Drive assembly and spacer for a drug delivery system

Abstract

A drug delivery system (200) for injecting a drug agent includes: a housing (20); a container (222) configured to contain a drug agent, the container including a plug and a closure configured to move within the container; a needle in fluid communication with the container; a spacer (226) configured to engage the plug; a first plunger (238); a first spring (236) configured to bias the first plunger in an axial direction; a second plunger (240) disposed around the first plunger; and a second spring (242) configured to bias the second plunger in an axial direction. The first plunger is configured to move the spacer and the container relative to the housing via the first spring to establish fluid communication between the container and the patient needle, and the second plunger is configured to move the spacer and the plug relative to the container via the second spring.

Description

[0001] This application is a divisional application of Chinese patent application No. 202110543060.8, filed on June 8, 2017, entitled "Drive assembly and spacer for drug delivery system". The original parent application is Chinese patent application No. PCT / US2017 / 036572, Chinese application No. 201780045591.6, filed on June 8, 2017, entitled "Drive assembly and spacer for drug delivery system".

[0002] Cross-references to related applications

[0003] This application claims priority to U.S. Provisional Application Serial No. 62 / 347,948, filed June 9, 2016, and U.S. Patent Application Serial No. 15 / 616,250, filed June 7, 2017, both of which are incorporated herein by reference in their entirety. Technical Field

[0004] This disclosure generally relates to syringe devices and methods for delivering fluids into a patient via injection. Background Technology

[0005] Various automated injection devices have been developed to allow untrained personnel to administer drug solutions and other liquid therapeutic preparations, or to perform self-injection. Generally, 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 injected is approximately less than a certain volume (e.g., 1 mL), an autoinjector is typically used, which generally has an injection time of about 10 to 15 seconds. When the volume of the fluid or drug to be injected is greater than 1 mL, the injection time is generally longer, making it difficult for the patient to maintain contact between the device and the target area of ​​the patient's skin. Furthermore, when the volume of the drug to be injected is larger, increasing the injection time is necessary. The traditional method of slowly injecting drugs into the patient is via IV. This procedure is generally performed in hospitals or outpatient clinics.

[0006] Some devices allow for self-injection at home and can gradually inject liquid therapeutic agents into a patient's skin. In some cases, these devices are small enough (both in height and overall size) that they can be "worn" by the patient while simultaneously administering the liquid therapeutic agent. These devices typically include a pump or other type of dispensing mechanism to force the liquid therapeutic agent out of a reservoir and into the injection needle. They also generally include valves or flow control mechanisms to initiate the flow of the liquid therapeutic agent at the appropriate time, as well as a trigger mechanism to initiate the injection. Summary of the Invention

[0007] In one aspect, a drug delivery system for injecting a drug agent includes a housing, a container configured to contain a drug agent (the container including a closure and a plug configured to move within the container), a needle in fluid communication with the container, a spacer configured to engage the plug, a first plunger, a first spring configured to bias the first plunger in an axial direction, a second plunger disposed around the first plunger, and a second spring configured to bias the second plunger in an axial direction. The first plunger is configured to move the spacer and the container relative to the housing via the first spring to establish fluid communication between the container and the patient needle, and the second plunger is configured to move the spacer and the plug relative to the container via the second spring.

[0008] The second plunger may include an outer plunger member and an inner plunger member, wherein at least a portion of the inner plunger member is received within the outer plunger member. The outer plunger member has an inwardly extending protrusion configured to engage an outwardly extending protrusion of the inner plunger member after a predetermined axial displacement of the inner plunger member relative to the outer plunger member. The outer plunger member is configured to retract a trigger pin into the housing after the predetermined axial displacement. The first plunger may include a flange that engages with the proximal end of a second spring. The housing may include a stop, the flange of the first plunger being configured to engage the stop of the housing after a predetermined axial displacement of the first plunger relative to the housing to limit the axial displacement of the first plunger. The first spring may have a larger spring constant or a larger spring force than the second spring. The spacer may include a buffer feature configured to dissipate energy of the second plunger during displacement of the second plunger relative to the spacer. The buffer feature may include at least one resistance rib. The spacer may include a body and a flange extending radially outward from the body, wherein the body of the spacer is configured to engage with a first plunger and the flange of the spacer is configured to engage with a second plunger.

[0009] In another aspect, a method of assembling a drug delivery device includes: selecting a spacer from a plurality of spacers of different sizes to occupy space from the proximal end of a plug disposed in a drug container to the proximal end of the container; inserting the spacer into the container; and loading the drug container with the spacer into the drug delivery device.

[0010] The method may further include: providing a first spring; providing a first plunger disposed around a distal end of an inner spring; providing a second plunger disposed around the first plunger; and providing a second spring disposed between the first plunger and the second plunger.

[0011] In another aspect, a drive assembly for a drug delivery system includes: a first plunger, a first spring configured to bias the first plunger in an axial direction, and a second plunger disposed around the first plunger, wherein the second plunger includes an outer plunger member and an inner plunger member, at least a portion of the inner plunger member being received within the outer plunger member. The outer plunger member has a protrusion configured to engage with the protrusion of the inner plunger member after a predetermined axial displacement of the inner plunger member relative to the outer plunger member. The assembly also includes a second spring configured to bias the inner plunger member of the second plunger in an axial direction.

[0012] In another aspect, a drive assembly for a drug delivery system includes a plunger member configured to engage and move a plug within a 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 rotatable relative to the plunger member, wherein the plunger actuation member has a first rotational position and a second rotational position, in which the plunger member is axially fixed relative to the plunger actuation member, and in the second rotational position, the plunger member is axially movable relative to the plunger actuation member.

[0013] A plunger actuation member may include a body comprising a drive surface and an actuator locking surface, wherein the plunger member includes the plunger locking surface, and the actuator locking surface engages with the plunger locking surface when the plunger actuation member is in a first rotational position. The plunger locking surface may include a plurality of protrusions, wherein the actuator locking surface of the plunger member defines a plurality of recesses, and the plurality of protrusions of the plunger locking surface are received within the plurality of recesses of the plunger member when the plunger actuation member is in a second rotational position. The body of the plunger actuation member may include an annular portion and a shaft portion, wherein the drive surface is located on the annular portion and the actuator locking surface is located on the shaft portion. The drive surface may be configured to engage with a portion of a needle actuator. The plunger member may include first and second plunger members, wherein the second plunger member is received within the first plunger member and is axially movable relative to the first plunger member. A biasing member may engage with the second plunger member, wherein the second plunger member is configured to engage with and move the first plunger member when the second plunger moves axially a predetermined axial distance. The biasing member may include an inner spring and an outer spring, wherein the inner spring has a different spring constant or a different spring force than the outer spring.

[0014] In another aspect, a drug delivery system for injecting a drug agent includes: a container configured to contain a drug agent (the container including a plug and a closure configured to move within the container) and a drive assembly including a plunger member configured to move the plug within the container, wherein the plunger member has a first position and a second position axially spaced apart from the first position, a biasing member configured to move the plunger member from the first position to the second position, and a plunger actuating member rotatable relative to the plunger member. The plunger actuating member has a first rotational position and a second rotational position, in the first rotational position the plunger member is axially fixed relative to the plunger actuating member, and in the second rotational position the plunger member is axially movable relative to the plunger actuating member. The system also includes a needle actuator assembly including a needle configured to be placed in fluid communication with the container, wherein the needle is movable from the first position and the second position spaced apart from the first position, wherein a portion of the needle actuator is configured to engage with the plunger actuating member to move the plunger actuating member from the first rotational position to the second rotational position.

[0015] In another aspect, a drug delivery system for injecting a drug agent includes: a container configured to contain a drug agent (including a plug and a closure configured to move within the container) and a drive assembly including a plunger member configured to move the plug within the container (the plunger member having a first position and a second position axially spaced from the first position, the plunger member defining a plurality of coded protrusions), a biasing member configured to move the plunger member from the first position to the second position, and a plunger actuating member movable relative to the plunger member. The plunger actuating member has a first position and a second position, in the first position the plunger member is axially fixed relative to the plunger actuating member, and in the second position the plunger member is axially movable relative to the plunger actuating member. The system also includes a needle actuator assembly including a needle configured to be placed in fluid communication with the container, wherein the needle is movable from the first position and the second position spaced from the first position, a portion of the needle actuator being configured to engage with the plunger actuating member to move the plunger actuating member from a first rotational position to the second rotational position. The system also includes a limiting member and a spacer assembly, the limiting member being aligned with and configured to engage with one of the plurality of coding protrusions to limit movement of the needle actuator assembly, the spacer assembly engaging with the plug of the container and configured to engage with the plunger member.

[0016] A portion of the needle actuator assembly can be configured to engage with and move a limiting member, wherein axial movement of the needle actuator assembly is limited by engagement of the limiting member with one of the plurality of coded protrusions. When the plunger assembly is in a second position, the limiting member can disengage from one of the plurality of coded protrusions and the needle actuator assembly can move axially relative to the limiting member. A spacer assembly can include spacers and spacer retainers, wherein the spacer retainer is received by a plug of the container, and the spacers are received by the spacer retainer. The system can include a plurality of spacers, each having a different length, wherein each of the plurality of spacers is configured to correspond to one of the plurality of coded protrusions of the plunger assembly. The system can also include a housing housing the container, the drive assembly, and the needle actuator assembly, wherein the drive assembly includes a coded member rotatable relative to the housing, wherein rotation of the coded member causes rotation of the plurality of coded protrusions of the plunger assembly. Attached Figure Description

[0017] The above-mentioned and other features and advantages of this disclosure, as well as the ways in which they are implemented, will become apparent from the following description of embodiments of this disclosure, taken in conjunction with the accompanying drawings, in which:

[0018] Figure 1 This is a perspective view of a drug delivery system according to one aspect of the present invention.

