Needle actuator assembly for drug delivery system

Abstract

To provide a drug delivery system including an index member configured to rotate one way with regard to a housing.SOLUTION: A needle actuator assembly for a drug delivery system is provided, the assembly including: a housing; a container configured to contain a medicament; a needle connected to the housing; a stopper configured to move within the container; and a drive assembly configured to move the stopper within the container. The drive assembly includes a first plunger member, a second plunger member, and an index member. The first plunger member is received within the second plunger member and extends from the second plunger member during axial movement from a pre-use position to a use position. The index member receives a part of the second plunger member and rotates the second plunger member with regard to the housing.SELECTED DRAWING: Figure 26

Description

[Technical Field]

[0001] This application claims priority to U.S. Provisional Application No. 62 / 347,921, filed June 9, 2016, and U.S. Patent Application No. 15 / 616,212, filed June 7, 2017, each of which is incorporated by reference herein in its entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to infusion devices and methods for delivering fluids into a patient's body by infusion. [Background technology]

[0003] Various types of automatic injection devices have been developed to allow drug solutions and other liquid therapeutic preparations to be administered or self-injected by untrained personnel. These devices generally include a reservoir prefilled with the liquid therapeutic preparation and some type of automatic needle injection mechanism that can be triggered by the user. Automatic injectors are typically used when the volume of fluid or medication to be administered is less than a certain amount, typically 1 mL, and typically have an injection time of approximately 10 to 15 seconds. When the volume of fluid or medication to be administered exceeds 1 mL, the injection time generally increases, resulting in difficulty maintaining contact between the device and the target site on the patient's skin. Furthermore, as the volume of medication administered increases, it is desirable to increase the injection time. The conventional method for slowly injecting medication into a patient is to start an IV and slowly infuse the medication into the patient's body. Such procedures are typically performed in a hospital or outpatient setting. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] International Publication No. 2013 / 155153 [Patent Document 2] International Publication No. 2014 / 179774 [Patent Document 3] International Publication No. 2015 / 081337 Summary of the Invention [Problem to be solved by the invention]

[0005] Certain devices allow for self-injection in a home setting, gradually infusing a liquid therapeutic formulation into a patient's skin. In some cases, these devices are small enough (both in height and overall size) to be "worn" by the patient while the liquid therapeutic formulation is being injected into the patient's body. These devices typically include a pump or other type of ejection mechanism that forces the liquid therapeutic formulation from a reservoir into a syringe needle. Such devices also typically include a valve or flow control mechanism to allow the liquid therapeutic preparation to begin flow at the appropriate time, and a trigger mechanism to initiate the injection. [Means for solving the problem]

[0006] In one aspect, a needle actuator assembly for a medication delivery system includes a needle actuator body having a guide surface and a needle shuttle having a cam surface, the needle shuttle being movable along a vertical axis between a first position and a second position. The needle shuttle is configured to move between the first position and the second position by engagement of the guide surface of the needle actuator body with the cam surface of the needle shuttle. The assembly further includes a needle received by the needle shuttle.

[0007] The needle shuttle may include a biasing member configured to move the needle shuttle from the first position to the second position, with the guide surface of the needle actuator body disengaging from the cam surface of the needle shuttle. The assembly may include a guide post along which the needle shuttle moves. The guide post may be linear. The cam surface of the needle shuttle includes a first cam member and a second cam member spaced from the first cam member, where the guide surface is non-linear and includes a first side and a second side opposite the first side. The second cam member of the needle shuttle may be configured to engage the second side of the guide surface to move the needle shuttle from the first position to the second position, and the first cam member of the needle shuttle may be configured to engage the first side of the guide surface to move the needle shuttle from the second position to the first position.

[0008] In a further aspect, a medication delivery system for injecting a medication includes a housing and a needle actuator assembly contained within the housing, the needle actuator assembly including a needle actuator body having a guide surface, the needle actuator body being movable between a first position and a second position, and a needle shuttle having a cam surface. The needle shuttle is movable along a vertical axis between the first position and the second position, the needle shuttle being configured to move between the first position and the second position through engagement of the guide surface of the needle actuator body with the cam surface of the needle shuttle. The needle actuator assembly also includes a needle received by the needle shuttle. The system further includes a button actuator at least partially received by the housing, wherein movement of the button actuator is configured to move the needle actuator body from the first position to the second position, and movement of the needle actuator body from the first position to the second position is configured to move the needle shuttle from the first position to the second position.

[0009] The needle shuttle may include a biasing member configured to move the needle shuttle from the first position to the second position, wherein the guide surface of the needle actuator body disengages from the cam surface of the needle shuttle. The system may include a guide post extending from the housing, the needle shuttle moving along the guide post. The guide post may extend substantially perpendicularly from the housing.

[0010] The system can include a pad configured to engage the needle when the needle actuator is in the second position. The pad can be received by a pad arm having a cam surface configured to engage a corresponding cam track on the housing to move the pad under the needle.

