Cartridge insertion for drug delivery device

Abstract

To provide an insertion assembly for a drug device including an internal telescope type assembly.SOLUTION: The device comprises a housing, a cartridge bay, a motor, and an expansion assembly. The expansion assembly comprises: a drive part which is rotated by a motor and is distally supported by a linear stabilization part including a bearing engaged with the housing so as to allow for the rotation of the drive part while keeping the drive part from proximally moving to the housing; a first intermediate screw connected to the surrounding of the drive part using a screw thread; a second intermediate screw connected to the surrounding of the first intermediate screw using a screw thread; a plunger drive part which is connected to the surrounding of the second intermediate screw using a screw thread and pushes a plunger encapsulation part to deliver a drug; and a rotation prevention guide part which is disposed around the plunger drive part and prevents the rotation of the plunger drive part relative to the housing. The plunger drive part has a protrusion sliding along the track of the rotation prevention guide part.SELECTED DRAWING: Figure 8A

Description

[Technical field]

[0001] This application claims the benefit of priority under 35 USC 119(e) to U.S. Provisional Patent Application No. 62 / 171,002, filed June 4, 2015, the entire contents of which are incorporated herein by reference.

[0002] SUMMARY OF THE DISCLOSURE The present invention, in some embodiments thereof, relates to a cartridge insert assembly for a drug delivery device, and more particularly, but not exclusively, to an insert assembly for a drug device that includes an internal nesting assembly. [Background technology]

[0003] U.S. Patent No. 6,800,071 discloses an improved pump, reservoir, and reservoir piston for controlled fluid delivery. A motor is operatively coupled to a drive member, such as a drive screw, configured to advance a plunger slide in response to operation of the motor. The plunger slide is removably coupled to the piston. The piston includes a first member and a second member. The first member has an exterior proximal side and an exterior distal side. The exterior proximal side is configured to contact the fluid and is made of a material having a first stiffness. The second member has a first side and a second side and is disposed at least partially within the first member. The first side of the second member is adjacent the exterior proximal side of the first member and is made of a material having a stiffness greater than the first stiffness.

[0004] Cabiri in US Patent Application Publication No. 2013 / 0253472 discloses "Method and Device for Delivery of Drug to a Recipient." In some embodiments, the delivery device opens a drug containing reservoir. In some embodiments, the delivery rate can be controlled and / or adjustable. Optionally, the device may be disposable. Optionally, the device may be unobtrusive and / or wearable and / or attachable to the recipient. Optionally, the release of the drug and / or the opening of the reservoir may be driven by a plunger that moves parallel to the base of the device. Optionally, the device may eject a hypodermic needle into the recipient. Optionally, the ejection of the hypodermic needle may be in a direction non-parallel and / or perpendicular to the direction of movement of the plunger.

[0005] Optionally, prior to ejection, the hypodermic needle may be kept sterile by a needle opening septum that seals the needle opening. Optionally, upon ejection, the hypodermic needle may pierce the needle opening septum.

[0006] Additional background art includes International Patent Application Publication No. WO / 2011 / 090956 to Cabiri, U.S. Patent Application Publication No. 2009 / 0093792 to Gross, U.S. Patent Application Publication No. 20130304021, U.S. Patent Application Publication No. 20130296799, U.S. Patent Application Publication No. 20130245596, U.S. Patent No. 8,465,455, International Patent Application Publication No. WO / 2011 / 090956, and U.S. Patent Application Publication No. 2009 / 0093792.

[0007] Examples of syringe stoppers actuated by telescoping assemblies can be found, for example, in International Patent Application Publication No. WO / 2011 / 090956 to Cabiri, and / or U.S. Patent Application Publication No. 2009 / 0093792 to Gross which are incorporated herein by reference in their entireties. Summary of the Invention [Problem to be solved by the invention]

[0008] Unless otherwise defined, all technical and / or scientific terms have the same meaning as commonly understood by one of ordinary skill in the art to which the present invention pertains. Although methods and materials similar or equivalent to those described herein can be used in practicing or testing embodiments of the present invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. Additionally, the materials, methods, and examples are illustrative only and are not necessarily intended to be limiting. [Means for solving the problem]

[0009] According to an aspect of some embodiments of the present invention, the method includes: a compartment sized to receive a cartridge, the compartment comprising a cartridge bay opening outwardly from the compartment, in an open position the cartridge may be inserted into the cartridge bay and in a closed position the cartridge is received in the compartment, the cartridge bay being configured to pivot between the open and closed positions; a housing containing the expansion assembly; The expansion assembly includes: a drive unit supported at its distal end on the housing by a linear stabilizer including a bearing that presses against the housing, the drive unit being rotated by a motor; two intermediate screws threadably connected to the drive; A plunger drive connected to the two intermediate screws by threads; A drug delivery device having a rotation prevention guide portion that prevents the plunger drive portion from rotating.

[0010] According to some embodiments of the present invention, the method includes: a cartridge containing a drug, the cartridge being configured to be contained in a drug delivery device; a compartment of a drug delivery device, the compartment being dimensioned to receive a cartridge, the compartment comprising a cartridge bay opening outwardly from the compartment, in an open position the cartridge can be inserted into the cartridge bay, and in a closed position the cartridge is received in the compartment, the cartridge bay being configured to pivot between the open and closed positions; a housing of the drug delivery device containing the expansion assembly; The expansion assembly includes: a drive unit supported at its distal end on the housing by a linear stabilizer including a bearing that presses against the housing, the drive unit being rotated by a motor; two intermediate screws threadably connected to the drive; A plunger drive connected to the two intermediate screws by threads; and a rotation prevention guide portion that prevents the plunger drive portion from rotating.

[0011] According to some embodiments of the present invention, the method includes: A housing having a partition; a cartridge bay configured to pivot relative to the housing between an open position and a closed position, the cartridge bay configured to receive a cartridge in the open position and to be received in the compartment in the closed position; A motor inside the housing; an expansion assembly within the housing; The expansion assembly includes: a drive configured to be rotated by the motor, the drive being distally supported by a linear stabilizer including a bearing engaged with the housing to permit rotation of the drive while preventing proximal movement of the drive relative to the housing; A first intermediate screw threadably connected to the periphery of the drive portion; a second intermediate screw threadably connected to the periphery of the first intermediate screw; a plunger driver threadably connected around the second intermediate screw and configured to push a plunger seal through a reservoir of the cartridge to deliver a drug; a rotation prevention guide portion disposed around the plunger drive portion and preventing rotation of the plunger drive portion relative to the housing; A drug delivery device, wherein the plunger driver has a protrusion that slides along a track on the anti-rotation guide. Effect of the Invention

[0012] A stopper pushing assembly movably mounted to the device for movement between a position that opens the proximal opening proximal to the chamber and a position that blocks the proximal opening proximal to the chamber. [Brief description of the drawings]

[0013] Some embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: Figure 1 is a schematic diagram of a method for manufacturing a semiconductor device according to the present invention; Figure 2 is a schematic diagram of a semiconductor device according to the present invention; Figure 3 is a schematic diagram of a semiconductor device according to the present invention;

[0014] FIG. 1A is a block diagram of a cartridge insert assembly with a movable cartridge bay in a loading position according to an embodiment of the present invention.

[0015] FIG. 1B is a block diagram of a cartridge insert assembly with a movable cartridge bay in a delivery position according to an embodiment of the present invention.

[0016] FIG. 1C is a block diagram of a cartridge insertion assembly according to an embodiment of the present invention.

[0017] [Figure 1D] Block diagram of a drug delivery device and cartridge insertion assembly according to an embodiment of the present invention.

[0018]

[0023] FIG. 2A is a diagram of an exemplary drug delivery device according to an embodiment of the present invention.

[0019] [Figure 2B] An illustration of an exemplary drug delivery device according to an embodiment of the present invention.

[0020] FIG. 3A is a flowchart illustrating a cartridge insertion method according to an embodiment of the present invention.

[0021] FIG. 3B is a flowchart illustrating a cartridge insertion method according to an embodiment of the present invention.

[0022] FIG. 4A is a perspective view of a cartridge insertion according to an embodiment of the present invention.

[0023] FIG. 4B is a perspective view of an angle-adjustable bay in the process of closing according to an embodiment of the present invention.

[0024] FIG. 4C is a perspective view of a closed tilt-adjustable bay according to an embodiment of the present invention.

[0025] [Figure 4D] A cross-sectional view of a drug delivery device and cartridge according to an embodiment of the present invention.

[0026] FIG. 5A is a perspective view illustrating insertion of a cartridge into a hinged bay according to an embodiment of the present invention.

[0027] FIG. 5B is a perspective view of a hinged bay in the process of closing according to an embodiment of the invention.

[0028] FIG. 5C is a perspective view of a closed hinged bay according to an embodiment of the invention.

[0029] [Figure 6A] A perspective view showing the insertion of a cartridge into a drug delivery device according to an embodiment of the present invention.

[0030] FIG. 6B is a perspective view of a hinged cover in the process of closing according to an embodiment of the invention.

[0031] FIG. 6C is a perspective view of a closed hinged cover according to an embodiment of the invention.

[0032] FIG. 7A is a perspective view illustrating the insertion of a cartridge into a drug delivery device according to an embodiment of the present invention.

[0033] FIG. 7B is a perspective view of the sliding cover in the process of closing according to the embodiment of the present invention.

[0034] FIG. 7C is a perspective view of a closed sliding cover according to an embodiment of the present invention.

[0035] FIG. 8A is an enlarged cross-sectional view of a stabilizing stopper actuator in a retracted configuration according to an embodiment of the present invention.

[0036] FIG. 8B is a cross-sectional view of a reservoir and stabilizing stopper actuator in an expanded configuration according to an embodiment of the present invention.

[0037] FIG. 9 is a flowchart showing a method for driving a stopper according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0038] The present invention, in some embodiments thereof, relates to a cartridge insertion assembly for a drug delivery device, and particularly, but not exclusively, to an insertion assembly for a drug device that includes an internal nesting assembly.