[0019] Figure 2 According to one aspect of the present invention Figure 1 A cross-sectional perspective view of a drug delivery system.

[0020] Figure 3 According to one aspect of the present invention Figure 1 A frontal cross-sectional view of the drug delivery system.

[0021] Figure 4 According to one aspect of the present invention Figure 1 A top view of the drug delivery system, showing the top of the housing removed and the drug delivery system in its pre-use position.

[0022] Figure 5 According to one aspect of the present invention Figure 1 A top-view cross-sectional view of the drug delivery system, showing the system in its pre-use position.

[0023] Figure 6 According to one aspect of the present invention Figure 1 A frontal cross-sectional view of the drug delivery system, showing the system in its pre-use position.

[0024] Figure 7 According to one aspect of the present invention Figure 1 A top view of the drug delivery system, showing the top of the housing removed and the drug delivery system in the initial actuated position.

[0025] Figure 8 According to one aspect of the present invention Figure 1 A frontal cross-sectional view of the drug delivery system, showing the drug delivery system in its initial actuated position.

[0026] Figure 9 According to one aspect of the present invention Figure 1 A frontal cross-sectional view of the drug delivery system, showing the drug delivery system in its initial actuated position.

[0027] Figure 10 According to one aspect of the present invention Figure 1 A top view of the drug delivery system, showing the top of the housing removed and the drug delivery system in the use position.

[0028] Figure 11 According to one aspect of the present invention Figure 1 A top-view cross-sectional view of the drug delivery system, showing the drug delivery system in its usage position.

[0029] Figure 12 According to one aspect of the present invention Figure 1 A frontal cross-sectional view of the drug delivery system, showing the drug delivery system in its usage position.

[0030] Figure 13 According to one aspect of the present invention Figure 1 A top view of the drug delivery system, showing the top of the housing removed and the drug delivery system in its post-use position.

[0031] Figure 14 According to one aspect of the present invention Figure 1 A top-view cross-sectional view of the drug delivery system, showing the drug delivery system in its post-use position.

[0032] Figure 15 According to one aspect of the present invention Figure 1 A frontal cross-sectional view of the drug delivery system, showing the drug delivery system in its post-use position.

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

[0034] Figure 15B According to one aspect of the present invention Figure 1 A cross-sectional perspective view of a drug delivery system, showing the liner in the pre-use position of the drug delivery system.

[0035] Figure 15C According to one aspect of the present invention Figure 1 A cross-sectional perspective view of a drug delivery system, showing the liner in the pre-use position of the drug delivery system.

[0036] 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.

[0037] Figure 17 This is a perspective view of a drive assembly of a drug delivery system according to one aspect of the present invention.

[0038] 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 position before use.

[0039] Figure 19 According to one aspect of the present invention Figure 17 A cross-sectional view of the drive component shows the location where the drive component is used.

[0040] Figure 20 According to one aspect of the present invention Figure 17 A cross-sectional view of the drive component, showing the position of the drive component after use.

[0041] Figure 21 According to one aspect of the present invention Figure 17 A perspective view of the plunger actuation component of the drive assembly.

[0042] Figure 22 According to one aspect of the present invention Figure 17 A perspective view of the first plunger component of the drive assembly.

[0043] 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 engaged with the first plunger member.

[0044] Figure 24 According to one aspect of the present invention Figure 17A 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.

[0045] 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 the first plunger member.

[0046] Figure 26 According to one aspect of the present invention Figure 17 A front view of the first and second plunger components of the drive assembly.

[0047] Figure 27 This is a top view of a drive assembly for a drug delivery system according to another aspect of the present invention.

[0048] Figure 28 According to one aspect of the present invention Figure 27 A perspective view of the driving component.

[0049] 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 position before use.

[0050] Figure 30 According to one aspect of the present invention Figure 27 A perspective view of the drive assembly, showing the drive assembly housed in the bottom of the housing.

[0051] Figure 31 According to one aspect of the present invention Figure 30 A perspective view of the casing.

[0052] Figure 32 According to one aspect of the present invention Figure 27 A top view of the drive assembly, showing engagement of the drive assembly with a portion of the needle actuator in the initial actuated position of the drive assembly.

[0053] Figure 33 According to one aspect of the present invention Figure 27 An enlarged perspective view of the drive assembly shows the engagement of the drive assembly with a portion of the needle actuator in the initial actuated position of the drive assembly.

[0054] Figure 34 This is a front view of a needle actuator assembly according to one aspect of the present invention.

[0055] Figure 35 According to one aspect of the present invention Figure 34Left perspective view of the needle shuttle of the needle actuator assembly.

[0056] 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.

[0057] 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.

[0058] 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.

[0059] 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.

[0060] 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 its used position.

[0061] 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.

[0062] Figure 38B According 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.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] Figure 41 This is a perspective view of a drive assembly for a drug delivery system according to another aspect of the present invention.

[0067] Figure 42 According to one aspect of the present invention Figure 41 A perspective view of the drive components, showing the top of the housing removed.

[0068] Figure 43 According to one aspect of the present invention Figure 41 A cross-sectional view of the driving component.

[0069] Figure 44 According to one aspect of the present invention Figure 41 A perspective view of the driving component.

[0070] 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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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.

[0075] 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.

[0076] 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.

[0077] Figure 52 According to one aspect of the present invention Figure 41A top view of the drive component, showing the drive component in its usage position.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] 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 use position.

[0084] 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 use position.

[0085] 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.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] Figure 64 This is a perspective view of a drive component according to another aspect of the present invention.

[0090] 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.

[0091] 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.

[0092] 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.

[0093] 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 its used position.

[0094] 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.

[0095] Figure 65F 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.

[0096] 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 its pre-use position with axial displacement of the button actuator.

[0097] 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 axial displacement of the button actuator.

[0098] Figure 66 According to one aspect of the present invention Figure 65A A perspective view of the button spring of the needle actuator assembly.

[0099] Figure 67According to one aspect of the present invention Figure 65A A perspective view of the actuator button of the needle actuator assembly.

[0100] 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.

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

[0102] Figure 68B According to another aspect of the invention Figure 65A A bottom view of the actuator button of the needle actuator assembly.

[0103] Figure 68C According to another aspect of the invention Figure 65A A front view of the actuator button of the needle actuator assembly.

[0104] 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.

[0105] Figure 68E According to another aspect of the invention Figure 65A A front view of the actuator button of the needle actuator assembly, showing the actuator button in the pre-use position.

[0106] 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.

[0107] Figure 68G According to another aspect of the invention Figure 65A A front view of the actuator button of the needle actuator assembly, showing the actuator button in the use position.

[0108] Figure 69 According to one aspect of the present invention Figure 65A A top view of the actuator button of the needle actuator assembly.

[0109] Figure 70A This is a schematic diagram of a drive assembly according to one aspect of the present invention, showing the drive assembly in a position before use.

[0110] Figure 70B According to one aspect of the present invention Figure 70AA schematic diagram of the driver component shows the driver component in its usage position.

[0111] Figure 70C According to one aspect of the present invention Figure 70A A schematic diagram of the driver component shows the driver component in its usage position.

[0112] Figure 70D According to one aspect of the present invention Figure 70A A schematic diagram of the driver component shows the driver component in its usage position.

[0113] Figure 70E According to one aspect of the present invention Figure 70A A schematic diagram of the driver component shows the driver component in its usage position.

[0114] Figure 70F According to one aspect of the present invention Figure 70A A schematic diagram of the driver component shows the driver component in its post-use position.

[0115] Figure 70G According to one aspect of the present invention Figure 70A A schematic diagram of the driver component shows the driver component in its post-use position.

[0116] 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.

[0117] Figure 72 According to one aspect of the present invention Figure 71 A perspective view of the spacer assembly, showing where the spacer assembly is used.

[0118] Figure 73 According to one aspect of the present invention Figure 71 A perspective view of the spacer assembly, showing the position of the spacer assembly after initial use.

[0119] Figure 74 This is a perspective view of a limiting member according to one aspect of the present invention.

[0120] Figure 75 This is a front view of a spacer assembly of a drug delivery system according to another aspect of the present invention.

[0121] Figure 76 This is a top view of a spacer assembly of a drug delivery system according to one aspect of the present invention.

[0122] Figure 77 According to one aspect of the present invention Figure 76 A perspective view of the spacer component.

[0123] Figure 78 According to one aspect of the present invention Figure 76 A cross-sectional view of the spacer assembly.

[0124] Figure 79 This is a perspective view of a spacer assembly for a drug delivery system according to another aspect of the present invention.

[0125] Figure 80 This is a perspective view of a spacer assembly for a drug delivery system according to another aspect of the present invention.

[0126] Figure 81A According to one aspect of the present invention Figure 80 A cross-sectional view of the spacer assembly, showing the spacer assembly in its position before assembly.

[0127] Figure 81B According to one aspect of the present invention Figure 80 A cross-sectional view of the spacer assembly, showing the assembled position of the spacer assembly.

[0128] Figure 82 This is a perspective view of a drive assembly for a drug delivery system according to one aspect of the present invention.

[0129] Figure 83 According to one aspect of the present invention Figure 82 A perspective view of the drive components, showing the top of the housing removed.

[0130] 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 position before use.

[0131] Figure 85 According to one aspect of the present invention Figure 82 An enlarged cross-sectional view of the drive component shows its position before use.

[0132] Figure 86 According to one aspect of the present invention Figure 82 A top view of the biasing component of the drive assembly.

[0133] Figure 87 According to one aspect of the present invention Figure 82 A perspective view of the drive assembly, showing the limiting member that engages with the drive assembly.

[0134] Figure 88This is a perspective view of a drive assembly for a drug delivery system according to one aspect of the present invention.

[0135] Figure 89 According to one aspect of the present invention Figure 88 The perspective view of the driver component shows the position of the driver component before use.

[0136] Figure 90 According to one aspect of the present invention Figure 88 A cross-sectional view of the driving component.

