Oral drug delivery device with extendable arms

The oral drug delivery device with expandable arms addresses the inefficacy of oral drug delivery by penetrating the gastrointestinal wall to deliver drugs, ensuring effective and convenient administration.

JP2025533495APending Publication Date: 2025-10-07ELI LILLY & CO
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Patent Information

Application Number
JP2025516280
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-09-19
Filing Date
2023-09-18
Publication Date
2025-10-07

AI Technical Summary

Technical Problem

Certain drugs and biologically active compounds are ineffective when taken orally due to denaturation, digestion, or low diffusion rates in the gastrointestinal system, necessitating inconvenient injection methods.

Method used

An oral drug delivery device with expandable arms that penetrate the gastrointestinal wall to deliver drugs, utilizing a deployment mechanism to extend arms and a drive mechanism to force the drug through the wall, dissolving or biodegrading after delivery.

Benefits of technology

Effectively delivers drugs through the gastrointestinal wall, ensuring sufficient dosage without painful injections, maintaining drug efficacy and convenience.

✦ Generated by Eureka AI based on patent content.

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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, the arms of the drug delivery device extend, causing the piercing tip to penetrate the GI tract wall. A driver then drives a plunger within the drug delivery device, pushing the drug through the piercing tip and the patient's GI tract wall. After a period of time, a portion of the drug delivery device dissolves, allowing the drug delivery device to pass through the GI tract.
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Description

[Technical Field]

[0001] The present disclosure relates to oral drug delivery devices. More particularly, 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 some other biologically active compounds, it is often most convenient to take the drug 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 via 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 within the patient's gastrointestinal (GI) tract. Upon actuation, arms of the drug delivery device extend and a penetrating tip penetrates the GI tract. A driver then drives a plunger within the drug delivery device, forcing 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 exits through the GI tract.

[0004] In an exemplary embodiment, the drug delivery device includes a capsule configured to disintegrate in the patient's gastrointestinal tract. A drug delivery mechanism is disposed within the capsule and configured to interact with the patient's gastrointestinal tract wall. The drug delivery mechanism includes a plurality of deployable arms, a plurality of mating ends coupled to the plurality of deployable arms, and a plurality of drug delivery channels. The plurality of mating 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 configured to contain a volume of drug. A deployment mechanism is coupled to the drug housing and configured to move the plurality of deployable arms from an initial configuration to a deployed configuration after disintegration of the capsule. 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 mating ends.

[0005] In another embodiment, a drug delivery device includes a capsule configured to disintegrate in the patient's gastrointestinal tract. A drug delivery mechanism is disposed within the capsule and configured to interact with the patient's gastrointestinal wall. 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 mating end in fluid communication with the drug delivery channel. The mating end of each deployable arm is configured to interact with the patient's gastrointestinal wall. A drug housing is in fluid communication with the drug delivery mechanism and configured to contain a volume of drug. The deployment mechanism includes a collar configured to engage with the drug delivery mechanism. A drive mechanism is coupled to the drug housing and the deployment mechanism. The drive mechanism is operative to move the collar of the deployment mechanism to engage with the plurality of deployable arms and deploy the plurality of deployable arms. The drive mechanism is further operative to forcibly deliver the drug through the plurality of drug delivery channels. [Brief explanation of the drawings]

[0006] 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. [Figure 1] FIG. 1 is a perspective view of an exemplary embodiment of a drug delivery device according to the present disclosure in an initial configuration. [Figure 2] FIG. 2 is a perspective view of the drug delivery device of FIG. 1 in a deployed configuration. [Figure 3] FIG. 2 is an exploded perspective view of the drug delivery device of FIG. 1. [Figure 4] FIG. 2 is a side view of the drug delivery device of FIG. 1 in a deployed configuration. [Figure 5] FIG. 2 is a side cross-sectional view of the drug delivery device of FIG. 1 in a deployed configuration. [Figure 6] FIG. 2 is a front view of the drug delivery device of FIG. 1 in a deployed configuration. [Figure 7] FIG. 2 is a detailed perspective view of a delivery member of the drug delivery device of FIG. 1. [Figure 8] FIG. 8 is a detailed side view of the delivery member of FIG. 7. [Figure 9] FIG. 2 is a detailed side view of the unidirectional motion mechanism of the drug delivery device of FIG. 1. [Figure 10] 2 is a side cross-sectional view of the drug delivery device of FIG. 1 in an intermediate configuration. [Figure 11] FIG. 2 is another side view of the drug delivery device of FIG. 1 in a deployed configuration. [Figure 12] 2 is another cross-sectional side view of the drug delivery device of FIG. 1 in a deployed configuration.

