Spacer assembly for a drug delivery system

Abstract

A drug delivery system includes a container including a closure and a stopper (434) configured to move within the container from a pre-use position to a post-use position. The system includes a drive assembly configured to move the stopper (434) between a first position and a second position and a spacer assembly (430) engaged with the stopper (434) and configured to be engaged by the drive assembly. The spacer assembly (430) includes a first spacer portion (432) received within the stopper (434), a second spacer portion (438) spaced apart from the first spacer portion, an inner plunger (436), and a spacer shuttle (440) received by the inner plunger (436). The inner plunger (436), the spacer shuttle (440), and the second portion (438) are configured to move relative to the stopper (434), wherein movement of the second spacer portion (438) is limited by the spacer shuttle (440), movement of the spacer shuttle (440) is limited by the inner plunger (436), and movement of the inner plunger (436) is limited by the stopper (434).

Description

[0001] Cross-reference of related applications

[0002] This application claims priority to U.S. Provisional Application Serial No. 62 / 347,911, filed June 9, 2016, and U.S. Patent Application Serial No. 15 / 616,183, filed June 7, 2017, each of which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure generally relates to syringe devices and methods for delivering fluids into a patient via injection. Background Technology

[0004] Various types of automated injection devices have been developed to allow drug solutions and other liquid therapeutic preparations to be administered or self-injected by untrained personnel. Typically, these devices include a reservoir pre-filled with the liquid therapeutic preparation and some types of automated needle injection mechanisms that can be triggered by the user. When the volume of the fluid or drug to be administered is typically less than a certain volume (such as 1 mL), an automated injector is usually used, which typically has an injection time of about 10 to 15 seconds. When the volume of the fluid or drug to be administered is greater than 1 mL, the injection time usually becomes longer, making it difficult for the patient to maintain contact between the device and the target area of ​​the patient's skin. Furthermore, as the volume of the drug to be administered increases, increasing the injection time becomes necessary. The traditional method of slowly injecting drugs into the patient is to initiate intravenous (IV) infusion and slowly inject the drug into the patient. This procedure is typically performed in hospital or outpatient settings.

[0005] Some devices allow for self-injection in a home setting and are capable of gradually injecting liquid therapeutic agents into a patient's skin. In some cases, these devices are small enough (both in height and overall size) to allow the patient to "wear" them while the liquid therapeutic agent is being infused into the patient's body. These devices typically include a pump or other type of discharge mechanism to force the liquid therapeutic agent out of the reservoir and into the injection needle. Such devices often also include: a valve or flow control mechanism for initiating the flow of the liquid therapeutic agent at the appropriate time; and a trigger mechanism for initiating the injection. Summary of the Invention

[0006] In one aspect, a drug delivery system for injecting a drug includes a container configured to receive the drug, the container including a stopper and a closure, wherein the stopper is configured to move within the container from a pre-use position to a post-use position. The system includes a drive assembly and a spacer assembly, the drive assembly being configured to move the stopper between a first position and a second position, and the spacer assembly engaging with and configured to be engaged by the stopper of the container. The spacer assembly includes: a first spacer portion received within the stopper; a second spacer portion spaced apart from the first spacer portion by a predetermined distance; an internal plunger; and a spacer shuttle received by the internal plunger. The internal plunger, the spacer shuttle, and the second portion are configured to move relative to the stopper, wherein movement of the second spacer portion is limited by the spacer shuttle, movement of the spacer shuttle is limited by the internal plunger, and movement of the internal plunger is limited by the stopper.

[0007] The internal plunger may have a first position and a second position, the second position being axially spaced from the first position, wherein when the internal plunger is in the first position, axial movement of the spacer shuttle is restricted, and when the internal plunger is in the second position, the spacer shuttle is movable relative to a stop. When the internal plunger is in the first position, axial movement of a second spacer portion may be restricted via the spacer shuttle, and when the internal plunger is in the second position, the second spacer portion is movable relative to the stop. The stop may have a closed first end and an open second end, wherein the closed first end of the stop is axially movable relative to the container between a use position in which the closed first end of the stop engages with the internal plunger and a dose-end position in which the closed first end of the stop is spaced from the internal plunger, and wherein when the stop is in the dose-end position, the internal plunger is free to move from the first position to the second position. The stop may be configured to move between the use position and the dose-end position based on engagement with a drug received within the container.

[0008] The stop may have a closed first end and an open second end, wherein the closed first end of the stop is axially movable relative to the container between a use position in which the closed first end of the stop engages with an internal plunger and a dose-end position in which the closed first end of the stop is spaced apart from the internal plunger, and wherein when the stop is in the dose-end position, the internal plunger is freely movable from the first position to the second position. The stop may be configured to move between the use position and the dose-end position based on engagement with a drug received within the container. Movement of a second portion of the spacer assembly by the predetermined distance may be configured to retract the trigger needle of the drive assembly. The spacer shuttle may be rotatable relative to the internal plunger, and wherein axial displacement of the second portion of the spacer assembly is configured to cause rotation of the spacer shuttle. The second portion of the spacer assembly may define an access opening configured to allow direct engagement of the first spacer portion of the spacer assembly.

[0009] In another aspect, a spacer assembly for a drug delivery system for injecting drugs is provided. The spacer assembly includes: a first spacer portion configured to be received by a stop; a second spacer portion spaced apart from the first spacer portion by a predetermined distance; an internal plunger; and a spacer shuttle received by the internal plunger, wherein the internal plunger, the spacer shuttle, and the second portion of the spacer are configured to move relative to the first spacer portion. The movement of the second spacer portion is limited by the spacer shuttle, and the movement of the spacer shuttle is limited by the internal plunger.

[0010] The internal plunger may have a first position and a second position, the second position being axially spaced from the first position. When the internal plunger is in the first position, axial movement of the spacer shuttle may be restricted, and when the internal plunger is in the second position, the spacer shuttle may move relative to a stop. When the internal plunger is in the first position, axial movement of the second spacer portion may be restricted via the spacer shuttle, and when the internal plunger is in the second position, the second spacer portion may move relative to the stop. When the first plunger is in the second position, the second portion of the spacer assembly may move freely toward the first portion of the spacer assembly. The spacer shuttle may rotate relative to the internal plunger, wherein axial displacement of the second portion of the spacer assembly is configured to cause rotation of the spacer shuttle. The second spacer portion of the spacer assembly may define an inlet opening configured to allow direct engagement of the first spacer portion of the spacer assembly. The first and second portions of the spacer assembly may be fixed to each other while allowing relative axial movement of the predetermined distance.

[0011] On the other hand, a drug delivery system for injecting drugs includes a drug container configured to receive a drug container, the container including a stop and a closure, wherein the stop is configured to move within the container from a pre-use position to a post-use position. The system also includes a spacer assembly comprising a fixed spacer and an adjustable spacer, wherein the fixed spacer is received by the stop. The adjustable spacer is fixed to the fixed spacer and is movable relative to the spacer assembly by a predetermined axial distance.

[0012] The adjustable spacer can move only relative to the fixed spacer in a first axial direction. The spacer assembly may include a ratchet arrangement, wherein one of the fixed and adjustable spacers includes a plurality of ratchet stops, and the other of the fixed and adjustable spacers includes a spring-loaded pawl arm, and wherein rotation of the adjustable spacer relative to the fixed spacer in a first rotational direction causes the adjustable spacer to move the predetermined axial distance. The system may also include a shim configured to be fixed to the adjustable spacer.

[0013] In another aspect, a drug delivery system for injecting drugs includes a container and a drive assembly. The container is configured to receive a drug, wherein the container includes a stop and a closure, the stop being movable within the container. The drive assembly includes: a plunger member configured to move the stop within the container, wherein the plunger member has a first position and a second position axially spaced from the first position; a biasing member configured to move the plunger member from the first position to the second position; and a plunger actuation member movable relative to the plunger member. The plunger actuation member has a first position in which the plunger member is axially fixed relative to the plunger actuation member and a second position in which the plunger member is axially movable relative to the plunger actuation member. The system further includes: a needle actuator assembly including a needle configured to be in fluid communication with the container, wherein the needle is movable from the first position to the second position spaced from the first position; a limiting member configured to limit movement of the needle actuator assembly; and a spacer assembly including a fixed spacer and an adjustable spacer, wherein the fixed spacer is received by the stop. The adjustable spacer is fixed to the fixed spacer and can move a predetermined axial distance relative to the spacer assembly.

[0014] The limiting member can be configured to engage the rear portion of the container. Attached Figure Description

[0015] The above and other features and advantages of this disclosure, as well as the ways in which they are implemented, will become more apparent and the disclosure itself will be better understood through the following description of embodiments of this disclosure taken in conjunction with the accompanying drawings, in which:

[0016] Figure 1 This is a perspective view of a drug delivery system according to one aspect of the present invention.

[0017] Figure 2 According to one aspect of the present invention Figure 1 A perspective cross-sectional view of a drug delivery system.

[0018] Figure 3 According to one aspect of the present invention Figure 1 A front sectional view of a drug delivery system.

[0019] Figure 4 According to one aspect of the present invention Figure 1 A top view of the drug delivery system, showing the top portion of the housing removed and the drug delivery system in its pre-use position.

[0020] Figure 5 According to one aspect of the present invention Figure 1 The top sectional view of the drug delivery system shows the drug delivery system in its pre-use position.

[0021] Figure 6 According to one aspect of the present invention Figure 1 A front sectional view of a drug delivery system, showing the drug delivery system in its pre-use position.

[0022] Figure 7 According to one aspect of the present invention Figure 1 A top view of the drug delivery system, shown with the top portion of the housing removed and the drug delivery system in the initial actuated position.

[0023] Figure 8 According to one aspect of the present invention Figure 1 The top sectional view of the drug delivery system shows the drug delivery system in the initial actuation position.

[0024] Figure 9 According to one aspect of the present invention Figure 1 A front sectional view of a drug delivery system, showing the drug delivery system in its initial actuation position.

[0025] Figure 10 According to one aspect of the present invention Figure 1 A top view of the drug delivery system, showing the top portion of the housing removed and the drug delivery system in the use position.

[0026] Figure 11 According to one aspect of the present invention Figure 1 The image shows a top sectional view of a drug delivery system in its use position.

[0027] Figure 12 According to one aspect of the present invention Figure 1 A front sectional view of a drug delivery system, showing the drug delivery system in its use position.

[0028] Figure 13 According to one aspect of the present invention Figure 1 A top view of the drug delivery system, showing the top portion of the housing removed and the drug delivery system in the post-use position.

[0029] Figure 14 According to one aspect of the present invention Figure 1 The top sectional view of the drug delivery system shows the drug delivery system in its post-use position.

[0030] Figure 15 According to one aspect of the present invention Figure 1 A front sectional view of a drug delivery system, showing the drug delivery system in its post-use position.

[0031] Figure 15A According to one aspect of the present invention Figure 1 A front sectional view of a drug delivery system, showing the liner in the pre-use position of the drug delivery system.

[0032] Figure 15B According to one aspect of the present invention Figure 1 A perspective cross-sectional view of a drug delivery system, showing the liner in the pre-use position of the drug delivery system.

[0033] Figure 15C According to one aspect of the present invention Figure 1 A perspective cross-sectional view of a drug delivery system, showing the liner in the pre-use position of the drug delivery system.

[0034] Figure 16 According to one aspect of the present invention Figure 1 A partial cross-sectional view of a drug delivery system, showing the valve assembly.

[0035] Figure 17 This is a perspective view of a drive assembly for a drug delivery system according to one aspect of the present invention.

[0036] Figure 18 According to one aspect of the present invention Figure 17 A cross-sectional view of the drive component, showing the drive component in its pre-use position.

