Closure tool system for attaching a valved stopper to a syringe barrel

Abstract

This specification provides a vent tube closure system for positioning a stopper within a syringe barrel. The system includes a vent tube insertable into the chamber of a syringe barrel, the vent tube having an internal volume configured to contain a stopper in a compressed state. The system also includes a mounting rod movable within the internal volume of the vent tube, the mounting rod being operable to push the stopper distally out of the vent tube and into the syringe barrel. The distal end of the mounting rod is provided with a shoulder and a tip extending distally from the shoulder. When pushing the stopper distally out of the vent tube, the tip engages with the bottom surface of the stopper's cavity to apply a first pressure, and the shoulder engages with the proximal surface of the stopper to apply a second pressure.

Description

[Technical Field]

[0001] This disclosure relates, in general terms, to a closure tool system for attaching a stopper to a syringe, and more specifically, to a closure tool system for attaching a valved stopper to a syringe barrel. [Background technology]

[0002] This application claims priority to U.S. Provisional Application No. 63 / 468,668, filed on 24 May 2023, entitled “A Closing Tool System for Attaching a Valved Stopper to a Syringe Barrel,” the disclosure of which is incorporated herein by reference in its entirety.

[0003] Pre-filled syringes are common containers used to administer liquids (e.g., drugs or medications) to patients, and include syringes, cartridges, and auto-injectors. They typically include a plunger stopper that slides into the container, and the container is filled with the pharmaceutical composition to provide a ready-to-use syringe for a patient.

[0004] The container has a substantially cylindrical shape and includes a proximal end that can be sealed by a plunger stopper, a distal end from which the pharmaceutical composition is released from the container, and a side wall extending between the proximal and distal ends of the container. In practice, the plunger stopper is intended to move from the proximal end to the distal end of the container in response to the pressure applied by the plunger, thereby releasing the drug contained in the container.

[0005] Compared to empty syringes that are filled with the pharmaceutical composition stored in the vial immediately before injection into the patient's body, the use of pre-filled syringes offers several advantages. In particular, by limiting pre-injection preparation, pre-filled syringes offer reduced medical administration errors, minimized the risk of microbial contamination, and improved convenience of use for healthcare professionals. Furthermore, such pre-filled containers can facilitate and simplify patient self-administration, thereby reducing treatment costs and increasing patient adherence. Finally, pre-filled syringes reduce the loss of valuable pharmaceutical composition that typically occurs when the pharmaceutical composition is transferred from a vial to a non-pre-filled syringe. This allows for more doses per given production batch of the pharmaceutical composition, reducing purchase and supply chain costs.

[0006] A pre-filled syringe can be used to administer injections of multiple compositions to a patient. In such a case, the container may contain two chambers, a first chamber adapted to contain a first composition and a second chamber adapted to contain a second composition. The two chambers are separated by a second stopper, which may be called a continuous or valved stopper, preventing the compositions from passing from one chamber to the other and mixing. The valved stopper has a small diameter opening or slit that is sufficient to prevent the two solutions from mixing before the first solution is injected, while simultaneously allowing the subsequent injection of the second solution.

[0007] Pre-filled syringes like the ones described above are typically obtained by filling an empty medical container with the desired pharmaceutical composition, and then sealing the filled container under vacuum, with a vent tube, or a combination of both.

[0008] Filled containers are generally sealed immediately after the drug is filled into the container body using a sealing device, according to the following method: The medical container to be sealed is placed on a suitable support (e.g., in a nest or clipped directly onto a sealing device) with its proximal end facing upwards and its distal end facing downwards, and maintained in this position.

[0009] In the case of vent tube closure, the stopper is typically compressed into a tube called a "vent tube," which has an outer diameter smaller than the inner diameter of the container. When the stopper is placed inside the vent tube, the vent tube is partially positioned inside the container, and because the outer diameter of the vent tube is smaller than the inner diameter of the container, air can circulate between the vent tube and the container during such positioning. Then, once the vent tube is positioned inside the container, the stopper, which was previously positioned inside the tube, is pushed distally out of the vent tube by the installation rod and pushed to a desired position inside the container over the composition (for example, towards the proximal end of the container).

[0010] In known vent tube closure systems, the installation rod used to push the stopper is a simple cylindrical rod configured to pass through the center of the vent tube and enter the threads or cavity of the stopper's plunger rod. By engaging with the stopper's cavity, the installation rod can apply a forward pushing force to the bottom of the internal cavity, thereby stretching the stopper while it is inside the vent tube and making it easier to pass through the tube.

