Drug delivery device

Abstract

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

Description

Technical Field

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

[0002] Many active pharmaceutical ingredients, such as those with low permeability and / or low water solubility, are currently delivered via subcutaneous, intradermal, intramuscular, rectal, vaginal, or intravenous routes. Oral administration has the greatest potential for broad 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 route of administration, but with limited success, particularly due to lack of stability and limited absorption from the gastrointestinal tract.

[0003] Stability is related to the stability of the active drug during the manufacture and storage of the delivery device, as well as the stability of the active drug during its passage through the gastrointestinal tract before it can be absorbed.

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

[0005] Various approaches have been proposed to address these stability and absorption issues, but no effective solution has yet been found. Summary of the Invention

[0006] Therefore, there is an unmet need for a drug delivery device capable of delivering drugs for absorption in the gastrointestinal tract. More generally, there remains a need for drug products and methods that enhance drug delivery when administering drug products orally to patients.

[0007] A drug delivery device (e.g. for oral drug delivery) is disclosed, the drug delivery device having a central axis and comprising: a first body component; a first attachment component attached to the first body component and having a first distal end; a second attachment component having a second distal end; and an actuation mechanism optionally configured to move (e.g., rotate) the first distal end toward the second distal end.

[0008] A pharmaceutical composition comprising an active pharmaceutical ingredient and one or more delivery devices described herein is also disclosed.

[0009] The advantage of this invention is that the drug delivery device ensures the stability of the active drug during its passage through the gastrointestinal tract and facilitates the effective absorption of the active drug from the gastrointestinal tract after oral administration.

[0010] Furthermore, an advantage of the present invention is that the drug delivery device provides active attachment of the drug delivery device to the gastric wall (e.g., the stomach wall and / or intestinal wall).

[0011] Furthermore, the present invention advantageously provides oral delivery of a low-permeability active drug into or at the site of the gastric interior. Attached Figure Description

[0012] The above and other features and advantages of the present 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] Figure 2 A side sectional view of an exemplary drug delivery device is shown;

[0015] Figure 3 A perspective view of an exemplary drug delivery device is shown;

[0016] Figure 4 A perspective view of an exemplary drug delivery device is shown;

[0017] Figure 5 A front view of an exemplary drug delivery device is shown;

[0018] Figure 6 A side view of an exemplary drug delivery device is shown;

[0019] Figure 7 A front view of an exemplary drug delivery device coupled with biomaterials is shown;

[0020] Figure 8 A packaged drug delivery device is shown;

[0021] Figure 9 An exploded view of an exemplary drug delivery device with a rotatable attachment component is shown;

[0022] Figure 10 A perspective view of an exemplary drug delivery device is shown;

[0023] Figures 11A to 11D A schematic diagram illustrating the operation of the drug delivery device is shown;

[0024] Figure 12 The drug delivery device in its first state is shown;

[0025] Figure 13 The drug delivery device in its second state is shown;

[0026] Figure 14 The drug delivery device in its first state is shown;

[0027] Figure 15 The drug delivery device in its second state is shown;

[0028] Figure 16 A drug delivery device is shown;

[0029] Figure 17 Shown in exploded view Figure 16 Drug delivery devices;

[0030] Figures 18 to 22 The results of the trial using the drug delivery device are shown; and

[0031] Figure 23 The efficacy data using the drug delivery device are shown. Detailed Implementation

[0032] Various exemplary embodiments and details are described below with reference to the accompanying drawings. It should be noted that the drawings may be drawn to scale or not, and elements with similar structures or functions are indicated by the same reference numerals throughout the drawings. It should also be noted that the drawings are for convenience only in illustrating the embodiments and their associated functions. They 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.

[0033] A drug delivery device with a central axis is disclosed, comprising: a first body component; a first attachment component; a second attachment component; and an actuation mechanism configured to move the first attachment component and the second attachment component relative to each other, for example, by moving (e.g., rotating) the first body component relative to the second body component.

[0034] Drug delivery devices may have dimensions and geometries designed to be assembled into drug compositions for oral administration.

[0035] The drug delivery device / drug composition can be configured to be administered into the body via the mouth. Therefore, the external size of the drug delivery device / drug composition can be small enough for a user to swallow. The drug delivery device can be adapted to deliver the drug into the user's body via the digestive system, such that the drug delivery device can travel from the user's mouth to the stomach, for example, via the esophagus. The drug delivery device can further travel from the stomach to the intestines, and optionally to the large intestine and be expelled through the rectum.

[0036] A drug delivery device can be configured to deliver a drug in any part of a user's digestive system, in one example it can be configured to deliver the drug into the user's stomach. In another example, the drug delivery device can be adapted to initiate drug delivery once the device has passed through the stomach and entered the user's intestines. In other words, the drug delivery device can be configured to attach to the stomach wall or intestinal wall, for example, depending on the desired release site of the active drug.

[0037] The drug delivery device may have multiple attachment components configured to interact with the inner lining 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 multiple attachment components may be configured to interact with the mucosa, thereby securing or attaching the drug delivery device within the user's body for a period of time. Attaching the drug delivery device allows medication to be delivered into a portion of the digestive system to provide the medication to the user's body. The multiple attachment components may also be configured to interact with the mucosa, for example, thereby injecting the medication into the gastrointestinal wall.

[0038] The drug delivery device has a central axis that optionally extends from a first end to a second end of the drug delivery device. The drug delivery device may have a length in the range of 3 mm to 35 mm (e.g., in the range of 5 mm to 26 mm) (e.g., the maximum extension along the central axis from the first end to the second end). The drug delivery device may be elongated.

[0039] The drug delivery device may have a width and / or height ranging from 1 mm to 20 mm (e.g., the maximum extension along the width axis and height axis, respectively). The height and width are the maximum extensions of the drug delivery device perpendicular to its central axis.

[0040] In one or more exemplary drug delivery devices, at least in an initial or first state prior to actuation of the first attachment member and / or the second attachment member, 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 axis and the width axis). 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.

[0041] In one or more exemplary drug delivery devices, the drug delivery device may be configured to ensure that the drug delivery unit delivers a payload or active drug into internal tissue or internal surface to distribute the active drug into the body of a subject via blood vessels.

[0042] Advantageously, the drug delivery device can be attached to and can deliver an active drug 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 to other locations. In one or more exemplary drug delivery devices, the drug delivery device (e.g., a spike) can penetrate the muscularis mucosae. In one or more exemplary drug delivery devices, the drug delivery device (e.g., a spike) may not penetrate the muscularis externa. In one or more exemplary drug delivery devices, the spike can be positioned in the submucosa. In one or more exemplary drug delivery devices, the spike can be positioned parallel to the intestinal wall in the submucosa.

[0043] The drug delivery device includes a first main body component. The first main body component may be a two-piece component, meaning it may include a first primary main body component and a first secondary main body component. The first main body component has an outer surface. A first primary recess and / or a first secondary recess may be formed in the outer surface of the first main body component.

[0044] The drug delivery device may optionally include a housing having a first housing component. The outer surface of the first main body component may form at least a portion of the first housing component.

[0045] The drug delivery device includes a first attachment member. The first attachment member may include a first base and / or a first needle (e.g., a spike). The first attachment member has a first proximal end and a first distal end. The first attachment member (e.g., a first needle or spike) optionally has a first attachment axis or extends along a first attachment axis. A first tip of the first needle forms the first distal end. In other words, the first distal end is the first tip of the first needle. The first base may be located at or form part of the first proximal end of the first attachment member. The length of the first needle may be in the range of 1 mm to 15 mm, for example, in the range of 3 mm to 10 mm. Therefore, sufficient penetration into internal tissue can be ensured while reducing the risk of damage to internal tissue. The first distal end of the first attachment member may be provided with a tip configured to penetrate biological tissue. The first distal end of the first attachment member may be provided with a clamping member configured to clamp biological tissue.

[0046] The cross-sectional diameter of the first needle can be in the range of 0.1mm to 5mm, for example, in the range of 0.5mm to 2.0mm.

[0047] The first needle can be straight and / or curved. The first needle may include a straight first main segment. The first needle may include a first secondary segment, for example, between the first main segment and the first distal end or between the first base and the first main segment. The first secondary segment may be curved.

[0048] The first needle may include two or more straight portions forming an angle. For example, the first 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 connector (e.g., a bend, a connector, a corner joint) and have an engagement angle between the proximal and distal portions. The engagement angle may be acute, obtuse, or right. This angle may be, for example, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 130, 140, 150, 160, or 170 degrees. This can advantageously allow for different attachment angles when the first needle interacts with the inner surface liner. This can improve the attachment of the drug delivery device while helping to reduce or avoid tissue damage. Furthermore, the connector may be flexible. Alternatively, the connector may not be flexible.

[0049] The connector may be located at or approximately at the center of the length of the first needle. Alternatively, the connector may be located at 40%, 45%, 55%, 60%, or 65% of the length of the first needle from the proximal end.

[0050] In one or more exemplary first attachment components, the first pin may have three, four, or five distinct portions at different angles, each connected by a connector. In some iterations, any one or all of the distinct portions may be straight or curved. Each connector may be flexible or not.

[0051] The attachment component of the drug delivery device can be considered as any kind of attachment component capable of attaching the drug delivery device to biological tissues such as the stomach wall, large intestine, and / or intestinal wall of a human or animal body. The attachment component may be adapted to extend in a direction remote from the central axis of the drug delivery device and / or the central axis of the first attachment component. This may mean, for example, at least in the activated state or second state of the drug delivery device, that the attachment component may extend in a direction (in the radial direction) remote from the outer peripheral surface of the first body component and / or the second body component, such that the attachment component extends further in the radial direction than the outer peripheral surface or outer surface of the body component.

[0052] The first attachment component can be fixedly or rotatably attached to the first body component.

[0053] In one or more exemplary drug delivery devices, the drug delivery device includes a second body component. The second body component may be a two-piece body component, that is, the second body component may include a second main body component and a second auxiliary body component. A second attachment component may optionally be attached to the second body component. The second attachment component may be fixedly or rotatably attached to the second body component. The second body component has an outer surface. A second main recess and / or a second auxiliary recess may be formed in the outer surface of the second body component.

[0054] In one or more exemplary drug delivery devices, an actuation mechanism is configured to rotate a first body component relative to a second body component about a main axis of the drug delivery device. The main axis may be parallel to and / or coincide with a central axis.

[0055] In one or more exemplary drug delivery devices, a first body component is configured to rotate in a first direction and / or a second body component is configured to rotate in a second direction opposite to the first direction.

[0056] Drug delivery devices may include a frame component, wherein different components, such as a first body component and / or a second body component, are attached (e.g., fixedly or rotatably attached) to the frame component. In one or more exemplary drug delivery devices, an actuation mechanism or a portion thereof may be attached to the frame component. This allows the first and second body components to rotate independently relative to the frame component.

[0057] The rotational connection between the first and second body components allows the first body component to rotate relative to the second body component without separating from each other before the attachment components(s) interact with internal tissues (e.g., mucous membranes). This connection can be achieved in various ways, where in one example the first body component has a plug-in connection and the second body component has a socket-in connection, wherein this plug-and-socket configuration allows the first body component to rotate relative to the second body component. 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 components are configured to receive the shaft, and stop devices are provided at a first end and a second end of the shaft located on each side of the combined first and second body components to prevent the first and second body components from sliding along the shaft in the longitudinal direction. The shaft can be integrated into either the first or second body component.

[0058] If a shaft is used, it can be made of any number of different materials. For example, a shaft can be made of metal and / or alloy and / or polymer and / or composite material and / or a combination thereof.

[0059] The first and / or second body components can be configured to rotate freely relative to each other, for example, at least in a second state, thereby allowing the attachment components to rotate relative to each other. Thus, the attachment components can be adapted to contact and / or penetrate gastrointestinal tissue. Using an elastic force to rotate the body components relative to each other can move the attachment components, enabling them to, for example, penetrate or clamp the mucosa, thereby securing the drug delivery device at a specific location in the gastrointestinal tract, such as the stomach or intestine. The penetration and / or clamping force can originate from an actuating mechanism / elastic component, wherein the elastic component is adapted to store an elastic force capable of forcing the attachment components closer together when the elastic force of the elastic component has been at least partially released. The elastic component 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 wound to store mechanical energy, which can be transmitted to the first and / or second body components. When the mechanical energy is released, the first body component can rotate relative to the second body component, and wherein the mechanical energy can be transmitted to the attachment components via the body components.

