Stoppering tool system and method with distally loaded stopper for installtion in a syringe barrel

Abstract

Provided herein is a vent tube stoppering system for positioning a stopper within a syringe barrel. The system includes a vent tube insertable into a chamber of the syringe barrel, with the vent tube including proximal and distal ends each having an opening, a passageway extending from the proximal opening to the distal opening and having a first portion having a first diameter and a second portion having a second diameter greater than the first diameter, and a stopper seat positioned at the distal end that defines the second portion of the passageway, the stopper seat configured to retain the stopper in a compressed state and including an abutment preventing proximal movement of the stopper. The system also includes an installation rod moveable inside the passageway so that installation rod may push the stopper distally out of the stopper seat and into the syringe barrel.

Description

STOPPERING TOOL SYSTEM AND METHOD WITH DISTALLY LOADEDSTOPPER FOR INSTALL TION IN A SYRINGE BARRELCROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to European Patent Application No. 23198905.4 entitled “Stoppering Tool System and Method with Distally Loaded Stopper for Installation in a Syringe Barrel” filed September 21, 2023, the disclosure of which is hereby incorporated by reference in its entirety.BACKGROUND OF THE INVENTIONField of the Invention

[0002] The present disclosure relates generally to a stoppering tool system for installing a plunger stopper in a syringe and, more particularly, to a stoppering tool system for installing a plunger stopper in a syringe barrel that prevents damage to the stopper during insertion.Description of Related Art

[0003] Prefilled injection devices are common containers used to administer liquids (e.g., medications or drugs) to a patient and include syringes, cartridges and auto-injectors or the like. They usually comprise a plunger stopper in gliding engagement within a container, the container being filled with a pharmaceutical composition in order to provide the practitioners with a ready-to-use injection device for patients.

[0004] A container has a substantially cylindrical shape, and comprises a proximal end able to be stoppered by a plunger stopper, a distal end wherein the pharmaceutical composition is expelled from the container, and a lateral wall extending between the proximal end and the distal end of the container. In practice, the plunger stopper is aimed at moving, upon the pressure exerted by a plunger, from a proximal end of the container towards the distal end of the container, thereby expelling the drug contained into the container.

[0005] When compared to empty injection devices that are filled with a vial-stored pharmaceutical composition just prior to the injection to the patient's body, the use of prefilled injection devices leads to several advantages. In particular, by limiting the preparation prior to the injection, the prefilled injection devices provide a reduction of medical dosing errors, a minimized risk of microbial contamination and an enhanced convenience of use for the practitioners. Furthermore, such prefilled containers may encourage and simplify selfadministration by the patients which allows reducing the cost of therapy and increasing thepatient adherence. Finally, prefilled injection devices reduce loss of valuable pharmaceutical composition that usually occurs when a pharmaceutical composition is transferred from a vial to a non-prefilled injection device. This results in a greater number of possible injections for a given manufacturing batch of pharmaceutical composition thus reducing buying and supply chain costs.

[0006] Prefilled injection devices as described above are usually obtained by filling an empty medical container with a desired pharmaceutical composition, then stoppering the filled container under vacuum or by vent tube or a combination of both. A filled container is generally stoppered right after filling of the drug into the container body using stoppering machines according to the following method: the medical container to be stoppered is positioned on an adapted support (for example, in a nest or clipped directly on the stoppering machine), with its proximal end up, that is with its distal end down and maintained in this position.

[0007] In the case of vent tube stoppering, the stopper is compressed in a tube, usually called a “vent tube,” whose outer diameter is smaller than the inner diameter of the medical container. Upon placement of the stopper within the vent tube, the vent tube is then partially positioned within the container and, with the outer diameter of the vent tube being smaller than the inner diameter of the medical container, air is allowed to circulate between the vent tube and the container during such placement. With the vent tube positioned within the medical container, the stopper, previously positioned inside the tube, is then pushed distally by an installation rod out of the vent tube and to a desired position within the container above the composition (e.g., towards the proximal end of the container).

[0008] In known vent tube stoppering systems and methods, the stopper is inserted into the vent tube at a proximal end thereof, and the installation rod is then used to push the stopper through the entire length of the vent tube, before the stopper exits out the distal end of the vent tube and to a desired position within the medical container. While such a method of vent tube stoppering allows for accurate placement of the stopper within the container, pushing the stopper through the entire length of the vent tube may cause damage to the stopper. As one example, pushing the stopper through the entire length of the vent tube increases the amount of friction between the stopper and the vent tube, along with heating associated with the friction, which may damage the stopper (e.g., a film / layer on the outer surface of stopper may become worn), particularly if the stopper is a lubricant-free or low lubricant stopper. As another example, pushing the stopper through the entire length of the vent tube increases the time that the installation rod is in contact with the stopper and applying a pushing force thereto, with such contact / forces potentially causing damage to the internal structure of the stopper as it isforced through the vent tube. Additionally, with the installation rod applying a pushing force only to the center portion of the stopper, it is possible for the stopper to tilt as it is being pushed out of the vent tube and into the medical container - with the result being that the stopper may not form a proper seal with the container wall when pushed into position.