[0011] The pushing force applied to the stopper cavity by an installation rod is suitable for pushing a typical sealing stopper out of a vent tube, but due to the unique structure of valved stoppers (as described above), such installation rods may not be suitable for pushing a valved stopper out of a vent tube. Specifically, because valved stoppers contain an opening / slit valve at the bottom of their cavity, using a conventional installation rod to engage and push a valved stopper could cause the installation rod to open the valve slit and "pierce" the stopper instead of pushing it, thereby not only damaging the stopper valve but also making proper insertion impossible due to axial and overall distortion of the stopper's shape. Furthermore, if the installation rod applies pushing force only to the central portion of the valved stopper, the stopper may tilt as it is being pushed out of the vent tube into the container, resulting in a failure to form a proper seal with the container wall when the stopper is pushed into place. [Overview of the Initiative] [Problems that the invention aims to solve]

[0012] Therefore, in the art, there is a need for a vent tube closure system having an installation rod suitable for use in pushing a valved stopper out of the vent tube to a desired position inside a container while preventing damage to the stopper. [Means for solving the problem]

[0013] Provided herein is a vent tube closure system for positioning a stopper within a syringe barrel. The system includes a vent tube configured to be inserted into the chamber of a syringe barrel, the vent tube being movable along a longitudinal axis between a proximal tube resting position where the vent tube is outside the chamber of the syringe barrel and a distal tube operating position where the distal portion of the vent tube is positioned inside the chamber of the syringe barrel, the vent tube having an internal volume configured to contain a stopper when compressed. The system also includes an installation rod movable within the internal volume of the vent tube along a longitudinal axis between the proximal rod resting position and the distal rod operating position, the installation rod pushing the stopper distally out of the vent tube and into the syringe barrel when the vent tube is in the distal tube operating position. The installation rod includes a shoulder portion having a first diameter and a shouldered distal end including a tip portion extending distally from the shoulder portion and having a second diameter smaller than the first diameter. When the stopper is pushed distally from the vent tube, the tip engages with the bottom surface of the cavity formed in the stopper, applying a first pressure thereto, and the shoulder engages with the proximal surface of the stopper, applying a second pressure thereto.

[0014] In a particular configuration, the tip has a first height, the cavity formed within the stopper has a second height which is smaller than the first height, and the cavity has the second height when compressed within the vent tube.

[0015] In certain configurations, the first height of the tip is approximately 3-8% greater than the second height of the cavity formed in the stopper.

[0016] In a particular configuration, the tip applies a first pressure to the bottom surface of the cavity before the shoulder engages with the proximal surface of the stopper and applies a second pressure thereto.

[0017] In certain configurations, the first pressure is between 1 and 10 Newtons.

[0018] In certain configurations, the first pressure extends the stopper distally, preventing it from binding within the vent tube.

[0019] In a particular configuration, the bottom surface of the cavity contains a slit formed within it, and the first pressure is less than the pressure required to push the tip through the slit.

[0020] In certain configurations, the vent tube closure system further includes a container holder configured to receive the proximal end of the syringe barrel and hold the syringe barrel aligned with the direction of movement of the vent tube, so that the vent tube enters the syringe barrel as it moves from the proximal tube resting position to the distal tube operating position.

[0021] Also provided herein is a method for vent tube plugging a syringe barrel with a valve stopper using a vent tube plugging system. The method includes providing a vent tube plugging system that includes a vent tube having an internal volume and configured to be inserted into the chamber of the syringe barrel, and an installation rod movable inside the internal volume of the vent tube, the installation rod including a shoulder end having a shoulder with a first diameter and a distal end extending distally from the shoulder and having a second diameter less than the first diameter. The method also includes placing a valve stopper into the internal volume of the vent tube, the valve stopper being housed in the stopper in a compressed state. The method further includes moving the vent tube along the longitudinal axis from a proximal tube stationary position where the vent tube is outside the chamber of the syringe barrel to a distal tube operating position where the distal portion of the vent tube is disposed within the chamber of the syringe barrel, and in a state where the vent tube is in the distal tube operating position, pushing the installation rod distally through the vent tube from a proximal rod stationary position to a distal rod operating position, and pushing the valve stopper distally out of the vent tube and into the syringe barrel. In pushing the valve stopper with the installation rod, the method further includes engaging the bottom surface of the cavity in the valve stopper with the tip, the tip applying a first pressure to the bottom surface and axially stretching the valve stopper, engaging the proximal surface of the side wall of the valve stopper with the shoulder, and the tip applying a second pressure to the proximal surface.

[0022] In certain configurations, the first pressure axially stretches the stopper in the distal direction so as to prevent the stopper from binding within the vent tube.