[0060] In the context of this specification, the term "rotational force" may be considered as torque, moment, rotational force, or "rotational action." 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 via the main body component from the elastic component to the attachment member of the drug delivery device.

[0061] 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 and second body components, the first attachment member can contact the surface to be attached, and the rotational force applied to the second body component can cause the second attachment member to contact the same surface, wherein the first attachment member provides force and the second attachment member provides a reaction force to the first attachment member, thereby applying force by pushing the first attachment member in the direction toward the second attachment member or vice versa.

[0062] 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 first attachment axis of the first attachment member and the main axis is greater than 0.5 mm.

[0063] 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 second attachment axis of the second attachment member and the main axis is greater than 0.5 mm.

[0064] In one or more exemplary drug delivery devices, a first attachment member is rotatably attached to a first body member, for example, via a first connector having a first axis of rotation. In other words, the first attachment member may optionally be configured to rotate, for example, about a first axis of rotation relative to the first body member. The first axis of rotation may be parallel to a central axis and / or a 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°, for example, 90° ± 5° or 90°.

[0065] In one or more exemplary drug delivery devices, a first body component may define a first body recess (e.g., cavity, slot, or aperture) extending to the outer surface of the first body component. The first body recess may be formed of solid walls on all sides except the open outermost surface. A first attachment component may be rotatably connected within the first body recess along a first attachment component axis. The first attachment component axis may, for example, be a pin (e.g., arm, support). The first attachment component axis may be parallel to a central axis and / or a main axis. The first attachment component axis may be inclined relative to the central axis and / or the main axis. Therefore, the first attachment component may be configured to rotate within the recess along its first attachment component axis. Furthermore, rotation of the first attachment component may stop at an end surface of the recess.

[0066] The first body recess may extend along a portion of the outer surface of the first body. The first body recess may extend entirely along the outer circumference 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 circumference 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%, or more than 95% of the outer circumference of the first body. The first body recess may extend about 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100% of the outer circumference of the first body. The first body may optionally include more than one first body recess, for example, by using multiple first attachment members on the first body. If more than one first body recess is used, they may be longitudinally spaced and / or circumferentially spaced.

[0067] The first main body recess may extend from the outer surface toward the central axis through 5%, 10%, 15%, 20%, 25%, 30%, 35%, or 40% of the drug delivery device. The first main body recess may 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 main body recess may 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.

[0068] In one or more exemplary drug delivery devices, a first body recess may extend circumferentially or partially circumferentially around a first body with its central axis in the longitudinal direction. The first body recess may extend perpendicularly to the central axis and / or the main passage (e.g., along a cross-section of the drug delivery device perpendicular to the central axis and / or the main passage). 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 a triangle. The first body recess may be a sector of a circle. 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.

[0069] Therefore, the first attachment member can rotate about its axis to move perpendicular to the central axis and / or the main axis. In certain embodiments, the first attachment member can rotate according to an angle between perpendicular and parallel to the central axis and / or the main axis.

[0070] In one or more exemplary drug delivery devices, when the first body component and / or the second body component rotate relative to each other, the first attachment component and / or the second attachment component can rotate out from their respective recesses (e.g., the first body recess and the second body recess) due to the rotation of the first body component and / or the second body component. Continued rotation of the first body component and / or the second body component then causes the first attachment component and / or the second attachment component to pierce tissue to hold the drug delivery device in place.

[0071] In one or more exemplary drug delivery devices, 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 first attachment member extends in a direction away from the first body member. In other words, for example, at least in the activated state of the drug delivery device and optionally in the initial state, the first needle may protrude from the outer surface of the first body member. Alternatively, 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 first attachment axis may form an angle of at least 45° with the central axis and / or the main axis. The extension of the attachment member in a particular direction should be understood as a direction along the attachment axis of the attachment member from the proximal end of the attachment member / needle member to the distal end of the attachment member.

[0072] The first attachment member can extend in a first primary direction in a first state of the drug delivery device and in a first secondary direction in a second state of the drug delivery device. The first primary direction and the first secondary direction can form an angle of at least 30°. The first primary direction can be parallel to or substantially parallel to the central axis. The first primary direction can form an angle of less than 60° with the central axis. The first secondary direction can form an angle of at least 60° (e.g., approximately 90°) with the central axis. The first secondary direction can be perpendicular to the central axis.

[0073] The first distal end of the first attachment member can be configured to move from a first primary position in a first state of the drug delivery device to, or be moved to, a first secondary position in a second state.

[0074] The drug delivery device includes a second attachment member. The second attachment member may include a second base and / or a second needle (e.g., a spike). The second attachment member has a second proximal end portion and a second distal end portion. The second attachment member (e.g., the second needle) optionally has a second attachment axis or extends along a second attachment axis. A second tip of the second needle forms the second distal end portion. In other words, the second distal end portion is the second tip of the second needle. The second base may be located at or form part of the second proximal end portion of the second attachment member. The length of the second needle may be in the range of 1 mm to 15 mm, for example, in the range of 3 mm to 10 mm. Therefore, sufficient penetration into internal tissue can be ensured while reducing the risk of damage to internal tissue. The second distal end portion of the second attachment member may be provided with a tip configured to penetrate biological tissue. The second distal end portion of the second attachment member may be provided with a clamping member configured to clamp biological tissue.

[0075] The cross-sectional diameter of the second needle can be in the range of 0.1mm to 5mm, for example, in the range of 0.5mm to 2.0mm.

[0076] The second needle can be straight and / or curved. The second needle may include a straight second main segment. The second needle may include a second secondary segment, for example, between the second main segment and the second distal end or between the second base and the second main segment. The second secondary segment may be curved.

[0077] The second needle may include two or more straight portions forming an angle. For example, the second 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 and second angles may be different. The proximal portion may connect to the distal portion at a connector (e.g., a bend, connector, corner joint) and have an engagement angle between the proximal and distal portions. The engagement angle may be acute, obtuse, or right. This angle may, for example, be 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 130, 140, 150, 160, or 170 degrees. This can advantageously allow for different attachment angles when the second needle interacts with the inner surface liner. This can improve the attachment of the drug delivery device while helping to reduce or avoid tissue damage. Furthermore, the connector may be flexible. Alternatively, the connector may not be flexible.

[0078] The connector may be located at or approximately at the center of the length of the second pin. Alternatively, the connector may be located at 40%, 45%, 55%, 60%, or 65% of the length of the second pin from the proximal end.

[0079] In one or more exemplary second attachment components, the second pin may have three, four, or five distinct sections at different angles, each connected by a connector. In some iterations, any one or all of the distinct sections may be straight or curved. Each connector may be flexible or not.

[0080] In one or more exemplary drug delivery devices, both the first needle and the second needle include a connector. However, only one of the first needle and the second needle may include a connector while the other is straight and / or curved. If both the first needle and the second needle include connectors, the first distal tip and the second distal tip may be tilted toward each other to facilitate attachment when the first body component and the second body component rotate relative to each other.

[0081] In one or more exemplary drug delivery devices, a second attachment member is rotatably attached to a second body member, for example, via a second connector having a second axis of rotation. In other words, the second attachment member may optionally be configured to rotate, for example, about a second axis of rotation relative to the second body member. The second axis of rotation may be parallel to the central axis and / or the main axis. The second axis of rotation may form a second angle with the central axis and / or the main axis. The second angle may be less than 15°. The second angle may be in the range of 75° to 105°, for example, 90° ± 5° or 90°.

[0082] In one or more exemplary drug delivery devices, a second body component may define a second body recess (e.g., cavity, slot, or aperture) extending to the outer surface of the second body component. The second body recess may be formed of solid walls on all sides except the open outermost surface. A second attachment component may be rotatably connected within the second body recess along a second attachment component axis. The second attachment component axis may, for example, be a pin (e.g., arm, support). The second attachment component axis may be parallel to a central axis and / or a main axis. The second attachment component axis may be inclined relative to the central axis and / or the main axis. Therefore, the second attachment component may be configured to rotate within the recess along its axis. Furthermore, rotation of the second attachment component may stop at an end surface of the second body recess.

[0083] The second body recess may extend along a portion of the outer surface of the second body. The second body recess may extend entirely along the outer circumference 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 circumference 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%, or more than 95% of the outer circumference of the second body. The second body recess may extend about 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or less than 100% of the outer circumference of the second body. The second body may optionally include more than one second body recess, for example, by using multiple second attachment members on the second body. If more than one second body recess is used, they may be longitudinally spaced and / or circumferentially spaced.

[0084] The second body recess may extend from the outer surface toward the central axis through 5%, 10%, 15%, 20%, 25%, 30%, 35%, or 40% of the drug delivery device. The second body recess may 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 may 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.

[0085] In one or more exemplary drug delivery devices, a second body recess may extend circumferentially or partially circumferentially around a second body with its central axis in the longitudinal direction. The second body recess may extend perpendicularly to the central axis and / or the main pathway (e.g., along a cross-section of the drug delivery device perpendicular to the central axis and / or the main pathway). 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.

[0086] Therefore, the second attachment member can rotate about its axis to move perpendicular to the central axis and / or the main axis. In certain embodiments, the second attachment member can rotate according to an angle between perpendicular and parallel to the central axis and / or the main axis.

[0087] In one or more exemplary drug delivery devices, when the first body component and / or the second body component rotate relative to each other, the first attachment component and / or the second attachment component can rotate out from their respective recesses (e.g., the first body recess and the second body recess) due to the rotation of the first body component and / or the second body component. Continued rotation of the first body component and / or the second body component then causes the first attachment component and / or the second attachment component to pierce tissue to hold the drug delivery device in place.

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

[0089] The second attachment member can extend in a second primary direction in a first state of the drug delivery device and in a second secondary direction in a second state of the drug delivery device. The second primary direction and the second secondary direction can form an angle of at least 30°. The second primary direction can be parallel to or substantially parallel to the central axis. The second primary direction can form an angle of less than 60° with the central axis. The second secondary direction can form an angle of at least 60° (e.g., approximately 90°) with the central axis. The second secondary direction can be perpendicular to the central axis.

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

[0091] The drug delivery device includes an actuation mechanism. The actuation mechanism is configured to move a first attachment member relative to a second attachment member, for example, to move a first distal end toward and / or away from a second distal end, for example, at least during a portion of rotation (e.g., in a first rotation and optionally in a second rotation). Moving the first distal end toward the second distal end can be understood as reducing the distance between the first and second distal ends. Moving the first distal end toward the second distal end can be understood as reducing the angle between the first and second attachment axes, for example, reducing the angle between a first secondary direction of the first attachment member and a second secondary direction of the second attachment member. In one or more exemplary drug delivery devices, the actuation mechanism is configured to move the first distal end toward the second distal end by, for example, rotating a first body member relative to a second body member and / or vice versa, in a second state of the drug delivery device. The actuation mechanism can be configured to rotate the first body member relative to the second body member about a main axis by at least 90°, for example, at least 450°, at least 810°, at least 1170°, at least 1530°, or at least 1890°. The actuation mechanism can be configured to rotate the first body component relative to the second body component about a main axis in a progressive manner. In other words, rotating the first body component relative to the second body component about the main axis can include multiple rotations, including a first rotation and a second rotation, for example, a first rotation followed by a first time period of reduced or no rotation, followed by a second rotation. Performing a second rotation after the first time period following the first rotation increases the likelihood of the drug delivery device attaching to biological tissue. The first time period between rotations, or generally multiple time periods, allows the drug delivery device to move to other locations in the gastrointestinal tract. In other words, if the drug delivery device does not attach to biological tissue during the first rotation, further rotation increases the chance of attachment to internal tissue. The first rotation can be at least 90°, and the second rotation can be at least 180°. Multiple rotations can include a third rotation. The third rotation can be at least 180°.

[0092] In one or more exemplary drug delivery devices, movement of the first distal end toward the second distal end may be later than and / or earlier than movement of the first distal end away from the second distal end. In other words, movement of the first distal end toward the second distal end may precede and / or follow movement of the first distal end away from the second distal end. For example, a first rotation may include moving the first distal end toward the second distal end and / or moving the first distal end away from the second distal end. For example, a second rotation may include moving the first distal end toward the second distal end and / or moving the first distal end away from the second distal end. For example, a third rotation may include moving the first distal end toward the second distal end and / or moving the first distal end away from the second distal end.

