Oral drug delivery device with expansion arms

Abstract

The present disclosure provides a drug delivery device. The drug delivery device is orally taken by a patient and then activated within the patient's gastrointestinal (GI) tract. Upon activation, the arms of the drug delivery device expand and the penetrating tip penetrates the GI tract wall. The driver then actuates a plunger within the drug delivery device, pushing the drug through the penetrating tip and through the GI tract wall of the patient. After a period of time, a portion of the drug delivery device dissolves and the drug delivery device passes through the GI track.

Description

Technical Field

[0001] The present disclosure relates to an oral drug delivery device. More specifically, the present disclosure relates to an oral drug delivery device having expansion arms that are activated in the small intestine to deliver a drug through the gastrointestinal wall. Background Art

[0002] For patients receiving drugs or some other bioactive compounds for treatment, oral administration of drugs is usually the most convenient. However, the properties of some compounds make it impossible to maintain their activity once they are eaten. For example, some compounds are denatured, digested or otherwise inactivated once they are placed in the environment of the gastrointestinal (GI) system. In addition, the diffusion rate of some compounds from the GI system to the blood is low, which may make it impossible to deliver enough doses to the patient. For compounds with these properties, patients usually receive compounds by 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 administered by a patient and then activated within the patient's gastrointestinal (GI) tract. Upon activation, the arms of the drug delivery device expand and the penetrating tip penetrates the GI tract. The driver then drives a plunger within the drug delivery device, thereby pushing the drug through the penetrating tip and into the wall of the patient's GI tract. After a period of time, at least a portion of the drug delivery device dissolves or biodegrades, and the drug delivery device passes through and exits the GI tract.

[0004] In an exemplary embodiment, a drug delivery device includes a capsule configured to degrade within a patient's gastrointestinal tract. A drug delivery mechanism is disposed within the capsule and configured to interact with a wall of the patient's gastrointestinal tract. The drug delivery mechanism includes a plurality of deployable arms, a plurality of connection ends coupled to the plurality of deployable arms, and a plurality of drug delivery channels. The plurality of connection ends are in fluid communication with the plurality of drug delivery channels. A drug housing is in fluid communication with the drug delivery mechanism and is configured to accommodate a volume of drug. An expansion mechanism is coupled to the drug housing and is configured to move the plurality of deployable arms from an initial configuration to an expanded configuration after the capsule degrades. A drive mechanism is coupled to the drug housing and includes a driver and a stopper. The driver is configured to move the stopper to force the drug through the plurality of drug delivery channels and the plurality of connection ends.

[0005] In another embodiment, a drug delivery device includes a capsule configured to degrade within the gastrointestinal tract of a patient. A drug delivery mechanism is disposed within the capsule and is configured to interact with the gastrointestinal wall of the patient. The drug delivery mechanism includes a base and a plurality of deployable arms coupled to the base. Each deployable arm includes a drug delivery channel and a connection end in fluid communication with the drug delivery channel. The connection end of each deployable arm is configured to interact with the gastrointestinal wall of the patient. The drug housing is in fluid communication with the drug delivery mechanism and is configured to accommodate a certain volume of drug. The deployment mechanism includes a collar configured to engage the drug delivery mechanism. A drive mechanism is coupled to the drug housing and the deployment mechanism. The drive mechanism is operable to move the collar of the deployment mechanism to engage with a plurality of deployable arms to deploy a plurality of deployable arms. The drive mechanism is also operable to force the drug to be delivered through a plurality of drug delivery channels. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The above and other features and advantages of the present disclosure and the manner in which they are obtained will become more apparent, and the present invention itself will be better understood, by referring to the following description of embodiments of the present invention in conjunction with the accompanying drawings, in which:

[0007] Figure 1 is a perspective view of an exemplary embodiment of a drug delivery device according to the present disclosure in an initial configuration;

[0008] Figure 2 Is in expanded configuration Figure 1 A perspective view of a drug delivery device;

[0009] Figure 3 yes Figure 1 An exploded perspective view of a drug delivery device;