[0023] In certain configurations, engaging the tip with the bottom surface of the cavity includes inserting a tip having a first height into a cavity having a second height less than the first height while the valve stopper is in a compressed state within the vent tube.

[0024] In a specific configuration, the first height of the tip is approximately 3 - 8% greater than the second height of the cavity.

[0025] In a specific configuration, the tip applies a first pressure to the bottom surface of the cavity before the shoulder engages the proximal surface of the side wall to apply a second pressure.

[0026] In a specific configuration, the first pressure is 1 - 10 Newtons.

[0027] In a specific configuration, the bottom surface of the cavity includes a slit valve formed therein, and the first pressure is less than the pressure required to push the tip through the slit valve.

[0028] In a specific configuration, the vent tube closure system further includes a container holder configured to receive the proximal end of the syringe barrel, and the method further includes coupling the container holder to the syringe barrel, aligning the syringe barrel with the movement direction of the vent tube, and causing the vent tube to enter the syringe barrel when moving the vent tube from the proximal tube stationary position to the distal tube operating position along the longitudinal axis.

[0029] Also provided herein is a pair of a valve stopper and an installation rod for inserting the valve stopper into the barrel of the syringe via a vent tube closure process. The pair of the valve stopper and the installation rod includes a valve stopper including a cylindrical side wall extending between a proximal surface and a distal surface and defining a cavity therein, and a membrane disposed in the cavity and including the proximal surface and the distal surface, the membrane separating the cavity into a proximal cavity and a distal cavity. The pair of the valve stopper and the installation rod also includes an elongated installation rod having a shoulder distal end configured to fit with the valve stopper, the shoulder distal end including a shoulder having a first diameter and a tip extending distally from the shoulder and having a second diameter less than the first diameter. When the shoulder distal end fits with the valve stopper, the tip is disposed in the proximal cavity and engages the proximal surface of the membrane to apply a first pressure thereto, and the shoulder engages the proximal surface of the cylindrical side wall to apply a second pressure thereto.

[0030] In a particular configuration, the tip has a first height, and the proximal cavity has a second height that is lower than the first height, and this proximal cavity has a second height when compressed within the vent tube.

[0031] In certain configurations, the first height of the tip is approximately 3–8% greater than the second height of the proximal cavity formed in the barrel-attached stopper.

[0032] In certain configurations, when the shouldered distal end engages with the barreled stopper, the tip applies a first pressure to the proximal surface of the membrane before the shoulder engages with the proximal surface of the cylindrical side wall and applies a second pressure to it. [Brief explanation of the drawing]

[0033] [Figure 1] Figure 1 is a side cross-sectional view of a syringe in which an embodiment of the present disclosure may be implemented. [Figure 2A] Figure 2A is a perspective view of a valved stopper included in the syringe of Figure 1, according to a non-limiting embodiment described herein. [Figure 2B] Figure 2B is a side cross-sectional view of the valved stopper shown in Figure 2A. [Figure 3] Figure 3 is an exploded perspective view of a vent tube closure system for positioning a barrel-type stopper within a syringe barrel, according to a non-limiting embodiment described herein. [Figure 4] Figure 4 is a cross-sectional view of the vent tube closure system of Figure 3, showing the vent tube and installation rod of the system in its proximal resting position. [Figure 5] Figure 5 is a cross-sectional view of the vent tube closure system of Figure 3, showing the vent tube and mounting rod of the system in the distal operating position. [Figure 6A] Figure 6A is a perspective view of the distal shouldered end of the mounting rod included in the system of Figure 5, according to a non-limiting embodiment described herein. [Figure 6B]Figure 6B is a side cross-sectional view of the distal shoulder end of Figure 6A. [Figure 7] Figure 7 is a side cross-sectional view showing the distal shoulder end of the installation rod fitted with a valve stopper. [Modes for carrying out the invention]

[0034] [Detailed description of the invention] The following description is provided to enable those skilled in the art to create and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutes will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutes are intended to fall within the spirit and scope of the invention.

[0035] Hereinafter, for illustrative purposes, “top,” “bottom,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “horizontal,” “vertical,” and their derivatives shall be used in relation to the present invention as oriented in the drawings. However, it should be understood that the present invention may presuppose various alternative modifications unless expressly otherwise specified. It should also be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, specific dimensions and other physical features relating to the embodiments disclosed herein should not be considered restrictive.