[0093] The actuation mechanism may optionally include an elastic component, such as a spring element, configured to apply force to the first body component and / or the second body component. The elastic component may include a first portion, such as a first end, connected to the first body component. The elastic component may also include a second portion, such as a second end, connected to the second body component.

[0094] In one or more exemplary drug delivery devices, the actuation mechanism may optionally include a medium that expands, for example, upon contact with a fluid, i.e., a medium that increases its volume, thereby providing rotation of the components relative to each other. In one or more exemplary drug delivery devices, the expanding medium provides rotation of a first attachment member relative to a first body member and / or provides rotation of a second attachment member relative to a second body member. In one or more exemplary drug delivery devices, the expanding medium provides rotation of the first body member relative to the second body member.

[0095] An actuation mechanism (e.g., an elastic member) can be configured to rotate the first attachment member relative to the first body member about a first axis of rotation.

[0096] The actuation mechanism (e.g., an elastic member) can be configured to rotate the second attachment member relative to the second body member about a second rotation axis.

[0097] In one or more exemplary drug delivery devices, the drug delivery device includes a first compartment, configured to deliver an active drug from the first compartment to the surrounding environment of the drug delivery device. The first compartment may be disposed in a first attachment member, such as in a first needle, for example, within a distance of 8 mm from a first distal end, such as within a distance of 5 mm. The first attachment member (e.g., the first needle) may have one or more openings providing passage 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.

[0098] The first compartment can be located in any part of the drug delivery device, for example, in the form of a cavity within the volume of a first body component, a second body component, or both the first and second body components. Alternatively, the first compartment can be a compartment within a first attachment member, wherein penetration of the first attachment member into biological tissue can release the drug in the first compartment into the biological tissue. Alternatively, the first compartment can be a compartment in the form of a recess or opening, or a spike or hollow spike on the outer surface of the first and / or second body components, wherein the drug delivery device can be adapted to release the drug into a body organ through which the drug delivery device is adapted to pass.

[0099] In one or more exemplary drug delivery devices, a first compartment can be opened from the internal volume of the drug delivery device and toward the outside of the drug delivery device. In one or more examples, the first compartment can be within a first body member, and wherein the first compartment is fluidly connected to a first attachment member, such that when a first distal end of the first attachment member has penetrated biological tissue, the drug can be released from the first compartment and enter the biological tissue via the first attachment member. For example, this could be a case where the first attachment member is a tubular member and has a first distal end in fluid communication with the first compartment of the drug delivery device.

[0100] In one or more exemplary drug delivery devices, the drug delivery device includes a second compartment, configured to deliver an active drug from the second compartment to the surrounding environment of the drug delivery device. The second compartment may be disposed in a first attachment member or a second attachment member (e.g., disposed in a second needle), for example, within a distance of 8 mm from the second distal end, such as within a distance of 5 mm. The second attachment member (e.g., a second needle) may have one or more openings providing passageway to the second compartment. In one or more exemplary drug delivery devices, the second compartment is formed as a through-hole in the first needle or the second needle.

[0101] In one or more exemplary drug delivery devices, when the first distal end and the second distal end are located in a plane including the main axis, the first attachment member and the second attachment member form an angle. In other words, when the first distal end and the second distal end are located in a plane including the main axis, the first attachment axis and the second attachment axis can form an angle, for example greater than 5°, for example in the range of 10° to 75°.

[0102] In one or more exemplary drug delivery devices, the drug delivery device has a first state (also referred to as an initial state) and a second state (also referred to as an activated state), in which a first body component and a second body component are rotatably fixed relative to each other, and in the second state, the first body component and the second body component are rotatably movable relative to each other, for example, rotatable about the main axis of the drug delivery device. In other words, the first body component may be locked relative to the second body component, for example, prevented from rotating. The first state may 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 wherein the first body component and the second body component are fixed relative to each other. In the first state, the elastic member may have a predetermined amount of stored energy, wherein the energy level in the elastic member is fixed when the body component is fixed.

[0103] In one or more exemplary drug delivery devices, the drug delivery device has a first state in which an elastic member has a constant elastic force load and a second state in which the elastic member at least partially releases the elastic force load. In other words, the elastic member can be biased or preloaded in the first state of the drug delivery device, and when released, for example by a release locking mechanism (i.e., the drug delivery device is in the second state), the force from the elastic member can achieve rotation of the first body member relative to the second body member, i.e., including movement of the first distal end toward the second distal end.

[0104] In one or more exemplary drug delivery devices, an actuation mechanism is configured to move a first distal end portion from a first primary position (e.g., in a first state of the drug delivery device) at a first primary radial distance from the central axis of the delivery device, to a first secondary radial distance (e.g., in a second state of the drug delivery device) at a first secondary radial distance from the central axis and / or the primary axis, wherein the first secondary radial distance is greater than the first primary radial distance. Therefore, when the drug delivery device is in the first state, the first distal end portion of the first attachment member may be in the first primary position and / or when the drug delivery device is in the second state, the first distal end portion of the first attachment member may be in the first secondary position.

[0105] The first primary radial distance can be less than 10 mm, for example, less than 8 mm or less than 5 mm. The first secondary radial distance can be greater than the first primary radial distance. The first secondary radial distance can be greater than 5 mm, for example, greater than 6 mm or greater than 8 mm. In one or more exemplary drug delivery devices, the first secondary radial distance is in the range of 6 mm to 15 mm.

[0106] In one or more exemplary drug delivery devices, a first attachment member (e.g., a portion of a first needle and / or a first distal end) may be disposed, or at least partially disposed, within a first main recess of a first body member in a first state. In the first state, the first distal end may be disposed within the first body member.

[0107] In one or more exemplary drug delivery devices, a first attachment member (e.g., a portion of a first needle and / or a first distal end) may be disposed in a second state outside a first main recess of a first body member.

[0108] In one or more exemplary drug delivery devices, a first attachment member (e.g., a portion of a first needle and / or a first distal end) may be disposed within a second main recess of a second body member in a first state. Thus, the first attachment member may be configured to lock the first body member relative to the second body member in the first state of the drug delivery device.

[0109] In one or more exemplary drug delivery devices, a first attachment component (e.g., a portion of a first needle and / or a first distal end) may be disposed outside the second body component and / or at least outside the second main recess of the second body component in a second state.

[0110] In one or more exemplary drug delivery devices, an actuation mechanism is configured to move a second distal end portion from a second primary position (e.g., in a first state of the drug delivery device) at a second primary radial distance from the central axis of the delivery device to a second secondary radial distance (e.g., in a second state of the drug delivery device) at a second secondary radial distance from the central axis and / or the primary axis, wherein the second secondary radial distance is greater than the second primary radial distance. Therefore, when the drug delivery device is in the first state, the second distal end portion of the second attachment member may be in the second primary position and / or when the drug delivery device is in the second state, the second distal end portion of the second attachment member may be in the second secondary position.

[0111] The second primary radial distance can be less than 10 mm, for example, less than 8 mm or less than 5 mm. The second secondary radial distance can be greater than the second primary radial distance. The second secondary radial distance can be greater than 5 mm, for example, greater than 6 mm or greater than 8 mm. In one or more exemplary drug delivery devices, the second secondary radial distance is in the range of 6 mm to 15 mm.

[0112] In one or more exemplary drug delivery devices, a second attachment member (e.g., a portion of a second needle and / or a second distal end) may be disposed, or at least partially disposed, within a first recess of a first body member in a first state. Thus, the second attachment member may be configured to lock the first body member relative to the second body member in the first state of the drug delivery device. In the first state, the second distal end may be disposed within the second body member.

[0113] In one or more exemplary drug delivery devices, a second attachment member (e.g., a portion of a second needle and / or a second distal end) may be disposed in a second state or at least partially disposed outside the first body member and / or at least outside the first secondary recess of the first body member.

[0114] In one or more exemplary drug delivery devices, a second attachment component (e.g., a portion of a second needle and / or a second distal end) may be disposed within a second recess of a second body component in a first state.

[0115] In one or more exemplary drug delivery devices, a second attachment component (e.g., a portion of a second needle and / or a second distal end) may be disposed outside a second recess of the second body component in a second state.

[0116] In one or more exemplary drug delivery devices, the actuation mechanism is configured, for example, to move a first distal end relative to a first proximal end of the first attachment member from a first principal position to a first secondary position by rotating about a first axis of rotation of the first attachment member (first base). The angle between the first principal position and the first secondary position may be greater than 10°, for example greater than 45° or greater than 60°.

[0117] In one or more exemplary drug delivery devices, the actuation mechanism is configured, for example, to move the second distal end relative to the second proximal end of the second attachment member from a second principal position to a second secondary position at a second secondary angle position by rotating, for example, about a second rotation axis of the second attachment member (second base). The angle between the second principal position and the second secondary angle position may be greater than 10°, for example greater than 45° or greater than 60°.

[0118] 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 component relative to a second body component (e.g., prevent rotation therefrom) in a first state of the drug delivery device. The locking mechanism may be configured to lock a first attachment component in a first primary position relative to the first body component when the drug delivery device is in the first state. Upon release of the locking mechanism, the first attachment component may be allowed to move from the first primary position to a first secondary position. The locking mechanism may be configured to allow rotation of the first body component relative to the second body component upon release, for example, in a second state of the drug delivery device. The locking mechanism may be configured to lock a second attachment component in a second primary position relative to the second body component when the drug delivery device is in the first state, for example, relative to the second body component. The locking mechanism may be configured to allow the second attachment component to move from the second primary position to a second secondary position upon release.

[0119] The locking mechanism may include a first locking element, optionally configured to lock and / or unlock (release) the first body component relative to the second body component. The first locking element may be configured to lock and / or unlock (release) the first attachment component relative to the first body component. The first locking element may be configured to lock and / or unlock (release) the second attachment component relative to the second body component. The first locking element may be disposed in a first main recess of the first body component and / or a second main recess of the second body component. The first locking element may be configured to dissolve upon the drug delivery device entering or being at a desired location within the gastrointestinal tract, thereby releasing the first body component relative to the second body component and allowing an actuating mechanism to rotate the first body component relative to the second body component, thereby moving the first distal end toward the second distal end, and consequently causing the drug delivery device to attach to internal tissue.

[0120] The first locking element may be a first locking band (e.g., a ring, loop, half-ring, half-loop). The first locking band may have a circumferential length greater than the longitudinal width. For example, the circumferential length may be 2, 3, 4, 5, 6, 7, 8, 9, or 10 times the longitudinal width.

[0121] 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 component or the second body component. 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.

[0122] In one or more exemplary drug delivery devices, the first locking band may be in the shape of a capsule component. 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 locking band and the second locking band may form a complete capsule.

[0123] If the first locking band is located on the first body, it can partially or completely cover the first body recess. Therefore, the first locking band can prevent movement of the first attachment member. If the first locking band is located on the second body, it can partially or completely cover the second body recess. Therefore, the first locking band can prevent movement of the second attachment member. The first locking band can partially or completely cover both the first body recess and the second body recess. The first locking band can partially or completely cover the first body recess, and the second locking band can partially or completely cover the second body recess.

[0124] The first locking band may extend completely along the outer circumference of the drug delivery device. The first locking band may extend around 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100% of the outer circumference of the drug delivery device. The first locking band may extend around 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or more than 95% of the outer circumference of the drug delivery device. The first locking band may extend around the outer circumference of the drug delivery device by up to 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100%.

[0125] In one or more exemplary drug delivery devices, the first locking band may include one or more locking protrusions (e.g., extensions, tabs, fingers, bumps, teeth). For example, the first locking band may include 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 locking protrusions. Locking protrusions may extend longitudinally from only one side of the first locking band. Locking protrusions may extend longitudinally from both sides of the first locking band. Locking protrusions may be equidistantly spaced along the first locking band. Locking protrusions may be unequally spaced along the first locking band.

[0126] One or more locking protrusions may extend toward the longitudinal center of the drug delivery device (e.g., if the first locking band is on the first body component, it extends along the outer surface of the body toward the second body component, or if the first locking band is on the second body component, it extends along the outer surface of the body toward the first body component).

[0127] One or more locking protrusions may be triangular, square, rectangular, circular, or other polygonal shapes. One or more locking protrusions may vary in shape along the first locking band.