[0010] Figure 4 Is in expanded configuration Figure 1 A side view of a drug delivery device;

[0011] Figure 5 Is in expanded configuration Figure 1 A side cross-sectional view of a drug delivery device;

[0012] Figure 6 Is in expanded configuration Figure 1 A front view of a drug delivery device;

[0013] Figure 7 yes Figure 1 A detailed perspective view of a delivery member of a drug delivery device;

[0014] Figure 8 yes Figure 7 A detailed side view of a conveying member;

[0015] Fig. 9 yes Figure 1 A detailed side view of a unidirectional motion mechanism of a drug delivery device;

[0016] Fig.10 It is in the middle configuration Figure 1 A side cross-sectional view of a drug delivery device;

[0017] Fig.11 Is in expanded configuration Figure 1 Another side view of the drug delivery device; and

[0018] Fig.12 Is in expanded configuration Figure 1 Another side cross-sectional view of a drug delivery device.

[0019] Corresponding reference numerals indicate corresponding parts throughout the several views.The exemplifications set out herein illustrate exemplary embodiments of the invention and are not to be construed as limiting the scope of the invention in any way. DETAILED DESCRIPTION

[0020] First reference Figure 1-Figure 6 , an exemplary drug delivery device 100 is illustrated. Figure 1 The drug delivery device 100 is shown in an initial configuration, and Figure 2-Figure 6 The drug delivery device 100 is shown in an expanded configuration. The drug delivery device 100 includes a capsule 102 ( Figure 1 and Figure 3 )、Transport mechanism 104、Deployment mechanism 106、Drive mechanism 108( Figure 3 and Figure 5 ) and a drug housing 110. The drug housing 110 may also be referred to as a cartridge. When the drug delivery device 100 is fully assembled and in an initial configuration ( Figure 1 ), capsule 102 encloses and contains delivery mechanism 104, deployment mechanism 106, drive mechanism 108, and drug housing 110. As discussed in more detail herein, drug delivery device 100 is orally administered to a patient. Upon entering a portion of the patient's gastrointestinal (GI) tract (e.g., the small intestine), capsule 102 dissolves or otherwise degrades. Figure 2 , the deployment mechanism 106 then causes the delivery mechanism 104 to deploy. More specifically, the deployment mechanism 106 causes the delivery mechanism 104 to interact with the inner wall of the GI tract and secure the drug delivery device 100 in place in the GI tract. Once the delivery mechanism 104 has interacted with the patient's GI tract, the drive mechanism 108 causes the drug 112 ( Figure 3 and Figure 5) is delivered from the drug housing 110 to the patient through the GI tract wall. In the illustrated embodiment, once deployed, the penetrating tip of the delivery mechanism 104 is positioned in the GI tract wall so that the drug 112 is delivered into the GI tract wall. Once the drug 112 has been delivered, at least a portion of the drug delivery device 100 dissolves, and the drug delivery device 100 passes through and exits the GI tract.

[0021] In an exemplary embodiment, as the pH of the environment surrounding the drug delivery device 100 changes, such as when leaving the acidic stomach and entering the relatively alkaline small intestine, at least a portion of the capsule 102 degrades. Figure 1 In the illustrative embodiment of the present invention, the capsule 102 includes two parts, specifically, a first rear capsule portion 114 and a second front capsule portion 116. The first capsule portion 114 and the second capsule portion 116 can be coupled together to form the capsule 102. The capsule 102 can be constructed at least in part of one or more dissolvable or otherwise degradable materials. In some embodiments, the first capsule portion 114 and the second capsule portion 116 are connected by an enteric seam 118 ( Figure 1 ) are coupled together, the enteric seam 118 degrades in the GI tract to permit the capsule 102 to separate and release the remainder of the device 100 into the GI tract.