[0011] The above and other features and advantages of the present disclosure, and the manner in which they are achieved, will be better understood by referring to the following description of the embodiments of the disclosure taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0012] [Figure 1] 1 is a perspective view of a drug delivery system according to one embodiment of the present invention. [Figure 2] 2 is a perspective cross-sectional view of the drug delivery system of FIG. 1 according to one embodiment of the present invention. [Figure 3] 2 is a front cross-sectional view of the drug delivery system of FIG. 1 according to one embodiment of the present invention. [Figure 4] 2 is a top view of the drug delivery system of FIG. 1, showing the top of the housing shown in FIG. 1 removed and the drug delivery system in a pre-use position, according to one embodiment of the present invention. [Figure 5] 2 is a top cross-sectional view of the drug delivery system of FIG. 1, showing the drug delivery system in a pre-use position, according to one embodiment of the present invention. [Figure 6] 2 is a front cross-sectional view of the drug delivery system of FIG. 1, showing the drug delivery system in a pre-use position, according to one embodiment of the present invention. [Figure 7]2 is a top view of the drug delivery system of FIG. 1 showing the housing with the top removed and the drug delivery system in an initial, activated position, according to one embodiment of the present invention. [Figure 8] 2 is a top cross-sectional view of the drug delivery system of FIG. 1, showing the drug delivery system in an initial actuated position, according to one embodiment of the present invention. [Figure 9] 2 is a top cross-sectional view of the drug delivery system of FIG. 1, showing the drug delivery system in an initial actuated position, according to one embodiment of the present invention. [Figure 10] 2 is a top view of the drug delivery system of FIG. 1 showing the top of the housing removed and the drug delivery system in a position of use, according to one embodiment of the present invention. [Figure 11] 2 is a top cross-sectional view of the drug delivery system of FIG. 1, showing the drug delivery system in a position of use, according to one embodiment of the present invention. [Figure 12] 2 is a top cross-sectional view of the drug delivery system of FIG. 1, showing the drug delivery system in a position of use, according to one embodiment of the present invention. [Figure 13] 2 is a top view of the drug delivery system of FIG. 1 showing the top of the housing removed and the drug delivery system in a post-use position, according to one embodiment of the present invention. [Figure 14] 2 is a top cross-sectional view of the drug delivery system of FIG. 1, showing the drug delivery system in a post-use position, according to one embodiment of the present invention. [Figure 15] 2 is a front cross-sectional view of the drug delivery system of FIG. 1, showing the drug delivery system in a post-use position, according to one embodiment of the present invention. [Figure 15A] 2 is a front cross-sectional view of the drug delivery system of FIG. 1 showing a pad with the drug delivery system in a pre-use position, according to one embodiment of the present invention. [Figure 15B] 2 is a perspective cross-sectional view of the drug delivery system of FIG. 1 showing a pad with the drug delivery system in a pre-use position, according to one embodiment of the present invention. [Figure 15C]2 is a perspective cross-sectional view of the drug delivery system of FIG. 1 showing a pad with the drug delivery system in a pre-use position according to one embodiment of the present invention. FIG. [Figure 16] 2 is a partial cross-sectional view of the drug delivery system of FIG. 1 showing a valve assembly according to one embodiment of the present invention. [Figure 17] 1 is a perspective view of a drive assembly for a medication delivery system according to one aspect of the present invention; [Figure 18] FIG. 18 is a cross-sectional view of the drive assembly of FIG. 17, illustrating the drive assembly in a pre-use position, according to one embodiment of the present invention. [Figure 19] 18 is a cross-sectional view of the drive assembly of FIG. 17, showing the drive assembly in an in-use position, according to one embodiment of the present invention. [Figure 20] 18 is a cross-sectional view of the drive assembly of FIG. 17, showing the drive assembly in a post-use position, according to one embodiment of the present invention. [Figure 21] FIG. 18 is a perspective view of a plunger actuation member of the drive assembly of FIG. 17 in accordance with one embodiment of the present invention. [Figure 22] FIG. 18 is a perspective view of a first plunger member of the drive assembly of FIG. 17 according to one embodiment of the present invention. [Figure 23] FIG. 18 is a perspective view of the plunger actuation member and first plunger member of the drive assembly of FIG. 17, showing the plunger actuation member engaged with the first plunger member, in accordance with an embodiment of the present invention. [Figure 24] FIG. 18 is a perspective view of the plunger actuation member and first plunger member of the drive assembly of FIG. 17, showing the plunger actuation member disengaged from the first plunger member, in accordance with an embodiment of the present invention. [Figure 25] FIG. 18 is a perspective view of the plunger actuation member and first plunger member of the drive assembly of FIG. 17, showing the plunger actuation member disengaged from and axially displaced relative to the first plunger member, in accordance with one embodiment of the present invention. [Figure 26] FIG. 18 is a front view of the first plunger member and the second plunger member of the drive assembly of FIG. 17 according to one embodiment of the present invention. [Figure 27]FIG. 10 is a top view of a drive assembly for a medication delivery system according to a further aspect of the present invention. [Figure 28] FIG. 28 is a perspective view of the drive assembly of FIG. 27 according to one embodiment of the present invention. [Figure 29] FIG. 28 is a cross-sectional view of the drive assembly of FIG. 27, showing the drive assembly in a pre-use position, according to one embodiment of the present invention. [Figure 30] FIG. 28 is a perspective view of the drive assembly of FIG. 27, showing the drive assembly received by the bottom of the housing, according to one embodiment of the present invention. [Figure 31] FIG. 31 is a perspective view of the housing of FIG. 30 according to one embodiment of the present invention. [Figure 32] FIG. 28 is a top view of the drive assembly of FIG. 27 illustrating engagement of the drive assembly with a portion of the needle actuator in the initial actuated position of the drive assembly, according to one embodiment of the present invention. [Figure 33] FIG. 28 is an enlarged perspective view of the drive assembly of FIG. 27, illustrating engagement of the drive assembly with a portion of the needle actuator in the initial actuated position of the drive assembly, according to one embodiment of the present invention. [Figure 34] FIG. 1 is a front view of a needle actuator assembly according to one aspect of the present invention. [Figure 35] FIG. 35 is a left perspective view of the needle shuttle of the needle actuator assembly of FIG. 34, according to one embodiment of the present invention. [Figure 36] FIG. 35 is a right-side perspective view of the needle shuttle of the needle actuator assembly of FIG. 34, according to one embodiment of the present invention. [Figure 37A] FIG. 35 is a front view of the needle actuator assembly of FIG. 34, showing the needle actuator assembly in a pre-use position, according to an embodiment of the present invention. [Figure 37B] FIG. 35 is a front view of the needle actuator assembly of FIG. 34, showing the needle actuator assembly in the use position. [Figure 37C] FIG. 35 is a front view of the needle actuator assembly of FIG. 34, showing the needle actuator assembly in an initial position after use, according to one embodiment of the present invention. [Figure 37D]FIG. 35 is a front view of the needle actuator assembly of FIG. 34, showing the needle actuator assembly in a post-needle position, according to one embodiment of the present invention. [Figure 38A] 35 is a perspective view of the needle actuator assembly of FIG. 34 in the needle use position, according to one embodiment of the present invention. [Figure 38B] FIG. 35 is a perspective view of the needle actuator assembly of FIG. 34, showing the needle actuator assembly in an initial, post-use position, according to one embodiment of the present invention. [Figure 39] FIG. 35 is a perspective view of the actuator button and needle actuator assembly of FIG. 34, showing the needle actuator assembly in an initial position after use, according to one embodiment of the present invention. [Figure 40A] FIG. 35 is a cross-sectional view of the actuator button and needle actuator assembly of FIG. 34, showing the needle actuator assembly in an initial position after use. [Figure 40B] FIG. 35 is a perspective view of the actuator button and needle actuator assembly of FIG. 34, showing the needle actuator assembly in a post-use position, according to an embodiment of the present invention. [Figure 41] FIG. 10 is a perspective view of a drive assembly for a medication delivery system according to a further aspect of the present invention. [Figure 42] 42 is a perspective view of the drive assembly of FIG. 41, showing the top of the housing removed in the embodiment of FIG. 41, in accordance with an aspect of the present invention. [Figure 43] FIG. 42 is a cross-sectional view of the drive assembly of FIG. 41 according to one embodiment of the present invention. [Figure 44] FIG. 42 is a perspective view of the drive assembly of FIG. 41 according to one embodiment of the present invention. [Figure 45] FIG. 42 is a cross-sectional view of the drive assembly of FIG. 41 showing the drive assembly in a pre-use position, according to one embodiment of the present invention. [Figure 46] FIG. 42 is a cross-sectional view of the drive assembly of FIG. 41 showing the drive assembly in a pre-use position, according to one embodiment of the present invention. [Figure 47]FIG. 42 is a top view of the drive assembly of FIG. 41 showing the drive assembly in a pre-use position, according to one embodiment of the present invention. [Figure 48] FIG. 42 is a top view of the drive assembly of FIG. 41, showing the drive assembly in an initial actuated position, according to one embodiment of the present invention. [Figure 49] FIG. 42 is a top view of the drive assembly of FIG. 41, showing the drive assembly in an initial actuated position, according to one embodiment of the present invention. [Figure 50] FIG. 42 is a top view of the drive assembly of FIG. 41, showing the drive assembly in an initial actuated position, according to one embodiment of the present invention. [Figure 51] FIG. 42 is a top view of the drive assembly of FIG. 41, showing the drive assembly in an in-use position, according to one embodiment of the present invention. [Figure 52] FIG. 42 is a top view of the drive assembly of FIG. 41, showing the drive assembly in an in-use position, according to one embodiment of the present invention. [Figure 53] FIG. 42 is a cross-sectional view of the drive assembly of FIG. 41, showing the drive assembly in an in-use position, according to one embodiment of the present invention. [Figure 54] FIG. 42 is a top view of the drive assembly of FIG. 41, showing the drive assembly in an in-use position, according to one embodiment of the present invention. [Figure 55] FIG. 42 is a cross-sectional view of the drive assembly of FIG. 41, showing the drive assembly in an in-use position, according to one embodiment of the present invention. [Figure 56] FIG. 42 is a cross-sectional view of the drive assembly of FIG. 41, showing the drive assembly in an in-use position, according to one embodiment of the present invention. [Figure 57] FIG. 42 is a top view of the drive assembly of FIG. 41, showing the drive assembly in an in-use position, according to one embodiment of the present invention. [Figure 58] FIG. 42 is a top view of the drive assembly of FIG. 41, showing the drive assembly in an initial position after use, according to one embodiment of the present invention. [Figure 59] FIG. 42 is a perspective view of the drive assembly of FIG. 41 in an initial position after use, according to one embodiment of the present invention. [Figure 60]FIG. 42 is a top view of the drive assembly of FIG. 41 showing the drive assembly in a post-use position, according to one embodiment of the present invention. [Figure 61] FIG. 42 is a top view of the drive assembly of FIG. 41 showing the drive assembly in a post-use position, according to one embodiment of the present invention. [Figure 62] FIG. 42 is a cross-sectional view of the drive assembly of FIG. 41 showing the drive assembly in a pre-use position, according to one embodiment of the present invention. [Figure 63] FIG. 42 is a cross-sectional view of the drive assembly of FIG. 41, showing the drive assembly in an in-use position, according to one embodiment of the present invention. [Figure 64] FIG. 10 is a perspective view of a drive assembly according to a further aspect of the present invention. [Figure 65A] FIG. 2 is a front view of a needle actuator assembly in a use position, according to one aspect of the present invention. [Figure 65B] FIG. 65B is a front view of the needle actuator assembly of FIG. 65A, showing the needle actuator assembly in a use position, according to one embodiment of the present invention. [Figure 65C] FIG. 65B is a front view of the needle actuator assembly of FIG. 65A showing the needle actuator assembly in an initial, post-use position, according to an embodiment of the present invention. [Figure 65D] FIG. 65B is a front view of the needle actuator assembly of FIG. 65A showing the needle actuator assembly in a post-use position, according to an embodiment of the present invention. [Figure 65E] FIG. 65B is a front view of the needle actuator assembly of FIG. 65A showing the needle actuator assembly in a pre-use position, according to an embodiment of the present invention. [Figure 65F] FIG. 65B is a cross-sectional view of the needle actuator assembly of FIG. 65A showing the needle actuator assembly in a pre-use position, according to an embodiment of the present invention. [Figure 65G] FIG. 65B is a front view of the needle actuator assembly of FIG. 65A showing the needle actuator assembly in an axially displaced, pre-use position according to one embodiment of the present invention. [Figure 65H]FIG. 65B is a cross-sectional view of the needle actuator assembly of FIG. 65A showing the needle actuator assembly in an axially displaced, pre-use position according to one embodiment of the present invention. [Figure 66] FIG. 65B is a perspective view of a button spring of the needle actuator assembly of FIG. 65A according to one embodiment of the present invention. [Figure 67] FIG. 65B is a perspective view of an actuator button of the needle actuator assembly of FIG. 65A according to one embodiment of the present invention. [Figure 68] FIG. 65B is a cross-sectional view of the button spring and actuator button of the needle actuator assembly of FIG. 65A according to one embodiment of the present invention. [Figure 68A] FIG. 65B is a perspective view of an actuator button of the needle actuator assembly of FIG. 65A according to a further embodiment of the present invention. [Figure 68B] FIG. 65B is a bottom view of the actuator button of the needle actuator assembly of FIG. 65A according to a further embodiment of the present invention. [Figure 68C] FIG. 65B is a front view of an actuator button of the needle actuator assembly of FIG. 65A according to a further embodiment of the present invention. [Figure 68D] FIG. 65B is a top view of the actuator button of the needle actuator assembly of FIG. 65A, showing the actuator button in a pre-use position, according to a further embodiment of the present invention. [Figure 68E] FIG. 65B is a front view of the actuator button of the needle actuator assembly of FIG. 65A, showing the actuator button in a pre-use position, according to a further embodiment of the present invention. [Figure 68F] FIG. 65B is a top view of the actuator button of the needle actuator assembly of FIG. 65A, showing the actuator button in a use position, according to a further embodiment of the present invention. [Figure 68G] FIG. 65B is a front view of the actuator button of the needle actuator assembly of FIG. 65A, showing the actuator button in a use position, according to a further embodiment of the present invention. [Figure 69]FIG. 65B is a top view of the actuator button of the needle actuator assembly of FIG. 65A according to one embodiment of the present invention. [Figure 70A] FIG. 1 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. [Figure 70B] FIG. 70B is a schematic diagram of the drive assembly of FIG. 70A, showing the drive assembly in a use position, according to one embodiment of the present invention. [Figure 70C] FIG. 70B is a schematic diagram of the drive assembly of FIG. 70A, showing the drive assembly in a use position, according to one embodiment of the present invention. [Figure 70D] FIG. 70B is a schematic diagram of the drive assembly of FIG. 70A, showing the drive assembly in a use position, according to one embodiment of the present invention. [Figure 70E] FIG. 70B is a schematic diagram of the drive assembly of FIG. 70A, showing the drive assembly in a use position, according to one embodiment of the present invention. [Figure 70F] FIG. 70B is a schematic diagram of the drive assembly of FIG. 70A, showing the drive assembly in a post-use position, according to one embodiment of the present invention. [Figure 70G] FIG. 1 is a schematic diagram of a drive assembly according to one aspect of the present invention, showing the drive assembly in a post-use position. [Figure 71] FIG. 1 is a perspective view of a spacer assembly for a drug delivery system according to one aspect of the present invention, showing the spacer assembly in an assembled, pre-use position. [Figure 72] FIG. 72 is a perspective view of the spacer assembly of FIG. 71, showing the spacer assembly in use position, according to one embodiment of the present invention. [Figure 73] FIG. 72 is a perspective view of the spacer assembly of FIG. 71 showing the initial, post-use position of the spacer assembly, according to one embodiment of the present invention. [Figure 74] FIG. 2 is a perspective view of a restraining member according to one aspect of the present invention. [Figure 75] FIG. 10 is a front view of a spacer assembly for a medication delivery system according to a further aspect of the present invention. [Figure 76] 1 is a top view of a spacer assembly for a drug delivery system according to one aspect of the present invention. [Figure 77] FIG. 77 is a perspective view of the spacer assembly of FIG. 76 according to one embodiment of the present invention. [Figure 78] FIG. 77 is a cross-sectional view of the spacer assembly of FIG. 76, according to one embodiment of the present invention. [Figure 79] FIG. 10 is a perspective view of a spacer assembly for a drug delivery system according to a further aspect of the present invention. [Figure 80] FIG. 10 is a perspective view of a spacer assembly for a drug delivery system according to another aspect of the present invention. [Figure 81A] 81 is a cross-sectional view of the spacer assembly of FIG. 80 showing the spacer assembly in a pre-assembled position, according to one embodiment of the present invention. [Figure 81B] FIG. 81 is a cross-sectional view of the spacer assembly of FIG. 80, showing the spacer assembly in an assembled position, according to one embodiment of the present invention. [Figure 82] 1 is a perspective view of a drive assembly for a medication delivery system according to one aspect of the present invention; [Figure 83] FIG. 83 is a perspective view of the drive assembly of FIG. 82 with the top of the housing removed, in accordance with one embodiment of the present invention. [Figure 84] FIG. 83 is a cross-sectional view of the drive assembly of FIG. 82 showing the drive assembly in a pre-use position, according to one embodiment of the present invention. [Figure 85] FIG. 83 is an enlarged cross-sectional view of the drive assembly of FIG. 82, illustrating the drive assembly in a pre-use position, according to one embodiment of the present invention. [Figure 86] FIG. 83 is a top view of a biasing member of the drive assembly of FIG. 82 in accordance with an embodiment of the present invention. [Figure 87] FIG. 83 is a perspective view of the drive assembly of FIG. 82 showing a restricting member engaged with the drive assembly, according to one aspect of the present invention. [Figure 88] 1 is a perspective view of a drive assembly for a medication delivery system according to one aspect of the present invention; [Figure 89] FIG. 89 is a perspective view of the drive assembly of FIG. 88, showing the drive assembly in a pre-use position, according to one embodiment of the present invention. [Figure 90]FIG. 89 is a cross-sectional view of the drive assembly of FIG. 88, according to one embodiment of the present invention. [Figure 91] FIG. 1 is a perspective view of a drive assembly according to one aspect of the present invention, showing the drive assembly in a post-use position. [Figure 92] FIG. 89 is a cross-sectional view of the drive assembly of FIG. 88, showing the drive assembly in a pre-use position, according to one embodiment of the present invention. [Figure 93] FIG. 89 is a front view of the drive assembly of FIG. 88, showing the drive assembly in an in-use position, according to one embodiment of the present invention. [Figure 94] 1 is a perspective view of a spacer assembly for a drug delivery system according to one aspect of the present invention; [Figure 95] FIG. 95 is a front view of the spacer assembly of FIG. 94 according to one embodiment of the present invention. [Figure 96] FIG. 95 is a cross-sectional view of the spacer assembly of FIG. 94, according to one embodiment of the present invention. [Figure 97] FIG. 95 is a perspective view of the spacer assembly of FIG. 94 showing the shim removed, according to one embodiment of the present invention. [Figure 98] FIG. 95 is a perspective view of a fixed spacer of the spacer assembly of FIG. 94 according to one embodiment of the present invention. [Figure 99] FIG. 95 is a perspective view of an adjustable spacer of the spacer assembly of FIG. 94 according to one embodiment of the present invention. [Figure 100] FIG. 95 is a perspective view of a shim of the spacer assembly of FIG. 94 according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0013] Corresponding reference numerals indicate corresponding parts throughout the several views. The exemplifications set forth herein illustrate exemplary embodiments of the present disclosure, and such exemplifications should not be construed as limiting the scope of the present disclosure in any way.

