Drive assembly for a drug delivery system

Abstract

The present application relates to a drive assembly for a drug delivery system, comprising a plunger member configured to engage and move a stopper within a container, a biasing member configured to move the plunger member, and an adjustable spacer assembly positioned between the plunger member and the stopper. The spacer assembly comprises a spacer element attached to the stopper and at least one compensator, or comprises a spacer element and a holder to which the spacer element is attached. The holder can be attached to the stopper and the spacer element can be attached to the holder by a threaded engagement. Further, the present application relates to a drug delivery system for injecting a drug, comprising a container configured to receive a drug, the container comprising a stopper configured to move within the container and a closure, a drive assembly as described above, and a needle actuator assembly.

Description

[0001] This application is a divisional application of the invention patent application entitled "Spacer Assembly for Drug Delivery Device", with an international filing date of October 15, 2018, international application number PCT / US2018 / 055895, and national application number 201880077925.2.

[0002] Cross-reference of related applications

[0003] This application claims priority to U.S. Provisional Application Serial No. 62 / 572,704, filed October 16, 2017, entitled “Spacer Assembly for Drug Delivery Device,” the entire disclosure of which is incorporated herein by reference. Technical Field

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

[0005] Various types of automated infusion devices have been developed to allow drug solutions and other liquid therapeutic preparations to be administered or self-injected by untrained personnel. Typically, these devices include a reservoir pre-filled with the liquid therapeutic preparation and some type of automated needle-injection mechanism that can be triggered by the user. When the volume of the fluid or drug to be administered is typically less than a certain volume, such as 1 mL, an autoinjector is usually used, which typically has an injection time of about 10 to 15 seconds. When the volume of the fluid or drug to be administered is greater than 1 mL, the injection time typically becomes longer, making it difficult for the patient to maintain contact between the device and the target area of ​​the patient's skin. Furthermore, as the volume of the drug to be administered becomes larger, an increased injection time is desired. The conventional method for slowly injecting drugs into a patient is to initiate an IV and slowly inject the drug into the patient. This procedure is typically performed in hospital or outpatient settings.

[0006] Some devices allow for self-injection in a home setting and are capable of gradually injecting liquid therapeutic agents into a patient's skin. In some cases, these devices are small enough (in both height and overall size) to allow the patient to "wear" the device while the liquid therapeutic agent is being injected. These devices typically include a pump or other type of discharge mechanism to force the liquid therapeutic agent out of the reservoir and into the injection needle. Such devices often also include a valve or flow control mechanism to cause the liquid therapeutic agent to begin flowing at the appropriate time, and a trigger mechanism to initiate the injection. Summary of the Invention

[0007] The present invention relates to a drive assembly for a drug delivery system, comprising: a plunger member configured to engage and move a stopper within a container, the plunger member having 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 an adjustable spacer assembly positioned between the plunger member and the stopper.

[0008] In one aspect, the spacer assembly may include a spacer element attached to the plug and at least one compensation element.

[0009] In another aspect, the spacer assembly may include a spacer element and a retainer to which the spacer element is attached. The retainer may be attached to the plug and the spacer element may be attached to the retainer via a threaded engagement. The threaded engagement allows the spacer element to rotate relative to the retainer when torque is applied to it, and prevents rotation of the spacer element relative to the retainer when an axial force is applied to it. The thread on the spacer element may extend in a radially outward direction. The thread on the spacer element may be angled such that applying an axial force to the spacer element causes the thread to engage the sidewall of the retainer.

[0010] When the spacer element is in a first position relative to the retainer, the spacer assembly has a first length in the longitudinal direction, and when the spacer element is in a second position relative to the retainer, the spacer assembly has a second length in the longitudinal direction, the first length being greater than the second length.

[0011] In another aspect, the spacer assembly may further include a flexible tab extending from the spacer element and a plurality of ratchet teeth on the surface of the spacer retainer. The flexible tab engages the ratchet teeth, and the engagement of the flexible tab with the ratchet teeth allows the spacer element to rotate in a direction for screwing the spacer element into the retainer and prevents the spacer element from rotating in a direction for removing the spacer element from the retainer.

[0012] On the other hand, the spacer element is in a first position relative to the retainer, the spacer assembly has a first length in the longitudinal direction, and when the spacer element is in a second position relative to the retainer, the spacer assembly has a second length in the longitudinal direction, the first length being greater than the second length.

[0013] In another aspect, the spacer element may include a first protrusion, and the retainer may include a second protrusion. When the spacer element is in the first position relative to the retainer, the first protrusion contacts the second protrusion and the spacer assembly has the first length in the longitudinal direction, and when the spacer element is in the second position relative to the retainer, the first protrusion does not contact the second protrusion and the spacer assembly has the second length in the longitudinal direction.

[0014] In another embodiment, the spacer element may include an annular sidewall, and the retainer may include a sidewall and a central post. The outer surface of the annular sidewall of the spacer element may be threadedly engaged with the inner surface of the sidewall of the retainer, and the inner surface of the sidewall of the spacer may be threadedly engaged with the outer surface of the central post. When the central post is in a first position, movement of the spacer element relative to the retainer is prevented, and when the central post extends axially to a second position, the spacer element is free to rotate relative to the retainer.

[0015] On the other hand, the spacer assembly may also include a locking pin, and the spacer element may also include a recess for receiving the locking pin.

[0016] In another aspect, the spacer assembly may further include an expandable container positioned within the spacer element and the retainer, between the upper proximal portion of the spacer element and the lower bottom portion of the retainer. Expansion or contraction of the expandable container can cause movement of the spacer element relative to the retainer.

[0017] In another aspect, the spacer assembly may include a spacer element fixed to the plug and a plunger extension movably fixed to the plunger member. The plunger extension may be threadedly engaged with the plunger member.

[0018] The present invention also relates to a drug delivery system for injecting drugs, the system comprising: a container configured to receive a drug, the container including a plug and a closure configured to move within the container; a drive assembly as described above; and a needle actuator assembly including a needle configured to be in fluid communication with the container. Attached Figure Description

[0019] The above and other features and advantages of this disclosure, as well as the ways in which they are implemented, will become more apparent and the disclosure itself will be better understood by referring to the following description of embodiments of this disclosure taken in conjunction with the accompanying drawings, wherein:

[0020] Figure 1This is a perspective view of a drug delivery system according to one aspect of the present invention.

[0021] Figure 2 According to one aspect of the invention Figure 1 A perspective cross-sectional view of a drug delivery system.

[0022] Figure 3 According to one aspect of the invention Figure 1 A front sectional view of a drug delivery system.

[0023] Figure 4 According to one aspect of the invention Figure 1 A top view of the drug delivery system, showing the top portion of the housing removed and the drug delivery system in its pre-use position.

[0024] Figure 5 According to one aspect of the invention Figure 1 The top sectional view of the drug delivery system shows the drug delivery system in its pre-use position.

[0025] Figure 6 According to one aspect of the invention Figure 1 A front sectional view of a drug delivery system, showing the drug delivery system in its pre-use position.

[0026] Figure 7 According to one aspect of the invention Figure 1 A top view of the drug delivery system, showing the top portion of the housing removed and the drug delivery system in the initial actuation position.

[0027] Figure 8 According to one aspect of the invention Figure 1 The top sectional view of the drug delivery system shows the drug delivery system in the initial actuation position.

[0028] Figure 9 According to one aspect of the invention Figure 1 A front sectional view of a drug delivery system, showing the drug delivery system in the initial actuation position.

[0029] Figure 10 According to one aspect of the invention Figure 1 A top view of the drug delivery system, showing the top portion of the housing removed and the drug delivery system in the use position.

[0030] Figure 11 According to one aspect of the invention Figure 1 The top sectional view of the drug delivery system shows the drug delivery system in its use position.

[0031] Figure 12According to one aspect of the invention Figure 1 A front sectional view of a drug delivery system, showing the drug delivery system in its use position.

[0032] Figure 13 According to one aspect of the invention Figure 1 A top view of the drug delivery system, showing the top portion of the housing removed and the drug delivery system in its post-use position.

[0033] Figure 14 According to one aspect of the invention Figure 1 The top sectional view of the drug delivery system shows the drug delivery system in its post-use position.

[0034] Figure 15A According to one aspect of the invention Figure 1 A front sectional view of a drug delivery system, showing the drug delivery system in its post-use position.

[0035] Figure 15B According to one aspect of the invention Figure 1 A front sectional view of a drug delivery system, showing the liner and the drug delivery system in its pre-use position.

[0036] Figure 15C According to one aspect of the invention Figure 1 A perspective cross-sectional view of a drug delivery system, showing the liner and the drug delivery system in its pre-use position.

[0037] Figure 15D According to one aspect of the invention Figure 1 A perspective cross-sectional view of a drug delivery system, showing the liner and the drug delivery system in its pre-use position.

[0038] Figure 16 According to one aspect of the invention Figure 1 A partial cross-sectional view of a drug delivery system, showing the valve assembly.

[0039] Figure 17 This is a perspective view of a drive assembly for a drug delivery system according to one aspect of the present invention.

[0040] Figure 18 According to one aspect of the invention Figure 17 A cross-sectional view of the drive component, showing the drive component in its pre-use position.

[0041] Figure 19 According to one aspect of the invention Figure 17 A cross-sectional view of the driver component, showing where the driver component is used.

[0042] Figure 20According to one aspect of the invention Figure 17 A cross-sectional view of the driver component, showing the position of the driver component after use.

[0043] Figure 21 According to one aspect of the invention Figure 17 A perspective view of the plunger actuation component of the drive assembly.

[0044] Figure 22 According to one aspect of the invention Figure 17 A perspective view of the first plunger component of the drive assembly.

[0045] Figure 23 According to one aspect of the 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.

[0046] Figure 24 According to one aspect of the 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.

[0047] Figure 25 According to one aspect of the 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 axially displaced relative to the first plunger member.

[0048] Figure 26 According to one aspect of the invention Figure 17 Front view of the first and second plunger components of the drive assembly.

[0049] Figure 27 This is a top view of a drive component for a drug delivery system according to another aspect of the present invention.

[0050] Figure 28 According to one aspect of the invention Figure 27 A perspective view of the driving component.

[0051] Figure 29 According to one aspect of the invention Figure 27 A cross-sectional view of the drive component, showing the drive component in its pre-use position.

[0052] Figure 30 According to one aspect of the invention Figure 27 A perspective view of the drive assembly, showing the drive assembly received by the bottom portion of the housing.

[0053] Figure 31 According to one aspect of the invention Figure 30 A perspective view of the casing.

[0054] Figure 32 According to one aspect of the invention Figure 27 A perspective view of the drive assembly, showing the engagement of the drive assembly with a portion of the needle actuator in the initial actuated position of the drive assembly.

[0055] Figure 33 According to one aspect of the invention Figure 27 An enlarged perspective view of the drive assembly, showing the engagement of the drive assembly with a portion of the needle actuator in the initial actuated position of the drive assembly.

[0056] Figure 34 This is a front view of a needle actuator assembly according to one aspect of the present invention.

[0057] Figure 35 According to one aspect of the invention Figure 34 Left perspective view of the needle shuttle of the needle actuator assembly.

[0058] Figure 36 According to one aspect of the invention Figure 34 The right perspective view of the needle shuttle of the needle actuator assembly.

[0059] Figure 37A According to one aspect of the invention Figure 34 A front view of the needle actuator assembly, showing the needle actuator assembly in its pre-use position.

[0060] Figure 37B According to one aspect of the invention Figure 34 A front view of the needle actuator assembly, showing the needle actuator assembly in the use position.

[0061] Figure 37C According to one aspect of the invention Figure 34 A front view of the needle actuator assembly, showing the needle actuator assembly in its initial use position.

[0062] Figure 37D According to one aspect of the invention Figure 34 A front view of the needle actuator assembly, showing the needle actuator assembly in the used position.

[0063] Figure 38A According to one aspect of the invention Figure 34 A perspective view of the needle actuator assembly, showing the needle actuator assembly in the use position.

[0064] Figure 38B According to one aspect of the invention Figure 34A perspective view of the needle actuator assembly, showing the needle actuator assembly in its initial use position.

[0065] Figure 39 An actuator button according to one aspect of the present invention and Figure 34 A perspective view of the needle actuator assembly, showing the needle actuator assembly in its initial use position.

[0066] Figure 40A An actuator button according to one aspect of the present invention and Figure 34 A cross-sectional view of the needle actuator assembly, showing the needle actuator assembly in its initial use position.

[0067] Figure 40B An actuator button according to one aspect of the present invention and Figure 34 A perspective view of the needle actuator assembly, showing the needle actuator assembly in the used position.

[0068] Figure 41 This is a perspective view of a drive component for a drug delivery system according to another aspect of the present invention.