[0022] When the drug delivery device 100 is assembled, the delivery mechanism 104 is assembled within the capsule 102. In the illustrated embodiment, the delivery mechanism 104 includes a delivery base 120, a plurality of delivery members 122 extending from the delivery base 120, one or more septa (not shown), and a central hole 124 ( Figure 3 and Figure 5 ). Specific reference Figure 6 , and additional reference Figure 7 and Figure 8 , each delivery member 122 includes a deployable arm 126, a delivery channel 128, a connecting end 130, and a penetrating tip 132. In the illustrated embodiment, three delivery members 122 are coupled to and extend from the delivery base 120; however, in other embodiments, any number of delivery members 122 may be used. In some embodiments, the connecting end 130 and / or other components of the delivery member 122 carry or otherwise include an adhesive (e.g., a mucoadhesive) or a fastener (e.g., a hook) to facilitate fastening the device 100 to the inner wall of the GI tract.

[0023] The delivery mechanism 104 promotes the flow of the drug from the central hole 124 through the delivery channel 128 to the connection end 130. The delivery channel 128 extends into the central hole 124 and is in fluid communication with the central hole 124, and extends along the deployable arm 126. In one embodiment, the delivery channel 128 is formed as an exposed groove in the outer surface of the deployable arm 126. One or more septa (not shown) are adhered to the surface of the deployable arm 126 to close and seal the delivery channel 128. The septum can be adhered to the surface of the deployable arm 126 by adhesive, welding (thermal welding, ultraviolet welding, laser welding, ultrasonic welding, solvent welding, friction welding, injection welding, high frequency welding, etc.), mechanical connection or any other connection method. The use of a septum can simplify the production (e.g., molding, cutting) of the channel 128 into the outer surface of the deployable arm 126. In other embodiments, the delivery channel 128 can be a separate component, such as a tube, connected to a portion of the delivery mechanism 104. Furthermore, the delivery passage 128 may be located entirely within the deployable arm 126 such that the interior of the delivery passage 128 is completely enclosed (eg, through a hole in the deployable arm 126 ).

[0024] refer to Figure 7 and Figure 8 , a connecting end 130 is located near the end of each deployable arm 126. Each connecting end 130 includes a penetrating tip 132 that, in the deployed configuration, pierces or penetrates the wall of the GI tract of the patient. In an exemplary embodiment, the tip 132 is at least partially formed of a material that begins to degrade or dissolve when exposed to small intestinal fluid. In the illustrated embodiment, after an amount of time sufficient to complete delivery has passed after deployment, the penetrating tip 132 degrades sufficiently to disengage from the GI tract, thereby allowing the drug delivery device 100 to continue along the GI tract and ultimately exit the patient.

[0025] In the illustrated embodiment, the penetration tip 132 has a beveled shape similar to a hypodermic needle. In other embodiments, the penetration tip 132 may include a piercing tip, wherein the fluid outlet is located below the piercing tip (e.g., in the side surface of the penetration tip 132) to reduce the possibility of blockage in the delivery of the drug 112. In addition, each delivery member 122 may include any number of penetration tips 132, including a microneedle array. In some embodiments, and as illustrated, when the deployable arm 126 is deployed, the connecting end 130 is arranged along the inclined direction D1 ( Figure 8 ) extends, and the inclined direction D1 is arranged obliquely relative to the longitudinal axis A1 of the drug delivery device 100 ( Figure 4 In some embodiments, the penetrating tip 132 is substantially perpendicular to the tilt direction D1.

[0026] In some embodiments, the penetrating tip 132 may form a portion of a penetrating assembly and corresponding receptacle or receiving aperture described in International Application Publication No. WO2022 / 060817, the disclosure of which is hereby incorporated by reference herein for all purposes. In an alternative embodiment, the connecting end 130 may include a liquid jet delivery mechanism for delivering fluid through the GI tract, as described in the previously cited International Application Publication No. WO2022 / 060817.

