CN121175089A

CN121175089A - Closure tool system for installing valved stopper in syringe barrel

Info

Publication number: CN121175089A
Application number: CN202480034289.0A
Authority: CN
Inventors: 阿尔弗雷德·W·普拉伊斯
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 2023-05-24
Filing date: 2024-05-07
Publication date: 2025-12-19
Also published as: WO2024242865A1

Abstract

A vent tube occlusion system for positioning a stopper within a syringe barrel is provided herein. The system includes a vent tube insertable into the chamber of the syringe barrel and having an interior volume configured to receive the stopper in a compressed state. The system also includes a mounting rod movable within the interior volume of the vent tube such that the mounting rod may be operable to push the stopper distally out of the vent tube and into the syringe barrel. The distal end of the mounting rod includes a shoulder and a tip portion extending distally from the shoulder. When the stopper is pushed distally out of the vent tube, the tip engages a bottom surface of a cavity in the stopper to apply a first pressure to the bottom surface, and the shoulder engages a proximal face of the stopper to apply a second pressure to the proximal face.

Description

Closure tool system for installing valved stopper in syringe barrel

Cross Reference to Related Applications

The present application claims priority from U.S. provisional application No. 63/468,668, entitled "Stoppering Tool System for INSTALLING A VALVED Stopper IN A SYRINGE Barrel (a closure tool system for installing a valved Stopper in a syringe barrel)" filed on month 24 of 2023, the disclosure of which is incorporated herein by reference in its entirety.

Background

Technical Field

The present disclosure relates generally to a capping tool system for installing a stopper in a syringe, and more particularly to a capping tool system for installing a valved stopper (valved stopper) in a syringe barrel.

Description of the Related Art

Prefilled injection devices are common containers for administering liquids (e.g., medicaments or drugs) to a patient and include syringes, cartridges, and auto-injectors, among others. These prefilled injection devices typically include a plunger stopper slidably engaged within a container filled with a pharmaceutical composition to provide a physician with a ready-to-use injection device for the patient.

The container has a generally cylindrical shape and includes a proximal end that is capable of being occluded by the plunger stop, a distal end at which the pharmaceutical composition is expelled from the container, and a lateral wall extending between the proximal and distal ends of the container. In practice, the purpose of the plunger stop is to move from the proximal end of the container to the distal end of the container upon application of pressure by the plunger, thereby expelling the drug contained in the container.

The use of a prefilled injection device has several advantages when compared to an empty injection device filled with a pharmaceutical composition stored in a vial just prior to injection into a patient. In particular, by limiting preparation prior to injection, the prefilled injection device reduces medical dose errors, minimizes the risk of microbial contamination, and improves the ease of use for the physician. Furthermore, such a prefilled container may encourage and simplify self-administration by the patient, which allows for reduced treatment costs and increased patient compliance. Finally, the prefilled injection device reduces the loss of valuable pharmaceutical composition that typically occurs when the pharmaceutical composition is transferred from a vial to a non-prefilled injection device. This allows for a greater number of possible injections of a pharmaceutical composition for a given manufacturing lot, thereby reducing purchase and supply chain costs.

Prefilled injection devices may be used to inject a variety of compositions into a patient. In this case, the container may comprise two chambers comprising a first chamber adapted to contain the first composition and a second chamber adapted to contain the second composition. The two chambers are separated by a second stop, which may be referred to as a sequential stop or a valved stop, that prevents the composition from flowing from one chamber to the other and mixing. The valved stopper is provided with a small diameter opening or slit sufficient to prevent mixing of the two solutions prior to injection of the first solution while allowing subsequent injection of the second solution.

Prefilled injection devices as described above are typically obtained by filling an empty medical container with the desired pharmaceutical composition and then plugging the filled container under vacuum or by means of a vent tube or a combination of both.

The filled container is usually plugged immediately after filling the drug into the container body using a plugging machine in such a way that the medical container to be plugged is positioned on a suitable support (e.g. in a nest or directly clamped to the plugging machine) with its proximal end facing upwards, i.e. with its distal end facing downwards and maintained in this position.

