Controlled Dispensing Syringes

Abstract

A syringe with a plunger assembly is described that is adapted to have a dispensing stroke sized to dispense a fluid therapeutic product from the syringe without dispensing any air or headspace. The syringe includes a plunger rod having a stop feature that stops the dispensing stroke of the plunger rod at a distance corresponding to the level of air or headspace within the syringe, thereby avoiding an additional air dispensing step by a healthcare provider.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] Priority is hereby claimed to U.S. Provisional Patent Application No. 62 / 990,819, filed on March 17, 2020, the entire contents of which are hereby incorporated by reference herein. Technical Field

[0003] The present disclosure relates generally to syringes and, more particularly, to prefilled syringes. Background Art

[0004] For some drug dispensing devices, a healthcare provider needs to transfer a therapeutic product from a pre-filled syringe to a cartridge or device reservoir configured for a drug dispensing device. Typically, a pre-filled syringe is filled with a predetermined amount of therapeutic product and a predetermined amount of air. In order to transfer the therapeutic product to a cartridge or device reservoir, the healthcare provider can direct the pre-filled syringe so that air is adjacent to the needle and presses the plunger of the pre-filled syringe to distribute air. This air distribution operation may inadvertently distribute some therapeutic products, which may waste expensive products and may cause the amount of the therapeutic product in the pre-filled syringe to be less than the prescribed amount of the patient. On the other hand, if the air is not completely discharged from the pre-filled syringe, some air may be transferred to the cartridge or device reservoir. The air in the fluid flow path of the drug dispensing device may have a negative impact on the operation of the device, such as uncontrolled forward or backward flow due to atmospheric pressure changes. Summary of the invention

[0005] According to a first aspect, a syringe is disclosed herein, comprising: a barrel having an interior, a dispensing opening at a distal end, and an open proximal end; a stopper disposed within the barrel interior; a plunger rod having a first end and a second end, the first end being configured to at least selectively operably couple with the stopper, the second end extending through the open proximal end of the barrel, wherein the second end includes an outwardly extending flange; and a stop assembly comprising a plunger stopper coupled to the plunger rod at a position between the flange and the open proximal end of the barrel and a removable portion coupled to the plunger rod or barrel. The plunger stopper is configured and sized to engage a stopper surface adjacent to the open proximal end of the barrel to selectively limit displacement of the plunger and stopper along the interior of the barrel.

[0006] According to one form, the plunger stop and removable portion of the stop assembly may include a first body and a second body that are pivotable relative to each other to capture the plunger rod therebetween. In this form, the plunger stop and removable portion of the stop assembly may be a clip that includes a hinge that pivotally couples a first side of the first body and the second body, and a fastening mechanism that releasably connects a second side of the first body and the second body. Alternatively, in this form, the plunger stop and removable portion of the stop assembly may be a clamp that includes a biasing mechanism, and the first body and the second body may include a jaw at a first end thereof and a handle at a second end thereof, wherein the biasing mechanism biases the jaws of the first body and the second body together to capture the plunger rod therebetween.

[0007] According to one form, the plunger stop and removable portion of the stop assembly may include: a body defining a cavity having an opening through an end wall of the body, wherein the cavity is configured to receive the plunger rod therein to limit longitudinal movement of the plunger rod relative to the body; and a fastening mechanism coupled to the body to retain the plunger rod within the cavity. In this form, the fastening mechanism may be an adhesive member extending over the cavity. Alternatively, in this form, the body may include first and second clamshell components having inner faces configured to be brought together to define a cavity therebetween, and the fastening mechanism may retain the first and second clamshell components in a closed configuration with the plunger rod stuck within the cavity.

[0008] According to one form, the proximal end of the barrel may include an outwardly protruding flange, and the plunger stop may be a stop flange, which extends outwardly from the plunger rod adjacent to the first end of the plunger rod and whose perimeter size is determined to be suitable for fitting inside the barrel. The removable portion of the stop assembly may be a blocking member, which is configured to removably engage the flange of the barrel so that a portion of the blocking member is disposed within the travel path of the stop flange to limit the longitudinal movement of the plunger rod. In this form, the blocking member may be a clip having a first wall and a second wall spaced apart from each other and connected by an end wall, wherein the clip is configured to engage the flange of the barrel between the first wall and the second wall. Alternatively, in this form, the blocking member may be a tab, the distal end of which has a configuration complementary to a portion of the horizontal cross section of the plunger rod, and the flange of the barrel may include a channel, the size of which is determined to receive the tab therein, wherein the channel is configured to guide the tab to engage with the plunger rod.

[0009] According to other forms, the plunger stop and removable portion of the stop assembly can be a snap-fit ​​component, which includes a first wall and a second wall spaced apart from each other and connected by an end wall, wherein the first wall and the second wall define a channel on their inner faces and are configured to flex apart to set the plunger rod therebetween and return to an unflexed position to retain a portion of the plunger rod in the channel; or it can be a tab that is connected to the plunger rod along the longitudinal length of the plunger rod by a break feature.

[0010] According to any of the above forms, the stopper assembly may include a wall portion, and information about the operation of the stopper is displayed on a surface of the wall portion.

[0011] According to a second aspect, a method for dispensing head space from a syringe containing a liquid therapeutic product is disclosed, the method comprising providing a syringe comprising: a barrel having an interior, a dispensing opening at a distal end, and an open proximal end; a stopper disposed within the interior of the barrel; a plunger rod having a first end and a second end, the first end being configured to be at least selectively operably coupled to the stopper, the second end extending through the open proximal end of the barrel, wherein the second end includes an outwardly extending flange; a fluid therapeutic product and head space disposed in the interior of the barrel, between the stopper and the dispensing opening; and a stop assembly comprising a plunger stop coupled to the plunger rod and a removable portion coupled to the plunger rod or the barrel. The method further includes: driving the plunger rod toward the open proximal end of the barrel of the syringe to drive the stopper along the interior of the barrel to dispense the head space through the dispensing opening; abutting the plunger stopper against a stop surface adjacent to the open proximal end of the barrel to stop movement of the stopper and prevent the fluid therapeutic product from being expelled; and removing the removable portion of the stopper assembly from the plunger rod or barrel.

[0012] According to some forms, the method may include one or more of the following aspects: the plunger stop and removable portion of the stop assembly may include a first body and a second body, the plunger rod is captured between the first body and the second body, and removing the removable portion of the stop assembly from the plunger rod or barrel may include pivoting the first body and the second body of the stop relative to each other; removing the removable portion of the stop assembly from the plunger rod or barrel may include breaking off a tab from the plunger rod; the plunger stop and removable portion of the stop assembly may include: a body and a fastening mechanism, the body defining a cavity having an opening through an end wall of the body, wherein the plunger rod is received in the cavity, the fastening mechanism being coupled to the body to retain the plunger rod in the cavity , and removing the removable portion of the stop assembly from the plunger rod or barrel may include manipulating the body and the fastening mechanism to release the plunger rod from the cavity; removing the removable portion of the stop assembly from the plunger rod or barrel may include flexing the first wall and the second wall of the stop assembly away from each other to release the plunger rod so that it is not captured therebetween; or the proximal end of the barrel may include an outwardly protruding flange, and the plunger stop may be a stop flange extending outward from the plunger rod, wherein the circumferential size of the stop flange is determined to be suitable for fitting within the interior of the barrel, and removing the removable portion of the stop assembly from the plunger rod or barrel may include decoupling a blocking member, a portion of which is disposed within the travel path of the stop flange to limit the longitudinal movement of the plunger rod from the flange of the barrel.

[0013] According to a third aspect, a syringe is disclosed, the syringe comprising: a barrel having an interior, a dispensing opening at a distal end, and an open proximal end having an end surface; a stopper disposed within the barrel interior; a plunger rod having a first end and a second end, the first end being configured to at least selectively operably couple with the stopper, the second end extending through the open proximal end of the barrel; an outwardly protruding stop adjacent to the second end of the plunger rod; an engagement portion spaced apart from the stop at the second end of the plunger rod; and at least one wall portion extending longitudinally between the stop and the engagement portion and extending laterally outward from the plunger rod, wherein the at least one wall portion is formed integrally with the plunger rod and has information regarding the operation of the stop displayed on its surface.