[0027] Reference again Figure 1-Figure 6 In the illustrated embodiment, the delivery base 120 and the delivery member 122 of the delivery mechanism 104 are constructed as a single piece. In an exemplary embodiment, the delivery mechanism 104 is constructed of a polymer; however, in other embodiments, the delivery mechanism 104 can be constructed of metal or any other biocompatible material. Exemplary polymers include polyethylene glycol acid, polylactic acid, polycaprolactone, and copolymers and mixtures thereof that may include polyethylene glycol. In other embodiments, the delivery mechanism 104 can be constructed of multiple components, which are connected by one or more connecting members (not shown). Examples of such constructions and connecting members are provided in the previously cited International Application Publication No. WO2022 / 060817.

[0028] Specific reference Figure 5 , the drug housing 110 is in fluid communication with the delivery mechanism 104. The drug housing 110 stores a certain volume of drug 112, usually in a liquid or other flowable form. In an exemplary embodiment, the drug 112 is a compound that is generally less effective when delivered and digested by a standard oral cavity, such as a peptide or protein (such as insulin) and a vaccine or a gene-based drug. In other embodiments, the drug 112 can be any biologically active compound given to a patient. In an exemplary embodiment, the drug 112 includes one or more therapeutic agents, including but not limited to insulin, insulin analogs (such as lispro insulin or glargine insulin), 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 tirpotide), gastrin analogs, gastrin derivatives, therapeutic antibodies, and other suitable therapeutic agents. The drug housing 110 may be constructed of a polymer, a metal, a ceramic, a crystalline solid, or any other material capable of retaining the volume of the drug 112 .

[0029] refer to Figure 3 and Figure 5The drive mechanism 108 is at least partially positioned within the drug housing 110 and is configured to force the drug 112 out of the drug housing 110 and through the delivery mechanism 104. The drive mechanism 108 illustratively includes a first stopper or piston 136, a second stopper or piston 138, a plunger 140, a cap 142 of the housing 110, a driver or biasing member 144, and a trigger 146 ( Figure 3 ). The drive mechanism 108 is arranged generally coaxially with the longitudinal axis A1. The cap 142 includes an annular end wall having a central opening sized to receive the plunger 140. As described herein, due to the force applied by the driver 144, the plunger 140 and the first stop 136 and the second stop 138 can be moved generally along the axis A1 relative to the drug housing 110 toward the base 120. The plunger 140 includes a stopper end 148 positioned adjacent to the first stopper 136 and a trigger end 150 positioned adjacent to the trigger 146. The plunger 140 is illustratively fixed to the first stopper 136 at the end 148, but alternatively, the plunger 140 can be removably coupled to the first stopper 136. The driver 14 is held between the stopper end 148 and the inner surface of the cap 142.

[0030] The trigger end 150 of the plunger 140 is removably coupled to the deployment mechanism 106, illustratively coupled to the hub 152 of the deployment mechanism 106, so that the plunger 140 initially moves axially with the deployment mechanism 106 relative to the drug housing 110 during deployment, but is separated from the hub 152 when the deployment mechanism 106 reaches the end of its stroke, as further described herein. The deployment mechanism 106 includes a plurality of legs 154, illustratively including three legs 154, which are coupled to the hub 152, extend along the drug housing 110 and are generally parallel to the axis A1. The legs 154 are fixedly coupled to a collar 156 of the deployment mechanism 106 that is axially opposite to the hub 152. The collar 156 can take various forms, such as a closed annular ring or an open ring as shown. The hub 152, legs 154, and collar 156 of the deployment mechanism 106 are illustratively formed integrally, but alternatively, can include one or more separate components coupled together.

[0031] The deployment mechanism 106 and the delivery member 122 cooperate to form a deployment interface 158 that facilitates deployment of the delivery member 122 by illustratively moving or extending the delivery member 122 outwardly relative to the drug housing 110 when the deployment mechanism 106 moves toward the base 120 relative to the drug housing 110. In the illustrated embodiment, the deployment interface 158 includes a first annular ramp 160 ( Figure 4 and Figure 5), which slidably engages the second ramp 162 of the arm 126. During movement of the deployment mechanism 106 toward the base 120, the engagement of the ramps 160, 162 forces the member 122 to extend radially outward relative to the axis A1, causing the penetrating tip 132 to engage the intestinal wall. In other embodiments, the collar 156 or the legs 154 may not have ramps, or the deployment interface 158 may take a different form.