[0128] 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 protrusions of a first locking band. The mating features may include one or more mating protrusions (e.g., extensions, projections, fingers, bumps, teeth) extending radially outward from the outer surface of the drug delivery device. The mating features may extend from a first body member, a second body member, or both. The mating features 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 member (e.g., the first body member or the second body member). In an alternative embodiment, one circumferential row of mating features may be located on the first body member, and a second circumferential row of mating features may be located on the second body member.

[0129] 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 locking band. One or more mating protrusions may be inclined in the circumferential direction to form mating recesses (e.g., bends, cavities, spaces, gaps). These mating recesses help lock one or more mating protrusions to one or more protrusions of the first locking band. Furthermore, the mating recesses 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 may fit between one or more mating protrusions. One or more locking protrusions may fit within adjacent mating protrusions. This prevents rotation of the first body relative to the second body. For example, the first locking band will impede rotation of the first body. In some embodiments, a locking protrusion may be located between two mating protrusions, wherein each mating protrusion is inclined in an opposite direction to hold the locking protrusion in place.

[0130] In some embodiments, the mating feature may be a recess extending internally into the drug delivery device. The locking protrusion may therefore extend radially inward rather than longitudinally to mate with the mating feature.

[0131] As described above, when the first locking band is attached and one or more protrusions engage with the mating features, the first body component is locked in place relative to the second body component. As discussed herein, when the first locking band dissolves, the first body component and the second body component can be released from the first locking band.

[0132] Furthermore, the dissolution of the first locking band allows either the first or second attachment member to further rotate out of one of the first and second body recesses. Therefore, when the first and second bodies rotate relative to each other, the first and second attachment members can be rotatably inserted into the tissue.

[0133] In one or more exemplary drug delivery devices, the first locking band may include one or more square locking protrusions and / or one or more triangular locking protrusions. The square locking protrusions can be used to hold the cap in place under the force of the mating protrusions. The triangular locking protrusions can be used to properly position the first locking band.

[0134] In one or more exemplary drug delivery systems, the first locking band may be entirely soluble. In one or more exemplary drug delivery systems, only the square locking protrusions may be formed of a soluble material. Once the square locking protrusions dissolve, rotation of the first body component and the second body component is permitted. Rotation of the first body component relative to the second body component can cause translation of the first locking band, such as movement, repositioning, or relocation. This can occur when the mating protrusions compress the triangular locking protrusions, thereby pushing them longitudinally apart. For example, rotation can cause the first locking band to translate along a central axis.

[0135] This translation can expose the first attachment member and / or the second attachment member, depending on the coverage area of ​​the first locking band. 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 first attachment member and / or the second attachment member while the first locking band remains associated with, for example, the drug delivery device, such as while attached.

[0136] The locking mechanism may include a second locking element, optionally configured to lock and / or unlock (release) the first body component relative to the second body component. The second locking element may be configured to lock and / or unlock (release) the second attachment component relative to the second body component. The second locking element may be disposed in a first secondary recess of the first body component and / or a second secondary recess of the second body component. 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 component relative to the second body component and allowing an actuating mechanism to rotate the first body component relative to the second body component, thereby moving the first distal end toward the second distal end, and consequently causing the drug delivery device to attach to internal tissue.

[0137] One or more exemplary drug delivery devices may include a first covering strip (e.g., a loop, ring, half-loop, or half-circle). The first covering strip may cooperate with a first locking element (e.g., a locking element, locking mechanism). In one or more exemplary drug delivery devices, the first covering strip may be a first locking strip. In one or more exemplary drug delivery devices, the first covering strip may include any or all of the features discussed above with respect to the first locking strip. The first covering strip may have a circumferential length greater than the longitudinal width. For example, the circumferential length may be 2, 3, 4, 5, 6, 7, 8, 9, or 10 times the longitudinal width.

[0138] 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 component or the second body component.

[0139] In one or more exemplary drug delivery devices, the first cover strip may be in the shape of a capsule component. For example, the first cover strip may form a first half of a capsule. The first cover strip may form a first half of a capsule and the second cover strip may form a second half of a capsule. When assembled together, the first cover strip and the second cover strip may form a complete capsule.

[0140] The first cover strip can be mechanically fitted onto 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.

[0141] If the first covering strip is located on the first body, it can partially or completely cover the first body recess. Therefore, the first covering strip can prevent movement of the first attachment member. If the first covering strip is located on the second body, it can partially or completely cover the second body recess. Therefore, the first covering strip can prevent movement of the second attachment member. The first covering strip can partially or completely cover both the first body recess and the second body recess. The first covering strip can partially or completely cover the first body recess, and the second covering strip can partially or completely cover the second body recess.

[0142] The first covering strip may extend completely along the outer circumference 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 circumference 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%, or more than 95% of the outer circumference of the drug delivery device. The first covering band may extend around the outer circumference of the drug delivery device by up to 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100%.

[0143] In one or more exemplary drug delivery devices, the first cover may include one or more mating protrusions (e.g., extensions, projections, fingers, bumps, 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.

[0144] 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 component, it extends along the outer surface of the body toward the second body component, or if the first cover strip is on the second body component, it extends along the outer surface of the body toward the first body component).

[0145] In one or more exemplary drug delivery devices, the drug delivery device may include mating features. The mating features may be configured to mate (e.g., receive, retain, contact) with one or more mating protrusions of a first cover strip. The mating features may include one or more body mating protrusions (e.g., extensions, tabs, fingers, bumps, teeth) extending radially outward from the outer surface of the drug delivery device. The mating features may extend from a first body member, a second body member, or both. The mating features 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 member (e.g., the first body member or the second body member). In an alternative embodiment, one circumferential row of mating features may be located on the first body member, and a second circumferential row of mating features may be located on the second body member.

[0146] 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 inclined in the circumferential direction to form mating recesses (e.g., bends, cavities, spaces, gaps). These mating recesses facilitate the fitting of one or more body mating protrusions onto one or more protrusions of the first cover band. Furthermore, the mating recesses prevent unintended release of the first cover band.

[0147] 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 fit within adjacent mating features. This helps to properly align the first cover strip.

[0148] In some embodiments, the mating feature may be a recess extending internally into the drug delivery device. The mating protrusion may therefore 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 component relative to the second body component can cause translation of the cover strip, such as movement, repositioning, or relocation. For example, rotation can cause translation of the cover strip along a central axis. This translation can expose the first and / or second attachment components, depending on the coverage area of ​​the cover strip. This can occur, for example, when the mating protrusion can compress triangular or other shaped mating protrusions, thereby pushing them longitudinally away. Translation can cause the cover strip to be completely translated away from the drug delivery device. Translation can also cause the cover strip to be partially translated to expose the first and / or second attachment components when associated with, for example, the drug delivery device, such as when attached.

[0149] In one or more exemplary drug delivery devices, the first cover strip may be soluble. Dissolution of the first cover strip may allow the first or second attachment member to further rotate out of one of the first and second body recesses. Thus, when the first and second bodies rotate relative to each other, the first and second attachment members can be rotatably inserted 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 components and / or activation of drug delivery are controlled to occur at a desired location in the gastrointestinal tract (e.g., in 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 / fluids.

[0150] In one or more exemplary drug delivery devices, at least a portion of the first attachment member and / or the second attachment member may be made of a biodegradable material, an absorbent material, or a similar material that allows the attachment member to be decomposed, degraded, and / or dissolved by processes present in vivo (e.g., corrosion, degradation, hydrolysis, and / or proteolytic enzyme degradation). Therefore, when the attachment members have been present in the human body for a period of time, the attachment members may dissolve, decompose, or degrade to a degree that the attachment members lose their structural stability, thereby releasing the drug delivery device from the surface to which it is attached. Thus, after a period of time, such as when a drug has been released from the attachment members, the degree of degradation of the attachment members may allow the drug delivery device to be released and to continue its journey through the gastrointestinal tract to be released by the user's or patient's natural bowel and / or defecation movements.

[0151] In one or more exemplary drug delivery devices, the axis of rotation (main axis) of the first body component and / or the second body component may be the central axis of the drug delivery device. For example, the main axis of the first body component may be coaxial with the central axis. Therefore, the central axis intersects with both the first and second body components and may define the main axis.

[0152] In one or more exemplary drug delivery devices, the first body component and the second body component may be substantially symmetrical in a radial direction perpendicular to the central axis. This may mean that the first body component and / or the second body component may have a circular outer periphery, which may extend in a radial direction away from and perpendicular to the central axis.

[0153] The first attachment axis can be considered as an axis coaxial with the length of the first attachment member. The second attachment axis can be considered as an axis coaxial with the length of the second attachment member. When the first attachment member has a non-flat shape, the first attachment axis can be defined as an axis intersecting the first distal end and the first proximal end of the first attachment member. When the second attachment member has a non-flat shape, the second attachment axis can be defined as an axis intersecting the second distal end and the second proximal end of the second attachment member.

[0154] In one or more exemplary drug delivery devices, a first attachment axis may be positioned at a first distance from the central axis, while a second attachment axis may be positioned at a second distance from the central axis and / or the main axis.

[0155] For example, in the first state of the drug delivery device, the first attachment axis can be positioned at a first principal distance from the central axis. The first principal distance can be greater than 0.5 mm, for example, in the range of 1 mm to 15 mm or greater than 1 mm, such as 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 first attachment axis may intersect or approach the central axis (with a distance of less than 0.5 mm).

[0157] In the second state of the drug delivery device, the first attachment axis can be positioned at a distance from the central axis at a first set distance. The first set distance can be greater than 0.5 mm, for example, in the range of 1 mm to 15 mm or greater than 1 mm, such as 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 first attachment axis may intersect or approach the central axis (with a distance of less than 0.5 mm).

[0159] For example, in the first state of the drug delivery device, the second attachment axis can be positioned at a second principal distance from the central axis. The second principal distance can be greater than 0.5 mm, for example, in the range of 1 mm to 15 mm or greater than 1 mm, such as 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.

[0160] In the first state of the drug delivery device, the second attachment axis may intersect or approach the central axis (with a distance of less than 0.5 mm).

[0161] In the second state of the drug delivery device, the second attachment axis can be positioned at a second distance from the central axis. The second distance can be greater than 0.5 mm, for example, in the range of 1 mm to 15 mm or greater than 1 mm, such as 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.

[0162] In the second state of the drug delivery device, the second attachment axis may intersect or approach the central axis (with a distance of less than 0.5 mm).

[0163] In one or more exemplary drug delivery devices, a first attachment member (first attachment axis) and / or a second attachment member (second attachment axis) may be configured to be at an angle to each other when they intersect a plane including a central axis. This plane may be a plane including the central axis, wherein the plane also includes a radial axis extending perpendicularly to the central axis. When the first attachment member intersects the plane, the first attachment axis of the first attachment member may be at an angle to the plane such that a first distal end of the first attachment member is a first portion of the first attachment member intersecting the plane, wherein the remainder of the first attachment member subsequently intersects the plane during rotational movement. The second attachment member may intersect the same plane from an opposite side, wherein a second distal end of the second attachment member is a first portion of the second attachment member intersecting the plane, wherein the remainder of the second attachment member subsequently intersects the plane during rotational movement. Thus, the second attachment member may optionally intersect the plane from a direction of rotation opposite to that of the first attachment member. This also means that when the first and second distal ends of the respective first and second attachment components contact the plane, the first attachment component (first attachment axis) forms an angle with the plane and an angle with the second attachment component (second attachment axis). The angle between the first attachment component (first attachment axis) and the second attachment component (second attachment axis) and the plane can be approximately half the size of the angle between the first and second attachment components.

[0164] In one or more exemplary drug delivery devices, a first body component may be configured to rotate in a first direction and a second body component may be configured to rotate in a second direction, wherein the first direction is opposite to the second direction. Thus, as an example, the first body component may rotate clockwise, while the second body component may rotate counterclockwise. In one or more examples where the drug delivery device includes three or more body components, abutting or adjacent body components may rotate in opposite directions. This could also mean that every other body component may rotate in the same direction. For example, where the first and third body components rotate in the same first direction, the second and / or fourth body components may rotate in a second direction opposite to the first direction.

[0165] In one or more exemplary drug delivery devices, the actuation mechanism may include one or more resilient components, such as multiple resilient components.

[0166] In one or more exemplary drug delivery devices, a first distal end of a first attachment member and / or a second distal end of a second attachment member may be provided with a sharp tip configured to penetrate biological tissue. The sharp tip may be positioned near the distal end of the respective attachment member, wherein the sharp tip may be configured such that its diameter at the distal end is smaller than the diameter of the attachment member at a distance from the distal end. The sharp tip may be configured such that when a rotational force is applied to the first attachment member and a reaction force is applied to the second attachment member, the reaction force may cause the sharp tip to penetrate the biological tissue due to the force applied by the actuation mechanism.

