Single attachment part drug delivery device

Abstract

A drug delivery device having a central axis, the drug delivery device comprising a first body portion, a second body portion, an attachment portion, and an actuator mechanism configured to rotate the first body portion relative to the second body portion about the main axis of the drug delivery device, wherein the drug delivery device comprises only a single attachment portion.

Description

[0001] This disclosure relates to a drug delivery device, and more specifically, to a drug delivery device for oral administration. The drug delivery device is advantageously configured for delivering an active pharmaceutical ingredient in the gastrointestinal tract, including the stomach and / or intestines (such as the small intestine and / or large intestine (colon)). Background Technology

[0002] Currently, many active pharmaceutical ingredients, such as those with low permeability and / or low water solubility, are delivered via subcutaneous, intradermal, intramuscular, rectal, vaginal, or intravenous routes. Oral administration may have the broadest patient acceptance, and therefore attempts have been made to deliver active pharmaceutical ingredients with low permeability and / or low water solubility via the preferred oral administration route, but with limited success, particularly due to a lack of stability and limited absorption from the gastrointestinal tract.

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

[0004] Limited gastrointestinal absorption is due to the gastrointestinal wall barrier preventing the absorption of active pharmaceutical ingredients after oral administration. This is because of the low permeability of the active pharmaceutical ingredient (e.g., due to pre-systemic metabolism, size, and / or charge) and / or because of its water solubility.

[0005] Several approaches have been suggested to address these stability and absorption issues, but an effective solution has yet to be found. Summary of the Invention

[0006] Therefore, there is a need for a drug delivery device capable of delivering drug substances for absorption in the gastrointestinal tract. More generally, when drug products are administered orally to patients, there is still a need for drug products and methods that can enhance drug delivery.

[0007] A drug delivery device is disclosed. The drug delivery device has a central axis. The drug delivery device includes a first body portion. The drug delivery device includes a second body portion. The drug delivery device includes an attachment portion. The attachment portion can be attached to the first body portion. The attachment portion may have a distal end. The drug delivery device includes an actuator mechanism. The actuator mechanism can be configured to rotate the first body portion about the central axis of the drug delivery device relative to the second body portion. The drug delivery device includes only a single attachment portion.

[0008] The advantage of this disclosure is that the drug delivery device ensures the stability of the active pharmaceutical ingredient during its passage through the gastrointestinal tract and promotes the effective absorption of the active pharmaceutical ingredient from the gastrointestinal tract after oral administration.

[0009] Furthermore, an advantage of this disclosure is that the drug delivery device provides active attachment of the drug delivery device to the gastric wall (such as the stomach wall and / or intestinal wall).

[0010] Furthermore, this disclosure advantageously provides oral delivery of a low-permeability active pharmaceutical substance into or at the site of gastric tissue.

[0011] Furthermore, this disclosure advantageously reduces the complexity of drug delivery devices while maintaining the effective use of methods such as delivering active pharmaceutical substances. Attached Figure Description

[0012] The above and other features and advantages of the invention will become apparent to those skilled in the art from the following detailed description of exemplary embodiments of the invention with reference to the accompanying drawings, in which:

[0013] Figure 1 An exploded view of an exemplary drug delivery device is shown.

[0014] Figures 2A to 2B A perspective view of an exemplary drug delivery device is shown.

[0015] Figure 3 The encapsulated drug delivery device is shown.

[0016] Figure 4 An exploded view of an exemplary drug delivery device with a rotatable attachment portion is shown.

[0017] Figure 5A A drug delivery device is shown.

[0018] Figure 5B Shown in exploded view Figure 5A The drug delivery device, and

[0019] Figures 6A to 6C Different views of an exemplary drug delivery device are shown. Detailed Implementation

[0020] In the following description, several exemplary embodiments and details are illustrated with reference to the accompanying drawings. It should be noted that the drawings may or may not be drawn to scale, and in all drawings, elements with similar structures or functions are indicated by similar reference numerals. It should also be noted that the drawings are intended only to facilitate the description of the embodiments and functions associated with them. These drawings are not intended as an exhaustive description of the invention or as a limitation on the scope or physical appearance of the invention. Furthermore, the illustrated embodiments do not need to have all the aspects or advantages shown. Aspects or advantages described in connection with a particular embodiment are not necessarily limited to that embodiment and may be practiced in any other embodiment, even if not so shown or so explicitly described.

[0021] A centrally located drug delivery device is disclosed. The drug delivery device includes a first body portion. The drug delivery device includes a second body portion. The drug delivery device includes an attachment portion that can be attached to the first body portion. The attachment portion has a distal end. The drug delivery device includes an actuator mechanism. The actuator mechanism can be configured to rotate the first body portion about a main axis of the drug delivery device relative to the second body portion. The drug delivery device includes only a single attachment portion.

[0022] Drug delivery devices can have sizes and geometries designed to be suitable for oral administration of pharmaceutical compositions.

[0023] The drug delivery device / pharmaceutical composition can be configured to be ingested via the mouth. Therefore, the external dimensions of the drug delivery device / pharmaceutical composition can be small enough for the user to swallow. The drug delivery device can be adapted to deliver the drug substance into the user's body via the digestive system, such that the drug delivery device can travel, for example, from the user's mouth through the esophagus to the stomach. The drug delivery device can further travel from the stomach to the intestines, and optionally can travel into the intestinal tract and exit through the rectum.

[0024] Drug delivery devices can be configured to deliver drugs in any part of a user's digestive system. In one example, a drug delivery device can be configured to deliver a drug substance into the user's stomach. In another example, a drug delivery device can be adapted to initiate drug delivery as the device passes through the stomach and enters the user's intestines. In other words, a drug delivery device can be configured to attach to the stomach wall or the intestinal wall, for example, depending on the desired release site of the active drug substance.

[0025] The attachment portion of a drug delivery device (e.g., a single attachment portion, or attachment only) can be configured to interact with the inner surface membrane of the gastrointestinal tract, allowing the drug delivery device to attach, for example, to the inner surface (mucosa) of the stomach, or alternatively, to the mucosa of the intestine. The attachment portion can be configured to interact with the mucosa, for example, 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, the device allows a drug substance to be delivered into a portion of the digestive system to provide the drug substance to the user's body. The attachment portion can also be configured to interact with the mucosa, for example, to inject a drug substance into the gastrointestinal wall.

[0026] As discussed herein, this attachment portion is considered to be the only attachment portion on the drug delivery device. Therefore, this attachment portion is the only attachment portion on the drug delivery device. This attachment portion is a single attachment portion. The drug delivery device may include this attachment portion but not other attachment portions. The drug delivery device may include only one attachment portion. The drug delivery device may include other features, but only a single attachment portion configured to interact with tissue. The terms "attachment portion" and "single attachment portion" are used interchangeably.

[0027] This disclosure overcomes the difficulties inherent in drug delivery devices using a single attachment portion. As a non-limiting example, the drug delivery device may have modified inertia, such as that attributable to weight, increased friction elements, protrusions, and / or other characteristics between the various parts of the drug delivery device. Furthermore, the attachment portion may possess appropriate force to penetrate tissue solely through a single attachment portion. Additionally, excessive rotation can be limited or reduced in the drug delivery device.

[0028] The drug delivery device has a central axis that optionally extends from a first end to a second end. The drug delivery device can have a length in the range of 3 mm to 35 mm (e.g., the maximum extension along the central axis from the first end to the second end). The drug delivery device can be elongated.

[0029] The drug delivery device may have a width and / or height ranging from 1 mm to 20 mm (e.g., the maximum extent of extension along the width axis and height axis, respectively). The height and width are the maximum extent of extension of the drug delivery device perpendicular to the central axis.

[0030] In one or more exemplary drug delivery devices, at least in an initial or first state prior to actuation of the attachment portion, the dimensions of the drug delivery device may be represented by length (maximum extension along the central axis), width (maximum extension along the width axis perpendicular to the central axis), and height (maximum extension along the height axis perpendicular to both the central and width axes). The height of the drug delivery device may range from 1 mm to 15 mm. The width of the drug delivery device may range from 1 mm to 15 mm.

[0031] In one or more exemplary drug delivery devices, the drug delivery device may be configured to fix the drug delivery portion to deliver a payload or active drug substance to an internal tissue or internal surface for distribution of the active drug substance in a subject via blood vessels.

[0032] Advantageously, the drug delivery device can be attached to and can deliver an active drug substance to a specific location in the patient's intestinal wall. Of course, the delivery device can also be attached to and can deliver the active drug substance to other locations. In one or more exemplary drug delivery devices, a tip, such as a prong, can penetrate the muscularis mucosae. In one or more exemplary drug delivery devices, the drug delivery device, such as a prong, may not penetrate the outer muscularis mucosae. In one or more exemplary drug delivery devices, the prong can be positioned in the submucosa. In one or more exemplary drug delivery devices, the prong can be positioned parallel to the intestinal wall in the submucosa.

[0033] The drug delivery device includes a first body portion. The first body portion may be a two-part body portion, that is, the first body portion may include 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.

[0034] The drug delivery device may optionally include a housing having a first housing portion. The outer surface of the first body portion may form at least a portion of the first housing portion.

[0035] The drug delivery device includes an attachment portion. This attachment portion may include a base and / or a needle (e.g., a tip). The attachment portion has a proximal end and a distal end. Therefore, the drug delivery device may have only one or a single base and needle (e.g., a tip).

[0036] The attachment portion (such as a needle or tip) optionally has an attachment axis or extends along that attachment axis. The tip of the needle forms a distal end. In other words, the distal end is the tip of the needle. The base may be located at or constitute the proximal end of the attachment portion. The needle may have a length in the range of 1 mm to 15 mm (e.g., in the range of 3 mm to 10 mm). Therefore, it can penetrate sufficiently into the internal tissue while reducing the risk of damaging the internal tissue. The distal end of the attachment portion may be provided with a tip configured to penetrate biological tissue. The distal end of the attachment portion may be provided with a clamping portion configured to clamp biological tissue.

[0037] The needle can have a cross-sectional diameter in the range of 0.1 mm to 5 mm (such as in the range of 0.5 mm to 2.0 mm).

[0038] The needle can be straight and / or curved. The needle may include a straight primary segment. The needle may include, for example, a secondary segment located between the primary segment and the distal end, or between the base and the primary segment. The secondary segment may be curved.

[0039] The needle may include two or more straight portions formed at an angle. For example, the needle may have a proximal portion extending from the connection point at a first angle to the drug delivery device and a distal portion extending from the connection point at a second angle to the drug delivery device. The first angle and the second angle may be different. The proximal portion may connect to the distal portion at a junction (e.g., a bend, a connection, a corner) and have a junction angle between the proximal and distal portions. This junction angle may be acute, obtuse, or right. The angle may be, for example, 10 degrees, 20 degrees, 30 degrees, 40 degrees, 50 degrees, 60 degrees, 70 degrees, 80 degrees, 90 degrees, 100 degrees, 120 degrees, 130 degrees, 140 degrees, 150 degrees, 160 degrees, or 170 degrees. This can advantageously allow for different attachment angles when the needle interacts with the inner surface membrane. This can allow for improved attachment of the drug delivery device while helping to reduce or avoid tissue damage. Furthermore, the junction may be flexible. Alternatively, the junction may not be flexible.