[0036] In this disclosure, the distal end of a component or device means the end furthest from the user's hand when the component or device is in use, i.e., when the user is holding the syringe in preparation for or during use, and the proximal end means the end closest to the user's hand. Similarly, in this application, the terms “distally” and “distally” mean the direction toward the distal tip of the syringe, and the terms “proximal” and “proximal” mean the direction opposite to the direction toward the distal tip of the syringe.

[0037] Referring to Figures 1 and 2, non-limiting embodiments of a medical container 10 in which aspects or embodiments of the present disclosure may be implemented are shown. According to aspects of the present disclosure, the medical container 10 is provided as a pre-filled syringe (hereinafter, "syringe 10"), providing the convenience of rapidly delivering the liquid within it to a patient without the need to first draw the drug from another container and measure its volume. However, it is recognized that aspects of the present disclosure may also extend to other medical containers, including cartridges and auto-injectors, as additional non-limiting examples.

[0038] As shown in Figure 1, the syringe 10 includes a syringe barrel 12 formed from a generally cylindrical outer wall 16 and an end member 18 that collectively defines a chamber 20 for holding fluid therein. The syringe barrel 12 includes an open proximal end 22 and a distal end 24, with the end member 18 located at the distal end 24. The proximal end 22 of the syringe barrel 12 may include a flange 26 for facilitating the handling and positioning of the syringe 10 and for maintaining the relative position of the syringe barrel 12 with respect to a vent tube closure system used for inserting one or more stoppers into the syringe barrel 12, as will be described in more detail below. At the distal end 24, the end member 18 may include a shoulder portion 28 that narrows relative to the cylindrical outer wall 16 and a hub portion 30 that extends distally from the shoulder portion 28. The hub portion 30 is formed as a partially hollow member that defines a channel 32 through which fluid communicates with and passes in the chamber 20. The needle 34 is attached to the hub portion 30 in the channel 32, either by being glued or otherwise fixed to the hub portion 30, and the needle 34 provides the liquid (or more liquids) to be transported from the chamber 20 and administered to the patient.

[0039] The syringe 10 also includes a pair of stoppers 36, 38 (i.e., “sequential” stoppers) adapted to be translatably movable within the syringe barrel 12 for injecting liquid. The pair of stoppers 36, 38 includes a plunger stopper 36 and a sequential or “valved” stopper 38.

[0040] The plunger stopper 36 includes a closed distal surface 40 and a hollow volume 42 having a shape corresponding to the shape of the distal tip of a plunger rod (not shown) that engages with the plunger stopper 36. In use of the syringe 10, the plunger rod can be actuated by the user to advance the plunger rod and push the plunger stopper 36 distally to perform injection.

[0041] A valved stopper 38 is positioned and arranged between the distal end 24 of the barrel and the plunger stopper 36 and is translationally movable inside the syringe barrel 12. The valved stopper 38 separates two sections of the chamber 20 within the syringe barrel 12, including a first section 44 between the valved stopper 38 and the distal end 24 of the barrel 12, and a second section 46 between the valved stopper 38 and the plunger stopper 36. The first section 44 may contain a first composition intended to be injected first, and the second section 46 may contain a second composition intended to be injected after the first composition has been injected.

[0042] Figures 2A and 2B provide more detailed illustrations of the valved stopper 38. The valved stopper can be made from any material having elastomer properties commonly used to manufacture stoppers for medical injection devices. For example, the valved stopper may be made of elastomer, rubber, thermoplastic elastomer, and liquid silicone rubber.

[0043] The valved stopper 38 has a substantially cylindrical shape, which corresponds to the shape of the syringe barrel 12 of the syringe 10. The valved stopper 38 comprises a membrane 50 having a proximal surface 52 and a distal surface 54. The side wall 56 of the valved stopper 38 extends both distally and proximal from the membrane 50. The side wall 56 defines a proximal cavity 58, which is a hollow volume defined by the inner surface 60 of the side wall and the proximal surface 52 of the membrane 50, and a distal cavity 62, which is a hollow volume defined by the inner surface 60 of the side wall 56 and the distal surface 54 of the membrane 50.

[0044] The side wall 56 is advantageously provided with an outer sealing surface 64 configured to engage sealantly with the inner surface of the syringe barrel 12. The sealing surface 64 is continuous, meaning that it extends continuously along the circumference of the valved stopper 38, forming a ring. Because the continuous sealing surface 64 extends between the outer surface of the side wall 56 of the valved stopper 38 and the inner surface of the syringe barrel 12 of the syringe 10, the passage of the composition between the valved stopper 38 and the syringe barrel 12 is prevented, thus ensuring an optimal seal. According to a preferred embodiment, the sealing surface 64 may include two or more sealing ribs 68. The number of ribs 68, as well as the dimensions of each rib 68, such as height, width, and distance between two adjacent ribs 68, can be adapted to further optimize the seal depending on the dimensions of the valved stopper 38 and the barrel 12.