[0009] Accordingly, a need exists in the art for a vent tube stoppering system and method that reduces the potential for damage to the stopper. The system and method would reduce the amount of travel of the stopper when being transitioned out from the vent tube into a medical container, so as to lower the amount of friction and forces experienced by the stopper, especially when the stopper is a lubricant-free or low lubricant stopper.SUMMARY OF THE INVENTION

[0010] Provided herein is a vent tube stoppering system for positioning a stopper within a syringe barrel. The system includes a vent tube configured to be inserted into a chamber of the syringe barrel, with the vent tube being moveable along a longitudinal axis between a proximal tube rest position where the vent tube is outside the chamber of the syringe barrel and a distal tube operative position where a distal portion of the vent tube is positioned within the chamber of the syringe barrel. The vent tube further includes a proximal end having an opening therein, a distal end having an opening therein, a passageway extending from the proximal opening to the distal opening and having a first portion having a first diameter and a second portion having a second diameter greater than the first diameter, the second portion distal to the first portion, and a stopper seat positioned at the distal end that defines the second portion of the passageway, the stopper seat configured to retain the stopper in a compressed state, the stopper seat including an abutment preventing proximal movement of the stopper from the second portion to the first portion. The system also includes an installation rod moveable inside the passageway of the vent tube along the longitudinal axis between a proximal rod rest position and a distal rod operative position, wherein the installation rod pushes the stopper distally out of the stopper seat and into the syringe barrel when the vent tube is in the distal tube operative position and the installation rod is in the distal rod operative position.

[0011] In certain configurations, a longitudinal dimension of the second portion of the passageway defined by the stopper seat is approximately equal to a height of the stopper.

[0012] In certain configurations, the opening at the proximal end of the vent tube has a diameter equal to the first diameter and the opening at the distal end of the vent tube has a diameter equal to the second diameter.

[0013] In certain configurations, the opening at the distal end of the vent tube enables insertion of the stopper, while in the compressed state, into the stopper seat.

[0014] In certain configurations, the first diameter of the first portion of the passageway is smaller than a diameter of the stopper while in the compressed state.

[0015] In certain configurations, the first diameter of the first portion of the passageway is approximately equal to a diameter of the installation rod.

[0016] In certain configurations, the vent tube stoppering system further includes a compression insert engageable with the distal end of the stopper tube, the compression insert including an insert body defining a chamber, a first opening provided at a first end of the chamber, and a second opening provided at a second end of the chamber, wherein the first opening and the chamber are configured to receive the stopper while in an uncompressed state and wherein the second opening transition is configured to transition the stopper to the compressed state as the stopper is pushed out therethrough, to enable loading of the stopper from the compression insert to the stopper seat while the stopper is in the compressed state.

[0017] In certain configurations, the vent tube stoppering system further includes a holder configured to receive a distal end of the syringe barrel and to hold the syringe barrel aligned with the direction of travel of the vent tube, so that the syringe barrel is stabilized when moving the vent tube from the proximal tube rest position to the distal tube operative position.

[0018] In certain configurations, the installation rod includes a shouldered distal end having a shoulder portion with a first rod diameter and a tip portion extending out distally from the shoulder portion and having a second rod diameter less than the first rod diameter, wherein when pushing the stopper distally out of the stopper seat, the tip portion engages a bottom surface of a cavity formed in the stopper and the shoulder portion engages a proximal face of the stopper.

[0019] Also provided herein is a method for vent tube stoppering a syringe barrel with a valved stopper using a vent tube stoppering system. The method includes compressing the stopper from an uncompressed state to a compressed state, inserting the stopper into the vent tube via the opening at the distal end thereof, such that the stopper is positioned and retained within the stopper seat, and moving the vent tube along a longitudinal axis from a proximal tube rest position where the vent tube is outside the passageway of the syringe barrel to a distal tube operative position where a distal portion of the vent tube is positioned within the passageway of the syringe barrel. With the vent tube in the distal tube operative position, the method further includes pushing the installation rod distally through the passageway of the venttube from a proximal rod rest position to a distal rod operative position, so as to push the stopper distally out of the stopper seat and into the syringe barrel.

[0020] In certain configurations, in inserting the stopper into the vent tube to be positioned and retained within the stopper seat, the stopper is pushed distally into the vent tube until coming into contact with the abutment of the stopper seat.

[0021] In certain configurations, in pushing the stopper distally out of the stopper seat and into the syringe barrel, a travel distance of the stopper is approximately equal to a height of the stopper.

[0022] In certain configurations, compressing the stopper includes placing the stopper into a compression insert with the stopper in an uncompressed state, the compression insert engageable with the distal end of the stopper tube, and statically compressing the stopper from the uncompressed state to the compressed state via the compression insert, with the stopper inserted into the vent tube from the compression insert while in the compressed state.

[0023] In certain configurations, the method further includes transitioning the stopper from a rail system to the loading device, wherein in transitioning the stopper, an orientation of the stopper is kept constant or reversed, to facilitate placement thereof into the loading device.

[0024] In certain configurations, the stopper comprises a lubricant-free or low lubricant stopper, and pushing the stopper distally out of the stopper seat and into the syringe barrel prevents friction damage to the lubricant-free or low lubricant stopper and / or limits heating of the lubricant-free or low lubricant stopper by friction, as compared to distally pushing the lubricant-free or low lubricant stopper through an entire length of the vent tube and into the syringe barrel.BRIEF DESCRIPTION OF THE DRAWINGS

[0025] FIG. 1 is a perspective view of a syringe, with which embodiments of the disclosure may be implemented;

[0026] FIG. 2 is an exploded view of the syringe of FIG. 1;

[0027] FIG. 3 is an exploded perspective view of a vent tube stoppering system for positioning a stopper within a syringe barrel, according to a non-limiting embodiment described herein;

[0028] FIG. 4 is a cross-sectional view of a vent tube included in the vent tube stoppering system of FIG. 3, taken along line 4-4 of FIG. 3;

[0029] FIG. 5 is a graphical illustration of a method for vent tube stoppering a syringe barrel with a stopper using the system of FIG. 3, according to a non-limiting embodiment described herein;

[0030] FIG. 6 is a graphical illustration of a method for vent tube stoppering a syringe barrel with a stopper using the system of FIG. 3, according to another non-limiting embodiment described herein; and

[0031] FIG. 7 is a graphical illustration of a method for vent tube stoppering a syringe barrel with a stopper using the system of FIG. 3, according to another non-limiting embodiment described herein.DESCRIPTION OF THE INVENTION

[0032] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, 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 present invention.

