Occlusion tool systems and methods for mounting distal loading stop within syringe barrel

Abstract

A vent tube closure system for positioning a stop within a syringe barrel is provided herein. The system comprises a breather tube insertable into a chamber of the syringe barrel, where the breather tube comprises: a proximal end and a distal end, each having an opening; a channel extending from the proximal opening to the distal opening and having a first portion having a first diameter and a second portion having a second diameter greater than the first diameter; and a stopper seat positioned at the distal end, the stopper seat defining a second portion of the channel, the stopper seat configured to hold the stopper in a compressed state and including an abutment preventing proximal movement of the stopper. The system also includes a mounting rod movable within the channel such that the mounting rod can push the stopper distally out of the stopper seat and into the syringe barrel.

Description

Cross-reference to related applications

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

[0002] Background of the Invention Field of the Invention This disclosure generally relates to a plugging tool system for installing a plunger stop in a syringe, and more specifically to a plugging tool system for installing a plunger stop in a syringe barrel to prevent damage to the stop during insertion.

[0003] Description of related technologies Pre-filled injection devices are common containers used to administer liquids (e.g., medications or drugs) to patients and include syringes, cartridges, and auto-injectors. These pre-filled injection devices typically include a plunger stop that slides within the container, which is filled with the drug composition, to provide physicians with a ready-to-use injection device for patients.

[0004] The container has a generally cylindrical shape and includes a proximal end, a distal end, and lateral walls. The proximal end can be sealed by a plunger stop, and the pharmaceutical composition is discharged from the container at the distal end. The lateral walls extend between the proximal and distal ends of the container. In effect, the plunger stop is designed to move from the proximal end to the distal end of the container under pressure applied by the plunger, thereby discharging the pharmaceutical product contained within the container.

[0005] Using pre-filled injection devices offers several advantages compared to empty injection devices that are filled with the drug composition stored in the vial just before injection into the patient. In particular, by limiting pre-injection preparation, pre-filled injection devices reduce medical dosing errors, minimize the risk of microbial contamination, and improve ease of use for physicians. Furthermore, such pre-filled containers encourage and simplify patient self-administration, allowing for lower treatment costs and increased patient adherence. Finally, pre-filled injection devices reduce the loss of valuable drug compositions that typically occurs when transferring them from vials to non-pre-filled devices. This allows for more possible injections of a given batch of drug composition, thereby reducing purchasing and supply chain costs.

[0006] The pre-filled injection device described above is typically obtained by filling an empty medical container with the desired drug composition and then sealing the filled container under vacuum or by means of a venting tube or a combination of both. Typically, immediately after filling the container body, the filled container is sealed using a sealing machine by positioning the medical container to be sealed on a suitable support (e.g., in a nest or directly clamped to the sealing machine) with the proximal end of the medical container facing upwards, i.e., with the distal end of the medical container facing downwards, and maintaining this position.

[0007] When the ventilator is blocked, a stop is compressed within a tube, commonly referred to as the "ventilator," whose outer diameter is smaller than the inner diameter of the medical container. When the stop is placed within the ventilator, the ventilator is thus partially positioned within the container, and air is allowed to circulate between the ventilator and the container during this placement process, given that the outer diameter of the ventilator is smaller than the inner diameter of the medical container. When the ventilator is positioned within the medical container, the stop, previously positioned inside the tube, is then pushed distally by an mounting rod out of the ventilator to a desired position above the composition within the container (e.g., towards the proximal end of the container).

[0008] In known ventilator occlusion systems and methods, a stop is inserted into the ventilator at the proximal end, and then an mounting rod is used to push the stop through the entire length of the ventilator before it is withdrawn from the distal end and reaches the desired position within the medical container. While this method of ventilator occlusion allows for accurate placement of the stop within the container, pushing the stop through the entire length of the ventilator can damage it. As an example, pushing the stop through the entire length of the ventilator increases the amount of friction between the stop and the ventilator, and the associated heat generation, which can damage the stop (e.g., the film / layer on the outer surface of the stop may be worn away), especially if the stop is unlubricated or low-lubricant. As another example, pushing the stop through the entire length of the ventilator increases the time the mounting rod contacts and applies a thrust to the stop, and this contact / force can damage the internal structure of the stop as it is forced through the ventilator. Furthermore, if the mounting rod applies a thrust only to the center portion of the stop, the stop may tilt as it is pushed out of the ventilator and into the medical container, resulting in the stop not forming a proper seal with the container wall when it is pushed into place.

[0009] Therefore, there is a need in the art for a ventilator sealing system and method that reduces the likelihood of damage to the stop. This system and method will reduce the amount of travel of the stop during transfer from the ventilator into the medical container, thereby reducing the amount of friction and force experienced by the stop, particularly when the stop is a non-lubricated or low-lubricated stop. Summary of the Invention

[0010] This document provides a venting system for positioning a stop within a syringe barrel. The system includes a venting tube configured to be inserted into a chamber of the syringe barrel, wherein the venting tube is movable along a longitudinal axis between a proximal tube rest position and a distal tube operating position. In the proximal tube rest position, the venting tube is located outside the chamber of the syringe barrel, and in the distal tube operating position, a distal portion of the venting tube is positioned within the chamber of the syringe barrel. The ventilator further includes: a proximal end having an opening therein; a distal end having an opening therein; a channel extending from the proximal opening to the distal opening, the channel having a first portion and a second portion, the first portion having a first diameter, the second portion having a second diameter larger than the first diameter, the second portion being located distal to the first portion; and a stop seat positioned at the distal end, the stop seat defining the second portion of the channel, the stop seat being configured to hold the stop in a compressed state, the stop seat including an abutment preventing the stop from moving proximally from the second portion to the first portion. The system also includes a mounting rod movable within the channel of the ventilator along the longitudinal axis between a proximal rod rest position and a distal rod operating position, wherein when the ventilator is in the distal rod operating position and the mounting rod is in the distal rod operating position, the mounting rod pushes the stop distally out of the stop seat and into the syringe barrel.