[0014] The following description is provided to enable any person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the invention.

[0015] For purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "transverse," "longitudinal," and their derivatives will refer to the present invention as oriented in the drawings. However, it should be understood that the present invention may contemplate various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0016] 1-16 , a drug delivery system 10 according to one embodiment of the present invention includes a drive assembly 12, a reservoir 14, a valve assembly 16, and a needle actuator assembly 18. The drive assembly 12, the reservoir 14, the valve assembly 16, and the needle actuator assembly 18 are at least partially disposed within a housing 20. The housing 20 includes a top portion 22 and a bottom portion 24, although other suitable arrangements for the housing 20 may be utilized. In one embodiment, the drug delivery system 10 is a syringe device worn or secured to a user and configured to deliver a predetermined dose of a drug provided in the reservoir 14 by injection into the user. The system 10 may be utilized to deliver a “bolus injection” in which the drug is delivered within a set time period. The drug may be delivered over a period of up to 45 minutes, although other suitable injection volumes and durations may be utilized. The bolus administration or delivery may be performed with or without a specific speed control. The system 10 may deliver the drug to the user at a constant pressure with a variable rate. The general operation of system 10 is described below with reference to Figures 1-16, and drive assembly 12, needle actuator assembly 18, and other features of system 10 are discussed below in connection with Figures 17-93.

[0017] 1-16 , system 10 is configured to operate via engagement of actuator button 26 by a user, which causes needle 28 of needle actuator assembly 18 to pierce the user's skin, actuation of drive assembly 12 to place needle 28 in fluid communication with container 14 and expel fluid or medication from container 14, and complete withdrawal of needle 28 after medication is injected. The general operation of a medication delivery system is shown and described in U.S. Patent Nos. 5,629,999 and 5,729,999, which are incorporated herein by reference in their entireties. Housing 20 of system 10 includes an indicator window 30 for viewing indicator arrangement 32 configured to provide instructions to the user regarding the status of system 10, and a container window 31 for viewing container 14. Indicator window 30 may be a magnifying lens to provide a clear view of indicator arrangement 32. Indicator arrangement 32 moves with needle actuator assembly 18 during use of system 10, indicating pre-use, use, and post-use states of system 10. The indicator arrangement 32 provides a visual indication of the status, but may alternatively or additionally provide other suitable indications, such as audio or tactile.

[0018] 4-6 , during the pre-use position of system 10, container 14 is spaced from drive assembly 12 and valve assembly 16, and needle 28 is in a retracted position. As shown in FIGS. 7-9 , during initial actuation of system 10, drive assembly 12 engages container 14 and moves container 14 toward valve assembly 16, which is configured to puncture closure 36 of container 14 and place the medicament within container 14 in fluid communication with needle 28 via tubing (not shown) or other suitable arrangement. Drive assembly 12 is configured to engage stopper 34 of container 14, which, due to the incompressibility of the fluid or medicament within container 14, will initially move the entire container 14 into engagement with valve assembly 16. Initial actuation of system 10 is triggered by engagement of actuator button 26 by a user, which releases needle actuator assembly 18 and drive assembly 12, as described in detail below. During the first actuation, needle 28 is still in the retracted position and is about to move to the extended position to inject the user of system 10 .

[0019] As shown in FIGS. 10-12 , during the use position of system 10, needle 28 is in an extended position at least partially outside housing 20, and drive assembly 12 moves stopper 34 within container 14 to deliver medication from container 14, through needle 28, and to the user. In the use position, valve assembly 16 has already pierced closure 36 of container 14, placing container 14 in fluid communication with needle 28, which also allows drive assembly 12 to move stopper 34 relative to container 14 so that fluid can be dispensed from container 14. In the post-use position of system 10, shown in FIGS. 13-15 , needle 28 is in a retracted position, engaging pad 38 to seal needle 28 and prevent any residual flow of fluid or medication from container 14. The container 14 and valve assembly 16 may be the container 14 and valve assembly 16 shown and described in U.S. Patent Application Publication No. 2009 / 0129994, the entirety of which is incorporated herein by reference.

[0020] 15A-15C, the pad 38 is urged into the needle when the needle actuator body 96 moves from the use position to the post-use position. Specifically, the pad 38 is received by a pad arm 122 having a cam surface 124 that cooperates with a cam track 126 on the bottom 24 of the housing 20. The pad arm 122 is connected to the needle actuator body 96 via a torsion bar 128. The cam surface 124 is configured to engage the cam track 126 and bias the pad arm 122 downward, so that the pad 38 passes under the needle 28 before being urged upward into the needle 28. The torsion bar 128 allows the pad arm 122 to twist about the pivot of the needle actuator body 96. The pad 38 may be press-fit into an opening in the pad arm 122, although other suitable arrangements for securing the pad 38 may be utilized.

[0021] Referring to Figures 1-33, a drive assembly 12 according to one embodiment of the present invention is shown. As described above, the drive assembly 12 is configured to move the container 14, pierce the closure 36 of the container 14, and move the stopper 34 within the container 14 to dispense a fluid or medication from the container 14. The drive assembly 12 shown in Figures 17-33 is configured to engage and cooperate with a spacer assembly 40 that is received by the stopper 34 of the container 14. The spacer assembly 40 includes a spacer 42 and a spacer holder 44. The spacer holder 44 is received in the stopper 34, and the spacer 42 is received in the spacer holder 44. The spacer holder 44 includes a first threaded portion 46 that engages with a corresponding threaded portion of the stopper 34, although other suitable configurations may be utilized. The spacer 42 also includes a threaded portion 48 that engages a corresponding second threaded portion 50 of the spacer holder 44 to secure the spacer 42 to the spacer holder 44, although other suitable configurations may be utilized. The drive assembly 12 is configured to dispense a range of predetermined fill volumes for the container 14 while maintaining the functional characteristics of the system 10 described above, including, but not limited to, retraction of the needle 28 after the end of the dose and providing an indication of the status of the system 10, while also minimizing abrupt engagement of the stopper 34 by the drive assembly 12. The drive assembly 12 is configured to dispense multiple distinct fill volume ranges by utilizing multiple sizes of spacers 42. In one embodiment, 12 fill volume ranges and 12 sizes of spacers 42 are provided. In one embodiment, the length of the spacer 42 is varied to accommodate different fill volumes in the container 14. Alternatively, a single size spacer 42 may be utilized, and multiple fill volumes in the container 14 are accommodated by utilizing multiple shims received by the spacer 42.

[0022] 17-26, 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 movable from a pre-use position (shown in FIG. 18), a use position (shown in FIG. 19), and a post-use position (shown in FIG. 20), and the first plunger member 52 is configured to engage the spacer assembly 40 and move the stopper 34 into the container 14 to dispense the medicament from the container 14. The first plunger member 52 is configured to move axially. The second plunger member 54 and the first plunger member 52 form a nested structure, and the second plunger 54 is configured to move axially after the first plunger member 52 has moved a predetermined axial distance. Movement of the first and second plunger members 52, 54 is effected by first and second biasing members 56, 58 which are compression springs, although other suitable configurations for the biasing members 56, 58 may be utilized.