In the case of a vent tube closure, the stopper is compressed in a tube, commonly referred to as a "vent tube", having an outer diameter less than the inner diameter of the container. The vent tube is then positioned partially within the container when the stopper is placed within the vent tube, and in the event that the outside diameter of the vent tube is less than the inside diameter of the container, air is allowed to circulate between the vent tube and the container during such placement. With the vent tube positioned within the container, the stopper previously positioned within the tube is then pushed distally out of the vent tube by the mounting rod and to a desired location within the container above the composition (e.g., toward the proximal end of the container).

In known vent tube plugging systems, the mounting rod for pushing the stopper is a simple cylindrical rod configured to pass through the center of the vent tube and into the plunger rod thread or cavity of the stopper. With the mounting rod engaged with the cavity of the stopper, the mounting rod is able to apply a forward pushing force to the bottom of the internal cavity, which stretches the stopper when it is in the snorkel and makes it easier for the stopper to pass through the tube.

While the thrust force exerted by the mounting rod into the stopper's cavity well pushes the typical sealing stopper out of the vent tube, the unique structure of the valved stopper (as described above) may make such a mounting rod unsuitable for pushing the valved stopper out of the vent tube. That is, because the valved stopper includes an opening/slit valve at the bottom of its cavity, engaging and pushing the valved stopper using a conventional mounting stem may cause the mounting stem to open the valve slit and "puncture (impale)" the stopper rather than pushing the stopper, thereby damaging not only the stopper valve, but also making correct insertion impossible due to axial and overall deformation of the stopper shape. Furthermore, where the mounting rod applies a pushing force only to the central portion of the valved stopper, the stopper may tilt as it is pushed out of the vent tube and into the container, with the result that the stopper may not form an appropriate seal with the container wall as it is pushed into place.

Accordingly, there is a need in the art for a vent tube plugging system having a mounting stem adapted to push a valved stopper out of a vent tube and into a desired position within a container while preventing damage to the stopper.

Disclosure of Invention

A vent tube occlusion system for positioning a stopper within a syringe barrel is provided herein. The system includes a vent tube configured to be inserted into a chamber of the syringe barrel, wherein the vent tube is movable along a longitudinal axis between a proximal tube rest position, in which the vent tube is located outside the chamber of the syringe barrel, and a distal tube operational position, in which a distal portion of the vent tube is positioned within the chamber of the syringe barrel, the vent tube having an interior volume configured to receive the stopper in a compressed state. The system also includes a mounting rod movable within the interior volume of the vent tube along the longitudinal axis between a proximal rod rest position and a distal rod operational position, wherein the mounting rod pushes the stopper distally out of the vent tube and into the syringe barrel when the vent tube is in the distal tube operational position. The mounting rod includes a shouldered distal end including a shoulder having a first diameter and a tip portion extending distally from the shoulder and having a second diameter less than the first diameter. When the stopper is pushed distally out of the vent tube, the tip engages a bottom surface of a cavity formed in the stopper to apply a first pressure to the bottom surface, and the shoulder engages a proximal face of the stopper to apply a second pressure to the proximal face.

In some configurations, the head has a first height and the cavity formed in the stopper has a second height that is less than the first height, the cavity having the second height when compressed within the vent tube.

In some configurations, the first height of the head is about 3% to 8% greater than the second height of the cavity formed in the stopper.

In some configurations, the tip applies the first pressure to the bottom surface of the cavity before the shoulder engages the proximal face of the stop to apply the second pressure to the proximal face.

In certain configurations, the first pressure is 1 oregano 10 newtons.

In some configurations, the first pressure stretches the stopper in a distal direction to prevent binding (bind) of the stopper within the vent tube.

In some configurations, the bottom surface of the cavity includes a slit formed in the bottom surface, and wherein the first pressure is less than a pressure required to push the tip portion through the slit.

In some configurations, the vent tube occlusion system further includes a container holder configured to receive the proximal end of the syringe barrel and to maintain the syringe barrel aligned with the direction of travel of the vent tube such that the vent tube enters the syringe barrel when the vent tube is moved from the proximal tube rest position to the distal tube operational position.