[0040] The junction may be located at or approximately at the center of the needle's length. Alternatively, the junction may be located at 40%, 45%, 55%, 60%, or 65% of the needle's length from the proximal end upwards.

[0041] In one or more exemplary attachment portions, the needle may have three, four, or five distinct sections at different angles, each section connected by a joint. In some embodiments, any or all of the distinct sections may be straight or curved. Each joint may be flexible or non-flexible.

[0042] The attachment portion of the drug delivery device can be considered as any type of attachment portion capable of attaching the drug delivery device to biological tissue, such as the stomach wall, intestinal wall, and / or gut wall of a human or animal body. The attachment portion can be adapted to extend in a direction remote from the central axis of the drug delivery device and / or the central axis of the attachment portion. This may mean, for example, at least in the activated state or a second state of the drug delivery device, that the attachment portion can extend in a direction (radial direction) remote from the outer peripheral surface of the first body portion and / or the second body portion, such that the attachment portion extends further in the radial direction than the outer periphery or outer surface of the body portion.

[0043] The attachment portion can be fixedly or rotatably attached to the first body portion.

[0044] 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, that is, the second body portion may include a second primary body portion and a second secondary body portion. An attachment portion may be fixedly or rotatably attached to the second body portion instead of the first body portion. A second primary recess and / or a second secondary recess may be formed in the outer surface of the second body portion.

[0045] Therefore, the attachment portion can be fixedly or rotatably attached to either the first body portion or the second body portion. The attachment portion can also be fixedly or rotatably attached to only one of the first body portion or the second body portion. As mentioned above, the drug delivery device has only a single attachment portion attached to either the first body portion or the second body portion. If the attachment portion is attached to the first body portion, then the second body portion will not have an attachment portion attached. If the attachment portion is attached to the second body portion, then the first body portion will not have an attachment portion attached.

[0046] In one or more exemplary drug delivery devices, an actuator mechanism is configured to rotate a first body portion about a main axis of the drug delivery device relative to a second body portion. The main axis may be parallel to and / or coincide with a central axis.

[0047] In one or more exemplary drug delivery devices, a first body portion is configured to rotate in a first direction and / or a second body portion is configured to rotate in a second direction opposite to the first direction.

[0048] Drug delivery devices may include a frame portion, wherein different portions, such as a first body portion and / or a second body portion, are attached (e.g., fixedly or rotatably attached) to the frame portion. In one or more exemplary drug delivery devices, an actuator mechanism or a portion thereof may be attached to the frame portion. Thus, separate rotation of the first body portion and the second body portion relative to the frame portion can be provided.

[0049] The rotatable connection between the first and second body parts allows the first body part to rotate relative to the second body part, and the two parts do not separate from each other before the attachment portion interacts with internal tissues (such as mucous membranes). This connection can be implemented in several ways. In one example, the first body part has a plug connection and the second body part has a socket connection, wherein the plug and socket configuration allows the first body part to rotate relative to the second body part. A second example could be providing a shaft that can be coaxial with a central axis and / or a main axis, wherein the first and second body parts are configured to receive the shaft, and at a first and a second end of the shaft, stop devices are arranged on each side of the combined first and second body parts to prevent the first and second body parts from sliding along the shaft in the longitudinal direction. This shaft can be integrated into either the first or second body part.

[0050] If a shaft is used, it can be made of any of several different materials. For example, a shaft can be made of metals and / or alloys and / or polymers and / or composites and / or combinations thereof.

[0051] The first body portion and / or the second body portion may be arranged to rotate freely relative to each other, for example, at least in a second state, thereby allowing the attachment portion to rotate. For example, if the attachment portion is located on the first body portion, then the attachment portion can rotate relative to the second body portion. Alternatively, if the attachment portion is located on the second body portion, then the attachment portion can rotate relative to the first body portion.

[0052] Therefore, the attachment portion can be adapted to contact and / or penetrate gastrointestinal tissue. Using an elastic force to rotate the body portions relative to each other can move the attachment portion, allowing it to penetrate the mucosa to secure the drug delivery device in place within the gastrointestinal tract (such as the stomach or intestine). The penetrating force can originate from the actuator mechanism / elastic portion, wherein the elastic portion can be adapted to store elastic force that, when at least partially released, can push the attachment portion toward the tissue. The elastic portion can be, for example, in the form of a spring or spring element, such as a torsion spring or a power spring, wherein the spring can be coiled to store mechanical energy, which can be transferred to the first body portion and / or the second body portion. When the mechanical energy is released, the first body portion can rotate relative to the second body portion, and the mechanical energy can be transferred to the attachment portion via the body portion. The actuator mechanism may include an elastic portion configured to apply force to the first body portion and / or the second body portion.

[0053] In the context of this specification, the term "rotational force" may be considered as torque, moment, torque, 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 from the line of action of the force to the axis of rotation. Rotational force may be considered as a force transmitted from the elastic part to the attachment part of the drug delivery device via the body part.

[0054] The rotational force can be limited to be large enough to penetrate into the gastrointestinal tissue. When the rotational force is applied to both the first body portion and the second body portion, the attachment portion can contact the surface to be attached.

[0055] In one or more exemplary drug delivery devices, the drug delivery device may include one or more resistance features. The one or more resistance features may be configured to change the resistance to movement of at least a portion of the drug delivery device. The one or more resistance features may be located on a first body portion. The one or more resistance features may be located on a second body portion. The one or more resistance features may be located on both the first and second body portions. In one or more exemplary drug delivery devices, the drug delivery device may not include any resistance features. In one or more exemplary drug delivery devices, the first body portion and / or the second body portion may include resistance features.

[0056] In one or more exemplary drug delivery devices, the drag feature may be selected from one or more of the following: a high-friction surface, a feature configured to change moment of inertia, and a feature configured to generate turbulence. The drag feature may include a small tip and / or a micro tip. The drag feature may include a flexible mining tube. The drag feature may include a bioadhesion feature. The drag feature may be a retaining element or a retaining feature.

[0057] For example, a drug delivery device may include a high-friction surface. The friction of this surface may be higher than that of any other surface in the drug delivery device. For example, a high-friction surface may include one or more of the following: protrusions, corrugations, projections, films, blades, fins, and bulges.

[0058] In one or more exemplary drug delivery devices, the resistance feature may be one or more barbs (or points). The one or more barbs may be positioned in opposite directions relative to the attachment portion to prevent movement when a reverse rotation occurs after the first or second body portion has completed its rotation.

[0059] In one or more exemplary drug delivery devices, the resistance feature may include the weight displacement of the drug delivery device.

[0060] In one or more exemplary drug delivery devices, the attachment portion may include features configured to reduce resistance to the attachment portion. For example, the attachment portion may be of a small caliber. Furthermore, the attachment portion may include insertion and / or cutting features. This may be used in conjunction with or in place of resistance features.

[0061] In one or more exemplary drug delivery devices, the inertia of the second body portion may be higher than that of the first body portion. In one or more exemplary drug delivery devices, the inertia of the first body portion may be lower than that of the second body portion.

[0062] For example, the first body portion and / or the second body portion may include protrusions. The protrusions may be configured to push the attachment portion toward the tissue. For example, the weight of the first body portion may be less than the weight of the second body portion. The drug delivery device may have an eccentric weight balance. The first body portion and the second body portion may have different surface areas. The first body portion may have a pin that connects to the second body portion. The drug delivery device may be shaped and / or configured to generate turbulent motion. For example, the drug delivery device may be egg-shaped. The drug delivery device may be shaped like a gyroscope.

[0063] In one or more exemplary drug delivery devices, the weight of the second body portion may be greater than the weight of the first body portion. In one or more exemplary drug delivery devices, the weight of the second body portion may be less than the weight of the first body portion. In one or more exemplary drug delivery devices, the weight of the second body portion may be greater or less than the weight of the first body portion.

[0064] In one or more exemplary drug delivery devices, the density of the second body portion may be higher than the density of the first body portion. In one or more exemplary drug delivery devices, the density of the second body portion may be lower than the density of the first body portion.

[0065] In one or more exemplary drug delivery devices, the density of the drug delivery device may be higher than the density of body tissue. For example, the density of the drug delivery device may be higher than the density of stomach tissue. The density of the drug delivery device may be higher than the density of intestinal tissue (such as one or more of the small intestine and large intestine).

[0066] The density of a drug delivery device can be higher than the density of the fluid held within the gastrointestinal system. This can advantageously allow the drug delivery device to be positioned at the bottom of a given organ, such as adjacent tissues.

[0067] For example, the density of a drug delivery device can be higher than the density of gastric acid (such as gastric acid) in the stomach. The density of a drug delivery device can be higher than the density of fluids and / or liquids retained (such as those held in the stomach). A drug delivery device can have a density that allows it to be located at the bottom of the stomach.

[0068] For example, the density of a drug delivery device can be higher than the density of fluids and / or liquids held (e.g., retained) within the intestine (such as one or more of the small and large intestines). The drug delivery device can have a density that allows it to be located at the bottom of the intestine (such as one or more of the small and large intestines).

[0069] In one or more exemplary drug delivery devices, for example at least in the active state or second state of the drug delivery device and optionally in the initial state of the drug delivery device, the distance between the attachment axis of the attachment portion and the main axis is greater than 0.5 mm.

[0070] In one or more exemplary drug delivery devices, an attachment portion is rotatably attached to a first body portion, for example, via a first joint having a first axis of rotation. In one or more exemplary drug delivery devices, the attachment portion is rotatably attached to the first body portion via a hinge and configured to rotate about a first axis of rotation perpendicular to or parallel to a main axis. In other words, the attachment portion may optionally be configured to rotate about the first axis of rotation, for example, 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°, such as 90° ± 5° or 90°.

[0071] In one or more exemplary drug delivery devices, a first body portion may define a first body recess (e.g., cavity, slot, or aperture) extending to the outer surface of the first body portion. The first body recess may be formed by solid walls on all sides except the open outermost surface. An attachment portion may be rotatably connected within the first body recess along an axis of the first attachment portion. The axis of the first attachment portion may be, for example, a pin (e.g., an arm, a support). The axis of the first attachment portion may be parallel to a central axis and / or a main axis. The axis of the first attachment portion may be angled relative to the central axis and / or the main axis. Therefore, the attachment portion may be configured to rotate within the recess along the axis of the first attachment portion. Furthermore, rotation of the attachment portion may stop at an end surface of the recess.

[0072] The first body recess may extend along a portion of the outer surface of the first body. The first body recess may extend completely along the outer periphery of the first body. 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 outer periphery of the first body. The first body recess may 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 outer periphery of the first body. The recessed portion of the first body may extend around the outer periphery of the first body by less than 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100%.

[0073] 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.

[0074] In one or more exemplary drug delivery devices, a first body recess may extend circumferentially or partially circumferentially around a first body having a central axis as its longitudinal direction. The first body recess may extend perpendicularly to the central axis and / or the main channel (e.g., it may extend along a cross-section of the drug delivery device perpendicular to the central axis and / or the main channel). The first body recess may have any number of shapes. For example, the first body recess may be a portion of a circle, such as a semicircle. The first body recess may be triangular. The first body recess may be fan-shaped. The first body recess may be a curved edge connected by two straight edges. The first body recess may be two curved edges connected to each other by two straight edges.