[0011] In some configurations, the longitudinal dimension of the second portion of the channel defined by the stop seat is approximately equal to the height of the stop.

[0012] In some configurations, the diameter of the opening at the proximal end of the ventilator is equal to the first diameter, and the diameter of the opening at the distal end of the ventilator is equal to the second diameter.

[0013] In some configurations, the opening at the distal end of the vent allows the stop to be inserted into the stop seat when in the compressed state.

[0014] In some configurations, the first diameter of the first portion of the channel is smaller than the diameter of the stop when it is in the compressed state.

[0015] In some configurations, the first diameter of the first portion of the channel is approximately equal to the diameter of the mounting rod.

[0016] In some configurations, the ventilator sealing system further includes a compression insert capable of engaging the distal end of the stop tube. The compression insert includes: an insert body defining a chamber; a first opening at a first end of the chamber; and a second opening at a second end of the chamber. The first opening and the chamber are configured to receive the stop in an uncompressed state. The second opening transition is configured to transition the stop to the compressed state when it is pushed out through the second opening transition, such that the stop can be loaded from the compression insert into the stop seat when the stop is in the compressed state.

[0017] In some configurations, the ventilator occlusion system also includes a retainer configured to receive the proximal end of the syringe barrel and keep the syringe barrel aligned with the direction of travel of the ventilator, such that the syringe barrel is stable when the ventilator is moved from the proximal tube rest position to the distal tube operating position.

[0018] In some configurations, the mounting rod includes a shouldered distal end having: a shoulder portion having a first rod diameter; and an end portion extending distally from the shoulder portion and having a second rod diameter smaller than the first rod diameter; wherein, when the stop is pushed distally out of the stop seat, the end portion engages with the bottom surface of a cavity formed in the stop, and the shoulder portion engages with the proximal side of the stop.

[0019] This article also provides a method for sealing the vent tube of a syringe barrel using a valved stop in a vent tube sealing system. The method includes: compressing the stop from an uncompressed state to a compressed state; inserting the stop into the vent tube through an opening at the distal end, such that the stop is positioned and held within a stop seat; and moving the vent tube along the longitudinal axis from a proximal tube rest position to a distal tube operating position, wherein in the proximal tube rest position, the vent tube is located outside the channel of the syringe barrel, and in the distal tube operating position, the distal portion of the vent tube is positioned within the channel of the syringe barrel. When the vent tube is in the distal tube operating position, the method further includes: pushing an mounting rod distally from the proximal rod rest position through the channel of the vent tube to the distal rod operating position, thereby pushing the stop distally out of the stop seat and into the syringe barrel.

[0020] In some configurations, when the stop is inserted into the vent to be positioned and held in the stop seat, the stop is pushed distally into the vent until it contacts the abutment portion of the stop seat.

[0021] In some configurations, when the stop is pushed distally out of the stop seat and into the syringe barrel, the distance the stop travels is approximately equal to the height of the stop.

[0022] In some configurations, compressing the stop includes: placing the stop in a compression insert, the compression insert being capable of engaging the distal end of the stop tube, while the stop is in an uncompressed state; and statically compressing the stop from the uncompressed state to the compressed state via the compression insert, wherein the stop is inserted into the vent tube from the compression insert while in the compressed state.

[0023] In some configurations, the method further includes transferring the stop from the track system to the loading device, wherein the orientation of the stop remains unchanged or is reversed during the transfer to facilitate placement of the stop into the loading device.

[0024] In some configurations, the stop includes a non-lubricated or low-lubricated stop, and pushing the stop distally out of the stop seat and into the syringe barrel prevents frictional damage to the non-lubricated or low-lubricated stop and / or limits the heat generated by friction of the non-lubricated or low-lubricated stop compared to pushing the non-lubricated or low-lubricated stop distally through the entire length of the vent tube and into the syringe barrel. Attached Figure Description

[0025] Figure 1 This is a perspective view of a syringe, which can be used to implement various embodiments of the present disclosure; Figure 2 for Figure 1 An exploded view of the syringe; Figure 3 This is an exploded perspective view of a vent tube sealing system for positioning a stop within a syringe barrel according to a non-limiting embodiment described herein; Figure 4 for Figure 3 The ventilation pipe sealing system includes ventilation pipes along Figure 3 Cross-sectional view taken at centerline 4-4; Figure 5 For use according to the non-limiting embodiments described herein Figure 3 A diagram illustrating the method of using a stopper to block the vent tube of a syringe barrel in a system; Figure 6 For use according to another non-limiting embodiment described herein Figure 3 A diagram illustrating the method of using a stop to seal the vent tube of a syringe barrel in a system; and Figure 7 For use according to another non-limiting embodiment described herein Figure 3A diagram illustrating the method of using a stopper to block the vent tube of a syringe barrel in a system. Detailed Implementation

[0026] The following description is provided to enable those skilled in the art to make and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will still be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the invention.