[0069] Figure 42 According to one aspect of the invention Figure 41 A perspective view of the drive assembly, showing the top portion of the housing removed.

[0070] Figure 43 According to one aspect of the invention Figure 41 A cross-sectional view of the driving component.

[0071] Figure 44 According to one aspect of the invention Figure 41 A perspective view of the driving component.

[0072] Figure 45 According to one aspect of the invention Figure 41 A cross-sectional view of the drive component, showing the drive component in its pre-use position.

[0073] Figure 46 According to one aspect of the invention Figure 41 A cross-sectional view of the drive component, showing the drive component in its pre-use position.

[0074] Figure 47 According to one aspect of the invention Figure 41 A top view of the drive component, showing the drive component in its pre-use position.

[0075] Figure 48 According to one aspect of the invention Figure 41 A top view of the drive component, showing the drive component in its initial actuated position.

[0076] Figure 49 According to one aspect of the invention Figure 41 A top view of the drive component, showing the drive component in its initial actuated position.

[0077] Figure 50 According to one aspect of the invention Figure 41 A top view of the drive component, showing the drive component in its initial actuated position.

[0078] Figure 51 According to one aspect of the invention Figure 41 A top view of the driver component, showing the driver component in its usage position.

[0079] Figure 52 According to one aspect of the invention Figure 41 A top view of the driver component, showing the driver component in its usage position.

[0080] Figure 53 According to one aspect of the invention Figure 41 A cross-sectional view of the drive component, showing the drive component in its usage position.

[0081] Figure 54 According to one aspect of the invention Figure 41 A top view of the driver component, showing the driver component in its usage position.

[0082] Figure 55 According to one aspect of the invention Figure 41 A cross-sectional view of the drive component, showing the drive component in its usage position.

[0083] Figure 56 According to one aspect of the invention Figure 41 A cross-sectional view of the drive component, showing the drive component in its usage position.

[0084] Figure 57 According to one aspect of the invention Figure 41 A top view of the driver component, showing the driver component in its usage position.

[0085] Figure 58 According to one aspect of the invention Figure 41 A top view of the drive component, showing the drive component in its initial use position.

[0086] Figure 59 According to one aspect of the invention Figure 41 A perspective view of the driver component, showing the driver component in its initial use position.

[0087] Figure 60According to one aspect of the invention Figure 41 A top view of the drive component, showing the drive component in its post-use position.

[0088] Figure 61 According to one aspect of the invention Figure 41 A top view of the drive component, showing the drive component in its post-use position.

[0089] Figure 62 According to one aspect of the invention Figure 41 A cross-sectional view of the drive component, showing the drive component in its pre-use position.

[0090] Figure 63 According to one aspect of the invention Figure 41 A cross-sectional view of the drive component, showing the drive component in its usage position.

[0091] Figure 64 This is a perspective view of a drive component according to another aspect of the present invention.

[0092] 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.

[0093] Figure 65B According to one aspect of the invention Figure 65A A front view of the needle actuator assembly, showing the needle actuator assembly in the use position.

[0094] Figure 65C According to one aspect of the invention Figure 65A A front view of the needle actuator assembly, showing the needle actuator assembly in its initial use position.

[0095] Figure 65D According to one aspect of the invention Figure 65A A front view of the needle actuator assembly, showing the needle actuator assembly in the used position.

[0096] Figure 65E According to one aspect of the invention Figure 65A A front view of the needle actuator assembly, showing the needle actuator assembly in its pre-use position.

[0097] Figure 65F According to one aspect of the invention Figure 65A A cross-sectional view of the needle actuator assembly, showing the needle actuator assembly in its pre-use position.

[0098] Figure 65G According to one aspect of the invention Figure 65AA front view of the needle actuator assembly, showing the needle actuator assembly in the pre-use position, with the button actuator axially displaced.

[0099] Figure 65H According to one aspect of the invention Figure 65A A cross-sectional view of the needle actuator assembly, showing the needle actuator assembly in its pre-use position, with the button actuator axially displaced.

[0100] Figure 66 According to one aspect of the invention Figure 65A A perspective view of the button spring of the needle actuator assembly.

[0101] Figure 67 According to one aspect of the invention Figure 65A A perspective view of the actuator button of the needle actuator assembly.

[0102] Figure 68A According to one aspect of the invention Figure 65A A cross-sectional view of the button spring and actuator button of the needle actuator assembly.

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

[0104] Figure 68C According to another aspect of the invention Figure 65A Bottom view of the actuator button of the needle actuator assembly.

[0105] Figure 68D According to another aspect of the invention Figure 65A Front view of the actuator button of the needle actuator assembly.

[0106] Figure 68E 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.

[0107] Figure 68F According to another aspect of the invention Figure 65A The front view of the actuator button of the needle actuator assembly shows the actuator button in the pre-use position.

[0108] Figure 68G 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.

[0109] Figure 68H According to another aspect of the invention Figure 65AThe front view of the actuator button of the needle actuator assembly shows the actuator button in the use position.

[0110] Figure 69 According to one aspect of the invention Figure 65A A top view of the actuator button of the needle actuator assembly.

[0111] Figure 70 This is a perspective view of a limiting member according to one aspect of the present invention.

[0112] Figure 71 This is a front view of a spacer assembly for a drug delivery system according to another aspect of the invention.

[0113] Figure 72 This is a perspective view of a drive assembly for a drug delivery system according to one aspect of the present invention.

[0114] Figure 73 According to one aspect of the invention Figure 72 A perspective view of the drive assembly, showing the top portion of the housing removed.

[0115] Figure 74 According to one aspect of the invention Figure 72 A cross-sectional view of the drive component, showing the drive component in its pre-use position.

[0116] Figure 75 According to one aspect of the invention Figure 72 An enlarged cross-sectional view of the drive component, showing the drive component in its pre-use position.

[0117] Figure 76 According to one aspect of the invention Figure 72 A top view of the bias component of the driving component.

[0118] Figure 77 According to one aspect of the invention Figure 72 A perspective view of the drive assembly, showing the limiting member that engages with the drive assembly.

[0119] Figure 78 This is a perspective view of a drive assembly for a drug delivery system according to one aspect of the present invention.

[0120] Figure 79 According to one aspect of the invention Figure 78 A perspective view of the driver component, showing the driver component in its pre-use position.

[0121] Figure 80 According to one aspect of the invention Figure 78 A cross-sectional view of the driving component.

[0122] Figure 81According to one aspect of the invention Figure 78 A perspective view of the driver component, showing the position of the driver component after use.

[0123] Figure 82 According to one aspect of the invention Figure 78 A cross-sectional view of the drive component, showing the drive component in its pre-use position.

[0124] Figure 83 According to one aspect of the invention Figure 78 The front view of the driver component shows where the driver component is used.

[0125] Figure 84A This is a schematic diagram of a drive assembly according to one aspect of the present invention, showing the drive assembly in a pre-use position.

[0126] Figure 84B According to one aspect of the invention Figure 84A A schematic diagram of the driver component, showing the driver component in the usage position.

[0127] Figure 84C According to one aspect of the invention Figure 84A A schematic diagram of the driver component, showing the driver component in the usage position.

[0128] Figure 84D According to one aspect of the invention Figure 84A A schematic diagram of the driver component, showing the driver component in the usage position.

[0129] Figure 84E According to one aspect of the invention Figure 84A A schematic diagram of the driver component, showing the driver component in the usage position.

[0130] Figure 84F According to one aspect of the invention Figure 84A A schematic diagram of the drive component, showing the drive component in its post-use position.

[0131] Figure 84G According to one aspect of the invention Figure 84A A schematic diagram of the drive component, showing the drive component in its post-use position.

[0132] Figure 85 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 after assembly.

[0133] Figure 86 According to one aspect of the invention Figure 85 A perspective view of the spacer assembly, showing where the spacer assembly is used.

[0134] Figure 87 According to one aspect of the invention Figure 85 A perspective view of the spacer assembly, showing the spacer assembly in its initial, used position.

[0135] Figure 88 This is a top view of a spacer assembly for a drug delivery system according to one aspect of the present invention.

[0136] Figure 89 According to one aspect of the invention Figure 88 A perspective view of the spacer component.

[0137] Figure 90 According to one aspect of the invention Figure 88 A cross-sectional view of the spacer component.

[0138] Figure 91 This is a perspective view of a spacer assembly for a drug delivery system according to another aspect of the invention.

[0139] Figure 92 This is a perspective view of a spacer assembly for a drug delivery system according to another aspect of the invention.

[0140] Figure 93A According to one aspect of the invention Figure 92 A cross-sectional view of the spacer assembly, showing the spacer assembly in its pre-assembly position.

[0141] Figure 93B According to one aspect of the invention Figure 92 A cross-sectional view of the spacer assembly, showing the assembled position of the spacer assembly.

[0142] Figure 94 This is a perspective view of a spacer assembly for a drug delivery system according to one aspect of the present invention.

[0143] Figure 95 According to one aspect of the invention Figure 94 The front view of the spacer component.

[0144] Figure 96 According to one aspect of the invention Figure 94 A cross-sectional view of the spacer component.

[0145] Figure 97 According to one aspect of the invention Figure 94 A perspective view of the spacer assembly, showing that the compensation element has been removed.

[0146] Figure 98 According to one aspect of the invention Figure 94 A perspective view of the fixed spacer of the spacer assembly.

[0147] Figure 99 According to one aspect of the invention Figure 94 A perspective view of the adjustable spacer of the spacer assembly.

[0148] Figure 100 According to one aspect of the invention Figure 94 A perspective view of the compensation component of the spacer assembly.

[0149] Figure 101 This is a cross-sectional view of a spacer assembly having a single compensation element according to one aspect of the present invention.

[0150] Figure 102 According to one aspect of the invention, it has multiple compensation elements. Figure 101 A cross-sectional view of the spacer component.

[0151] Figure 103 According to one aspect of the invention and Figure 101 A cross-sectional view of a set of compensating members used together with spacer components.

[0152] Figure 104 This is a cross-sectional view of a spacer assembly according to one aspect of the present invention.

[0153] Figure 105 This is a cross-sectional view of a spacer assembly according to one aspect of the present invention.

[0154] Figure 106 This is a cross-sectional view of a spacer assembly according to one aspect of the present invention.

[0155] Figure 107 This is a cross-sectional view of a spacer assembly according to one aspect of the present invention.

[0156] Figure 108 This is a cross-sectional view of a spacer assembly according to one aspect of the present invention.

[0157] Figure 109 This is a cross-sectional view of the spacer assembly shown in a first position according to one aspect of the invention.

[0158] Figure 110 It is shown in the second position according to one aspect of the invention. Figure 109 A cross-sectional view of the spacer component.

[0159] Figure 111 This is a cross-sectional view of a spacer assembly according to one aspect of the present invention.

[0160] Figure 112 According to one aspect of the invention Figure 111 An enlarged sectional view of the indicator portion of the spacer assembly.

[0161] Figure 113 This is a cross-sectional view of the spacer assembly shown in a first position according to one aspect of the invention.

[0162] Figure 114 It is shown in the second position according to one aspect of the invention. Figure 113 A cross-sectional view of the spacer component.

[0163] Figure 115A According to one aspect of the invention Figure 113 A cross-sectional view of the first step in the assembly of the spacer assembly.

[0164] Figure 115B According to one aspect of the invention Figure 113 A cross-sectional view of the second step in the assembly of the spacer component.

[0165] Figure 115C According to one aspect of the invention Figure 113 A cross-sectional view of the first step in the assembly of the spacer assembly.

[0166] Figure 116 This is a cross-sectional view of the spacer assembly before the insertion of the locking pin, according to one aspect of the invention.

[0167] Figure 117 According to one aspect of the invention, after the locking pin is inserted... Figure 116 A cross-sectional view of the spacer component.

[0168] Figure 118 This is a cross-sectional view of a spacer assembly according to one aspect of the present invention.

[0169] Figure 119 This is a cross-sectional view of an adjustable plunger assembly according to one aspect of the present invention.

[0170] The examples presented herein illustrate exemplary aspects of this disclosure, and such examples should not be construed as limiting the scope of this disclosure in any way. Detailed Implementation

[0171] The following description is provided to enable those skilled in the art to make and use the embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will remain apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the invention.

[0172] For the purposes described below, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives should be understood in relation to the orientation of the invention in the accompanying drawings. However, it should be understood that various alternative variations of the invention may be taken unless explicitly stated otherwise. It should also be understood that the specific devices shown in the drawings and described in the following description are merely exemplary embodiments of the invention. Therefore, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0173] refer to Figures 1 to 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 portion 22 and a bottom portion 24, but other suitable arrangements for the housing 20 may be utilized. In one aspect, the drug delivery system 10 is a syringe device configured to be worn or secured to a user and to deliver a predetermined dose of drug disposed within the container 14 by injection into the user's body. The system 10 can be used to deliver "bolus injections," in which drug is delivered over a set time period. Drug can be delivered over a time period of up to 45 minutes, but other suitable injection volumes and durations may be utilized. Bolus administration or delivery may be performed with rate control or without specific rate control. The system 10 can deliver drug to the user at a fixed pressure, wherein the rate is variable. Reference is made below. Figures 1 to 16 The general operation of System 10 is described below, in conjunction with... Figures 17 to 9 3. Details of the drive assembly 12, the needle actuator assembly 18, and other features of the system 10 are discussed.