[0023] The first biasing member 56 is received by the second plunger member 54 and is captured between the plunger actuation member 60 (and indexing member 62) and a first spring seat 64 of the second plunger member 54. The second biasing member 58 is disposed radially inward from the first biasing member 56 and is received by the second plunger member 54. The second biasing member 58 is captured between the second spring seat 66 of the second plunger member 54 and the first plunger member 52. The second biasing member 58 is configured to bias the first plunger member 52 toward the container 14 from a pre-use position to a use position and to a post-use position. The first biasing member 56 is configured to bias the second plunger member 54 toward the container 14, which in turn biases the first plunger member 52 toward the container 14 from a pre-use position to a use position and to a post-use position. More specifically, the second biasing member 58 is configured to drive the first plunger member 52 toward the spacer assembly 40 or stopper 34, moving the container 14 into engagement with the valve assembly 16, thereby puncturing the closure 36 of the container 14 and placing the container 14 in fluid communication with the needle 28. The first biasing member 56 is configured to move the stopper 34 within the container 14 and dispense the medicament into the container 14. The second biasing member 58 has a different spring constant than the first biasing member 56. In particular, the second biasing member 58 is stiffer than the first biasing member 56 and provides a higher force for puncturing the closure 36 of the container 14, while the first biasing member 56 provides a dispensing force appropriate for the viscosity of the fluid or medicament within the container 14.

[0024] 17-26, the plunger actuation member 60 has an annular portion 68 and a spindle portion 70. The plunger actuation member 60 is rotationally 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, although other suitable positions may be utilized. The annular portion 68 includes a drive surface 72 including a plurality of gears 74, although other suitable arrangements may be utilized for the drive surface 72. The spindle portion 70 includes an actuator locking surface 76 configured to engage and disengage 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 notches 81 defined by the actuator locking surface 76.

[0025] 18 and 23, in a first rotational position of the plunger actuation member 60, the plurality of protrusions 80 and the plurality of slots or notches 81 are misaligned and the plunger actuation member 60 engages the first plunger member 52 to prevent movement of the first and second plunger members 52, 54, and the first and second biasing members 56, 58 bias the first and second plunger members 52, 54 away from the plunger actuation member 60. As shown in FIGS. 19 and 24, in a second rotational position of the plunger actuation member 60, the plurality of protrusions 80 and the plurality of slots or notches 81 are aligned and the plunger actuation member 60 disengages from the first plunger member 52 to allow movement of the first and second plunger members 52, 54, thereby initiating the dispensing process from the container 14.

[0026] 7 and 33 , the drive surface 72 of the plunger actuation member 60 is configured to be engaged by a portion of the needle actuator assembly 18. As will be described in more detail below, after engagement of the actuator button 26 and release of the needle actuator assembly 18, the needle actuator assembly 18 moves within the housing 20 from a pre-use position to a use position and 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. As shown in FIG. 33 , an angled blade portion 82 of the needle actuator assembly 18 engages the drive surface 72 of the plunger actuation member 60 to cause rotation of the plunger actuation member 60.

[0027] 11 , 13 , and 26 , the second plunger member 54 includes a plurality of coding projections 84, a pre-selected one of which is configured to engage a limiting member 86 of the system 10. As described in more detail below, the limiting member 86 cooperates with the needle actuator assembly 18 to limit movement of the needle actuator assembly 18 from the use position to the post-use position until a predetermined end-of-dose position of the stopper 34 is reached. In one aspect, the limiting member 86 is configured to limit axial movement of the needle actuator assembly 18 from the use position via engagement between the limiting member 86 and a portion of the needle actuator assembly 18. Such engagement between the limiting member 86 and the needle actuator assembly 18 is released by rotation of the limiting member 86 when the stopper 34 reaches the end-of-dose position. During the use position of the needle actuator assembly 18, the stop member 86 is rotationally biased, and rotation of the stop member 86 is prevented via engagement between the stop member 86 and one of the coding protrusions 84 on the second plunger member 54. The coding protrusions 84 may be axial ribs of varying lengths, although other suitable arrangements may be utilized. Each of the coding protrusions 84 defines a point at which the stop member 86 may rotate to release the needle actuator assembly 18. A smooth portion on the second plunger member 54 may provide an additional "code" for determining when the system 10 transitions to the end-of-dose position.

[0028] As described above, indicator arrangement 32 moves as system 10 moves from its pre-use, use, and post-use or end-of-dose positions, and different portions of indicator arrangement 32 are visible through indicator window 30. More specifically, indicator arrangement 32 engages a portion of restricting member 86 and moves with restricting member 86 through various stages of system 10, providing an indication to the user as to the status of system 10.

[0029] During assembly of the system 10, the dose volume of the container 14 is matched with a particular spacer 42 having a set length, and a corresponding one of the plurality of coding projections 84 is aligned with the restricting member 86. Thus, as described above, the container 14 may be provided with multiple doses, each volume corresponding to a particular spacer 42 and coding projection 84. Thus, even with different doses, the system 10 is configured to inject the needle 28 into a user to deliver a dose of medication from the container 14, retract the injection needle 28 after administration, and provide an indication of the status of the system 10, while minimizing abrupt engagement of the stopper 34 by the drive assembly 12. Notably, the size of the stopper 34 may be selected to minimize the distance between the first plunger member 52 and the spacer assembly 40, eliminating the need for vibration damping material.

[0030] Referring to Figures 27-33, a drive assembly 12A according to a further embodiment of the present invention is shown. The drive assembly 12 shown in Figures 27-33 is similar to the drive assembly 12 shown in Figures 17-26 and described above, and operates in a similar manner. In the drive assembly of Figures 17-26, however, the first plunger member 52 is received in the second plunger member 54 and extends from the second plunger member 54 during axial movement from the pre-use position to the use position. Additionally, the first plunger member 52 includes an extension portion 88 configured to engage the second plunger member 54 after the first plunger member 52 has moved a predetermined axial distance, and the first plunger member 52 and the second plunger member 54 move together. The first and second biasing members 56, 58 engage and act on the first and second plunger members 52, 54 in the same manner as the drive assembly 12 of Figures 17-26.

[0031] 27-32, the indexing member 62 includes a plurality of ratchet teeth 90 disposed about the first and second plunger members 52, 54 and configured to engage flexible tabs 92 disposed on the bottom 24 of the housing 20. When the drive assembly 12, 12A is attached to the bottom 24 of the housing 20, engagement of the ratchet teeth 90 of the indexing member 62 with the flexible tabs 92 of the housing 20 provides unidirectional rotation of the indexing member 62. The indexing member 62 is configured to rotate to align one of the coding projections 84 of the second plunger member 52 with the limiting member 86 based on the dose amount and the size of the spacer 42, as described above. The indexing member 62 can provide the drive assembly 12, 12A with 24 rotational positions each of which can have a unique dose value associated therewith.

[0032] 1-16 and 34-40B, a needle actuator assembly 18 according to one embodiment of the present invention is shown. 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 for fluid communication with the container 14 as described above. The needle actuator body 96 is generally rectangular, with the guide surface 98 projecting radially inward. The needle shuttle 102 is received within the needle actuator body 96. As described above, the needle actuator body 96 is movable within the housing 20 from a pre-use position (shown in FIGS. 4-6), an initial actuated position (FIGS. 7-9), a use position (FIGS. 10-12), and a post-use position (FIGS. 13-15). The needle actuator body 96 is biased from the pre-use position to the post-use position via an extension spring 106, although other suitable biasing arrangements may be utilized. The needle actuator body 96 is released by engagement of the actuator button 26 and is free to move from the pre-use position to the use position, as will be described in more detail below. The needle actuator body 96 moves from the use position to the post-use position after rotation of the restricting member 86, as described above in connection with Figures 17-33.

[0033] 34-40B, the needle shuttle 102 is movable along a vertical axis between a retracted position, in which the needle 28 is disposed within the housing 20, and an extended position, in which at least a portion of the needle 28 extends outside the housing 20. The needle shuttle 102 is configured to move between the retracted and extended positions by engagement of a guide surface 98 of the needle actuator body 96 with a cam surface 104 of the needle shuttle 102. The cam surface 104 is provided by first and second cam members 108, 110, with the first cam member 108 spaced apart from the second cam member 110. The housing 20 includes a guide post 112 having a recess configured to receive a T-shaped protrusion 114 on the needle shuttle 102, although other shapes and configurations can be utilized for the guide post 112 and the T-shaped protrusion 114. The needle shuttle 102 moves along the guide post 112 between the retracted and extended positions. The guide posts 112 are linear and extend generally perpendicularly from the housing 20, although other suitable arrangements may be utilized. The guide surfaces 98 of the needle actuator body 96 are non-linear and each include a first side 116 and a second side 118 opposite the first side 116.

[0034] As described below, the guide surfaces 98 of the needle actuator body 96 cooperate with the cam members 108, 110 of the needle shuttle 102 to move the needle shuttle 102 vertically between the retracted and extended positions as the needle actuator body 96 moves axially from the pre-use position to the post-use position. The needle shuttle 102 also includes a shuttle biasing member 120 configured to engage with the housing 20 or the actuator button 26. In particular, the shuttle biasing member 120 engages with the housing 20 or the actuator button 26 to provide a biasing force as the needle actuator body 96 moves from the use position to the post-use position. When the needle actuator body 96 is fully moved to the post-use position, the cam members 108, 110 of the needle shuttle 102 disengage from the guide surfaces 98 of the needle actuator body 96, and the shuttle biasing member 120 biases the needle shuttle 102 downward, causing the needle 28 to engage the pad 38, as described above. 1-16, however, the pad 38 may be biased against the needle 28 rather than biasing the needle shuttle 102 downward via the shuttle biasing member 120. The needle actuator body 96 may interact with the actuator button 26 to prevent the actuator button 26 from snapping back until a post-use position is reached, which is described in more detail below.

[0035] 37A-40B, in the pre-use position (FIG. 37A), the needle shuttle 102 is in a retracted position and the cam members 108, 110 are spaced apart from the guide surface 98 of the needle actuator body 96. When the needle actuator body 96 moves to the use position (FIGS. 37B and 38A), the second cam member 110 of the needle shuttle 102 engages the second side 118 of the guide surface 98, moving the needle shuttle 102 from the retracted position to the extended position. During transition of the needle actuator body 96 from the use position to the post-use position (FIG. 37C), the first cam member 108 of the needle shuttle 102 engages the first side 116 of the guide surface 98, moving the needle shuttle 102 from the second position to the first position. After the needle actuator body 96 is fully transitioned to the post-use position (FIGS. 37D and 38B), the shuttle biasing member 120 urges the needle shuttle 102 downward as the cam members 108, 110 disengage from the needle guiding surface 98, causing the needle 28 to engage the pad 38. The transition of the needle actuator body 96 and the corresponding position of the needle shuttle 102 are also shown in FIGS. 39-40B. The interaction between the actuator button 26 and the needle actuator body 96 is described in more detail in connection with FIGS. 65A-67. Referring to FIGS. 41-64, a drug delivery system 200 according to a further embodiment is shown. The system 200 includes a housing 202 having an upper housing 204 and a lower housing 206. The housing has a proximal end 205 and a distal end 207. The upper housing 204 has a status viewing port 208, allowing a user to view the operating status of the system 200. System 200 also includes a valve assembly 212 and a tube 214 that fluidly connects valve assembly 212 with a patient needle 215 disposed at the proximal end of needle arm 216. A spring 218 biases needle actuator 220 distally.