[0045] The valved stopper 38 is further configured such that the membrane 50 includes a slit or opening 70 therein. The slit 70 extends through at least a portion of the thickness of the membrane 50 between its proximal surface 52 and distal surface 54. The slit 70 is configured to create a fluid path through the membrane 50. The slit 70 forms a valve configured to open and close in response to pressure applied to the proximal surface 52 of the membrane 50 by the composition. Preferably, the slit 70 is in the form of a line passing through the center of the proximal surface 52 of the membrane 50.

[0046] According to aspects of the present disclosure, a vent tube closure system is provided in which a stopper with a barrel 38 can be inserted and positioned within a syringe barrel 12 during the assembly of a pre-filled syringe 10. The vent tube closure system operates to allow the desired position of the stopper with a valve 38 within the syringe barrel 12 while preventing damage to the stopper with a valve 38 during such positioning.

[0047] Referring to Figures 3-5, the vent tube closure system 100 (hereinafter, "system 100") includes a container holder 102 configured to receive the proximal end 22 of the syringe barrel 12 to be closure (for example, a flange 26 on the proximal end 22 of the syringe barrel 12), and a vent device 104 that can be interlocked with the container holder 102 to position a stopper (i.e., a valved stopper 38) inside the syringe barrel 12.

[0048] The vent device 104 includes a vent tube 106 movable through a container holder 102 along a longitudinal axis (A) and an installation rod 108 movable within the vent tube 106 along the longitudinal axis (A) for positioning a valved stopper 38 within a syringe barrel 12 to be closed. The vent tube 106 is elongated, preferably with a substantially circular cross-section, and includes two portions 110, 112 separated by a shoulder portion 114 to form an abutment, the diameter of which the second portion 112 of the vent tube is greater than the diameter of the first portion 110. In some embodiments, a flange 116 is provided on the second portion 112 at the proximal end 118 of the vent tube 106. The first portion 110 of the vent tube 106 is fitted to be inserted into the container holder 102 through a first opening 120 provided at the proximal end of the container holder 102, and for this purpose has a diameter smaller than the first opening 120.

[0049] The vent tube 106 is configured to receive a valved stopper 38, which is intended to be pushed into the internal volume of the vent tube along axis (A) by an installation rod 108. In one embodiment, the valved stopper 38 is introduced into the vent tube 106 through an opening 122 provided in the flange 116 (i.e., a proximal opening 122 of the vent tube 106), and the opening 122 is aligned along axis (A).

[0050] When the valved stopper 38 is positioned inside the vent tube 106, the first portion 110 of the vent tube 106 can be inserted into the container holder 102. The first portion 110 of the vent tube 106 is slidably engaged with the inside of the container holder 102 and is movable through there along the longitudinal axis (A), so that the first portion 110 exits through a second opening 124 located at the distal end of the container holder 102. More specifically, the vent tube 106 is movable between a proximal tube resting position shown in Figure 4, where the distal end of the vent tube 106 is located inside the container holder 102 near the first opening 120, and a distal tube operating position shown in Figure 5, where the distal end of the vent tube 106 passes through the second opening 124 at the distal end of the container holder 102 and enters the syringe barrel 12 through the proximal end 22 of its opening so that it is relatively close to the surface of the (first) composition contained in the syringe barrel 12.

[0051] When the vent tube 106 is pushed distally to the distal tube operating position, the first portion 110 of the vent tube 106 slides inward along axis (A) into the container holder 102 until the shoulder portion 114 between the first portion 110 and the second portion 112 of the vent tube 106 abuts against the proximal end of the container holder 102. The vent tube 106 can no longer slide toward the container holder 102. This position of the vent tube 106 relative to the container holder 102 corresponds to the maximum operating position in which the distal end of the vent tube 106 is positioned within the syringe barrel 12 at a determined position, as shown in Figure 5.

[0052] In this maximum operating position, the distal end of the vent tube 106 protrudes into the syringe barrel 12 from the distal end of the container holder 102. However, after the vent tube 106 has been pushed distally along axis (A) to reach the maximum operating position, the installation rod 108 is also pushed distally to position the valved stopper 38 into the syringe barrel 12, thereby pushing the valved stopper 38 out of the vent tube 106 through the distal opening 126 of the vent tube. Thus, the mechanical positioning of the valved stopper 38 is determined by the positioning of the distal opening 126, and therefore by the length to which the vent tube 106 extends into the syringe barrel 12 when in the maximum operating position.