[0027] In the following text, for descriptive purposes, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be used in connection with the invention as oriented as shown in the accompanying drawings. However, it should be understood that the invention may take various alternative variations unless explicitly stated to the contrary. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary embodiments of the invention. Therefore, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0028] In this disclosure, the distal end of a component or device refers to the end furthest from the user's hand when the component or device is in the use position, i.e., when the user holds the syringe in preparation for or during use. The proximal end of a component or device refers to the end closest to the user's hand when the component or device is in the use position, i.e., when the user holds the syringe in preparation for or during use. Similarly, in this application, the terms "in the distal direction" and "towards the distal end" refer to the direction toward the distal tip of the syringe, while the terms "in the proximal direction" and "towards the proximal end" refer to the direction opposite to the direction of the distal tip of the syringe.

[0029] refer to Figure 1 and Figure 2 This illustration shows a non-limiting embodiment of a medical container 10, which can be used to implement aspects or embodiments of the present disclosure. According to aspects of the present disclosure, the medical container 10 is configured as a pre-filled syringe (hereinafter referred to as "syringe 10") that provides the convenience of rapidly delivering the liquid therein to a patient without first aspirating the medication from another container and measuring its volume. However, it should be appreciated that, as additional non-limiting examples, aspects of the present disclosure can also be extended to other medical containers, including cartridges and auto-injectors.

[0030] like Figure 1 and Figure 2As shown, syringe 10 typically includes a syringe barrel 12 and a plunger assembly 14. For example, plunger assembly 14 can be moved within syringe barrel 12 along a longitudinal axis to an advanced position to facilitate administration of an injectable fluid (e.g., a medication) to a patient. Syringe barrel 12 is formed by a generally cylindrical wall 16 and an end member 18, which together define a chamber 20 for retaining fluid therein. Syringe barrel 12 includes an open proximal end 22 and a distal end 24, the open proximal end 22 being configured to receive plunger assembly 14 therein, and the end member 18 being positioned at the distal end 24. The proximal end 22 of syringe barrel 12 may include a flange 26 to facilitate manipulation and positioning of syringe 10 and to maintain the relative position of syringe barrel 12 with respect to plunger assembly 14 during medication administration. At the distal end 24, end member 18 may include a shoulder 28 that narrows relative to the cylindrical outer wall 16, and a hub portion 30 extending distally from the shoulder 28. The hub portion 30 is formed as a partially hollow member that defines a channel 32 through which it is in fluid communication with the chamber 20. The needle 34 is attached to the hub portion 30 within the channel 32, for example by gluing or otherwise securing it to the hub portion 30. According to some aspects of this disclosure, the syringe 10 may also include a cap 35 that is coupled to the hub portion 30 of the syringe barrel 12 to protect the needle 34.

[0031] The plunger assembly 14 of the syringe 10 is formed by an elongated plunger rod 36 and a plunger head or stop 38. The plunger rod 36 may include a body 40 extending between a proximal plunger end 42 and a distal plunger end 44. In some embodiments, the body 40 may include a plurality of elongated blades or walls 46 extending axially along the length of the body between the proximal plunger end 42 and the distal plunger end 44. A thumb press 48 is positioned at the proximal plunger end 42, which can be engaged by a user's thumb (or other finger) to apply a distal force to the plunger assembly 14, thereby moving the plunger rod 36 relative to the syringe barrel 12. In some embodiments, an extension member 50 (e.g., a threaded cylindrical member) is positioned at the distal plunger end 44, the extension member being configured to engage with the stop 38.

[0032] A stop 38 of the plunger assembly 14 is positioned at the distal end 44 of the plunger to allow movement within the chamber 20 of the syringe barrel 12 together with the plunger rod 36. The stop 38 may be made of a material different from that of the plunger rod 36 and capable of forming a tight seal with the syringe barrel 12 as the stop advances through it. As a non-limiting example, the stop 38 may be formed of an elastomeric material, such as butyl rubber, styrene-butadiene, or isoprene; or it may be formed of a polymeric material, such as a crosslinked or thermoplastic elastomer. In some embodiments, the stop 38 may be configured as a lubricant-free or low-lubricant stop, which does not include any lubricant coating or outer layer, such as a coating / layer formed of per- or poly-fluoroalkyl substances (PFAS), i.e., the stop 38 is configured as a PFAS-free (or substantially PFAS-free) stop. As defined herein, a stop 38 that is “PFAS-free or substantially PFAS-free” or “PFAS-free” is understood to mean a material that is completely free of PFAS and / or a material that may contain trace amounts of PFAS. In one exemplary embodiment, a stop 38 is considered substantially PFAS-free if it contains 200 parts-per-million (200 PPM) or less (i.e., not more than 200 PPM) of PFAS, preferably 50 PPM or less (i.e., not more than 50 PPM) of PFAS.

[0033] The stop 38 includes a closed distal end 52 and an open proximal end 54, the open proximal end providing access to a cavity 56 formed in the stop, wherein the cavity 56 is configured to engage with an extension member 50 on the piston rod 36. In use of the syringe 10, the plunger rod 36 can be actuated by the user to advance the plunger rod 36 and push the stop 38 in a distal direction to perform an injection.

[0034] According to various aspects of this disclosure, a vent tube plugging system is provided, through which a stop 38 can be inserted and positioned within the syringe barrel 12 during the assembly of a pre-filled syringe 10. The vent tube plugging system operates to achieve the desired positioning of the stop 38 within the syringe barrel 12, while preventing damage to the stop 38 during such positioning.