[0036] 42-46, system 200 further includes a container or drug container 222 with a stopper 224 movably disposed therein, although stopper 224 has been omitted from the various views to promote clarity. Preferably, the distal end of drug container 222 has a septum assembly 228 that is spaced from valve assembly 212 prior to actuation of the device, as best shown in FIG.

[0037] For manufacturing purposes, it is often desirable to use one size of drug container, even if multiple fill volumes or dosages are expected to be used with the container. In such cases, different fill volumes result in different stopper positions when the drug container is filled. To accommodate these different stopper positions and to accommodate manufacturing variations in the stopper, embodiments of the present invention include a custom-made spacer 226 positioned at the proximal end of the container 222 adjacent to the stopper 224. In other words, the custom-made spacer 226 provides the option of dispensing a range of predetermined fill volumes set by the manufacturer through the selection of different spacers 226, reducing or eliminating the need for assembly operations. The size of the spacer 226 can be adapted to account for the underfill volume of the container 222 and to provide a consistent bearing surface at the proximal end of the container.

[0038] Spacer 226 is selected from a plurality of different sized spacers 226 and occupies the space from the proximal end of stopper 224 to the proximal end of container 222. According to one embodiment, as shown in Figures 45-47, spacer 226 is selected to be substantially flush with the proximal end of container 222. Furthermore, according to one embodiment, spacer 226 has a "top hat" shape, including a central column 230 and a distal flange 232, as best shown in Figure 45.

[0039] 44-47, the system 200 also includes a drive assembly 234 for distally displacing the reservoir 222 to establish a fluid connection between the reservoir 222 and the patient needle 215 and expel the medication from the reservoir 222. More specifically, the drive assembly 234 includes an inner spring 236 disposed within a central plunger 238, an outer plunger 240, an outer spring 242 disposed between the central plunger 238 and the outer plunger 240, a telescoping member 244, and a release gate 246.

[0040] Preferably, inner spring 236 has a greater spring constant than outer spring 242 and is therefore stronger or stiffer than outer spring 242. Inner spring 236 is disposed inside central plunger 238 and presses between a spring flange 248 (best shown in FIG. 46 ) of the lower housing and central plunger 238, which directly compresses the proximal end of spacer 226 after actuation of the device. Outer spring 242 is disposed inside outer plunger 240 and presses between a proximal outer flange 250 of central plunger 238 and a distal inner flange 252 of outer plunger 240. Thus, inner spring 236 and outer spring 242 may be nested to provide a more compact drive assembly (and therefore a more compact system 200) than using a single spring.

[0041] According to one embodiment, the inner spring 236 acts only to displace the reservoir 222 to establish a fluid connection with the patient needle 215, and the outer spring 242 acts only to continue administering the medication from the reservoir 222. According to another embodiment, the inner spring 236 acts to displace the reservoir 222 to establish a fluid connection with the patient needle 215 and also acts to begin dispensing the medication from the reservoir 222, and the outer spring 242 acts to complete the administration of the medication. In a further embodiment, the inner spring 236 initiates the initial puncture of the reservoir 222, and the outer spring 242 completes the puncture and dispensing of the medication from the reservoir 222.

[0042] As shown in Figures 44-47, and as subsequently described in further detail, outer plunger 240 includes a pair of proximal flanges or feet 254, each having an inclined surface that interacts with a corresponding inclined surface (or surfaces) on the release gate to retain and subsequently release the power module after actuation of device 200.

[0043] As best shown in FIGS. 46 and 47 , when initially assembled, the container 222 is spaced apart from the drive assembly 234 and the valve assembly 212. Side flanges 256 of the needle actuator 220 axially retain the drug container 222, and the needle actuator 220 prevents the release gate 246 from displacing laterally. According to one embodiment, a spring (not shown) biases the needle actuator 220 distally, while the activation button 210 (and / or its associated assembly) prevents distal displacement of the needle actuator 220 prior to actuation of the device 200. A status bar 258 is disposed on the needle actuator 220 and has an upper surface that is visible through the status viewing port 208. According to one embodiment, the upper surface of the status bar has multiple colors or patterns, and a first color or pattern, such as yellow, is visible through the status viewing port 208 when the device is in a pre-actuated state.

[0044] 48-52 are top views of the system 200, illustrating the operation of events during and after activation of the system 200. In FIG. 47, the user slides the activation 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). As shown in FIG. 49, as the needle actuator is displaced distally, the track 260 of the needle actuator 220 interacts with the lateral boss 262 of 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 passed the release gate 246, and therefore the drive assembly 234 has not yet been released. However, the lateral flange 256 is displaced distally, and therefore the container 222 is unrestrained.

[0045] 50 and 51, with continued distal movement, the proximal end of the needle actuator 220 passes through the release gate 246 (thereby releasing the drive assembly 234). The needle actuator 220 momentarily rests against a feature on the rotatable release flipper 264, forcing the release flipper 264 against the outrigger 266 (best shown in FIGS. 44 and 59) of the telescoping member 244. The needle actuator 220 remains in this position until the medication is dispensed. In this position, preferably, the second color or pattern of the status bar 258, e.g., green, is visible through the status viewing port 208.

[0046] At this stage, the force of springs 236 and 242 and the interaction of the ramped surface of proximal flange or foot 254 with the corresponding ramped surface(s) on release gate 246 cause release gate 246 to displace laterally, thereby releasing outer plunger 240 from its constraining interaction with release gate 246. Up until this point, outer plunger 240 has constrained central plunger 238.

[0047] 52 and 53 (for clarity, inner spring 236 is omitted from FIG. 52), stiff inner spring 236 drives central plunger 238 distally into contact with spacer 226. Because drug container 222 is filled with a substantially incompressible fluid, continued distal displacement of central plunger 238 displaces spacer 226, stopper 224, and container 222 distally relative to housing 202. This distal displacement causes septum assembly 228 to be pierced by valve assembly 212, establishing fluid communication between container 222 and patient needle 215. Central plunger 238 moves distally until its proximal outer flange 250 (best shown in FIG. 59) contacts a flange on lower housing 206, thereby limiting “puncture travel.” Preferably, another flange on the lower housing 206 and / or a side flange 256 on the needle actuator 220 limits the distal movement of the reservoir 222 .

[0048] Thereafter, because inner spring 236 can no longer displace central plunger 238 distally, weaker outer spring 242 displaces outer plunger 240 distally relative to central plunger 238 into contact with distal flange 232 of spacer 226, as shown in Figures 54 and 55. As will be explained in more detail below, preferably, contact between outer plunger 240 and spacer 226 is damped to minimize impact forces. Further expansion of outer spring 242 displaces outer plunger 240 distally to dispense the medication.

[0049] 56 and 57 , as outer spring 242 continues to expand and displace outer plunger 240 distally, at a predetermined distal displacement of outer plunger 240 relative to telescoping member 244, outer structure or flange 268 of outer plunger 240 interacts with inner distal structure or flange 270 of telescoping member 244 to “pick up” telescoping member 244. This ensures further distal displacement of outer plunger 240, resulting in a corresponding distal displacement of telescoping member 244. This paired distal displacement continues until the end of drug administration.

[0050] As previously described, outrigger 266 is disposed on telescoping member 244. The axial length of the outrigger and distal movement of telescoping member 244 control the timing of disengagement of outrigger 266 with release flipper 264. As shown in FIGS. 58 and 59 , at the end of medication delivery, the proximal end of outrigger 266 bypasses release flipper 264. This allows release flipper 264 to rotate out of engagement with needle actuator 220 ( FIG. 60 ), allowing needle actuator 220 to continue its distal displacement and retract patient needle 215 ( FIG. 61 ). At this stage, a different color or pattern, such as red, of status bar 258 is visible through status viewing port 208, indicating that device 200 has completed operation.

[0051] As previously mentioned, contact between the outer plunger 240 and the spacer 226 is preferably damped to minimize impact forces, as shown in Figures 62 and 63. For underfilled syringes containing viscous fluids, the highest level of energy dissipation is desired, as the outer spring 242 will be stiffer to provide the desired dispensing rate. For fully filled syringes containing low viscosity fluids, the lowest level of energy dissipation is desired, as the outer spring can be less stiff to provide the desired dispensing rate. Various methods, such as air damping or closed-cell damping, can be employed to adjust the damping level.

[0052] As another method of damping impact forces, FIG. 64 shows an embodiment of a spacer 226 in which one or more axial boundary ribs 272 are arranged circumferentially around the central column 230 of the spacer 226. In this embodiment, the outer plunger 240 must travel over the interference ribs 272, which provide frictional resistance to distal displacement of the outer plunger 240 relative to the spacer 226. The frictional force created by the interference between the interference ribs 272 and the outer plunger 240 is independent of plunger speed. Preferably, the frictional force does not exceed the minimum dispense spring load to avoid stalling the weak spring. The interference can be adjusted to provide the desired level of frictional resistance. Different dimensions (axial and / or radial) of the interference ribs 272 can be present for different fluid viscosities. This means that for each viscosity and fill level combination, there can be multiple structured positions depending on the number of springs required for a custom or bespoke spacer or viscosity range, so that a specific position can be set for a particular calibrated spring (that position has interference / damping tailored for that particular spring load / viscosity scenario).

[0053] 65A-69, an actuator button device 280 for activating the system 10 according to one embodiment of the present invention is shown. The actuator button device 280 includes an actuator button 26, a button spring 284, and a needle actuator body 286. The needle actuator body 286 may be similar to the needle actuator bodies 96, 220 described 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. As shown in FIG. 69, the actuator button 26 includes a user interface portion 288 for interfacing with a user. Preferably, the user interface portion 288 is approximately 22 mm in length and approximately 10 mm in width, although other suitable dimensions may be utilized. The actuator button 26 includes two pairs of lockout arms 290, 292 that interact with button contact surfaces 294, 296 of the needle actuator body 286 prior to device activation to prevent the needle actuator body 286 from swinging upward. As shown in Figure 65H, the overlap between the needle actuator body 286 and the housing 20 prevents premature actuation. Referring to Figure 66, the button spring 284 includes a first bearing surface 298, a second bearing surface 300 spaced from the first bearing surface 298, and a cantilevered central spring arm 302 surrounded by a pair of outer arms 304 connected by the first bearing surface 298.

[0054] The actuation button device 280 is configured to provide one or more of the following features, which are discussed in more detail below: unidirectional axial displacement or sliding of the actuator button 26, lateral movement of the actuator button 26 (raised and lowered positions) when the actuator button 26 remains depressed during the use position of the needle actuator body 286, and lockout of the actuator button 26 in the post-use position of the needle actuator body 286 so that the button 26 is in the raised position and cannot be depressed by the user.