[0053] In use of the installation rod 108, the installation rod 108 is inserted into the vent tube 106 through a proximal opening 122 formed in the flange 116 of the vent tube 106. Since the outer diameter of the installation rod 108 is smaller than the inner diameter of the vent tube 106, the installation rod 108 can slide inside the vent tube 106 and move along axis (A) relative to the vent tube 106 in both the proximal and distal directions. To enable the positioning of the valved stopper 38 in the syringe barrel 12, the length of the installation rod 108 is longer than the length of the vent tube 106, and the distal end of the installation rod 108 is fitted to protrude sufficiently from the distal end of the vent tube 106 to push the valved stopper 38 into the syringe barrel 12 at the desired position.

[0054] After the vent tube 106, equipped with a valved stopper 38, is pushed distally to its maximum operating position, the installation rod 108 is similarly pushed distally from the proximal rod resting position to the distal rod operating position, and the installation rod 108 pushes the valved stopper 38 out of the vent tube 106 through its distal opening 126. As a result, the valved stopper 38 is mechanically positioned in the syringe barrel 12 at a distance determined from the water surface of the composition contained herein, and transitions from a contracted state in which the valved stopper 38 is radially pressed against the inner surface of the vent tube 106 and its diameter is reduced, to a loosened state in which the valved stopper 38 expands radially and contacts the inner surface of the syringe barrel 12.

[0055] According to aspects of this disclosure, the distal end of the installation rod 108 is specifically configured to engage with a valved stopper 38 inserted into the syringe barrel 12, so that the installation rod 108 can effectively apply pressing force to the valved stopper 38 (to advance the stopper through the vent tube 106) without damaging the stopper. As shown in Figures 6A and 6B and 7, the distal end 130 of the installation rod 108 is configured as a shouldered end including a shoulder portion 132 and a tip portion 134, the tip portion 134 extending distally from the shoulder portion 132. Each of the shoulder portion 132 and the tip portion 134 is generally configured as a cylindrical member. In some embodiments, a hollow channel 136 may extend through each of the portions 132 and 134. The tip portion 134 is the outer diameter OD of the shoulder portion 132 肩 Smaller outer diameter (OD) 先端 It is configured to have the outer diameter OD of the tip portion 134, as can be seen in Figure 7. 先端 The inner diameter ID of the proximal cavity 58 of the valved stopper 38 空洞 It is approximately equal to (but smaller than) the outer diameter OD of the shoulder portion 132. 肩 The outer diameter OD of the valved stopper 38 allows for easy movement of the installation rod 108 through the vent tube 106. ストッパー It can be smaller than that.

[0056] According to multiple embodiments, the shouldered distal end 130 of the installation rod 108 has a height H of the tip portion 134 先端 which is configured to be slightly greater than the height / depth H of the proximal cavity 58 formed in the stopper 38 with valve (when the stopper 38 with valve is in a compressed state within the vent tube 106). In some non-limiting embodiments, the height H of the tip portion 134 空洞 is about 3 - 8% longer / deeper than the height / depth H of the proximal cavity 58 formed in the stopper 38 with valve when the stopper 38 with valve is in a compressed state within the vent tube 106. 先端 When the height of the tip portion 134 is slightly greater than the height / depth of the proximal cavity 58, the tip portion 134 is designed to apply a slight pressure to the bottom of the cavity (i.e., with respect to the proximal surface 52 of the membrane 50) before the shoulder 132 contacts and engages with the proximal surface 138 of the stopper 38 with valve (i.e., the proximal surface 138 of the side wall 56). That is, when the installation rod 108 engages with the stopper 38 with valve and is advanced to push the stopper 38 with valve distally out of the vent tube 106, the tip portion 134 applies a slight pressure (e.g., 1 - 10 Newtons) to the proximal surface 52 of the membrane 50 before the shoulder 132 contacts and engages with the proximal surface (along the side wall 56) of the stopper 38 with valve. The pressure applied by the tip portion 134 to the membrane 50 is sufficient to axially extend the stopper 38 such that the stopper 38 is not clogged in the vent tube 106, but is low enough so that the tip portion 不会损坏或突破 slit valve 70 during the plugging process. Further, the outer diameter OD of the tip portion 134 先端 is only slightly smaller than the outer diameter OD of the shoulder 132 肩 so that the force applied to the membrane 50 by the tip portion 134 is greater circumferentially of the membrane 50 than in the region of the slit valve 70, thereby further preventing the tip portion 134 from damaging or breaking the slit valve 70.