[0033] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.

[0034] In the present disclosure, the distal end of a component or of a device means the end furthest away from the hand of the user and the proximal end means the end closest to the hand of the user, when the component or device is in the use position, i.e., when the user is holding a syringe in preparation for or during use. Similarly, in this application, the terms "in the distal direction" and "distally" mean in the direction toward the distal tip of the syringe, and the terms "in the proximal direction" and "proximally" mean in the direction opposite the direction of the distal tip of the syringe.

[0035] Referring to FIGS. 1 and 2, shown is a non-limiting embodiment of a medical container 10 with which aspects or embodiments of the disclosure may be implemented. According to aspects of the disclosure, the medical container 10 is provided as a pre-filledsyringe (hereafter “ syringe 10”) that provides the convenience of rapidly delivering the liquid therein to a patient without the need to first aspirate the medication from another container and meter its volume. However, it is recognized that aspects of the disclosure may also extend to other medical containers, including cartridges and auto-injectors, as additional non-limiting examples.

[0036] As shown in FIGS. 1 and 2, the syringe 10 generally includes a syringe barrel 12 and a plunger assembly 14. The plunger assembly 14 is movable within the syringe barrel 12 along a longitudinal axis to an advanced position to facilitate administering of an injectable fluid (e.g., medication) to a patient, for example. The syringe barrel 12 is formed of a generally cylindrical wall 16 and an end member 18 that collectively define a chamber 20 for retaining fluid therein. The syringe barrel 12 includes an open proximal end 22 configured to receive the plunger assembly 14 therein and a distal end 24 at which end member 18 is positioned. The proximal end 22 of the syringe barrel 12 may include a flange 26 to facilitate handling and positioning of the syringe 10 and to maintain the relative position of the syringe barrel 12 with respect to the plunger assembly 14 during medication administration. At the distal end 24, the end member 18 may include a shoulder 28 which narrows with respect to the cylindrical outer wall 16, as well as a hub portion 30 extending out distally from shoulder 28. The hub portion 30 is formed as a partially hollow member that defines a channel 32 therethrough in fluid communication with the chamber 20. A needle 34 is attached to the hub portion 30 within channel 32, such as by being glued or otherwise secured to the hub portion 30. According to some aspects of the disclosure, syringe 10 may further include a cover 35 that couples to the hub portion 30 of syringe barrel 12 to protect the needle 34.

[0037] The plunger assembly 14 of syringe 10 is formed of an elongate plunger rod 36 and a plunger head or stopper 38. The plunger rod 36 may include a main body 40 extending between a plunger proximal end 42 and a plunger distal end 44. In some embodiments, the main body 40 may include a plurality of elongate vanes or walls 46 extending axially along a length thereof between the plunger proximal end 42 and the plunger distal end 44. A thumb press 48 is positioned at the plunger proximal end 42 that may be engaged by a thumb (or other finger) of the user to apply a distally directed force to the plunger assembly 14 to move the plunger rod 36 with respect to the syringe barrel 12. . In some embodiments, an extension member 50 (e.g., threaded cylindrical member) is positioned at the plunger distal end 44 that is configured to mate with the stopper 38.

[0038] The stopper 38 of plunger assembly 14 is positioned at the plunger distal end 44 so as to be movable along with the plunger rod 36 within the chamber 20 of syringe barrel 12.The stopper 38 may be made from a material that is different from the material of the plunger rod 36 and that is capable of forming a tight seal with the syringe barrel 12 as it is advanced therethrough. The stopper 38 may be formed of an elastomeric material such as butyl, styrene butadiene, isoprene, or may be formed of a polymeric material, such as cross-linked or thermoplastic elastomers, as non-limiting examples. In some embodiments, the stopper 38 may be provided as a lubricant-free or low lubricant stopper that does not include any lubricant coating or outer layer thereon, such as a coating / layer formed of per- or poly- fluoroalkyl substances (PFAS) - i.e., the stopper 38 is provided as a PFAS-free (or substantially PFAS- free) stopper. As defined herein, the stopper 38 being “free or substantially free of PFAS” or “PFAS-free” is understood to refer to materials that are entirely free of PFAS and / or materials that may contain trace amounts of PFAS therein. In an exemplary embodiment, the stopper 38 is considered to be substantially PFAS-free if it contains 200 parts-per-million (PPM) or less of PFAS therein (i.e., no more than 200 PPM), and preferably 50 PPM or less of PFAS therein (i.e., no more than 50 PPM).

[0039] The stopper 38 includes a closed distal end 52 and an open proximal end 54 providing access to a cavity 56 formed in the stopper, with the cavity 56 configured to mate with the extension member 50 on plunger rod 36. In use of syringe 10, the plunger rod 36 may be actuated by a user in order to advance the plunger rod 36 and push the stopper 38 in the distal direction to perform an injection.

[0040] According to aspects of the disclosure, a vent tube stoppering system is provided by which the stopper 38 may be inserted and positioned within syringe barrel 12 during assembly of the pre-filled syringe 10. The vent tube stoppering system operates to enable a desired positioning of the stopper 38 within syringe barrel 12, while preventing damage to the stopper 38 during such positioning.