[0037] Figure 19 According to one aspect of the present invention Figure 17 A cross-sectional view of the driving component, showing where the driving component is used.

[0038] Figure 20 According to one aspect of the present invention Figure 17 A cross-sectional view of the driver component, showing the position of the driver component after use.

[0039] Figure 21 According to one aspect of the present invention Figure 17 A perspective view of the plunger actuation component of the drive assembly.

[0040] Figure 22 According to one aspect of the present invention Figure 17 A perspective view of the first plunger component of the drive assembly.

[0041] Figure 23 According to one aspect of the present invention Figure 17 A perspective view of the plunger actuation member and the first plunger member of the drive assembly, showing the plunger actuation member engaging with the first plunger member.

[0042] Figure 24 According to one aspect of the present invention Figure 17 A perspective view of the plunger actuation member and the first plunger member of the drive assembly, showing the plunger actuation member disengaged from the first plunger member.

[0043] Figure 25 According to one aspect of the present invention Figure 17 A perspective view of the plunger actuation member and the first plunger member of the drive assembly, showing the plunger actuation member disengaged from the first plunger member and displaced axially relative to it.

[0044] Figure 26 According to one aspect of the present invention Figure 17 Front view of the first and second plunger components of the drive assembly.

[0045] Figure 27 This is a top view of a drive component for a drug delivery system according to another aspect of the present invention.

[0046] Figure 28 According to one aspect of the present invention Figure 27 A perspective view of the driving component.

[0047] Figure 29 According to one aspect of the present invention Figure 27 A cross-sectional view of the drive component, showing the drive component in its pre-use position.

[0048] Figure 30 According to one aspect of the present invention Figure 27 A perspective view of the drive assembly, showing the drive assembly received by the bottom portion of the housing.

[0049] Figure 31 According to one aspect of the present invention Figure 30 A perspective view of the casing.

[0050] Figure 32 According to one aspect of the present invention Figure 27 A top view of the drive assembly, showing the drive assembly engaging with a portion of the needle actuator in its initial actuated position.

[0051] Figure 33 According to one aspect of the present invention Figure 27 An enlarged perspective view of the drive assembly, showing the drive assembly engaging with a portion of the needle actuator in its initial actuated position.

[0052] Figure 34 This is a front view of a needle actuator assembly according to one aspect of the present invention.

[0053] Figure 35 According to one aspect of the present invention Figure 34 Left perspective view of the needle shuttle of the needle actuator assembly.

[0054] Figure 36 According to one aspect of the present invention Figure 34 The right perspective view of the needle shuttle of the needle actuator assembly.

[0055] Figure 37A According to one aspect of the present invention Figure 34 A front view of the needle actuator assembly, showing the needle actuator assembly in its pre-use position.

[0056] Figure 37B According to one aspect of the present invention Figure 34 A front view of the needle actuator assembly, showing the needle actuator assembly in the use position.

[0057] Figure 37C According to one aspect of the present invention Figure 34 A front view of the needle actuator assembly, showing the needle actuator assembly in its initial use position.

[0058] Figure 37D According to one aspect of the present invention Figure 34 A front view of the needle actuator assembly, showing the needle actuator assembly in the used position.

[0059] Figure 38A According to one aspect of the present invention Figure 34 A perspective view of the needle actuator assembly, showing the needle actuator assembly in the use position.

[0060] Figure 38BAccording to one aspect of the present invention Figure 34 A perspective view of the needle actuator assembly, showing the needle actuator assembly in its initial use position.

[0061] Figure 39 According to one aspect of the present invention Figure 34 A perspective view of the actuator button and needle actuator assembly, showing the needle actuator assembly in its initial use position.

[0062] Figure 40A According to one aspect of the present invention Figure 34 A cross-sectional view of the actuator button and needle actuator assembly, showing the needle actuator assembly in its initial use position.

[0063] Figure 40B According to one aspect of the present invention Figure 34 A perspective view of the actuator button and needle actuator assembly, showing the needle actuator assembly in the used position.

[0064] Figure 41 This is a perspective view of a drive component for a drug delivery system according to another aspect of the present invention.

[0065] Figure 42 According to one aspect of the present invention Figure 41 A perspective view of the drive assembly, shown with the top portion of the housing removed.

[0066] Figure 43 According to one aspect of the present invention Figure 41 A cross-sectional view of the driving component.

[0067] Figure 44 According to one aspect of the present invention Figure 41 A perspective view of the driving component.

[0068] Figure 45 According to one aspect of the present invention Figure 41 A cross-sectional view of the drive component, showing the drive component in its pre-use position.

[0069] Figure 46 According to one aspect of the present invention Figure 41 A cross-sectional view of the drive component, showing the drive component in its pre-use position.

[0070] Figure 47 According to one aspect of the present invention Figure 41 A top view of the drive component, showing the drive component in its pre-use position.

[0071] Figure 48 According to one aspect of the present invention Figure 41 A top view of the drive assembly, showing the drive assembly in its initial actuated position.

[0072] Figure 49 According to one aspect of the present invention Figure 41 A top view of the drive assembly, showing the drive assembly in its initial actuated position.

[0073] Figure 50 According to one aspect of the present invention Figure 41 A top view of the drive assembly, showing the drive assembly in its initial actuated position.

[0074] Figure 51 According to one aspect of the present invention Figure 41 A top view of the drive component, showing the drive component in its usage position.

[0075] Figure 52 According to one aspect of the present invention Figure 41 A top view of the drive component, showing the drive component in its usage position.

[0076] Figure 53 According to one aspect of the present invention Figure 41 A cross-sectional view of the drive component, showing the drive component in its usage position.

[0077] Figure 54 According to one aspect of the present invention Figure 41 A top view of the drive component, showing the drive component in its usage position.

[0078] Figure 55 According to one aspect of the present invention Figure 41 A cross-sectional view of the drive component, showing the drive component in its usage position.

[0079] Figure 56 According to one aspect of the present invention Figure 41 A cross-sectional view of the drive component, showing the drive component in its usage position.

[0080] Figure 57 According to one aspect of the present invention Figure 41 A top view of the drive component, showing the drive component in its usage position.

[0081] Figure 58 According to one aspect of the present invention Figure 41 A top view of the drive component, showing the drive component in its initial, post-use position.

[0082] Figure 59 According to one aspect of the present invention Figure 41 A perspective view of the driver components, showing the driver components in their initial, post-use position.

[0083] Figure 60 According to one aspect of the present invention Figure 41 A top view of the drive component, showing the drive component in its post-use position.

[0084] Figure 61 According to one aspect of the present invention Figure 41 A top view of the drive component, showing the drive component in its post-use position.

[0085] Figure 62 According to one aspect of the present invention Figure 41 A cross-sectional view of the drive component, showing the drive component in its pre-use position.

[0086] Figure 63 According to one aspect of the present invention Figure 41 A cross-sectional view of the drive component, showing the drive component in its usage position.

[0087] Figure 64 This is a perspective view of a drive component according to another aspect of the present invention.

[0088] Figure 65A This is a front view of a needle actuator assembly according to one aspect of the invention, showing the needle actuator assembly in the use position.

[0089] Figure 65B According to one aspect of the present invention Figure 65A A front view of the needle actuator assembly, showing the needle actuator assembly in the use position.

[0090] Figure 65C According to one aspect of the present invention Figure 65A A front view of the needle actuator assembly, showing the needle actuator assembly in its initial use position.

[0091] Figure 65D According to one aspect of the present invention Figure 65A A front view of the needle actuator assembly, showing the needle actuator assembly in the used position.

[0092] Figure 65E According to one aspect of the present invention Figure 65A A front view of the needle actuator assembly, showing the needle actuator assembly in its pre-use position.

[0093] Figure 65F According to one aspect of the present invention Figure 65AA cross-sectional view of the needle actuator assembly, showing the needle actuator assembly in its pre-use position.

[0094] Figure 65G According to one aspect of the present invention Figure 65A A front view of the needle actuator assembly, showing the needle actuator assembly in a pre-use position, with the button actuator axially displaced.

[0095] Figure 65H According to one aspect of the present invention Figure 65A A cross-sectional view of the needle actuator assembly, showing the needle actuator assembly in its pre-use position, with the button actuator axially displaced.

[0096] Figure 66 According to one aspect of the present invention Figure 65A A perspective view of the button spring of the needle actuator assembly.

[0097] Figure 67 According to one aspect of the present invention Figure 65A A perspective view of the actuator button of the needle actuator assembly.

[0098] Figure 68 According to one aspect of the present invention Figure 65A A cross-sectional view of the button spring and actuator button of the needle actuator assembly.

[0099] Figure 68A According to another aspect of the invention Figure 65A A perspective view of the actuator button of the needle actuator assembly.

[0100] Figure 68B According to another aspect of the invention Figure 65A Bottom view of the actuator button of the needle actuator assembly.

[0101] Figure 68C According to another aspect of the invention Figure 65A Front view of the actuator button of the needle actuator assembly.

[0102] Figure 68D According to another aspect of the invention Figure 65A A top view of the actuator button of the needle actuator assembly, showing the actuator button in the pre-use position.

[0103] Figure 68E According to another aspect of the invention Figure 65A The front view of the actuator button of the needle actuator assembly shows the actuator button in the pre-use position.

[0104] Figure 68F According to another aspect of the invention Figure 65A A top view of the actuator button of the needle actuator assembly, showing the actuator button in the use position.

[0105] Figure 68G According to another aspect of the invention Figure 65A The front view of the actuator button of the needle actuator assembly shows the actuator button in the use position.

[0106] Figure 69 According to one aspect of the present invention Figure 65A A top view of the actuator button of the needle actuator assembly.

[0107] Figure 70A This is a schematic diagram of a drive assembly according to one aspect of the invention, showing the drive assembly in a pre-use position.

[0108] Figure 70B According to one aspect of the present invention Figure 70A A schematic diagram of the driving component, showing the driving component in the usage position.

[0109] Figure 70C According to one aspect of the present invention Figure 70A A schematic diagram of the driving component, showing the driving component in the usage position.

[0110] Figure 70D According to one aspect of the present invention Figure 70A A schematic diagram of the driving component, showing the driving component in the usage position.

[0111] Figure 70E According to one aspect of the present invention Figure 70A A schematic diagram of the driving component, showing the driving component in the usage position.

[0112] Figure 70F According to one aspect of the present invention Figure 70A A schematic diagram of the drive component, showing the drive component in its post-use position.

[0113] Figure 70G According to one aspect of the present invention Figure 70A A schematic diagram of the drive component, showing the drive component in its post-use position.

[0114] Figure 71 This is a perspective view of a spacer assembly for a drug delivery system according to one aspect of the invention, showing the spacer assembly in its pre-use position before assembly.

[0115] Figure 72 According to one aspect of the present invention Figure 71A perspective view of the spacer assembly, showing where the spacer assembly is used.

[0116] Figure 73 According to one aspect of the present invention Figure 71 A perspective view of the spacer assembly, showing the spacer assembly in its initial, used position.

[0117] Figure 74 This is a perspective view of a limiting member according to one aspect of the present invention.

[0118] Figure 75 This is a front view of a spacer assembly for a drug delivery system according to another aspect of the invention.

[0119] Figure 76 This is a top view of a spacer assembly for a drug delivery system according to one aspect of the present invention.

[0120] Figure 77 According to one aspect of the present invention Figure 76 A perspective view of the spacer component.

[0121] Figure 78 According to one aspect of the present invention Figure 76 A cross-sectional view of the spacer component.

[0122] Figure 79 This is a perspective view of a spacer assembly for a drug delivery system according to another aspect of the present invention.

[0123] Figure 80 This is a perspective view of a spacer assembly for a drug delivery system according to another aspect of the present invention.