[0014] In some forms, the at least one wall portion may be a wall portion extending laterally outward from an opposite side of the plunger rod.

[0015] According to a fourth aspect, a syringe is disclosed, the syringe comprising: a barrel having an interior, a dispensing opening at a distal end, and an open proximal end having an end surface; a stopper disposed within the barrel interior; a plunger rod having a first end and a second end, the first end being configured to at least selectively operably couple with the stopper, the second end extending through the open proximal end of the barrel; an engagement portion at the second end of the plunger rod; a flange adjacent to the second end of the plunger and spaced from the engagement portion; and a snap-fit ​​member releasably coupled to the plunger rod. The snap-fit ​​member comprises a first wall and a second wall spaced from each other and connected by an end wall, wherein the first wall and the second wall are configured to flex apart to dispose the plunger rod therebetween and return toward an unflexed position to retain the snap-fit ​​member on the plunger rod between the engagement portion and the flange.

[0016] In some forms, the first and second walls of the snap-fit ​​member define channels on inner faces thereof, and the channels are configured to receive a portion of the plunger rod therein when the first and second walls are in an unflexed position. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 is a perspective view of a first exemplary syringe having a stop assembly in a complete configuration showing a fluid therapeutic product within the barrel and the headspace according to an embodiment of the present disclosure.

[0018] Figure 2 yes Figure 1 A side elevation view of the syringe in its complete configuration.

[0019] Figure 3 yes Figure 1 A side elevation view of a syringe in a dispensing configuration showing a fluid therapeutic product within the barrel.

[0020] Figure 4 yes Figure 1 A side elevation view of a syringe of , showing a removable portion of the stop assembly in an uncoupled configuration.

[0021] Figure 5 is a perspective view of a second exemplary syringe in a complete configuration with a stop assembly showing a fluid therapeutic product within the barrel and the headspace according to an embodiment of the present disclosure.

[0022] Figure 6 is a perspective view of a third exemplary syringe with a stop assembly in a complete configuration showing a fluid therapeutic product within the barrel and the headspace according to an embodiment of the present disclosure.

[0023] Figure 7 yes Figure 6A perspective view of a syringe of , showing the removable portion of the stop assembly in an uncoupled configuration.

[0024] Figure 8 is a perspective view of a fourth exemplary syringe in a complete configuration with a stop assembly showing a fluid therapeutic product within the barrel and the headspace according to an embodiment of the present disclosure.

[0025] Fig. 9 yes Figure 8 A perspective view of a syringe of , showing the removable portion of the stop assembly in an uncoupled configuration.

[0026] Fig.10 is a perspective view of a fifth exemplary syringe in a complete configuration with a stop assembly showing a fluid therapeutic product within the barrel and the headspace according to an embodiment of the present disclosure.

[0027] Fig.11 is a perspective view of a sixth exemplary syringe in a complete configuration with a stop assembly showing a fluid therapeutic product within the barrel and the headspace according to an embodiment of the present disclosure.

[0028] Fig.12 yes Fig.11 An exploded view of a syringe of , showing a removable portion of the stop assembly in an uncoupled configuration.

[0029] Fig.13 is a perspective view of a seventh exemplary syringe in a complete configuration with a stop assembly showing a fluid therapeutic product within the barrel and the headspace according to an embodiment of the present disclosure.

[0030] Fig.14 yes Fig.13 Detail view of a syringe.

[0031] Fig.15 is a perspective view of an eighth exemplary syringe in a complete configuration with a stop assembly showing a fluid therapeutic product within the barrel and the headspace according to an embodiment of the present disclosure.

[0032] Fig.16 yes Fig.15 An exploded view of a syringe of , showing a removable portion of the stop assembly in an uncoupled configuration.

[0033] Fig.17 is a perspective view of a ninth exemplary syringe in a complete configuration with a stop assembly showing a fluid therapeutic product within the barrel and the headspace according to an embodiment of the present disclosure.

[0034] Fig.18 yes Fig.17 Front elevation view of the syringe in the complete configuration.

[0035] Fig.19 yes Fig.17 A front elevation view of a syringe in a dispensing configuration and the head space within the barrel.

[0036] Fig. 20 is a perspective view of a tenth exemplary syringe having a stop assembly in a dispensing configuration showing the head space within the barrel according to an embodiment of the present disclosure.

[0037] Fig.21 yes Fig. 20 An exploded detailed view of the syringe of shows the removable portion of the stop assembly in an uncoupled configuration. DETAILED DESCRIPTION

[0038] The syringe and syringe assembly are provided with a plunger assembly adapted to provide a distribution stroke for controlling the head space in the syringe. The control of the head space may include clearing the head space before dispensing the therapeutic product, or dispensing the therapeutic product without dispensing any head space. More specifically, the syringe includes a stopper or stopper assembly for stopping the distribution stroke of the plunger rod at a predetermined distance corresponding to the head space level in the syringe. The distance may be used to provide a controlled distribution of the head space, or may be configured such that the stroke of the plunger rod leaves head space in the syringe. Therefore, a syringe with such a configuration allows a practitioner to safely handle or skip the step of expelling bubbles from the syringe.

[0039] Referring now to the accompanying drawings, a syringe 10 is shown extending along a longitudinal axis X. The syringe 10 is shown in a pre-filled state, i.e., a dose or other predetermined amount of a fluid therapeutic product 12 is contained within a barrel or reservoir 14. The barrel 14 has a tubular configuration oriented along the longitudinal axis X, with an annular sidewall 15 extending between a dispensing opening 16 at a distal end 18 and an open proximal end 20. The proximal end 20 may include a radially protruding flange 22 that provides an upper end surface 24 facing upward. If desired, the barrel 14 may include measurement markings 26 distributed along its length L to provide a visual indication of the amount of product 12. The barrel 14 may be made of any suitable material, such as glass or a polymer. At the distal end 18 of the barrel 14, the syringe 10 includes a needle 32 and a needle seat 34 coupled to the barrel 14 so that the needle 32 is fluidly coupled to the interior 36 of the barrel 14. If desired, the syringe 10 may further include a rigid or non-rigid needle shield 33 ( Figure 1). The syringe 10 further includes a stopper (plunger-stopper) 38 and a plunger rod 40, which is configured to at least selectively engage the stopper 38 and protrude outwardly through the open proximal end 20 of the barrel 14 along the longitudinal axis X. The plunger rod 40 includes an elongated body 41 coaxial with the barrel 14. The body 41 engages the stopper 38 at a distal end 42 and includes a thumb rest or engagement portion 44 at an opposite proximal end 46. The plunger rod 40 can be at least selectively operably coupled to the stopper 38 by any suitable method (such as embedded therein, having mating components, abutting end surfaces, selectively disposed in a recess of the stopper 38, etc.). For example, the plunger rod 40 and the stopper 38 can have a retractable or non-retractable configuration as desired. In this way, the plunger rod 40 can be coupled to the stopper 38 so that the plunger rod 40 is retracted through the barrel 14 and the stopper 38 is pulled back along the barrel 14, or can be selectively coupled to the stopper 38 so that the plunger rod 40 is retracted through the barrel 14 without correspondingly retracting the stopper 38. The plunger rod 40 can be as shown in the figure, and the engagement portion 44 can include a flange 48, which extends outwardly from the body 41 generally perpendicular to the longitudinal axis X to provide a flat or contoured upwardly facing engagement surface 50 for use. So configured, the user can grasp the flange 22 of the proximal end 20 of the barrel 14 with two fingers and grasp the engagement surface 50 with the thumb to press the stopper 38 down and drive it through the barrel 14 during the dispensing operation.

[0040] As shown, the barrel 14 also defines a head space 52, such as air, with the product 12. Traditionally, a healthcare provider manipulates the syringe 10 so that the needle 32 points upward, and depresses the plunger rod 40 to drive the stopper 38 through the barrel 14 to dispense the head space 52 through the needle 32, or watches the amount of product 12 during dispensing to avoid expelling any head space 52.

[0041] exist Figures 1 to 16 In the first example shown, the syringe 10 is ready for use by the following steps. In the first step, the practitioner tilts the syringe 10 upward to visually inspect the syringe 10 and observe the head space 52 moving toward the dispensing opening 16 of the barrel 14. In the second step, if applicable, the practitioner removes the needle shield 33 to expose the distal end of the needle 32. In the third step, the practitioner pushes the plunger rod 40 to expel the head space 52.