[0167] When the first attachment member and / or the second attachment member penetrates biological tissue due to rotation between the first and second main body components (movement of the first distal end toward the second distal end), corresponding penetration points(s) in the biological tissue can be used to deliver the drug from the drug delivery device into the biological tissue, and the drug can be introduced into the biological tissue beyond the mucosa. Thus, compared to the release of the drug in the stomach or intestinal lumen, the drug can more easily enter the bloodstream, and drug delivery can be more efficient. An example of this is the case where the drug is insulin, where insulin may degrade in the gastrointestinal tract and cannot be absorbed from it, but when the mucosa has been penetrated and insulin is released through the penetrated gastrointestinal tract, the insulin will remain intact and reach the user's bloodstream via blood vessels in the intestinal layer beyond the mucosa (surface).

[0168] In one or more exemplary drug delivery devices, a first attachment member and / or a second attachment member may be provided with a clamping member configured to clamp biological tissue. The clamping member can be used to increase the traction between the attachment member and the mucosa, thereby allowing the attachment member to anchor the drug delivery device within the user's body. The clamping member can be a component that increases the mechanical friction between the attachment member and the surface to be attached, wherein the clamping member may, for example, be hook-shaped, or, for example, have a shape such that the clamping member of the first attachment member faces the clamping member of the second attachment member, such that biological tissue positioned between the first and second attachment members is clamped between the two clamping members.

[0169] In one or more exemplary drug delivery devices, a portion of an elastic member may be connected to a first body member, and a second portion of the elastic member may be connected to a second body member. This means that the elastic member can be used to store energy, such as rotational energy or rotational force applied to the first and second body members, wherein the energy is stored in the elastic member. Furthermore, when energy is released, such as when the locking element dissolves or degrades, force can be released to both the first and second body members, which in turn transmits force to the first and second attachment members. The elastic member may be, for example, in the form of a helical coil spring (main spring) and / or a helical torsion spring, wherein the first body member can be wound relative to the second body member by rotating the first body member relative to the second body member. This stores energy in the main spring by twisting the helix more tightly. Then, as the main spring unfolds, the force stored in the main spring can cause the first body member to rotate in the opposite direction. Thus, the force of the main spring can cause the first and second attachment members to travel in opposite directions, and wherein the attachment members can clamp and hold or penetrate biological tissue to attach the drug delivery device to the biological tissue.

[0170] Once the drug delivery device has entered the body and, for example, reached a desired site in the gastrointestinal tract, can be configured to transition from a first state to a second state. This transition can be activated in various ways, such as by using a locking mechanism to hold the first and second body components in the first state. This locking mechanism may include, for example, one or more locking elements made of a soluble, expandable, or degradable material, which reacts with the surrounding environment (e.g., a fluid) within the desired body site, thereby unlocking or releasing the locking mechanism. The material of the locking elements may be one that loses its structural force upon contact with the surrounding environment within the desired body site. An example could be that the locking elements(s) are made of a polymeric material or a sugar-containing substance that dissolves, expands, or degrades upon contact with a specific type of fluid, which may include enzymes or specific types of acids found in the digestive system. When the locking elements come into contact with a reagent, the material may dissolve, expand, or degrade over time, and the rotational force can be released via rotation of the first body component relative to the second body component, or vice versa, when the rotational force of the drug delivery device exceeds the resting force of the locking elements.

[0171] In one or more exemplary drug delivery devices, a locking element can secure the attachment member in a position where the attachment element locks the first body member relative to the second member, i.e., preventing the first body member from rotating relative to the second body member. When the locking element dissolves or degrades, the attachment member can be moved to a secondary position, for example by an actuation mechanism, in which the attachment member does not lock the first body member relative to the second member, the actuation mechanism causing the body member to which the attachment member is rotatably attached to rotate about a rotation axis.

[0172] The second state of the drug delivery device can be considered as a state activated by releasing energy stored in the actuation mechanism (e.g., the elastic components of the actuation mechanism) into rotational forces of the first main component and / or the second main component and / or rotational forces of the first attachment component relative to the first main component. The termination of the second state can be considered as the point in time when the energy stored in the elastic components becomes fixed again, i.e., when the attachment component has clamped or penetrated biological tissue and / or the rotational movement between the first and second main components ceases.

[0173] In one or more exemplary drug delivery devices, the drug delivery device may have a first state in which the actuating mechanism has a constant elastic force load and a second state in which the actuating mechanism releases the elastic force load. In the first state, the constant elastic force load can be considered as energy stored in the actuating mechanism and in which the elastic force load is greater than zero. The second state can be considered as a state in which the actuating mechanism releases its elastic force load, wherein the elastic force load is reduced, for example, by rotating the first body component relative to the second body component, such as bringing it close to zero. The second state may terminate when the attachment component contacts or penetrates biological tissue and the elastic force load does not change even though it has not reached zero. Thus, 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 fixed after the elastic force is released.

[0174] The first and / or second attachment members may have an unfolding function, wherein during a first state of the drug delivery device (i.e., the initial state of the drug delivery device), the attachment members are positioned or disposed within the first and / or second body members, or alternatively, the first and / or second attachment members may fold along the sides of the body members. Other ways to achieve the same are conceivable. The folded state (first state) may be held in place, for example, using a releasable locking mechanism, band, or stopper (e.g., made of gelatin, sugar, or other soluble or non-structural materials) similar to a drug capsule encapsulation. Thus, the attachment members may be held in place until the drug delivery device enters the gastrointestinal tract (e.g., the stomach) so that the attachment members do not interfere with or damage the lining of the mouth and / or esophagus. Before or during the transition to the second state, the attachment members may extend outward from the body members, preparing them to interact with the lining of the digestive system. When one or more attachment members are in the folded or collapsed position, the distance from the central axis to the distal end of the attachment member is longer in the second state than in the first state. Therefore, the diameter of the drug delivery device in the first state will be smaller than the diameter of the drug delivery device in the second state.

[0175] In one or more exemplary drug delivery devices, at least a portion of the first attachment member and / or the second attachment member (e.g., the first needle and / or the second needle) may be made of one or more materials including magnesium, titanium, iron, and zinc to allow for precise and accurate control of the size and / or shape / geometry of the first attachment member and / or the second attachment member, thereby allowing the delivery device to have the desired attachment capability and / or small manufacturing variations that are particularly important in the pharmaceutical industry.

[0176] The first attachment component (e.g., the first needle) may be made of one or more materials including magnesium, titanium, iron, and zinc. The material of the first attachment component / first needle may be biocompatible and / or biodegradable, such as biocompatible and / or biodegradable materials. The material of the first attachment component / first needle may include one or more biodegradable polymers, such as PLA and / or POLGA. Some, a portion, most, substantially all, or all of the material of the first attachment component / first needle may be biocompatible and / or biodegradable. The material of the first attachment component (e.g., the first needle) may include, be composed of, or substantially composed of, a biocompatible and / or biodegradable material (e.g., a biocompatible and / or biodegradable metal). The material of the first attachment component (e.g., the first needle) may include a biodegradable or bioabsorbable metal or metal alloy, such as magnesium, zinc, and / or iron, or an alloy containing one or more of magnesium, zinc, and iron. Biodegradable or bioabsorbable metals or metal alloys can be understood as metals or metal alloys that degrade safely in the human body, for example, within a practical timeframe relevant to their application. The material of the first attachment component (e.g., the first needle) may include one or more metals, such as combinations of one or more metals (e.g., metal alloys).

[0177] The second attachment component (e.g., the second needle) may be made of one or more materials including magnesium, titanium, iron, and zinc. The material of the second attachment component / second needle may be biocompatible and / or biodegradable, such as biocompatible and / or biodegradable materials. The material of the second attachment component / second needle may include one or more biodegradable polymers, such as PLA and / or POLGA. Some, a portion, most, substantially all, or all of the material of the second attachment component / second needle may be biocompatible and / or biodegradable. The material of the second attachment component (e.g., the second needle) may include biocompatible and / or biodegradable materials (e.g., biocompatible and / or biodegradable metals), be composed of, or be substantially composed of such materials. The material of the second attachment component (e.g., the second needle) may include biodegradable or bioabsorbable metals or metal alloys, such as magnesium, zinc, and / or iron, or alloys containing one or more of magnesium, zinc, and iron. Biodegradable or bioabsorbable metals or metal alloys can be understood as metals or metal alloys that degrade safely in the human body, for example, within a practical timeframe relevant to their application. The material of the second attachment (e.g., the second needle) may include one or more metals, such as a combination of one or more metals (e.g., a metal alloy).

[0178] The advantage of using biodegradable materials for the attachment components is that, because the biodegradable materials will gradually degrade over time, the delivery device can deliver the active drug or payload disposed in the attachment components and / or body components of the delivery device at a specific body part (e.g., stomach or intestine) of the subject and over an extended period of time, after the delivery device has been attached to an inner surface (e.g., the intestinal wall) according to the sharp characteristics of the materials of the attachment components. Furthermore, when the materials of the attachment components are biodegradable, the attachment components will degrade and disappear in the human body after delivery of the payload / active drug contained in the drug delivery device, thereby avoiding harm to the human subject over time. The attachment components can be configured to degrade within 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).

[0179] The material of the (multiple) attachment components (e.g., (multiple) needles) may include one or more of magnesium (Mg), zinc (Zn), and / or iron (Fe) or combinations thereof. An advantage of having (multiple) attachment components made of materials including Mg, Zn, and / or Fe is that the shape and size of (multiple) attachment components can be precisely controlled, thereby improving attachment to internal surfaces (e.g., the intestinal lining of a human subject).

[0180] For example, the material of (multiple) attachment components (e.g., (multiple) pins) may include 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.

[0181] For example, the material of (multiple) attachment components (e.g., (multiple) pins) may include 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.

[0182] For example, the material of (multiple) attachment components (e.g., (multiple) pins) may include 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.

[0183] For example, the material of (multiple) attachment components (e.g., (multiple) pins) may include 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.

[0184] The material of the (multiple) attachment parts (e.g., (multiple) pins) may include a metallic alloy, such as Zn-Mg, Zn-Fe, Mg-Fe, or Zn-Mg-Fe. For example, the material of the (multiple) attachment parts (e.g., (multiple) pins) may include a Zn-Mg alloy containing 0.001 wt% Mg, 0.005 wt% Mg, 0.01 wt% Mg, 0.05 wt% Mg, 0.1 wt% Mg, 0.5 wt% Mg, 1 wt% Mg, 5 wt% Mg, 10 wt% Mg, 20 wt% Mg, 30 wt% Mg, 40 wt% Mg, 50 wt% Mg, 60 wt% Mg, 70 wt% Mg, 80 wt% Mg, or 90 wt% Mg.

[0185] For example, the material of (multiple) attachment components (e.g., (multiple) pins) may include a Zn-Fe alloy containing 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.

[0186] For example, the material of (multiple) attachment components (e.g., (multiple) pins) may include an alloy of Mg-Fe, wherein 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.

[0187] For example, the material of (multiple) attachment components (e.g., (multiple) pins) may include a Zn-Mg-Fe alloy, wherein 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, 0.5 wt% Mg, 0.5 wt% Mg, 0.001 wt% Mg, 0.005 wt% Mg, 0.01 wt% Mg, 0.05 wt% Mg, 0.1 ...001 wt Mg by weight, 1% Mg, 5% Mg, 10% Mg, 20% Mg, 30% Mg, 40% Mg, 50% Mg, 60% Mg, 70% Mg, 80% Mg, 90% Mg, 0.001% Zn, 0.005% Zn, 0.01% Zn, 0.05% Zn, 0.1% Zn, 0.5% Zn, 1% Zn, 5% Zn, 10% Zn, 20% Zn, 30% Zn, 40% Zn, 50% Zn, 60% Zn, 70% Zn, 80% Zn or 90% Zn.

[0188] Multiple attachment components (e.g., multiple needles) may be made of a material comprising one or more thermoplastic or thermosetting polymers. The material of the multiple attachment components (e.g., multiple needles) may include one or more active pharmaceutical ingredients. Thus, an active pharmaceutical ingredient may be embedded in the material of the multiple attachment components (e.g., multiple needles) to form a pharmaceutical composition.