Also provided herein is a method of vent tube sealing a syringe barrel having a valved stopper using a vent tube sealing system. The method includes providing a vent tube plugging system including a vent tube having an interior volume and configured to be inserted into a chamber of the syringe barrel, and a mounting rod movable within the interior volume of the vent tube, the mounting rod including a shouldered distal end including a shoulder having a first diameter and a tip portion extending distally from the shoulder and having a second diameter less than the first diameter. The method also includes positioning the valved stopper within the interior volume of the vent tube, the valved stopper being received within the stopper in a compressed state. The method further includes moving the vent tube along a longitudinal axis from a proximal tube rest position, in which the vent tube is located outside the chamber of the syringe barrel, to a distal tube operational position, in which a distal portion of the vent tube is positioned within the chamber of the syringe barrel, and with the vent tube in the distal tube operational position, pushing the mounting rod distally from the proximal rod rest position through the vent tube to a distal rod operational position, pushing the valved stopper distally out of the vent tube and into the syringe barrel. During pushing of the valved stopper using the mounting stem, the method further includes engaging a bottom surface of a cavity in the valved stopper with the tip portion, the tip portion applying a first pressure to the bottom surface to axially stretch the valved stopper, and engaging a proximal face of a lateral wall of the valved stopper with the shoulder portion, the tip portion applying a second pressure to the proximal face.

In some configurations, the first pressure axially expands the stopper in a distal direction to prevent the stopper from binding within the vent tube.

In some configurations, engaging the bottom surface of the cavity with the head includes inserting the head into the cavity, the head having a first height, the cavity having a second height that is less than the first height when the valved stopper is compressed within the vent tube.

In some configurations, the first height of the tip is about 3% to 8% greater than the second height of the cavity.

In some configurations, the tip portion applies the first pressure to the bottom surface of the cavity before the shoulder engages the proximal face of the lateral wall to apply the second pressure to the proximal face.

In certain configurations, the first pressure is 1 oregano 10 newtons.

In some configurations, the bottom surface of the cavity includes a slit valve formed in the bottom surface, and the first pressure is less than a pressure required to push the tip portion through the slit valve.

In some configurations, the vent tube plugging system further comprises a container holder configured to receive a proximal end of the syringe barrel, and the method further comprises coupling the container holder to the syringe barrel to maintain the syringe barrel aligned with a direction of travel of the vent tube such that the vent tube enters the syringe barrel when the vent tube is moved along the longitudinal axis from the proximal tube rest position to the distal tube operational position.

Also provided herein is a valved stopper and mounting stem pair (valved stopper and installation rod pair) for inserting the valved stopper into a barrel of a syringe via a vent tube plugging process. The valved stopper and mounting stem pair includes a valved stopper including a cylindrical lateral wall extending between a proximal face and a distal face, the cylindrical lateral wall defining a cavity therein, and a membrane positioned within the cavity and including proximal and distal surfaces, the membrane dividing the cavity into proximal and distal cavities. The valved stopper and mounting rod pair also includes an elongated mounting rod having a shouldered distal end configured to mate with the valved stopper, the shouldered distal end including a shoulder having a first diameter, and a tip portion projecting distally from the shoulder and having a second diameter less than the first diameter. When the shoulder distal end is mated with the valved stopper, the tip is positioned in the proximal cavity and engages the proximal surface of the membrane to apply a first pressure to the proximal surface, the shoulder engages the proximal face of the cylindrical lateral wall to apply a second pressure to the proximal face.

In some configurations, the tip has a first height and the proximal cavity has a second height that is less than the first height, the proximal cavity having the second height when compressed within the vent tube.

In certain configurations, the first height of the tip is about 3% to 8% greater than the second height of the proximal cavity formed in the valved stopper.

In some configurations, when the shoulder distal end is mated with the valved stopper, the tip portion applies the first pressure to the proximal surface of the membrane before the shoulder engages the proximal surface of the cylindrical lateral wall to apply the second pressure to the proximal surface.

Drawings

FIG. 1 is a side cross-sectional view of a syringe with which embodiments of the present disclosure may be implemented;

FIG. 2A is a perspective view of a valved stopper included in the syringe of FIG. 1 according to non-limiting embodiments described herein;

FIG. 2B is a side cross-sectional view of the valved stopper of FIG. 2A;

FIG. 3 is an exploded perspective view of a vent tube plugging system for positioning a valved stopper within a syringe barrel according to non-limiting embodiments described herein;

FIG. 4 is a cross-sectional view of the vent tube plugging system of FIG. 3, showing the vent tube and mounting stem of the system in a proximal rest position;

FIG. 5 is a cross-sectional view of the vent tube plugging system of FIG. 3, showing the vent tube and mounting stem of the system in a distal operative position;

FIG. 6A is a perspective view of a shouldered distal end of a mounting rod included in the system of FIG. 5 according to a non-limiting embodiment described herein;

FIG. 6B is a side cross-sectional view of the shouldered distal end of FIG. 6A, and

FIG. 7 is a side cross-sectional view showing the shoulder distal end of the mounting rod engaged with the valved stopper.