[0039] Overview. Aspects of some embodiments of the invention relate to an assembly and method of coupling between a drug reservoir and a drug delivery device. In some embodiments, the interface includes a compartment and holds a cartridge and / or an expansion assembly mounted on the device on one side of the compartment and / or a coupler to a fluid path on the other side of the compartment. Optionally, the expansion axis of the pushing assembly points into the compartment and is generally parallel to the skin-contacting surface of the device. Optionally, the reservoir is held in the compartment coaxial with the expansion axis of the pushing assembly. For example, a distal opening of the reservoir faces the coupler and / or is located proximal to the coupler and / or is connected to the coupler. Optionally, the coupler connects the distal opening to a fluid path of the delivery device. Optionally, when the cartridge is installed, the pushing assembly expands into a proximal opening of the reservoir and / or pushes a stopper, e.g., a plunger seal, distally on the reservoir.

[0040] Depressing the plunger seal optionally releases the drug from the reservoir, for example, the drug is released from the distal opening into the fluid path.

[0041] In some embodiments, the cartridge may contain a drug in a cylindrical reservoir.

[0042] Optionally, the reservoir comprises a distal opening and / or a proximal opening.

[0043] For example, the drug may be stored between the distal and proximal seals.

[0044] Optionally, the proximal seal may comprise a plunger seal inserted into the reservoir between the drug location and the proximal opening. For example, the plunger seal may be free to slide along the reservoir. Optionally, the distal seal may comprise a septum.

[0045] In some embodiments, the pushing assembly may include an expansion assembly, for example, the expansion assembly may include a telescoping screw and / or an expansion piston (e.g., gas and / or hydraulically actuated).

[0046] Alternatively or additionally, the pushing assembly may comprise a moving element and / or a linear actuator.

[0047] In some embodiments, the connector may open the opening of the reservoir and / or provide a connection between the reservoir and a fluid path in the delivery device. For example, the opening of the reservoir may be sealed by a septum. The connector optionally includes a hollow needle having a sharpened first end. For example, the needle and / or the reservoir may be integrated by longitudinal movement of the first end of the needle through the septum. Optionally, the second end of the needle is connected to a fluid path in the delivery device.

[0048] For example, a needle may provide a fluid connection from the reservoir to the fluid path. Alternatively or additionally, the coupler may comprise a septum that is pierced by the needle of the cartridge. Alternatively or additionally, other types of connections may be included, such as, for example, a slip lock and / or a luer lock. In some embodiments, the coupler may be connected to the cartridge by a user action, such as, for example, inserting the cartridge into the device. For example, inserting the cartridge into the device may cause the needle to open the septum. Alternatively or additionally, the coupler may be connected to the cartridge during the operation of other components of the device and / or as part of the operation sequence of the device. For example, the force of an actuator, such as, for example, pushing an assembly, may exert a force on the cartridge to connect with the coupler. Alternatively or additionally, the coupler may be moved to connect with the cartridge.

[0049] In some embodiments, the compartment of the delivery device may hold the cartridge in functional connection with the coupler and / or the pushing assembly. For example, the chamber may align the axis in a desired direction and / or position the cartridge in a desired location. For example, the chamber may facilitate insertion of the cartridge in a particular direction and / or position. For example, the compartment may include elements that orient and / or fit the cartridge (e.g., tapered pins and / or tapered openings). Alternatively or additionally, the compartment may include elements that orient and / or push the cartridge in a desired position (e.g., elastic elements pushing the cartridge to a desired position). Alternatively or additionally, the compartment may include retention elements that hold the cartridge in place (e.g., clips and / or latches).

[0050] In some embodiments, the cartridge and / or reservoir may be placed in the compartment by sliding it longitudinally into the compartment. Alternatively or additionally, a first side of the cartridge and / or reservoir may be positioned in the compartment and then the cartridge and / or reservoir may be rotated into position at a second end of the compartment. Alternatively or additionally, the cartridge and / or reservoir may be placed in the compartment by inserting it into the compartment from the side. Optionally, the cartridge and / or reservoir may be positioned in a bay and placed in a compartment having a bay.

[0051] For example, the bay may tilt into the compartment and / or rotate and / or slide laterally or longitudinally within the compartment.

[0052] In some embodiments, the drug delivery device may include a drug administration interface. Optionally, the drug administration interface may include a skin-contacting surface. Alternatively or additionally, the drug administration interface may include an injection device. For example, the injection device may inject a drug under one or more layers of the user's skin. For example, the injection device may include a needle and / or a needleless injection portion, such as a jet injection portion.

[0053] In some embodiments, the longitudinal axis of the fluid reservoir (e.g., the longitudinal axis of the cylindrical portion of the cavity) is substantially parallel to the skin-contacting surface. For example, between The angle between the longitudinal axis of the reservoir and the skin-contacting surface may range between 0 and 5 degrees, and / or between 5 and 15 degrees, and / or between 15 and 30 degrees, and / or between 30 and 60 degrees. Optionally, the injection device may have an axis (e.g., the longitudinal axis of the needle and / or the direction of fluid ejection). Optionally, the axis of the injection device may be substantially perpendicular to the longitudinal axis of the reservoir. Additionally or alternatively, between The angle between the injection device axis and the longitudinal axis of the reservoir may range between 90 and 85 degrees, and / or between 85 and 70 degrees, and / or between 70 and 30 degrees. In some embodiments, the skin-contacting surface may not be flat. For example, the axis of the reservoir may be parallel to the skin-contacting surface at a point on the surface near the needle hole and / or injection site and / or at a point closest to the center of the reservoir and / or near the axis of the reservoir.

[0054] In some embodiments, the cartridge fits into the channel and / or the cartridge and / or cartridge bay may just fit into the compartment of the delivery device (e.g., there may be a tolerance of less than 0.1 mm and / or between 0.1 and 0.5 mm and / or between 0.5 and 1 mm and / or between 1 and 3 mm. Alternatively or additionally, the compartment may be longer than the cartridge and the coupler. For example, the spacing between the pushing assembly and the cartridge may be between 3 and 5 mm and / or between 5 and 10 mm greater than the length of the cartridge. For example, the cartridge may be inserted into the compartment without connecting a coupler to the cartridge. After placing the cartridge in the compartment, the pushing assembly may push the cartridge into the coupler and / or connect the reservoir to the coupler.

[0055] Optionally, the channel may be sized and shaped so that the distal opening of the reservoir faces the connector.

[0056] For example, when the distal end of the cartridge is fully inserted into the channel, the distal opening of the reservoir may contact the coupler and / or the coupler may form a fluid path through the distal opening of the reservoir. For example, the channel may be sized and shaped to prevent the cartridge from twisting and / or rotating and to prevent the distal opening of the reservoir from contacting and / or connecting with and / or being immediately proximal to the coupler. For example, the channel may precisely fit the side of the cartridge. Optionally, the channel may be sized and shaped so that a proximal opening of the reservoir faces the expansion assembly. For example, the channel may align a distal opening of the reservoir with respect to an expansion axis of the expansion assembly such that distal expansion of the assembly moves a distal end of the assembly into the reservoir.

[0057] Optionally, the drug delivery device includes a compartment that holds the cartridge during drug delivery and / or a stopper pushing assembly mounted behind (proximal to) the compartment, in some embodiments the cartridge may be inserted into the compartment from the side, in front (distal) of the pushing assembly.

[0058] In some embodiments, the delivery device may include a moving cartridge bay. A cartridge is optionally inserted into the bay while the bay is in a loading position. Subsequently, the bay and cartridge are optionally moved into a delivery position, such as into a cartridge compartment. For example, a cartridge may be loaded into the bay while the axis of the reservoir is not coaxial with the pushing assembly.

[0059] Subsequently, the bay and cartridge are moved into the compartment and / or array together with the pushing assembly. For example, the bay may be moved laterally and / or rotated into the compartment. Optionally, in the loading position, a proximal opening of the bay is located outside the cartridge compartment of the drug delivery device.

[0060] In some embodiments, the cartridge compartment may have a proximal opening into which the cartridge is inserted. Optionally, the pushing assembly may be moved into a position behind the proximal opening after insertion of the cartridge.

[0061] In some embodiments, the cartridge may be sealed. Optionally, the seal may be broken by longitudinal movement. For example, the cartridge may include a seal (e.g., a septum) at the front (distal) end of the cartridge. The seal is optionally opened by axially inserting a cannula through the front of the cartridge.

[0062] For example, a cannula may be loaded into the cartridge bay and / or a distal opening of the cartridge may be unsealed by inserting a distal portion of the cartridge longitudinally into the bay, and the bay and cartridge may be moved laterally into the cartridge compartment.

[0063] Alternatively or additionally, the seal may be opened by a cannula located on the housing of the delivery device. For example, the seal may be opened when a cartridge is inserted into the compartment. For example, the cartridge may be inserted longitudinally into a proximal opening of the cartridge compartment.

[0064] Alternatively or additionally, after insertion the seal may be broken.

[0065] For example, the plunger drive assembly may push the cartridge distally into the cannula, piercing the cartridge seal.

[0066] In some embodiments, the cartridge is fully loaded into the bay and / or connected to the coupler while the bay is in the loading position. For example, when the cartridge is fully loaded while the bay is in the loading position, the proximal opening of the reservoir is outside the cartridge compartment and / or a portion of the reservoir is outside the compartment, e.g., between 5 and 15%, and / or between 15 and 40%, and / or between 40 and 80%, and / or between 80 and 100% of the reservoir. For example, the portion of the reservoir outside the compartment may be defined as the portion of the drug contained in the reservoir that is outside the compartment.

[0067] In some embodiments, the pushing assembly may comprise a telescoping assembly (TSA) and / or a linear and / or rotating stabilization. For example, the rotating stabilization may be mounted to the housing of the drug delivery device and / or to the motor mount, such that the rotational force of the final element of the telescoping assembly pushing the stopper is counterbalanced against the motor and / or the housing of the delivery device.

[0068] Optionally, the rotational force is not applied to the drug reservoir and / or the stopper and / or any components in contact with the drug.

[0069] In some embodiments, the cartridge pushing assembly may be positioned behind the proximal opening of the drug cartridge, regardless of the exact longitudinal position of the stopper of the cartridge. Optionally, after positioning the stopper pushing assembly and / or the cartridge, the TSA may extend until the pushing assembly contacts the stopper. For example, the TSA may extend after insertion into the drug delivery device and / or after positioning the TSA behind the cartridge.

[0070] In some embodiments, the stroke length of the TSA may be greater than the minimum length of the TSA.