[0035] Now for reference Figure 3 and Figure 4This illustration shows a venting tube occlusion system 100 (hereinafter referred to as "System 100") according to one aspect of the present disclosure. System 100 may include: a container retainer 102 configured to receive the proximal end 22 of a syringe barrel 12 to be occluded (e.g., a flange 26 on the proximal end 22 of the syringe barrel 12); a compression insert 104 for initially compressing a stop 38; and a venting device 106 that receives the stop 38 compressed from the compression insert 104 and is operable with the container retainer 102 to position the stop 38 within the syringe barrel 12.

[0036] The compression insert 104 can be provided as a separate static insert or component that initially receives (e.g., from a track system) an uncompressed stop 38. The uncompressed stop 38 advances through a first end opening 108 of the insert 104 and into a chamber 110 of the insert, wherein the first end opening 108 and the chamber 110 have a first diameter equal to the diameter of the uncompressed stop 38. To compress the stop 38, the stop 38 is then pushed out / forced through a second end opening 112 of the insert 104, the second end opening of the insert having a second diameter smaller than the diameter of the uncompressed stop 38, such that the stop 38 is compressed as it passes through the second end opening 112. As the stop 38 passes through the second end opening 112 in a compressed state, the compressed stop 38 can be positioned within the venting device 104 (i.e., into its venting tube), as explained in further detail below.

[0037] The container retainer 102 may be a support structure for securing / retaining the syringe barrel 12 to allow the stop 38 to be inserted therein. According to various embodiments, the container retainer 102 may be provided as a slot (as known in the art) for holding multiple syringe barrels therein, or it may be provided as a retainer that clamps directly onto the occlusion device. After the stop 38 has been positioned within the venting device 106 (i.e., into its venting tube), the venting device 106 is then positioned relative to the container retainer 102 to enable the positioning of the stop 38 within the syringe barrel 12.

[0038] like Figure 3 and Figure 4As shown, the venting device 106 includes a venting tube 114 movable along a longitudinal axis (A) and a mounting rod 116 movable along the longitudinal axis (A) within the venting tube 114 for positioning the stop 38 within the syringe barrel 12 to be sealed. The venting tube 114 has an elongated shape, preferably with a generally circular cross-section, and includes two sections 118, 120 (i.e., a first section 118 and a second section 120) separated by a shoulder 122, wherein the outer diameter of the second section 120 of the venting tube 114 is larger than the outer diameter of the first section 118. The first section 118 is located at the distal end 124 of the venting tube 114 and is configured to have a smaller diameter than the syringe barrel 12, such that the first section 118 can be inserted into the syringe barrel 12. The second section 120 is located at the proximal end 126 of the vent tube 114 and is configured to have a larger diameter than the syringe barrel 12, such that the second section 120 is prevented from being inserted into the syringe barrel 12 and is instead used as a stop.

[0039] like Figure 4 As shown, an internal channel 128 is defined in the ventilator 114, extending along the length of the ventilator 114 from a proximal opening 130 (formed in the first segment 118) to a distal opening 132 (formed in the second segment 120). The channel 128 can be described as including a first portion 134 and a second portion 136, wherein the first portion 134 of the channel 128 has a first diameter D1, the second portion 136 of the channel 128 has a second diameter D2 greater than the first diameter D1, and wherein the second portion 136 is located distal to the first portion 134.

[0040] According to various aspects of this disclosure, the ventilator 114 includes a stop seat 138 formed / positioned within the ventilator at its distal end 124. The stop seat 138 can be considered to define a second portion 136 of the passage 128 having a second diameter D2, wherein an abutment portion 140 of the stop seat 138 defines a transition between the second portion 136 of the passage 128 and the first portion 134 of the passage 128. As explained in more detail below, the ventilator 114 is specifically configured such that a stop 38 is introduced into the ventilator through the distal end 124 / distal opening 132 (from the compression insert 104), wherein the stop 38 is positioned within the stop seat 138. The stop seat 138 (and its abutment portion 140) retains the stop 38 therein until it is necessary to remove the stop 38 from the ventilator 114 and transfer it into the syringe barrel 12.

[0041] When the stop 38 is placed into the vent tube 114, the first section 118 of the vent tube 114 can be inserted into the syringe barrel 12 (which is secured by the container holder 102). More specifically, the vent tube 114 is movable between a proximal tube rest position and a distal tube operating position, in which the distal end 124 of the vent tube 114 is located outside the syringe barrel 12, and in the distal tube operating position, the distal end 124 of the vent tube 114 enters the syringe barrel 12 via the open proximal end 22 of the syringe barrel 12, thereby coming relatively close to the surface of the composition contained in the syringe barrel 12.

[0042] When the vent tube 114 is pushed distally to the distal tube operating position, the first segment 118 of the vent tube 114 slides along axis (A) within the syringe barrel 12 until the shoulder 122 between the first segment 118 and the second segment 120 of the vent tube 114 abuts against the proximal end 22 of the syringe barrel 12. At this point, the vent tube 114 cannot slide further into the syringe barrel 12. This position of the vent tube 114 relative to the syringe barrel 12 corresponds to the maximum operating position, in which the distal end 124 of the vent tube 114 is located in a defined position within the syringe barrel 12.

[0043] In this maximum operating position, the mounting rod 116 is also pushed in the distal direction, thereby pushing the stop 38 out of the vent tube 114 through the distal opening 132. In use, the mounting rod 116 is inserted into the vent tube 114 via the proximal opening 130. Because the outer diameter of the mounting rod 116 is smaller than the inner diameter of the internal channel 128 (i.e., the first portion 134 of the channel 128), for example, within 0.5 mm, the mounting rod 116 can slide within the vent tube 114 and move relative to the vent tube 114 along the axis (A) both proximal and distally. To allow the stop 38 to be positioned in the syringe barrel 12, the length of the mounting rod 116 is longer than the length of the vent tube 114, and is adapted such that the distal end 142 of the mounting rod 116 protrudes sufficiently from the distal end 124 of the vent tube 114 for pushing the stop 38 into the desired position in the syringe barrel 12.