Detailed Description

The following description is presented to enable one of ordinary skill in the art to make and use the described embodiments of the invention as contemplated for its practice. Various modifications, equivalents, changes, and alternatives will, however, be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

Hereinafter, for the purposes of description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "longitudinal" and derivatives thereof shall relate to the invention as oriented in the drawings. 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. Thus, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.

In the present disclosure, the distal end of the member or the distal end of the device refers to the end furthest from the user's hand when the member or device is in the use position, i.e. when the user is holding the syringe in preparation for use or during use, and the proximal end of the member or the proximal end of the device refers to the end closest to the user's hand when the member or device is in the use position, i.e. when the user is holding the syringe in preparation for use or during use. Similarly, in the present application, the terms "in the distal direction" and "distally" refer to in a direction toward the distal tip of the syringe, while the terms "in the proximal direction" and "proximally" refer to in a direction opposite to the direction of the distal tip of the syringe.

Referring to fig. 1 and 2, there is shown a non-limiting embodiment of a medical container 10 with which aspects or embodiments of the present disclosure may be practiced. According to aspects of the present disclosure, the medical container 10 is provided as a prefilled syringe (hereinafter "syringe 10") that provides the convenience of rapidly delivering the liquid therein to a patient without the need to first aspirate the medicament from another container and meter its volume. However, it should be appreciated that aspects of the present disclosure may also be extended to other medical containers, including cartridges and auto-injectors, as additional non-limiting examples.

As shown in fig. 1, the syringe 10 includes a syringe barrel 12 formed from a generally cylindrical outer wall 16 and an end member 18 that together define a chamber 20 for retaining fluid therein. The syringe barrel 12 includes an open proximal end 22 and a distal end 24 with the end member 18 positioned at the distal end 24. 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 a vent tube plugging system for inserting one or more stops into the syringe barrel 12, as discussed in more detail below. At the distal end 24, the end member 18 may include a shoulder 28 that narrows relative to the cylindrical outer wall 16, and a hub 30 that extends distally from the shoulder 28. The hub 30 is formed as a partially hollow member defining a passage 32 therethrough in fluid communication with the chamber 20. A needle 34 is attached to the hub 30 within the channel 32, such as by gluing or otherwise securing to the hub 30, wherein the needle 34 transfers the liquid (or liquids) out of the chamber 20 and is administered to the patient.

The syringe 10 also includes a pair of stops 36, 38 (i.e., a "sequential" closure) adapted to move translationally within the syringe barrel 12 for injecting a liquid. The pair of stops 36, 38 includes a plunger stop 36 and a sequential stop or "valved" stop 38.

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 mates with the plunger stopper 36. During use of the syringe 10, the plunger rod may be actuated by a user to advance the plunger rod and push the plunger stopper 36 in a distal direction to perform an injection.

A valved stopper 38 is positioned and disposed between the distal end 24 of the barrel and the plunger stopper 36, translatably movable within the syringe barrel 12. The valved stopper 38 divides the chamber 20 in the syringe barrel 12 into two sections 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 comprise a first composition intended for injection first and the second section 46 may comprise a second composition intended for injection of the first composition after injection.

Fig. 2A and 2B provide a more detailed view of valved stopper 38. The valved stopper 38 may be made of any material having resilient properties commonly used to manufacture stoppers for medical injection devices. For example, the valved stopper 38 may be made of an elastomer, rubber, thermoplastic elastomer, and/or liquid silicone rubber.

The valved stopper 38 has a generally cylindrical shape corresponding to the shape of the syringe barrel 12 of the syringe 10. The valved stopper 38 includes a membrane 50 that includes a proximal face 52 and a distal face 54. A lateral wall 56 of the valved stopper 38 extends distally and proximally from the membrane 50. The lateral wall 56 defines a proximal cavity 58, which is a hollow volume defined by the inner face 60 of the lateral wall and the proximal face 52 of the membrane 50, and a distal cavity 62, which is a hollow volume defined by the inner face 60 of the lateral wall 56 and the distal face 54 of the membrane 50.