[0055] To activate system 10 using actuator button 26, the user first slides user interface portion 288 in a first axial direction, which is to the right in FIGS. 65G and 65H. The user may need to slide user interface portion 288 approximately 10 mm or approximately 8 mm, although other suitable distances may be utilized. Movement of actuator button 26 axially moves lockout arms 290, 292 past button contact surfaces 294, 296 of needle actuator body 286, allowing movement of actuator button 26 from the raised position to the lowered position.

[0056] When the user slides the user interface portion 288 distally, the central spring arm 302 of the button spring 284 rides over the spring bearing surface 306 of the housing 20 and the first and second bearing surfaces 298, 300 engage the first and second angled bearing surfaces 308, 310 of the housing 20. The force of the button spring 284 is balanced by the engagement with the spring arm bearing surface 306 and the first and second angled bearing surfaces 308, 310, providing smooth axial displacement or sliding of the actuator button 26.

[0057] When the actuator button 26 and button spring 284 reach the end of their axial sliding travel, the central spring arm 302 and first bearing surface 298 pass the ends of their respective stops 312, 314, preventing the actuator button 26 from returning to its original position, as shown in FIG. 65H. Furthermore, when the actuator button 26 and button spring 284 reach the end of their axial sliding travel, the user engages the user interface portion 288 to move the actuator button 26 downward to its lowered position. The actuator button 26 is depressed 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, although other suitable distances and minimum forces may be utilized.

[0058] When a user presses the user interface portion 288, shown in FIG. 65A and FIG. 65B, the actuator button 26 rotates and releases the needle actuator body 286, causing the needle actuator body 286 to move from the pre-use position to the use position. As the needle actuator body 286 moves to the use position, as shown in FIG. 65B, the lockout arms 290, 292 run along the underside of the button contact surfaces 294, 296, preventing the actuator button 26 from bouncing upward. After the medication is delivered, as the needle actuator body 286 moves from the use position to the post-use position, the lockout arms 290, 292 disengage from the button contact surfaces 294, 296, allowing the actuator button 26 to bounce back under the influence of the button spring 284, as shown in FIG. 65C. 65D, the actuator button 26 has completed movement from the lowered position to the raised position due to the biasing force of the button spring 284. When the needle actuator body 286 is in the post-use position, the spring arm 316 on the needle actuator body 286 engages the actuator button 26 to prevent it from moving to the lowered position, although axial movement is still limited by the engagement of the spring arm 302 with the stops 312, 314. Thus, the actuator button 26 is locked after medication delivery is complete, providing a clear indication between used and unused systems.

[0059] Additionally, if the user holds down the actuator button 26 during medication administration, the proper administration and needle retraction will still be completed, but the actuator button 26 will not return to the raised position until the button 26 is released.

[0060] In one embodiment, the button spring 284 is made of plastic. The button spring 284 may alternatively be a pressed metal spring, although any other suitable material may be utilized.

[0061] 68-68G, rather than providing a separate actuator button 26 and button spring 284, the spring may be integral with the button 26. More specifically, an actuator button 320 according to a further embodiment of the present invention includes an integral spring arm 322. The actuator button 320 also includes a lockout arm 324, a retention arm 326, and a rear pivot 328. As shown in FIGS. 68D and 68E, the spring arm 322 engages a protrusion 330 on the top 22 of the housing 20. During transition of the system 10 from the pre-use position to the use position, the spring arm 322 slides past a detent on the protrusion 330, which provides an axial spring force. An end of the spring arm 322 engages a portion of the top 22 of the housing 20, providing a vertical spring force as the spring arm 322 deflects. The actuator button 320 is configured for a fluid movement between sliding and depressing the button 320, even though two separate movements occur, similar to the operation of button 26 described above. During the transition between the pre-use and use positions, the button 320 pivots about pivot 328 and the retaining arm 326 engages a portion of the needle actuator body 286, thereby maintaining the button 320 in a depressed position until the end-of-dose position is reached, in a manner similar to actuator button 26. Once the needle actuator body 286 moves to the end-of-dose position, the lockout arm 324 flexes 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 actuator button 26 described above.

[0062] Aspects of the present invention provide improvements over previous button designs. For example, the activation button device 280 provides multiple surfaces that hold the needle actuator body 286 in place against the needle actuator spring 106 prior to activation, thereby reducing the likelihood of premature activation during a drop impact. The activation button device 280 physically prevents the needle actuator body 286 from moving prior to activation by holding the needle actuator body 286 in a tilted (locked) position so that the surfaces do not allow room for pre-activation.

[0063] Additionally, the button sliding force of the actuator button device 280 is more precisely controlled by utilizing a bending arm rather than using a simple bump detent. This allows for a longer sliding stroke of the button 26 with better force control, resulting in a more economical and effective design. Furthermore, the actuator button device 280 causes the button 26 to be pushed back at the end of the injection, giving the user additional visual, audible, and tactile indication that medication delivery is complete.

[0064] According to one embodiment, the fluid delivery volume of system 10 is determined by the endpoint position of the plunger relative to a point within the housing, regardless of the actual fill volume, the inside diameter of the container, and the start position and length of the stopper. Because the tolerances for the above factors can be very large, variability in dosing accuracy can be significant. Embodiments of the present invention allow for the elimination of some or all of these tolerances from dosing issues, resulting in more accurate and less variable drug delivery volumes.

[0065] 70A-70G, a spacer assembly 400 for use in connection with a drive assembly according to one aspect of the present invention is shown.

[0066] Elements in the tolerance chain of the stopper spacer assembly 400 include the thickness (A) of the flange 402 of the inner plunger 404, the internal length (B) of the outer plunger 406 between the internal proximal end 408 and the internal shoulder 410, and the initial offset distance (C1) between the inner plunger flange 402 and the internal proximal end 408 of the outer plunger. This initial offset distance (C1) is preferably greater than the gap distance (C2) between the outer plunger 406 and the proximal end of the drug barrel 412. The tolerance chain of the stopper spacer assembly 400 also includes the internal barrel diameter (D). Once assembled, the stopper spacer 414 and outer plunger 406 are specific to a given drug dose.

[0067] 70B-70G illustrate the operation of the stopper-spacer assembly 400. As shown in FIG. 70B, when the system is actuated, both the inner plunger 404 and the outer plunger 406 are released. The outer spring 416 pushes the outer plunger 406 into the barrel 412, compressing the damping material 418 and pushing against the inner spring 420. The stopper 422 does not yet move relative to the barrel 412 due to the fluid column of medication.

[0068] 70C, outer spring 416 then displaces outer plunger 406 and barrel 412 distally, opening a valve (not shown) at the distal end of barrel 412 and establishing fluid communication with the needle (not shown). Due to the incompressibility of the liquid medication, stopper 422 cannot be displaced relative to barrel 412 until the valve is opened and a fluid path to the patient needle is established.

[0069] Subsequently, as shown in Figures 70D and 70E, inner spring 420 displaces inner plunger 404, stopper spacer 414 and stopper 422 to dispense the fluid.

[0070] Figure 70F shows the end 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 displacement of the inner plunger 404 (and stopper spacer 414 and stopper 422) relative to the drug barrel 412 and stopping the flow of drug.

[0071] According to one embodiment, as shown in FIG. 70G, cessation of displacement of the inner plunger 404 relative to the medication barrel 412 triggers an end-of-dose indicator for the system.

[0072] 71 and 72, the collapsible spacer assembly 430 includes a front spacer portion 432 secured to a stopper 434, an inner plunger 436, a rear spacer portion 438, and a rotational shuttle 440. The inner plunger 436 is repositionable relative to the front spacer portion 432 but does not rotate relative to the front spacer portion 432. Similarly, the rear spacer portion 438 is repositionable axially relative to the front spacer portion 432 but does not rotate relative to the front spacer portion 432. As will be described in more detail below, the rotational shuttle 440 first rotates and then repositions.

[0073] According to one embodiment, the forward spacer portion 432 is securely secured to the stopper 434. Those skilled in the art will appreciate that many methods may be employed to secure the forward spacer portion 432 to the stopper 434, such as, for example, adhesives, mechanical fasteners, or any other suitable arrangement. Preferably, the forward spacer portion 432 includes threads that engage with mating threads in the stopper 434.

[0074] When the stopper-spacer assembly 430 is threaded onto the stopper 434, an axial load is applied through the access opening 442 in the rear spacer portion 438. This force can be used to push the stopper 434 forward and apply pressure to the fluid drug. This pressure deflects the front (distal) surface of the stopper 434 proximally, pushing the rear spacer portion 438 back and rotating the rotating shuttle 440 to its "assembled" state. In other words, when the drug barrel is filled with drug and the system's plunger applies an axial force to the drug through the spacer assembly 430, the distal surface of the stopper 434 deforms due to the drug pressure. During drug delivery, pressure is applied to the rear spacer portion 438 by the drive assembly (via the plunger), applying a rotational torque to the rotating shuttle 440 through the helical surface 444 of the rear spacer portion 438. However, stopper deformation from the drug exerts a rearward or proximal force on the inner plunger 436, preventing the rotating shuttle 440 from rotating.

[0075] According to one embodiment, the axial reaction load on the inner plunger 436 can be increased by increasing the length of the inner plunger 436 .

[0076] Once drug delivery is complete, as shown in FIG. 73 , pressure on the stopper 434 is reduced, thereby allowing the distal end of the inner plunger 436 to be distally displaced. This distal displacement allows the rotating shuttle 440 to rotate. A subsequent axial force applied by the drive assembly rotates and distally displaces the rotating shuttle 440 due to the interaction of the helical surface 444 of the rear spacer portion 438 with the corresponding cam surface arm 446 of the rotating shuttle 440. According to one embodiment, this final movement of the rotating shuttle 440 causes the drive assembly to trigger needle retraction.

[0077] 74 and 75, a limiting member 452 according to one aspect of the present invention is positioned with the drive assembly. The limiting member 452 governs the timing of the final displacement of the needle actuator body 96, 220 after the drug dose is completed. Instead of rotating about a fixed post, the limiting member 452 is free-floating. When the plunger is displaced distally enough (as shown in FIGS. 74 and 75) so that the gap aligns with the limiting member 452, the limiting member 452 is displaced laterally into the gap due to the force of the spring on the needle actuator body 96, 220 and the beveled surface 454 at the rear of the arm of the limiting member 452 that engages the needle actuator body (best shown in FIG. 75). Once the limiting member no longer holds the needle actuator body 96, 220, the needle actuator body 96, 220 is free to complete its axial movement to the post-use position. Also, as shown in FIG. 75, the restricting member 452 is biased toward the rear of the body of the container 14, which minimizes the buildup of tolerances in the various components and improves dosage accuracy.