[0042] As shown in the figure, Figures 1 to 16Each syringe 10 of the illustrated embodiment may include a stop assembly 100 for limiting the distance that the plunger rod 40 can be pushed into the barrel 14. Specifically, the stop assembly 100 only allows the plunger rod 40 to be pushed into the barrel 14 to clear the head space 52. It should be understood that clearing the head space 52 from the barrel 14 may include dispensing a small amount of product 12 from the syringe 10 along with the head space 52 to ensure that the head space 52 has been completely cleared. Advantageously, the stop assembly 100 prevents the dispensing of an excessive amount of product 12 during the head space clearing step. Next, in a fourth step, the practitioner removes or disables the removable portion 101 of the stop assembly 100, and in a fifth step, the product 12 is applied according to a normal operating routine.

[0043] In each of these examples, the stop assembly 100 has a plunger stop 102 that is spaced a distance D from the proximal end 20 of the barrel 14, which corresponds to the length L1 and the corresponding volume of the head space 52 within the barrel 14. It should be understood that the size of L1 can be determined to include a small amount of product 12, such as 2%-10% of the delivered mL amount, to ensure that the head space 52 is completely cleared. In the case of this configuration, the user can push the plunger rod 40 to drive the stopper 38 through the barrel 14, and the plunger stop 102 will abut the barrel 14 or a structure associated with the barrel 14 adjacent to the open proximal end 20 to prevent the plunger rod 40 and the stopper 38 from moving further. Accordingly, the stop assembly 100 ensures that the distance moved by the plunger rod 40 is sufficient to clear the head space 52 without dispensing an excess of product 12. In other words, by configuring the plunger rod 40 and the stop assembly 100 to move the plunger rod 40 a predetermined length corresponding to a desired portion of the barrel 14, the syringe 10 can be preconfigured to dispense a specific volume of the syringe 10 that corresponds to the head space 52 within a conventional prefilled syringe.

[0044] Figures 1 to 41. A first exemplary syringe 10 is shown in FIG. 1. In this form, a stop assembly 100 (which includes a removable portion 101 and a plunger stop 102) is provided by a clip 104 having a first body 106 and a second body 108 that are pivotably coupled together by a hinge or other pivot 110. The first body 106 and the second body 108 are pivotable relative to each other to removably mount the clip 104 to the plunger rod 40. As shown, the bodies 106, 108 each include a curved portion 112 such that when the second bodies 106, 108 are in a closed configuration, the curved portion 112 defines a through hole 114 that is sized to allow the plunger rod 40 to extend through the clip 104. The size of the hole 114 is determined so that the clip 104 is retained between the flange 48 of the engagement portion 44 and the barrel 14, wherein the upper surface 116 of the clip 104 is configured to abut the flange 48 of the engagement portion 44, and the lower surface 118 of the clip 104 is configured to abut the end surface 24 of the barrel proximal end 20 after initial displacement. Accordingly, in this form, the lower surface 118 of the clip 104 provides the plunger stop 102 of the stop assembly 100. With this configuration, if the user pushes the plunger rod 40, the clip 104 limits the full movement of the plunger rod 40 to dispense the product 12. For example, the hole 114 can have at least one dimension, such as a diameter, that is smaller than the flange 48 of the engagement portion 44, so that the clip 104 is retained on the plunger rod 40 by the upper surface 116 hitting the flange 48. Furthermore, the clip 104 may be prevented from transferring to the barrel 14 by the flange 22 abutting the clip 104 and / or the hole 114 having a smaller size, diameter than the barrel 14 such that the lower surface 118 of the clip 104 abuts the end surface 24 of the barrel 14 .

[0045] As shown, the curved portion 112 of the body 106, 108 can be disposed on its lateral side, and the body 106, 108 can further include a generally planar portion 120 extending laterally away from the curved portion 112. When the bodies 106, 108 are in a closed configuration, the planar portions 120 extend along and abut each other, so that the sides of the hole 114 are closed by the hinge 110 and the planar portion 120. The clip 104 can include a latch or other fastening mechanism 122, such as a snap fit, with complementary parts on the lateral edge 124 of the planar portion 120. The latch 122 allows the clip 104 to be attached to the plunger rod 40 and removed therefrom. In addition, the main face 126 of the planar portion 120 can have instructions, drug identification information or other information for the user to view. For example, the information can inform the user about the proper operation and use of the clip 104. The information can be printed directly on the planar portion 116 and / or can be applied thereto, for example, with a sticker or the like.

[0046] Thus, the clip 104 can be attached to the plunger rod 40, and after the practitioner inspects and turns the syringe 10 upward, the practitioner can push the plunger rod 40 until the clip 104 restricts further movement of the plunger rod by extending between the proximal end 20 of the barrel 14 and the flange 48 of the engagement portion 44. Thereafter, the clip 104 can be removed by uncoupling the latch 122 and pivoting the bodies 106, 108 away from each other. After the clip 104 is removed, the plunger rod 40 is unrestricted for use in a normal dosing routine.

[0047] Figure 5 1 and 2. A second exemplary syringe 10 is shown in FIG. 2. In this form, the stop assembly 100 (which includes a removable portion 101 and a stop flange 102) is provided by a tab 130 that is removably and rigidly fixed to the plunger rod 40. The tab 130 extends along the longitudinal length of the plunger rod 40 and is fixed thereto along a side edge 132. As shown, the lower edge 134 of the tab 130 provides the plunger stop 102 of the stop assembly 100 to limit the movement of the plunger rod 40. For example, the tab 130 can be fixed to the plunger rod 40 so that the lower edge 134 is spaced apart from the proximal end 20 of the barrel 14 before use and is configured to abut the proximal end 20 of the barrel 14 after the plunger rod 40 has traveled a distance D relative to the barrel 14 to clear the head space 52. In the case of this configuration, if the user pushes the plunger rod 40, the tab 130 limits the complete movement of the plunger rod 40 to prevent the product 12 from being dispensed.

[0048] Thereafter, the tab 130 may be broken or removed from the plunger rod 40 to allow the plunger rod 40 to move freely. If desired, the connection 136 between the tab 130 and the plunger rod 40 may be defined by a breakable feature (such as a perforation or a rip in the material) extending between the tab 130 and the plunger rod 40. So configured, after use, the user can easily bend the tab 130 relative to the plunger rod 40 to break the connection between the tab 130 and the plunger rod 40, thereby allowing the plunger rod 40 to be used for normal dosing routines without restriction. In one example, the plunger rod 40 and the tab 130 may be integrally formed as a single-piece component. In addition, the main face 138 of the tab 130 may have instructions, drug identification information or other information thereon for the convenience of the user to view. For example, the information may inform the user about the proper operation and use of the tab 130. The information may be printed directly on one or both faces 138 and / or may be applied thereto, for example, with a sticker or the like.

[0049] Figure 6 and Figure 71 and 2. A third exemplary syringe 150 is shown in FIG. 2. In this form, the stop assembly 100 (including the removable portion 101 and the plunger stop 102) is provided by a block 150 having a body 152 having a front major face 154 and a rear major face 156 defined by side edges 158 and an end edge 160, and a fastening mechanism 170. A cavity 162 is formed in the body 152, wherein an opening 164 leading to the cavity 162 extends through the front major face 154 and the end wall 168 of the block 150. As shown, the shape of the cavity 162 corresponds to the proximal end of the plunger rod 40, wherein the rod portion 165 is sized to receive the rod 40 therein, and the thumb rest portion 166 is sized to receive the engagement portion 44 therein. The shape of the cavity 162 limits the longitudinal movement of the plunger rod 40 relative to the block 150 due to the T-shape abutting the engagement portion 44. In one form, the thumb rest portion 166 of the cavity 162 can extend completely through the block 150 to allow the body 152 to have a reduced depth. In addition, if desired, the stem portion 165 of the cavity 162 can extend completely through the block 150, and the block 150 can include a retaining member 167 that extends along the rear major face 156 to extend over at least a portion of the stem portion 164. The rear major face 156 or the retaining member 167 can have instructions, drug identification information, or other information on it for the user to see. For example, the information can inform the user about the proper operation and use of the block 150. The information can be printed directly on the face 156 or the retaining member 167 and / or can be applied thereto, such as with a sticker or the like.