[0075] Therefore, the attachment portion can rotate on the axis of the first attachment portion to move perpendicular to the central axis and / or the main axis. In some embodiments, the attachment portion can rotate at an angle between the angle perpendicular to the central axis and / or the main axis and the angle parallel to the central axis and / or the main axis.

[0076] In one or more exemplary drug delivery devices, when the first body portion and / or the second body portion rotate relative to each other, the attachment portion can rotate away from its recess (e.g., the first body recess or the second body recess) due to the rotation of the first body portion and / or the second body portion. The first body portion and / or the second body portion then continue to rotate, causing the attachment portion to penetrate the tissue to hold the drug delivery device in place.

[0077] In one or more exemplary drug delivery devices, the attachment portion extends in a direction remote from the first body portion, for example, 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 needle may extend from the outer surface of the first body portion, for example, at least in the activated state of the drug delivery device and optionally in the initial state. In other words, the axis of the first attachment portion may form an angle of at least 45° with the central axis and / or the main axis, for example, at least in the activated state of the drug delivery device and optionally in the initial state of the drug delivery device. The direction of extension of the attachment portion should be understood as the direction along the attachment axis of the attachment portion from the proximal end of the attachment portion / needle portion to the distal end of the attachment portion.

[0078] In a first state of the drug delivery device, the attachment portion may extend along a first primary direction, and in a second state of the drug delivery device, the attachment portion may extend along a first secondary direction. The first primary direction and the first secondary direction may form an angle of at least 30°. The first primary direction may be parallel to 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° with the central axis, such as approximately 90°. The first secondary direction may be perpendicular to the central axis.

[0079] The distal end of the attachment portion can be configured to move from a first primary position in a first state of the drug delivery device or be moved to a first secondary position in a second state.

[0080] In one or more exemplary drug delivery devices, an attachment portion is rotatably attached to a second body portion, rather than a first body portion, for example, via a joint (such as a hinge) having a rotational axis. In other words, the attachment portion may optionally be configured to rotate about a second rotational axis, for example, relative to the second body portion. The second rotational axis may be parallel to the central axis and / or the main axis. The second rotational axis 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°, such as 90° ± 5° or 90°.

[0081] In one or more exemplary drug delivery devices, a second body portion may define a second body recess (e.g., cavity, slot, or aperture) extending to the outer surface of the second body portion. The second body recess may be formed by solid walls on all sides except the open outermost surface. An attachment portion may be rotatably connected within the second body recess along an axis of the second attachment portion. The axis of the second attachment portion may be, for example, a pin (e.g., arm, support). The axis of the second attachment portion may be parallel to a central axis and / or a main axis. The axis of the second attachment portion may be angled relative to the central axis and / or the main axis. Therefore, the attachment portion may be configured to rotate within the recess along the axis of the second attachment portion. Furthermore, rotation of the attachment portion may stop at an end surface of the second body recess.

[0082] The second body recess may extend along a portion of the outer surface of the second body. The second body recess may extend completely along the outer periphery of the second body. 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 outer periphery of the second body. The second body recess may 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 outer periphery of the second body. The second body recess may extend around the outer periphery of the second body by less than 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100%.

[0083] The second 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 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.

[0084] In one or more exemplary drug delivery devices, a second body recess may extend circumferentially or partially circumferentially around a second body having a central axis as its longitudinal direction. The second body recess may extend perpendicularly to the central axis and / or the main channel (e.g., it may extend along a cross-section of the drug delivery device perpendicular to the central axis and / or the main channel). The second body recess may have any number of shapes. For example, the second body recess may be a portion of a circle, such as a semicircle. The second body recess may be triangular. The second body recess may be a sector of a circle. The second body recess may be a curved edge connected by two straight edges. The second body recess may be two curved edges connected to each other by two straight edges.

[0085] Therefore, the attachment portion can rotate on the axis of the second attachment portion to move perpendicular to the central axis and / or the main axis. In some embodiments, the attachment portion can rotate at an angle between the angle perpendicular to the central axis and / or the main axis and the angle parallel to the central axis and / or the main axis.

[0086] In one or more exemplary drug delivery systems, a first body portion may have a first body recess, while a second body portion may not have a second body recess. The body portion having a particular recess may depend on which body portion includes the attachment portion. For example, if the attachment portion is located on the first body portion, the first body portion may have a first body recess, while the second body portion may not have a second body recess. Alternatively, if the attachment portion is located on the second body portion, the second body portion may have a second body recess, while the first body portion may not have a first body recess.

[0087] In one or more exemplary drug delivery devices, when the first body portion and / or the second body portion rotate relative to each other, the attachment portion can rotate away from its respective recess (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. The first body portion and / or the second body portion then continue to rotate, such that the attachment portion penetrates the tissue to hold the drug delivery device in place.

[0088] In one or more exemplary drug delivery devices, the attachment portion extends, for example, at least in the activated state of the drug delivery device and optionally in the initial state of the drug delivery device, in a direction optionally away from the second body portion. In other words, the needle may extend from the outer surface of the second body portion, for example, at least in the activated state of the drug delivery device and optionally in the initial state. In other words, the second attachment axis may form an angle of at least 45° with the central axis and / or the main axis, for example, at least in the activated state of the drug delivery device and optionally in the initial state of the drug delivery device.

[0089] In a first state of the drug delivery device, the attachment portion may extend along a second primary direction, and in a second state of the drug delivery device, the attachment portion may extend along a second-secondary direction. The second primary direction and the second-secondary direction may form an angle of at least 30°. The second primary direction may be parallel to 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° with the central axis, such as approximately 90°. The second-secondary direction may be perpendicular to the central axis.

[0090] The distal end of the attachment portion can be configured to move from a second primary position in the first state of the drug delivery device or be moved to a second secondary position in the second state.

[0091] The drug delivery device includes an actuator mechanism. This actuator mechanism is configured to move an attachment portion relative to a second body portion or a first body portion, for example, at least during a portion of rotation (such as in a first rotation and optionally in a second rotation). In one or more exemplary drug delivery devices, the actuator mechanism is configured to move a distal end, for example, in a second state of the drug delivery device by rotating the first body portion relative to the second body portion, and vice versa. The actuator mechanism may be configured to rotate the first body portion about a main axis relative to the second body portion by at least 90°, such as at least 450°, at least 810°, at least 1170°, at least 1530°, or even at least 1890°. The actuator mechanism may be configured to rotate the first body portion about the main axis relative to the second body portion in a stepwise manner. In other words, rotating the first body portion about the main axis relative to the second body portion may include multiple rotations, such as a first rotation followed by a second rotation, for example, a first rotation followed by a first period of time with reduced or no rotation, and then a second rotation. A second rotation following the first rotation, after the first time interval, increases the likelihood of the drug delivery device attaching to biological tissue. The first time interval, or typically the time interval between multiple rotations, allows the drug delivery device to move to other locations within the gastrointestinal tract. In other words, if the drug delivery device does not attach to 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 may include a third rotation. The third rotation can be at least 180°.

[0092] The actuator mechanism may optionally include a resilient portion (such as a spring element) configured to apply force to a first body portion and / or a second body portion. The resilient portion may include a first portion, such as a first end, connected to the first body portion. The resilient portion may also include a second portion, such as a second end, connected to the second body portion.

[0093] In one or more exemplary drug delivery devices, the actuator mechanism optionally includes an expansion medium, i.e., a medium that increases its volume upon contact with a fluid, for example, to provide rotation of the portions relative to each other. In one or more exemplary drug delivery devices, the expansion medium provides rotation of the attachment portion relative to a first body portion or provides rotation of the attachment portion relative to a second body portion. In one or more exemplary drug delivery devices, the expansion medium provides rotation of the first body portion relative to a second body portion.

[0094] The actuator mechanism (such as the elastic portion) can be configured to rotate the attachment portion about a first axis of rotation relative to the first body portion.

[0095] The actuator mechanism (such as the elastic portion) can be configured to cause the attachment portion to rotate about a second rotation axis relative to the second body portion.

[0096] In one or more exemplary drug delivery devices, the drug delivery device includes a first compartment, configured to deliver an active pharmaceutical ingredient from the first compartment to the surrounding environment of the drug delivery device. The first compartment may be disposed in an attachment portion (such as a first needle), for example within a distance of 8 mm (such as 5 mm) from a first distal end. The attachment portion (such as the first needle) may have one or more openings that provide 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.

[0097] The first compartment can be arranged in any part of the drug delivery device, such as in the form of a cavity within the volume of a first body portion, a second body portion, or both the first and second body portions. Alternatively, the first compartment can be a compartment located within an attachment portion, wherein the attachment portion penetrates into biological tissue to release the drug substance in the first compartment into the biological tissue. Alternatively, the first compartment can be a compartment located on the outer surface of the first and / or second body portions in the form of a recess, opening, point, or hollow point, wherein the drug delivery device is adapted to release the drug substance within a body organ through which the drug delivery device is adapted to pass.

[0098] In one or more exemplary drug delivery devices, a first compartment may open from an internal volume portion of the drug delivery device toward an external portion. In one or more instances, the first compartment may be located within a first body portion, and wherein the first compartment is fluidly connected to an attachment portion such that when the distal end of the attachment portion penetrates biological tissue, a drug substance may be released from the first compartment and enter the biological tissue via the attachment portion. This may be, for example, a case where the attachment portion is a tubular portion having a distal end in fluid communication with the first compartment of the drug delivery device.

[0099] In one or more exemplary drug delivery devices, the drug delivery device includes a second compartment configured to deliver an active pharmaceutical ingredient from the second compartment to the surrounding environment of the drug delivery device. The second compartment may be disposed in an attachment portion (such as a needle), for example, within a distance of 8 mm (e.g., within 5 mm) from a distal end. The attachment portion (such as a 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 needle.

[0100] In one or more exemplary drug delivery devices, rotational forces of the first body portion and the second body portion can force an active pharmaceutical ingredient out of the drug delivery device, such as out of the first compartment or the second compartment. For example, rotational forces can discharge (e.g., expel, release, eject) the active pharmaceutical ingredient from the drug delivery device, such as out of the first compartment or the second compartment. This force can come from a force independent of rotation.

[0101] The drug delivery device may have a first compartment or a second compartment. For example, if the attachment portion is attached to a first body portion, the drug delivery device may have a first compartment instead of a second compartment. For example, if the attachment portion is attached to a second body portion, the drug delivery device may have a second compartment instead of a first compartment.

[0102] 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 a first body portion and a second body portion do not rotate relative to each other; and a second state, also referred to as an activated state, in which the first body portion and the second body portion are rotatable relative to each other, for example, they can rotate about the main axis of the drug delivery device. In other words, the first body portion can be locked relative to the second body portion, for example, preventing the first body portion from rotating relative to the second body portion. 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 the body, and in which 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, wherein the energy level in the elastic portion remains unchanged when the body portion is stationary.

[0103] In one or more exemplary drug delivery devices, the drug delivery device may have a first state and a second state, in which a first body portion and a second body portion do not rotate relative to each other, and in which the first body portion and the second body portion can rotate relative to each other.