The lateral wall 56 is advantageously provided with an outer sealing surface 64 configured to sealingly engage the inner surface of the syringe barrel 12. The sealing surface 64 is continuous, meaning that it extends continuously along the circumference of the valve stop 38 and forms a ring. Since the continuous sealing surface 64 extends between the outside of the lateral wall 56 of the valved stopper 38 and the inside surface of the syringe barrel 12 of the syringe 10, any passage of the composition between the valved stopper 38 and the syringe barrel 12 is prevented, thereby 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 and the size of each rib 68 (e.g., height, width, and distance between two adjacent ribs 68) may be adjusted based on the size of valved stopper 38 and barrel 12 to further optimize the seal.

The valved stopper 38 is also configured such that the membrane 50 includes a slit or opening 70 in the membrane. Slit 70 extends through at least a portion of the thickness of film 50 between its proximal and distal faces 52, 54. The slit 70 is configured to create a fluid path through the membrane 50. The slit 70 forms a valve configured to open or close depending on the pressure exerted by the composition on the proximal face 52 of the membrane 50. The slit 70 is preferably in the form of a linear structure passing through the center of the proximal face 52 of the membrane 50.

In accordance with aspects of the present invention, a vent tube closure system is provided by which a valved stopper 38 may be inserted and positioned within the syringe barrel 12 during assembly of the prefilled syringe 10. The vent tube plugging system operates to achieve a desired positioning of the valved stopper 38 within the syringe barrel 12 while preventing damage to the valved stopper 38 during such positioning.

Referring now to fig. 3-5, vent tube plugging system 100 (hereinafter "system 100") includes a container holder 102 configured to receive a proximal end 22 of a syringe barrel 12 (e.g., flange 26 on proximal end 22 of syringe barrel 12) to be plugged, and a venting device 104 operable with container holder 102 to position a stopper (i.e., valved stopper 38) into syringe barrel 12.

The vent 104 includes a vent tube 106 movable through the container holder 102 along a longitudinal axis (a) and a mounting rod 108 movable within the vent tube 106 along the longitudinal axis (a) for positioning the valved stopper 38 in the syringe barrel 12 to be plugged. The vent tube 106 has an elongated shape, preferably having a generally circular cross-section, and includes two portions 110, 112 separated by a shoulder 114, thereby forming an abutment, the diameter of the second portion 112 of the vent tube being greater than the diameter of the first portion 110. In some embodiments, a flange 116 is provided on the second portion 112 at a proximal end 118 of the vent tube 106. The first portion 110 of the vent tube 106 is adapted to be inserted into the container holder 102 via a first opening 120 provided in the proximal end of the container holder 102 and for this purpose has a smaller diameter than the first opening 120.

The vent tube 106 is configured to receive a valved stopper 38 that is intended to be pushed into the interior volume of the vent tube along axis (a) by a mounting stem 108. In one embodiment, valved stopper 38 is introduced into the interior of vent tube 106 via an aperture 122 provided in flange 116 (i.e., proximal aperture 122 of vent tube 106), wherein aperture 122 is aligned with axis (a).

When the valved stopper 38 is placed inside the vent tube 106, the first portion 110 of the vent tube 106 may be inserted into the container holder 102. The first portion 110 of the vent tube 106 is slidably engaged within the container holder 102 and is movable through the container holder along a longitudinal axis (a) such that the first portion 110 exits through a second opening 124 at the distal end of the container holder 102. In more detail, the vent tube 106 is movable between a proximal tube rest position, shown in fig. 4, in which the distal end of the vent tube 106 is located within the container holder 102, adjacent the first opening 120, and a distal tube operational position, shown in fig. 5, in which the distal end of the vent tube 106 passes through the second opening 124 in the distal end of the container holder 102 and into the syringe barrel 12 via its open proximal end 22, relatively close to the surface of the (first) composition contained in the syringe barrel 12.

When the vent tube 106 is pushed in the distal direction to the distal tube operating position, the first portion 110 of the vent tube 106 slides inside the container holder 102 along the axis (a) until the shoulder 114 between the first portion 110 and the second portion 112 of the vent tube 106 abuts the proximal end of the container holder 102. The vent tube 106 is then unable to slide further toward the container holder 102. This position of the vent tube 106 relative to the container holder 102 corresponds to a maximum operational position in which the distal end of the vent tube 106 is located in a defined position inside the syringe barrel 12, as shown in fig. 5.