[0041] Referring now to FIGS. 3 and 4, a vent tube stoppering system 100 (hereafter “system 100”) is shown in accordance with an aspect of the disclosure. The system 100 may include a container holder 102 configured to receive the proximal end 22 of the syringe barrel 12 to be stoppered (e.g., the flange 26 on the proximal end 22 of syringe barrel 12), a compression insert 104 for initially compressing the stopper 38, and a vent device 106 that receives the compressed stopper 38 from the compression insert 104 and that is operable with the container holder 102 to position the stopper 38 into the syringe barrel 12.

[0042] The compression insert 104 may be provided as a separate, static insert or component that initially receives the stopper 38 (such as from a rail system) in an uncompressed state. The uncompressed stopper 38 is advanced through a first end opening 108 of the insert 104 and intoa chamber 110 thereof, with the first end opening 108 and chamber 110 having a first diameter that is equal to a diameter of the uncompressed stopper 38. In order to compress the stopper 38, the stopper 38 is then pushed / forced out through a second end opening 112 of the insert 104, which has a second diameter that is less than the diameter of the uncompressed stopper 38, such that the stopper 38 is compressed as it passes through the second end opening 112. As the stopper 38 is passes through the second end opening 112 in a compressed state, the compressed stopper 38 may be positioned within the vent device 104 (i.e., into a vent tube thereof), as explained in further detail below.

[0043] The container holder 102 may be a support structure that secures / holds the syringe barrel 12 to allow for insertion of the stopper 38 therein. According to embodiments, the container holder 102 may be provided as a nest that holds a plurality of syringe barrels therein, as known in the art, or may be provided as a holder that is clipped directly onto the stoppering machine. After the stopper 38 has been positioned within the vent device 106 (i.e., into a vent tube thereof), the vent device 106 is then positioned relative to the container holder 102, to enable positioning of the stopper 38 within the syringe barrel 12.

[0044] As shown in FIGS. 3 and 4, the vent device 106 includes a vent tube 114 moveable along a longitudinal axis (A) and an installation rod 116 moveable inside the vent tube 114 along the longitudinal axis (A), for positioning a stopper 38 into the syringe barrel 12 to be stoppered. The vent tube 114 is of an elongated shape, preferably of a substantially circular section, and comprises two sections 118, 120 (i.e., a first section 118 and a second section 120) separated by a shoulder 122, with an outer diameter of the second section 120 of the vent tube 114 being greater than the outer diameter of the first section 118. The first section 118 is provided at a distal end 124 of the vent tube 114 and is configured to have a smaller diameter than the syringe barrel 12, such that the first section 118 can be inserted into the syringe barrel 12. The second section 120 is provided at a proximal end 126 of the vent tube 114 and is configured to have a larger diameter than the syringe barrel 12, such that the second section 120 is prevented from being inserted into the syringe barrel 12, but instead serves as a stop.

[0045] As shown in FIG. 4, the vent tube 114 defines an internal passageway 128 therein that extends through a length of the vent tube 114 - from a proximal opening 130 of the vent tube 114 (formed in first section 118) to a distal opening 132 of the vent tube 114 (formed in second section 120). The passageway 128 may be described as including a first portion 134 and a second portion 136 - with the first portion 134 of passageway 128 having a first diameter, DI, and the second portion 136 of passageway 128 having a second diameter, D2, that is greater than the first diameter DI, and with the second portion 136 being distal to the first portion 134.

[0046] According to aspects of the disclosure, the vent tube 114 includes a stopper seat 138 formed / positioned therein at the distal end 124 of the vent tube 114. The stopper seat 138 may be considered to define the second portion 136 of the passageway 128 having the second diameter, D2, with an abutment 140 of the stopper seat 138 defining the transition between the second portion 136 of the passageway 128 and the first portion 134 of the passageway 128. As explained in more detail below, the vent tube 114 is specifically configured such that the stopper 38 is to be introduced therein (from compression insert 104) through the distal end 124 / distal opening 132 of the vent tube 114, with the stopper 38 being positioned in the stopper seat 138. The stopper seat 138 (and the abutment 140 thereof) retains the stopper 38 therein, until it is desired to transition the stopper 38 out from the vent tube 114 and into the syringe barrel 12.

[0047] Upon placement of the stopper 38 inside the vent tube 114, the first section 118 of the vent tube 114 may be inserted into the syringe barrel 12 (which is secured by container holder 102). In more detail, the vent tube 114 is movable between a proximal tube rest position where the distal end 124 of the vent tube 114 is located outside the syringe barrel 12, and a distal tube operative position where the distal end 124 of the vent tube 114 enters into the syringe barrel 12 via the open proximal end 22 thereof, so as to be relatively close to the surface of a composition contained in the syringe barrel 12.

[0048] When the vent tube 114 is pushed in the distal direction to the distal tube operative position, the first section 118 of the vent tube 114 slides inside the syringe barrel 12 along the axis (A) until the shoulder 122 between the first and the second sections 118, 120 of the vent tube 114 abuts the proximal end 22 of the syringe barrel 12. The vent tube 114 then cannot slide further towards the syringe barrel 12. This position of the vent tube 114 relative to the syringe barrel 12 corresponds to a maximal operative position wherein the distal end 124 of the vent tube 114 is located inside the syringe barrel 12 at a determined position.