[0104] In one or more exemplary drug delivery devices, the drug delivery device has a first state and a second state, in the first state, an elastic portion having a constant elastic force load, and in the second state, the elastic portion at least partially releasing the elastic force load. In other words, the elastic portion can be biased or preloaded in the first state of drug delivery, and when released, for example, by a release locking mechanism (i.e., when the drug delivery device is in the second state), the force from the elastic portion can affect the rotation of the first body portion relative to the second body portion, i.e., including movement of the first distal end toward the second distal end.

[0105] In one or more exemplary drug delivery devices, an actuator mechanism is configured to move the distal end from a primary position, for example, having a first-order radial distance from the central axis of the delivery device in a first state of the drug delivery device, to a secondary position, for example, having a second-order radial distance from the central axis and / or main axis in a second state of the drug delivery device, wherein the secondary radial distance is greater than the primary radial distance. Therefore, when the drug delivery device is in the first state, the distal end of the attachment portion can be in the primary position, and / or when the drug delivery device is in the second state, the distal end of the attachment portion can be in the secondary position.

[0106] The primary radial distance can be less than 10 mm, such as less than 8 mm or even less than 5 mm. The secondary radial distance can be greater than the primary radial distance. The secondary radial distance can be greater than 5 mm, such as greater than 6 mm or greater than 8 mm. In one or more exemplary drug delivery devices, the secondary radial distance is in the range of 6 mm to 15 mm.

[0107] In one or more exemplary drug delivery devices, an attachment portion (such as a portion and / or distal end of a needle) may be disposed, or at least partially disposed, within a first body recess of a first body portion in a first state. In the first state, the distal end may be disposed inside the first body portion.

[0108] In one or more exemplary drug delivery devices, the attachment portion (such as a portion and / or distal end of a needle) may be arranged, or at least partially arranged, outside the first body recess of the first body portion in a second state.

[0109] In one or more exemplary drug delivery devices, an attachment portion (such as a portion and / or distal end of a needle) may be disposed within a second body recess of a second body portion in a first state. Therefore, the attachment portion may be configured to lock the first body portion relative to the second body portion in the first state of the drug delivery device.

[0110] In one or more exemplary drug delivery devices, the attachment portion (such as a portion and / or distal end of a needle) may be arranged outside the second body portion and / or at least outside the second body recess of the second body portion in a second state.

[0111] In one or more exemplary drug delivery devices, an actuator mechanism is configured to move a distal end relative to the proximal end of the attachment portion from a primary angular position to a secondary angular position relative to the proximal end of the attachment portion, for example, by rotating it about a first axis of rotation of the attachment portion (base portion). The angle between the primary angular position and the secondary angular position may be greater than 10°, such as greater than 45° or greater than 60°.

[0112] In one or more exemplary drug delivery devices, the drug delivery device includes a locking mechanism. The locking mechanism may be configured to lock a first body portion relative to a second body portion in a first state of the drug delivery device, for example, preventing the first body portion from rotating relative to the second body portion. The locking mechanism may be configured to lock an attachment portion, for example, in a 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 attachment portion may be allowed to move from the primary position to a secondary position. The locking mechanism may be configured to allow the first body portion to rotate relative to the second body portion upon release, for example, in a second state of the drug delivery device.

[0113] 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 attachment portion relative to either the first or second body portion. The first locking element may be disposed in a first primary recess of the first body portion and / or a 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 is located at a desired position within the gastrointestinal tract, thereby releasing the first body portion relative to the second body portion and allowing the actuator mechanism to rotate the first body portion relative to the second body portion, thereby moving the distal end and ultimately attaching the drug delivery device to the internal tissue.

[0114] The first locking element may be a first locking band (e.g., a ring, loop, partial ring, partial loop). The circumferential length of the first locking band may be greater than its longitudinal width. For example, the circumferential length may be 2, 3, 4, 5, 6, 7, 8, 9, or 10 times the longitudinal width.

[0115] The first locking band can be fitted onto the outer surface of the drug delivery device. For example, the first locking band can be located on the outer surface of the first body portion or the outer surface of the second body portion. The first locking band can be mechanically fitted onto the drug delivery device. For example, the first locking band can be snap-fitted onto the drug delivery device. The first locking band can be chemically attached to the drug delivery device.

[0116] In one or more exemplary drug delivery devices, the first locking band may be shaped like a portion of a capsule. For example, the first locking band may form a first half of the capsule. The first locking band may form a first half of the capsule, and the second locking band may form a second half of the capsule. When assembled together, the first and second locking bands may form a complete capsule.

[0117] When the first locking band is located on the first body, it can partially or completely cover the recess of the first body. Therefore, when the first locking band is located in the first body portion, it can prevent movement of the attachment portion. When the first locking band is located on the second body, it can partially or completely cover the recess of the second body. Therefore, when the first locking band is located in the second body portion, it can prevent movement of the attachment portion.

[0118] The first locking band may extend completely along the outer periphery 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 outer periphery of the drug delivery device. The first locking band may 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 outer periphery of the drug delivery device. The first locking band may extend around the outer periphery of the drug delivery device by less than 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100%.

[0119] In one or more exemplary drug delivery devices, the first locking band may include one or more locking protrusions (e.g., extensions, tabs, fingers, projections, teeth). For example, the first locking band may include 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 locking protrusions. The locking protrusions may extend longitudinally from only one side of the first locking band. The locking protrusions may extend longitudinally from both sides of the first locking band. The locking protrusions may be equidistantly spaced along the first locking band. The locking protrusions may be unequally spaced along the first locking band.

[0120] One or more locking protrusions may extend toward the longitudinal center of the drug delivery device (e.g., if the first locking band is located on the first body portion, it extends along the outer surface of the body toward the second body portion, or if the first locking band is located on the second body portion, it extends along the outer surface of the body toward the first body portion).

[0121] One or more locking protrusions may be triangular, square, rectangular, circular, or other polygonal shapes. The shape of one or more locking protrusions may vary along the first locking band.

[0122] In one or more exemplary drug delivery devices, the drug delivery device may include a mating feature. The mating feature may be configured to mate with one or more protrusions of a first locking band. The mating feature may include one or more mating protrusions (e.g., extensions, tabs, fingers, projections, teeth) extending radially outward from an outer surface of the drug delivery device. The mating feature may extend from a first body portion, a second body portion, or both. The mating feature may form one or more circumferential rows. For example, there may be one circumferential row of mating features or two circumferential rows of mating features. The two circumferential rows may be located on the same body portion (e.g., the first body portion or the second body portion). In an alternative implementation, one circumferential row of mating features may be located on the first body portion, and the second circumferential row of mating features may be located on the second body portion.

[0123] One or more mating protrusions may be triangular, square, rectangular, circular, or other polygonal in shape. The shape of one or more mating protrusions may vary along the first locking band. One or more mating protrusions may be angled in the circumferential direction to form a mating recess (e.g., a bend, cavity, space, gap). This mating recess can help lock one or more mating protrusions to one or more protrusions of the first locking band. Furthermore, the mating recess can prevent undesirable release of the first locking band. Therefore, when the first locking band is attached to the drug delivery device, one or more locking protrusions can be fitted between one or more mating protrusions. One or more locking protrusions may fit within adjacent mating protrusions. This prevents the first body from rotating relative to the second body. For example, the first body will be prevented from rotating by the first locking band. In some embodiments, the locking protrusions may be located between two mating protrusions, each angled in opposite directions to hold the locking protrusions in place.

[0124] In some implementations, the mating feature may be a recess extending internally into the drug delivery device. The locking protrusion may then extend radially inward rather than longitudinally to mate with the mating feature.

[0125] As discussed above, when the first locking band is attached and one or more protrusions engage with the mating features, the first body portion is locked in place relative to the second body portion. When the first locking band dissolves as discussed herein, the first body portion and the second body portion can be released from the first locking band.

[0126] Furthermore, the dissolution of the first locking band allows the attachment portion to rotate further away from either the first body recess or the second body recess. Therefore, as the first and second bodies rotate relative to each other, the attachment portion can rotate to insert into the tissue.

[0127] In one or more exemplary drug delivery devices, the first locking band may include a plurality of square locking protrusions and a plurality of triangular locking protrusions. The square locking protrusions can be used to hold the cover in place under the force of the engaging protrusions. The triangular locking protrusions can be used to properly position the first locking band.

[0128] In one or more exemplary drug delivery systems, the entire first locking band may be soluble. In one or more exemplary drug delivery systems, only the square locking protrusions may be made of a soluble material. Once the square locking protrusions dissolve, rotation of the first body portion and the second body portion may be permitted. Rotation of the first body portion relative to the second body portion may cause the first locking band to translate, such as move, change position, or reposition. This may occur when the mating protrusions can compress the triangular locking protrusions, thereby pushing them apart longitudinally. For example, rotation may cause the first locking band to translate along a central axis.

[0129] This translation can expose the attachment portion. Translation can completely move the first locking band away from the drug delivery device. Translation can also partially move the first locking band to expose the attachment portion, wherein the first locking band remains associated with, for example, the drug delivery device, or attached to it.

[0130] 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 disposed in a first secondary recess of the first body portion and / or a second secondary recess of the second body portion. The second locking element may be configured to dissolve upon entry of the drug delivery device into the gastrointestinal tract, thereby unlocking or releasing the first body portion relative to the second body portion and allowing an actuator mechanism to rotate the first body portion relative to the second body portion, thereby moving the first distal end toward the second distal end, and thus attaching the drug delivery device to internal tissue.

[0131] One or more exemplary drug delivery devices may include a first cover strip (e.g., a loop, a ring, a partial loop, a partial ring). The first cover strip may 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 strip may be a first locking strip. In one or more exemplary drug delivery devices, the first cover strip may include any or all of the features discussed above in conjunction with the first locking strip. The circumferential length of the first cover strip may be greater than its longitudinal width. For example, the circumferential length may be 2, 3, 4, 5, 6, 7, 8, 9, or 10 times the longitudinal width.

[0132] The first cover strip can be fitted onto the outer surface of the drug delivery device. For example, the first cover strip can be located on the outer surface of the first body portion or the outer surface of the second body portion.

[0133] In one or more exemplary drug delivery devices, the first cover strip may be in the shape of a portion of a capsule. For example, the first cover strip may form a first half of the capsule. The first cover strip may form a first half of the capsule, and the second cover strip may form a second half of the capsule. When assembled together, the first and second cover strips may form a complete capsule.

[0134] The first cover strip can be mechanically attached to the drug delivery device. For example, the first cover strip can be snap-fitted onto the drug delivery device. The first cover strip can also be chemically attached to the drug delivery device.

[0135] When the first covering strip is located on the first body portion, it can partially or completely cover the first body recess. Therefore, when the first covering strip is located on the first body portion, it can prevent movement of the attachment portion. When the first covering strip is located on the second body, it can partially or completely cover the second body recess. Therefore, when the first covering strip is located on the second body portion, it can prevent movement of the attachment portion.

[0136] The first covering strip may extend completely along the outer periphery of the drug delivery device. The first covering strip 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 outer periphery of the drug delivery device. The first covering strip may 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 outer periphery of the drug delivery device. The first covering band may extend around the outer periphery of the drug delivery device by less than 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100%.