[0137] Figure 91 According to one aspect of the present invention Figure 88 A perspective view of the driver component, showing the location of the driver component after use.

[0138] 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 position before use.

[0139] 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.

[0140] Figure 94 This is a perspective view of a spacer assembly for a drug delivery system according to one aspect of the present invention.

[0141] Figure 95 According to one aspect of the present invention Figure 94 The front view of the spacer component.

[0142] Figure 96 According to one aspect of the present invention Figure 94 A cross-sectional view of the spacer assembly.

[0143] Figure 97 According to one aspect of the present invention Figure 94 A perspective view of the spacer assembly, showing the spacer being removed.

[0144] Figure 98 According to one aspect of the present invention Figure 94 A perspective view of the fixed spacer of the spacer assembly.

[0145] Figure 99 According to one aspect of the present invention Figure 94 A perspective view of the adjustable spacer of the spacer assembly.

[0146] Figure 100 According to one aspect of the present invention Figure 94A perspective view of the spacer pads of the spacer assembly.

[0147] In the various views, corresponding reference numerals denote corresponding parts. The examples set forth herein illustrate exemplary aspects of the invention and are not to be construed as limiting the scope of this disclosure in any way. Detailed Implementation

[0148] The following description is provided to enable those skilled in the art to make and use the embodiments contemplated for carrying out the present invention. However, various modifications, equivalents, variations, and substitutions will be apparent to those skilled in the art. Any and all of these modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the present invention.

[0149] For the purposes described below, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives are used in relation to the orientation of the invention in the accompanying drawings. However, it should be understood that the invention can take various alternative variations unless explicitly stated otherwise. It should also be understood that the specific devices shown in the drawings and described below are merely exemplary embodiments of the invention. Therefore, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein are not considered to constitute a limitation.

[0150] See Figure 1-16 According 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 22 and a bottom 24, although other suitable arrangements may be used. In one aspect, the drug delivery system 10 is a syringe device configured to be worn or fastened to a user and to deliver a predetermined dose of medication disposed in the container 14 into the user's body via injection. The system 10 can be used for "bolus injections," in which medication is delivered over a set time period. Medication can be delivered over a time period of up to 45 minutes, although other suitable injection volumes and durations may be used. Bolus administration or delivery can be performed with or without specific speed control. With variable speed, the system 10 can deliver medication to the user at a fixed pressure. (Refer to below) Figure 1-16 and the following combination Figure 17-93 The details of the drive component 12, needle actuator component 18, and other features of the system 10 are discussed to describe the general operation of the system 10.

[0151] See you again Figure 1-16System 10 is configured to operate via user engagement of actuation button 26 (which causes the needle 28 of needle assembly 18 to pierce the user's skin), actuation of drive assembly 12 (to fluidly connect needle 28 to container 14 and expel fluid or medication from container 14), and retraction of needle 28 after medication injection is completed. A general operation of a drug delivery system is shown and described in International Publications Nos. 2013 / 155135 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 indicator device 32 and a container window 31 for viewing container 14. Indicator device 32 is configured to provide the user with indications regarding the status of system 10. Indicator window 30 may be a magnifying glass for providing a clear view of indicator device 32. During use of system 10, indicator device 32 moves together with needle actuator assembly 18 to indicate the pre-use, used, and post-use status of system 10. The indicator device 32 provides a visual marker related to the state, but other suitable markers (such as auditory or tactile markers) can be provided as alternative or additional markers.

[0152] See Figure 4-6 In 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. Figure 7-9 As shown, during the initial actuation of system 10, drive assembly 12 engages container 14 to move container 14 toward valve assembly 16, which is configured to pierce the closure 36 of container 14 and fluidly communicate the medication within container 14 with needle 28 via a tube (not shown) or other suitable means. Drive assembly 12 is configured to engage plug 34 of container 14, thus initially moving the entire container 14 into engagement with valve assembly 16 due to the incompressibility of the fluid or medication within container 14. Initial actuation of system 10 is achieved by the user engaging actuation button 26, thus releasing needle actuator assembly 18 and drive assembly 12, as discussed in more detail below. During initial actuation, needle 28 remains in the retracted position and is about to move to the extended position to administer an injection to the user of system 10.

[0153] like Figure 10-12 As shown, in the use position of system 10, the needle 28 is in the extended position, at least partially outside the housing 20, where the drive assembly 12 moves the plug 34 within the container 14 to deliver medication from the container 14 through the needle 28 to the user. In the use position, the valve assembly 16 has pierced the closure 36 of the container 14 to fluidly connect the container 14 with the needle 28, thus also allowing the drive assembly 12 to move the plug 34 relative to the container 14, as fluid can be dispensed from the container 14. Figure 13-15As shown, in the post-use position of system 10, needle 28 is in the retracted position and engages with gasket 38 to seal needle 28 and prevent any residual fluid or agent 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.

[0154] See Figures 15A-15C When the needle actuator body 96 moves from the used position to the post-use position, the pad 38 is biased into the needle actuator body 96. 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 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, 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 the opening of the pad arm 122, although other suitable means for securing the pad 38 may be used.

[0155] See Figure 1-33 The diagram illustrates a drive assembly 12 according to one aspect of the invention. As discussed above, the drive assembly 12 is configured to move the container 14 to pierce the closure 36 of the container 14 and move the plug 34 within the container 14 to dispense fluid or pharmaceuticals from the container 14. Figure 17-33The drive assembly 12 shown is configured to engage and cooperate with a spacer assembly 40 received by a plug 34 of container 14. The spacer assembly 40 includes a spacer 42 and a spacer retainer 44. The spacer retainer 44 is received by the plug 34, and the spacer 42 is received by the spacer retainer 44. The spacer retainer 44 includes a first threaded portion 46 that engages with a corresponding threaded portion of the plug 34, although other suitable means may be used. The spacer 42 also includes a threaded portion 48 that engages with a corresponding second threaded portion 50 of the spacer retainer 44 for securing the spacer 42 to the spacer retainer 44, although other suitable means may be used. The drive assembly 12 is configured to dispense a predetermined range of filling volume into container 14 while maintaining the functional characteristics of system 10 described above, including but not limited to retracting the needle 28 after dose dispensing and providing an indication of the status of system 10, while minimizing the possibility of sudden engagement between the plug 34 and the drive assembly 12. The drive assembly 12 is configured to distribute multiple discontinuous fill volume ranges using spacers 42 of multiple sizes. In one aspect, 12 fill volume ranges and 12 spacers 42 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 the multiple fill volumes in the container 14 are adapted by using multiple gaskets accommodated by the spacers 42.

[0156] See Figure 17-26 The drive assembly 12 includes a first plunger member 52, a second plunger member 54 housed within the first plunger member 52, a first biasing member 56, a second biasing member 58, a plunger actuation member 60, and a rotation member 62. The first plunger member 52 can be positioned from its pre-use position (e.g., ...). Figure 18 (As shown) Move to the usage location (such as) Figure 19 As shown), move to the location after use (such as...) Figure 20 (As shown in the diagram), a first plunger member 52 is configured to engage with a spacer assembly 40 and move a plug 34 within a container 14 to dispense medication from the container 14. The first plunger member 52 is configured to move axially. A second plunger member 54 and the first plunger member 52 form a telescopic device, 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 and second plunger members 52, 54 is provided by first and second biasing members 56, 58, which are compression springs, although other suitable devices may be used as biasing members 56, 58.

[0157] The first biasing member 56 is received by the second plunger member 54 and constrained between the plunger actuation member 60 (and the indexing 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 then 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 then to a post-use position. More specifically, the second biasing member 58 is configured to drive the first plunger member 52 onto the spacer assembly 40 or the plug 34, causing the container 14 to move into engagement with the valve assembly 16, thereby piercing the closure 36 of the container 14 and fluidly communicating the container 14 with the needle 28. The first biasing member 56 is configured to move the plug 34 within the container 14 to dispense the 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 stiff than the first biasing member 56 to provide a larger force to pierce the closure 36 of the container 14, while the first biasing member 56 provides a smaller force for appropriate dispensing based on the viscosity of the fluid or medication within the container 14.

[0158] See you again Figure 17-26 The plunger actuating member 60 has an annular portion 68 and a shaft portion 70. The plunger actuating 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 spaced 15 degrees from the second rotational position, although other suitable positions may be used. The annular portion 68 includes a drive surface 72 comprising a plurality of teeth 74, although other suitable means for the drive surface 72 may be used. The shaft portion 70 includes an actuator locking surface 76 configured to engage and release from 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 in a plurality of slots or cutouts 81 defined by the actuator locking surface 76.

[0159] like Figure 18 and 23 As shown, in the first rotational position of the plunger actuation member 60, the plurality of protrusions 80 and the plurality of slots or cutouts 81 are not aligned, such that the plunger actuation member 80 engages with the first plunger member 52 to prevent the first and second plunger members 52, 54 from moving together with the first and second biasing members 56, 58 that bias the first and second plunger members 52, 54 away from the plunger actuation member 60. Figure 19 and 24 As shown, in the second rotational position of the plunger actuating member 60, the plurality of protrusions 80 and the plurality of slots or cutouts 81 are aligned with each other, such that the plunger actuating member 60 is disengaged from the first plunger member 52, so that the first and second plunger members 52, 54 can move to initiate the dispensing process from the container 14.

[0160] See Figure 7 and 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 a post-use position. During the initial movement of the needle actuator assembly 18, a portion of the needle actuator assembly 18 engages with 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 inclined blade portion 82 of the needle actuator assembly 18 engages with the drive surface 72 of the plunger actuator member 60 to rotate the plunger actuator member 60.

