Drug Delivery Devices

Abstract

1. A drug delivery device having a central axis, the drug delivery device comprising: a first body portion; a first attachment portion attached to the first body portion and having a first distal end; a second attachment portion having a second distal end; and an actuation mechanism configured to move the first distal end toward the second distal end.

Description

[Technical Field]

[0001] The present disclosure relates to drug delivery devices, and in particular to drug delivery devices for oral administration, which are configured to deliver an active drug substance into the gastrointestinal tract, advantageously including the stomach and / or intestines, e.g., the small intestine and / or large intestine (colon). [Background technology]

[0002] Some, for example, poorly permeable and / or poorly water soluble active drug substances are currently delivered by, i.e., subcutaneous, intradermal, intramuscular, rectal, vaginal or intravenous routes. Oral administration has the potential for the widest acceptance by patients, and therefore attempts to deliver poorly permeable and / or poorly water soluble active drug substances via the preferred oral administration route have been attempted with limited success, particularly due to lack of stability and limited absorption from the gastrointestinal tract.

[0003] Stability relates both to the stability of the active drug substance during manufacture and storage of the delivery device, and to the stability of the active drug substance during its passage through the gastrointestinal tract before it becomes available for absorption.

[0004] Limited gastrointestinal absorption is due to a gastrointestinal wall barrier that prevents the active drug substance from being absorbed after oral administration, for example due to pre-systemic metabolism, low permeability of the active drug substance due to size and / or charge, and / or aqueous solubility of the active drug substance.

[0005] Although several approaches have been proposed to overcome these stability and absorption challenges, an effective solution to these challenges remains unsolved. Summary of the Invention [Problem to be solved by the invention]

[0006] Thus, there is an unmet need to provide a drug delivery device that can deliver a drug substance for absorption in gastrointestinal tissue. More generally, there remains a need for drug products and methods that allow for enhanced drug delivery when the drug product is orally administered to a patient. [Means for solving the problem]

[0007] For example, a drug delivery device for oral drug delivery is disclosed, the drug delivery having a central axis and comprising a first body portion, a first attachment portion attached to the first body portion and having a first distal end, a second attachment portion having a second distal end, and an actuation mechanism configured to optionally move, such as rotate, the first distal end toward the second distal end.

[0008] Also disclosed are pharmaceutical compositions comprising the active drug substances described herein and one or more delivery devices.

[0009] An advantage of the present disclosure is that the drug delivery device ensures stability of the active drug substance during transit through the gastrointestinal tract and promotes effective absorption of the active drug substance from the gastrointestinal tract after oral administration.

[0010] Furthermore, an advantage of the present disclosure is that the drug delivery device provides active attachment of the drug delivery device to an inner gastric wall, such as the stomach wall and / or intestinal wall.

[0011] Additionally, the present disclosure advantageously provides for oral delivery of low permeability active drug substances in or at the gastric lining tissue.

[0012] These and other features and advantages of the present invention will become readily apparent to those skilled in the art from the following detailed description of exemplary embodiments, which proceeds with reference to the accompanying drawings. [Brief explanation of the drawings]

[0013] [Figure 1] FIG. 1 shows an exploded view of an exemplary drug delivery device. [Figure 2]FIG. 2 shows a cross-sectional side view of an exemplary drug delivery device. [Figure 3] FIG. 3 shows a perspective view of an exemplary drug delivery device. [Figure 4] FIG. 4 shows a perspective view of an exemplary drug delivery device. [Figure 5] FIG. 5 shows a front view of an exemplary drug delivery device. [Figure 6] FIG. 6 shows a side view of an exemplary drug delivery device. [Figure 7] FIG. 7 shows a front view of an exemplary drug delivery device engaged with a biological material. [Figure 8] FIG. 8 shows an encapsulated drug delivery device. [Figure 9] FIG. 9 shows an exploded view of an exemplary drug delivery device having a rotatable fastener. [Figure 10] FIG. 10 shows a perspective view of an exemplary drug delivery device. [Figures 11A-11D] 11A-11D show schematic diagrams of the operation of a drug delivery device. [Figure 12] FIG. 12 shows the drug delivery device in a first state. [Figure 13] FIG. 13 shows the drug delivery device in a second state. [Figure 14] FIG. 14 shows the drug delivery device in a first state. [Figure 15] FIG. 15 shows the drug delivery device in a second state. [Figure 16] FIG. 16 shows a drug delivery device. [Figure 17] FIG. 17 shows the drug delivery device of FIG. 16 in an exploded view. [Figure 18-22] Figures 18-22 show the results of experiments using drug delivery devices. [Figure 23] FIG. 23 shows pharmacodynamic data using the drug delivery device. DETAILED DESCRIPTION OF THE INVENTION

[0014] Various exemplary embodiments and details are described below with reference to the figures, where relevant. It should be noted that, whether the figures are drawn to scale or not, elements of similar structure or function are represented by similar reference numerals throughout the figures. It should also be noted that the figures are intended only to facilitate the description of the embodiments and their associated functions. They are not intended as an exhaustive description of the invention or as limitations on the scope of the invention or the physical appearance of the invention. In addition, an illustrated embodiment need not have all aspects or advantages shown. An aspect or advantage described in connection with a particular embodiment is not necessarily limited to that embodiment and may be implemented in any other embodiment, even if not shown or explicitly described.

[0015] A drug delivery device having a central axis is disclosed, the drug delivery device comprising a first body portion, a first engaging portion, a second engaging portion, and an actuation mechanism configured to move the first engaging portion and the second engaging portion relative to one another, such as by rotating the first body portion relative to the second body portion.

[0016] The drug delivery device may have a size and geometry designed to accommodate a pharmaceutical composition for oral administration.

[0017] The drug delivery device / pharmaceutical composition may be configured to be taken into the body via an oral nozzle. Thus, the overall dimensions of the drug delivery device / pharmaceutical composition may be small enough for a user to swallow. The drug delivery device may be adapted to transport the drug substance to the user's body via the digestive system, such that the drug delivery device may travel, for example, from the user's mouth into the stomach and through the esophagus. From the stomach, the drug delivery device may further travel into the intestine, and optionally, into the intestine and exit through the rectum.

[0018] The drug delivery device may be configured to deliver a drug to any part of a user's digestive system, and in one example, may be configured to deliver a drug substance into the user's stomach. In another example, the drug delivery device may be adapted to initiate drug delivery when the device passes through the stomach and enters the user's intestine. In other words, the drug delivery device may be configured to be attached to, for example, the stomach wall or the intestinal wall, depending on the desired location of release of the active drug substance.

[0019] The anchoring portion of the drug delivery device may be configured to interact with the inner lining of the gastrointestinal tract, such that the drug delivery device may be attached, for example, to the inside (mucosa) of the stomach, or alternatively, to the mucosa of the intestine. The anchoring portion may be configured, for example, to interact with the mucosa to secure or attach the drug delivery device to the user's body, for example, for a period of time. By attaching the drug delivery device, it allows the drug substance to be delivered to a portion of the digestive system to provide the drug substance to the user's body. The anchoring portion may be configured, for example, to interact with the mucosa to inject the drug substance into the gastrointestinal tract wall.

[0020] The drug delivery device has a central axis that optionally extends from a first end to a second end of the drug delivery device. The drug delivery device can have a length (e.g., in the direction of maximum extension from the first end to the second end along the central axis) in the range of 3 mm to 35 mm, e.g., in the range of 5 mm to 26 mm. The drug delivery device can be elongated.

[0021] The drug delivery device can have a width and / or height (e.g., directions of maximum extension along the width and height axes, respectively) ranging from 1 mm to 20 mm, where height and width are directions of maximum extension of the drug delivery device perpendicular to the central axis.

[0022] In one or more exemplary drug delivery devices, the dimensions of the drug delivery device, at least in an initial or first state prior to activation of the first and / or second fastening portions, can be represented by a length (maximum extension along a central axis), a width (maximum extension along an axis perpendicular to the central axis), and a height (maximum extension along a height axis perpendicular to the central and width axes). The height of the drug delivery device can range from 1 mm to 15 mm. The width of the drug delivery device can range from 1 mm to 15 mm.

[0023] In one or more exemplary drug delivery devices, the drug delivery device may be constructed to secure a drug delivery portion to deliver a payload or active drug substance to an internal tissue or surface for distribution of the active drug substance within a subject through a blood vessel.

[0024] Advantageously, the drug delivery device can be attached to a specific location within the patient's intestinal wall and deliver the active drug substance. Of course, the delivery device can be attached to other locations and deliver the active drug substance. In one or more exemplary drug delivery devices, the drug delivery device, such as a spike, can penetrate the muscularis mucosae. In one or more exemplary drug delivery devices, the drug delivery device, such as a spike, can not penetrate the external muscularis mucosa. In one or more exemplary drug delivery devices, the spike can be positioned within the submucosa. In one or more exemplary drug delivery devices, the spike can be positioned within the submucosa parallel to the intestinal wall.

[0025] The drug delivery device includes a first body portion. The first body portion may be a two-part body portion, i.e., the first body portion may comprise a first primary body portion and a first secondary body portion. The first body portion has an outer surface. A first primary recess and / or a first secondary recess may be formed in the outer surface of the first body portion.

[0026] The drug delivery device optionally includes a shell having a first shell portion, the exterior surface of the first body portion may form at least a portion of the first shell portion.

[0027] The drug delivery device includes a first fastening portion. The first fastening portion may include a first base and / or a first needle, e.g., a spike. The first fastening portion has a first proximal end and a first distal end. The first fastening portion, e.g., the first needle or spike, optionally has a first fastening axis or extends along the first fastening axis. The first tip of the first needle forms the first distal end. In other words, the first distal end is the first tip of the first needle. The first base may be located at or constitute the first proximal end of the first fastening portion. The first needle may have a length in the range of 1 mm to 15 mm, e.g., 3 mm to 10 mm. This provides sufficient penetration into the internal tissue while simultaneously reducing the risk of damaging the internal tissue. The first distal end of the first fastening portion may include a tip configured to penetrate biological tissue. The first distal end of the first engaging part may be provided with a gripping part for gripping biological tissue.

[0028] The first needle may have a cross-sectional diameter in the range of 0.1 mm to 5 mm, for example in the range of 0.5 mm to 2.0 mm.

[0029] The first needle may be straight and / or curved. The first needle may include a straight first primary section. For example, the first needle may include a first secondary section between the first primary section and the first distal end, or between the first base and the first primary section. The first secondary section may be curved. The first needle may include two or more straight sections formed at an angle. For example, the first needle may have a proximal section extending at a first angle from a connection point to the drug delivery device and a distal section extending at a second angle from a connection point to the drug delivery device. The first angle and the second angle may be different. The proximal section may connect to the distal section at a connection (e.g., a bend, connection, angle), and the connection angle between the proximal and distal sections may be an acute angle, an obtuse angle, or a right angle. The angle may be, for example, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 130, 140, 150, 160, or 170 degrees. This may advantageously allow for different engagement angles when the first needle interacts with the inner surface lining. This may allow for improved attachment of the drug delivery device while helping to reduce or avoid tissue damage. Additionally, the coupling may be flexible. Alternatively, the coupling may be inflexible.

[0030] The connector may be located at or generally at the center of the length of the first needle, or may be located 40, 45, 55, 60, or 65% up the length of the first needle from the proximal end.

[0031] In one or more exemplary first anchors, the first needle may have three, four, or five different sections at different angles, each connected by a link. In some iterations, any or all of the different sections may be straight or curved. Each link may be flexible or inflexible.

[0032] The fastening portion of the drug delivery device can be considered to be any type of fastening portion that may be capable of attaching the drug delivery device to biological tissue, such as the stomach wall, intestinal wall, and / or bowel wall, of a human or animal body. The fastening portion may be adapted to extend in a direction away from the central axis of the drug delivery device and / or the central axis of the first fastening portion. This may mean, for example, that the fastening portion may extend in a direction (radially) away from the circumferential surface of the first body portion and / or the second body portion, at least in the activated state or the second state of the drug delivery device, such that the fastening portion extends radially farther than the circumferential or outer surfaces of the body portions.

[0033] The first fastening portion may be fixedly or rotatably attached to the first body portion.

[0034] In one or more exemplary drug delivery devices, the drug delivery device includes a second body portion. The second body portion may be a two-part body portion, i.e., the second body portion may include a second primary body portion and a second secondary body portion. A second attachment portion is optionally attached to the second body portion. The second attachment portion may be fixedly or rotatably attached to the second body portion. The second body portion has an outer surface. A second primary recess and / or a second secondary recess may be formed in the outer surface of the second body portion.

[0035] In one or more exemplary drug delivery devices, the actuation mechanism is configured to rotate the first body portion relative to the second body portion about a major axis of the drug delivery device, which may be parallel to and / or coincident with the central axis.

[0036] In one or more exemplary drug delivery devices, the first body portion is configured to rotate in a first direction and / or the second body portion is configured to rotate in a second direction opposite the first direction.

[0037] The drug delivery device may include a rim body portion to which different portions, such as a first body portion and / or a second body portion, are attached, e.g., fixedly or rotatably attached, to the rim body portion. In one or more exemplary drug delivery devices, an actuation mechanism or part thereof may be attached to the rim body portion.

[0038] Separate rotation of the first and second body portions relative to the rim portion can thereby be provided for by a rotational connection between the first and second body portions, allowing the first body portion to rotate relative to the second body portion without the two portions separating from each other before the fastening portion(s) interact with internal tissue, such as the mucosa. Such a connection can be achieved in several ways. In one example, the first body portion has a plug connection and the second body portion has a socket connection, the plug connection and socket isolation configuration allowing the first body portion to rotate relative to the second body portion. A second example can be providing a shaft that can be coaxial with the central and / or main shaft, with the first and second body portions configured to receive the shaft, and stops disposed at first and second ends of the shaft on either side of the combined first and second body portions to prevent the first and second body portions from sliding longitudinally along the shaft. The shaft can also be integral with the first or second body portion.

[0039] If a shaft is used, the shaft may be made from any number of different materials, for example, the shaft may be made from metals and / or alloys and / or polymers and / or composites and / or composite materials and / or combinations thereof.