[0071] For example, the TSA may have three or more telescoping shafts and / or one or more telescoping guides. For example, the telescoping shafts may comprise extension rods. Alternatively or additionally, the TSA may have four telescoping shafts and / or one or more telescoping guides. Alternatively or additionally, the TSA may have five telescoping shafts and / or two or more telescoping guides. For example, the TSA may have a shortened configuration with a length range between 0.8 and 1.6 cm and / or between 1.6 and 3.2 cm. For example, the TSA may have an extended configuration with a length range between 2.0 and 6.0 cm and / or between 6 and 12 cm.

[0072] Optionally, the extended length of the TSA may range between 2.0 and 3.0 times the shortened length and / or may range between 3.0 and 5.0 times the shortened length.

[0073] Before describing at least one embodiment of the present invention in detail, it is to be understood that the invention is not necessarily limited in its application to the detailed construction and arrangement of constructions and / or methods set forth in the following description and / or illustrated in the drawings and / or examples, as the invention is capable of other embodiments and of being practiced and carried out in various ways.

[0074] Cartridge insertion assembly. Referring now to the drawings, FIG. 1A is a block diagram of a cartridge inserted into a loading position relative to a cartridge bay in an embodiment of the present invention. In some embodiments, the cartridge bay 123 is movably connected to a delivery device (e.g., a housing 122a of the delivery device) by a multi-position mount 125 (e.g., including a pivot and / or a sliding member and / or a hinge). The bay optionally includes a coupling 148 that connects the reservoir 120 of the drug cartridge 153 with a fluid path 149 of the delivery device. Optionally, all or a portion of the cartridge 153 is loaded into the bay 123 while the bay 123 is in the loading position. For example, the cartridge 153 may be connected to the coupling 148 when loading the cartridge 153 into the bay. Optionally, all or a portion of the bay 123 is located outside the housing of the delivery device while the bay 123 is in the loading position. For example, in the loading position, between 100 and 75%, and / or between 75 and 50%, and / or between 50 and 25%, and / or between 25 and 5% of the bay 123 and / or cartridge 153 may be outside the delivery device and / or the housing 122a and / or the cartridge compartment of the delivery device. Alternatively or additionally, the bay 123 may have a proximal opening for loading the cartridge 153 into the bay 123. In the loading position, the proximal opening is optionally free of the delivery device.

[0075] In some embodiments, the cartridge 153 includes a drug reservoir 120. For example, the reservoir 120 can have a proximal opening 141 and / or a distal opening.

[0076] Optionally, the opening may be blocked by a seal 146, such as, for example, a septum. The opening 141 may be free of the delivery device during loading in a loading position relative to the bay 153 and / or the opening 141 may be external to the delivery device. The reservoir 120 may contain a drug. For example, the drug may be sealed between the stopper 140 and the seal 146.

[0077] In some embodiments, the coupling 148 may comprise a cannula. When the cartridge 153 is loaded into the bay 123, the cannula is optionally passed through a septum of the seal 146 to provide fluid communication between the drug 144 and the fluid path 149. Optionally, the coupling 148 is mounted to the bay 123 and / or moves with the bay 123. Optionally, the coupling 148 is mounted to the housing 122a. Optionally, the fluid path 149 remains in fluid communication between the coupling 148 and the delivery device to accommodate various positions of the bay 123.

[0078] For example, the fluid path 149 may comprise a flexible tube. In some embodiments, the cannula and / or the fluid path may be in fluid communication with a syringe needle.

[0079] In some embodiments, the delivery device may include a patch at the infusion site.

[0080] Optionally, in the dispensing position, the major axis of the cartridge and / or the major axis of the cartridge compartment is substantially parallel and / or has an angle of less than 10 degrees and / or between 10 and 30 degrees with respect to the base of the patch infusion portion.

[0081] Optionally, the base of the injection portion contacts the skin of the patient. Optionally, the base of the injection portion may include an adhesive for adhering to the patient. In some embodiments, the injection needle may be inserted into the patient. For example, the direction in which the injection needle is inserted into the patient may be substantially perpendicular to the base, and / or at an angle between 85 and 90 degrees to the base, and / or between 75 and 85 degrees to the base, and / or between 60 and 75 degrees to the base.

[0082] In some embodiments, the delivery device may include a stopper drive assembly 150. The drive assembly 150 is optionally fixedly mounted to the housing 122a proximal to the cartridge compartment. In the loaded position, the cartridge 153 and / or the bay 123 may not be aligned and / or coupled to the drive assembly 150.

[0083] Reference is now made to FIG. 1B, which is a block diagram of a cartridge inserted into a delivery position relative to a cartridge bay in an embodiment of the invention. In the delivery position, the drive assembly 150 is optionally positioned proximal to the cartridge 153 and / or the opening 141. In the delivery position, the drive assembly 150 is optionally aligned with the opening 141 and / or engaged with the stopper 140. For example, after placing the bay 123 and / or the cartridge 153 in the delivery position, the drive assembly 150 may advance a stopper contact portion to contact the stopper 140 and / or may push the stopper 140 and / or may release the drug 144 through the connection 148 into the fluid path 149.

[0084] For example, in the delivery position, between 100 and 75%, and / or between 75 and 50%, and / or between 50 and 25%, and / or between 25 and 5% of the bay 123 and / or cartridge 153 may be inside the delivery device and / or housing 122a and / or cartridge compartment.

[0085] Reference is now made to FIG. 1C, which is a block diagram of a cartridge inserted into a delivery device in an embodiment of the invention. In some embodiments, the coupling 148 may be mounted to the housing 122b of the delivery device. Optionally, the housing 122b may have a proximal opening to the cartridge compartment. For example, the cartridge 153 may be inserted longitudinally into the proximal opening such that the coupling 148 engages with the distal opening of the reservoir 120 and / or pierces the seal 146. Alternatively or additionally, the housing 122b may have a side opening. For example, the cartridge 153 may be inserted laterally into the side opening.

[0086] Optionally, drive assembly 150 may initially push cartridge 153 distally such that coupling portion 148 engages the distal opening of reservoir 120 and / or pierces seal 146 .

[0087] Reference is now made to Figure ID, which is a block diagram of a cartridge inserted in a delivery position relative to a cartridge bay in an embodiment of the invention, showing details of the plunger pushing assembly.

[0088] Drive assembly 150 is optionally supported by housing 122b. For example, housing 122b may balance linear forces between drive assembly 150 and stopper 140 and / or cartridge 153. Drive assembly 150 optionally includes an anti-rotation guide, such as guide 104. Anti-rotation guide 104 optionally supports the drive assembly and / or balances rotational forces between the drive assembly and a motor, such as motor 108.

[0089] In some embodiments, the stopper drive assembly 150 may include a telescoping assembly (eg, TSA 152).

[0090] Optionally, the TSA 152 includes a proximal shaft, e.g., a threaded drive shaft 110, and / or a threaded intermediate shaft 112, and / or a distal shaft, e.g., a threaded push shaft 114. The shafts 110, 112, and / or 114 may be coupled such that rotating the drive shaft 110 relative to the push shaft 114 extends and / or retracts the TSA 152. Optionally, the axial movement of the drive shaft 110 is limited by a linear stabilizer 106 such that rotating the drive shaft 110 relative to the push shaft 114 causes the push shaft 114 to move linearly relative to the linear stabilizer 106. Optionally, a coupling couples the guide 104 and / or the push shaft 114 to the housing 122b. For example, rotation of the push shaft 114 may be limited by the housing 122b such that rotating the drive shaft 110 relative to the housing 122b causes the TSA 152 to extend and / or retract.

[0091] Alternatively or additionally, the drive shaft 110 and / or the push shaft 114 may be replaced by a nut and / or a threaded disk and / or a ring.

[0092] In some embodiments, the motor 108 may comprise a DC motor, a chemical engine, a brushless motor, an AC motor, an actuator, or the like.

[0093] In some embodiments, the linear stabilizer 106 and / or the housing 122b may be attached to the drug cartridge 153 and / or the push shaft 114 may be abutted against the stopper 140 such that the TSA 152 is extended to move the stopper 140 axially relative to the reservoir 120.

[0094] The axial rearward force of the stopper 140 against the reservoir 120 (e.g., force due to friction between the stopper and the reservoir wall and / or force due to flow resistance) is optionally balanced against the linear stabilizer 106 and / or the housing 122b.

[0095] In some embodiments, the motor 108 may apply a rotational force to the drive shaft 110 .

[0096] Optionally, an anti-rotation guide 104 may be attached to the drug cartridge 153 such that actuation of the motor 108 causes the pusher shaft 114 to move axially relative to the drive shaft 110. Friction between the drive shaft 110, the intermediate shaft 112, and / or the pusher shaft 114 is optionally balanced by a counter-rotational force between the motor 108, the guide 104, and / or the housing 122b, such that the TSA 152 acts as a linear actuator, exerting a net linear force (and / or negligible rotational force) on the portion of the device in contact with the drug (e.g., the stopper 140 and / or the cartridge 153).

[0097] In some embodiments, the intermediate shaft 112 and / or the anti-rotation guide 104 may move axially. For example, the intermediate shaft 112 and / or the anti-rotation guide 104 may move into and / or out of the reservoir 120. For example, the guide 104 may be slidably and / or anti-rotationally connected to the housing 122b, for example by a groove.

[0098] In some embodiments, the order of movement of each portion of TSA 152 may not be fixed.

[0099] For example, in some embodiments, the intermediate shaft 112 is free to rotate with the drive shaft 110 and / or is free to rotate with the push shaft 114. For example, the position of a portion (e.g., the intermediate shaft 112) may be arbitrary in some configurations (e.g., when the TSA 152 is partially extended). For example, the portion may move without changing the length of the TSA 152.

[0100] In some embodiments, the guide portion 104 may be connected to the housing 122b in a sliding and / or anti-rotating manner. For example, the connection may include a longitudinal groove. By pushing the shaft 114, the pushing shaft 114 may be connected to the guide portion 104 by, for example, a longitudinal groove in a sliding and / or anti-rotating manner.

[0101] In some embodiments, the drive shaft 110 may be an inner shaft and the push shaft 114 may be an outer shaft. Alternatively or additionally, the drive shaft 110 may be an outer shaft and the push shaft 114 may be an inner shaft. Any or all of the components of the present invention may be made from plastic and / or metal and / or other materials.