[0161] See Figure 11 , 13 26. The second plunger member 52 includes a plurality of coded protrusions 84, one of which is pre-selected and configured to engage with a restraining member 86 of the system 10. As discussed in more detail below, the restraining member 86 engages with and restricts the needle actuator assembly 18 from a use position to a post-use position until the plug 34 reaches a predetermined end-of-use position. In one aspect, the restraining member 86 is configured to restrict axial movement of the needle actuator assembly 18 from the use position by engagement of the restraining member 86 with a portion of the needle actuator assembly 18. When the plug 34 reaches the end-of-use position, this engagement between the restraining member 86 and the needle actuator assembly 18 is released by rotation of the restraining member 86. In the use position of the needle actuator assembly 18, the restraining member 86 is biased in the rotational direction, wherein rotation of the restraining member 86 is prevented by engagement between the restraining 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 varying lengths, though other suitable devices may be used. Each coded protrusion 84 defines a point at which the limiting member 86 can rotate, thereby releasing 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 end-of-dosage position.

[0162] As discussed above, the indicator device 32 moves, wherein different portions of the indicator device 32 are visible through the indicator window 30 as the system 10 moves from the pre-use position, the use position, or the end-of-use position. 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 indications relating to the state of the system 10.

[0163] During the assembly of system 10, the dosage of container 14 is matched with a specific spacer 42 of a predetermined length, and a corresponding coded protrusion of the plurality of coded protrusions 84 is aligned with the restraining member 86. Therefore, as discussed above, container 14 can be provided with multiple dosage volumes, each corresponding to a specific spacer 42 and coded protrusion 84. Thus, even for different dosage volumes, system 10 is configured to inject needle 28 into the user's body to deliver a dose of medication from container 14, retract needle 28 after administration, and provide a status indication of system 10, while minimizing the possibility of sudden engagement of plug 34 with drive assembly 12. Specifically, the size of plug 34 can be selected to minimize the distance between the first plunger member 52 and spacer assembly 40 and eliminate the need for damping.

[0164] See Figure 27-33 The diagram shows a drive component 12A according to another aspect of the present invention. Figure 27-33 The drive component 12A shown in the figure and Figure 17-26 The drive component 12 shown and described above is similar and operates in the same manner. However, in Figure 27-33 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 with the second plunger member 54 after the first plunger member 52 has moved a predetermined axial distance, causing the first and second plunger members 52 and 54 to move together. First and second biasing members 56 and 58 are used to... Figure 17-26 The drive assembly 12 engages and acts on the first and second plunger members 52 and 54 in the same manner.

[0165] See Figure 27-32The indexing member 62 is located around the first and second plunger members 52, 54 and includes a plurality of ratchet teeth 90 configured to engage with flexible tabs 92 located on the bottom 24 of the housing 20. When the drive assemblies 12, 12A are mounted into the bottom 24 of the housing 20, the engagement of the ratchet teeth 90 of the indexing member 62 with the flexible tabs 92 of the housing 20 provides unidirectional rotation of the indexing member 62. The indexing member 62 is configured to rotate to align one of the coded protrusions 84 of the second plunger member 52 with the restraining member 86 based on the dose volume and spacer 42 dimensions discussed above. The indexing member 62 can provide 24 rotational positions for the drive assemblies 12, 12A, 12 of which have unique dose values ​​associated with them.

[0166] See Figure 1-16 Figures 34-40B illustrate a needle actuator assembly 18 according to one aspect of the invention. The needle actuator assembly 18 includes a needle actuator body 96 having a guide surface 98, a needle shuttle 102 having a cam surface 104, and a needle 28 received by the needle shuttle 102 and configured to be in fluid communication with a container 14 as discussed above. The needle actuator body 96 is generally rectangular, with the guide surface 98 projecting 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 the housing 20 from its pre-use position (e.g., ...). Figure 4-6 As shown), initial actuation position ( Figure 7-9 ), Location of use ( Figure 10-12 ), and the location after use ( Figure 13-15 The needle actuator body 96 is biased from the pre-use position to the post-use position via the tension spring 106, although other suitable biasing devices can be used. Once the actuator button 26 is engaged (discussed in more detail below), the needle actuator body 96 is released and freely moved from the pre-use position to the use position. As described above... Figure 17-33 The discussion focuses on the movement of the needle actuator body 96 from the used position to the post-use position after the restrictor component 86 has rotated.

[0167] See Figure 34-40BThe needle shuttle 102 is movable along a vertical axis between a retracted position and an extended position, in which the needle 28 is located within the housing 20, and in the extended position, 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 first and second cam members 108, 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 structures 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 straight and extends generally perpendicularly from the housing 20; however, other suitable means 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.

[0168] As discussed 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 with 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 biasing force when the needle actuator body 96 is switched from the use position to the post-use position. When the needle actuator body 96 is fully switched 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 so that the needle 28 engages the pad 38 as discussed above. However, as discussed above... Figure 1-16 As discussed, the pad 38 can also be biased into the needle 28 instead of biasing the needle shuttle 102 downward via the shuttle biasing member 120. The needle actuator body 96 can interact with the actuator button 26 to prevent the actuator button 26 from bouncing back until it reaches the used position, which will be discussed in more detail below.

[0169] See Figure 37A-40B In the position before use ( Figure 37A The needle shuttle 102 is in the retracted position, wherein the cam members 108, 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 38AThe second cam member 110 of the needle shuttle 102 engages with the second side surface 118 of the guide surface 98 to move the needle shuttle 102 from the retracted position to the extended position. During the transition of the needle actuator body 96 from the used position to the post-use position... Figure 37C The first cam member 108 of the needle shuttle 102 engages with the first side surface 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 is fully switched to the used position. Figure 37D and 38B Subsequently, when the cam members 108 and 110 disengage from the guide surface 98 of the needle actuator body 96 with the needle 28 engaging the pad 38, the shuttle biasing member 120 biases the needle shuttle 102 downward. Figure 39-40B The diagram also shows the switching of the needle actuator body 96 and the corresponding position of the needle shuttle 102. The actuator button 26 interacts with the needle actuator body 96. Figure 65A-67 Let's discuss this in detail. See also... Figures 41-64 The image shows 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 observation port 208, allowing a user to observe 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 proximal to a needle arm 216. A spring 218 biases a needle actuator 220 distally.

[0170] like Figures 42-46 As shown, system 200 also includes a container or medicine container 222, in which a plug 224 is movably disposed; however, for clarity, the plug 224 is omitted in the figures. Preferably, the distal end of the medicine container 222 has a diaphragm assembly 228, which is spaced apart from the valve assembly 212 before the device 222 is actuated, as shown in... Figure 47 The best example shown is...

[0171] For manufacturing purposes, a single size is generally required for the pharmaceutical container; however, it is conceivable that the container may use multiple filling volumes or dosages. In these cases, different filling volumes result in different stopper positions when the pharmaceutical container is filled. To accommodate these different stopper positions, and to accommodate manufacturing variations in the stoppers, aspects of the invention include custom-made or tailored spacers 226 disposed near the proximal end of the container 222, close to the stopper 224. In other words, the custom-made spacers 226 provide the option to allocate a range of predefined filling volumes set by the manufacturer by selecting different spacers 226, and reduce or eliminate the need for manipulation of the component structure. The dimensions of the spacers 226 can be used to compensate for unfilled volumes in the container 222 and to provide a consistent support surface at the proximal end of the container.

[0172] The spacers 226 are selected from a plurality of spacers 226 of different sizes to occupy the space from the proximal end of the plug 224 to the proximal end of the container 222. According to one embodiment, such as Figures 45-47 As shown, the spacer 226 is chosen to be substantially flush with the proximal end of the container 222. Furthermore, according to one embodiment, the spacer 226 has a "top hat" shape, comprising a central post 230 and a distal flange 232, as shown in... Figure 45 The best example shown is...

[0173] Back Figure 44-47 The system 200 also includes a drive assembly 234 for moving the container 222 distally to establish a fluid connection between the container 222 and the patient needle 215 and to dispense medication from the container 222. More specifically, the drive assembly 234 includes an inner spring 236 disposed within a central plunger 238, an outer plunger 240, an outer spring 242 disposed between the central plunger 238 and the outer plunger 240, a telescopic member 244, and a release gate 246.

[0174] Preferably, the inner spring 236 has a larger spring constant than the outer spring 242, and is therefore stiffer or more rigid than the outer spring 242. The inner spring 236 is disposed inside the central plunger 238 and within the spring flange 248 in the lower housing. Figure 46 (Best shown in the diagram) The inner spring 236 is driven between the central plunger 238 and the outer spring 242, which is directly supported on the proximal end of the spacer 226 after the device is activated. The outer spring 242 is disposed inside the outer plunger 240 and is driven 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.

[0175] According to one aspect, the inner spring 236 is used only to displace the container 222 to establish a fluid connection with the patient needle 215, and the outer spring 242 is used only to subsequently dispense medication from the container 222. According to another aspect, the inner 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 outer spring 242 completes the dispensing. In yet another aspect, the inner spring 236 achieves the initial puncture of the container 222, and the outer spring 242 completes the puncture and dispenses medication from the container 222.

[0176] like Figure 44-47 As shown, and as described in more detail below, the outer plunger 240 includes a pair of proximal flanges or feet 254, each having an inclined surface that interacts with a corresponding inclined surface (or a plurality of inclined surfaces) on the release gate to retain the power module after actuation of the device 200 and subsequently release the power module.

[0177] As in Figure 46 and 47 As best shown, when initially assembled, 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) biases needle actuator 220 distally, but actuation button 210 (and / or its associated components) prevents distal displacement of needle actuator 220 before device 200 is actuated. Status bar 258 is disposed on needle actuator 220 and has a top surface visible through status observation port 208. According to one embodiment, the top surface of status bar has multiple colors or patterns, with a first color or pattern, such as yellow, visible through status observation port 208 when the device is in a pre-actuated state.