[0044] After the vent tube 114 (which includes the stop 38) is pushed distally to the maximum operating position, the mounting rod 116 is also pushed distally from the proximal rod rest position to the distal rod operating position. In the distal rod operating position, the mounting rod 116 pushes the stop 38 out of the vent tube 114 through the distal opening 132 of the vent tube 114. As a result, the stop 38 is mechanically positioned in the syringe barrel 12 at a defined distance from the surface of the composition contained in the syringe barrel, and changes from a contracted state to a released state. In the contracted state, the stop 38 is radially pressed against the inner surface of the vent tube 114 (in the stop seat 138) and has a reduced diameter. In the released state, the stop 38 expands radially and contacts the inner surface of the syringe barrel 12.

[0045] According to some aspects of this disclosure, the distal end 142 of the mounting rod 116 is configured to engage with a stop 38 to be inserted into the syringe barrel 12, thus enabling the mounting rod 116 to effectively apply a thrust to the stop 38 (pushing the stop out of the vent tube 114). That is, the distal end 142 of the mounting rod 116 is configured as a shouldered end including a shoulder portion 144 and a tip portion 146, wherein the tip portion 146 extends distally from the shoulder portion 144. Each of the shoulder portion 144 and the tip portion 146 is configured as a generally cylindrical member. The tip portion 146 is configured to be positioned within a proximal cavity 56 of the stop 38, while the shoulder portion 144 is configured to contact and engage with the proximal side of the stop 38.

[0046] For reference Figures 5 to 7 And continue to refer to Figures 1 to 4 Based on various aspects of this disclosure, the use of Figure 3 and Figure 4 A method for sealing the vent tube of a syringe barrel 12 using a stopper 38 in a vent tube sealing system 100.

[0047] First refer to Figure 5 According to one embodiment, a method 150 is provided, which is shown in the figure as proceeding from right to left. The method begins at step 152: receiving a stop 38 in an uncompressed state at a compression insert 104. In some embodiments, the stop 38 may be disposed away from the track device or system (not shown) and adjacent to the compression insert 104. When providing the stop 38 at the compression insert 104, the orientation of the stop 38 may need to be reversed (i.e., rotated 180 degrees) (e.g. Figure 5 (as shown), so that the stop 38 can be positioned in the correct orientation within the compression insert 104.

[0048] As shown in step 154, the compression insert 104 can be positioned near the distal end 124 of the ventilator 114, and the compression insert can be secured to the distal end 124 so that the stop 38 can be transferred directly from the compression insert 104 at the distal end 124 of the ventilator 114 into the ventilator 114. With the compression insert 104 positioned near the distal end 124 of the ventilator 114 and the stop 38 placed near the compression insert 104, the stop 38 can then be forced into the chamber 110 of the compression insert 104, for example, by means of the insertion rod 148. That is, in response to the thrust applied by the insertion rod 148, the uncompressed stop 38 advances through the first end opening 108 of the compression insert 104 and into the chamber 110. Since the first end opening 108 of the insert 104 has a first diameter equal to the diameter of the uncompressed stop 38, the stop 38 is initially provided into the compression insert 104 in an uncompressed state. Also in step 154, as the insert rod 148 continues to apply a pushing force to the stop 38, the stop 38 is pushed out / forced through the second end opening 112 of the insert 104, which has a second diameter smaller than the diameter of the uncompressed stop 38, such that the stop 38 is compressed as it passes through the second end opening 112. When the stop 38 passes through the second end opening 112 in its compressed state, the compressed stop 38 is positioned within the stop seat 138 of the vent 114. As previously described, the abutment portion 140 of the stop seat 138 defines the transition between the second portion 136 and the first portion 134 of the channel 128 and serves to prevent the stop 38 from moving proximally away from the stop seat 138, thereby securing the stop 38 in place at the distal end 124 of the vent 114.

[0049] With the compressed stop 38 held within the stop seat 138, the compressed insert 104 can be removed from the vent tube 114 in step 155, and the vent tube 114 (which may or may not have a positioning mounting rod 116) can be moved to a position proximal to the syringe barrel 12 in step 156, wherein it should be recognized that the syringe barrel 12 is fixed / held in a container holder 102, for example, a slot. Once the vent tube 114 is aligned with the syringe barrel 12, the vent tube 114 can be moved in step 158 from its proximal tube rest position (in which the distal end 124 of the vent tube 114 is outside the syringe barrel 12) to its distal tube operating position (in which the distal end 124 of the vent tube 114 enters the syringe barrel 12 via the open proximal end 22 of the syringe barrel 12) to be relatively close to the surface of the composition contained in the syringe barrel 12. When the vent tube 114 is pushed distally to the distal tube operating position, the first segment 118 of the vent tube 114 slides along axis (A) within the syringe barrel 12 until the shoulder 122 between the first segment 118 and the second segment 120 of the vent tube 114 abuts against the proximal end 22 of the syringe barrel 12. The vent tube 114 can then not slide further toward the syringe barrel 12. This position of the vent tube 114 relative to the syringe barrel 12 corresponds to the maximum operating position, in which the distal end 124 of the vent tube 114 is located at a defined position within the syringe barrel 12.