[0174] Refer again Figures 1 to 16System 10 is configured to operate by the user engaging an actuation button 26, which causes the needle 28 of the needle assembly 18 to pierce the user's skin; actuating the drive assembly 12 to make the needle 28 fluidly communicate with the container 14 and expel fluid or medication from the container 14; and retracting the needle 28 after the medication injection is completed. The general operation of a drug delivery system is shown and described in International Publications 2013 / 155153 and 2014 / 179774, the entire contents of which are incorporated herein by reference. The housing 20 of system 10 includes an indicator window 30 for viewing an indicator arrangement 32 configured to provide the user with indications of the status of system 10, and a container window 31 for viewing the container 14. The indicator window 30 may be a magnifying glass for providing a clear view of the indicator arrangement 32. The indicator arrangement 32 moves with the needle actuator assembly 18 during use of system 10 to indicate the pre-use, used, and post-use status of system 10. The indicator arrangement 32 provides visual markings about the status, but may provide other suitable markings, such as auditory or tactile, as alternative or additional markings.

[0175] refer to Figures 4 to 6 During the pre-use position of system 10, container 14 is spaced apart from drive assembly 12 and valve assembly 16, and needle 28 is in the retracted position. During the initial actuation of system 10, as... Figures 7 to 9 As shown, the actuation assembly 12 engages the container 14 to move the container 14 toward the valve assembly 16, which is configured to pierce the closure 36 of the container 14 and fluidly communicate the medication within the container 14 with the needle 28 via a tube (not shown) or other suitable arrangement. The actuation assembly 12 is configured to engage the plug 34 of the container 14, which, due to the incompressibility of the fluid or medication within the container 14, will initially move the entire container 14 to engage with the valve assembly 16. Initial actuation of the system 10 is caused by the user engaging the actuation button 26, which releases the needle actuator assembly 18 and the actuation assembly 12, as discussed in more detail below. During initial actuation, the needle 28 is still in the retracted position and is about to move to the extended position to inject the user of the system 10.

[0176] In the usage location of system 10, such as Figures 10 to 12 As shown, the needle 28 is in an extended position, at least partially outside the housing 20, where the actuation assembly 12 moves the stopper 34 within the container 14 to deliver medication from the container 14 to the user via the needle 28. In the use position, the valve assembly 16 has pierced the closure 36 of the container 14 to establish fluid communication between the container 14 and the needle 28, which also allows the actuation assembly 12 to move the stopper 34 relative to the container 14, enabling the dispensing of fluid from the container 14. In the post-use position of the system 10, as... Figures 13 to 1As shown in Figure 5, the needle 28 is in the retracted position and engages with the gasket 38 to seal the needle 28 and prevent any residual flow of fluid or drug from the container 14. The container 14 and valve assembly 16 may be those shown and described in International Publication No. WO 2015 / 081337, the entire contents of which are incorporated herein by reference.

[0177] refer to Figures 15A to 15C When the needle actuator body 96 moves from the use position to the post-use position, the pad 38 is biased into the needle 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 portion 24 of the housing 20. The pad arm 122 is connected to the needle actuator body 96 via a torsion bar 128. The cam surface 124 is configured to engage the cam track 126 to deflect the pad arm 122 downward, thereby allowing the pad 38 to pass under the needle 28 before being biased upward into it. The torsion bar 128 allows the pad arm 122 to twist about a pivot of the needle actuator body 96. The pad 38 can be press-fitted into the opening of the pad arm 122, but other suitable arrangements for securing the pad 38 can be utilized.

[0178] refer to Figures 1 to 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 also to move the stopper 34 within the container 14 to dispense fluid or medication from the container 14.

[0179] For manufacturing purposes, it is generally desirable to use a single size of the drug container 14, even if multiple filling volumes or doses are envisioned for use with the container 14. In this case, different filling volumes result in different positions of the stopper 34 when the drug container is filled. To accommodate such different positions of the stopper 34 and to accommodate manufacturing variations of the stopper 34, aspects of the present invention include custom or tailored spacers or spacer assemblies 40 disposed in the proximal end of the container 14 near the stopper 34. Custom spacers or spacer assemblies 40 are selected from a plurality of spacers or spacer assemblies 40 of different sizes to occupy the space from the proximal end of the stopper 34 to the proximal end of the container 14. In other words, custom spacers or spacer assemblies 40 provide the option to allocate a range of manufacturer-defined filling volumes by selecting different spacers or spacer assemblies 40 and to reduce or eliminate the need for assembly configuration operations. The size of the custom spacers or spacer assemblies 40 can be used to address underfilled volumes of the container 14 and to provide a consistent support surface at the proximal end of the container 14.

[0180] Figures 17 to 33The illustrated drive assembly 12 is configured to engage and cooperate with a spacer assembly 40 received by the stopper 34 of the container 14. The spacer assembly 40 includes a spacer 42 and a spacer retainer 44. The spacer retainer 44 is received by the stopper 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 stopper 34, but other suitable arrangements 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 to secure the spacer 42 to the spacer retainer 44, but other suitable arrangements may be used. The drive assembly 12 is configured to dispense a predetermined filling volume of the container 14 within a certain range while maintaining the functional characteristics of the system 10 described above, including but not limited to retracting the needle 28 after the dose is dispensed and providing an indication of the status of the system 10, while also minimizing abrupt engagement of the drive assembly 12 with the stopper 34. As discussed above, the drive assembly 12 is configured to distribute multiple discrete fill volume ranges by utilizing various sizes of the spacers 42. In one aspect, twelve fill volume ranges and twelve spacer 42 sizes are provided.

[0181] refer to Figures 17 to 26 The drive assembly 12 includes a first plunger member 52, a second plunger member 54 received by the first plunger member 52, a first biasing member 56, a second biasing member 58, a plunger actuation member 60, and an indexing member 62. The first plunger member 52 is available from a pre-use position ( Figure 18 (As shown) Move to the usage position ( Figure 19 (as shown), to the post-use location ( Figure 20 As shown, the first plunger member 52 is configured to engage the spacer assembly 40 and move the stopper 34 within the container 14 to dispense medication from the container 14. The first plunger member 52 is configured to move axially. The second plunger member 54 forms a telescopic arrangement with the first plunger member 52, wherein the second plunger 54 is configured to move axially after the first plunger member 52 has moved a predetermined axial distance. The movement of the first plunger member 52 and the second plunger member 54 is provided by a first biasing member 56 and a second biasing member 58, which act as compression springs, but other suitable arrangements for the biasing members 56 and 58 may be used.

[0182] The first biasing member 56 is received by the second plunger member 54 and constrained between the plunger actuation member 60 (and 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 to a post-use position. The first biasing member 56 is configured to bias the second plunger member 54 toward the container 14, and the second plunger member, in turn, biases the first plunger member 52 toward the container 14 from a pre-use position to a use position and to a post-use position. More specifically, the second biasing member 58 is configured to drive the first plunger member 52 against the spacer assembly 40 or the stopper 34 to move the container 14 into engagement with the valve assembly 16, thereby piercing the closure 36 of the container 14 and establishing fluid communication between the container 14 and the needle 28. The first biasing member 56 is configured to move the stopper 34 within the container 14 to dispense medication within the container 14. The second biasing member 58 has a different spring constant than the first biasing member 56. Specifically, the second biasing member 58 is more rigid than the first biasing member 56 to provide a higher force to pierce the closure 36 of the container 14, while the first biasing member 56 provides a lower force to dispense medication as appropriate for the viscosity of the fluid or medication within the container 14.

[0183] Refer again Figures 17 to 26 The plunger actuation member 60 has an annular portion 68 and a spindle portion 70. The plunger actuation member 60 is rotatably movable relative to the first plunger member 52 between a first rotational position and a second rotational position spaced apart from the first rotational position. The first rotational position may be 15 degrees from the second rotational position, but other suitable positions may be utilized. The annular portion 68 includes a drive surface 72 comprising a plurality of teeth 74, but other suitable arrangements may be used for the drive surface 72. The spindle portion 70 includes an actuator locking surface 76 configured to engage and release from a plunger locking surface 78 of the first plunger member 52. The plunger locking surface 78 includes a plurality of protrusions 80 configured to be received by a plurality of slots or cutouts 81 defined by the actuator locking surface 76.

[0184] like Figure 18 and Figure 23As shown, in the first rotational position of the plunger actuating member 60, the plurality of protrusions 80 and the plurality of slots or cutouts 81 are misaligned, such that the plunger actuating member 80 engages with the first plunger member 52 to prevent movement of the first plunger member 52 and the second plunger member 54, wherein the first biasing member 56 and the second biasing member 58 bias the first plunger member 52 and the second plunger member 54 away from the plunger actuating member 60. Figure 19 and Figure 24 As shown, in the second rotational position of the plunger actuating member 60, the plurality of protrusions 80 and the plurality of slots or cuts 81 are aligned with each other so that the plunger actuating member 60 is separated from the first plunger member 52, allowing the first plunger member 52 and the second plunger member 54 to move, thereby initiating the dispensing process from the container 14.

[0185] refer to Figure 7 and Figure 33 The drive surface 72 of the plunger actuation member 60 is configured to engage with a portion of the needle actuator assembly 18. After engagement of the actuator button 26 and release of the needle actuator assembly 18 (discussed in more detail below), the needle actuator assembly 18 moves within the housing 20 from a pre-use position to a use position and then to a post-use position. During the initial movement of the needle actuator assembly 18, a portion of the needle actuator assembly 18 engages the drive surface 72 of the plunger actuation member 60 to move the plunger actuation member 60 from a first rotational position to a second rotational position. Figure 33 As shown, the angled blade portion 82 of the needle actuator assembly 18 engages the drive surface 72 of the plunger actuator member 60 to cause rotation of the plunger actuator member 60.

[0186] refer to Figure 11 , Figure 13 and Figure 26The second plunger member 52 includes a plurality of coded protrusions 84, wherein a pre-selected one of the plurality of coded protrusions 84 is configured to engage a restraining member 86 of the system 10. As discussed in more detail below, the restraining member 86 engages with the needle actuator assembly 18 and restricts the movement of the needle actuator assembly 18 from the use position to the post-use position until a predetermined dose-end position is reached on the stopper 34. 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 between the restraining member 86 and a portion thereof. When the stopper 34 reaches the dose-end position, this engagement between the restraining member 86 and the needle actuator assembly 18 is released by rotation of the restraining member 86. During the use position of the needle actuator assembly 18, the restraining member 86 is biased in the direction of rotation, 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, but other suitable arrangements may be utilized. Each coded protrusion 84 defines a point at which the limiting member 86 can rotate to release the needle actuator assembly 18. The smooth portion of the second plunger member 52 may also provide additional "coding" for determining when the system 10 transitions to the dose termination position.

[0187] As discussed above, when system 10 moves from before use, during use and after use, or at the end of the dose position, the indicator arrangement 32 moves, wherein different portions of the indicator arrangement 32 are visible through the indicator window 30. More specifically, the indicator arrangement 32 engages a portion of the limiting member 86 and moves together with the limiting member 86 through the various stages of system 10 to provide the user with indications about the status of system 10.

[0188] During the assembly of system 10, the dose of container 14 is matched with a specific spacer 42 of a predetermined length, and a corresponding one of the plurality of coded protrusions 84 is aligned with the restraining member 86. Thus, as discussed above, container 14 can be provided with multiple dose volumes, each corresponding to a specific spacer 42 and a coded protrusion 84. Therefore, even with different dose volumes, system 10 is configured to inject needle 28 into the user to deliver a dose of medication from container 14, retract needle 28 after the dose is completed, and provide an indication of the status of system 10, while minimizing abrupt engagement of the drive assembly 12 with the stopper 34. Specifically, the size of the stopper 34 can be selected to minimize the distance between the first plunger member 52 and the spacer assembly 40, and damping is not required.

[0189] refer to Figures 27 to 33 The diagram shows a drive component 12A according to another aspect of the present invention. Figures 27 to 33 The drive component 12A shown is Figures 17 to 26 The drive component 12 shown and described above is similar to and operates in the same manner. However, in Figures 27 to 33 In the drive assembly, a first plunger member 52 is received by a second plunger member 54 and extends from the second plunger member 54 during axial movement from a pre-use position to a use position. Furthermore, the first plunger member 52 includes an extension 88 configured to engage the second plunger member 54 after the first plunger member 52 has moved a predetermined axial distance, such that the first plunger member 52 and the second plunger member 54 move together. A first biasing member 56 and a second biasing member 58 are used to... Figures 17 to 26 The drive assembly 12 engages and acts on the first plunger member 52 and the second plunger member 54 in the same manner.