[0102] Drug Delivery Devices 2A and 2B show a drug delivery device according to some embodiments of the present invention. Optionally, the drug delivery device includes a plunger pushing assembly and / or a fluid path connector at opposite ends of a cartridge compartment. Optionally, the cartridge compartment aligns the drug cartridge with the axis of the cartridge reservoir parallel to the skin contact surface of the device.

[0103] 2A is a perspective view of a drug delivery device 222 and a cartridge 220 according to an exemplary embodiment of the present invention. In some embodiments, the drug delivery device 222 may include a cartridge compartment 224.

[0104] Optionally, compartment 224 is sized to fit cartridge 220. For example, cartridge 220 fits snugly into compartment 224 between piston pushing assembly 252 and a coupler (e.g., a coupler that may include a hollow needle 248 as shown in FIG. 2B).

[0105] In some embodiments, the cartridge 220 fits into a compartment 224 within a cartridge bay 223. Optionally, the bay 223 is open to the exterior from the compartment 224. For example, the cartridge 220 may be inserted into the bay 223 in an open position (e.g., as shown in FIG. 2A ). For example, to place the cartridge 220 in the compartment 224, a user may insert the cartridge 220 into the compartment by inserting the cartridge 220 into the bay 223 in the open position and then closing the bay 223.

[0106] Optionally, the bay 223 opens and / or closes by pivoting into and / or out of the compartment 224 .

[0107] In some embodiments, the drug delivery device 222 may have a medication contact portion. For example, the device 222 may have a skin-contacting surface 230.

[0108] For example, when delivering a drug, surface 230 is placed in contact with the skin of a user. Optionally, all or a portion of skin-contacting surface 230 is coated with an adhesive.

[0109] For example, the adhesive may hold the device in contact with the user during drug delivery.

[0110] Optionally, surface 230 includes a needle shield 232 and / or a drug delivery hole 234 .

[0111] For example, the needle may extend out of hole 234 and enter the user's skin, and / or the drug may be released through the needle and / or hole 234 and delivered into the user's body. Optionally, after use, shielding member 232 may extend to cover the needle and / or prevent a puncture hazard. Alternatively or additionally, the needle may retract into device 222 after drug release, for example to prevent a puncture hazard. Alternatively or additionally, the drug delivery device may include a jet injector and / or other injection device.

[0112] 2B is a cutaway view of an injection portion 222 according to an embodiment of the present invention. In FIG. 2B, a cartridge 220 is shown disposed within the compartment 224. Optionally, the cartridge 220 includes a tubular reservoir 219. For example, when disposed within the compartment 224, the longitudinal axis of the tubular reservoir 219 is parallel to the skin-contacting surface 230. In the exemplary injection device 220, the injection needle 236 is shown in an extended state. Optionally, the needle 236 is perpendicular to the longitudinal axis of the reservoir 219 when extended. Optionally, a fluid path, including, for example, a flexible tube 249, connects the needle 236 to a connector. For example, the connector may include a hollow needle 248. Optionally, the needle 248 of the connector is mounted to the device 222 at one end of the compartment 224. Optionally, an extension assembly 252 is mounted to the device 222 at the opposite end of the compartment 224. When cartridge 220 is loaded into device 222, optionally, cartridge 220 is positioned between expansion assembly 252 and the coupler. Optionally, expansion assembly 252 expands along an axis of expansion that is coaxial with cartridge 220 when cartridge 220 is placed within compartment 224.

[0113] In some embodiments, the coupler includes a hollow needle 248. For example, the needle 248 allows for fluid communication between the fluid line 249 and the reservoir 219.

[0114] For example, when cartridge 220 is inserted into bay 223 , septum 246 is pierced by needle 248 .

[0115] In some embodiments, after cartridge 220 is placed in compartment 224, needle 248 may be pierced through septum 246. For example, expansion assembly 252 may push cartridge 220 longitudinally into needle 248. For example, compartment 224 may be slightly longer than cartridge 223. Optionally, the needle may penetrate septum, for example, between 1 and 3 mm, and / or between 3 and 6 mm, and / or between 6 and 12 mm. Optionally, cartridge may move between 1 and 3 mm, and / or between 3 and 6 mm beyond needle penetration. For example, compartment may be 3 to 6 mm, and / or 6 to 12 mm longer than cartridge.

[0116] In some embodiments, the cartridge 220 can include a syringe. For example, the syringe can include a cylindrical reservoir 219. The reservoir 219 can optionally include a cylindrical cavity having a distal opening 256 and / or a proximal opening 241.

[0117] Optionally, the distal portion of reservoir 219 is loaded with a drug.

[0118] In some embodiments, the plunger seal 240 is inserted into the reservoir 219. For example, the stopper 240 may be used to seal the reservoir 219 between the location of the drug and the proximal opening 241. Optionally, the syringe may include a proximal flange 221. For example, the flange 221 may be used to facilitate placing and / or retaining the syringe in the bay 223 and / or the compartment 224. Alternatively or additionally, the syringe 220 may be filled with an automated filling machine. For example, the flange 221 may be used by the filling machine to handle and / or position the syringe. For example, the syringe of the cartridge 220 may have a standard size and / or shape to fit into a standard filling machine. In some embodiments, the opening 256 is coaxial with the reservoir 219.

[0119] Alternatively or additionally, the opening 256 may be located off-center of the reservoir 219 .

[0120] Optionally, the expansion assembly 252 comprises a telescoping screw assembly.

[0121] For example, the nested assembly 252 includes a drive 210 that is optionally rotated by a transmission and / or a motor. For example, the transmission may include gears 226. Optionally, the transmission and / or drive and / or motor are permanently engaged. For example, the transmission and / or motor and / or drive may be engaged before, during and / or after insertion of a cartridge into a compartment of the device.

[0122] The driver 210 is optionally supported at its distal end by a linear stabilizer, for example a bearing 206 that presses against a housing of the device 222. Optionally, the driver 210 is connected by an intermediate screw 212a 212b and / or to the plunger driver 214 using a thread.

[0123] For example, plunger driver 214 may be allowed to move longitudinally relative to driver 210 and / or may be prevented from rotating relative to the housing of device 222, for example, by anti-rotation guide 204. For example, rotation of driver 210 causes relative rotation of threaded components, such as shaft 210, 212a, 212 band, 214, and / or longitudinal extension of assembly 252. For example, plunger driver 214 may be driven along the axis of reservoir 219 and / or into reservoir 219. As the plunger driver 214 moves into the reservoir 219, the plunger driver 214 optionally pushes the plunger seal 240 distally and / or displaces the drug out of the opening 246 and / or through the needle 248 and / or into the fluid path 249 and / or through the needle 236 and / or into the user's body. In some embodiments, the expansion assembly 202 drives the plunger driver 214 into the opening 241. For example, the plunger driver 214 may move into the opening 241 to engage and / or contact the plunger seal 240. Optionally, after the plunger driver 214 engages the seal 240, the expansion assembly 252 is further expanded to drive the seal 240 distally into the reservoir 219.

[0124] Optionally, seal 240 can be actuated distally into reservoir 219 to release the drug, for example through a distal opening 256 of reservoir 219. Filling the Cartridge In some embodiments of the invention, the reservoirs may be capable of being filled using standard pharmaceutical equipment (e.g., in existing clean rooms with standard syringes and / or filling equipment made for cartridges).

[0125] Optionally, the stopper driver engages the stopper at any position within the reservoir. In some embodiments, the stopper driver may be assembled using mating parts. The parts are optionally made of a molding material, such as a plastic, for example polyoxymethylene (POM) resin.

[0126] In some embodiments, a drug reservoir is provided. Optionally, the reservoir may be pre-filled. For example, the reservoir may be filled using standard filling equipment. For example, the reservoir may have a cylindrical and / or tubular perforation or cavity and / or perforation of any cross section. For example, the body may be a right cylinder. Optionally, the internal cavity may have any shape. For example, the internal cavity may have flat walls over at least half of its length and / or over at least 90% of its length. For example, the reservoir cavity may be substantially a right cylinder over at least half of its length and / or over at least 90% of its length. For example, the internal cavity may be coaxial with the outer walls of the cartridge over at least half of its length and / or over at least 90% of its length.

[0127] For example, the cross-section of the void may be uniform over at least half of its length and / or over at least 90% of its length.Optionally, the reservoir may have a distal opening.

[0128] In some embodiments, the distal portion of the reservoir may comprise a cannula, e.g., a hypodermic needle, and / or a mount therefor. Alternatively or additionally, the distal portion of the reservoir and / or the distal opening may comprise a seal, e.g., a septum, and / or a sterile cover, e.g., a needle cover. The proximal end of the reservoir may have a proximal opening. Optionally, the proximal opening may be larger than the distal opening. For example, the cross-sectional area of ​​the proximal opening may be between 5 and 50 times the cross-sectional area of ​​the distal opening, and / or between 50 and 500 times the cross-sectional area of ​​the distal opening. Optionally, the opening may be beveled and / or may smoothly flow into the interior cavity of the reservoir. Optionally, a stopper may be inserted into the proximal opening. Optionally, a plunger seal, e.g., a stopper, may seal the reservoir and / or maintain the sterility of the contents of the reservoir. Optionally, the location of the stopper may vary depending on the volume of the contents of the reservoir. Optionally, the proximal end of the cartridge may be provided with a flange. For example, the flange may extend 20 to 100% of the circumference of the cartridge. For example, the flange may extend 1 mm to 2 cm away from the inner wall of the proximal opening. Optionally, the reservoir may be fabricated as a single integral unit, for example, from molded glass or molded plastic, and / or cut and / or fabricated tubing. Inserting the Drug Cartridge FIG. 3A is a flow chart illustrating a cartridge insertion method according to an embodiment of the invention. For example, a cartridge may be inserted using a moving bay. For example, the bay may be open to a loading position (385). With the bay in the loading position, the cartridge, and / or a portion thereof, is optionally loaded into the bay (323a). For example, the bay may have a proximal opening and / or a distal portion of the cartridge may be inserted longitudinally into the bay, for example, through the proximal opening of the bay. For example, 1 to 5% of the cartridge may be inserted into the bay, and / or 5 to 15% of the cartridge may be inserted into the bay, and / or 15 to 40% of the cartridge may be inserted into the bay, and / or 40 to 75% of the cartridge may be inserted into the bay, and / or 75 to 100% of the cartridge may be inserted into the bay. In some embodiments, inserting the cartridge into the bay may connect a coupler to the cartridge (326a). For example, the bay may include a cannula that projects proximally into the distal end of the channel of the cartridge in the bay.