[0189] In some embodiments, for example, the attachment components (e.g., the needles) may include water-soluble, water-insoluble, biodegradable, non-biodegradable, and / or pH-dependent soluble materials. In some embodiments, the attachment components (e.g., the needles) may include water-soluble, biodegradable, and / or pH-dependent materials that are soluble and / or degradable, such that the attachment components (e.g., the needles) temporarily placed in intestinal tissue may gradually degrade and / or dissolve. In some embodiments, the attachment components (e.g., the needles) may include water-soluble materials to allow for immediate or moderate release of the active drug, depending on the selected material. In some embodiments, water-insoluble or biodegradable materials may allow for the storage of the active drug within the attachment components (e.g., the needles) to extend the duration of release (e.g., days, weeks, or months). In some embodiments, pH-dependent soluble materials may allow the attachment components (e.g., needles) to remain intact at pH conditions below physiological levels (e.g., pH approximately 7.4), thus remaining intact in the gastrointestinal lumen, but subsequently dissolving 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 drug over a controlled release duration (e.g., minutes, hours, days, weeks, or months), for example, through diffusion or corrosion of the attachment components (e.g., needles).

[0190] In some embodiments, the (multiple) attachment components (e.g., multiple) needles may be made of different compositions. For example, the outer portion of the (multiple) attachment components (e.g., multiple) needles may be made of one composition, and the inner core of the (multiple) attachment components (e.g., multiple) needles may be made of another composition. In some embodiments, the outer portion and inner core of the (multiple) attachment components (e.g., multiple) needles may be composed of, for example, water-soluble materials, water-insoluble materials, biodegradable materials, and / or pH-dependent materials. In some embodiments, one or more water-soluble materials, water-insoluble materials, biodegradable materials, and / or pH-dependent materials may be combined to control the release of the active drug after the (multiple) attachment components (e.g., multiple) needles have moved their position from the lumen to internal tissue (e.g., from the gastrointestinal lumen to the gastrointestinal tissue).

[0191] In some embodiments, the attachment components (e.g., the needles) may be tubular and may include a tubular body, which may include an active drug (e.g., a liquid payload containing the active drug) optionally connected to the tubular attachment components such that the payload containing the active drug can flow through the attachment components (e.g., the needles) into internal tissue (e.g., intestinal tissue). In some embodiments, the tubular body may include an expandable (e.g., swellable) excipient that can expand via a chemical reaction (e.g., volume expansion upon mixing) and / or generate gas to facilitate payload delivery. In some embodiments, expansion is achieved through osmosis.

[0192] In some embodiments, the first compartment (the compartment holding the active drug) may include a closing component for closing the first compartment. The closing component may help improve control over the release of the active drug. In some embodiments, the closing component may be composed, for example, of a water-soluble material, a water-insoluble material, a biodegradable material, and / or a pH-dependent material. In some embodiments, one or more water-soluble, water-insoluble, biodegradable, and / or pH-dependent materials may be combined to control the release of the active drug from the first compartment after the attachment component(s) (e.g., needle(s)) has moved its position from the lumen to internal tissue (e.g., from the gastrointestinal lumen to the gastrointestinal tissue).

[0193] Figure 1 An exploded view of a drug delivery device 2 according to the present invention is shown, wherein the drug delivery device includes a first body component 4 having a first end 6 and a second end 8, and a second body component 10 having a first end 12 and a second end 14. During assembly, the first body component 4 is rotatably connected to the second body component 10, wherein the first end 6 of the first body component abuts against the first end 12 of the second body component during connection.

[0194] The drug delivery device 2 also includes an actuation mechanism 16, which includes an elastic member 16A, which in this example is in the form of a helical torsion spring. A first portion 18 of the elastic member 16A (a first end of the helical torsion spring) is positioned on the outer periphery 22 of the helical torsion spring, and a second portion 20 of the elastic member 16A (a second end of the helical torsion spring) is located in the central portion 24 of the helical torsion spring.

[0195] The first body component 4 includes an internal volume 26 adapted to receive the resilient member 16A, and wherein the inner surface 28 of the internal volume 26 includes one or more first engagement portions 30 configured to engage with a first portion 18 of the resilient member 16A, and wherein the first engagement portions can hold the position of the first portion during rotational movement of the first body component 4 and the second body component 10 relative to each other. A second portion 20 of the resilient member 16A is configured to engage with a second engagement portion 32 (see...). Figure 2 The second joint is centrally located within the second main body component 10. For example... Figure 2 As shown, the second engagement portion 32 is configured to extend into the central portion 24 of the spring when the spring is positioned within the internal volume 26 of the first body member 4. The second engagement portion 32 includes a slit or groove 34 adapted to engage with the second portion 20 of the elastic member 16A, such that rotational movement of the first body member 4 and / or the second body member 10 when the first portion 18 engages with the first engagement portion 30 can cause the elastic member 16A to be wound.

[0196] 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 main body component 4 toward the second end 14 (the second end of the drug delivery device) of the second main body component. The central axis A can be considered as defining the main axis around which the first main body component 4 and the second main body component 10 rotate.

[0197] The first engagement 30 and the first portion 18 of the elastic member 16A are engageable, meaning that when the load in the spring exceeds a predetermined level, the first end releases the first engagement 30 and jumps to engage with the next engagement 30'. This means that the drug delivery device can have a torque limiter, which ensures that the energy stored in the elastic member 16 does not exceed a predetermined limit.

[0198] The drug delivery device 2 includes a first attachment member 36 having a first proximal end portion 38 and a first distal end portion 40. The first attachment member 36 includes a straight first needle 37 and is securely attached to a first body member 4. The first attachment member 36 extends from the outer surface 42 of the first body member 4 along a first attachment axis (see [link to attachment axis]). Figure 2 The first distal end 40 of the first attachment member 36 may be a sharp tip capable of penetrating biological tissue, wherein the rotational force provided by the elastic member 16A can be used to penetrate body tissue (see also...). Figure 7 ).

[0199] The drug delivery device 2 includes a second attachment member 44 having a second proximal end portion 46 and a second distal end portion 48. The second attachment member 44 includes a straight second needle 45 and is securely attached to the first body member 4. The second attachment member 44 extends from the outer surface 50 of the second body member 10 along a second attachment axis (see [link to attachment]). Figure 2 The second distal end 48 of the second attachment member 44 may be a sharp tip capable of penetrating biological tissue, wherein the rotational force provided by the elastic member 16A can be used to penetrate body tissue (see also...). Figure 7 ).

[0200] The distal ends 40 and 48 of the attachment parts 36 and 44 may be sharp tips 52, which may be similar to the sharp tip of a hypodermic needle, and are capable of penetrating body tissue, such as the intestine, stomach, large intestine, or other parts of the digestive system and / or the mucosa of the gastrointestinal system. The needles 37 and 45 may be hollow, having an opening 56 at the distal ends 40 and 48, such that after the attachment parts 36 and 44 have penetrated biological tissue (e.g.,... Figure 7 (As shown) The active drug can then be introduced into the body tissues through opening 56.

[0201] The elastic force of the elastic member 16A is used to rotate the first main body member about the central axis A in the first direction B and to rotate the second main body member about the central axis A, which serves as the main axis, in the second direction C. Figure 1 and Figure 2 As shown and in Figure 11A-11D The details are shown in more detail. In other words, the actuation mechanism 16 (elastic member 16A) is configured to move the first distal end 40 toward the second distal end 48.

[0202] The first main body component 4 has a first main recess 64 in its outer surface 42, and the second main body component 10 has a second main recess 66 in its outer surface 50. The first main recess 64 and the second main recess 66 are part of a locking mechanism for locking the first main body component 4 relative to the second main body component 10, for example, preventing rotation, by providing a first locking element in the first main recess 64 and the second main recess 66 when the drug delivery device 2 is in the first state.

[0203] Figure 2A side sectional view of the drug delivery device 2 is shown. A first attachment member 36 / first needle 37 extends along a first attachment axis X_1 perpendicular to the central axis A. A second attachment member 44 / second needle 45 extends along a second attachment axis X_2 perpendicular to the central axis A. The first needle 37 optionally includes a first compartment 68 configured to contain an active drug substance. The first compartment 68 may optionally be configured as a through-hole or cavity in the first needle 37. The second needle 45 optionally includes a second compartment 69 configured to contain an active drug substance. The second compartment 69 may optionally be configured as a through-hole or cavity in the second needle 45.

[0204] Figure 3 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 main recess 64, a second main recess 66, and a first locking element 72 disposed in the first main recess 64 and the second main recess 66. The first locking element 72 is capable of preventing rotational movement of the first body component 4 and the second body component 10 relative to each other, thereby maintaining a stationary relationship between the body components 4 and 10. The first locking element 72 may be in the form of a biodegradable material (e.g., 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 components 4 and 10 via the elastic member 16A exceeds the stationary force of the (degraded) first locking element 72, the first locking element 72 will release the body components 4 and 10, and allow the elastic member 16A to release its stored energy, thereby causing the first body component 4 to rotate relative to the second body component 10 in a second state of the drug delivery device.

[0205] Figure 4 The drug delivery device 2 is shown, wherein the first locking element 72 has been degraded or dissolved, and the second body component 10 has been rotated relative to the first body component 4 in direction C. Therefore, the second distal end 48 of the second attachment member 44 is released from the body components 4, 10 by a rotational force (torque) applied from within the internal volume 26. Figure 3 The second master position in the first state is moved to Figure 4 The second auxiliary position is shown. During the rotation of the first main body component 4 relative to the second main body component 10, the actuation mechanism moves the first distal end 40 toward the second distal end 48.

[0206] Figure 5 and Figure 6 Shown through side and end views Figure 4The drug delivery device 2 shown illustrates that attachment members 36 and 44 have crossed axis D, which can be considered, for example, as a plane including both central axis A and axis D. When attachment members 36 and 44 cross the imaginary plane (considered axis D), the opposing forces applied to the distal ends of the attachment members in direction B against the first attachment member 36 and in direction C against the second attachment member 44 ensure that the distal ends can clamp onto the surface area and penetrate or clamp the surface of the biological tissue. When the drug delivery device 2 is located, for example, in the intestine, the intestine pushes the device to at least one surface area of ​​the biological tissue such that the forces applied to the attachment members do not push the device away from the surface, as the opposing surface holds the device near the surface. If the device is not initially clamped, the actuating mechanism can have sufficient force for multiple rotations such that the attachment members will again attempt to clamp the surface and fix the drug delivery device relative to the biological tissue when the attachment members come closer together again.

[0207] Figure 7 A drug delivery device 2 is shown in a second state after attachment to body tissue 74, such as the stomach or intestinal wall. Rotation of the first main body member 4 relative to the second main body member 10 and movement of the first distal end 40 toward the second distal end 48 cause the distal ends 40, 48 to penetrate the body tissue 74 and enter the body tissue. Residual elastic forces from the actuating mechanism retain the attachment members 36, 44 within the body tissue 74. Thus, the drug delivery device 2 is attached to the body tissue, and the active drug can be released from compartments 68, 69 and / or via opening 56, thereby reaching the bloodstream, for example, via blood vessels in the body tissue 74.

[0208] Figure 8 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 includes an active drug disposed in a first compartment 68 and / or a second compartment 69. The shell 76 may close the drug delivery device 2 to make it easier to swallow. The soluble shell 76 dissolves in the gastrointestinal tract, and the drug delivery device 2 cannot be engaged or attached before the shell 76 is dissolved. These shells are known in the art in the form of drug capsules, wherein the material of the drug capsule may be similar to that of rigid drug capsule shells known in the art, such as gelatin. In one or more exemplary pharmaceutical compositions, the drug delivery device may be coated.

[0209] Figure 9An exploded view of an exemplary drug delivery device according to the present invention is shown. The drug delivery device 2A has a central axis A and includes a two-piece first body component 4, comprising a first main body component 4A and a first auxiliary body component 4B. The drug delivery device 2A includes a first attachment component 36, which includes a first base 36A and a first needle 37 attached to the first base 36A. The first attachment component 36 has a first distal end 40 and is rotatably attached to the first body component 4 via a first connector connection formed by a cylindrical first base 36A and a corresponding cylindrical cavity in the first body component 4, the first connector having a first axis of rotation X_R_1. Therefore, the first attachment component 36 is configured to rotate relative to the first body component 4 about the first axis of rotation. The first axis of rotation X_R_1 is parallel to the central axis A.