[0124] Figure 81A According to one aspect of the present invention Figure 80 A cross-sectional view of the spacer assembly, showing the pre-assembled position of the spacer assembly.

[0125] Figure 81B According to one aspect of the present invention Figure 80 A cross-sectional view of the spacer assembly, showing the assembly location of the spacer assembly.

[0126] Figure 82 This is a perspective view of a drive assembly for a drug delivery system according to one aspect of the present invention.

[0127] Figure 83 According to one aspect of the present invention Figure 82 A perspective view of the drive assembly, shown with the top portion of the housing removed.

[0128] Figure 84 According to one aspect of the present invention Figure 82 A cross-sectional view of the drive component, showing the drive component in its pre-use position.

[0129] Figure 85 According to one aspect of the present invention Figure 82 An enlarged cross-sectional view of the drive component, showing the drive component in its pre-use position.

[0130] Figure 86 According to one aspect of the present invention Figure 82 A top view of the bias component of the driving component.

[0131] Figure 87 According to one aspect of the present invention Figure 82 A perspective view of the drive assembly, showing the engagement of the limiting member with the drive assembly.

[0132] Figure 88 This is a perspective view of a drive assembly for a drug delivery system according to one aspect of the present invention.

[0133] Figure 89 According to one aspect of the present invention Figure 88 A perspective view of the driver component, showing its position before use.

[0134] Figure 90 According to one aspect of the present invention Figure 88 A cross-sectional view of the driving component.

[0135] Figure 91 According to one aspect of the present invention Figure 88 A perspective view of the driver component, showing the position of the driver component after use.

[0136] Figure 92 According to one aspect of the present invention Figure 88 A cross-sectional view of the drive component, showing the drive component in its pre-use position.

[0137] Figure 93 According to one aspect of the present invention Figure 88 The front view of the driver component shows where the driver component is used.

[0138] Figure 94 This is a perspective view of a spacer assembly for a drug delivery system according to one aspect of the present invention.

[0139] Figure 95 According to one aspect of the present invention Figure 94 The front view of the spacer component.

[0140] Figure 96 According to one aspect of the present invention Figure 94A cross-sectional view of the spacer component.

[0141] Figure 97 According to one aspect of the present invention Figure 94 A perspective view of the spacer assembly, showing the compensation element removed.

[0142] Figure 98 According to one aspect of the present invention Figure 94 A perspective view of the fixed spacer of the spacer assembly.

[0143] Figure 99 According to one aspect of the present invention Figure 94 A perspective view of the adjustable spacer of the spacer assembly.

[0144] Figure 100 According to one aspect of the present invention Figure 94 A perspective view of the compensation component of the spacer assembly.

[0145] In the various views, corresponding reference numerals denote corresponding parts. The examples set forth herein illustrate exemplary aspects of this disclosure, and such examples should not be construed as limiting the scope of this disclosure in any way. Detailed Implementation

[0146] The following description is provided to enable those skilled in the art to make and use the embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the invention.

[0147] For the purposes of the following description, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be used in relation to the invention as oriented to it in the accompanying drawings. However, it should be understood that various alternative variations of the invention are possible unless explicitly stated otherwise herein. It should also be understood that the specific devices shown in the drawings and described in the following description are merely exemplary embodiments of the invention. Therefore, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0148] refer to Figures 1 to 16According to one aspect of the invention, a drug delivery system 10 includes a drive assembly 12, a container 14, a valve assembly 16, and a needle actuator assembly 18. The drive assembly 12, container 14, valve assembly 16, and needle actuator assembly 18 are at least partially located within a housing 20. The housing 20 includes a top portion 22 and a bottom portion 24, but other suitable arrangements of the housing 20 may be used. In one aspect, the drug delivery system 10 is a syringe device configured to be worn or secured to a user and to deliver a predetermined dose of drug, provided in the container 14, into the user's body via injection. The system 10 can be used to deliver "bolus injections," in which the drug is delivered over a set time period. The drug can be delivered over a time period of up to 45 minutes, but other suitable injection volumes and durations may be used. Bolus administration or delivery can be performed with or without specific rate control. The system 10 can deliver the drug to the user at a fixed pressure, wherein the rate is variable. Reference is made below. Figures 1 to 16 The general operation of system 10 is described below, with details of the drive assembly 12, the needle actuator assembly 18, and other features of system 10 combined. Figures 17 to 93 discuss.

[0149] Refer again Figures 1 to 16 System 10 is configured to operate by the following steps: a user engages an actuation button 26, which causes the needle 28 of the needle assembly 18 to pierce the user's skin; actuates the drive assembly 12 to make the needle 28 fluidly communicate with the container 14 and to expel fluid or medication from the container 14; and retracts the needle 28 after the medication has been completely injected. The general operation of the drug delivery system is shown and described in International Publications 2013 / 155153 and 2014 / 179774, the entire contents of which are incorporated herein by reference. The housing 20 of system 10 includes an indicator window 30 for viewing an indicator device 32 configured to provide the user with indications about the status of system 10, and a container window for viewing the container 14. The indicator window 30 may be a magnifying lens for providing a clear view of the indicator device 32. The indicator device 32 moves with the needle actuator assembly 18 during use of system 10 to indicate the pre-use, used, and post-use states of system 10. The indicator device 32 provides visual markings about the status, but may provide other suitable markings, such as auditory or tactile markings, as alternatives or additional markings.

[0150] refer to Figures 4 to 6 During the pre-use position of system 10, container 14 is spaced apart from drive assembly 12 and valve assembly 16, and needle 28 is in the retracted position. During the initial actuation of system 10, as... Figures 7 to 9As shown, the actuation assembly 12 engages the container 14 to move the container 14 toward the valve assembly 16, which is configured to pierce the closure 36 of the container 14 and fluidly communicate the medication within the container 14 with the needle 28 via a tube (not shown) or other suitable arrangement. The actuation assembly 12 is configured to engage the stop 34 of the container 14, which, due to the incompressibility of the fluid or medication within the container 14, will initially move the entire container 14 into engagement with the valve assembly 16. Initial actuation of the system 10 is caused by the user engaging the actuation button 26, which releases the needle actuator assembly 18 and the actuation assembly 12, as discussed in more detail below. During initial actuation, the needle 28 remains in the retracted position and is about to move to the extended position for the user to inject the system 10.

[0151] During the use of system 10, such as Figures 10 to 12 As shown, the needle 28 is in an extended position, at least partially outside the housing 20, where the drive assembly 12 moves the stop 34 within the container 14 to deliver medication from the container 14 to the user via the needle 28. In the use position, the valve assembly 16 has pierced the closure 36 of the container 14 to establish fluid communication between the container 14 and the needle 28, which also allows the drive assembly 12 to move the stop 34 relative to the container 14, enabling the dispensing of fluid from the container 14. In the post-use position of the system 10, as... Figures 13 to 15 As shown, needle 28 is in the retracted position and engages with gasket 38 to seal needle 28 and prevent any residual fluid or drug from leaking from container 14. Container 14 and valve assembly 16 can be those shown and described in International Publication No. WO2015 / 081337, which is incorporated herein by reference in its entirety.

[0152] refer to Figures 15A to 15C When the needle actuator body 96 moves from the use position to the post-use position, the pad 38 is biased into the needle. Specifically, the pad 38 is received by a pad arm 122 having a cam surface 124 that engages with a cam track 126 on the bottom portion 24 of the housing 20. The pad arm 122 is connected to the needle actuator body 96 via a torsion bar 128. The cam surface 124 is configured to engage the cam track 126 to deflect the pad arm 122 downward, thereby allowing the pad 38 to pass under the needle 28 before being biased upward into it. The torsion bar 128 allows the pad arm 122 to twist about a pivot of the needle actuator body 96. The pad 38 can be press-fitted into an opening in the pad arm 122, but other suitable arrangements for securing the pad 38 can be used.

[0153] refer to Figures 1 to 33The diagram illustrates a drive assembly 12 according to one aspect of the invention. As described above, the drive assembly 12 is configured to move the container 14 to pierce the closure 36 of the container 14, and also to move the stop 34 within the container 14 to dispense fluid or medicine from the container 14. Figures 17 to 33 The drive assembly 12 shown is configured to engage and cooperate with the spacer assembly 40 received by the stop 34 of the container 14. The spacer assembly 40 includes a spacer 42 and a spacer retainer 44. The spacer retainer 44 is received by the stop 34, and the spacer 42 is received by the spacer retainer 44. The spacer retainer 44 includes a first threaded portion 46 that engages a corresponding threaded portion of the stop 34, although other suitable arrangements may be used. The spacer 42 also includes a threaded portion 48 that engages a corresponding second threaded portion 50 of the spacer retainer 44 for securing the spacer 42 to the spacer retainer 44, although other suitable arrangements may be used. The drive assembly 12 is configured to dispense a predetermined filling volume range of the container 14 while maintaining the aforementioned functional characteristics of the system 10, including but not limited to the retraction of the needle 28 after the dose is dispensed and providing an indication of the status of the system 10, while also minimizing abrupt engagement of the stop 34 by the drive assembly 12. The drive assembly 12 is configured to distribute multiple discrete fill volume ranges by utilizing spacers 42 of multiple sizes. In one aspect, twelve fill volume ranges and twelve spacer 42 sizes are provided. In another aspect, the length of the spacers 42 is varied to accommodate different fill volumes in the container 14. Alternatively, a single-size spacer 42 may be used, wherein multiple fill volumes in the container 14 are accommodated by utilizing multiple compensation elements received by the spacers 42.

[0154] refer to Figures 17 to 26 The drive assembly 12 includes a first plunger member 52, a second plunger member 54 received by the first plunger member 52, a first biasing member 56, a second biasing member 58, a plunger actuation member 60, and an index member 62. The first plunger member 52 is available from a pre-use position ( Figure 18 (As shown) Move to the usage position ( Figure 19 As shown), move to the post-use position ( Figure 20 As shown in the diagram, the first plunger member 52 is configured to engage the spacer assembly 40 and move the stop member 34 within the container 14 to dispense medication from the container 14. The first plunger member 52 is configured to move axially. The second plunger member 54 forms a telescopic arrangement with the first plunger member 52, wherein the second plunger 54 is configured to move axially after the first plunger member 52 has moved a predetermined axial distance. The movement of the first plunger member 52 and the second plunger member 54 is provided by a first biasing member 56 and a second biasing member 58, which are acting as compression springs, but other suitable arrangements for the biasing members 56 and 58 may be used.

[0155] The first biasing member 56 is received by the second plunger member 54 and constrained between the plunger actuation member 60 (and the scaling member 62) and the first spring seat 64 of the second plunger member 54. The second biasing member 58 is radially inwardly positioned from the first biasing member 56 and received by the second plunger member 54. The second biasing member 58 is constrained between the second spring seat 66 of the second plunger member 54 and the first plunger member 52. The second biasing member 58 is configured to bias the first plunger member 52 toward the container 14 from a pre-use position to a use position and to a post-use position. The first biasing member 56 is configured to bias the second plunger member 54 toward the container 14, which in turn biases the first plunger member 52 toward the container 14 from a pre-use position to a use position and to a post-use position. More specifically, the second biasing member 58 is configured to drive the first plunger member 52 against the spacer assembly 40 or the stop member 34 to move the container 14 into engagement with the valve assembly 16, thereby piercing the closure 36 of the container 14 and establishing fluid communication between the container 14 and the needle 28. The first biasing member 56 is configured to move the stop member 34 within the container 14 to dispense medication within the container 14. The second biasing member 58 has a different spring constant than the first biasing member 56. In particular, the second biasing member 58 is more rigid than the first biasing member 56 to provide a larger force for piercing the closure 36 of the container 14, while the first biasing member 56 provides a smaller force for dispensing, as appropriate for the viscosity of the fluid or medication within the container 14.