[0058] ​​​​​​Within the proximal cavity 58, following the initial engagement of the tip 134 with the membrane 50, the shoulder 132 then contacts the proximal surface of the side wall 56, applying pressure thereto, so that the further pushing force applied to the valved stopper 38 by the installation rod 108 is more evenly distributed between the membrane 50 and the side wall 56. The engagement and contact of the shoulder 132 with the proximal surface of the side surface 56 of the stopper 38 restricts the movement / protrusion of the tip 134 with respect to the membrane 50, thereby preventing the tip 134 from penetrating the slit 70 in the membrane 50 and damaging the stopper 38.

[0059] The structure of the shouldered distal end 130 of the installation rod 108 not only prevents the tip 134 from penetrating the slit 70 in the membrane 50 while it is pressing the stopper 38, but also helps prevent the stopper 38 from tilting when it is pressed and comes out through / out of the vent tube 106. That is, applying force (1) to the membrane 50 by the tip 134 along the circumference of the membrane 50 rather than in the area of ​​the slit valve 70, and applying force (2) to the proximal surface 138 of the side wall 56 by the shoulder 132 helps prevent the valved stopper 38 from tilting (relative to the vent tube 106 and / or syringe barrel 12) which is likely to occur when the valved stopper 38 is pressed by the installation rod 108 if the installation rod is applying force to the stopper 38 only in the central part of the valved stopper 38.

[0060] Therefore, beneficially, embodiments of the present invention relate to systems and methods for vent tube closure for positioning a valved stopper within a syringe barrel. The vent tube closure system includes a mounting rod suitable for use in pushing a valved stopper out of the vent tube to a desired position within the syringe barrel. The mounting rod includes a shouldered distal end that engages with the valved stopper, the tip of which engages with the proximal cavity of the stopper, and the shoulder engaging with the proximal surface of the side wall of the stopper. The tip is configured to engage first and apply small pressure to the bottom membrane of the cavity to axially stretch the stopper, and then the shoulder engages with the proximal surface of the stopper and applies additional pressure thereto. Thus, the shouldered distal end applies pressure to the stopper in a manner that allows movement from the vent tube while preventing damage to the stopper that may occur if the distal end of the mounting rod penetrates a slit valve formed in the bottom membrane, and preventing the stopper from tilting relative to the vent tube and / or syringe barrel.

[0061] This disclosure has been described in detail for illustrative purposes based on what is currently considered to be the most practical and preferred embodiments or aspects, but such details are for that purpose only, and this disclosure is not limited to the disclosed embodiments or aspects, but rather intended to encompass modifications and equivalent arrangements that fall within the spirit and scope of the appended claims. For example, this disclosure is intended to be, wherever possible, to allow one or more features of any embodiment to be combined with one or more features of any other embodiment.

Claims

1. A vent tube closure system for positioning a stopper inside a syringe barrel, wherein the system is A vent tube configured to be inserted into the chamber of the syringe barrel, wherein the vent tube is movable along its longitudinal axis between a proximal tube resting position where it is outside the chamber of the syringe barrel and a distal tube operating position where its distal portion is positioned inside the chamber of the syringe barrel, and the vent tube has an internal volume configured to include a compressed stopper, and An installation rod that is movable within the internal volume of the vent tube along the longitudinal axis between the proximal rod resting position and the distal rod operating position, wherein the installation rod pushes the stopper distally from the vent tube into the syringe barrel when the vent tube is in the distal tube operating position. Includes, The aforementioned installation rod is A shoulder portion having a first diameter, A shouldered distal end including a tip portion that extends distally from the shoulder portion and has a second diameter smaller than the first diameter, Includes, A vent tube closing system wherein, when the stopper is pushed distally from the vent tube, the tip engages with the bottom surface of a cavity formed in the stopper and applies a first pressure thereto, and the shoulder engages with the proximal surface of the stopper and applies a second pressure thereto.

2. The system according to claim 1, wherein the tip portion has a first height, the cavity formed within the stopper has a second height smaller than the first height, and the cavity has the second height when compressed within the vent tube.

3. The system according to claim 2, wherein the first height of the tip portion is about 3 to 8% greater than the second height of the cavity formed in the stopper.

4. The system according to claim 1, wherein the tip portion applies the first pressure to the bottom surface of the cavity before the shoulder portion engages with the proximal surface of the stopper and applies the second pressure thereto.

5. The system according to claim 1, wherein the first pressure is 1 to 10 Newtons.

6. The system according to claim 1, wherein the first pressure extends the stopper distally so as to prevent the stopper from coupling within the vent tube.