[0007] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set forth herein illustrate exemplary embodiments of the present invention, and such exemplifications should not be construed as limiting the scope of the present invention in any way. DETAILED DESCRIPTION OF THE INVENTION

[0008] Referring initially to FIGS. 1-6, an exemplary drug delivery device 100 is shown. FIG. 1 illustrates the drug delivery device 100 in an initial configuration, and FIGS. 2-6 illustrate the drug delivery device 100 in a deployed configuration. The drug delivery device 100 includes a capsule 102 (FIGS. 1 and 3), a delivery mechanism 104, a deployment mechanism 106, a drive mechanism 108 (FIGS. 3 and 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 its initial configuration (FIG. 1), the capsule 102 encloses and houses the delivery mechanism 104, the deployment mechanism 106, the drive mechanism 108, and the drug housing 110. As discussed in more detail herein, the drug delivery device 100 is ingested orally by a patient. Upon entering a portion of the patient's gastrointestinal (GI) tract (e.g., the small intestine), the capsule 102 dissolves or otherwise disintegrates. As illustrated in FIG. 2 , the deployment mechanism 106 then deploys the delivery mechanism 104. More specifically, the deployment mechanism 106 causes the delivery mechanism 104 to interact with the inner wall of the GI tract, anchoring the drug delivery device 100 within the GI tract. As the delivery mechanism 104 interacts with the patient's GI tract, the drive mechanism 108 delivers the drug 112 ( FIGS. 3 and 5 ) from the drug housing 110 through the GI tract wall and into the patient. In the illustrated embodiment, upon deployment, the penetrating tip of the delivery mechanism 104 is positioned within the GI tract wall such that the drug 112 is delivered into the GI tract wall. Once the drug 112 is delivered, at least a portion of the drug delivery device 100 dissolves and the drug delivery device 100 exits through the GI tract.

[0009] In exemplary embodiments, at least a portion of the capsule 102 disintegrates as the environment around the drug delivery device 100 changes pH, for example, when leaving the acidic stomach and entering the relatively alkaline small intestine. In the exemplary embodiment of FIG. 1 , the capsule 102 includes two components, specifically, a first, posterior capsule portion 114 and a second, anterior capsule portion 116. The first capsule portion 114 and the second capsule portion 116 may be joined together to form the capsule 102. The capsule 102 may be constructed, at least in part, from one or more dissolvable or degradable materials. In some embodiments, the first capsule portion 114 and the second capsule portion 116 are joined together by an enteric seam 118 ( FIG. 1 ), which disintegrates in the GI tract, allowing the capsule 102 to separate and release the remainder of the device 100 into the GI tract.

[0010] The delivery mechanism 104 fits within the capsule 102 when the drug delivery device 100 is assembled. In the illustrated embodiment, the delivery mechanism 104 comprises a delivery base 120, a plurality of delivery members 122 extending from the delivery base 120, one or more membranes (not shown), and a central bore 124 ( FIGS. 3 and 5 ) extending through the delivery base 120. With particular reference to FIG. 6 and further reference to FIGS. 7 and 8 , each delivery member 122 comprises a deployable arm 126, a delivery channel 128, a joining end 130, and a piercing tip 132. In the illustrated embodiment, three delivery members 122 are coupled to and extend from the delivery base 120, although in other embodiments, any number of delivery members 122 may be used. In some embodiments, the joining end 130 and / or other components of the delivery member 122 carry or are provided with an adhesive (e.g., a mucoadhesive) or fastener (e.g., a hook(s)) to facilitate adherence of the device 100 to the inner wall of the GI tract.