[0178] Figures 48-52 These are top views of system 200, showing its operation during and after actuation. Figure 47 In this configuration, the user slides the actuation button 210 towards the proximal end, causing the button 210 to move vertically into the housing 202, thereby releasing the needle actuator 220 to move distally under the action 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 lateral lug 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 lateral flange 256 has already displaced distally, so the container 222 is no longer restricted.

[0179] Subsequently, as Figure 50 and 51 As shown, with continued distal displacement, the proximal end of the needle actuator 220 avoids the release gate 246 (thus releasing the drive assembly 234). The needle actuator 220 temporarily rests against a component on the rotatable release fin 264, driving the release fin 264 to abut against the cantilever bracket 266 of the telescopic member 244 (in... Figure 44 and 59 (Best shown in the image). The needle actuator 220 remains in this position until the medication has been dispensed. Preferably, in this position, a second color or pattern, such as green, can be seen on the status bar 258 through the status observation port 208.

[0180] 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 on the release gate 246, cause the release gate 246 to shift laterally, thereby releasing the outer plunger 240 so that it no longer interacts with the release gate 246. At this point, the outer plunger 240 restrains the central plunger 238.

[0181] See Figure 52 and 53 (For clarity, Figure 52 The inner spring 236 (omitted) is rigid and drives the central plunger 238 distally to contact the spacer 226. Because the drug container 222 is filled with a substantially incompressible fluid, the continuous distal displacement of the central plunger 238 displaces the spacer 226, plug 224, and container 222 distally relative to the housing 202. This distal displacement causes the valve assembly 212 to puncture the diaphragm assembly 228, establishing fluid communication between the container 222 and the patient needle 215. The central plunger 238 travels distally until its proximal outer flange 250 (in...) Figure 59 (Best shown in the image) until it contacts the flange on the lower housing 206, thereby limiting the “puncture travel”. Preferably, another flange on the lower housing 206 and / or the lateral flange 256 of the needle actuator 220 limit the distal travel of the container 222.

[0182] Subsequently, because the inner spring 236 is no longer able to displace the central plunger 238 distally, the lighter outer spring 242 displaces the outer plunger 240 distally relative to the central plunger 238 to contact the distal flange 232 of the spacer 226, as... Figure 54 and 55 As shown in the diagram. As will be described in more detail later, preferably, the contact between the outer plunger 240 and the spacer 226 is cushioned to minimize impact force. Further extension of the outer spring 242 displaces the outer plunger 240 distally to dispense the medication.

[0183] like Figure 56 and 57 As shown, after the outer spring 242 continues to extend and displace the outer plunger 240 distally, causing the outer plunger 240 to reach a predetermined distal displacement 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 results in a corresponding distal displacement of the telescopic member 244. This paired distal displacement continues until drug dispensing is complete.

[0184] As previously noted, the cantilever bracket 266 is mounted on the telescopic member 244. The axial length of the cantilever bracket and the distal stroke of the telescopic member 144 control the time at which the cantilever bracket 266 disengages from the release fin 264. Figure 58 and 59 As shown, at the end of the drug dispensing, the proximal end of the cantilever 266 bypasses the release fin 264. This allows the release fin 264 to rotate and disengage from the needle actuator 220. Figure 60 ), and allows the needle actuator 220 to continue its distal displacement and retracts the patient needle 215. Figure 61 During this stage, the status bar 258 can be viewed in a different color or pattern (e.g., red) through the status observation port 208, indicating that the device 200 has completed its operation.

[0185] As previously pointed out, such as Figure 62 and 63 As shown, the contact between the outer plunger 240 and the spacer 226 is preferably buffered to minimize impact force. For an underfilled syringe containing a viscous fluid, the highest level of energy dissipation is desirable because the outer spring 242 will be stiffer 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 desirable because the outer spring can be less stiff to provide the required dispensing rate. Various methods can be used to adjust the buffering level, such as air buffering or closed-cell foam buffering.

[0186] As another method to cushion the impact. Figure 64One embodiment of spacer 226 is shown, wherein one or more axial interference ribs 272 are arranged on a circumferential surface around a central post 230 of spacer 226. In this embodiment, the outer plunger 240 must be driven through the interference ribs 272, thus providing frictional resistance to the 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, this frictional force does not exceed the minimum distributed spring load to avoid stopping the weaker spring. This interference can be adjusted to obtain the desired level of frictional resistance. For different fluid viscosities, the interference ribs 272 can have different dimensions (axial and / or radial dimensions). This can mean that the spacer can be customized or custom-made for each viscosity and fill level combination or according to the number of springs required for a viscosity range, and can have many bifurcated positions, thereby allowing the spacer to be set to a specific position suitable for a specific modulus of spring (this position has interference / buffering adjusted for a specific spring load / viscosity scheme).

[0187] See Figure 65A-69 The diagram illustrates an actuator button device 280 for actuating a system 10 according to one aspect of the invention. 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 configured to move within the housing 20 to switch 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 interaction with the user. Preferably, the user interface portion 288 is approximately 22 mm long and approximately 10 mm wide, although other suitable sizes may be used. The actuator button 26 includes two pairs of locking arms 290 that 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. See also 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 an outer arm 304 connected to the first support surface 298.

[0188] The actuator 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 in the used position of the needle actuator body 286; and locking of 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 depressed by the user.

[0189] In order to actuate the system 10 using the actuator button 26, the user first slides the user interface section 288 in the first axial direction, as shown in... Figure 65G and 65H As shown on the right. The user needs to slide the user interface section 288 by about 10 mm or about 8 mm, but other suitable distances can be used. The axial movement of the actuator button 26 causes the locking arms 290, 292 to avoid the button contact surfaces 294, 296 on the open-pin actuator body 286, thereby enabling the actuator button 26 to move from the raised position to the pressed position.

[0190] When the user slides the user interface section 288 to the distal end, the central spring arm 302 of the button spring 284 passes over the spring arm support surface 306 on the housing 20, while the first and second support surfaces 298, 300 engage with the first and second support ramps 308, 310 on the housing 20. The force on the button spring 284 is balanced by the engagement with the spring arm support surface 306 and the first and second support ramps 308, 310 to provide smooth axial displacement or sliding of the actuator button 26.

[0191] 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 their respective stops 312, 314 to prevent the actuator button 26 from sliding backward to its original position, as... Figure 65H As shown in the diagram. 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 depressed by approximately 2 mm, and the minimum force required to depress the actuator button 26 is approximately 3 N, most preferably approximately 2.8 N, although other suitable distances and minimum forces can be used.

[0192] When the user presses down on the user interface section 288, such as Figure 65A and 65B As shown, actuator button 26 rotates the needle actuator body 286 to release the needle actuator body 286, thereby moving the needle actuator body 286 from its pre-use position to its use position. Figure 65BAs shown, when the needle actuator body 286 travels to the use position, locking arms 290, 292 extend 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 changes 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, allowing actuator button 26 to spring back under the action of button spring 284. Once the needle actuator body 286 is fully rotated to the used position, as shown... Figure 65D As shown, due to the biasing force of the button spring 284, the actuator button 26 has completed its movement from the depressed position to the raised position. When the needle actuator body 286 is in the used position, the spring arm 316 on the needle actuator body 286 engages the actuator button 26 to prevent it from moving to the depressed position, while its axial movement is still restricted by the engagement of the spring arm 302 with the stops 312, 314. Therefore, the actuator button 26 is locked after the drug delivery is completed to provide a clear indication between the used and unused systems.

[0193] In addition, if the user presses the actuator button 26 during the medication dispensing process, the appropriate dosage 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.

[0194] In one respect, the button spring 284 is made of plastic. The button spring 284 can also be a stamped metal spring, but any suitable material can be used.

[0195] See Figure 68A-68G Instead of providing separate actuator button 26 and button spring 284, the spring can be integrally provided with button 26. More specifically, according to another aspect of the invention, actuator button 320 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 68EAs shown, spring arm 322 engages fork 330 in the top 22 of housing 20. During the transition of system 10 from the pre-use position to the use position, spring arm 322 slides through pawls of fork 330 that provide axial spring force. The end of spring arm 322 engages a portion of the top 22 of housing 20 to provide vertical spring force when spring arm 322 deflects. Actuator button 320 is configured to provide fluid motion between sliding and pressing movements of button 320, although two separate movements similar to the operation of button 26 discussed above occur. During the transition between the pre-use and use positions, button 320 pivots about rear pivot 328, wherein retaining arm 326 engages a portion of needle actuator body 286, thereby holding button 320 in the pressed position until reaching the end-of-dosage position in a manner similar to actuator button 26. When the needle actuator body 286 moves to the end-of-dose position, the locking arm 324 deflects inward and engages with a portion of the needle actuator body 286, thereby preventing further movement of the actuator button 320 in a manner similar to that of the actuator button 26 discussed above.

[0196] Various aspects of the present invention improve upon existing button designs. For example, the actuator button device 280 provides multiple surfaces to hold the needle actuator body 286 in place against the needle actuator spring 106 before actuation, thereby reducing the likelihood of premature actuation during a drop impact. The actuator button device 280 physically prevents the needle actuator body 286 from moving before actuation by keeping the needle actuator body 286 in a tilted (locked) state such that these surfaces have no space to separate and pre-activate.

[0197] Furthermore, the sliding force of the actuator button device 280 is more precisely controlled by using a flexible arm instead of a simple raised pawl. This allows for a longer sliding stroke of the button 26 with better force control, resulting in a more ergonomic design. Additionally, the actuator button device 280 causes the button 26 to return at the end of the injection, providing the user with additional visual, auditory, and tactile indications of drug delivery completion.

[0198] According to one aspect, the fluid delivery volume of system 10 is determined by the termination position of the plunger relative to a point inside the housing, regardless of the actual filling volume, container inner diameter, and plunger activation position and length. Because the tolerances of the above factors are very large, the accuracy of dosage is significantly varied. Aspects of the present invention eliminate some or all of these tolerances from the dosage equation, resulting in a more accurate and less variable drug injection volume.