[0190] refer to Figures 27 to 32 The indexing member 62 is positioned around the first plunger member 52 and the second plunger member 54, and includes a plurality of ratchet teeth 90 configured to engage a flexible tab 92 positioned on the bottom portion 24 of the housing 20. When the drive assemblies 12, 12A are mounted into the bottom portion 24 of the housing 20, the engagement of the ratchet teeth 90 of the indexing member 62 with the flexible tab 92 of the housing 20 provides unidirectional rotation of the indexing member 62. The indexing member 62 is configured to rotate based on the dose volume and spacer 42 dimensions discussed above to align one of the coding protrusions 84 of the second plunger member 52 with the restraining member 86. The indexing member 62 can provide 24 rotational positions for the drive assemblies 12, 12A, 12 of which can have a unique dose value associated with them.

[0191] refer to Figures 1 to 16 and Figures 34 to 40B This illustrates 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 discussed above, the needle actuator body 96 can be positioned within a housing 20 from its pre-use position (…). Figures 4 to 6 As shown), initial actuation position ( Figures 7 to 9 ), Location of use ( Figures 10 to 12 ) and post-use location ( Figures 13 to 15) Movement. The needle actuator body 96 is biased from the pre-use position to the post-use position via the extension spring 106, but other suitable biasing arrangements can be used. When the actuator button 26 is engaged, the needle actuator body 96 is released and freely moves from the pre-use position to the use position, which is discussed in more detail below. After the restraining member 86 rotates, the needle actuator body 96 moves from the use position to the post-use position, as described above. Figures 17 to 33 The discussion.

[0192] refer to Figures 34 to 40B The needle shuttle 102 is movable along a vertical axis between a retracted position where the needle 28 is positioned within the housing 20 and an extended position where at least a portion of the needle 28 extends out of the housing 20. The needle shuttle 102 is configured to move between the retracted and extended positions via engagement between a guide surface 98 of the needle actuator 96 and a cam surface 104 of the needle shuttle 102. The cam surface 104 is provided by a first cam member 108 and a second cam member 110, wherein the first cam member 108 is spaced apart from the second cam member 110. The housing 20 includes a guide rod 112 with a recess configured to receive a T-shaped protrusion 114 on the needle shuttle 102; however, other shapes and configurations may be used for the guide rod 112 and the T-shaped protrusion 114. The needle shuttle 102 moves along the guide rod 112 between the retracted and extended positions. The guide rod 112 is linear and extends approximately perpendicularly from the housing 20; however, other suitable arrangements may be utilized. 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.

[0193] 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 the housing 20 or the actuator button 26. Specifically, the shuttle biasing member 120 engages the housing 20 or the actuator button 26 and provides a biasing force as the needle actuator body 96 transitions from the use position to the post-use position. When the needle actuator body 96 has fully transitioned to the post-use position, the cam members 108, 110 of the needle shuttle 102 disengage from the guide surface 98 of the needle actuator body 96, and the shuttle biasing member 120 biases the needle shuttle 102 downward so that the needle 28 engages the pad 38, as discussed above. However, as described above... Figures 1 to 16 As discussed, the pad 38 may also be biased into the needle 28, rather than biasing the needle shuttle 102 downward via the shuttle bias member 120. The needle actuator body 96 may interact with the actuator button 26 to prevent the actuator button 26 from bouncing back until it reaches the post-use position, which is discussed in more detail below.

[0194] refer to Figures 37A to 40B Before use (position) 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. As the needle actuator body 96 moves to the operating position... Figure 37B and Figure 38A The second cam member 110 of the needle shuttle 102 engages the second side 118 of the guide surface 98 to move the needle shuttle 102 from the retracted position to the extended position. During the transition from the use position to the post-use position of the needle actuator body 96 ( Figure 37C The first cam member 108 of the needle shuttle 102 engages with the first side 116 of the guide surface 98 to move the needle shuttle 102 from the second position to the first position. After the needle actuator body 96 has fully transitioned to the post-use position ( Figure 37D and Figure 38B When the cam components 108 and 110 disengage from the guide surface 98 of the needle actuator body 96, the shuttle biasing component 120 biases the needle shuttle 102 downward, wherein the needle 28 engages the pad 38. The transition between the needle actuator body 96 and the corresponding position of the needle shuttle 102 is also... Figures 39 to 40B As shown in the image. Combined with... Figures 65A to 67 The interaction between actuator button 26 and needle actuator body 96 is discussed in detail. (Reference) Figures 41 to 64 This diagram illustrates a drug delivery system 200 according to another embodiment. System 200 includes a housing 202 having an upper housing 204 and a lower housing 206. The housing has a proximal end 205 and a distal end 207. The upper housing 204 has a status observation port 208 to allow 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 in the proximal end of a needle arm 216. A spring 218 distally biases a needle actuator 220.

[0195] like Figures 42 to 46 As shown, system 200 further includes a container or drug container 222 in which a stopper 224 is movably disposed, but the stopper 224 is omitted in the various figures for clarity. Preferably, the distal end of the drug container 222 has a diaphragm assembly 228, which is spaced apart from the valve assembly 212 before the actuation device 222, as... Figure 47 The best result is shown in the middle.

[0196] like Figures 45 to 47 As shown, spacers 226 are selected from a plurality of spacers 226 of different sizes to occupy the space from the proximal end of the stopper 224 to the proximal end of the container 222. The spacers 226 are substantially flush with the proximal end of the container 222. Additionally, the spacers 226 have a "cap" shape, including a central post 230 and a distal flange 232, as shown. Figure 45The best result is shown in the middle.

[0197] Return to Figures 44 to 47 The system 200 also includes a drive assembly 234 for displacing the container 222 distally to establish a fluid connection between the container 222 and the patient needle 215, and for dispensing medication from the container 222. More specifically, the drive assembly 234 includes an internal spring 236 disposed within a central plunger 238, an external plunger 240, an external spring 242 disposed between the central plunger 238 and the external plunger 240, a telescopic member 244, and a release gate 246.

[0198] Preferably, the internal spring 236 has a larger spring constant than the external spring 242, and is therefore stronger or more rigid than the external spring 242. The internal spring 236 is disposed inside the central plunger 238, and in the spring flange 248 in the lower housing. Figure 46 The inner spring 236 (best shown in the diagram) pushes between the inner spring 238 and the central plunger 238, which is directly supported on the proximal end of the spacer 226 after the device is activated. An outer spring 242 is disposed inside the outer plunger 240 and pushes between the proximal outer flange 250 of the central plunger 238 and the distal inner flange 252 of the outer plunger 240. Thus, the inner spring 236 and the outer spring 242 are nested, and a more compact drive assembly (and therefore a more compact system 200) can be provided compared to using a single spring.

[0199] In one embodiment, the internal spring 236 is used only to displace the container 222 to establish a fluid connection with the patient needle 215, and the external spring 242 is used only for subsequently dispensing medication from the container 222. In another embodiment, the internal spring 236 is used to displace the container 222 to establish a fluid connection with the patient needle 215 and also to initiate the dispensing of medication from the container 222, while the external spring 242 completes the medication dispensing. In yet another embodiment, the internal spring 236 causes an initial puncture of the container 222, wherein the external spring 242 completes the puncture and the dispensing of medication from the container 222.

[0200] like Figures 44 to 47 As shown and described in more detail below, the external plunger 240 includes a pair of proximal flanges or legs 254, each having an inclined surface, which interact with corresponding inclined surfaces (or multiple surfaces) on the release gate to hold the power module and subsequently release it after the device 200 is actuated.

[0201] like Figure 46 and Figure 47As best shown, during initial assembly, container 222 is configured to have a gap with drive assembly 234 and valve assembly 212. Lateral flange 256 on needle actuator 220 axially holds 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 actuator button 210 (and / or its associated components) prevents distal displacement of needle actuator 220 before device 200 is actuated. Status bar 258 is provided 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, and a first color or pattern, such as yellow, is visible through status observation port 208 when the device is in a pre-actuated state.

[0202] Figures 48 to 52 This is a top view of system 200, showing the operation of events during and after the activation of system 200. Figure 47 In this case, the user slides the actuation button 210 proximally and then vertically displaces the button 210 into the housing 202, thereby releasing the needle actuator 220 to displace distally under the influence of a spring (omitted for clarity). Figure 49 As shown, as the needle actuator displaces distally, the track 260 on the needle actuator 220 interacts with the lateral boss 262 on the needle arm 216 to insert the patient needle 215. Preferably, at this stage, the proximal end of the needle actuator 220 has not yet released the release gate 246, and therefore the drive assembly 234 has not yet been released. However, the lateral flange 256 has already displaced distally, and therefore, the container 222 is unconstrained.

[0203] Subsequently, as Figure 50 and Figure 51 As shown, during continued distal displacement, the proximal end of the needle actuator 220 releases the release gate 246 (thus releasing the drive assembly 234). The needle actuator 220 temporarily rests against a feature on the rotatable release flipper 264, thereby abutting against the outrigger 266 of the telescopic member 244. Figure 44 and Figure 59 (Best shown in the image) Drive release fin 264. Needle actuator 220 remains in this position until medication has been dispensed. In this position, preferably, a second color or pattern, such as green, of the status bar 258 is visible through status observation port 208.

[0204] During this phase, the forces of springs 236 and 242, along with the interaction between the angled surface of the proximal flange or foot 254 and the corresponding angled surface (or multiple angled surfaces) on the release valve 246, cause a lateral displacement of the release valve 246, thereby freeing the outer plunger 240 from its constraining interaction with the release valve 246. Up to this point, the outer plunger 240 has been constraining the central plunger 238.

[0205] refer to Figure 52 and Figure 53 (For clarity, in) Figure 52 The internal spring 236 (omitted) rigidly drives the central plunger 238 distally to contact the spacer 226. Because the drug container 222 is filled with a substantially incompressible fluid, the continued distal displacement of the central plunger 238 displaces the spacer 226, the plug 224, and the container 222 distally relative to the housing 202. This distal displacement causes the diaphragm assembly 228 to be punctured by the valve assembly 212, thereby establishing fluid communication between the container 222 and the patient needle 215. The central plunger 238 travels distally until its proximal external flange 250 (… Figure 59 (Best shown in the image) A flange on the lower housing 206 contacts the piercing travel. Preferably, another flange on the lower housing 206 and / or a lateral flange 256 of the needle actuator 220 restricts the distal travel of the container 222.

[0206] Subsequently, because the internal spring 236 is no longer able to displace the central plunger 238 distally, the lighter external spring 242 displaces the external plunger 240 distally relative to the central plunger 238 to contact the distal flange 232 of the spacer 226, as... Figure 54 and Figure 55 As shown. As described in more detail below, preferably, the contact between the outer plunger 240 and the spacer 226 is damped to minimize impact force. Further expansion of the outer spring 242 displaces the outer plunger 240 distally to dispense the drug.

[0207] like Figure 56 and Figure 57 As shown, as the outer spring 242 continues to expand and displace the outer plunger 240 distally, during the predetermined distal displacement of the outer plunger 240 relative to the telescopic member 244, the outer feature or flange 268 of the outer plunger 240 interacts with the inner distal feature or flange 270 of the telescopic member 244 to “pick up” the telescopic member 244. This ensures that further distal displacement of the outer plunger 240 causes a corresponding distal displacement of the telescopic member 244. This paired distal displacement continues until drug dispensing is complete.

[0208] As previously described, the extendable leg 266 is mounted on the telescopic member 244. The axial length of the extendable leg and the distal travel of the telescopic member 144 control the timing of the disengagement of the extendable leg 266 from the release fin 264. Figure 58 and Figure 59 As shown, at the end of drug dispensing, the proximal end of the outrigger 266 bypasses the release fin 264. This allows the release fin 264 to rotate to disengage from the needle actuator 220. Figure 60 ), and allows the needle actuator 220 to continue its distal displacement and retract the patient needle 215 ( Figure 61 At this stage, another color or pattern of the status bar 258, such as red, is visible through the status observation port 208, indicating that the device 200 has completed operation.

[0209] As previously stated, the contact between the external plunger 240 and the spacer 226 is as follows: Figure 62 and Figure 63 The damping is preferably applied to minimize impact force. For underfilled syringes containing viscous fluids, the highest level of energy dissipation is desired because the external spring 242 will be more rigid to provide the desired dispensing rate. For maximally filled syringes containing low-viscosity fluids, the lowest level of energy dissipation is desired because the external spring may be less rigid to provide the desired dispensing rate. Various methods can be employed to adjust the damping level, such as air damping or closed-cell foam damping.