[0129] When inserting the cartridge into the channel, the cannula optionally pierces a septum at the distal end of the cartridge.

[0130] In some embodiments, with a cartridge loaded into the bay (323a), the bay may be closed (325) to place the bay and / or cartridge into a dispensing position.

[0131] For example, the bay may be slid or pivoted to accommodate an opening in a side of the delivery device. When the cartridge is in the delivery position, the stopper pushing assembly may optionally be located proximal to the cartridge and / or aligned with the proximal opening of the drug reservoir and / or the stopper.

[0132] In some embodiments, the stopper drive assembly may be advanced (313) with the cartridge and / or bay closed (325) (eg, in the dispense position).

[0133] The stopper driver may be extended to engage the stopper by the stopper contact portion and / or drive the stopper forward into the drug reservoir and / or release the drug (314).

[0134] 3B is a flow chart illustrating a cartridge insertion method according to an embodiment of the present invention. In some embodiments, the cartridge may be inserted laterally (323b) and received in the dispensing device without a transfer bay. Alternatively or additionally, the cartridge may be inserted longitudinally (323b) and received in the device.

[0135] In some embodiments, the cartridge may be inserted (323b) from the side and received in the delivery device. For example, the cartridge may be inserted (323b) into an opening in the side of the device housing that leads to the cartridge compartment. Optionally, after insertion (323b), a stopper actuator is advanced (313) from the rear of the cartridge toward the stopper. The stopper actuator optionally engages the stopper. The cartridge is optionally driven forward (e.g., by the stopper actuator). For example, while the distal end of the cartridge is sealed, applying pressure to the plunger may not release the drug. The cartridge is optionally driven forward by pressure against the stopper and / or hydraulic pressure. Driving the cartridge forward optionally connects the drug reservoir to a connector (326b) and / or forms a fluid passage between the cartridge and the delivery device (e.g., by piercing a septum). Opening a fluid path out of the reservoir to the drug delivery device may facilitate advancement of the stopper within the drug reservoir and / or release of the drug.

[0136] Further advancement of the stopper drive assembly (313) optionally advances the stopper into the drug reservoir and / or releases the drug (314). For example, the drug may be released through the coupler and / or into a fluid passageway of the delivery device and / or into the user. Alternatively or additionally, the syringe may be driven forward to connect with the coupler after insertion into the bay (e.g., while and / or after the bay is closed to the delivery position) by a mechanism other than the expansion assembly, for example, such as being pushed forward by an angled surface.

[0137] In some embodiments, the cartridge may be inserted longitudinally into the device (323b). For example, the device may have a proximal opening that connects to the cartridge compartment. Inserting the cartridge longitudinally into the cartridge compartment optionally connects the drug reservoir to the coupler (326b) and / or forms a fluid passageway between the cartridge and the delivery device (e.g., piercing the septum). Optionally, after the septum is pierced, a stopper driver is advanced from the rear of the cartridge toward the stopper (313). The stopper driver optionally engages the stopper. Further advancement of the stopper driver assembly (313) optionally advances the stopper into the drug reservoir and / or releases the drug 314. For example, the drug may be released via the coupler and / or into the fluid passageway of the delivery device and / or to the user.

[0138] Insert assembly into angle-adjustable cartridge bay. FIG. 4 is a perspective view showing insertion of a cartridge into an angle-adjustable bay according to an embodiment of the invention. In some embodiments, the cartridge bay (423) tilts to a loading position, for example, as shown in FIG. 4A, outside the drug delivery device (422). Optionally, the bay (423) has a proximal opening (441b) to a cylindrical channel (as seen, for example, through a window 447). The channel is optionally dimensioned to fit the cartridge (420). For example, the cartridge is optionally inserted 473 into the channel through opening 441b. For example, the bay 423 tilts along a movable multi-position mount (e.g., pivot 425). An optional support 445 supports the bay 423 in the loading position. Optionally, the bay 423 and / or the cartridge 420 rotate about pivot 425 into a closed position in the cartridge compartment 424, for example, as shown in FIG. 4B.

[0139] Optionally, in the closed position, the cartridge 420 and / or the bay 423 are coaxial with the plunger pushing assembly and / or the compartment 424, for example as shown in FIG. 2B.

[0140] In some embodiments, cartridge 420 may comprise a standard syringe. For example, cartridge 420 may include a proximal opening 441a. A plunger seal 440 is optionally inserted through opening 441 to seal a proximal portion of cartridge 420 from a drug contained in its distal portion.

[0141] The distal end of the reservoir optionally includes an opening 456 and / or a seal (eg, septum 446, shown in FIG. 4D) and / or a needle mount. Optionally, cartridge 420 includes a proximal flange 421.

[0142] In some embodiments, the delivery device 422 may comprise a patch injector. For example, the skin-contacting surface 430 of the injector may be oriented parallel and / or approximately parallel to the long axis of the cartridge 420. For example, in Figures 4A-D, the skin-surface base of the injector faces the page. The skin-contacting surface is optionally covered, fully or partially, with an adhesive layer 429. The delivery device optionally includes an electronics compartment 435. The delivery device optionally includes a needle insertion assembly 433. For example, after placing the skin-contacting surface on the patient's body, the user may press a protruding button on the assembly 433 into the injector to expel the needle outwardly from the skin-contacting surface into the patient.

[0143] 4B is a perspective view of an articulable bay in a loaded position with a cartridge inserted, according to an embodiment of the invention. In FIG. 4B, a cartridge 420 is optionally inserted 473 into the bay 423 and is visible through a window 447. In the exemplary embodiment of FIGS. 4A-D, after insertion 473 of the cartridge into the bay 423, the bay 423 is optionally closed by being articulated into a cartridge compartment of the delivery device 422.

[0144] 4C is a perspective view of a closed, angle-adjustable bay according to an embodiment of the invention. Once the bay 423 is closed, a plunger drive assembly located at the proximal end of the device 422, proximal to the opening 441, optionally drives the plunger seal 440 distally and / or releases the drug.

[0145] FIG. 4D is a cross-sectional view of a drug delivery device with an angle-adjustable bay and cartridge in a loaded position according to an embodiment of the present invention. In FIG. 4D, an exemplary embodiment of a stopper drive assembly is shown. The stopper drive may include a TSA, including, for example, an anti-rotation guide 404, and / or a stopper drive shaft 410, and / or an intermediate shaft 412, and / or a stopper push shaft 414. Optionally, the guide 404 is connected to the device 422 with a track that prevents the guide 404 from rotating relative to the device 422 while allowing linear sliding of the guide in a distal direction. Optionally, the drive shaft 410 is supported by a linear stabilizer, for example a bearing 406. For example, the bearing 406 is located in the housing of the device 422. The bearing 406 optionally allows the shaft 410 to rotate, but prevents the shaft 410 from moving proximally relative to the device 422.

[0146] In some embodiments, a transmission including, for example, gears 426, optionally connects the shaft 410 to the motor 408. The motor 408 optionally rotates the shaft 410 relative to the device 422. Rotating the drive shaft 410 relative to the device 422, while the guide 404 optionally prevents the shaft 414 from rotating relative to the device 422, optionally generates relative rotation between the shafts 410 and 414. An optional combination of threads mating with the shafts 410, 412, and 414 converts the relative rotation into, optionally, a linear nesting motion of the assemblies. Optionally, a stopper pushing assembly is fixed proximal to the device 422 and / or proximal to the cartridge compartment and / or proximal to the dispensing position of the cartridge 420. The electronics compartment 435 includes, for example, a power source (e.g., battery 493) and / or a control unit (e.g., printed wiring board 499).

[0147] In some embodiments, in the loading position, the bay is rotated between 1 to 10 degrees, and / or 10 to 30 degrees, and / or 30 to 60 degrees, and / or 60 to 90 degrees from the compartment 424.

[0148] In some embodiments, when the cartridge 420 is inserted into the bay 423 and the bay 423 is closed and / or the cartridge 420 is in a dispensing position, distal advancement of the push shaft 414 pushes the plunger seal 440 distally and / or expels the drug 444 into the fluid path of the infusion section. The fluid path of the infusion section optionally includes a cannula 448 that extends from the cartridge 420 to a tube 449, to an injection needle of the insertion assembly 433 and / or into the patient's body. Optionally, the tube 449 is flexible and / or allows the cannula 448 to move the corresponding device 422 and / or the insertion assembly 433 (e.g., the cannula 448 moves along the bay 423 when the bay 423 is opened and / or closed). Optionally, the cannula 448 is bent, for example, in the range of 90 to 85 degrees, and / or 85 to 60 degrees, and / or 60 to 45 degrees.

[0149] Insertion of the assembly into the hinged cartridge bay. 5 is a perspective view showing insertion of a cartridge into a hinged bay according to an embodiment of the invention. In the exemplary device 522, the cartridge bay 523 rotates to a loading position (e.g., as shown in FIG. 5A).

[0150] In the loading position, the cartridge 420 may be inserted 573 into the bay 523 via the proximal opening 541. For example, the opening 541 may extend into a channel.

[0151] Optionally, the channel is cylindrical and / or cartridge-fitting. A closed distal wall 545 optionally supports the distal end of the bay 523. Optionally, the bay 523 is rotated to a closed position (e.g., as shown in FIG. 5C ) in which the bay 523 and / or the cartridge 520 inserted therein are coaxial with the cartridge compartment 524 and / or the cartridge pushing assembly.

[0152] 5B is a perspective view of a hinged bay in a loading position and loaded with a cartridge according to an embodiment of the invention. For example, once loaded, the bay 523 is closed 575 in a dispensing position by rotating about a movable, multi-position mount (e.g., hinge 525 shown in FIG. 5C).

[0153] Figure 5C is a perspective view of a hinged bay in a dispensing position according to an embodiment of the invention. The proximal end of device 422 optionally includes a stopper drive assembly, as illustrated in Figure 4D. Bay 523 optionally includes a cannula.