[0156] Refer again Figures 17 to 26 The plunger actuation member 60 has an annular portion 68 and a spindle portion 70. The plunger actuation member 60 is rotatably movable relative to the first plunger member 52 between a first rotational position and a second rotational position spaced apart from the first rotational position. The first rotational position may be 15 degrees from the second rotational position, but other suitable positions may be used. The annular portion 68 includes a drive surface 72 comprising a plurality of teeth 74, but other suitable arrangements may be used for the drive surface 72. The spindle portion 70 includes an actuator locking surface 76 configured for engaging and disengaging with the plunger locking surface 78 of the first plunger member 52. The plunger locking surface 78 includes a plurality of protrusions 80 configured to be received by a plurality of slots or cutouts 81 defined by the actuator locking surface 76.

[0157] like Figure 18 and Figure 23As shown, in the first rotational position of the plunger actuating member 60, the plurality of protrusions 80 and the plurality of slots or cutouts 81 are misaligned, causing the plunger actuating member 80 to engage the first plunger member 52 to prevent movement of the first plunger member 52 and the second plunger member 54, wherein the first biasing member 56 and the second biasing member 58 bias the first plunger member 52 and the second plunger member 54 away from the plunger actuating member 60. Figure 19 and Figure 24 As shown, in the second rotational position of the plunger actuation member 60, the plurality of protrusions 80 and the plurality of slots or cuts 81 are aligned with each other, such that the plunger actuation member 60 disengages from the first plunger member 52 to allow the first plunger member 52 and the second plunger member 54 to move, thereby initiating the dispensing process from the container 14.

[0158] refer to Figure 7 and Figure 33 The drive surface 72 of the plunger actuation member 60 is configured to engage with a portion of the needle actuator assembly 18. After engaging the actuator button 26 and releasing the needle actuator assembly 18 (discussed in more detail below), the needle actuator assembly 18 moves within the housing 20 from a pre-use position to a use position and then to a post-use position. During the initial movement of the needle actuator assembly 18, a portion of the needle actuator assembly 18 engages the drive surface 72 of the plunger actuation member 60 to move the plunger actuation member 60 from a first rotational position to a second rotational position. Figure 33 As shown, the angled blade portion 82 of the needle actuator assembly 18 engages the drive surface 72 of the plunger actuator member 60 to cause rotation of the plunger actuator member 60.

[0159] refer to Figure 11 , Figure 13 and Figure 26As shown, the second plunger member 52 includes a plurality of coded protrusions 84, wherein a pre-selected one of the plurality of coded protrusions 84 is configured to engage a limiting member 86 of the system 10. As discussed in more detail below, the limiting member 86 engages with the needle actuator assembly 18 and limits movement of the needle actuator assembly 18 from a use position to a post-use position until a predetermined dose-end position is reached at the stop 34. In one aspect, the limiting member 86 is configured to limit axial movement of the needle actuator assembly 18 from the use position by engagement between the limiting member 86 and a portion thereof. When the stop 34 reaches the dose-end position, this engagement between the limiting member 86 and the needle actuator assembly 18 is released by rotation of the limiting member 86. During the use position of the needle actuator assembly 18, the limiting member 86 is biased in the direction of rotation, wherein rotation of the limiting member 86 is prevented by engagement between the limiting member 86 and one of the plurality of coded protrusions 84 of the second plunger member 54. The plurality of coded protrusions 84 may be axial ribs of different lengths, but other suitable arrangements may be used. Each coded protrusion 84 defines a point where the limiting member 86 can rotate to release the needle actuator assembly 18. The smooth portion of the second plunger member 52 may also provide additional "coding" for determining when the system 10 transitions to the dose end position.

[0160] As described above, when the system 10 moves from the pre-use position, the use position, and the post-use or dose-end position, the indicator device 32 moves, wherein different portions of the indicator device 32 are visible through the indicator window 30. More specifically, the indicator device 32 engages a portion of the restraining member 86 and moves together with the restraining member 86 through the various stages of the system 10 to provide the user with an indication of the status of the system 10.

[0161] During the assembly of system 10, the dose of container 14 is matched with a specific spacer 42 of a predetermined length, and a corresponding one of the plurality of coded protrusions 84 is aligned with restraining member 86. Thus, as described above, container 14 can be provided with multiple dose volumes, each corresponding to a specific spacer 42 and a coded protrusion 84. Therefore, even for different dose volumes, system 10 is configured to inject needle 28 into the user to deliver a drug dose from container 14, retract needle 28 after the dose is administered, and provide indication of the status of system 10, while minimizing abrupt engagement of stop member 34 via drive assembly 12. In particular, the size of stop member 34 can be selected to minimize the distance between first plunger member 52 and spacer assembly 40, and damping is not required.

[0162] refer to Figures 27 to 33 The diagram shows a drive component 12A according to another aspect of the present invention. Figures 27 to 33 The drive component 12A shown is Figures 17 to 26The drive component 12 shown above is similar to and operates in the same manner. However, in Figures 27 to 33 In the drive assembly, a first plunger member 52 is received by a second plunger member 54 and extends from the second plunger member 54 during axial movement from a pre-use position to a use position. Furthermore, the first plunger member 52 includes an extension 88 configured to engage the second plunger member 54 after the first plunger member 52 has moved a predetermined axial distance, such that the first plunger member 52 and the second plunger member 54 move together. A first biasing member 56 and a second biasing member 58 are used to... Figures 17 to 26 The drive assembly 12 engages and acts on the first plunger member 52 and the second plunger member 54 in the same manner.

[0163] refer to Figures 27 to 32 The scaling member 62 is positioned around the first plunger member 52 and the second plunger member 54 and includes a plurality of ratchet teeth 90 configured to engage flexible tabs 92 positioned on the bottom portion 24 of the housing 20. When the drive assemblies 12, 12A are mounted into the bottom portion 24 of the housing 20, the engagement of the ratchet teeth 90 of the scaling member 62 with the flexible tabs 92 of the housing 20 provides unidirectional rotation of the scaling member 62. As described above, the scaling member 62 is configured to rotate based on the dose volume and the dimensions of the spacer 42 to align one of the coded protrusions 84 of the second plunger member 52 with the restraining member 86. The scaling member 62 can provide 24 rotational positions for the drive assemblies 12, 12A, of which 12 rotational positions can have unique dose values ​​associated with them.

[0164] refer to Figures 1 to 16 and Figures 34 to 40B The diagram illustrates a needle actuator assembly 18 according to one aspect of the invention. The needle actuator assembly 18 includes a needle actuator body 96, a needle shuttle 102, and a needle 28. The needle actuator body has a guide surface 98, the needle shuttle has a cam surface 104, and the needle is received by the needle shuttle 102 and configured as described above to be in fluid communication with a container 14. The needle actuator body 96 is generally rectangular, wherein the guide surface 98 projects radially inward. The needle shuttle 102 is received within the needle actuator body 96. As described above, the needle actuator body 96 can be positioned within a housing 20 from its pre-use position (…). Figures 4 to 6 As shown), initial actuation position ( Figures 7 to 9 ), Location of use ( Figures 10 to 12 ) and post-use location ( Figures 13 to 15 The needle actuator body 96 is biased from the pre-use position to the post-use position via the tension spring 106, but other suitable biasing devices can be used. When the actuator button 26 is engaged, the needle actuator body 96 is released and freely moves from the pre-use position to the use position, which will be discussed in more detail below. As described above... Figures 17 to 33The needle actuator body 96 is moved from the use position to the post-use position after the restrictor component 86 has rotated.

[0165] refer to Figures 34 to 40B The needle shuttle 102 is movable along a vertical axis between a retracted position in which the needle 28 is positioned within the housing 20 and an extended position in which at least a portion of the needle 28 extends out of the housing 20. The needle shuttle 102 is configured to move between the retracted and extended positions via engagement between a guide surface 98 of the needle actuator 96 and a cam surface 104 of the needle shuttle 102. The cam surface 104 is provided by a first cam member 108 and a second cam member 110, wherein the first cam member 108 is spaced apart from the second cam member 110. The housing 20 includes a guide post 112 having a recess configured to receive a T-shaped protrusion 114 on the needle shuttle 102; however, other shapes and configurations may be used for the guide post 112 and the T-shaped protrusion 114. The needle shuttle 102 moves along the guide post 112 between the retracted and extended positions. The guide post 112 is linear and extends generally perpendicularly from the housing 20; however, other suitable arrangements may be used. The guide surface 98 of the needle actuator body 86 is non-linear and each includes a first side 116 and a second side 118 positioned opposite to the first side 116.

[0166] As described below, the guide surface 98 of the needle actuator body 96 engages with the cam members 108, 110 of the needle shuttle 102 to vertically move the needle shuttle 102 between a retracted position and an extended position as the needle actuator body 96 moves axially from a pre-use position to a post-use position. The needle shuttle 102 also includes a shuttle biasing member 120 configured to engage the housing 20 or the actuator button 26. Specifically, the shuttle biasing member 120 engages the housing 20 or the actuator button 26 and provides a biasing force as the needle actuator body 96 transitions from the use position to the post-use position. When the needle actuator body 96 has fully transitioned to the post-use position, the cam members 108, 110 of the needle shuttle 102 disengage from the guide surface 98 of the needle actuator body 96, and the shuttle biasing member 120 biases the needle shuttle 102 downward, such that the needle 28 engages the pad 38, as described above. However, as described above... Figures 1 to 16 As discussed, the pad 38 can also be biased into the needle 28, rather than biasing the needle shuttle 102 downward via the shuttle bias member 120. The needle actuator body 96 can interact with the actuator button 26 to prevent the actuator button 26 from bouncing upward until it reaches the post-use position, which will be discussed in more detail below.

[0167] refer to Figures 37A to 40B In the position before use ( Figure 37A When the needle shuttle 102 is in the retracted position, the cam members 108 and 110 are spaced apart from the guide surface 98 of the needle actuator body 96. When the needle actuator body 96 moves to the working position ( Figure 37B and Figure 38A The second cam member 110 of the needle shuttle 102 engages the second side 118 of the guide surface 98 to move the needle shuttle 102 from the retracted position to the extended position. During the transition from the use position to the post-use position of the needle actuator body 96 ( Figure 37C The first cam member 108 of the needle shuttle 102 engages with the first side 116 of the guide surface 98 to move the needle shuttle 102 from the second position to the first position. This occurs when the needle actuator body 96 has fully transitioned to the post-use position. Figure 37D and Figure 38B Subsequently, when the cam members 108 and 110 disengage from the guide surface 98 of the needle actuator body 96, the shuttle biasing member 120 biases the needle shuttle 102 downward, wherein the needle 28 engages the pad 38. The transition of the needle actuator body 96 and the corresponding position of the needle shuttle 102 also occur... Figures 39 to 40B As shown in the image. Combined with... Figures 65A to 67 The interaction between actuator button 26 and needle actuator body 96 is discussed in detail. (Reference) Figures 41 to 64 The image illustrates a drug delivery system 200 according to another embodiment. System 200 includes a housing 202 having an upper housing 204 and a lower housing 206. The housing has a proximal end 205 and a distal end 207. The upper housing 204 has a status viewing port 208 allowing a user to view the operational status of system 200. System 200 also includes a valve assembly 212 and a tube 214 fluidly connecting the valve assembly 212 to a patient needle 215 disposed in the proximal end of a needle arm 216. A spring 218 distally biases a needle actuator 220.

[0168] like Figures 42 to 46 As shown, system 200 further includes a container or drug container 222 having a stop 224 movably disposed therein, although the stop 224 is omitted from the various figures for clarity. Preferably, the distal end of the drug container 222 has a diaphragm assembly 228, which is spaced apart from the valve assembly 212 before the actuation device 222, as... Figure 47 The best example shown is...