In this maximum operational position, the distal end of the vent tube 106 protrudes from the distal end of the container holder 102 and into the syringe barrel 12. However, to position the valved stopper 38 inside the syringe barrel 12 after the vent tube 106 is pushed in the distal direction along axis (a) to the maximum operational position, the mounting stem 108 is then also pushed in the distal direction, pushing the valved stopper 38 out of the vent tube 106 through the distal aperture 126 of the vent tube. Thus, the mechanical positioning of the valved stopper 38 is determined by the positioning of the distal aperture 126, and thus the length of the vent tube 106 that extends into the syringe barrel 12 when in the maximum operating position.

During use of the mounting stem 108, the mounting stem 108 is inserted into the vent tube 106 through a proximal aperture 122 formed in the flange 116 of the vent tube 106. Since the outer diameter of the mounting rod 108 is smaller than the inner diameter of the vent tube 106, the mounting rod 108 can slide inside the vent tube 106 and move in a proximal direction and in a distal direction relative to the vent tube 106 along the axis (a). To allow for positioning of the valved stopper 38 in the syringe barrel 12, the mounting stem 108 is longer in length than the vent tube 106 and is adapted such that the distal end of the mounting stem 108 protrudes sufficiently from the distal end of the vent tube 106 for pushing the valved stopper 38 into a desired position in the syringe barrel 12.

After pushing the vent tube 106 having the valved stopper 38 therein in the distal direction to the maximum operational position, the mounting rod 108 is also pushed in the distal direction from the proximal rod rest position to the distal rod operational position where the mounting rod 108 pushes the valved stopper 38 out of the vent tube 106 via the distal aperture 126 of the vent tube. As a result, the valved stopper 38 is mechanically positioned in the syringe barrel 12 at a determined distance from the surface of the composition contained therein 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 has a reduced diameter to a relaxed state in which the valved stopper 38 radially expands and contacts the inner surface of the syringe barrel 12.

In accordance with aspects of the present invention, the distal end of the mounting stem 108 is specifically configured to engage the valved stopper 38 to be inserted into the syringe barrel 12 such that the mounting stem 108 is effective to apply a pushing force to the valved stopper 38 (to advance the stopper through the vent tube 106) without damaging the stopper. As shown in fig. 6A and 6B and fig. 7, the distal end 130 of the mounting rod 108 is configured as a shouldered end comprising a shoulder 132 and a head 134, wherein the head 134 protrudes distally from the shoulder 132. Each of the shoulder 132 and the head 134 is configured as a generally cylindrical member. In some embodiments, a hollow passage 136 may extend through each of the portions 132, 134. The tip portion 134 is configured to have an outer diameter OD _{End head} that is less than the outer diameter OD _Shoulder of the shoulder portion 132, and as seen in fig. 7, the outer diameter OD _{End head} of the tip portion 134 is about equal to (but less than) the inner diameter ID _{Cavity cavity} of the proximal cavity 58 of the valved stopper 38. The outer diameter OD _Shoulder of the shoulder 132 may be less than the outer diameter OD _{Stop piece} of the valved stopper 38 so that the mounting stem 108 easily moves through the breather tube 106.

According to an embodiment, the shoulder distal end 130 of the mounting stem 108 is configured such that the height H _{End head} of the tip 134 (when the valved stopper 38 is in its compressed state within the breather tube 106) is slightly greater than the height/depth H _{Cavity cavity} of the proximal cavity 58 formed in the valved stopper 38. In some non-limiting embodiments, when valved stopper 38 is in its compressed state within vent tube 106, height H _{End head} of head 134 is about 3% to 8% longer/deeper than height/depth H _{Cavity cavity} of proximal cavity 58 formed in valved stopper 38.