[0210] As another method of damping impact force. Figure 64 An embodiment of spacer 226 is shown, wherein one or more axial interface ribs 272 are arranged circumferentially around a central post 230 of spacer 226. In this embodiment, an outer plunger 240 must be driven through interference ribs 272, which provide 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, the frictional force does not exceed the minimum distributed spring load to avoid stalling the weaker spring. The interference can be adjusted to provide a desired level of frictional resistance. For different fluid viscosities, the interference ribs 272 can have different dimensions (axial and / or radial). This can mean that there can be custom or tailored spacers for every combination of viscosity and fill level, or multiple adjustment positions can exist depending on the number of springs required for a viscosity range, allowing the spacer to be positioned in a specific location for a particular modular spring (the position has been adjusted for interference / damping for that particular spring load / viscosity condition).

[0211] refer to Figures 65A to 69This illustrates an actuator button arrangement 280 for an actuation system 10 according to one aspect of the invention. The actuator button arrangement 280 includes an actuator button 26, a button spring 284, and a needle actuator body 286. The needle actuator body 286 may be similar to the needle actuator bodies 96, 220 discussed above and is configured to move within the housing 20 to transition the needle shuttle 102 or needle 28 between a retracted position and an extended position. Figure 69 As shown, the actuator button 26 includes a user interface portion 288 for user interaction. Preferably, the user interface portion 288 is approximately 22 mm long and approximately 10 mm wide, but other suitable dimensions may be used. The actuator button 26 includes two pairs of locking arms 290, 292, which interact with button contact surfaces 294, 296 on the needle actuator body 286 before the device is actuated to prevent the needle actuator body 286 from swinging upward. Figure 65H As shown, the overlap between the needle actuator body 286 and the housing 20 prevents premature actuation. (Reference) Figure 66 The button spring 284 includes a first support surface 298 and a second support surface 300 spaced apart from the first support surface 298, and a cantilever central spring arm 302 surrounded by a pair of outer arms 304 connected through the first support surface 298.

[0212] The actuation button arrangement 280 is configured to provide one or more of the following features, discussed in more detail below: unidirectional axial displacement or sliding of the actuator button 26; lateral movement of the actuator button 26 (raised position and depressed position), wherein the actuator button 26 remains depressed during the use position of the needle actuator body 286; and locking 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.

[0213] In order to actuate the system 10 using the actuator button 26, the user first slides the user interface portion 288 in the first axial direction, as shown in the diagram. Figure 65G and Figure 65H On the right side. The user may be required to slide the user interface portion 288 by about 10 mm or about 8 mm, but other suitable distances can be used. Move the actuator button 26 axially to move the locking arms 290, 292 to release the button contact surfaces 294, 296 on the needle actuator body 286, allowing the actuator button 26 to move from the raised position to the depressed position.

[0214] When the user slides the user interface portion 288 to the distal end, the central spring arm 302 of the button spring 284 rides on the spring arm support surface 306 on the housing 20, while the first support surface 298 and the second support surface 300 engage with the first support ramp 308 and the second support ramp 310 on the housing 20. Through engagement with the spring arm support surface 306 and the first support ramp 308 and the second support ramp 310, the forces on the button spring 284 are balanced to provide smooth axial displacement or sliding of the actuator button 26.

[0215] When the actuator button 26 and the button spring 284 reach the end of their axial sliding stroke, the central spring arm 302 and the first support surface 298 pass through the ends of the corresponding stops 312, 314 to prevent the actuator button 26 from sliding backward to its original position. Figure 65H As shown. Furthermore, when the actuator button 26 and the button spring 284 reach the end of their axial sliding stroke, the user engages the user interface portion 288 to move the actuator button 26 downwards to its depressed position. The actuator button 26 can be depressed by approximately 2 mm, and the minimum force required to depress the actuator button 26 is approximately 3 N, and most preferably approximately 2.8 N, but other suitable distances and minimum forces can be used.

[0216] When the user presses the user interface section 288, such as Figure 65A and Figure 65B As shown, actuator button 26 rotates the needle actuator body 286 to release the needle actuator body 286, thereby allowing the needle actuator body 286 to move from the pre-use position to the use position. Figure 65B As shown, as the needle actuator body 286 moves to the use position, locking arms 290, 292 travel along the underside of button contact surfaces 294, 296 to prevent the actuator button 26 from springing upwards. This occurs after the medication has been delivered and as the needle actuator body 286 transitions from the use position to the post-use position, as... Figure 65C As shown, locking arms 290, 292 disengage from button contact surfaces 294, 296, thereby allowing actuator button 26 to spring upward under the influence of button spring 284. Once the needle actuator body 286 has fully transitioned to the used position, as... 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 axial movement is still limited by the engagement of the spring arm 302 with the stops 312, 314. Therefore, after drug delivery is completed, the actuator button 26 is locked to provide a clear indication between the used and unused systems.

[0217] In addition, if the user keeps pressing the actuator button 26 during medication dispensing, the correct 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.

[0218] On one hand, the button spring 284 is made of plastic. The button spring 284 can also be a compressed metal spring, but any other suitable material can be used.

[0219] refer to Figures 68A to 68G Instead of providing separate actuator button 26 and button spring 284, the spring can be integrally provided with button 26. More specifically, actuator button 320 according to another aspect of the invention includes an integral spring arm 322. Actuator button 320 also includes a locking arm 324, a retaining arm 326, and a rear pivot 328. Figure 68D and Figure 68E As shown, the spring arm 322 engages the fork-shaped portion 330 in the top portion 22 of the housing 20. During the transition of the system 10 from the pre-use position to the use position, the spring arm 322 slides over the stop of the fork-shaped portion 330, thereby providing an axial spring force. As the spring arm 322 deflects, the end of the spring arm 322 engages a portion of the top portion 22 of the housing 20 to provide a vertical spring force. The actuator button 320 is configured to have a fluid movement between sliding and pressing movements, even when two separate movements are occurring, similar to the operation of the button 26 discussed above. During the transition between the pre-use position and the use position, the button 320 pivots about the rear pivot 328, where the holding arm 326 engages a portion of the needle actuator body 286, thereby holding the button 320 in the pressed position until the dose termination position is reached in a manner similar to that of the actuator button 26. When the needle actuator body 286 moves to the dose termination position, the locking arm 324 deflects inward and engages 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.

[0220] Various aspects of the present invention provide improvements over prior button designs. For example, the actuation button arrangement 280 provides multiple surfaces to resist the needle actuator spring 106 and hold the needle actuator body 286 in place before actuation, thereby reducing the likelihood of premature actuation during a drop impact. The actuation button arrangement 280 physically prevents the needle actuator body 286 from moving before actuation by holding it in a tilted (locked) state with no space for surface separation and pre-activation.

[0221] Furthermore, the sliding force of the actuated button arrangement 280 is more precisely controlled by utilizing a flexible arm instead of a simple bump detent. This allows for a longer sliding stroke of button 26 with better force control, resulting in a more ergonomic and efficient design. Additionally, the actuated button arrangement 280 causes button 26 to spring back at the end of injection, providing the user with additional visual, auditory, and tactile indications of drug delivery completion.

[0222] According to one aspect, the fluid delivery volume of system 10 is determined by the end position of the plunger relative to a point inside the housing, independent of the actual filling volume, the container inner diameter, and the starting position and length of the plunger. Dosing accuracy can be significantly variable because the tolerances of the aforementioned factors can be large. Aspects of the present invention allow some or all of these tolerances to be eliminated from the dosing equation, resulting in more accurate and less variable drug injection volumes.

[0223] refer to Figure 69 and Figure 70 According 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 drug dosage has been administered. Instead of rotating about a fixed rod, the limiting member 452 floats freely. Once the plunger has been sufficiently displaced distally to align the gap with the limiting member 452 (e.g., ...), Figure 70 and Figure 71 As shown), due to the force of the spring on the needle actuators 96 and 220 and the angled surface 454 of the engaging needle actuator body on the rear part of the arm of the limiting member 174, the limiting member 452 is laterally displaced into the gap. Figure 71 (Best shown in the diagram). Once the restraining member no longer holds the needle actuator bodies 96, 220, the needle actuator bodies 96, 220 are free to complete axial movement to their post-use position. Furthermore, as... Figure 71 As shown, the limiting member 452 is biased onto the rear of the cylindrical portion of the container 14, which minimizes the tolerance chain of the various components and improves dosage accuracy.

[0224] refer to Figures 72 to 77 This illustration shows a drive assembly 500 for a drug delivery system according to one aspect of the invention. 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 drum portion 518 with externally radially projecting blades 520, and as shown... Figure 74 and Figure 75 The threaded portion 522 is best shown and described in more detail thereafter. Before activation, as... Figure 73 and Figure 76As shown in the best embodiment, one end 513 of the actuation release member 512 engages one of the blades 520 to prevent rotation of the lead screw 514.

[0225] According to one aspect, such as Figures 74 to 76 As shown, the threaded portion 522 of the lead screw 514 engages with the internal thread of the nut 524 connected to the plunger 516. According to another aspect, the nut and its internal thread are integrally formed with the plunger as a single unit. Additionally, a constant force spring 526 is received within the drum portion 518 and biases the lead screw 514 in the rotational direction. According to one aspect, the spring 526 is fixed to the base cap 504. According to another aspect, as... Figures 74 to 76 As shown, the drive assembly housing 528 is disposed within the system, and the spring 526 is fixed to the power supply housing 528.

[0226] Unlike helical springs (such as compression springs) which have force characteristics proportional to their displacement, constant force springs 526 and the like maintain relatively flat or uniform force characteristics over a long working length. Uniform force characteristics advantageously provide an injection force proportional to the spring force. This provides a flat or uniform injection force and thus a substantially constant injection rate for the drug. Although in Figure 76 The diagram shows that spring 526 has only two turns of material; those skilled in the art will understand that fewer or more turns can be used. Preferably, when the drive assembly 500 is assembled, the assembler winds the spring 526, and the spring 526 is stored in the wound position until the actuation time.

[0227] When the system is actuated, the needle actuator assembly 510 is released to be axially displaced (towards) from its pre-use position under the influence of the biasing member 530. Figures 72 to 75 (right side of the middle) to the post-use position ( Figure 73 (Best shown in the diagram). During this displacement, the needle actuator assembly 510 abuts against the second end 532 of the actuation release member 512 and rotates the release member 512 counterclockwise, as shown in the diagram. Figure 77 As shown. This counterclockwise rotation of the actuating release member 512 disengages its first end 513 from engagement with the blade 520. After the first end 513 disengages from the blade 520, the spring 526 unwinds and drives the rotation of the lead screw 514, which, in combination with the nut 524, advances the plunger 514 to dispense the drug.

[0228] As the lead screw 514 rotates, the rotation of the drum portion 518 and the blades 520 is visible through a window 534 in the housing. This window 534 indicates the progress of the screw in a much more obvious way than observing the linear movement of the stopper 536 in the container 508. In fact, this rotational motion is many times more sensitive than linear motion. Those skilled in the art will understand that the exact amount of advantage or enhancement depends on the pitch of the threaded portion 522 of the lead screw 514, the diameter of the drum portion 518, and the number of blades 520 on the drum portion 518.

[0229] refer to Figures 78 to 83 This diagram illustrates a drive assembly 600 for a drug delivery system according to another aspect of the invention. The drive assembly 600 stores the mechanical energy of a spring and activates it upon triggering. The drive assembly 600 includes a drug cartridge 601, a plug 602 slidably disposed within the cartridge 601, a first valve plunger 603, a second valve plunger 604, a first swivel nut 605, and a second swivel nut 606. The drive assembly 600 also includes a rotation indicator 607, a locking element 608, a constant force spring 609 disposed within the rotation indicator 607, and an actuation release member or fin 610. The drive assembly 600 is at least partially disposed within a housing 611 that can be assembled into a drug delivery system.

[0230] A constant force spring 609 is housed within the drum portion 616 of the rotary indicator 607, between the housing 611 and the rotary indicator 607. In the inactive state of the drive assembly, energy is applied by deploying the spring 609 and geometrically harnessing it using the housing 611, the rotary indicator 607, and the actuation release member 610. When the drive assembly 600 is deactivated, the spring recoils and converts mechanical energy into rotational movement of the rotary indicator.