[0011] The delivery mechanism 104 facilitates the flow of drug from the central bore 124 through the delivery channels 128 to the mating end 130. The delivery channels 128 extend into and are in fluid communication with the central bore 124 and extend along the deployable arms 126. In one embodiment, the delivery channels 128 are formed as grooves exposed on the outer surface of the deployable arms 126. One or more membranes (not shown) are adhered to the surface of the deployable arms 126 to enclose and seal the delivery channels 128. The membrane(s) may be adhered to the surface of the deployable arms 126 through adhesives, welding (heat, UV, laser, ultrasonic, solvent, friction, injection, radio frequency, etc.), mechanical connection, or any other connecting means. The use of membranes can simplify providing (e.g., molding, cutting) the channels 128 on the outer surface of the deployable arms 126. In other embodiments, the delivery channels 128 may be a separate component, such as a tube, coupled to a portion of the delivery mechanism 104. Additionally, the delivery channel 128 may be located entirely within the deployable arm 126 (eg, as a bore through the deployable arm 126) such that the interior of the delivery channel 128 is completely enclosed.

[0012] 7 and 8, a mating end 130 is located near the end of each deployable arm 126. Each mating end 130 includes a piercing tip 132 that punctures or penetrates the wall of the patient's GI tract when in the deployed configuration. In an exemplary embodiment, the tip 132 is formed, at least in part, from a material that begins to degrade or dissolve in response to exposure to small intestinal fluids. In the illustrated embodiment, after a period of time post-deployment sufficient to complete delivery, the piercing tip 132 degrades sufficiently to detach from the GI tract, thereby allowing the drug delivery device 100 to persist along the GI tract and ultimately exit the patient.

[0013] In the illustrated embodiment, the piercing tip 132 has a beveled shape similar to that of a hypodermic needle. In other embodiments, the piercing tip 132 may comprise a piercing tip with a fluid outlet located below the piercing tip (e.g., on a side of the piercing tip 132) to reduce the possibility of blockage in the delivery of the drug 112. Furthermore, each delivery member 122 may comprise any number of piercing tips 132, including an array of microneedles. In some embodiments, as shown, when the deployable arms 126 are deployed, the joint end 130 extends along a diagonal direction D1 ( FIG. 8 ), which is disposed obliquely with respect to the longitudinal axis A1 ( FIG. 4 ) of the drug delivery device 100. In some embodiments, the piercing tip 132 is approximately perpendicular to the diagonal direction D1.

[0014] In some embodiments, the penetrating tip 132 may form part of the penetrating assembly and corresponding socket or receiving bore described in WO 2022 / 060817, the disclosure of which is incorporated herein by reference for all purposes. In an alternative embodiment, the mating end 130 may include a liquid jet delivery mechanism for delivering fluids through the GI tract, as described in the previously referenced WO 2022 / 060817.

[0015] Referring again to Figures 1-6, in the illustrated embodiment, the delivery base 120 and delivery member 122 of the delivery mechanism 104 are constructed as a single piece. In the exemplary embodiment, the delivery mechanism 104 is constructed from a polymer, although in other embodiments, the delivery mechanism 104 can be constructed from a metal or any other biocompatible material. Exemplary polymers include polyglycolic acid, polylactic acid, polycaprolactone, and copolymers and blends thereof, which may include polyethylene glycol. In other embodiments, the delivery mechanism 104 may be constructed from multiple pieces connected through one or more linking members (not shown). Examples of such structures and linking members are provided in the above-referenced International Publication No. WO 2022 / 060817.