[0154] FIG. 6 is a perspective view showing the insertion of a cartridge into a drug delivery device according to an embodiment of the present invention. For example, the device may have a hinged cover 623. For example, the embodiment of FIG. 6A-C does not include a cartridge bay. Optionally, in the loading position, the proximal cover 623 of the device 622 rotates open to reveal an opening 641 to the cartridge compartment 624 (e.g., seen through window 447). The cartridge 420 may optionally be inserted 673 longitudinally into the cartridge compartment 624. A cannula, optionally protruding at the distal end of the cartridge compartment, optionally pierces a septum at the distal end of the cartridge 420 prior to insertion 673 and / or connects the cartridge 420 to the fluid path of the device 622 prior to insertion 673. Alternatively or additionally, the septum may be pierced after insertion. For example, the cartridge may be pushed into the connector by an extension assembly. 6B is a perspective view of a hinged cover device in a loaded position after insertion into a cartridge according to an embodiment of the invention. After insertion 673 of the cartridge 420, the proximal cover of the device 623 is optionally rotated 675 closed.

[0155] 6C is a perspective view of a closed hinged cover 623 according to an embodiment of the present invention. Optionally, a plunger pushing assembly is located on the proximal cover 623 and / or disposed proximal to the cartridge 420 when the cover is closed.

[0156] FIG. 7 is a perspective view of the insertion of a cartridge into a drug delivery device according to an embodiment of the present invention. For example, the device of FIGS. 7A-7C includes a sliding cover 723. For example, the embodiment of FIGS. 7A-7C does not include a cartridge bay. Optionally, in the loaded position, a proximal cover 723 of the device 722 slides open to reveal an opening 741 to a cartridge compartment (e.g., seen through window 447). The cartridge 420 may be optionally inserted 773 longitudinally into the cartridge compartment 724. A cannula optionally protrudes into a distal end of the cartridge compartment 724. The cannula optionally pierces a septum at the distal end of the cartridge 420 prior to insertion 773 and / or connects the cartridge 420 to a fluid path of the device 722 prior to and / or after insertion.

[0157] 7B is a perspective view of a sliding cover device in a loaded position after insertion of a cartridge, according to an embodiment of the invention. After insertion 773 of the cartridge 420, optionally, the proximal cover 723 of the device 722 is slid s775 closed.

[0158] 7C is a perspective view of a closed sliding cover 723 according to an embodiment of the present invention. Optionally, when the cover 723 is closed, a plunger pushing assembly is located proximal to the cover 723 and / or is disposed proximal to the cartridge 420.

[0159] A stopper drive with anti-rotation guide stabilized by the device housing. 8 is an enlarged cross-sectional view of a stopper driver in a shortened configuration according to an embodiment of the present invention. In some embodiments, the TS 452 is stabilized by the housing of the drug delivery device 822. For example, the protrusion 405 of the anti-rotation guide 404 is attached to and / or connects to a guide track 805 provided on the housing of the device 822. The drive shaft 410 is optionally linearly stabilized relative to the housing of the device 822. For example, the linear stabilization may be via a bearing 806. For simplicity, the transmission and motor assembly are not shown in FIGS. 8A-8B. Optionally, the device 822 has a skin contacting surface 830.

[0160] FIG. 8B is a cross-sectional view of a cartridge and stopper actuator in an expanded configuration according to an embodiment of the invention.

[0161] Optionally, drive shaft 410 rotates while expanding TS 452. For example, TS 452 may expands into cartridge 420 and / or push plunger seal 440 into cartridge 420 and / or release drug from cartridge 420. Optionally, as TS 452 expands, anti-rotation guide 404 moves into cartridge 420. For example, protrusion 405 may slide down track 805 as anti-rotation guide 404 slides into cartridge 420, and / or protrusion 415 may slide down track 415b as push shaft 414 slides against anti-rotation guide 404. Ridge 821 holds cartridge 420 from linearly moving distally relative to device 822. Optionally, contact surface 830 is parallel to an axis of the reservoir of cartridge 420 when cartridge 420 is inserted into a cartridge compartment of device 822 (e.g., a delivery position). Optionally, contact surface 830 is parallel to an axis of extension assembly 452. Optionally, the extension axis of extension assembly 452 is also coaxial with cartridge 420 when cartridge 420 is inserted into a cartridge compartment of device 822.

[0162] Stopper drive. 9 is a flow chart illustrating a method of actuating a plunger seal according to an embodiment of the present invention. In some embodiments, the TSA may extend or retract 100% or more of its minimum length by rotating 910 a single shaft and / or constraining rotation of a single shaft. For example, the TSA may be opened by rotating 910 a drive shaft. Optionally, a proximal drive shaft may be located proximal to the distal push shaft. For example, the drive shaft may be rotated 910 relative to the drug delivery device by a motor mounted on the device.

[0163] For example, the drive shaft may rotate 910 relative to a housing of the drug delivery device and / or relative to a mount for the motor. Optionally, the push shaft may be restrained 902 from rotating while the drive shaft rotates.

[0164] For example, the anti-rotation guide may prevent the pusher shaft from rotating relative to the drug delivery device housing, and / or relative to the motor, and / or relative to the motor mount. Rotating the drive shaft 910 relative to the pusher shaft optionally extends the TSA, and / or the pusher shaft, and / or the stopper.

[0165] In some embodiments and / or in some configurations, the intermediate shaft may move axially independent of the length of the TSA, for example, as the TSA extends, the intermediate shaft may extend 912 linearly with the push shaft and / or rotate 913 with the drive shaft.

[0166] Optionally, for some TSA lengths, the position of the countershaft may be undetermined. For example, rotating the drive shaft 910 may result in, for example, extending 912 the countershaft into the reservoir (e.g., when the drive shaft rotates faster than the countershaft and / or by means of coupling the drive shaft with a countershaft screw).

[0167] Optionally, extending 912 the intermediate shaft into the reservoir simultaneously extends 914 the push shaft into the reservoir. Alternatively or additionally, rotating 910 the drive shaft may rotate 913 the intermediate shaft. Optionally, rotating 913 the intermediate shaft extends 914 the push shaft into the reservoir (e.g., by means of a threaded connection of the drive shaft to the intermediate shaft). The rotation and / or extension of the intermediate shaft may occur in unison and / or sequentially.

[0168] In some embodiments, the anti-rotation guide may float axially. For example, as the TSA extends, the anti-rotation guide may extend 904 along the push shaft (e.g., moving axially relative to and / or into the reservoir), and / or the anti-rotation guide may remain stationary relative to the reservoir, and / or the push shaft may extend 914 axially relative to the anti-rotation guide. Optionally, for some lengths of TSA, the position of the anti-rotation guide may be undetermined.

[0169] Exemplary dimensions of the drug delivery device. In some embodiments, the volume of the reservoir (e.g., syringe) contains, for example, between 0.5 and 3 ml, and / or between 3 and 6 ml, and / or between 6 and 10 ml, and / or between 10 and 15 ml of drug, and / or more. Optionally, the length of the reservoir (e.g., the length of the tubular portion of the cavity that holds the drug) can range from 2 to 5 cm, and / or 5 to 10 cm.

[0170] Optionally, the width of the reservoir (e.g., the inner width and / or diameter of the cavity of the tubular portion that holds the drug) may range, for example, from 0.5 cm to 2 cm and / or from 2 to 5 cm. In some embodiments, the injector may release the entire volume as a single dose. The drug delivery device may include, for example, a pen injector and / or a patch injector and / or an internally powered driver that drives the stopper and / or releases the volume. The reservoir of the injector may be oriented parallel to the subject's skin and / or perpendicular to the skin and / or at an angle between parallel and perpendicular, for example, 60 to 90 degrees and / or 30 to 60 degrees and / or 0 to 30 degrees.

[0171] For purposes of this application, an internally powered injector drive is defined as a drive mechanism that is powered, at least temporarily, by energy stored within the injector.

[0172] Power can be, for example, chemical (e.g., expanding gases and / or chemicals producing batteries) and / or mechanical (e.g., storing in an The energy may be stored in the power supply as a resilient member, and / or a spring, and / or a compressed gas. For example, the actuator may be designed to release the volume over a range of 20 to 120 seconds, and / or 120 to 600 seconds, and / or 600 to 7200 seconds, and / or longer. In some embodiments, the release may be driven by the actuator. An internally powered actuator may be powered by a variety of mechanisms including, for example, a motor (including, for example, a DC motor, actuator, brushless motor), and / or a gearing including, for example, a nested assembly, and / or a threaded element, and / or a gear, and / or a linkage, and / or a resilient mechanism (e.g., a spring, and / or a rubber band), and / or an expanding gas, and / or a hydraulic actuator, etc.

[0173] The drug delivery device of some embodiments of the present invention may include a reservoir. For example, the reservoir may include a drug container and / or a standard syringe. Optionally, the standard syringe may be preloaded with a drug using standard equipment and / or in a sterile room. The preloaded standard syringe may optionally include a proximal opening. A stopper may optionally seal the proximal opening and / or protect the sterility of the contents of the syringe.

[0174] A sterile needle (e.g., a hollow needle) may optionally be connected to the barrel of the syringe. For example, the hollow portion of the needle may be in fluid communication with the interior of the barrel. The needle may optionally be rigidly attached to the distal end of the barrel. Sterility of the entire and / or part of the needle may be protected by a sterile cover. The sterile cover may remain on the needle when the syringe is delivered and / or inserted into the injection site. For example, the drug container may optionally include a cylindrical barrel rigidly attached to the needle. Optionally, the long axis of the needle and the long axis of the syringe barrel may be parallel and / or coaxial. Optionally, the needle may be mounted at the distal end of the barrel. Optionally, the needle tip may point in a distal direction. In some embodiments, a stopper may slide axially along the inside of the barrel to release the drug volume. For example, the drug may be released through the hollow needle.