[0032] In some embodiments, arms 126 may be constructed at least in part of an elastic material to further facilitate deployment. For example, arms 126 may include a shape memory material with time-dependent recovery, such as a shape memory polymer, that is compressed during initial deployment. In this embodiment, the elastic material biases arms 126 outwardly so that when device 100 enters the deployed configuration and arms 126 are released, as described herein, arms 126 extend outwardly due to the radially outward spring force of elastic arms 126 and the force of deployment mechanism 106 at interface 158. In some embodiments, arms 126 are constructed of an elastic material as described in previously cited International Application Publication No. WO2022 / 060817.

[0033] refer to Fig. 9 , the device 100 illustratively includes a one-way motion mechanism 150 to permit the deployment mechanism 106 to move in a first direction relative to the medication housing 110 toward the base 120 (to deploy the delivery member 122, as described above), and inhibit movement of the deployment mechanism 106 in a second, opposite direction relative to the medication housing 110 away from the base 120 (to inhibit movement of the delivery member 122 toward its initial position). In the illustrated embodiment, the one-way motion mechanism 150 includes a ratchet mechanism that includes one or more ratchet teeth 152 of the medication housing 110 that engage with one or more corresponding ratchet teeth 154 of the collar 156. The corresponding teeth 152, 154 include mating angled surfaces that allow movement toward the base 120, but inhibit movement of the mechanism 106 away from the base 120. Other suitable mechanisms may be provided to allow movement in the deployment direction while inhibiting movement in the opposite direction.

[0034] refer to Figure 5, the first stopper 136 and the second stopper 138 initially seal the drug 112 therebetween and within the drug housing 110. As described in further detail herein, once the device 100 is deployed, the first stopper 136 and the second stopper 138 then slide generally along the axis A1 due to the force of the driver 144. Thus, the drug 112 also moves with the stops 136, 138 and within the housing 110. In some embodiments, during deployment, the stopper 136 pushes the drug 112, and the drug 112 in turn pushes the stopper 138; although alternatively, the stopper 138 can be fixedly coupled to the stopper 136 or the plunger 140 so as to move together. The movement of the second stopper 138 through the opening in the base 120 permits the drug 112 to flow out of the drug housing 110 and into the channel 128 of the delivery member 122.

[0035] Reference now Fig.10 , the device 100 is illustrated in an intermediate configuration, wherein the capsule 102 has dissolved upon entering the target portion of the GI tract, but the device 100 has not yet been deployed. The driver 144 applies a force (e.g., an axial force) that pushes the plunger 140, the first stop 136, the drug 112, and the second stop 138 toward the base 120 of the delivery mechanism 104. In the initial configuration and the intermediate configuration ( Figure 1 , Fig.10 ), the trigger 146 is positioned or wedged between the end 150 of the plunger 140 and the cap 142 of the housing 110 to prevent movement of the plunger 140 and prevent the end 150 from passing through the opening in the cap 142. Therefore, the presence of the trigger 146 also prevents the deployment mechanism 106 from moving while the plunger 140 is still coupled to the hub 152. The trigger 146 illustratively has an annular shape with a central opening sized to receive the central portion of the plunger 140 but blocking the end 150. The trigger 146 is constructed of a degradable or dissolvable material that degrades or dissolves after being exposed to GI tract fluid for a period of time, such as a degradable polymer or another suitable degradable material. In an exemplary embodiment, when the capsule 102 is separated from the device 100 and the trigger 146 is exposed to the small intestinal fluid, the trigger 146 begins to degrade.