[0016] With particular reference to FIG. 5 , drug housing 110 is in fluid communication with delivery mechanism 104. Drug housing 110 holds a volume of drug 112, generally in a liquid or flowable form. In an exemplary embodiment, drug 112 is a compound, such as a peptide or protein, like insulin, that typically has low efficacy when taken through standard oral delivery and ingestion, as well as a vaccine or gene-based drug. In other embodiments, drug 112 can be any biologically active compound administered to a patient. In an exemplary embodiment, drug 112 comprises one or more therapeutic agents, including, but not limited to, insulin, an insulin analog, such as insulin lispro or insulin glargine, an insulin derivative, a GLP-1 receptor agonist, such as dulaglutide or liraglutide, glucagon, a glucagon analog, a glucagon derivative, a gastric inhibitory polypeptide (GIP), a GIP analog, a GIP derivative, a combined GIP / GLP-1 agonist, such as tirzepatide, an oxyntomodulin analog, an oxyntomodulin derivative, a therapeutic antibody, and other suitable therapeutic agents. The drug housing 110 may be constructed from a polymer, metal, ceramic, crystalline solid, or any other material capable of holding a volume of the drug 112 .

[0017] 3 and 5, the drive mechanism 108 is positioned at least partially within the drug housing 110 and is configured to urge the flow of the drug 112 from the drug housing 110 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 (FIG. 3). The drive mechanism 108 is disposed generally coaxially with a longitudinal axis A1. The cap 142 includes an annular-shaped end wall having a central opening sized to receive the plunger 140. As described herein, the plunger 140 and the first and second stops 136, 138 are movable relative to the drug housing 110 generally along the axis A1 toward the base 120 by a force exerted by the driver 144. Plunger 140 includes a stopper end 148 positioned adjacent first stopper 136 and a trigger end 150 positioned adjacent trigger 146. Plunger 140 is illustratively fixed to first stopper 136 at end 148, although plunger 140 may alternatively be removably coupled to first stopper 136. Driver 144 is held between stopper end 148 and the inner surface of cap 142.

[0018] A trigger end 150 of the plunger 140 is removably coupled to the deployment mechanism 106, illustratively to a hub 152 of the deployment mechanism 106, such that the plunger 140 initially moves axially with the deployment mechanism 106 relative to the drug housing 110 during deployment, as described further herein, but when the deployment mechanism 106 reaches the end of its travel, the plunger 140 disengages from the hub 152. The deployment mechanism 106 includes multiple legs 154, illustratively three legs 154, coupled to the hub 152, which 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 positioned axially opposite the hub 152. The collar 156 can take various forms, such as a closed annular ring as shown, or an open ring. The hub 152, legs 154, and collar 156 of the deployment mechanism 106 are illustratively integrally formed, but may alternatively comprise one or more separate components coupled together.

[0019] The deployment mechanism 106 and delivery member 122 cooperate to form a deployment joint 158 ​​that facilitates deployment of the delivery member 122, illustratively by moving or extending the delivery member 122 outward relative to the drug housing 110 as the deployment mechanism 106 moves relative to the drug housing 110 toward the base 120. In the illustrated embodiment, the deployment joint 158 ​​includes a first annular beveled surface 160 of the collar 156 ( FIGS. 4 and 5 ) that slidably engages a second beveled surface 162 of the arm 126. Engagement of the beveled surfaces 160, 162 during movement of the deployment mechanism 106 toward the base 120 extends the member 122 radially outward relative to the axis A1 such that the piercing tip 132 engages the intestinal wall. In other embodiments, the collar 156 or the legs 154 may lack a beveled surface, or the deployment joint 158 ​​may take a different form.

[0020] In some embodiments, arms 126 may be constructed at least in part from a resilient 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 in an initial configuration. In this embodiment, the resilient material biases arms 126 outward. This is done so that when device 100 is in the deployed configuration and arms 126 are released, arms 126 extend outward due to both the radially outward spring force of resilient arms 126 and the force of deployment mechanism 106 at joint 158, as described herein. In some embodiments, arms 126 are constructed from a resilient material, as described in previously referenced WO 2022 / 060817.

[0021] 9 , device 100 illustratively includes a unidirectional motion mechanism 150 that allows deployment mechanism 106 to move relative to drug housing 110 in a first direction toward base 120 (to deploy delivery member 122, as described above) and restricts deployment mechanism 106 from moving relative to drug housing 110 in a second, opposite direction away from base 120 (to restrict delivery member 122 from moving toward their initial positions). In the illustrated embodiment, unidirectional motion mechanism 150 comprises a ratchet mechanism including one or more ratchet teeth 152 on drug housing 110 engaged with one or more corresponding ratchet teeth 154 on collar 156. Corresponding teeth 152, 154 include cooperating angled surfaces that allow movement toward base 120 while preventing movement of mechanism 106 away from base 120. Other suitable mechanisms capable of allowing movement in the deployment direction while preventing movement in the opposite direction may also be provided.