[0050] The body 152 is sized to extend along the length of the plunger rod 40 so that the end wall 168 of the block 150 provides the plunger stop 102 of the stop assembly 100 to limit the movement of the plunger rod 40. For example, the end wall 168 can be spaced apart from the proximal end 20 of the barrel 14 before use, and can be configured to abut the proximal end 20 of the barrel 14 after the plunger rod 40 has traveled a distance D relative to the barrel 14 to clear the head space 52. With this configuration, if the user pushes the plunger rod 40, the block 150 prevents complete movement of the plunger rod 40 to prevent the product 12 from being dispensed.

[0051] The plunger rod 40 can be retained within the cavity 162 by a fastening mechanism 170. In one example, the fastening mechanism 170 can be an adhesive member, such as a tape or sticker, that is fastened to the block 150 and extends over at least a portion of the opening 164 to the cavity 162, such as the rod portion 165. So configured, after the headspace 52 has been cleared, the user can at least partially remove the adhesive member 170 and remove the plunger rod 40 from the cavity 162. In another example, the fastening mechanism 170 can be an elastic member that extends around the block 150.

[0052] Figure 8and Fig. 9 A fourth exemplary syringe 10 is shown in FIG. 1 . In this form, the stop assembly 100 (which includes a removable portion 101 and a plunger stop 102) is provided by a clamshell member 180 and a fastening mechanism 198. The clamshell member 180 has a first body 182 and a second body 184, the inner faces 186 of which are configured to extend along and abut each other when the member 180 is in a closed configuration. Each body 182, 184 defines a cavity 188 having an opening 190 extending through the inner faces 186 and end wall 196 of the bodies 182, 184. As shown, the shape of the cavity 188 corresponds to the proximal half of the plunger rod 40, wherein the rod portion 192 is sized to receive the rod 40 therein, and the thumb rest portion 194 is sized to receive the engagement portion 44 therein. Due to the T-shape of the abutment engagement portion 44, the shape of the cavity 188 limits the longitudinal movement of the plunger rod 40 relative to the member 180. As such, the bodies 182, 184 are configured to be brought together by the inner faces 186 abutting each other to capture the plunger rod 40 within the member 180.

[0053] The member 180 is sized to extend along the length of the plunger rod 40 so that the end wall 196 provides the plunger stop 102 of the stop assembly 100 to limit the movement of the plunger rod 40. For example, the end wall 196 can be spaced apart from the proximal end 20 of the barrel 14 before use, and can be configured to abut the proximal end 20 of the barrel 14 after the plunger rod 40 has traveled a distance D relative to the barrel 14 to clear the head space 52. With this configuration, if the user pushes the plunger rod 40, the member 180 prevents complete movement of the plunger rod 40 to prevent the product 12 from being dispensed.

[0054] The member 180 can be held in a closed configuration around the plunger rod 40 by a fastening mechanism 198. In one example, the fastening mechanism 198 can be an adhesive member, such as a tape or sticker, that fastens the bodies 182, 184 together. In another example, the fastening mechanism 198 can be a connecting structure, such as a snap-fit ​​feature, a tongue and groove feature, etc. If desired, one side of the bodies 182, 184 can be pivotally coupled together by a hinge or other pivot, and the fastening mechanism 198 can couple the other sides of these bodies together. Alternatively, the bodies 182, 184 can be separate components, and the fastening mechanism 198 can couple the bodies 182, 184 together. So configured, after the head space 52 has been cleared, the user can at least partially remove the adhesive member 198 and remove the member 180 from the plunger rod 40. In another example, the fastening mechanism 198 can be an elastic member extending around the member 180.

[0055] Fig.10A fifth exemplary syringe 10 is shown in FIG. 1 . In this form, the stop assembly 100 (which includes the removable portion 101 and the plunger stop 102) is provided by a clamp 200 having a first body 202 and a second body 204 that are pivotally coupled together by a pivot 206. The first body 202 and the second body 204 each include a jaw 208 at a distal end 210 thereof and a handle 212 at a proximal end 214 thereof. The bodies 202, 204 are held in a closed configuration by a biasing device 216. So configured, a user can squeeze the handles 212 together to open the jaws 208. The jaws 208 combine to define a through hole 218 extending through the clamp 200 when in a closed configuration, the through hole being sized to allow the plunger rod 40 to extend through the clamp 200. The hole 218 can extend completely through the clamp 200, or can be defined by an opening in the outer wall of the jaws 208. The jaws 208 are sized so that the clamp 200 is retained between the flange 48 of the engagement portion 44 and the barrel 14, wherein the upper surface 220 of the clamp 200 is configured to abut the flange 48 of the engagement portion 44, and the lower surface 222 of the clamp 200 (providing this form of the plunger stop 102) is configured to abut the proximal end 20 of the barrel 14. With this configuration, if the user pushes the plunger rod 40, the clamp 200 limits the full movement of the plunger rod 40 to dispense the product 12. For example, the aperture 218 may have at least one dimension, such as a diameter, that is smaller than the flange 48 of the engagement portion 44, so that the clamp 200 is retained on the plunger rod 40 by the upper surface 220 hitting the flange 48. Furthermore, the clamp 200 may be prevented from transferring to the barrel 14 by the flange 22 abutting the clamp 200 and / or the aperture 218 having a smaller size, diameter than the barrel 14 such that the lower surface 222 of the clamp 200 abuts the proximal end 20 of the barrel 14 .

[0056] Accordingly, the user can open the jaws 208 by squeezing the handles 212 together and position the jaws 208 on either side of the plunger rod 40. The biasing device 216 causes the jaws 208 to close around the plunger rod 40 to attach the clamp 200 thereto. After the practitioner inspects and turns the syringe 10 upward, the practitioner can push the plunger rod 40 until the clamp 200 restricts further movement of the plunger rod by extending between the proximal end 20 of the barrel 14 and the flange 48 of the engagement portion 44. Thereafter, the clamp 200 can be removed by opening the jaws 208. After removing the clamp 200, the plunger rod 40 is unrestricted for use in a normal dosing routine.

[0057] Fig.11 and Fig.12, a sixth exemplary syringe 10 is shown in FIG. 1 . In this form, the stop assembly 100 (which includes the removable portion 101 and the plunger stop 102) is provided by a snap-fit ​​member 220 having opposing first and second walls 222, 224, which are joined together by an end wall 226 and have opposing open ends 227. The first and second walls 222, 224 are spaced apart from each other to removably receive and retain the plunger rod 40 therebetween. In the illustrated form, the plunger rod 40 has a cross-shaped horizontal cross-section and intersecting walls 41a. In this configuration, the inner face 228 of the walls 222, 224 may include a vertical channel 230 defined therein, and the walls 222, 224 may be spaced apart a distance such that one of the walls 41a of the plunger rod 40 is received in the channel 230 and retained by it. Furthermore, the snap fit member 220 may be made of a material that allows the first and second walls 222, 224 to resiliently flex away from each other such that the plunger rod 40 may be inserted into and removed from the storage position while being retained between the walls 222, 224.

[0058] The snap-fit ​​member 230 is sized to be retained between the flange 48 of the engagement portion 44 and the barrel 14, wherein the upper surface 232 of the member 230 is configured to abut the flange 48 of the engagement portion 44, while the lower surface 234 of the member 230 (providing this form of the plunger stop 102) is configured to abut the proximal end 20 of the barrel 14. With this configuration, if the user pushes the plunger rod 40, the snap-fit ​​member 230 limits the full movement of the plunger rod 40 to dispense the product 12. For example, the flange 48 of the engagement portion 44 can have a size that is larger than the space between the walls 222, 224, so that the snap-fit ​​member 230 is retained on the plunger rod 40 by the upper surface 232 hitting the flange 48. In addition, by the flange 22 or other surface of the proximal end 20 of the barrel 14 abutting the lower surface 234, the snap-fit ​​member 230 can be prevented from transferring to the barrel 14.