[0050] With the vent tube 114 moved to its maximum operating position relative to the syringe barrel 12, in step 160, the mounting rod 116 is then pushed distally through the channel 128 of the vent tube 114—from the proximal rod rest position to the distal rod operating position. As the mounting rod advances through the channel 128 toward the distal rod operating position, the mounting rod 116 contacts the stop 38, which is positioned / retained in the stop seat 138. As the mounting rod 116 fully advances to the distal rod operating position, the mounting rod 116 pushes the stop 38 out of the stop seat 138 (and out of the vent tube 114) via the distal opening 132 of the vent tube. As a result, the stop 38 is mechanically positioned in the syringe barrel 12 at a predetermined distance from the surface of the composition contained therein, and transitions from a contracted state to a released state in which the stop 38 is radially pressed against the inner surface of the vent tube 114 (in the stop seat 138) and has a reduced diameter; in the released state, the stop 38 expands radially and contacts the inner surface of the syringe barrel 12.

[0051] According to various aspects of this disclosure, by initially inserting the stop 38 into the stop seat 138 located at the distal end 124 of the vent 114, any potential damage that may occur when forcing the stop out of the vent 114 (by pushing the stop with the mounting rod 116) can be minimized. That is, with the stop 38 held in the stop seat 138 located at the distal end 124 of the vent 114, the distance that must be pushed with the mounting rod 116 to force the stop 38 out of the vent 114 is significantly reduced compared to when the stop is initially inserted at the proximal end 126 of the vent 114. Therefore, the length of time the mounting rod 116 contacts and applies a pushing force to the stop 38 is significantly reduced, thereby reducing the likelihood of the mounting rod 116 damaging the stop 38. Furthermore, the reduced distance by which the mounting rod 116 pushes the stop 38 to force it out of the vent 114 is used to reduce the amount of friction generated between the stop 38 and the inner surface of the vent 114 when the stop 38 is forced through / out of the vent 114, thereby reducing the level of heat generated by friction exposed to the stop 38 and minimizing the possibility of wear / damage to the stop 38. Reducing / preventing friction between the stop 38 and the vent 114 may be particularly beneficial for stops more susceptible to friction-related damage, including stops without lubricant or with low lubricant and / or stops with a coating / film laminated on them.

[0052] Now for reference Figure 6 According to one embodiment, another method 164 is provided, which is shown in the figure as being performed from right to left. Method 164 is substantially similar to... Figure 5 Method 150, wherein steps 156, 158, and 160 are performed identically in each of methods 164 and 150. However, in method 164, the steps of providing the stop 38 and loading the stop into the compression insert 104 and the vent tube 114 are performed in a different manner. Figure 6 As seen, method 164 begins at step 166: receiving the uncompressed stop 38 at the compression insert 104. In some embodiments, the stop 38 may be disposed away from the track device or system (not shown) and adjacent to the compression insert 104. When the stop 38 is provided at the compression insert 104, the orientation of the stop 38 may need to be reversed (i.e., rotated 180 degrees), as... Figure 6 As shown, this is so that the stop 38 can be positioned correctly within the compression insert 104.

[0053] As shown in step 168, after the stop 38 is provided at the compression insert 104, the stop 38 can then be forced into the chamber 110 of the compression insert 104 (e.g., by means of the insertion rod 148). That is, in response to the thrust applied by the insertion rod 148, the uncompressed stop 38 advances through the first end opening 108 of the compression insert 104 and into the chamber 110. Since the first end opening 108 of the insert 104 has a first diameter equal to the diameter of the uncompressed stop 38, the stop 38 is initially provided into the compression insert 104 in an uncompressed state.

[0054] With the stop 38 positioned within the chamber 110 of the compression insert 104, the compression insert 104 (and the stop 38) can be moved and positioned near the distal end 124 of the vent tube 114, and the compression insert 104 can be secured to the distal end 124 in step 170, thereby transferring the stop 38 directly from the compression insert 104 at the distal end 124 of the vent tube 114 into the vent tube 114. In step 170, another (or identical) insert rod 148 is actuated to apply a thrust to the stop 38 to push / force the stop 38 out through the second end opening 112 of the insert 104, the second end opening of which has a second diameter smaller than the diameter of the uncompressed stop 38, such that the stop 38 is compressed as it passes through the second end opening 112. When the stop 38 passes through the second end opening 112 in its compressed state, the compressed stop 38 is positioned within the stop seat 138 of the vent 114. As described above, the abutment portion 140 of the stop seat 138 defines the transition between the second portion 136 and the first portion 134 of the channel 128 and serves to prevent the stop 38 from moving proximally away from the stop seat 138, thereby securing the stop 38 in place at the distal end 124 of the vent 114. Then, in step 172, the compressed insert 104 can be removed from the vent 114.

[0055] After the stop 38 is positioned within the stop seat 38 (and the compression insert 104 is removed from the vent tube 114), method 164 proceeds to steps 156, 158, and 160, which have been described in detail above with respect to method 150. Via steps 156, 158, and 160, the vent tube 114 is moved to a position proximal to the syringe barrel 12 (step 156), and the vent tube 114 is moved from its proximal tube rest position to its distal tube operating position (step 158), such that the distal end 124 of the vent tube 114 is positioned close to the surface of the composition contained in the syringe barrel 12. Then, the mounting rod 116 is pushed through the channel 128 of the vent tube 114 and contacts the stop 38 held in the stop seat 138. As the mounting rod 116 advances fully to the distal rod operating position, the mounting rod 116 pushes the stop 38 out of the stop seat 138 (and out the vent tube 114) and into the syringe barrel 12 (step 160).