7. The system according to claim 1, wherein the bottom surface of the cavity includes a slit formed therein, and the first pressure is less than the pressure required to push the tip through the slit.

8. The system according to claim 1, further comprising a container holder configured to receive the proximal end of the syringe barrel and hold the syringe barrel aligned with the direction of movement of the vent tube, such that the vent tube enters the syringe barrel when moving from the proximal tube resting position to the distal tube operating position.

9. A method for venting a syringe barrel with a valved stopper using a vent tube closure system, the method being To provide a vent tube sealing system, the vent tube sealing system is A vent tube configured to be inserted into the chamber of the syringe barrel, the vent tube having an internal volume, An installation rod that is movable within the internal volume of the vent tube, and includes a shouldered distal end having a shoulder portion having a first diameter and a tip portion extending distally from the shoulder portion and having a second diameter less than the first diameter. including That thing, The valved stopper is placed within the internal volume of the vent tube, and the valved stopper is housed within the stopper in a compressed state. The vent tube is moved along its longitudinal axis from a proximal tube resting position where the vent tube is outside the chamber of the syringe barrel to a distal tube operating position where the distal portion of the vent tube is inside the chamber of the syringe barrel. With the vent tube in the distal tube operating position, the installation rod is pushed distally through the vent tube from the proximal rod resting position to the distal rod operating position so that the valved stopper is pushed distally out of the vent tube and into the syringe barrel. Includes, The above method further involves pressing the valve-equipped stopper with the installation rod, The bottom surface of the cavity inside the valved stopper engages with the tip, the tip applies a first pressure to the bottom surface, and the valved stopper is extended in the axial direction, and A method comprising engaging the proximal surface of the side wall of the valved stopper with the shoulder portion, and the tip portion applying a second pressure to the proximal surface.

10. The method according to claim 9, wherein the first pressure extends the stopper axially distally so as to prevent the stopper from coupling within the vent tube.

11. The method according to claim 9, wherein engaging the bottom surface of the cavity with the tip portion includes inserting the tip portion having a first height into the cavity, and the valved stopper having a second height smaller than the first height when compressed within the vent tube.

12. The method according to claim 11, wherein the first height of the tip portion is about 3 to 8% greater than the second height of the cavity.

13. The method according to claim 9, wherein the tip portion applies the first pressure to the bottom surface of the cavity before the shoulder portion engages with the proximal surface of the side wall and applies the second pressure thereto.

14. The method according to claim 9, wherein the first pressure is 1 to 10 Newtons.

15. The method according to claim 9, wherein the bottom surface of the cavity includes a slit valve formed therein, and the first pressure is less than the pressure required to push the tip through the slit valve.

16. The method according to any one of claims 12 to 15, further comprising: a container holder configured to receive the proximal end of the syringe barrel, the container holder being coupled to the syringe barrel to align the syringe barrel with the direction of movement of the vent tube, and the vent tube entering the syringe barrel when the vent tube is moved along the longitudinal axis from the proximal tube resting position to the distal tube operating position.

17. A pair of valved stopper and mounting rod for inserting the valved stopper into the barrel of a syringe via a vent tube closure process, wherein the pair of valved stopper and mounting rod is A cylindrical side wall extends between the proximal and distal surfaces, defining a cavity within it, A membrane disposed within the cavity and including a proximal surface and a distal surface, the membrane separating the cavity into a proximal cavity and a distal cavity, A stopper with a valve, and An elongated installation rod having a shouldered distal end configured to engage with the valved stopper, wherein the shouldered distal end is A shoulder portion having a first diameter, A tip portion extending distally from the shoulder portion and having a second diameter less than the first diameter, including, Long and slender installation rod, Includes, A pair of valve stoppers and mounting rods, including an elongated mounting rod, wherein when the shouldered distal end is fitted with the barrel stopper, the tip portion is positioned in the proximal cavity and engages with the proximal surface of the membrane to apply a first pressure, and the shoulder portion engages with the proximal surface of the cylindrical side wall to apply a second pressure.

18. The pair according to claim 17, wherein the tip portion has a first height, the proximal cavity has a second height lower than the first height, and the proximal cavity has the second height when compressed within the vent tube.

19. The pair according to claim 18, wherein the first height of the tip portion is about 3 to 8% greater than the second height of the proximal cavity formed in the barrel-attached stopper.

20. The pair according to claim 18, wherein when the shouldered distal end is fitted with the barrel-shaped stopper, the tip applies the first pressure to the proximal surface of the membrane before the shoulder engages with the proximal surface of the cylindrical side wall and applies the second pressure.

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