[0137] In one or more exemplary drug delivery devices, a first cover may include one or more mating protrusions (e.g., extensions, tabs, fingers, projections, teeth). For example, the first cover may include 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mating protrusions. The mating protrusions may extend longitudinally from only one side of the first cover. The mating protrusions may extend longitudinally from both sides of the first cover. The mating protrusions may be equidistantly spaced along the first cover. The mating protrusions may be unequally spaced along the first cover.

[0138] One or more mating protrusions may extend toward the longitudinal center of the drug delivery device (e.g., if the first cover strip is on the first body portion, it extends along the outer surface of the body toward the second body portion, or if the first cover strip is on the second body portion, it extends along the outer surface of the body toward the first body portion).

[0139] In one or more exemplary drug delivery devices, the drug delivery device may include mating features. The mating features may be configured to mate with one or more mating protrusions of a first cover strip, for example, to receive, hold, or contact the one or more mating protrusions. The mating features may include one or more body mating protrusions (e.g., extensions, tabs, fingers, projections, teeth) extending radially outward from an outer surface of the drug delivery device. The mating features may extend from a first body portion, a second body portion, or both. The mating features may be formed in one or more circumferential rows. For example, there may be one circumferential row of mating features or two circumferential rows of mating features. The two circumferential rows may be located on the same body portion (e.g., the first body portion or the second body portion). In an alternative implementation, one circumferential row of mating features may be located on the first body portion, and the second circumferential row of mating features may be located on the second body portion.

[0140] One or more mating protrusions may be triangular, square, rectangular, circular, or other polygonal shapes. The shape of one or more mating protrusions may vary along the first cover band. One or more mating protrusions may be angled in the circumferential direction to form mating recesses (e.g., bends, cavities, spaces, gaps). The mating recesses may facilitate fitting one or more body mating protrusions to one or more protrusions of the first cover band. Furthermore, the mating recesses may prevent undesirable release of the first cover band.

[0141] Therefore, when the first cover strip is attached to the drug delivery device, one or more mating protrusions can be fitted between one or more mating features. One or more mating protrusions can be fitted within adjacent mating features. This helps to ensure proper alignment of the first cover strip.

[0142] In some implementations, the mating feature may be a recess extending internally into the drug delivery device. The mating protrusion may then extend radially inward rather than longitudinally to mate with the mating feature. In one or more exemplary drug delivery devices, rotation of the first body portion relative to the second body portion can translate the cover strip, such as moving, changing position, or repositioning it. For example, rotation can translate the cover strip along a central axis. This translation can expose the attachment portion. This may occur, for example, when the mating protrusion can compress triangular mating protrusions or other shaped mating protrusions, thereby pushing them longitudinally away. Translation can completely translate the cover strip away from the drug delivery device. Translation can partially translate the cover strip to expose the attachment portion, where the cover strip is associated with, for example, attached to, the drug delivery device.

[0143] In one or more exemplary drug delivery devices, the first cover strip may be soluble. Dissolution of the first cover strip may allow the attachment portion to further rotate away from one of the first and second body recesses. Thus, as the first and second bodies rotate relative to each other, the attachment portion may rotate to insert into tissue. The materials and / or properties of the first and / or second locking elements may be selected such that the release of the body portion and / or activation of drug delivery is controlled to occur at a desired location in the gastrointestinal tract (such as the stomach or intestine). The materials of the first and / or second locking elements may include one or more of sugars, sugar derivatives, hydrophilic polymers, pH-dependent polymers, and pharmaceutically acceptable excipients that disperse, dissolve, swell, and / or gel upon contact with water / fluid.

[0144] In one or more exemplary drug delivery devices, at least a portion of the attachment portion may be made of a biodegradable, absorbable, or similar material, allowing the material of the attachment portion to decompose, degrade, and / or dissolve through processes present in the body, such as corrosion, degradation, hydrolysis, and / or proteolytic enzyme degradation. Thus, after a period of time in the body, the attachment portion may dissolve, decompose, or degrade to the extent that it may lose its structural stability, thereby releasing the drug delivery device from its own attached surface. Therefore, after a period of time, such as after the drug substance has been released from the attachment portion, the attachment portion may degrade to such an extent that the drug delivery device can be released and can continue its journey through the gastrointestinal tract to be released through the user's or patient's natural bowel movements and / or intestinal peristalsis.

[0145] In one or more exemplary drug delivery devices, the drug delivery device may be partially biodegradable. In one or more exemplary drug delivery devices, the drug delivery device may be fully biodegradable. For example, each component of the drug delivery device may be biodegradable. Therefore, the patient does not need to excrete anything after swallowing the drug delivery device. In one or more exemplary drug delivery devices, the drug delivery device is biodegradable. In one or more exemplary drug delivery devices, the drug delivery device may be biodegradable.

[0146] For example, the first body portion, the second body portion, the attachment portion, and the actuator mechanism can all be biodegradable. Furthermore, any connecting parts between them can also be biodegradable.

[0147] In one or more exemplary drug delivery devices, the axis of rotation (main axis) of the first body portion and / or the second body portion may be the central axis of the drug delivery device. For example, the main axis of the first body portion may be coaxial with the central axis. Therefore, the central axis intersects with both the first and second body portions and may define the main axis.

[0148] In one or more exemplary drug delivery devices, a first body portion and a second body portion may be substantially symmetrical in a radial direction perpendicular to a central axis. This may mean that the first body portion and / or the second body portion may have a circular periphery, wherein the periphery may extend in a radial direction away from and perpendicular to the central axis.

[0149] The first attachment axis can be considered as an axis coaxial with the length of the attachment portion. The second attachment axis can also be considered as an axis coaxial with the length of the attachment portion. When the shape of the attachment portion is not straight, the first attachment axis can be defined as an axis intersecting the distal and proximal ends of the attachment portion. Furthermore, the second attachment axis can be defined as an axis intersecting the distal and proximal ends of the attachment portion.

[0150] In one or more exemplary drug delivery devices, a first attachment axis may be located at a first distance from the central axis, while a second attachment axis may be located at a second distance from the central axis and / or the main axis.

[0151] For example, in the first state of the drug delivery device, the first attachment axis may be located at a first-order distance from the central axis. The first-order distance may be greater than 0.5 mm, such as 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.

[0152] In the first state of the drug delivery device, the first attachment axis may intersect with or be close to the central axis (distance less than 0.5 mm).

[0153] In the second state of the drug delivery device, the first attachment axis can be located at a first or second distance from the central axis. The first or second distance can be greater than 0.5 mm, such as 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.

[0154] In the second state of the drug delivery device, the first attachment axis may intersect with or be close to the central axis (within a distance of less than 0.5 mm).

[0155] For example, in the first state of the drug delivery device, the second attachment axis can be located at a second-level distance from the central axis. The second-level distance can be greater than 0.5 mm, such as 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.

[0156] In the first state of the drug delivery device, the second attachment axis can intersect with or be close to the central axis (within a distance of less than 0.5 mm).

[0157] In the second state of the drug delivery device, the second attachment axis can be located at a second or second distance from the central axis. The second or second distance can be greater than 0.5 mm, such as 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.

[0158] In the second state of the drug delivery device, the second attachment axis may intersect with or be close to the central axis (within a distance of less than 0.5 mm).

[0159] In one or more exemplary drug delivery devices, a first body portion may be configured to rotate along a first direction, and a second body portion may be configured to rotate along a second direction, wherein the first direction is opposite to the second direction. Thus, as an example, the first body portion may rotate clockwise, while the second body portion may rotate counterclockwise. In one or more instances where the drug delivery device includes three or more body portions, adjacent or adjacent body portions may rotate in opposite directions. This may also mean that every two 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, then the second body portion and / or the fourth body portion may rotate in a second direction opposite to the first direction.

[0160] In one or more exemplary drug delivery devices, the actuator mechanism may include one or more resilient portions, such as multiple resilient portions.

[0161] In one or more exemplary drug delivery devices, the distal end of the attachment portion may be provided with an end configured to penetrate biological tissue. In another one or more exemplary drug delivery devices, the distal end of the attachment portion may be provided with a pointed end configured to penetrate biological tissue. The pointed end may be located near the distal end of the attachment portion, wherein the pointed end may be configured such that its diameter at the distal end is smaller than the diameter of the attachment portion at a distance from the distal end. The pointed end may be configured such that when a rotational force is applied to the attachment portion, the attachment portion may cause the pointed end to penetrate the biological tissue due to a force applied by an actuator mechanism.

[0162] When the attachment portion penetrates biological tissue due to rotation between the first and second body portions (causing distal movement), the drug substance can be delivered from the drug delivery device into the biological tissue via the penetration point, and the drug substance can be introduced into the biological tissue outside the mucosa. Therefore, compared to the release of the drug substance in the gastric or intestinal lumen, the drug substance may enter the bloodstream more easily, and drug delivery may be more efficient. An example of this is the case of insulin, which may degrade in the gastrointestinal tract and not be absorbed, but after the mucosa is penetrated and insulin is released through the penetrated gastrointestinal wall, the insulin remains intact and reaches the user's bloodstream via blood vessels in the intestinal layer outside the mucosa (surface).

[0163] In one or more exemplary drug delivery devices, the attachment portion may be provided with a clamping portion configured to hold biological tissue. This clamping portion can be used to improve the traction between the attachment portion and the mucosa, thereby allowing the attachment portion to anchor the drug delivery device within the user's body. The clamping portion may be a portion that increases mechanical friction between the attachment portion and the surface to be attached, wherein the clamping portion may have, for example, a hook shape, such that biological tissue located near the attachment portion is held by the portion.

[0164] In one or more exemplary drug delivery devices, a portion of an elastic section may be connected to a first body section, and a second portion of the elastic section may be connected to a second body section. This means that energy (such as rotational energy or rotational force applied to the first and second body sections) can be stored in the elastic section. Furthermore, when the energy is released, for example when the locking element dissolves or degrades, the force can be released to both the first and second body sections, which in turn transfers the force to the attachment portion. The elastic section may be, for example, in the form of a helical spring (main spring) and / or a helical torsion spring, wherein the first body section can be wound relative to the second body section by rotating the first body section relative to the second body section. Energy is stored in the main spring by tightening the helix. The force stored in the main spring can then cause the first body section to rotate in the opposite direction when the main spring unfolds. Thus, the force of the main spring can propel the attachment portion, and the attachment portion can penetrate tissue to attach the drug delivery device to biological tissue.

[0165] After the drug delivery device enters the body and, for example, reaches a desired portion of the gastrointestinal tract, it can be configured to transition from a first state to a second state. This transition can be initiated in various ways, where, for example, the first and second body portions can be held in the first state using a locking mechanism. This locking mechanism, for example, includes one or more locking elements made of a soluble, expandable, or degradable material, which chemically reacts with the surrounding environment (such as a fluid) within the desired body portion, thereby unlocking or releasing the locking mechanism. The material of the locking elements can be one that loses its structural strength upon contact with the surrounding environment within the desired body portion. An example could be a locking element made of a polymeric material or a sugary substance that can dissolve, expand, or degrade when it comes into contact with a fluid within the digestive system that may include enzymes or an acid. When the locking element comes into contact with a reactant, the material can dissolve, expand, or degrade over time, and when the rotational force of the drug delivery device exceeds the static force of the locking element, this rotational force can be released via rotation of the first body portion relative to the second body portion, and vice versa.