[0056] Now for reference Figure 7 According to one embodiment, another method 174 is provided, which is shown in the figure as being performed from right to left. Method 174 is substantially similar to... Figure 5 Method 150 and Figure 6 Method 164, wherein steps 156, 158, and 160 are performed identically in each of methods 174, 150, and 164. However, in method 174, the steps of providing the stop 38 and loading the stop into the compression insert 104 and the vent tube 114 are performed in a different manner. Figure 7 As shown, method 164 begins at step 176: receiving the uncompressed stop 38 at the compression insert 104. In some embodiments, the stop 38 may be disposed away from the track device or system (not shown) and adjacent to the compression insert 104. In method 174, it is not necessary to reverse the orientation of the stop 38 because the stop 38 is already correctly oriented for subsequent loading into the compression insert 104.

[0057] As shown in step 178, after the stop 38 is provided at the compression insert 104, the stop 38 can then be forced into the chamber 110 of the compression insert 104 (e.g., by means of the insertion rod 148). That is, in response to the thrust applied by the insertion rod 148, the uncompressed stop 38 advances through the first end opening 108 of the compression insert 104 and into the chamber 110. Since the first end opening 108 of the insert 104 has a first diameter equal to the diameter of the uncompressed stop 38, the stop 38 is initially provided into the compression insert 104 in an uncompressed state.

[0058] With the stop 38 positioned within the chamber 110 of the compression insert 104, the compression insert 104 (and the stop 38) are then reoriented in step 180 and positioned near the distal end 124 of the vent tube 114. In step 182, the compression insert 104 (and the stop 38) can be secured to the distal end 124, thereby transferring the stop 38 directly from the compression insert 104 at the distal end 124 of the vent tube 114 into the vent tube 114. In step 182, another (or identical) insert rod 148 is actuated to apply a thrust to the stop 38, pushing / forcing the stop 38 through the second end opening 112 of the insert 104, the second end opening of which has a second diameter smaller than the diameter of the uncompressed stop 38, such that the stop 38 is compressed as it passes through the second end opening 112. When the stop 38 passes through the second end opening 112 in its compressed state, the compressed stop 38 is positioned within the stop seat 138 of the vent 114. As described above, the abutment portion 140 of the stop seat 138 defines the transition between the second portion 136 and the first portion 134 of the channel 128 and serves to prevent the stop 38 from moving proximally away from the stop seat 138, thereby securing the stop 38 in place at the distal end 124 of the vent 114. Then, in step 184, the compressed insert 104 can be removed from the vent 114.

[0059] After the stop 38 is positioned within the stop seat 38 (and the compression insert 104 is removed from the vent tube 114), method 174 proceeds to steps 156, 158, and 160, which have been described in detail above with respect to method 150. Via steps 156, 158, and 160, the vent tube 114 is moved to a position close to the syringe barrel 12 (step 156), and the vent tube 114 is moved from its proximal tube rest position to its distal tube operating position (step 158), such that the distal end 124 of the vent tube 114 is positioned close to the surface of the composition contained in the syringe barrel 12, and then the mounting rod 116 is pushed through the channel 128 of the vent tube 114 and contacts the stop 38 held in the stop seat 138. As the mounting rod 116 advances fully to the distal rod operating position, the mounting rod 116 pushes the stop 38 out of the stop seat 138 (and out the vent tube 114) and into the syringe barrel 12 (step 160).

[0060] Advantageously, embodiments of the invention therefore relate to a system and method for ventilator occlusion to place a stop within a syringe barrel. The ventilator occlusion system includes a ventilator having a stop seat at its distal end, in which the stop is initially inserted. By initially inserting the stop into the stop seat at the distal end of the ventilator, the distance that must be pushed with an mounting rod to force the stop out of the ventilator is significantly reduced compared to the case where the stop is initially inserted proximally. Therefore, the duration of contact between the mounting rod and the stop, and the time it applies a pushing force to it, is greatly reduced, thereby decreasing the likelihood of the mounting rod damaging the stop. In addition, the stop must be pushed with the mounting rod to reduce the distance the stop travels from the vent pipe. This is to reduce the amount of friction generated between the stop and the inner surface of the vent pipe when the stop is forced out of the vent pipe, thereby reducing the level of heat exposed to friction and minimizing the possibility of wear / damage to the stop and / or the coating / layers on the stop.

[0061] While this disclosure has been described in detail for illustrative purposes based on embodiments or aspects currently considered most practical and preferred, it should be understood that such detailed description is for that purpose only, and that this disclosure is not limited to the disclosed embodiments or aspects. Rather, this disclosure is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that this disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A venting system for positioning a stop within a syringe barrel, the system comprising: A venting tube configured to be inserted into the chamber of the syringe barrel, wherein the venting tube is movable along a longitudinal axis between a proximal tube rest position and a distal tube operating position, wherein in the proximal tube rest position the venting tube is located outside the chamber of the syringe barrel, and in the distal tube operating position the distal portion of the venting tube is positioned within the chamber of the syringe barrel, the venting tube comprising: The proximal end has an opening therein; The distal end has an opening therein; A channel extending from the proximal opening to the distal opening, the channel having a first portion and a second portion, the first portion having a first diameter, the second portion having a second diameter larger than the first diameter, the second portion being located distal to the first portion; and A stop seat, positioned at the distal end, defining a second portion of the channel, the stop seat configured to hold the stop member in a compressed state, the stop seat including an abutment portion preventing the stop member from moving proximally from the second portion to the first portion; and The mounting rod is movable along the longitudinal axis within the channel of the ventilator between a proximal rod rest position and a distal rod operating position, wherein when the ventilator is in the distal rod operating position and the mounting rod is in the distal rod operating position, the mounting rod pushes the stop member distally out of the stop member seat and into the syringe barrel.