[0169] For manufacturing purposes, it is generally desirable to use a single-size drug container, even when multiple fill volumes or doses are anticipated to be used with the container. In such cases, different fill volumes result in different stop positions when the drug container is filled. To accommodate such different stop positions, and to accommodate manufacturing variations in the stops, aspects of the invention include a bespoke or custom spacer 226 disposed proximal to the stop 224 in the container 222. In other words, the bespoke spacer 226 provides the option to allocate a range of manufacturer-defined predetermined fill volumes by selecting different spacers 226, and to reduce or eliminate the need for assembly configuration operations. The dimensions of the spacer 226 can be used to address unfilled volumes in the container 222 and to provide a consistent support surface at the proximal end of the container.

[0170] Spacers 226 are selected from a plurality of spacers 226 of different sizes to occupy the space from the proximal end of the stop 224 to the proximal end of the container 222. According to one embodiment, as... Figures 45 to 47 As shown, the spacer 226 is chosen to be substantially flush with the proximal end of the container 222. Additionally, according to one embodiment, the spacer 226 has a "cap" shape, comprising a central post 230 and a distal flange 232, as... Figure 45 The best example shown is...

[0171] Return to Figures 44 to 47 The system 200 also includes a drive assembly 234 for distally moving the container 222 to establish a fluid connection between the container 222 and the patient needle 215, and for dispensing medication from the container 222. More specifically, the drive assembly 234 includes an internal spring 236 disposed within a central plunger 238, an external plunger 240, an external spring 242 disposed between the central plunger 238 and the external plunger 240, a telescopic member 244, and a release gate 246.

[0172] Preferably, the internal spring 236 has a larger spring constant than the external spring 242, and therefore has greater strength and stiffness. The internal spring 236 is disposed inside the central plunger 238, and in the spring flange 248 in the lower housing. Figure 46 The inner spring 236 (best shown in the diagram) and the outer spring 240 actuate between the inner spring 236 and the central plunger 238, which is directly supported on the proximal end of the spacer 226 after the device is activated. An outer spring 242 is disposed inside the outer plunger 240 and actuates between the proximal outer flange 250 of the central plunger 238 and the distal inner flange 252 of the outer plunger 240. Therefore, the inner spring 236 and the outer spring 242 are nested, and a more compact drive assembly (and thus a more compact system 200) can be provided compared to using a single spring.

[0173] According to one aspect, the internal spring 236 is used only to displace the container 222 to establish a fluid connection with the patient needle 215, and the external spring 242 is used only to subsequently dispense medication from the container 222. According to another aspect, the internal spring 236 is used to displace the container 222 to establish a fluid connection with the patient needle 215 and also to initiate the dispensing of medication from the container 222, while the external spring 242 is used to complete the medication dispensing. In yet another aspect, the internal spring 236 causes an initial puncture of the container 222, wherein the external spring 242 completes the puncture and the dispensing of medication from the container 222.

[0174] like Figures 44 to 47 As shown and described in more detail below, the external plunger 240 includes a pair of proximal flanges or feet 254, each having an inclined surface that interacts with a corresponding inclined surface (or multiple surfaces) on the release gate to retain the power module and subsequently release it after the actuation device 200.

[0175] like Figure 46 and Figure 47 As best shown, during initial assembly, container 222 is positioned with a gap from drive assembly 234 and valve assembly 212. A lateral flange 256 on needle actuator 220 axially holds the drug container 222, and needle actuator 220 prevents lateral displacement of release gate 246. According to one embodiment, a spring (not shown) distally biases needle actuator 220, but actuation button 210 (and / or its associated components) prevents distal displacement of needle actuator 220 before actuation device 200. A status bar 258 is provided on needle actuator 220 and has a top surface visible through status viewing port 208. According to one embodiment, the top surface of the status bar has multiple colors or patterns, and a first color or pattern (such as yellow) is visible through status viewing port 208 when the device is in a pre-actuated state.

[0176] Figures 48 to 52 This is a top view of system 200, showing the operation of events during and after the actuation of system 200. Figure 47 In this case, the user slides the actuation button 210 proximally and then moves the button 210 vertically into the housing 202, thereby releasing the needle actuator 220 to move distally under the influence of a spring (omitted for clarity). Figure 49 As shown, when the needle actuator is displaced distally, the track 260 on the needle actuator 220 interacts with the transverse boss 262 on the needle arm 216 to insert the patient needle 215. Preferably, at this stage, the proximal end of the needle actuator 220 has not yet cleared the release gate 246, and therefore the drive assembly 234 has not yet been released. However, the transverse flange 256 is displaced distally, and therefore the container 222 is unconstrained.

[0177] Subsequently, as Figure 50 and Figure 51 As shown, under continuous distal displacement, the proximal end of the needle actuator 220 moves away from the release gate 246 (thus releasing the drive assembly 234). The needle actuator 220 temporarily rests against a feature on the rotatable release fin 264, thereby driving the release fin 264 against the outrigger 266 of the telescopic member 244 (in... Figure 44 and Figure 59 (Best shown in the image). The needle actuator 220 remains in this position until the medication has been dispensed. In this position, preferably, the second color or pattern (such as green) of the status bar 258 is visible through the status viewing port 208.

[0178] At this stage, the forces of springs 236 and 242, along with the interaction between the inclined surface of the proximal flange or foot 254 and the corresponding inclined surface (or multiple surfaces) on the release gate 246, cause the release gate 246 to shift laterally, thereby releasing the outer plunger 240 from its restrictive interaction with the release gate 246. Up to this point, the outer plunger 240 has restrained the central plunger 238.

[0179] refer to Figure 52 and Figure 53 (For clarity, Figure 52 The internal spring 236 (omitted) rigidly drives the central plunger 238 distally to contact the spacer 226. Because the drug container 222 is filled with a substantially incompressible fluid, the continued distal displacement of the central plunger 238 displaces the spacer 226, the stop 224, and the container 222 distally relative to the housing 202. This distal displacement causes the diaphragm assembly 228 to be punctured by the valve assembly 212, thereby establishing fluid communication between the container 222 and the patient needle 215. The central plunger 238 travels distally until its proximal outer flange 250 (… Figure 59 (Best shown in the image) a flange on the lower housing 206 contacts the piercing travel. Preferably, another flange on the lower housing 206 and / or the lateral flange 256 of the needle actuator 220 restricts the distal travel of the container 222.

[0180] Subsequently, because the internal spring 236 is no longer able to displace the central plunger 238 distally, the lighter external spring 242 displaces the external plunger 240 distally relative to the central plunger 238 to contact the distal flange 232 of the spacer 226, as... Figure 54 and Figure 55 As shown. As described in more detail below, preferably, the contact between the outer plunger 240 and the spacer 226 is damped to minimize impact force. Further expansion of the outer spring 242 causes the outer plunger 240 to be displaced distally to dispense the drug.

[0181] like Figure 56 and Figure 57 As shown, as the outer spring 242 continues to expand and displace the outer plunger 240 distally, upon predetermined distal displacement of the outer plunger 240 relative to the telescopic member 244, the outer feature or flange 268 of the outer plunger 240 interacts with the inner distal feature or flange 270 of the telescopic member 244 to “pick up” the telescopic member 244. This ensures that further distal displacement of the outer plunger 240 causes a corresponding distal displacement of the telescopic member 244. This paired distal displacement continues until drug dispensing is complete.

[0182] As previously described, the extendable leg 266 is mounted on the telescopic member 244. The axial length of the extendable leg and the distal travel of the telescopic member 144 control the timing of the disengagement of the extendable leg 266 from the release fin 264. Figure 58 and Figure 59 As shown, at the end of drug dispensing, the proximal end of the outrigger 266 bypasses the release fin 264. This allows the release fin 264 to rotate out of engagement with the needle actuator 220. Figure 60 ), and allows the needle actuator 220 to continue its distal displacement and retract the patient needle 215. Figure 61 At this stage, another color or pattern (such as red) of the status bar 258 becomes visible through the status viewing port 208, thereby indicating that the device 200 has completed operation.

[0183] As previously described, the contact between the external plunger 240 and the spacer 226, such as Figure 62 and Figure 63 As shown, the fluid is preferably damped to minimize impact force. For an unfilled syringe containing a viscous fluid, the highest level of energy dissipation is desired because the external spring 242 is more rigid to provide the required dispensing rate. For a syringe with a maximum fill containing a low-viscosity fluid, the lowest level of energy dissipation is desired because the external spring can be less rigid to provide the required dispensing rate. Various methods can be used to adjust the damping level, such as air damping or closed-cell foam damping.

[0184] As another method of damping impact force. Figure 64An embodiment of spacer 226 is shown, wherein one or more axial interference ribs 272 are arranged circumferentially around a central post 230 of spacer 226. In this embodiment, an outer plunger 240 must be driven through the interference ribs 272, which provide frictional resistance to distal displacement of the outer plunger 240 relative to spacer 226. The frictional force generated by the interference between the interference ribs 272 and the outer plunger 240 is independent of the plunger speed. Preferably, the frictional force does not exceed the minimum distribution spring load to avoid stalling the weaker spring. The interference can be adjusted to provide the desired level of frictional resistance. For different fluid viscosities, the interference ribs 272 can have different dimensions (axial and / or radial). This may mean custom or tailored spacers for every combination of viscosity and fill level, or, depending on the number of springs required for a viscosity range, multiple adjustment positions may be available, allowing the spacer to be positioned for a specific modular spring (the position having already adjusted the interference / damping for that specific spring load / viscosity condition).

[0185] refer to Figures 65A to 69 An actuator button device 280 for an actuation system 10 according to one aspect of the invention is shown. The actuator button device 280 includes an actuator button 26, a button spring 284, and a needle actuator body 286. The needle actuator body 286 may be similar to the needle actuator bodies 96, 220 discussed above and is configured to move within a housing 20 to transition the needle shuttle 102 or needle 28 between a retracted position and an extended position. Figure 69 As shown, the actuator button 26 includes a user interface portion 288 for user interaction. Preferably, the user interface portion 288 is approximately 22 mm long and 10 mm wide, but other suitable dimensions may be used. The actuator button 26 includes two pairs of locking arms 290, 292, which interact with button contact surfaces 294, 296 on the needle actuator body 286 before the device is actuated to prevent the needle actuator body 286 from swinging upward. Figure 65H As shown, the overlap between the needle actuator body 286 and the housing 20 prevents premature actuation. (Reference) Figure 66 The button spring 284 includes a first support surface 298 and a second support surface 300 spaced apart from the first support surface 298, and a cantilevered central spring arm 302 surrounded by a pair of outer arms 304 connected by the first support surface 298.

[0186] The actuation button device 280 is configured to provide one or more of the following features, which will be discussed in more detail below: unidirectional axial displacement or sliding of the actuator button 26; lateral movement of the actuator button 26 (raised position and depressed position), wherein the actuator button 26 remains depressed during the use position of the needle actuator body 286; and locking the actuator button 26 in the post-use position of the needle actuator body 286 such that the button 26 is in the raised position and cannot be pressed down by the user.

[0187] To actuate the system 10 using the actuator button 26, the user first slides the user interface portion 288 along the first axial direction, as shown in... Figure 65G and Figure 65H The image is shown facing right. The user may be required to slide the user interface portion 288 approximately 10 mm or 8 mm, but other suitable distances may be used. Moving the actuator button 26 causes the locking arms 290, 292 to move axially away from the button contact surfaces 294, 296 on the needle actuator body 286, thereby allowing the actuator button 26 to move from the raised position to the depressed position.