[0231] The telescopic multi-piece plunger is oriented along the force axis between the drug cartridge 601 and the rotary indicator 607. The rotary indicator 607 has a threaded shaft 618. According to one aspect, the thread is double-leaded and is essentially square or rectangular. The multi-piece telescopic plunger includes a two-piece nut (a first swivel nut 605 and a second swivel nut 606) and a two-piece plunger (a first valve plunger 603 and a second valve plunger 604). The second swivel nut 606 is a threaded shaft that mates with the rotary indicator 607 and the first swivel nut 605 and has matching threads (internal and external threads, respectively) on its inner and outer surfaces to mate with them. The second swivel nut 606 also has a circular collar 620 at its proximal end. Figure 82(Best shown in the diagram), the circular collar rests bottom-down on the second valve plunger 604. The second swivel nut 606 rotates freely along the force axis. The first swivel nut 605 is also a threaded shaft, having threads on its inner diameter corresponding to the external threads of the second swivel nut 606, to mate with the second swivel nut 606.

[0232] According to one aspect, the first rotary nut 605 has a hexagonal collar at one end, which presses against the first valve plunger 603 to fix the first valve plunger 603 to the first rotary nut 605. In the drive assembly 600, the first rotary nut cannot rotate freely and will only translate when the power module subassembly is actuated.

[0233] The second valve plunger 604 is a hollow cylindrical component having a small collar 622 at its distal end, a large collar 624 at its proximal end, and an extending L-shaped arm 626 protruding from the proximal large collar 624. Figure 83 (Best shown in the diagram). According to one embodiment, the small collar 622 is discontinuous and has four plate-shaped cantilever or leaf springs 623 that allow the collar to bend and engage with the first valve plunger 603. The inner surface of the second valve plunger 604 has an undercut extending through its length, and a radially inwardly projecting shelf 628 of the large collar 624 is terminated at its proximal end. The shelf 628 engages with a second swivel nut 606 within the telescopic assembly.

[0234] The first valve plunger 603 is attached to the plug 602 and is also a hollow cylindrical component that mates with the second valve plunger 604. More specifically, the first valve plunger 603 has a cylindrical protrusion 630 at its distal end for mates with the plug 602. According to one aspect, such as Figure 79 As best shown, four through slots 632 are provided on the proximal quadrant of the first valve plunger 603 to engage with the leaf spring or arm 623 and the small collar portion 622 of the second valve plunger 604. Both the first valve plunger 603 and the second valve plunger 604 are free to slide.

[0235] Extension and retraction are achieved when the constant force spring 609 rewinds and the rotary indicator 607 begins to rotate. The threaded attachment between the rotary indicator 607 and the second rotary nut 606 causes the second rotary nut 606 to rotate. However, because the second rotary nut 606 is threadedly connected to the first rotary nut 605, the first rotary nut cannot rotate and experiences resistance to distal translation due to the pressure caused by the drug in the cylinder 601. Therefore, the second rotary nut 606 will displace proximally and rest its bottom against the radially inwardly projecting shelf 628 of the second valve plunger. Proximal displacement of the second valve plunger 604 is prevented by the housing 611. Subsequently, and as the rotary indicator 607 continues to rotate, because the second rotary nut 606 is threadedly connected to the first rotary nut 605 (which cannot rotate), the first rotary nut 605 translates distally to push the first valve plunger 603 (and the plug 602) to dispense the drug from the cylinder 601.

[0236] 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 groove 632 of the first valve plunger 603. This locks the relative position of the first valve plunger 603 and the second valve plunger 604. As the rotation indicator 607 continues to rotate, the two valve plungers translate distally while simultaneously pushing the second swivel nut (due to its proximal engagement with the shelf 624).

[0237] The initial and final positions of the telescopic plunger, and thus the drug dosage, are controlled by the rectangular thread of the threaded shaft 618 of the rotary indicator 607, the threaded shaft on the drum portion 616 of the rotary indicator 607, and the stepped pin serving as the locking element 608. According to one aspect, the threaded shaft on the drum portion 616 of the rotary indicator 607 is single-lead, and because the remaining components of the telescopic chain have double-lead threads, the axial travel of the other threaded components is twice the axial travel of the lock 608 relative to the rotary indicator.

[0238] According to one embodiment, the lock 608 is cylindrical and has a dome-shaped end at one end and a cylindrical collar at the other end. Threads on the exterior of the drum portion 616 of the rotary indicator and grooves and undercuts 636 at the bottom of the housing 611 hold the lock 608 in place, allowing it to slide parallel to the force axis. Therefore, as the spring 609 is released and the rotary indicator 607 rotates, the lock 608 also translates and forms a stop when it reaches the distal end of the threads on the exterior of the drum portion 616 of the rotary indicator.

[0239] One advantage of the various aspects of the drive assembly 600 includes the use of a constant-force spring 609, the mechanical energy of which is converted into a substantially constant linear force on the drug in the cylinder 601. This, in turn, produces a uniform drug delivery rate. Another advantage 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 drug dosing through initial and final mechanical constraints within the same component.

[0240] As previously mentioned, other drug delivery systems utilize compression helical springs that apply a maximum force upon actuation, which eventually decreases as the spring expands. This reduced force at the plunger translates into variable drug delivery time and drug outlet pressure. By using a constant-force spring, the force applied to the plunger is constant from the start to the end of the dose. Furthermore, the distance the helical spring must travel, in addition to the length of the static plunger that needs to be translated within the drug container, can result in a relatively long assembly. Conversely, in embodiments of the present invention, the constant-force spring is radially accommodated and requires no additional space before or after activation. Moreover, the various aspects of the telescopic plunger allow for a significant reduction in plunger length compared to the length of the static plunger.

[0241] Previous drug delivery systems have variable dosage accuracy performance because the mechanical components that deliver the drug are geometrically dependent on the bottom resting against the container, which cannot be manufactured with tight tolerances. Some embodiments of the present invention achieve control over the start and end times of the translational plunger via a threaded form in a rotary indicator and the use of a constant-force spring.

[0242] In addition to the well-controlled timing, size, and pressure of the drug delivery device, the drive components also form a space-saving geometry, which translates into a more attractive, compact, and precise drug delivery device.

[0243] Some aspects of the drive assembly implement three rotating threaded shafts to achieve a linear space saving of approximately 0.75 inches. In other aspects, the same concept using two rotating threaded shafts can be adopted 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.

[0244] refer to Figures 84A to 84G This illustrates a plunger assembly 400 used in conjunction with a drive assembly according to one aspect of the invention.

[0245] Elements in the tolerance chain of the plunger assembly 400 include the thickness (A) of the flange 402 of the inner plunger 404, the internal length (B) of the outer plunger 406 between its inner proximal end 408 and inner shoulder 410, and the initial offset distance (C1) between the inner plunger flange 402 and the inner proximal end 408 of the outer plunger. This initial offset distance (C1) is preferably greater than the clearance distance (C2) between the outer plunger 406 and the proximal end of the drug cartridge 412. The tolerance chain of the stopper spacer assembly 400 also includes the inner cartridge diameter (D). Once assembled, the stopper spacer 414 and the outer plunger 406 are unique for a given drug volume.

[0246] Figures 84B to 84G The operation of the plunger assembly 400 is shown. For example... Figure 84B As shown, when the system is actuated, both the inner plunger 404 and the outer plunger 406 are released. The outer spring 416 pushes the outer plunger 406 into the cylinder 412, thereby compressing the damping material 418 and the inner spring 420. Due to the fluid column of the drug, the plug 422 has not yet moved relative to the cylinder 412.

[0247] Next, as Figure 84C As shown, an external spring 416 displaces an external plunger 406 and a cylinder 412 distally to open a valve (not shown) at the distal end of the cylinder 412, which establishes fluid communication with a needle (not shown). Due to the incompressibility of the liquid medication, the plug 422 cannot be displaced relative to the cylinder 412 until the valve opens and a fluid path to the patient needle is established.

[0248] Subsequently, as Figure 84D and Figure 84E As shown, the internal spring 420 displaces the internal plunger 404, the plug spacer 414, and the plug 422 to distribute fluid.

[0249] Figure 84F This illustrates the termination of drug delivery when the proximal flange 402 of the inner plunger 404 contacts the inner shoulder 410 of the outer plunger 406, thereby stopping the displacement of the inner plunger 404 (and the stopper spacer 414 and the stopper 422) relative to the drug cartridge 212 and stopping the flow of the drug.

[0250] According to one aspect, such as Figure 84G As shown, the cessation of displacement of the internal plunger 404 relative to the drug cartridge 412 triggers the system's end-of-dose indicator.

[0251] Although specific spacer assemblies 40 and 226 have been described above, custom spacer assemblies can have various configurations. Custom spacer assemblies can be placed proximal to the stopper in the container or otherwise connected to the stopper. The spacer is designed so that its effective length can be varied to allow for the dispensing of precise amounts of medication. Length adjustment is designed to compensate for manufacturing tolerances within the container, filling volume, and especially the stopper length, which can collectively account for up to one-third of the variation in delivered dose when using non-adjustable spacers. Depending on specific aspects, spacer length can be adjusted using a variety of techniques. The spacer length can be self-adjusting based on its position relative to the back of the container, can be adjusted via assembly equipment during the final assembly of the main container into the sub-assembly, or can be integrally formed with the stopper and adjusted as a sub-assembly prior to filling. Compared to non-adjustable stoppers, adjustable spacers allow for the injection of more precise volumes of fluid.

[0252] refer to Figure 85 and Figure 86 The foldable spacer assembly 430 includes a front spacer portion 432 fixed to a stopper 434, an inner plunger 436, a rear spacer portion 438, and a rotating 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 described in more detail later, the rotating shuttle 440 first rotates and then translates.

[0253] According to one aspect, the front spacer portion 432 is fixedly attached to the plug 434. Those skilled in the art will understand that many methods (e.g., adhesives, mechanical fasteners, or any other suitable arrangement) can be used to attach the front spacer portion 432 to the plug 434. Preferably, the front spacer portion 432 includes threads that engage mating threads in the plug 434.

[0254] 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 medication. This pressure causes the front (distal) face of the stopper 434 to deflect proximally and press, thereby pushing the rear spacer portion 438 backward and rotating the rotary shuttle to its "as assmebled" state. In other words, when the medication cartridge is filled with medication and the system's plunger applies an axial force to the medication via the spacer assembly 430, the distal end face of the stopper 434 deforms due to the pressure of the medication. During medication delivery, pressure is applied to the rear spacer portion 438 by 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 medication provides a rearward or proximal force on the inner plunger 436, which prevents the rotation of the rotary shuttle 440.

[0255] On one hand, the axial reactive load on the internal plunger 436 can be increased by increasing the length of the internal plunger 436.

[0256] Once drug delivery is complete, such as Figure 87 As shown, the pressure on the plug 434 decreases, thereby allowing the distal end of the internal plunger 436 to displace distally. This distal displacement allows the rotary shuttle 440 to rotate. Due to the interaction between the helical surface 444 in the rear spacer portion 438 and the corresponding cam arm 446 of the rotary shuttle 440, a continuous axial force applied by the drive assembly causes the rotary shuttle 440 to rotate and displace distally. According to one aspect, this final movement of the rotary shuttle 440 causes the drive assembly trigger pin to retract.

[0257] refer to Figures 88 to 90 This illustrates a spacer assembly 460 according to another aspect of the invention. Figures 88 to 90 The spacer assembly 460 shown allows the effects of manufacturing tolerance accumulation to be eliminated by adjusting the spacer assembly, thereby allowing each system to inject the same amount of drug.

[0258] like Figure 89 As shown, the spacer assembly 460 includes a plug 462 and a plug spacer 464. The plug spacer 464 includes a fixed spacer block or fixed spacer 466 fixedly connected to the plug 462, and an adjustable spacer block or adjustable spacer 468 that can be rotated relative to the fixed spacer 466 in one direction.

[0259] Those skilled in the art will understand that many methods (e.g., adhesives, mechanical fasteners, or any other suitable arrangement) can be used to secure the retaining spacer 466 to the plug 462. Preferably, the retaining spacer 466 includes one or more external threads that engage 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 distal rod thread 470 engages the internal thread 472 in the retaining spacer 466. Figure 90 (best shown in the diagram) to rotatably control the axial displacement of the adjustable spacer 468 relative to the fixed spacer 466.

[0260] like Figure 88 and Figure 89 As shown, the fixed spacer 466 includes radially spaced stop portions 474, and the adjustable spacer 468 includes a spring-loaded pawl arm 476, the free end of which engages a selected one of the stop portions 474 to prevent rotation and axial displacement of the adjustable spacer 468 toward the fixed spacer 466. The free end of the spring-loaded pawl arm 476 is shaped to extend beyond the stop portion 474 in one direction, thereby allowing rotation of the adjustable spacer 468 away from the fixed spacer 466 and axial displacement toward the proximal side.

[0261] Despite variations in the dimensions of the plug and container, the adjustable spacer 468 can be adjusted relative to the fixed spacer 466 to provide a consistent axial length for the plug assembly 460.