[0049] In this maximal operative position, the installation rod 116 is then also pushed in the distal direction, thereby pushing the stopper 38 out of the vent tube 114 through the distal opening 132 of the vent tube 114. In use of the installation rod 116, the installation rod 116 is inserted into the vent tube 114 via proximal opening 130. As the outer diameter of the installation rod 116 is smaller than the inner diameter of the internal passageway 128 (i.e., the first portion 134 of the passageway 128), such as within 0.5 mm of the inner diameter of first portion 134, the installation rod 116 may slide inside the vent tube 114 and move along the axis (A) relative to the vent tube 114, both in a proximal and in a distal direction. To allow the positioning of the stopper 38 in the syringe barrel 12, the length of the installation rod 116 islonger than the length of the vent tube 114 and is adapted so that a distal end 142 of the installation rod 116 sufficiently protrudes from the distal end 124 of the vent tube 114 for pushing the stopper 38 in a desired position into the syringe barrel 12.

[0050] After the vent tube 114 (with the stopper 38 therein) is pushed in the distal direction up to the maximal operative position, the installation rod 116 is pushed also in the distal direction, from a proximal rod rest position to a distal rod operative position, wherein the installation rod 116 pushes the stopper 38 out of the vent tube 114 via the distal opening 132 thereof. As a result, the stopper 38 is mechanically positioned in the syringe barrel 12 at a determined distance from the surface of the composition contained herein, and passes from a contracted state wherein stopper 38 is pressed radially against the inner surface of the vent tube 114 (in stopper seat 138) and has a reduced diameter, to a loosened state wherein stopper 38 expands radially and contacts the inner surface of the syringe barrel 12.

[0051] According to some aspects of the disclosure, the distal end 142 of the installation rod 116 is configured to engage the stopper 38 to be inserted in syringe barrel 12, so that the installation rod 116 is able to effectively apply a pushing force to the stopper 38 (to push the stopper out from vent tube 114). That is, the distal end 142 of installation rod 116 is configured as a shouldered end that includes a shoulder portion 144 and a tip portion 146, with the tip portion 146 extending out distally from the shoulder portion 144. Each of the shoulder portion 144 and the tip portion 146 are configured as generally cylindrical members. The tip portion 146 is configured to be positioned within the proximal cavity 56 of stopper 38, while the shoulder portion 144 is configured to make contact with and engage a proximal face of the stopper 38.

[0052] Referring now to FIGS. 5-7, and with continued reference to FIGS. 1-4, methods for vent tube stoppering the syringe barrel 12 with stopper 38 using the vent tube stoppering system 100 of FIGS. 3 and 4 are described, according to aspects of the disclosure.

[0053] Referring first to FIG. 5, a method 150 is provided according to one embodiment, with the method illustrated as proceeding from right to left in the figure. The method begins at Step 152 with the receiving of stopper 38 at compression insert 104 in an uncompressed state. In some embodiments, the stopper 38 may exit a rail device or system (not shown) and provided adjacent the compression insert 104. In providing the stopper 38 at compression insert 104, the orientation of the stopper 38 may need to be reversed (i.e., rotated 180 degrees), as shown in FIG. 5, so as to enable positioning of the stopper 38 within the compression insert 104 in the correct orientation.

[0054] At shown at Step 154, the compression insert 104 may be positioned adjacent the distal end 124 of vent tube 114 and may be secured to the distal end 124 so as to provide for transitioning of the stopper 38 from the compression insert 104 directly into the vent tube 114 at the distal end 124 thereof. With the compression insert 104 positioned adjacent the distal end 124 of vent tube 114 and the stopper 38 deposited adjacent the compression insert 104, the stopper 38 may then be forced into a chamber 110 of the compression insert 104, such as by an insertion rod 148. That is, the uncompressed stopper 38 is advanced though a first end opening 108 of the compression insert 104 and into chamber 110 responsive to a pushing force applied by insertion rod 148. As the first end opening 108 of insert 104 has a first diameter that is equal to a diameter of the uncompressed stopper 38, the stopper 38 is initially provided into compression insert 104 in an uncompressed state. Also at Step 154, with the insertion rod 148 continuing to apply a pushing force to the stopper 38, the stopper 38 is pushed / forced out through the second end opening 112 of the insert 104, which has a second diameter that is less than the diameter of the uncompressed stopper 38, such that the stopper 38 is compressed as it passes through the second end opening 112. As the stopper 38 is passed through the second end opening 112 in its compressed state, the compressed stopper 38 is positioned within the stopper seat 138 of vent tube 114. As previously explained, the abutment 140 of the stopper seat 138 defines the transition between the second portion 136 of the passageway 128 and the first portion 134 of the passageway 128 and functions to prevent proximal movement of the stopper 38 out of stopper seat 138, thereby retaining the stopper 38 in place at the distal end 124 of the vent tube 114.

[0055] With the compressed stopper 38 retained within stopper seat 138, the compression insert 104 may be removed from vent tube 114 at Step 155 and the vent tube 114 (which may or may not have installation rod 116 already positioned therein) may be moved to a location proximate the syringe barrel 12 at Step 156 - with it recognized that syringe barrel 12 is secured / retained in container holder 102, which may be a nest for example. Upon the vent tube 114 being aligned with the syringe barrel 12, the vent tube 114 may be moved from its proximal tube rest position (where the distal end 124 of the vent tube 114 is located outside the syringe barrel 12) to its distal tube operative position (where the distal end 124 of the vent tube 114 enters into the syringe barrel 12 via the open proximal end 22 thereof) at Step 158, so as to be relatively close to the surface of a composition contained in the syringe barrel 12. When the vent tube 114 is pushed in the distal direction to the distal tube operative position, the first section 118 of the vent tube 114 slides inside the syringe barrel 12 along the axis (A) until the shoulder 122 between the first and the second sections 118, 120 of the vent tube 114 abuts theproximal end 22 of the syringe barrel 12. The vent tube 114 then cannot slide further towards the syringe barrel 12. This position of the vent tube 114 relative to the syringe barrel 12 corresponds to a maximal operative position wherein the distal end 124 of the vent tube 114 is located inside the syringe barrel 12 at a determined position.

