stop 310 move generally toward the housing connector 450, thereby reducing the available volume of the drug housing 400 and pushing the drug 500 out of the drug housing 400 into the delivery mechanism 200.

[0026] In the illustrated embodiment, the actuator 360 is a spring. In other embodiments, the actuator 360 can be any component capable of transmitting force to move the plunger 340 from a first position to a second position, including a balloon, piston, or motor. In the illustrated embodiment, due to the presence of the cap 330, the stop 310, plunger 340, and actuator 360 remain within the drug housing 400 after the drug delivery device 100 has been activated and the drug 500 has been delivered. In this embodiment, housing most of the drive mechanism 300 within the drug housing 400 prevents the release of additional, potentially harmful components into the gastrointestinal tract, instead keeping the components within the relatively smooth drug housing 400 that will ultimately be passed through by the patient.

[0027] Now refer to Figure 22 The trigger 350 includes an interior 352, an interior edge 353, an upper surface 354, and at least one ramp 355. The ramp 355 may also be located at other points along the interior edge 353, or even extend entirely around the interior edge 353. Furthermore, the upper surface 354 may slope downwards toward the interior 352 on a portion or all of the trigger 350. A plunger 340 is configured to fit within the interior 352 of the trigger 350. The ramp 355, along with the generally horseshoe shape of the trigger 350, is configured to direct forces from the actuator 360 through the trigger end 344 of the plunger 340 to a smaller area of ​​the trigger 350. Therefore, the trigger 350 is configured to break more easily than if the trigger 350 were a solid disc. Furthermore, since many biodegradable materials do not completely dissolve within a short time, the shape of the trigger 350 and the ramp 355 causes the trigger 350 to suddenly break or fracture after a threshold level of degradation, resulting in abrupt failure. Once the trigger 350 degrades beyond a threshold amount, this configuration allows the drive mechanism 300 to be activated in a relatively rapid manner.

[0028] Reference Figure 7-8 The drug delivery device 100 can be switched from a first state, or a closed state (see...). Figure 7 Move to the second state, or the open state (see...) Figure 8 The conveying members 210 of the conveying mechanism 200 are made of an elastic material, such as a polymer with flexible rigidity and spring-like properties. In the illustrated embodiment, their natural state is the open state when no force is applied to the conveying members 210. However, the conveying members 210 can be moved to the closed state and then, due to the elasticity of the conveying members 210, can spring back or unfold back to the second state. In the closed state, the conveying members 210 are contained within the capsule 110, generally parallel to axis A1 (see [link to capsule 110]). Figure 7In the closed state, the delivery member 210 applies a radially outward force inside the capsule 110. When the capsule 110 degrades, dissolves, or otherwise decomposes beyond a predetermined point, the delivery member 210 may break through any remaining capsule 110 and move radially outward from axis A1 to enter the open state (see...). Figure 8 ).

[0029] When the drug delivery device 100 is used to treat a patient, the patient orally takes the drug delivery device 100, which passes through the patient's gastrointestinal tract. In an exemplary embodiment, the capsule 110 degrades when the pH of the environment surrounding the drug delivery device 100 changes, for example, when it leaves the acidic stomach and enters the relatively alkaline small intestine. When the degradation of the capsule 110 exceeds a threshold amount at the aforementioned predetermined point, the drug delivery mechanism 200 breaks through the capsule 110, and the delivery member 210 extends outward. Inside the patient's gastrointestinal tract, as the delivery member 210 extends outward, the docking end 217 docks with the inside of the patient's gastrointestinal tract, also referred to as the gastrointestinal wall 700. The penetrating tip 266 penetrates the gastrointestinal wall 700, thereby anchoring the drug delivery device 100 to the wall 700 at the point of penetration (see [link to documentation]). Figure 9 The mating end 217 is configured to abut against the wall surface 710 when the penetrating tip 266 penetrates the wall 700. In embodiments using liquid jet delivery, the spring force of the delivery member 210 abutting against the wall 700 can be configured to provide sufficient anchoring force to deliver the drug. Additionally or alternatively, the end 217 may include mating features, such as a penetrating tip or ridge, for gripping and anchoring the device 100 to the wall 700 during liquid jet delivery.

[0030] After the drug delivery device 100 penetrates the gastrointestinal wall 700, the trigger 350 degrades beyond a threshold, allowing the actuator 360 to drive the plunger 340 and the stop 310 into the drug casing 400, propelling the drug 500 through the delivery mechanism 200 (see...). Figure 10 ), and enters the wall 700 through the penetrating tip 266 (see Figure 11 After the drug 500 has been delivered to the patient through the penetration tip 266, the penetration component 260 will degrade. Once the degradation of the penetration component 260 exceeds a threshold, the delivery mechanism 200 will rupture or be released from the penetration component 260 and will pass through the gastrointestinal tract. As described above, other components of the delivery mechanism 200 may also rupture upon degradation of the connecting member 270. In some embodiments, components of the delivery mechanism 200 made of a biodegradable / bioabsorbable polymer (described herein) are also adapted to degrade and dissolve after drug delivery.