[0262] like Figure 90 As shown, once the container is filled, axial loads, such as those encountered when installed in systems 10, 200, can be applied to the adjustable spacer 468 (and thus, the fixed spacer 466 and the stopper 462). Once the axial load is applied, the adjustable spacer 468 can be retracted proximally to ensure a consistent gap 478 between the proximal end of the cartridge 480 and the proximal side of the adjustable spacer 468, thereby addressing variations in the cartridge glass and any compressibility of trapped air. In other words, the spacer assembly 460 allows the adjustable spacer 468 to have a predetermined set position relative to the container 14, independent of variations in the length of the container 14 and the stopper. 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 stopper 462 is limited by the effective length of the plungers 52, 54 of the drive assembly 12.

[0263] refer to Figure 91 and Figure 92The diagram illustrates a base post 482 and a cap 484 of an automatically adjusting spacer 486 according to one aspect of the invention. The base post 482 includes a base portion 488 and an axially extending post 490. According to one embodiment, the base post 482 includes a plurality of columnar protrusions 491, each columnar protrusion having a plurality of ratchet teeth 492 disposed on its proximal portion. A locking barb 493 is disposed at the proximal end of each of the plurality of ratchet teeth 492. The cap 484 is hollow, and the distal end of the cap 484 includes one or more axial springs 494. According to one aspect, the axial spring 494 is a curved cantilever formed during the molding of the cap 484. According to another aspect, a separate biasing member, such as a compression spring, may be used in the automatically adjusting spacer 486. When assembled with the base post 482, the spring 494 engages the base portion 488 and maintains an initial spacing between the base post 482 and the cap 484. According to one aspect, the spring 494 is omitted. The cap 484 also includes a plurality of flexible cantilever or tab 496, each cantilever or tab having a free proximal portion with a plurality of internal ratchet teeth 497. The proximal end of each flexible tab 496 includes a foot 498.

[0264] Figure 93A and Figure 93B A cap for an automatically adjusting spacer is shown, located in a proximal recess of a stopper 494 on the proximal portion of the drug cartridge. A base post 482 is assembled into the hollow cap 484, wherein the base portion 482 engages the stopper 494 and a foot 498 located on the proximal outer side of the cartridge.

[0265] In operation, such as Figure 93A and Figure 93B As shown, the cap 484 is displaced distally relative to the base post 482 (and the stopper 494 and the cartridge) until the proximal end of the cap 484 is flush with the end of the cartridge. This action causes the foot 498 to engage the inner surface of the cartridge and displace radially inward, thereby forcing the ratchet 492 to lock into engagement with the ratchet 497. The engagement of the locking barbs 493, the ratchet 492 and 497, and the engagement of the foot 498 with the inner surface of the cartridge prevent displacement of the cap 484 relative to the base post 482. Therefore, the automatically adjusting spacer 486 can accommodate differences in the stopper, cartridge diameter, and drug filling volume to automatically provide a support surface flush with the proximal end of the cartridge.

[0266] refer to Figures 94 to 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... Figures 76 to 78The spacer assembly 660 shown in the diagram operates in a similar manner to achieve similar advantages. The spacer assembly 660 includes a fixed spacer 666 and an adjustable spacer 668. The fixed spacer 666 is configured to be received by a plug 462, wherein a lug 670 engages the plug 462 to secure the fixed spacer 666 within the plug 462; however, other suitable securing arrangements, such as threads, can be utilized. The fixed spacer 666 includes an internal thread 672 that receives an external thread 678 of the adjustable spacer 668. The fixed spacer 666 includes a plurality of ratchet stops 674 positioned on the helical portion of the fixed spacer 666. The adjustable spacer 668 includes a spring-loaded pawl arm 676 that engages one of the ratchet stops 674 to prevent rotation and axial displacement of the adjustable spacer 668 relative to the fixed spacer 666. The spring-loaded pawl arm 676 is shaped and configured to extend beyond the stop 674 in one direction to allow rotation and axial displacement of the adjustable spacer 668 away from the fixed spacer 666. By applying a force to the top of the spring-loaded pawl arm 676, the adjustable spacer 668 can be initially secured to the fixed spacer 666 via threads 672, 678, which biases the spring-loaded pawl arm 676 away from the stop 674 to allow the spacers 666, 668 to be fixed to each other. Therefore, in the same manner as discussed above with the spacer assembly 460, the adjustable spacer can rotate freely in one axial direction to adjust the length of the spacer assembly 660.

[0267] Refer again Figures 94 to 100 The spacer assembly 660 also includes a compensating member 680 configured to receive and secure to the adjustable spacer 668. Instead of providing adjustable spacers 468, 668 in multiple sizes, multiple compensating member 680 sizes can be provided to accommodate various filling volumes within the container 14. The compensating member 680 can be secured to the adjustable spacer 668 via a connector 682 extending from the compensating member 680, which is received by the adjustable spacer 668 using a snap-fit ​​engagement, but other suitable securing arrangements can be utilized. 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 together with the adjustable spacer 268. The central portion 684 of the fixed spacer 666 can be accessed through an opening in the compensating member 680.

[0268] refer to Figures 101 to 103The diagram illustrates a spacer assembly 700 according to another aspect of the invention. The spacer assembly 700 has a spacer 702 and a compensation member 704. The spacer 702 has a central post 706 and a proximal flange 708. The central post 706 is received within and attached to a stopper 710 of a container 712 such that the proximal flange 708 abuts the proximal end of the stopper 710. The spacer 702 can be attached to the stopper 710 using any suitable method (including, but not limited to, adhesives, threaded connections, and snap-fit ​​connections). Instead of providing spacers 702 with proximal flanges 708 of varying thicknesses, a plurality of compensation members 704 of varying sizes are provided to accommodate a variety of different filling volumes within the container 712. The compensation members 704 may have a shape corresponding to the shape of the proximal flange 708 and may be secured to the proximal flange 708 via snap-fit ​​connections or adhesives, but other suitable securing arrangements may be utilized. The dimensions of the available compensating elements 704 can be arranged in a binary manner, that is, the thickness of each successively thicker compensating element 704 is twice that of the previous compensating element 704, such as... Figure 103 As shown. The compensation element 704 can be attached to the spacer 702 before and / or after it is attached to the plug 710.

[0269] refer to Figure 104 and Figure 105 This diagram illustrates a spacer assembly 800 according to another aspect of the invention. The spacer assembly 800 has a movable spacer 802 and a fixed spacer retainer 804. The spacer 802 has a central post 806 and a proximal flange 808. The spacer retainer 804 is received by a plug 810 and has a central cavity 812 for receiving the central post 806 of the spacer 802. The spacer retainer 804 can be securely attached to the plug 810 using any suitable method (including, but not limited to, adhesives, threaded connections, and snap-fit ​​connections). Adhesive 814 attaches the outer surface of the sidewall 816 of the central post 806 to the inner surface of the sidewall 818 of the central cavity 812 of the spacer retainer 804. Adhesive 814 can be any suitable adhesive, including, but not limited to, contact adhesives, UV-curable adhesives, and laser-curable adhesives. Figure 104 As shown, the inner surface of the sidewall 818 of the central cavity 812 of the spacer holder 804 may include a threaded portion 820, which engages a corresponding threaded portion 822 in the outer surface of the sidewall 816 of the central post 806 of the spacer 802. Adhesive may be applied to the threaded portions of the spacer 802 and / or the spacer holder 804. After the spacer 802 is screwed into the central cavity 812 of the spacer holder 804 and the desired length of the spacer assembly 800 is set, the adhesive 814 is cured, thereby attaching the spacer 802 to the spacer holder 804 and fixing the length of the spacer assembly 800. Alternatively, as... Figure 105As shown, the laser or ultrasonic welding part 824 can be used to attach the spacer 802 to the spacer holder 804, thereby fixing the length of the spacer assembly 800. The spacer 802 can be transparent, while the spacer holder is opaque.

[0270] refer to Figure 106 The diagram illustrates a spacer assembly 900 according to another aspect of the invention. The spacer assembly 900 has a spacer 902 and a spacer retainer 904. The spacer 902 has a central post 906 and a proximal flange 908. The spacer retainer 904 is received by a plug 910 and has a central cavity 912 for receiving the central post 906 of the spacer 902. The spacer retainer 904 can be attached to the plug 910 using any suitable method (including, but not limited to, adhesive, threaded connection, and snap-fit ​​connection). An ultrasonic or laser weld 914 attaches the outer distal surface 916 of the central post 906 to the inner bottom surface 918 of the central cavity 912 of the spacer retainer 904, locking the position of the spacer 902 relative to the spacer retainer 904, thereby fixing the length of the spacer assembly 900. The height of the spacer 902 can be adjusted relative to the spacer retainer 904 to provide an unlimited number of height increments.

[0271] refer to Figure 107 and Figure 108 This illustration shows a spacer assembly 1000 according to another aspect of the invention. The spacer assembly 1000 has a spacer 1002 and a spacer retainer 1004. The spacer 1002 has a central post 1006 and a proximal flange 1008. The spacer retainer 1004 is received by a plug 1010 and includes a sidewall 1012 extending proximally from a bottom portion 1014. The sidewall 1012 and the bottom portion 1014 define a central cavity 1016 that receives the central post 1006 of the spacer 1002. The spacer retainer 1004 can be attached to the plug 1010 using any suitable method (including, but not limited to, adhesives, threaded connections, and snap-fit ​​connections). The inner surface of the sidewall 1012 of the spacer retainer 1004 includes a threaded portion 1018 that engages a corresponding threaded portion 1020 in the outer surface of the central post 1006 of the spacer 1002. Figure 107As shown, the proximal surface of the sidewall 1012 of the spacer holder 1004 includes a plurality of ratchet teeth configured to engage a flexible tab 1024 extending axially in a distal direction from the proximal flange 1008 of the spacer 1002. The proximal surface of the sidewall 1012 of the spacer holder 1004, on which the ratchet teeth are positioned, is angled in a distal direction about the circumference of the sidewall 1012 to ensure that the flexible tab 1024 remains engaged with the ratchet teeth when the central post 1006 of the spacer 1002 is screwed into the central cavity 1016 of the spacer holder 1004. The engagement between the ratchet teeth on the spacer holder 1004 and the flexible tab 1024 only allows the spacer 1002 to rotate in one direction relative to the spacer holder 1004. Therefore, the central post 1006 of the spacer 1002 can be screwed into the central cavity 1016 of the spacer holder 1004, but is prevented from being screwed out of the central cavity 1016 of the spacer holder 1004 by the locking engagement between the ratchet and the flexible tab 1024.

[0272] Alternatively, such as Figure 108 As shown, flange 1026 extends from the proximal surface of sidewall 1012 of spacer holder 1004. Flange 1026 includes a plurality of ratchet teeth configured to engage flexible tab 1028, which extends radially from proximal flange 1008 of spacer 1002. The flange 1026, with the ratchet teeth positioned thereon, is circumferentially arranged around the sidewall 1012 of spacer holder 1004 to ensure that the flexible tab 1028 remains engaged with the ratchet teeth when the central post 1006 of spacer 1002 is screwed into the central cavity 1016 of spacer holder 1004.

[0273] The bottom portion 1014 of the spacer retainer 1004 can be as follows: Figure 107 The diagram shows various thickness settings to provide another dimension of adjustability for containers with different filling volumes.

[0274] refer to Figure 109 and Figure 110The diagram illustrates a spacer assembly 1100 according to another aspect of the invention. The spacer assembly 1100 has a spacer 1102 and a spacer retainer 1104. The spacer 1102 has a central post 1106 and a proximal flange 1108. The spacer retainer 1104 is received by a plug 1110 and includes a sidewall 1112 extending proximally from a bottom portion 1114. The sidewall 1112 and the bottom portion 1114 define a central cavity 1116 for receiving the central post 1106 of the spacer 1102. The spacer retainer 1104 can be attached to the plug 1010 using any suitable method (including, but not limited to, adhesives, threaded connections, and snap-fit ​​connections). The spacer 1102 includes a protrusion 1118 extending axially in a distal direction from a proximal bottom surface 1120 of the central post 1106. The protrusion 1118 extends less than half the circumference of the proximal bottom surface 1120 of the central post 1106. The spacer holder 1104 includes a protrusion 1122 extending axially from the bottom portion 1114 of the spacer holder 1104 into the central cavity 1116. The protrusion 1122 extends less than half the circumference of the bottom portion 1114 of the spacer holder 1104. When the spacer 1102 is in the first position, as Figure 109 As shown, the protrusion 1118 on the spacer 1102 contacts the bottom portion 1114 of the spacer holder 1104, and the protrusion 1122 on the spacer holder 1104 contacts the proximal bottom surface 1120 of the spacer 1102, such that the spacer assembly has a first length. When the spacer 1102 is in the second position, as... Figure 110 As shown, the protrusion 1118 on the spacer 1102 contacts the protrusion 1122 on the spacer holder 1104, such that the spacer assembly has a second length greater than the first length. Although a specific embodiment using spacers and spacer holders has been described, which has a configuration that allows the length of the spacer assembly to be changed based on the relative position of the spacer with respect to the spacer holder, other similar configurations may also be utilized.