[0036] When the trigger 146 is degraded sufficiently to be removed from its position between the trigger end 150 and the cap 142, the device 100 activates and enters the deployed configuration ( Fig.11 ). In this configuration, the force applied to the plunger 140 by the driver 144 moves the plunger 140 and the deployment mechanism 106 together generally along the axis A1 toward the base 120. In the illustrated embodiment, the deployment mechanism 106 reaches the end of its travel when the hub 152 abuts the cap 142 of the housing 110. Fig.11, the deployment mechanism 106 engages the delivery member 122 and moves the delivery member 122 outward relative to the drug housing 110, and the device 100 reaches a fully deployed configuration. In some embodiments, the delivery member 122 is composed of an elastic material that further pushes the member 122 outward when the trigger 146 dissolves, as described herein. The penetrating tip 132 of the delivery mechanism 104 penetrates the patient's GI tract wall and anchors the drug delivery device 100 to the GI tract wall at the penetration point. As described herein, during drug delivery by the unidirectional motion mechanism 150, the deployment mechanism 106 is prevented from moving backward, thereby maintaining the connecting end 130 against the GI tract wall during delivery. Illustratively, in Fig.11 In the configuration of FIG. 1 , the second stopper 138 continues to block the opening in the base 120 , thereby preventing the drug from flowing into the delivery member 122 .

[0037] With the deployment mechanism 106 at the end of its travel, the driver 144 continues to apply force to the plunger 140 to disengage or decouple the plunger 140 from the hub 152 and further move the plunger 140 generally along the axis A1, as shown in FIG. Fig.12 In one embodiment, the end 150 of the plunger 140 is frictionally or interference fit within the hub 152, and the force of the driver 144 is sufficient to overcome this friction when the deployment mechanism 106 reaches the end of its stroke. Other suitable decoupling features may be provided, such as a spring or other mechanism that facilitates relative movement between the plunger 140 and the deployment mechanism 106 when the mechanism 106 reaches the end of its stroke.

[0038] Continued movement of the plunger 140 causes the first stop 136, the medication 112, and the second stop 138 to move toward the base 120 of the delivery mechanism 104. Eventually and as Fig.12 , the second stopper 138 moves through the delivery channel 128 of the delivery mechanism 104, which allows the drug 112 to flow from the housing 110 into the delivery channel 128 and through the arm 126 and the penetrating tip 132 for delivery to the patient. In the case where the drug 112 is delivered to the patient through the penetrating tip 132, the penetrating tip 132 is configured to degrade after a period of time. After the penetrating tip 132 has degraded beyond a threshold, the device 100 breaks or is released from the penetrating tip 132 and passes through the GI tract.

[0039] In the illustrated embodiment, the driver 144 is a spring that is compressed in the initial configuration and the intermediate configuration, but extends during the deployment configuration. In other embodiments, the driver 144 can be any suitable mechanism capable of delivering force to move the plunger 140 as described herein, including a balloon, a compressed gas, a chemical reaction, or a motor. In the illustrated embodiment, after the drug delivery device 100 has been activated and the drug 112 has been delivered, the first stopper 136, the second stopper 138, the plunger 140, and the driver 144 are all kept contained within the drug housing 110 due to the presence of the cap 142. After delivery, at least most of the drive mechanism 108 is contained within the drug housing 110 to reduce the possibility of the components being released into the GI tract. Instead, the components are kept within the drug housing 110, and the drug housing 110 eventually passes through the patient with the rest of the device 100.

[0040] In some embodiments, instead of including a second stopper 138, the device 100 alternatively includes one or more different components that can retain the drug 112 in a sealed manner within the drug housing 110 until the drug 112 is ready to be introduced into the delivery mechanism 104. The components may include, for example, any of the sealing assemblies described in the previously referenced International Application Publication No. WO2022 / 060817 and similar components.

[0041] In another embodiment, a subset of the delivery members 122 (e.g., in an embodiment having a total of three members 122, only one or two members 122) may contain a delivery channel 128, and thus only this subset of the delivery members 122 will be configured to deliver the drug 112 to the patient. Other delivery members 122 may act as "dummy" or structural delivery members 122 only, and may exist to help secure the drug delivery device 100 within the GI tract without acting as a device for delivering the drug 112. These structural delivery members 122 only may optionally not include a penetrating tip 132, since no drug 112 will flow through the channel, and may instead include a connection feature on the connection end 130 to grip the GI tract wall. Such a connection feature may include a ridge, a protrusion, an adhesive, or other gripping / attachment device. The structural delivery member 122 may also include a microneedle, a patch, a solid drug deposition device, or other drug delivery device to allow the drug or other active agent to diffuse through the wall but not penetrate the wall.