[0056] With the vent tube 114 moved to its maximal operative position relative to the syringe barrel 12, the installation rod 116 is then pushed through the passageway 128 of vent tube 114 in the distal direction at Step 160 - from its proximal rod rest position to its distal rod operative position. When advanced through the passageway 128 toward the distal rod operative position, the installation rod 116 is brought into contact with stopper 38, which is positioned / retained in stopper seat 138. As the installation rod 116 is advanced fully to the distal rod operative position, the installation rod 116 pushes the stopper 38 out of the stopper seat 138 (and out of vent tube 114) via the distal opening 132 thereof. As a result, the stopper 38 is mechanically positioned in the syringe barrel 12 at a determined distance from the surface of the composition contained herein, and passes from a contracted state wherein stopper 38 is pressed radially against the inner surface of the vent tube 114 (in stopper seat 138) and has a reduced diameter, to a loosened state wherein stopper 38 expands radially and contacts the inner surface of the syringe barrel 12.

[0057] According to aspects of the disclosure, by initially inserting the stopper 38 into the stopper seat 138 at the distal end 124 of the vent tube 114, any potential damage that might occur in forcing the stopper out of vent tube 114 (via pushing thereof by installation rod 116) may be minimized. That is, with the stopper 38 retained in the stopper seat 138 at the distal end 124 of the vent tube 114, the distance that the stopper 38 must be pushed by installation rod 116 to force the stopper 38 out of the vent tube 114 is greatly reduced as compared to if the stopper were initially inserted at the proximal end 126 of the vent tube 114. Accordingly, the length of time that installation rod 116 is in contact with stopper 38 and applying a pushing force thereto is greatly reduced, reducing the potential for damage to the stopper 38 by installation rod 116. Also, the reduction in distance by which the stopper 38 must be pushed by installation rod 116 to force the stopper 38 out of the vent tube 114 serves to lower the amount of friction created between the stopper 38 and the inner surface of vent tube 114 as the stopper 38 is forced through / out the vent tube 114, thereby reducing the level of friction- generated heat to which the stopper 38 is exposed, and minimizing the potential for wear / damage to the stopper 38. The reduction / prevention of friction between the stopper 38 and vent tube 114 may be especially beneficial for stoppers that are more susceptible to friction-related damage, including lubricant-free or low lubricant stoppers and / or a stoppers with a coating / film laminated thereon.

[0058] Referring now to FIG. 6, another method 164 is provided according to one embodiment, with the method illustrated as proceeding from right to left in the figure. The method 164 is substantially similar to the method 150 of FIG. 5, with Steps 156, 158 and 160 being identically performed in each of method 164 and method 150. However, in method 164, steps of providing the stopper 38 and loading the stopper into compression insert 104 and into vent tube 114 are performed differently. As seen in FIG. 6, the method 164 begins at Step 166 with the receiving of stopper 38 at compression insert 104 in an uncompressed state. In some embodiments, the stopper 38 may exit a rail device or system (not shown) and provided adjacent the compression insert 104. In providing the stopper 38 at compression insert 104, the orientation of the stopper 38 may need to be reversed (i.e., rotated 180 degrees), as shown in FIG. 6, so as to enable positioning of the stopper 38 within the compression insert 104 in the correct orientation.

[0059] At shown at Step 168, upon providing the stopper 38 at compression insert 104, the stopper 38 may then be forced into a chamber 110 of the compression insert 104, such as by an insertion rod 148. That is, the uncompressed stopper 38 is advanced though a first end opening 108 of the compression insert 104 and into chamber 110 responsive to a pushing force applied by insertion rod 148. As the first end opening 108 of insert 104 has a first diameter that is equal to a diameter of the uncompressed stopper 38, the stopper 38 is initially provided into compression insert 104 in an uncompressed state.

[0060] With the stopper 38 positioned within the chamber 110 of compression insert 104, the compression insert 104 (and stopper 38) may then be moved and positioned adjacent the distal end 124 of vent tube 114 and may be secured to the distal end 124 at Step 170, so as to provide for transitioning of the stopper 38 from the compression insert 104 directly into the vent tube 114 at the distal end 124 thereof. At Step 170, another (or the same) insertion rod 148 is actuated to apply a pushing force to the stopper 38, to push / force the stopper 38 out through the second end opening 112 of the insert 104, which has a second diameter that is less than the diameter of the uncompressed stopper 38, such that the stopper 38 is compressed as it passes through the second end opening 112. As the stopper 38 is passed through the second end opening 112 in its compressed state, the compressed stopper 38 is positioned within the stopper seat 138 of vent tube 114. As previously explained, the abutment 140 of the stopper seat 138 defines the transition between the second portion 136 of the passageway 128 and the first portion 134 of the passageway 128 and functions to prevent proximal movement of the stopper38 out of stopper seat 138, thereby retaining the stopper 38 in place at the distal end 124 of the vent tube 114. The compression insert 104 may then be removed from vent tube 114 at Step 172.