[0275] refer to Figure 111The diagram illustrates a spacer assembly 1200 according to another aspect of the invention. The spacer assembly 1200 has a spacer 1202 and a spacer retainer 1204. The spacer 1202 has a central post 1206 and a proximal flange 1208. The spacer retainer 1204 is received by a plug 1210 and includes a sidewall 1212 extending proximally from a bottom portion 1214. The sidewall 1212 and the bottom portion 1214 define a central cavity 1216 for receiving the central post 1206 of the spacer 1202. The spacer retainer 1204 can be attached to the plug 1210 using any suitable method (including, but not limited to, adhesives, threaded connections, and snap-fit ​​connections). The inner surface of the sidewall 1212 of the spacer retainer 1204 includes a non-overhauling threaded portion 1218 that engages a corresponding non-overhauling threaded portion 1220 in the outer surface of the central post 1206 of the spacer 1202. As used herein, self-locking threads result in a threaded connection in which applying torque to a first component of the threaded system causes the first component to rotate relative to a second component, but any further axial force applied to the first component will not cause it to rotate relative to the second component. In this embodiment, the threaded portion 1220 of the center post 1206 of spacer 1202 and the threaded portion 1218 of the sidewall 1212 of spacer retainer 1204 are configured such that after applying torque to spacer 1202 to thread it onto spacer retainer 1204, subsequent application of axial force will not cause spacer 1202 to rotate relative to spacer retainer 1204. At least a portion of the threaded portion 1220 in the outer surface of the center post 1206 of spacer 1202 may have radially outwardly extending threads to increase the locking engagement between the threaded portion 1218 of spacer retainer 1204 and the threaded portion 1220 of spacer 1202. Alternatively or additionally, as Figure 112 As shown, the threaded portion 1220 of the spacer may have a thread 1224 having an upper outer surface 1226 angled downward in the proximal direction and a bottom outer surface 1228 extending in the radial direction, thereby forming a pointed tooth-like structure. When an axial force in the distal direction, as indicated by arrow 1230, is applied to the spacer 1202 to move the plug 1210 in the distal direction, the pointed thread 1224 drills into the sidewall 1212 of the spacer holder 1204 to lock the spacer 1202 to the spacer holder 1204.

[0276] refer to Figures 113 to 115. A spacer assembly 1300 according to another aspect of the invention is shown. The spacer assembly 1300 has a spacer 1302 and a spacer retainer 1304. The spacer 1302 has an annular ring 1306 extending from a proximal flange 1308. The spacer retainer 1304 is received by a plug 1310 and includes a sidewall 1312 and a central post 1314, both extending from a bottom portion 1316 in a proximal direction. The sidewall 1312, the central post 1314, and the bottom portion 1316 define an annular cavity 1318 for receiving the annular ring 1306 of the spacer 1302. The spacer retainer 1304 can be attached to the plug 1310 using any suitable method (including, but not limited to, adhesives, threaded connections, and snap-fit ​​connections). The inner surface of the sidewall 1312 of the spacer retainer 1304 includes a non-locking thread portion 1320 of a corresponding non-overhauling thread portion 1322 in the outer surface of the annular ring 1306 engaging the spacer 1302, and the outer surface of the center post 1314 includes a self-locking thread portion 1324 of a corresponding self-locking thread portion 1326 in the inner surface of the annular ring 1306 engaging the spacer 1302. The self-locking thread portion, as used herein, results in a threaded connection where applying torque to the first component of the threaded system will cause the first component to rotate relative to the second component, but any further axial force applied to the first component will not cause it to rotate relative to the second component. The non-locking thread portion, as used herein, results in a threaded connection where applying torque or axial force to the first component of the threaded system will cause the component to rotate relative to the second component. The threads of the self-locking thread portion and the non-locking thread portion can have the same pitch.

[0277] In this embodiment, as Figure 113 As shown, when the proximal axial force indicated by arrow 1328 is applied to the central post 1314, the load path for the distal axial force, indicated by arrow 1330, is guided through the non-self-locking threaded connection between the non-self-locking threaded portion 1320 in the inner surface of the sidewall 1312 of the spacer retainer 1304 and the non-self-locking threaded portion 1322 in the outer surface of the annular ring 1306 of the spacer 1302. Because this threaded connection has a non-self-locking thread, the axial force 1330 causes the spacer 1302 to rotate and screw into the annular cavity 1318 of the spacer retainer 1304. When the force 1328 is released, the load path for the axial force 1330 is guided through the self-locking threaded connection between the self-locking threaded portion 1324 in the outer surface of the central post 1314 of the spacer retainer 1304 and the self-locking threaded portion 1326 in the inner surface of the annular ring 1306 of the spacer 1302. Figure 114 Because the threaded connection has a self-locking thread, the axial force 1330 will not cause the spacer 1302 to rotate, thus restricting the movement of the spacer 1302 relative to the spacer retainer 1304.

[0278] Figures 115A to 115C This illustrates how the spacer assembly 1300 is assembled. In the first step, as... Figure 115A As shown, the distal axial force indicated by arrow 1332 is applied to the proximal end of the sidewall 1312 of the spacer retainer 1304, and the proximal axial force indicated by arrow 1334 is applied to the central post 1314. Subsequently, the fixing device 1336 is used to apply the proximal axial force indicated by arrow 1338 to the proximal flange 1308 of the spacer 1302. Figure 115B The fixing device 1336 has a support surface 1340 that contacts the proximal flange 1308 of the spacer 1302, thereby allowing the spacer 1302 to rotate. When the distally extending flange 1342 on the fixing device 1336 contacts the proximal end 1344 of the container 1344, the rotation of the spacer 1302 stops as a proximal axial load 1338 is transferred to the container 1344. Figure 115C ).

[0279] refer to Figure 116 and Figure 117 The diagram illustrates a spacer assembly 1400 according to another aspect of the invention. The spacer assembly 1400 has a spacer 1402, a spacer retainer 1404, and a locking pin 1406. The spacer 1402 has a sidewall 1408 extending proximally from a bottom portion 1410 and a proximal flange 1412. The sidewall 1408 and the bottom portion 1410 define a recess 1414 for receiving the locking pin 1406. The spacer retainer 1404 is received by a plug 1416 and includes a sidewall 1418 extending proximally from a bottom portion 1420. The sidewall 1418 and the bottom portion 1420 define a central cavity 1422 for receiving the spacer 1402. The spacer retainer 1404 can be attached to the plug 1416 using any suitable method (including, but not limited to, adhesives, threaded connections, and snap-fit ​​connections). The inner surface of the sidewall 1418 of the spacer retainer 1404 includes a threaded portion 1424 that engages a corresponding threaded portion 1426 in the outer surface of the sidewall 1408 of the spacer 1402. After the spacer 1402 is screwed into the central cavity 1422 of the spacer retainer 1404 to give the spacer assembly 1400 the desired length, a locking pin 1406 is inserted into the recess 1414 of the spacer 1402. The locking pin 1406 has substantially the same shape as the recess 1414 of the spacer 1402. The locking pin 1406 maintains good contact between the threaded portion 1426 of the sidewall 1408 of the spacer 1402 and the threaded portion 1424 of the sidewall 1418 of the spacer retainer 1404, thereby forming a locking engagement between the sidewall 1408 of the spacer 1402 and the sidewall 1418 of the spacer retainer 1404.

[0280] refer to Figure 118 The diagram illustrates a spacer assembly 1500 according to another aspect of the invention. The spacer assembly 1500 includes a spacer 1502, a spacer retainer 1504, and an expandable container 1506. The spacer 1502 has a sidewall 1508 extending distally from a proximal flange 1510. The spacer retainer 1504 is received by a plug 1512 and includes a sidewall 1514 extending proximally from a bottom portion 1516. The sidewall 1514 and the bottom portion 1516 define a central cavity 1518 that receives the sidewall 1508 of the spacer 1502. The spacer retainer 1504 can be attached to the plug 1512 using any suitable method (including, but not limited to, adhesives, threaded connections, and snap-fit ​​connections). An opening having a valve 1520 extends through the proximal flange 1510 of the spacer 1502 and into the expandable container 1506. The expandable container 1506 can be filled with air or any other suitable fluid via valve 1520 to change the distance between the proximal flange 1510 and the proximal end of the sidewall 1514 of the spacer retainer 1504, thereby changing the length of the spacer assembly 1600.

[0281] An adjustable plunger assembly 1700 can be provided as an alternative to the adjustable spacer assembly. In this embodiment, as... Figure 119 As shown, the container remains stationary, and the valve assembly is configured to puncture the diaphragm without any movement of the container. A single plunger assembly 1700 is provided, comprising a plunger 1702 having a central channel 1704, a plunger extension 1706, and a biasing member 1708. The inner surface of the central channel 1704 includes a threaded portion 1710 that engages a corresponding threaded portion 1712 in the outer surface of the plunger extension 1706. During assembly of the drug delivery system, the distance by which the plunger extension 1706 extends beyond the distal end 1714 of the plunger 1702 can be varied by adjusting the length of the plunger extension 1706 inserted into the central channel 1704 of the plunger 1702. The plunger assembly 1700 is adjusted by rotating the plunger extension 1706 until the distal end 1716 of the plunger extension 1706 contacts a standard spacer 1718 attached to the stopper 1720. In this way, the plunger extension 1706 replaces the aforementioned adjustable spacer assembly, while still allowing the use of containers with different filling volumes.

[0282] An element of one disclosed aspect may be combined with elements of one or more other disclosed aspects to form different combinations, all of which are considered to be within the scope of the invention.

[0283] Although this disclosure has been described as having an exemplary design, further modifications may be made to this disclosure within its spirit and scope. Therefore, this application is intended to cover any variations, uses, or adaptations of this disclosure using its general principles. Furthermore, this application is intended to cover any deviations from the known or customary practices within the field to which this disclosure pertains and that fall within the limitations of the appended claims.

Claims

1. A drive assembly for a drug delivery system, the drive assembly comprising: a stopper; a plunger member configured to engage and move the stopper within a container, the plunger member having 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 an adjustable spacer assembly positioned between the plunger member and the stopper; wherein the spacer assembly includes a spacer element and a retainer to which the spacer element is attached, wherein the retainer is attached to the stopper, wherein the spacer element is attached to the retainer by a threaded engagement, wherein the threaded engagement allows the spacer element to rotate relative to the retainer when a torque is applied to the spacer element and prevents the spacer element from rotating relative to the retainer when an axial force is applied to the spacer element, and wherein threads disposed on the spacer element are downwardly angled such that applying an axial force to the spacer element causes the threads to drill into a sidewall of the retainer.

2. The drive assembly of claim 1, wherein the spacer assembly further includes a flexible tab extending from the spacer element and a surface of the retainer includes a plurality of ratchets with which the flexible tab engages, wherein the engagement of the flexible tab with the ratchets allows the spacer element to rotate in a direction that threads the spacer element into the retainer and prevents the spacer element from rotating in a direction that removes the spacer element from the retainer.

3. The drive assembly of claim 1, wherein the spacer assembly has a first length in a longitudinal direction when the spacer element is in a first position relative to the retainer and a second length in the longitudinal direction when the spacer element is in a second position relative to the retainer, the first length being greater than the second length.

4. The drive assembly of claim 1, wherein threads disposed on the spacer element extend in a radially outward direction.

5. The drive assembly of claim 1, wherein the retainer is attached to the stopper by a threaded engagement.

6. The drive assembly of claim 1, wherein the spacer assembly further includes a locking pin and the spacer element further includes a recess for receiving the locking pin.

7. A drug delivery system for injecting a drug, the drug delivery system comprising: a container configured to receive a drug, the container including a stopper configured to move within the container and a closure; a drive assembly comprising: a plunger member configured to engage and move the stopper within the container, the plunger member having 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 an adjustable spacer assembly positioned between the plunger member and the stopper; ​ wherein the spacer assembly comprises a spacer element and a retainer to which the spacer element is attached, wherein the retainer is attached to the stopper, wherein the spacer element is attached to the retainer by a threaded engagement, wherein the threaded engagement allows the spacer element to rotate relative to the retainer when a torque is applied to the spacer element and prevents the spacer element from rotating relative to the retainer when an axial force is applied to the spacer element, and wherein the threads disposed on the spacer element are downwardly angled such that application of an axial force to the spacer element causes the threads to drill into the sidewall of the retainer; and a needle actuator assembly comprising a needle configured to be placed in fluid communication with the container.

8. The drug delivery system of claim 7, wherein the retainer is attached to the stopper by a threaded engagement.

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