[0042] In some embodiments, the drug delivery device 100 may include a wireless communication device to send signals to and / or receive signals from a wireless receiver (such as a computer, handheld device, smart phone, or other device). The wireless communication device can measure or sense biological information in the patient's body after the drug delivery device 100 has been ingested. For example, when the delivery mechanism 104 has expanded, or when a portion of the drug delivery device 100 has degraded, the wireless receiver can send a signal. In addition, the wireless communication device can measure / sense other biological information in the GI tract, such as chemical concentration, pH value, temperature, or other biological information. The wireless receiver can be used by the patient receiving treatment, or by another user such as a doctor or caregiver. The wireless communication device and the wireless receiver can communicate via RFID, magnetoacoustics, near field communication, ultrasound, Bluetooth technology, or other suitable wireless communication methods.

[0043] Although the present invention has been described as having an exemplary design, the present invention can be further modified within the spirit and scope of the present disclosure. Therefore, the present application is intended to cover any variation, use or adaptation of the present invention using its general principles. In addition, the present application is intended to cover such schemes that depart from the present disclosure within the known or customary practices of the field to which the present invention belongs and fall within the limitations of the appended claims.

Claims

1. A drug delivery device, comprising: a capsule configured to degrade within the gastrointestinal tract of a patient; a drug delivery mechanism disposed within the capsule and configured to interact with a wall of a gastrointestinal tract of a patient, the drug delivery mechanism comprising a plurality of deployable arms, a plurality of connecting ends coupled to the plurality of deployable arms, and a plurality of drug delivery channels, wherein the plurality of connecting ends are in fluid communication with the plurality of drug delivery channels; a drug housing in fluid communication with the drug delivery mechanism and configured to contain a volume of drug; a deployment mechanism coupled to the drug housing, wherein the deployment mechanism is configured to move the plurality of deployable arms from an initial configuration to a deployed configuration after degradation of the capsule; and A drive mechanism is coupled to the drug housing, the drive mechanism comprising a driver and a stopper, wherein the driver is configured to move the stopper to force the drug through the plurality of drug delivery channels and the plurality of connection ends.

2. The drug delivery device according to claim 1, wherein: The plurality of connecting ends include a plurality of wall-penetrating tips, and movement of the plurality of deployable arms to the deployed configuration causes the plurality of wall-penetrating tips to interact with a wall of the patient's gastrointestinal tract.

3. The drug delivery device according to any one of claims 1 to 2, wherein: In the initial configuration, the drive mechanism is coupled to the deployment mechanism, and the drive mechanism is further configured to move the deployment mechanism to move the plurality of deployable arms to the deployed configuration.

4. The drug delivery device according to any one of claims 1 to 3, wherein: The drive mechanism further includes a trigger operable to prevent movement of the drive mechanism and the deployment mechanism in the initial configuration, wherein the trigger is configured to degrade upon exposure to gastrointestinal fluids of a patient.

5. The drug delivery device according to claim 4, wherein: In response to degradation of the trigger, the drive mechanism moves the deployment mechanism to extend the plurality of deployable arms to the deployed configuration and force delivery of the drug through the plurality of drug delivery pathways and the plurality of connection ends.

6. The drug delivery device according to any one of claims 4-5, wherein: The drive mechanism includes a first end positioned adjacent to the trigger and a second end positioned adjacent to the stop, wherein the trigger is positioned between the housing and the first end of the drive mechanism to prevent movement of the drive mechanism and the deployment mechanism in the initial configuration.

7. The drug delivery device according to any one of claims 1 to 6, wherein: The plurality of connection ends include needles configured to pierce a wall of a patient's gastrointestinal tract and degrade within the patient's gastrointestinal fluids.