[0199] See Figure 70A-70G The illustration shows a spacer assembly 400 used in conjunction with a drive assembly according to one aspect of the present invention.

[0200] The elements in the tolerance chain of the stopper 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 reagent canister 412. The tolerance chain in the stopper spacer assembly 400 also includes the canister inner diameter (D). Once assembled, the stopper spacer 414 and the outer plunger 406 are unique for a given reagent volume.

[0201] Figure 70B-70G The operation of the spacer assembly 400 is shown. (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 barrel 412, compressing the cushioning material 418 and the inner spring 420. Due to the fluid volume of the agent, the plug 422 has not yet moved relative to the barrel 412.

[0202] Next, as Figure 70C As shown, the outer spring 416 displaces the outer plunger 406 and the barrel 412 distally to open a valve (not shown) at the distal end of the barrel 412, which establishes fluid communication with the needle (not shown). Due to the incompressibility of the liquid medication, the plug 422 cannot be displaced relative to the barrel 412 until the valve is open and a fluid path to the patient needle is established.

[0203] Subsequently, as Figure 70D and 70E As shown, the inner spring 420 displaces the inner plunger 404, the plunger spacer 414, and the plunger 422 to distribute fluid.

[0204] Figure 70F The termination of drug delivery is shown 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 (and the spacer 414 and the plug 422) relative to the drug container 212 and stopping the flow of the drug.

[0205] According to one aspect, such as Figure 70G As shown, the medication end indicator is a stop trigger system for the displacement of the inner plunger 404 relative to the medication container 412.

[0206] See Figure 71 and 72The retractable spacer assembly 430 includes a front spacer portion 432 fastened to a plug 434, an inner plunger 436, a rear spacer portion 438, and a rotary shuttle 440. The inner 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 will be described in more detail later, the rotary shuttle 440 first rotates and then translates.

[0207] According to one aspect, the front spacer portion 432 is securely fastened to the plug 434. Those skilled in the art will understand that many methods can be used to fasten the front spacer portion 432 to the plug 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 plug 434.

[0208] When the stopper spacer assembly 430 is screwed into the stopper 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 stopper 434 forward, thereby applying pressure to the fluid agent. This pressure deflects the front (distal) face of the stopper 434 and applies pressure proximally, pushing it backward on the rear spacer portion 438 and rotating the rotary shuttle to its "as assembled" state. In other words, when the agent tank is filled with agent and the system's plunger applies an axial force to the agent via the spacer assembly 430, the pressure of the agent deforms the distal face of the stopper 434. During agent delivery, pressure is applied to the rear spacer portion 438 via the drive assembly (via the plunger), which in turn applies a rotational torque to the rotary shuttle 440 via the helical surface 444 of the rear spacer portion 438. However, the stopper deformation from the agent provides a rearward or proximal force on the inner plunger 436, which prevents the rotation of the rotary shuttle 440.

[0209] According to one aspect, the axial reactive load on the inner plunger 436 can be increased by increasing the length of the inner plunger 436.

[0210] After the drug delivery is completed, such as Figure 73 As shown, the pressure on plug 434 decreases, thereby allowing the distal end of inner plunger 436 to displace distally. This distal displacement allows rotary shuttle 440 to rotate. Due to the interaction between the helical surface 444 in the rear spacer portion 438 and the corresponding arm 446 of rotary shuttle 440 with a cam surface, a continuous axial force applied by the drive assembly causes rotary shuttle 440 to rotate and displace distally. According to one aspect, this final movement of rotary shuttle 440 causes the drive assembly trigger pin to retract.

[0211] See Figure 74 and 75According to one aspect of the invention, a limiting member 452 is provided together with the drive assembly. The limiting member 452 controls the timing of the final displacement of the needle actuator bodies 96, 220 after the medication administration is completed. Instead of rotating around a fixed post, the limiting member 452 floats freely. A gap is formed between the plunger and the limiting member 452 as the plunger moves sufficiently toward the distal end (e.g., ...). Figure 74 and 75 As shown), due to the force of the springs on the needle actuators 96 and 220 and the inclined surface 454 on the rear part of the arm of the limiting member 174 connected to the needle actuator body (in... Figure 75 (As best shown in the diagram), the limiting member 452 moves laterally into the gap. After the limiting member no longer holds the needle actuator bodies 96, 220, the needle actuator bodies 96, 220 are released to complete the axial movement to the used position. Furthermore, as... Figure 75 As shown, the limiting member 452 is biased to the rear end of the barrel portion of the container 14, thereby minimizing the tolerance chain of various elements and improving the accuracy of medication.

[0212] See Figures 76-78 The image shows a spacer assembly 460 according to another aspect of the invention. Figures 76-78 The spacer assembly 460 shown in the figure removes the effects of accumulated manufacturing tolerances by adjusting the spacer assembly, thereby allowing each system to inject the same amount of agent.

[0213] like Figure 77 As shown, the spacer assembly 460 includes a plug 462 and a plug spacer 464. The plug spacer 464 includes: a fixed spacer component or a fixed spacer 466 fixedly connected to the plug 462; and an adjustable spacer component or an adjustable spacer 468 rotatably movable in one direction relative to the fixed spacer 466.

[0214] Those skilled in the art will understand that many methods can be used to fasten the retaining spacer 466 to the plug 462, such as adhesives, mechanical fasteners, or any other suitable means. Preferably, the retaining spacer 466 includes one or more external threads that engage with one or more mating threads in the plug 462. According to one aspect, the adjustable spacer 468 has a distal rod with external threads 470. The external threads 470 of the distal rod engage the internal threads 472 in the retaining spacer 466 (in... Figure 78 (best shown in the diagram) to rotatably control the axial movement of the adjustable spacer 468 relative to the fixed spacer 466.

[0215] like Figure 76 and 77As shown, the fixed spacer 466 includes radially spaced pawls 474, and the adjustable spacer 468 includes a spring-loaded pawl arm 476, the free end of which engages one of the selected pawls 474 to prevent the adjustable spacer 468 from rotating toward the fixed spacer 466 and from moving axially. The free end of the spring-loaded pawl arm 476 is shaped to extend beyond the pawls 474 in one direction, thereby allowing the adjustable spacer 468 to rotate away from the fixed spacer 466 and move proximally axially.

[0216] Although plugs and containers come in a variety of sizes, the adjustable spacer 468 can be adjusted relative to the fixed spacer 466 to provide a consistent axial length for the plug assembly 460.

[0217] like Figure 78 As shown, after the container is filled, an axial load, such as the load encountered when installed in systems 10, 200, can be applied to the adjustable spacer 468 (and thus to the fixed spacer 466 and plug 462). After this axial load is applied, the adjustable spacer 468 can retract proximally to ensure a consistent gap 478 between the proximal end of the cartridge 480 and the proximal end face of the adjustable spacer 468, taking into account variations in the cartridge glass and the compressibility of any confined air. In other words, the spacer assembly 460 positions the adjustable spacer 468 relative to the container 14 at a predetermined location independent of variations in the length of the container 14 and the plug. 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 plug 462 is limited by the effective length of the plungers 52, 54 of the drive assembly 12.

[0218] See Figure 79 and 80The diagram illustrates a base post 482 and a cover 484 of an automatically adjusting spacer 486 according to one aspect of the invention. The base post 482 includes a base 488 and an axially extending post 490. According to one embodiment, the base post 482 includes a plurality of columnar protrusions 491, each columnar protrusion having a plurality of ratchet teeth 492 disposed on its proximal end. A locking barb 493 is provided on the proximal end of each of the plurality of ratchet teeth 492. The cover 484 is hollow, and its distal end includes one or more axial springs 494. According to one aspect, the axial spring 494 is a curved cantilever formed during the molding process of the cover 484. According to another aspect, a separate biasing member, such as a compression spring, can be used in the automatically adjusting spacer 486. When the base post 482 is assembled, the spring 494 engages the base 488 and maintains an initial distance between the base post 482 and the cover 484. According to one aspect, the spring 494 is omitted. The cover 484 also includes a plurality of flexible cantilever or tabs 496, each having a free proximal end having a plurality of internal ratchet teeth 497. The proximal end of each flexible tab 496 includes a foot 498.

[0219] Figure 81B A cover is shown with an automatically adjusting spacer in a proximal recess of a plug 494 used at the proximal end of a medicine container. A base 482 is assembled into the hollow cover 484, wherein the base 482 engages the plug 494 and a foot 498 is disposed on the outside of the proximal end of the container.

[0220] 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 plug 494 and the barrel) until the proximal end of the cap 484 is flush with the end of the barrel. This action causes the foot 498 to engage the inner surface of the barrel and displace radially inward, thereby forcing the ratchet teeth 492 and 497 to lock into engagement. The locking barb 493, the engagement of the ratchet teeth 492 and 497, and the engagement of the foot 498 with the inner surface of the barrel prevent the cap 484 from displacing relative to the base post 482. Therefore, the automatically adjusting spacer 486 can accommodate different plug, barrel diameter, and filling volume of the medicine to automatically provide a support surface flush with the proximal end of the medicine barrel.

[0221] One aspect of the invention is a spacer assembly 486 relying on a plug in a container within the system. This spacer design allows for adjustment of its effective length to facilitate precise dosage dispensing. The length adjustment is designed to compensate for manufacturing tolerances in the container, filling volume, and especially the plug length, which can vary by up to one-third in delivery metering using non-adjustable spacers. The spacer length can be adjusted in various ways depending on specific aspects. The spacer length can be self-adjusting based on its position relative to the rear of the container, and can be adjusted via an assembly device when the main container is finally assembled into the sub-assembly, and can be manufactured integrally with the plug and adjusted as a sub-assembly before filling. The adjustable spacer 486 achieves a more precise volume of fluid to be injected compared to a non-adjustable plug.