[0059] Accordingly, the user can flex the walls 222, 224 away from each other and position the plunger rod 40 to be received within the channel 230. The snap-fit ​​member 220 elastically returns to the unflexed position, thereby retaining the snap-fit ​​member 220 on the plunger rod 40. The snap-fit ​​member 220 is sized to allow the plunger rod 40 to be pushed into the barrel 14 only a certain distance D to clear the head space 52 from the syringe 10. After the practitioner inspects and turns the syringe 10 upward, the practitioner can push the plunger rod 40 until the snap-fit ​​member 220 extends between the proximal end 20 of the barrel 14 and the flange 48 of the engagement portion 44 and limits the plunger rod from further movement. Thereafter, the snap-fit ​​member 220 can be removed by flexing the walls 222, 224 away from each other and removing the plunger rod 40. After removing the snap-fit ​​member 220, the plunger rod 40 is used for normal dosing routines without restriction.

[0060] Figures 13 to 16 , a seventh and eighth exemplary syringe 10 are shown in FIG. In these forms, the stop assembly 100 includes a plunger rod 40 flange 250 providing this form of plunger stop 102, which flange interacts with a blocking member 252 removably coupled to the barrel 14, which provides this form of removable portion 101. In one example, the plunger rod body 41 has an x-shaped cross-section formed by intersecting walls 41a. In other examples, the plunger rod body 41 can have a circular cross-section, etc., which is smaller than the inner diameter of the barrel 14. Obviously, in any form, the cross-sectional width of the plunger rod body 41 is smaller than the inner diameter of the barrel 14, so that the plunger rod 40 can be inserted into the barrel 14. As shown, at least a portion 254 of the distal end 42 of the plunger rod body 41 has a free space 256 between the structure of the plunger rod body 41 and the radial dimension corresponding to the inner diameter of the barrel 14. The flange 250 extends at least partially within this space 256, while being sized to fit within the barrel 14 and allow normal operation of the plunger rod 40. In this configuration, when the plunger rod 40 is pushed into the barrel 14, the flange 250 travels through a different path than the distal portion 254. The blocking member 252 is coupled to the proximal end 20 of the barrel 14 to extend at least partially into the path of the flange 250, thereby preventing the plunger rod 40 from further movement. In these forms, the flange 250 provides a plunger stop 102 of the stop assembly 100 that is spaced a distance D from an upper surface 257 of the blocking member 252 (which is associated with the proximal end 20 of the barrel 14). After the head space 52 has been cleared by driving the flange 250 into contact with the blocking member 252, the user can remove the blocking member 252 from the barrel 14, which allows the plunger rod 40 to be used for normal dosing routines without restriction.

[0061] exist Fig.13 and Fig.14In the seventh exemplary syringe 10 shown in FIG. 1 , the blocking member 252 is a clip 258 having a first wall 260 and a second wall 262 spaced apart, the two walls being connected by an end wall 264 and having opposite open ends 265. The first wall 260 and the second wall 262 are spaced apart by a distance, the size of the distance being determined to receive the flange 22 of the barrel proximal end 20 therebetween. In one form, the size of the distance between the walls 260, 262 can be determined to allow the clip 258 to be frictionally retained on the flange 22. Alternatively, a snap-fit ​​structure, a tongue and groove structure or a similar complementary structure can be utilized. So configured, the clip 258 can be removably mounted to the flange 22, thereby coupling the clip 258 to the barrel 14. In the illustrated form, the first upper wall 260 includes a distal slot 263 to receive a portion of the wall 41a of the plunger rod 40 therein, and the second lower wall 262 is configured to extend around the barrel 14 adjacent to the flange 22. As described above, when the clip 258 is mounted to the flange 22, a portion of the upper surface 266 of the clip 258 is placed within the path of the flange 250, thereby limiting the movement of the plunger rod 40 after the plunger rod 40 has been driven a distance D sufficient to clear the head space 52 in the barrel 14. After the head space 52 has been cleared, the user can simply slide the clip 258 off the flange 44.

[0062] exist Fig.15 and Fig.16 In the eighth exemplary syringe 10 shown in , the blocking member 252 is a tab 270, which can be planar, as shown. In one form, the tab 270 can have an elongated configuration to provide a user with an easy-to-grip portion. The distal end 272 of the tab 270 has a configuration complementary to a portion of the cross section of the plunger rod 40. For example, for the x-shaped cross section shown, the distal end 272 includes a slot 274 to receive a portion of the protruding wall of the plunger rod 40, and a lateral space 276 to receive the transverse wall therein, so that the tab 270 can slide into engagement with the plunger rod 40. Of course, the distal end 272 can alternatively include a concave edge or other configurations complementary to the plunger rod 40. As shown, the flange 22 may include a channel 278 formed therein to receive the tab 270 and align it with the plunger rod 40. In one form, the size of the channel 278 can be determined to frictionally receive the tab 270 to keep the tab 270 engaged with the plunger rod 40. Alternatively or additionally, the slot 274 and / or the lateral space 276 may be sized to frictionally engage the plunger rod 40 .

[0063] With this configuration, when the tab 270 is engaged with the plunger rod 40, the upper surface 280 of the tab 270 is placed within the path of the flange 250, thereby limiting the movement of the plunger rod 40 after the plunger rod 40 has been driven a distance D sufficient to clear the head space 52 in the barrel 14. After the head space 52 has been cleared, the user can simply pull the tab 270 away from the plunger rod 40 and remove it from the flange 22.

[0064] exist Figures 17 to 21 In the second example shown in , the syringe 10 is ready for use by the following steps. In the first step, if applicable, the practitioner removes the needle shield 33 to expose the distal end of the needle 32. In the second step, the practitioner orients the syringe 10 to a generally vertical orientation, such as within 45 degrees from the vertical plane, and preferably within 20 degrees from the vertical plane, with the engagement portion 44 disposed above the barrel 14 and the needle 32 pointing downward and observes the head space 52 moving toward the proximal end 20 of the barrel 14. As shown in the figure, Figures 17 to 21 Each syringe 10 of the illustrated embodiment may include a stopper 300 for limiting the distance the plunger rod 40 can be pushed into the barrel 14. For example, the stopper 300 may extend outwardly from the plunger rod body 41 in a direction generally perpendicular to the longitudinal axis of the plunger rod 40 a sufficient distance to engage the end surface 24 of the barrel proximal end 20 during a dispensing operation. In this regard, the stopper 300 may have at least one radial dimension that is greater than the corresponding radius of the opening of the barrel proximal end 20. In a third step, the practitioner may press the plunger rod 40 to drive the stopper 38 through the barrel 14. Advantageously, the plunger rod 40 moves until the stopper 300 abuts the end surface 24 of the barrel 14, thereby stopping the movement of the stopper 38 within the barrel 14. Fig.19 As shown, the plunger rod 40 and barrel 14 are adapted such that this position of the plunger rod 14 and stopper 38 leaves a head space 52 within the barrel 14 while dispensing a predetermined dose of the product 12 .

[0065] So configured, the stopper 300 prevents the plunger rod 40, and therefore the stopper 38, from being further displaced through the barrel 14, so that the dispensing operation dispenses a predetermined volume. In other words, by configuring the plunger rod 40 to have a predetermined length between the distal end 42 and the stopper 54 corresponding to a desired portion of the barrel 14, the syringe 10 can be preconfigured for dispensing a specific volume of fluid. Advantageously, this can be used to avoid problems associated with the head space in conventional pre-filled syringes by limiting the dispensing operation to a volume that prevents the head space 52 from being expelled.

[0066] The predetermined length of the plunger rod 40 between the distal end 42 and the stopper 300 plus the length of the stopper 38 corresponds to a portion L2 of the length L of the barrel 14. The length L2 is Fig.19, the plunger rod 40 is shown fully inserted into the barrel 14 and the stopper 300 abuts the end surface 24. Thus, during preparation of the syringe 10, the barrel 14 can be filled with a desired amount or dose of the product 12, and the stopper 38 can be positioned within the barrel 14 so that the head space 52 has a length and corresponding volume generally equal to the remaining portion L2 of the length L of the barrel 14.

[0067] Of course, the fluid of product 12 may interact with barrel 14 to have a meniscus rather than a flat top surface. To ensure that no head space 52 is dispensed, length L2 may have a value equal to or greater than the length of therapeutic product 12 at its elevated periphery adjacent barrel 14.