[0188] When the user slides the user interface portion 288 to the distal end, the central spring arm 302 of the button spring 284 rides on the spring arm support surface 306 on the housing 20, while the first support surface 298 and the second support surface 300 engage the first support ramp 308 and the second support ramp 310 on the housing 20. The force on the button spring 284 is balanced by engaging the spring arm support surface 306 and the first support ramp 308 and the second support ramp 310 to provide smooth axial displacement or sliding of the actuator button 26.

[0189] When the actuator button 26 and the button spring 284 reach the end of their axial sliding stroke, the central spring arm 302 and the first support surface 298 pass through the ends of the corresponding stops 312, 314 to prevent the actuator button 26 from sliding backward to its original position, as... Figure 65H As shown. Furthermore, when the actuator button 26 and the button spring 284 reach the end of their axial sliding stroke, the user engages the user interface portion 288 to move the actuator button 26 downwards to its depressed position. The actuator button 26 can be pressed down by approximately 2 mm, and the minimum force required to press down the actuator button 26 is approximately 3 N, and most preferably approximately 2.8 N, but other suitable distances and minimum forces can be used.

[0190] When the user presses the user interface section 288, such as Figure 65A and Figure 65B As shown, actuator button 26 rotates the needle actuator body 286 to release the needle actuator body 286, thereby allowing the needle actuator body 286 to move from the pre-use position to the use position. Figure 65B As shown, when the needle actuator body 286 travels to the use position, locking arms 290, 292 travel along the underside of button contact surfaces 294, 296 to prevent the actuator button 26 from springing upwards. After the medication has been delivered and when the needle actuator body 286 transitions from the use position to the post-use position, as... Figure 65C As shown, locking arms 290, 292 disengage from button contact surfaces 294, 296, thereby allowing actuator button 26 to spring upward under the influence of button spring 284. Once the needle actuator body 286 has fully transitioned to the post-use position, as... Figure 65D As shown, actuator button 26 has completed its movement from the depressed position to the raised position due to the biasing force of button spring 284. When needle actuator body 286 is in the used position, spring arm 316 on needle actuator body 286 engages actuator button 26 to prevent actuator button 26 from moving to the depressed position, while axial movement is still limited by the engagement of spring arm 302 with stops 312, 314. Therefore, actuator button 26 is locked after drug delivery to provide a clear indication between used and unused systems.

[0191] In addition, if the user presses down on the actuator button 26 during medication dispensing, the appropriate medication administration and needle retraction will still be completed, but the actuator button 26 will not spring back to the raised position until the button 26 is released.

[0192] In one respect, the button spring 284 is made of plastic. The button spring 284 can also be an alternative compression metal spring, but any other suitable material can be used.

[0193] refer to Figures 68A to 68G Instead of providing separate actuator button 26 and button spring 284, the spring can be integrally provided with button 26. More specifically, actuator button 320 according to another aspect of the invention includes an integral spring arm 322. Actuator button 320 also includes a locking arm 324, a retaining arm 326, and a rear pivot 328. Figure 68D and Figure 68EAs shown, the spring arm 322 engages the prong 330 in the top portion 22 of the housing 20. During the transition of the system 10 from the pre-use position to the use position, the spring arm 322 slides through the stop of the prong 330, thereby providing an axial spring force. When the spring arm 322 deflects, the end of the spring arm 322 engages a portion of the top portion 22 of the housing 20 to provide a vertical spring force. The actuator button 320 is configured to perform a fluid movement between the sliding and pressing movements of the button 320, even when two separate movements occur, similar to the operation of the button 26 discussed above. During the transition between the pre-use position and the use position, the button 320 pivots about the rear pivot 328, in which the retaining arm 326 engages a portion of the needle actuator body 286, thereby holding the button 320 in the pressed position in a manner similar to that of the actuator button 26 until the dose end position is reached. When the needle actuator body 286 moves to the dose end position, the locking arm 324 deflects inward and engages a portion of the needle actuator body 286, thereby preventing the actuator button 320 from moving further in a manner similar to that of the actuator button 26 discussed above.

[0194] Various aspects of the present invention provide improvements over prior button designs. For example, the actuation button device 280 provides multiple surfaces to hold the needle actuator body 286 in a proper position against the needle actuator spring 106 before actuation, thereby reducing the likelihood of premature actuation during a drop impact. The actuation button device 280 physically prevents the needle actuator body 286 from moving before actuation by holding it in a tilted (locked) state in a manner that leaves no space for separation and pre-activation of the surfaces.

[0195] Furthermore, the sliding force of the actuation button device 280 is more precisely controlled by utilizing a flexible arm instead of a simple bump-type stop. This allows for a longer sliding stroke of button 26 and better force control, resulting in a more ergonomic and efficient design. Additionally, the actuation button device 280 causes button 26 to spring back at the end of injection, providing the user with additional visual, auditory, and tactile indications of drug delivery completion.

[0196] According to one aspect, the fluid delivery volume of system 10 is determined by the end position of the plunger relative to a point inside the housing, independent of the actual filling volume, the container inner diameter, and the starting position and length of the stop. The variability in dosage accuracy can be significant because the tolerances of the aforementioned factors can be very large. Aspects of the present invention allow some or all of these tolerances to be eliminated from the dosage equation, resulting in a more precise and less variable drug injection volume.

[0197] refer to Figures 70A to 70G The illustration shows a spacer assembly 400 for use in conjunction with a drive assembly, according to one aspect of the present invention.

[0198] The elements in the tolerance chain of the stop spacer assembly 400 include the thickness (A) of the flange 402 of the inner plunger 404, the internal length (B) of the outer plunger 406 between its inner proximal end 408 and inner shoulder 410, and the initial offset distance (C1) between the inner plunger flange 402 and the inner proximal end 408 of the outer plunger. This initial offset distance (C1) is preferably greater than the clearance distance (C2) between the outer plunger 406 and the proximal end of the drug cartridge 412. The tolerance chain in the stop spacer assembly 400 also includes the inner cartridge diameter (D). Once assembled, the stop spacer 414 and the outer plunger 406 are unique for a given drug volume.

[0199] Figures 70B to 70G The operation of the stop spacer assembly 400 is shown. For example... Figure 70B As shown, when the system is actuated, both the inner plunger 404 and the outer plunger 406 are released. The outer spring 416 pushes the outer plunger 406 into the cylinder 412, thereby compressing the damping material 418 and the inner spring 420. Due to the fluid column of the drug, the stop 422 has not yet moved relative to the cylinder 412.

[0200] Next, as Figure 70C As shown, the external spring 416 displaces the external plunger 406 and the cylinder 412 distally to open a valve (not shown) at the distal end of the cylinder 412, establishing fluid communication with the needle (not shown). Due to the incompressibility of the liquid medication, the stop 422 cannot be displaced relative to the cylinder 412 until the valve is open and a fluid path to the patient needle is established.

[0201] Subsequently, as Figure 70D and Figure 70E As shown, the internal spring 420 displaces the internal plunger 404, the stop spacer 414, and the stop 422 to distribute fluid.

[0202] Figure 70F This illustrates the termination of drug delivery when the proximal flange 402 of the inner plunger 404 contacts the inner shoulder 410 of the outer plunger 406, thereby stopping the displacement of the inner plunger 404 (as well as the stop spacer 414 and the stop 422) relative to the drug cartridge 212 and stopping the drug flow.

[0203] According to one aspect, such as Figure 70G As shown, the cessation of displacement of the internal plunger 404 relative to the drug cartridge 412 triggers the system's dose end indicator.

[0204] refer to Figure 71 and Figure 72The foldable spacer assembly 430 includes: a front spacer portion 432 fixed to a stop 434; an internal plunger 436; a rear spacer portion 438; and a rotary shuttle 440. The internal plunger 436 can translate relative to the front spacer portion 432, but cannot rotate relative to it. Similarly, the rear spacer portion 438 can move axially relative to the front spacer portion 432, but cannot rotate relative to it. As described in more detail below, the rotary shuttle 440 first rotates and then translates.

[0205] According to one aspect, the front spacer portion 432 is fixedly attached to the stop 434. Those skilled in the art will understand that many methods can be used to attach the front spacer portion 432 to the stop 434, such as adhesives, mechanical fasteners, or any other suitable means. Preferably, the front spacer portion 432 includes threads that engage with mating threads in the stop 434.

[0206] When the stop-spacer assembly 430 is screwed into the stop 434, an axial load is applied through the inlet opening 442 in the rear spacer portion 438. This force can be used to push the stop 434 forward, thereby applying pressure to the fluid drug. This pressure causes the front (distal) side of the stop 434 to deflect and press proximally, thereby pushing back the rear spacer portion 438 and rotating the rotary shuttle to its "as assembled" state. In other words, when the drug cartridge is filled with drug and the system's plunger is applying an axial force to the drug via the spacer assembly 430, the distal side of the stop 434 deforms due to the pressure of the drug. During drug delivery, pressure is applied to the rear spacer portion 438 via the drive assembly (via the plunger), which in turn applies rotational torque to the rotary shuttle 440 via the helical surface 444 of the rear spacer portion 438. However, the deformation of the stop from the drug provides a rearward or proximal force on the internal plunger 436, which prevents the rotation of the rotary shuttle 440.

[0207] According to one aspect, the axial reaction load on the internal plunger 436 can be increased by increasing the length of the internal plunger 436.

[0208] Once drug delivery is complete, such as Figure 73 As shown, the pressure on the stop 434 decreases, thereby allowing the distal end of the internal plunger 436 to shift distally. This distal shift allows the rotary shuttle 440 to rotate. Due to the interaction between the helical surface 444 in the rear spacer portion 438 and the corresponding cam-faced arm 446 of the rotary shuttle 440, a continuous axial force applied by the drive assembly rotates and moves the rotary shuttle 440 distally. According to one aspect, this final movement of the rotary shuttle 440 causes the drive assembly trigger pin to retract.

[0209] refer to Figure 74and Figure 75 According to one aspect of the invention, a limiting member 452 is disposed together with the drive assembly. The limiting member 452 controls the timing of the final displacement of the needle actuator bodies 96, 220 after drug dosing is completed. Instead of rotating about a fixed post, the limiting member 452 floats freely. Once the plunger has been sufficiently displaced distally to align the gap with the limiting member 452 (e.g., ...), Figure 74 and Figure 75 As shown), due to the force of the spring on the needle actuators 96 and 220 and the inclined surface 454 on the rear part of the arm of the limiting member 174 that engages with the needle actuator body (in... Figure 75 (Best shown in the diagram), the limiting member 452 is laterally displaced into the gap. Once the limiting member no longer holds the needle actuator bodies 96, 220, the needle actuator bodies 96, 220 can freely complete axial movement to their post-use position. Furthermore, as... Figure 75 As shown, the limiting member 452 is biased onto the rear portion of the cylindrical portion of the container 14, which minimizes the tolerance chain of the various components and improves dosing accuracy.

[0210] refer to Figures 76 to 78 The image shows a spacer assembly 460 according to another aspect of the invention. Figures 76 to 78 The spacer assembly 460 shown allows the effects of manufacturing tolerance build-up to be eliminated by adjusting the spacer assembly, thereby allowing each system to inject the same amount of drug.

[0211] like Figure 77 As shown, the spacer assembly 460 includes a stop 462 and a stop spacer 464. The stop spacer 464 includes: a fixed spacer member or a fixed spacer 466, which is fixedly connected to the stop 462; and an adjustable spacer member or an adjustable spacer 468, which is rotatably displaced relative to the fixed spacer 466 in one direction.

[0212] Those skilled in the art will understand that many methods can be used to secure the fixed spacer 466 to the stop 462, such as adhesives, mechanical fasteners, or any other suitable means. Preferably, the fixed spacer 466 includes one or more external threads that engage with one or more mating threads in the stop 462. According to one aspect, the adjustable spacer 468 has a distal rod with external threads 470. The distal rod thread 470 engages with the internal thread 472 in the fixed spacer 466 (in... Figure 78 (best shown in the diagram) to rotatably control the axial displacement of the adjustable spacer 468 relative to the fixed spacer 466.