[0040] The first and / or second body portions can be arranged to freely rotate relative to one another, for example, at least in the second state, thereby allowing the fastening portions to rotate relative to one another. The fastening portions can thus be adapted to contact and / or penetrate tissue of the gastrointestinal tract. Rotating the body portions relative to one another using a resilient force can move the fastening portions to penetrate or pinch the mucosa, for example, to secure the drug delivery device at a location within the gastrointestinal tract, such as the stomach or intestines. The penetration and / or pinching force can originate from an actuation mechanism / resilient portion, which can be adapted to store a resilient force that can press the fastening portions toward one another when the resilience of the resilient portion is at least partially released. The resilient portion can be, for example, in the form of a spring or spring element, such as a torsion spring or a power spring, which can be wound up to store mechanical energy, which can be transmitted to the first and / or second body portions. When the mechanical energy is released, the first body portion can rotate relative to the second body portion and the mechanical energy can be transmitted through the body portions to the fastener.

[0041] In the context of this specification, the term "rotational force" can be considered a torque, moment, moment of force, rotational force, or "rotational effect." Another definition of the term "rotational force" may be the product of the magnitude of the force and the perpendicular distance of the line of action of the force from the axis of rotation. Rotational force can be viewed as a force transmitted from the elastic portion through the body portion to the attachment portion of the drug delivery device.

[0042] The rotational force can be defined as being sufficient to penetrate gastrointestinal tissue. When a rotational force is applied to both the first and second body portions, the first fastening portion may contact the surface to which it is attached, and a rotational force applied to the second body portion may cause the second fastening portion to contact the same surface, with the first fastening portion providing a force while the second fastening portion provides a counterforce to the first fastening portion, such that a force is applied such that the first fastening portion is urged in a direction toward the second fastening portion or vice versa.

[0043] In one or more exemplary drug delivery devices, the distance between the first engagement axis of the first engagement portion and the main axis is greater than 0.5 mm, for example, in at least the actuated state or the second state of the drug delivery device, and optionally in the initial state of the drug delivery device.

[0044] In one or more exemplary drug delivery devices, the first engaging portion is rotatably attached to the first body portion, e.g., via a first coupling having a first axis of rotation. In other words, the first engaging portion is optionally configured to rotate about the first axis of rotation, e.g., relative to the first body portion. The first axis of rotation may be parallel to the central axis and / or the main axis. The first axis of rotation may form a first angle with the central axis and / or the main axis. The first angle may be less than 15°. The first angle may be in the range of 75° to 105°, e.g., 90°±5° or 90°.

[0045] In one or more exemplary drug delivery devices, the first body portion may define a first body recess (e.g., a cavity, slot, or hole) extending along an outer surface of the first body portion. The first body recess may be formed by a solid wall on all sides except the open outermost surface. The first fastener may be rotatably connected within the first body recess along a first fastener axis. The first fastener axis may be, for example, a pin (e.g., an arm, a support). The first fastener axis may be parallel to the central axis and / or the main axis. The first fastener axis may be angled relative to the central axis and / or the main axis. Thus, the first fastener may be configured to rotate within the recess along the first fastener axis. Furthermore, rotation of the first fastener may be stopped by an end surface of the recess.

[0046] The first body recess may extend along a portion of the outer surface of the first body portion. The first body recess may extend completely around the circumference of the first body portion. The first body recess may extend around 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% of the circumference of the first body portion. The first body recess may extend more than 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, or 95% of the circumference of the first body portion. The first body recess may extend around less than 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% of the circumference of the first body portion. The first body portion can optionally include more than one first body recess, e.g., multiple first fastening portions are used on the first body portion. When more than one first body recess is used, they can be spaced longitudinally and / or circumferentially.

[0047] The first body recess can extend from the outer surface toward the central axis through 5%, 10%, 15%, 20%, 25%, 30%, 35%, or 40% of the drug delivery device. The first body recess can extend from the outer surface toward the central axis through more than 5%, 10%, 15%, 20%, 25%, 30%, 35%, or 40% of the drug delivery device. The first body recess can extend from the outer surface toward the central axis through less than 5%, 10%, 15%, 20%, 25%, 30%, 35%, or 40% of the drug delivery device.

[0048] In one or more exemplary drug delivery devices, the first body recess can extend circumferentially or partially circumferentially around the first body portion, with the central axis being longitudinal. The first body recess can extend perpendicular to the central axis and / or primary access (e.g., extend along a cross-section of the drug delivery device perpendicular to the central axis and / or primary access). The first body recess can have any number of shapes. For example, the first body recess can be a portion of a circle, such as a half circle. The first body recess can be triangular. The first body recess can be a sector of a circle. The first body recess can have curved edges connected by two straight edges. The first body recess can be two curved edges connected to each other by two straight edges.

[0049] Thus, the first engagement portion can rotate on the first engagement axis to move perpendicular to the central axis and / or main axis, and in certain embodiments, the first engagement portion can rotate at an angle between perpendicular and parallel to the central axis and / or main axis.

[0050] In one or more exemplary drug delivery devices, when the first body portion and / or the second body portion rotate relative to one another, the first fastening portion and / or the second fastening portion can rotate out of their respective recesses (e.g., the first body recess and the second body recess) due to the rotation of the first body portion and / or the second body portion. Continued rotation of the first body portion and / or the second body portion then causes the first fastening portion and / or the second fastening portion to pierce tissue and hold the drug delivery device in place.

[0051] In one or more exemplary drug delivery devices, the first anchoring portion extends in a direction away from the first body portion, e.g., at least in the activated state of the drug delivery device, and optionally in the initial state of the drug delivery device. In other words, the first needle may extend from the outer surface of the first body portion, e.g., at least in the activated state of the drug delivery device, and optionally in the initial state. In another formulation, the first anchoring axis may form an angle of at least 45° with the central axis and / or main axis, e.g., at least in the activated state of the drug delivery device, and optionally in the initial state of the drug delivery device. An anchoring portion extending in a direction should be understood as a direction from the proximal end of the anchoring portion / needle portion to the distal end of the anchoring portion along the anchoring axis of the anchoring portion.

[0052] The first anchoring portion may extend in a first primary direction in a first state of the drug delivery device and in a first secondary direction in a second state of the drug delivery device. The first primary direction and the first secondary direction may form an angle of at least 30°. The first primary direction may be parallel or substantially parallel to the central axis. The first primary direction may form an angle of less than 60° with the central axis. The first secondary direction may form an angle of at least 60°, for example, about 90°, with the central axis. The first secondary direction may be perpendicular to the central axis.

[0053] The first distal end of the first fastener can be moved or configured to move from a first primary position in the first state of the drug delivery device to a first secondary position in the second state.

[0054] The drug delivery device includes a second fastening portion. The second fastening portion may include a second base and / or a second needle, e.g., a spike. The second fastening portion has a second proximal end and a second distal end. The second fastening portion, such as the second needle, optionally has a second fastening axis or extends along the second fastening axis. The second tip of the second needle forms the second distal end. In other words, the second distal end is the second tip of the second needle. The second base may be located at or constitute the second proximal end of the second fastening portion. The second needle may have a length in the range of 1 mm to 15 mm, e.g., 3 mm to 10 mm. This provides sufficient penetration into the internal tissue while simultaneously reducing the risk of damaging the internal tissue. The second distal end of the second fastening portion may include a tip configured to penetrate biological tissue. The second distal end of the second engaging portion may be provided with a gripping portion for gripping biological tissue.

[0055] The second needle may have a cross-sectional diameter in the range of 0.1 mm to 5 mm, for example in the range of 0.5 mm to 2.0 mm.

[0056] The second needle may be straight and / or curved. The second needle may include a straight second primary portion. The second needle may include a second secondary portion, for example, between the second primary portion and the second distal end, or between the second base and the second primary portion. The second secondary portion may be curved.

[0057] The second needle may include two or more straight sections formed at an angle. For example, the second needle may have a proximal section extending at a first angle from the connection point to the drug delivery device and a distal section extending at a second angle from the connection point to the drug delivery device. The first and second angles may be different. The proximal section may connect to the distal section at a connection (e.g., a bend, connection, angle) to define a connection angle between the proximal and distal sections. The connection angle may be acute, obtuse, or right. The angle may be, for example, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 130, 140, 150, 160, or 170°. This may advantageously allow for different engagement angles when the second needle interacts with the inner surface lining. This may allow for improved attachment of the drug delivery device while helping to reduce or avoid tissue damage. Additionally, the link may be flexible, or alternatively, the link may be inflexible.

[0058] The connector may be located at or generally at the center of the length of the second needle, or may be located 40, 45, 55, 60, or 65% up the length of the second needle from the proximal end.

[0059] In one or more exemplary second anchors, the second needle can have three, four, or five distinct sections at different angles, each connected by a link. In some iterations, any or all of the distinct sections can be straight or curved. Each link can be flexible or inflexible.

[0060] In one or more exemplary drug delivery devices, both the first needle and the second needle include a connector. However, only one of the first needle and the second needle may include a junction with the other that is straight and / or curved. If both the first needle and the second needle include a connector, the first distal tip and the second distal tip may be angled toward each other to facilitate attachment when the first body portion and the second body portion are rotated relative to each other.

[0061] In one or more exemplary drug delivery devices, the second engaging portion is rotatably attached to the second body portion, e.g., via a second coupling having a second axis of rotation. In other words, the second engaging portion is optionally configured to rotate, e.g., about the second axis of rotation relative to the second body portion. The second axis of rotation may be parallel to the central axis and / or the main axis. The second axis of rotation may form a second angle with the central axis and / or the main axis. The second angle may be less than 15°. The second angle may be in the range of 75° to 105°, e.g., 90°±5° or 90°.

[0062] In one or more exemplary drug delivery devices, the second body portion may define a second body recess (e.g., a cavity, slot, or hole) extending along an outer surface of the second body portion. The second body recess may be formed by a solid wall on all sides except the open outermost surface. The second fastener may be rotatably connected within the second body recess along a second fastener axis. The second fastener axis may be, for example, a pin (e.g., an arm, a support). The second fastener axis may be parallel to the central axis and / or the main axis. The second fastener axis may be angled relative to the central axis and / or the main axis. Thus, the second fastener may be configured to rotate within the recess along the second fastener axis. Furthermore, rotation of the second fastener may be stopped by an end surface of the second body recess.

[0063] The second body recess may extend along a portion of the outer surface of the second body portion. The second body recess may extend completely around the circumference of the second body portion. The second body recess may extend around 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% of the circumference of the second body portion. The second body recess may extend more than 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, or 95% of the circumference of the second body portion. The second body recess may extend around less than 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% of the circumference of the second body portion. The second body portion can optionally include more than one second body recess, e.g., multiple second fastening portions are used on the second body portion. When more than one second body recess is used, they can be spaced longitudinally and / or circumferentially.

[0064] The second body recess may extend from the outer surface toward the central axis through 5, 10, 15, 20, 25, 30, 35, or 40% of the drug delivery device. The second body recess can extend from the outer surface toward the central axis through more than 5, 10, 15, 20, 25, 30, 35, or 40% of the drug delivery device. The second body recess can extend from the outer surface toward the central axis through less than 5, 10, 15, 20, 25, 30, 35, or 40% of the drug delivery device.

[0065] In one or more exemplary drug delivery devices, the second body recess can extend circumferentially or partially circumferentially around the second body portion, with the central axis being longitudinal. The second body recess can extend perpendicular to the central axis and / or primary access (e.g., extend along a cross-section of the drug delivery device perpendicular to the central axis and / or primary access). The second body recess can have any number of shapes. For example, the second body recess can be a portion of a circle, such as a half circle. The second body recess can be triangular. The second body recess can be a sector of a circle. The second body recess can have curved edges connected by two straight edges. The second body recess can be two curved edges connected to each other by two straight edges.

[0066] Thus, the second engagement portion can rotate on the second engagement axis to move perpendicular to the central axis and / or main axis, and in certain embodiments, the second engagement portion can rotate at an angle between perpendicular and parallel to the central axis and / or main axis.

[0067] In one or more exemplary drug delivery devices, when the first body portion and / or the second body portion rotate relative to one another, the first fastening portion and / or the second fastening portion can rotate out of their respective recesses (e.g., the first body recess and the second body recess) due to the rotation of the first body portion and / or the second body portion. Continued rotation of the first body portion and / or the second body portion then causes the first fastening portion and / or the second fastening portion to pierce tissue and hold the drug delivery device in place.

[0068] In one or more exemplary drug delivery devices, the second anchoring portion optionally extends away from the second body portion, e.g., at least in an activated state of the drug delivery device, and optionally in an initial state of the drug delivery device. In other words, the second needle may extend from an outer surface of the second body portion, e.g., at least in an activated state of the drug delivery device, and optionally in the initial state. In another formulation, the second anchoring axis may form an angle of at least 45° with the central axis and / or main axis, e.g., at least in an activated state of the drug delivery device, and optionally in the initial state of the drug delivery device.

[0069] The second anchoring portion may extend in a second primary direction in a first state of the drug delivery device and in a second secondary direction in a second state of the drug delivery device. The second primary direction and the second secondary direction may form an angle of at least 30°. The second primary direction may be parallel or substantially parallel to the central axis. The second primary direction may form an angle of less than 60° with the central axis. The second secondary direction may form an angle of at least 60°, for example, about 90°, with the central axis. The second secondary direction may be perpendicular to the central axis.

[0070] The second distal end of the second fastener may be configured to move or be moved from a second primary position in the first state of the drug delivery device to a second secondary position in the second state.

[0071] The drug delivery device includes an actuation mechanism configured to move the first fastener relative to the second fastener, e.g., move the first distal end toward and / or away from the second distal end, during at least a portion of a rotation, e.g., a first rotation and, optionally, a second rotation. Moving the first distal end toward the second distal end may be understood as decreasing the distance between the first and second distal ends. Moving the first distal end toward the second distal end may be understood as decreasing the angle between the first and second fastening axes, e.g., decreasing the angle between the first secondary direction of the first fastener and the second secondary direction of the second fastener. In one or more exemplary drug delivery devices, the actuation mechanism may be configured to, for example, rotate the first body portion relative to the second body portion in the second state of the drug delivery device, thereby moving the first distal end toward the second distal end, and / or vice versa. The actuation mechanism may be configured to rotate the first body portion relative to the second body portion at least 90°, e.g., at least 450°, at least 810°, at least 1170°, at least 1530°, or even at least 1890°, about the major axis. The actuation mechanism may be configured to rotate the first body portion relative to the second body portion about the major axis in steps. In other words, rotating the first body portion relative to the second body portion about the major axis may include multiple rotations, including a first rotation and a second rotation, e.g., a first rotation followed by a first period with reduced or no rotation, followed by a second rotation. The first period is followed by a first rotation, and the second rotation can increase the likelihood that the drug delivery device will attach to the biological tissue. The first period, or generally the period between rotations, allows the drug delivery to migrate to other locations within the gastrointestinal tract. In other words, if the drug delivery does not attach to the biological tissue during the first rotation, further rotations increase the chance of attachment to internal tissue. The first rotation can be at least 90°, and the second rotation can be at least 180°. The multiple rotations can include a third rotation. The third rotation can be at least 180°.