[0222] See Figures 82-87 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 lead screw 514, and a plunger 516. The lead screw includes a roller portion 518 having externally radially projecting blades 520, and as shown in... Figure 84 and 85 The lead screw thread portion 522 is best shown and will be described in more detail later. Before startup, as in Figure 83 and 86 As best shown, one end 513 of the actuation release member 512 engages one of the blades 520 to prevent the screw 514 from rotating.

[0223] According to one aspect, such as Figures 84-86 As shown, the lead screw 514's threaded portion 522 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 structure. Furthermore, a constant force spring 526 is housed within the roller portion 518 and biases the lead screw 514 in the rotational direction. According to one aspect, the spring 526 is secured to the bottom cover 504. According to another aspect, as... Figures 84-86 As described above, the drive assembly housing 528 is disposed within the system, and the spring 526 is fastened to the power unit housing 528.

[0224] Unlike helical springs, such as compression springs, which have a force curve proportional to their displacement, constant force springs like 526 maintain a relatively flat or even uniform force curve over a long working length. A uniform force curve advantageously provides an injection force proportional to the spring force. This provides a smooth or uniform injection force, thus providing a substantially constant drug injection rate. Although in Figure 86The spring 526 shown has only two turns of material, but those skilled in the art will recognize that fewer or more turns can be used. Preferably, the assembler winds the spring 526 when assembling the drive assembly 500 and stores the spring 526 in the wound position until the actuation time is reached.

[0225] After the system is actuated, the needle actuator assembly 510 is released to the bias member 530 (as in...). Figure 83 Under the action of (best shown in the diagram), it moves axially from the pre-use position to the post-use position. During this movement, the needle actuator assembly 510 supports the second end 532 of the actuation release member 512 and causes the release member 512 to rotate counterclockwise, as shown in the diagram. Figure 87 As shown in the diagram, this counterclockwise rotation of the actuation release member 512 disengages its first end 513 from the blade 520. After the first end 513 disengages from the blade 520, the spring 526 releases and drives the lead screw 514 to rotate, which, in conjunction with the nut 524, advances the plunger 514 to dispense the medication.

[0226] As the lead screw 514 rotates, the rotation of the roller 518 and the blades 520 can be seen through the window 534 in the housing. This window 534 indicates the lead screw's advance in a more noticeable way than observing the linear movement of the plug 536 in the container 508. In fact, this rotational movement is many times more sensitive than linear movement. Those skilled in the art will appreciate that the precise amount or increment of advance depends on the pitch of the lead screw thread 522 of the lead screw 514, the diameter of the roller 518, and the number of blades 520 on the roller 518.

[0227] See Figure 88-93 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 reservoir 601, a plug 602 slidably disposed within the reservoir 601, a first valve plunger 603, a second valve plunger 604, a first rotating nut 605, and a second rotating 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 element or fin 610. The drive assembly 600 is at least partially disposed within a housing 611 that can be assembled into a drug delivery system.

[0228] A constant force spring 609 is contained between the housing 611 and the rotation indicator 607 within the roller portion 616 of the rotation indicator 607. In the inactive state of the drive assembly, energy is applied by deploying the spring 609, and this energy is geometrically utilized together with the housing 611, the rotation indicator 607, and the actuation release member 610. When the drive assembly 600 is deactivated, the spring rewinds and converts mechanical energy into rotational motion of the rotation indicator.

[0229] The multi-part telescopic plunger is oriented along the force axis between the medicine container 601 and the rotation indicator 607. The rotation indicator 607 is characterized by a threaded shaft 618. According to one aspect, the thread is double-leaded and substantially square or rectangular. The multi-part telescopic plunger includes a two-part nut (a first rotating nut 605 and a second rotating nut 606) and a two-part plunger (a first valve plunger 603 and a second valve plunger 604). The second rotating nut 606 is a threaded shaft that mates with the rotation indicator 607 and the first rotating nut 605, and is characterized by threads on its inner and outer surfaces (matching internal and external threads respectively) to mate with the rotation indicator and the first rotating nut. The second rotating nut 606 also has a circular collar 620 on its proximal end (as shown in...). Figure 92 (best shown in the diagram), which extends downward to the bottom of the second valve plunger 604. The second rotating nut 606 rotates freely along the force axis. The first rotating nut 605 is also a threaded shaft, characterized in that the thread on its inner diameter corresponds to the external thread of the second rotating nut 606 to match the second rotating nut 606.

[0230] According to one aspect, the first rotating nut 605 has a hexagonal collar at one end, which presses against the first valve plunger 603 to securely connect the first valve plunger 603 to the first rotating nut 605. In the drive assembly 600, the first rotating nut cannot rotate freely but can only translate when actuating the power module subassembly.

[0231] The second valve plunger 604 is a hollow cylindrical element with a small collar 622 at its distal end and a large collar 624 at its proximal end, and has an L-shaped extension arm 626 protruding from the large collar 624 at the proximal end (in... Figure 93 (Best shown in the diagram). According to one embodiment, the small neck ring 622 is discontinuous, characterized by four leaf cantilever or leaf spring 623 that allow the neck ring to bend and mate with the first valve plunger 603. The inner surface of the second valve plunger 604 has an undercut that extends through a radially inwardly projecting shelf 628 of the large neck ring 624, terminating at its proximal end. The shelf 628 engages a second rotating nut 606 within the telescopic assembly.

[0232] The first valve plunger 603 is a hollow cylindrical element connected to the plug 602 and also mating with the second valve plunger 604. More specifically, the first valve plunger 603 is characterized by a cylindrical protrusion 630 at its distal end for mating with the plug 602. According to one aspect, as in Figure 89As best shown, four through slots 632 are provided on the four proximal sectors of the first valve plunger 603 to mate with the leaf spring or arm 623 and the small collar portion 622 of the second valve plunger 604. The first and second valve plungers 603 and 604 are free to slide.

[0233] The extension and retraction are achieved when the constant force spring 609 rewinds and the rotation indicator 607 begins to rotate. The threaded connection between the rotation indicator 607 and the second rotation nut 606 allows the second rotation nut 606 to rotate. However, because the second rotation nut 606 is threaded to the first rotation nut 605, the first rotation nut cannot rotate and restricts the distal translation caused by the pressure of the medicine in the container 601. The second rotation nut 606 will then displace proximally, descending to the lowest point on the radially inwardly protruding shelf 628 of the second valve plunger. The housing 611 prevents the second valve plunger 604 from displacing proximally. Subsequently, as the rotation indicator 607 continues to rotate, because the second rotation nut 606 is threaded to the first rotation nut 605 (which cannot rotate), the first rotation nut 605 translates distally to push the first valve plunger 603 (and plug 602) to dispense medicine from the container 601.

[0234] The first valve plunger 603 is displaced distally relative to the second valve plunger 604 until the small collar portion 622 (distributed on the distal end of the leaf spring or arm 623 of the second valve plunger 604) engages the corresponding proximal end of the slot 632 of the first valve plunger 603. This locks the relative positions of the first and second valve plungers 603 and 604. As the rotation indicator 607 continues to rotate, both valve plungers translate distally, simultaneously pushing the second rotating nut together (due to its proximal end engaging with the shelf 624).

[0235] The initial and final positions of the telescopic plunger, and thus the drug dosage, are controlled by the rectangular threaded form of the threaded shaft 618 of the rotary indicator 607, the threaded shaft on the roller 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 roller portion 616 of the rotary indicator 607 is single-lead, because the remaining elements in the telescopic chain have double-lead threads, so the axial travel of the other threaded elements relative to the rotary indicator is twice the axial travel of the locking element 608.

[0236] According to one embodiment, the locking member 608 is cylindrical and characterized by having a domed end and a cylindrical collar at the other end. The threads on the exterior of the rotating indicator's roller portion 616, along with a slot and undercut 636 at the bottom of the housing 611, constrain the locking member 608 into place, allowing it to slide parallel to the force axis. Therefore, when the spring 609 is released and the rotating indicator 607 rotates, the locking member 608 also translates and forms a positive stop when it reaches the distal end of the threads on the exterior of the rotating indicator's roller portion 616.

[0237] One advantageous aspect 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 acting on the medication in the container 601. This, in turn, results in a uniform medication delivery rate. Another benefit is the use of a threaded telescopic plunger, which saves up to 0.75 inches of linear space compared to other plunger designs. Furthermore, the drive assembly provides controlled medication dosage through initial and final mechanical constraints within the same element.

[0238] As previously noted, other drug delivery devices use compressed disc springs, which apply maximum force upon actuation and decrease as the spring expands. This reduced force at the plunger translates into varying drug delivery time and drug output pressure. By using a constant-force spring, the force applied to the plunger from the start to the end of dosing is constant. Furthermore, the distance the disc spring must travel, in addition to the length of the static plunger which needs to translate within the drug container, results in a long assembly. Conversely, in embodiments of the present invention, the constant-force spring is contained radially and requires no additional space before or after actuation. Moreover, the various aspects of the telescopic plunger allow for a significant reduction in plunger length compared to the length of the static plunger.

[0239] Previous drug delivery systems, due to the geometric dependence of drug delivery caused by the mechanical components extending from the bottom of the container, exhibited variable dosage accuracy 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 through a threaded design in the rotation indicator and the use of a constant-force spring.

[0240] In addition to providing excellent control over the timing, volume, and pressure of the drug delivery device, the drive components also result in geometric space savings, which translates into a more attractive, compact, and precise drug delivery device.

[0241] Some aspects of the drive assembly implement three rotating threaded shafts to create a linear space saving of approximately 0.75 inches. In other aspects, the same concept can be utilized to use two rotating threaded shafts and result in 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.