[0061] Upon stopper 38 being positioned within stopper seat 38 (and compression insert 104 being removed from vent tube 114), the method 164 continues with Steps 156, 158 and 160, which are described above in detail above for method 150. Via Steps 156, 158 and 160, the vent tube 114 is moved to a location proximate the syringe barrel 12 (Step 156) and is moved from its proximal tube rest position to its distal tube operative position (Step 158), such that the distal end 124 of vent tube 114 is positioned close to the surface of a composition contained in the syringe barrel 12, and the installation rod 116 is then pushed through the passageway 128 of vent tube 114 and into contact with stopper 38 retained in stopper seat 138. As the installation rod 116 is advanced fully to the distal rod operative position, with the installation rod 116 pushing the stopper 38 out of the stopper seat 138 (and out of vent tube 114) and into the syringe barrel 12 (Step 160).

[0062] Referring now to FIG. 7, another method 174 is provided according to one embodiment, with the method illustrated as proceeding from right to left in the figure. The method 174 is substantially similar to the methods 150, 164 of FIGS. 5 and 6, with Steps 156, 158 and 160 being identically performed in each of method 174 and methods 150, 164. However, in method 174, steps of providing the stopper 38 and loading the stopper into compression insert 104 and into vent tube 114 are performed differently. As seen in FIG. 7, the method 164 begins at Step 176 with the receiving of stopper 38 at compression insert 104 in an uncompressed state. In some embodiments, the stopper 38 may exit a rail device or system (not shown) and provided adjacent the compression insert 104. In method 174, no reversal of the orientation of the stopper 38 is required, as the stopper 38 is already properly oriented for a subsequent loading thereof into compression insert 104.

[0063] At shown at Step 178, upon providing the stopper 38 at compression insert 104, the stopper 38 may then be forced into a chamber 110 of the compression insert 104, such as by an insertion rod 148. That is, the uncompressed stopper 38 is advanced though a first end opening 108 of the compression insert 104 and into chamber 110 responsive to a pushing force applied by insertion rod 148. As the first end opening 108 of insert 104 has a first diameter that is equal to a diameter of the uncompressed stopper 38, the stopper 38 is initially provided into compression insert 104 in an uncompressed state.

[0064] With the stopper 38 positioned within the chamber 110 of compression insert 104, the compression insert 104 (and stopper 38) are then reoriented at Step 180 and then positionedadjacent the distal end 124 of vent tube 114 and may be secured to the distal end 124 at Step 182, so as to provide for transitioning of the stopper 38 from the compression insert 104 directly into the vent tube 114 at the distal end 124 thereof. At Step 182, another (or the same) insertion rod 148 is actuated to apply a pushing force to the stopper 38, to push / force the stopper 38 out through the second end opening 112 of the insert 104, which has a second diameter that is less than the diameter of the uncompressed stopper 38, such that the stopper 38 is compressed as it passes through the second end opening 112. As the stopper 38 is passed through the second end opening 112 in its compressed state, the compressed stopper 38 is positioned within the stopper seat 138 of vent tube 114. As previously explained, the abutment 140 of the stopper seat 138 defines the transition between the second portion 136 of the passageway 128 and the first portion 134 of the passageway 128 and functions to prevent proximal movement of the stopper 38 out of stopper seat 138, thereby retaining the stopper 38 in place at the distal end 124 of the vent tube 114. The compression insert 104 may then be removed from vent tube 114 at Step 184.

[0065] Upon stopper 38 being positioned within stopper seat 38 (and compression insert 104 being removed from vent tube 114), the method 174 continues with Steps 156, 158 and 160, which are described above in detail above for method 150. Via Steps 156, 158 and 160, the vent tube 114 is moved to a location proximate the syringe barrel 12 (Step 156) and is moved from its proximal tube rest position to its distal tube operative position (Step 158), such that the distal end 124 of vent tube 114 is positioned close to the surface of a composition contained in the syringe barrel 12, and the installation rod 116 is then pushed through the passageway 128 of vent tube 114 and into contact with stopper 38 retained in stopper seat 138. As the installation rod 116 is advanced fully to the distal rod operative position, with the installation rod 116 pushing the stopper 38 out of the stopper seat 138 (and out of vent tube 114) and into the syringe barrel 12 (Step 160).

[0066] Beneficially, embodiments of the invention thus are directed a system and method for vent tube stoppering to place a stopper within a syringe barrel. The vent tube stoppering system includes a vent tube having a stopper seat positioned at the distal end thereof into which the stopper is initially inserted. By initially inserting the stopper into the stopper seat at the distal end of the vent tube, the distance that the stopper must be pushed by the installation rod to force the stopper out of the vent tube is greatly reduced as compared to if the stopper were initially inserted at the proximal end of the vent tube. Accordingly, the length of time that installation rod is in contact with stopper and applying a pushing force thereto is greatly reduced, reducing the potential for damage to the stopper by the installation rod. Also, thereduction in distance by which the stopper must be pushed by the installation rod to force the stopper out of the vent tube serves to lower the amount of friction created between the stopper and the inner surface of vent tube as the stopper is forced out therefrom, thereby reducing the level of friction-generated heat to which the stopper is exposed and minimizing the potential for wear / damage to the stopper and / or a coating / laminated on the stopper.

[0067] Although the present disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is solely for that purpose and that the present disclosure is not limited to the disclosed embodiments or aspects, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

THE INVENTION CLAIMED IS1. A vent tube stoppering system for positioning a stopper within a syringe barrel, the system comprising: a vent tube configured to be inserted into a chamber of the syringe barrel, with the vent tube being moveable along a longitudinal axis between a proximal tube rest position where the vent tube is outside the chamber of the syringe barrel and a distal tube operative position where a distal portion of the vent tube is positioned within the chamber of the syringe barrel, the vent tube comprising: a proximal end having an opening therein; a distal end having an opening therein; a passageway extending from the proximal opening to the distal opening, the passageway having a first portion having a first diameter and a second portion having a second diameter greater than the first diameter, the second portion distal to the first portion; and a stopper seat positioned at the distal end that defines the second portion of the passageway, the stopper seat configured to retain the stopper in a compressed state, the stopper seat including an abutment preventing proximal movement of the stopper from the second portion to the first portion; and an installation rod moveable inside the passageway of the vent tube along the longitudinal axis between a proximal rod rest position and a distal rod operative position, wherein the installation rod pushes the stopper distally out of the stopper seat and into the syringe barrel when the vent tube is in the distal tube operative position and the installation rod is in the distal rod operative position.