[0072] In one or more exemplary drug delivery devices, movement of the first distal end toward the second distal end may occur before and / or after movement of the first distal end away from the second distal end. In other words, movement of the first distal end toward the second distal end may occur before and / or after movement of the first distal end away from the second distal end. For example, the first rotation may include moving the first distal end toward the second distal end and / or moving the first distal end away from the second distal end. For example, the second rotation may include moving the first distal end toward the second distal end and / or moving the first distal end away from the second distal end. For example, the third rotation may include moving the first distal end toward the second distal end and / or moving the first distal end away from the second distal end.

[0073] The actuation mechanism optionally comprises a resilient portion, such as a spring element, configured to apply a force to the first body portion and / or the second body portion. The resilient portion may comprise a first portion, such as a first end, connected to the first body portion. The resilient portion may comprise a second portion, such as a second end, connected to the second body portion.

[0074] In one or more exemplary drug delivery devices, the actuation mechanism optionally comprises an expansion medium, i.e., a medium that increases its volume upon contact with, e.g., a fluid, to provide for rotation of parts relative to one another, for example. In one or more exemplary drug delivery devices, the expansion inner portion provides for rotation of the first fastening portion relative to the first body portion and / or provides for rotation of the second fastening portion relative to the second body portion. In one or more exemplary drug delivery devices, the expansion inner portion provides for rotation of the first body portion relative to the second body portion.

[0075] An actuation mechanism, such as a resilient portion, may be configured to rotate the first engagement portion relative to the first body portion about a first axis of rotation.

[0076] An actuation mechanism, such as a resilient portion, may be configured to rotate the second engagement portion about a second axis of rotation relative to the second body portion.

[0077] In one or more exemplary drug delivery devices, the drug delivery device includes a first compartment, and the drug delivery device is configured to deliver an active drug substance from the first compartment to the surroundings of the drug delivery device. The first compartment may be positioned on a first attachment portion, such as a first needle, within a distance of, for example, 8 mm, e.g., 5 mm, from the first distal end. The first attachment portion, such as the first needle, may have one or more openings providing access to the first compartment. In one or more exemplary drug delivery devices, the first compartment is formed as a through-hole in the first needle.

[0078] The first compartment may be located in any part of the drug delivery device, such as in the form of a cavity inside the first body portion, the second body portion, or the volume of both the first and second body portions. Additionally or alternatively, the first compartment may be a compartment inside the first fastening portion, and penetration of the first fastening portion into the biological tissue may release the drug within the first compartment into the biological tissue. Additionally or alternatively, the first compartment may be a compartment in the form of a depression, opening, spike, or hollow spike on the outer surface of the first and / or second body portion, and the drug delivery device may be adapted to release a drug substance into the interior of a bodily organ through which the drug delivery device is adapted to pass.

[0079] In one or more exemplary drug delivery devices, the first compartment may open from the interior volume of the drug delivery device toward an exterior portion of the drug delivery device. In one or more examples, the first compartment may be inside the first body portion, and the first compartment may be fluidly connected to the first anchoring portion, such that when the first distal end of the first anchoring portion penetrates the biological tissue, the drug substance may be released from the first compartment into the biological tissue through the first anchoring portion. This may be, for example, when the first anchoring portion is a tubular portion having a first distal end in fluid communication with the first compartment of the drug delivery device.

[0080] In one or more exemplary drug delivery devices, the drug delivery device includes a second compartment, and the drug delivery device is configured to deliver an active drug substance from the second compartment to the surrounding area of ​​the drug delivery device. The second compartment may be located on the first or second fastening portion, e.g., the second needle, within a distance of, e.g., 8 mm or less, e.g., 5 mm or less, from the second distal end. The second fastening portion, e.g., the second needle, may have one or more openings providing access to the second compartment. In one or more exemplary drug delivery devices, the second compartment is formed as a through-hole in the first or second needle.

[0081] In one or more exemplary drug delivery devices, the first and second anchoring portions form an angle when the first and second distal ends are in a plane containing the major axis. In other words, the first and second anchoring axes may form an angle greater than 5°, such as in the range of 10° to 75°, when the first and second distal ends are in a plane containing the major axis.

[0082] In one or more exemplary drug delivery devices, the drug delivery device has a first state (also referred to as an initial state), in which the first body portion and the second body portion are rotationally stationary relative to each other, and a second state (also referred to as an actuated state), in which the first body portion and the second body portion are rotationally movable relative to each other, e.g., can rotate about a major axis of the drug delivery device. In other words, the first body portion can be locked relative to the second body portion, e.g., prevented from rotation. The first state can be, for example, an initial state or an introduction state, in which the drug delivery device is adapted to be introduced into a body and the first body portion and the second body portion are stationary relative to each other. In the first state, the elastic portion can have a predetermined amount of stored energy, and the energy level is stationary within the elastic portion while the body portion is stationary.

[0083] In one or more exemplary drug delivery devices, the drug delivery device has a first state in which the elastic portion has a constant elastic force load and a second state in which the elastic portion at least partially releases the elastic force load. In other words, the elastic portion is biased or preloaded in the first state of drug delivery, and upon release (i.e., the drug delivery device is in the second state), for example, by release of a locking mechanism, the force from the elastic portion can result in rotation of the first body portion relative to the second body portion, including movement of the first distal end toward the second distal end.

[0084] In one or more exemplary drug delivery devices, the actuation mechanism moves the first distal end from a first primary position, e.g., in a first state of the drug delivery device, to a first secondary position from a central axis of the delivery device, e.g., in a second state of the drug delivery device, the first distal end having a first primary radial distance and a first secondary radial distance from the central axis and / or main axis, the first secondary radial distance being greater than the first primary radial distance. Thus, when the drug delivery device is in the first state, the first distal end of the first anchor can be in the first primary position, and / or when the drug delivery device is in the second state, the first distal end of the first anchor can be in the first secondary position.

[0085] The first primary radial distance may be less than 10 mm, for example, less than 8 mm, or even less than 5 mm. The first secondary radial distance may be greater than the first primary radial distance. The first secondary radial distance may be greater than 5 mm, for example, greater than 6 mm, or greater than 8 mm. In one or more exemplary drug delivery devices, the first secondary radial distance is in the range of 6 mm to 15 mm.

[0086] In one or more exemplary drug delivery devices, a first anchoring portion, such as a portion of a first needle and / or a first distal end, can be disposed or at least partially disposed within a first primary recess of the first body portion in the first state. In the first state, the first distal end can be disposed inside the first body portion.

[0087] In one or more exemplary drug delivery devices, a first engagement portion, such as a portion of the first needle and / or a first distal end, can be positioned, or at least partially positioned, outside the first primary recess of the first body portion in the second state.

[0088] In one or more exemplary drug delivery devices, a first fastening portion, such as a portion and / or a first distal end of the first needle, can be disposed within a second primary recess of the second body portion in the first state, whereby the first fastening portion can be configured to lock the first body portion relative to the second body portion in the first state of the drug delivery device.

[0089] In one or more exemplary drug delivery devices, a first engagement portion, such as a portion of the first needle and / or a first distal end, can be positioned outside the second body portion and / or at least outside the second primary recess of the second body portion in the second state.

[0090] In one or more exemplary drug delivery devices, the actuation mechanism is configured to move the second distal end from a second primary position, e.g., in a first state of the drug delivery device, to a second secondary position from a central axis of the delivery device, e.g., a second primary radial distance from the central axis and / or main axis, in a second state of the drug delivery device, the second secondary radial distance being greater than the second primary radial distance. Thus, when the drug delivery device is in the first state, the second distal end of the second anchor can be in the second primary position, and / or when the drug delivery device is in the second state, the second distal end of the second anchor can be in the second secondary position.

[0091] The second primary radial distance may be less than 10 mm, for example, less than 8 mm, or even less than 5 mm. The second secondary radial distance may be greater than the second primary radial distance. The second secondary radial distance may be greater than 5 mm, for example, greater than 6 mm, or greater than 8 mm. In one or more exemplary drug delivery devices, the second secondary radial distance is in the range of 6 mm to 15 mm.

[0092] In one or more exemplary drug delivery devices, a second fastening portion, such as a portion of a second needle and / or a second distal end, can be disposed, or at least partially disposed, within a first secondary recess of the first body portion in the first state. The second fastening portion can thereby be configured to lock the first body portion relative to the second body portion in the first state of the drug delivery device. In the first state, the second distal end can be disposed inside the second body portion.

[0093] In one or more exemplary drug delivery devices, a second engagement portion, such as a portion of the second needle and / or a second distal end, may be positioned, or at least partially positioned, outside the first body portion and / or at least outside the first secondary recess of the first body portion in the second state.

[0094] In one or more exemplary drug delivery devices, a second engagement portion, such as a portion of a second needle and / or a second distal end, can be disposed within a second secondary recess of the second body portion in the first state.

[0095] In one or more exemplary drug delivery devices, a second engagement portion, such as a portion of the second needle and / or a second distal end, can be positioned outside a second secondary recess in the second body portion in the second state.

[0096] In one or more exemplary drug delivery devices, the actuation mechanism is configured to, for example, rotate the first anchor (first base portion) about the first axis of rotation to move the first distal end from a first primary angular position in a first primary position to a first secondary angular position in a first secondary position relative to the first proximal end of the first anchor. The angle between the first primary angular position and the first secondary angular position may be greater than 10°, e.g., greater than 45°, or greater than 60°.

[0097] In one or more exemplary drug delivery devices, the actuation mechanism is configured to move the second distal end relative to the second proximal end of the second anchor (the second base portion) from a second primary angular position in the second primary position to a second secondary angular position in the second secondary position, for example, by rotation of the second anchor (the second base portion) about the second axis of rotation. The angle between the second primary angular position and the second secondary angular position may be greater than 10°, e.g., greater than 45°, or greater than 60°.

[0098] In one or more exemplary drug delivery devices, the drug delivery device includes a locking mechanism. The locking mechanism can be configured to lock, e.g., prevent, rotation of the first body portion relative to the second body portion when the drug delivery device is in a first state. The locking mechanism can be configured to lock the first fastening portion in, e.g., a first primary position relative to the first body portion when the drug delivery device is in the first state. When the locking mechanism is released, the first fastening portion can be allowed to move from the first primary position to the first secondary position. When the locking mechanism is released, the locking mechanism can be configured to allow rotation of the first body portion relative to the second body portion when, e.g., in the second state of the drug delivery device. When the drug delivery device is in the first state, the locking mechanism can be configured to lock the second fastening portion in, e.g., a second primary position relative to the second body portion. When the drug delivery device is in the first state, the locking mechanism can be configured to allow the second fastening portion to move from the second primary position to the second secondary position when the drug delivery device is in the second state.

[0099] The locking mechanism may include a first locking element optionally configured to lock and / or unlock (release) the first body portion relative to the second body portion. The first locking element may be configured to lock and / or unlock (release) the first fastener relative to the first body portion. The first locking element may be configured to lock and / or unlock (release) the second fastener relative to the second body portion. The first locking element may be disposed within the first primary recess of the first body portion and / or the second primary recess of the second body portion. The first locking element may be configured to dissolve when the drug delivery device enters the gastrointestinal tract or at a desired location within the gastrointestinal tract, thereby releasing the first body portion relative to the second body portion, and the actuation mechanism rotates the first body portion relative to the second body portion, thereby moving the first distal end toward the second distal end, which in turn results in attachment of the drug delivery device to the internal tissue.

[0100] The first locking element may be a first locking band (e.g., a ring, a loop, a partial ring, or a partial loop). The first locking band may have a circumferential length that is greater than its longitudinal width. For example, the circumferential length may be 2x, 3x, 4x, 5x, 6x, 7x, 8x, 9x, or 10x the longitudinal width.

[0101] The first locking band may be fitted to the outer surface of the drug delivery device. For example, the first locking band may be disposed on the outer surface of the first body portion or the second body portion. The first locking band may be mechanically fitted onto the drug delivery device. For example, the first locking band may be snap-fit ​​onto the drug delivery device. The first locking band may be chemically attached onto the drug delivery device.

[0102] In one or more exemplary drug delivery devices, the first locking band can be in the shape of a capsule portion. For example, the first locking band can form a first half of a capsule. The first locking band can form the first half of the capsule, and the second locking band can form the second half of the capsule. When mated together, the first locking band and the second locking band can form a complete capsule.

[0103] When the first locking band is positioned on the first body portion, it may partially or completely cover the first body recess. Thus, the first locking band can prevent movement of the first fastening portion. When the first locking band is positioned on the second body portion, it may partially or completely cover the second body recess. Thus, the first locking band can prevent movement of the second fastening portion. The first locking band may partially or completely cover both the first body recess and the second body recess. The first locking band may partially or completely cover the first body recess, and the second locking band may partially or completely cover the second body recess.

[0104] The first locking band may extend completely around the circumference of the drug delivery device. The first locking band may extend around 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% of the circumference of the drug delivery device. The first locking band can extend around more than 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, or 95% of the circumference of the drug delivery device. The first anchoring band may extend around less than 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% of the circumference of the drug delivery device.

[0105] In one or more exemplary drug delivery devices, the first locking band can include one or more locking protrusions (e.g., extensions, tabs, fingers, protrusions, teeth). For example, the first locking band can include 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 locking protrusions. The locking protrusions can extend longitudinally from only one side of the first locking band. The locking protrusions can extend longitudinally from both sides of the first locking band. The locking protrusions can be equally spaced along the first locking band. The locking protrusions can be unevenly spaced along the first locking band.

[0106] The one or more locking protrusions may extend toward the longitudinal center of the drug delivery device (e.g., when the first locking band is located on the first body portion, along the outside of the body portion toward the second body portion, or when the first locking band is located on the second body portion, along the outside of the body portion toward the first body portion).

[0107] The one or more locking protrusions may be triangular, square, rectangular, round, or other polygonal in shape. The one or more locking protrusions may vary in shape along the first locking band.