[0242] See Figure 94-100 This illustrates a spacer assembly 660 according to another aspect of the invention. The spacer assembly 660 is similar to that discussed above and in… Figures 76-78 The spacer assembly 460 shown is similar and operates in a similar manner to achieve similar advantages. Spacer assembly 660 includes a fixed spacer 666 and an adjustable spacer 668. The fixed spacer 666 is configured to be received by a plug 462 having a lug 670 that engages with the plug 462 to secure the fixed spacer 666 within the plug 462; however, other suitable fastening 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 pawls 674 located 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 pawls 674 to prevent rotation and axial displacement of the adjustable spacer 668 toward the fixed spacer 666. Spring-loaded pawl arms 676 are shaped and configured to extend over the pawls 674 in one direction, allowing the adjustable spacer 668 to rotate and axially displace 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 force to the top of the spring-loaded pawl arms 676, which biases the spring-loaded pawl arms 676 away from the pawls 674, thus securing the spacers 666, 668 to each other. Therefore, the adjustable spacer rotates freely in one axial direction in the same manner as discussed above regarding the spacer assembly 460, to adjust the length of the spacer assembly 660.

[0243] See you again Figure 94-100 The spacer assembly 660 also includes a gasket 680 configured to receive and secure to the adjustable spacer 668. Instead of providing multiple sizes of adjustable spacers 468, 668, multiple gaskets 680 can be provided to accommodate multiple different filling volumes within the container 14. The gasket 680 can be secured to the adjustable spacer 668 via a snap-fit ​​connection from a connector 682 extending from the gasket 680 received by the adjustable spacer 668, although other suitable fastening methods may be used. The central portion 684 of the fixed spacer 666 is configured to engage while the adjustable spacer 668 rotates relative to the fixed spacer 666 to prevent the fixed spacer 666 from rotating with the adjustable spacer 268. The central portion 684 of the fixed spacer 666 is accessible through an opening in the gasket 680.

[0244] An element of one disclosed aspect may be combined with one or more elements of other disclosed aspects to form different combinations, all of which are considered to be within the scope of the invention.

[0245] While this disclosure has been described as having an exemplary design, further modifications can be made to this disclosure within its spirit and scope. This application is therefore intended to cover any variations, uses, or modifications using the basic principles of this disclosure. Furthermore, this application is intended to cover such modifications from this disclosure as those known or commonly practiced in the art, as included in and falling within the scope of the appended claims.

Claims

1. A drug delivery system for injecting a drug, the drug delivery system comprising: case; A container configured to contain a pharmaceutical agent, the container including a closure and a plug configured to move within the container; A needle that is in fluid communication with a container; First plunger; A first spring configured to bias the first plunger relative to the container in the axial direction; A second plunger positioned around the first plunger; A second spring configured to bias the second plunger in the axial direction; as well as A spacer having a first end configured to engage with a plug and a second end configured to engage with a second plunger, wherein the spacer has an adjustable length between the first end and the second end. The first plunger is configured to move the spacer and the container relative to the housing in the axial direction via a first spring. The second plunger is configured to move the spacer and the plug relative to the container in the axial direction via a second spring.

2. The drug delivery system of claim 1, wherein the second plunger includes an outer plunger member and an inner plunger member, at least a portion of the inner plunger member is housed within the outer plunger member, the outer plunger member having an inwardly extending protrusion configured to engage an outwardly extending protrusion of the inner plunger member after a predetermined axial displacement of the inner plunger member relative to the outer plunger member, and wherein the outer plunger member is configured to retract a trigger needle into the housing after a predetermined axial displacement of the outer plunger member.

3. The drug delivery system of claim 1, wherein the first plunger includes a flange at the proximal end that engages the second spring.

4. The drug delivery system of claim 3, wherein the housing includes a stop, and wherein the flange of the first plunger is configured to engage the stop of the housing after the first plunger has undergone a predetermined axial displacement relative to the housing, thereby limiting the axial displacement of the first plunger.

5. The drug delivery system according to claim 1, wherein the first spring has a larger spring constant or a larger spring force than the second spring.

6. The drug delivery system of claim 1, wherein the spacer includes a buffer feature configured to dissipate energy of the second plunger during displacement of the second plunger relative to the spacer.

7. The drug delivery system according to claim 6, wherein the buffer feature includes at least one resistance rib.

8. A drive assembly for a drug delivery system, the drive assembly comprising: A plunger member configured to engage with and move a plug within a container, the plunger member having a first position and a second position axially spaced apart from the first position, the plunger member defining a coding protrusion; A biasing member configured to move the plunger assembly from a first position to a second position; as well as A plunger actuating member capable of rotating relative to a plunger member, the plunger actuating member having a first rotational position and a second rotational position, wherein in the first rotational position the plunger member is axially fixed relative to the plunger actuating member, and in the second rotational position the plunger member is axially movable relative to the plunger actuating member. The drive assembly is configured to engage a spacer assembly, the spacer assembly including a spacer and a spacer retainer, the spacer retainer being received by a plug of the container, the spacer being received by the spacer retainer, wherein the spacer is configured to correspond to an encoded protrusion of a plunger member, and wherein the spacer has a first end configured to engage with the spacer retainer and a second end configured to engage with the plunger member, wherein the spacer has an adjustable length between the first end and the second end.

9. The drive assembly of claim 8, wherein the plunger actuation member includes a body including a drive surface and an actuator locking surface, and wherein the plunger member includes a plunger locking surface, wherein the actuator locking surface engages with the plunger locking surface when the plunger actuation member is in a first rotational position.

10. The drive assembly of claim 9, wherein the plunger locking surface includes a plurality of protrusions, and wherein the actuator locking surface of the plunger actuating member defines a plurality of grooves, wherein when the plunger actuating member is in a second rotational position, the plurality of protrusions of the plunger locking surface are received within the plurality of grooves of the plunger actuating member.

11. The drive assembly of claim 10, wherein the body of the plunger actuation member includes an annular portion and a shaft portion, a drive surface is located on the annular portion, and an actuator locking surface is located on the shaft portion.

12. The drive assembly of claim 9, wherein the drive surface is configured to engage a portion of the needle actuator.

13. The drive assembly of claim 8, wherein the plunger member includes a first plunger member and a second plunger member, the second plunger member being housed within the first plunger member and the second plunger member being axially movable relative to the first plunger member.

14. The drive assembly of claim 13, wherein the biasing member engages with the second plunger member, the second plunger member being configured to engage with and move the first plunger member when the second plunger moves axially a predetermined axial distance.

15. The drive assembly of claim 8, wherein the biasing member comprises an inner spring and an outer spring, the inner spring having a different spring constant than the outer spring.

16. A drug delivery system for injecting a drug, the drug delivery system comprising: A container configured to contain a pharmaceutical agent, the container including a closure and a plug configured to move within the container; The driver component includes: A plunger member configured to move a plug within a container, the plunger member having a first position and a second position axially spaced apart from the first position, the plunger member defining a plurality of coded protrusions; A biasing member configured to move the plunger member from a first position to a second position; and A plunger actuating member capable of rotating relative to a plunger member, the plunger actuating member having a first rotational position and a second rotational position, wherein in the first rotational position the plunger member is axially fixed relative to the plunger actuating member, and in the second rotational position the plunger member is capable of axially moving relative to the plunger actuating member. A spacer assembly including a spacer and a spacer retainer, the spacer retainer being received by a plug of a container, the spacer being received by the spacer retainer, wherein the spacer is configured to correspond to one of the plurality of coded protrusions of a plunger member, wherein the spacer has a first end configured to engage with the spacer retainer and a second end configured to engage with the plunger member, wherein the spacer has an adjustable length between the first end and the second end; and A needle actuator assembly including a needle configured to be placed in fluid communication with a container, the needle being movable from a first position and a second position spaced apart from the first position. A portion of the needle actuator assembly is configured to engage a plunger actuation member to move the plunger actuation member from a first rotational position to a second rotational position.

17. A drug delivery system for injecting a drug, the drug delivery system comprising: A container configured to contain a pharmaceutical agent, the container including a closure and a plug configured to move within the container; The driver component includes: A plunger member configured to move a plug within a container, the plunger member having a first position and a second position axially spaced apart from the first position, the plunger member defining a plurality of coded protrusions; A biasing member configured to move the plunger member from a first position to a second position; and A plunger actuating member movable relative to a plunger member, the plunger actuating member having a first position and a second position, wherein in the first position the plunger actuating member is axially fixed relative to the plunger actuating member, and in the second position the plunger actuating member is movable relative to the plunger actuating member. A needle actuator assembly including a needle configured to be placed in fluid communication with a container, the needle being movable from a first position and a second position spaced apart from the first position, a portion of the needle actuator assembly being configured to engage a plunger actuator member to move the plunger actuator member from its first position to its second position. A limiting member, aligned with and configured to engage with one of the plurality of coding protrusions to limit movement of the needle actuator assembly; and A spacer assembly that engages with a stopper of a container and is configured to engage with a plunger member, wherein the spacer assembly includes a spacer and a spacer retainer, wherein the spacer has a first end configured to engage with the spacer retainer and a second end configured to engage with the plunger member, wherein the spacer has an adjustable length between the first end and the second end, and the spacer retainer is received by the stopper of the container, and the spacer is received by the spacer retainer.

18. The drug delivery system of claim 17, wherein a portion of the needle actuator assembly is configured to engage and move the limiting member, and wherein axial movement of the needle actuator assembly is limited by engagement of the limiting member with one of the plurality of coded protrusions.

19. The drug delivery system of claim 18, wherein when the plunger member is in the second position, the limiting member is disengaged from one of the plurality of coded protrusions and the needle actuator assembly is axially movable relative to the limiting member.

20. The drug delivery system of claim 17, further comprising a housing housing the container, drive assembly, and needle actuator assembly, wherein the drive assembly further comprises an encoding member rotatable relative to the housing, and wherein rotation of the encoding member causes rotation of the plurality of encoded protrusions of the plunger assembly.

21. The drug delivery system according to claim 17, wherein, The limiting member is configured to engage the rear of the container.

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