[0068] exist Figures 17 to 19 In the first exemplary syringe 10 of this form shown in , the stopper 300 is provided by a flange 302 that extends away from the plunger rod body 41 in a direction generally perpendicular (e.g., between about 1 and 5 degrees) relative to the longitudinal axis of the plunger rod 40. In one example, the flange 302 can extend radially outward away from the entire perimeter of the plunger rod body 41, such as having a circular or polygonal configuration. Alternatively, the flange 302 can extend outward away from a portion of the perimeter.

[0069] In addition, as shown, the plunger rod 40 may include one or more wall portions 304 extending longitudinally between the stopper flange 302 and the flange 48 of the engagement portion 44 to provide a major surface 306 visible along the longitudinal axis of the syringe 10. If desired, the wall portion 304 may extend laterally outwardly away from the plunger rod body 41 a greater distance than the flanges 302, 48 so that the major surface 306 provides an extended surface area to provide instructions, drug identification information or other information thereon for the convenience of the user to view. For example, the information may inform the user of the proper operation and use of the syringe 10. The information may be printed directly on the major surface 306 and / or may be applied thereto, for example, with a sticker or the like.

[0070] exist Fig. 20 and Fig.21In the second exemplary syringe 10 of this form shown in , the stopper 300 is provided by a snap-fit ​​member 320 having a first wall 322 and a second wall 324 opposite to each other, which are connected by an end wall 326 and have opposite open ends 327. The first wall 322 and the second wall 324 are spaced a certain distance from each other to removably receive and retain the plunger rod 40 therebetween. In the illustrated form, the plunger rod 40 has a cross-shaped horizontal cross-section and intersecting walls 41a. In the case of this configuration, the inner face 328 of the walls 322, 324 may include a vertical channel 330 defined therein, and the walls 322, 324 may be spaced a certain distance apart so that one of the walls 41a of the plunger rod 40 is received in the channel 330 and retained by it. In addition, the snap-fit ​​member 320 can be made of a material that allows the first wall 322 and the second wall 324 to resiliently flex away from each other so that the plunger rod 40 can be inserted into and removed from the storage position while being retained between the walls 322, 324. If desired, the plunger rod 40 can include a flange 331 having a perimeter sized to fit within the barrel 14 and spaced apart from the engagement portion 44 by a distance substantially equal to the height of the snap-fit ​​member 320 to retain the snap-fit ​​member 320 on a discrete portion of the plunger rod 40.

[0071] The snap-fit ​​member 320 is sized to be retained between the flange 48 of the engagement portion 44 and the barrel 14, wherein the upper surface 332 of the member 320 is configured to abut the flange 48 of the engagement portion 44, and the lower surface 334 of the member 320 is configured to abut the proximal end 20 of the barrel 14. In this configuration, if the user pushes the plunger rod 40, the snap-fit ​​member 320 limits the full movement of the plunger rod 40 to allow only the practitioner to dispense the desired dose of the product 12. For example, the flange 48 of the engagement portion 44 can have a size greater than the space between the walls 322, 324, so that the snap-fit ​​member 320 is retained on the plunger rod 40 by the upper surface 332 hitting the flange 48. In addition, the snap-fit ​​member 320 can be prevented from being transferred to the barrel 14 by the flange 22 or other surface of the proximal end 20 of the barrel 14 abutting the lower surface 334.

[0072] Accordingly, the user can flex the walls 322, 324 away from each other and position the plunger rod 40 to be received within the channel 330. The snap-fit ​​member 320 elastically returns to the unflexed position, thereby retaining the snap-fit ​​member 320 on the plunger rod 40. The height of the snap-fit ​​member 320 is determined to allow the plunger rod 40 to be pushed only a certain distance L2 into the barrel 14 to administer the product 12 and leave the head space 52 in the syringe 10.

[0073] The disclosure provided herein can be used with any desired dose and syringe size while ensuring the delivery of an accurate dose. This is applicable to pre-filled syringes for self-injection by patients or for injection by practitioners. The components of the syringe 10 (such as the barrel 14 and the plunger rod 40) can be made of any suitable material, such as plastic or glass. In one example, the syringe 10 described herein can provide the desired accuracy of + / - 10 microliters of fluid therapy product injection. In a 1 mL syringe, the movement of the plunger can be controlled within + / - 0.3 mm to achieve the desired accuracy.

[0074] It will be understood that the elements in the figures are shown for simplicity and clarity and are not necessarily drawn to scale. For example, the size and / or relative position of some elements in the figure may be enlarged relative to other elements to help improve the understanding of various embodiments of the present invention. Moreover, commonly used but easy-to-understand elements that are available or necessary in commercially feasible embodiments are usually not drawn to facilitate viewing these various embodiments with less obstruction. The same reference numerals may be used to describe the same or similar parts. Further, although several examples have been disclosed herein, any feature from any example can be combined with other features from other examples or replaced by other features. In addition, although several examples have been disclosed herein, the disclosed examples may be changed without departing from the scope of the claims.

[0075] The above description describes various devices, assemblies, parts, subsystems and methods used in relation to drug delivery devices. Devices, assemblies, parts, subsystems, methods or drug delivery devices may further include drugs or be used together with drugs, including but not limited to those drugs identified below and their generic counterparts and biosimilar counterparts. As used herein, the term drug can be used interchangeably with other similar terms, and can be used to refer to any type of medicament or therapeutic material, including traditional and non-traditional drugs, nutritional supplements, supplements, biologics, bioactive agents and compositions, macromolecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules and generics. Non-therapeutic injectable materials are also included. The drug can be in liquid form, in lyophilized form or in a form that can be reconstructed by lyophilized form. The following exemplary drug list should not be considered to include all or restrictive.

[0076] The drug will be contained in a reservoir. In some cases, the reservoir is a primary container that is filled or pre-filled with the drug for treatment. The primary container can be a vial, a cartridge, or a pre-filled syringe.

[0077] In some embodiments, the reservoir of the drug delivery device can be filled with a colony stimulating factor, such as granulocyte colony stimulating factor (G-CSF), or the device can be used with a colony stimulating factor. Such G-CSF agents include, but are not limited to, Neulasta® (pegfilgrastim, pegylated filgrastim, pegylated G-CSF, pegylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0078] In other embodiments, the drug delivery device may contain or be used with an erythropoiesis stimulating agent (ESA), which may be in liquid or lyophilized form. ESA is any molecule that stimulates erythropoiesis. In some embodiments, ESA is an erythropoiesis stimulating protein. As used herein, "erythropoiesis stimulating protein" means any protein that directly or indirectly causes activation of the erythropoietin receptor (e.g., by binding to and causing dimerization of the receptor). Erythropoiesis stimulating proteins include erythropoietin and variants, analogs or derivatives thereof that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoiesis stimulating proteins include, but are not limited to, Epogen® (epoetin alpha), Aranesp® (darbepoetin alpha), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alpha), epoetin alpha Hexal, Abseamed® (epoetin alpha), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta and epoetin delta, pegylated erythropoietin, carbamylated erythropoietin, and molecules thereof or variants or analogs thereof.