[0108] In one or more exemplary drug delivery devices, the drug delivery device may include a mating portion. The mating portion may be configured to mate with one or more protrusions of the first locking band. The mating portion may include one or more mating protrusions (e.g., extensions, tabs, fingers, projections, teeth) extending radially outward from the outer surface of the drug delivery device. The mating portion may extend from the first body portion, the second body portion, or both. The mating portion may be formed in one or more circumferential rows. For example, there may be one circumferential row of mating portions or two circumferential rows of mating portions. Both circumferential rows may be on the same body portion (e.g., the first body portion or the second body portion). In an alternative embodiment, one circumferential row of mating portions may be on the first body portion and the second circumferential row of mating portions may be on the second body portion.

[0109] The one or more mating protrusions may be triangular, square, rectangular, round, or other polygonal shapes. The one or more mating protrusions may vary in shape along the first locking band. The one or more mating protrusions may be angled circumferentially to form a mating recess (e.g., a curve, a cavity, a space, or a gap). This mating recess can help lock the one or more mating protrusions to the one or more protrusions of the first locking band. Furthermore, the mating recess can prevent undesired release of the first locking band. Thus, when the first locking band is attached to the drug delivery device, the one or more locking protrusions can fit between the one or more mating protrusions. The one or more locking protrusions can fit within adjacent mating protrusions. This can prevent rotation of the first body portion relative to the second body portion. For example, the first body portion is prevented from rotating by the first locking band. In some embodiments, a locking protrusion can be located between two mating protrusions, each of which is angled in an opposite direction to hold the locking protrusion in place.

[0110] In some implementations, the mating portion may be a recess that extends into the interior of the drug delivery device, and the locking protrusion can then extend radially inward rather than longitudinally to mate with the mating portion.

[0111] As described above, when the first locking band is attached and the one or more protrusions mate with the mating portions, the first body portion is locked in place relative to the second body portion. The first and second body portions can be released from the first locking band when the first locking band dissolves, as discussed herein.

[0112] Additionally, dissolving the first locking band may allow the first fastening portion or the second fastening portion to further rotate out of one of the first body recess or the second body recess, such that when the first and second body portions rotate relative to one another, the first and second fastening portions can rotate for insertion into tissue.

[0113] In one or more exemplary drug delivery devices, the first locking band can include one or more square locking protrusions and / or one or more triangular locking protrusions. The square locking protrusions can be used to hold the cover in place under the force of the mating protrusions. The triangular locking protrusions can be used to properly position the first locking band.

[0114] In one or more exemplary drug delivery systems, the entire first locking band may be dissolvable. In one or more exemplary drug delivery systems, only the square-shaped locking protrusions may be formed from a dissolvable material. When the square-shaped locking protrusions dissolve, the first and second body portions may be rotated. Rotation of the first body portion relative to the second body portion may translate, e.g., move, reposition, or reposition, the first locking band. This may occur when the mating protrusions compress the triangular-shaped locking protrusions, pushing them apart longitudinally. For example, rotation may translate the first locking band along a central axis.

[0115] The translation can expose the first fastening portion and / or the second fastening portion, depending on the coverage of the first fastening band. The translation can completely translate the first fastening band on the drug delivery device. The translation can partially translate the first fastening band to expose the first fastening portion and / or the second fastening portion, while the first fastening band remains associated with, e.g., attached to, the drug delivery device.

[0116] The locking mechanism may include a second locking element optionally configured to lock and / or unlock (release) the first body portion relative to the second body portion. The second locking element may be configured to lock and / or unlock (release) the second fastener relative to the second body portion. The second locking element may be disposed in the first secondary recess of the first body portion and / or the second secondary recess of the second body portion. The second locking element may be configured to dissolve when the drug delivery device enters the gastrointestinal tract, thereby unlocking or releasing the first body portion relative to the second body portion, and the actuation mechanism may rotate the first body portion relative to the second body portion, thereby moving the first distal end toward the second distal end, which then allows the drug delivery device to attach to internal tissue.

[0117] One or more exemplary drug delivery devices can include a first cover band (e.g., a ring, a loop, a partial ring, a partial loop). The first cover band can be used in conjunction with a first locking element, e.g., a locking element, a locking mechanism. In one or more exemplary drug delivery devices, the first cover band can be a first locking band. In one or more exemplary drug delivery devices, the first cover band can include any or all of the features described above with respect to the first locking band. The first cover band can have a circumferential length that is greater than its longitudinal width. For example, the circumferential length can be 2x, 3x, 4x, 5x, 6x, 7x, 8x, 9x, or 10x the longitudinal width.

[0118] The first cover band can be fitted to an outer surface of the drug delivery device. For example, the first cover band can be located on an outer surface of the first body portion or the second body portion.

[0119] In one or more exemplary drug delivery devices, the first cover band can be in the shape of a capsule portion. For example, the first cover band can form a first half of the capsule. The first cover band can form the first half of the capsule, and the second cover band can form the second half of the capsule. When mated together, the first cover band and the second cover band can form a complete capsule.

[0120] The first cover band can be mechanically fitted onto the drug delivery device. For example, the first cover band can be snapped onto the drug delivery device. The first cover band can be chemically attached onto the drug delivery device.

[0121] When the first cover band is positioned on the first body portion, it may partially or completely cover the first body recess. Thus, the first cover band can prevent movement of the first fastening portion. When the first cover band is positioned on the second body portion, it may partially or completely cover the second body recess. Thus, the first cover band can prevent movement of the second fastening portion. The first cover band may partially or completely cover both the first body recess and the second body recess. The first cover band may partially or completely cover the first body recess, and the second cover band may partially or completely cover the second body recess.

[0122] The first cover band may extend completely around the circumference of the drug delivery device. The first cover band may extend around 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% of the circumference of the drug delivery device. The first cover band can extend around more than 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, or 95% of the circumference of the drug delivery device. The first cover band may extend around less than 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% of the circumference of the drug delivery device.

[0123] In one or more exemplary drug delivery devices, the first cover band may include one or more mating protrusions (e.g., extensions, tabs, fingers, protrusions, teeth). For example, the first cover band may include 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mating protrusions. The mating protrusions may only extend longitudinally from one side of the first cover band. The mating protrusions may extend longitudinally from both sides of the first cover band. The mating protrusions may be evenly spaced along the first cover band. The mating protrusions may be unevenly spaced along the first cover band.

[0124] The one or more mating projections may extend toward the longitudinal center of the drug delivery device (e.g., when the first cover band is located on the first body portion, along the outside of the body portion toward the second body portion, or when the first cover band is located on the second body portion, along the outside of the body portion toward the first body portion).

[0125] In one or more exemplary drug delivery devices, the drug delivery device may include a mating portion. The mating portion may be configured to mate with, e.g., receive, retain, or contact, one or more mating protrusions of the first cover band. The mating portion may include one or more body mating protrusions (e.g., extensions, tabs, fingers, protrusions, teeth) extending radially outward from the outer surface of the drug delivery device. The mating portion may extend from the first body portion, the second body portion, or both. The mating portion may be formed in one or more circumferential rows. For example, there may be one circumferential row of mating portions or two circumferential rows of mating portions. Both circumferential rows may be on the same body portion (e.g., the first body portion or the second body portion). In an alternative embodiment, one circumferential row of mating features may be on the first body portion and a second circumferential row of mating features may be on the second body portion.

[0126] The one or more mating protrusions may be triangular, square, rectangular, round, or other polygonal in shape. The one or more mating protrusions may vary in shape along the first cover band. The one or more mating protrusions may be angled circumferentially to form a mating recess (e.g., a curve, a cavity, a space, a gap). The mating recess can help mate the one or more main body mating protrusions with the one or more protrusions of the first cover band. Additionally, the mating recess can prevent undesired release of the first cover band.

[0127] Thus, when the first cover band is attached to the drug delivery device, one or more of the mating projections can fit between one or more of the mating portions. One or more of the mating projections can fit within adjacent mating portions. This can help properly align the first cover band.

[0128] In some implementations, the mating portion may be a recess extending into the drug delivery device. The mating protrusion can then extend radially inward rather than longitudinally to mate with the mating portion. In one or more exemplary drug delivery devices, rotation of the first body portion relative to the second body portion can translate, e.g., move, reposition, or reposition, the cover band. For example, rotation can translate the cover band along the central axis. This translation can expose the first fastening portion and / or the second fastening portion, depending on the coverage of the cover band. This can occur, for example, when the mating protrusion can press against triangular-shaped or other-shaped mating protrusions and push them apart longitudinally. Translation can completely translate the cover band from the drug delivery device. Translation can partially translate the cover band to expose the first fastening portion and / or the second fastening portion on a cover band associated with, e.g., attached to, the drug delivery device.

[0129] In one or more exemplary drug delivery devices, the first cover band may be dissolvable. Dissolution of the first cover band may allow the first fastening portion or the second fastening portion to further rotate out of one of the first body recess or the second body recess. Thus, when the first and second body portions rotate relative to each other, the first and second fastening portions may rotate for insertion into tissue. The materials and / or properties of the first and / or second locking elements may be selected to control the release of the body portions and / or the activation of drug delivery to occur at a desired location in the gastrointestinal tract, such as the stomach or intestines. The materials of the first and / or second locking elements may include one or more of a sugar, a sugar derivative, a hydrophilic polymer, a pH-dependent polymer, and a pharmaceutically acceptable excipient that disperses, dissolves, swells, and / or gels upon contact with water / fluid.

[0130] In one or more exemplary drug delivery devices, at least a portion of the first anchor portion and / or the second anchor portion may be made from a biodegradable, absorbable, or similar material that allows the anchor material to be broken down, degraded, and / or dissolved by processes present in the body, such as corrosion, decomposition, hydrolysis, and / or proteolytic enzyme degradation. Thus, when the anchor portion is within the human body for a period of time, the anchor portion may dissolve, degrade, or disintegrate to an extent that the anchor portion may lose its structural stability, which may then release the drug delivery device from the surface to which it is attached. Thus, after a period of time, for example, when a medicinal material is released from the anchor portion, the anchor portion may degrade to an extent that the drug delivery device may be released and continue its journey through the user's or patient's natural intestine and / or gastrointestinal tract via intestinal movements.

[0131] In one or more exemplary drug delivery devices, the first body portion and the second body portion can be substantially symmetrical in a radial direction perpendicular to the central axis, which can mean that the first body portion and / or the second body portion can have a circular periphery that can extend away from the central axis in a radial direction perpendicular to the central axis.

[0132] The first engagement axis can be viewed as an axis coaxial with the length of the first engagement portion. The second engagement axis can be viewed as an axis coaxial with the length of the second engagement portion. If the first engagement portion has a non-linear shape, the first engagement axis can be defined as an axis intersecting the first distal end and the first proximal end of the first engagement portion. If the second engagement portion has a non-linear shape, the second engagement axis can be defined as an axis intersecting the second distal end and the second proximal end of the second engagement portion.

[0133] In one or more exemplary drug delivery devices, the first engagement axis may be positioned a first distance from the central axis, while the second engagement axis may be positioned a second distance from the central axis and / or main axis.

[0134] For example, the first engagement axis can be positioned a first primary distance from the central axis in the first state of the drug delivery device, and the first primary distance can be greater than 0.5 mm, e.g., in the range of 1 mm to 15 mm, or greater than 1 mm, e.g., 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, or 14 mm.

[0135] The first engagement axis may intersect with or be close to (a distance of less than 0.5 mm) the central axis in the first state of the drug delivery device.

[0136] The first engagement axis can be positioned a first secondary distance from the central axis in the second state of the drug delivery device, and the first secondary distance can be greater than 0.5 mm, for example, in the range of 1 mm to 15 mm, or greater than 1 mm, for example, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, or 14 mm.

[0137] The first engagement axis may intersect with or be close to (a distance of less than 0.5 mm) the central axis in the second state of the drug delivery device.

[0138] For example, the second engagement axis can be positioned at a second primary distance from the central axis in the first state of the drug delivery device, and the second primary distance can be greater than 0.5 mm, e.g., in the range of 1 mm to 15 mm, or greater than 1 mm, e.g., 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, or 14 mm.

[0139] The second engagement axis may intersect with or be close to (a distance of less than 0.5 mm) the central axis in the first state of the drug delivery device.

[0140] The second engagement axis can be positioned at a second secondary distance from the central axis in the second state of the drug delivery device, and the second secondary distance can be greater than 0.5 mm, for example, in the range of 1 mm to 15 mm, or greater than 1 mm, for example, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, or 14 mm.

[0141] The second engagement axis may intersect with or be close to (a distance of less than 0.5 mm) the central axis in the second state of the drug delivery device.

[0142] In one or more exemplary drug delivery devices, the first fastening portion (first fastening axis) and / or the second fastening portion (second fastening axis) may be configured to form an angle with respect to each other when intersecting a plane containing their central axes. The plane may be a plane containing the central axis, and the plane may also include a radial axis extending perpendicularly from the central axis. When the first fastening portion intersects the plane, the first fastening axis of the first fastening portion may be at an angle with respect to the plane such that a first distal end of the first fastening portion is a first portion of the first fastening portion that intersects the plane, and the remainder of the first fastening portion continues to intersect the plane during rotational movement. The second fastening portion may intersect the same plane from the opposite side, such that a second distal end of the second fastening portion is a first portion of the second fastening portion that intersects the plane, and the remainder of the second fastening portion continues to intersect the plane during rotational movement. Thus, the second fastening portion optionally intersects the plane from an opposite rotational direction to the first fastening portion. This may also mean that when the first and second distal ends of the respective first and second fastening portions contact the plane, the first fastening portion (first fastening axis) is at an angle to the plane and the second fastening portion (second fastening axis) is at an angle to the plane. The angle between the first fastening portion (first fastening axis) and the second fastening portion (second fastening axis) and the plane may be approximately half the size of the angle between the first fastening portion and the second fastening portion.

[0143] In one or more exemplary drug delivery devices, a first body portion may be configured to rotate in a first direction and a second body portion may be configured to rotate in a second direction, the first direction being opposite the second direction. Thus, by way of example, the first body portion may rotate in a clockwise direction and the second body portion may rotate in an opposite counterclockwise direction. In one or more examples where the drug delivery device includes three or more body portions, adjacent or neighboring body portions may rotate in opposite directions. This may also mean that all second body portions may rotate in the same direction. For example, if the first body portion and the third body portion rotate in the same first direction, the second body portion and / or the fourth body portion may rotate in a second direction opposite the first direction.

[0144] In one or more exemplary drug delivery devices, the actuation mechanism can include one or more resilient portions, such as multiple resilient portions.