2. The system according to claim 1, wherein, The longitudinal dimension of the second portion of the channel, defined by the stop seat, is approximately equal to the height of the stop.

3. The system according to claim 1, wherein, The diameter of the opening at the proximal end of the ventilator is equal to the first diameter, and the diameter of the opening at the distal end of the ventilator is equal to the second diameter.

4. The system according to claim 3, wherein, The opening at the distal end of the vent tube allows the stop to be inserted into the stop seat when it is in the compressed state.

5. The system according to claim 1, wherein, The first diameter of the first portion of the channel is smaller than the diameter of the stop when it is in the compressed state.

6. The system according to claim 1, wherein, The first diameter of the first portion of the channel is approximately equal to the diameter of the mounting rod.

7. The system of claim 1, further comprising a compression insert capable of engaging the distal end of the stop tube, the compression insert comprising: The insert body that defines the chamber; A first opening is provided at the first end of the chamber; as well as A second opening is provided at the second end of the chamber; The first opening and the chamber are configured to receive the stop when it is in an uncompressed state; and The second opening transition portion is configured to transform the stop member into the compressed state when the stop member is pushed out through the second opening transition portion, so that the stop member can be loaded from the compression insert into the stop member seat when the stop member is in the compressed state.

8. The system of claim 1, further comprising a retainer configured to receive the proximal end of the syringe barrel and maintain the syringe barrel aligned with the direction of travel of the venting tube such that the syringe barrel is stable when the venting tube is moved from the rest position of the proximal tube to the operating position of the distal tube.

9. The system according to claim 1, wherein, The mounting rod includes a mounting rod, the mounting rod including a shouldered distal end, the shouldered distal end including: The shoulder portion, said shoulder portion having a first rod diameter; and The end portion extends distally from the shoulder portion and has a second rod diameter smaller than the diameter of the first rod. When the stop is pushed out of the stop seat, the end portion engages with the bottom surface of the cavity formed in the stop, and the shoulder portion engages with the proximal side of the stop.

10. A method for sealing the vent tube of a syringe barrel using a stopper, the method comprising: A venting tube is provided, the venting tube being configured to be inserted into a chamber of the syringe barrel, wherein the venting tube is movable along a longitudinal axis between a proximal tube rest position and a distal tube operating position, wherein in the proximal tube rest position the venting tube is located outside the chamber of the syringe barrel, and in the distal tube operating position the distal portion of the venting tube is positioned within the chamber of the syringe barrel, the venting tube comprising: The proximal end has an opening therein; The distal end has an opening therein; A channel extending from the proximal opening to the distal opening, the channel having a first portion and a second portion, the first portion having a first diameter, the second portion having a second diameter larger than the first diameter, the second portion being located distal to the first portion; and A stop seat, positioned at the distal end, defining a second portion of the channel, the stop seat configured to hold the stop member in a compressed state, the stop seat including an abutment portion preventing the stop member from moving proximally from the second portion to the first portion; and Mounting rod, which is movable along the longitudinal axis within the channel of the ventilator between a proximal rod rest position and a distal rod operating position, wherein when the ventilator is in the distal rod operating position and the mounting rod is in the distal rod operating position, the mounting rod pushes the stop member distally out of the stop member seat and into the syringe barrel; The stop member is compressed from an uncompressed state to a compressed state; The stop is inserted into the vent tube through the opening at the distal end of the vent tube, so that the stop is positioned and held in the stop seat; The venting tube is moved along the longitudinal axis from a proximal tube rest position to a distal tube operating position. In the proximal tube rest position, the venting tube is located outside the channel of the syringe barrel. In the distal tube operating position, the distal portion of the venting tube is positioned within the channel of the syringe barrel. With the venting tube in the distal tube operating position, the mounting rod is pushed distally from the proximal rod rest position through the channel of the venting tube to the distal rod operating position, thereby pushing the stop member distally out of the stop member seat and into the syringe barrel.

11. The method according to claim 10, wherein, When the stop is inserted into the vent tube to be positioned and held in the stop seat, the stop is pushed distally into the vent tube until it contacts the abutment portion of the stop seat.

12. The method according to claim 10, wherein, When the stop is pushed distally out of the stop seat and into the syringe barrel, the distance the stop travels is approximately equal to the height of the stop.

13. The method of claim 10, wherein, The compression of the stop member includes: With the stop member in an uncompressed state, the stop member is placed into a compression insert, the compression insert engaging with the distal end of the stop member tube; and The stop member is statically compressed from the uncompressed state to the compressed state via the compression insert; The stop member is inserted into the vent pipe from the compression insert when it is in the compressed state.

14. The method of claim 13, further comprising transferring the stop from the track system to the loading device, wherein, When transferring the stop, the orientation of the stop remains unchanged or is reversed to facilitate placement of the stop into the loading device.

15. The method according to claim 10, wherein, The stop includes a non-lubricated or low-lubricated stop, and wherein, compared to pushing the non-lubricated or low-lubricated stop distally through the entire length of the vent tube and into the syringe barrel, pushing the non-lubricated or low-lubricated stop distally out of the stop seat and into the syringe barrel prevents frictional damage to the non-lubricated or low-lubricated stop and / or limits the heat generated by friction of the non-lubricated or low-lubricated stop.

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