[0079] Specific illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL-specific antibodies, peptibodies, related proteins, etc. (also referred to as RANKL-specific antibodies, peptibodies, etc.), including fully humanized OPGL-specific antibodies and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies; myostatin binding proteins, peptibodies, related proteins, etc., including myostatin-specific peptibodies; IL-4 receptor-specific antibodies, peptibodies, related proteins, etc., particularly those that inhibit the production of IL-4 and / or IL -13 and receptor-mediated activities; interleukin 1-receptor 1 ("IL1-R1") specific antibodies, peptibodies, related proteins, etc.; Ang2 specific antibodies, peptibodies, related proteins, etc.; NGF specific antibodies, peptibodies, related proteins, etc.; CD22 specific antibodies, peptibodies, related proteins, etc., in particular human CD22 specific antibodies, such as but not limited to humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, in particular including but not limited to human CD22 specific IgG antibodies, such as human-mouse monoclonal hLL2 Dimers of a γ-chain and a human-mouse monoclonal hLL2 κ chain that are disulfide-linked, for example, the human CD22-specific fully humanized antibody in Epratuzumab, CAS Registry No. 501423-23-0; IGF-1 receptor-specific antibodies, peptibodies, and related proteins, etc., including but not limited to anti-IGF-1R antibodies; B-7-related protein 1-specific antibodies, peptibodies, related proteins, etc. ("B7RP-1", also known as B7H2, ICOSL, B7h, and CD275), including but not limited to B7RP-specific fully human monoclonal IgG2 antibodies, including but not limited to fully human IgG2 monoclonal antibodies that bind to epitopes in the first immunoglobulin-like domain of B7RP-1, including but not limited to those that inhibit the interaction of B7RP-1 with its natural receptor ICOS on activated T cells; IL-15-specific antibodies, peptibodies, related proteins, etc., such as, in particular, humanized monoclonal antibodies, including but not limited to HuMaxIL-15 antibodies and related proteins, such as 145c7; IFN γ-specific antibodies, peptibodies, related proteins, etc., including but not limited to human IFNγ-specific antibodies, and including but not limited to fully human anti-IFNγ antibodies; TALL-1-specific antibodies, peptibodies, related proteins, etc., and other TALL-specific binding proteins; parathyroid hormone ("PTH")-specific antibodies, peptibodies, related proteins, etc.; thrombopoietin receptor ("TPO-R")-specific antibodies, peptibodies, related proteins, etc.;Hepatocyte growth factor ("HGF") specific antibodies, peptibodies, related proteins, etc., including those targeting the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter (HGF / SF); TRAIL-R2 specific antibodies, peptibodies, related proteins, etc.; activin A specific antibodies, peptibodies, proteins, etc.; TGF-β specific antibodies, peptibodies, related proteins, etc.; amyloid-β protein specific antibodies, peptibodies, related proteins, etc.; c-Kit specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind to c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind to OX40L and / or OX40 receptors other ligands of activase® (alteplase, tPA); Aranesp® (darbepoetin alfa) erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, novel erythropoiesis-stimulating protein (NESP); Epogen® (epoetin alfa, or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-α4ß7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu (erbB2) receptor mAb); Kanjinti™ (trastuzumab-anns) anti-HER2 monoclonal antibody, a biosimilar of Herceptin®, or another product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalimumab);Vectibix® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), immunoglobulin G2 human monoclonal antibody to RANK ligand, Enbrel® (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP)); Kineret® (anakinra); Leukine® (sargramostim, rhuGM-CSF); LymphoCide® (epatuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxypolyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-C5 complement); Numax® (MEDI-524); Lucentis® (ranibizumab); Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (viciluzumab); cantuzumabmertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Orthoclone OKT3® (meromob-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alfa); Remicade® (infliximab, anti-TNFα monoclonal antibody); Reopro® (abciximab, anti-GP lIb / Ilia receptor monoclonal antibody); Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab); HuMax-CD4 (zanolimumab); Mvasi; TM(bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A® (interferon α-2a); Simulect® (basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); Tysabri® (natalizumab, anti-α4 integrin mAb); Valortim® (MDX-1303, anti-anthrax protective antigen mAb); ABthrax™; Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (Fc portion of human IgG1 and extracellular domain of IL-1 receptor components (type I receptor and receptor accessory protein)); VEGF trap (IgG1 Fc-fused Ig domain of VEGFR1); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2Rα mAb); Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (ruximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatumumab); human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAb; anti-Clostridium difficile toxin A and toxin BC mAbs MDX-066 (CDA-1) and MDX-1388); anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb;Anti-CTGF idiopathic pulmonary fibrosis stage I fibrinogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb; anti-ganglioside GM2 mAb; anti-GDF-8 human mAb (MYO-029); anti-GM-CSF receptor mAb (CAM-3001); anti-HepC mAb (HuMax HepC); anti-IFNα mAb (MEDI-545, MDX-198); anti-IGF1R mAb; anti-IGF-1R mAb (HuMax-Inflam); anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 receptor mAb; anti-integrin receptor mAb (MDX-018, CNTO 95); anti-IP10 ulcerative colitis mAb (MDX-1100); BMS-66513; anti-mannose receptor / hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFß mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3). ;

[0080] In some embodiments, the drug delivery device may contain or be used with a sclerostin antibody, such as, but not limited to, romosozumab, blosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product for the treatment of postmenopausal osteoporosis and / or fracture healing containing romosozumab, and in other embodiments, a monoclonal antibody (IgG) that binds human proprotein convertase subtilisin / Kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, panitumumab. In some embodiments, the reservoir of the drug delivery device may be filled with or be used with IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, including but not limited to OncoVEXGALV / CD; OrienX010; G207; 1716; NV1020; NV12023; NV1034 and NV1042. In some embodiments, the drug delivery device may contain or be used with an endogenous tissue metalloproteinase inhibitor (TIMP), such as but not limited to TIMP-3. In some embodiments, the drug delivery device may contain or be used with Aimovig® (Anovimab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product for treating migraine containing Anovimab. Antagonistic antibodies to human calcitonin gene-related peptide (CGRP) receptors (such as but not limited to Anovimab) and bispecific antibody molecules targeting CGRP receptors and other headache targets may also be delivered using the drug delivery device of the present disclosure. Additionally, bispecific T cell engager (BiTE®) antibodies (such as but not limited to BLINCYTO® (blinatumomab)) may be used in or used with the drug delivery device of the present disclosure.In some embodiments, the drug delivery device may contain or be used with an APJ macromolecular agonist, such as, but not limited to, apelin or its analogs. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody is used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain Avsola for the treatment of autoimmune diseases. TM (infliximab-axxq), an anti-TNF alpha monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab or used together with it. In some embodiments, the drug delivery device may contain Kyprolis® (carfilzomib) for the treatment of multiple myeloma, (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutyramido)-4-methylpentanamide, or another product containing carfilzomib or used together with it. In some embodiments, the drug delivery device may contain or be used with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast, for the treatment of various inflammatory diseases. In some embodiments, the drug delivery device may contain Parsabiv® for the treatment of secondary hyperparathyroidism (sHPT), such as in chronic kidney disease (KD) dialysis patients. TM(vecositriptyline HCl, KAI-4169) or another product comprising vecositriptyline HCl or used with it. In some embodiments, the drug delivery device may comprise or be used with ABP 798 (rituximab), a biosimilar candidate of Rituxan® / MabThera™, or another product comprising an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may comprise or be used with a VEGF antagonist (such as a non-antibody VEGF antagonist) and / or a VEGF-Trap (such as aflibercept (Ig domain 2 of VEGFR1 and Ig domain 3 of VEGFR2 fused to the Fc domain of IgG1)). In some embodiments, the drug delivery device may comprise or be used with ABP 959 (eculizumab), a biosimilar candidate of Soliris®, or another product comprising a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used with Rozibafusp alfa (formerly AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used with omecadimecarb (a small molecule selective cardiac myosin activator), or a myotrope that directly targets the cardiac contractile machinery, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain sotolacib (formerly AMG 510), KRAS G12C Small molecule inhibitors, or KRAS G12CIn some embodiments, the drug delivery device may contain or be used with another product that is a small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used with Tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product that contains a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or another product that contains a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with AMG 890, a small interfering RNA (siRNA) that lowers lipoprotein (a) (also known as Lp(a)), or another product that contains a small interfering RNA (siRNA) that lowers lipoprotein (a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG1 κ antibody), a biosimilar candidate to Stelara®, or another product containing a human IgG1 κ antibody and / or binding to the p40 subunit of the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain Amjevita TM or Amgevita TM(formerly ABP 501) (mab anti-TNF human IgG1), a biosimilar candidate for Humira®, or another product comprising human mab anti-TNF human IgG1. In some embodiments, the drug delivery device may comprise or be used with AMG 160, or another product comprising a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may comprise or be used with AMG 119, or another product comprising a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may comprise or be used with AMG 119, or another product comprising a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may comprise or be used with AMG 133, or another product comprising a gastric inhibitory peptide receptor (GIPR) antagonist and a GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with AMG171 or another product containing a growth differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with AMG 176 or another product containing a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with AMG 199 or another product containing a half-life extended (HLE) bispecific T cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain or be used with AMG 256 or another product (containing an anti-PD-1 x IL21 mutein and / or an IL-21 receptor agonist) designed to selectively turn on the interleukin 21 (IL-21) pathway in programmed cell death-1 (PD-1) positive cells. In some embodiments, the drug delivery device may contain or be used with AMG 330 or another product containing an anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 404 or another product comprising a human anti-programmed cell death-1 (PD-1) monoclonal antibody that is being studied for the treatment of patients with solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 427 or another product comprising a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T cell engager) construct.In some embodiments, the drug delivery device may contain or be used with AMG 430 or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with AMG 506 or another product (containing a multispecific FAP x 4-1BB-targeting DARPin® biologic) being studied for solid tumor treatment. In some embodiments, the drug delivery device may contain or be used with AMG 509 or another product containing a bivalent T cell engager and is designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used with AMG 562 or another product containing a half-life extended (HLE) CD19 x CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with Efavaleukin alpha (formerly AMG 592) or another product containing an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used with AMG 596 or another product containing a CD3 x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain or be used with AMG 673 or another product containing a half-life extended (HLE) anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 701 or another product containing a half-life extended (HLE) anti-B cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used with AMG 757 or another product containing a half-life extended (HLE) anti-delta-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, a drug delivery device may contain AMG 910 or another product containing a half-life extended (HLE) claudin 18.2 xCD3 BiTE® (bispecific T cell engager) construct for use therewith.