[0166] In one or more exemplary drug delivery devices, a locking element can secure the attachment portion in a position where the attachment element 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 degrades, the attachment portion can move to a secondary position in which the attachment portion does not lock the first body portion relative to the second portion, for example, by means of an actuator mechanism that causes the attachment portion to rotate about a rotation axis relative to the body portion to which it is rotatably attached.

[0167] The second state of the drug delivery device can be considered as a state initiated by releasing energy stored in the actuator mechanism (e.g., the elastic portion of the actuator mechanism) as rotational force of the first body portion and / or the second body portion and / or rotational force of the attachment portion relative to the first body portion or the second body portion. The termination of the second state can be considered as the point in time when the energy stored in the elastic portion remains constant again, i.e., when the attachment portion has clamped or penetrated biological tissue and / or the rotational movement between the first body portion and the second body portion ceases.

[0168] In one or more exemplary drug delivery devices, the drug delivery device may have a first state and a second state, in which the actuator mechanism has a constant elastic force load, and in the second state, the actuator mechanism releases the elastic force load. In the first state, the constant elastic force load can be considered as energy stored in the actuator mechanism, and in which the elastic force load is greater than zero. The second state can be considered as a state in which the actuator mechanism releases its elastic force load, in which the elastic force load is reduced, for example, by rotating the first body portion relative to the second body portion, for example, approaching zero. The second state may terminate even if the elastic force load has not yet reached zero, when the attachment portion contacts or penetrates biological tissue and the elastic force load does not change. Therefore, a third state may follow the second state when the drug delivery device has been attached to the wall of the biological material and the elastic force load remains unchanged after the elastic force is released.

[0169] The attachment portion can have an unfolding function, wherein during the first state of the drug delivery device (i.e., the initial state of the drug delivery device), the attachment portion is positioned or arranged inside the first or second body portion, or alternatively, the attachment portion can be folded along the side of the body portion. Other methods are conceivable to achieve the same result. The folded state (first state) can be held in place using a releasable locking mechanism, for example, in the form of a drug substance capsule, band, or plug, made of, for example, gelatin, sugar, or other soluble material or a material that has lost its structural strength. Thus, the attachment portion can be held in place until the drug delivery device enters the gastrointestinal tract (e.g., the stomach), so that the attachment portion does not interfere with or damage the membranes of the mouth and / or esophagus. Before or during transition to the second state, the attachment portion can extend outward from the body portion, so that the attachment portion is ready to interact with the membranes of the digestive system. When the attachment portion is in the folded or retracted position, the distance from the central axis to the distal end of the attachment portion is longer in the second state than in the first state. Therefore, 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.

[0170] In one or more exemplary drug delivery devices, at least a portion of the attachment portion (such as a needle) may be made of a material comprising one or more of magnesium, titanium, iron, and zinc. This allows for precise and accurate control of the size and / or shape / geometry of the attachment portion, thereby allowing the delivery device to have the desired attachment capability and / or small manufacturing variability, which is particularly important in the pharmaceutical industry.

[0171] The attachment portion (such as the needle) may be made of one or more materials comprising magnesium, titanium, iron, and zinc. The material of the attachment portion / needle may be biodegradable and / or biodegradable, such as biodegradable materials and / or biodegradable polymers. The material of the attachment portion / needle may contain one or more biodegradable polymers, such as PLA and / or POLGA. Some, a portion, most, substantially all, or all of the material of the attachment portion / needle may be biodegradable and / or biodegradable. The material of the attachment portion (such as the needle) may contain, include, or substantially include biodegradable and / or biodegradable materials, such as biodegradable and / or biodegradable metals. The material of the attachment portion (such as the needle) may contain biodegradable or bioabsorbable metals or metal alloys (such as magnesium, zinc, and / or iron), or alloys comprising one or more of magnesium, zinc, and iron. Biodegradable or bioabsorbable metals or metal alloys can be understood as metals or metal alloys that safely degrade within, for example, the human body within a practical timeframe relevant to their application. The material of the attachment part (such as the needle) may contain one or more metals, such as a combination of one or more metals (e.g., a metal alloy).

[0172] The advantage of using biodegradable materials in the attachment portion is that the delivery device can deliver the active drug substance or payload disposed in the attachment portion and / or body portion of the delivery device to a specific part of the subject's body (such as the stomach or intestines), for example, after the delivery device has been attached to an inner surface (e.g., the intestinal wall). This is due to the sharp nature of the attachment portion material and its long-term durability, as the biodegradable material will gradually degrade over time. Furthermore, when the attachment portion material is biodegradable, the attachment portion will degrade in the human body and disappear after the payload / active drug substance included in the drug delivery device has been delivered, thus avoiding harm to the human subject over time. The attachment portion can be configured to degrade over time periods of hours (e.g., 2 hours, 5 hours, 10 hours, 20 hours, or 24 hours), days (e.g., 1 day, 2 days, 5 days), or weeks (e.g., 1 week, 2 weeks, 3 weeks, or 5 weeks).

[0173] The material of the attachment portion (such as the needle tip) may contain one or more of magnesium (Mg), zinc (Zn), and / or iron (Fe), or a combination thereof. The advantage of using Mg, Zn, and / or Fe as the material for the attachment portion is that the shape and size of the attachment portion can be precisely controlled, thereby improving attachment to inner surfaces (such as the lining of the intestine in human subjects).

[0174] For example, the material of the attachment part (such as the needle) may contain 0.001 wt% to 100 wt% of biodegradable metals, such as 0.001 wt% to 100 wt% of magnesium, 0.001 wt% to 100 wt% of zinc, and 0.001 wt% to 100 wt% of iron.

[0175] The material of the attachment portion (such as the needle) may, for example, contain 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, 90 wt% Mg, or 100 wt% Mg.

[0176] The material of the attachment portion (such as the needle) may, for example, contain 0.001 wt% Zn, 0.005 wt% Zn, 0.01 wt% Zn, 0.05 wt% Zn, 0.1 wt% Zn, 0.5 wt% Zn, 1 wt% Zn, 5 wt% Zn, 10 wt% Zn, 20 wt% Zn, 30 wt% Zn, 40 wt% Zn, 50 wt% Zn, 60 wt% Zn, 70 wt% Zn, 80 wt% Zn, 90 wt% Zn, or 100 wt% Zn.

[0177] The material of the attachment portion (such as the needle) may, for example, contain 0.001 wt% Fe, 0.005 wt% Fe, 0.01 wt% Fe, 0.05 wt% Fe, 0.1 wt% Fe, 0.5 wt% Fe, 1 wt% Fe, 5 wt% Fe, 10 wt% Fe, 20 wt% Fe, 30 wt% Fe, 40 wt% Fe, 50 wt% Fe, 60 wt% Fe, 70 wt% Fe, 80 wt% Fe, 90 wt% Fe or 100 wt% Fe.

[0178] The material of the attachment part (such as the needle) may comprise a metallic alloy, such as Zn-Mg, Zn-Fe, Mg-Fe, or Zn-Mg-Fe. The material of the attachment part (such as the needle) may, for example, comprise a Zn-Mg alloy having 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.

[0179] The material of the attachment portion (such as the needle) may, for example, contain a Zn-Fe alloy having 0.001 wt% Fe, 0.005 wt% Fe, 0.01 wt% Fe, 0.05 wt% Fe, 0.1 wt% Fe, 0.5 wt% Fe, 1 wt% Fe, 5 wt% Fe, 10 wt% Fe, 20 wt% Fe, 30 wt% Fe, 40 wt% Fe, 50 wt% Fe, 60 wt% Fe, 70 wt% Fe, 80 wt% Fe, or 90 wt% Fe.

[0180] The material of the attachment portion (such as the needle) may, for example, contain a Mg-Fe alloy having 0.001 wt% Fe, 0.005 wt% Fe, 0.01 wt% Fe, 0.05 wt% Fe, 0.1 wt% Fe, 0.5 wt% Fe, 1 wt% Fe, 5 wt% Fe, 10 wt% Fe, 20 wt% Fe, 30 wt% Fe, 40 wt% Fe, 50 wt% Fe, 60 wt% Fe, 70 wt% Fe, 80 wt% Fe, or 90 wt% Fe.

[0181] The material of the attachment portion (such as the needle) may, for example, comprise a Zn-Mg-Fe alloy having 0.001 wt% Fe, 0.005 wt% Fe, 0.01 wt% Fe, 0.05 wt% Fe, 0.1 wt% Fe, 0.5 wt% Fe, 1 wt% Fe, 5 wt% Fe, 10 wt% Fe, 20 wt% Fe, 30 wt% Fe, 40 wt% Fe, 50 wt% Fe, 60 wt% Fe, 70 wt% Fe, 80 wt% Fe, 90 wt% Fe, 0.001 wt% Mg, 0.005 wt% Mg, 0.01 wt% Mg, 0.05 wt% Mg, 0.1 wt% Mg, and 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, 90 wt% Mg, 0.001 wt% Zn, 0.005 wt% Zn, 0.01 wt% Zn, 0.05 wt% Zn, 0.1 wt% Zn, 0.5 wt% Zn, 1 wt% Zn, 5 wt% Zn, 10 wt% Zn, 20 wt% Zn, 30 wt% Zn, 40 wt% Zn, 50 wt% Zn, 60 wt% Zn, 70 wt% Zn, 80 wt% Zn, or 90 wt% Zn.

[0182] The attachment portion (such as a needle) may be made of a material comprising one or more thermoplastic or thermosetting polymers. The material of the attachment portion (such as a needle) may contain one or more active pharmaceutical ingredients. Therefore, the active pharmaceutical ingredient may be embedded in the material of the attachment portion (such as a needle) to form a pharmaceutical composition.

[0183] In some embodiments, the attachment portion (such as a needle) may include, for example, water-soluble, water-insoluble, biodegradable, non-biodegradable materials and / or pH-dependent soluble materials. In some embodiments, the attachment portion (such as a needle) may include water-soluble, biodegradable, and / or pH-dependent materials that can dissolve and / or degrade, such that the attachment portion (such as a needle) contained in intestinal tissue can gradually degrade and / or dissolve. In some embodiments, the attachment portion (such as a needle) may include a water-soluble material to allow the active pharmaceutical substance to be released immediately or modified for release, depending on the material selected. In some embodiments, water-insoluble or biodegradable materials may allow the active pharmaceutical substance to be stored in the attachment portion (such as a needle) for a longer duration of release (e.g., days, weeks, or months). In some embodiments, pH-dependent soluble materials may allow the attachment portion (such as a needle) to remain intact at pH conditions below, for example, a physiological pH of approximately 7.4, to remain intact within the gastrointestinal lumen, but may dissolve once located within 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 pharmaceutical substance, for example, through diffusion or erosion of the attachment portion (such as a needle), for a sustained, controlled release time (e.g., minutes, hours, days, weeks, or months).