[0145] In one or more exemplary drug delivery devices, the first distal end of the first fastening portion and / or the second distal end of the second fastening portion may include a sharp tip configured to penetrate biological tissue. The sharp tip may be disposed near the distal end of each fastening portion, and the sharp tip may be configured to have a diameter at the distal end that is smaller than the diameter of the fastening portion at a distance from the distal end. The sharp tip may also be configured to pierce biological tissue by a counter force applied by a force applied by the actuation mechanism when a rotational force is applied to the first fastening portion and a counter force is applied to the second fastening portion.

[0146] When the first and / or second fastening portions penetrate the biological tissue due to rotation between the first and second body portions (the first distal end moving toward the second distal end), each penetration point in the biological tissue can be utilized to deliver a drug substance from the drug delivery device into the biological tissue, and the drug substance can be introduced into the biological tissue across the mucosa. This allows the drug substance to enter the bloodstream more easily than if the drug substance were released within the stomach or intestinal lumen, resulting in more effective drug delivery. An example of this is when the drug substance is insulin, which degrades in the gastrointestinal tract and cannot be absorbed from the gastrointestinal tract, but the mucosa is penetrated and the insulin released through the penetrated gastrointestinal wall remains intact and crosses the mucosa (surface) to reach the user's bloodstream via blood vessels in the intestinal layer.

[0147] In one or more exemplary drug delivery devices, the first and / or second fastening portions may include gripping portions configured to grip biological tissue. The gripping portions may be utilized to improve traction between the fastening portions and the mucosa, allowing the fastening portions to secure the drug delivery device to the user's body. The gripping portions may be portions that increase mechanical friction between the fastening portions and the surface to which they are attached, such as having a hook shape, or may have a shape in which the gripping portion of the first fastening portion faces the gripping portion of the second fastening portion, such that biological tissue positioned between the first and second fastening portions is gripped between the two gripping portions.

[0148] In one or more exemplary drug delivery devices, a portion of the elastic portion can be connected to the first body portion, and a second portion of the elastic portion can be connected to the second body portion. This means that the elastic portion can be utilized to store energy, such as rotational energy or rotational force, that is applied to the first and second body portions, with the energy stored in the elastic portion. Furthermore, when the energy is released, e.g., when the locking element dissolves or decomposes, the force can be released in both the first and second body portions, which then transmits the force to the first and second fastening portions. The elastic portion can be, for example, a spiral spring and / or a spiral torsion spring, and the first body portion can be wound relative to the second body portion by rotating the first body portion relative to the second body portion. This stores energy in the spiral spring by twisting the helix more tightly. The stored force of the helical spring can then rotate the first body portion in opposite directions as the helical spring unwinds, thus moving the first and second fastening portions in opposite directions, allowing the fastening portions to clamp or penetrate tissue to clamp and attach the drug delivery device to the tissue.

[0149] The drug delivery device can be configured to transform from a first state to a second state when the drug delivery device enters the body, for example, within a desired portion of the gastrointestinal tract. The transformation can be initiated by different means; for example, the first and second body portions can be held in the first state using a locking mechanism, which can include, for example, one or more locking elements made from a dissolvable, expandable, or degradable material that reacts with the surroundings, such as fluid inside the desired body portion, thereby unlocking or releasing the locking mechanism. The locking element material can be a material that loses its structural strength upon contact with the surroundings inside the desired body portion. One example would be when the locking element is made from a polymeric or carbohydrate material that can dissolve, expand, or decompose upon contact with certain types of fluids, such as enzymes or certain types of acids, found inside the digestive system. When the locking element comes into contact with the reagent, the material may dissolve, swell, or degrade over time, and when the rotational force of the drug delivery device exceeds the static force of the locking element, the rotational force may be released via rotation of the first body portion relative to the second body portion, or vice versa.

[0150] In one or more exemplary drug delivery devices, the locking element may secure the fastener in a position where it locks the first body portion relative to the second portion, i.e., prevents the first body portion from rotating relative to the second body portion. When the locking element dissolves or decomposes, the fastener can be moved to a secondary position where it does not lock the first body portion relative to the second portion, for example, by an actuation mechanism causing rotation of the fastener about an axis of rotation relative to the body portion to which the fastener is rotatably mounted.

[0151] The second state of the drug delivery device can be considered to be initiated by the release of energy stored in the actuation mechanism, e.g., the rotational force of the resilient portion of the actuation mechanism on the first and / or second body portions and / or the rotational force of the first fastening portion relative to the first body portion. The end of the second state can be viewed as the point at which the energy stored in the resilient portion comes to rest again, i.e., when the fastening portion grasps or penetrates the biological tissue, and / or when rotational motion between the first and second body portions is stopped.

[0152] In one or more exemplary drug delivery devices, the drug delivery device can have a first state in which the actuation mechanism has a constant elastic force load and a second state in which the actuation mechanism releases the elastic force load. In the first state, the constant elastic force load can be viewed as energy stored in the actuation mechanism, where the elastic force load is greater than zero. The second state can be viewed as a state in which the actuation mechanism releases its elastic force load, where the elastic force load approaches zero, for example, by rotating the first body portion relative to the second body portion. The second state can be terminated when the anchoring portion contacts or penetrates biological tissue and the elastic force load remains unchanged despite not reaching zero. Thus, a third state can follow the second state when the drug delivery device is attached to a wall of biological material and the elastic force load is stationary after the elastic force release.

[0153] The first and / or second fastening portions may have a deployment function, and during the first state of the drug delivery device, i.e., the initial state of the drug delivery device, the fastening portions may be positioned or disposed inside the first and / or second body portions, or the first and / or second fastening portions may be folded along the sides of the body portions. Other methods similar to those described above are also envisioned. The folded state (first state) may be maintained, for example, using a releasable locking mechanism in the form of an encapsulation similar to a drug capsule, e.g., a band or plug made of gelatin, sugar, or other dissolvable material or material that loses its structural strength. Thus, the fastening portions may be held in place until the drug delivery device enters the gastrointestinal tract, such as the stomach, so that the fastening portions do not interfere with or damage the lining of the mouth and / or esophagus. Before or during transition to the second state, the fastening portions may extend outward from the body portions, allowing the fastening portions to immediately interact with the lining of the digestive system. When the fastener is in a folded or collapsed position, the distance from the central axis to the distal end of the fastener is greater in the second state than in the first state, and thus the diameter of the drug delivery device in the first state is smaller than the diameter of the drug delivery device in the second state.

[0154] In one or more exemplary drug delivery devices, at least a portion of the first and / or second attachment portions, such as the first and / or second needles, may be made from a material including one or more of magnesium, titanium, iron, and zinc, which allows for accurate and precise control of the size and / or shape / geometry of the first and / or second attachment portions, which in turn allows for a delivery device with desired attachment capabilities and / or small production variations, which is important particularly in the pharmaceutical industry.

[0155] The first fastening portion, such as the first needle, may be made of a material including one or more of magnesium, titanium, iron, and zinc. The material of the first fastening portion / first needle may be biocompatible and / or biodegradable, such as a biocompatible and / or biodegradable material. The material of the first fastening portion / first needle may include one or more biodegradable polymers, such as PLA and / or POLGA. Some, most, substantially all, or all of the material of the first fastening portion / first needle may be biocompatible and / or biodegradable. The material of the first fastening portion, such as the first needle, may include, consist of, or consist essentially of a biocompatible and / or biodegradable material, such as a biocompatible and / or biodegradable metal. The material of the first fastening portion, such as the first needle, may include a biodegradable or bioabsorbable metal or metal alloy, such as magnesium, zinc, and / or iron, or an alloy including one or more of magnesium, zinc, and iron. A biodegradable or bioabsorbable metal or metal alloy may be understood as, for example, a metal or metal alloy that decomposes safely within a practical timeframe, for example in relation to their application, for example in the human body. The material of the first fastening portion, such as the first needle, may comprise one or more metals, such as one or more metals, for example a combination of one or more metals, such as a metal alloy.

[0156] The second fastening portion, such as the second needle, may be made of a material including one or more of magnesium, titanium, iron, and zinc. The material of the second fastening portion / second needle may be biocompatible and / or biodegradable, such as a biocompatible and / or biodegradable material. The material of the second fastening portion / second needle may include one or more biodegradable polymers, such as PLA and / or POLGA. Some, most, substantially all, or all of the material of the second fastening portion / second needle may be biocompatible and / or biodegradable. The material of the second fastening portion, such as the second needle, may include, consist of, or consist essentially of a biocompatible and / or biodegradable material, such as a biocompatible and / or biodegradable metal. The material of the second fastening portion, such as the second needle, may include a biodegradable or bioabsorbable metal or metal alloy, such as magnesium, zinc, and / or iron, or an alloy including one or more of magnesium, zinc, and iron. A biodegradable or bioabsorbable metal or metal alloy may be understood as, for example, a metal or metal alloy that decomposes safely within a practical timeframe, e.g., in relation to their application, e.g., in the human body. The material of the second fastening portion, e.g., the second needle, may comprise one or more metals, e.g., a combination of one or more metals, e.g., a metal alloy.

[0157] An advantage of using a biodegradable material for the anchoring portion may be that the delivery device can deliver the active drug or payload disposed in the anchoring portion(s) and / or the body portion of the delivery device to a specific part of the subject's body, such as the stomach or intestine, after the delivery device is attached to an inner surface, such as the intestinal wall, over an extended period of time due to the sharp properties of the anchoring portion material and because the biodegradable material gradually degrades over time. Furthermore, if the anchoring portion material is biodegradable, the anchoring portion will degrade and disappear within the human body after delivering the payload / active drug substance contained in the drug delivery device, thereby avoiding harm to the body over time. The anchoring portion may be configured to degrade within a period of, for example, 2 hours, 5 hours, 10 hours, 20 hours, or 24 hours, a day, such as 1 day, 2 days, or 5 days, or a week, such as 1 week, 2 weeks, 3 weeks, or 5 weeks.

[0158] The material of the anchoring portion, such as a needle, may comprise one or more or a combination of magnesium (Mg), zinc (Zn), and / or iron (Fe). An advantage of having an anchoring portion of a material comprising Mg, Zn, and / or Fe may be that the shape and size of the anchoring portion can be precisely controlled, thereby providing improved attachment to an internal surface, for example, to the lining of the intestine of a human subject.

[0159] For example, the material of the fastening part such as a needle may contain 0.001% to 100% by weight of biodegradable metal, for example, 0.001% to 100% by weight of magnesium, 0.001% to 100% by weight of zinc, or 0.001% to 100% by weight of iron.

[0160] The material of an accessory such as a needle may contain, for example, 0.001% by weight Mg, 0.005% by weight Mg, 0.01% by weight Mg, 0.05% by weight Mg, 0.1% by weight Mg, 0.5% by weight Mg, 5% by weight Mg, 10% by weight Mg, 20% by weight Mg, 30% by weight Mg, 40% by weight Mg, 50% by weight Mg, 60% by weight Mg, 70% by weight Mg, 80% by weight Mg, 90% by weight Mg or 100% by weight Mg.

[0161] The material of the fastening portion, such as a needle, may contain, for example, 0.001% by weight Zn, 0.005% by weight Zn, 0.01% by weight Zn, 0.05% by weight Zn, 0.1% by weight Zn, 0.5% by weight Zn, 1% by weight Zn, 5% by weight Zn, 10% by weight Zn, 20% by weight Zn, 30% by weight Zn, 40% by weight Zn, 50% by weight Zn, 60% by weight Zn, 70% by weight Zn, 80% by weight Zn, 90% by weight Zn, or 100% by weight Zn.

[0162] The material of an accessory such as a needle may include, for example, 0.001% by weight Fe, 0.005% by weight Fe, 0.01% by weight Fe, 0.05% by weight Fe, 0.1% by weight Fe, 0.5% by weight Fe, 1% by weight Fe, 5% by weight Fe, 10% by weight Fe, 20% by weight Fe, 30% by weight Fe, 40% by weight Fe, 50% by weight Fe, 60% by weight Fe, 70% by weight Fe, 80% by weight Fe, 90% by weight Fe, or 100% by weight Fe.

[0163] The material of the fastening portion such as the needle may include a metal alloy such as Zn-Mg, Zn-Fe, Mg-Fe, or Zn-Mg-Fe. The material of the fastening portion such as the needle may include, for example, a Zn-Mg alloy containing 0.001 wt % Mg, 0.005 wt % Mg, 0.01 wt % Mg, 0.05 wt % Mg, 0.1 wt % Mg, 0.5 wt % Mg, 1 wt % Mg, 5 wt % Mg, 10 wt % Mg, 20 wt % Mg, 30 wt % Mg, 40 wt % Mg, 50 wt % Mg, 60 wt % Mg, 70 wt % Mg, 80 wt % Mg, or 90 wt % Mg.

[0164] The material of the fastening portion, such as the needle, may include, for example, a Zn-Fe alloy containing 0.001% by weight Fe, 0.005% by weight Fe, 0.01% by weight Fe, 0.05% by weight Fe, 0.1% by weight Fe, 0.5% by weight Fe, 1% by weight Fe, 1% by weight Fe, 5% by weight Fe, 10% by weight Fe, 20% by weight Fe, 30% by weight Fe, 40% by weight Fe, 50% by weight Fe, 60% by weight Fe, 70% by weight Fe, 80% by weight Fe, or 90% by weight Fe.

[0165] The material of the fastening portion, such as the needle, may include, for example, a Mg-Fe alloy containing 0.001% by weight Fe, 0.005% by weight Fe, 0.01% by weight Fe, 0.05% by weight Fe, 0.1% by weight Fe, 0.5% by weight Fe, 1% by weight Fe, 5% by weight Fe, 10% by weight Fe, 20% by weight Fe, 30% by weight Fe, 40% by weight Fe, 50% by weight Fe, 60% by weight Fe, 70% by weight Fe, 80% by weight Fe, or 90% by weight Fe.