[0078] 76-78, a spacer assembly 460 according to a further embodiment of the present invention is shown. The spacer assembly 460 shown in Figures 76-78 allows for elimination of the effects of manufacturing tolerance buildup through adjustment of the spacer assembly, thereby allowing each system to inject the same amount of drug.

[0079] 77, the spacer assembly 460 includes a stopper 462 and a stopper spacer 464. The stopper spacer 464 includes a fixed spacer piece or fixed spacer 466 fixedly connected to the stopper 462, and an adjustable spacer piece or adjustable spacer 468 that is rotatably displaceable in one direction relative to the fixed spacer 466.

[0080] Those skilled in the art will appreciate that many methods may be used to secure the fixed spacer 466 to the stopper 462, such as, for example, adhesives, mechanical fasteners, or other suitable arrangements. Preferably, the fixed spacer 466 includes one or more external threads that engage with one or more mating threads in the stopper 462. According to one embodiment, the adjustable spacer 468 has a distal stem with external threads 470. The distal stem threads 470 engage with internal threads 472 in the fixed spacer 466 (best shown in FIG. 78 ) to rotationally control the axial displacement of the adjustable spacer 468 relative to the fixed spacer 466.

[0081] 76 and 77, fixed spacer 466 includes radially spaced detents 474, and adjustable spacer 468 includes a spring-loaded detent arm 476 whose free end engages a selected one of detents 474 to prevent rotational and axial displacement of adjustable spacer 468 toward fixed spacer 466. The free end of spring-loaded detent arm 476 is shaped to pass over detent 474 in one direction, thereby allowing rotational and proximal axial displacement of adjustable spacer 468 away from fixed spacer 466.

[0082] The adjustable spacer 468 can be adjusted relative to the fixed spacer 466 to provide a consistent axial length of the spacer assembly 460 despite variations in the dimensions of the stopper and container.

[0083] As shown in FIG. 78 , once the container is filled, an axial load, such as that which would be encountered when installed in the system 10, 200, is applied to the adjustable spacer 468 (and thus the fixed spacer 466 and stopper 462). When the axial load is applied, the adjustable spacer 468 may retract proximally, ensuring a consistent gap 478 between the proximal end of the drug barrel 480 and the proximal face of the adjustable spacer 468, thereby disabling variations in the drug barrel glass and the compressibility of any trapped air. In other words, the spacer assembly 460 allows the adjustable spacer 468 to have a predetermined set position relative to the container 14, regardless of variations in the container 14 and the length of the stopper. Thus, the starting position of the spacer assembly 460 is a predetermined distance from the container 14, the end position of the spacer assembly 460 is also a predetermined distance from the container 14, and the travel of the stopper 462 is defined by the effective length of the plungers 52, 54 of the drive assembly 12.

[0084] 79 and 80 , a base column 482 and a cap 484 of a self-adjusting spacer 486 are shown in accordance with one aspect of the present invention. The base column 482 includes a base portion 488 and an axially extending column 490. According to one embodiment, the base column 482 includes a plurality of post-like projections 491, each of which has a plurality of ratchet teeth 492 disposed on a proximal portion thereof. 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 a distal end of the cap 484 includes one or more axial springs 494. According to one aspect, the axial springs 494 are bent, cantilevered arms formed during molding of the cap 484. According to another aspect, a separate biasing member, such as a compression spring, may be employed in the self-adjusting spacer 486. When assembled with base column 482, spring 494 engages base portion 488 to maintain an initial spacing between base column 482 and cap 484. According to one embodiment, spring 494 is omitted. Cap 484 also includes a plurality of flexible cantilever arms or tabs 496, each of which has a free proximal portion with a plurality of ratchet teeth 497. The proximal end of each flexible tab 496 includes a leg 498.

[0085] 81B shows the self-adjusting spacer cap deployed in the proximal recess of stopper 494 at the proximal portion of the drug barrel. Base column 482 is incorporated into hollow cap 484, base portion 488 engages stopper 494, and legs 498 are positioned outside the proximal end of the barrel.

[0086] In operation, as shown in Figures 81A and 81B, the cap 484 is displaced distally relative to the base column 482 (as well as the stopper 494 and barrel) until the proximal end of the cap 484 is flush with the end of the drug barrel. This action causes the legs 498 to engage the inner surface of the barrel and displace radially inward, thereby forcing the ratchet teeth 492 into locking engagement with the ratchet teeth 497. The engagement of the locking barb 493, the ratchet teeth 492 and 497, and the engagement of the legs 498 with the inner surface of the barrel prevent displacement of the cap 484 relative to the base column 482. Thus, the self-adjusting spacer 486 can accommodate differences in stopper, barrel diameter, and drug load, automatically providing a flat bearing surface with the proximal end of the drug barrel.

[0087] One aspect of the present invention is a spacer assembly 486 positioned relative to the stopper in the container within the system. The spacer design allows its effective length to be adjusted to allow for precise administration of a medication. The length adjustment is intended to compensate for manufacturing tolerances in the container, fill volume, and particularly the length of the stopper, resulting in one-third of the variability in dosage using a non-adjustable spacer. The spacer length can be adjusted by several techniques, depending on the particular embodiment. The spacer length can be self-adjusting based on its position at the rear of the container, adjusted by the assembly machine during final assembly to the primary container subassembly, formed as an integral part of the stopper, or adjusted as a subassembly prior to filling. The adjustable spacer 486 allows for a more precise volume of fluid to be injected compared to a non-adjustable stopper.

[0088] 82-87, a drive assembly 500 for a medication delivery system according to one embodiment of the present invention is shown. The drive assembly 500 includes an activation button 506, a reservoir 508, a needle actuator assembly 510, a deactivation or flipper 512, a lead screw 514, and a plunger 516. The lead screw includes a drum portion 518 with radially protruding external vanes 520, including a threaded portion 522, best shown in FIGS. 84 and 85 and described in more detail subsequently. Prior to activation, one end 513 of the deactivation 512 engages one of the vanes 520 to prevent rotation of the lead screw 514, as best shown in FIGS. 83 and 86.

[0089] According to one embodiment, as shown in FIGS. 84-86, a threaded portion 522 of the lead screw 514 engages the internal threads of a nut 524 connected to the plunger 516. According to another embodiment, the nut and its internal threads are formed integrally with the plunger as a unitary structure. Additionally, a constant force spring 526 is received within the drum portion 518 and biases the lead screw 514 in a rotational direction. According to one embodiment, the spring 526 is secured to the base cover 504. According to another embodiment, as shown in FIGS. 84-86, a drive assembly housing 528 is disposed within the system, and the spring 526 is secured to the power pack housing 528.

[0090] Unlike helical springs, such as compression springs, which have a force profile proportional to their displacement, constant force springs such as constant force spring 526 maintain a relatively flat or uniform force profile over a long working length. A uniform force profile advantageously provides an injection force proportional to the spring force. This provides a flat or uniform injection force and, therefore, a substantially constant injection rate of the medication. While spring 526 is shown in FIG. 86 as having only two turns of material, one skilled in the art will understand that fewer or more turns may be used. Preferably, an assembler winds spring 526 when drive assembly 500 is assembled, and spring 526 remains in the wound position until actuation.

[0091] Upon actuation of the system, the needle actuator assembly 510 is released and displaces axially (to the right in FIGS. 82-85) from a pre-use position to a post-use position under the influence of a biasing member 530 (best shown in FIG. 83). During this displacement, the needle actuator assembly 510 abuts the second end 532 of the deactivation 512, causing the deactivation 512 to rotate counterclockwise, as shown in FIG. 87. This counterclockwise rotation of the deactivation 512 releases its first end 513 from engagement with the vanes 520. Following disengagement of the first end 513 from the vanes 520, the spring 526 unwinds, driving rotation of the lead screw 514, which, in combination with the nut 524, advances the plunger 516 to dispense the medicament.

[0092] As the lead screw 514 rotates, the rotation of the drum portion 518 and the vanes 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 viewing the linear movement of the stopper 536 in the container 508. In fact, this rotational movement is many times more sensitive than linear movement. Those skilled in the art will understand that the exact amount of advantage or enhancement will depend on the pitch of the threaded portion 522 of the lead screw 514, the diameter of the drum portion 518, and the number of vanes 520 on the drum portion 518.

[0093] 88-93, a drive assembly 600 for a medication delivery system according to a further embodiment of the present invention is shown. The drive assembly 600 acts to store mechanical energy in a spring and activate it when triggered. The drive assembly 600 includes a medication barrel 601, a stopper 602 slidably disposed within the barrel 601, a first valve plunger 603, a second valve plunger 604, a first rotating nut 605, and a second rotating nut 606. The drive assembly 600 also includes a rotation indicator 607, a locking element 608, a constant force spring 609 disposed within the rotation indicator 607, and an actuation release or flipper 610. The drive assembly 600 is at least partially disposed within a housing 611, which can be assembled into the medication delivery system.

[0094] A constant force spring 609 is housed between the housing 611 and the rotation indicator 607 within the drum portion 616 of the rotation indicator 607. The de-activated state of the drive assembly is such that energy is applied by unwinding the spring 609 and geometrically utilizing this energy in the housing 611, the rotation indicator 607, and the deactivation 610. When the drive assembly 600 is de-activated, the spring recoils and converts mechanical energy into rotational motion of the rotation indicator.

[0095] The telescoping multi-part plunger is oriented along a force axis between the medication barrel 601 and the rotation indicator 607. The rotation indicator 607 features a threaded axis 618. According to one embodiment, the threads are compound helices and are either square or rectangular in nature. The telescoping multi-part plunger includes a two-part threaded nut (first rotating nut 605 and second rotating nut 606) and a two-part plunger (first valve plunger 603 and second valve plunger 604). The second rotating nut 606 is a threaded shaft that mates with the rotation indicator 607 and the first rotating nut 605 and features corresponding threads on its inner and outer surfaces (internal and external threads, respectively). The second rotating nut 606 also has a circular collar 620 (best shown in FIG. 92) at its proximal end that seats downwardly on the second valve plunger 604. The second rotating nut 606 is free to rotate along the force axis. The first rotating nut 605 is also a threaded shaft featuring threads on its inner diameter that correspond to the external threads of the second rotating nut 606 so as to mate with the second rotating nut 606.

[0096] According to one embodiment, at one end, the first rotating nut 605 has a hexagonal collar that press-fits onto the first valve plunger 603, fixedly connecting the first valve plunger 603 to the first rotating nut 605. In the drive assembly 600, the first rotating nut is not free to rotate and will only translate when the power module subassembly is actuated.