[0184] In some embodiments, the attachment portion (such as a needle) may be made of different compositions. For example, the outer portion of the attachment portion (such as a needle) may be made of one composition, and the inner core of the attachment portion (such as a needle) may be made of another composition. In some embodiments, the outer portion and the inner core of the attachment portion (such as a needle) may be made of, for example, water-soluble, water-insoluble, biodegradable, and / or pH-dependent materials. In some embodiments, once the attachment portion (such as a needle) can move its position from the lumen to internal tissue (e.g., from the gastrointestinal lumen to gastrointestinal tissue), one or more water-soluble, water-insoluble, biodegradable, and / or pH-dependent materials may be combined to control the release of the active pharmaceutical ingredient.

[0185] In some embodiments, the attachment portion (such as a needle) may be tubular and may include a tubular body, which may include an active pharmaceutical ingredient (e.g., a liquid payload containing the active pharmaceutical ingredient). The tubular body is optionally connected to the tubular attachment portion, so that the payload containing the active pharmaceutical ingredient can flow through the attachment portion (such as a needle) and into internal tissue (e.g., intestinal tissue). In some embodiments, the tubular body may include an expandable excipient (such as a swelling excipient) that can expand through a chemical reaction, such as expanding in volume and / or generating gas when mixed to propel the delivery of the payload. In some embodiments, this expansion is achieved through osmosis.

[0186] In some embodiments, the first compartment (the compartment for holding the active pharmaceutical ingredient) may include a sealing portion for closing the first compartment. This sealing portion can help improve control over the release of the active pharmaceutical ingredient. In some embodiments, the sealing portion may be composed of, for example, water-soluble, water-insoluble, biodegradable, and / or pH-dependent materials. In some embodiments, once the attachment portion (such as a needle) moves its position from the lumen to internal tissue (e.g., from the gastrointestinal lumen to gastrointestinal tissue), one or more water-soluble, water-insoluble, biodegradable, and / or pH-dependent materials may be combined to control the release of the active pharmaceutical ingredient from the first compartment.

[0187] Figure 1 An exploded view of a drug delivery device 2 according to the present disclosure is shown, wherein the drug delivery device includes 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, the first body portion 4 is rotatably connected to the second body portion 10, wherein when connected, the first end 6 of the first body portion is adjacent to the first end 12 of the second body portion.

[0188] The drug delivery device 2 also includes an actuator mechanism 16, which includes an elastic portion 16A, in this example in the form of a helical torsion spring. A first portion 18 (the first end of the helical torsion spring) of the elastic portion 16A is located on the outer periphery 22 of the helical torsion spring, and a second portion 20 (the second end of the helical torsion spring) of the elastic portion 16A is located in the central portion 24 of the helical torsion spring.

[0189] The first body portion 4 includes an internal volume portion 26 adapted to receive an elastic portion 16A, and wherein an inner surface 28 of the internal volume portion 26 includes one or more first engagement portions 30 configured to engage a first portion 18 of the elastic portion 16A, and wherein the first engagement portions can maintain the position of the first portion during rotational movement of the first body portion 4 and the second body portion 10 relative to each other. A second portion 20 of the elastic portion 16A is configured to engage a second engagement portion centrally located within the second body portion 10. The second engagement portion is configured to extend into a central portion 24 of the spring when the spring is positioned within the internal volume portion 26 of the first body portion 4. The second engagement portion includes a slit or groove adapted to engage with the second portion 20 of the elastic portion 16A such that rotational movement of the first body portion 4 and / or the second body portion 10 can cause the elastic portion 16A to roll up when the first portion 18 engages with the first engagement portion 30.

[0190] The drug delivery device 2 has a central axis A that extends in a direction from the second end 8 (the first end of the drug delivery device) of the first body portion 4 toward the second end 14 (the second end of the drug delivery device) of the second body portion. The central axis A can be considered as defining a main axis about which the first body portion 4 and the second body portion 10 rotate.

[0191] The first engaging portion 30 and the first portion 18 of the elastic portion 16A may have an engagement, meaning that when the load in the spring exceeds a predetermined level, the first end releases the first engaging portion 30 and enters a state of engagement with the next engaging portion 30'. This means that the drug delivery device may have a torque limiter, wherein the torque limiter ensures that the energy stored inside the elastic member 16 does not exceed a predetermined limit.

[0192] The drug delivery device 2 includes an attachment portion 36 having a proximal end 38 and a distal end 40. The attachment portion 36 includes a straight needle tip 37 (or a pointed tip) and is fixedly attached to a first body portion 4. The attachment portion 36 extends from the outer surface 42 of the first body portion 4 in a direction remote from the outer surface 42 along a first attachment axis. The distal end 40 of the attachment portion 36 may be a sharp tip to allow penetration of biological tissue, wherein the rotational force provided by the elastic member 16A can be used to penetrate body tissue.

[0193] The distal end 40 of the attachment portion 36 may be a pointed tip, which may be similar to the pointed tip of a hypodermic needle, and the pointed tip may be capable of penetrating body tissue, such as the mucosa of the intestine, stomach, tract, or other parts of the digestive system and / or gastrointestinal system. The needle 37 may be hollow and have an opening at the distal end 40, so that after the attachment portion 36 penetrates the biological tissue, the active drug substance can be introduced into the body tissue through the opening.

[0194] The elastic force of the elastic portion 16A is used to rotate the first body portion about the central axis A, which is the main axis, along the first direction B and to rotate the second body portion about the central axis along the second direction C. In other words, the actuator mechanism 16 (elastic portion 16A) is configured to move the first distal end 40 toward the second distal end 48.

[0195] The first body portion 4 has a first primary recess 64 located in the outer surface 42, and the second body portion 10 has a second primary recess 66 located in the outer surface 50. The first primary recess 64 and the second primary recess 66 are part of a locking mechanism for locking, for example, when the drug delivery device 2 is in a first state, by arranging a first locking element in the first primary recess 64 and the second primary recess 66, rotation of the first body portion 4 relative to the second body portion 10 is prevented.

[0196] Figure 2A A drug delivery device 2 in a first state is shown. The drug delivery device includes a locking mechanism, indicated by a dashed ellipse 70, comprising 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 rotational movement of the first body portion 4 and the second body portion 10 relative to each other, thereby maintaining a static relationship between the body portions 4 and 10. The first locking element 72 may be in the form of a biodegradable material, such as a sugary substance, wherein contact with fluids in the gastrointestinal tract causes the material of the first locking element 72 to degrade. When the rotational force applied to the body portions 4 and 10 via the elastic member 16A exceeds the static force of the (degraded) first locking element 72, the first locking element 72 releases the body portions 4 and 10, and allows the elastic member 16A to release its stored energy, thereby allowing the first body portion 4 to rotate relative to the second body portion 10 in a second state of the drug delivery device.

[0197] Figure 2B A drug delivery device 2 is shown, wherein the first locking element 72 has been degraded or dissolved, and the first body portion 4 and the second body portion 10 (respectively) rotate relative to each other in directions B and C, respectively. Thus, the attachment member 36 rotates via a rotational force (torque) applied to the body portion 4 to puncture tissue, such as via a needle 37.

[0198] Figure 3 An exemplary pharmaceutical composition 100 is shown, comprising a drug delivery device 2 encapsulated in a shell 76 optionally made of a soluble material. The pharmaceutical composition 100 comprises an active pharmaceutical substance disposed in a first compartment and / or a second compartment. The shell 76 may encapsulate the drug delivery device 2 to make it easier to swallow. The soluble shell 76 is soluble in the gastrointestinal tract, and the drug delivery device 2 cannot be attached or joined before the shell 76 dissolves. These types of shells are known in the art to be in the form of drug capsules, wherein the material of the drug capsule may be, for example, gelatin, similar to the shells of rigid drug capsules known in the art. In one or more exemplary pharmaceutical compositions, the drug delivery device may be coated.

[0199] Figure 4 An exploded view of an exemplary drug delivery device according to the present disclosure is shown. The drug delivery device 2A has a central axis A and includes a two-part first body portion 4, which includes a first primary body portion 4A and a first secondary body portion 4B. The first body portion 4 may include a cylindrical first base 39.

[0200] The drug delivery device 2A includes a two-part second body portion 10, which includes a second primary body portion 10A and a second secondary body portion 10B. The drug delivery device 2A includes an attachment portion 36, which includes a base 36A and a needle 37 attached to the base 36A. The attachment portion 36 has a distal end 40 and is optionally rotatably attached to the second body portion 10 via a second coupling formed by a cylindrical second base 41 and a corresponding cylindrical cavity in the second body portion 10. The second coupling has a second axis of rotation X_R_2. Therefore, the attachment portion 36 is configured to rotate relative to the second body portion 10 about a first axis of rotation. The second axis of rotation X_R_2 is parallel to the central axis A.

[0201] The drug delivery device 2A includes a frame portion 78 formed as a shaft member or rod, wherein different portions such as the first body portion 4 and / or the second body portion 10 are attached (e.g., fixedly or rotatably attached) to the frame portion 78.

[0202] The drug delivery device 2A includes an actuator mechanism 16, which includes a resilient portion 16A configured to move the attachment portion 36 (specifically the distal end of the attachment portion 40) by rotating the first body portion 4 relative to the second body portion 10.

[0203] Figure 5A An exemplary drug delivery device 2B is shown. Figure 5BAn exploded view of an exemplary drug delivery device 2B is shown. Unless otherwise stated, the drug delivery device 2B may include the components described above. Figures 1 to 4 Any and / or all of the features discussed.

[0204] As shown, the drug delivery device 2B may include a first body recess 108 configured to allow rotation of the attachment portion 104. The attachment portion 104 may include a joint 116 to form a curved needle or tip. This allows for easier penetration of tissue.

[0205] Additionally, as shown, the drug delivery system 2B may include a first locking band 102. The first locking band 102 prevents the first body portion 4 from rotating relative to the second body portion 10. The first locking band 102 can be used instead of the locking element 72. Alternatively, the first locking band 102 can be used as a first cover band 103 and in conjunction with the locking element 72. Specifically, the first locking band 102 may include a plurality of locking protrusions 112. These locking protrusions 112 can be fitted into the mating feature 114 of the drug delivery system 2B. After mating, the locking protrusions 112 prevent the first body portion 4 and the second body portion 10 from rotating. Then, the first locking band 112 can dissolve to allow rotation.

[0206] Figures 6A to 6C A view of the drug delivery device 2C is shown. Unless otherwise stated, the drug delivery device 2C may include the components described above. Figures 1 to 5B Any and / or all of the features discussed.

[0207] As shown, the drug delivery device 2C may include a central axis A, a first body portion 4, and a second body portion 10. The drug delivery device 2C may also include an attachment portion 36 attached to the first body portion 4 and having a distal end 40. The attachment portion 36 may include a base 36A and a needle (or tip) 37. The attachment portion 36 may be rotatably located within a recess 108 of the first body portion. The distal end 40 of the attachment portion 36 (such as the needle 37) is provided with an end configured to penetrate biological tissue.

[0208] The drug delivery device 2C may include a first compartment, configured to deliver an active drug substance from the first compartment to its surrounding environment. For example, after the attachment portion 36 penetrates the tissue, the drug delivery device 2C can release the active drug substance into the tissue.