[0213] like Figure 76 and Figure 77As shown, the fixed spacer 466 includes radially spaced ratchet stops 474, and the adjustable spacer 468 includes a spring-loaded pawl arm 476, the free end of which engages one of the ratchet stops 474 to prevent rotation and axial displacement of the adjustable spacer 468 toward the fixed spacer 466. The free end of the spring-loaded pawl arm 476 is shaped to extend beyond the ratchet stops 474 in one direction, thereby allowing rotation and proximal axial displacement of the adjustable spacer 468 away from the fixed spacer 466.

[0214] Despite the variations in the dimensions of the stop and the container, the adjustable spacer 468 can be adjusted relative to the fixed spacer 466 to provide a consistent axial length for the stop assembly 460.

[0215] like Figure 78 As shown, once the container is filled, an axial load (such as that encountered when installed in systems 10, 200) can be applied to the adjustable spacer 468 (and therefore, to the fixed spacer 466 and the stop 462). Once the axial load is applied, the adjustable spacer 468 can be retracted proximally to ensure a consistent gap 478 between the proximal end of the cartridge 480 and the proximal side of the adjustable spacer 468, thereby addressing variations in the cartridge glass and the compressibility of any trapped air. In other words, the spacer assembly 460 allows the adjustable spacer 468 to have a predetermined set position relative to the container 14, independent of the variations in the container 14 and the length of the stop. Therefore, the starting position of the spacer assembly 460 is a predetermined distance from the container 14, and the ending position of the spacer assembly 460 is also a predetermined distance from the container 14, such that the stroke of the stop 462 is limited by the effective length of the plungers 52, 54 of the drive assembly 12.

[0216] refer to Figure 79 and Figure 80The diagram illustrates a base post 482 and a cap 484 of an automatically adjusting spacer 486 according to one aspect of the invention. The base post 482 includes a base portion 488 and an axially extending post 490. According to one embodiment, the base post 482 includes a plurality of columnar protrusions 491, each having a plurality of ratchet teeth 492 disposed on its proximal portion. A locking barb 493 is disposed at the proximal end of each of the plurality of ratchet teeth 492. The cap 484 is hollow, and the distal end of the cap 484 includes one or more axial springs 494. According to one aspect, the axial spring 494 is a curved cantilever formed during the molding of the cap 484. According to another aspect, a separate biasing member, such as a compression spring, may be used in the automatically adjusting spacer 486. When assembled with the base post 482, the spring 494 engages the base portion 488 and maintains an initial spacing between the base post 482 and the cap 484. According to one aspect, the spring 494 is omitted. The cap 484 also includes a plurality of flexible cantilevers or tabs 496, each having a free proximal portion with a plurality of internal ratchet teeth 497. The proximal end of each flexible tab 496 includes a foot 498.

[0217] Figure 81B The illustration shows an automatic adjusting spacer cap positioned within a proximal recess of a stop 494 at the proximal portion of the drug cartridge. A base 482 is assembled into the hollow cap 484, wherein the base portion 482 engages the stop 494, and a foot 498 is positioned on the proximal outer side of the cartridge.

[0218] In operation, such as Figure 81A and Figure 81B As shown, the cap 484 is displaced distally relative to the base post 482 (and the stop 494 and the cartridge) until the proximal end of the cap 484 is flush with the end of the cartridge. This action causes the foot 498 to engage the inner surface of the cartridge and displace radially inward, thereby forcing the ratchet 492 to lock into engagement with the ratchet 497. The engagement of the locking barbs 493, the ratchet 492 and 497, and the engagement of the foot 498 with the inner surface of the cartridge prevent displacement of the cap 484 relative to the base post 482. Therefore, the automatically adjusting spacer 486 can accommodate differences in the stop, cartridge diameter, and drug filling volume to automatically provide a support surface flush with the proximal end of the cartridge.

[0219] One aspect of the invention is a spacer assembly 486 positioned within the system against a stop in the container. The spacer is designed such that its effective length is adjustable to allow for the dispensing of precise amounts of medication. Length adjustment is intended to compensate for manufacturing tolerances within the container, filling volume, and particularly within the stop length, which could increase the variability of the delivered dose by up to one-third during the use of a non-adjustable spacer. Depending on the specific aspect, the spacer length can be adjusted using several techniques. The spacer length can be automatically adjusted based on its position relative to the back of the container, can be adjusted via an assembly device when the main container is finally assembled into the sub-assembly, and can be made integral with the stop and adjusted as a sub-assembly prior to filling. Compared to a non-adjustable stop, the adjustable spacer 486 allows for the injection of more precise volumes of fluid.

[0220] refer to Figures 82 to 87 A drive assembly 500 for a drug delivery system according to one aspect of the invention is shown. The drive assembly 500 includes an actuation button 506, a container 508, a needle actuator assembly 510, an actuation release element or fin 512, a guide screw 514, and a plunger 516. The guide screw includes a drum portion 518 having externally radially projecting vanes 520 and a... Figure 84 and Figure 85 The threaded portion 522 is best shown and described in more detail thereafter. Before activation, as... Figure 83 and Figure 86 As shown in the best embodiment, one end 513 of the actuation release member 512 engages one of the blades 520 to prevent the guide screw 514 from rotating.

[0221] According to one aspect, such as Figures 84 to 86 As shown, the threaded portion 522 of the guide screw 514 engages with the internal thread of the nut 524 connected to the plunger 516. According to another aspect, the nut and its internal thread are integrally formed with the plunger as a single unit. Additionally, a constant force spring 526 is received within the drum portion 518 and biases the guide screw 514 in the direction of rotation. According to one aspect, the spring 526 is fixed to the base cap 504. According to another aspect, as... Figures 84 to 86 As shown, the drive assembly housing 528 is disposed within the system, and the spring 526 is fixed to the power supply housing 528.

[0222] Unlike helical springs, such as compression springs, which have a force profile proportional to their displacement, constant force springs like 526 maintain a relatively flat or uniform force profile over a long working length. This uniform force profile advantageously provides an injection force proportional to the spring force. This provides a flat or uniform injection force and thus a substantially constant injection rate of the drug. Although spring 526... Figure 86The diagram shows only two turns of material, but those skilled in the art will understand that fewer or more turns can be used. Preferably, the assembler winds the spring 526 when assembling the drive assembly 500, and the spring 526 is stored in the wound position until the moment of actuation.

[0223] When the actuation system is activated, the needle actuator assembly 510 is released to axially displace from its pre-use position under the influence of the biasing member 530 (in Figures 82 to 85 From center to right) to the post-use position ( Figure 83 (Best shown in the diagram). During this displacement, the needle actuator assembly 510 is supported against the second end 532 of the actuation release member 512 and the release member 512 is rotated counterclockwise, as shown in the diagram. Figure 87 As shown. This counterclockwise rotation of the actuating release member 512 releases its first end 513 from engagement with the blade 520. After the first end 513 disengages from the blade 520, the spring 526 unfolds and drives the rotation of the guide screw 514, which, in combination with the nut 524, advances the plunger 514 to dispense the drug.

[0224] As the guide screw 514 rotates, the rotation of the drum portion 518 and the blades 520 is visible through a window 534 in the housing. This window 534 indicates the progress of the screw in a manner far more noticeable than the linear movement of the stop 536 in the observation container 508. In fact, this rotational movement is many times more sensitive than linear movement. Those skilled in the art will understand that the exact amount of advantage or enhancement depends on the pitch of the threaded portion 522 of the guide screw 514, the diameter of the drum portion 518, and the number of blades 520 on the drum portion 518.

[0225] refer to Figures 88 to 93 The diagram illustrates a drive assembly 600 for a drug delivery system according to another aspect of the invention. The drive assembly 600 stores the mechanical energy of a spring and activates it upon triggering. The drive assembly 600 includes a drug cartridge 601, a stop 602 slidably disposed within the cartridge 601, a first valve plunger 603, a second valve plunger 604, a first swivel nut 605, and a second swivel nut 606. The drive assembly 600 also includes a rotation indicator 607, a locking element 608, a constant force spring 609 disposed within the rotation indicator 607, and an actuation release member or fin 610. The drive assembly 600 is at least partially disposed within a housing 611, which can be assembled into a drug delivery system.

[0226] A constant force spring 609 is housed within the drum portion 616 of the rotary indicator 607, between the housing 611 and the rotary indicator 607. In the inactive state of the drive assembly, energy is applied by deploying the spring 609, and this energy is geometrically utilized using the housing 611, the rotary indicator 607, and the actuation release member 610. When the drive assembly 600 is deactivated, the spring recoils and converts mechanical energy into rotational movement of the rotary indicator.

[0227] The telescopic multi-piece plunger is oriented along the force axis between the drug cartridge 601 and the rotary indicator 607. The rotary indicator 607 has a threaded shaft 618. According to one aspect, the thread is double-lead and is essentially square or rectangular. The multi-piece telescopic plunger includes a two-piece nut (a first swivel nut 605 and a second swivel nut 606) and a two-piece plunger (a first valve plunger 603 and a second valve plunger 604). The second swivel nut 606 is a threaded shaft that mates with the rotary indicator 607 and the first swivel nut 605, and has matching threads (internal and external threads, respectively) on its inner and outer surfaces to mate with them. The second swivel nut 606 also has a circular collar 620 on its proximal end (in... Figure 92 (Best shown in the image), it rests bottom down on the second valve plunger 604. The second swivel nut 606 rotates freely along the force axis. The first swivel nut 605 is also a threaded shaft, having threads on its inner diameter corresponding to the external threads of the second swivel nut 606, to mate with the second swivel nut 606.

[0228] According to one aspect, at one end, the first swivel nut 605 has a hexagonal collar that presses against the first valve plunger 603 to securely connect the first valve plunger 603 to the first swivel nut 605. In the drive assembly 600, the first swivel nut cannot rotate freely and will only translate when actuating the power module subassembly.

[0229] The second valve plunger 604 is a hollow cylindrical component having a small collar 622 at its distal end, a large collar 624 at its proximal end, and an extended L-shaped arm 626 protruding from the proximal large collar 624. Figure 93 (Best shown in the diagram). According to one embodiment, the small collar 622 is discontinuous and has four leaf cantilever or leaf springs 623, which allow the collar to bend and mate with the first valve plunger 603. The inner surface of the second valve plunger 604 has an undercut extending through its length, and at its proximal end terminates a radially inwardly projecting shelf 628 of the large collar 624. The shelf 628 engages a second swivel nut 606 within the telescopic assembly.

[0230] The first valve plunger 603 is attached to the stop 602 and is also a hollow cylindrical component that mates with the second valve plunger 604. More specifically, the first valve plunger 603 has a cylindrical protrusion 630 at its distal end to mate with the stop 602. According to one aspect, such as Figure 89 As shown in the optimal configuration, four through slots 632 are provided on the proximal quadrant of the first valve plunger 603 to engage with the leaf spring or arm 623 and the small collar portion 622 of the second valve plunger 604. Both the first valve plunger 603 and the second valve plunger 604 can slide freely.

[0231] Extension and retraction are achieved when the constant force spring 609 recoils and the rotary indicator 607 begins to rotate. The threaded attachment between the rotary indicator 607 and the second rotary nut 606 allows the second rotary nut 606 to rotate. However, because the second rotary nut 606 is threadedly connected to the first rotary nut 605, the first rotary nut cannot rotate and experiences resistance to distal translation due to pressure from the medication in the cylinder 601. Therefore, the second rotary nut 606 will shift proximally and rest its bottom against the radially inwardly projecting shelf 628 of the second valve plunger. Proximal displacement of the second valve plunger 604 is prevented by the housing 611. Subsequently, as the rotary indicator 607 continues to rotate, because the second rotary nut 606 is threadedly connected to the first rotary nut 605 (which cannot rotate), the first rotary nut 605 translates distally to push the first valve plunger 603 (and the stop 602), thereby dispensing medication from the cylinder 601.