8. The drug delivery device according to any one of claims 1 to 7, wherein: The medication housing extends along a longitudinal axis, and the deployment mechanism moves longitudinally along the medication housing to cause the plurality of deployable arms to move to the deployed configuration.

9. The drug delivery device according to any one of claims 1 to 8, wherein: The drive mechanism further comprises a plunger coupled to the stopper and the deployment mechanism, wherein the driver drives the plunger and the deployment mechanism to cause the plurality of deployable arms to move to the deployed configuration, and wherein the driver drives the plunger and the stopper in the drug housing to cause delivery of the drug through the plurality of drug delivery channels and the plurality of connection ends.

10. The drug delivery device of claim 9, wherein: The driver causes the plunger to decouple from the deployment mechanism after the plurality of deployable arms are moved to the deployed configuration, and then the driver drives the plunger and stopper in the drug housing to cause delivery of the drug through the plurality of drug delivery channels and the plurality of connection ends.

11. The drug delivery device of claim 10, wherein: The stopper is a first stopper, and the drive mechanism further includes a second stopper, and the drug is disposed between the first stopper and the second stopper.

12. The drug delivery device of claim 11, wherein: The second stop prevents the drug from flowing through the plurality of drug delivery channels during movement of the plurality of deployable arms to the deployed configuration, and wherein the drive mechanism moves the second stop to allow the drug to flow through the plurality of drug delivery channels after the plurality of deployable arms move to the deployed configuration.

13. The drug delivery device of any one of claims 1-12, further comprising a one-way motion mechanism that prevents the plurality of deployable arms from moving away from the deployed configuration.

14. The drug delivery device of claim 13, wherein: The one-way motion mechanism includes a plurality of ratchet teeth.

15. The drug delivery device according to any one of claims 1 to 14, wherein: The plurality of deployable arms are constructed of a resilient material configured to urge the plurality of deployable arms toward the deployed configuration.

16. A drug delivery device comprising: a capsule configured to degrade within the gastrointestinal tract of a patient; a drug delivery mechanism disposed within the capsule, the drug delivery mechanism comprising a base and a plurality of deployable arms coupled to the base, each deployable arm comprising a drug delivery channel and a connection end in fluid communication with the drug delivery channel, the connection end of each deployable arm being configured to interact with a wall of a patient's gastrointestinal tract; a drug housing in fluid communication with the drug delivery mechanism and configured to contain a volume of drug; a deployment mechanism comprising a collar configured to engage the drug delivery mechanism; as well as a drive mechanism coupled to the drug housing and the deployment mechanism, wherein the drive mechanism is operable to move a collar of the deployment mechanism into engagement with the plurality of deployable arms to deploy the plurality of deployable arms, and the drive mechanism is further operable to force delivery of the drug through the plurality of drug delivery channels.

17. The drug delivery device of claim 16, wherein: The connected end of each deployable arm includes a wall-penetrating tip, and deployment of the plurality of deployable arms causes each wall-penetrating tip to interact with a wall of the patient's gastrointestinal tract.

18. A drug delivery device according to any one of claims 16-17, wherein: The drive mechanism includes a trigger configured to degrade within the gastrointestinal tract of a patient, wherein dissolution of the trigger allows the drive mechanism to move a collar of the deployment mechanism along the drug housing to engage and deploy the plurality of deployable arms, and the drive mechanism forces delivery of the drug through the plurality of drug delivery channels after deployment of the plurality of deployable arms.

19. The drug delivery device of claim 18, wherein: The drive mechanism is decoupled from the deployment mechanism after the plurality of deployable arms are deployed and before forced delivery of the drug through the plurality of drug delivery pathways.

20. The drug delivery device according to any one of claims 16 to 19, wherein: The drug housing extends along a longitudinal axis, the deployment mechanism moves longitudinally along the drug housing to cause the plurality of deployable arms to deploy, and the drive mechanism moves longitudinally along the drug housing to cause delivery of the drug through the plurality of drug delivery channels.

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