[0209] The drug delivery device 2C may also include an actuator mechanism (not shown, but may include the resilient portion 16A discussed above) configured to rotate the first body portion 4 about a main axis (e.g., but not limited to, central axis A) of the drug delivery device 2C relative to the second body portion 10. As shown, the drug delivery device 2C includes only a single attachment portion 36. The actuator mechanism may include a resilient portion configured to apply force to the first body portion 4 and / or the second body portion 10. 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.

[0210] The drug delivery device 2C can have a first state and a second state. In the first state, the first body portion 4 and the second body portion 10 do not rotate relative to each other. In the second state, the first body portion 4 and the second body portion 10 can rotate relative to each other. Therefore, the actuator mechanism can be configured to move the distal end 40 from a first position having a first-order radial distance from the central axis A of the delivery device 2C to a second position having a second-order radial distance from the central axis A, wherein the second-order radial distance is greater than the first-order radial distance.

[0211] Therefore, when the first body portion 4 rotates relative to the second body portion 10, the attachment portion 36 can rotate away from the first body recess 108 to penetrate tissue. The attachment portion 36 can be rotatably attached to the first body portion 4 via a hinge (such as one located on the base 36A) and configured to rotate about a first axis of rotation perpendicular to or parallel to the main axis A.

[0212] Furthermore, as shown, the drug delivery device 2C may include a locking mechanism 70, which includes a first locking element 72 held to prevent rotation of the first body portion 4 relative to the second body portion 10. The locking mechanism 70 may be configured to lock the first body portion 4 relative to the second body portion 10 in a first state of the drug delivery device 2C.

[0213] Optionally, the first body portion 4 and / or the second body portion 10 may include a drag feature 118. As shown, the drag feature 118 is located on the second body portion 10. The drag feature 118 may be selected from one or more of the following: a high-friction surface, a feature configured to change the moment of inertia, and a feature configured to generate turbulence.

[0214] The second body portion 10 may have a higher moment of inertia than the first body portion 4. The second body portion 10 may have a higher or lower weight than the first body portion 4. This may, for example, improve the penetration of the attachment portion 36 into the tissue.

[0215] Drug delivery devices 2, 2A, 2B, and 2C can be biodegradable, for example, completely biodegradable.

[0216] Also disclosed are conveying devices, methods, and compositions according to any of the following items.

[0217] Project 1. A drug delivery device with a central axis, the drug delivery device comprising:

[0218] First body part;

[0219] The second body part;

[0220] The attachment portion is attached to the first body portion and has a distal end; and

[0221] An actuator mechanism is configured to cause the first body portion to rotate relative to the second body portion about the main axis of the drug delivery device.

[0222] The drug delivery device consists of only a single attachment part.

[0223] Project 2. The drug delivery device according to Project 1, wherein the first body portion and / or the second body portion includes a resistance feature.

[0224] Project 3. The drug delivery device according to Project 2, wherein the resistance feature is selected from one or more of the following: a high-friction surface, a feature configured to change the moment of inertia, and a feature configured to generate turbulence.

[0225] Project 4. A drug delivery device according to any of the preceding projects, wherein the second body portion has a larger moment of inertia than the first body portion.

[0226] Project 5. A drug delivery device according to any of the preceding projects, wherein the second body portion has a weight greater or less than that of the first body portion.

[0227] Project 6. A drug delivery device according to any of the preceding projects, wherein the actuator mechanism includes an elastic portion configured to apply force to a first body portion and / or a second body portion.

[0228] Item 7. A drug delivery device according to any of the preceding items, wherein a first body portion is configured to rotate in a first direction, and a second body portion is configured to rotate in a second direction opposite to the first direction.

[0229] Project 8. A drug delivery device according to any of the preceding projects, wherein the distal end of the attachment portion is provided with a terminal configured to penetrate biological tissue.

[0230] Project 9. A drug delivery device according to any of the preceding projects, wherein 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 surrounding environment of the drug delivery device.

[0231] Item 10. A drug delivery device according to any one of the preceding items, wherein the drug delivery device has a first state and a second state, wherein in the first state, a first body part and a second body part do not rotate relative to each other, and in the second state, the first body part and the second body part can rotate relative to each other.

[0232] Project 11. A drug delivery device according to any of the preceding projects, wherein the actuator mechanism is configured to move the distal end from a primary position having a first-order radial distance from the central axis of the delivery device to a secondary position having a second-order radial distance from the central axis, wherein the secondary radial distance is greater than the primary radial distance.

[0233] Item 12. A drug delivery device according to any of the preceding items, wherein the drug delivery device includes a locking mechanism configured to lock a first body portion relative to a second body portion in a first state of the drug delivery device.

[0234] Item 13. A drug delivery device according to any of the preceding items, wherein the attachment portion is rotatably attached to the first body portion via a hinge and configured to rotate about a first rotation axis perpendicular to or parallel to the main axis.

[0235] Project 14. A drug delivery device according to any of the preceding projects, wherein the drug delivery device is biodegradable.

[0236] The use of terms such as "first," "second," "third," and "fourth," "primary," "secondary," and "tertiary" does not imply any particular order, but is included to identify individual elements. Furthermore, the use of terms such as "first," "second," "third," and "fourth," "primary," "secondary," and "tertiary" does not indicate any order or importance, but is used to distinguish one element from another. Note that the terms "first," "second," "third," and "fourth," "primary," "secondary," and "tertiary" are used here and elsewhere for labelling purposes only and are not intended to indicate any particular spatial or temporal order. Moreover, the labeling of a first element does not imply the existence of a second element, and vice versa.

[0237] It should be noted that the word "including" does not necessarily exclude the presence of other elements or steps besides those listed.

[0238] It should be noted that the word "one" or "a" preceding the component does not preclude the existence of multiple such components.

[0239] It should also be noted that any reference numerals do not limit the scope of the claims, exemplary embodiments may be implemented at least in part by hardware and software, and multiple “devices”, “units” or “apparatus” may be represented by the same hardware article.

[0240] Although features have been shown and described, it should be understood that these are not intended to limit the claimed invention, and it will be apparent to those skilled in the art that various changes and modifications can be made without departing from the spirit and scope of the claimed invention. Therefore, the specification and drawings should be considered illustrative rather than restrictive. The claimed invention is intended to cover all substitutions, modifications, and equivalents.

[0241] List of reference markers

[0242] 2. Drug delivery devices 2A, 2B, and 2C

[0243] 4. First Body Part

[0244] 4A First-level body part

[0245] 4B First and second level body parts

[0246] 6. First end of the first body part

[0247] 8. The second end of the first body part

[0248] 10 Second Body Part

[0249] 10A Second-level body part

[0250] 10B Second and Secondary Body Part

[0251] 12 The first end of the second body part

[0252] 14 The second end of the second body part

[0253] 16 Actuator Mechanism

[0254] 16A Elastic Part

[0255] 18. The first part of the elastic section

[0256] 20. The second part of the elastic section

[0257] 22. Outer periphery of the helical torsion spring

[0258] 24. The central part of the helical torsion spring

[0259] 26 Internal volume section

[0260] 28 Inner surface

[0261] 30 First joint portion

[0262] 30' First joint portion

[0263] 36. Attachment

[0264] 36A base

[0265] 37 needles

[0266] 38. Proximal end of the attachment portion

[0267] 40. The distal end of the attachment portion

[0268] 42 Outer surface of the first body part

[0269] 50 Outer surface of the second body part

[0270] 64 The first-level recess in the first body part

[0271] 66. The second-level recess in the second body part

[0272] 70 Locking mechanisms

[0273] 72 First locking element

[0274] 76. Shell

[0275] 100 Pharmaceutical Compositions

[0276] 102 First Locking Strap

[0277] 103 First Cover Zone

[0278] 104 Appendix

[0279] 108 First body recess

[0280] 112 Locking the protrusion

[0281] 114 Matching Feature Section

[0282] 116 Joint

[0283] 118 Resistance Feature Section

[0284] A. Central axis / Main axis

[0285] B. Rotation direction

[0286] C. Rotation direction

Claims

1. A drug delivery device (2, 2A, 2B, 2C) configured for delivering an active drug substance in the gastrointestinal tract, the drug delivery device (2, 2A, 2B, 2C) having a central axis, the drug delivery device (2, 2A, 2B, 2C) comprising: First body part (2); Second body part (4); An attachment portion (36) is attached to the first body portion (2) and has a distal end (40), wherein the distal end of the attachment portion is provided with an end configured to penetrate biological tissue; as well as The actuator mechanism (16) is configured to cause the first body portion (2) to rotate relative to the second body portion about the main axis of the drug delivery device; The drug delivery devices (2, 2A, 2B, 2C) each include only a single attachment portion, and the second body portion has a greater inertia than the first body portion. The material of the attachment portion includes one or more active pharmaceutical substances.

2. The drug delivery device (2, 2A, 2B, 2C) according to claim 1, wherein, The first body portion and / or the second body portion include a resistance feature.

3. The drug delivery device (2, 2A, 2B, 2C) according to claim 2, wherein, The drag feature is selected from one or more of the following: high-friction surfaces and features configured to generate turbulence.

4. The drug delivery device (2, 2A, 2B, 2C) according to any one of claims 1 to 3, wherein, The second body part has a weight that is greater or less than that of the first body part.

5. The drug delivery device (2, 2A, 2B, 2C) according to any one of claims 1 to 3, wherein, The actuator mechanism (16) includes an elastic portion (16A) configured to apply force to the first body portion (2) and / or the second body portion (4).

6. The drug delivery device (2, 2A, 2B, 2C) according to any one of claims 1 to 3, wherein, The first body part (2) is configured to rotate in a first direction, and the second body part (4) is configured to rotate in a second direction opposite to the first direction.

7. The drug delivery device (2, 2A, 2B, 2C) according to any one of claims 1 to 3, wherein, The drug delivery device includes a first compartment and is configured to deliver an active drug substance from the first compartment to the surrounding environment of the drug delivery device.

8. The drug delivery device (2, 2A, 2B, 2C) according to any one of claims 1 to 3, wherein, The drug delivery device has a first state and a second state. In the first state, the first body part and the second body part do not rotate relative to each other. In the second state, the first body part and the second body part can rotate relative to each other.

9. The drug delivery device (2, 2A, 2B, 2C) according to any one of claims 1 to 3, wherein, The actuator mechanism (16) is configured to move the distal end from a primary position having a first-order radial distance from the central axis of the conveying device to a secondary position having a second-order radial distance from the central axis, wherein the secondary radial distance is greater than the primary radial distance.

10. The drug delivery device (2, 2A, 2B, 2C) according to any one of claims 1 to 3, wherein, The drug delivery device includes a locking mechanism (70) configured to lock the first body portion relative to the second body portion in a first state of the drug delivery device.

11. The drug delivery device (2, 2A, 2B, 2C) according to any one of claims 1 to 3, wherein, The attachment portion is rotatably attached to the first body portion via a hinge and configured to rotate about a first rotation axis that is perpendicular to or parallel to the main axis.

12. The drug delivery device (2, 2A, 2B, 2C) according to any one of claims 1 to 3, wherein, The drug delivery device is biodegradable.

Images