Where the height of the tip 134 is slightly greater than the height/depth of the proximal cavity 58, the tip 134 is designed to apply a slight pressure to the bottom of the cavity (i.e., against the proximal face 52 of the membrane 50) before the shoulder 132 contacts and engages the proximal face 138 of the valved stopper 38 (i.e., the proximal face 138 of the lateral wall 56). That is, when the mounting stem 108 is engaged with the valved stopper 38 and advanced to push the valved stopper 38 distally out of the vent tube 106, the tip 134 applies a slight pressure (e.g., 1 to 10 newtons) against the proximal side 52 of the membrane 50 before the shoulder 132 contacts and engages the proximal side of the valved stopper 38 (along the lateral wall 56). The pressure exerted by the head 134 against the membrane 50 is sufficient to extend the stopper 38 in the axial direction by an amount such that the stopper 38 is not trapped in the vent tube 106, but is low enough such that the head 134 does not damage or penetrate the slit valve 70 during the plugging process. Furthermore, in the event that the outer diameter OD _{End head} of the tip 134 is only slightly less than the outer diameter OD _Shoulder of the shoulder 132, the force applied to the membrane 50 by the tip 134 more surrounds the circumference of the membrane 50 than in the area of the slit valve 70, thereby further preventing/preventing the tip 134 from damaging or penetrating the slit valve 70.

After the tip 134 is initially engaged within the proximal cavity 58 and against the membrane 50, the shoulder 132 then contacts and applies pressure to the proximal face of the lateral wall 56 such that further thrust exerted by the mounting stem 108 against the valved stopper 38 is more evenly distributed between the membrane 50 and the lateral wall 56. The engagement and abutment of shoulder 132 against the proximal face of side 56 of stop 38 limits the travel/protrusion of tip 134 relative to membrane 50, thereby preventing tip 134 from piercing slit 70 of membrane 50 and damaging stop 38.

The structure of the shouldered distal end 130 of the mounting stem 108 not only prevents the end head 134 from piercing the slit 70 of the membrane 50 during pushing of the stopper 38, but also helps prevent the stopper 38 from tipping as it is pushed through/out of the vent tube 106. That is, (1) the application of force to the membrane 50 by the end head 134 around the circumference of the membrane 50, rather than in the area of the slit valve 70, and (2) the application of force by the shoulder 132 against the proximal face 138 of the lateral wall 56 helps prevent the valved stopper 38 from tilting when pushed by the mounting stem 108 (relative to the vent tube 106 and/or syringe barrel 12) -tilting may occur more readily if the mounting stem applies thrust against the stopper 38 only in the central portion of the valved stopper 38.

Advantageously, embodiments of the present invention relate to a vent tube plugging system and method for placing a valved stopper within a syringe barrel. The vent tube occlusion system includes a mounting rod adapted to push the valved stopper out of the vent tube and into a desired position within the syringe barrel. The mounting rod includes a shoulder distal end that engages the valved stopper, wherein the tip end of the rod engages the proximal cavity of the stopper and the shoulder engages the proximal face of the lateral wall of the stopper. The tip portion is configured to initially engage and apply a small pressure to the bottom membrane of the cavity to axially extend the stop before the shoulder subsequently engages and applies additional pressure to the proximal face of the stop. Thus, the shoulder distal end applies pressure to the stopper in a manner that enables the stopper to move out of 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 film and preventing the stopper from tilting relative to the vent tube and/or syringe barrel.

Although the 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 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 can be combined with one or more features of any other embodiment.

Claims

1. A vent tube occlusion 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, wherein the vent tube is movable along a longitudinal axis between a proximal tube rest position, in which the vent tube is located outside the chamber of the syringe barrel, and a distal tube operational position, in which a distal portion of the vent tube is positioned within the chamber of the syringe barrel, the vent tube having an interior volume configured to accommodate the stopper in a compressed state, and

A mounting rod movable within the interior volume of the vent tube along the longitudinal axis between a proximal rod rest position and a distal rod operational position, wherein the mounting rod pushes the stopper distally out of the vent tube and into the syringe barrel when the vent tube is in the distal tube operational position;

wherein the mounting bar includes a shouldered distal end comprising:

A shoulder having a first diameter, and

A tip portion extending distally from the shoulder portion and having a second diameter smaller than the first diameter;

Wherein when the stopper is pushed distally out of the vent tube, the tip engages a bottom surface of a cavity formed in the stopper to apply a first pressure to the bottom surface, and the shoulder engages a proximal face of the stopper to apply a second pressure to the proximal face.

2. The system of claim 1, wherein the head has a first height and the cavity formed in the stopper has a second height less than the first height, the cavity having the second height when compressed within the vent tube.

3. The system of 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 stop.

4. The system of claim 1, wherein the tip portion applies the first pressure to the bottom surface of the cavity before the shoulder engages the proximal face of the stop to apply the second pressure to the proximal face.