[0166] The material of the fastening part such as a needle may be, for example, 0.001% by weight Fe, 0.005% by weight Fe, 0.01% by weight Fe, 0.05% by weight Fe, 0.1% by weight Fe, 0.5% by weight Fe, 1% by weight Fe, 5% by weight Fe, 10% by weight Fe, 20% by weight Fe, 30% by weight Fe, 40% by weight Fe, 50% by weight Fe, 60% by weight Fe, 70% by weight Fe, 80% by weight Fe, 90% by weight Fe, 0.001% by weight Mg, 0.005% by weight Mg, 0.01% by weight Mg, 0.05% by weight Mg, 0.1% by weight Mg, 0.5% by weight Mg, 1% by weight Mg, 5% by weight Mg, 10% by weight Mg, 20% by weight Mg, 30% by weight Mg, 40% by weight Mg, 50% by weight Mg, 60% by weight Mg, 70% by weight Mg, 80% by weight Mg, 90% by weight Mg ... The Zn-Mg-Fe alloy may comprise 0.001% by weight Mg, 20% by weight Mg, 30% by weight Mg, 40% by weight Mg, 50% by weight Mg, 60% by weight Mg, 70% by weight Mg, 80% by weight Mg, 90% by weight Mg, 0.001% by weight Zn, 0.005% by weight Zn, 0.01% by weight Zn, 0.05% by weight Zn, 0.1% by weight Zn, 0.5% by weight Zn, 1% by weight Zn, 5% by weight Zn, 10% by weight Zn, 20% by weight Zn, 30% by weight Zn, 40% by weight Zn, 50% by weight Zn, 60% by weight Zn, 70% by weight Zn, 80% by weight Zn or 90% by weight Zn.

[0167] The needle or other attachment portion may be made from a material including one or more thermoplastic or thermosetting polymers. The material of the needle or other attachment portion may include one or more active drug substances. Thus, the active drug substances may be embedded in the material of the needle or other attachment portion to form a pharmaceutical composition.

[0168] In some embodiments, the anchoring portion, such as a needle, may comprise, for example, a water-soluble, water-insoluble, biodegradable, non-biodegradable, and / or pH-dependently soluble material. In some embodiments, the anchoring portion, such as a needle, may comprise a water-soluble, biodegradable, and / or pH-dependent material that can dissolve and / or degrade so that the anchoring portion, such as a needle, gradually degrades and / or dissolves as it lodges in the intestinal tissue. In some embodiments, the anchoring portion, such as a needle, may comprise a water-soluble material to enable immediate or modified release of the active drug substance, depending on the material selected. In some embodiments, a water-insoluble or biodegradable material may enable depotting of the active drug substance in the anchoring portion, such as a needle, for a longer release duration (e.g., several days, weeks, or months). In some embodiments, a pH-dependently soluble material may enable the anchoring portion, such as a needle, to remain intact under physiological conditions, e.g., pH conditions below about 7.4, but may subsequently dissolve once in the gastrointestinal wall. In some embodiments, one or more water-soluble, water-insoluble, biodegradable, and / or pH-dependent materials may be optionally combined to control the release of the active drug substance over a controlled release duration (e.g., minutes, hours, days, weeks, or months) by diffusion or erosion between attachment points, such as needles.

[0169] In some embodiments, the anchoring portion, such as a needle, may be made from different compositions. For example, the outer portion of the anchoring portion, such as a needle, may be made from one composition, and the inner core of the anchoring portion, such as a needle, may be made from another composition. In some embodiments, the outer portion and inner core of the anchoring portion, such as a needle, may be composed of, for example, water-soluble, water-insoluble, biodegradable, and / or pH-dependent materials. In some embodiments, one or more water-soluble, water-insoluble, biodegradable, and / or pH-dependent materials may be combined to control the release of an active drug substance as the anchoring portion, such as a needle, moves from its location in a lumen to an internal tissue, for example, from the gastrointestinal lumen to the gastrointestinal tissue.

[0170] In some embodiments, the anchoring portion, such as a needle, may be tubular and may include a tubular body, which may contain an active drug substance, such as a liquid payload containing an active drug substance, and may optionally be connected to the tubular anchoring portion, so that the payload containing the active drug substance may flow through the anchoring portion, such as a needle, and into internal tissue, such as intestinal tissue. In some embodiments, the tubular body may contain an expandable excipient, such as an expandable excipient that may expand by chemical reaction, for example, when mixed, expands in volume, and / or produces gas to advance delivery of the payload. In some embodiments, the expansion is by osmosis.

[0171] In some embodiments, the first compartment (the compartment for holding the active drug substance) may include a closure for closing the first compartment. The closure may contribute to improved control of the release of the active drug substance. In some embodiments, the closure may be composed of, for example, a water-soluble, water-insoluble, biodegradable, and / or pH-dependent material. In some embodiments, one or more water-soluble, water-insoluble, biodegradable, and / or pH-dependent materials may be combined to control the release of the active drug substance from the first compartment when an anchoring portion, such as a needle, moves from its position from the lumen to the internal tissue, for example, from the gastrointestinal lumen to the gastrointestinal tissue.

[0172] 1 shows an exploded view of a drug delivery device 2 according to the present disclosure, comprising a first body portion 4 having a first end 6 and a second end 8, and a second body portion 10 having a first end 12 and a second end 14. When assembled, first body portion 4 is rotatably connected to second body portion 10, with first end 6 of the first body portion abutting first end 12 of the second body portion upon connection.

[0173] Drug delivery device 2 further includes an actuation mechanism 16 that includes a resilient portion 16A, which in this example is in the form of a helical torsion spring. A first portion 18 of resilient portion 16A (a first end of the helical torsion spring) is located at an outer periphery 22 of the helical torsion spring, and a second portion 20 of resilient portion 16A (a second end of the helical torsion spring) is located at a central portion 24 of the helical torsion spring.

[0174] The first body portion 4 includes an internal volume 26 adapted to receive the resilient portion 16A, and an inner surface 28 of the internal volume 26 includes one or more first engagement portions 30 configured to engage with the first portion 18 of the resilient portion 16A, the first engagement portions capable of maintaining the position of the first portion during rotational movement of the first body portion 4 and the second body portion 10 relative to one another. The second portion 20 of the resilient portion 16A is configured to engage with a second engagement portion 32 (see FIG. 2 ) located centrally on the second body portion 10. As seen in FIG. 2 , the second engagement portion 32 is configured to extend into the central portion 24 of the spring when the spring is positioned inside the internal volume 26 of the first body portion 4. The second engagement portion 32 has a slit or groove 34 adapted to engage with the second portion 20 of the elastic portion 16A so that when the first portion 18 is engaged with the first engagement portion 30, rotational movement of the first body portion 4 and / or the second body portion 10 can wind up the elastic portion 16A.

[0175] The drug delivery device 2 has a central axis A that extends in a direction from the second end 8 of the first body portion 4 (the first end of the drug delivery device) toward the second end 14 of the second body portion (the second end of the drug delivery device). The central axis A can be viewed as defining the primary axis about which the first body portion 4 and the second body portion 10 rotate.

[0176] The first engaging portion 30 and the first portion 18 of the elastic portion 16A may spring up so that the first end releases the first engaging portion 30 and engages the next engaging portion 30' when the load in the spring exceeds a predetermined height. This means that the drug delivery device may have a torque limiter, and the torque limiter is an elastic Part 16A ensure that the energy stored inside does not exceed a predetermined limit.

[0177] The drug delivery device 2 includes a first fastening portion 36 having a first proximal end 38 and a first distal end 40. The first fastening portion 36 includes a straight first needle 37 and is fixedly attached to the first body portion 4. The first fastening portion 36 extends from an outer surface 42 of the first body portion 4 in a direction away from the outer surface 42 along a first fastening axis (see FIG. 2 ). The first distal end 40 of the first fastening portion 36 may be a sharp tip to enable penetration of biological tissue, and may be elastic. portion The rotational force provided by 16A may be used to penetrate body tissue (see also FIG. 7).

[0178] The drug delivery device 2 includes a second fastening portion 44 having a second proximal end 46 and a second distal end 48. The second fastening portion 44 includes a straight second needle 45 and is fixedly attached to the first body portion 4. The second fastening portion 44 extends from an outer surface 50 of the second body portion 10 in a direction away from the outer surface 50 along a second fastening axis (see FIG. 2). The second distal end 48 of the second fastening portion 44 may be a sharp tip to enable penetration of biological tissue, and the rotational force provided by the elastic member 16A may be used to penetrate the body tissue (see also FIG. 7).

[0179] The distal ends 40, 48 of the anchors 36, 44 may be sharp tips 52, which may be similar to the sharp tip of a hypodermic needle, capable of penetrating body tissue such as the mucosa of the intestines, stomach, bowels, or other portions of the digestive and / or gastrointestinal system. The needles 37, 45 may be hollow with openings 56 at their distal ends 40, 48, such that an active drug substance can be introduced into the body tissue through the openings 56 after the anchors 36, 44 have penetrated the body tissue, as seen in FIG.

[0180] The elastic force of the elastic portion 16A is used to rotate the first body portion in a first direction B and the second body portion in a second direction C about the central axis A as shown in FIGS. 1 and 2. A11. In other words, the actuation mechanism 16 (elastic portion 16A) is configured to move the first distal end 40 toward the second distal end 48.

[0181] The first body portion 4 has a first primary recess 64 on the outer surface 42, and the second body portion 10 has a second primary recess 66 on the outer surface 50. The first primary recess 64 and the second primary recess 66 are part of a locking mechanism that locks, e.g., prevents rotation, the first body portion 4 relative to the second body portion 10 when the drug delivery device 2 is in the first state by disposing a first locking element within the first primary recess 64 and the second primary recess 66.

[0182] 2 shows a cross-sectional side view of the drug delivery device 2. The first anchor 36 / first needle 37 extends along a first anchoring axis X_1 perpendicular to the central axis A. The second anchor 44 / second needle 45 extends along a second anchoring axis X_2 perpendicular to the central axis A. The first needle 37 optionally includes a first compartment 68 configured to accommodate an active drug substance. The first compartment 68 is optionally formed as a through-hole or cavity in the first needle 37. The second needle 45 optionally includes a second compartment 69 configured to accommodate an active drug substance. The second compartment 69 is optionally formed as a through-hole or cavity in the second needle 45.

[0183] 3 shows the drug delivery device 2 in a first condition. The drug delivery device includes a locking mechanism, represented by a dotted oval 70, that includes a first primary recess 64, a second primary recess 66, and a first locking element 72 disposed in the first primary recess 64 and the second primary recess 66. The first locking element 72 prevents relative rotational movement between the first body portion 4 and the second body portion 10, thereby maintaining a static relationship between the body portions 4, 10. The first locking element 72 may be formed of a degradable material, such as a carbohydrate substance, such that contact with fluids in the gastrointestinal tract results in the degradation of the material of the first locking element 72. When the rotational force applied to the body portions 4, 10 via the elastic member 16A exceeds the static force of the (disassembled) first locking element 72, the first locking element 72 releases the body portions 4, 10, allowing the elastic member 16A to release its stored energy, causing rotation of the first body portion 4 relative to the second body portion 10 in the second state of the drug delivery device.

[0184] 4 shows the drug delivery device 2 in which the first locking element 72 has been degraded or dissolved and the second body portion 10 has been rotated in direction C relative to the first body portion 4. Thus, the second anchor 44, second distal end 48, has been moved from a first condition, second primary position as shown in FIG. 3, to a second secondary position as seen in FIG. 4 via a rotational force (torque) applied to the body portions 4, 10 from inside the interior volume 26. During rotation of the first body portion 4 relative to the second body portion 10, the actuation mechanism moves the first distal end 40 toward the second distal end 48.

[0185] 5 and 6 show the drug delivery device 2 from a side view and an end view in FIG. 4, where the fastening portions 36, 44 can be seen to have passed through axis D, which can be seen, for example, as a plane containing both central axis A and axis D. As the fastening portions 36, 44 pass through the imaginary plane (seen as axis D), the distal ends of the fastening portions and the opposing force applied in direction B in direction C for the first fastening portion 36 and the second fastening portion 44 can ensure that the distal ends can grip a surface area and penetrate or grip the surface of the biological tissue. When the drug delivery device 2 is inside the intestine, for example, the intestine will push the device up against at least one surface area of ​​the biological tissue, so that the force applied to the fastening portions will not push the device away from the surface because the opposing surface will hold the device close to the surface. If the device does not grip in the first instance, the actuation mechanism may have sufficient force for multiple rotations so that when the fastening portions are again close to each other, they will again grip the surface and attempt to secure the drug delivery device against the biological tissue.

[0186] 7 shows the drug delivery device 2 in a second state after being attached to body tissue 74, such as a stomach or intestinal wall. Rotation of the first body portion 4 relative to the second body portion 10 and movement of the first distal end 40 toward the second distal end 48 resulted in the distal ends 40, 48 penetrating the body tissue 74 and being within the body tissue. The remaining elastic force from the actuation mechanism maintains the anchors 36, 44 within the body tissue 74. Thus, the drug delivery device 2 is attached to the body tissue, and the active drug substance can be released from the compartments 68, 69 and / or through the openings 56, for example, to reach the bloodstream via the blood vessels in the body tissue 74.

[0187] FIG. 8 shows an exemplary pharmaceutical composition 100 including a drug delivery device 2, where the drug delivery device 2 is enclosed within a housing 76, optionally made of a dissolvable material. The pharmaceutical composition 100 includes an active drug substance disposed in a first compartment 68 and / or a second compartment 69. The housing 76 can encapsulate the drug delivery device 2 to facilitate easier absorption. A dissolvable housing 76 can dissolve within the gastrointestinal tract, and the drug delivery device 2 cannot be engaged or attached before the housing 76 dissolves. These types of housings are known in the art and are the formation of a drug capsule, the material of which may be, for example, gelatin, similar to hard drug capsule shells known in the art. In one or more exemplary pharmaceutical compositions, the drug delivery device may be coated with a coating.

[0188] FIG. 9 shows an exploded view of an exemplary drug delivery device according to the present disclosure. The drug delivery device 2A has a central axis A and includes a two-part first body portion 4 including a first primary body portion 4A and a first secondary body portion 4B. The drug delivery device 2A includes a first attachment portion 36 including a first base 36A and a first needle 37 attached to the first base 36A. The first attachment portion 36 has a first distal end 40 and is rotatably attached to the first body portion 4 via a first coupling formed by the cylindrical first base 36A and a corresponding cylindrical cavity in the first body portion 4, the first coupling having a first axis of rotation X_R_1. Thus, the first attachment portion 36 is configured to rotate about the first axis of rotation relative to the first body portion 4. The first axis of rotation X_R_1 is parallel to the central axis A.