[0022] 5 , initially, drug 112 is sealed within drug housing 110 between first stopper 136 and second stopper 138. As described in further detail herein, once device 100 is deployed, first stopper 136 and second stopper 138 subsequently slide generally along axis A1 due to the force of driver 144. As a result, drug 112 also moves within housing 110 along with stoppers 136, 138. In some embodiments, stopper 136 pushes drug 112, which in turn pushes stopper 138, during deployment, although stopper 138 may alternatively be fixedly coupled to stopper 136 or plunger 140 and move therewith. Movement of second stopper 138 through an opening in base 120 allows flow of drug 112 from drug housing 110 into channel 128 of delivery member 122.

[0023] 10 , the device 100 is shown in an intermediate configuration in which the capsule 102 dissolves 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 urges the plunger 140, the first stopper 136, the drug 112, and the second stopper 138 toward the base 120 of the delivery mechanism 104. In the initial and intermediate configurations ( FIGS. 1 and 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 block movement of the plunger 140 and prevent the end 150 from passing through the opening in the cap 142. Thus, the presence of the trigger 146 also blocks movement of the deployment mechanism 106, with the plunger 140 still coupled to the hub 152. Trigger 146 illustratively has an annular shape with a central opening sized to receive a central portion of plunger 140 but block end 150. Trigger 146 is constructed from a degradable or dissolvable material, such as a degradable polymer or another suitable degradable material, and degrades or dissolves after a period of time upon exposure to GI tract fluids. In an exemplary embodiment, trigger 146 begins to degrade once capsule 102 separates from device 100 and trigger 146 is exposed to small intestinal fluids.

[0024] When trigger 146 is sufficiently dissolved and removed from its position between trigger end 150 and cap 142, device 100 is actuated into the deployed configuration ( FIG. 11 ). In this configuration, force applied to plunger 140 by driver 144 moves plunger 140 and deployment mechanism 106 together generally along axis A1 toward base 120. In the illustrated embodiment, deployment mechanism 106 reaches the end of its travel when hub 152 abuts cap 142 of housing 110. With reference to FIG. 11 , deployment mechanism 106 engages delivery member 122 and moves it outward relative to drug housing 110, and device 100 reaches its fully deployed configuration. In some embodiments, delivery member 122 is composed of a resilient material that further urges member 122 outward in response to dissolution of trigger 146, as described herein. The piercing tip 132 of the delivery mechanism 104 pierces the patient's GI tract wall, anchoring the drug delivery device 100 to the GI tract wall at the piercing point. As described herein, the deployment mechanism 106 is prevented from moving rearward during drug delivery by the unidirectional motion mechanism 150, which maintains the mating end 130 against the GI tract wall during delivery. Illustratively, in the configuration of FIG. 11 , the second stop 138 continues to block the opening(s) in the base 120, thereby preventing the flow of drug into the delivery member 122.

[0025] When the deployment mechanism 106 is at the end of its stroke, continued application of force by the driver 144 to the plunger 140 disengages or separates the plunger 140 from the hub 152, further moving the plunger 140 generally along axis A1, as shown in FIG. 12 . In one embodiment, the end 150 of the plunger 140 is frictionally or interference-fit within the hub 152, but the force of the driver 144 sufficiently overcomes this frictional force when the deployment mechanism 106 reaches the end of its stroke. Other suitable disengagement features, such as a spring or other mechanism, may be provided to facilitate relative movement between the plunger 140 and the deployment mechanism 106 when the mechanism 106 reaches the end of its stroke.