5. The system of claim 1, wherein the first pressure is 1 oregano 10 newtons.

6. The system of claim 1, wherein the first pressure stretches the stopper in a distal direction to prevent the stopper from binding within the vent tube.

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

8. The system of claim 1, further comprising a container holder configured to receive a proximal end of the syringe barrel and to maintain the syringe barrel aligned with a direction of travel of the vent tube such that the vent tube enters the syringe barrel when the vent tube moves from the proximal tube rest position to the distal tube operational position.

9. A method of vent tube sealing a syringe barrel having a valved stopper using a vent tube sealing system, the method comprising:

Providing a vent tube plugging system, the vent tube plugging system comprising:

A vent tube configured to be inserted into a chamber of the syringe barrel, the vent tube having an interior volume, and

A mounting rod movable within the interior volume of the vent tube, the mounting rod comprising a shouldered distal end including a shoulder having a first diameter and a tip portion projecting distally from the shoulder and having a second diameter less than the first diameter;

positioning the valved stopper within the interior volume of the vent tube, the valved stopper being housed within the stopper in a compressed state;

moving the vent tube along a longitudinal axis from a proximal tube rest position, in which the vent tube is located outside the chamber of the syringe barrel, to a distal tube operational position, in which a distal portion of the vent tube is positioned within the chamber of the syringe barrel, and

Pushing the mounting rod distally through the vent tube from a proximal rod rest position to a distal rod operational position with the vent tube in the distal tube operational position, thereby pushing the valved stopper distally out of the vent tube and into the syringe barrel;

wherein during pushing of the valved stopper using the mounting rod, the method further comprises:

Engaging a bottom surface of a cavity in the valved stopper with the head, the head applying a first pressure to the bottom surface to axially stretch the valved stopper, and

Engaging a proximal face of a lateral wall of the valved stopper with the shoulder, the tip portion applying a second pressure to the proximal face.

10. The method of claim 9, wherein the first pressure axially expands the stopper in a distal direction to prevent the stopper from binding within the vent tube.

11. The method of claim 9, wherein engaging the bottom surface of the cavity with the tip portion comprises inserting the tip portion into the cavity, the tip portion having a first height, the cavity having a second height that is less than the first height when the valved stopper is compressed within the breather tube.

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

13. The method of claim 9, wherein the tip portion applies the first pressure to the bottom surface of the cavity before the shoulder engages the proximal face of the lateral wall to apply the second pressure to the proximal face.

14. The method of claim 9, wherein the first pressure is 1 oregano 10 newtons.

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

16. The method of any of claims 12-15, wherein the vent tube plugging system further comprises a container holder configured to receive a proximal end of the syringe barrel, and wherein the method further comprises coupling the container holder to the syringe barrel to maintain a direction of travel of the syringe barrel in alignment with the vent tube such that the vent tube enters the syringe barrel when the vent tube is moved along the longitudinal axis from the proximal tube rest position to the distal tube operational position.

17. A valved stopper and mounting rod pair for inserting the valved stopper into a barrel of a syringe via a vent tube plugging process, the valved stopper and mounting rod pair comprising:

a valved stopper, the valved stopper comprising:

a cylindrical lateral wall extending between the proximal face and the distal face, the cylindrical lateral wall defining a cavity therein, and

A membrane positioned within the cavity and including a proximal surface and a distal surface, the membrane dividing the cavity into a proximal cavity and a distal cavity, and

An elongate mounting bar having a shouldered distal end configured to mate with the valved stopper, the shouldered distal end comprising:

A shoulder having a first diameter, and

Wherein when the shoulder distal end is mated with the valved stopper, the tip is positioned in the proximal cavity and engages the proximal surface of the membrane to apply a first pressure thereto, the shoulder engaging the proximal face of the cylindrical lateral wall to apply a second pressure thereto.

18. The pair of claim 17, wherein the tip has a first height and the proximal cavity has a second height that is less than the first height, the proximal cavity having the second height when compressed within the vent tube.

19. The pair of claim 18, wherein the first height of the end head is about 3% to 8% greater than the second height of the proximal cavity formed in the valved stopper.

20. The pair of claim 18, wherein when the shoulder distal end is mated with the valved stopper, the tip portion applies the first pressure to the proximal surface of the membrane before the shoulder engages the proximal face of the cylindrical lateral wall to apply the second pressure to the proximal face.