[0189] Drug delivery device 2A includes a two-part second body portion 10 including a second primary body portion 10A and a second secondary body portion 10B. Drug delivery device 2A includes a second anchor 44 comprising a second base 44A and a second needle 45 attached to second base 44A. Second anchor 44 has a second distal end 48 and is optionally rotatably attached to second body portion 10 via a second coupling formed by cylindrical second base 44A and a corresponding cylindrical cavity in second body portion 10, the second coupling having a second axis of rotation X_R_2. Thus, second anchor 44 is attached to second body portion 10 via a second coupling formed by cylindrical second base 44A and a corresponding cylindrical cavity in second body portion 10, the second coupling having a second axis of rotation X_R_2. 10 The second rotation axis X_R_2 is parallel to the central axis A.

[0190] The drug delivery device 2A comprises a frame body portion 78 formed as an axial member or rod, in which different portions, such as a first body portion and / or a second body portion, are attached to the frame body portion 78, e.g., fixedly or rotatably attached.

[0191] The drug delivery device 2A includes an actuation mechanism 16 having an elastic portion 16A configured to move the first distal end 40 toward the second distal end 48 by rotating the first body portion 4 relative to the second body portion 10.

[0192] 10 , the first engaging portion 36 is configured to rotate about a first rotation axis relative to the first body portion 4 to move the first distal end 40 from a first primary position, e.g., in a first state, to a first secondary radial distance (shown in FIG. 10 ) from the central axis A of the drug delivery device 2A, the first secondary radial distance being greater than the first primary radial distance, e.g., at least 2 mm greater. The first body portion 4 includes a first primary recess 64 that accommodates the first engaging portion 36, or at least a portion thereof, e.g., in the first state. The actuation mechanism 16 is optionally configured to move the first distal end from the first primary position to a first secondary position. In the first secondary position, the first engaging portion 36.

[0193] The first fastener 36 is configured to rotate about a first axis of rotation relative to the first body portion 4 to move the first distal end from a first primary angular position in the first primary position to a first secondary angular position (shown in FIG. 10 ) in the first secondary position relative to the first proximal end of the first fastener. In the illustrated drug delivery device 2A, the angle between the first primary angular position and the first secondary angular position is greater than 10°, or even greater than 30°, such as in the range of 35° to 85°. The actuation mechanism 16 is optionally configured to move the first distal end from the first primary angular position to the first secondary angular position.

[0194] The second fastening portion 44 is configured to rotate about a second rotational axis relative to the second body portion 10 to move the second distal end 48 from a second primary position, e.g., in a first state, to a second secondary radial distance (shown in FIG. 10 ) from the central axis A of the drug delivery device 2A, the second primary radial distance being greater than the second primary radial distance, e.g., at least 2 mm greater, from the central axis A. The second body portion 10 includes a second primary recess 66 that accommodates the second fastening portion 44, or at least a portion thereof, e.g., in the first state. The actuation mechanism 16 is optionally configured to move the second distal end from the second primary position to the second secondary position.

[0195] The second fastener 44 is configured to rotate about a second rotational axis relative to the second body portion 10 to move the second distal end from a second primary angular position in the second primary position to a second secondary angular position in the second secondary position (shown in FIG. 10 ) relative to the second proximal end of the second fastener. In the illustrated drug delivery device 2A, the angle between the second primary angular position and the second secondary angular position is greater than 10°, or even greater than 30°, such as in the range of 35° to 85°. The actuation mechanism 16 is optionally configured to move the second distal end from the second primary angular position to the second secondary angular position.

[0196] 11A-11D show schematic diagrams of drug delivery devices 2, 2A, 2B, and 2C, in which the first and second engaging portions 36 and 44 are in different positions in a second state of the drug delivery device. The first engaging portion 36 has a first engaging axis X_1, and the second engaging portion 44 has a second engaging axis X_2. When the first and second engaging portions 36 and 44 contact a plane containing the central axis A and the planar axis D, the angle α between the first and second engaging axes X_1 and X_2 may be in the range of 5° to 75°, for example, in the range of 20° to 60°. The magnitude of the angle may increase or decrease with the distance between the central axis and the engaging axes X_1 and X_2, or when the length of the engaging portions 36 and 44 is changed. However, angle α ensures that in the transition from the position seen in FIG. 11A to the position seen in FIG. 11C, the biological tissue can be sandwiched between the two fasteners 36, 44, and if the fasteners penetrate, increased rotation toward the position shown in FIG. 11D uses elastic forces to pull the drug delivery device 2 closer to the tissue surface where it can be captured by the fasteners.

[0197] 12 shows an exemplary drug delivery device 2B in a first state, and FIG. 13 shows the drug delivery device 2B in a second state. In the first state, a first anchoring portion 36 having a first needle 37 is optionally disposed inside the first body portion 4 and / or a first distal end is optionally disposed at a first primary position having a first primary radial distance relative to the central axis. The first primary radial distance may be less than 10 mm, e.g., less than 8 mm, or even less than 5 mm. In the first state, a first distal end 40 is optionally disposed inside the first body portion 4.

[0198] In the first state, the second fastener 44 with the second needle 45 is optionally located inside the second body portion 10 and / or the second distal end is optionally located at a second primary position having a second primary radial distance relative to the central axis. The second primary radial distance may be less than 10 mm, such as less than 8 mm, or even less than 5 mm. In the first state, the second distal end 48 is optionally located inside the second body portion 10. Locating the fastener / distal end inside the body portion facilitates or enables smooth oral administration.

[0199] In the second state, the first distal end 40 is ejected from the first body portion 4 through the first opening 80 in the first body portion 4 such that the first distal end 40 is in a first secondary position having a first secondary radial distance relative to the central axis. The first secondary radial distance is greater than the first primary radial distance, and may be greater than 5 mm, for example greater than 6 mm, or greater than 8 mm.

[0200] In the second state, the second distal end 48 exits the second body portion 10 through a second opening 82 in the second body portion 10 at a second secondary position having a second secondary radial distance relative to the central axis. The second secondary radial distance is greater than the second primary radial distance and may be greater than 5 mm, e.g., greater than 6 mm, or greater than 8 mm. In the second state of the drug delivery device 2B as shown in FIG. 13 , an actuation mechanism (not shown) rotates the first body portion 4 relative to the second body portion 10, and optionally relative to the rim body portion 78, about the central axis A to move the first distal end 40 toward the second distal end 48. The actuation mechanism may be configured to rotate the second body portion 10 relative to the rim body portion 78 about the central axis A.

[0201] FIG. 14 illustrates an exemplary drug delivery device 2C in a first state, and FIG. 15 illustrates the drug delivery device 2C in a second state. In the first state, the first fastening portion 36 having the first needle 37 is disposed within the first primary recess 64 and the second primary recess 66 and is locked by the first locking element 72. Thus, the first fastening portion 36 and the first locking element 72 prevent rotation of the first and second body portions. The second fastening portion 44 is similarly disposed within the first secondary recess of the opposite first body portion and the second secondary recess of the opposite second body portion and is locked by the second locking element. In the first state, the first fastening axis of the first fastening portion 36 is substantially parallel to the central axis, and the second fastening axis of the second fastening portion is substantially parallel to the central axis.

[0202] The first locking element 72 dissolves in the gastrointestinal tract, and the first distal end 40 moves from its first primary position in a first state (FIG. 14) to a first secondary position in a second state (FIG. 15) by rotation about a first axis of rotation X_R_1 perpendicular to the central axis A.

[0203] Similarly, the second locking element dissolves in the gastrointestinal tract and the second distal end 48 moves from its second primary position in the first state (FIG. 14) to a second secondary position in the second state (FIG. 15) by rotation about a second axis of rotation (not shown) perpendicular to the central axis A.

[0204] The angle between the first primary direction in the first state and the first secondary direction in the second state is at least 30°, for example 45° or more. The first secondary direction of the first anchoring portion may be perpendicular or substantially perpendicular to the central axis.

[0205] The angle between the second primary direction in the first state and the second secondary direction in the second state is at least 30°, for example, 45° or more. The second secondary direction of the second anchoring portion can be perpendicular or substantially perpendicular to the central axis A. In the second state, the actuation mechanism rotates the first body portion 4 relative to the second body portion 10, thereby moving the first distal end 40 toward the second distal end 48, thereby reducing the angle between the first secondary direction and the second secondary direction.

[0206] In the first control state, the first anchoring portion 36 having the first needle 37 is positioned with its distal end at a first primary position having a first primary radial distance relative to the central axis, which may be less than 10 mm, such as in the range of 3 mm to 8 mm.

[0207] In the first state, the second anchoring portion 44 having the second needle 45 is positioned with its second distal end at a second primary position having a second primary radial distance relative to the central axis, which may be less than 10 mm, such as in the range of 3 mm to 8 mm.

[0208] In the second state, the anchoring portions 36, 44 are deployed from the body portions 4, 10 such that the distal ends 40, 48 are in a first secondary position having a first secondary radial distance relative to the central axis and a second secondary position having a second secondary radial distance relative to the central axis. The first secondary radial distance is greater than the first primary radial distance, and may be greater than 5 mm, such as greater than 6 mm or greater than 8 mm. The second secondary radial distance is greater than the second primary radial distance, and may be greater than 5 mm, such as greater than 6 mm or greater than 8 mm.

[0209] In a second state of the drug delivery device 2C as shown in FIG. 15, an actuation mechanism (not shown) rotates the first body portion 4 relative to the second body portion 10 about the central axis A to move the first distal end 40 toward the second distal end 48.

[0210] Figure 16 illustrates an exemplary drug delivery device 2D, and Figure 17 illustrates an exploded view of the exemplary drug delivery device 2D. The drug delivery device 2D can include any and / or all of the features described above with respect to Figures 1-15, unless otherwise noted.

[0211] As shown, the drug delivery device 2D can include a first body recess 108 configured to allow rotation of the first fastener 104. Additionally, the drug delivery device 2D can include a second body recess (not shown) configured to allow rotation of the second fastener 106. Both the first fastener 104 and the second fastener 106 can include a linkage 116, thereby forming a bent needle or spike, which can allow for easier penetration of tissue.

[0212] In addition, as shown, drug delivery device2D may include a first locking band 102. The first locking band 102 may prevent rotation of the first body portion 4 relative to the second body portion 10. The first locking band 102 may be used in place of the locking element 72. Alternatively, the first locking band 102 may function as a first cover band 103 and may be used in conjunction with the locking element 72. Specifically, the first locking band 102 may include a plurality of locking protrusions 112. The locking protrusions 112 may be used to lock the drug delivery device 102. device The first locking band 112 can be fitted into the 2D fitting portion 114. When fitted, the locking protrusion 112 prevents the first body portion 4 and the second body portion 10 from rotating. 102 can be dissolved to allow rotation.

[0213] Embodiments of the drug delivery devices disclosed herein were used in animal studies to achieve the following experimental results. These experimental results demonstrate the success of one or more exemplary drug delivery devices in practical use. Successful "hooking" (e.g., retention) in the experimental results can be defined as attachment for at least four hours.

[0214] FIG. 18 shows an x-ray image of a drug delivery device having a hook (eg, an anchor, a connection) through one or more of the first or second anchors.

[0215] 19B shows an X-ray image and further data regarding an embodiment of the disclosed drug delivery device having a biodegradable anchor. As shown, the first or second anchor degrades in each of the tested animals, allowing recovery of the drug delivery device. Furthermore, as disclosed, the drug delivery device can be placed in the body for more than 24 or 48 hours. All testing of the drug delivery device was placed in the tissue of the tested animals.

[0216] 20 shows additional x-ray images and data relating to embodiments of the disclosed drug delivery devices having non-biodegradable anchors. This data provides further evidence of the success of the drug delivery devices when attached for at least 24 or 48 hours. All but one of the drug delivery devices tested was attached within the tissue of an animal.

[0217] FIG. 21 summarizes data achieved using an embodiment of the disclosed drug delivery device.

[0218] 22 illustrates a hooking study of an embodiment of the disclosed drug delivery device. As shown, all devices were confirmed to hook into the tissue of the animals tested. Furthermore, the devices remained attached within the tissue for at least 5 hours and 30 minutes.

[0219] Figure 23 shows pharmacodynamic data utilizing at least one of the drug delivery devices described above. As shown, the data demonstrates a drop in blood glucose after administration of 4 international units of insulin. Thus, Figure 23 shows the change in blood glucose levels upon delivery of an active drug substance, such as insulin.

[0220] Also disclosed are delivery devices, methods, and compositions according to any of the following items:

[0221] Item 1. 1. A drug delivery device having a central axis, The drug delivery device comprises: a first body portion; a first fastener attached to the first body portion and having a first distal end; a second fastening portion having a second distal end; an actuation mechanism configured to move the first distal end toward the second distal end.

[0222] Item 2. 2. The drug delivery device of claim 1, wherein the drug delivery device comprises a second body portion, the second attachment portion is attached to the second body portion, and the actuation mechanism is configured to rotate the first body portion relative to the second body portion about a main axis of the drug delivery device.

[0223] Item 3. Item 3. The drug delivery device of item 2, wherein the actuation mechanism comprises a resilient portion configured to apply a force to the first body portion and / or the second body portion.

[0224] Item 4. 4. The drug delivery device of claim 3, wherein a first portion of the elastic portion is connected to the first body portion and a second portion of the elastic portion is connected to the second body portion.

[0225] Item 5. 5. The drug delivery device according to any one of items 1 to 4, wherein the first engagement portion extends in a direction away from the first body portion.

[0226] Item 6. 6. The drug delivery device according to any one of items 1 to 5, which is dependent on item 2, wherein the second engaging portion extends in a direction away from the second body portion.

[0227] Item 7. 7. The drug delivery device according to any one of items 1 to 6, which is dependent on item 2, wherein the first engagement portion has a first engagement axis, and the distance between the first engagement axis and the main axis is greater than 0.5 mm.

[0228] Item 8. 8. The drug delivery device according to any one of items 1 to 7, which is dependent on item 2, wherein the second engagement portion has a second engagement axis, and the distance between the second engagement axis and the main axis is greater than 0.5 mm.

[0229] Item 9. 9. The drug delivery device of any one of items 1 to 8, dependent on item 2, wherein the first body portion is configured to rotate in a first direction and the second body portion is configured to rotate in a second direction opposite to the first direction.

[0230] Item 10. 10. The drug delivery device according to any one of items 1 to 9, wherein the first distal end of the first engagement portion and / or the second distal end of the second engagement portion comprises a tip configured to penetrate biological tissue.

[0231] Item 11. 11. The drug delivery device according to any one of items 1 to 10, wherein the first distal end of the first engagement portion and / or the second distal end of the second engagement portion comprises a gripping portion configured to grip biological tissue.