[0081] Although the drug delivery devices, assemblies, components, subsystems and methods have been described in terms of exemplary embodiments, they are not limited thereto. The detailed description is to be construed as merely exemplary and does not describe every possible embodiment of the present disclosure. Many alternative embodiments may be implemented using current technology or technology developed after the filing date of this patent application, which still fall within the scope of the claims defining the invention disclosed herein.

[0082] Those skilled in the art will appreciate that various modifications, changes and combinations may be made to the embodiments described above without departing from the spirit and scope of the invention disclosed herein, and that such modifications, changes and combinations may be deemed to be within the scope of the inventive concept.

Claims

1. A syringe, comprising: a barrel having an interior, a dispensing opening at a distal end, and an open proximal end; a plug disposed within the interior of the barrel; a plunger rod having a first end configured to at least selectively operably couple with the stopper and a second end extending through the open proximal end of the barrel, the second end including an outwardly extending flange; as well as a stop assembly including a plunger stop coupled to the plunger rod at a location between the flange and the open proximal end of the barrel, and a removable portion coupled to the plunger rod or the barrel, the plunger stop being configured and sized to engage a stop surface adjacent the open proximal end of the barrel to selectively limit displacement of the plunger and stopper along the interior of the barrel, Wherein the plunger rod and the stop assembly are configured to allow the plunger rod to move a predetermined length corresponding to the plunger rod dispensing at least a specific volume of head space in the syringe, and the stop assembly is configured for removal prior to administration.

2. The syringe according to claim 1, wherein: The plunger stop and removable portion of the stop assembly includes a first body and a second body that are pivotable relative to each other to capture the plunger rod therebetween.

3. The syringe according to claim 2, wherein: The plunger stop and removable portion of the stop assembly includes a clip including a hinge pivotably coupling a first side of the first body and the second body, and a fastening mechanism releasably connecting a second side of the first body and the second body.

4. The syringe according to claim 2, wherein: The plunger stop and removable portion of the stop assembly includes a clamp including a biasing mechanism, and the first body and the second body include jaws at their first ends and handles at their second ends, the biasing mechanism biasing the jaws of the first body and the second body together to capture the plunger rod therebetween.

5. The syringe according to claim 1, wherein: The plunger stop and removable portion of the stop assembly include a tab coupled to the plunger rod along a longitudinal length of the plunger rod via a breakaway feature.

6. The syringe according to claim 1, wherein: The plunger stop and removable portion of the stop assembly include: a body defining a cavity having an opening through an end wall of the body, the cavity being configured to receive the plunger rod therein to restrict longitudinal movement of the plunger rod relative to the body; and A securing mechanism is coupled to the body to retain the plunger rod within the cavity.

7. The syringe according to claim 6, wherein: The fastening mechanism includes an adhesive member extending over the cavity.

8. The syringe according to claim 6, wherein: The body includes first and second clamshell components having interior surfaces configured to be brought together to define a cavity therebetween, and the fastening mechanism retains the first and second clamshell components in a closed configuration with the plunger rod captured within the cavity.

9. The syringe according to claim 1, wherein: The plunger stop and removable portion of the stop assembly include a snap-fit ​​member including a first wall and a second wall spaced apart from each other and connected by an end wall, the first wall and the second wall defining a channel on their inner faces and being configured to flex apart to position the plunger rod therebetween and return toward an unflexed position to retain a portion of the plunger rod within the channel.

10. The syringe according to claim 1, wherein: The proximal end of the barrel includes an outwardly projecting flange, and the removable portion of the stop assembly includes a blocking member configured to removably engage the flange of the barrel; and wherein the plunger stop of the stop assembly includes a stop flange extending outwardly from the plunger rod adjacent to the first end of the plunger rod, the circumference of the stop flange being sized to fit within the interior of the barrel, and a portion of the blocking member being disposed within a path of travel of the stop flange to limit longitudinal movement of the plunger rod.

11. The syringe according to claim 10, wherein: The blocking member includes a clip having a first wall and a second wall spaced apart from each other and connected by an end wall, the clip being configured to engage a flange of the cartridge between the first wall and the second wall.

12. The syringe of claim 10, wherein: The blocking member includes a tab having a distal end having a configuration complementary to a portion of a horizontal cross-section of the plunger rod, and the flange of the barrel includes a channel sized to receive the tab therein, the channel being configured to guide the tab into engagement with the plunger rod.

13. A syringe as claimed in any one of the preceding claims, wherein The stop assembly includes a wall portion having information regarding the operation of the stop assembly displayed on a face of the wall portion.

14. A method of dispensing headspace from a syringe containing a liquid therapeutic product, the method comprising: A syringe is provided, the syringe comprising: a barrel having an interior, a dispensing opening at a distal end, and an open proximal end; a stopper disposed within the barrel interior; a plunger rod having a first end and a second end, the first end being configured to at least selectively operably couple with the stopper, the second end extending through the open proximal end of the barrel, wherein the second end comprises an outwardly extending flange; a fluid therapeutic product and a headspace disposed in the barrel interior between the stopper and the dispensing opening; and a stop assembly comprising a plunger stop coupled to the plunger rod and a removable portion coupled to the plunger rod or the barrel; driving the plunger rod toward the open proximal end of the barrel of the syringe to drive the stopper along the interior of the barrel toward the dispensing opening, thereby dispensing the head space through the dispensing opening; abutting the plunger stop against a stop surface adjacent the open proximal end of the barrel, thereby stopping movement of the stopper and preventing the fluid therapeutic product from being expelled; and removing the removable portion of the stop assembly from the plunger rod or barrel, Wherein the plunger rod and the stop assembly are configured to allow the plunger rod to move a predetermined length corresponding to the plunger rod dispensing at least a specific volume of head space in the syringe, and the stop assembly is configured for removal prior to administration.

15. The method of claim 14, wherein: The plunger stop and removable portion of the stop assembly includes a first body and a second body, the plunger rod is captured between the first body and the second body, and removing the removable portion of the stop assembly from the plunger rod or barrel includes pivoting the first body and the second body of the stop relative to each other.

16. The method of claim 14, wherein: Removing the removable portion of the stop assembly from the plunger rod or barrel includes breaking off a tab from the plunger rod.

17. The method of claim 14, wherein: The plunger stop and removable portion of the stop assembly includes: a body and a fastening mechanism, the body defining a cavity having an opening through an end wall of the body, the plunger rod being received in the cavity, the fastening mechanism being coupled to the body to retain the plunger rod in the cavity, and removing the removable portion of the stop assembly from the plunger rod or barrel includes manipulating the body and fastening mechanism to release the plunger rod from the cavity.

18. The method of claim 14, wherein: Removing the removable portion of the stop assembly from the plunger rod or barrel includes flexing the first wall and the second wall of the stop assembly away from one another to release the plunger rod from being captured therebetween.

19. The method of claim 14, wherein: The proximal end of the barrel includes an outwardly projecting flange, the plunger stop includes a stop flange extending outwardly from the plunger rod, wherein the circumference of the stop flange is sized to fit within the interior of the barrel, and removing the removable portion of the stop assembly from the plunger rod or barrel includes decoupling a blocking member having a portion disposed within the path of travel of the stop flange to limit longitudinal movement of the plunger rod from the flange of the barrel.

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