[0097] 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 elongated L-shaped arm 626 (best seen in FIG. 93) protruding from the large proximal collar 624. According to one embodiment, the small collar is discontinuous and features four spring-leaf cantilever arms or leaf springs 623 that allow the collar to flex and engage with the first valve plunger 603. The inner surface of the second valve plunger 604 has an undercut throughout its length that terminates in a ledge 628 that protrudes radially inward of the large collar 624 at its proximal end. The ledge 628 engages the second rotating nut 606 within the telescoping assembly.

[0098] The first valve plunger 603 is a hollow cylindrical component that is attached to the stopper 602 and mates with the second valve plunger 604. More specifically, the first valve plunger 603 features a cylindrical protrusion 630 at its distal end that mates with the stopper 602. According to one embodiment, as shown in FIG. 89 , four through slots 632 are located in the proximal quadrant of the first valve plunger 603 to engage the leaf spring or arm 623 and small collar 622 of the second valve plunger 604. Both the first and second valve plungers 603 and 604 are slidable.

[0099] Telescoping is achieved when the constant force spring 609 recoils and the rotation indicator 607 begins to rotate. The threaded attachment between the rotation indicator 607 and the second rotating nut 606 causes the second rotating nut 606 to rotate. However, because the second rotating nut 606 is threaded onto the first rotating nut 605, which cannot rotate due to pressure caused by the drug within the barrel 601 and experiences resistance to distal movement, the second rotating nut 606 displaces proximally and rests against the radially inward-projecting ledge 628 of the second valve plunger 604. The second valve plunger 604 is prevented from moving proximally by the housing 611. Thereafter, with continued rotation of the rotation indicator 607, the second rotating nut 606 is threadedly engaged with the first rotating nut 605 (which cannot rotate), causing the first rotating nut 605 to move away from the first valve plunger 603 (and stopper 602) and dispensing the drug from the barrel 601.

[0100] The first valve plunger 603 is displaced distally relative to the second valve plunger 604 until small collar portions 622 (disposed on the distal ends of the leaf springs or arms 623 of the second valve plunger 604, respectively) engage corresponding proximal ends of the slots 632 of the first valve plunger 603. This locks the relative positions of the first and second valve plungers 603 and 604, and with continued rotation of the rotation indicator 607, both valve plungers translate distally, also forcing the second rotation nut along with it (due to its proximal engagement with the ledge 624).

[0101] The initial and final positions of the telescopic plunger, and therefore the drug dose, are controlled by the rectangular thread profile of the threaded shaft 618 of the rotation indicator 607, the threaded shaft on the drum portion 616 of the rotation indicator 607, and the stepped pin that functions as the locking element 608. According to one embodiment, the threaded shaft on the drum portion 616 of the rotation indicator 607 is single helix and the remaining components in the telescopic chain have double helix threads, so that the axial movement of the other threaded components is twice the axial movement of the locking element 608 relative to the rotation indicator.

[0102] According to one embodiment, lock 608 is cylindrical and features a domed tip at one end and a cylindrical collar at the other end. The external threads of rotary indicator drum portion 616 and undercuts 636 in the bottom of housing 611 trap lock 608 in place and allow it to slide parallel to the force axis. Thus, when spring 609 is released and rotation indicator 607 rotates, lock 608 also translates, creating a positive stop when it reaches the distal end of the external threads of rotation indicator drum portion 616.

[0103] One advantage of embodiments of drive assembly 600 includes the use of constant force spring 609, whose mechanical energy is converted into a substantially constant linear force on the drug within barrel 601. This, in turn, results in a uniform drug delivery rate. Another advantage is the use of a telescoping plunger driven by a thread form, which allows the drive assembly to provide linear space savings of up to 0.75 inches compared to other plunger designs. Additionally, the drive assembly provides a controlled drug dose through initial and final mechanical constraints within the same component.

[0104] As previously mentioned, other drug delivery systems utilize compression coil springs that exert a maximum force upon actuation, which eventually decreases as the spring expands. The decreasing force on the plunger translates into variable drug delivery times and drug outlet pressures. By using a constant force spring, the force acting on the plunger is constant throughout the entire dose. Furthermore, the distance the coil spring must travel, along with the constant plunger length requiring translation within the drug container, can create a long assembly. In contrast, in embodiments of the present invention, the constant force spring is radially contained and does not require additional space before or after actuation. Furthermore, the telescoping plunger aspect allows the plunger length of the container to be significantly reduced compared to the constant plunger length.

[0105] Conventional drug delivery systems have variable dose accuracy because the mechanical components that enable drug delivery create geometric dependencies by bottoming out on the reservoir, but they cannot be manufactured to tight tolerances. Some embodiments of the present invention create control over the start and end times of the translation plunger through the use of a thread form and a constant force spring in the rotation indicator.

[0106] The drive assembly creates a space-saving geometry as well as well-controlled time, volume and pressure for the drug delivery device, which results in a more attractive, compact and accurate drug delivery device.

[0107] Some embodiments of the drive assembly implement three rotating threaded shafts to save approximately 0.75 inches of linear space. In other embodiments, the same concept can be employed using two rotating threaded shafts, resulting in a space savings of approximately 0.5 inches. Some embodiments of the present invention convert the rotational energy of a constant force spring into translational force motion of a plunger.

[0108] Referring to Figures 94-100, a spacer assembly 660 according to a further embodiment of the present invention is shown. The spacer assembly 660 is similar to the spacer assembly 460 described above and shown in Figures 76-78 and operates in a similar manner to achieve similar benefits. The spacer assembly 660 includes a fixed spacer 666 and an adjustable spacer 668. The fixed spacer 666 is configured to be received by the stopper 462, with a protrusion 670 engaging the stopper 462 to secure the fixed spacer 666 within the stopper 462, although other suitable securing configurations, such as threads, may be utilized. The fixed spacer 666 includes internal threads 672 that receive the external threads 678 of the adjustable spacer 668. The fixed spacer 666 includes a plurality of detents 674 disposed on a helical portion of the fixed spacer 666. The adjustable spacer 668 includes a spring detent arm 676 that engages one of the detents 674, preventing rotation and axial displacement of the adjustable spacer 668 relative to the fixed spacer 666. The spring detent arm 676 is shaped and configured to pass unidirectionally through the detents 674 to allow rotation and axial displacement of the adjustable spacer 668 from the fixed spacer 666. The adjustable spacer 668 can initially be locked to the fixed spacer 666 via the threads 672, 678 by applying a force to the top of the spring detent arm 676, which moves the spring detent arm 676 away from the detent 674, allowing the spacers 666, 668 to be locked together. Thus, in the same manner as described above with respect to the spacer assembly 460, the adjustable spacer is free to rotate in one axial direction, adjusting the length of the spacer assembly 660.

[0109] 94-100 , the spacer assembly 660 further includes a shim 680 configured to be received and secured within the adjustable spacer 668. Rather than providing multiple sizes of adjustable spacers 468, 668, multiple shim 680 sizes may be provided to accommodate multiple different fill volumes within the container 14. The shim 680 may be secured to the adjustable spacer 668 via a connector 682 extending from the shim 680 that is received by the adjustable spacer 668 using a snap fit, although other suitable securing configurations may be utilized. A central portion 684 of the fixed spacer 666 is configured to engage with the adjustable spacer 668 to prevent rotation of the fixed spacer 666 while the adjustable spacer 668 is rotated relative to the fixed spacer 666. The central portion 684 of the fixed spacer 666 is accessible through an opening in the shim 680.

[0110] Elements of one disclosed embodiment may be combined with elements of one or more other disclosed embodiments to form different combinations, all of which are contemplated as being within the scope of the invention.

[0111] While this disclosure has been described as having exemplary designs, the disclosure may be further modified within the spirit and scope of the disclosure. Accordingly, this application is intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the scope of the appended claims.

Claims

1. 1. A drug delivery system, comprising: Housing and a container disposed within the housing and configured to hold a medicament; a needle coupled to the housing; a stopper configured to move within the container to dispense the medication from the container to the needle; a drive assembly configured to move the stopper within the container, the drive assembly comprising: a first plunger member configured to move axially between a pre-use position, a use position, and a post-use position; a second plunger member, the first plunger member being received within the second plunger member and extending from the second plunger member during axial movement from the pre-use position to the use position, the second plunger member including a plurality of protrusions on an outer surface thereof; and a drive assembly comprising: an indexing member configured to rotate in one direction relative to the housing, the indexing member configured to receive a portion of the second plunger member therein and rotate the second plunger member relative to the housing.

2. 2. The drug delivery system of claim 1, wherein the second plunger member is configured to move axially after the first plunger member has moved a predetermined axial distance.

3. 10. The drug delivery system of claim 1, wherein the indexing member includes a plurality of ratchet teeth configured to engage tabs on the housing.

4. 10. The drug delivery system of claim 1, further comprising a plunger actuation member configured to engage and disengage from the first plunger member; the plunger actuation member is rotatable relative to the first plunger member between a first rotational position and a second rotational position; 1. A drug delivery system, comprising: a plunger actuation member configured to restrict axial movement of the first plunger member in the first rotational position; and a plunger actuation member configured to permit axial movement of the first plunger member in the second rotational position.

5. 5. The drug delivery system of claim 4, wherein the plunger actuation member comprises a plurality of protrusions configured to be received by a plurality of slots or notches defined by the first plunger member; in the first rotational position of the plunger actuation member, the plurality of protrusions and the plurality of slots or notches are not aligned; A drug delivery system, characterized in that in the second rotational position of the plunger actuation member, the plurality of protrusions and the plurality of slots or notches are aligned.

6. 5. The drug delivery system of claim 4, further comprising a needle actuator assembly configured to engage a drive surface of the plunger actuation member to move the plunger actuation member from the first rotational position to the second rotational position.

7. 7. The drug delivery system of claim 6, wherein the drive surface comprises a plurality of gears.

8. 7. The drug delivery system of claim 6, further comprising a regulating member rotatably disposed within the housing, wherein rotation of the regulating member is prevented by one or more of the plurality of protrusions of the second plunger member, and wherein rotation of the regulating member is configured to limit axial movement of the needle actuator assembly.

9. 10. The drug delivery system of claim 1, wherein the first plunger member forms a nested configuration with the second plunger member.

10. 10. The drug delivery system of claim 1, further comprising a first biasing member configured to move the stopper within the container, and a second biasing member configured to drive the first plunger member against the stopper.

11. 11. The drug delivery system of claim 10, wherein the first biasing member and the second biasing member each comprise a compression spring.

12. 11. The drug delivery system of claim 10, wherein the second biasing member is stiffer than the first biasing member.

13. 10. The drug delivery system of claim 1, wherein the plurality of protrusions comprises a plurality of axial ribs.

14. 10. The drug delivery system of claim 1, further comprising a spacer assembly disposed between the first plunger member and the stopper.

15. 15. The drug delivery system of claim 14, wherein the spacer assembly has an adjustable axial length.

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