[0031] Reference Figure 23According to an exemplary embodiment, a depiction of the relative degradation times of different components of a drug delivery device 100 is shown. In the illustrated embodiment, the first component to degrade is the capsule 110, which exposes the internal components of the device 100 and allows the device 100 to pop open and position itself within the gastrointestinal tract. The next component to degrade is the trigger 350, which activates the delivery mechanism 300 and delivers the drug 500 to the patient. The next components to degrade are the delivery member 210 and / or the coupling member 270, which allow the drug delivery device 100 to pass through the remainder of the gastrointestinal tract and be passed through by the patient. Finally, the penetration assembly 260 or specific components within the penetration assembly 260 degrade. The capsule 110 and the trigger 350 both degrade within a timeframe of approximately minutes or seconds. The delivery member 210 and / or the coupling member 270 degrade within a timeframe of approximately several hours. The penetration assembly 260 or its components degrade within a timeframe of approximately several hours or days. In other embodiments, components of the drug delivery device 100 may be designed to degrade on other suitable timescales.

[0032] In an exemplary embodiment, the delivery mechanism 200 includes a pressure regulator (not shown). When the penetrating tip 266 penetrates the gastrointestinal wall 700, interstitial pressure / intercellular pressure is generated on the wall surface 710. For the drug 500 to pass through the gastrointestinal wall surface 710, the actuator 360 must generate a pressure greater than the interstitial pressure within the drug 500, causing the drug 500 to flow through the wall 700. The pressure regulator sets a pressure threshold greater than the interstitial pressure of each delivery member 210, such that the actuator 360 must generate a pressure greater than the pressure threshold within the drug 500, causing the drug 500 to flow through the delivery member 210. Therefore, even if one or more penetrating tips 266 fail to penetrate the wall 700, the disengaged penetrating tips 266 that have not penetrated the wall 700 will still be affected by the pressure threshold set by the pressure regulator, and thus a portion of the drug 500 will still be delivered through the engaged penetrating tips 266 that have already penetrated the wall 700. Without the pressure regulator, most of the drug 500 would escape through the penetrating tips 266 that have not penetrated the wall 700, as they would provide a path of less resistance.

[0033] In another embodiment, only one delivery member 210 may include a delivery channel 213, so that only this one delivery member 210 can deliver the drug 500 to the patient. Other delivery members 210 may be configured to function as “virtual” or structural delivery members 210 and may be present to help secure the drug delivery device 100 within the gastrointestinal tract, rather than as a means of delivering the drug 500. The structural delivery member 210 may not include a penetration component 260, since no drug 500 will flow through the delivery member 210 and then through the penetration component 260. The structural delivery member 210 may include a mating feature structure (not shown) on the mating end 217 to grip the gastrointestinal wall 700. Such a mating feature structure may include ridges, protrusions, adhesives, or other clamping / attaching methods. The structural delivery member 210 may also include microneedles, patches, solid drug deposits, or other drug delivery methods to allow the drug or other active agent to diffuse through the wall 700 without penetrating.

[0034] Reference Figure 24-27 To reduce the possibility of viscoelastic creep within the delivery mechanism 200, a device assembly mechanism 800 is provided. In an exemplary embodiment, a user or patient may receive the device assembly mechanism 800 and assemble the drug delivery device 100 shortly before it is administered orally. 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 lever 840, a second closing lever 845, and a device retraction area 830. The assembly actuator 810 is configured to be pressed or otherwise activated by the user to trigger the assembly of a single drug delivery device 100 at a time. In the illustrated embodiment, the device assembly mechanism 800 carries multiple drug delivery devices 100. A first capsule portion 104 and 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 in the rotating member 850, and a second capsule portion 106 is held in the actuator 810. In the illustrated embodiment, the access window 825 can be removed to allow for additional loading of the device assembly mechanism 800. When the assembly actuator 810 is activated, 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, adhesive, mechanical fasteners, or other coupling methods. Once the capsule 110 is fully formed around the internal components of the drug delivery device 100, the second closing rod 845 releases the drug delivery device 100 from the rotating member 850 and allows the drug delivery device to enter the device retraction area 830. This process can be repeated before each drug delivery device 100 is orally administered to a patient.

[0035] Reference Figure 28-32 An exemplary embodiment of the device assembly process is depicted. The drug casing 400 and the drive mechanism 300 are combined and simplified within the drug drive unit 900. The delivery mechanism 200 is pushed into the first capsule portion 104 and enters a closed state, wherein the delivery member 210 partially encapsulates 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 connected. A second capsule portion 106 is then pushed onto the drug drive unit 900 and the delivery mechanism 200, and then sealed to the first capsule portion 104.