[0026] Continued movement by the plunger 140 moves the first stopper 136, the drug 112, and the second stopper 138 toward the base 120 of the delivery mechanism 104. Eventually, as shown in FIG. 12 , the second stopper 138 moves past the delivery channel 128 of the delivery mechanism 104, allowing the drug 112 to flow from the housing 110 into the delivery channel 128 and through the arms 126 and piercing tip 132 for delivery to the patient. Once the drug 112 has been delivered to the patient through the piercing tip 132, the piercing tip 132 is configured to degrade over time. Once the piercing tip 132 has degraded beyond a certain point, the device 100 is disconnected or released from the piercing tip 132 and passed through the GI tract.

[0027] In the illustrated embodiment, the driver 144 is a spring that is compressed in the initial and intermediate configurations but is expanded during the deployed configuration. In other embodiments, the driver 144 may be any suitable mechanism capable of delivering a force to move the plunger 140 as described herein, including a balloon, compressed gas, a chemical reaction, or a motor. In the illustrated embodiment, the first stopper 136, the second stopper 138, the plunger 140, and the driver 144 all remain contained within the drug housing 110 after the drug delivery device 100 is actuated and the drug 112 is delivered due to the presence of the cap 142. Having at least a majority of the drive mechanism 108 contained within the drug housing 110 after delivery reduces the likelihood of components being released into the GI tract. Instead, the components are retained within the drug housing 110 with the remainder of the device 100, which will eventually pass through the patient.

[0028] In some embodiments, instead of including second stopper 138, device 100 alternatively includes one or more different components capable of holding drug 112 in a sealed manner within drug housing 110 until drug 112 is ready to be introduced into delivery mechanism 104. Such components may include, for example, any of the sealing assemblies and similar components provided and described in previously referenced WO 2022 / 060817.

[0029] In another embodiment, a subset of the delivery members 122 (e.g., only one or two members 122 in one embodiment with a total of three members 122) may contain delivery channels 128, and thus only that subset of delivery members 122 would be configured to deliver the drug 112 to the patient. Other delivery member(s) 122 may serve as "dummy" or structural-only delivery members 122 and may be present to help secure the drug delivery device 100 within the GI tract without serving as a means for delivering the drug 112. These structural-only delivery members 122 may optionally not include a piercing tip 132, as the drug 112 is unlikely to flow through the channel, and instead may include a bonding feature on the bonding end 130 to grip the GI tract wall. Such a bonding feature may include a ridge, protrusion, adhesive, or other gripping / attachment means. The structural delivery member 122 may also comprise microneedles, patches, solid drug deposits, or other drug delivery means that allow the drug or other active agent to diffuse through the wall without penetration.

[0030] In some embodiments, the drug delivery device 100 may include a wireless communication device for transmitting and receiving signals to a wireless receiver, such as a computer, handheld device, smartphone, or other device. The wireless communication device can measure or sense biological information within the patient after the drug delivery device 100 is ingested. For example, the wireless receiver can transmit a signal when the delivery mechanism 104 expands or when a portion of the drug delivery device 100 degrades. Additionally, the wireless communication device may measure / sense other biological information within the GI tract, such as chemical concentrations, pH, 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 can communicate through RFID, magnetic acoustic, short-range wireless communication, ultrasound, Bluetooth technology, or other suitable wireless communication means.

[0031] While this invention has been described as having an exemplary design, the invention can be further modified within the spirit and scope of this disclosure. Accordingly, this application is intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the 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 the gastrointestinal tract of a patient; a drug delivery mechanism disposed within the capsule and configured to interact with a gastrointestinal wall of the patient, the drug delivery mechanism comprising a plurality of deployable arms, a plurality of mating ends coupled to the plurality of deployable arms, and a plurality of drug delivery channels, the plurality of mating ends being 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, the deployment mechanism configured to move the plurality of deployable arms from an initial configuration to a deployed configuration after disintegration of the capsule; and A drug delivery device comprising: a drive mechanism coupled to the drug housing, the drive mechanism comprising a driver and a stopper, the driver configured to move the stopper to push the drug through the multiple drug delivery channels and the multiple joint ends.

2. 2. The drug delivery device of claim 1, wherein the plurality of joint 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 the gastrointestinal wall of the patient.