[0175] In some embodiments, the length of the exposed needle (e.g., protruding from the skin contact surface during drug release and / or during cannulation) may be suitable for performing an injection. For example, the length of the exposed needle may be suitable for intradermal injection and / or have a size range of, for example, between 24G and 30G and / or a length range of, for example, between 7 and 10 mm, and / or the length of the exposed needle may be suitable for subcutaneous injection and / or have a size range of, for example, between 23G and 28G and / or a length range of, for example, between 9 and 28 mm, and / or the length of the exposed needle may be suitable for intramuscular injection and / or have a size range of, for example, between 18G and 23G and / or a length range of, for example, between 24 and 40 mm, and / or the length of the exposed needle may be suitable for intravenous injection and / or have a size range of, for example, between 15G and 22G and / or a length range of, for example, between 24 and 40 mm.

[0176] In some embodiments, the TSA generates forces in the range of, for example, between 0.02 and 0.2 N, and / or between 0.2 and 0.5 N, and / or between 0.5 and 5 N, and / or between 5 and 60 N, and / or between 60 and 90 N. For example, the force required to inject a drug depends on the injection rate, and / or the drug viscosity, and / or the syringe geometry, and / or the needle dimensions.

[0177] In some embodiments, the pressure to inject the agent may include a rotational force.

[0178] For example, the injection of the drug may be driven by a stopper. The stopper may optionally be driven by a threaded assembly, such as, for example, a threaded screw and / or gears and / or a telescoping assembly. Optionally, the spacing of the gears and / or the associated threads may range, for example, between 0.5 and 2 mm and / or between 2 and 4 mm and / or between 4 and 8 mm. The diameter of the threads may range, for example, between 4 and 15 mm. The rotational force powering the injection may be, for example, between 0.2 and 1.0 N. * cm and / or 1.0 to 10 N * The range may be between 1 cm.

[0179] During injection, the linear movement of the stopper may range, for example, between 5-40 mm and / or between 40-50 mm. The length of the stopper movement may, for example, vary depending on the volume of drug to be injected, for example, between 0.5 and 3 ml and / or between 3 and 10 ml and / or between 10 and 30 ml.

[0180] Much related technology will be developed during the life of any patent that may result from this application, and the scope of the terms in this application will, a priori, include all such new technologies.

[0181] As used herein, the term "about" means ±5%.

[0182] The terms "include," "including," "comprises," "having," "including," and variations thereof mean "including, but not limited to."

[0183] The term "consisting of" means "including and limited to."

[0184] The term "consisting essentially of" means that a composition, method, or structure may include additional elements, steps, and / or components only if the additional elements, steps, and / or components do not substantially change the basic and novel characteristics of the claimed composition, method, or structure.

[0185] As used herein, the singular terms "a," "one," and "the" include the plural. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

[0186] Throughout this application, various embodiments of the invention are presented in a range format. This description in range format is merely for convenience and brevity and should not be construed as a hard limitation on the scope of the invention. Thus, the description of a range should be construed as specifically disclosing not only the individual numerical values ​​within the range but also all the possible subranges. For example, a description of a range from 1 to 6 should be construed as specifically disclosing subranges, e.g., 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., along with the individual numerical values ​​within the range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0187] Whenever a numerical range is given herein, it is meant to include every number (decimal or integer) within the given range. "Ranging between" a first reference number and a second reference number, and "ranging from" a first reference number to a "second reference number" are used interchangeably herein and are meant to include the first and second reference numbers and all decimal and integer numbers therebetween.

[0188] Certain features of the invention may be described in separate embodiments for clarity, or may be provided in combination in a single embodiment. Conversely, various features of the invention may be described in a single embodiment for brevity, or may be provided separately or in any suitable subcombination, or as appropriate in any other described embodiment of the invention. Certain features described in the various embodiments are not considered essential to those embodiments, unless the embodiment is inoperable without those elements.

[0189] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference herein. Additionally, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. Although section headings are used, they should not be construed as necessarily limiting.

[0190] 〔summary〕 According to an aspect of some embodiments of the present invention, the method includes: An interface for connecting a tubular reservoir to a drug delivery device having a skin contacting surface, comprising: a coupler attached to the drug delivery device independent of the tubular reservoir, the coupler being sized and shaped to provide a flow path between a distal opening of the tubular reservoir and a fluid path of the drug delivery device; an expansion assembly attached to the drug delivery device independently of the tubular reservoir and configured to expand along an axis parallel to the skin-contacting surface; a compartment shaped and dimensioned to hold the tubular reservoir, with a longitudinal axis of the tubular reservoir coaxial with the axis of expansion, and with a proximal opening of the tubular reservoir facing the expansion assembly and a distal opening of the reservoir facing the connector.

[0191] According to some embodiments of the present invention, The coupler has a cannula sized and shaped to pierce a seal at the distal opening of the reservoir.

[0192] According to some embodiments of the present invention, The interface further comprises: The connector includes a channel configured to direct longitudinal movement of the reservoir, toward the connector and along the channel, such that the connector penetrates a seal at the distal opening of the reservoir.

[0193] According to some embodiments of the present invention, the channel is within the compartment; The interface further comprises: a proximal opening of the channel sized and shaped for axial insertion of a proximal end of the reservoir into the channel, toward the connector; and a movable mount connecting the expansion assembly to the delivery device for movement between a first position blocking insertion of the reservoir into the proximal opening of the channel and a second position in which the expansion assembly is released from the proximal opening of the channel.

[0194] According to some embodiments of the present invention, The interface further comprises: a bay including the channel and movably mounted to the delivery device for moving between a loading position and a delivery position; In the loading position, an opening of the channel is outside the compartment, and in the delivery position, the channel and the opening of the channel are inside the compartment.

[0195] According to some embodiments of the present invention, The bay further includes a rotation axis for movably mounting the bay to the delivery device.

[0196] According to some embodiments of the present invention, When the bay moves from the loading position to the delivery position, The opening of the channel is at a proximal portion of the bay and the axis of rotation is at a distal portion of the bay such that the opening rotates about the axis of rotation towards the compartment.

[0197] According to some embodiments of the present invention, The bay moves independently of the coupler such that when the bay is in the delivery position, the coupler aligns with the channel and when the bay is in the loading position, the coupler does not align with the channel.

[0198] According to some embodiments of the present invention, The coupler is attached to the bay such that the coupler aligns with the channel when the bay is in the delivery position and the loading position.

[0199] According to some embodiments of the present invention, The coupler is attached to the bay such that when the reservoir is inserted into the bay, the coupler forms the flow path while the bay is in the loaded position.

[0200] According to some embodiments of the present invention, The expansion assembly includes a telescoping screw.

[0201] According to some embodiments of the present invention, The device further comprises an opening for inserting the reservoir into the compartment from the side.

[0202] According to some embodiments of the present invention, The device further includes a hollow needle in fluid communication with the flow passage and extending outwardly from the skin-contacting surface.

[0203] According to some embodiments of the present invention, 1. A method for loading a tubular reservoir containing a drug into a patch infusion portion having a skin-contacting surface, comprising: providing an expansion assembly mounted to the patch infusion portion with an expansion axis parallel to the skin contact surface and independent of the tubular reservoir; and providing a connector mounted to the patch infusion portion independent of the tubular reservoir; positioning the tubular reservoir in the patch infusion compartment between the connector and the expansion assembly coaxial with the expansion shaft such that a proximal opening of the tubular reservoir faces the expansion assembly and a distal opening of the tubular reservoir faces the connector; opening a fluid path between the reservoir and an injection device of the patch infusion unit via the distal opening of the reservoir; expanding the expansion assembly through a proximal opening of the reservoir; Depressing a plunger seal along a longitudinal axis of the reservoir; A method of delivering the drug from the reservoir, through the distal opening of the reservoir, and into the fluid path.

[0204] According to some embodiments of the present invention, The method further includes breaking a seal at the distal opening of the tubular reservoir with the coupler.

[0205] According to some embodiments of the present invention, The placing, inserting at least one distal portion of the reservoir axially into the compartment of the patch infusion portion through an opening in the compartment and toward the coupler; and after said insertion, pressing said sealing portion against a connecting portion; The method further comprises: The expansion assembly, a first position proximal to the proximal opening that blocks insertion of the reservoir into the proximal opening of the channel; a second position in which the pushing assembly is released from the proximal opening.

[0206] According to some embodiments of the present invention, axially inserting at least one distal portion of a cartridge into a channel of a cartridge bay, said inserting and said opening a fluid path comprising: inserting, which occurs while the cartridge bay is in a loaded position and the proximal opening of the tubular reservoir remains outside of the compartment; and moving the cartridge bay and the cartridge together after the opening to a delivery position between the expansion assembly and the coupler and within the compartment.

[0207] According to some embodiments of the present invention, inserting at least one distal portion of a cartridge axially into a channel of a cartridge bay in a loaded position in which the proximal opening of the tubular reservoir remains outside the compartment; and moving the cartridge bay and the cartridge together to a position of the cartridge within the compartment between the expansion assembly and the coupler; After the moving, the expanding of the expansion assembly presses a distal seal of the cartridge against the connector, causing the opening.

[0208] According to some embodiments of the present invention, placing the skin-contacting surface against the skin of a user; and inserting a hollow needle into the user at an angle between 30 and 150 degrees relative to the extension axis, the hollow needle being in fluid communication with the fluid path.

[0209] According to some embodiments of the present invention, 1. An interface assembly for a drug delivery device having a drug cartridge with a seal at a distal portion thereof and a stopper inserted into a proximal opening thereof, said assembly comprising: a cartridge holding compartment; a stopper pushing assembly fixedly mounted to the delivery device proximal to the compartment; a cartridge bay movably mounted to the delivery device; a channel that fits over at least one of the distal portions of the cartridge to hold the cartridge, the channel including a proximal opening that is sized for longitudinal insertion of the distal portion of the cartridge into the channel; a distal cannula that projects axially into a distal end of the channel to pierce the seal when the distal portion is inserted into the channel; The bay includes a loading position where the cartridge is inserted into the channel; The cartridge moves between a delivery position and a cartridge retained inside the compartment.

[0210] Here, the bay moves between a load position, in which a cartridge is inserted into the channel, and a delivery position, in which a cartridge is held inside the compartment.