[0210] The drug delivery device 2A includes a two-piece second body component 10, comprising a second main body component 10A and a second auxiliary body component 10B. The drug delivery device 2A includes a second attachment component 44, which includes a second base 44A and a second needle 45 attached to the second base 44A. The second attachment component 44 has a second distal end portion 48 and is optionally rotatably attached to the second body component 10 via a second connector connection formed by a cylindrical second base 44A and a corresponding cylindrical cavity in the second body component 10, the second connector having a second axis of rotation X_R_2. Therefore, the second attachment component 44 is configured to rotate relative to the second body component 10 about the second axis of rotation. The second axis of rotation X_R_2 is parallel to the central axis A.

[0211] The drug delivery device 2A includes a frame member 78 formed as a shaft member or rod, wherein different components such as a first body member and / or a second body member are attached (e.g., fixedly or rotatably attached) to the frame member 78.

[0212] The drug delivery device 2A includes an actuation mechanism 16, which includes an elastic member 16A configured to move the first distal end 40 toward the second distal end 48 by rotating the first body member 4 relative to the second body member 10.

[0213] Now refer to Figure 10 The first attachment member 36 is configured to rotate relative to the first main body member 4 about a first axis of rotation, such that the first distal end 40 moves from a first primary position (e.g., in the first state) at a first primary radial distance from the central axis A of the delivery device 2A to a first secondary position (in the second state) at a first secondary radial distance from the central axis A. Figure 10(as shown in the diagram), wherein the first secondary radial distance is larger than the first primary radial distance, for example, at least 2 mm larger. The first body 4 includes a first primary recess 64 that receives the first attachment member 36 or at least some portions thereof (e.g., in the first state). The actuation mechanism 16 is optionally configured to move the first distal end from the first primary position to the first secondary position. In the first secondary position, the first attachment member 36 is configured to rotate relative to the first body member 4 about a first axis of rotation to move the first distal end relative to the first proximal end of the first attachment member from the first primary position to the first secondary angular position of the first secondary position (in the first primary position). Figure 10 (As shown in the diagram). In the illustrated drug delivery device 2A, the angle between the first principal position and the first secondary position is greater than 10°, or even greater than 30°, for example, in the range of 35° to 85°. The actuation mechanism 16 is optionally configured to move the first distal end from the first principal position to the first secondary position.

[0214] The second attachment member 44 is configured to rotate about a second rotation axis relative to the second main member 10, such that the second distal end 48 moves from a second primary position (e.g., in the first state) at a second primary radial distance from the central axis A of the delivery device 2A to a second secondary position (in the second secondary radial distance from the central axis A). Figure 10 (as shown in the diagram), wherein the second secondary radial distance is larger than the second primary radial distance, for example, by at least 2 mm. The second body 10 includes a second primary recess 66 that receives the second attachment member 44 or at least some portions thereof (e.g., in the first state). The actuation mechanism 16 is optionally configured to move the second distal end from the second primary position to the second secondary position.

[0215] The second attachment member 44 is configured to rotate about a second rotation axis relative to the second main body member 10, such that the second distal end relative to the second proximal end of the second attachment member moves from a second principal position to a second secondary position (in the second main position). Figure 10 (As shown in the diagram). In the illustrated drug delivery device 2A, the angle between the second principal position and the second auxiliary position is greater than 10°, or even greater than 30°, for example, in the range of 35° to 85°. The actuation mechanism 16 is optionally configured to move the second distal end from the second principal position to the second auxiliary position.

[0216] Figures 11A to 11DSchematic diagrams of drug delivery devices 2, 2A, 2B, and 2C are shown, wherein the first attachment member 36 and the second attachment member 44 are in different positions in a second state of the drug delivery device. The first attachment member 36 has a first attachment axis X_1, and the second attachment member 44 has a second attachment axis X_2. When the first attachment member 36 and the second attachment member 44 are in contact with a plane including the central axis A and the planar axis D, the angle α between the first attachment axis X_1 and the second attachment axis X_2 can be in the range of 5° to 75°, for example, in the range of 20° to 60°. The magnitude of this angle can increase or decrease as the distance between the central axis and the attachment axes X_1 and X_2 or as the length of the attachment members 36 and 44 changes. However, angle α ensures that the drug delivery device can deliver drugs in a safe and efficient manner. Figure 11A The position shown is oriented towards Figure 11C During the positional shift shown, the biological tissue can be clamped between the two attachment members 36 and 44, and if the attachment members penetrate, it will move towards... Figure 11D The increased rotation at the indicated position uses elastic force to pull the drug delivery device 2 closer to the tissue surface that can be captured by the attachment component.

[0217] Figure 12 An exemplary drug delivery device 2B in a first state is shown, and Figure 13 The drug delivery device 2B in a second state is shown. In the first state, a first attachment member 36 having a first needle 37 is optionally disposed within a first body member 4 and / or a first distal end portion is disposed at a first main position at a first main radial distance from the central axis. The first main radial distance may be less than 10 mm, for example less than 8 mm or less than 5 mm. In the first state, a first distal end portion 40 is optionally disposed within the first body member 4.

[0218] In the first state, the second attachment member 44, having the second needle 45, is optionally disposed within the second body member 10 and / or the second distal end is positioned at a second primary position at a second primary radial distance from the central axis. The second primary radial distance may be less than 10 mm, for example, less than 8 mm or less than 5 mm. In the first state, the second distal end 48 is optionally disposed within the second body member 10. Disposing of the attachment member(s) / distal end(s) within the body member(s) facilitates or allows for smooth oral administration.

[0219] In the second state, the first distal end 40 has been ejected from the first main body component 4 through the first opening 80 to a first secondary position at a first secondary radial distance from the central axis. The first secondary radial distance is greater than the first main radial distance and can be greater than 5 mm, for example, greater than 6 mm or greater than 8 mm.

[0220] In the second state, the second distal end 48 has been ejected from the second main body component 10 through the second opening 82 to a second secondary position located a second secondary radial distance from the central axis. This second secondary radial distance is greater than the second main radial distance and can be greater than 5 mm, for example, greater than 6 mm or greater than 8 mm. Figure 13 In the second state of the drug delivery device 2B shown, an actuation mechanism (not shown) rotates the first body member 4 relative to the second body member 10 and optionally relative to the frame member 78 about a central axis A, so that the first distal end 40 moves toward the second distal end 48. The actuation mechanism may be configured to rotate the second body member 10 relative to the frame member 78 about a central axis A.

[0221] Figure 14 An exemplary drug delivery device 2C in a first state is shown, and Figure 15 The drug delivery device 2C in its second state is shown. In the first state, a first attachment member 36 having a first needle 37 is disposed within a first main recess 64 and a second main recess 66 and locked by a first locking element 72. Therefore, the first attachment member 36 and the first locking element 72 prevent rotation of the first and second main body components. A second attachment member 44 is similarly disposed on opposite sides within a first secondary recess of the first main body component and a second secondary recess of the second main body component and locked by a second locking element. In the first state, the first attachment axis of the first attachment member 36 is substantially parallel to the central axis, and the second attachment axis of the second attachment member is substantially parallel to the central axis.

[0222] The first locking element 72 dissolves in the gastrointestinal tract, and the first distal end 40 is removed from its first master position in its first state by rotating about a first rotation axis X_R_1 perpendicular to the central axis A. Figure 14 Move to the first sub-position in the second state. Figure 15 ).

[0223] Similarly, the second locking element dissolves in the gastrointestinal tract, and the second distal end 48 rotates from its second primary position in its first state by rotating about a second rotation axis (not shown) perpendicular to the central axis A. Figure 14 Move to the second sub-position in the second state. Figure 15 ).

[0224] The angle between the first primary direction in the first state and the first secondary direction in the second state is at least 30°, for example, 45° or more. The first secondary direction of the first attachment component may be perpendicular to or substantially perpendicular to the central axis.

[0225] The angle between the second primary direction in the first state and the second secondary direction in the second state is at least 30°, for example, 45° or more. The second secondary direction of the second attachment member may be perpendicular to or substantially perpendicular to the central axis A. In the second state, the actuation mechanism reduces the angle between the first secondary direction and the second secondary direction by rotating the first main body member 4 relative to the second main body member 10 to move the first distal end 40 toward the second distal end 48.

[0226] In the first state, the first attachment member 36 having the first pin 37 is configured such that the first distal end is in a first primary position at a first primary radial distance from the central axis. The first primary radial distance may be less than 10 mm, for example, in the range of 3 mm to 8 mm.

[0227] In the first state, the second attachment member 44, having the second pin 45, is configured such that the second distal end is in a second primary position at a second primary radial distance from the central axis. The second primary radial distance can be less than 10 mm, for example, in the range of 3 mm to 8 mm.

[0228] In the second state, the attachment parts 36 and 44 have been extended from the main body parts 4 and 10, such that the distal ends 40 and 48 are in corresponding first secondary positions with a first secondary radial distance from the central axis and second secondary positions with a second secondary radial distance from the central axis. The first secondary radial distance is greater than the first main radial distance and can be greater than 5 mm, for example, greater than 6 mm or greater than 8 mm. The second secondary radial distance is greater than the second main radial distance and can be greater than 5 mm, for example, greater than 6 mm or greater than 8 mm.

[0229] exist Figure 15 In the second state of the drug delivery device 2C shown, the actuation mechanism (not shown) causes the first main body component 4 to rotate relative to the second main body component 10 about the central axis A, so that the first distal end 40 moves toward the second distal end 48.

[0230] Figure 16 An exemplary drug delivery device 2D is shown, and Figure 17 An exploded view of an exemplary drug delivery device 2D is shown. Unless otherwise stated, the drug delivery device 2D may include the components described above. Figures 1 to 15 Any and / or all of the features discussed.

[0231] As shown, the drug delivery device 2D may include a first body recess 108 configured to allow rotation of the first attachment member 104. Furthermore, the drug delivery device 2D may include a second body recess (not shown) configured to allow rotation of the second attachment member 106. Both the first attachment member 104 and the second attachment member 106 may include a connector 116, thereby forming a bent needle or spike. This allows for easier tissue penetration.

[0232] Additionally, as shown in the figure, the drug delivery system 2D may include a first locking band 102. The first locking band 102 prevents the first body component 4 from rotating relative to the second body component 10. The first locking band 102 may be used in place of the locking element 72. Alternatively, the first locking band 102 may serve as a first cover band 103 and cooperate with the locking element 72. Specifically, the first locking band 102 may include a plurality of locking protrusions 112. The locking protrusions 112 may fit within a mating feature 114 of the drug delivery system 2D. Once mated, the locking protrusions 112 prevent rotation of the first body component 4 and the second body component 10. The first locking band 112 may then dissolve to allow rotation.

[0233] The embodiments of the drug delivery devices disclosed herein were used in animal studies to achieve the following experimental results. These experimental results illustrate the success of one or more exemplary drug delivery devices in practical use. A successful “hook” (e.g., attachment) in the experimental results can be defined as attachment for at least 4 hours.

[0234] Figure 18 An X-ray image of a drug delivery device that is hooked (e.g., attached, connected) via one or more of a first attachment member and a second attachment member is shown.

[0235] Figure 19 B shows X-ray images and additional data regarding an embodiment of the disclosed drug delivery device with biodegradable attachment components. As shown, either the first or second attachment component degraded in each animal tested, allowing for the recovery of the drug delivery device. Furthermore, according to the disclosure, the drug delivery device can remain attached in vivo for more than 24 or 48 hours. All tested drug delivery devices were attached to the tissues of the tested animals.

[0236] Figure 20 Further X-ray images and data are shown regarding embodiments of the disclosed drug delivery device with non-biodegradable attachment components. This data provides further evidence of the success of the drug delivery device, which was attached for at least 24 or 48 hours. With one exception, all tested drug delivery devices were attached to animal tissue.

[0237] Figure 21 Data achieved using the disclosed drug delivery device is summarized.

[0238] Figure 22A study of the attachment of embodiments of the disclosed drug delivery device is shown. As illustrated, all devices were confirmed to be attached to the tissues of the test animals. Furthermore, the devices remained attached to the tissues for at least 5 hours and 30 minutes.

[0239] Figure 23 Efficacy data using at least one of the aforementioned drug delivery devices are shown. As illustrated, the data indicate a decrease in blood glucose after the injection of 4 international units of insulin. Therefore, Figure 23 The changes in blood glucose levels during hooking and delivery of active drugs (e.g., insulin) are shown.