3. 3. The drug delivery device of claim 1, wherein the drive mechanism is coupled to the deployment mechanism in the initial configuration, and the drive mechanism is further configured to move the deployment mechanism to move the multiple deployable arms to the deployed configuration.

4. 4. The drug delivery device of claim 1, wherein the drive mechanism further comprises a trigger operable to prevent movement of the drive mechanism and the deployment mechanism in the initial configuration, the trigger configured to degrade upon exposure to gastrointestinal fluids of the patient.

5. 5. The drug delivery device of claim 4, wherein in response to the trigger being decomposed, the drive mechanism moves the deployment mechanism to spread the multiple deployable arms to the deployed configuration and forcibly deliver the drug through the multiple drug delivery channels and the multiple joint ends.

6. 6. The drug delivery device of claim 4 or 5, wherein the drive mechanism includes a first end positioned adjacent to the trigger and a second end positioned adjacent to the stopper, and 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 from the initial configuration.

7. 7. The drug delivery device of claim 1, wherein the plurality of joint ends include needles configured to pierce a gastrointestinal wall of the patient and to dissolve within fluid of the gastrointestinal tract of the patient.

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

9. The drug delivery device of any one of claims 1 to 8, wherein the drive mechanism further includes a plunger coupled to the stopper and the deployment mechanism, the driver drives the plunger and the deployment mechanism to move the multiple deployable arms to the deployed configuration, and the driver drives the plunger and the stopper within the drug housing to deliver the drug through the multiple drug delivery channels and the multiple joint ends.

10. The drug delivery device of claim 9, wherein the driver separates the plunger from the deployment mechanism after the multiple deployable arms have moved to the deployed configuration, and then the driver drives the plunger and the stopper within the drug housing to deliver the drug through the multiple drug delivery channels and the multiple joint ends.

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

12. 12. The drug delivery device of claim 11, wherein the second stopper prevents the flow of the drug through the drug delivery channels during transition of the deployable arms to the deployed configuration, and the second stopper is moved by the drive mechanism to allow the flow of the drug through the drug delivery channels after the deployable arms have moved to the deployed configuration.

13. The drug delivery device of any one of claims 1 to 12, further comprising a unidirectional movement mechanism that prevents movement of the plurality of deployable arms away from the deployed configuration.

14. The drug delivery device of claim 13 , wherein the unidirectional movement mechanism comprises a plurality of ratchet teeth.

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

16. 1. A drug delivery device comprising: a capsule configured to disintegrate in 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 including a drug delivery channel and a mating end in fluid communication with the drug delivery channel, the mating end of each deployable arm configured to interact with a gastrointestinal wall of the patient; a drug housing in fluid communication with the drug delivery mechanism and configured to contain a volume of drug; a deployment mechanism including a collar configured to engage the drug delivery mechanism; A drug delivery device comprising: a drive mechanism coupled to the drug housing and the deployment mechanism, the drive mechanism operative to move the collar of the deployment mechanism to engage with the multiple deployable arms and deploy the multiple deployable arms, the drive mechanism further operative to forcibly deliver the drug through the multiple drug delivery channels.

17. 17. The drug delivery device of claim 16, wherein the joint end of each deployable arm includes a wall-piercing tip, and deployment of the multiple deployable arms causes each wall-piercing tip to interact with the gastrointestinal wall of the patient.

18. 18. The drug delivery device of claim 16 or 17, wherein the drive mechanism includes a trigger configured to decompose in the gastrointestinal tract of the patient, wherein dissolution of the trigger enables the drive mechanism to move the collar of the deployment mechanism along the drug housing to engage with the multiple deployable arms and deploy the deployable arms, and the drive mechanism forcibly delivers the drug through the multiple drug delivery channels after deployment of the multiple deployable arms.

19. 20. The drug delivery device of claim 18, wherein the drive mechanism decouples from the deployment mechanism after deployment of the plurality of deployable arms and before forcibly delivering the drug through the plurality of drug delivery channels.

20. A drug delivery device described in 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 deploy the multiple deployable arms, and the drive mechanism moves longitudinally along the drug housing to deliver the drug through the multiple drug delivery channels.

Citation Information

Patent Citations

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