[0232] Item 12. 12. The drug delivery device of any one of items 1 to 11, wherein the drug delivery device comprises a first compartment, and the drug delivery device is configured to deliver an active drug substance from the first compartment to a surrounding area of ​​the drug delivery device.

[0233] Item 13. 13. The drug delivery device of any one of items 1 to 12, dependent on item 2, wherein the first and second attachment portions form an angle when the first and second distal ends are in a plane containing the major axis.

[0234] Item 14. 14. The drug delivery device according to any one of items 1 to 13, which is dependent on item 2, wherein the drug delivery device has a first state in which the first body portion and the second body portion are rotationally stationary relative to each other, and a second state in which the first body portion and the second body portion are rotationally movable relative to each other.

[0235] Item 15. 15. The drug delivery device of any one of claims 1 to 14, dependent on claim 3, wherein the drug delivery device has a first state in which the elastic portion has a constant elastic force load and a second state in which the elastic portion at least partially releases the elastic force load.

[0236] Item 16. 16. The drug delivery device of any one of items 1 to 15, wherein the actuation mechanism is configured to move the first distal end from a first primary position having a first primary radial distance from the central axis of the delivery device to a first secondary position having a first secondary radial distance from the central axis, the first secondary radial distance being greater than the first primary radial distance.

[0237] Item 17. 17. The drug delivery device of any one of items 1 to 16, wherein the actuation mechanism is configured to move the first distal end relative to the first proximal end of the first engagement portion from a first primary angular position of a first primary position to a first secondary angular position of a first secondary position, and an angle between the first primary angular position and the first secondary angular position is greater than 10°.

[0238] Item 18. 18. The drug delivery device of any one of claims 1 to 17, wherein the drug delivery device comprises a locking mechanism configured to lock the first body portion relative to the second body portion in a first state of the drug delivery device.

[0239] Item 19. Item 19. The drug delivery device of item 18, wherein the locking mechanism is configured to lock the first anchor in a first primary position when the drug delivery device is in the first state.

[0240] Item 20. 19. The drug delivery device of claim 1, wherein the first attachment portion is rotatably attached to the first body portion and configured to rotate about a first axis of rotation that is perpendicular to or parallel to the main axis.

[0241] Item 21. 21. The drug delivery device according to any one of items 1 to 20, dependent on item 2, wherein the second attachment portion is rotatably attached to the second body portion and configured to rotate about a second axis of rotation that is perpendicular to or parallel to the main axis.

[0242] Item 22. 21. A pharmaceutical composition comprising a drug delivery device according to any one of items 1 to 20 and an active drug substance.

[0243] The use of terms such as "first," "second," "third," and "fourth," "primary," "secondary," "tertiary," etc. does not imply a particular order, but is included to identify particular elements. Furthermore, the use of terms such as "first," "second," "third," and "fourth," "primary," "secondary," "tertiary," etc. does not denote any order or importance, but rather, the terms "first," "second," "third," and "fourth," "primary," "secondary," "tertiary," etc., refer to the placement of one element relative to another. Note that the terms "first," "second," "third," and "fourth," "primary," "secondary," "tertiary," etc., are used here and elsewhere for labeling purposes only and are not intended to denote a particular spatial or temporal ordering.

[0244] Furthermore, the labeling of a first element does not imply the presence of the second element, and vice versa.

[0245] It should be noted that the term "comprising" does not necessarily exclude the presence of other elements or steps than those listed.

[0246] It should be noted that the word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements.

[0247] Furthermore, it should be noted that any reference numerals do not limit the scope of the claims, and that the exemplary embodiments may be implemented at least in part by means of both hardware and software, and that several "means", "units" or "apparatus" may be represented by the same item of hardware.

[0248] While features have been illustrated and described, they are not intended to limit the claimed invention, and it will be understood that various changes and modifications may be made by those skilled in the art without departing from the spirit and scope of the claimed invention. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense. The claimed invention is intended to cover all alternatives, modifications, and equivalents. The present invention has the following aspects (configurations). [Aspect 1] 1. A drug delivery device having a central axis, The drug delivery device comprises: a first body portion; a first fastener attached to the first body portion and having a first distal end; a second fastening portion having a second distal end; an actuation mechanism configured to move the first distal end toward the second distal end; A drug delivery device comprising: [Aspect 2] the drug delivery device comprises a second body portion, the second engaging portion is attached to the second body portion, and the actuation mechanism is configured to rotate the first body portion relative to the second body portion about a major axis of the drug delivery device. 2. The drug delivery device of embodiment 1. [Aspect 3] 3. The drug delivery device of aspect 2, wherein the actuation mechanism comprises a resilient portion configured to apply a force to the first body portion and / or the second body portion. [Aspect 4] 4. The drug delivery device of aspect 3, wherein a first portion of the elastic portion is connected to the first body portion and a second portion of the elastic portion is connected to the second body portion. [Aspect 5] Aspect 5. The drug delivery device of any one of aspects 1 to 4, wherein the first engagement portion extends in a direction away from the first body portion. [Aspect 6] Aspect 6. The drug delivery device of any one of Aspects 1 to 5 dependent on Aspect 2, wherein the second engagement portion extends in a direction away from the second body portion. [Aspect 7] The drug delivery device of any one of Aspects 1 to 6, which is dependent on Aspect 2, wherein the first engagement portion has a first engagement axis, and the distance between the first engagement axis and the main axis is greater than 0.5 mm. [Aspect 8] The drug delivery device of any one of Aspects 1 to 7, which is dependent on Aspect 2, wherein the second engagement portion has a second engagement axis, and the distance between the second engagement axis and the main axis is greater than 0.5 mm. [Aspect 9] 9. The drug delivery device of any one of Aspects 1 to 8, dependent on Aspect 2, wherein the first body portion is configured to rotate in a first direction and the second body portion is configured to rotate in a second direction opposite to the first direction. [Aspect 10] 10. The drug delivery device of any one of aspects 1 to 9, wherein the first distal end of the first engagement portion and / or the second distal end of the second engagement portion comprises a tip configured to penetrate biological tissue. [Aspect 11] 11. The drug delivery device of any one of aspects 1 to 10, wherein the first distal end of the first engagement portion and / or the second distal end of the second engagement portion comprises a gripping portion configured to grip biological tissue. [Aspect 12] 12. The drug delivery device of any one of aspects 1-11, wherein the drug delivery device comprises a first compartment, and the drug delivery device is configured to deliver an active drug substance from the first compartment to a surrounding area of ​​the drug delivery device. [Aspect 13] 13. The drug delivery device of any one of Aspects 1 to 12, dependent on Aspect 2, wherein the first and second attachment portions form an angle when the first and second distal ends are in a plane containing the major axis. [Aspect 14] 14. The drug delivery device of any one of Aspects 1 to 13, dependent on Aspect 2, wherein the drug delivery device has a first state in which the first body portion and the second body portion are rotationally stationary relative to each other, and a second state in which the first body portion and the second body portion are rotationally movable relative to each other. [Aspect 15] 15. The drug delivery device of any one of Aspects 1 to 14, dependent on Aspect 3, wherein the drug delivery device has a first state in which the elastic portion has a constant elastic force load and a second state in which the elastic portion at least partially releases the elastic force load. [Aspect 16] 16. The drug delivery device of any one of aspects 1 to 15, wherein the actuation mechanism is configured to move the first distal end from a first primary position having a first primary radial distance from the central axis of the drug delivery device to a first secondary position having a first secondary radial distance from the central axis, the first secondary radial distance being greater than the first primary radial distance. [Aspect 17] 17. The drug delivery device of any one of aspects 1 to 16, wherein the actuation mechanism is configured to move the first distal end relative to the first proximal end of the first engagement portion from a first primary angular position in a first primary position to a first secondary angular position in a first secondary position, and wherein an angle between the first primary angular position and the first secondary angular position is greater than 10°. [Aspect 18] 18. The drug delivery device of any of aspects 1-17, wherein the drug delivery device comprises a locking mechanism configured to lock the first body portion relative to the second body portion in a first state of the drug delivery device. [Aspect 19] Aspect 19. The drug delivery device of aspect 18, wherein the locking mechanism is configured to lock the first anchor in a first primary position when the drug delivery device is in the first state. [Aspect 20] 19. The drug delivery device of any one of Aspects 1 to 19, dependent on Aspect 2, wherein the first attachment portion is rotatably attached to the first body portion and configured to rotate about a first axis of rotation that is perpendicular or parallel to the main axis. [Aspect 21] 21. The drug delivery device of any one of Aspects 1 to 20, dependent on Aspect 2, wherein the second attachment portion is rotatably attached to the second body portion and configured to rotate about a second axis of rotation that is perpendicular or parallel to the main axis. [Aspect 22] A pharmaceutical composition comprising the drug delivery device of any one of aspects 1 to 20 and an active drug substance. [Explanation of symbols]

[0249] 2,2A,2B,2C,2D Drug delivery device 4 First body part 4A First Primary Body Part 4B First secondary body part 6 First end of first body portion 8 second end of first body portion 10 Second body part 10A Second Primary Body Part 10B Second secondary body portion 12 first end of second body portion 14 second end of second body portion 16 Operating mechanism 16A Elastic part 18 First part of elastic portion 20 Second part of elastic part 22 Circumference of spiral torsion spring 24 Spiral torsion spring center part 26 Internal volume 28 Inner 30 first engagement portion 30' First engagement portion 32 second engagement portion 34 Slit 36 First attachment part 36A First base 37 First Needle 38 first proximal end of first fastening portion 40 first distal end of first fastening portion 42 outer surface of first body portion 44 Second attachment point 45 Second Needle 46 second proximal end of second fastening portion 48 second distal end of second fastening portion 50 outer surface of second body portion 52 Sharp Tip 56 Opening 64 first primary recess of first body portion 66 second primary recess of second body portion 68 First Section 69 Second Section 70 Locking mechanism 72 first locking element 74 Body tissues 76 Case 78 Frame part 80 First opening of first body portion 82 second opening of second body portion 100 Pharmaceutical composition 102 first fastening band 103 The First Cover Band 104 First attachment part 106 Second attachment part 108 first body recess 112 Locking protrusion 114 Fitting part 116 Connection section A Center axis / main axis B Rotation direction C Rotation direction D plane axis X_1 First engaging shaft X_R_1 First rotation axis X_2 Second engaging shaft X_R_2 Second rotation axis α angle

Claims

1. A drug delivery device (2, 2A, 2B, 2C, 2D) for oral administration having a central axis (A), The drug delivery device (2, 2A, 2B, 2C, 2D) comprises: a first body portion (4); a first fastening portion (36) attached to the first body portion (4) and having a first distal end (40) with a tip configured to penetrate biological tissue; a second fastening portion (44) having a second distal end (48); a second body portion (10) to which the second attachment portion (44) is attached; an actuation mechanism (16) configured to move the first distal end (40) toward the second distal end (48), the actuation mechanism (16) configured to rotate the first body portion (4) relative to the second body portion (10) about a major axis of the drug delivery device (2, 2A, 2B, 2C, 2D); A drug delivery device (2, 2A, 2B, 2C, 2D) comprising:

2. 2. The drug delivery device (2, 2A, 2B, 2C, 2D) of claim 1, wherein the actuation mechanism (16) comprises an elastic portion (16A) configured to apply a force to the first body portion (4) and / or the second body portion (10).

3. 3. The drug delivery device (2, 2A, 2B, 2C, 2D) of claim 2, wherein a first portion of the elastic portion (16A) is connected to the first body portion (18) and a second portion of the elastic portion (16A) is connected to the second body portion (10).

4. The drug delivery device (2, 2A, 2B, 2C, 2D) of any one of claims 1 to 3, wherein the first engagement portion (36) extends in a direction away from the first body portion (4).

5. The drug delivery device (2, 2A, 2B, 2C, 2D) of any one of claims 1 to 4, wherein the second engagement portion (44) extends in a direction away from the second body portion (10).

6. 6. The drug delivery device (2, 2A, 2B, 2C, 2D) of claim 1, wherein the first engagement portion (36) has a first engagement axis (X1), and the distance between the first engagement axis (X1) and the main axis is greater than 0.5 mm.

7. 7. The drug delivery device (2, 2A, 2B, 2C, 2D) of any one of claims 1 to 6, wherein the second engagement portion (44) has a second engagement axis (X2), and the distance between the second engagement axis (X2) and the main axis is greater than 0.5 mm.

8. 8. The drug delivery device (2, 2A, 2B, 2C, 2D) of any one of claims 1 to 7, wherein the first body portion (4) is configured to rotate in a first direction and the second body portion (10) is configured to rotate in a second direction opposite to the first direction.

9. A drug delivery device (2, 2A, 2B, 2C, 2D) as described in any one of claims 1 to 8, wherein the second distal end (48) of the second attachment portion (44) has a tip (52) configured to penetrate biological tissue.

10. A drug delivery device (2, 2A, 2B, 2C, 2D) as described in any one of claims 1 to 9, wherein the second distal end (48) of the second attachment portion (44) is provided with a gripping portion configured to grip biological tissue.

11. The drug delivery device (2, 2A, 2B, 2C, 2D) of any one of claims 1 to 10, wherein the drug delivery device (2, 2A, 2B, 2C, 2D) comprises a first compartment (68), and the drug delivery device (2, 2A, 2B, 2C, 2D) is configured to deliver an active drug substance from the first compartment (68) to a surrounding area of ​​the drug delivery device (2, 2A, 2B, 2C, 2D).

12. A drug delivery device (2, 2A, 2B, 2C, 2D) as described in claim 11, wherein the first compartment (68) is disposed in the first attachment portion (36).

13. 13. The drug delivery device (2, 2A, 2B, 2C, 2D) of any one of claims 1 to 12, wherein the actuation mechanism (16) is configured to move the first distal end (40) relative to the first proximal end of the first engagement portion (36) from a first angular position in a first position to a second angular position in a second position, wherein an angle between the first angular position and the second angular position is greater than 10 degrees.

14. 14. The drug delivery device (2, 2A, 2B, 2C, 2D) of any one of claims 1 to 13, wherein the first engaging portion (36) is rotatably mounted to the first body portion (4) and configured to rotate about a first axis of rotation that is perpendicular or parallel to the main axis.

15. A pharmaceutical composition comprising a drug delivery device (2, 2A, 2B, 2C, 2D) according to any one of claims 1 to 14 and an active drug substance.

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