[0036] In another embodiment, the drug delivery device 100 may include a wireless communication device configured to send and / or receive signals to / from a wireless receiver (not shown). This wireless communication device may be configured to measure or sense biological information within the patient's body after the drug delivery device 100 has been ingested. For example, the wireless receiver may send signals when the delivery mechanism 200 has expanded, or when a portion of the drug delivery device 100 has degraded. Furthermore, the wireless communication device may measure / sensor other biological information within the gastrointestinal tract, such as chemical concentrations, pH levels, temperature, or other biological information. The wireless receiver may be used by the patient receiving treatment, or by another user such as a physician or caregiver. The wireless communication device and the wireless receiver may communicate via RFID, magnetoacoustics, near-field communication, ultrasound, Bluetooth technology, or other wireless communication methods.

[0037] While the invention has been described as having an exemplary design, it may be further modified within the spirit and scope of this disclosure. Therefore, this application is intended to cover any variations, uses, or modifications of the invention using its general principles. Furthermore, this application is intended to cover any deviations from this disclosure in known or conventional practice within the art to which this invention pertains and that fall within the limitations of the appended claims.

Claims

1. A drug delivery device, comprising: Constructed into capsules that degrade within the patient's gastrointestinal tract; A drug delivery mechanism within a capsule, the drug delivery mechanism comprising a base and a plurality of arms extending from the base at an axial end of the drug delivery mechanism; in, The drug delivery mechanism has: 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 the patient's gastrointestinal wall after the capsule degrades; as well as A delivery configuration in which a drug is delivered from at least one of the plurality of arms to the patient’s gastrointestinal wall.

2. The drug delivery device according to claim 1, wherein, In the closed configuration, the plurality of arms are parallel to the longitudinal axis of the drug delivery mechanism.

3. The drug delivery device according to claim 1, wherein, The drug delivery mechanism also has a release configuration in which the plurality of arms are separated from the gastrointestinal wall to pass through the patient.

4. The drug delivery device according to claim 3, wherein, Each of the plurality of arms includes a wall mating end, and each wall mating end includes a penetrating tip configured to penetrate the patient's gastrointestinal wall in both the opening and delivery configurations.

5. The drug delivery device according to claim 4, wherein, The penetrating tip is configured to degrade within the patient's gastrointestinal tract to separate the plurality of arms from the gastrointestinal wall in a release configuration.

6. The drug delivery device according to claim 4, wherein, The penetrating tip has a dissolvable needle structure.

7. The drug delivery device according to claim 1, further comprising a housing, the housing being connected to the drug delivery mechanism and containing the drug, wherein, The base of the drug delivery mechanism is located at the axial end of the housing.

8. The drug delivery device according to claim 7, wherein, In the closed configuration, the plurality of arms are positioned adjacent to the housing.

9. The drug delivery device of claim 7, further comprising a drive mechanism coupled to the housing, the drive mechanism comprising a trigger and a plunger capable of moving within the housing in response to degradation of the trigger, wherein, After the trigger has at least partially degraded and the plunger has moved through the housing, the drug delivery mechanism changes to the delivery configuration.

10. The drug delivery device according to claim 9, wherein, The base, the housing, and the drive mechanism are arranged along a longitudinal axis.

11. The drug delivery device according to claim 7, wherein, Each of the plurality of arms includes a drug delivery channel formed within the arm, the drug delivery channel being in fluid communication with the housing.

12. The drug delivery device according to any one of claims 1 to 11, wherein, The plurality of arms are circumferentially spaced around the base of the drug delivery mechanism.

13. The drug delivery device according to any one of claims 1 to 11, wherein, The plurality of arms are connected to the base by a plurality of soluble connecting members configured to degrade within the patient’s gastrointestinal tract.

14. A drug delivery device, comprising: Constructed into capsules that degrade within the patient's gastrointestinal tract; A drug delivery mechanism located within a capsule, the drug delivery mechanism comprising at least one drug delivery component; A housing, which is connected to the drug delivery mechanism and configured to maintain a certain volume of drug; and A drive mechanism, which is coupled to the housing and at least partially located within the housing, the drive mechanism comprising: A housing cap connected to the housing; A plunger that can move within the housing; and A driver connected to the plunger; Wherein, after the capsule degrades in the gastrointestinal tract, the actuator pushes the plunger from a first position to a second position, and when the plunger moves from the first position to the second position, the drug is delivered from the shell through the drug delivery mechanism.

15. The drug delivery device according to claim 14, wherein, The at least one drug delivery component extends from the base of the drug delivery mechanism, and the base, the housing, and the drive mechanism are arranged along a longitudinal axis.

16. The drug delivery device according to claim 14, wherein, The drug delivery mechanism is configured to change from a closed position to an open position after the capsule degrades, wherein at least one drug delivery member is positioned adjacent to the shell in the closed position and extends radially outward to the open position to interact with the gastrointestinal wall.

17. The drug delivery device according to claim 14, wherein, The at least one drug delivery component includes a docking end and a channel in fluid communication with the housing and the docking end, the docking end including a penetrating tip configured to penetrate the gastrointestinal wall.

18. The drug delivery device according to claim 14, wherein, The drive mechanism further includes a soluble trigger configured to hold the plunger in a first position, and the actuator to push the plunger from the first position to a second position when the soluble trigger degrades in the gastrointestinal tract.

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