[0211] According to some embodiments of the present invention, An interface assembly for a drug cartridge and drug delivery device is provided, the interface assembly having a seal at a distal end thereof and a stopper inserted into a proximal opening thereof; The assembly comprises: a cartridge holding chamber, a stopper pushing assembly fixedly mounted to the delivery device proximal to the chamber, and a cartridge bay movably mounted to the delivery device; Bay is a channel that fits over at least one distal portion of the cartridge for holding the cartridge, a proximal opening dimensioned for longitudinal insertion of a distal portion of the cartridge into the channel; a distal cannula that protrudes axially into a distal end of the channel for piercing the seal when the proximal portion is inserted into the channel; The bay moves between a load position, in which the cartridge is inserted into the channel, and a delivery position, in which the cartridge is held inside the chamber.

[0212] According to some embodiments of the present invention, An interface assembly for a drug cartridge and drug delivery device is provided, the interface assembly having a seal at a distal end thereof and a stopper inserted into a proximal opening thereof; The assembly has a cartridge retaining chamber; The chamber fits a cartridge including a proximal opening for insertion of the cartridge and a connector at a distal end of the chamber, the connector configured to connect the cartridge to a fluid passage of the delivery device, and the stopper pusher is movably mounted to the delivery device for movement between a first position proximal to the proximal opening that blocks insertion of the cartridge into the proximal opening and a second position in which the proximal opening is open from insertion of the cartridge.

[0213] According to some embodiments of the present invention, There is provided a method of connecting a drug cartridge and a drug delivery device, the method comprising: providing a drug cartridge having a seal at a distal end thereof and a stopper inserted in a proximal opening thereof; providing a stopper pushing assembly configured to be mounted to a delivery device; inserting at least one distal portion of a cartridge into a chamber of the drug device through a proximal opening of the chamber; opening a fluid path between the drug delivery device and the cartridge by pressing a seal located at a distal end of the cartridge against a coupling mounted at the distal end of the chamber; A cartridge pushing assembly is positioned in an opening behind the proximal opening.

[0214] According to some embodiments of the present invention, There is provided a method of connecting a drug cartridge and a drug delivery device, the method comprising: providing a drug cartridge having a seal at a distal end thereof and a stopper inserted in a proximal opening thereof; providing a stopper pushing assembly configured to be mounted to a delivery device; inserting at least a distal portion of the cartridge longitudinally into a channel of the movable cartridge bay; opening a fluid path between the drug delivery device and the cartridge by pressing a seal located at a distal end of the cartridge against a coupling mounted at the distal end of the channel; The cartridge bay is moved to a cartridge position distal to the cartridge pushing assembly.

[0215] According to some embodiments of the present invention, There is provided a method of connecting a drug cartridge and a drug delivery device, the method comprising: connecting a distal opening of the drug cartridge to a fluid path of the device; inserting a drug cartridge into the device distal to a stopper pushing assembly mounted on the device; A stopper pushing device releases the drug by pushing the stopper distally within the cartridge.

[0216] According to some embodiments of the present invention, An assembly for connecting a drug cartridge and a drug delivery is provided, the assembly comprising: a chamber within the device for holding a cartridge; a coupler connecting a distal opening of the cartridge to a fluid passageway of the device; an opening in a side of the device for inserting a cartridge into the chamber at the opening; and a stopper pushing assembly mounted to the device proximal to the chamber.

[0217] According to some embodiments of the present invention, An assembly for connecting a drug cartridge and a drug delivery is provided, the assembly comprising: a chamber within the device for holding a cartridge; a coupler connecting a distal opening of the cartridge to a fluid passageway of the device; a proximal opening at a proximal end of the chamber for inserting a cartridge into the chamber; and a movable stopper pushing assembly mounted to the device for movement between a position proximal to the chamber for opening the proximal opening and a position proximal to the chamber for blocking the proximal opening of the chamber.

[0218] Aspect 1 is A housing having a partition; a cartridge bay configured to pivot relative to the housing between an open position and a closed position, the cartridge bay configured to receive a cartridge in the open position and to be received in the compartment in the closed position; A motor inside the housing; an expansion assembly within the housing; The expansion assembly includes: a drive configured to be rotated by the motor, the drive being distally supported by a linear stabilizer including a bearing engaged with the housing to permit rotation of the drive while preventing proximal movement of the drive relative to the housing; A first intermediate screw threadably connected to the periphery of the drive portion; a second intermediate screw threadably connected to the periphery of the first intermediate screw; a plunger driver threadably connected around the second intermediate screw and configured to push a plunger seal through a reservoir of the cartridge to deliver a drug; a rotation prevention guide portion disposed around the plunger drive portion and preventing rotation of the plunger drive portion relative to the housing; A drug delivery device, wherein the plunger drive portion has a protrusion that slides down the track of the anti-rotation guide portion.

[0219] Aspect 2 is 2. The drug delivery device of embodiment 1, further comprising a needle shield and a drug delivery hole.

[0220] Aspect 3 is 3. The drug delivery device of claim 2, wherein the housing has a skin-contacting surface on at least a portion of which an adhesive is applied.

[0221] Aspect 4 is an injection needle that, in an extended state, is perpendicular to the longitudinal axis of the reservoir of the cartridge; a coupler including a hollow needle; 2. The drug delivery device of embodiment 1, further comprising a flexible tube connecting the injection needle and the coupler.

[0222] Aspect 5 is 5. The drug delivery device of claim 4, wherein a septum of the cartridge is pierced by the hollow needle when the cartridge is inserted into the cartridge bay.

[0223] Aspect 6 is 6. The drug delivery device of claim 5, wherein the expansion assembly is configured to push the cartridge longitudinally into the hollow needle to pierce the septum.

[0224] Aspect 7 is A drug delivery device as described in aspect 4, wherein the hollow needle of the connector is mounted to the drug delivery device at one end of the compartment and the expansion assembly is mounted to the drug delivery device at an opposite end of the compartment.

[0225] Aspect 8 is 8. The drug delivery device of claim 7, wherein the cartridge is disposed between the expansion assembly and the coupler.

[0226] Aspect 9 is 8. The drug delivery device of claim 7, wherein the expansion assembly is configured to expand along an expansion axis that is coaxial with the cartridge.

[0227] Aspect 10 is a method for producing a semiconductor device comprising the steps of: 2. The drug delivery device of claim 1, wherein the cartridge is configured to hold a syringe in the cartridge bay using a flange.

[0228] Aspect 11 is a The drug delivery device of claim 1, wherein the plunger drive portion is configured to move within the opening of the cartridge to engage with the plunger seal, and further expands after engaging with the plunger seal to drive the plunger seal distally through the reservoir of the cartridge.

[0229] Aspect 12 is a method for producing a a cartridge having a reservoir including a drug and a plunger seal; a drug delivery device, The drug delivery device comprises: A housing having a partition; a cartridge bay configured to pivot relative to the housing between an open position and a closed position, the cartridge bay configured to receive the cartridge in the open position and to be received in the compartment in the closed position; A motor inside the housing; an expansion assembly internal to the housing; The expansion assembly includes: a drive configured to be rotated by the motor, the drive being distally supported by a linear stabilizer including a bearing engaged with the housing to permit rotation of the drive while preventing proximal movement of the drive relative to the housing; A first intermediate screw threadably connected to the periphery of the drive portion; a second intermediate screw threadably connected to the periphery of the first intermediate screw; a plunger driver threadably connected around the second intermediate screw and configured to push the plunger seal through the reservoir to deliver the drug; a rotation prevention guide portion disposed around the plunger drive portion and preventing rotation of the plunger drive portion relative to the housing; an assembly in which the plunger driver has a protrusion that slides down a track on the anti-rotation guide.

[0230] Aspect 13 is 13. The assembly of embodiment 12, further comprising a needle shielding member and a drug delivery hole formed in the housing.

[0231] Aspect 14 is a method for producing a 14. The assembly of claim 13, wherein the housing of the drug delivery device has a skin-contacting surface having at least a portion thereof coated with adhesive.

[0232] Aspect 15 is a method for producing a The drug delivery device comprises: an injection needle that, in an extended state, is perpendicular to the longitudinal axis of the reservoir of the cartridge; a coupler including a hollow needle; 13. The assembly of embodiment 12, further comprising a flexible tube connecting the injection needle and the coupler.

[0233] Aspect 16 is a method for producing a 16. The assembly of claim 15, wherein the hollow needle of the coupler is mounted to the drug delivery device at one end of the compartment and the expansion assembly is mounted to the drug delivery device at an opposing end of the compartment.

[0234] Aspect 17 is a method for producing a 17. The assembly of claim 16, wherein the cartridge is disposed between the expansion assembly and the coupler.

[0235] Aspect 18 is a method for producing a 17. The assembly of claim 16, wherein the expansion assembly is configured to expand along an expansion axis that is coaxial with the cartridge.

[0236] Aspect 19 is a method for producing a 13. The assembly of embodiment 12, wherein the cartridge is configured to hold a syringe in the cartridge bay using a flange.

[0237] Aspect 20 is a method for producing a The assembly of claim 12, wherein the plunger driver is configured to move within the opening of the cartridge to engage with the plunger seal, and further expands after engaging with the plunger seal to drive the plunger seal distally through the reservoir of the cartridge.

[0238] Aspect 21 is The drug delivery device of embodiment 1, further comprising a guide track attached to the housing and / or provided on the housing, the guide track preventing rotation of the anti-rotation guide portion.

[0239] Aspect 22 is A drug delivery device as described in aspect 21, wherein the anti-rotation guide portion has a protrusion that is received in the guide track, and the protrusion slides down the guide track as the plunger drive portion pushes the plunger seal through the reservoir portion of the cartridge.

Claims

[Claim 1] A housing having a partition; a cartridge bay configured to pivot relative to the housing between an open position and a closed position, the cartridge bay configured to receive a cartridge in the open position and to be received in the compartment in the closed position; A motor inside the housing; an expansion assembly within the housing; The expansion assembly includes: a drive configured to be rotated by the motor, the drive being distally supported by a linear stabilizer including a bearing engaged with the housing to permit rotation of the drive while preventing proximal movement of the drive relative to the housing; a first intermediate screw threadably connected to the periphery of the drive; a second intermediate screw threadably connected to the first intermediate screw; a plunger driver threadably connected around the second intermediate screw and configured to push a plunger seal through a reservoir of the cartridge to deliver a drug; a rotation prevention guide portion disposed around the plunger drive portion and preventing rotation of the plunger drive portion relative to the housing; A drug delivery device, wherein the plunger driver has a protrusion that slides along a track on the anti-rotation guide.

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