2. The system of claim 1, wherein a longitudinal dimension of the second portion of the passageway defined by the stopper seat is approximately equal to a height of the stopper.

3. The system of claim 1, wherein the opening at the proximal end of the vent tube has a diameter equal to the first diameter and the opening at the distal end of the vent tube has a diameter equal to the second diameter.

4. The system of claim 3, wherein the opening at the distal end of the vent tube enables insertion of the stopper, while in the compressed state, into the stopper seat.

5. The system of claim 1, wherein the first diameter of the first portion of the passageway is smaller than a diameter of the stopper while in the compressed state.

6. The system of claim 1, wherein the first diameter of the first portion of the passageway is approximately equal to a diameter of the installation rod.

7. The system of claim 1, further comprising a compression insert engageable with the distal end of the stopper tube, the compression insert comprising: an insert body defining a chamber; a first opening provided at a first end of the chamber; and a second opening provided at a second end of the chamber; wherein the first opening and the chamber are configured to receive the stopper while in an uncompressed state; and wherein the second opening transition is configured to transition the stopper to the compressed state as the stopper is pushed out therethrough, to enable loading of the stopper from the compression insert to the stopper seat while the stopper is in the compressed state.

8. The system of claim 1 , further comprising a holder configured to receive a proximal end of the syringe barrel and to hold the syringe barrel aligned with the direction of travel of the vent tube, so that the syringe barrel is stabilized when moving the vent tube from the proximal tube rest position to the distal tube operative position.

9. The system of claim 1, wherein the installation rod comprises an installation rod comprises a shouldered distal end including: a shoulder portion having a first rod diameter; and a tip portion extending out distally from the shoulder portion and having a second rod diameter less than the first rod diameter; wherein, when pushing the stopper distally out of the stopper seat, the tip portion engages a bottom surface of a cavity formed in the stopper and the shoulder portion engages a proximal face of the stopper.

10. A method for vent tube stoppering a syringe barrel with a stopper, the method comprising: providing a vent tube configured to be inserted into a chamber of the syringe barrel, with the vent tube being moveable along a longitudinal axis between a proximal tube rest position where the vent tube is outside the chamber of the syringe barrel and a distal tube operative position where a distal portion of the vent tube is positioned within the chamber of the syringe barrel, the vent tube comprising: a proximal end having an opening therein; a distal end having an opening therein; a passageway extending from the proximal opening to the distal opening, the passageway having a first portion having a first diameter and a second portion having a second diameter greater than the first diameter, the second portion distal to the first portion; and a stopper seat positioned at the distal end that defines the second portion of the passageway, the stopper seat configured to retain the stopper in a compressed state, the stopper seat including an abutment preventing proximal movement of the stopper from the second portion to the first portion; and an installation rod moveable inside the passageway of the vent tube along the longitudinal axis between a proximal rod rest position and a distal rod operative position, wherein the installation rod pushes the stopper distally out of the stopper seat and into the syringe barrel when the vent tube is in the distal tube operative position and the installation rod is in the distal rod operative position; compressing the stopper from an uncompressed state to a compressed state; inserting the stopper into the vent tube via the opening at the distal end thereof, such that the stopper is positioned and retained within the stopper seat; moving the vent tube along a longitudinal axis from a proximal tube rest position where the vent tube is outside the passageway of the syringe barrel to a distal tube operative position where a distal portion of the vent tube is positioned within the passageway of the syringe barrel; and with the vent tube in the distal tube operative position, pushing the installation rod distally through the passageway of the vent tube from a proximal rod rest position to a distal rod operative position, so as to push the stopper distally out of the stopper seat and into the syringe barrel.

11. The method of claim 10, wherein in inserting the stopper into the vent tube to be positioned and retained within the stopper seat, the stopper is pushed distally into the vent tube until coming into contact with the abutment of the stopper seat.

12. The method of claim 10, wherein in pushing the stopper distally out of the stopper seat and into the syringe barrel, a travel distance of the stopper is approximately equal to a height of the stopper.

13. The method of claim 10, wherein compressing the stopper comprises: placing the stopper into a compression insert with the stopper in an uncompressed state, the compression insert engageable with the distal end of the stopper tube; and statically compressing the stopper from the uncompressed state to the compressed state via the compression insert; wherein the stopper is inserted into the vent tube from the compression insert while in the compressed state.

14. The method of claim 13, further comprising transitioning the stopper from a rail system to the loading device, wherein in transitioning the stopper, an orientation of the stopper is kept constant or reversed, to facilitate placement thereof into the loading device.

15. The method of claim 10, wherein the stopper comprises a lubricant-free or low lubricant stopper, and wherein pushing the lubricant-free or low lubricant stopper distally out of the stopper seat and into the syringe barrel prevents friction damage to the lubricant-free or low lubricant stopper and / or limits heating of the lubricant-free or low lubricant stopper by friction, as compared to distally pushing the lubricant-free or low lubricant stopper through an entire length of the vent tube and into the syringe barrel.

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