[0240] Delivery devices, methods, and compositions according to any of the following items are also disclosed.

[0241] Project 1. A drug delivery device with a central axis, the drug delivery device comprising:

[0242] First main component;

[0243] A first attachment member is attached to a first body member and has a first distal end;

[0244] The second attachment member has a second distal end; and

[0245] An actuation mechanism is configured to move the first distal end toward the second distal end.

[0246] Item 2. A drug delivery device according to Item 1, the drug delivery device comprising a second body component, wherein a second attachment component is attached to the second body component, and an actuation mechanism is configured to cause a first body component to rotate relative to the second body component about the main axis of the drug delivery device.

[0247] Project 3. The drug delivery device according to Project 2, wherein the actuation mechanism includes an elastic member configured to apply force to a first body member and / or a second body member.

[0248] Project 4. The drug delivery device according to Project 3, wherein a first portion of the elastic member is connected to a first main body member, and a second portion of the elastic member is connected to a second main body member.

[0249] Item 5. A drug delivery device according to any one of Items 1 to 4, wherein the first attachment member extends in a direction away from the first body member.

[0250] Item 6. A drug delivery device according to any one of items 1 to 5 when subordinate to item 2, wherein the second attachment member extends in a direction away from the second main body member.

[0251] Item 7. A drug delivery device according to any one of items 1 to 6 when subordinate to item 2, wherein the first attachment member has a first attachment axis, and wherein the distance between the first attachment axis and the main axis is greater than 0.5 mm.

[0252] Item 8. A drug delivery device according to any one of items 1 to 7 when subordinate to item 2, wherein the second attachment member has a second attachment axis, and wherein the distance between the second attachment axis and the main axis is greater than 0.5 mm.

[0253] Item 9. A drug delivery device according to any one of items 1 to 8 when subordinate to item 2, wherein a first main body component is configured to rotate in a first direction and a second main body component is configured to rotate in a second direction opposite to the first direction.

[0254] Item 10. A drug delivery device according to any one of Items 1 to 9, wherein a first distal end of a first attachment member and / or a second distal end of a second attachment member are provided with a tip configured to penetrate biological tissue.

[0255] Item 11. A drug delivery device according to any one of Items 1 to 10, wherein a first distal end of a first attachment member and / or a second distal end of a second attachment member are provided with a clamping member configured to clamp biological tissue.

[0256] Item 12. A drug delivery device according to any one of Items 1 to 11, wherein the drug delivery device includes a first compartment and the drug delivery device is configured to deliver an active drug from the first compartment to the surrounding environment of the drug delivery device.

[0257] Item 13. A drug delivery device according to any one of items 1 to 12 when subordinate to item 2, wherein the first attachment member and the second attachment member form an angle when the first distal end and the second distal end are in a plane including the main axis.

[0258] Item 14. A drug delivery device according to any one of items 1 to 13 when subordinate to item 2, wherein the drug delivery device has a first state in which a first main body component and a second main body component are fixed relative to each other by rotation and a second state in which the first main body component and the second main body component are moved relative to each other by rotation.

[0259] Item 15. A drug delivery device according to any one of items 1 to 14 when subordinate to item 3, wherein the drug delivery device has a first state in which the elastic member has a constant elastic force load and a second state in which the elastic member at least partially releases the elastic force load.

[0260] Item 16. A drug delivery device according to any one of Items 1 to 15, wherein the actuation mechanism is configured to move a first distal end from a first primary position at a first primary radial distance from the central axis of the delivery device to a first secondary position at a first secondary radial distance from the central axis, wherein the first secondary radial distance is greater than the first primary radial distance.

[0261] Item 17. A drug delivery device according to any one of Items 1 to 16, wherein the actuation mechanism is configured to move the first distal end relative to the first proximal end of the first attachment member from a first principal position to a first secondary position to a first secondary angle position, wherein the angle between the first principal position and the first secondary angle position is greater than 10 degrees.

[0262] Item 18. 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 component relative to a second body component in a first state of the drug delivery device.

[0263] Item 19. A drug delivery device according to Item 18, wherein the locking mechanism is configured to lock the first attachment member in a first main position when the drug delivery device is in a first state.

[0264] Item 20. A drug delivery device according to any one of items 1 to 19 when subordinate to item 2, wherein a first attachment member is rotatably attached to a first body member and is configured to rotate about a first rotation axis that is perpendicular or parallel to the main axis.

[0265] Item 21. A drug delivery device according to any one of items 1 to 20 when subordinate to item 2, wherein a second attachment member is rotatably attached to a second body member and is configured to rotate about a second rotation axis that is perpendicular or parallel to the main axis.

[0266] Item 22. A pharmaceutical composition comprising a drug delivery device according to any one of Items 1 to 20 and an active pharmaceutical ingredient.

[0267] The use of terms such as "first," "second," "third," and "fourth," "primary," "secondary," and "third-level" does not imply any specific order, but is included to identify individual elements. Furthermore, the use of terms such as "first," "second," "third," and "fourth," "primary," "secondary," and "third-level" does not indicate any order or importance; these terms are only used to distinguish one element from another. Note that the terms "first," "second," "third," and "fourth," "primary," "secondary," and "third-level," here and in other positions, are for labelling purposes only and do not indicate any specific spatial or temporal order.

[0268] Furthermore, the marking of the first element does not imply the existence of the second element, and vice versa.

[0269] It should be noted that the word "including" does not necessarily exclude the presence of other elements or steps besides those listed.

[0270] It should be noted that the word "the" before a component does not preclude the existence of multiple such components.

[0271] It should also be noted that any reference numerals in the drawings do not limit the scope of the claims, exemplary embodiments can be implemented at least in part by hardware and software, and several “mechanisms,” “units,” or “devices” can be represented by the same hardware.

[0272] Although features have been shown and described, it should be understood that they are not intended to limit the claimed invention, and it will be apparent to those skilled in the art that various modifications and variations can be made without departing from the spirit and scope of the claimed invention. Therefore, the specification and drawings are to be considered illustrative rather than restrictive. The claimed invention is intended to cover all alternatives, variations, and equivalents.

[0273] List of reference numerals

[0274] 2, 2A, 2B, 2C, 2D Drug delivery devices

[0275] 4 First main component

[0276] 4A First Main Body Component

[0277] 4B First Main Component

[0278] 6. First end of the first main body component

[0279] 8. The second end of the first main body component

[0280] 10 Second main body component

[0281] 10A Second Main Body Component

[0282] 10B Second Main Component

[0283] 12 The first end of the second main body component

[0284] 14 The second end of the second main body component

[0285] 16 Actuation Mechanism

[0286] 16A Elastic Component

[0287] 18. The first part of the elastic component

[0288] 20. The second part of the elastic component

[0289] 22. Outer periphery of a helical torsion spring

[0290] 24. The central part of the helical torsion spring

[0291] 26 Content Volume

[0292] 28 Inner surface

[0293] 30 First joint

[0294] 30' First joint

[0295] 32 Second joint

[0296] 34 Slit

[0297] 36 First Attachment Component

[0298] 36A First Base

[0299] 37 First injection

[0300] 38 First proximal end of the first attachment component

[0301] 40 First distal end of the first attachment component

[0302] 42 Outer surface of the first main component

[0303] 44 Second attachment component

[0304] 45 Second shot

[0305] 46 The second proximal end of the second attachment component

[0306] 48 The second distal end of the second attachment component

[0307] 50 Outer surface of the second main component

[0308] 52 Sharp tip

[0309] 56 Opening

[0310] 64 First main recess in first body part

[0311] 66 The second main recess in the second main body component

[0312] 68 First compartment

[0313] 69 Second compartment

[0314] 70 Locking mechanisms

[0315] 72 First locking element

[0316] 74 Body tissues

[0317] 76. Outer shell

[0318] 78 Frame components

[0319] 80 The first opening in the first main body component

[0320] 82 The second opening in the second main body component

[0321] 100 Pharmaceutical Compositions

[0322] 102 First Locking Band

[0323] 103 First Coverage Zone

[0324] 104 First Attachment Component

[0325] 106 Second Attachment Component

[0326] 108 First body recess

[0327] 112 Locking Protrusion

[0328] 114. Coordination characteristics

[0329] 116 connector

[0330] A. Central axis / Main axis

[0331] B. Rotation direction

[0332] C. Rotation direction

[0333] D plane axis

[0334] X_1 First Attachment Axis

[0335] X_R_1 First axis of rotation

[0336] X_2 Second Attached Axis

[0337] X_R_2 Second axis of rotation

[0338] α angle

Claims

1. A drug delivery device for oral administration, the drug delivery device having a central axis, the drug delivery device comprising: First main component; A first attachment member is attached to the first body member and has a first distal end portion, the first distal end portion being provided with a tip configured to penetrate biological tissue. The second attachment component has a second distal end; The second body component, wherein the second attachment component is attached to the second body component, and An actuation mechanism is configured to move the first distal end toward the second distal end, and wherein the actuation mechanism is configured to rotate the first body component relative to the second body component about the main axis of the drug delivery device.

2. The drug delivery device according to claim 1, wherein, The actuation mechanism includes an elastic component configured to apply force to the first body component and / or the second body component.

3. The drug delivery device according to claim 2, wherein, The first portion of the elastic component is connected to the first main component, and the second portion of the elastic component is connected to the second main component.

4. The drug delivery device according to claim 1, wherein, The first attachment member extends in a direction away from the first body member.

5. The drug delivery device according to claim 1, wherein, The second attachment member extends in a direction away from the second main body member.

6. The drug delivery device according to claim 1, wherein, The first attachment component has a first attachment axis, and the distance between the first attachment axis and the main axis is greater than 0.5 mm.

7. The drug delivery device according to claim 1, wherein, The second attachment component has a second attachment axis, wherein the distance between the second attachment axis and the main axis is greater than 0.5 mm.

8. The drug delivery device according to claim 1, wherein, The first main body component is configured to rotate in a first direction and the second main body component is configured to rotate in a second direction opposite to the first direction.

9. The drug delivery device according to claim 1, wherein, The second distal end of the second attachment member is provided with a tip configured to penetrate biological tissue.

10. The drug delivery device according to claim 1, wherein, The first distal end of the first attachment member and / or the second distal end of the second attachment member are provided with clamping members configured to clamp biological tissue.

11. The drug delivery device according to claim 1, wherein, The drug delivery device includes a first compartment and is configured to deliver an active drug from the first compartment to the surrounding environment of the drug delivery device.

12. The drug delivery device according to claim 1, wherein, When the first distal end and the second distal end are in a plane containing the main axis, the first attachment member and the second attachment member form an angle.

13. The drug delivery device according to claim 1, wherein, The drug delivery device has a first state in which the first main component and the second main component are fixed relative to each other by rotation, and a second state in which the first main component and the second main component are moved relative to each other by rotation.

14. The drug delivery device according to claim 2, wherein, The drug delivery device has a first state in which the elastic component has a constant elastic force load and a second state in which the elastic component at least partially releases the elastic force load.

15. The drug delivery device according to claim 1, wherein, The actuation mechanism is configured to move the first distal end from a first primary position at a first primary radial distance from the central axis of the delivery device to a first secondary radial distance from the central axis, wherein the first secondary radial distance is greater than the first primary radial distance.

16. The drug delivery device according to claim 1, wherein, The actuation mechanism is configured to move the first distal end relative to the first proximal end of the first attachment member from a first principal position to a first secondary position to a first secondary angle position, wherein the angle between the first principal position and the first secondary angle position is greater than 10 degrees.

17. The drug delivery device according to claim 13 or 14, wherein, The drug delivery device includes a locking mechanism configured to lock the first main component relative to the second main component in the first state of the drug delivery device.

18. The drug delivery device according to claim 17, wherein, The locking mechanism is configured to lock the first attachment component in a first primary position when the drug delivery device is in the first state.

19. The drug delivery device according to claim 1, wherein, The first attachment component is rotatably attached to the first body component and is configured to rotate about a first rotation axis that is perpendicular or parallel to the main axis.

20. The drug delivery device according to claim 1, wherein, The second attachment member is rotatably attached to the second main body member and is configured to rotate about a second rotation axis that is perpendicular or parallel to the main axis.

21. A pharmaceutical composition comprising a drug delivery device according to any one of claims 1 to 20 and an active pharmaceutical ingredient.

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