[0232] The first valve plunger 603 is displaced distally relative to the second valve plunger 604 until the small collar portion 622 (which is respectively disposed on the distal end of the leaf spring or arm 623 of the second valve plunger 604) engages the corresponding proximal end of the groove 632 of the first valve plunger 603. This locks the relative position of the first valve plunger 603 and the second valve plunger 604. As the rotation indicator 607 continues to rotate, the two valve plungers translate distally while simultaneously pushing the second swivel nut (due to its proximal engagement with the shelf 624).

[0233] The initial and final positions of the telescopic plunger, and thus the drug dosage, are controlled by the rectangular thread of the threaded shaft 618 of the rotary indicator 607, the threaded shaft on the drum portion 616 of the rotary indicator 607, and the stepped pin serving as the locking element 608. According to one aspect, the threaded shaft on the drum portion 616 of the rotary indicator 607 is single-lead, and because the remaining components of the telescopic chain have double-lead threads, the axial travel of the other threaded components is twice the axial travel of the lock 608 relative to the rotary indicator.

[0234] According to one embodiment, the lock 608 is cylindrical and has a dome-shaped end at one end and a cylindrical collar at the other end. The threads on the exterior of the drum portion 616 of the rotary indicator, together with the groove and undercut 636 at the bottom of the housing 611, hold the lock 608 in place, allowing it to slide parallel to the force axis. Therefore, when the spring 609 is released and the rotary indicator 607 rotates, the lock 608 also translates and creates a positive stop when it reaches the distal end of the threads on the exterior of the drum portion 616 of the rotary indicator.

[0235] One benefit of the various aspects of the drive assembly 600 includes the use of a constant-force spring 609, whose mechanical energy is converted into a substantially constant linear force on the drug in the cylinder 601. This, in turn, produces a uniform drug delivery rate. Another benefit is the use of a threaded telescopic plunger, which allows the drive assembly to achieve linear space savings of up to 0.75 inches compared to other plunger designs. Furthermore, the drive assembly provides controlled drug dosing through initial and final mechanical constraints within the same component.

[0236] As previously mentioned, other drug delivery systems use compression helical springs, which apply maximum force upon actuation, a force that eventually decreases as the spring expands. This reduced force at the plunger translates into variable drug delivery time and drug output pressure. By using a constant-force spring, the force applied to the plunger is constant from the start to the end of the dose. Furthermore, the distance the helical spring must travel, in addition to the length of the static plunger that needs to be translated within the drug container, can result in a long assembly. Conversely, in embodiments of the invention, the constant-force spring is radially accommodated and requires no additional space before or after activation. Moreover, various aspects of the telescopic plunger allow for a significant reduction in its plunger length compared to the static plunger.

[0237] Previous drug delivery systems had variable dosing accuracy because the mechanical components enabling drug delivery were geometrically dependent on the bottom resting against the container, and could not be manufactured with tight tolerances. Some embodiments of the present invention achieve control over the start and end times of the translational plunger via a threaded form in a rotary indicator and the use of a constant-force spring.

[0238] In addition to the excellent control over time, volume, and pressure for drug delivery devices, the drive components also produce a space-saving geometry, which translates into an advantageously compact and precise drug delivery device.

[0239] Some aspects of the drive assembly implement three rotating threaded shafts to produce a linear space saving of approximately 0.75 inches. In other aspects, the same concept can be used with two rotating threaded shafts and achieve a space saving of approximately 0.5 inches. Some aspects of the invention convert the rotational energy of a constant force spring into the translational force of a plunger.

[0240] refer to Figures 94 to 100 The diagram illustrates a spacer assembly 660 according to another aspect of the invention. The spacer assembly 660 is similar to that discussed above and... Figures 76 to 78 The spacer assembly 660 shown herein operates in a similar manner to achieve similar advantages. The spacer assembly 660 includes a fixed spacer 666 and an adjustable spacer 668. The fixed spacer 666 is configured to be received by a stop 462, wherein a lug 670 engages the stop 462 to secure the fixed spacer 666 within the stop 462; however, other suitable securing means, such as threads, may be used. The fixed spacer 666 includes an internal thread 672 that receives the external thread 678 of the adjustable spacer 668. The fixed spacer 666 includes a plurality of ratchet stops 674 positioned on the helical portion of the fixed spacer 666. The adjustable spacer 668 includes a spring-loaded pawl arm 676 that engages one of the ratchet stops 674 to prevent rotation and axial displacement of the adjustable spacer 668 relative to the fixed spacer 666. The spring-loaded pawl arm 676 is shaped and configured to extend beyond the stop 674 in one direction to allow rotation and axial displacement of the adjustable spacer 668 away from the fixed spacer 666. The adjustable spacer 668 can initially be secured to the fixed spacer 666 via threads 672, 678 by applying a force to the top of the spring-loaded pawl arm 676, which biases the spring-loaded pawl arm 676 away from the pawl 674 to allow the spacers 666, 668 to be secured to each other. Therefore, in the same manner as discussed above with the spacer assembly 460, the adjustable spacer can rotate freely in one axial direction to adjust the length of the spacer assembly 660.

[0241] Refer again Figures 94 to 100 The spacer assembly 660 also includes a compensation member 680 configured to receive and secure to the adjustable spacer 668. Multiple compensation member 680 sizes can be provided to accommodate various filling volumes within the container 14, instead of providing multiple sizes of adjustable spacers 468, 668. The compensation member 680 can be secured to the adjustable spacer 668 via a connector 682 extending from the compensation member 680, the connector being received by the adjustable spacer 668 using a snap-fit ​​engagement; however, other suitable securing devices can be used. The central portion 684 of the securing spacer 666 is configured to engage while the adjustable spacer 668 rotates relative to the securing spacer 666 to prevent the securing spacer 666 from rotating with the adjustable spacer 268. The central portion 684 of the securing compensation member 666 can be accessed through an opening in the compensation member 680.

[0242] An element of one disclosed aspect may be combined with elements of one or more other disclosed aspects to form different combinations, all of which are considered to be within the scope of the invention.

[0243] Although this disclosure has been described as having an exemplary design, further modifications may be made to this disclosure within its spirit and scope. Therefore, this application is intended to cover any variations, uses, or adaptations of this disclosure using its general principles. Furthermore, this application is intended to cover any deviations from the known or customary practices within the field to which this disclosure pertains and that fall within the limitations of the appended claims.

Claims

1. A drug delivery system for injecting drugs, the drug delivery system comprising: A container configured to receive a drug, the container including a stop and a closure, the stop being movable within the container; A drive assembly configured to move the stop between a first position and a second position; as well as A spacer assembly, which engages with the stop of the container and is configured to be engaged by the drive assembly, the spacer assembly comprising: a first spacer portion received within and fixed to the stop; a second spacer portion spaced apart from the first spacer portion by a predetermined distance; an internal plunger received within the first spacer portion; and a spacer shuttle received by the internal plunger and capable of translation, the internal plunger, the spacer shuttle, and the second spacer portion being configured to move relative to the stop; The internal plunger has a first position and a second position, the second position being axially spaced from the first position. When the internal plunger is in the first position, the axial movement of the spacer shuttle is restricted, and when the internal plunger is in the second position, the spacer shuttle is movable relative to the stop. The movement of the second spacer portion is restricted by the spacer shuttle, the movement of the spacer shuttle is restricted by the internal plunger, and the movement of the internal plunger is restricted by the stop. When the internal plunger is in the first position, axial movement of the second spacer portion is restricted via the spacer shuttle, and when the internal plunger is in the second position, the second spacer portion is movable relative to the stop, such that the movement of the internal plunger allows the spacer shuttle to rotate and displace, such that during drug delivery, the drive assembly applies pressure to the second spacer portion, which in turn applies rotational torque to the spacer shuttle via a helical surface of the second spacer portion engaging the spacer shuttle's cam-faced arm, and the stop provides a proximal force on the internal plunger to prevent rotation of the spacer shuttle, while when drug delivery is complete, the pressure on the stop decreases, thereby allowing movement of the internal plunger to the second position and rotation of the spacer shuttle, and the drive assembly is configured to rotate and move the spacer shuttle distally via the helical surface of the second spacer portion engaging the spacer shuttle's cam-faced arm.

2. The drug delivery system of claim 1, wherein the stop has a closed first end and an open second end, the closed first end of the stop being axially movable relative to the container between a use position in which the closed first end of the stop engages with the internal plunger and a dose-end position in which the closed first end of the stop is spaced apart from the internal plunger, and wherein when the stop is in the dose-end position, the internal plunger is freely movable from the first position to the second position.

3. The drug delivery system of claim 2, wherein the stop is configured to move between the use position and the dose end position based on engagement with a drug contained within the container.

4. The drug delivery system of claim 1, wherein movement of the second spacer portion of the spacer assembly by the predetermined distance causes the limiting member to release the needle actuator body, the needle actuator body causing the needle to retract.

5. The drug delivery system of claim 1, wherein the spacer shuttle is rotatable relative to the inner plunger, and wherein axial displacement of the second spacer portion of the spacer assembly is configured to cause rotation of the spacer shuttle.

6. A spacer assembly for a drug delivery system, the drug delivery system being used to inject a drug, the spacer assembly comprising: The first spacer portion is configured to be received by and fixed to the stop member; The second spacer portion is spaced apart from the first spacer portion by a predetermined distance; An internal plunger, which is received within the first spacer portion; as well as A spacer shuttle, which is received by the internal plunger, the internal plunger, the spacer shuttle and the second spacer portion are configured to move relative to the first spacer portion; The internal plunger has a first position and a second position, the second position being axially spaced from the first position. When the internal plunger is in the first position, the axial movement of the spacer shuttle is restricted, and when the internal plunger is in the second position, the spacer shuttle is movable relative to the stop. The movement of the second spacer portion is restricted by the spacer shuttle, and the movement of the spacer shuttle is restricted by the internal plunger; When the internal plunger is in the first position, the axial movement of the second spacer portion is restricted via the spacer shuttle, and when the internal plunger is in the second position, the second spacer portion is movable relative to the stop; and The spacer shuttle is movable relative to the inner plunger, such that the movement of the inner plunger allows the second spacer portion to cause rotation and displacement of the spacer shuttle, allowing pressure to be applied to the second spacer portion during drug delivery, the second spacer portion applying rotational torque to the spacer shuttle via a helical surface of the second spacer portion engaging the spacer shuttle's cam-faced arm, and the stop provides a proximal force on the inner plunger to prevent rotation of the spacer shuttle, while when drug delivery is complete, the pressure on the stop decreases, allowing movement of the inner plunger to the second position and rotation of the spacer shuttle, and allowing the spacer shuttle to rotate and move distally via the helical surface of the second spacer portion engaging the spacer shuttle's cam-faced arm.

7. The spacer assembly of claim 6, wherein when the internal plunger is in the second position, the second spacer portion of the spacer assembly is freely movable toward the first spacer portion of the spacer assembly.

8. The spacer assembly of claim 6, wherein the spacer shuttle is rotatable relative to the inner plunger, and wherein axial displacement of the second spacer portion of the spacer assembly is configured to cause rotation of the spacer shuttle.

9. The spacer assembly of claim 6, wherein the first spacer portion and the second spacer portion of the spacer assembly are fixed to each other while allowing relative axial movement of the predetermined distance.

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